UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K

þANNUAL REPORT PURSUANTTO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934


(Mark One)
☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended September 30, 2017

2020

OR
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

¨TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from        to           


Commission file number: 001-37619

Stellar Biotechnologies, Inc.

EDESA BIOTECH, INC.
(Exact name of registrant as specified in its charter)

British Columbia, CanadaN/A

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

  

332 E. Scott Street

Port Hueneme, California

100 Spy Court
Markham, ON, Canada
93041L3R 5H6
(Address of principal executive offices)(Zip Code)

Registrant’s telephone number, including area code: (805) 488-2800

(289) 800-9600

Securities registered pursuant to Section 12(b) of the Act: 

 Name of each exchange on which
Title of each class Trading Symbolregistered
Common Shares, without par value EDSAThe Nasdaq Stock Market LLC 

Securities registered pursuant to Section 12(g) of the Act:

None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.   Yes  ¨    No  x

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.   Yes  ¨    No  x

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.   Yes  x    No  ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yesx   No¨

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter) is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer¨Accelerated filer¨
Non-accelerated filerx     (Do not check if a smaller reporting company) ☒     Smaller reporting company¨
 Emerging growth companyx

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.x

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes  ¨    No  x

As of March 31, 2017,2020, the last business day of the registrant’s most recently completed second fiscal quarter, the aggregate market value of the registrant’s outstanding common shares held by non-affiliates was approximately $16,119,024,$8,422,972, which was calculated based on 10,136,2588,859,159 common shares outstanding as of that date, of which 9,888,9723,935,968 common shares were held by non-affiliates at the closing price of the registrant’s common shares on The Nasdaq Capital Market on such date.


As of November 30, 2017,December 2, 2020, the registrant had 10,520,09610,523,087 common shares issued and outstanding.

Documents incorporated by reference:

DOCUMENTS INCORPORATED BY REFERENCE: NONE 


 

Stellar Biotechnologies, Inc.

Annual Report


EDESA BIOTECH, INC.
ANNUAL REPORT ON FORM 10-K

Fiscal

Year Ended September 30, 2017

2020

Table of Contents

Item Page
PART I  
1.Business4
1A.Risk Factors13
1B.Unresolved Staff Comments24
2.Properties24
3.Legal Proceedings24
4.Mine Safety Disclosures24
   
PART II  
5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities25
6.Selected Financial Data27
7.Management’s Discussion and Analysis of Financial Condition and Results of Operations28
7A.Quantitative and Qualitative Disclosures About Market Risk38
8.Financial Statements and Supplementary Data39
9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure39
9A.Controls and Procedures39
9B.Other Information40
   
PART III  
10.Directors, Executive Officers and Corporate Governance41
11.Executive Compensation44
12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters49
13.Certain Relationships and Related Transactions, and Director Independence51
14.Principal Accounting Fees and Services51
   
PART IV  
15.Exhibits, Financial Statement Schedules53
   
SIGNATURES 57

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SPECIAL NOTE REGARDING

Item Page
  
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52

FORWARD-LOOKING STATEMENTS

AND OTHER MATTERS

This Annual Report on Form 10-K contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act) and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act) and, as such, may involve known and unknown risks, uncertainties and assumptions. Forward-looking statements are based upon our current expectations, speak only as of the date hereof, and are subject to change. change and include statements about, among other things: the status, progress and results of our clinical programs; our ability to obtain regulatory approvals for or successfully commercialize any of our product candidates; our business plans, strategies and objectives, including plans to pursue collaboration, licensing or other similar arrangements or transactions; our expectations regarding our liquidity and performance, including our expense levels, sources of capital and ability to maintain our operations; the competitive landscape of our industry; and general market, economic and political conditions.
Forward-looking statements are those that predict or describe future events or trends and that do not relate solely to historical matters. You can generally identify forward-looking statements as those statements containing the words“anticipate,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “will,” “would,” “could,” “should,” “might,” “potential,” “continue”or other similar expressions. You should not rely on our forward-looking statements as they are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate because the matters they describe are subject to assumptions, known and unknown risks, uncertainties and other unpredictable factors, many of which are beyond our control.
Our actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various factors, some of which are listed underdiscussed in this report in the “Risk Factors” section ofPart I, Item 1A. Risk Factors and elsewhere in this Annual Report.report. Risks and uncertainties include, among others,
our ability to obtain funding for our operations;
our estimates regarding our expenses, revenues, anticipated capital requirements and our needs for additional financing;
the availabilitytiming of fundsthe commencement, progress and resources to pursuereceipt of data from any of our researchpreclinical and development projects, clinical trials;
the successful and timely completionexpected results of any preclinical or clinical studies by third parties in which our products are utilized, our ability to meettrial and the goalsimpact on the likelihood or timing of any regulatory approval;
the therapeutic benefits, effectiveness and safety of our joint venturesproduct candidates;
the timing or likelihood of regulatory filings and strategic partnerships, the degree of market acceptance for our products or for other companies’ products in which our products are components, our ability to take advantage of business opportunities in the pharmaceutical industry, approvals;
changes in our strategy or development plans, plans;
the volatility of our common share price;
the rate and degree of market acceptance and clinical utility of any future products;
the effect of competition;
our ability to protect our intellectual property uncertainties relatedas well as comply with the terms of license agreements with third parties;
our ability to governmental regulationsidentify, develop and regulatory processes, the volatility of our common share price, the effect of competition, the effect of technological changes, commercialize additional products or product candidates;
reliance on key personnel,personnel; and
general changes in economic or business conditions.
Except as required by law, we undertake no obligation to update forward-looking statements.

As used in this Annual Report on Form 10-K, “Stellar,“Edesa,” “the Company,” “we,” “us,” and “our” refer to Stellar Biotechnologies,Edesa Biotech, Inc. and our consolidated subsidiaries, except where the context otherwise requires.

Our logo Stellar KLH and other trademarks or service marks of Stellar Biotechnologies,Edesa Biotech, Inc. appearing in this Annual Report on Form 10-K are the property of Stellar Biotechnologies,Edesa Biotech, Inc. This Annual Report on Form 10-K contains additional trade names, trademarks and service marks of other companies. We do not intend our use or display of other companies’ trade names, trademarks or service marks to imply relationships with, or endorsement or sponsorship of us by, these other companies.

Page 3

All historical references to common shares, warrants and share options outstanding prior to June 7, 2019 and the related exercise prices in this Form 10-K have been adjusted to reflect the effect of the one for six reverse split, effected at the close of market on June 7, 2019.

PART I
PART I

Item 1.BUSINESS.

tem 1.BUSINESS.

Overview

Stellar Biotechnologies, Inc.

We are a biopharmaceutical company focused on acquiring, developing and commercializing clinical-stage drugs for inflammatory and immune-related diseases with clear unmet medical needs. Our two lead product candidates, EB05 and EB01, are in later stage clinical studies.
EB05 is a biotechnology company engaged in the aquaculture, research and development, manufacture and commercialization of Keyhole Limpet Hemocyanin (KLH). KLH is an immune-stimulating protein with an extensive history of safe and effective use in immunological applications.

Immunotherapies (also known as therapeutic vaccines) are an emerging class of treatmentsmonoclonal antibody therapy that involve using the body’s own immune system to target and treat disease. Today, multiple companies and institutionswe are developing drugsas a treatment for Acute Respiratory Distress Syndrome (ARDS) in COVID-19 patients. ARDS is a life-threatening form of respiratory failure, and the leading cause of death among COVID-19 patients. ARDS can be also caused by bacterial pneumonia, sepsis, chest injury and other causes. Specifically, EB05 inhibits toll-like receptor 4 (TLR4), a key immune signaling protein and an important mediator of inflammation that combine disease-targeting agentshas been shown to be activated by SARS-COV2 as well as other respiratory infections such as influenza. In multiple third-party studies, high serum levels of alarmins (damage signaling molecules) that bind to and activate TLR4 are associated with KLH. These disease-targeting agents do not evoke a robust immune response by themselvespoor outcomes and thus require a carrier molecule like KLH.

The versatilitydisease progression in COVID-19 patients. Since EB05 has demonstrated the ability to block signaling irrespective of the KLH molecule and its use in multiple drug development pipelines provide numerous commercial opportunities for us. KLH is currently utilized in immunotherapies in clinicalpresence or pre-clinical development for Alzheimer’s disease, metastatic breast cancer, type 1 diabetes, dermatomyositis, systemic lupus erythematous, ovarian cancer andconcentration of the various other cancers and diseases. The successful commercialization of one or more of these drug development pipelines, especially in a major indication, could have a significant impact on the industry’s ability to produce sufficient quantities of KLH. The protein is derived only from the Giant Keyhole Limpet, a scarce ocean molluskmolecules that is native to a limited stretch of Pacific Ocean coastline. Due in part to the inherent limitations of utilizing of wild sources of KLH,frequently bind with TLR4, we believe that aquaculture production methods, likeEB05 could ameliorate TLR4-mediated inflammation cascades in ARDS patients, thereby reducing lung injury, ventilation rates and mortality. In November 2020, we initiated a Phase 2/Phase 3 clinical study of EB05 and are currently enrolling subjects.

In addition to EB05, we are developing an sPLA2 inhibitor, designated as EB01, as a topical treatment for chronic allergic contact dermatitis (ACD), a common, potentially debilitating condition and occupational illness. EB01 employs a novel, non-steroidal mechanism of action and in two clinical studies has demonstrated statistically significant improvement of multiple symptoms in ACD patients. We initiated a Phase 2B clinical study evaluating EB01 for chronic ACD in the methodsfourth calendar quarter of 2019 and are currently enrolling subjects.
In addition to our current clinical programs, we practice, will be requiredintend to provide scalable, fully traceable suppliesexpand the utility of KLH.

Based upon our specialized knowledge of aquaculture sciencetechnologies and KLH, we have built unique land-based aquaculture, laboratory and production facilities in Port Hueneme, California, and developed production and manufacturing processes to produce medical-grade KLH using Current Good Manufacturing Practices (GMP). Using our proprietary aquaculture technology, we can support the marine mollusk from embryo to protein-producing adult, and we now support multiple generations of limpets grown entirely within our land-based aquaculture facility. Other KLH suppliers do not have this capability and thus are reliant on scarce, wild populations of limpets.

We market and sell our KLH products under the brand Stellar KLH. Our customers and partners include multinational biotechnology and pharmaceutical companies, academic institutions, clinical research organizations and research centers. We have multiple agreements to license and supply Stellar KLH andclinical-stage assets across other technology in exchange for fees, revenues or royalties. Our customers manage and fund all product development and regulatory submissions for their respective drug products that utilize our KLH protein.

indications.

Competitive Strengths

We believe that we possess a number of competitive strengths that position us to become a leading biopharmaceutical company focused on inflammatory and immune-related diseases, including:
Validated technology and drug development capabilities.We believe that the world leader in the sustainable manufacturestrength of GMP grade KLHour technologies has been validated by favorable clinical data from Phase 1 and KLH-conjugated vaccines, including:

Fully permitted, land-based aquaculture facility produces a barrier to market entry.Ourproprietary methods, infrastructure and aquaculture facility give us the capability to support the source animal in aquaculture. Due to the time needed to raise the source animal to maturity, and the time needed to build and validate facilities and manufacturing processes, including water discharge permits, we believe that we have a five to seven year lead over any new market entrants attempting to produce KLH in a similar manner. Due to its exceptional size and complexity, KLH has not been reproduced synthetically.

Fully traceable, GMP grade product offerings benefit commercialization programs.Using our proprietary production and manufacturing methods, we are able to produce a high quality, GMP grade KLH product that is fully traceable and controlled from native source to finished product, which we believe are important considerations for our pharmaceutical partners as they pursue later-stage trials and commercial introductions subject to more rigorous regulatory standards than early-stage research. Due to the known origin of material and continuity of data, we believe we are able to create a more consistent, high quality, immunogenic product than other KLH proteins in the market. In contrast, commercial supplies of KLH from other sources have historically differed widely in their source, traceability, purity, form and preparation, as well as their immunogenicity (their ability to stimulate an immune response). We believe that we are the only company that offers GMP grade KLH supported by fully traceable manufacturing methods.

Multiple supply and collaboration agreements reduce single-customer dependence.We believe that our supply and collaboration agreements with drug developers, which include binding orders, allow us to better manage our working capital as well as build long- term relationships. Our manufacturing and quality experts work closely with our collaboration partners and customers to deliver KLH products according to their specifications. We believe that our long-term relationships and collaborative approach have helped build customer trust and loyalty.

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Business model leverages growth potential.We believe we have an attractive business model due to the unique nature of our product offerings, embedded growth opportunities within our existing customer base and operating leverage. As we increase production volumes and sales, we expect our operating expenses to decrease as a percentage of revenue, providing for greater operating leverage. In addition, we have established a model via our joint venture, Neostell, S.A.S., to participate in the manufacturing of KLH-conjugated vaccines, which provides additional revenue and growth opportunities.

Intellectual property portfolio includes protection for specialized systems and technologies.We have intellectual property related to KLH development and manufacturing and to the environmental protection of the Giant Keyhole Limpet, including patents, trade secrets and know-how related to specialized aquaculture systems and technologies; spawning, selection and maintenance of the species; non- lethal KLH protein extraction methods; and the processing, purification and production of KLH formulations.

Safety profile and extensive citations in scientific literature contribute to the appeal of KLH as a carrier platform for immunotherapies.KLH has been used for decades in immune system testing, it has an extensive safety record, and continues to be selected for new immunotherapies preparing to enter clinical testing. According to a search on PubMed, a service of the U.S. National Library of Medicine, there are more than 3,600 publications referencing Keyhole Limpet Hemocyanin in biomedical literature.

Sustainability practices protect marine source and promote scalabilityOur KLH protein is produced using environmentally sound, sustainable practices intended to protect and renew the live marine source. We believe this is a critical component of ensuring long-term, scalable supplies, since rapid growth in demand has had severe consequences to other related species. In California, for example, failure to manage wild populations of abalone resulted in dramatic declines and eventually led to closure of commercial abalone harvests.

Leadership team provides extensive aquaculture production and related industry expertise.Our leadership team includes industry experts who have extensive experience in the field of aquaculture and Giant Keyhole Limpet production, and possess a deep understanding of a variety of biotechnology businesses. Our President and CEO has more than 40 years of experience leading commercial aquaculture businesses and projects focused on mollusk domestication and production.

Our Strategy

We intendPhase 2 studies; and, our multiple arrangements with third parties to develop and expand the market for KLH and KLH-conjugated vaccines. Our near-term focus is to support the further development of third partycommercialize their clinical-stage drug candidates utilizing Stellar KLH and to expand our customer base. This strategy seeks to preserve the opportunity for Stellar to share in the successful development and commercialization ofcandidates.

Novel pipeline addressing large underserved markets.Our product candidates utilizinginclude novel clinical-stage compounds and antibodies that have significant scientific rationale for effectiveness. By initially targeting large markets that have significant unmet medical needs, we believe that we can drive adoption of new products and improve our licensed KLH products. In addition to fees, revenues or royalties we may receive,competitive position. For example, we believe that the successful developmentnovel, non-steroidal mode of third party drug candidates will further validate our technologies, increase awareness and promote broader adoptionaction of our sPLA2 technology will be appealing alternatives for managing the symptoms of ACD and hemorrnoids disease (HD). These diseases impact millions of people in the United States and Canada, and can have significant effects on patients’ quality of life and, in the case of many chronic ACD patients and their employers, significant workplace-related costs and limitations.
Intellectual property protection and market exclusivity.We have opportunities to develop our competitive position through patents, trade secrets, technical know-how and continuing technological innovation. We have exclusive license rights in our target indications to multiple patents and pending patent applications in the United States and in various foreign jurisdictions. In addition to patent protection, we intend to utilize trade secrets and market exclusivity afforded to a New Chemical Entity, where applicable, to enhance or maintain our competitive position.
Experienced leadership.Our leadership team possesses core capabilities in dermatology, infectious diseases, gastrointestinal medicine, drug development and commercialization, chemistry, manufacturing and controls, and finance. Our founder, Chief Executive Officer, Pardeep Nijhawan, MD, FRCPC, AGAF, is a board-certified gastroenterologist and hepatologist with a successful track record of building life science businesses, including Medical Futures, Inc., which was sold to Tribute Pharmaceuticals in 2015. In addition to our internal capabilities, we have also established a network of key opinion leaders, contract research organizations, contract manufacturing organizations and consultants. As a result, we believe we are well positioned to efficiently develop novel treatments for inflammatory and immune-related diseases.

Our Business Strategy
We plan to develop and commercialize innovative drug products by additional third parties.that address unmet medical needs for large, underserved markets where there is limited competition. Key elements of our business strategy include:

Expand infrastructure and capacity while prudently managing our working capital. We currently have multiple customers with KLH-based drug candidates in Phase 2 studies. While the outcome of these clinical studies cannot be predicted, we are preparing for the possible impact that favorable clinical results could have on the KLH market and the company’s supply capabilities. We plan to incrementally increase our infrastructure, manufacturing capabilities and KLH production capacity based on our customers’ forecasts and the anticipated future requirements of commercial-scale vaccine manufacturing, which we estimate could require multiple kilograms of GMP grade KLH per year. In order to produce such volumes and to provide our customers with greater certainty of future supply, we intend to have the capacity to support commercial drug launches in a variety of indications, with planned redundancy at multiple locations. We also plan to increase efficiency and throughput capacity by optimizing our manufacturing and purification processes.

Pursue additional supply and collaboration agreements.We plan to continue pursuing opportunities for commercial growth that build on our strengths and core competencies in KLH development and manufacturing, including additional supply and collaboration agreements. We regularly engage in discussions with various entities involved in immunotherapies, in connection with opportunities for licensing, supply and collaborative research.

Support continuing development of our Neostell Growth Initiative.In July 2016, we formed Neostell S.A.S., a joint venture with Neovacs S.A, to produce Neovacs’ Kinoid immunotherapy product candidates which utilize Stellar KLH as a carrier molecule. In addition to expanding our market opportunities related to manufacturing of Neovacs’ KLH-conjugated vaccines, this joint venture provides the opportunity to manufacture and sell KLH-based immunotherapies for third party customers.

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Continue innovation and new product development.We plan to expand our KLH technology portfolio through ongoing research and development. Our research and development activities are focused primarily on the aquaculture of the Giant Keyhole Limpet; improvements in KLH protein characterization and manufacturing; the development of functional assays; and new uses for KLH in immunotherapy and immunodiagnostic applications. We believe that these activities provide long-term strategic, revenue and clinical opportunities by extending the commercial use of Stellar KLH and furthering our understanding of the KLH molecule.

Pursue additional markets for our technology and products. We intend to evaluate additional markets for our current products and technologies. Due to the immune-stimulating characteristics of KLH, we believe the protein could have broader applications in the medical field or other markets.

Keyhole Limpet Hemocyanin (KLH)

KLH

Rapidly develop EB05 as a novel therapy for hospitalized COVID-19 patients.We intend to apply our expertise in immune modulation and inflammation therapies and clinical trial management to rapidly develop EB05 as a potential treatment for ARDS. With potential investigational sites in multiple jurisdictions, we believe there will be sufficient patients available and that we can complete the study amid the global health crisis. Should the antibody treatment demonstrate promising results at the Phase 2 readout, we plan to continue with a pivotal Phase 3 study, subject to funding and additional regulatory approvals in certain jurisdictions.
Establish EB01 as the leading treatment for chronic ACD.Our goal is to obtain regulatory approval for EB01 and commercialize EB01 for use in the treatment of ACD. Based on promising clinical trial results in which patients treated with EB01 experienced statistically significant improvements of their symptoms with minimal side effects, we initiated a Phase 2B clinical study evaluating EB01. The protocol includes a blinded interim readout following the completion of the first part of the Phase 2B study. In November 2020, we completed enrollment of more than 50% of the patients planned for this part of a study.
Selectively targeting additional indications.In addition to our ARDS and ACD programs, we plan to efficiently generate proof-of-concept data for other programs where modulation of immune pathways or the inhibition of sPLA2 activity may have therapeutic benefits. For example, we are planning a proof-of-concept clinical study of our sPLA2 technology as a potential treatment for patients with HD, subject to funding and the resumption of normal, pre-pandemic operations at targeted clinical sites.
In-license promising product candidates.We are applying our cost-effective development approach to advance and expand our pipeline. Our current product candidates are in-licensed from academic institutions or other biopharmaceutical companies, and, from time to time, we plan to identify, evaluate and potentially obtain rights to and develop additional assets. Our objective is to maintain a well-balanced portfolio with product candidates across various stages of development. In general, we seek to identify product candidates and technology that represent a novel therapeutic approach, are supported by compelling science, target an unmet medical need, and provide a meaningful commercial opportunity. We do not currently intend to invest significant capital in basic research, which can be expensive and time-consuming.
Capture the full commercial potential of our product candidates.If our product candidates are successfully developed and approved, we may build commercial infrastructure capable of directly marketing the products in North America and potentially other major geographies of strategic interest. We also plan to evaluate strategic licensing arrangements with pharmaceutical companies for the commercialization of our drugs, where applicable, such as in territories where a partner may contribute additional resources, infrastructure and expertise.

Acute Respiratory Distress Syndrome (ARDS)
Acute respiratory distress syndrome (ARDS) is a safe, potent, immune-stimulating protein. life-threatening form of respiratory failure, and the leading cause of death among COVID-19 patients. In addition to virus-induced pneumonia, ARDS can be caused by bacterial pneumonia, sepsis, chest injury and other causes.
Specifically, ARDS involves an exaggerated immune response leading to inflammation and injury to the lungs that deprives the body of oxygen. ARDS is classified as mild, moderate and severe by using an arterial partial pressure of oxygen (PaO2) to fraction of inspired oxygen (FIO2) threshold of 300, 200, and 100 mm Hg, respectively. For moderate to severe cases, there are currently few meaningful treatments, other than supplemental oxygen and mechanical ventilation, and patients suffer high mortality rates. Prior to COVID-19, ARDS accounted for 10% of intensive care unit admissions, representing more than 3 million patients globally each year. ARDS has historically affected approximately 200,000 patients each year in the United States, resulting in nearly 75,000 deaths annually, according to medical literature.
Countering the exaggerated innate immune response in ARDS has been a key area of interest among researchers. One of the most studied targets has been Toll-like receptor 4 (TLR4) – a key component of the innate immune system and an important mediator of inflammation. Since TLR4 detects molecules found in pathogens and also binds to endogenous molecules produced as a result of injury, it is a very large, high molecular weight, oxygen-carrying glycoprotein. In additionkey receptor on which both infectious and noninfectious stimuli converge to induce a proinflammatory response. Specifically, TLR4 signaling activates leukocytes to secrete proinflammatory cytokines (i.e., CXCL10, IL-6, IFN-b, IL-1b, TNF-a), which under certain circumstances can result in a “cytokine storm” – a severe immune reaction in which the native molecule, KLH can be chemically dissociatedbody releases too many cytokines into a subunit formulation commonly used in the productionblood too quickly.
Such upregulation of immunotherapies. Both the native, high molecular weight moleculeTLR4 and subunit forms of KLH are excellent immune stimulants. The KLH molecular structure offers numerous sites for conjugation, and can generate multiple product configurations. Because of its large size, immune-stimulating properties, numerous sites for conjugation, and safety profile, KLH is used by researchers and product developers as a vaccine carrier protein. However, due to its exceptional size and complexity, KLH has not been reproduced synthetically.

KLH can be used as a carrier molecule, or it can be used as a finished, injectable product in the immunodiagnostic market.

As a carrier molecule, KLH is combined, or conjugated, to vaccine antigens that are used to promote the generation of antibody and cell-mediated immune responses against targeted diseases. By themselves, the small haptens (partial antigens) and vaccine antigens used to target these diseases are not usually immunogenic enough to awaken the immune system and therefore, require a carrier molecule or adjuvant, like KLH, in order to be effective. The combination of an antigen against specific pathogenic targets, such as tumors, and over-expressed proteins, conjugated to the immunogenic KLH molecule, is the basis for a promising new class of drugs in development known as active immunotherapies or therapeutic vaccines. Unlike preventative vaccines, active immunotherapies are designed to stimulate the body’s own immune system to generate an immune response to target and attack an existing disease or condition. We believe immunotherapies are, and will continue to be, one of the fastest-growing sectors of pharmaceutical research and development. KLH is an important component for drugs used in clinical development, including major indications such as Alzheimer’s disease, metastatic breast cancer, systemic lupus erythematous, dermatomyositis, ovarian cancer and various other cancers and diseases. New indications expected to enter clinical trials, such as type 1 diabetes, point to expanding clinical potential for KLH.

As a finished injectable product, KLHassociated cytokines has been used extensively by pharmaceutical companies and researchers as a safe, immune-stimulating antigenobserved in drug-screening, drug immunotoxicology, and assessment of immune status. KLH is a standard immunogen in T-Cell Dependent Antibody Response (TDAR), a functional assay which is widely recognized as a standard test for monitoring the effects of drugs on the immune system.

KLH protein is derived only from the hemolymph of the Giant Keyhole Limpet (Megathura crenulata), a mollusk native only to a limited stretch of the Pacific Ocean coastline along Southern California and Baja California, Mexico. Historically, suppliers other than us have obtained KLH protein directly from wild and sensitive populations of Giant Keyhole Limpet, or have utilized lethal production processes. Based on publicly available information and reports, commercial supplies of KLH differ widely in their source, traceability, purity, form, and preparation,SARS-CoV-2 as well as other respiratory infections such as influenza. In multiple third-party studies, high serum levels of alarmins, such as calprotectin and HMGB1(high mobility group protein B1), that bind to and activate TLR4 are associated with poor outcomes and disease progression in immunogenicity (their abilityCOVID-19 patients. In addition, TLR4 inhibition (antagonism) prevents cytokine production at a very early stage and has been shown to stimulate an immune response)have a protective effect. For example, in preclinical studies in mice, it was demonstrated that administration of a TLR4 antagonist blocked influenza-induced lethality and ameliorated virus-induced acute lung injury. Antagonism of TLR4 has also been shown to modulate the secretion of proinflammatory cytokines (IL-6, CRP, IFNb, TNF-a, CXCL-10, IL8 and MIP-1b). We believe that highly-specialized aquaculture manufacturing methods, like the methods we practice, protect the KLH molecule’s source species and provide sustainable, scalable supplies of quality KLH protein. The concept of sustainability involves sound, responsible management of environmental resources and, especially where biological systems are concerned, includes protecting native species so that the species thrive and remain diverse and productive over time. Further,Based on this data as well as previous clinical results, we believe that environmentally sound methods associatedthe modulation of the TLR4 provides a compelling opportunity to treat ARDS.


EB05
Overview and Status
EB05 is a monoclonal antibody (mAb) that has been engineered to alter inflammatory signaling by binding to and blocking the activation of TLR4. Specifically, EB05 dampens TLR4 signaling by blocking receptor dimerization (and subsequent intracellular signaling cascades). The drug has demonstrated the ability to block signaling irrespective of the presence or concentration of the various molecules that frequently bind with professionalTLR4, known as ligands. Based on this broad mechanism of action, we believe that EB05 could ameliorate TLR4-mediated inflammation cascades in ARDS patients, thereby reducing lung injury, ventilation rates and specialized aquaculture can minimize variabilitymortality. EB05 has demonstrated the ability to resolve fever and stabilize heart and breathing rates in KLH productshuman subjects that were injected with lipopolysaccharide (LPS) – a potent inducer of the acute systemic inflammation. In previous Phase 1 and assure full traceability to their biological source.

Phase 2 clinical studies, EB05 has demonstrated favorable safety and tolerability profiles.

Our Technology

Phase 2/3 protocol has been approved in Canada. We have spent more than 15 years developing and optimizing sustainable KLH production methods, specifically focused on protectionalso received approved for the Phase 2 portion of the Giant Keyhole Limpet and a patented, non-lethal method to extract KLH protein. We believe our proprietary methods will provide a scalable supply of GMP grade KLH and meet pharmaceutical industry standards for immune response, consistency, purity, and traceability while protecting the natural source species.

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Our proprietary aquaculture technology involves methods we developed and optimized to control the reproduction and growth of the Giant Keyhole Limpet including, but not limited to, culture systems, nutritional requirements and the recirculation of seawater. We achieved a significant milestone in aquaculture science by developing the capability to sustain the complete life cycle of the Giant Keyhole Limpet. Using our proprietary methods, we can support the marine mollusk from embryo to protein-producing adult, and we now support multiple generations of limpets grown entirely within our land-based aquaculture facility. We believe that other KLH suppliers do not have this capability and thus are reliant on scarce, wild populations of limpets.

The aquaculture cycle to raise Giant Keyhole Limpets from fertilized eggs to maturity for KLH production is approximately five years, with multiple complex larval and juvenile stages. The hemolymph circulatory fluid, which contains KLH, is extracted in a non-lethal manner utilizing our patented methods. Once extracted, the hemolymph is processed and purified through our proprietary methods, which are protected as trade secrets. KLH can be extracted from mature limpets multiple times per year.

We currently maintain a production inventory of limpets sufficient for an annual capacity of up to 1,500 grams/year of KLH pharmaceutical intermediate, which can be further processed and purified to produce various final product grades and formulations. We believe we can continue to scale up capacity to meet anticipated customer demandstudy in the near term. Given sufficient fundingUnited States. The company is currently enrolling patients at U.S. and Canadian hospitals.

As planned, our Phase 2/Phase 3 study is an adaptive, multicenter, randomized, double-blind, placebo-controlled trial to continue scale- up, our projected production capacity is up to 20,000 grams (20 kg) of KLH pharmaceutical intermediate in five to seven years. We plan to incrementally increase hatchery production of limpets and expand aquaculture infrastructure, which will thereby increase our KLH production capacity, in order to meetevaluate the anticipated future multi-kilogram KLH requirements of immunotherapy commercialization.

In December 2016, we initiated plans to optimize our protein manufacturing processes at our primary facility in Port Hueneme, California, including the evaluation and use of new equipment. This initiative is intended to increase the scalability and throughput capacity of existing manufacturing systems, which were originally developed to provide clinical development stage quantities of our Stellar KLH products.

We rely on contract manufacturing organizations and contract testing organizations for certain steps of cGMP processing and quality control testing. The services performed by these contract vendors have included sterile fill/finish and product release testing.

As a result of these operational capabilities, we believe we will be able to supply GMP grade KLH in commercial quantities to meet the anticipated long-term demand within the pharmaceutical industry, while protecting the natural source species. We base these beliefs on our intellectual property, achievements in aquaculture science, KLH production capacity, KLH sustainable manufacturing know-how, and survey data used to estimate populations of Giant Keyhole Limpets in the wild.

Our Aquaculture and KLH Production Facilities

We maintain research and manufacturing facilities directly along the Pacific Ocean with dedicated, land-based aquaculture operations in Port Hueneme, California. We have approximately 37,000 square feet of leased aquaculture, manufacturing and laboratory space. We believe our waterfront location is a proprietary asset that allows our marine scientists to work in close proximity to naturally resident Giant Keyhole Limpet colonies, and to be at the forefront in developing protective measures and environmentally sound practices for KLH production. At this location, our seawater supply and discharge system is fully permitted, which we believe is a competitive strength due in part to the time required and uncertainties related to obtaining new water discharge permits in the State of California.

Our aquaculture operations include, among other specialized infrastructure, systems for spawning, larval development, and maturation of limpets, recirculating seawater supply systems and environmental controls. Our facility currently includes multiple production tanks and numerous individual limpet production modules in two independent aquaculture production systems. Each closed recirculating system is equipped with temperature controlled seawater distribution, filtration and treatment equipment. The facility also contains a fabrication shop for production of equipment and culture apparatus.

Additional Aquaculture and KLH Production Locations

In January 2017, we established a wholly owned Mexican subsidiary under the name BioEstelar, S.A. de C.V. to support our plan to establish additional aquaculture capabilities in Baja California, including the development of regional marine resources, aquaculture and raw material processing for Stellar’s KLH products. Since 2015, we have leased undeveloped land in Baja California as part of multi-year site suitability studies. We have a related, exclusive collaboration agreement with the lessor to collaborate on the design, expansion and development of marine aquaculture resources for hatchery and maturation of Giant Keyhole Limpets on the leased property. The collaboration agreement expires in June 2018, unless terminated earlier. We believe this expansion in Mexico will support our goal to meet the anticipated long-term industry demand for KLH protein.

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Research and Development

Our research and development is focused primarily on the aquaculture of the Giant Keyhole Limpet; improvements in KLH protein characterization and manufacturing; the development of functional assays; and new uses for KLH in immunotherapy and immunodiagnostic applications. These activities involve both internal programs and external collaborations with other biopharmaceutical companies or research organizations.

Our internal research has included, among other activities, improvement of methods for the culture and growth of Giant Keyhole Limpet, developing proprietary formulated limpet diets, innovations in aquaculture systems and infrastructure, biophysical and biochemical characterization of the KLH molecule, analytical processes to enhance performance of our products, KLH manufacturing process improvements, and new KLH formulations and KLH-related technologies.

Our external collaborations have historically involved both development and evaluation projects, with multiple biopharmaceutical companies and research institutions, for the use of Stellar KLH in their programs. We believe that these collaborations provide for strategic, revenue and clinical opportunities for our future business by extending the commercial use of Stellar KLH and furthering our understanding of the KLH molecule.

For the years ended September 30, 2017, 2016 and 2015, our research and development expense were $1.97 million, $1.73 million and $1.03 million, respectively. These amounts related mainly to research and development in aquaculture, improvements in analytical, manufacturing, and purification processes, stability studies and formulation development.

Our Stellar KLH Products

We offer Stellar KLH protein in various grades, formulations, custom configurations and fill finishes for both drug development and research applications. Our portfolio includes GMP and research grade products intended for: conjugation as a carrier molecule in therapeutic vaccines; assessing immune function; and, in immunotoxicology studies, for monitoring the immunomodulatory effects of drug candidates. We also offer KLH-based in vitro diagnostic kits for research and preclinical use.

We currently have limited revenue from sales of our Stellar KLH products. The list price for bulk Stellar KLH protein ranges from approximately $15,000 to $50,000 per gram, depending on the purity, grade, preparation, packaging configuration and volume ordered. While our customer base has not changed significantly from year to year, product sales volumes have been highly dependent and subject to variability associated with the rate of development and progression of clinical studies of third-party immunotherapies and other technologies that utilize our products. The rate of progression towards later stage studies is expected to continue to affect the timing and volume of future product sales. The advancement and commercial success of third-party products utilizing Stellar KLH is dependent upon many factors, including available capital, trial recruitment and progress, and regulatory review.

Revenues from the sale of products and contract services revenues in fiscal years 2017, 2016 and 2015 are as follows:

  2017  2016  2015 
          
Product sales $178,287  $1,239,689  $563,689 
Contract services revenue  50,000   32,000   195,000 

The geographic breakdown of revenues in fiscal years 2017, 2016 and 2015 are as follows:

  2017  2016  2015 
          
Europe  64%  43%  53%
North America  33%  12%  9%
Asia  3%  45%  38%

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Drug Master Files for Stellar KLH

We have submitted Type II Master Files for our high molecular weight and subunit KLH product formulations to the FDA Center for Biologics Evaluation and Research (CBER) and Type II Drug Master Files to the FDA Center for Drug Evaluation and Research (CDER). A Master File is a confidential, detailed dossier kept on file at the FDA that contains the proprietary information on the manufactureefficacy and safety of aEB05 in adult hospitalized COVID-19 patients. We expect to enroll approximately 316 patients. Patients will be intravenously infused with EB05 or placebo. Standard-of-care COVID-19 treatment will be given to all patients. The total follow-up duration of each patient will be 28 days. Should the drug component. These files can be used to supporttreatment demonstrate promising results at the regulatory approval processPhase 2 readout, the protocol allows for customers’ immunotherapy products that use our Stellar KLH, while allowing us to control access to our manufacturing data.

Customers

We primarily market and distribute our products directly to biotechnology and pharmaceutical companies, academic institutions, clinical research organizations and research centers. Products are shipped to our customers from our facilities in Port Hueneme, California using a common carrier chosen by the customer. The geographic markets of our customers are principally Europe, North America and Asia.

The customers that represent 10% or more of our total consolidated revenue in fiscal years 2017, 2016 and 2015 are as follows:

CustomerPercentage
2017
Araclon Biotech, SL57%
Matrivax R&D Corporation22%
2016
OBI Pharma, Inc.41%
Eurogentec25%
Neovacs SA10%
2015
Araclon Biotech, SL19%
Amaran Biotechnology, Inc.19%
OBI Pharma, Inc.17%
AXON Neuroscience SE16%
Neovacs SA15%

Supply Agreements, Collaboration Agreements and Contracts

We have entered into, and intendenrollment to continue to enter into, agreements with third parties that will allow us to supply Stellar KLH in exchange for fees, revenues or royalties. Supply agreements generally involve a customer’s commitment to purchase our Stellar KLH for use as a carrier moleculepivotal Phase 3 study in Canada. In the customer’s own immunotherapy products or as a finished product in their development programs. In return,U.S., we license and provide exclusive or priority supply in a given field and territory, and provide technical and regulatory support. When applicable, we also agreeexpect to maintain a master filehave an end of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to finalize the Phase 3 protocol.

Previous Phase 1 and Phase 2 Clinical Studies of EB05
In a randomized, double blind, placebo-controlled, PK/PD guided Phase 1 study, 60 healthy volunteers were given escalating, single intravenous infusion of EB05 in the absence and presence of an in vivo LPS challenge. Forty-eight (48) subjects were exposed to escalating doses between 0.001 to 15 mg/kg in Part 1 of the study. The highest dose of EB05 displayed a pharmacological effect (defined by 80% inhibition of cytokine after ex vivo LPS challenge) lasting up to 14 weeks. Twelve (12) subjects were exposed to an in vivo LPS challenge (2 ng/kg) in Part 2 of the study. Of these, 3 received EB05 at a dose of 0.01 mg/kg and 9 at a dose of 0.25 mg/kg. No safety signals were identified after administration up to a dose of 15 mg/kg.
In a previous Phase 2 clinical study, EB05 was administered to 57 rheumatoid arthritis patients and demonstrated a favorable safety and tolerability profile. Patients received intravenous infusions of EB05 at 5mg/kg every 2 weeks for a total of 6 doses. EB05 blocked cytokine release after ex vivo LPS challenge, with full effect from a dose of 1 mg/kg onwards. The duration of inhibition of cytokine release was dependent on the dose and lasted up to 14 weeks at a dose of 15 mg/kg. The pharmacological effects of EB05 after the ex vivo and in vivo LPS challenges were comparable. At a dose of 0.25 mg/kg, EB05 prevented the laboratory and clinical changes induced by an in vivo LPS administration, up to 22 days. LPS effects were fully recovered between 22 and 40 days after EB05 administration.
Allergic Contact Dermatitis
Contact dermatitis is one of the most common occupational and work-related skin conditions in the United States. The disease can be either irritant contact dermatitis or ACD. Together, these conditions have been estimated to cost up to $2 billion annually as a result of lost work, reduced productivity, medical care and disability payments. Based on published reports and U.S. insurance claims data, we estimate that there are more than 2.5 million people in the United States with ACD, including more than 1 million people who have chronic ACD. Since primary care physicians do not always distinguish between irritant and allergic contact dermatitis, a potentially larger undiagnosed patient population may also be present.
ACD is caused by an allergen interacting with skin and usually occurs on areas of the body that have been directly exposed to the environment, with a high prevalence on the hands and face. Common allergens associated with ACD include plants, metals, plastics and resins, rubber additives, dyes, biocides, and various cosmetics. The disease is characterized by inflammation, erythema (redness), pruritus (itchiness), and blistering of the skin. Inflammation can vary from mild irritation and redness to open sores, depending on the type of irritant, the body part affected and the degree of sensitivity. ACD can become chronic if not treated or if the causative allergen is not removed. In many chronic cases, the causative allergen is unknown or difficult to avoid (as an example, the allergen is present in the workplace).

The immune mechanisms involved in ACD are well documented. During the initial contact with the offending allergen, the immune system is sensitized. Upon subsequent contact, a delayed-type hypersensitivity reaction (Type IV) occurs at the point of contact between the skin and the allergen. As a cell-mediated response, the immune reaction primarily involves the interaction of T cells with antigens rather than an antibody response. More specifically, ACD involves an exogenous substance binding a cell surface protein to form a hapten that is recognized as a foreign antigen by the immune system. Haptens are known to signal through toll-like receptors, a family of receptors involved in the innate immune system recognizing pathogens, leading to the induction of pro-inflammatory cytokines such as interleukin (IL)-1b. EB01 has been shown in preclinical studies to inhibit the production of pro-inflammatory cytokines induced via toll-like receptor signaling (IL-1b, IL-6, IL-8, MIP-1a, and TNFa), suggesting that EB01 may address the underlying disease mechanism of ACD.
Current Treatments
Generally, dermatologists view chronic ACD from both a duration and recurrence perspective, considering how often and how long symptoms persist. Chronic disease affects patients over a prolonged period, typically greater than six months or even years. These chronic patients have either frequent intermittent exposure or continuous exposure. Since inflammation in ACD is driven by external exposure to an allergen, the severity of ACD does not necessarily correlate with body surface area, as is often the case with other dermatological diseases.
Current treatment plans begin by attempting to identify and remove exposure to the allergen. However, the offending allergen(s) is frequently not identified, and even when it is, avoiding exposure is often not possible (e.g., present in the workplace), according to our market research. To our knowledge, there are no drug treatment options specifically indicated for ACD. As such, physicians must utilize agents approved for other dermatological conditions. Topical corticosteroids are the most commonly used therapeutic intervention for ACD but cannot be used continuously since they have well-known side-effects including skin thinning, stretch marks, acne, testicular atrophy, nosebleeds, stinging, burning and dryness. Other topical treatments for ACD include immunomodulators such as topical calcineurin inhibitors. However, these are less efficacious than topical corticosteroids and have an FDA “black box warning” for risk of malignancies. Systemic corticosteroids can be used for acute control of severe cases of ACD but have safety concerns including hypothalamic-pituitary-adrenal axis suppression, growth suppression and loss of bone-density, thereby limiting the utility of steroids for treating chronic disease. Finally, patients may be treated with systemic immunomodulators, which have a series of “black box warnings” and associated safety issues. Systemic therapies also need to be tapered off each time the physician wants to patch test allergens to identify the source of a patient’s ACD.
EB01
Overview and Status
EB01 is a topical vanishing cream containing a novel, non-steroidal anti-inflammatory compound. EB01 exerts its anti-inflammatory activity through the inhibition of certain pro-inflammatory enzymes known as secretory phospholipase 2, or sPLA2. These enzymes are secreted by immune cells upon their activation and produce arachidonic acid via phospholipid hydrolysis, which, in turn, initiates a broad inflammatory cascade. The sPLA2 enzyme family plays a key role in initiating inflammation associated with many diseases, and we believe that targeting the sPLAenzyme family with enzyme inhibitors will have a superior anti-inflammatory therapeutic effect because the inflammatory process will be inhibited at its inception rather than after inflammation has occurred.
In October 2019, we initiated patient enrollment for a multi-center Phase 2B clinical study evaluating EB01 as a monotherapy for patients with moderate to severe chronic ACD. The double-blind, vehicle-controlled study will primarily evaluate the safety and efficacy of EB01 in ACD patients. Investigators will also evaluate symptom reduction, quality of life and dose-relationships among various strengths of EB01 cream as secondary and exploratory measures. We plan to perform a blinded interim analysis following the completion of the first cohort to determine the total number of patients for the KLH product. Our current supply agreements are limitedsecond part of the study. The sample-size adaptive protocol contemplates up to clinical trials166 total subjects.
In April 2020, we filed a protocol amendment with the FDA. The amendment provides for, among other changes, a reduction in the number of in-person office visits, allowances for remote telehealth appointments and typically have an initial multi-year term, which may be renewedother procedural updates to simplify enrollment and patient care during the COVID-19 pandemic. The pandemic has generally resulted in slower than expected enrollment due in part to temporary closures of investigational sites and the scheduling of fewer office visits by customersphysicians for additional one-year periods. Our supply agreements also typically provide us with first negotiation rightssocial distancing purposes. In November 2020, we completed enrollment of more than 50% of the patients planned for the supplyfirst part of KLHa study. While enrollment is now steady and ongoing, due to the changing nature of the pandemic and potential future closures of clinical sites, we are unable to predict with certainly the timing for the interim analysis or the completion of the study.
Previous Results
EB01 has demonstrated anti-inflammatory activity in a variety ofin vitroandin vivopreclinical pharmacology models. In addition, EB01 has demonstrated efficacy for the treatment of ACD in two previous clinical trials.
A variety ofin vitroand invivopreclinical pharmacology models were used to assess the anti-inflammatory activity of EB01. Using a model for hapten signaling indicative of ACD, lipopolysaccharide-stimulated peripheral blood mononuclear cells were treated with EB01 and shown to inhibit pro-inflammatory cytokines including IL-1b, IL-6, IL-8, MIP-1a, and TNFa at the protein and mRNA expression levels. Additionally, the safety of EB01 has been established in several Good Laboratory Practice toxicology studies, including an eight-week study involving topical application of 2.0% EB01 cream to minipigs and a 6-week continuous infusion study in rats. Overall, EB01 was well-tolerated and systemic exposure was negligible (below the limit of detection). No genotoxicity has been demonstrated in bacterial reverse mutation and micronucleus testing.

Clinical experience with EB01 includes five clinical studies involving a total of 176 subjects. No serious adverse reactions were encountered during these clinical studies. Healthy volunteers were treated with EB01 under occlusion. EB01 was classified as a weak sensitizer by maximization assay (Grade 1) and is, therefore, considered safe to use under any conditions. EB01 has demonstrated efficacy for the treatment of ACD in two separate clinical trials. Both studies were double-blind, vehicle-controlled bilateral comparison studies to assess the safety, tolerability and efficacy of EB01 cream applied twice daily for the treatment of ACD of the hand and forearm as determined by the Contact Dermatitis Severity Index (CDSI), a physician’s visual assessment. The CDSI is a composite endpoint, which grades each symptom of the disease (dryness, scaling, redness, pruritus, and fissures) scored from 0 (none) to 3 (severe), with a maximum severity score of 15. A diagnosis of ACD was confirmed by a positive patch test deemed to be clinically relevant by the investigator.
The first study (n=11) was a double-blind, placebo-controlled clinical study to assess the safety and efficacy of topical 1.0% EB01 cream for the treatment of ACD. Subjects selected for inclusion had bilateral ACD. Prior to randomization, subjects were patch tested. Patch tests were applied to the upper part of each subjects’ back for 2 days and were read on Days 2 and 4. Only “++” reactions were considered clinically relevant and positive for the study. The study was bilateral in design with one lesion treated with 1.0% EB01 cream twice daily, while a comparable lesion was treated with placebo cream. Disease severity was assessed before treatment (Day 0) and at Day 30 by the investigator using the CDSI. For each individual patient, the change in disease score in the drug-treated hand was compared to that in the placebo-treated hand, thus making the latter an internal control for each patient. The mean change from baseline for 1.0% EB01 cream treated lesions was 69.9%, compared to 36.5% in the placebo cream lesions (p = 0.0024). No serious adverse events were reported.
A second, larger (n=30) bilateral study was conducted to assess 2.0% EB01 cream applied twice daily for 21 consecutive days in connection with potential future commercializationthe treatment of ACD. To be included in the study, patients had to have bilateral ACD with a customer’s products.

To date, our Stellar KLH proteinCDSI score of at least 10 on each side, with no more than a 1-point difference between lesions. At Day 21, EB01-treated lesions had a mean improvement from baseline of 56%, compared to 24% for those treated with placebo cream (p < 0.001). Efficacy of the 2.0% EB01 cream was maintained through Day 42 (21-days after ending treatment) with a 49% decrease in total CDSI score for 2.0% EB01 cream-treated hands, compared to 15% in the vehicle-treated hands (p < 0.001). Within the total CDSI score, EB01 demonstrated statistically significant reductions for each of the individual CDSI components (dryness, scaling, redness, pruritus, and fissures).

Hemorrhoids Disease
Hemorrhoids disease (HD) is a common disorder, characterized by itching, inflammation, pain, tenderness, bleeding and difficulty defecating. According to National Institutes of Health reports, HD affects approximately 5% of the U.S. adult population, or approximately 12.5 million adults in the U.S. Almost half of individuals 50 years and older have experienced symptomatic hemorrhoids. Despite the high prevalence of hemorrhoids, we are not aware of any prescription drugs with an approved New Drug Application for the treatment of hemorrhoids. While there are commonly used prescription and over-the-counter products for HD, none has been approved by the FDA through the NDA process because they entered the market prior to 1962. The mechanism of action of these treatments is either general, such as steroids, or unknown, in the case of herbal remedies, and we are not aware of any reports published in medical journals on the efficacy of safety of any product currently marketed in the U.S. As a result of these factors, we believe that HD remains a significant unmet medical need and market opportunity.
Confusion often arises because the term hemorrhoid has been used to refer to both normal anatomic structures and pathologic structures. Hemorrhoids are cushions of fibromuscular tissue that line the anal canal. With HD, the muscle fibers that anchor the cushions become attenuated, the hemorrhoids slide, become congested, bleed, and eventually prolapse or protrude into the anal canal. The two types of hemorrhoids, external and internal, refer to their location. Internal hemorrhoids are typically classified as first degree (grade I) – hemorrhoids bleed but do not protrude; second degree (grade II) – hemorrhoids protrude but reduce on their own; third degree (grade III) – hemorrhoids protrude and require manual re-insertion; and fourth degree (grade IV) – hemorrhoids are permanently prolapsed and cannot be re-inserted.
The treatment of HD typically begins with conservative therapy consisting of diet and lifestyle modification, fiber supplements, sitz baths and stool softeners. In addition to this conservative therapy, physicians may prescribe topical steroids and analgesics. Because of the lack of effective prescription products, most hemorrhoid patients will use over-the-counter preparations or the prescription drugs available, which are similar to the over-the-counter treatment, but formulated with a higher dose. Based on public filings and reports, we estimate that as many as 4.0 million prescriptions are written and more than 20 million over-the-counter units are sold each year in researchthe U.S. for the treatment of HD. Alternatives are invasive procedures, including rubber band ligation, the injection of a sclerosing agent, electrocoagulation, light therapy and hemorrhoidectomy.
EB02
Overview and Status
Our EB02 drug candidate represents a potential extension of our sPLA2 anti-inflammatory technology. Based on our analysis of clinical data in dermatitis, we believe that EB02, which is currently formulated as a cream, may be effective in treating the erythema, swelling and exudation associated with HD. Specifically, sPLA2 has been demonstrated to be a mediator of processes that characterize hemorrhoidal pathophysiology, including inflammation and micro- vascularization.
In September 2019, we received approval from Health Canada to begin a clinical study of EB02 as a potential treatment for patients with grade I-III internal hemorrhoids. Health Canada reviewed our clinical trial application (CTA) and approved it by issuing a "no objection letter," a standard guidance document that allows us to proceed with our study. We believe this approval represents a significant milestone in our goal of demonstrating the broad potential of our novel non-steroidal anti-inflammatory technology.

Our exploratory Phase 2a study is designed to assess the safety and efficacy of EB02 among hemorrhoid patients at investigational centers in Canada. The study plan includes up to 48 subjects in a randomized, double-blind, vehicle-controlled design. Should the initial results be encouraging, we plan to transition from a proof of concept study to a Phase 2 study of up to 80 to 400 subjects. In light of our focus on the development preclinicalof EB05, we are currently evaluating the timing for the initiation of this planned study of EB02.
Other Product Candidates
We are also seeking to advance additional product candidates, including EB06, which is an monoclonal antibody candidate that binds specifically and selectively to chemokine ligand 10 (CXCL10) and inhibits the interaction of CXCL10 with its receptor. In addition, we plan to continue to identify, evaluate and potentially obtain rights to and develop additional clinical phasesassets across various stages of development, but has not yet been used in any commercializedfocusing primarily on inflammatory and marketed drug products. Quantities required for clinical trials depend on, among other variables, the nature of the trial, the clinical indication, the number of patients enrolled, dosing regimensimmune-related diseases.
Intellectual Property and vaccine manufacturing processes.

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Key Licenses

We have supply agreements with Araclon Biotech SL, a privately-held biotechnologyan exclusive license from Yissum Research Development Company, the technology transfer company headquartered in Spainof Hebrew University of Jerusalem Ltd. (Yissum), for patents and majority-owned by global healthcare company Grifols, who is developing beta amyloid-targeting active immunotherapies for neurodegenerative diseases with a primary focus on Alzheimer's disease; Amaran Biotechnology, Inc., a biopharmaceuticals manufacturer based in Taiwanpatent applications that manufactures a KLH conjugate vaccine for OBI Pharma, Inc., a publicly-listed Taiwan biotech company;cover our product candidates EB01 and French biotechnology company Neovacs S.A, for the use of Stellar KLHEB02 in the developmentUnited States, Canada, Australia and manufacturevarious countries in Europe. Method of Neovacs’ active immunotherapies. As previously disclosed, our agreement with Neovacs providesuse patents, for Neovacs to purchase Stellar KLHwhich we hold an inbound license from Yissum and an affiliate of Yissum, have been issued for use in its proprietary KLH-based Kinoid immunotherapiesdermatologic and gastrointestinal conditions and infections that will expire in 2024. We expect to seek patent term extension in the United States related to time under IND, which could add up to three to five years of additional protection. Additional patents subject to the license agreement have been filed by Yissum which we believe, if issued, could potentially prevent generic substitution until after 2033. 
We also hold an exclusive license from NovImmune SA, for patents and patent applications that cover our product candidates EB05 and EB06 in the United States, Canada and various other countries. Composition of matter patents, for which we hold an inbound license from NovImmune, have been issued that will expire as late as 2033 and 2028, respectively. We expect to seek patent term extension in the United States related to time under IND, which could extend protection. We have also filed additional method of use patent applications which we believe, if issued, could potentially prevent biosimilar substitution until as late as 2041.
In the event we are successful in commercializing a new drug candidate, we believe we would be eligible for data/market exclusivity, in addition to exclusivity rights granted through patent protection. We would be eligible for up to five years of exclusivity for EB01 and EB02 and up to twelve years of exclusivity for EB05 or EB06 after approval in the United States, and eight years of exclusivity after approval in Canada and ten years of exclusivity after approval in the European Union Latin America, Asia, the U.S.in any case.
We expect patents and Canada. Our customers manage and fund all product development and regulatory submissions for their respective drug products that utilize Stellar KLH.

Neostell Joint Venture Agreement

In May 2016, we entered into a joint venture agreement with Neovacs S.A., a publicly-held biotechnology company in Paris, France for the formation of a joint venture company to manufacture and sell conjugated therapeutic vaccines. In July 2016, Neostell S.A.S., a French simplified stock corporation (Neostell), was formed to carry out the business of the joint venture. Neostell is expected to produce Neovacs’ Kinoid immunotherapy product candidates which utilize Stellar KLH as a carrier molecule. Neostell may also manufacture and sell other KLH-based immunotherapy products for third-party customers worldwide.

We hold a 30% equity interest in the joint venture in exchange for an initial capital contribution of €120,000. One-half of the initial contribution, approximately $67,000, was paid in June 2016 with the balance due upon the occurrence of certain defined future events. We will also provide additional financing to Neostell, as may be required, on a pro rata basis in line with our equity interest. If Neostell does not achieve certain milestones by December 31, 2017, it will be dissolved, unless the parties mutually agree to pursue the joint venture arrangement, or either party decides to purchase the equity interests of the other party. As of the date of this Annual Report, these milestones have not been achieved, and the parties have discussed their mutual desire to extend the deadline. Each of the parties is entitled, upon the occurrence of certain defined events, to acquire the interest of the other party. Except as otherwise described herein, the joint venture has an initial ten-year term, renewable for successive five-year terms. If either party provides notice at least six months prior to the expiration date of an applicable term that it does not wish to continue its participation in the joint venture, the other party will have a right to acquire all of such terminating party’s equity interests in Neostell.

In connection with the formation of Neostell and the execution of its strategy, the parties intend over time to enter into an exclusive supply agreement within a limited field of use for Stellar to supply KLH to Neostell, a supply agreement designating Neostell as the exclusive manufacturer and supplier of the Neovacs’ vaccines, and services agreements for the provision of various knowledge and expertise by each of the parties. Neovacs will also license certain of its intellectual property to Neostell.

Intellectual Property and License Agreements

We hold important proprietary intellectual property rights to be an essential element of our business. We intend to protect our proprietary positions by, among other methods, filing U.S. and foreign patent applications related to KLH developmentour proprietary technology, inventions, and manufacture and to the environmental protection of the Giant Keyhole Limpet including, but not limited to, patents andimprovements. We also rely on trade secrets, relatedknow-how, continuing technological innovation and other in-licensing opportunities to specialized aquaculture systemsdevelop and technologies; spawning, selection and maintenance of the Giant Keyhole Limpet; non-lethal KLH protein extraction methods; and the processing, purification and production of KLH formulations. Ourmaintain our proprietary methods also include methods for the control of larval development, metamorphosis and maturation of the Giant Keyhole Limpets, which we protect as trade secrets.

position.  Our success dependswill depend, in part, on our ability to obtain and maintain proprietary protection for our product candidates, technology, and know-how, to operate without infringing on the proprietary rights of others, and to prevent others from infringing our proprietary rights. We seek


License Agreement with NovImmune SA
On April 17, 2020, our wholly-owned subsidiary Edesa Biotech Research, Inc. entered into an exclusive license agreement with NovImmune SA, which operates under the brand Light Chain Bioscience, whereby we obtained exclusive rights throughout the world to protect our proprietary position by, among other methods, filing, when possible, U.S.certain know-how, patents and foreign patent applicationsdata relating to the monoclonal antibodies targeting TLR4 and CXCL10 (the “Constructs”). Edesa will use the exclusive rights to develop products containing these Constructs (the “Licensed Products”) for therapeutic, prophylactic and diagnostic applications in humans and animals. Unless earlier terminated, the term of the license agreement will remain in effect for twenty-five years from the date of first commercial sale of Licensed Products. Subsequently, the license agreement will automatically renew for five (5) year periods unless either party terminates the agreement in accordance with its terms.
Under the license agreement, we are exclusively responsible, at our technology, inventionsexpense, for the research, development manufacture, marketing, distribution and improvements that are importantcommercialization of the Constructs and Licensed Products and to our business. We also rely on trade secrets, know-how, continuing technological innovation,obtain all necessary licenses and in-licensing opportunitiesrights. Edesa is required to use commercially reasonable efforts to develop and maintain our proprietary position.commercialize the Constructs in accordance with the terms of a development plan established by the parties. In exchange for the exclusive rights to develop and commercialize the Constructs, we issued to NovImmune $2.5 million of newly designated Series A-1 Convertible Preferred Shares pursuant to the terms of a securities purchase agreement entered into between the parties concurrently with the license agreement. In addition, Edesa is committed to payments of various amounts to NovImmune upon meeting certain development, approval and commercialization milestones as outlined in the license agreement up to an aggregate amount of $356 million. We require our employees, consultantsalso have a commitment to pay NovImmune a royalty based on net sales of Licensed Products in countries where Edesa directly commercializes Licensed Products and advisorsa percentage of sublicensing revenue received by Edesa in the countries where Edesa does not directly commercialize Licensed Products.
The license agreement provides that Light Chain will remain the exclusive owner of existing intellectual property in the Constructs and that Edesa will be the exclusive owner of all intellectual property resulting from the exploitation of the Constructs pursuant to execute confidentiality agreements inthe license. Subject to certain limitations, Edesa is responsible for prosecuting, maintaining and enforcing all intellectual property relating to the Constructs. During the term of the agreement, Edesa also has the option to purchase the licensed patents and know-how at a price to be negotiated by the parties. If Edesa defaults or fails to perform any of the terms, covenants, provisions or its obligations under the license agreement, Light Chain has the option to terminate the license agreement, subject to providing Edesa an opportunity to cure such default. The license agreement is also terminable by Light Chain upon the occurrence of certain bankruptcy related events pertaining to Edesa. In connection with their employment, consultingthe license agreement and pursuant to a purchase agreement entered into by the parties on April 17, 2020, we acquired from NovImmune its inventory of the TLR4 antibody for an aggregate purchase price of $5.0 million, payable in two installments in 2021 and 2022.
License and Development Agreement with Pendopharm
On August 27, 2017, our wholly owned subsidiary, Edesa Biotech Research, Inc. entered into an exclusive license and development agreement with Pendopharm, a division of Pharmascience Inc. Pursuant to the license and development agreement, we granted to Pendopharm an exclusive license throughout Canada to certain know-how, patents and data for the sole purpose of obtaining regulatory approval for certain pharmaceutical products to allow Pendopharm to distribute, market and sell the licensed products for human therapeutic use in certain gastrointestinal conditions. If Pendopharm elects not to seek regulatory approval of the applicable product, the applicable product will be removed from the license rights granted to Pendopharm and will revert to us. If Pendopharm elects to seek regulatory approval in Canada for the sale and marketing of the applicable product, Pendopharm will be responsible for obtaining regulatory approval for the applicable licensed product in Canada. In exchange for the exclusive rights to market, import, distribute, and sell the pharmaceutical products, Pendopharm is required to pay us a royalty in respect of aggregate annual net sales for each pharmaceutical product sold in Canada. Unless earlier terminated, the term of the license and development agreement will expire, on a licensed product by licensed product basis, on the later to occur of (i) the date that is 13 years after the first commercial sale of the licensed product in Canada; (ii) the date of expiry of the last valid licensed patent in Canada relating to the licensed product; or advisory relationship(iii) the date of expiry of any period of exclusivity granted to the licensed product by a regulatory authority in Canada. The license and development agreement shall also terminate upon the termination of certain license agreements that Edesa has with third parties. Pendopharm also has the right to terminate the license and development agreement for any reason upon 120 days notice to us.
License Agreement with Yissum
On June 29, 2016, our wholly owned subsidiary, Edesa Biotech Research, Inc., entered into an exclusive license agreement withYissum, which agreement was subsequently amended on each of April 3, 2017 and May 7, 2017. Pursuant to the license agreement as amended, weobtained exclusive rights throughout the world to certain know-how, patents and data relating to a pharmaceutical product. We will use the exclusive rights to develop the product for therapeutic, prophylactic and diagnostic uses in topical dermal applications and anorectal applications. Unless earlier terminated, the term of the license agreement will expire on a country by country basis on the later of (i) the date of expiry of the last valid licensed patent in such country; (ii) the date of expiry of any period of exclusivity granted to a product by a regulatory authority in such country or (iii) the date that is 15 years after the first commercial sale of a product in such country.

Under the license agreement, we are exclusively responsible, at our expense, for the development of the product, including conducting clinical trials and seeking regulatory approval for the product, and once regulatory approval has been obtained, for the commercialization of the product. We are required to use our commercially reasonable efforts to develop and commercialize the product in accordance with the terms of a development plan established by the parties. Subject to certain conditions, we are permitted to engage third parties to perform our activities or obligations under the agreement. In exchange for the exclusive rights to develop and commercialize the product topical dermal applications and anorectal applications, we are committed to payments of various amounts to Yissum upon meeting certain milestones outlined in the license agreement up to an aggregate amount of $18.6 million. In addition, upon divestiture of substantially all of our assets, we are obligated to pay Yissum a percentage of the valuation of the licensed technology sold as determined by an external objective expert.  We also requirehave a commitment to pay Yissum a royalty based on net sales of the product in countries where we, or an affiliate of ours, directly commercializes the product and a percentage of sublicensing revenue received by us and our employees,affiliates in the countries where we do not directly commercialize the product.
The license agreement provides that Yissum shall remain the exclusive owner of the licensed technology and that we are responsible for preparing, filing, prosecuting and maintaining the patents on the licensed technology in Yissum’s name. Notwithstanding the foregoing, we will be the exclusive owner of all patents and other intellectual property that is made by or on our behalf after the date of the agreement, including all improvements to the extent practicable,licensed technology. If we default or fail to perform any of the terms, covenants, provisions or our consultantsobligations under the license agreement, Yissum has the option to terminate the license agreement, subject to providing us with an opportunity to cure such default. We have the right to terminate the agreement if we determine that the development and advisors with whomcommercialization of the product is no longer commercially viable. Subject to certain exceptions, we have undertaken to indemnify Yissum against any liability, including product liability, damage, loss or expense derived from the use, development, manufacture, marketing, sale or sublicensing of the licensed product and technology.
Manufacturing and Marketing
We rely, and expect to workcontinue to rely for the foreseeable future, on third party contract manufacturing organizations, or CMOs, to produce both our productssynthetic chemical and biological product candidates for clinical testing, as well as for commercial manufacture if our product candidates receive marketing approval. We believe that this strategy will enable us to agreedirect operational and financial resources to disclose and assign to us all inventions made in the coursedevelopment of our working relationshipproduct candidates rather than diverting resources to establishing manufacturing infrastructure. Our arrangements with them, while using our intellectual propertymanufacturers are subject to industry-standard terms and conditions and manufacturing is performed on an as-requested basis. We believe there is sufficient supplies of raw materials and manufacturing capacity with our current manufacturers, as well as others, to service our current and future product needs. We do not have current plans to establish laboratories or which relate to our business.

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manufacturing facilities for significant clinical production.

We hold patent protection

Because we are focused on the discovery and development of drugs, we do not have any marketing or distribution capabilities, nor are we at a stage where we would have any customers for our non-lethal extraction methods of hemocyanininvestigational medicines. If we receive marketing approval in the United States, and other countries, including one issued patentCanada or Europe for a product candidate, we plan to build the capabilities to commercialize the product candidate in the applicable region with our own focused, specialized sales force. Outside of the United States U.S. Patent No. 6,852,338,and Canada, we plan to selectively utilize collaboration, distribution or other marketing arrangements with third parties to commercialize our product candidates. Also, we intend to selectively seek licensing, collaboration or similar arrangements to assist us in furthering the development or commercialization of product candidates targeting large primary care markets that must be served by large sales and marketing organizations.
Competition
The pharmaceutical and biotechnology industry is highly competitive, and the development and commercialization of new drugs is influenced by rapid technological developments and innovation. We face competition from companies developing and commercializing products that will be competitive with our drug candidates, including large pharmaceutical and smaller biotechnology companies, many of which currently expires in 2023,have greater financial and covers a two-step methodcommercial resources than we do. For our EB01 and EB02 product candidates, our potential competitors include Aclaris Therapeutics, Inc., Brickell Biotech, Inc., Citius Pharmaceuticals Inc., Dermavant Sciences, Inc. and Leo Pharma A/S. For COVID-19, there are hundreds of competing therapies under evaluation, including prophylactic vaccines for obtaining hemolymph from a live gastropod mollusk. This U.S. patent was originally grantedthe SARS-Cov2 virus, experimental stem cell therapies and repurposed commercial drugs. Our potential competitors include, among others: Aqualung Therapeutics Corporation, Athersys, Inc., Caladrius Biosciences, Inc., Enzychem Lifesciences Corp., Merck & Co., Inc., Mesoblast Limited, Regeneron Pharmaceuticals, Inc. and Roche Holding AG. Some of the competing product development programs may be based on scientific approaches that are similar to our Chief Executive Officer, Frank Oakes, who assigned the patent to the Company in August 2002. Foreign patent counterparts were granted in Canada, France and Germany. In August 2011 we acquired an exclusive, worldwide sub-licensable and royalty-free license to the technology we developed under collaboration with Bayer Innovation GmbH (Bayer) for the improved production method and process yields for Stellar KLH. The license included a carve-out by Bayer to use the technology in certain non-Hodgkin Lymphoma active immunotherapies, but we may exclusively commercialize the technology in other fields.

The scope of any patent protection may not exclude competitors or provide competitive advantages to us, and any of our patents may not be held valid if subsequently challenged,approach, and others may claim rights in or ownershipbe based on entirely different approaches. Potential competitors also include new entrants to the market, academic institutions, government agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization of our patents and proprietary rights. Furthermore, others may develop products similar to our productsours or that otherwise target indications that we are pursuing. Key factors affecting the success of any approved product will be its efficacy, safety profile, drug interactions, method of administration, pricing, reimbursement and may duplicate anylevel of our products or design around our patents.

Our trademarks include, but are not limitedpromotional activity relative to “Powering and Improving Immunotherapy™”, “Stellar KLH™” and “KLH Site™”. In addition to patents and trademarks, we rely on trade secrets and other intellectual property laws, nondisclosure agreements and other measures to protect our intellectual property rights.

Competition

The immunotherapy industry is rapidly evolving and new competitors withthose of competing technologies and products are regularly entering clinical development and the market. We compete on the basis of: the advantages and disadvantages of Stellar KLH as compared to other KLH proteins manufactured by our competitors; our ability to educate the industry about the high quality, and sustainable and traceable features, of Stellar KLH; our ability to supply scalable quantities of GMP grade KLH; product efficacy; customer service; and the price and demonstrated cost-effectiveness of Stellar KLH as compared to our competitors.drugs. We believe that our products and services currentlyproduct candidates will compete favorably with respect to such factors. However, we may not be able to maintain our competitive position against current and potential competitors. We compete directly with Biosyn Corporation, a pharmaceutical and biotechnology company which manufactures KLH starting material and offers clinical and research grade KLH products. We also compete directly with SAFC, a division of Sigma-Aldrich, which offers clinical and research grade KLH products. In addition to competition from current suppliers of KLH, we also face indirect competition from developers of other carrier proteins, adjuvants or therapeutic vaccine platforms. We are unable to predict what effect evolution of the KLH and immunotherapy industries and potential new entrants may have on price, selling strategies, intellectual property or our competitive position.


Government Regulation

Our operations, including

We plan to conduct clinical studies and seek approvals for our aquaculture and harvesting activities, as well as production operations, manufacturing site development, and drug research, development and sales, are subject to complex regulation at the local, state and federal levelsproduct candidates in the United States, by a number of regulatory agencies including, but not limited to, the U.S. FoodCanada and Drug Administration, the U.S. Environmental Protection Agency, the U.S. Fishother jurisdictions. Therefore, we currently are, and Wildlife Service, the U.S. Secretary of the Navy, the Regional Water Quality Control Board Los Angeles Region, the California Department of Fish and Wildlife, the California Coastal Commission, the California Air Pollution Control Board, the County of Ventura, and the City of Port Hueneme.

We are subject to laws and regulations covering clean water and waste discharge, and are required to hold licenses for the aquaculture production and wild harvesting of the Giant Keyhole Limpet. Our aquaculture facility is subject to regulation by the California Department of Fish and Wildlife and the Regional Water Quality Control Board, Los Angeles Region. These agencies impose regulations that restrict any activity that could pose a potential risk to the California marine environment including, but not limited to, seawater waste discharge limitations specified in our National Pollution Discharge Elimination Systems (NPDES) permit. We regularly monitor our KLH production and manufacturing processes for compliance with applicable regulations.

In addition to regulationsmay in the United States, we mayfuture be, subject to a variety of foreignnational and regional regulations related to research, manufacturing, and thegoverning clinical trials as well as commercial salesales and distribution of our products, if approved.

To conduct clinical trials for our product candidates, we rely on third parties, such as contract research organizations, medical institutions, and clinical investigators. Although we have entered into agreements with these third parties, we continue to be responsible for confirming that each of our clinical trials is conducted in accordance with our investigational plan or research protocol, as well as International Conference on Harmonization Good Clinical Practices, or GCP, which include guidelines for conducting, recording and reporting the extent we choose to manufacture, sell or distribute any products outsideresults of the United States. clinical trials.
The requirements governing our activitiesFDA in jurisdictions outside the United States, vary greatly from country to country.

In Mexico, our currentHealth Canada in Canada, the European Medicines Agency (EMA) in the European Union and comparable regulatory agencies in foreign countries impose substantial requirements on the clinical development, manufacture and marketing of pharmaceutical products and product candidates. These agencies and other federal, state, provincial and local entities regulate research and development activities and collaborations,the testing, manufacture, packaging, importing, distribution, quality control, safety, effectiveness, labeling, storage, record-keeping, approval and potential future operations,promotion of our products and product candidates. All of our product candidates will require regulatory approval before commercialization. In particular, therapeutic product candidates for human use are subject to regulation, permittingrigorous preclinical and oversightclinical testing and other statutory and regulatory requirements of the United States, Canada, the EU and foreign countries. Obtaining these marketing approvals and subsequently complying with ongoing statutory and regulatory requirements require substantial time, effort and financial resources.

United States
In the United States, the FDA regulates drugs under the federal Food, Drug and Cosmetic Act as well as the Public Health Service (PHS) Act for biological drugs. The process required by the SecretariatFDA before our product candidates may be marketed in the United States generally involves the following:

Pre-clinical testing. Drug developers complete extensive pre-clinical laboratory tests, animal studies and formulation studies, performed in accordance with the FDA’s Good Laboratory Practice regulations and other applicable requirements. These studies typically assess efficacy, toxicology and pharmacokinetics.
Submission to the FDA of Agriculture, Livestock, Rural Development, Fisheriesan Investigational New Drug application (IND), which must become effective before human clinical trials may begin. As part of an IND application to the FDA, trial sponsors submit the results of pre-clinical tests, together with manufacturing information and Food (SAGARPA)analytical data. The IND automatically becomes effective 30-days after receipt by the FDA, unless the FDA, within the 30-day time frame, has questions or concerns about the proposed study. In such a case, the IND sponsor and the FDA must resolve any outstanding items before the clinical trial can begin. A separate submission to an existing IND must also be made for each successive phase of a clinical trial conducted during product development.
Approval by a central or institutional review board (IRB), or ethics committee at each clinical trial site before each trial may be initiated. An IRB is charged with protecting the welfare and rights of trial participants and considers such items as whether the risks to individuals participating in the clinical trials are minimized and are reasonable in relation to anticipated benefits. The IRB also approves the informed consent form that must be provided to each clinical trial subject or his or her legal representative and must monitor the clinical trial until completion. There are also requirements governing the reporting of ongoing clinical trials and completed clinical trial results to public registries.
Multiple Phases of Human Clinical Trials. Drug developers conduct adequate and well-controlled human clinical trials that establish the safety and efficacy of the product candidate for the intended use, typically in the following three stages, which are often sequential but may overlap:
o
Phase 1: The clinical trials are initially conducted in a limited population to test the product candidate for safety, dose tolerance, absorption, metabolism, distribution and excretion in healthy humans or, on occasion, in patients, such as cancer patients. Phase 1 clinical trials can be designed to evaluate the impact of the product candidate in combination with currently approved drugs.
o
Phase 2: These clinical trials are generally conducted in a limited patient population to identify possible adverse effects and safety risks, to determine the efficacy of the product candidate for specific targeted indications and to determine dose tolerance and optimal dosage. Multiple Phase 2 clinical trials may be conducted by the sponsor to obtain information before beginning a larger and more expensive Phase 3 clinical trial.
o
Phase 3: These clinical trials are commonly referred to as pivotal clinical trials. If the Phase 2 clinical trials demonstrate that a dose range of the product candidate is effective and has an acceptable safety profile, Phase 3 clinical trials are then undertaken in large patient populations to further evaluate dosage, to provide substantial evidence of clinical efficacy and to further test for safety in an expanded and diverse patient population at multiple, geographically dispersed clinical trial sites.

Manufacturing Facilities. Satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities where the drug is produced to assess compliance with Current Good Manufacturing Practice, or cGMP, requirements to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity.
New Drug Application (NDA) or Biologics License Application (BLA). The results of the nonclinical studies and clinical trials, together with other detailed information, including extensive manufacturing information and information on the composition of the drug and proposed labeling, are submitted to the FDA in the form of an NDA or BLA requesting approval to market the drug for one or more specified indications. The FDA reviews an application to determine, among other things, whether a drug is safe and effective for its intended use and whether the product is being manufactured in accordance with cGMP to assure and preserve the product's identity, strength, quality and purity. FDA approval of an NDA or BLA must be obtained before a drug may be offered for sale in the United States. The FDA may deny approval of an NDA or BLA if the applicable regulatory criteria are not satisfied, or it may require additional clinical data. Even if such data are submitted, the FDA may ultimately decide that the application does not satisfy the criteria for approval. Data from clinical trials are not always conclusive and the FDA may interpret data differently than we or our collaborators do. Once issued, the FDA may withdraw a drug approval if ongoing regulatory requirements are not met or if safety problems occur after the drug reaches the market. In addition, the FDA may require further testing, including Phase 4 clinical trials (post-marketing), and surveillance programs to monitor the effect of approved drugs which have been commercialized. The FDA has the power to prevent or limit further marketing of a drug based on the results of these post-marketing programs. Drugs may be marketed only for the approved indications and in accordance with the provisions of the approved label. Further, if there are any modifications to a drug, including changes in indications, labeling or manufacturing processes or facilities, we may be required to submit and obtain FDA approval of a new NDA or BLA or a supplement, which may require us to develop additional data or conduct additional pre-clinical studies and clinical trials. In addition, under the Pediatric Research Equity Act, or PREA, an NDA or supplement to an NDA must contain data to assess the safety and efficacy of the drug for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective. The FDA may grant deferrals for submission of pediatric data or full or partial waivers.
Satisfaction of FDA regulations and requirements or similar requirements of state, local and foreign regulatory agencies typically take several years, and the actual time required may vary substantially based upon the type, complexity and novelty of the product or disease. Typically, if a product candidate is intended to treat a chronic disease, as is the case with some of our product candidates, safety and efficacy data must be gathered over an extended period.
Other regulatory requirements
Any products manufactured or distributed by us or our collaborators (pursuant to FDA approval) are subject to continuing regulation by the FDA, including recordkeeping requirements and reporting of adverse experiences associated with the drug. Drug manufacturers and their subcontractors are required to register their establishments with the FDA and certain state agencies and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with ongoing regulatory requirements, including cGMP, which impose certain procedural and documentation requirements upon us and our third-party manufacturers. Failure to comply with the statutory and regulatory requirements can subject a manufacturer to possible legal or regulatory action, such as warning letters, suspension of manufacturing, seizure of product, injunctive action or possible civil penalties.
The FDA closely regulates the post-approval marketing and promotion of drugs, including standards and regulations for direct-to-consumer advertising, off-label promotion, industry-sponsored scientific and educational activities and promotional activities involving the Internet. A company can make only those claims relating to safety and efficacy that are approved by the FDA. Failure to comply with these requirements can result in adverse publicity, warning letters, corrective advertising and potential civil and criminal penalties. Physicians may prescribe legally available drugs for uses that are not described in the drug’s labeling and that differ from those tested by us and approved by the FDA. Such off-label uses are common across medical specialties. Physicians may believe that such off-label uses are the best treatment for many patients in varied circumstances. The FDA does not regulate the behavior of physicians in their choice of treatments. The FDA does, however, impose stringent restrictions on manufacturers’ communications regarding off-label use.
The federal anti-kickback statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or paying remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made, in whole or in part, under a federal healthcare program such as Medicare and Medicaid. This statute has been broadly interpreted to apply to manufacturer arrangements with prescribers, purchasers and pharmacy benefit managers, among others. Several other countries, including the National ServiceUnited Kingdom, have enacted similar anti-kickback laws and regulations.
The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program or for knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services. HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH Act, and its implementing regulations, also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information.

The federal Physician Payments Sunshine Act requirements under the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, referred to together as the Affordable Care Act, require manufacturers of FDA-approved drugs, devices, biologics and medical supplies covered by Medicare or Medicaid to report to the Department of Health and Human Services information related to payments and other transfers of value made to or at the request of covered recipients, such as physicians and teaching hospitals, and physician ownership and investment interests in such manufacturers. Among other payments, the law requires payments made to physicians and teaching hospitals for clinical trials be disclosed.
Analogous state laws and regulations, such as state anti-kickback and false claims laws, may apply to future potential sales or marketing arrangements and claims involving healthcare items or services reimbursed by nongovernmental third-party payors, including private insurers. Some state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines, or the relevant compliance guidance promulgated by the federal government, in addition to requiring drug manufacturers to report information related to payments to physicians and other health care providers or marketing expenditures to the extent that those laws impose requirements that are more stringent than the Physician Payments Sunshine Act. State and foreign laws also govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
Canada
Health Canada is the Canadian federal authority that regulates, evaluates and monitors the safety, effectiveness, and quality of drugs, medical devices, and other therapeutic products available to Canadians. Health Canada’s regulatory process for review, approval and regulatory oversight of products is similar to the regulatory process conducted by the FDA. To initiate clinical testing of a drug candidate in human subjects in Canada, a Clinical Trial Application (CTA) must be filed with and approved by Health Canada. In addition, all federally regulated trials must be approved and monitored by research ethics boards. The review boards study and approve study-related documents and monitor trial data.
Prior to being given market authorization for a drug product, a manufacturer must present substantive scientific evidence of a product’s safety, efficacy and quality as required by the Food Safety and Quality (SENASICA)Drugs Act (Canada) and its associated regulations, including the Food and Drug Regulations. This information is usually submitted in the form of a New Drug Submission (NDS). Health Canada reviews the submitted information, sometimes using external consultants and advisory committees, to evaluate the potential benefits and risks of a drug. If after of the review, the conclusion is that the patient benefits outweigh the risks associated with the drug, the drug is issued a Drug Identification Number (DIN), followed by a Notice of Compliance (NOC), which permits the market authorization holder (i.e., the National Commission of FisheriesNOC and Aquaculture (CONAPESCA), andDIN holder) to market the National Institute of Fisheries and Aquaculture (INAPESCA), all of which are administrative bodies of SAGARPA. We are alsodrug in Canada. Drugs granted an NOC may be subject to regulation, permittingadditional postmarket surveillance and oversight byreporting requirements.
All establishments engaged in the Secretariatfabrication, packaging/labeling, importation, distribution, and wholesale of drugs and operation of a testing laboratory relating to drugs are required to hold a Drug Establishment License to conduct one or more of the Environmentlicensed activities unless expressly exempted under the Food and Natural Resources (SEMARNAT), the Secretariat of Health’s Federal CommissionDrug Regulations. The basis for the Protection Against Sanitary Risks (COFEPRIS), and by and other state and local agencies.

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Good Manufacturing Practices

The FDA and other regulatory agencies regulate and inspect equipment, facilities and processes usedissuance of a Drug Establishment License is to ensure the facility complies with cGMP as stipulated in the manufacture of pharmaceuticalFood and biologic products prior to approving a product. If, after receiving approval from regulatory agencies, a company makes a material change in manufacturing equipment, location or process, additional regulatory reviewDrug Regulations and approval may be required. All facilities and manufacturing techniques used for the manufacture of our products must comply with applicable regulations governing the productionas determined by cGMP inspection conducted by Health Canada. An importer of pharmaceutical products known as Current Good Manufacturing Practices. These requirements include, among other things, quality control, quality assurancemanufactured at foreign sites must also be able to demonstrate that the foreign sites comply with cGMP, and such foreign sites are included on the maintenance of recordsimporter’s Drug Establishment License.

Regulatory obligations and documentation. We are responsible for regularly assessing compliance with GMP requirements through record reviews and periodic audits and for ensuring that we take corrective action for any identified deficiencies.

The FDA and other regulatory agencies also conduct regular, periodic visits to re-inspect equipment, facilities and processesoversight continue following the initial market approval of a pharmaceutical product. If, asFor example, every market authorization holder must report any new information received concerning adverse drug reactions, including timely reporting of serious adverse drug reactions that occur in Canada and any serious unexpected adverse drug reactions that occur outside of Canada. The market authorization holder must also notify Health Canada of any new safety and efficacy issues that it becomes aware of after the launch of a resultproduct.

Employees
As of these inspections, it is determined that our equipment, facilities or processes do not comply with applicable regulations and conditions of product approval, regulatory agencies may issue warning or similar letters or may seek civil, criminal, or administrative sanctions against us. To date,December 2, 2020, we have not been subject to inspection by the FDA or other drug regulatory agency because none of our customers or partners has filed an application12 full-time employees: five employees are primarily engaged in any country for marketing approval of a product encompassing our Stellar KLH protein.

New Drug Development

None of our KLH products have been subject to approval as a drug by any regulatory authority. However, a number of our customersresearch and strategic partnersdevelopment, and seven employees are utilizing Stellar KLHengaged in themanagement, administration, business development of pharmaceuticals and immunotherapies thatfinance. All employees are subject to the regulatory approval processlocated in various jurisdictions. The regulatory approval process for new drugs under development by our customers is typically long and expensive. Clinical trials that they conduct may not be successful and such products may not receive regulatory approval. Delays by our customers in obtaining,Canada or the inability to obtain, regulatory approvals for their products which use Stellar KLH will have a direct effect on the demand for our products.

Employees

As of November 30, 2017, we had 28 employees. We consider our employee relations to be good.U.S. None of our employees are representedmembers of any labor unions.

Legal Proceedings
We are not currently subject to any material legal proceedings.

Business Combination
On June 7, 2019, we completed a business combination with Edesa Biotech Research, Inc., formerly known as Edesa Biotech Inc. (“Edesa Research”), a company organized under the laws of the province of Ontario in 2015, in accordance with the terms of a Share Exchange Agreement, dated March 7, 2019, by and among the Company, Edesa Research and the shareholders of Edesa Research. At the closing of the transaction, we acquired the entire issued share capital of Edesa Research, with Edesa Research becoming a labor union or collective bargaining agreement.

wholly owned subsidiary of ours. Also on June 7, 2019, in connection with and following the completion of the reverse acquisition, we effected a 1-for-6 reverse split of our Common Shares and changed our name to “Edesa Biotech, Inc.” At the closing of the transaction, the Edesa Research shareholders exchanged their shares for 88% of our outstanding shares on a fully diluted basis.


Corporate Information

We are incorporated under the laws of British Columbia, Canada, and operate through our wholly-owned subsidiary, Stellar Biotechnologies,wholly owned subsidiaries, Edesa Biotech Research, Inc. an Ontario, Canada corporation and Edesa Biotech USA, Inc., a California, USA corporation which was organized September 9, 1999. Wefounded in 1999 (formerly known as Stellar Biotechnologies, Inc. prior to November 2020). In June 2019, we acquired the Ontario corporation through a reverse acquisition and changed our name from Stellar Biotechnologies, Inc. to Edesa Biotech, Inc. We subsequently changed the name of the Ontario subsidiary on April 12, 2010to Edesa Biotech Research, Inc. (formerly Edesa Biotech Inc.). The California subsidiary was acquired through a reverse merger and began trading onin April 2010, when the TSX Venture Exchange (TSX-V) under the symbol “KLH” on April 19, 2010. We were originally incorporated in Canada on June 12, 2007 under the name China Growth Capital, Inc. and subsequently changed our name to CAG Capital, Inc. on April 15, 2008. We began trading on the TSX Venture Exchangecompany was organized as a Canadian capital pool company on August 29, 2008, and became a British Columbia corporation on November 25, 2009. Our reverse merger in April 2010 constituted our “qualifying transaction” under Canadian law, at which time we changed our name to Stellar Biotechnologies, Inc. In January 2013, we began trading on the U.S. OTCQB Marketplace Exchange under the symbol “SBOTF” and, on November 5, 2015, our common shares began trading on The Nasdaq Capital Market (Nasdaq) under the symbol “SBOT.” On March 29, 2016, at our request, our common shares were voluntarily delisted from the TSX-V in Canada and ceased trading on the TSX-V as of the close of business on April 8, 2016.

company.

Our executive offices are located at 332 East Scott Street, Port Hueneme, California 93041.100 Spy Court, Markham, Ontario, L3R 5H6, Canada. Our phone number is (805) 488-2800.289-800-9600. Our registered and records office is 2900 - 550 Burrard Street, Vancouver, British Columbia, V6C 0A3, Canada. Our website address is www.stellarbiotechnologies.com.www.edesabiotech.com. The contents of our website are not part of this Annual Report on Form 10-Kour SEC reports for any purpose or otherwise incorporated by reference. OurAny references to website address is included for informationaddresses contained in this report are intended to be inactive textual references only.

Available Information

We file or furnish periodic reports and amendments thereto, including our annual reports on Form 10-K, our quarterly reports on Form 10-Q and current reports on Form 8-K, proxy statements and other information with the SEC,U.S. Securities and amendments to suchExchange Commission (SEC). Such reports and other information filed or furnished pursuant to Section 13(a) or 15(d)by us with the SEC are available free of the Securities Exchange of 1934, as amended,charge on our website at www.edesabiotech.com/investors/sec-filings as soon as reasonably practicable after we electronically file or furnish such materials toreports are available on the SEC. Such reports andSEC’s website at www.sec.gov. Our filings may be obtainedare also available at the Canadian Securities Administrators’ SEDAR website at www.sedar.com.
Smaller Reporting Company
We are currently a “smaller reporting company” as defined by visiting the Public Reference RoomRule 12b-2 of the SEC at 100 F Street, NE, Washington, D.C. 20549, by callingSecurities Exchange Act of 1934 (Exchange Act), and are thus allowed to provide simplified executive compensation disclosures in our filings, are exempt from the SEC at (800) SEC-0330 or by sendingprovisions of Section 404(b) of the Sarbanes-Oxley Act requiring that an email toindependent registered public accounting firm provide an attestation report on the SEC at publicinfo@sec.gov. In addition, the SEC maintains a website (www.sec.gov) that contains reports, proxyeffectiveness of internal control over financial reporting and information statements, andhave certain other information regarding issuers that file electronicallyreduced disclosure obligations with the SEC. Our reports, proxy statements and other information are also made available, free of charge, on our investor relations website at ir.stellarbiotechnologies.com as soon as reasonably practicable after we electronically file such information with the SEC. Referencesrespect to our corporate website address (www.stellarbiotechnologies.com) in this Annual Report on Form 10-K are intended to be inactive textual references only, and none of the information contained on our website is part of this report or incorporated in this report by reference.

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SEC filings.

Item 1A.RISK FACTORS.

Item 1A.RISK FACTORS.
Certain factors may have a material adverse effect on our business, prospects, financial conditionscondition and results of operations. You should carefully consider the risks and uncertainties described below together with all of the other information contained in this Annual Report on Form 10-K, including our financial statements and the related notes, before deciding to invest in our common shares. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties not presently known to us or that we currently believe to be immaterial may also adversely affect our business. If any of the following risks actually occurs, our business, financial condition, results of operations and future prospects could be materially and adversely affected.

Risks Related to Our Business

We have a history of netincurred significant losses since our inception and expect to continue to incur losses and limited cash flow to sustain our operations.

We currentlymay never generate profits from operations or maintain profitability.

Since inception, we have limited revenue from product sales of Stellar KLH, and anticipate our planned totalincurred significant operating expenses will be greater than our revenues for the foreseeable future. We incurred net losses of $5.03 million in fiscal 2017, $5.03 million in fiscal 2016, and $2.84 million in fiscal 2015.losses. As of September 30, 2017,2020, we have an accumulated deficit of $45.4 million since inception. To date, we have not paid dividends on our common shares and do not anticipate doing so in the foreseeable future.$13.1 million. We have historically relied upon the salefinanced operations primarily through issuances of common shares, the exercise of common share purchase warrants, convertible preferred shares, convertible loans, government grants and tax incentives. We have devoted substantially all of our efforts to help fundresearch and development, including clinical trials, and have not completed the development of any of our drug candidates.

We expect to continue to incur significant expenses and operating losses for the foreseeable future as we continue the development of, and seek marketing approvals for our product candidates, prepare for and begin the commercialization of any approved products, and add infrastructure and personnel to support our product development efforts and operations as a public company in the United States and Canada. The net losses we incur may fluctuate significantly from quarter to quarter and year to year.
Based on our current plans, we do not expect to generate significant revenue unless and until we or a current or potential future licensee obtains marketing approval for, and commercializes, one or more of our product candidates, which may require several years. Neither we nor a licensee may ever succeed in obtaining marketing approval for, or commercializing our product candidates and, even if marketing approval is obtained, we may never generate revenues that are significant enough to generate profits from operations.

We will need substantial additional funding to finance our operations through regulatory approval of one or more of our product candidates. If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.
We expect our research and meetdevelopment expenses to increase substantially in the future, particularly if we advance any drug candidates beyond Phase 2 clinical development or expand the number of drug candidates in clinical studies. In addition, if we obtain marketing approval for any of our obligations. Anyproduct candidates that are not then subject to licensing, collaboration or similar arrangements with third parties, we expect to incur significant commercialization expenses related to product sales, marketing, distribution and manufacturing. If we are unable to raise capital when needed, or on attractive terms, we could be forced to delay, reduce or eliminate research and development programs or future commercialization efforts.
We depend heavily on the success of our drug product candidates. If we are unable to obtain regulatory approval or commercialize one or more of these experimental treatments, or experience significant delays in doing so, our business will be materially harmed.
Our ability to generate product revenues, which may not occur for multiple years, if at all, will depend heavily on the successful development and commercialization of our drug product candidates. The success of our product candidates will depend on a number of factors, including the following:
our ability to obtain additional capital from potential future licensing, collaboration or similar arrangements or from any future offering of our debt or equity financing would cause dilutionsecurities;
our ability to current shareholders. identify and enter into potential future licenses or other collaboration arrangements with third parties and the terms of the arrangements;
our timing to obtain applicable regulatory approvals;
successful completion of clinical development;
the ability to provide acceptable evidence demonstrating a product candidates’ safety and efficacy;
receipt of marketing approvals from applicable regulatory authorities and similar foreign regulatory authorities;
the availability of raw materials to produce our product candidates;
obtaining and maintaining commercial manufacturing arrangements with third-party manufacturers or establishing commercial-scale manufacturing capabilities;
obtaining and maintaining patent and trade secret protection and regulatory exclusivity;
establishing sales, marketing and distribution capabilities;
generating commercial sales of the product candidate, if and when approved, whether alone or in collaboration with others;
acceptance of the product candidate, if and when approved, by patients, the medical community and third-party payors;
effectively competing with other therapies; and
maintaining an acceptable safety profile of the product candidate following approval.
If we do not have sufficient capital forachieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize any of our operations, management would be forced to reduce or discontinue our activities,product candidates, which would materially harm our business. Many of these factors are beyond our control. Accordingly, we may never be able to generate revenues through the license or sale of any of our product candidates.

Public health threats could have a negativean adverse effect on our operations and financial condition.

results.

Public health threats could adversely affect our ongoing or planned research and development activities, particularly SARS-CoV-2 (which causes the disease now called COVID-19). The outbreak of COVID-19 has severely impacted global economic activity and caused significant volatility and negative pressure in financial markets. The global impact of the outbreak has been rapidly evolving and many countries, including the United States, have reacted by instituting quarantines, mandating business and school closures and restricting travel. As a result, the COVID-19 pandemic is negatively impacting almost every industry directly or indirectly. We depend heavilycannot presently predict the scope and severity of any potential business shutdowns or disruptions, but if we or any of the third parties with whom we engage, including the suppliers, clinical trial sites, regulators and other third parties with whom we conduct business, were to experience shutdowns or other business disruptions, our ability to conduct our business in the manner and on the timelines presently planned could be materially and negatively impacted. Global epidemics, such as the coronavirus, could also negatively affect site activation, as well as recruitment and retention, at sites in a region or city whose health care system becomes overwhelmed due to the illness, which could have a material adverse effect on our business and our results of operation and financial condition.

Our limited operating history may make it difficult for you to evaluate the success of our business to date and market acceptanceto assess our future viability.
Our primarily operating entity, Edesa Biotech Research, Inc. was formed in July 2015. To date, our operations have been limited to organization and staffing, developing and securing our technology, entering into licensing arrangements, raising capital and undertaking preclinical studies and clinical trials of Stellar KLHour product candidates. We have not yet demonstrated our ability to successfully complete development of any product candidate, obtain marketing approval, manufacture a commercial scale product, or arrange for a third-party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization. Assuming we obtain marketing approval for any of our product candidates, we will need to transition from a company with a research and development focus to a company capable of supporting commercial activities. We may encounter unforeseen expenses, difficulties, complications and delays and may not be successful in such a transition. Any predictions made about our future success or viability may not be as accurate as they could be if we had a longer operating history.
We may not be successful in our efforts to identify and acquire or in-license additional product candidates.
Part of our strategy involves diversifying our product development risk by identifying and acquiring or in-licensing novel product candidates. We may fail to identify and acquire or in-license promising product candidates. The competition to acquire or in-license promising product candidates is fierce, especially from large multinational companies that have greater resources and experience than we have. If we are unable to identify and acquire or in-license suitable product candidates, we will be unable to diversify our product risk. We believe that any such failure could have a significant negative impact on our prospects because the risk of failure of any particular development program in the pharmaceutical field is high.
We may expend our limited resources to pursue a particular product candidate and fail to capitalize on product candidates that may be more profitable or for which there is a greater likelihood of success.
Because we have limited financial and managerial resources, we focus on specific product candidates. As a result, we may never recoupforego or delay pursuit of opportunities with other product candidates that later could prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. If we do not accurately evaluate the commercial potential or target market for a particular product candidate, our investment into itsbusiness may be negatively impacted.
Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
We are highly dependent on Dr. Pardeep Nijhawan, our Chief Executive Officer and Secretary; and Michael Brooks, our President; as well as other principal members of our management and scientific teams. Although we have employment agreements with each of our executive officers, these agreements do not prevent our executives from terminating their employment with the company at any time. The unplanned loss of the services of any of these persons could materially impact the achievement of our research, development, financial and commercialization objectives. Recruiting and retaining qualified personnel, including in the United States and Canada, will also be critical to our success. We may not be able to attract and retain these personnel on acceptable terms given the competition among numerous biotechnology and pharmaceutical companies for similar personnel. In addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development.

development and commercialization strategy. Our consultants and advisors may have commitments with other entities that may limit their availability to us.


We have investedexpect to expand our capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
We expect to experience growth in the number of our employees and the scope of our operations, particularly in the areas of drug development, regulatory affairs, finance and administration and, potentially, sales and marketing. To manage our anticipated future growth, we must continue to implement and improve our managerial, operational and financial systems, expand our facilities and continue to recruit and train additional qualified personnel. We may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel. The physical expansion of our operations may lead to significant costs and may divert our management and business development resources. Any inability to manage growth could delay the execution of our business plans or disrupt our operations.

We are exposed to risks related to currency exchange rates.
We conduct a significant portion of our timeoperations outside of the United States. Because our financial statements are presented in U.S. dollars, changes in currency exchange rates have had and financial resources into the development of Stellar KLH. We anticipate thatcould have in the near termfuture a significant effect on our ability to generate revenues will depend solely on the commercial success of Stellar KLH, which depends upon its market acceptance by purchasers in the pharmaceutical market and the future market demand and medical need for products and research utilizing KLH. The degree of market acceptance of Stellar KLH depends on a number of factors including: the advantages and disadvantages of Stellar KLH as compared to other KLH proteins;operating results when our ability to educate the industry about the high quality, sustainable and traceable qualities of Stellar KLH; product efficacy; customer service; and the price and demonstrated cost-effectiveness of Stellar KLH as compared to our competitors.

Our customers face uncertainties related to regulatory approval, which could reduce the market for our products.

A primary market for our Stellar KLH products is its use as a component of active immunotherapies under development. The pharmaceutical industry isoperating results are translated into U.S. dollars.

We are subject to significant government regulation, which varies from countryanti-corruption laws, as well as export control laws, customs laws, sanctions laws and other laws governing our operations. If we fail to country. Many of the products being developed by our customers that utilize our Stellar KLH are not yet approved for commercial sale. Before regulatory approvals for the commercial sale of any drug is granted,comply with these laws, it must be demonstrated through preclinical research and clinical trials to be safe and effective for its intended use in humans. The process to determine safety and efficacy, including clinical trials, is expensive, prolonged and uncertain. The time necessary to complete these processes and clinical trials, and to submit applications for regulatory approvals, is difficult to predict and is subject to numerous factors outside of our control. Such clinical trials may not be successful. Larger or later stage clinical trials may not produce the same results as earlier trials. Successful results in clinical trials may not result in regulatory approval, due to certain factors including unacceptable side effects or safety issues. If regulatory approval is granted for any drug or product that utilizes Stellar KLH, it willcould be subject to ongoing regulatory requirements, which include registration, manufacturing, labeling, advertisingcivil or criminal penalties, other remedial measures and promotion, packaging, distribution, record keeping and reporting, and storage. Manufacturing facilities, both those operated by us and by our contractors, would be subject to continual review and inspection, and failure to meet these regulatory requirements can interrupt, delay, or shut down these facilities. Previously unknown problems may result in regulatory restrictions on such products, including withdrawal from the marketplace. Delays in obtaining regulatory approvals for products developed by our customers that use Stellar KLH, or failure to obtain or maintain regulatory approvals altogether, would have a negative effect on market demand for our Stellar KLH products, and have a negative effect on our operations and financial condition.

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Our business is geographically concentrated and if a catastrophic event, such as a hurricane, an earthquake or coastal flooding, were to impact our facilities, our business may be disruptedlegal expenses, which could result in serious harm toadversely affect our business, results of operations and financial condition.

Our aquaculture operations research and manufacturing facilities, laboratory space, and executive offices are all located in Port Hueneme, California, a coastal city located along the Pacific Ocean. To date, we have conducted all of our aquaculture operations, research and manufacturing at these facilities and we currently have no active backup facilities or second sites. In January 2017, we established a wholly owned Mexican subsidiary to support our plan to establish additional aquaculture capabilities in Baja California, including the development of regional marine resources, aquaculture and raw material processing for Stellar’s KLH products. However, we do not anticipate the site to be available for manufacture and production until 2019 at the earliest. There can be no assurance that these expansion plans will result in successful development of additional sites of research and manufacturing and KLH production outside of our Port Hueneme location. If a hurricane, an earthquake or other natural disaster, including coastal flooding, or a virus affecting our limpet colony, were to impact our facilities, we may be unable to manufacture our KLH products, which would have a serious disruptive impact on our business and a material adverse effect on our results of operations and financial condition. While we carry personal property insurance, such insurance may not be adequate to compensate us for losses from any damage or interruption of our business operations resulting from a hurricane, an earthquake, coastal flooding or other catastrophic event.

Government and geopolitical changes may impede the implementation of our strategy outside the United States.

Changes in geopolitical policies of the United States, such as changes in U.S. support for existing treaty and trade relationships with other countries, may adversely impact (i) the ability or willingness of non-U.S. companies to transact business in the United States, including with Stellar (ii) regulation and trade agreements affecting U.S. companies, (iii) global stock markets (including The Nasdaq Capital Market on which our common shares are traded), and (iv) general global economic conditions. These factors are outside of our control, but may nonetheless cause us to adjust our strategy in order to compete effectively in global markets.

Our joint venture with Neovacs involves numerous risks that could adversely impact our financial results.

In May 2016, we entered into a strategic relationship with Neovacs S.A. to manufacture and sell conjugated therapeutic vaccines through a newly-formed joint venture entity in France called Neostell S.A.S. This relationship is subject to various risks that could adversely affect the value of our investments and our results of operations. These risks include the following:

our interests could diverge from those of Neovacs or we may not be able to agree on ongoing manufacturing and operational activities, or on the amount, timing, or nature of further investments in Neostell;

we may experience difficulties in transferring technology to Neostell;

we may experience difficulties and delays in manufacturing and production at Neostell;

as a minority partner, our control over the operations of Neostell is limited;

Neovacs may be unable to meet its commitments to us or to Neostell, which may pose credit risks for our transactions with them;

due to differing business models or long-term business goals, we and Neovacs may not participate to the same extent on funding capital investments in Neostell;

our working capital or cash flows may be inadequate to fund increased capital requirements in Neostell;

we may experience difficulties or delays in collecting amounts due to us from Neostell and/or Neovacs due to multinational financial regulations or geopolitical forces beyond our control; and

shifts in the geopolitical landscape may result in tax, legal, or regulatory changes in the United States, France and/or the European Union, thereby necessitating amendments to the agreements with Neovacs and/or the structure of the joint venture.

If our joint venture with Neovacs is unsuccessful, our business, results of operations, or financial condition may be materially adversely affected.

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Our expansion plans include the design and development of aquaculture infrastructure and KLH production in Mexico which presents substantial risks to our business and personnel. We may never recoup our investment into this location.

We plan to establish additional aquaculture capabilities in Baja California,anti-corruption laws, including the development of regional marine resources, aquaculture and raw material processing for Stellar’s KLH products. There are certain administrative, legal, governmental and societal risks to operating in Mexico that could adversely impact our ability to expand our operations there. Any one or more of the risks that could adversely affect our ability to successfully implement our expansion and therefore ultimately have a material adverse effect on our business, financial condition and results of operations include, without limitation:

geopolitical factors could adversely impact the ongoing relationship between the United States and Mexico and/or the continuity of the North American Free Trade Agreement, or NAFTA, in its present form;

regional political and economic instability;

ability to hire and maintain a significant work force;

burdensome and evolving government regulations;

cooperation of various departments of the Mexican government in issuing permits, and inspecting our operations on a timely basis;

providing adequate security for our employees; and

change in the value of the Mexican peso.

In addition, our international operations are governed by the U.S. Foreign Corrupt Practices Act, or the FCPA, and other anti-corruption laws that apply in countries where we do business and may do business in the future. The FCPA and these other laws generally prohibit us, our officers, and our employees and intermediaries from bribing, being bribed or making other prohibited payments to government officials or other persons to obtain or retain business or gain some other business advantage. We may in the future operate in jurisdictions that pose a high risk of potential FCPA violations, and we may participate in collaborations and relationships with third parties whose actions could potentially subject us to liability under the FCPA or local anti-corruption laws. We are also subject to other laws and regulations governing our international operations, including regulations administered by the government of the United States and authorities in the European Union, including applicable export control regulations, economic sanctions on countries and persons, customs requirements and currency exchange regulations, collectively referred to as the Trade Control laws. There is no assurance that we will be completely effective in ensuring our compliance with all applicable anti-corruption laws, including the FCPA or other legal requirements, including Trade Control laws. If we are not in compliance with the FCPA and other anti-corruption laws or Trade Control laws, we may be subject to criminal and civil penalties, disgorgement and other sanctions and remedial measures, and legal expenses, which could have an adverse impact on our business, financial condition, results of operations and liquidity. Likewise, any investigation of any potential violations of the FCPA, other anti-corruption laws or Trade Control laws by U.S. or other authorities could also have an adverse impact on our reputation, our business, results of operations and financial condition.

Our employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading, which could cause significant liability for us and harm our reputation.
We are exposed to the risk of fraud or other misconduct by our employees, principal investigators, consultants and collaborators, including intentional failures to comply with FDA or Office of Inspector General regulations or similar regulations of comparable non-U.S. regulatory authorities, provide accurate information to the FDA or comparable non-U.S. regulatory authorities, comply with manufacturing standards we have established, comply with federal and state healthcare fraud and abuse laws and regulations and similar anti-corruption laws outsideand regulations established and enforced by comparable non-U.S. regulatory authorities, report financial information or data accurately or disclose unauthorized activities to us. Misconduct by these parties could also involve the U.S. Global enforcementimproper use of anti-corruptioninformation obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. It is not always possible to identify and deter misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws, has increased substantiallystandards or regulations. If any such actions are instituted against us, and we are not successful in recent years, with more enforcement proceedings by U.S.defending ourselves or asserting our rights, those actions could have a significant impact on our business and foreign governmental agencies andresults of operations, including the imposition of significant fines or other sanctions.
We rely significantly on information technology and penalties. Whileany failure, inadequacy, interruption or security lapse of that technology, including any cyber security incidents, could harm our ability to operate our business effectively.
Despite the implementation of security measures, our internal computer systems and those of third parties with which we contract are vulnerable to damage from cyber-attacks, computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. System failures, accidents or security breaches could cause interruptions in our operations, and could result in a material disruption of ours clinical and commercialization activities and business operations, in addition to possibly requiring substantial expenditures of resources to remedy. The loss of clinical trial data could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and our product research, development and commercialization efforts could be delayed.

The wind down of our Stellar subsidiary’s legacy business may not deliver the expected results or may create unexpected liabilities.
Following the business combination completed in June 2019, we refocused our business on the development of innovative therapeutics for inflammatory and immune-related diseases. Since then, we have implemented policiesplans to sell off or wind down the principal assets and proceduresoperations of our Stellar subsidiary’s legacy business, which includes product inventory. We cannot be sure that the sale and wind down of Stellar’s operations will eliminate costs related to enhance compliance with these laws, our international operations create the risk that there may be unauthorized paymentslegacy business; or offers of payments made by employees, consultants, sales agentsresult in any unplanned expenditures or distributors. Any allegedunknown, contingent or actual violations of these laws may subject us to government investigations, significant criminal or civil sanctions and other liabilities, and negatively affectincluding litigation arising in connection with legacy operations or sales of Stellar’s product inventory. If our reputation.

Our sales in international markets subject us to foreign currency exchangeplans do not achieve the expected results, our business and other risks and costs, which could harm our business.

Substantial portions of our revenues are derived from outside the United States; primarily from Europe and Asia. We anticipate that revenues from international customers will continue to represent a substantial portion of our revenues for the foreseeable future. All our revenues are generated in U.S. dollars. However, if the effective price of our products were to increase as a result of fluctuations in foreign currency exchange rates, demand for our products could decline and adversely affect our results of operations will be adversely impacted.

Risks Related to Clinical Development, Regulatory Approval and financial condition.

We competeCommercialization

If clinical trials of our product candidates fail to demonstrate safety and efficacy to the satisfaction of the FDA, Health Canada (HC) or the European Medicines Agency (EMA), or do not otherwise produce favorable results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization our product candidates.
In connection with other companiesobtaining marketing approval from regulatory authorities for the sale of any product candidate, we must complete preclinical development and then conduct extensive clinical trials to demonstrate the safety and efficacy of our product candidates in KLH productionhumans. Clinical trials are expensive, difficult to design and manufacturing that may have greater resources than we do.

implement, can take many years to complete and are uncertain as to outcome. A failure of one or more clinical trials can occur at any stage of testing. The immunotherapy industry is rapidly evolvingoutcome of preclinical testing and new competitors with competing technologies and products are regularly entering the market. Our Stellar KLH products are similar to KLH-based products produced by other companies. While we believe we are the only company that offers GMP grade KLH supported by fully traceable manufacturing methods, weearly clinical trials may not be predictive of the success of later clinical trials. In particular, the small number of subjects and patients in early clinical trials of our product candidates may make the results of these clinical trials less predictive of the outcome of later clinical trials. The design of a clinical trial can determine whether our results will support approval of a product, and flaws in the design of a clinical trial may not become apparent until the clinical trial is well advanced or completed. There is no assurance that we will be able to maintain our competitive position against currentdesign and potential competitors. We compete directly with Biosyn Corporation,execute a clinical trial to support marketing approval. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of their products.

Positive results in pre-clinical studies of a product candidate may not be predictive of similar results in humans during clinical trials, and promising results from early clinical trials of a product candidate may not be replicated in later clinical trials. A number of companies in the pharmaceutical and biotechnology company which manufactures KLH starting materialindustries have suffered significant setbacks in late-stage clinical trials even after achieving promising results in early-stage development. Accordingly, the results from completed pre-clinical studies and offers clinical and research grade KLH products. We also compete directly with SAFC, a division of Sigma-Aldrich, which offers clinical and research grade KLH products. Some oftrials for our competitors, both public and private, have greater financial and personnel resources than us, and have greater sales and marketing experience in the industry than us. If they are able to produce and sell comparable KLH products for less than us, it will have a negative effect on our operations and financial position. In addition to competition from current suppliers of KLH, we also face indirect competition from developers of other carrier proteins, adjuvants or therapeutic vaccine platforms. We are unable to predict what effect evolution of the KLH and immunotherapy industries and potential new entrants may have on price, selling strategies, intellectual property or our competitive position.

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Weproduct candidates may not be able to meet demand for KLH from either internally raised or ocean harvest sources.

We are dependent upon a supply of Giant Keyhole Limpets (Megathura crenulata) for KLH production. The rangepredictive of the Giant Keyhole Limpetresults we may obtain in the wild is limited,later stage trials or studies. Pre-clinical studies or clinical trials may produce negative or inconclusive results, and duewe may decide, or regulators may require us, to the lack of a regulated harvest, the wild stocks of Giant Keyhole Limpets are believedconduct additional pre-clinical studies or clinical trials, or to be declining. If the wild stocks are depleted, and our hatchery and aquaculture operations are unable to produce sufficient supplies of captive Giant Keyhole Limpets to meet demand, it would have a negative effect on our operations and financial condition.

We may not be able to manufacture our products in commercial quantities and currently depend on third parties for certain steps in our manufacturing operations, which could prevent us from marketing our products.

The manufacture of pharmaceutical starting materials like KLH requires significant expertise, including the development of advanced manufacturing techniques and process controls. We may encounter difficulties in production, particularly in scaling up production. These problems include difficulties with production costs and yields, quality control, including stability of the product and quality assurance testing, shortages of qualified personnel, as well as compliance with federal, state and foreign regulations.

In addition,discontinue clinical trials altogether. Ultimately, we contract with third party vendors, including contract manufacturing organizations and contract testing organizations, for certain steps in the manufacture and testing of our products, and may be unable to establish and maintain relationships with qualified vendors in order to produce sufficient supplies of our finished products.

We are currently dependent upon a small number of contractors and locations for certain steps in our manufacturing operations, namely product release testing. We do not currently have backup manufacturing capacity for some of our key products. If we are unable to retain our current contractors, or are unable to obtain new contractors to provide manufacturing services in a timely manner and on similar terms, it will have a negative effect on our operations. Further, these contract manufacturers and testing organizations provide services to many biotechnology and research companies, and such third party contractors may not provide acceptable quality, quantity or costs required by us. In addition, they may not be able to provide the services required on a schedule acceptable to us. These issues may result in us being unable to manufacture our products in the required quantities or at an acceptable cost, which would have a negative effect on our operations and financial condition.

We have been, and expect to continue to be in the future, significantly dependent on collaboration and supply agreements forcomplete the development and salescommercialization of Stellar KLH.

In conductingany of our researchproduct candidates.

Interim results, top-line, initial data may not accurately reflect the complete results of a particular study or trial.
We may publicly disclose interim, top-line or initial data from time to time that is based on a preliminary analysis of then-available efficacy and developmentsafety data, and commercialization activities, we currently rely,the results and expect to continue to rely, on collaborationrelated findings and supply agreements with third parties, such as contract research organizations, commercial partners, universities, governmental agencies and not-for-profit organizations, for strategic, technological, and financial resources. The inability to secure agreements on acceptable terms, the termination of these relationships, changes in our strategy or development plans or those of third parties, or failure to perform by us or third parties whoconclusions are subject to change following a more comprehensive review of the data related to the particular study or trial. We also make assumptions, estimates, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully evaluate all data. Interim, top-line and initial data should be viewed with caution until the final data are available. In addition, the information we may publicly disclose regarding a particular preclinical or clinical study is based on what is typically extensive information, and you or others may not agree with what we determine is the material or otherwise appropriate information to include in our disclosure, and any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular drug, drug candidate or our business. If the interim, top-line or initial data that we report differ from actual results, or if others, including regulatory competitiveauthorities, disagree with the conclusions reached, our ability to obtain approval for, and other risks, under their respective agreementscommercialize, our product candidates may be harmed or arrangements with us, would substantially disrupt or delay our research and development and commercialization activities, including anticipated commercial sales. Any such loss would likely increase our expenses and materiallydelayed, which could harm our business, financial condition, operating results or prospects. 
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If clinical trials for our product candidates are prolonged or delayed, we may be unable to commercialize our product candidates on a timely basis, which would require us to incur additional costs and delay our receipt of any revenue from potential product sales.
We cannot predict whether we will encounter problems with any of our ongoing or planned clinical trials that will cause us or any regulatory authority to delay or suspend those clinical trials. A number of events, including any of the following, could delay the completion of our ongoing and planned clinical trials and negatively impact our ability to obtain regulatory approval for, and to market and sell, a particular product candidate:
conditions imposed by the FDA or any foreign regulatory authority regarding the scope or design of our clinical trials;
delays in obtaining, or the inability to obtain, required approvals from institutional review boards, or IRBs, or other reviewing entities at clinical sites selected for participation in our clinical trials;
insufficient supply or deficient quality of product candidates supply or materials to produce our product candidates or other materials necessary to conduct our clinical trials;
delays in obtaining regulatory agreement for the conduct of the clinical trials;
lower than anticipated enrollment and retention rate of subjects in clinical trials for a variety of reasons, including size of patient population, nature of trial protocol, the availability of approved effective treatments for the relevant disease and competition from other clinical trial programs for similar indications;
serious and unexpected drug-related side effects experienced by patients in clinical trials;
failure of third-party contractors to meet their contractual obligations in a timely manner;
pre-clinical or clinical trials may produce negative or inconclusive results, which may require us or any potential future collaborators to conduct additional pre-clinical or clinical testing or to abandon projects that we expect to be promising;
even if pre-clinical or clinical trial results are positive, the FDA or foreign regulatory authorities could nonetheless require unanticipated additional clinical trials;
regulators or institutional review boards may suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements;
product candidates may not have the desired effects; and
the lack of adequate funding to continue clinical trials.
Additionally, changes in standard of care or regulatory requirements and guidance may occur and we may need to amend clinical trial protocols to reflect these changes. Such amendments may require us to resubmit our clinical trial protocols to IRBs for re-examination, which may impact the cost, timing or successful completion of a clinical trial. Such changes may also require us to reassess the viability of the program in question.
We do not know whether our clinical trials will begin as planned, will need to be restructured or will be completed on schedule, if at all. Delays in clinical trials will result in increased development costs for our product candidates. In addition, if we experience delays in completion of, or if we terminate, any of our clinical trials, the commercial prospects for our product candidates may be affected and our ability to generate product revenues will be delayed. Furthermore, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of a product candidate.
The clinical trial designs, endpoints and outcomes that will be required to obtain marketing approval for our drug candidates are uncertain. We may never receive marketing approval for our drug candidates.
To our knowledge, there are currently no FDA-approved drug treatment options specifically approved for many of the disease indications we are targeting with our drug candidates. Accordingly, there may not be well-established development paths and outcomes. The FDA, Health Canada or any other regulatory authority outside of the United States may determine that the designs or endpoints of any trial that we conduct, or that the outcome shown on any particular endpoint in any trial that we conduct, are not sufficient to establish a clinically meaningful benefit for our drug candidates, or otherwise, to support approval, even if the primary endpoint(s) of the trial is met with statistical significance. If this occurs, our business could be materially harmed. Moreover, if the regulatory authorities require us to conduct additional clinical trials beyond the ones that we currently contemplate, our finances and results from operations will be adversely impacted. If our clinical studies meet their respective primary endpoints, we plan to request an end of operation.

Phase 2 meeting with the regulators and/or seek marketing approval. We cannot predict whether each of these regulatory agencies will agree that our study data and information will be sufficient to meet the requirements for filing a marketing application or the standards for approval. If the regulatory agencies determine that more data and information are needed, it could delay and/or negatively impact our ability to obtain regulatory approval to market and sell a particular product candidate.



If the commercial opportunity in chronic ACD or COVID-19-induced ARDS is smaller than we anticipate, our future revenue from EB01 or EB05, as applicable, will be adversely affected and our business will suffer.
It is critical to our ability to grow and become profitable that we successfully identify patients with chronic ACD or COVID-19-induced ARDS. Our projections of the number of people who have these conditions as well as the subset who have the potential to benefit from treatment with EB01 or EB05, are based on a variety of sources, including third-party estimates and analyses in the scientific literature, and may prove to be incorrect. Further, new information may emerge that changes our estimate of the prevalence of these diseases or the number of patient candidates for these drug candidates. The effort to identify patients for our other potential target indications is at an early stage, and we cannot accurately predict the number of patients for whom treatment might be possible. Additionally, the potentially addressable patient population for our drug candidates may be limited or may not be amenable to treatment with our drug candidates, and new patients may become increasingly difficult to identify or access. If the commercial opportunity for these conditions is smaller than we anticipate, our future financial performance may be adversely impacted.

While we have chosen to test our product candidates in specific clinical indications based in part on our understanding of their mechanisms of action, our understanding may be incorrect or incomplete and, therefore, our product candidates may not be effective against the diseases tested in our clinical trials.
Our rationale for selecting the particular therapeutic indications for each of our product candidates is based in part on our understanding of the mechanism of action of these product candidates. However, our understanding of the product candidates’ mechanism of action may be incomplete or incorrect, or the mechanism may not be clinically relevant to the diseases treated. In such cases, our product candidates may prove to be ineffective in the clinical trials for treating those diseases, and adverse clinical trial results would likely negatively impact our business and results from operations.
A successful sPLA2 drug has not been developed to date and we can provide no assurances that we will be successful or that there will be no adverse side effects.
Our sPLA2 product candidates employ a novel mechanism of action. To our knowledge no drug companies have successfully commercialized an sPLA2 inhibitor and as a result the efficacy and long-term side effects are not known. There is no guarantee that we will successfully develop and/or commercialize an sPLA2 inhibitor and/or that our product candidates will have no adverse side effects.
Even if one of our product candidates receives marketing salesapproval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and distribution experienceothers in the medical community necessary for commercial success.
If any product candidate receives marketing approval, the approved product may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors and capabilities. We will needothers in the medical community. If an approved product does not achieve an adequate level of acceptance, we may not generate significant product revenues or any profits from operations. Our ability to negotiate, secure and maintain third-party coverage and reimbursement for our product candidates may be affected by political, economic and regulatory developments in the United States, Canada, the European Union and other jurisdictions. Governments continue to impose cost containment measures, and third-party payors are increasingly challenging prices charged for medicines and examining their cost effectiveness, in addition to their safety and efficacy. These and other similar developments could significantly limit the degree of market acceptance of any of our future product candidates that receive marketing approval.
If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sellany of our products.

other current or future product candidates, we may not be successful in commercializing the applicable product candidate if it receives marketing approval.

We currentlydo not have limiteda sales or marketing infrastructure and have no experience as a company in the sale or marketing of pharmaceutical products. To achieve commercial success for any approved product, we must either develop a sales and distributionmarketing organization or outsource these functions to third parties. There are risks involved with establishing our own sales and marketing capabilities and entering into arrangements with third parties to perform these services. For example, recruiting and training a sales force is expensive and time consuming and could delay any product launch. If the commercial launch of KLH-based therapeutica product candidate for which we recruit a sales force and establish marketing capabilities is delayed or diagnostic products. Dependingdoes not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel. If we enter into arrangements with third parties to perform sales and marketing services, our product revenues or the profitability of these product revenues to us could be lower than if we were to market and sell any products that we develop ourselves. In addition, we may not be successful in entering into arrangements with third parties to sell and market our product candidates or may be unable to do so on terms that are acceptable to us. We likely will have little control over such third parties, and any of them may fail to devote the necessary resources and attention to sell and market acceptanceour products effectively. If we do not establish sales and marketing capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing our product candidates.

We face substantial competition, which may result in others discovering, developing or commercializing products to treat our target indications or markets before or more successfully than we do.
The development and commercialization of new drug products is highly competitive. We face competition with respect to our Stellar KLHcurrent product candidates and any products we may seek to develop or commercialize in the future from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide. Competitors may also include academic institutions, government agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization. Many of our competitors have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining approvals from regulatory authorities and marketing approved products than we do. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Our commercial opportunities could be reduced or eliminated if our competitors develop and commercialize products that are more effective, safer, have fewer or less severe side effects, are approved for broader indications or patient populations, or are more convenient or less expensive than any products that we develop and commercializes. Our competitors may also obtain marketing approval for their products more rapidly than we may obtain approval for our products, which could result in our competitors establishing a strong market position before we are able to enter the market. If approved, our product candidates will compete for a share of the existing market with numerous other products being used to treat ACD, ARDS, or any other indications for which we may receive government approval.

Even if we are able to commercialize one of our product candidates, the product may become subject to unfavorable pricing regulations, third- party reimbursement practices or healthcare reform initiatives, which would harm our business.
The regulations that govern marketing approvals, pricing, coverage and reimbursement for new drug products vary widely from country to country. Current and future legislation may significantly change the approval requirements in ways that could involve additional costs and cause delays in obtaining approvals. Some countries require approval of the sale price of a drug before it can be marketed. In many countries, the pricing review period begins after marketing or product licensing approval is granted and, in some markets, prescription pharmaceutical pricing remains subject to continuing governmental control even after initial approval is granted. As a result, we might obtain marketing approval for a product in a particular country, but then be subject to price regulations that delay our commercial launch of the product, possibly for lengthy time periods, and negatively impact the revenues we are able to generate from the sale of the product in that country. Adverse pricing limitations may hinder our ability to recoup our investment in one or more product candidates, even if our product candidates obtain marketing approval.
Our ability to commercialize EB01, EB05 or any other product candidate successfully also will depend in part on the extent to which coverage and adequate reimbursement for these products and related treatments will be available from government health administration authorities, private health insurers and other organizations. Government authorities and other third-party payors, such as private health insurers and health maintenance organizations, decide which medications they will pay for and establish reimbursement levels. Our inability to promptly obtain coverage and adequate reimbursement rates from both government-funded and private payors for any approved products that we develop could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize products and our overall financial condition.

Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.
We face an inherent risk of product liability exposure related to the testing of our product candidates in human clinical trials and will face an even greater risk if we commercially sell any products that we may develop. If we cannot successfully defend ourselves against claims that our product candidates or products caused injuries, we will incur substantial liabilities. We have separate liability insurance policies that cover each of our ongoing clinical trials, which provide coverage in varying amounts. The amount of insurance that we currently hold may not be adequate to cover all liabilities that we may incur. We will need to expandincrease our capabilities.insurance coverage when and if we begin conducting more expansive clinical development of our product candidates. Insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.
We will be dependent on third parties for the synthesis, formulation, and manufacturing, including optimization, technology transfers and scaling up of clinical scale quantities of all of our product candidates.
We have no direct experience in synthesizing, formulating and manufacturing any of our product candidates, and currently lack the resources or capability to synthesize, formulate and manufacture any of our product candidates on a clinical or commercial scale. As a result, we will be dependent on third parties for the synthesis, formulation, and manufacturing, including optimization, technology transfers and scaling up of clinical scale quantities of all our product candidates. We believe that this strategy will enable us to direct operational and financial resources to the development of our product candidates rather than diverting resources to establishing manufacturing infrastructure; however our use of third parties to manufacture our product candidates may increase the risk that we will not have sufficient quantities of our product candidates or products or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
We do not currently have any agreements with third-party manufacturers for the long-term clinical or commercial supply of any of our product candidates and may in the future be unable to scale-up and/or conclude agreements for commercial supply with commercial third-party manufacturers on acceptable terms, or at all. Even if we are able to establish and maintain arrangements with third-party manufacturers, they may encounter difficulties in achieving volume production, laboratory testing, quality control or quality assurance or suffer shortages of qualified personnel, any of which could result in our inability to manufacture sufficient quantities to meet clinical timelines for a particular product candidate, to obtain marketing approval for the product candidate or to commercialize the product candidate. We may compete with other companies for access to manufacturing facilities. There are a limited number of manufacturers that operate under cGMP regulations and that might be capable of manufacturing for us.



If the third parties that we contract to manufacture product for our preclinical tests and clinical trials cease to continue to do so for any reason or if we elect to change suppliers, we likely would experience delays in advancing these clinical trials while we identify and qualify replacement suppliers and we may be unable to obtain replacement suppliers on terms that are favorable to us. In addition, if we are not able to obtain adequate supplies of our product candidates or the drug substances used to manufacture them, it will be more difficult for us to develop our product candidates and compete effectively. Our current and anticipated future dependence upon others for the manufacture of our product candidates may adversely affect our future profit margins and our ability to develop product candidates and commercialize any products that receive marketing approval on a timely and competitive basis.

The manufacturing of our monoclonal antibody candidates is complex and subject to a multitude of risks.  These manufacturing risks could substantially increase our costs and limit supply of these drug candidates for clinical development, and commercialization.
The manufacture of our monoclonal antibody candidates requires processing steps that are more complex than those required for most small molecule drugs As a result of the complexities in manufacturing biologics, the cost to manufacture biologics in general, and our cell product candidates in particular, is generally higher than traditional small molecule chemical compounds, and the manufacturing processes are less reliable and are more difficult to reproduce.  Although we are working with third parties to develop reproducible and commercially viable manufacturing processes for our product candidates, doing so is a difficult and uncertain task, and there are risks associated with scaling to the level required for advanced clinical trials or commercialization, including, among others, cost overruns, potential problems with process scale-out, process reproducibility, stability issues, lot consistency, and timely availability of reagents or raw materials.
We may make changes as we continue to evolve the manufacturing processes for our product candidates for advanced clinical trials and commercialization, and we cannot be sure that even minor changes in these processes will not cause our product candidates to perform differently and affect the results of our ongoing clinical trials, future clinical trials, or the performance of the product once commercialized. In some circumstances, changes in manufacturing operations, including to our protocols, processes, materials or facilities used, may require us to perform additional preclinical or comparability studies, or to collect additional clinical data from patients prior to undertaking additional clinical studies or filing for regulatory approval for a product candidate. These requirements may lead to delays in our clinical development and commercialization plans for our product candidates, and may increase our development costs substantially.  
We may also decide to transfer certain manufacturing process know-how and certain intermediates to other contract manufacturing organizations. Transferring manufacturing testing and processes and know-how is complex and involves review and incorporation of both documented and undocumented processes that may have evolved over time. We and any CMOs or third parties that we engage for manufacturing our product candidates will need to conduct significant development work to transfer these processes and manufacture each of our product candidates for clinical trials and commercialization.  In addition, we may be required to demonstrate the comparability of material generated by any CMO or third parties that we engage for manufacturing our product candidates with material previously produced and used in testing. The inability to manufacture comparable drug product by us or our CMO could delay the continued development of our product candidates.
We rely on third parties to conduct our clinical trials and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such additional capabilities in-house,clinical trials.
We do not independently conduct clinical trials for our product candidates. We rely on third parties, such as contract research organizations, clinical data management organizations, medical institutions, drug distributers, clinical investigators and then willgovernment agencies, to perform this function. Any of these third parties may terminate their engagements with us at any time. If we need to enter into agreements withalternative arrangements, it would delay our product development activities. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our clinical trials in accordance with regulatory requirements or our stated protocols, we will not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidates and will not be able to, or may be delayed in our efforts to, successfully performcommercialize our product candidates. Our product development costs will increase if we experience delays in testing or obtaining marketing approvals.
Our reliance on these tasks. If we contract or make arrangements with third parties for the sales and marketingclinical development activities reduces our control over these activities but does not relieve us of our products,responsibilities. For example, we remain responsible for ensuring that each of our revenues will be dependent onclinical trials is conducted in accordance with the effortsgeneral investigational plan and protocols for the clinical trial. Moreover, the FDA and foreign regulatory authorities require us to comply with standards, commonly referred to as Good Clinical Practice, or GCP, for conducting, recording and reporting the results of these third parties, whose efforts may not be successful. clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity of data and confidentiality of clinical trial participants are protected.
If we market anyare not able to establish additional collaborations, we may have to alter our development and commercialization plans.
We may decide to collaborate with pharmaceutical and biotechnology companies for the development and potential commercialization of our products directly, we must either internally develop or acquire a marketingproduct candidates. Collaborations are complex and sales force, which would require substantial resourcestime-consuming to negotiate and management attention.

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We rely on the significant experience and specialized expertise of our Chief Executive Officer and other members of our senior management team,document and we will need to hire and retain other highly skilled personnel to maintain and grow our business.

Our ability to be successfulface significant competition in the highly competitive biotechnology andseeking appropriate collaborators. In addition, there have been a significant number of business combinations among large pharmaceutical industries dependscompanies that have resulted in large part upon our ability to attract and retain highly qualified managerial, scientific, medical, sales and other personnel. Our performance is substantially dependent on the research and development and business development expertisea reduced number of Frank Oakes, our President and Chief Executive Officer, and other executive officers. We do not have employment agreements currently in effect with Mr. Oakes and other executive officers, and they are free to leave their employment with us at any time.

There is little possibility that this dependence will decrease in the near term. The loss of the services of Mr. Oakes, or the increased demands placed on our key executives and personnel by our continued growth, could adversely affect our financial performance and our ability to execute our strategies. Our continued success also depends on our ability to attract and retain qualified team members to meet ourpotential future growth needs.collaborators. We may not be able to attractnegotiate collaborations on a timely basis, on acceptable terms, or at all. If we are unable to do so, we may have to curtail the development of a product candidate, reduce or delay our development program or one or more of our other development programs, delay our potential commercialization or reduce the scope of any sales or marketing activities, or increase our expenditures and retain necessary team membersundertake development or commercialization activities at our own expense. If we elect to operateincrease our business.

In addition, our future success dependsexpenditures to fund development or commercialization activities on our ability to identify, attract, hire, train, retain and motivate highly skilled technical, managerial and research personnel in all areas within our organization. We plan to continue to grow our business and willown, we would likely need to hireobtain additional personnelcapital, which may not be available to support this growth. We believe that there are only a limited number of individuals with the requisite skills to serve in many of our key positions, and we compete for key personnel with other biotechnology companies, as well as universities and research institutions. It is often difficult to hire and retain these persons, and we may be unable to timely replace key persons if they leaveus on acceptable terms, or be unable to fill new positions, as they become available, requiring key persons with appropriate experience.at all. If we fail to attract, integrate and retain the necessary personnel, our ability to maintain and grow our business could suffer significantly.

We are subject to the risk of product liability claims, for which we maydo not have or be able to obtain, adequate insurance coverage.

The pharmaceutical industry is subject to product liability claims in the event of adverse effects, even in respect to products that have received regulatory approval for commercial sale. Such claims might be made directly by consumers, healthcare providers or by pharmaceutical companies, or others selling or utilizing our Stellar KLH products. Although we currently maintain liability insurance for our products,sufficient funds, we may not be able to obtainfurther develop our product candidates or maintain sufficientbring them to market and affordable insurance coveragegenerate product revenue.



Even if we complete the necessary clinical trials, the marketing approval process is expensive, time consuming and uncertain and may prevent us from obtaining approvals for the commercialization of some or all claims that may occur. The cost of anyour product liability litigation or other proceeding, even if resolved in our favor, could be substantial. In addition, our inabilitycandidates. If we are not able to obtain, or maintain sufficient insurance coverage atif there are delays in obtaining, required marketing approvals, we will not be able to commercialize our product candidates, and our ability to generate revenue will be materially impaired.
Our product candidates and the activities associated with their development and commercialization, including their design, testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale and distribution, are subject to comprehensive regulation by the FDA, Health Canada and by comparable authorities in other countries. Failure to obtain marketing approval for a product candidate will prevent us from commercializing the product candidate. We have not received approval to market EB01, EB05 or any other Edesa product candidate from regulatory authorities in any jurisdiction.
We have only limited experience in filing and supporting the applications necessary to obtain marketing approvals for product candidates and expect to rely on third-party contract research organizations to assist us in this process. Securing marketing approval requires the submission of extensive preclinical and clinical data and supporting information to regulatory authorities for each therapeutic indication to establish the product candidate’s safety and effectiveness. Securing marketing approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities by, the regulatory authorities. Regulatory authorities may determine that EB01, EB05 or any of our other product candidates is not effective, is only moderately effective or has undesirable or unintended side effects, toxicities, safety profiles or other characteristics that preclude us from obtaining marketing approval or that prevent or limit commercial use.
Regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may decide that our data are insufficient for approval and require additional preclinical studies, clinical trials or other trials. In addition, varying interpretations of the data obtained from preclinical and clinical testing could delay, limit or prevent marketing approval of a product candidate. Any marketing approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the approved product not commercially viable. If we experience delays in obtaining approval or if we fail to obtain approval of our product candidates, the commercial prospects for our product candidates may be harmed and our ability to generate revenues will be materially impaired.
Even if we obtain marketing approval for our product candidates, the terms of approvals and ongoing regulation of our products may limit how we manufacture and market our products, and compliance with such requirements may involve substantial resources, which could materially impair our ability to generate revenue.
Even if marketing approval of a product candidate is granted, an acceptable costapproved product and our manufacturer and marketer are subject to ongoing review and extensive regulation, including the possible requirement to implement a risk evaluation and mitigation strategy or to otherwise protect against potential product liability claims could preventconduct costly post-marketing studies or inhibitclinical trials and surveillance to monitor the developmentsafety or efficacy of the product. We must also comply with requirements concerning advertising and commercial production and salepromotion for any of our product candidates for which we obtain marketing approval. Promotional communications with respect to prescription drugs are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the product’s approved labeling. Thus, we will not be able to promote any products we develop for indications or uses for which they are not approved. In addition, manufacturers of approved products and those manufacturers’ facilities are required to ensure that quality control and manufacturing procedures conform to cGMP, which include requirements relating to quality control, quality assurance and documentation. Accordingly, assuming we receive marketing approval for one or more of our product candidates, we and our contract manufacturers will continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production, product surveillance and quality control. If we are not able to comply with post-approval regulatory requirements, we could have the marketing approvals for our products withdrawn by regulatory authorities and our ability to market any future products could be limited, which could adversely affect our business,ability to achieve or sustain profitability. Thus, the cost of compliance with post-approval regulations may have a negative effect on our operating results and financial conditioncondition.
Our relationships with customers, healthcare providers and results of operations.

Our activities areprofessionals and third-party payors will be subject to regulationapplicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.

Healthcare providers, physicians and third-party payors play a primary role in the United Statesrecommendation and in the foreign jurisdictions inprescription of any product candidate for which we operate. Failuremay obtain marketing approval. Our future arrangements with customers, healthcare providers and professionals, and third-party payors may expose us to broadly applicable federal anti-kickback, federal and state fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we market, sell and distribute any product candidate for which we obtain marketing approval.

Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations could adversely impactwill involve substantial costs. It is possible that governmental authorities will conclude that our operations.

Ourbusiness practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations including our aquaculture and harvesting activities, and our production activities, are subjectfound to regulation at the local, state and federal levelsbe in the United States by a numberviolation of regulatory agencies including, but not limitedany of these laws or any other governmental regulations that may apply to the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency, the U.S. Fish and Wildlife Service, the U.S. Secretary of the Navy, The Regional Water Quality Control Board, the California Department of Fish and Wildlife, and similar foreign agencies. In addition to regulations in the United States,us, we may be subject to a variety of foreign regulations related to research, manufacturing,significant civil, criminal and administrative penalties, damages, fines, exclusion from government funded healthcare programs, such as Medicare and Medicaid, and the commercial sales and distributioncurtailment or restructuring of our products,operations. Violation of certain of these laws could also result in exclusion, suspension and debarment from government funded healthcare programs. Exclusion, suspension or debarment would significantly impact our ability to the extent we choose to manufacture,commercialize, sell or distribute any products outsideproduct candidate for which we obtain regulatory approval. If any of the United States. physicians or other providers or entities with whom we expect to do business are found to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.


Use of social media platforms presents new risks.
We believe that our potential patient population is active on social media. Social media practices in the pharmaceutical and biotechnology industries are evolving, which creates uncertainty and risk of noncompliance with regulations applicable to our business. For example, patients may use social media platforms to comment on the effectiveness of, or adverse experiences with, a product candidate, which could result in reporting obligations. In addition, there is a risk of inappropriate disclosure of sensitive information or negative or inaccurate posts or comments about us or our product candidates on any social networking website. If any of these events were to occur or we otherwise fail to comply with applicable regulations, we could incur liability, face restrictive regulatory actions or incur other harm to our business.
Risks Related to Our Intellectual Property
We are dependent on license relationships with third parties for our key drug development programs.
In 2016, we entered into an exclusive license agreement with Yissum Research Development Company of the Hebrew University of Jerusalem to obtain exclusive rights to certain know-how, patents and data relating to a pharmaceutical product. We are using the exclusive rights to develop the product for therapeutic, prophylactic and diagnostic uses in topical dermal applications and anorectal applications, including for the development of EB01 to treat ACD and EB02 to treat HD. Concurrently, we also entered into a consulting agreement with an individual associated with Yissum for the development of the product. If we default or fail to perform any of the terms, covenants, provisions or our obligations under the License Agreement, Yissum has the option to terminate the License Agreement, subject to advance notice to cure such default. Any termination of this license agreement would have a materially adverse impact on our business and results from operations.
In April 2020, we entered into an exclusive license agreement with NovImmune SA to obtain exclusive rights throughout the world to certain know-how, patents and data relating to the monoclonal antibodies targeting TLR4 and CXCL10. We are using these rights to develop EB05 as a potential treatment for ARDS resulting from COVID-19. If we default or fail to perform any of the terms, covenants, provisions or our obligations under the License Agreement, NovImmune has the option to terminate the License Agreement, subject to advance notice to cure such default. Any termination of this license agreement would have a materially adverse impact on our business and results from operations.
If we are unable to comply with lawsobtain and regulations in the United States and elsewhere,maintain patent protection for our operations could be restricted, or sanctions could be imposed on us, if we are found to not be in compliance with any such regulation.

We may face environmental risks related to handling regulated substances and hazardous materials.

Our research and clinical development activities, as well as the manufacture of materialslicensed technology and products, are subjector if the scope of the patent protection is not sufficiently broad, our competitors could develop and commercialize technology and products similar or identical to federal, stateours, and local laws, rules, regulationsour ability to successfully commercialize our licensed technology and policies governing the use, generation, manufacture, storage, air emission, effluent discharge, handling and disposal of certain materials, biological specimens and wastes. Weproducts may be required to incur significant costs to comply with environmental and health and safety regulations in the future. Our research and clinical development, both now and in the future, may involve the controlled use of hazardous materials, including but not limited to certain hazardous chemicals. We cannot completely eliminate the risk of accidental contamination or injury from these materials. In the event of such an occurrence, we could be held liable for any damages that result and any such liability could exceed our resources.

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adversely affected.

We deal with hazardous materials and must comply with environmental, health and safety laws and regulations, which can be expensive and restrict how we do business and/or give rise to significant liabilities.

As we operate a manufacturing facility, we are subject to various environmental, health and safety laws and regulations, including those governing air emissions, water and wastewater discharges, noise emissions, the use, management and disposal of hazardous materials and wastes, and the cleanup of contaminated sites. The cost of compliance with these laws and regulations could be significant. In the event of a violation of these requirements, including from accidental contamination or injury, we could be held liable for damages exceeding our available financial resources. We could be subject to monetary fines, penalties or third party damage claims as a result of violations of such laws and regulations or noncompliance with environmental permits required at our facility. As an operator of real property and a generator of hazardous materials and wastes, we also could be subject to environmental cleanup liability, in some cases without regard to fault or whether we were aware of the conditions giving rise to such liability. In addition, we may be subject to liability and may be required to comply with new or existing environmental laws regulating pharmaceuticals in the environment. Environmental laws or regulations (or their interpretation) may become more stringent in the future. If any such future revisions require significant changes in our operations, or if we engage in the development and manufacturing of new products or otherwise expand our operations requiring new or different environmental controls, we will have to dedicate additional management resources and incur additional expenses to comply with such laws and regulations.

In the event of an accident, applicable authorities may curtail our use of hazardous materials and interrupt our business operations. In addition, with respect to our manufacturing facility, we may incur substantial costs to comply with environmental regulations and may become subject to the risk of accidental contamination or injury from the use of hazardous materials in our manufacturing process.

Risks Related to Intellectual Property

The inability to protect our intellectual property rights could result in competitive harm to our Company.

Our success and ability to maintain our competitive position dependswill partially depend on our ability to protect our intellectual property, including by obtainingobtain and maintain patent protection in the United States and other countries or through protection ofwith respect to our trade secrets, including unpatented know-how,proprietary technology and other proprietary information. When appropriate, we seekproducts. We intend to protect our proprietary position by filing patent applications in the United States, in Europe and other countries. If we are unable to protect our intellectual property, whether by obtaining patents or through trade secret protection, our competitors could develop and commercialize products similar or identical to ours.

We may not have adequate remedies for any infringement or funds to take action against those infringing any of our intellectual property rights, or if our trade secrets otherwise become known or independently developed by competitors. There can be no assurance that any current or future patents held, licensed by or applied for by us will be upheld, if challenged, or that the protections afforded will not be circumvented by others. The patent positions of biotechnology and pharmaceutical companies, which often involve licensing agreements, are frequently uncertain and involve complex legal and factual questions. In addition, the coverage claimed in a patent application can be significantly reduced before the patent is issued. Consequently, our patents, patent applications and licensed rights may not provide protection against competitive technologies or may be held invalid if challenged or could be circumvented. If we enter litigation in regardscertain additional jurisdictions related to our business or to protect or enforce our patents, it may involve substantial expendituresnovel technologies and require significant management attention, even if we ultimately prevail.

The patent position of biotechnology companies is generally highly uncertain. The degree of patent protection we require may be unavailable or severely limited in some cases and may not adequately protect our rights, provide sufficient exclusivity, or preserve our competitive advantage. For example:

we might not have been the first to invent or the first to file patent applications on the inventions covered by each of our pending patent applications;

others may independently develop similar or alternative technologies or duplicate any of our technologies;

the patents of others may have an adverse effect on our business;

any patents we obtain or license from others in the future may not encompass commercially viable products, may not provide us with any competitive advantages or may be challenged by third parties;

any patents we have obtained, will obtain or license from others in the future may not be valid or enforceable; and

we may not develop additional proprietary technologiesproduct candidates that are patentable.

Patents have a limited lifespan. In the United States, the natural expiration of a utility patent typicallyimportant to our business. This process is generally 20 years after it is filed. Various extensions may be available; however, the life of a patent,expensive and the protection it affords, is limited.

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In addition, some of our technologies are not covered by any patent applicationtime-consuming, and we rely instead on confidentiality agreements and trade secret law to protect such intellectual property rights. We require all of our employees and consultants to sign confidentiality agreements. The agreements also oblige our employees, and to the extent practicable, our consultants, and advisors, to assign to us ideas, developments, discoveries and inventions made by such persons in connection with their work with us. We cannot be sure that these agreements will maintain confidentiality, will prevent disclosure, or will protect our proprietary information or intellectual property, or that others will not independently develop substantially equivalent proprietary information or intellectual property.

The failure of our patents, patent applications, applicable intellectual property law or our confidentiality agreements to protect our intellectual property and other proprietary information, including our trade secrets, could have a material adverse effect on our competitive advantages and on our operations and financial position.

Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our products and our technologies. There are numerous recent changes to the U.S. patent laws and proposed changes to the rules of the United States Patent and Trademark Office (USPTO) that may have a significant impact on our ability to obtain and enforce intellectual property rights. In particular, the Leahy-Smith America Invents Act (Leahy-Smith Act) was adopted in September 2011. The Leahy-Smith Act includes a number of significant changes to U.S. patent law, including provisions that affect the way patent applications will be prosecuted and may also affect patent litigation. Under the Leahy-Smith Act, the United States transitioned from a “first-to-invent” system to a “first-inventor-to-file” system for patent applications filed on or after March 16, 2013. With respect to patent applications filed on or after March 16, 2013, if we are the first to invent but not the first to file a patent application, we may not be able to fully protectfile and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable aspects of our intellectual property rightsresearch and may be founddevelopment output before it is too late to have violated the intellectual property rights of othersobtain patent protection. Moreover, if we continue to operatelicense technology or product candidates from third parties in the absencefuture, these license agreements may not permit us to control the preparation, filing and prosecution of patent applications, or to maintain or enforce the patents, covering the licensed technology or product candidates. These agreements could also give our licensors the right to enforce the licensed patents without our involvement, or to decide not to enforce the patents at all. Therefore, in these circumstances, these patents and applications may not be prosecuted or enforced in a patent issued to us. Many of the substantive changes to patent law associatedmanner consistent with the Leahy-Smith Act have recently become effective. Accordingly, it is not clear what, if any, impact the Leahy-Smith Act will have on the operationbest interests of our business. However,

The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has been the Leahy-Smith Actsubject of much litigation. As a result, the issuance, scope, validity, enforceability and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defensecommercial value of any patents that issue, all of which could have a material adverse effect on our business and financial condition.

In addition, patent reform legislation may pass in the future that could leadissued to additional uncertainties and increased costs surrounding the prosecution, enforcement, and defense of patent applications and any patents we may obtain. Furthermore, the U.S. Supreme Court and the U.S. Court of Appeals for the Federal Circuit have made, andus will likely continue to make, changesbe highly uncertain. Patent applications that we file may not result in howpatents being issued which protect our technology or products, in whole or in part, or which effectively prevent others from commercializing competitive technologies and products. Changes in either the patent laws or interpretation of the United States are interpreted. Similarly, foreign courts have made, and will likely continue to make, changes in how the patent laws in their respective jurisdictions are interpreted. We cannot predict future changes in the interpretation of patent laws or changes to patent laws that might be enacted into law by United States and foreign legislative bodies. Those changes may materially affect our patents and patent applications or any patents we may obtain and our ability to obtain and enforce or defend additional patent protection in the future.

We may not be able to adequately protect our intellectual property rights throughout the world.

Filing, prosecuting and defending patents on our products and technologies in all countries throughout the world would be prohibitively expensive. The requirements for patentability may differ in certain countries, particularly developing countries, and the breadth of patent claims allowed can be inconsistent. In addition, the laws of some foreign countries may not protect our intellectual property rights to the same extent as laws in the United States. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we have patent protection, but enforcement on infringing activities is inadequate.

We seek to protect our proprietary position by, among other methods, filing, when possible, U.S. and foreign patent applications relating to our technology, inventions and improvements that are important to our business. We have obtained patent protection for our non-lethal extraction methods of hemocyanin in the United States and other countries. Wecountries may also rely on trade secrets, know-how, continuing technological innovation, and in-licensing opportunitiesdiminish the value of patents issued to develop and maintain our proprietary position.

We plan to file other international patent applications directed to patentable featuresus, narrow the scope of our products and technologies from time to time. If patent rights are obtained in foreign jurisdictions, proceedings to enforce such rights could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidatedprotection or interpreted narrowly, could put our pending patent applications at risk of not issuing, and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate and the damagesmake enforcement more difficult or other remedies awarded, if any, may not be commercially meaningful. Thus, we may not be able to stop a competitor from marketing and selling in foreign countries products that are the same as or similar to our product.

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uncertain.


We may become involved in lawsuits or other enforcement proceedings to protect or enforce our patents and patent applications, any patents that may be issued to us or other intellectual property, which could be expensive, time consuming and potentially unsuccessful.

Competitors may infringe our patents, or patent applications,trademarks, copyrights or other of our intellectual property. To counter infringement or unauthorized use, we may be required to file infringement or misappropriation claims, which can be expensive and time consuming.consuming to prosecute. Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe their patentsintellectual property or claiming that our patentspatent and other intellectual property rights are invalid or unenforceable. Groundsunenforceable, including for antitrust reasons. As a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, non-enablement or lack of statutory subject matter. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant material information from the USPTO, or made a materially misleading statement, during prosecution. Third parties may also raise similar validity claims before the USPTO in post-grant proceedings such asex partereexaminations,inter partesreview, or post-grant review, or oppositions or similar proceedings outside the United States, in parallel with litigation or even outside the context of litigation. The outcome following legal assertions of invalidity and unenforceability is unpredictable. We cannot be certain that there is no invalidating prior art, of which we and the patent examiner were unaware during prosecution. For any patents and patent applications we may license, we may have limited or no right to participate in the defense of any such patents against challenge by a third party. If a defendant were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of any future patent protection on our products. Such a loss of patent protection could harm our business. In addition,result, in a patent infringement proceeding, a court or administrative body may decide that oura patent applications or patents, if issued, areof ours is invalid or unenforceable, in whole or in part, or may construe the patent’s claims narrowly orand so refuse to stop the other party from using the technology at issue on the grounds that our patent applicationspatents do not cover the technology. Ancompetitor technology in question. Even if we are successful in a patent infringement action, the unsuccessful party may subsequently raise antitrust issues and bring a follow-on action thereon. Antitrust issues may also provide a bar to settlement or constrain the permissible settlement terms.
Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse resulteffect on the success of our business.
Our commercial success depends upon our ability and the ability of our collaborators to develop, manufacture, market and sell our product candidates and use our proprietary technologies without infringing the intellectual property and other proprietary rights of third parties. There is considerable intellectual property litigation in the biotechnology and pharmaceutical industries, and we may become party to, or threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to our products and technology, including interference, derivation, inter partes review, reexamination, reissue or post-grant review proceedings before the USPTO. The risks of being involved in such litigation and office proceedings may also increase as our product candidates approach commercialization, and as our business gains greater visibility operating as a publicly traded company in the United States. Third parties may assert infringement claims against us based on existing or future intellectual property rights and to restrict our freedom to operate. Third parties may also seek injunctive relief against us, whereby they would attempt to prevent us from practicing our technologies altogether pending outcome of any litigation proceeding could put oneagainst us. We may not be aware of all such intellectual property rights potentially relating to our product candidates prior to their assertion against us. For example, we have not conducted an in-depth freedom-to-operate search or moreanalysis of any of our product candidates. Any freedom-to-operate search or analysis previously conducted may not have uncovered all relevant patents and pending patent applications, and there may be pending or future patent applications that, if issued, would block us from commercializing any of our product candidates. Thus, we do not know with certainty whether our product candidates or our commercialization thereof, does not and will not infringe any third party’s intellectual property.
If we are found to infringe a third party’s intellectual property rights, to avoid or settle litigation, we could be required to obtain a license to enable us to continue developing and marketing our products and technology. However, we may not be able to obtain any required license on commercially reasonable terms, or at riskall. Even if we were able to obtain a license, it could be nonexclusive, thereby giving our competitors access to the same technologies as are licensed to us, and could require us to make substantial payments. Absent a license, we could be forced, including by court order, to cease commercializing the infringing technology or product. In addition, we could be found liable for monetary damages, including treble damages and attorneys’ fees if we are found to have willfully infringed a patent or other intellectual property right. A finding of being invalidatedinfringement could prevent us from commercializing our product candidates or interpreted narrowly.

Ourforce us to cease some of our business operations, which could materially harm our business.

Intellectual property litigation could cause us to spend substantial resources and could distract our personnel from their normal responsibilities.
Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and likely would distract our technical and management personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments that could have a substantial adverse effect on the price of our common shares. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development, sales, marketing or distribution activities. We may not have sufficient financial or other resources to adequately conduct such litigation or proceedings. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources. Accordingly, costs and lost management time, as well as uncertainties resulting from the initiation and continuation of patent litigation or other proceedings, could have a material adverse effect on our ability to compete in the marketplace.
If we are unable to protect the confidentiality of our trade secrets, are difficultour business and competitive position would be harmed.
We partially rely on trade secrets and know-how, including unpatented know-how, technology and other proprietary and confidential information, to maintain our competitive position. We seek to protect these trade secrets, in part, by entering into nondisclosure and misappropriation could reduceconfidentiality agreements with parties who have access to them, such as our employees, corporate collaborators, outside scientific collaborators, contract manufacturers, consultants, advisors and other third parties. However, we cannot guarantee that we have executed these agreements with each party that may have or have had access to our trade secrets or that the market foragreements we have executed will provide adequate protection. Any party with whom we have executed such an agreement may breach that agreement and disclose our products.

Weproprietary or confidential information, including our trade secrets, and we may not be able to obtain adequate remedies for the unauthorized use or disclosure of our proprietary information, including our trade secrets.such breaches. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time consuming,time-consuming, and the outcome is unpredictable. In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent them, or those to whom they communicate it, from using that technology or information to compete with us. If any of our trade secrets, particularly unpatented know-how, were to be disclosed toobtained or independently developed by a competitor, our competitive position couldwould be harmed.

Third parties




Risks Related to Owning Our Securities
The price of our common shares may initiate legal proceedings allegingcontinue to be volatile.

Market prices for securities of early stage pharmaceutical, biotechnology and other life sciences companies have historically been particularly volatile, and the market price of our common shares has been subject to significant fluctuations. This volatility can be exacerbated by low trading volume. Some of the factors that may cause the market price of our shares to fluctuate include:
sales or potential sales of substantial amounts of our common shares;
announcements about us or our competitors, including funding announcements, corporate or business updates, updates on manufacturing of our products, clinical trial results, regulatory approvals or new product introductions;
developments concerning our product manufacturers;
litigation and other developments relating to our licensed patents or other proprietary rights or those of our competitors;
governmental regulation and legislation;
change in securities analysts’ estimates of our performance, or failure to meet analysts’ expectations;
the terms and timing of any future collaborative, licensing or other arrangements that we are infringing their intellectual property rights, may establish;
Our ability to raise additional capital to carry through with our development plans and current and future operations;
the outcometiming of which would be uncertainachievement of, or failure to achieve, our manufacturing, pre-clinical, clinical, regulatory and couldother milestones, such as the commencement of clinical development, the completion of a clinical trial or the receipt of regulatory approval;
actions taken by regulatory agencies with respect to our product candidates;
uncontemplated problems in the supply of the raw materials used to produce our product candidates;
introductions or announcements of technological innovations or new products candidates by us, our potential future collaborators, or our competitors, and the timing of these introductions or announcements;
market conditions for equity investments in general, or the biotechnology or pharmaceutical industries in particular;
we may have a material adverse effect onlimited or very low trading volume that may increase the successvolatility of the market price of our business.

common shares;

actual or anticipated fluctuations in our results of operations;
hedging or arbitrage trading activity that may develop regarding our common shares;
regional or worldwide recession;
sales of our common shares by our executive officers, directors and significant shareholders;
changes in accounting principles; and
the loss of any of our key scientific or management personnel.
Moreover, the stock markets in general have experienced substantial volatility that has often been unrelated to the operating performance of individual companies. These broad market fluctuations may also adversely affect the trading price of our common shares. In the past, following periods of volatility in the market price of a company’s securities, shareholders have often instituted class action securities litigation. Such litigation, if instituted, could result in substantial costs and diversion of management attention and resources, which could significantly harm our profitability and reputation.
If we fail to meet all applicable Nasdaq Capital Market requirements and Nasdaq determines to delist our common shares, the delisting could adversely affect the market liquidity of our common shares and the market price of our common shares could decrease.
Our success depends, in part,common shares are listed on The Nasdaq Capital Market. To maintain our listing, we must meet minimum financial, operating and other requirements, including requirements for a minimum amount of capital, a minimum price per share, and active operations. If we are unable to comply with Nasdaq’s listing standards, Nasdaq may determine to delist our common shares. If our common shares are delisted for any reason, it could reduce the value of our common shares and their liquidity. Delisting could also adversely affect our ability to operate without infringingobtain financing for the patents and other proprietary intellectual property rightscontinuation of third parties. This is generally referredour operations, or to as having the “freedom to operate.” The biotechnology and pharmaceutical industries are characterized by extensive litigation regarding patents and other intellectual property rights. The defense and prosecution of intellectual property claims, interference proceedings and related legal and administrative proceedings, bothuse our common shares in acquisitions. Delisting may also result in the United Statesloss of confidence by suppliers, investors and internationally, involve complex legalemployees.
Raising additional capital may cause dilution to our investors, restrict our operations or require us to relinquish rights to our technologies or product candidates
Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity offerings, licensing, collaboration or similar arrangements, grants and factual questions. As a result, such proceedings are lengthy, costlydebt financings. We do not have any committed external source of funds. To the extent that the we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and time-consuming, and their outcome is highly uncertain. Wethe terms of these securities may become involved in protracted and expensive litigation in order to determine the enforceability, scope and validity of the proprietary rights of others, or to determine whether we have the freedom to operate with respect to the intellectual property rights of others.

Patent applications in the United States are, in most cases, maintained in secrecy until approximately 18 months after the patent application is filed. The publication of discoveries in the scientific or patent literature frequently occurs substantially later than the date on which the underlying discoveries were made. Therefore, patent applications relating to a product or method similar to ours may have already been filed by others without our knowledge. In the event that a third party has also filed a patent application covering our products, methodsinclude liquidation or other claims,preferences that adversely affect your rights as a holder of our common shares. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends or other distributions. If we raise additional funds through licensing, collaboration or similar arrangements, we may have to participate in an adversarial proceeding, such as an interferencerelinquish valuable rights to our technologies, future revenue streams, research and development programs or derivation proceeding in the USPTOproduct candidates or similar proceedings into grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other countries, to determine the priority of invention. In the event an infringement claim is brought against us,arrangements when needed, we may be required to pay substantial legal fees and other expenses to defend such a claim and, if we are unsuccessful in defending the claim, we may be subject to injunctionsdelay, limit, reduce or damage awards.

In theterminate our product development or future the USPTOcommercialization efforts or a foreign patent office may grant patent rights to our claims to third parties. Subject to the issuance of these future patents, the claims of which will be unknown until issued, we may need to obtain a license or sublicense to these rights in order to have the appropriate freedom to further use, develop or commercialize such products or methods. Any required licenses may not be available to us on acceptable terms, if at all. If it is determinedand market product candidates that we have infringed an issued patentwould otherwise prefer to develop and do not havemarket ourselves.


Failure to maintain effective internal control over financial reporting in accordance with Section 404 of the freedom to operate, we could be subject to injunctions, and compelled to pay significant damages, including punitive damages, which could harm our business.

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We may become involved in lawsuits to protect or enforce our patents and patent applications, any patents that may be issued to us or other intellectual property, which could be expensive, time consuming and unsuccessful.

If we become involved in any patent litigation or other legal proceedings, we could incur substantial expense, and the effortsSarbanes-Oxley Act of our technical and management personnel could be significantly diverted. A negative outcome of such litigation or proceedings may expose us to the loss of our proprietary position or to significant liabilities, or require us to seek licenses that may not be available from third parties on commercially acceptable terms, if at all. We may be restricted or prevented from using or developing methods, or manufacturing and selling our products in the event of an adverse determination in a judicial or an administrative proceeding, or if we fail to obtain necessary licenses. Further, even if we are successful in defending against claims of infringement, such litigation could be burdensome and costly, and divert management’s attention away from executing our business plan.

We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.

Certain of our employees were previously employed at other biotechnology or pharmaceutical companies. We may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise improperly used or disclosed confidential information of these third parties or our employees’ former employers. We may also be subject to claims that former employees, consultants, independent contractors or other third parties have an ownership interest in our patents or other intellectual property. Litigation may be necessary to defend against these and other claims challenging our right to and use of confidential and proprietary information. If we fail in defending any such claims, we may lose our rights to such information, in addition to paying monetary damages. Such an outcome2002 could have a material adverse effect on our business. Even ifshare price.

Section 404 of the Sarbanes-Oxley Act of 2002 and the related rules and regulations of the SEC require an annual management assessment of the effectiveness of our internal control over financial reporting. As a smaller reporting company as defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended, we are successfulcurrently exempt from the auditor attestation requirement of Section 404(b). If we lose this eligibility, we will incur increased personnel and audit fees in defending against these claims, litigationconnection with the additional audit requirements. If we fail to maintain the adequacy of our internal control over financial reporting, we may not be able to ensure that we can conclude on an ongoing basis that we have effective internal control over financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act of 2002 and the related rules and regulations of the SEC. If we cannot in the future favorably assess the effectiveness of our internal control over financial reporting, investor confidence in the reliability of our financial reports may be adversely affected, which could result in substantial cost and behave a distraction tomaterial adverse effect on our management and employees.

Risks Related to Ownership of Our Securities

share price.

The priceownership of our common shares is highly concentrated, which may be subject to substantial volatility.

Althoughprevent you and other shareholders from influencing significant corporate decisions and may result in conflicts of interest that could cause our common shares are listed on price to decline.

The Nasdaq Capital Market in the United States, there can be no assurance that an active public market will be sustained for our common shares. If there is a thin trading market or “float” forownership of our common shares is highly concentrated among insiders and affiliates. Accordingly, these shareholders will have substantial influence over the market price for our common sharesoutcome of corporate actions requiring shareholder approval, including the election of directors, any merger, consolidation or sale of all or substantially all of the company’s assets or any other significant corporate transaction. These shareholders may fluctuate significantly more thanalso delay or prevent a change of control of the stock market ascompany, even if such a whole. Without a large float, our common shareschange of control would be less liquid thanbenefit the stockother shareholders of companies with broader publicthe company. The significant concentration of share ownership and, as a result,may adversely affect the trading price of our common shares due to investors’ perception that conflicts of interest may exist or arise.
We may be more volatile.

Furthermore, the stock market is subject to significant pricedeemed a passive foreign investment company, and volume fluctuations, and the price of our common shares has been in the past, andas a result, U.S. shareholders may continue in the future to be subject to wide fluctuations in responsespecial taxation rules that restrict capital gains treatment, unless the shareholders make a timely tax election to several factors, including:

treat the company as a qualified electing fund.
A special set of U.S. federal income tax rules applies to a foreign corporation that is deemed a passive foreign investment company (“PFIC”) for U.S. federal income tax purposes. Based on our quarterly or annual operating results;

our cashaudited financial statements, income tax returns, and cash equivalents position;

changes in our earnings estimates;

investment recommendations by securities analysts following our business or our industry;

additions or departures of key personnel;

changesrelevant market and shareholder data, we believe that we likely will not be classified as a PFIC in the business, earnings estimates or market perceptions of our competitors;

our failure to achieve operating results consistent with securities analysts’ projections;

announcements or the expectation of raising additional financing;

sales of our common shares by us, our insiders or other shareholders;

the status of our listing on the Nasdaq;

changes in industry, general market or economic conditions; and

announcements of legislative or regulatory changes in the United States and in other countries whereSeptember 30, 2020 taxable year. There can be no assurance, however, that we transact business.

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The stock markets in general, and the small-cap biotech market, in particular, have experienced extreme price and volume fluctuations in recent years that have significantly affected the quoted prices of the securities of many companies, including companies in our industry. The changes often appear to occur without regard to specific operating performance. The price of our common shares could fluctuate based upon factors that have little or nothing to do with our company and these fluctuations could materially reduce our share price.

Our common shares are thinly traded and there maywill not be an active, liquid trading market for our common shares.

There is no guarantee that an active trading market for our common shares willconsidered to be maintained on Nasdaq, or that the volume of trading will be sufficient to allow for timely trades. Investors may not be able to sell our common shares quickly or at the latest market price if trading in our shares is not active or if trading volume is limited. In addition, if trading volume in our common shares is limited, trades of relatively small numbers of shares may have a disproportionate effect on the market price of our common shares.

If we cannot meet Nasdaq’s continuing listing requirements and Nasdaq rules, Nasdaq may delist our securities, which could negatively affect our company and the price of our securities.

Although our shares are currently listed on Nasdaq, in the future, we may not be able to meet the continued listing requirements of Nasdaq, which require, among other things, a minimum bid price of $1.00 per share for common shares listed on the exchange. If we are unable to satisfy the Nasdaq criteria for maintaining our listing, our securities could be subject to delisting. Trading of our securities may still be eligible for an over-the-counter market or electronic bulletin board. As a consequence of any such delisting, our shareholders would likely find it more difficult to dispose of, or to obtain accurate quotations as to the prices of our securities.

We may require additional financing or financings, which would result in substantial dilution to existing shareholders.

While the Company plans to finance company operations for the next twelve months with cash on hand and product sales, management expects to continue incurring losses for the foreseeable future and will need to raise additional capital to pursue our business plan beyond December 2018. In addition, we may decide to expand operations, undertake strategic acquisitions or determine some other business need. Financing could include debt and/or equity financings, including transactions with strategic customers and partners that may include debt and/or equity arrangements. Such sources of financing may not be available on acceptable terms, if at all. Failure to obtain such financing may cause us to curtail operations and/or result in delay or indefinite postponement of research and development of our Stellar KLH, expansion initiatives, capital expenditures and other operational priorities. Any transaction involving the issuance of previously authorized but unissued common shares, or securities convertible into common shares, could result in dilution, possibly substantial, to present and prospective holders of common shares and may be on terms less favorable to us.

We could be deemed a “passive foreign investment company” in the future, which could have negative consequences for U.S. investors.

We would be designated as a “passive foreign investment company”, or a PFIC, under the meaning of Section 1297 of the United States Internal Revenue Code of 1986, as amended, or the Code, if (a) 75% or more of our gross income is “passive income” (generally, dividends, interest, rents, royalties and gains from the disposition of assets producing passive income) in any taxable year, or (b) at least 50% of the average value of our assets produce, or are held for the production of, passive income. If we are designated a PFIC for any particular year in the future because PFIC status is factual in nature, depends upon factors not wholly within our control, generally cannot be determined until the close of the taxable year during which a U.S. shareholder holds our common shares, it would likely result in materially adverse U.S. federal income tax consequences for such U.S. shareholder, including, but not limited to, any gain from the sale of our common shares would be taxed as ordinary income, as opposed to capital gain, and such gain and certain distributions on our common shares would be subject to an interest charge, except in certain circumstances. In addition, U.S. shareholders should be aware that there can be no assurances that we would be able to satisfy the record keeping requirements that apply to a PFIC, or that we would supply U.S. shareholders with the information that such U.S. shareholders require to make certain elections available under the Code that are intended to mitigate the adverse tax consequences of the PFIC rules. The PFIC rules are extremely complex. A U.S. shareholder of our common shares is encouraged to consult a tax advisor regarding the PFIC rules and the U.S. federal income tax consequences of the acquisition, ownership and disposition of our common shares.

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We are governed by the corporate laws in British Columbia, Canada which in some cases have a different effect on shareholders than the corporate laws in Delaware.

The material differences between the British Columbia Business Corporations Act (BCBCA) as compared to the Delaware General Corporation Law (DGCL) which may be of most interest to shareholders include the following: (i) for material corporate transactions (such as amalgamations, other extraordinary corporate transactions, amendments to the notice of articles and amendments to the Articles), the BCBCA generally requires a two-thirds majority vote by shareholders (and, in addition, especially where the holders of a class of shares are being affected differently from others, approval will be required by holders of two-thirds of the shares of such class voting in a meeting called for that purpose), whereas the DGCL generally only requires a majority vote of shareholders for similar material corporate transactions; (ii) quorum for shareholders meetings is not prescribed under the BCBCAquestion, and is 33-1/3% under our Articles (to assure compliance with Nasdaq corporate governance requirements); whereas, under the DGCL, quorum requires the holders of a majority of the shares entitled to vote to be present; and (iii) our Articles require a two-thirds majority vote of shareholders to pass a resolution for one or more directors to be removed, whereas the DGCL requires only the affirmative vote of a majority of the shareholders. Accordingly, certain provisions of our corporate governance under the laws of British Columbia may be disadvantageous to our shareholders.

Risks Related to an Emerging Growth Company

We are an “emerging growth company” under the JOBS Act of 2012 and we cannot be certain if the reduced disclosure requirements applicable to emerging growth companies will make our common shares less attractive to investors.

We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012 (JOBS Act), and as a result, we may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies.” We may take advantage of these reporting exemptions until we are no longer an “emerging growth company.” We will remain an “emerging growth company” until the earlier of: (i) the last day of the fiscal year (a) following the fifth anniversary of the date of our first sale of common equity securities pursuant to an effective registration statement under the Securities Act of 1933, (b) in which we have more than $1.07 billion in annual revenues ($1.0 billion threshold adjusted for inflation effective April 2017), or (c) in whichdetermined annually. If we are deemed to be a large accelerated filer, which meansPFIC during the market valuecurrent or any future taxable year, U.S. shareholders would be subject to special taxation rules related to gain on sale or disposition of our common shares that is held by non-affiliates exceeded $700 millionand excess distributions unless they make a timely election to treat our shares as a qualified electing fund (“QEF election”). A QEF election cannot be made unless we provide U.S. shareholders the information and computations needed to report income and gains pursuant to a QEF election. Without a QEF election, U.S. shareholders may not be able to use capital gains tax treatment and may be subject to potentially adverse tax consequences. Given the complexities of the prior March 31stPFIC and (ii)QEF election rules, U.S. shareholders may need to incur the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period. While we becametime and expense of consulting a reporting company following the effectiveness of our Form 20-F, filed with the Securities and Exchange Commission on February 3, 2012, our first sale of common equity securities pursuant to an effective registration statement under the Securities Act of 1933 was July 6, 2016. We may choose to take advantage of some but not all oftax adviser about these reduced reporting burdens.

For so long as we remain an emerging growth company, we will not be required to:

have an auditor report on our internal control over financial reporting pursuant to Section 404(b) of Sarbanes-Oxley;

comply with any requirement that may be adopted by the Public Company Accounting Oversight Board (PCAOB), regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements (auditor discussion and analysis);

submit certain executive compensation matters to shareholders advisory votes pursuant to the “say on frequency” and “say on pay” provisions (requiring a non-binding shareholder vote to approve compensation of certain executive officers) and the “say on golden parachute” provisions (requiring a non-binding shareholder vote to approve golden parachute arrangements for certain executive officers in connection with mergers and certain other business combinations) of the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010; and

include detailed compensation discussion and analysis in our filings under the Exchange Act, and, instead, may provide a reduced level of disclosure concerning executive compensation.

In addition, Section 107 of the JOBS Act also provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected not to take advantage of the extended transition period for complying with new or revised accounting standards.

If we take advantage of any of these reduced reporting burdens in future filings, the information that we provide our security holders may be different than information such security holders might receive from other public companies in which they hold equity interests. We cannot predict if investors will find our common shares less attractive because we may rely on these exemptions. If some investors find our common shares less attractive as a result, there may be a less active trading market for our common shares and our share price may be more volatile.

Page 23
rules.

Item 1B.UNRESOLVED STAFF COMMENTS.

Item 1B.UNRESOLVED STAFF COMMENTS.
None.

Item 2.PROPERTIES.

Item 2.PROPERTIES.
We currently lease 4,300approximately 2,800 square feet of executive office and laboratory space in Port Hueneme, CaliforniaMarkham, Ontario, from a related company under a lease which was renewedthat expires in July 2016 for a two-year term,December 2022, with optionsan option to renew for three successiveanother two-year terms.

Our aquaculture and KLH manufacturing operations are located on approximately 37,000 square feet of oceanfront land in the Port Hueneme Aquaculture Business Park. Our facilities here include specialized aquaculture infrastructure, seawater supply and discharge systems, laboratories, manufacturing and administrative offices. We have two sublease agreements which expire in September and October 2020, respectively, with options to extend the leases for two additional five-year terms.

We also currently lease undeveloped land in Baja California, Mexico under a lease agreement which we entered into in June 2015, with a three-year term, which lease agreement is terminable at will at any time with 30 days prior notice by either party. We are utilizing the undeveloped land to conduct suitability studies for the potential development of an additional aquaculture locale and future expansion of production. We also have a short-term lease for office space in a business center located in Ensenada, Baja California. This office serves as the administrative headquarters of our BioEstelar subsidiary.

Item 3.LEGAL PROCEEDINGS.

term.

Item 3.LEGAL PROCEEDINGS.
From time to time, we may be involved in legal proceedings, claims and litigation arising in the ordinary course of business, including contract disputes, employment matters and intellectual property disputes. We are not currently a party to any material legal proceedings or claims outside the ordinary course of business. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.

Item 4.MINE SAFETY DISCLOSURES.

Item 4.MINE SAFETY DISCLOSURES.
Not applicable.

Page 24


PPARTART II

Item 5.MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES.

Item 5.MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES.
Market Information

Our common shares trade on The Nasdaq Capital Market in the United States under the symbol “SBOT” since November 5, 2015.

From January 15, 2013 through November 4, 2015, our common shares were traded in the United States on the U.S. OTCQB Marketplace Exchange under the symbol “SBOTF.” From April 19, 2010 to April 8, 2016 our common shares traded on the TSX Venture Exchange in Canada under the symbol “KLH.”

The table below lists the high and low closing prices for our common shares for each fiscal quarter during 2017 and 2016 as reported by Nasdaq, Inc. or OTC Markets Group, Inc., as applicable. The OTC quotations reflect inter-dealer prices, without retail mark-up, mark-down or commission, and may not necessarily represent actual transactions.

Common Shares Trading Activity

Nasdaq Capital Market and OTCQB Marketplace

  US Dollars 
Period High  Low 
       
Fiscal Year 2017      
Fourth Quarter Ended 9/30/17 $1.44  $1.11 
Third Quarter Ended 6/30/17 $1.64  $1.12 
Second Quarter Ended 3/31/17 $2.16  $1.53 
First Quarter Ended 12/31/16 $2.50  $1.87 
         
Fiscal Year 2016        
Fourth Quarter Ended 9/30/16 $3.82  $2.13 
Third Quarter Ended 6/30/16 $4.70  $2.44 
Second Quarter Ended 3/31/16 $6.85  $4.81 
First Quarter Ended 12/31/15 (after 11/4/15) $9.41  $6.49 
First Quarter Ended 12/31/15 (through 11/4/15) * $8.56  $6.75 

 

* OTC quotations

        

“EDSA”.

Holders

As of November 30, 2017,December 2, 2020, we had 10,520,09610,523,087 common shares outstanding, with 1927 shareholders of record. The number of record shareholders was determined from the records of our stock transfer agent and does not reflect persons or entities that hold their shares in nominee or “street” name through various brokerage firms.

Securities Authorized for Issuance Under Equity Compensation Plans

See Part III, Item 12 “Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters” of this report.

Dividends

We have not declared any dividends on our common shares since our incorporation and do not anticipate that we will do so in the foreseeable future. Our present policy is to retain future earnings, if any, for use in our operations and the expansion of our business.

Page 25

Performance Graph

The following performance graph and related information shall not be deemed to be “soliciting material” or to be “filed” with the SEC, nor shall such information be incorporated by reference into any future filing under the Securities Act, except to the extent that we specifically incorporate it by reference into such filing.

The graph set forth below compares the cumulative total return of our common shares to the Nasdaq Composite Index and the Nasdaq Biotechnology Index based on the period from August 31, 2012 through the Company’s fiscal year end on September 30, 2017. The graph assumes $100 was invested on August 31, 2012 in our common shares and in each of the comparative indices and assumes reinvestment of dividends, if any.

The comparisons shown in the graph below are based on historical data. We caution that the stock price performance showing in the graph below is not necessarily indicative of, nor is it intended to forecast, the potential future performance of our common shares. Information used in the graph was obtained from S&P Capital IQ, a source believed to be reliable, but we are not responsible for any errors or omissions in such information. Please also note that, due to the fact that the graph begins in August and includes a transition period resulting from a change in fiscal year-end, the horizontal segments of the graph do not represent equal time intervals.

Prepared by S&P Global Market Intelligence

  Base     Years Ending       
  Period                
Company / Index 8/31/12  8/31/13  8/31/14  9/30/15  9/30/16  9/30/17 
Stellar Biotechnologies, Inc. $100  $417.91  $474.63  $191.04  $71.64  $33.87 
NASDAQ Composite Index $100  $118.75  $153.37  $156.60  $182.32  $225.50 
NASDAQ Biotechnology Index $100  $142.71  $204.08  $224.20  $215.04  $249.29 

Page 26

Recent Sales of Unregistered Securities; Use of Proceeds from Registered Securities

None.

Purchase of Equity Securities by the Issuer and Affiliated Purchasers

None.

Canadian Federal Income Tax Consequences Applicable to Holders in the United States
The following summary of the material Canadian federal income tax consequences is stated in general terms and is not intended to be legal or tax advice to any particular shareholder. Management urges holders to consult their own tax advisor with respect to the income tax consequences applicable to them based on their own particular circumstances.
This summary is applicable only to holders who are resident in the United States for income tax purposes, have never been resident in Canada for income tax purposes, deal at arm’s length with the company, hold their Common Shares as capital property and who will not use or hold the Common Shares in carrying on business in Canada. This summary does not discuss any non-Canadian income or other tax consequences of acquiring, holding or disposing of Common Shares.
This summary is based upon the provisions of the Income Tax Act (Canada) and the regulations thereunder (collectively, the Tax Act or ITA) and the Canada-United States Tax Convention (1980) as amended (the Tax Convention) at the date of this Annual Report on Form 10-K and the current administrative practices of the Canada Revenue Agency. This summary does not take into account provincial income tax consequences. The comments in this summary that are based on the Tax Convention are applicable to U.S. Holders only if they qualify for benefits under the Tax Convention.
Dividends
A Holder will be subject to Canadian withholding tax (Part XIII Tax) equal to 25%, or such lower rates as may be available under an applicable tax treaty, of the gross amount of any dividend paid or credited or deemed to be paid or credited to the Holder on the Common Shares. For example, under the Tax Convention, where dividends on the Common Shares are considered to be paid to a Holder that is the beneficial owner of the dividends and is a resident of the United States for the purposes of, and is entitled to all the benefits of, the Tax Convention, the applicable rate of Canadian withholding tax is generally reduced to 15%. The company will be required to withhold the applicable amount of Part XIII Tax from each dividend so paid and remit the withheld amount directly to the Receiver General for Canada for the account of the Holder. We have not declared any dividends on our common shares since our incorporation and do not anticipate that we will do so in the foreseeable future.

Disposition of Common Shares
A Holder who is a resident of the United States and realizes a capital gain on a disposition of Common Shares will generally be exempt from Canadian income tax on that capital gain, unless the shares are taxable Canadian property. 
Provided the Common Shares are listed on a “designated stock exchange” (as defined in the Tax Act) (which currently includes the Nasdaq Capital Market) at the time of disposition, the Common Shares will generally not constitute taxable Canadian property of a Holder at that time, unless any of the following conditions are met: (a) at the time of disposition more than 50% of the fair market value of the Common Shares is derived directly or indirectly from real property situated in Canada, which generally includes certain Canadian natural resource properties; (b) the Common Shares formed part of the business property of a permanent establishment that the Holder has or had in Canada within the 12 months preceding disposition; or (c) the Holder is an individual who (i) was a resident of Canada at any time within the ten years immediately preceding the disposition, and for a total of 120 months during any period of 20 consecutive years, preceding the disposition, (ii) owned the Common Shares when the individual ceased to be resident in Canada, and (iii) the Common Shares were not subject to a deemed disposition on the Holder’s departure from Canada.. Notwithstanding the foregoing, a Common Share may otherwise be deemed to be taxable Canadian property to a Holder for purposes of the Tax Act in particular circumstances.
Inclusion in Taxable Income
A Holder who is subject to Canadian income tax in respect of a capital gain realized on a disposition of Common Shares must include one half of the capital gain (“taxable capital gain”) in computing the Holder’s taxable income earned in Canada. The Holder may, subject to certain limitations, deduct one half of any capital loss (“allowable capital loss”) arising on a disposition of taxable Canadian property from taxable capital gains realized in the year of disposition in respect of taxable Canadian property and, to the extent not so deductible, from such taxable capital gains of any of the three preceding years or any subsequent year.
Subject to certain exceptions, a non-resident person who disposes of taxable Canadian property must notify the Canada Revenue Agency either before or after the disposition (within ten days of the disposition).
Item 6.SELECTED FINANCIAL DATA.

Our selected financial data in

Item 6. SELECTED FINANCIAL DATA.
We are a smaller reporting company and are not required to provide the table below is derived from our audited financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States (US GAAP). Our auditors for the fiscal years ended September 30, 2017, 2016 and 2015 and August 31, 2014, Moss Adams LLP, conducted the audits in accordance with United States generally accepted auditing standards, and the standards of the Public Company Accounting Oversight Board. Our auditors for the fiscal year ended August 31, 2013, D&H Group LLP, conducted the audit in accordance with Canadian generally accepted auditing standards, and the standards of the Public Company Accounting Oversight Board. You should read these selected financial data together with “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in information under this item.
Item 7 and our audited financial statements and notes thereto that are included in this Annual Report on Form 10-K.

Selected Financial Data

Expressed in U.S. dollars

  Year Ended
September 30,
2017
  Year Ended
September 30,
2016
  Year Ended
September 30,
2015
  Year Ended
August 31,
2014
  Year Ended
August 31,
2013
 
                
Revenues $228,287  $1,271,689  $758,689  $372,132  $545,469 
Net loss  (5,030,648)  (5,026,080)  (2,843,029)  (8,439,523)  (14,495,779)
Net loss per share  (0.49)  (0.57)  (0.36)  (1.11)  (2.81)
Total assets  7,720,005   12,937,804   10,385,927   14,473,962   8,513,358 
Long-term obligations  -   -   -   5,352,663   6,835,199 

Supplementary Financial Information

Selected Quarterly Financial Data

U.S. dollars are shown in thousands, except per share data

  For the Year Ended September 30,  For the Year Ended September 30, 
  2017  2016 
  Q4  Q3  Q2  Q1  Q4  Q3  Q2  Q1 
                         
Revenues $3  $21  $63  $141  $277  $181  $326  $488 
Net loss for period  (1,221)  (1,220)  (1,104)  (1,486)  (1,349)  (1,194)  (861)  (1,622)
Net loss per share - basic and diluted  (0.11)  (0.12)  (0.11)  (0.15)  (0.14)  (0.14)  (0.10)  (0.19)

Page 27
7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

Fluctuations in net income (loss) between quarters can be mainly attributed to fluctuations in revenue and changes in noncash gains and losses shown in thousands as follows:

  For the Year Ended September 30,  For the Year Ended September 30, 
  2017  2016 
  Q4  Q3  Q2  Q1  Q4  Q3  Q2  Q1 
                         
Loss in fair value of warrant liability $-  $-  $-  $-  $-  $-  $-  $(212)
Foreign exchange gain (loss)  140   64   35   (77)  (33)  (8)  227   (109)

Item 7.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

This discussion contains forward-looking statements that involve risks and uncertainties that could cause actual results or events to differ materially from those expressed or implied by such forward-looking statements as a result of many important factors, including those set forth in Part I of this Annual Report on Form 10-K under the caption “Risk Factors.” Please see “Special Note Regarding Forward-Looking Statements”“Forward-Looking Statements and Other Matters” in Part I above. We do not undertake any obligation to update forward-looking statements to reflect events or circumstances occurring after the date of this Annual Report.

Operating and Financial Review and Prospects

Overview

Our financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP) and include the accounts of the Company and our wholly-ownedwholly owned subsidiaries, Edesa Biotech Research, Inc. and Edesa Biotech USA, Inc. (formerly known as Stellar Biotechnologies, Inc. and BioEstelar S.A. de C.V.

In the past,).

Our operations of the Company have primarily been funded by the issuanceprimarily through issuances of common shares, exerciseexercises of common share purchase warrants, grant revenues, contract services revenueconvertible preferred shares, convertible loans, government grants and product sales. In July 2016,tax incentives. We have devoted substantially all of our efforts to research and development, including clinical trials, and have not completed the Company closed a $6.75 million registered direct offering. Management believes the Company’sdevelopment of any of our drug candidates. We believe our working capital is sufficient to support the Company’s operations for at least the next 12 months. Management also seeks

As a clinical-stage biopharmaceutical company, we expect to expandcontinue to incur significant expenses and operating losses for the customer baseforeseeable future as we continue the development of, and seek marketing approvals for existing marketedour product candidates, prepare for and begin the commercialization of any approved products, and is currently evaluating opportunitiesadd infrastructure and personnel to securesupport our product development efforts and operations as a public company in the United States and Canada. To fund operations, we may seek additional financing through the sale of equity, government grants, debt and/financings or equity financings,other capital sources, including transactionspotential future licensing, collaboration or similar arrangements with third parties or other strategic customers and partners that may include debt and/or equity arrangements.

transactions.

Results of Operations

Fiscal

Year Ended September 30, 2017

2020 Compared to Nine-Month Period Ended September 30, 2019

Financial results for any periods ended prior to June 7, 2019 reflect the financials of our subsidiary Edesa Biotech Research, Inc. on a standalone basis. Upon the completion of the reverse acquisition, Edesa Biotech Research, Inc. changed its year end to September 30 from December 31 to align with our fiscal year end. As a result, our financial results for the full fiscal year ended September 30, 2020 may not be directly comparable to the nine-month period ended September 30, 2019.
Our total revenues decreased by $1.040.08 million to $.23$0.33 million for fiscal 2017the year ended September 30, 2020 compared to $1.27$0.41 million for fiscal 2016 primarily due tothe nine-month period ended September 30, 2019, reflecting a decreasereduction in sales of product sales. While our customer base has not changed significantly, productinventory obtained in the June 2019 reverse acquisition. Product sales volumes are subject to variability associated with the rate of development and progression of clinical studies of third-party products that utilize Stellar KLH. For fiscal 2017, product sales consisted of KLH for clinical and pre-clinical studies and immune system assays. For fiscal 2016, product sales primarily consisted of higher volume orders for later stage clinical studies. The rate of progression toward later stage studies is expected to continue to affectdecline as a result of the timing and volumediscontinuation of future product sales

legacy operations.

Our total operating expenses decreasedincreased by $.73$3.49 million to $5.45 million for fiscal 2017 compared to $6.18 million for fiscal 2016:

·Our costs of sales and contract services decreased by $.57 million to $.25 million for fiscal 2017 compared to $.82 million for fiscal 2016 primarily due to decreased product sales.
·Our research and development expenses increased by $.24 million to $1.97 million for fiscal 2017 compared to $1.73 million for fiscal 2016. The increase was primarily due to research and development activities intended to increase the scalability and throughput capacity of existing manufacturing systems, including additional research and development in aquaculture, both in the U.S. and for our aquaculture feasibility assessment in Baja California, Mexico; improvements in analytical, manufacturing, and purification processes; stability studies; and formulation development.
·Our general and administrative expenses decreased by $.38 million to $2.94 million for fiscal 2017 compared to $3.32 million for fiscal 2016primarily due to management’s actions to reduce corporate expenses, including travel and professional fees, as well as lower legal fees and public company expenses.

Page 28

Our other income (loss) increased by $.31 million to an overall gain of $.19 million for fiscal 2017 compared to an overall loss of $.11 million for fiscal 2016. The increase was primarily due to a noncash change in fair value of warrant liability related to warrants with Canadian dollar exercise prices. All such warrants were exercised or expired by December 2015 and, consequently, there was no warrant liability and no gain/loss in fair value of warrant liability for fiscal 2017 compared to a loss of $.21 million for fiscal 2016. Foreign exchange gain (loss) was a gain of $.16$6.73 million for the fiscal 2017year ended September 30, 2020 compared to a gain of $.08$3.24 million for fiscal 2016 duethe nine-month period ended September 30, 2019:

Cost of sales was $0.02 million for the year ended September 30, 2020 compared to fluctuations$0.10 million for the nine-month period ended September 30, 2019, reflecting a reduction in exchange ratessales of product inventory obtained in the reverse acquisition.
Research and decreased amounts held in Canadian cashdevelopment expenses were $3.33 million for the year ended September 30, 2020, reflecting increased external research expenses related to the clinical study of the company’s EB01 drug candidate, and cash equivalents.

Ourincreased activities and preparations related to the ongoing Phase 2/Phase 3 clinical study of EB05 as a potential treatment for hospitalized COVID-19 patients, as well as increased salary and related personnel expenses. Research and development expenses were $1.10 million for the nine-month period ended September 30, 2019.

General and administrative expenses were $3.38 million for the year ended September 30, 2020, reflecting increased salary and related personnel expenses, and increased public company expenses. General and administrative expenses were $2.05 million for the nine-month period ended September 30, 2019.
Total other income was $0.04 million for the year ended September 30, 2020, reflecting relatively lower interest income. Total other income was $0.06 million for the nine-month period ended September 30, 2019.
For the year ended September 30, 2020, our net loss for fiscal 2017 was $5.03$6.36 million, or $0.49$0.74 per basiccommon share, compared to a net loss of $5.03$2.78 million, or $0.57$0.55 per basiccommon share, for fiscal 2016.

Fiscal Year Endedthe nine-month period ended September 30, 2016

Our total revenues increased by $.51 million to $1.27 million for fiscal 2016 compared to $.76 million for fiscal 2015. Product sales increased by $.68 million to $1.24 million for fiscal 2016 compared to $.56 million for fiscal 2015 primarily due to an increase in the number of customers and greater product sales volume, including sales under supply agreements and custom manufactured products. Contract services revenue decreased by $.17 million to $.03 million for fiscal 2016 compared to $.20 million for fiscal 2015 as a result of the successful conclusion of a collaboration agreement in December 2015.

Our total expenses increased by $1.08 million to $6.18 million for fiscal 2016 compared to $5.10 million for fiscal 2015.

Our costs of sales and contract services increased by $.24 million to $.82 million for fiscal 2016 compared to $.58 million for fiscal 2015, due to increased product sales.

Our research and development expenses increased by $.70 million to $1.73 million fiscal 2016 compared to $1.03 million for fiscal 2015. The increase was a result of additional research and development in aquaculture, both in the U.S. and for our aquaculture feasibility assessment in Baja California, Mexico; improvements in analytical, manufacturing, and purification processes; stability studies; and formulation development.

Our general and administrative expenses increased by $.09 million to $3.32 million for fiscal 2016 compared to $3.23 million for fiscal 2015. The increase resulted from increased corporate expenses, including our Nasdaq listing fees; compensation increases; and expanded business development and investor relations activities; offset by decreases in legal fees due to the Form S-3 shelf registration statement and our transition to reporting as a U.S. domestic issuer during fiscal 2015.

Other income decreased by $1.64 million to an overall loss of $.11 million for fiscal 2016 compared to an overall gain of $1.53 million for fiscal 2015 primarily due to a noncash change in fair value of warrant liability, which fluctuated to a loss of $.21 million for fiscal 2016 compared to a gain of $2.13 million in fiscal 2015. All warrants with Canadian dollar exercise prices were exercised or expired by December 2015 and, consequently, there was no warrant liability and no gain/loss in fair value of warrant liability after that time. These fair value gains and losses occur in inverse relation to changes in our share price that affect the Black Scholes valuation model. The loss in fiscal 2016 is a result of the increase in our share price from September 30, 2015 to the exercise dates of the warrants compared to the gain in fiscal 2015 as a reflection of both the decrease in our share price from September 30, 2014 to the exercise dates of warrants during the year and the decrease in our share price from $11.90 at September 30, 2014 to $6.40 for warrants outstanding at September 30, 2015. Our foreign exchange gain in fiscal 2016 was $.08 million compared to a foreign exchange loss of $.65 million in fiscal 2015. The change over the prior year was due to improved exchange rates for our Canadian cash and cash equivalents.

Our net loss for fiscal 2016 was $5.03 million, or $0.57 per basic share, compared to a net loss of $2.84 million, or $0.36 per basic share, for fiscal 2015. The increase in net loss of approximately $2.19 million for fiscal 2016 was primarily due to significant fluctuations in non-cash gain/loss in fair value of warrant liability and non-cash foreign exchange gain/loss, as well as increased research and development expenses, which were offset by increased product sales.

2019.

Capital Expenditures

Our capital expenditures which primarily consist of scientific, manufacturing,computer and aquaculture equipment, and facility leasehold improvementsoffice equipment. There were no significant capital expenditures for the previous three fiscal years are as follows:

2017 $302,733 
2016  402,271 
2015  274,589 

Capital expenditures include $145,318 of construction in progress, primarily for aquaculture site improvementsyear ended September 30, 2020 and installation of lab equipment.

Page 29
nine-month period ended September 30, 2019. 

Liquidity and Capital Resources

Company

As a clinical-stage company we have not generated significant revenue, and we expect to incur operating losses as we continue our efforts to acquire, develop, seek regulatory approval for and commercialize product candidates and execute on our strategic initiatives. Our operations have historically been funded by the issuancethrough issuances of common shares, exerciseexercises of common share purchase warrants, grant revenues, contract services revenueconvertible preferred shares, convertible loans, government grants and product sales.tax incentives. For the fiscal years 2017, 2016,year ended September 30, 2020 and 2015, the Companynine-month period ended September 30, 2019, we reported net losses of approximately $5.0 million, $5.0$6.36 million and $2.8$2.78 million, respectively. As of September 30, 2017, the Company had an accumulated deficit of approximately $45.4 million and working capital of approximately $6.4 million. While the Company plans to finance company operations for the next twelve months with cash on hand and product sales, management expects to continue incurring losses for the foreseeable future and will need to raise additional capital to pursue our business plan beyond December 2018. Management is taking action to ensure the Company will continue as a going concern for at least one year beyond the date of the issuance of the Company’s financial statements. First, management has flexibility to adjust planned expenditures based on a number of factors including the size and timing of capital expenditures, staffing levels, inventory levels, and the status of customer clinical trials. Management also seeks to expand the customer base for existing marketed products, and is currently evaluating opportunities to secure additional financing through debt and/or equity financings, including transactions with strategic customers and partners that may include debt and/or equity arrangements. We have not secured any commitment for new financing at this time, nor can we provide any assurance that new financing will be available on commercially acceptable terms, if needed.

In July 2016,

On January 8, 2020, we completed a registered direct offering of an aggregate of 1,687,500 of our1,354,691 common shares, no par value, and a concurrent private placement of warrantsClass A Purchase Warrants to purchase up to an aggregate of 1,265,626up to 1,016,036 common shares withand Class B Purchase Warrants to purchase an exercise priceaggregate of $4.50 per share,up to 677,358 common shares, resulting in net proceeds of approximately $6$3.89 million.

We have filed


On September 28, 2020, we entered into the Equity Distribution Agreement with RBC Capital Markets, LLC (RBCCM), as sales agent, pursuant to which the Securitiescompany may offer and Exchange Commission, and the Securities and Exchange Commission declared effective, a universal shelf registration statement of up to $100 million worth of registered equity securities, of which we utilized approximately $6.75 million in our July 2016 offering. Under this effective registration statement, we may issue registered securities,sell, from time to time, common shares through an at-the-market equity offering program for up to $9.2 million in one or more separate offerings or other transactionsgross cash proceeds. Any shares offered and sold in the offering will be issued pursuant to the company’s shelf registration statement on Form S-3 (File No. 333-233567), which was declared effective on September 12, 2019; the prospectus supplement relating to the offering filed with the size, priceSEC on September 28, 2020; and termsany applicable additional prospectus supplements related to be determined at the time of issuance. Pursuant to General Instruction I.B.6 of Form S-3, in no event will we sell securities inoffering that form a public primary offering with a value of more than one-thirdpart of the aggregateregistration statement. RBCCM will use commercially reasonable efforts to sell the common shares from time to time, based upon our instructions. We have no obligation to sell any of the shares, and may at any time suspend sales under the distribution agreement or terminate the agreement in accordance with its terms. The total amount of cash that may be generated under this distribution agreement is uncertain and depends on a variety of factors, including market valueconditions and the trading price of our common shares. No shares held by non-affiliateswere sold under the distribution agreement prior to the end of the fiscal year.
At September 30, 2020, we had cash and cash equivalents of $7.21 million, working capital of $6.57 million, shareholders’ equity and temporary equity of $9.11 million and an accumulated deficit of $13.13 million. From October 1, 2020 to December 2, 2020, the exercise of Class A and Class B warrants resulted in any twelve-month period, so long as the aggregate market valueissuance of our243,369 common shares heldand cash proceeds of approximately $1.0 million. From October 1, 2020 to December 2, 2020, we sold 169,753 common shares under our distribution agreement with RBCCM for net proceeds of approximately $0.99 million.
We plan to finance company operations over the course of the next twelve months with cash and cash equivalents on hand. Management has flexibility to adjust this timeline by non-affiliates remains below $75 million. Registered securities issued usinga making changes to planned expenditures related to, among other factors, the size and timing of clinical trial expenditures, staffing levels, and the acquisition or in-licensing of new product candidates. To help fund our existing shelfoperations and meet our obligations, we may be usedalso seek additional financing through the sale of equity, government grants, debt financings or other capital sources, including potential future licensing, collaboration or similar arrangements with third parties or other strategic transactions. If we determine it is advisable to raise additional capitalfunds, there is no assurance that adequate funding will be available to fundus or, if available, that such funding will be available on terms that we or our working capital, R&Dshareholders view as favorable. Market volatility and other corporate needs.

concerns over a global recession related to the COVID-19 pandemic may have a significant impact on the availability of funding sources and the terms at which any funding may be available.

Research and Development

Our coreprimary business is developing and commercializing Keyhole Limpet Hemocyanin for use in immunotherapy and immunodiagnostic applications. Our internal research has included, among other activities, continual improvement of methods for the culture and growth of Giant Keyhole Limpet, innovations in aquaculture systems and infrastructure, biophysical and biochemical characterization of the KLH molecule, analytical processes to enhance performance of our products, KLH manufacturing process improvements, new KLH formulations, and early development of potential new KLH-based immunotherapies.

Researchinnovative therapeutics for inflammatory and immune-related diseases with clear unmet medical needs. We focus our resources on research and development activities, including the conduct of clinical studies and product development, and expense such costs as they are incurred. Our research and development expenses have primarily consisted of employee-related expenses, including materials, KLH designatedsalaries, benefits, taxes, travel, and share-based compensation expense for internal research use only and salaries of employees directly involvedpersonnel in research and development efforts,functions; expenses related to process development and production of product candidates paid to contract manufacturing organizations, including the cost of acquiring, developing, and manufacturing research material; costs associated with clinical activities, including expenses for contract research organizations; and clinical trials and activities related to regulatory filings for our product candidates, including regulatory consultants.

Research and development expenses, which have historically varied based on the level of activity in our clinical programs, are expensedsignificantly influenced by study initiation expenses and patient recruitment rates, and as incurred.

The following table includes oura result are expected to continue to fluctuate, sometimes substantially. Our research and development costs were $3.33 million and $1.10 million for eachthe year ended September 30, 2020 and the nine-month period ended September 30, 2019, respectively. The increase was due primarily to increased activities and preparations related to the ongoing Phase 2/Phase 3 clinical study of the most recent three fiscal years:

2017 $1,973,400 
2016  1,729,445 
2015  1,029,489 

our EB05 drug candidate as a potential treatment for hospitalized COVID-19 patients.

Off Balance Sheet Arrangements

We do not have any off balance sheet arrangements that have or are reasonably likely to have a current or future material effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital resources.

Disclosure

Foreign Exchange Risk
Our exposure to foreign exchange risk is primarily related to fluctuations between the Canadian dollar and the U.S. dollar. We have balances in Canadian dollars which are subject to foreign currency fluctuations relating to the impact of Contractual Obligations

translating to U.S. dollars for financial statements presentation. We currently lease 4,300 square feetalso periodically exchange U.S. dollars for Canadian dollars since most operating expenses are incurred in Canadian dollars. The fluctuation of executive officethe U.S. dollar in relation to the Canadian dollar will have an impact upon our profitability and laboratory spacemay also affect the value of our assets and the amount of shareholders’ equity. We have not entered into any agreements or purchased any instruments to hedge possible currency risks. At September 30, 2020, we had assets denominated in Port Hueneme, California underCanadian dollars of approximately C$3.24 million and the U.S. dollar exchange rate as at this date was equal to 1.3365 Canadian dollars. Based on the exposure at September 30, 2020, a lease which was renewed in July 2016 for a two-year term, with options to renew for three successive two-year terms.

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Our aquaculture and KLH manufacturing operations are located on approximately 37,000 square feet of oceanfront land10% annual change in the Port Hueneme Aquaculture Business Park. Our facilities here include specialized aquaculture infrastructure, seawater supplyCanadian/U.S. exchange rate would impact our net loss and discharge systems, laboratories, manufacturing and administrative offices. We have two sublease agreements which expire in September and October 2020, respectively, with options to extend the leases for two additional five-year terms.

We also currently lease undeveloped land in Baja California, Mexico under a lease agreement which we entered into in June 2015, with a three-year term, which lease agreement is terminable at will at any time with 30 days prior noticeother comprehensive loss by either party. $0.24 million.




Concentration of Credit Risk
We are utilizingpotentially subject to financial instrument concentration of credit risk through our cash and cash equivalents, US Treasury bills and accounts and other receivable. We place our cash and cash equivalents in US Treasury bills, money market mutual funds of U.S. government securities or financial institutions believed to be credit worthy and perform periodic evaluations of their relative credit standing. There were no Treasury bills outstanding at September 30, 2020 and 2019. Accounts receivable can be potentially exposed to a concentration of credit risk with our major customers. We assess the undeveloped land to conduct suitability studies for the potential development of an additional aquaculture locale and future expansion of production. We also have a short-term lease for office space in a business center located in Ensenada, Baja California. This office serves as the administrative headquarterscollectability of our BioEstelar subsidiary.

We have purchase commitments for contract research organizations, consultants and construction contractors.

The approximate amountsaccounts receivable through a review of our contractual obligations arecurrent aging, as follows:

Contractual Obligations

well as an analysis of our historical collection rate, general economic conditions and credit status of our customers. Accounts and other receivable also include Harmonized Sales Tax (HST) refunds receivable from the Canada Revenue Agency. As of September 30, 2017

     Less than 1  1-3  3-5  More than 
  Total  year  years  years  5 years 
                
Operating lease obligations $378,000  $160,000  $212,000  $6,000  $- 
Purchase obligations  252,000   186,900   65,100   -   - 
                     
Total $630,000  $346,900  $277,100  $6,000  $- 

2020 and 2019, all outstanding accounts and other receivable were deemed to be fully collectible, and therefore, no allowance for doubtful accounts was recorded. We determine terms and conditions for our customers primarily based on the volume purchased by the customer, customer creditworthiness and past transaction history. Management works to mitigate our concentration of credit risk with respect to accounts receivable through our credit evaluation policies, reasonably short payment terms and geographical dispersion of sales.


Significant Accounting Policies and Estimates

Our consolidated financial statements, which are indexed under Item 15 of this Annual Report on Form 10-K, have been prepared in accordance with accounting principles generally accepted in the United States, which require that the management make certain assumptions and estimates and, in connection therewith, adopt certain accounting policies. Our significant accounting policies are set forth in Note 3 in the Notes to Consolidated Financial Statements. Of those policies, we believe that the policies discussed below may involve a higher degree of judgment or may otherwise be more relevant to our financial condition and results of operations.

Investments

Investments at

Accounts and other receivable
We assess the collectability of our accounts receivable through a review of current aging, as well as an analysis of historical collection rates, general economic conditions and credit status of our customers.  Accounts and other receivable include Harmonized Sales Tax (HST) refunds receivable. As of September 30, 20172020, all outstanding accounts and 2016 consisted of U.S. Treasury bills with original maturities between 13 and 52 weeks. They are classified as held-to-maturity and are reported at amortized cost, which approximates fair value. We regularly review these investments to determine whether any decline in fair value below the amortized cost basis has occurred that is other than temporary. If a decline in fair value has occurred that is determinedHST refunds receivable were deemed to be other than temporary,fully collectible, and therefore, no allowance for doubtful accounts was recorded.
Intangible assets
Intangible assets represent the cost basisexclusive world-wide rights to know-how, patents and data relating to certain monoclonal antibodies (“the Constructs”), including sublicensing rights, acquired by entering into a license agreement with a pharmaceutical development company. Unless earlier terminated, the term of the investmentlicense agreement will remain in effect for 25 years from the date of first commercial sale of licensed products containing the Constructs. Subsequently, the license agreement will automatically renew for five-year periods unless either party terminates the agreement in accordance with its terms. We recognize intangible assets at their historical cost, amortized on a straight-line basis over their expected useful lives, which is written down25 years, and subject to fair value.

Inventory

We record inventory at the lower of cost or market, with market not in excess of net realizable value. Raw materials are measured using FIFO (first-in first-out) cost. Work in process and finished goods are measured using average cost. Raw materials include inventory of manufacturing supplies. Work in process includes manufacturing supplies, direct and indirect labor, contracted manufacturing and testing, and allocated manufacturing overhead for inventory in process at the end of the year. Finished goods include products that are complete and available for sale. The Company recorded work in process and finished goods inventory only for those products with recent sales levels to evaluate net realizable value.

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Warrant Liability

Our equity offerings in prior years included the issuance of warrants with exercise prices denominated in Canadian dollars. As a result of having exercise prices denominated in a currency other than our functional currency, our warrants with Canadian dollar exercise prices met the definition of derivatives and were therefore classified as derivative liabilities measured at fair value with noncash adjustments to fair value recognized through the consolidated statements of operations. Upon exercise of these warrants, the fair value of warrants included in derivative liabilities was reclassified to common shares. If these warrants expired, the related decrease in warrant liability was recognized as gain in fair value of warrant liability. There was no cash flow impact as a result of this accounting treatment. The fair value of the warrants was determined using the Black-Scholes option valuation modelimpairment review at the end of each reporting period.

All warrants with exercise prices denominated in Canadian dollars were exercised or expired by December 2015. Therefore, there is no outstanding warrant liability at

Right-of-Use assets
We adopted Accounting Standards Codification (ASC) Topic 842 Leases for the year ended September 30, 2017.

Revenue Recognition

Product Sales

2020 using the modified retrospective transition method. We elected the package of practical expedients in transition and the ongoing practical expedient not to recognize operating lease right-of-use assets and operating lease liabilities for short-term leases. As a result of adopting the new standard, we recognized operating lease right-of-use (“ROU”) assets and operating lease liabilities on the balance sheet for one operating lease with a term longer than 12 months at adoption. There was no impact to opening accumulated deficit. There were three short-term operating leases upon adoption that did not follow the ROU model. The Company recognizes product sales when KLH product is shipped (for whichROU assets are initially measured at cost and amortized using the risk is typically transferred upon deliverystraight-line method through the end of the lease term. The lease liabilities are initially measured at the present value of the lease payments that are not paid at the commencement date, discounted using our incremental borrowing rate.

Share-based compensation
We measure the cost of equity-settled transactions by reference to the shipping carrier) and there is persuasive evidencefair value of an arrangement, the fee is fixedequity instruments at the date at which they are granted if the fair value of the goods or determinable, and collectability is reasonably assured. The Company documents arrangements with customers with purchase orders and sales agreements.

Product sales include sales made under supply agreements with customers for a fixed price per gram of KLH products based on quantities ordered. Supply agreements are typically on a non-exclusive basis except within that customer’s field of use.

Contract services revenue

The Company recognizes contract services revenue when contract services have been performed and reasonable assurance exists regarding measurement and collectability. An appropriate amount will be recognized as revenue in the period thatreceived by the Company is assured of fulfilling the contract requirements. Amounts received in advance of performance of contract services are recorded as deferred revenue.

Contract services include services performed under collaboration agreements and technology transfer and purchase agreement.

Share-Based Compensation

cannot be reliably estimated.

We grant options to buy common shares of the Company to ourits directors, officers, employees and consultants, and grantgrants other equity-based instruments such as warrants to non-employees.

The fair value of share-based compensation is measured on the date of grant, using the Black-Scholes option valuation model and is recognized over the vesting period net of estimated forfeitures for employees or the service period for non-employees. The provisions of our share-based compensation plans do not require the Company to settle any options by transferring cash or other assets, and therefore we classify the awards as equity. The Black-Scholes option valuation model requires the input of subjective assumptions, including price volatility of the underlying shares,stock, risk-free interest rate, dividend yield, and expected life of the option.

Foreign Exchange

Items included in




Translation of foreign currency transactions
Our reporting currency is the U.S. dollar. The financial statements of our wholly owned Canadian subsidiary is measured using the Canadian dollar as the functional currency. Assets and liabilities of the Canadian operation have been translated at year-end exchange rates and related revenue and expenses have been translated at average exchange rates for the year. Accumulated gains and losses resulting from the translation of the financial statements of our subsidiariesthe Canadian operation are measured using the currencyincluded as part of the primary economic environment in which the entity operates (the functional currency). Our functional currency and the functional currencyaccumulated other comprehensive loss, a separate component of our subsidiaries is the U.S. dollar.

Transactionsshareholders' equity.

In respect of other transactions denominated in currencies other than our functional currency, the U.S. dollarmonetary assets and liabilities are recordedtranslated at the year-end rates. Revenue and expenses are translated at rates of exchange rates prevailing on the datestransaction dates. Non-monetary balance sheet and related income statement accounts are remeasured into U.S. dollar using historical exchange rates. All of the transactions.

exchange gains or losses resulting from these other transactions are recognized in the statements of operations and comprehensive loss.

Recent Accounting Pronouncements

Recent accounting pronouncements are contained in Note 3 to the financial statements, which are indexed under Item 15 of this this Annual Report on Form 10-K.

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CERTAIN INCOME TAX CONSIDERATIONS

United States Federal Income Taxation

As used below,

Item 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
We are a “U.S. holder” is a beneficial owner of a common share that is, for U.S. federal income tax purposes, (i) a citizen or resident alien individual of the United States, (ii) a corporation (or an entity treated as a corporation) created or organized under the law of the United States, any State thereof or the District of Columbia, (iii) an estate the income of which is subject to U.S. federal income tax without regard to its source or (iv) a trust if (1) a court within the United States is able to exercise primary supervision over the administration of the trust, and one or more United States persons have the authority to control all substantial decisions of the trust, or (2) the trust has a valid election in effect under applicable U.S. Treasury Regulations to be treated as a United States person. For purposes of this discussion, a “non-U.S. holder” is a beneficial owner of a common share that is (i) a nonresident alien individual, (ii) a corporation (or an entity treated as a corporation) created or organized in or under the law of a country other than the United States or a political subdivision thereof or (iii) an estate or trust that is not a U.S. Holder. If a partnership (including for this purpose any entity treated as a partnership for U.S. federal tax purposes) is a beneficial owner of a common share, the U.S. federal tax treatment of a partner in the partnership generally will depend on the status of the partner and the activities of the partnership. A holder of a common share that is a partnership and partners in that partnership should consult their own tax advisers regarding the U.S. federal income tax consequences of holding and disposing of common shares. We have not sought a ruling from the Internal Revenue Service (IRS) or an opinion of counsel as to any U.S. federal income tax consequence described herein. The IRS may disagree with the description herein, and its determination may be upheld by a court. This discussion does not address U.S. federal tax laws other than those pertaining to U.S. federal income taxation (such as estate or gift tax laws), nor does it address any aspects of U.S. state or local or non-U.S. taxation.

GIVEN THE COMPLEXITY OF THE TAX LAWS AND BECAUSE THE TAX CONSEQUENCES TO ANY PARTICULAR SHAREHOLDER MAY BE AFFECTED BY MATTERS NOT DISCUSSED HEREIN, SHAREHOLDERS ARE URGED TO CONSULT THEIR OWN TAX ADVISORS WITH RESPECT TO THE SPECIFIC TAX CONSEQUENCES OF THE ACQUISITION, OWNERSHIP AND DISPOSITION OF COMMON SHARES, INCLUDING THE APPLICABILITY AND EFFECT OF STATE, LOCAL AND NON-U.S. TAX LAWS, AS WELL AS U.S. FEDERAL TAX LAWS.

Taxation of Dividends

U.S. Holders.In general, subject to the passive foreign investmentsmaller reporting company rules discussed below, a distribution on a common share will constitute a dividend for U.S. federal income tax purposes to the extent that it is made from a corporation’s current or accumulated earnings and profits as determined under U.S. federal income tax principles. If a distribution exceeds the current and accumulated earnings and profits of the distributing corporation, it will generally be treated as a non-taxable reduction of basis to the extent of the U.S. holder’s tax basis in the common share on which it is paid, and to the extent it exceeds that basis it will be treated as capital gain. The Company has not and does not plan to maintain calculations of earnings and profits under U.S. federal income tax principles. Accordingly, it is unlikely that U.S. holders will be able to establish that a distribution by the Company is in excess of its current and accumulated earnings and profits (as computed under U.S. federal income tax principles). Therefore, a U.S. holder should expect that a distribution by the Company will generally be taxable in its entirety as a dividend to U.S. holders for U.S. federal income tax purposes even though the distribution may be treated in whole or in part as a non-taxable distribution for Canadian tax purposes.

The gross amount of any dividend on a common share (which will include the amount of any Canadian taxes withheld with respect to such dividend) generally will be subject to U.S. federal income tax as foreign source dividend income, and will not be eligible for the corporate dividends received deduction. The amount of a dividend paid in Canadian dollars will be its value in U.S. dollars based on the prevailing spot market exchange rate in effect on the day the U.S. holder receives the dividend. A U.S. holder will have a tax basis in any distributed Canadian dollars equal to their U.S. dollar value on the date of receipt, and any gain or loss realized on a subsequent conversion or other disposition of such Canadian dollars generally will be treated as U.S. source ordinary income or loss. If dividends paid in Canadian dollars are converted into U.S. dollars on the date they are received by a U.S. holder, the U.S. holder generally should not be required to recognize foreign currency gain or loss in respect of the dividend income.

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Subject to certain exceptions for short-term and hedged positions, as well as the passive foreign investment rules, a dividend that a non-corporate holder receives on a common share will generally be subject to a maximum federal income tax rate of 20% if the dividend is a “qualified dividend.” A dividend on a common share will be a qualified dividend if (i) either (a) the common shares are readily tradable on an established market in the United States or (b) we are eligible for the benefits of a comprehensive income tax treaty with the United States that the Secretary of the Treasury determines is satisfactory for purposes of these rules and that includes an exchange of information program, and (ii) we were not, in the year prior to the year the dividend was paid, and are not in the year the dividend is paid, a passive foreign investment company (PFIC). The common shares are listed on The Nasdaq Capital Market which should be treated as an established securities market in the United States. In any event, the U.S. Canada Income Convention (the Treaty) satisfies the requirements of clause (i)(b), the Company is incorporated in and tax resident of Canada and should be entitled to the benefits of the Treaty. Based on our audited financial statements, income tax returns and relevant market and shareholder data, we believe that we likely will not be classified as a PFIC in the September 30, 2017 taxable year. There can be no assurance, however, that the Company will not be considered to be a PFIC for any particular year in the future because PFIC status is factual in nature, depends upon factors not wholly within the Company’s control, generally cannot be determined until the close of the taxable year in question, and is determined annually. Accordingly, no assurance can be made that a dividend paid, if any, would be a “qualified dividend.” In addition, as described in the section below entitled “Passive Foreign Investment Company Rules,” if we were a PFIC in a year while a U.S. holder held a common share, and if the U.S. holder has not made a qualified electing fund election effective for the first year the U.S. holder held the common share, the common share remains an interest in a PFIC for all future years or until such an election is made. The IRS takes the position that such rule will apply for purposes of determining whether a common share is an interest in a PFIC in the year a dividend is paid or in the prior year, even if we do not satisfy the tests to be a PFIC in either of those years. Even if dividends on the common shares would otherwise be eligible for qualified dividend treatment, in order to qualify for the reduced qualified dividend tax rates, a non-corporate holder must hold the common share on which a dividend is paid for more than 60 days during the 120-day period beginning 60 days before the ex-dividend date, disregarding for this purpose any period during which the non-corporate holder has an option to sell, is under a contractual obligation to sell or has made (and not closed) a short sale of substantially identical stock or securities, is the grantor of an option to buy substantially identical stock or securities or, pursuant to U.S. Treasury regulations, has diminished such holder’s risk of loss by holding one or more other positions with respect to substantially similar or related property. In addition, to qualify for the reduced qualified dividend tax rates, the non-corporate holder must not be obligated to make related payments with respect to positions in substantially similar or related property. Payments in lieu of dividends from short sales or other similar transactions will not qualify for the reduced qualified dividend tax rates.

A non-corporate holder that receives an extraordinary dividend (generally, any dividend that is in excess of 10% of the holder's adjusted basis in the common share on which the dividend is paid) that is eligible for the reduced qualified dividend rates must treat any loss on the sale of the common share as a long-term capital loss to the extent of the dividend. For purposes of determining the amount of a non-corporate holder’s deductible investment interest expense, a dividend is treated as investment income only if the non-corporate holder elects to treat the dividend as not eligible for the reduced qualified dividend tax rates. Special limitations on foreign tax credits with respect to dividends subject to the reduced qualified dividend tax rates apply to reflect the reduced rates of tax.

The U.S. Treasury has announced its intention to promulgate rules pursuant to which non-corporate holders of stock of non-U.S. corporations, and intermediaries through which the stock is held, will be permitted to rely on certifications from issuers to establish that dividends are treated as qualified dividends. Because those procedures have not yet been issued, it is not clear whether we will be able to comply with them.

Non-corporate holders of common shares are urged to consult their own tax advisers regarding the availability of the reduced qualified dividend tax rates with respect to dividends, if any, received on the common shares in the light of their own particular circumstances.

Any Canadian withholding tax imposed on dividends received with respect to the common shares will be treated as a foreign income tax eligible for credit against a U.S. holder’s U.S. federal income tax liability, subject to generally applicable limitations under U.S. federal income tax law. For purposes of computing those limitations separately under current law for specific categories of income, a dividend generally will constitute foreign source “passive category income” or, in the case of certain holders, “general category income.” A U.S. holder will be denied a foreign tax credit with respect to Canadian income tax withheld from dividends received with respect to the common shares to the extent the U.S. holder has not held the common shares for at least 16 days of the 30-day period beginning on the date which is 15 days before the ex-dividend date or to the extent the U.S. holder is under an obligation to make related payments with respect to substantially similar or related property. Any days during which a U.S. holder has substantially diminished its risk of loss on the common shares are not counted toward meeting the 16-day holding period required by the statute. The rules relating to the determination of the foreign tax credit are complex, and U.S. holders are urged to consult with their own tax advisers to determine whether and to what extent they will be entitled to foreign tax credits as well as with respect to the determination of the foreign tax credit limitation. Alternatively, any Canadian withholding tax may be taken as a deduction against taxable income, provided the U.S. holder takes a deduction and not a credit for all foreign income taxes paid or accrued in the same taxable year. In general, special rules will apply to the calculation of foreign tax credits in respect of dividend income that is subject to preferential rates of U.S. federal income tax.

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Non-U.S. Holders.A dividend paid to a non-U.S. holder of a common share will generally not be subject to U.S. federal income tax unless the dividend is effectively connected with the conduct of trade or business by the non-U.S. holder within the United States (and is attributable to a permanent establishment or fixed base the non-U.S. holder maintains in the United States if an applicable income tax treaty so requires as a condition for the non-U.S. holder to be subject to U.S. taxation on a net income basis on income from the common share). A non-U.S. holder generally will be subject to tax on an effectively connected dividend in the same manner as a U.S. holder. A corporate non-U.S. holder under certain circumstances may also be subject to an additional “branch profits tax,” the rate of which may be reduced pursuant to an applicable income tax treaty.

Taxation of Capital Gains

U.S. Holders.Subject to the passive foreign investment company rules discussed below, on a sale or other taxable disposition of a common share, a U.S. holder will recognize capital gain or loss in an amount equal to the difference between the U.S. holder’s adjusted basis in the common share and the amount realized on the sale or other disposition, each determined in U.S. dollars. Such capital gain or loss will be long-term capital gain or loss if at the time of the sale or other taxable disposition the common share has been held for more than one year. In general, any adjusted net capital gain of an individual is subject to a maximum federal income tax rate of 20%. Capital gains recognized by corporate U.S. holders generally are subject to U.S. federal income tax at the same rate as ordinary income. The deductibility of capital losses is subject to limitations.

Any gain a U.S. holder recognizes generally will be U.S. source income for U.S. foreign tax credit purposes, and, subject to certain exceptions, any loss will generally be a U.S. source loss. If a Canadian tax is paid on a sale or other disposition of a common share, the amount realized will include the gross amount of the proceeds of that sale or disposition before deduction of the Canadian tax. The generally applicable limitations under U.S. federal income tax law on crediting foreign income taxes may preclude a U.S. holder from obtaining a foreign tax credit for any Canadian tax paid on a sale or other disposition of a common share. The rules relating to the determination of the foreign tax credit are complex, and U.S. holders are urged to consult with their own tax advisers regarding the application of such rules. Alternatively, any Canadian tax paid on the sale or other disposition of a common share may be taken as a deduction against taxable income, provided the U.S. holder takes a deduction and not a credit for all foreign income taxes paid or accrued in the same taxable year.

Non-U.S. Holders.A non-U.S. holder will not be subject to U.S. federal income tax on gain recognized on a sale or other disposition of a common share unless (i) the gain is effectively connected with the conduct of trade or business by the non-U.S. holder within the United States (and is attributable to a permanent establishment or fixed base the non-U.S. holder maintains in the United States if an applicable income tax treaty so requires as a condition for the non-U.S. holder to be subject to U.S. taxation on a net income basis on income from the common share), or (ii) in the case of a non-U.S. holder who is an individual, the holder is present in the United States for 183 or more days in the taxable year of the sale or other disposition and certain other conditions apply. Any effectively connected gain of a corporate non-U.S. holder may also be subject under certain circumstances to an additional “branch profits tax,” the rate of which may be reduced pursuant to an applicable income tax treaty.

Passive Foreign Investment Company Rules

A special set of U.S. federal income tax rules applies to a foreign corporation that is a PFIC for U.S. federal income tax purposes. As noted above, based on our audited financial statements, income tax returns, and relevant market and shareholder data, we believe that we likely will not be classified as a PFIC in the September 30, 2017 taxable year. There can be no assurance, however, that the Company will not be considered to be a PFIC for any particular year in the future because PFIC status is factual in nature, depends upon factors not wholly within the Company’s control, generally cannot be determined until the close of the taxable year in question, and is determined annually.

In general, a non-US corporation is a PFIC if in any taxable year either (i) at least 75% of its gross income is “passive income” or (ii) at least 50% of the quarterly average value of its assets is attributable to assets that produce or are held to produce “passive income.” In applying these tests, the Company generally is treated as holding its proportionate share of the assets and receiving its proportionate share of the income of any other corporation in which the Company owns at least 25% by value of the shares. Passive income for this purpose generally includes dividends, interest, royalties, rent and capital gains, but generally does not include certain royalties derived in an active business. Passive assets are those assets that are held for production of passive income or do not produce income at all. Thus cash will be a passive asset. Interest, including interest on working capital, is treated as passive income for purposes of the income test. Without taking into account the value of its goodwill, more than 50% of the Company’s assets by value would be passive so that the Company would be a PFIC under the asset test. Based upon its current operations, its goodwill (the value of which should be based upon the Company’s market capitalization) will likely be attributable to its activities that will generate active income and to such extent, should be treated as an active asset. The determination of whether a foreign corporation is a PFIC is a factual determination made annually and is therefore subject to change. Subject to exceptions pursuant to certain elections that generally require the payment of tax, once stock in a foreign corporation is stock in a PFIC in the hands of a particular shareholder that is a United States person, it remains stock in a PFIC in the hands of that shareholder.

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If we are treated as a PFIC, contrary to the tax consequences described in “Taxation of Dividends” and “Taxation of Capital Gains” above, a U.S. holder that does not make an election described in the succeeding two paragraphs would be subject to special rules with respect to (i) any gain realized on a sale or other disposition of a common share (for purposes of these rules, a disposition of a common share includes many transactions on which gain or loss is not realized under general U.S. federal income tax rules) and (ii) any “excess distribution” by the Company to the U.S. holder (generally, any distribution during a taxable year in which distributions to the U.S. holder on the common share exceed 125% of the average annual taxable distributions (whether actual or constructive and whether or not out of earnings and profits) the U.S. holder received on the common share during the preceding three taxable years or, if shorter, the U.S. holder’s holding period for the common share). Under those rules, (i) the gain or excess distribution would be allocated ratably over the U.S. holder’s holding period for the common share, (ii) the amount allocated to the taxable year in which the gain or excess distribution is realized would be taxable as ordinary income in its entirety and not as capital gain, would be ineligible for the reduced qualified dividend rates, and could not be offset by any deductions or losses, and (iii) the amount allocated to each prior year, with certain exceptions, would be subject to tax at the highest tax rate in effect for that year, and the interest charge generally applicable to underpayments of tax would be imposed in respect of the tax attributable to each of those years.

The special PFIC rules described above will not apply to a U.S. holder if the U.S. holder makes a timely election, which remains in effect, to treat the Company as a “qualified electing fund” (QEF) in the first taxable year in which the U.S. holder owns a common share and the Company is a PFIC and if the Company complies with certain requirements. Instead, a shareholder of a QEF generally is currently taxable on a pro rata share of the Company’s ordinary earnings and net capital gain as ordinary income and long-term capital gain, respectively. Neither that ordinary income nor any actual dividend from the Company would qualify for the 20% maximum federal income tax rate on dividends described above if the Company is a PFIC in the taxable year the ordinary income is realized or the dividend is paid or in the preceding taxable year. A QEF election cannot be made unless the Company provides U.S. Holders the information and computations needed to report income and gains pursuant to a QEF election. The Company expects that will not provide this information. It is, therefore, likely that U.S. holders would not be able to make a QEF election in any year we are a PFIC.

In lieu of a QEF election, a U.S. holder of stock in a PFIC that is considered marketable stock could elect to mark the stock to market annually, recognizing as ordinary income or loss each year an amount equal to the difference as of the close of the taxable year between the fair market value of the stock and the U.S. holder’s adjusted basis in the stock. Losses would be allowed only to the extent of net mark-to-market gain previously included in income by the U.S. holder under the election for prior taxable years. A U.S. holder’s adjusted basis in the common shares will be adjusted to reflect the amounts included or deducted with respect to the mark-to-market election. If the mark-to-market election were made, the rules set forth in the second preceding paragraph would not apply for periods covered by the election. A mark-to-market election will not apply during any later taxable year in which the Company does not satisfy the tests to be a PFIC. In general, the common shares will be marketable stock if the common shares are traded, other than inde minimis quantities, on at least 15 days during each calendar quarter on a national securities exchange that is registered with the SEC or on a designated national market system or on any exchange or market that the Treasury Department determines to have rules sufficient to ensure that the market price accurately represents the fair market value of the stock.Under current law, the mark-to-market election may be available to U.S. holders of common shares because the common shares are listed on The Nasdaq Capital Market and the TSX Venture Exchange (at least one of which should constitute a qualified exchange for this purpose), although there can be no assurance that the common shares will be “regularly traded” for purposes of the mark-to-market election.

If we are treated as a PFIC, each U.S. holder generally will be required to file a separate annual information return with the United States Internal Revenue Service (IRS) with respect to the Company (and any lower-tier PFICs). A failure to fileprovide disclosure under this return will suspend the statute of limitations with respect to any tax return, event, or period to which such report relates (potentially including with respect to items that do not relate to a U.S. holder’s investment in the common shares). Given the complexities of the PFIC rules and their potentially adverse tax consequences, U.S. holders of common shares are urged to consult their tax advisers about the PFIC rules.

Medicare Surtax on Net Investment Income

Non-corporate U.S. Holders whose income exceeds certain thresholds generally will be subject to 3.8% surtax on their “net investment income” (which generally includes, among other things, dividends on, and capital gain from the sale or other taxable disposition of, the common shares). Absent an election to the contrary, if a QEF election is available and made, QEF inclusions will not be included in net investment income at the time a U.S. Holder includes such amounts in income, but rather will be included at the time distributions are received or gains are recognized. Non-corporate U.S. Holders should consult their own tax advisors regarding the possible effect of such tax on their ownership and disposition of the common shares, in particular the applicability of this surtax with respect to a non-corporate U.S. Holder that makes a QEF or mark-to-market election in respect of their common shares.

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item.

Information Reporting and Backup Withholding

Dividends paid on, and proceeds from the sale or other disposition of, a common share to a U.S. holder generally may be subject to information reporting requirements and may be subject to backup withholding unless the U.S. holder provides an accurate taxpayer identification number or otherwise establishes an exemption. The amount of any backup withholding collected from a payment to a U.S. holder will be allowed as a credit against the U.S. holder’s U.S. federal income tax liability and may entitle the U.S. holder to a refund, provided certain required information is furnished to the Internal Revenue Service. A non-U.S. holder generally will be exempt from these information reporting requirements and backup withholding tax but may be required to comply with certain certification and identification procedures in order to establish its eligibility for exemption.

Under U.S. federal income tax law and U.S. Treasury Regulations, certain categories of U.S. holders must file information returns with respect to their investment in, or involvement in, a foreign corporation. U.S. holders are urged to consult with their own tax advisors concerning such reporting requirements.

Reporting Obligations of Individual Owners of Foreign Financial Assets

Section 6038D of the Code generally requires U.S. individuals (and possibly certain entities that have U.S. individual owners) to file IRS Form 8938 if they hold certain “specified foreign financial assets,” the aggregate value of which exceeds $50,000 on the last day of the year or $75,000 at any time during the year. The definition of specified foreign financial assets includes not only financial accounts maintained in foreign financial institutions, but also, unless held in accounts maintained by a financial institution, any stock or security issued by a non-US. person, any financial instrument or contract held for investment that has an issuer or counterparty other than a U.S. person and any interest in a foreign entity. Persons who are required to report foreign financial assets and fail to do so may be subject to substantial penalties.

Canadian Federal Income Tax Consequences

The following summary of the material Canadian federal income tax consequences is stated in general terms and is not intended to be legal or tax advice to any particular shareholder. Each shareholder or prospective shareholder is urged to consult his or her own tax advisor regarding the tax consequences of his or her purchase, ownership and disposition of common shares. The tax consequences to any particular holder of common shares will vary according to the status of that holder as an individual, trust, corporation or member of a partnership, the jurisdiction in which that holder is subject to taxation, the place where that holder is resident and, generally, according to that holder’s particular circumstances.

This summary is applicable only to holders who are resident in the United States for income tax purposes, have never been resident in Canada for income tax purposes, deal at arm’s length with the Company, hold their common shares as capital property and who will not use or hold the common shares in carrying on business in Canada. Special rules, which are not discussed in this summary, may apply to a United States holder that is an issuer that carries on business in Canada and elsewhere.

This summary is based upon the provisions of the Income Tax Act (Canada) and the regulations thereunder (collectively, the Tax Act or ITA) and the Canada-United States Tax Convention (the Tax Convention) at the date of this Annual Report and the current administrative practices of the Canada Revenue Agency. This summary does not take into account provincial income tax consequences. The comments in this summary that are based on the Tax Convention are applicable to U.S. holders only if they qualify for benefits under the Tax Convention. Management urges each holder to consult his own tax advisor with respect to the income tax consequences applicable to him in his own particular circumstances.

Non-Resident Holders

The summary below is restricted to the case of a holder (a Holder) of one or more common shares who for the purposes of the Tax Act is a non-resident of Canada, holds his common shares as capital property and deals at arm’s length with the Company.

Dividends

A Holder will be subject to Canadian withholding tax (Part XIII Tax) equal to 25%, or such lower rates as may be available under an applicable tax treaty, of the gross amount of any dividend paid or deemed to be paid on his common shares. The Company will be required to withhold the applicable amount of Part XIII Tax from each dividend so paid and remit the withheld amount directly to the Receiver General for Canada for the account of the Holder.

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Disposition of Common Shares

A Holder who disposes of common shares, including by deemed disposition on death, will not be subject to Canadian tax on any capital gain thereby realized unless the common share constituted “taxable Canadian property” as defined by the Tax Act. Generally, a common share of a public corporation will not constitute taxable Canadian property of a Holder unless he held the common share as capital property used by him carrying on a business in Canada, or he, persons with whom he did not deal at arm’s length or partnerships in which he or persons with whom he did not deal at arm’s length held an interest, alone or together held or held options to acquire, at any time within the 60 months preceding the disposition, 25% or more of the issued shares of any class of the capital shares of the Company and at any time during the 60 months preceding the disposition more than 50% of the value of the common shares is derived from, or from an interest in, Canadian real estate, including Canadian resource or timber resource properties.

Holders Resident in the United States

A Holder who is a resident of the United States and realizes a capital gain on disposition of common shares that was taxable Canadian property will, if qualified for benefits under the Tax Convention, generally be exempt from Canadian tax thereon unless (a) more than 50% of the value of the common shares is derived from, or from an interest in, Canadian real estate, including Canadian natural resource properties, (b) the common shares formed part of the business property of a permanent establishment that the Holder has or had in Canada within the 12 months preceding disposition, or (c) the Holder (i) was a resident of Canada at any time within the ten years immediately preceding the disposition, and for a total of 120 months during any period of 20 consecutive years, preceding the disposition, (ii) owned the common shares when he ceased to be resident in Canada, and (iii) the common shares were not subject to a deemed disposition on the Holder’s departure from Canada.

Inclusion in Taxable Income

A Holder who is subject to Canadian tax in respect of a capital gain realized on disposition of common shares must include one half of the capital gain (“taxable capital gain”) in computing his taxable income earned in Canada. The Holder may, subject to certain limitations, deduct one half of any capital loss (“allowable capital loss”) arising on disposition of taxable Canadian property from taxable capital gains realized in the year of disposition in respect to taxable Canadian property and, to the extent not so deductible, from such taxable capital gains of any of the three preceding years or any subsequent year.

Subject to certain exceptions, a non-resident person who disposes of taxable Canadian property must notify the Canada Revenue Agency either before or after the disposition (within ten days of the disposition)Item 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.

Item 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

We are exposed to financial market risks associated with foreign exchange rates, concentration of credit, and liquidity. In accordance with our policies, we manage our exposure to various market-based risks and where material, these risks are reviewed and monitored by our Board of Directors.

Foreign Exchange Risk

Our exposure to foreign exchange risk is primarily related to fluctuations between the Canadian dollar and the U.S. dollar. Funds held in Mexican pesos are nominal. We incur operating expenses and capital expenditures mostly in U.S. dollars, with some operating expenses incurred in Canadian dollars which are subject to foreign currency fluctuations. The fluctuation of the U.S. dollar in relation to the Canadian dollar will have an impact upon our profitability and may also affect the value of our assets and the amount of shareholders’ equity. We have not entered into any agreements or purchased any instruments to hedge possible currency risks. At September 30, 2017, we held approximately CDN$1.5 million in cash and cash equivalents in Canadian dollars and the U.S. dollar was equal to 1.2458 Canadian dollars. Based on the exposure at September 30, 2017, a 10% annual change in the Canadian/U.S. exchange rate over the prior year would impact our net loss by approximately $122,000.

Concentration of Credit Risk

We are potentially subject to financial instrument concentration of credit risk through our cash equivalents, US Treasury bills and accounts receivables. We place our cash and cash equivalents in 4 week US Treasury bills or financial institutions believed to be credit worthy and perform periodic evaluations of their relative credit standing. We place short-term investments in 13 to 52 week US Treasury bills. Accounts receivables can be potentially exposed to a concentration of credit risk with our major customers.

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The Company had concentrations of revenues in fiscal 2017, 2016 and 2015 as follows:

  2017  2016  2015 
          
Product sales and contract services revenue   79% from
2 customers
    76% from
3 customers
    82% from
3 customers
 

The Company had concentrations of accounts receivable at fiscal year-end 2016 as follows:

2016
Accounts receivable 100 % from
1 customer

There were no customer accounts receivable at September 30, 2017.

We assess the collectability of our accounts receivable through a review of our current aging, as well as an analysis of our historical collection rate, general economic conditions and credit status of our customers.  As of September 30, 2017 and 2016, all outstanding accounts receivable were deemed to be fully collectible, and therefore, no allowance for doubtful accounts was recorded. We determine terms and conditions for our customers primarily based on the volume purchased by the customer, customer creditworthiness and past transaction history.

Management works to mitigate our concentration of credit risk with respect to accounts receivable through our credit evaluation policies, reasonably short payment terms and geographical dispersion of sales. Revenue includes export sales to foreign companies located principally in Europe and Asia.

Liquidity Risk

Liquidity risk is the risk that we will not be able to meet our financial obligations as they fall due. We attempt to manage liquidity risk by maintaining sufficient cash and cash equivalent and short-term investment balances. Liquidity requirements are managed based on expected cash flows to ensure that there is sufficient capital in order to meet our short-term obligations. At September 30, 2017 and 2016, we had cash and cash equivalents and short-term investment balances totaling $6.6 million and $11.4 million, respectively, to settle current liabilities of $.32 million and $.62 million, respectively.

Item 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.

The financial statements and related financial information required to be filed hereunder are indexed under Item 15 of this Annual Report on Form 10-K and are incorporated herein by reference.

Item 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE.

There were no reportable events under this item during the past two fiscal years.

Item 9A.CONTROLS AND PROCEDURES.

Item 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE.
Not applicable. 
Item 9A.CONTROLS AND PROCEDURES.
Disclosure Controls and Procedures

Our management is responsible for establishing and maintaining disclosure controls and procedures to provide reasonable assurance that material information related to our Company, including our consolidated subsidiaries, is made known to senior management, including our Chief Executive Officer and the Chief Financial Officer, by others within those entities on a timely basis so that appropriate decisions can be made regarding public disclosure.

We carried out an evaluation, under the supervision and with the participation of our management, including our Principal Executive Officer and our Principal Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e)) under the Securities and Exchange Act of 1934, as amended) as of September 30, 2017.2020. Our Chief Executive Officer and Chief Financial Officer concluded that the disclosure controls and procedures as of September 30, 2017,2020, were effective.

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Management’s Annual Report on Internal Control over Financial Reporting

Our management is responsible for designing, establishing and maintaining a system of internal controls over financial reporting (as defined in Exchange Act Rule 13a-15(f)) to provide reasonable assurance that the financial information prepared by us for external purposes is reliable and has been recorded, processed and reported in an accurate and timely manner in accordance with accounting principles generally accepted in the United States. The Board of Directors is responsible for ensuring that management fulfills its responsibilities. The Audit Committee fulfills its role of ensuring the integrity of the reported information through its review of the interim and annual financial statements. Management reviewed the results of their assessment with our Audit Committee.

Because of its inherent limitations, our internal control over financial reporting may not prevent or detect all possible misstatements or frauds. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with policies or procedures may deteriorate.

Management has used the criteria issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in “Internal Control — Integrated Framework (2013)” to evaluate the effectiveness of our internal control over financial reporting. Management has assessed the effectiveness of our internal control over financial reporting and concluded that such internal control over financial reporting was effective as of September 30, 2017.

2020.



Attestation Report of Our Registered Public Accounting Firm

This Annual Report does not include an attestation report from our independent registered public accounting firm. We are an “emerging growth company,” as defined under the JOBS Act and a “smaller reporting company” as defined by Rule 12b-2 of the Exchange Act, and are subject to reduced public company reporting requirements. The JOBS Act provides that an emerging growth company isWe are not required to have the effectiveness of such company’sour internal control over financial reporting audited by itsour external auditors for as long as such company is deemed to be an emerging growth company.

auditors.

Limitations on the Effectiveness of Controls

Our management, including the Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls or our internal controls will prevent all error and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control. The design of any system of controls is also based, in part, upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed achieving its stated goals under all potential future conditions; over time, control may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting that occurred during the fourth quarteryear ended September 30, 20172020 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Item 9B.OTHER INFORMATION.

None.

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IPARTtem 9B.OTHER INFORMATION.
On December 1, 2020, we entered into a new employment agreement with Ms. Niffenegger.  The disclosure under the heading “Employment Agreement with Kathi Niffenegger effective as of December 1, 2020” appearing in Part III

Item 10.DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.

of this Annual Report on Form 10-K is hereby incorporated herein by reference.


PART III
Item 10.    DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.
Directors

Our directors and their ages as of November 30, 2017December 2, 2020 are set forth below.

NameAge AgePosition(s) HeldDirector Since
Tessie M. Che, Ph.D.Lorin Johnson, PhD (2)6768DirectorSeptember 25, 2013June 7, 2019
Paul ChunSean MacDonald (1)(2)(3)4436Chairman of Board of DirectorsDirectorDecember 8, 2016June 7, 2019
David L. Hill, Ph.D. (1)(2)(3)Pardeep Nijhawan, MD6650Director, Chief Executive Officer and Corporate SecretaryMay 17, 2011June 7, 2019
Daniel E. Morse, Ph.D.Frank Oakes7670DirectorApril 9, 2010
Frank R. Oakes67

President, Chief Executive Officer and

Chairman of our Board of Directors

April 9, 2010
Charles V. Olson, D.Sc. Paul Pay (1)(2)6066DirectorDecember 8, 2016June 7, 2019
Mayank D. SampatCarlo Sistilli, CPA, CMA (1)(2)(3)6264DirectorJune 7, 2019
Peter van der Velden (3)August 15, 201259DirectorJune 7, 2019

(1)
Member of Audit Committee.

(2)
Member of Compensation Committee.

(3)
Member of the Nominating and Corporate Governance Committee.

There are no family relationships between any of our directors or executive officers.

Biographies and Qualifications.
The biographies of our directors and certain information regarding each director’s experience, attributes, skills and/or qualifications that led to the conclusion that the director should be serving as a director of our Company are as follows:
Lorin Johnson,

Tessie M. Che, Ph.D. PhDis a seasoned pharmaceutical entrepreneur and innovator with more than 30 years of experience in building companies. He has been a directormember of Stellarour board of directors since September 2013. Dr. Che is currently General Manager and Chair of the Board of Directors of Amaran Biotechnology Inc., a privately-held biopharmaceuticals manufacturer based in Taiwan, a position she has held since 2012. She is alsoJune 2019, having previously served as a director of OBIthe company’s principal operating subsidiary, Edesa Biotech Research, Inc., from its founding in January 2015 to January 2016. Dr. Johnson is currently the Chief Scientist of Glycyx Pharma USA, a wholly-owned subsidiary of OBI Pharma, Inc.Ventures Ltd., a publicly traded biotechnology corporationbiopharma investment and development company he founded in Taiwan. From 1998March 2016. Prior to 2011 she served as COO and Sr. V.P., Corporate Affairs of OptimerGlycyx, Dr. Johnson co-founded Salix Pharmaceuticals, Inc., a specialty pharmaceutical company, she co-founded. At Optimer,and held senior leadership positions prior to its acquisition by Valeant Pharmaceuticals International, Inc. in April 2015. Earlier in his career, Dr. Che guidedJohnson served as Director of Scientific Operations and Chief Scientist at Scios, Inc. (formerly California Biotechnology, Inc). In addition to Edesa, he currently serves on the company’s CMC team toboards of Innovate Biopharmaceuticals, Inc. (trading symbol INNT), Glycyx MOR, LTD, Kinisi Therapeutics, Ltd., Intact Therapeutics, Inc. and ATXA Therapeutics, Ltd. Dr. Johnson has also held academic positions at Stanford University School of Medicine where he served as an Assistant Professor of Pathology and at the successful registrationUniversity of California, San Francisco. He is the co-author of 76 journal articles and commercialization of DificidTM inbook chapters and is the U.S., Canada and Europe. Prior to Optimer,co-inventor on 23 issued patents. Dr. Che’s experience includes 20 years in research, operations and management at global companies, including Exxon Mobil Corp., Aventis Pharmaceuticals Inc., and EniChem SpA. Dr. CheJohnson holds bachelor degrees in chemistry from Illinois State University and Fu-Jen Catholic University (Taiwan) and a PhD in physical-inorganic chemistry from Brandeis University. She has authored numerous scientific publicationsthe University of Southern California and holds over 20 U.S. patents.was a Postdoctoral Fellow at the University of California, San Francisco. Dr. Che has extensive scientific, operational, manufacturing, quality assurance, product developmentJohnson’s qualifications to serve on the board of directors include his knowledge of our business and senior managementhis significant experience in the pharmaceutical and biotechnology industries, as well as experience serving on a board of directors within our industry.

Paul Chun 

Sean MacDonald has been our Chairman of the Board since June 2019, having previously served as a director of Stellarthe company’s principal operating subsidiary, Edesa Biotech Research, Inc., since December 2016and serves asSeptember 2017. Mr. MacDonald is currently the chairHead of the Nominating and Governance Committee.  He isBusiness Development for Cosmo Pharmaceuticals NV, a Managing Partner of Eldred Advisors LLC, a life sciences advisory firm he founded in May 2016.  From November 2015 to April 2016, he served as Director of Strategy and Corporate Development at Kiromic, LLC. From May 2011 to October 2015, Mr. Chun served as a life sciences principal with Westwicke Partners, LLC, a capital markets advisory firm. During his tenure at Westwicke, he supported the capital markets and investor engagement objectives of private and public biopharma companies, including the support of multiple initial public offerings and other strategic transactions. Prior to Westwicke, he held various roles in investment research and corporate finance, including at Amgen, Inc., Tavistock Life Sciences and Goldman, Sachs & Co. He received his bachelors in biological sciences from Columbia University. Mr. Chun has broad experience in therapeutics development and commercialization, valuation, corporate development and finance.

David L. Hill, Ph.D.has been a director of Stellar since May 2011, and serves as the chair of the Compensation Committee. He served as Scientific Director for the ART Reproductive Center, Beverly Hills, California, from December 1999 until his retirement in December 2016. He is also an Assistant Clinical Professor in the Dept. of Obstetrics and Gynecology at the David Geffen School of Medicine, University of California, Los Angeles, and a Research Assistant IV at Cedars-Sinai Medical Center, Los Angeles, California. Dr. Hill received his Ph.D. in Biological Sciences from the Department of Pathology, School of Life Sciences, University of Connecticut and completed a Postdoctoral Fellowship at the Dana Farber Cancer Institute through an appointment by the Department of Physiology and Biophysics, Harvard Medical School, Boston, Massachusetts. Dr. Hill has extensive scientific and clinical research experience in our industry.

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Daniel E. Morse, Ph.D. has been a director of Stellar since April 2010. Dr. Morse is the Wilcox Professor Emeritus of Molecular Genetics and Biochemistry Biotechnology, Biomolecular Science and Engineering,European gastroenterology focused pharmaceutical company, a position he has held since 2008, and DirectorApril 2019, as well as the chief executive of the Marine Biotechnology Center, at the University of California, Santa Barbara,Corbin Therapeutics, a positionMontreal-based biotech company focused on treating neuroinflammation, a role he has held since 1986. Previously, heOctober 2018. From October 2012 to October 2018, Mr. MacDonald held various operational and executive leadership roles at Pharmascience Inc., one of Canada’s largest pharmaceutical companies, including Vice President of Business Development and Corporate Development. He received his BSc in Molecular Biology and MBA from the University of Ottawa. Mr. MacDonald’s qualifications to serve on the board of directors include his extensive operational experience and background in the pharmaceutical/biotechnology industry.


Pardeep Nijhawan, MD, FRCPC, AGAF has served as Director of the UCSB-MIT-Caltech Institute of Collaborative Biotechnologies from 2003 to 2010, and also served as Stellar’s Executive Vice-President, Science & Technology from 2010 until December 2011. Dr. Morse is an expert in the structure and function of the KLH molecule and internationally recognized expert in protein chemistry, molecular biology, molluscan reproductive biology, and aquaculture, and has an intimate understanding of our technology.

Frank R. Oakes was appointed our President and Chief Executive Officer, Corporate Secretary and Chairmana member of our Boardboard of Directorsdirectors since June 2019, having previously founded and led the company’s principal operating subsidiary, Edesa Biotech Research, Inc., since January 2015. Dr. Nijhawan is a seasoned pharmaceutical entrepreneur with 20 years of experience in April 2010.cross-functional leadership roles in finance, marketing, corporate strategy and business development. Prior to that time, heEdesa, in 2002 Dr. Nijhawan founded Medical Futures Inc., and served as founderits CEO. He sold Medical Futures to Tribute Pharmaceuticals in 2015. Dr. Nijhawan also founded Digestive Health Clinic in 2000 and Chief Executive Officerled it to become Canada’s largest provider of Stellar’s California subsidiary since 1999.private endoscopy services. In 2014, he founded Exzell Pharma, a specialty Canadian-based pharmaceutical organization that markets and commercializes approved products. He continues to serve on the Boards of Exzell Pharma and Digestive Health Clinic. Dr. Nijhawan received his MD from the University of Ottawa and completed his internship at Yale University, and his internal medicine residency and fellowship at the Mayo Clinic. Dr. Nijhawan’s qualifications to serve on the board of directors include his extensive executive leadership and experience in the life sciences industry and his knowledge of our business as its chief executive.


Frank Oakes has more than 40 years of management experience in aquaculture includingexecutive leadership experience. He has been a decadedirector of the company since April 2010 and served as the Chairman of the Board until June 2019. From 1999 to 2019, he also served as the President and Chief Executive Officer of the company’s legacy operating subsidiary, which he founded. Prior to founding Stellar Biotechnologies, Inc., he was the Chief Executive Officer of The Abalone Farm, Inc., during whichwhere he led the company through the R&D,research and development, capitalization, and commercialization phases of development to become the largest abalone producer in the United States. Mr. Oakes isStates at the inventor of our patented method for non-lethal extraction of hemolymph from a live gastropod mollusk. He was the principal investigator on our Small Business Innovation Research (SBIR) grant from the National Science Foundation and was principal investigator on our Phase I and II SBIR grants from the NIH’s Center for Research Resources, and a California Technology Investment Partnership (CalTIP) grant from the Department of Commerce.time. Mr. Oakes has consulted and lectured for the aquaculture industry around the world. He received his Bachelor of ScienceBS degree from California State Polytechnic University, San Luis Obispo and is a graduate of the Los Angeles Regional Technology Alliance University’s management-trainingmanagement program. Mr. Oakes qualifications to serve on the board of directors include his extensive operational experience building companies and management teams and leading a U.S. and Canadian publicly listed life science company.
Paul Pay is an executive with 40 years of experience in the pharmaceutical/biotechnology industry. He has been a valuable member of our Board dueboard of directors since June 2019, having previously served as a director of the company’s principal operating subsidiary, Edesa Biotech Research, Inc., since its founding in January 2015. From November 2002 to his depthpresent, he has led all business development activity at Norgine and is currently the Chief Business Development Officer and serves as a member of operating, strategic, andthe company’s executive committee. Prior to joining Norgine, Mr. Pay held senior management positions at large, specialty and early-stage pharmaceutical companies, and cofounded a university spin-out company. His commercial roles have included sales, marketing, market research, licensing, business development, public relations, intellectual property and product development. In addition to Edesa, Mr. Pay is currently a director of Exzell Pharma, a specialty pharmaceutical company; Arc Medical Design, a medical device development company and a portfolio company of Norgine; and Norgine Ltd., an affiliate of Norgine. Mr. Pay is also the President and CEO of Merus Labs Inc., a Norgine wholly owned affiliate company. Mr. Pay received a BSC (hons) from the University of Leeds. Mr. Pay’s qualifications to serve on the board of directors include his extensive experience in ourthe pharmaceutical/biotechnology industry specifically as related to aquaculture. Additionally, Mr. Oakes holds an intimateand his knowledge of Stellar due toEdesa’s business.
Carlo Sistilli, CPA, CMAhas more than 35 years of financial experience and has held a variety of executive positions in accounting and finance during his longevity in the industry and with us.

Charles V. Olson, D.Sc. career. He has been a directormember of Stellarour board of directors since December 2016June 2019, having previously served as a board observer of the company’s principal operating subsidiary, Edesa Biotech Research, Inc., since September 2017. Mr. Sistilli has served as the Chief Financial Officer of Arista Homes since March 2003 to present. Prior to Arista, Mr. Sistilli was a founder and served as CFO and a board member of an Internet start-up company in the automotive sector, and played a key role in taking the company public on the Alberta Ventures Exchange. Earlier in his career, Mr. Sistilli was the Controller and a member of our scientific advisorythe senior management team of a major regional trust company, which Mr. Sistilli helped sell to Manulife Financial. In addition to his professional career, Mr. Sistilli is an officer and a member of the board since June 2014.  Since September 2017, he has served at Applied Molecular Transport Inc., as the Vice President of Biologics. He has also been a Principal Biotechnology Consultant for Compass Biotechnology LLC since 2006. Dr. Olson previously held senior and executive management positions at Anthera Pharmaceuticals Inc. from April 2010 to August 2017, NGM Bioharmaceuticals Inc, Coherus BioSciences Inc, Nexbio Inc., Cell Genesys, Inc., Biomarin Pharmaceuticals, Inc, and Onyx Pharmaceuticals, Inc. After graduate school, Dr. Olson was a Research Scientist at Kaiser Hospitals, followed by Scientist and Senior Scientist positions at Genentech and Bayer, respectively. Hedirectors of Mother of Mercy Centre. Mr. Sistilli holds a B.A.Bachelor of Arts from York University, with a major in biology and chemistry from Westmont College, an M.A. in chemistry from the University of California at Santa Barbaraeconomics, Certified Management Accountant Designation and a D.Sc.Chartered Professional Accountant Designation. Mr. Sistilli’s qualifications to serve on the board of directors include his knowledge of Edesa’s business and his background in biochemistry. Dr. Olson has extensive scientific, manufacturing operations, process development,accounting and senior managementfinance.

Peter van der Velden is an investor and business executive with more than 28 years of experience in the biopharmaceutical industry.

Mayank (Mike) D. Sampatbuilding growth companies. He has been a member of our board of directors since June 2019, having previously served as a director of Stellarthe company’s principal operating subsidiary, Edesa Biotech Research, Inc., since August 2012,September 2017. From 2007 to present, Mr. van der Velden has been the Managing General Partner of Lumira Ventures, one of Canada’s largest dedicated life sciences venture capital investors. Mr. van der Velden currently serves on the boards of Exact Imaging, Medexus Pharmaceuticals (trading symbol PDDPF) and serves as the chairAmacaThera. His past corporate board roles include: Milcom Ventures, Spinal Kinetics, Alveolus Inc., CML Healthcare, First Aid Shot Therapy, Life Sciences Ontario, Skinstore.com, and Vendorlink.ca. Mr. van der Velden is a past President and Chairman of the Audit Committee.Canadian Venture and Private Equity Association and currently serves on the board or as an advisor to a number of industry groups and non-profit organizations. Mr. Sampat isvan der Velden holds an independent consultant providing business services to companies seeking expertise in financial planning and analysis, accounting and financial reporting, M&A transactions support and financial system implementation. He previously held the positions of controller at Precision Toxicology, LLC, a healthcare focused clinical laboratory specializing in providing quantitative drug testing, from February 2015 to May 2016, Zpower, LLC, an emerging manufacturer in the microbattery industry, from June 2012 to September 2014, and Imaging Advantage LLC from September 2010 to June 2012, and the position of Chief Financial Officer for Gamma Medica-Ideas, a supplier of imaging equipment to the medical industry, from September 2007 to June 2010. Mr. Sampat received a BBA in accounting from Bombay University and his MBA in Finance at Mercerand Policy from the Schulich School of Business, and a MSc in Pathology and BSc (honors) in Life Sciences from Queen’s University. Mr. Sampat is a seasoned financevan der Velden’s qualifications to serve on the board of directors include his extensive operational experience building growth companies and accounting executive, having worked with multiple companies ranginghis knowledge acquired from startups to large Fortune 100serving on the boards of other companies.


Executive Officers

Set forth below is certain information with respect to the names, ages, and positions of our executive officers as of November 30, 2017.December 2, 2020. Biographical information pertaining to Mr. Oakes,Dr. Nijhawan, who is a director and an executive officer, may be found in the above section entitled “Directors.” The executive officers serve at the pleasure of our Board of Directors.

NameAgeAgePosition(s) HeldDate of Appointment
Frank R. OakesPardeep Nijhawan, MD5067President,Director, Chief Executive Officer and Chairman of our Board of DirectorsCorporate SecretaryApril 9, 2010June 7, 2019
Kathi Niffenegger, CPA6063Chief Financial Officer and Corporate SecretaryNovember 1, 2013
Gregory T. Baxter, Ph.D.Michael Brooks, PhD4258PresidentExecutive Vice President of Corporate DevelopmentDecember 1, 2016June 7, 2019

Kathi Niffenegger, CPAwas appointed has served as our Chief Financial Officer in November 2013 and Corporate Secretary in Junesince 2013. She initially joined Stellar in May 2012 as Controller, afteralso previously servingserved as the company’s outside Certified Public Accountant for more than 12 years.Corporate Secretary from 2013 to June 2019. Ms. Niffenegger has more than 30 years of experience in accounting and finance in a range of industries.industries, and has led audits of manufacturing, pharmaceutical and governmental grant clients. She has also developed specialized expertise in cost accounting systems and internal controls. Prior to joining the company, she held positions of increasing responsibility in the audit division of Glenn Burdette CPAs from 1988 to 2012 and served most recently as technical partner. She obtained CFO experience at Martin Aviation, and beganEarlier in her career, at Peat, Marwick, Mitchell & Co. (now KPMG LLP). Ms. Niffenegger has held leadership roles for auditsshe was the Chief Financial Officer of manufacturing, aquaculture, pharmaceutical and governmental grant clients, and developed specific expertise in cost accounting systems and internal controls.Martin Aviation. Ms. Niffenegger holds a B.S. degree in Business Administration, Accounting from California State University, Long Beach andBeach. She is a member of the American Institute of Certified Public Accountants (AICPA).

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and holds the Chartered Global Management Accountant (CGMA) designation.

Gregory T. Baxter, Ph.D. joined Stellar’s executive management team



Michael Brooks, PhDwas appointed President of Edesa in December 2016 following his service onJune 2019, having served as Vice President of Corporate Development and Strategy for the company’s Boardprincipal operating subsidiary, Edesa Biotech Research, Inc., since January 2015. Prior to joining Edesa, Dr. Brooks held positions of Directors, which he joinedincreasing responsibility at Cipher Pharmaceuticals Inc from 2010 to 2015 and served most recently as the company's as Director of Business Development. Prior to joining Cipher, Dr. Brooks was a Post-Doctoral fellow at the University of Toronto. Dr. Brooks holds a Hons B.Sc. degree in August 2012.Microbiology and a PhD in Molecular Genetics from the University of Toronto. Dr. Baxter has served as an executive and scientist for several biotechnology corporations and foundations. Since 2001, Dr. Baxter has been a Senior Scientist in the Department of Clinical Drug Development for CCS Associates Inc., a scientific research consulting firm specializing in technical and support services for clinical research, design strategies for preclinical studies, chemical information sciences and research and development support for translational science. His prior experience includes serving as Program Director for the National Science Foundation (NSF) Division of Industrial Innovation and Partnerships, Founder and CSO of Hurel Corporation, Founder and CEO of Aegen Biosciences and Research Scientist for Molecular Device Corporation. He also serves as Adjunct Associate Professor at Cornell University in the College of Chemical Engineering and on the Founders Board of Stanford University's StartX Med Program. Dr. BaxterBrooks received his B.A. and Ph.D. in Biochemistry/Molecular BiologyMBA degree from Universitythe Rotman School of California, Santa Barbara.

Management where he was a Canadian Institute for Health Research (CIHR) Science-to-Business Scholar.

Section 16(a) Beneficial Ownership Reporting Compliance

Reports

Section 16(a) of the Exchange Act requires that our directors, executive officers, and greater-than-10% shareholdersbeneficial owners of more than ten percent of our common shares file reports with the SEC on their initial beneficial ownership of our common shares and any subsequent changes. To our knowledge, based solely on a review of copies of such reports furnished to us by our officersfiled electronically with the Securities and directors, we believe that,Exchange Commission during the fiscalCompany’s year ended September 30, 2017, no person2020, during such period, each of our directors, executive officers, and beneficial owners of more than ten percent of our common shares filed on a timely basis all reports required to file reports underby Section 16(a) of the Exchange Act failed to file such reports on a timely basis during such fiscal year.

Act.

Code of Ethics

We have adopted a Code of Ethics and Business Conduct that applies to all of our directors, officers, and employees.employees, including our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions. A copy of our Code of Ethics and Business Conduct is available on the Investor Relations section of our website at http://ir.stellarbiotechnologies.com.edesabiotech.com/investors/governance, in the Corporate Governance section, under the Governance Documents section. We intend to satisfy the SEC’s disclosure requirements regarding amendments to, or waivers of, our Code of Ethics and Business Conduct by posting such information on our website. Copies of our Code of Ethics and Business Conduct may be obtained, free of charge, by writing to our Corporate Secretary, Stellar Biotechnologies,Edesa Biotech, Inc., 332 East Scott Street, Port Hueneme, California 93041.

Nominations for Board of Directors

The Board of Directors has approved an advance notice policy, which was subsequently approved by our shareholders, that requires advance notice be given to us in certain circumstances where nominations of persons for election to the Board are made by our shareholders.

In the case of an annual meeting of shareholders, notice to the Company must be made not less than 30 days nor more than 65 days prior to the date of the annual meeting. However, in the event that the annual meeting is to be held on a date that is less than 40 days after the date on which the first public announcement of the date of the annual meeting was made, notice may be made not later than the close of business on the tenth (10th) day following such public announcement.

In the case of a special meeting of shareholders (which is not also an annual meeting), notice to the Company must be made not later than the close of business on the fifteenth (15th) day following the day on which the first public announcement of the dateof the special meeting was made.

100 Spy Court, Markham, ON Canada L3R 5H6.

Information about our Board Committees

Our Board of Directors has appointed an Audit Committee, a Compensation Committee, and a Nominating and Corporate Governance Committee. The Board of Directors has determined that each director who serves on these committees is “independent,” as that term is defined by the listing rules of Nasdaq and rules of the Securities and Exchange Commission. The Board of Directors has adopted written charters for its Audit Committee, Compensation Committee, and Nominating and Corporate Governance Committee. Copies of these charters are available on our website athttp://ir.stellarbiotechnologies.com. In addition, our board of directors appointed a temporary Strategic Investments Committee to approve actions related to potential strategic investments and a Pricing Committee to approve actions related to our capital raising transactions. There was no requirement for directors who served on these committees to be “independent” edesabiotech.com/investors/governance.

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Audit Committee

Our Audit Committee is composed of Sean MacDonald, Paul Chun, David Hill,Pay and Mayank SampatCarlo Sistilli (chair). The purpose of the Audit Committee is to oversee our accounting and financial reporting processes and the audits of our financial statements. In that regard, the Audit Committee assists the Board in monitoring: (a) the integrity of our financial statements; (b) our independent auditor’s qualifications, independence, and performance; (c) the performance of our system of internal controls, financial reporting, and disclosure controls; and (d) our compliance with legal and regulatory requirements. To fulfill this obligation and perform its duties, the Audit Committee maintains effective working relationships with the Board, management, our internal auditor, and our independent auditor.

Mayank Sampat

Carlo Sistilli is the Chair of our Audit Committee and has extensive financial experience. He received an MBA holds a Bachelor of Arts from York University, with a major in Finance from Mercer University,economics, Certified Management Accountant Designation and a Chartered Professional Accountant Designation. Hehas servedheld a variety of executive positions in several financial positions with other companies, including severalaccounting and finance during the past 35 years as Chief Financial Officer for a medical equipment manufacturer. Mr. Sampat is considered to be “independent” as defined pursuant to the listing rules of the Nasdaq.. The Board has determined that Mr. SampatSistilli is an “audit committee financial expert” as defined in Item 407(d)(5)(ii) of Regulation S-K.


Compensation Committee

Our Compensation Committee is composed of Lorin Johnson, Sean MacDonald and Paul Chun, David HillPay (chair), Charles Olson and Mayank Sampat.. The purpose of the Compensation Committee is to overseeassist the Board’s responsibilitiesoversight relating to compensation, including (i) the approval of compensation for our Company’s Chief Executive Officer and (ii) the review of compensation for our other executivenamed executive officers. It has overall responsibility for evaluating, and approving and evaluating allor recommending to the independent members of the Board for approval, our compensation plans, policies and programs as such plans, policies and programs affect executive officers.

Nominating and Corporate Governance Committee

Our Nominating and Corporate GovernanceGovernance Committee is composed of Paul ChunSean MacDonald, Carlo Sistilli and Peter van der Velden (chair), David Hill and Mayank Sampat.. The purpose of the Nominating and Corporate Governance Committee is to identify individuals qualified to become Board members; recommend to the Board individuals to serve as directors; advise the Board with respect to Board composition, procedures and committees; develop, recommend to the Board and annually review a set of corporate governance principles applicable to the Company; and oversee any related matters required by the federal secsecurities laws.

Item 11.urities laws.

Item 11.EXECUTIVE COMPENSATION.

EXECUTIVE COMPENSATION.

Executive Compensation

Our named executive officers for 2017the year ended September 30, 2020 were Frank R. Oakes,Pardeep Nijhawan, MD, Director, Chief Executive Officer President and Executive Chairman of our Board of Directors;Corporate Secretary; Kathi Niffenegger, CPA, Chief Financial OfficerOfficer; and Corporate Secretary; and Gregory T. Baxter, Ph.D., our Executive Vice President of Corporate Development.

Michael Brooks, PhD, President.

Summary Compensation Table

The following table sets forth information regarding the compensation awarded to, earned by or paid to the named executive officers.

Name and Principal Position Fiscal Year  Salary ($)  Bonus ($)  Stock Awards ($) (1)   

Option Awards

($) (2)

  All Other
Compensation ($)
   Total ($) 
Frank R. Oakes  2017  $257,100  $25,000  $296,969 (3) $-  $23,669 (4)  602,738 
President, Chief Executive  2016   250,100   120,000   -    -   59,737    429,837 
Officer and Chairman of our                              
Board of Directors                              
                               
Kathi Niffenegger, CPA  2017   202,560   20,000   -    19,744   18,526 (5)  260,830 
Chief Financial Officer and  2016   196,560   47,250   -    61,148   19,004    323,962 
Corporate Secretary                              
                               
Gregory T. Baxter, Ph.D.  2017   157,372   500   -    15,605   18,406 (7)  191,883 
Executive Vice President of
Corporate Development (6)
  2016   -   -   -    -   11,800   11,800 

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officers for the year ended September 30, 2020 and the nine-month period ended September 30, 2019.

(1)The amounts shown in this column represent the aggregate grant date fair value of the share awards based on the closing price on Nasdaq, not the actual amounts paid to or realized by the named executive officerduring the covered fiscal year.  It differs from the amounts recorded in accordance with Financial Accounting Standards Board (FASB) Accounting Standards Codification 718, which were based on the share value at the inception of the performance share plan in April 2010 expensed over the estimated vesting period ended August 31, 2012.  The vesting requirements of these awards are set forth in Note 8 to our audited consolidated financial statements for the year ended September 30, 2017 included in this Annual Report.

(2)The amounts shown in this column represent the aggregate grant date fair value of the share option awards computed in accordance with Financial Accounting Standards Board (FASB) Accounting Standards Codification 718, not the actual amounts paid to or realized by the named executive officersduring the covered fiscal year. The assumptions used in determining grant date fair value of these awards are set forth in Note 8 to our audited consolidated financial statements for the year ended September 30, 2017 included in this Annual Report.

(3)235,690 shares were issued under our Performance Share Plan.

(4)Represents (i) $15,719 in health insurance and (ii) $7,950 in 401(k) Company contributions.

(5)Represents (i) $11,984 in health insurance and (ii) $6,542 in 401(k) Company contributions.

(6)Dr. Baxter’s employment with the Company began December 1, 2016. Dr. Baxter was a director of the Company from August 15, 2012 until December 1, 2016.

(7)Represents (i) $8,656 in health insurance, (ii) $1,050 in director fees and (iii) $8,700 in consultant fees prior to becoming an employee.

Name and Principal Position
 
Fiscal Year
 
Salary ($)
 
 
Bonus ($)
 
 
Option Awards ($)(1)
 
 
All Other Compensation ($)
 
 
Total ($)
 
Pardeep Nijhawan, MD
 
2020
 $300,000 
 $56,000 
 $- 
 $55,204(2)
 $411,204 
Director, Chief Executive Officer
 
2019
  105,461 
  - 
  - 
  24,571(2)
  130,032 
and Corporate Secretary
 
 
    
    
    
    
    

 
 
    
    
    
    
    
Kathi Niffenegger, CPA
 
2020
  234,069 
  31,354 
  214,275 
  25,613(4) 
  505,311 
Chief Financial Officer
 
2019 (3)
  63,604 
  53,750 
  - 
  5,000(4)
  122,354 

 
 
    
    
    
    
    
Michael Brooks, PhD
 
2020
  275,000 
  51,333 
  166,658 
  36,220(5)
  529,211 
President
 
2019
  158,114 
  37,243 
  - 
  11,897(5)
  207,254 
(1)
The amounts shown in this column represent the aggregate grant date fair value of the share option awards computed in accordance with Financial Accounting Standards Board (FASB) Accounting Standards Codification 718, not the actual amounts paid to or realized by the named executive officers during the covered fiscal year. The assumptions used in determining grant date fair value of these awards are set forth in Note 9 to our audited consolidated financial statements for the year ended September 30, 2020 included in this Annual Report.
(2)
Represents (i) $32,435 in car allowance (ii) $2,187 in health insurance and (iii) $20,582 in vacation payout in 2020 and (i) $23,884 in car allowance and (ii) $687 in health insurance in 2019. The compensation was paid in Canadian dollars and was converted to US dollars using the average foreign exchange rate for the year from oanada.com.
(3)
Ms. Niffenegger was our Chief Financial Officer prior to our business combination with Edesa Research and her compensation during that time is not reflected in our audited consolidated financial statements included in this Annual Report. In the nine-month period September 30, 2019 prior to our business combination on June 7, 2019, she received salary of $97,599, bonus of $53,725 and other compensation of (i) $6,775 in health insurance and (ii) $4,540 in 401(k) company contributions.
(4)
Represents (i) $17,650 in health insurance and (ii) $7,963 in 401(k) company contributions in 2020 and (i) $3,719 in health insurance and (ii) $1,281 in 401(k) company contributions in 2019.
(5)
Represents (i) $24,015 in car allowance (ii) $2,213 in health insurance and (iii) $9,992 in vacation payout in 2020 and (i) $9,698 in car allowance and (ii) $2,199 in health insurance in 2019. The compensation was paid in Canadian dollars and was converted to US dollars using the average foreign exchange rate for the year from oanda.com.
Narrative Disclosure to Summary Compensation Table
Employment Agreements

We do not have

Prior to the completion of our business combination with Edesa Research, Edesa Research had employment agreements currently in effect with anyDr. Pardeep Nijhawan and Dr. Michael Brooks which are described below. Upon completion of our named executive officers. Likebusiness combination transaction with Edesa Research, Dr. Nijhawan and Dr. Brooks each entered into new employment agreements with us which are also described below, and the old employment agreements were terminated. Kathi Niffenegger entered into a new employment agreement with us on December 1, 2020 as described below and the employment agreement she entered into upon completion of our other employees, our executives arebusiness combination transaction with Edesa Research was superseded.



Terminated Employment Agreement with Dr. Pardeep Nijhawan
On August 1, 2017, Edesa Research entered into an employment agreement with Dr. Pardeep Nijhawan which was to continue indefinitely until terminated in accordance with its terms. The employment agreement provided that during the term of the agreement, Dr. Nijhawan was to serve as Edesa Research’s Chief Executive Officer. In consideration for his services to Edesa Research, Dr. Nijhawan received a base salary of C$35,000 per annum and was eligible for coverage under Edesa Research’s standard benefit programs. The agreement was terminable by Edesa Research (i) for cause without notice or severance pay or (ii) without cause, in which case Edesa Research was to provide 18 months notice of termination or pay in lieu of notice (based on Dr. Nijhawan’s base salary) and benefits for up to 18 months following the provision of notice of termination. In addition, upon a termination by Edesa Research without cause, all options on a pro-rated basis were to be deemed vested on the business day immediately preceding the termination date and would remain exercisable for a period of 180 days. Dr. Nijhawan could resign from his employment at any time by providing two weeks advance notice to Edesa Research.

Employment Agreement with Pardeep Nijhawan effective as of June 7, 2019
On June 14, 2019 but effective as of June 7, 2019, we entered into an employment agreement with Pardeep Nijhawan. Pursuant to the employment agreement, Dr. Nijhawan will serve as our Chief Executive Officer for an indefinite term until Dr. Nijhawan’s employment is terminated in accordance with the agreement. As compensation for his services to us, Dr. Nijhawan will receive a base salary of $300,000 per year and be eligible to receive a target annual bonus of 40% of his base salary, increasessubject to achieving corporate and discretionarypersonal targets to be determined by us. Dr. Nijhawan will also receive an automobile allowance of $2,700 per month and be eligible to participate in our group insured benefits program, as may be in effect from time-to-time for our employees generally, and executive employees specifically. Dr. Nijhawan is also eligible for future share and/or option grants, as determined by our Compensation Committee, commensurate with Dr. Nijhawan’s position and any business milestones which may be established by the Compensation Committee and subject to availability of shares and/or options for grant under our Equity Incentive Compensation Plan.
If Dr. Nijhawan’s employment with us is terminated for “Cause” (as such term is defined in the employment agreement), subject to applicable law, our only obligation shall be to provide Dr. Nijhawan with his base salary and vacation pay earned through the date of termination and all of Dr. Nijhawan’s vested or non-vested stock options which have not been exercised by Dr. Nijhawan as of the date of termination will be automatically extinguished. If Dr. Nijhawan is terminated by us without “Cause”, our only obligation shall be to provide Dr. Nijhawan with (i) a lump sum payment equal to Dr. Nijhawan’s then current base salary for twenty-four months (the “Severance Period”), (ii) a lump sum payment of the annual bonus to which Dr. Nijhawan is entitled for the fiscal year immediately preceding the date of termination, if such bonus has not already been paid, (iii) a lump sum payment equal to Dr. Nijhawan’s annual bonus entitlement, prorated over Dr. Nijhawan’s length of service in the fiscal year in which his employment is terminated, calculated in accordance with the terms of the employment agreement, (iv) payment of Dr. Nijhawan’s annual bonus entitlement during the full Severance Period, calculated in accordance with the terms of the employment agreement, (v) continuation of Dr. Nijhawan’s benefits and car allowance and any other benefit required to be maintained by law in accordance with the terms of the employment agreement and (vi) subject to applicable law, all stock options granted to Dr. Nijhawan shall be exercisable in accordance with the terms of the applicable stock option plan. Dr. Nijhawan may resign from his employment at any time by providing us with a minimum of sixty days advance notice, in writing. Dr. Nijhawan’s notice may be waived by us, subject only to providing Dr. Nijhawan with payment of his base salary and continuation of benefits until the end of the notice period. If Dr. Nijhawan resigns from his employment, subject to applicable law, (i) all non-vested stock options and all vested stock options held by Dr. Nijhawan which have not been exercised by Dr. Nijhawan as of the date of termination shall be automatically extinguished and (ii) Dr. Nijhawan shall not be entitled to any bonus or pro rata bonus payment not already paid on or before the date of termination.
During the term of Dr. Nijhawan’s employment with us and for twelve months following the cessation of Dr. Nijhawan’s employment with us, Dr. Nijhawan is prohibited from competing with our business in North America. In addition, for twenty-four months following the cessation of Dr. Nijhawan’s employment with us, Dr. Nijhawan is prohibited from soliciting customers or prospective customers for any purpose competitive with our business, encouraging any customer to cease doing business with us and soliciting the employment or engagement of certain of our employees. 

Terminated Employment Agreement with Michael Brooks
On August 28, 2017, Edesa Research entered into an employment agreement with Michael Brooks which was to continue indefinitely until terminated in accordance with its terms. The employment agreement provided that during the term of the agreement, Dr. Brooks was to serve as Edesa Research’s Vice President Corporate Development and Strategy. In consideration for his services to Edesa Research, Dr. Brooks received a base salary of C$220,000 per annum and was eligible for coverage under Edesa Research’s standard benefit programs. In addition, subject to achievement of bonus criteria established by Edesa Research, Dr. Brooks was eligible to receive an annual bonus award of up to 30% of his base salary.
The agreement was terminable by Edesa Research (i) for cause without notice or severance pay or (ii) without cause, in which case Edesa Research was to provide 12 months notice of termination or pay in lieu of notice (based on Dr. Brooks’ base salary) and benefits for up to 12 months following the provision of notice of termination. In addition, upon a termination by Edesa Research without cause, Dr. Brooks was entitled to a pro-rated bonus covering any year or partial actively worked from the time of the past applicable bonus period through to the termination date of Dr. Brooks employment and all options on a pro-rated basis would be deemed to be vested on the business day immediately preceding the termination date and would remain exercisable for a period of 180 days. In the event Dr. Brook’s employment was terminated in connection with a change of control event, any unvested options or other equity grants.

Performance Share Plan

Underawards then held by Dr. Brooks would be deemed to be vested on the merger agreement between our Companybusiness day immediately preceding the termination date and our California subsidiary, we allotted 1,000,000 common shares (the Performance Shares) underwere to remain exercisable for a performance share plan (the Plan). The performance shares were reservedperiod of 180 days. Dr. Brooks could also resign from his employment at any time by providing two weeks advance notice to Edesa Research. During the term of his employment and for issuancea period of 12 months thereafter, Dr. Brooks was subject to certain officers, directorsnon-solicitation provisions relating to Edesa Research’s employees, customers, prospective customers and suppliers. In addition, the agreement provided that, subject to certain exceptions, Dr. Brooks could not compete with the business of Edesa Research during the employment period and any notice period (or period paid in lieu of notice).


Employment Agreement with Michael Brooks effective as of June 7, 2019
On June 14, 2019 but effective as of June 7, 2019, we entered into an employment agreement with Michael Brooks, PhD. Pursuant to the employment agreement, Dr. Brooks will serve as our President for an indefinite term until Dr. Brooks’ employment is terminated in accordance with the agreement. As compensation for his services to us, Dr. Brooks will receive a base salary of $275,000 per year and be eligible to receive a target annual bonus of 40% of his base salary, subject to achieving corporate and personal targets to be determined by us. Dr. Brooks will also receive an automobile allowance of $2,000 per month and be eligible to participate in our group insured benefits program, as may be in effect from time-to-time for our employees generally, and executive employees specifically. Dr. Brooks is also eligible for future share and/or option grants, as determined by our Compensation Committee, commensurate with Dr. Brooks’ position and any business milestones which may be established by the Compensation Committee and subject to availability of shares and/or options for grant under our Equity Incentive Compensation Plan.
If Dr. Brooks’ employment with us is terminated for “Cause” (as such term is defined in the employment agreement), subject to applicable law, our only obligation shall be to provide Dr. Brooks with his base salary and vacation pay earned through the date of termination and all of Dr. Brooks’ vested or non-vested stock options which have not been exercised by Dr. Brooks as of the date of termination will be automatically extinguished. If Dr. Brooks is terminated by us without “Cause”, our only obligation shall be to provide Dr. Brooks with (i) a lump sum payment equal to Dr. Brooks’ then current base salary for twelve months plus one additional month for every completed year of service since September 2015, not to exceed an aggregate of twenty-four months (the “Severance Period”), (ii) a lump sum payment of the annual bonus to which Dr. Brooks is entitled for the fiscal year immediately preceding the date of termination, if such bonus has not already been paid, (iii) a lump sum payment equal to Dr. Brooks’ annual bonus entitlement, prorated over Dr. Brooks’ length of service in the fiscal year in which his employment is terminated, calculated in accordance with the terms of the employment agreement, (iv) payment of Dr. Brooks’ annual bonus entitlement during the full Severance Period, calculated in accordance with the terms of the employment agreement, (v) continuation of Dr. Brooks’ benefits and car allowance and any other benefit required to be maintained by law in accordance with the terms of the employment agreement and (vi) subject to applicable law, all stock options granted to Dr. Brooks shall be exercisable in accordance with the terms of the applicable stock option plan. If Dr. Brooks’ employment is terminated or “constructively terminated” (as such term is defined in the employment agreement) by us without “Cause” upon or within a twelve month period following a Change of Control (as such term is defined in the employment agreement), Dr. Brooks shall be entitled to the payments and benefits provided as described in clauses (ii) to (vi) above, plus a change of control payment equal to twenty-four months of the his then current base salary. Dr. Brooks may resign from his employment at any time by providing us with a minimum of sixty days advance notice, in writing. Dr. Brooks’ notice may be waived by us, subject only to providing Dr. Brooks with payment of his base salary and continuation of benefits until the end of the notice period. If Dr. Brooks resigns from his employment, subject to applicable law, (i) all non-vested stock options and all vested stock options held by Dr. Brooks which have not been exercised by Dr. Brooks as of the date of termination shall be automatically extinguished and (ii) Dr. Brooks shall not be entitled to any bonus or pro rata bonus payment not already paid on or before the date of termination.

During the term of Dr. Brooks’ employment with us and for twelve months following the cessation of Dr. Brooks' employment with us, Dr. Brooks is prohibited from competing with our business in North America. In addition, for twenty-four months following the cessation of Dr. Brooks' employment with us, Dr. Brooks is prohibited from soliciting customers or prospective customers for any purpose competitive with our business, encouraging any customer to cease doing business with us and soliciting the employment or engagement of certain of our employees.


Employment Agreement with Kathi Niffenegger effective as of June 7, 2019
On June 7, 2019, we entered into an employment agreement with Ms. Niffenegger which has subsequently been superseded by the employment agreement with Ms. Niffenegger described below. Pursuant to the employment agreement, Ms. Niffenegger served as our Chief Financial Officer. Both Ms. Niffenegger and we had the right to terminate the employment relationship at any time, with or without cause. As compensation for her services to us, Ms. Niffenegger received a base salary of $215,000 per year, a discretionary bonus in an amount up to 25% of her base salary based on her performance and the company’s performance, a one-time hiring and retention bonus of $53,750 which was subject to partial claw back if Ms. Niffenegger voluntary terminated her employment prior to March 1, 2020 and such other employee benefits as are generally provided to similarly situated employees of the Companycompany. Ms. Niffenegger was also eligible for future share and/or option grants in accordance with our executive compensation policy as in effect from time to time as determined by our Compensation Committee subject to availability of shares and/or options for grant under our Equity Incentive Compensation Plan.
If Ms. Niffenegger’s employment with us was terminated for “Cause” (as defined in the employment agreement) or if Ms. Niffenegger resigned from her employment at any time, our only obligation was to provide Ms. Niffenegger with: (i) her accrued salary through and including her last day of employment (the “Separation Date”); (ii) reimbursement of any reimbursable expenses properly incurred through and including the Separation Date; and (iii) any benefit required under applicable law. If we terminate Ms. Niffenegger’s employment without “Cause” or if Ms. Niffenegger’s employment with us was “constructively terminated” (as defined in the employment agreement), our only obligations were: (a) to provide Ms. Niffenegger with the same payments and benefits as would be provided if we had terminated her employment for Cause; and (b) subject to Ms. Niffenegger’s execution of a release in our favor, Ms. Niffenegger would also have been paid, as severance, an amount equal to twelve months of her base salary at her then-current rate. In the event that Ms. Niffenegger’s employment was terminated or constructively terminated by us without Cause upon achievementor within a twelve month period following a Change of three milestones relatedControl (as defined in the employment agreement), Ms. Niffenegger was entitled to completionthe payments and benefits as though she was terminated without “Cause”, plus an additional change of method developmentcontrol payment equal to twelve months of her base salary.
The Agreement provided that during the term of Ms. Niffenegger’s employment with us, Ms. Niffenegger is prohibited from competing with our business and during such period and for commercial-scale manufacturea period of KLH, compilationone year thereafter, Ms. Niffenegger is prohibited from soliciting for employment certain of our employees.
Employment Agreement with Kathi Niffenegger effective as of December 1, 2020
On December 1, 2020, we entered into an employment agreement with Ms. Niffenegger. Pursuant to the employment agreement, Ms. Niffenegger will continue to serve as our Chief Financial Officer. Both Ms. Niffenegger and regulatory submittalwe have the right to terminate the employment relationship at any time, with or without cause. As compensation for her services to us, Ms. Niffenegger will receive a base salary of all$275,000 per year retroactive to June 1, 2020, a discretionary bonus in an amount up to 40% of her base salary based on her performance and the company’s performance and such other employee benefits as are generally provided to similarly situated employees of the company. Ms. Niffenegger may be eligible for future share and/or option grants in accordance with our executive compensation policy as in effect from time to time as determined by the independent members of our Board of Directors subject to availability of shares and/or options for grant under our Equity Incentive Compensation Plan.
If Ms. Niffenegger’s employment with us is terminated for “Cause” (as defined in the employment agreement) or if Ms. Niffenegger resigns from her employment at any time, our only obligation is to provide Ms. Niffenegger with: (i) her accrued salary and accrued unused vacation pay through and including her last day of employment (the “Separation Date”); (ii) reimbursement of any reimbursable expenses properly incurred through and including the Separation Date; and (iii) any benefit required chemistry, manufacturingunder applicable law. If Ms. Niffenegger is terminated by us without “Cause”, our only obligations are (a) to provide Ms. Niffenegger with the same payments and control databenefits as would be provided if we had terminated her employment for Cause; and completion(b) subject to Ms. Niffenegger’s execution of preclinical toxicity and immunogenicity testinga release in our favor, Ms. Niffenegger will also be paid, as severance (the “Severance Amount”), (i) a lump sum payment equal to twelve months of products. Share-based compensation was recorded overMs. Niffenegger’s then current base salary, plus one additional month of base salary for every completed year of service since June 2019, not to exceed an aggregate of twenty-four months, (ii) a lump sum payment of any discretionary bonus for the estimated vesting period ending in August 2012.

As each milestone was met asprior calendar year already determined by our Board of Directors, one thirdbut not yet paid; and (iii) a lump sum payment equal to Ms. Niffenegger’s potential discretionary bonus for the calendar year in which the Separation Date occurs, prorated over Ms. Niffenegger’s length of service in the calendar year in which her employment is terminated, calculated in accordance with the terms of the Performance Shares were available toemployment agreement. If Ms. Niffenegger’s employment is terminated or “constructively terminated” (as such term is defined in the employment agreement) by us without “Cause” upon or within a twelve month period following a Change of Control (as such term is defined in the employment agreement), Ms. Niffenegger shall be releasedentitled to the Plan participants. The three milestones were met on or before August 2012, and all Performance Shares had been issued to non-director employees by August 2012. In December 2013,Severance Amount described above, except that the Board issued 151,515 Performance Shares to a former directorportion of the Company. Severance Payment established by (b)(i) shall be equal to twenty four months of Ms. Niffenegger’s base salary.

The Board issuedAgreement provides that during the remaining Performance Shares in June 2017,term of which (a) 13,468 Performance Shares were issuedMs. Niffenegger’s employment with us and for a period of one year thereafter, Ms. Niffenegger is prohibited from soliciting for employment certain of our employees. The Agreement also provides that both during and after Ms. Niffenegger’s employment with us, she is prohibited from (i) making use of our trade secrets to a former directorsolicit on behalf of the Company, (b) 235,690 Performance Shares were issuedMs. Niffenegger or any other person business from any of our customers and (ii) inducing or attempting to Mr. Oakes, the Company’s current President, CEO and Chairman and an eligible participant in the Plan, and (c) 134,680 Performance Shares were issuedinduce any person to Dr. Morse, a current director of the Company and an eligible participant in the Plan. Since all Performance Shares under the Plansever any existing contractual relationship they have been issued, the Plan was terminated.

Page 45
with us.


Outstanding Equity Awards at 2017 Fiscal Year-End

September 30, 2020

The following table summarizes the equity awards made to our named executive officers that were outstanding at September 30, 2017.

    Option Awards
Name Award grant date Number of
securities
underlying
unexercised
options (#)
exercisable
  Number of
securities
underlying
unexercised
options (#)
unexercisable
(1)
  Option
exercise prices ($)
  Option
expiration date
Frank R. Oakes 8/8/11  42,560   -  CDN6.50  8/8/18
  4/13/12  37,560   -   CDN4.20  4/13/19
                 
Kathi Niffenegger, CPA 6/18/12  9,000   -   CDN2.90  6/18/19
  12/19/12  5,000   -   CDN2.50  12/19/19
  5/14/13  9,000   -   CDN5.80  5/14/20
  11/1/13  10,000   -   US18.30  11/1/20
  11/12/14  9,000   -   CDN15.20  11/12/21
  12/22/15  10,000   -   US7.24  12/22/22
  12/20/16  3,333   6,667   US2.03  12/20/23
                 
Gregory T. Baxter, Ph.D. 8/16/12  7,000   -   CDN3.70  8/16/19
  11/12/14  1,250   -   CDN15.20  11/12/21
  3/28/17  -   10,000   US1.60  3/28/24

(1)2020.

 
 
 
  Option Awards  
 
Name
 
Award grant date
 
Number of securities underlying unexercised options (#) exercisable
 
 
Number of securities underlying unexercised options (#) unexercisable (1)
 
 
Option exercise prices
 
 
Option expiration date
Pardeep Nijhawan, MD
 
9/26/17
  47,490 
  - 
 C$2.16 
 
9/26/27

 
12/28/18
  945 
  675(2)
 C$2.16 
 
12/28/28

 
 
    
    
    
 
 
Kathi Niffenegger, CPA
 
11/1/13
  238 
  - 
 $768.60 
 
11/1/20

 
11/12/14
  214 
  - 
 C$638.40 
 
11/12/21

 
12/22/15
  238 
  - 
 $304.08 
 
12/22/22

 
12/20/16
  238 
  - 
 $85.26 
 
12/20/23

 
3/12/18
  833 
  - 
 $35.28 
 
3/12/25

 
2/12/20
  40,828 
  47,871(3)
 $3.16 
 
2/12/30

 
 
    
    
    
 
 
Michael Brooks, PhD
 
8/28/17
  136,416 
  - 
 C$2.16 
 
8/28/27

 
9/26/17
  24,299 
  - 
 C$2.16 
 
9/26/27

 
12/28/18
  945 
  675(2)
 C$2.16 
 
12/28/28

 
2/12/20
  31,754 
  37,234(3)
 $3.16 
 
2/12/30
(1)
Our options vesting policy is described in the Outstanding Equity Awards Narrative Disclosure section.

Outstanding Equity Awards Narrative Disclosure

section.

(2)
The option will vest over a period of three years, with one-third vesting on the first anniversary of the date of grant and the remainder vesting on a pro-rata basis monthly thereafter.
(3)
The option will vest over a period of three years, with one-third vesting on the date of grant and the remainder vesting on a pro-rata basis monthly thereafter.

Outstanding Equity Awards Narrative Disclosure
Equity Incentive Compensation Plan

We adopted an Equity Incentive Compensation Plan in 20172019 (the 2017 Plan) administered by the Board of Directors,“2019 Plan”) which amended and restated our 2017 Incentive Compensation Plan (the “2017 Plan”). Under the 2013 fixed share option plan (the 2013 Plan). Options,2019 Plan, we are authorized to grant options, restricted shares and restricted share units are eligible for grant under the 2017 Plan.(RSUs) to any of our officers, directors, employees, and consultants and those of our subsidiaries and other designated affiliates. The number of shares available for issuance under the 20172019 Plan is 1,597,000,1,148,697, including shares available for the exercise of outstanding options under the 20132017 Plan. The purpose of the 20172019 Plan is to advance the interests of the Company by encouraging equity participation through the acquisition of common shares of the Company. OurThe 2019 Plan is to be administered by the Compensation Committee of our Board is responsible forof Directors, except to the general administrationextent (and subject to the limitations set forth in the 2019 Plan) the Board elects to administer the 2019 Plan, in which case the 2019 Plan shall be administered by only those members of the 2017Board who are “independent” members of the Board. The administrator of the 2019 Plan and the proper execution of its provisions, its interpretation and the determination of all questions arising thereunder. Specifically, the Board has the power to, among other things:

·allot common shares for issuance in connection with the exercise of options;

·
allot common shares for issuance in connection with the exercise of options;
grant options, restricted shares or restricted share units;

·amend, suspend, terminate or discontinue the plan; and

·delegate all or a portion of its administrative powers as it may determine to one or more committees.

Options, restricted shares or restricted share unitsunits;

amend, suspend, terminate or discontinue the plan; and
delegate all or a portion of its administrative powers as it may be awardeddetermine to our directors, officers, employees and consultants.

one or more committees.

Options to purchase 410,970675,437 common shares at prices ranging from CDN$2.50C$2.16 to CDN$18.70C$638.40 and $1.60$3.16 to $18.40$768.60 are outstanding at September 30, 2017.2020. No restricted shares or restricted share units have been granted as of September 30, 2017.

2020.

Options granted during fiscal 2017the year ended September 30, 2020 to employeesdirectors, officers and consultantsemployees under the 20172019 Plan totaled 71,600366,365 options to purchase common shares at exercise prices ranging from $1.60$3.16 to $2.03.

Page 46
$8.07. There were no options granted during the nine-month period ended September 30, 2019.


Options Vesting Policy

Options granted

Vesting requirements for past serviceoption awards are subject todetermined by the following vesting schedule: (a) one-thirdindependent members of the option shall vestBoard of Directors. Outstanding options granted by Stellar Biotechnologies before the completion of our business combination became fully vested on June 7, 2019, the date of grant; (b) one-third of the option shall vest 12 months from the date of grant; and (c) the remaining one-third of the option shall vest 18 months from the date of grant. our business combination with Edesa Research. Options granted for future service are subject toby Edesa Research generally vested one-third upon the following vesting schedule: (x) one-third shall vest at 12 months from the datefirst anniversary of grant, (y) one-third shall vest at 24 months from the date of grant and (z) one-third shall vest at 36 months frommonthly thereafter until the third anniversary of the date of grant.

Grants The options granted by Edesa Research on August 28, 2017 were fully vested upon the grant date. Options granted by the Company during the year ended September 30, 2020 generally vested one-third upon the date of Plan-Based Awards

The following table provides information regarding grantsgrant and monthly thereafter until the third anniversary of plan-based awards to our named executive officers during fiscal year 2017.

Name Grant Date All Other
Stock Awards:
Number of
Shares of
Stock or Units
(#)
  All Other
Option Awards:
Number of
Securities Underlying
Options (#)
  Exercise or
Base Price of
Option Awards
($/Sh)
  Grant Date
Fair Value of
Stock and
Option Awards
($)(1)
  
Frank R. Oakes 6/26/17  235,690   -  $-  $296,969 (2)
Kathi Niffenegger, CPA 12/20/16  -   10,000   2.03   19,744 (3)
Gregory T. Baxter, Ph.D. 3/28/17  -   10,000   1.60   15,605 (4)

(1)

The amounts shown in this column for share awards represent the aggregate grant date fair value of the share awards based on the closing price on Nasdaq, not the actual amounts paid to or realized by the named executive officerduring the covered fiscal year. It differs from the amounts recorded in accordance with Financial Accounting Standards Board (FASB) Accounting Standards Codification 718, which were based on the share value at the inception of the performance share plan in April 2010 expensed over the estimated vesting period ended August 31, 2012.The vesting requirements of these awards are set forth in Note 8 to our audited consolidated financial statements for the year ended September 30, 2017 included in this Annual Report.

The amounts shown in this column for share option awards represent the aggregate grant date fair value of the share option awards computed in accordance with Financial Accounting Standards Board (FASB) Accounting Standards Codification 718, not the actual amounts paid to or realized by the named executive officersduring the fiscal year. The assumptions used in determining grant date fair value of these awards are set forth in Note 8 to our audited consolidated financial statements for the year ended September 30, 2017 included in this Annual Report.

(2)The shares were issued under our Performance Share Plan and are fully vested.

(3)The option awards were issued under our 2017 Plan for past service, and vest in thirds annually beginning December 2016.

(4)The option awards were issued under our 2017 Plan for future service, and vest in thirds annually beginning March 2018.

the date of grant.

Retirement Benefits

We have established a 401(k) plan to provide retirement benefits to eligible executive

Executive officers and employees. Employees may enteremployees of our California subsidiary are eligible to receive the plan after they have been employed by us for at least three consecutive months. Under the plan, we contribute a flatcompany’s non-elective contribution of 3% of eligible compensation for eachunder a 401(k) plan participant at the end of the calendar year.to provide retirement benefits. Any Companycompany contributions we made to the plan for our named executive officers are reflected in the “All Other Compensation” column of the Summary Compensation Table above.

Other than the funds contributed under our 401(k) plan, no other funds were set aside or accrued by us during fiscal 2017the year ended September 30, 2020 or in the nine-month period ended September 30, 2019 to provide pension, retirement or similar benefits for our named executive officers.

Page 47


Director Compensation

The following table sets forth information regarding the compensation of our non-employee directors for the fiscal year ended September 30, 2017.

Name Fees Earned or
Paid in Cash
($)
  Stock Awards
($) (1)
   

Option
Awards
($) (2)

   All Other
Compensation
($)
   Total  ($) 
Tessie M. Che, Ph.D. $1,000  $-   $8,996 (4) $-   $9,996 
Paul Chun  8,850   -    8,996 (5)  -    17,846 
David L. Hill, Ph.D.  10,250   -    8,996 (4)  -    19,246 
Daniel E. Morse, Ph.D.  5,700   169,697 (3)  8,996 (4)  900 (6)  185,293 
Charles V. Olson, D.Sc.  4,700   -    8,996 (5)  5,775 (7)  19,471 
Mayank D. Sampat  10,250   -    8,996 (4)  -    19,246 

(1)The amounts shown in this column represent the aggregate grant date fair value of the share awards based on the closing price on Nasdaq, not the actual amounts paid to or realized by the named executive officerduring the covered fiscal year.  It differs from the amounts recorded in accordance with Financial Accounting Standards Board (FASB) Accounting Standards Codification 718, which were based on the share value at the inception of the performance share plan in April 2010 expensed over the estimated vesting period ended August 31, 2012.  The vesting requirements of these awards are set forth in Note 8 to our audited consolidated financial statements for the year ended September 30, 2017 included in this Annual Report.

(2)The amounts shown in this column represent the aggregate grant date fair value of the share option awards computed in accordance with Financial Accounting Standards Board (FASB) Accounting Standards Codification 718, not the actual amounts paid to or realized by the directorsduring the fiscal year. The assumptions used in determining grant date fair value of these awards are set forth in Note 8 to our audited consolidated financial statements for the year ended September 30, 2017 included in this Annual Report.

(3)134,680 shares were issued under our Performance Share Plan and are fully vested.

(4)The option awards were issued under our 2017 Incentive Compensation Plan for past service, with 2,500 options vesting in thirds beginning December 2016 and 2,500 options vesting in thirds beginning March 2017.

(5)The option awards were issued under our 2017 Incentive Compensation Plan, with 2,500 options for future service vesting in thirds beginning December 2017 and 2,500 options for past service vesting in thirds beginning March 2017.

(6)Represents amount for service as member of our Scientific Advisory Board.

(7)Represents (i) $5,425 in consultant fees and (ii) $350 for service as member of our Scientific Advisory Board.

2020.

Name
 
Fees Earned or Paid in Cash ($)
 
 
Option Awards($) (1)
 
 
All Other Compensation($)
 
 
Total ($)
 
Lorin Johnson, PhD
 $33,500 
 $27,513 
  - 
 $61,013 
Sean MacDonald
  50,000(2)
  27,513 
  - 
  77,513 
Frank Oakes
  30,000 
  27,513 
  - 
  57,513 
Paul Pay
  42,500(2)
  27,513 
  - 
  70,013 
Carlo Sistilli, CPA, CMA
  43,500(2)
  27,513 
  - 
  71,013 
Peter van der Velden
  37,500(2)(3)
  27,513 
  - 
  65,013 
(1)
The amounts shown in this column represent the aggregate grant date fair value of the share option awards computed in accordance with Financial Accounting Standards Board (FASB) Accounting Standards Codification 718, not the actual amounts paid to or realized by the directors during the covered fiscal year. The assumptions used in determining grant date fair value of these awards are set forth in Note 9 to our audited consolidated financial statements for the year ended September 30, 2020 included in this Annual Report.
(2)
The compensation was paid in Canadian dollars or British pounds and was converted from US dollars using the average foreign exchange rate for each month of the year from oanda.com.
(3)
Fees of $34,326 and $3,174 were paid to Lumira Capital II, L.P. and Lumira Capital II (International), L.P., respectively, as compensation for Mr. van der Velden’s services on our board of directors.
Outstanding Equity Awards at 2017 Fiscal Year-End

September 30, 2020

The following table summarizes the equity awards made to our directors that were outstanding at September 30, 2017.

NameOutstanding
Options (#)
Tessie M. Che, Ph.D.12,000
Paul Chun5,000
David L. Hill, Ph.D.15,000
Daniel E. Morse, Ph.D.31,600
Charles V. Olson, D.Sc.6,250
Mayank D. Sampat12,000

2020.
 Page 48
Outstanding Options (#)
Lorin Johnson, PhD
11,389
Sean MacDonald
11,389
Frank Oakes
12,341
Paul Pay
43,788
Carlo Sistilli, CPA, CMA
11,389
Peter van der Velden
11,389




Narrative to Director Compensation Table

Non-Employee Director Compensation Policy

Pursuant to our non-employee director

The board adopted a compensation policy non-employee directors receive $1,000 for each Board meeting attended in person and $350 for each Board meeting attended by telephone. Members of Board committees also receive $350 for each committee meeting attended. Non-executive directors may also receive share option awards at the discretion of the Board of Directors.

Non-Employee Directors on our Scientific Advisory Board

Dr. Morse and Dr. Olson are memberseffective upon completion of our Scientific Advisory Board.business combination on June 7, 2019. As compensation for their services on the membersboard of our Scientific Advisorydirectors, each non-executive board member will receive annual base remuneration of $30,000 and the Chairman of the Board will receive certain advisory feesannual remuneration of $50,000, inclusive of compensation for his services on committees of the board of directors. Each member of the Company’s Audit Committee will receive annual remuneration of $5,000, and expense reimbursements. Amountsthe Chair of the Audit Committee will receive $10,000 annually for their services as membershis services. Each member of our Scientific Advisory Board are reflected in the Director Compensation table above.

Company’s Compensation Committee Interlocks and Insider Participation

The membersNominating and Corporate Governance Committee will receive annual remuneration of our Compensation Committee during$3,500 for each committee on which they serve, and the fiscal year ended September 30, 2017 were Paul Chun, David Hill (chairman), Charles Olson and Mayank Sampat.

NoneChairs of the individuals who served as a membereach of the Compensation Committee during fiscal 2017 was atand Nominating and Corporate Governance Committee shall receive $7,500 annually for their services. The Chief Executive Officer will not receive any time during fiscal 2017 an officer or employeeadditional compensation for his services on the board of our Company.

Item 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS.

directors.

Item 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS.
Equity Compensation Plan Information

The following table provides certain information as of September 30, 20172020 about our common shares that may be issued under our equity compensation plans, which consists of our 20172019 Equity Incentive Compensation Plan:

Plan category Number of securities
to be issued upon
exercise of
outstanding options,
warrants and rights
  Weighted-average
exercise price of
outstanding options,
warrants and rights
  Number of securities
remaining available for
future issuance under
equity compensation plans
(excluding securities
reflected in column (a))
 
  (a)  (b)  (c) 
Equity compensation plans approved by security holders  410,970  $5.74   1,186,030 
Equity compensation plans not approved by security holders  N/A   N/A   N/A 
Total  410,970  $5.74   1,186,030 

Plan in effect at September 30, 2020:


Plan category
 
Number of securities to be issued upon exercise of outstanding options, warrants and rights
 
 
Weighted-average exercise price of outstanding options, warrants and rights
 
 
Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a))
 
 
 
(a)
 
 
(b)
 
 
(c)
 
Equity compensation plans approved by security holders
  675,437 
 $3.30 
  473,260 
Equity compensation plans not approved by security holders
  N/A 
  N/A 
  N/A 
Total
  675,437 
 $3.30 
  473,260 
Warrants and other equity held by directors, officers and employees outside of the compensation plans are not included in the table above.
Security Ownership of Certain Beneficial Owners and Management

The following tables sets forth certain information as of November 30, 2017,December 2, 2020, with respect to the beneficial ownership of our common shares by: (1) all of our directors; (2) our named executive officers listed in the Summary Compensation Table; (3) all of directors and executive officers as a group; and (4) each person known by us to beneficially own more than 5% of our outstanding common shares.

We have determined beneficial ownership in accordance with the rules of the SEC.SEC, based on a review of filings with the SEC and information known to us. Except as indicated by the footnotes below, we believe, based on the information furnished to us, that the persons and entities named in the table below have sole voting and investment power with respect to all common shares that they beneficially own, subject to applicable community property laws.

Common shares subject to options or warrants currently exercisable or exercisable within 60 days of November 30, 2017December 2, 2020 are deemed outstanding for computing the share ownership and percentage of the person holding such options and warrants, but are not deemed outstanding for computing the percentage of any other person. The percentage ownership of our common shares of each person or entity named in the following table is based on 10,520,09610,523,087 common shares outstanding as of November 30, 2017.

December 2, 2020.



Directors and Officers

Name and Address of Beneficial Owner (1)
Amount and Nature of BeneficialOwnership
Percent of Shares Beneficially Owned
 Page 49
Lorin Johnson, PhD
27,493(2)
*
Sean MacDonald
22,683(3)
*
Pardeep Nijhawan, MD
3,324,010(4)
31.6%
Frank Oakes
18,172(5)
*
Paul Pay
46,194(6)
*
Carlo Sistilli, CPA, CMA
13,795(7)
*
Peter van der Velden
2,186,666(8)
20.7%
Michael Brooks, PhD
210,898(9)
2.0%
Kathi Niffenegger, CPA
57,704(10)
*
All directors and executive officers as a group (9 persons)
5,907,615(11)
56.0%

Directors and Officers

Name and Address of Beneficial Owner (1) Amount and
Nature of Beneficial
Ownership
  Percent of Shares
Beneficially
Owned
 
Frank R. Oakes  464,587(2)  4.4%
Kathi Niffenegger, CPA  58,667(3)  * 
Gregory T. Baxter, Ph.D.  8,250(4)  * 
Tessie M. Che, Ph.D.  9,500(5)  * 
Paul Chun  1,666(6)  * 
David L. Hill, Ph.D.  14,500(7)  * 
Daniel E. Morse, Ph.D.  125,609(8)  1.2%
Charles V. Olson, D.Sc.  2,916(9)  * 
Mayank D. Sampat  9,500(10)  * 
         
All directors and executive officers as a group (9 persons)  695,195(11)  6.5%

* Percentage of shares beneficially owned does not exceed one percent.

(1)Unless otherwise indicated, the address of each beneficial owner is c/o Stellar Biotechnologies, Inc., 332 E. Scott Street, Port Hueneme, California 93041.

(2)This amount includes (i) 80,120 shares issuable upon the exercise of options currently exercisable or exercisable within 60 days of November 30, 2017; and excludes (ii) 20,867 common shares and 6,200 common shares issuable upon the exercise of outstanding options currently exercisable or exercisable within 60 days of November 30, 2017 which are held by Mr. Oakes’ spouse who has sole voting and dispositive power over the securities, and as to which Mr. Oakes disclaims beneficial ownership. Mr. Oakes does not have the power to vote or dispose of, or to direct the voting or disposition of, the shares held by his spouse, or with respect to any shares acquired under her outstanding options.

(3)Represents 58,667 shares issuable upon the exercise of options currently exercisable or exercisable within 60 days of November 30, 2017.

(4)Represents 8,250 shares issuable upon the exercise of options currently exercisable or exercisable within 60 days of November 30, 2017.

(5)Represents 9,500 shares issuable upon the exercise of options currently exercisable or exercisable within 60 days of November 30, 2017.

(6) Represents 1,666 shares issuable upon the exercise of options currently exercisable or exercisable within 60 days of November 30, 2017.

(7)This amount includes 12,500 shares issuable upon the exercise of options currently exercisable or exercisable within 60 days of November 30, 2017.

(8)This amount includes 29,100 shares issuable upon the exercise of options currently exercisable or exercisable within 60 days of November 30, 2017.

(9)Represents 2,916 shares issuable upon the exercise of options currently exercisable or exercisable within 60 days of November 30, 2017.

(10)Represents 9,500 shares issuable upon the exercise of options currently exercisable or exercisable within 60 days of November 30, 2017.

(11)This amount includes 212,219 shares issuable upon the exercise of options currently exercisable or exercisable within 60 days of November 30, 2017.


(1)
Unless otherwise indicated, the address of each beneficial owner is c/o Edesa Biotech, Inc., 100 Spy Court, Markham, ON Canada L3R 5H6.
(2)
Consists of (i) 12,786 Common Shares, (ii) 6,393 Common Shares issuable upon exercise of Class A Warrants and (iii) 8,314 Common Shares issuable upon exercise of options that are exercisable within sixty days of December 2, 2020.
(3)
Consists of (i) 14,369 Common Shares and (ii) 8,314 Common Shares issuable upon exercise of options exercisable within sixty days of December 2, 2020.
(4)
Consists of (A)(i) 537,312 Common Shares and (ii) 55,283 Common Shares issuable upon exercise of options exercisable within sixty days of December 2, 2020 held by Pardeep Nijhawan; (B)(i) 2,128,652 Common Shares and (ii) 6,942 Common Shares issuable upon exercise of Class A Warrants held by Pardeep Nijhawan Medicine Professional Corporation for which Pardeep Nijhawan has sole voting and dispositive power over all such shares; (C) 224,094 Common Shares held by The Digestive Health Clinic Inc. for which Pardeep Nijhawan has sole voting and dispositive power over all such shares and (D) 371,727 Common Shares held by 1968160 Ontario Inc. for which Pardeep Nijhawan has sole voting and dispositive power over all such shares.
(5)
Consists of (A)(i) 6,165 Common Shares and (ii) 9,266 Common Shares issuable upon exercise of options that are exercisable within sixty days of December 2, 2020 held by Frank Oakes and (B)(i) 1,827 Common Shares and (ii) 914 Common Shares issuable upon exercise of Class A Warrants held by Frank and Dorothy Oakes Family Trust for which each of Frank Oakes and Dorothy Oakes, as trustees, have voting and dispositive power over all such shares.
(6)
Consists of (i) 3,654 Common Shares, (ii) 1,827 Common Shares issuable upon exercise of Class A Warrants and (iii) 40,713 Common Shares issuable upon exercise of options exercisable within sixty days of December 2, 2020.
(7)
Consists of (A) 8,314 Common Shares issuable upon exercise of options exercisable within sixty days of December 2, 2020 held by Carlo Sistilli and (B)(i) 3,654 Common Shares and (ii) 1,827 Common Shares issuable upon exercise of Class A Warrants held by York-Cav Enterprises Inc. for which Carlo Sistilli, as President and Director, has sole voting and dispositive power over all such shares.
(8)
Consists of (A) 8,314 Common Shares issuable upon exercise of options exercisable within sixty days of December 2, 2020 held by Peter van der Velden; (B)(i) 1,897,425 Common Shares and (ii) 96,542 Common Shares issuable upon exercise of Class A Warrants held by Lumira Capital II, L.P. and (C)(i) 175,454 Common Shares and (ii) 8,928 Common Shares issuable upon exercise of Class A Warrants held by Lumira Capital II (International), L.P., an affiliate of Lumira Capital II, L.P. Lumira Capital GP, L.P., the general partners of which are Lumira GP Inc. and Lumira GP Holdings Co., is the general partner of each of Lumira Capital II, L.P. and Lumira Capital II (International), L.P. Each of Lumira Capital II, L.P. and Lumira Capital II (International), L.P. is managed by Lumira Capital Investment Management Inc. Each of Lumira Capital GP, L.P., Lumira GP Inc., Lumira GP Holdings Co. and Lumira Capital Investment Management Inc. may be deemed to beneficially own the shares held by Lumira Capital II, L.P. and Lumira Capital II (International), L.P. and such entities control voting and investment power over such shares through an investment committee of the Lumira group. Peter van der Velden is an executive officer of Lumira GP Inc., Lumira GP Holdings Co. and Lumira Capital Investment Management Inc.
(9)
Consists of (i) 5,241 Common Shares, (ii) 1,371 Common Shares issuable upon exercise of Class A Warrants and (iii) 204,286 Common Shares issuable upon exercise of options exercisable within sixty days of December 2, 2020.

(10)
Consists of (A) 54,963 Common Shares issuable upon exercise of options that are exercisable within sixty days of December 2, 2020 held by Kathi Niffenegger and (B) (i) 1,827 Common Shares and (ii) 914 Common Shares issuable upon exercise of Class A Warrants held by the Kathi Niffenegger Trust for which Kathi Niffenegger, as trustee, has sole voting and dispositive power over all such shares.
(11)
Consists of (i) 5,384,190 Common Shares, (ii) 125,658 Common Shares issuable upon exercise of Class A Warrants and (iii) 397,767 Common Shares issuable upon exercise of options that are exercisable within sixty days of December 2, 2020.



Shareholders Known by Us to Own 5% or More of Our Common Shares

Name and Address of Beneficial Owner 

Amount and
Nature of Beneficial
Ownership

  Percent of Shares
Beneficially
Owned
 
Ernesto Echavarria  
Blvd. Anaya
1225 Culiacan Sinaloa, Mexico 80040
  1,411,310   13.4%

Name and Address of Beneficial Owner
Amount and Nature of BeneficialOwnership
Percent of Shares Beneficially Owned
 Page 50
Inveready (1)
531,986(1) 
5.1%
Lumira Capital II, L.P. (2)
2,178,352(2) 
20.6%

Item 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE.

(1)
Consists of 531,986 Common Shares. Voting and investment power over the shares held by Inveready Innvierte Biotech II, S.C.R. S.A is exercised by its board of directors. The address of the shareholder is c/o Inveready Technology Investment Group, C/dels Cavaliers, 50, Barcelona, 08034, Spain.
(2)
Consists of (A)(i) 1,897,425 Common Shares and (ii) 96,542 Common Shares issuable upon exercise of Class A Warrants held by Lumira Capital II, L.P. and (B)(i) 175,454 Common Shares and (ii) 8,928 Common Shares issuable upon exercise of Class A Warrants held by Lumira Capital II (International), L.P., an affiliate of Lumira Capital II, L.P. Lumira Capital GP, L.P., the general partners of which are Lumira GP Inc. and Lumira GP Holdings Co., is the general partner of each of Lumira Capital II, L.P. and Lumira Capital II (International), L.P. Each of Lumira Capital II, L.P. and Lumira Capital II (International), L.P. is managed by Lumira Capital Investment Management Inc. Each of Lumira Capital GP, L.P., Lumira GP Inc., Lumira GP Holdings Co. and Lumira Capital Investment Management Inc. may be deemed to beneficially own the shares held by Lumira Capital II, L.P. and Lumira Capital II (International), L.P and such entities control voting and investment power over such shares through an investment committee of the Lumira group. The address of each entity listed in this note is 141 Adelaide Street West, Suite 770, Toronto, Ontario, Canada M5H 3L5.

Item 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE.
Related Party Transactions

Lease Agreement
In January 2017, Edesa Research entered into a lease agreement with a company related to Pardeep Nijhawan, our Chief Executive Officer, for executive office space which serves as our head office through December 2022, with the option to extend the lease for an additional two years. Monthly rents range from C$8,320 to C$9,020 plus HST. Rents of approximately $76,000 and $58,000 were incurred in the year ended September 30, 2020 and the nine-month period ended September 30, 2019, respectively. No rent was payable at September 30, 2020 or 2019.
Patent Royalty Agreement

On

In August 14, 2002, through our California subsidiary we entered into an agreement with Frank Oakes, our Chief Executive Officer,a director, where he would receive royalty payments in exchange for the assignment of his rights to U.S. Patent No. 6,852,338 to us.Edesa Biotech USA, Inc. The royalty is 5% of gross receipts from legacy products using this invention in excess of $500,000 annually. Our current operations utilize this invention. Patent royalties of $35,516approximately $20,000 were paid to Mr. Oakes forincurred in the nine-month period ended September 30, 2019 and royalties payable of approximately $23,000 were outstanding at September 30, 2019. No patent royalties were incurred during the year ended September 30, 2016. No royalties were paid for the year ended2020 or payable at September 30, 2017.

Collaboration Agreement

In December 2013, we entered into a collaboration agreement (the Amaran Agreement) with Amaran Biotechnology, Inc. to develop and evaluate methods for Amaran’s potential manufacture of the OBI-822 (Adagloxad Simolenin) active immunotherapy using our GMP grade Stellar KLH. The Amaran Agreement expired by its terms on December 7, 2015.

Revenues received from Amaran under the Amaran Agreement totaled $32,000 during the fiscal year ended September 30, 2016. The terms of the collaboration with Amaran also provided for negotiation of a commercial supply agreement for Stellar KLH in the future, which was executed in February 2017.

Tessie Che, a member of our Board of Directors, currently serves as general manager and chair of the board of directors of Amaran.

Policies and Procedures for Review of Related Party Transactions

The Audit Committee reviews, approves and oversees any transaction between us and any “related person” (as defined in Item 404 of Regulation S-K) and any other potential conflict of interest situations, on an ongoing basis. Under these policies and procedures, the Audit Committee is to be informed of transactions subject to review before their implementation. The procedures establish our practices for obtaining and reporting information to the Audit Committee regarding such transactions on a periodic and an as-needed basis. The policy provides that such transactions are to be submitted for approval before they are initiated but also provides for ratification of such transactions. No director who is interested in a transaction may participate in the Audit Committee’s determinations as to the appropriateness of such transaction.

2020.

Director Independence

In evaluating the independence of our Board members and the composition of the committees of our Board of Directors, the Board of Directors utilizes the definition of “independence” as that term is defined by the Securities Exchange Act of 1934, and the Nasdaq Listing Rules. Using this standard, the Board of Directors has determined that Lorin Johnson, Sean MacDonald, Paul Chun, David Hill, Daniel Morse, Charles OlsonPay, Carlo Sistilli and Mayank SampatPeter van der Velden are “independent directors.” This means that our Board of Directors is composed of a majority of independent directors as required by the rules of Nasdaq.

Item 14.PRINCIPAL ACCOUNTING FEES AND SERVICES.



Item 14.PRINCIPAL ACCOUNTING FEES AND SERVICES.
The following table shows the aggregate fees paid or accruedbilled for audit and other services provided for the yearsyear ended September 30, 20172020 and 2016nine- month period ended September 30, 2019 rendered by Moss AdamsMNP LLP.

Principal Accountant Fees and Services

Type of Service Fiscal Year 2017  Fiscal Year 2016 
       
Audit Fees $190,000  $238,000 
Audit-Related Fees  -   - 
Tax Fees  -   - 
All Other Fees  -   - 
Total $190,000  $238,000 

Type of Service
 
 Year Ended 2020
 
 
Nine-month Period 2019
 
 
 
 
 
 
 
 
Audit Fees
 $166,712 
 $143,095 
Tax Fees
  24,166 
  14,254 
 
    
    
Total
 $190,878 
 $157,349 
Audit Feesconsisted of fees incurred for professional services rendered for audits and interim reviews of the yearsyear ended September 30, 20172020 and 2016nine-month period ended September 30, 2019 and include procedures related to registrations and offerings.


Page 51

Tax Fees consisted of fees incurred for professional services rendered for tax compliance related to tax returns during the year ended September 30, 2020 and nine-month period ended September 30, 2019.
Pre-Approval Policies and Procedures

The Audit Committee is directly responsible for the appointment, compensation and oversight of our auditors. It has established procedures for the receipt, retention, and treatment of complaints received by us regarding accounting, internal accounting controls, or auditing matters, and the confidential, anonymous submission by our employees of concerns regarding questionable accounting or auditing matters. The Audit Committee also has the authority and the funding to engage independent counsel and other outside advisors.

The Audit Committee pre-approves all audit and permissible non-audit services provided by the independent registered public accounting firm.  These services may include audit services, audit-related services, tax services and other services.  Pre-approval is generally provided for up to one year, and any pre-approval is detailed as to the particular service or category of services and is generally subject to an amount or range of estimated fees.  All proposed engagements of the auditor for audit and permitted non-audit services are submitted to the Audit Committee for approval prior to the beginning of any such services. Our auditors are required to periodically report to the Audit Committee regarding the extent of services provided by the independent registered public accounting firm in accordance with the pre-approval, and the fees for the services performed to date.  The Audit Committee may also pre-approve particular services on a case-by-case basis. The Audit Committee pre-approved 100% of the audit and non-audit services performed by our independent registered public accounting firm for the fiscal year ended September 30, 2017.

Page 52
2020 and nine-month period ended September 30, 2019.



PPARTART IV

Item 15.EXHIBITS, FINANCIAL STATEMENT SCHEDULES.

(a)The following documents are filed as a part of this Annual Report:

Item 15.EXHIBITS, FINANCIAL STATEMENT SCHEDULES.
(a)
The following documents are filed as a part of this Annual Report:
(1) Financial Statements

The list of consolidated financial statements and notes required by this Item 15 (a) (1) is set forth in the “Index to Financial Statements” on page F-1 of this Annual Report.

(2) Financial Statement Schedules

All schedules have been omitted because the required information is included in the financial statements or notes thereto.

(b)Exhibits

(b)
Exhibits
The exhibits listed on the Exhibit Index below are filed as part of this Annual Report.

EXHIBIT INDEX
Exhibit No.Description 
2.1
Share Exchange Agreement, dated as of March 7, 2019, by and between Stellar Biotechnologies Inc., Edesa Biotech Inc. and the Edesa Shareholders (included as Exhibit 2.1 to the Company's Current Report on Form 8-K filed on March 8, 2019, and incorporated herein by reference). 
 Page 53

EXHIBIT INDEX

Exhibit No.Description

Certificate of Incorporation of the Company, dated June 12, 2007 (included as Exhibit 1(a) to the Company’sCompany's Registration Statement on Form 20-F filed on February 3, 2012, and incorporated herein by reference).

Certificate of Amendment of the Company, dated April 15, 2008 (included as Exhibit 1(b) to the Company’sCompany's Registration Statement on Form 20-F filed on February 3, 2012, and incorporated herein by reference).

Certificate of Continuation of the Company, dated November 25, 2009 (included as Exhibit 1(c) to the Company’sCompany's Registration Statement on Form 20-F filed on February 3, 2012, and incorporated herein by reference).

Certificate of Change of Name of the Company, dated April 7, 2010 (included as Exhibit 1(f) to the Company’s Registration Statement on Form 20-F filed on February 3, 2012, and incorporated herein by reference).

NoticeCertificate of ArticlesChange of Name of the Company, dated AprilJune 7, 20102019 (included as Exhibit 1(g)3.6 to the Company’s Registration StatementCompany's Annual Report on Form 20-F10-K filed on February 3, 2012,December 12, 2019, and incorporated herein by reference).

Articles of the Company, effective November 20, 2009 (included as Exhibit 1(h) to the Company’s Registration Statement on Form 20-F filed on February 3, 2012, and incorporated herein by reference).

3.7Amended and Restated Articles of the Company, dated October 29, 2015Edesa Biotech, Inc. (included as Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on October 30, 2015,April 23, 2020, and incorporated herein by reference).

Notice of Articles of Edesa Biotech, Inc. (included as Exhibit 3.2 to the Company’s Quarterly Report on Form 10-Q filed on May 15, 2020, and incorporated herein by reference)
Specimen of common share certificate (included as Exhibit 4.1 to the Company’s Registration Statement on Form S-3 filed on August 30, 2019 and incorporated herein by reference)
Form of Class A Purchase Warrant dated June 30, 2016issued to investors (included as Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on June 30, 2016,January 6, 2020 and incorporated herein by reference).
Form of Class B Purchase Warrant issued to investors (included as Exhibit 4.2 to the Company’s Current Report on Form 8-K filed on January 6, 2020 and incorporated herein by reference)
Form of Warrant issued to Brookline Capital Markets, a division of Arcadia Securities, LLC (included as Exhibit 4.3 to the Company’s Current Report on Form 8-K filed on January 6, 2020 and incorporated herein by reference)

4.5
Form of Warrant (included as Exhibit 4.2 to the Company's Registration Statement on Form S-1 filed on May 8, 2018, and incorporated herein by reference) 


Patent Assignment and Royalty Agreement between the Company and Frank Oakes, dated August 6, 2002 (included as Exhibit 4(a) to the Company’s Registration Statement on Form 20-F filed on February 3, 2012, and incorporated herein by reference).

Sublease Agreement (Units 3, 4 and 5) between the Company and the Port Hueneme Surplus Property Authority, datedAdvance Notice Policy, adopted October 2, 200031, 2013 (included as Exhibit 4(j)10.14 to the Company’s Registration StatementCompany's Annual Report on Form 20-F10-K filed on February 3, 2012,November 14, 2014, and incorporated herein by reference).

SubleaseForm of Securities Purchase Agreement (Unit 7) between the Company and the Port Hueneme Surplus Property Authority, dated March 21, 2005 (included as Exhibit 4(k)10.21 to the Company’sCompany's Registration Statement on Form 20-FS-1 filed on February 3, 2012,May 8, 2018, and incorporated herein by reference).

Lease

10.5Research Collaboration Agreement between the Company and Bayer Innovation GmbH, dated August 27, 2009 (included as Exhibit 4(16) to the Company’s Amendment No. 2 to its Registration Statement on Form 20-F filed on July 5, 2012, and incorporated herein by reference).

10.6 #Joint Venture Agreement, dated May 11, 2016, by and among the Company and Neovacs, S.A.June 7, 2019 (included as Exhibit 10.1 to the Company’sCompany's Current Report on Form 8-K filed on May 17, 2016,June 10, 2019, and incorporated herein by reference).

10.7
Employment Agreement by and between the Company and University of Guelph,Pardeep Nijhawan, dated July 24, 2013June 14, 2019 (included as Exhibit 99.110.2 to the Company’sCompany's Current Report on Form 6-K8-K/A filed on August 30, 2013,June 20, 2019, and incorporated herein by reference).
10.6
Employment Agreement by and between the Company and Michael Brooks, dated June 14, 2019 (included as Exhibit 10.3 to the Company's Current Report on Form 8-K/A filed on June 20, 2019, and incorporated herein by reference). 

10.7
Form of Indemnification Agreement, by and between the Company and each of its directors and executive officers (included as Exhibit 10.4 to the Company's Current Report on Form 8-K/A filed on June 20, 2019, and incorporated herein by reference). 
Fixed Share Option Plan dated December 18, 2013 (included as Exhibit 10.11 to the Company’s Annual Report on Form 10-K filed on November 14, 2014, and incorporated herein by reference).

2017 Incentive Compensation Plan (included as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on March 29, 2017, and incorporated herein by reference).

 Page 54

Performance Share2019 Equity Incentive Compensation Plan dated April 9, 2010 (included as Exhibit 10(d) to the Company’s Registration Statement on Form 20-F filed on February 3, 2012, and incorporated herein by reference).

10.11Advance Notice Policy, adopted October 31, 2013 (included as Exhibit 10.14 to the Company’s Annual Report on Form 10-K filed on November 14, 2014, and incorporated herein by reference).

10.12Amendment One to Lease Agreement between the Company and Beachport Center, dated June 24, 2014 (included as Exhibit 10.15 to the Company’s Annual Report on Form 10-K filed on November 14, 2014, and incorporated herein by reference).

10.13Sublease Amendment No. 2 (Units 4 and 5) to Sublease Agreement between the Company and the Port Hueneme Surplus Property Authority, dated October 2, 2010 (included as Exhibit 10.16 to the Company’s Annual Report on Form 10-K filed on November 14, 2014, and incorporated herein by reference).

10.14Sublease Amendment No. 1 (Unit 7) to Sublease Agreement between the Company and the Port Hueneme Surplus Property Authority, dated March 21, 2010 (included as Exhibit 10.17 to the Company’s Annual Report on Form 10-K filed on November 14, 2014, and incorporated herein by reference).

10.15Collaboration Agreement by and between Stellar Biotechnologies, Inc. and Amaran Biotechnology dated December 7, 2013 (included as Exhibit 10.18 to Amendment No. 2 of the Company’s Annual Report on Form 10-K filed on September 9, 2015, and incorporated herein by reference).

10.16Collaboration Agreement, dated July 27, 2015, by and between Stellar Biotechnologies, Inc. and Ostiones Guerrero SA de CV (included as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on July 30, 2015,October 25, 2019, and incorporated herein by reference).

10.17
Lease, dated as of January 1, (Units 42017, by and 5) to Sublease Agreement between the CompanyRegistrant and the Port Hueneme Surplus Property Authority, and establishment of new commencement date for Sublease Agreement (Unit 7) between the Company and the Port Hueneme Surplus Property Authority, dated October 31, 20051968160 Ontario Inc. (included as Exhibit 10.2010.1 to the Company’s AnnualCompany's Current Report on Form 10-K8-K filed on December 14, 2015,August 30, 2019, and incorporated herein by reference).

10.18
Exclusive License Agreement, dated as of June 29, 2016, by and 5) to Sublease Agreement between the CompanyRegistrant and the Port Hueneme Surplus Property Authority, dated June 4, 2015Yissum Research Development Company (included as Exhibit 10.2110.2 to the Company’s AnnualCompany's Current Report on Form 10-K8-K filed on December 14, 2015,August 30, 2019, and incorporated herein by reference). 
First Amendment to Exclusive License Agreement, dated April 3, 2017, by and between the Registrant and Yissum Research Development Company (included as Exhibit 10.3 to the Company's Current Report on Form 8-K filed on August 30, 2019, and incorporated herein by reference).

10.19
Second Amendment No. 2 (Unit 7) to SubleaseExclusive License Agreement, dated May 7, 2017, by and between the CompanyRegistrant and the Port Hueneme Surplus Property Authority, dated June 4, 2015Yissum Research Development Company (included as Exhibit 10.2210.4 to the Company’s AnnualCompany's Current Report on Form 10-K8-K filed on December 14, 2015,August 30, 2019, and incorporated herein by reference).
License and Development Agreement, dated as of August 27, 2017, by and between the Registrant and Pendopharm, a division of Pharmascience Inc. (included as Exhibit 10.6 to the Company's Current Report on Form 8-K filed on August 30, 2019, and incorporated herein by reference).


Form of Securities Purchase Agreement dated June 30, 2016between Edesa Biotech, Inc. and certain investors (included as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on June 30, 2016,January 6, 2020 and incorporated herein by reference)
Form of Subscription Agreement between Edesa Biotech, Inc. and certain investors (included as Exhibit 10.2 to the Company’s Current Report on Form 8-K filed on January 6, 2020 and incorporated herein by reference)
License Agreement by and between Edesa Biotech Research, Inc. and NovImmune SA dated April 17, 2020 (included as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on April 23, 2020, and incorporated herein by reference).
Purchase Agreement by and between Edesa Biotech Research, Inc. and NovImmune SA dated April 17, 2020 (included as Exhibit 10.2 to the Company’s Current Report on Form 8-K filed on April 23, 2020, and incorporated herein by reference).
Securities Purchase Agreement by and between Edesa Biotech, Inc. and NovImmune SA dated April 17, 2020 (included as Exhibit 10.3 to the Company’s Current Report on Form 8-K filed on April 23, 2020, and incorporated herein by reference).


Employment Agreement by and between the Company and Kathi Niffenegger, dated December 1, 2020 (filed herewith).


Certification of the Chief Executive Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (filed herewith).

Certification of the Chief Financial Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (filed herewith).

 Page 55

101.INSXBRL Instance Document

101.SCH
XBRL Taxonomy Extension Schema Document

101.CALXBRL Taxonomy Calculation Linkbase Document

101.DEFXBRL Taxonomy Extension Definition Linkbase Document

101.LABXBRL Taxonomy Label Linkbase Document

101.PREXBRL Taxonomy Presentation Linkbase Document

@Management contract or compensatory plan or arrangement.

#Confidential treatment has been granted for certain portions of this exhibit. Original copies have been filed separately with the Securities and Exchange Commission pursuant to Rule 24B-2 of the Securities Exchange Act of 1934, as amended.

^A signed original of this written statement required by Section 906 has been provided and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.

Page 56

All schedules and exhibits to the Share Exchange Agreement have been omitted pursuant to Item 601(b)(2) of Regulation S-K. A copy of any omitted schedule and/or exhibit will be furnished to the Securities and Exchange Commission upon request.
** The information in this exhibit is furnished and deemed not filed with the Securities and Exchange Commission for purposes of section 18 of the Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of Edesa Biotech, Inc. under the Securities Act of 1933, as amended, or the Exchange Act of 1934, as amended, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
@ Management contract or compensatory plan or arrangement.
+Portions of this exhibit have been omitted pursuant to Rule 601(b)(10)(iv) of Regulation S-K.
ISIGNATURES

tem 16. FORM 10-K Summary

None.

SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

Date: December 1, 20177, 2020STELLAR BIOTECHNOLOGIES,EDESA BIOTECH, INC.
  
 /s/ Frank R. OakesPardeep Nijhawan
 Frank R. OakesPardeep Nijhawan, MD
 President andDirector, Chief Executive Officer and Corporate Secretary
 (Principal Executive Officer)

POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Pardeep Nijhawan and Kathi Niffenegger, and each of them, as his or her true and lawful attorneys-in-fact and agents, with full power of substitution for him or her, and in his or her name in any and all capacities, to sign any and all amendments to this Annual Report on Form 10-K, and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done therewith, as fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, and any of them or his or her substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.

Signature Title Date
     
/s/ Frank R. OakesPardeep Nijhawan President,Director, Chief Executive Officer, and December 1, 20177, 2020
Frank R. OakesPardeep Nijhawan Chairman of the Board of DirectorsCorporate Secretary (Principal Executive Officer)  
     
/s/ Kathi Niffenegger Chief Financial Officer December 1, 20177, 2020
Kathi Niffenegger (Principal Financial and Accounting Officer)  
     
/s/ Tessie M. CheLorin Johnson Director December 1, 20177, 2020
Tessie M. CheLorin Johnson    
     
/s/ Paul ChunSean MacDonald DirectorChairman of the Board of Directors December 1, 20177, 2020
Paul ChunSean MacDonald    
     
/s/David L. Hill Frank Oakes Director December 1, 20177, 2020
David L. HillFrank Oakes    
     
/s/Daniel E. Morse Paul Pay Director December 1, 20177, 2020
Daniel E. MorsePaul Pay    
     
/s/ Charles V. OlsonCarlo Sistilli Director December 1, 20177, 2020
Charles V. OlsonCarlo Sistilli    
     
/s/Mayank D. Sampat Peter van der Velden Director December 1, 20177, 2020
Mayank D. SampatPeter van der Velden    


EDESA BIOTECH, INC.
INDEX TO FINANCIAL STATEMENTS
 Page 57

STELLAR BIOTECHNOLOGIES, INC.

INDEX TO FINANCIAL STATEMENTS

Page
  
F-3F-2
  
F-4F-3
  
F-5F-4
  
F-6F-5
  
F-7F-6
  
F-8

F-1F-7

Consolidated Financial Statements

For the Years Ended September 30, 2017, 2016 and 2015

 F-2



RReporteport of Independent Registered Public Accounting Firm

The

To the Board of Directors and Shareholders

Stellar Biotechnologies,

of Edesa Biotech, Inc.

Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance sheets of Stellar Biotechnologies,Edesa Biotech, Inc. (the Company) as of September 30, 20172020 and 2016, and2019, the related consolidated statements of operations and comprehensive loss, changes in shareholders’ equity and cash flows for the fiscal yearsyear ended September 30, 2017, 20162020 and 2015. the nine-month period ended September 30, 2019, and the related notes (collectively referred to as the consolidated financial statements).
In our opinion, the consolidated financial statements present fairly, in all material respects, the consolidated financial position of the Company as of September 30, 2020 and 2019, and the results of its consolidated operations and its consolidated cash flows for the year ended September 30, 2020 and the nine-month period ended September 30, 2019, in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on thesethe Company’s consolidated financial statements based on our audits.

We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States).PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement.misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audit included considerationAs part of our audits we are required to obtain an understanding of internal control over financial reporting, as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence supportingregarding the amounts and disclosures in the consolidated financial statements, assessingstatements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statement presentation.statements. We believe that our audits provide a reasonable basis for our opinion.

In our opinion,

/s/ MNP LLP
Chartered Professional Accountants
Licensed Public Accountants
We have served as the consolidated financial statements referred to above present fairly, in all material respects, the consolidated financial position of Stellar Biotechnologies,Company’s auditor since 2019.
Toronto, Canada
December 7, 2020

Edesa Biotech, Inc. as of September 30, 2017 and 2016, and the consolidated results of its operations and its cash flows for fiscal years ended September 30, 2017, 2016 and 2015, in conformity with accounting principles generally accepted in the United States of America.

/s/ Moss Adams LLP
Los Angeles, California
December 1, 2017

 F-3

Consolidated Balance Sheets

Stellar Biotechnologies, Inc.
Consolidated Balance Sheets

  September 30,  September 30, 
  2017  2016 
       
Assets:        
         
Current assets:        
Cash and cash equivalents $4,570,951  $7,416,904 
Accounts receivable  1,287   85,813 
Short-term investments  1,994,401   3,988,794 
Inventory  68,114   249,430 
Prepaid expenses  123,694   358,714 
         
Total current assets  6,758,447   12,099,655 
         
Noncurrent assets:        
         
Equity investment in joint venture  66,695   66,695 
Property, plant and equipment, net  879,523   756,114 
Deposits  15,340   15,340 
         
Total noncurrent assets  961,558   838,149 
         
Total Assets $7,720,005  $12,937,804 
         
Liabilities and Shareholders' Equity:        
         
Current liabilities:        
Accounts payable and accrued liabilities $320,947  $623,644 
         
Total Current Liabilities  320,947   623,644 
         
Commitments(Note 7)        
         
Shareholders' equity:        
Common shares, unlimited common shares authorized, no par value, 10,520,096 and 10,136,258 issued and outstanding at September 30, 2017 and 2016  48,351,701   47,280,792 
Accumulated share-based compensation  4,439,400   5,394,763 
Accumulated deficit  (45,392,043)  (40,361,395)
         
Total Shareholders' Equity  7,399,058   12,314,160 
         
Total Liabilities and Shareholders' Equity $7,720,005  $12,937,804 

 
 
September 30,
2020
 
 
September 30,
2019
 
 
 
 
 
 
 
 
Assets:
 
 
 
 
 
 
 
 
 
 
 
 
 
Current assets:
 
 
 
 
 
 
Cash and cash equivalents
 $7,213,695 
 $5,030,583 
Accounts and other receivable
  87,446 
  217,101 
Prepaid expenses and other current assets
  802,877 
  397,022 
 
    
    
Total current assets
  8,104,018 
  5,644,706 
 
    
    
Non-current assets:
    
    
Property and equipment, net
  14,815 
  73,058 
Intangible assets, net
  2,483,536 
  - 
Operating lease right-of-use assets
  160,006 
  - 
 
    
    
Total assets
 $10,762,375 
 $5,717,764 
 
    
    
 
    
    
Liabilities, shareholders' equity and temporary equity:
    
    
 
    
    
Current liabilities:
    
    
Accounts payable and accrued liabilities
 $1,460,127 
 $461,634 
Short-term operating lease liabilities
  69,730 
  - 
 
    
    
Total current liabilities
  1,529,857 
  461,634 
 
    
    
Non-current liabilities:
    
    
Long-term payables
  29,928 
  - 
Long-term operating lease liabilities
  94,460 
  - 
 
    
    
Total liabilities
  1,654,245 
  461,634 
 
    
    
Commitments (Note 7)
    
    
 
    
    
Temporary equity:
    
    
Convertible preferred shares
  2,476,955 
  - 
 
    
    
Shareholders' equity:
    
    
Capital shares
    
    
 
 Authorized unlimited common and preferred shares without par value
 
    
   Issued and outstanding:
    
    
9,615,119 common shares (2019 - 7,504,468)
  18,500,853 
  12,005,051 
Additional paid-in capital
  1,550,480 
  327,768 
Accumulated other comprehensive loss
  (287,204)
  (342,074)
Accumulated deficit
  (13,132,954)
  (6,734,615)
 
    
    
Total shareholders' equity
  6,631,175 
  5,256,130 
 
    
    
Total liabilities, shareholders' equity and temporary equity
 $10,762,375 
 $5,717,764 
The accompanying notes are an integral part of these consolidated financial statements.

 F-4

Stellar Biotechnologies, Inc.
Consolidated Statements of Operations

  Years Ended 
  September 30,  September 30,  September 30, 
  2017  2016  2015 
          
Revenues:            
Product sales $178,287  $1,239,689  $563,689 
Contract services revenue  50,000   32,000   195,000 
             
   228,287   1,271,689   758,689 
             
Expenses:            
Costs of sales and contract services  250,042   818,566   580,824 
Costs of aquaculture  284,411   309,262   259,423 
Research and development  1,973,400   1,729,445   1,029,489 
General and administrative  2,944,980   3,322,772   3,227,545 
             
   5,452,833   6,180,045   5,097,281 
             
Loss from Operations  (5,224,546)  (4,908,356)  (4,338,592)
             
Other Income (Loss)            
Foreign exchange gain (loss)  162,028   76,800   (653,333)
Gain (loss) in fair value of warrant liability  -   (211,956)  2,131,062 
Investment income  32,670   24,632   54,634 
             
   194,698   (110,524)  1,532,363 
             
Loss Before Income Tax  (5,029,848)  (5,018,880)  (2,806,229)
             
Income tax expense  800   7,200   36,800 
             
Net Loss $(5,030,648) $(5,026,080) $(2,843,029)
             
Loss per common share:            
Basic and diluted $(0.49) $(0.57) $(0.36)
Weighted average number of common shares outstanding:            
Basic and diluted  10,237,213   8,826,312   7,956,962 


Edesa Biotech, Inc.
Consolidated Statements of Operations and Comprehensive Loss
 
 
Year Ended
 
 
Nine-month Period Ended
 
 
 
September 30,
2020
 
 
September 30,
2019
 
 
 
 
 
 
 
 
Revenues:
 
 
 
 
 
 
Product sales
 $328,801 
 $410,870 
 
    
    
Expenses:
    
    
Cost of sales
  17,601 
  101,286 
Research and development
  3,329,451 
  1,096,426 
General and administrative
  3,382,591 
  2,045,296 
 
    
    
 
  6,729,643 
  3,243,008 
 
    
    
Loss from Operations
  (6,400,842)
  (2,832,138)
 
    
    
Other Income (Loss):
    
    
Interest income
  37,778 
  56,840 
Foreign exchange loss
  (366)
  (1,436)
 
    
    
 
  37,412 
  55,404 
 
    
    
Loss before income taxes
  (6,363,430)
  (2,776,734)
 
    
    
Income tax expense
  800 
  - 
 
    
    
Net Loss
  (6,364,230)
  (2,776,734)
 
    
    
Exchange differences on translation
  54,870 
  87,899 
 
    
    
Net Comprehensive Loss
 $(6,309,360)
 $(2,688,835)
 
    
    
Weighted average number of common shares
  8,607,161 
  5,036,331 
 
    
    
Loss per common share - basic and diluted
 $(0.74)
 $(0.55)
The accompanying notes are an integral part of these consolidated financial statements.

 F-5

Stellar Biotechnologies, Inc.
Consolidated Statements of Cash Flows

  Years Ended 
  September 30,  September 30,  September 30, 
  2017  2016  2015 
          
Cash Flows Used In Operating Activities:            
Net loss $(5,030,648) $(5,026,080) $(2,843,029)
Adjustments to reconcile net loss to net cash used in operating activities:            
Depreciation and amortization  179,322   149,565   159,521 
Share-based compensation  115,546   259,379   267,222 
Foreign exchange (gain) loss  (162,028)  (76,800)  653,333 
(Gain) loss in fair value of warrant liability  -   211,956   (2,131,062)
             
Changes in working capital items:            
Accounts receivable  84,573   71,827   (113,917)
Inventory  181,316   307,850   (522,389)
Prepaid expenses  235,001   (197,150)  (45,758)
Deposits  -   560   - 
Accounts payable and accrued liabilities  (302,731)  (33,403)  77,018 
Deferred revenue      (173,333)  86,666 
             
Net cash used in operating activities  (4,699,649)  (4,505,629)  (4,412,395)
             
Cash Flows From Investing Activities:            
Acquisition of property, plant and equipment  (302,733)  (402,271)  (274,589)
Purchase of short-term investments  (5,005,607)  (11,995,450)  (13,677)
Proceeds on sales and maturities of short-term investments  7,000,000   13,021,827   410,736 
Contribution to joint venture  -   (66,695)  - 
             
Net cash provided by investing activities  1,691,660   557,411   122,470 
             
Cash Flows From Financing Activities:            
Proceeds from issuance of common shares, net  -   6,277,500   - 
Payments for share issuance costs  -   (332,764)  - 
Proceeds from exercise of warrants and options  -   1,368,260   106,777 
             
Net cash provided by financing activities  -   7,312,996   106,777 
             
Effect of exchange rate changes on cash and cash equivalents  162,036   96,623   (629,808)
             
Net change in cash and cash equivalents  (2,845,953)  3,461,401   (4,812,956)
Cash and cash equivalents - beginning of year  7,416,904   3,955,503   8,768,459 
Cash and cash equivalents - end of year $4,570,951  $7,416,904  $3,955,503 
             
Cash (demand deposits) $3,847,655  $972,412  $3,955,503 
Cash equivalents  723,296   6,444,492   - 
             
Cash and cash equivalents $4,570,951  $7,416,904  $3,955,503 
             
Supplemental cash flow information:            
             
Cash paid during the year for taxes $800  $7,200  $36,800 
             
Supplemental disclosure of non-cash transactions:            
             
Share issuance costs withheld from escrow proceeds $-  $472,500  $- 



Edesa Biotech, Inc.
Consolidated Statements of Cash Flows


 
Year Ended
 
 
Nine-month Period Ended
 
 
 
September 30,
2020
 
 
September 30,
2019
 
 
 
 
 
 
 
 
Cash Flows From Operating Activities:
 
 
 
 
 
 
Net loss
 $(6,364,230)
 $(2,776,734)
Adjustments for:
    
    
Depreciation and amortization
  57,563 
  4,779 
Share-based compensation
  598,359 
  35,074 
Change in working capital items:
    
    
Accounts and other receivable
  127,131 
  9,737 
Prepaid expenses and other current assets
  (404,066)
  (311,466)
Inventory
  - 
  77,913 
Accounts payable and accrued liabilities
  998,903 
  (1,885,090)
 
    
    
Net cash used in operating activities
  (4,986,340)
  (4,845,787)
 
    
    
Cash Flows From Investing Activities:
    
    
Cash acquired from reverse acquisition
  - 
  6,389,322 
Proceeds on sales of property and equipment
  53,412 
  36,741 
Purchase of property and equipment
  (4,856)
  (8,095)
Purchase of intangible assets
  (29,483)
  - 
Purchase of short-term investments
  (500,000)
  - 
Proceeds from maturities of short-term investments
  500,000 
  - 
 
    
    
Net cash provided by investing activities
  19,073 
  6,417,968 
 
    
    
Cash Flows From Financing Activities:
    
    
Proceeds from issuance of common shares
  4,360,500 
  - 
Proceeds from exercise of warrants
  3,223,804 
  - 
Proceeds from exercise of share options
  11,571 
  - 
Payments for issuance costs of common shares
  (475,720)
  - 
Payments for issuance costs of convertible preferred shares
  (57,154)
  - 
Proceeds from borrowings
  29,748 
  - 
 
    
    
Net cash provided by financing activities
  7,092,749 
  - 
 
    
    
Effect of exchange rate changes on cash and cash equivalents
  57,630 
  91,304 
 
    
    
Net change in cash and cash equivalents
  2,183,112 
  1,663,485 
Cash and cash equivalents, beginning of period
  5,030,583 
  3,367,098 
 
    
    
Cash and cash equivalents, end of period
 $7,213,695 
 $5,030,583 
 
    
    
 
    
    
Supplemental Disclosure of Non-cash Investing and Financing Activities:
    
    
Issuance of convertible preferred shares to acquire intangible asset
  2,500,000 
  - 
Fair value of placement agent warrants
  18,051 
  - 
Non-cash assets acquired and liabilities assumed in reverse acquisition - See Note 13
  - 
  (1,693,921)
Preferred shares exchanged for common shares in reverse acquisition
  - 
  6,260,299 
The accompanying notes are an integral part of these consolidated financial statements.

 F-6

Stellar Biotechnologies, Inc.
Consolidated Statements of Changes in Equity

        Accumulated     Total 
     Common  Share-Based  Accumulated  Shareholders' 
  Shares  Shares  Compensation  Deficit  Equity 
Balance - September 30, 2014  7,941,985  $37,883,877  $5,073,144  $(32,492,286) $10,464,735 
                     
Proceeds from exercise of warrants  4,020   12,609   -   -   12,609 
Transfer to common shares on exercise of warrants  -   10,000   (426)  -   9,574 
Proceeds from exercise of options  38,753   94,168   -   -   94,168 
Transfer to common shares on exercise of options  -   113,561   (113,561)  -   - 
Share-based compensation  -   -   267,222   -   267,222 
Net loss  -   -   -   (2,843,029)  (2,843,029)
                     
Balance - September 30, 2015  7,984,758  $38,114,215  $5,226,379  $(35,335,315) $8,005,279 
                     
Issuance of common shares  1,687,500   6,750,000   -   -   6,750,000 
Share issuance costs  -   (805,264)  -   -   (805,264)
Proceeds from exercise of warrants  464,000   1,368,260   -   -   1,368,260 
Transfer to common shares on exercise of warrants  -   1,853,581   (90,995)  -   1,762,586 
Share-based compensation  -   -   259,379   -   259,379 
Net loss  -   -   -   (5,026,080)  (5,026,080)
                     
Balance - September 30, 2016  10,136,258  $47,280,792  $5,394,763  $(40,361,395) $12,314,160 
                     
Issuance of performance shares  383,838   1,070,909   (1,070,909)  -   - 
Share-based compensation  -   -   115,546   -   115,546 
Net loss  -   -   -   (5,030,648)  (5,030,648)
                     
Balance - September 30, 2017  10,520,096  $48,351,701  $4,439,400  $(45,392,043) $7,399,058 


Edesa Biotech, Inc.
Consolidated Statements of Changes in Shareholders' Equity
 
 
Shares #
 
 
Common Shares
 
 
Class A Preferred Shares
 
 
Additional Paid-in Capital
 
 
 Accumulated Other Comprehensive Loss
 
 
Accumulated Deficit
 
 
Total Shareholders' Equity
 
Balance - December 31, 2018
  3,239,902 
 $1,111,253 
 $6,064,013 
 $230,792 
 $(429,973)
 $(3,761,595)
 $3,214,490 
 
    
    
    
    
    
    
    
Preferred return on Class A preferred shares
  - 
  - 
  196,286 
  - 
  - 
  (196,286)
  - 
Effect of reverse acquisition
  4,264,566 
  10,893,798 
  (6,260,299)
  61,902 
  - 
  - 
  4,695,401 
Share-based compensation
  - 
  - 
  - 
  35,074 
  - 
  - 
  35,074 
Net loss and comprehensive loss
  - 
  -��
  - 
  - 
  87,899 
  (2,776,734)
  (2,688,835)
 
    
    
    
    
    
    
    
Balance - September 30, 2019
  7,504,468 
 $12,005,051 
 $- 
 $327,768 
 $(342,074)
 $(6,734,615)
 $5,256,130 
 
    
    
    
    
    
    
    
Issuance of common shares in equity offering
  1,354,691 
  3,070,358 
  - 
  1,290,142 
  - 
  - 
  4,360,500 
Issuance costs
  - 
  (349,756)
  - 
  (125,964)
  - 
  - 
  (475,720)
Issuance of common shares upon exercise of warrants
  751,510 
  3,754,265 
  - 
  (530,461)
  - 
  - 
  3,223,804 
Issuance of common shares upon exercise of share options
  4,450 
  20,935 
  - 
  (9,364)
  - 
  - 
  11,571 
Preferred return on convertible preferred shares
  - 
  - 
  - 
  - 
  - 
  (34,109)
  (34,109)
Share-based compensation
  - 
  - 
  - 
  598,359 
  - 
  - 
  598,359 
Net loss and comprehensive loss
  - 
  - 
  - 
  - 
  54,870 
  (6,364,230)
  (6,309,360)
 
    
    
    
    
    
    
    
Balance - September 30, 2020
  9,615,119 
 $18,500,853 
 $- 
 $1,550,480 
 $(287,204)
 $(13,132,954)
 $6,631,175 
The accompanying notes are an integral part of these consolidated financial statements.



 F-7

Stellar Biotechnologies,Edesa Biotech, Inc.
Notes
Notes to Consolidated Financial Statements
For the YearsYear Ended September 30, 2017, 20162020 and 2015Nine-month Period Ended September 30, 2019

1.Nature of Operations

Stellar Biotechnologies,

1.            Nature of operations
Edesa Biotech, Inc. (the Company)“Company” or “Edesa”) is a biopharmaceutical company focused on acquiring, developing and commercializing clinical stage drugs for inflammatory and immune-related diseases with clear unmet medical needs. The Company is organized under the laws of British Columbia, Canada.Canada and is headquartered in Markham, Ontario.
In June 2019, the Company changed its name from Stellar Biotechnologies, Inc. to Edesa Biotech, Inc. following a reverse acquisition with Edesa Biotech Research, Inc., formerly known as Edesa Biotech Inc., a company organized under the laws of the province of Ontario. At the closing of the transaction, which occurred on June 7, 2019, the Company acquired the entire issued share capital of Edesa Biotech Research, Inc., with Edesa Biotech Research, Inc., becoming a wholly-owned subsidiary of the Company. The other wholly-owned subsidiary of the Company is Edesa Biotech USA, Inc., a California, USA corporation founded in 1999 formerly known as Stellar Biotechnologies, Inc. prior to November 2020. Also, on June 7, 2019, in connection with and following the completion of the reverse acquisition, the Company effected a 1-for-6 reverse split of its common shares. Upon the completion of the reverse acquisition, Edesa Biotech Research, Inc. changed its fiscal year end from December 31 to September 30 to align with the Company’s business is the aquaculture, research and development, manufacture and commercialization of Keyhole Limpet Hemocyanin (KLH). The Company markets and distributes its KLH products to biotechnology and pharmaceutical companies, academic institutions, and clinical research organizations primarily in Europe, North American and Asia. fiscal year end.
The Company’s common shares have been listed for tradingtrade on The Nasdaq Capital Market in the United States under the symbol SBOT since November 5, 2015. From January 15, 2013 through November 4, 2015, the Company’s common shares were quoted in the United States on the U.S. OTCQB Marketplace Exchange under the symbol SBOTF. From April 19, 2010 to April 8, 2016 the Company’s common shares were listed in Canada on the TSX Venture Exchange as a Tier 2 issue under the trading symbol KLH.

In April 2010, the Company changed its name from CAG Capital, Inc. to Stellar Biotechnologies, Inc. and completed a reverse merger transaction with Stellar Biotechnologies, Inc., a California corporation, which was founded in September 1999, and remains the Company’s wholly-owned subsidiary and principal operating entity. In January 2017, the California subsidiary and the Company established a wholly-owned Mexican subsidiary under the name BioEstelar, S.A. de C.V. in Ensenada, Baja California to perform aquaculture research and development activities in Mexico. “EDSA”.

Liquidity
The Company’s executive offices are located at 332 E. Scott Street, Port Hueneme, California, 93041, USA, and its registered and records office is Royal Centre, 1055 West Georgia Street, Suite 1500, Vancouver, BC, V6E 4N7, Canada.

Functional Currency

The consolidated financial statements of the Company are presented in U.S. dollars, which is the Company’s functional currency, unless otherwise stated.

Management Plans

CompanyCompany's operations have historically been funded by the issuancethrough issuances of common shares, exerciseexercises of common share purchase warrants, grant revenues, contract services revenueconvertible preferred shares, convertible loans, government grants and product sales.tax incentives. For the fiscal years 2017, 2016,year ended September 30, 2020 and 2015,nine-month period ended September 30, 2019, the Company reported net losses of approximately $5.0 million, $5.0$6.36 million and $2.8$2.78 million, respectively. As

On January 8, 2020, the Company completed a registered direct offering resulting in net proceeds of approximately $3.89 million. On September 28, 2020, the Company entered into an Equity Distribution Agreement with RBC Capital Markets, LLC (“RBCCM”), as sales agent, pursuant to which the Company may offer and sell, from time to time, common shares through an at-the-market equity offering program for up to $9.2 million in gross cash proceeds. The total amount of cash that may be generated under this distribution agreement is uncertain and depends on a variety of factors, including market conditions and the trading price of the Company’s common shares. No shares were sold under the distribution agreement prior to September 30, 2017,2020.
At September 30, 2020, the Company had cash and cash equivalents of $7.21 million, working capital of $6.57 million, shareholders’ equity and temporary equity of $9.11 million and an accumulated deficit of approximately $45.4 million$13.13 million. From October 1, 2020 to December 2, 2020, the exercise of Class A and working capitalClass B warrants resulted in the issuance of 243,369 common shares and cash proceeds of approximately $6.4$1.0 million. WhileFrom October 1, 2020 to December 2, 2020, the Company sold 169,753 common shares under the Company’s equity distribution agreement for net proceeds of approximately $0.99 million. The Company plans to finance company operations for at least the next twelve months with cash and cash equivalents on handhand.
Impact of COVID-19
The ongoing COVID-19 pandemic has severely impacted global economic activity and product sales, management expectshas caused material disruptions to continue incurring losses for the foreseeable future and will need to raise additional capital to pursue our business plan beyond December 2018. Management is taking action to ensure the Company will continue as a going concern for at least one year beyond the datealmost every industry directly or indirectly. The full impact of the issuancepandemic remains uncertain and ongoing developments related to the pandemic may cause material impacts to the Company’s future operations, clinical study timelines and financial results. While the full impact of the COVID-19 pandemic to business and operating results presents additional uncertainty, the Company’s management continues to use reasonably available information to assess impacts to the Company’s business plans and financial statements. First, management has flexibility to adjust planned expenditures based on a numbercondition.
2.            Basis of factors including the size and timing of capital expenditures, staffing levels, inventory levels, and the status of customer clinical trials. Management also seeks to expand the customer base for existing marketed products, and is currently evaluating opportunities to secure additional financing through debt and/or equity financings, including transactions with strategic customers and partners that may include debt and/or equity arrangements.

2.Basis of Presentation

preparation

The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP) and include the accounts of the Company and its wholly-owned subsidiaries, Stellar Biotechnologies,Edesa Biotech Research, Inc., an Ontario corporation, and Edesa Biotech USA, Inc., a California corporation in the U.S. and BioEstelar, S.A. de C.V. a Baja California corporation in Mexico. All significant intercompany balances and transactions have been eliminated inupon consolidation.

The accompanying consolidated financial statements include the year ended September 30, 2020 and nine-month period ended September 30, 2019.


 F-8

Stellar Biotechnologies,Edesa Biotech, Inc.
Notes to Consolidated Financial Statements
For the YearsYear Ended September 30, 2017, 20162020 and 2015Nine-month Period Ended September 30, 2019

3.Significant Accounting Policies

a)Use of Estimates

3.Significant accounting policies
Use of estimates
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make certain estimates judgments and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the datesdate of the consolidated financial statements and the reported amounts of revenuesrevenue and expenses during the reported periods. Theseperiod or year. Actual results could differ from those estimates. Areas where significant judgment is involved in making estimates include warrant liabilities, share-based compensation, intangible assets,are valuation of accounts receivable,and other receivable; valuation and useful lives of inventory,property and equipment; intangible assets; operating lease right-of-use assets; deferred income taxes. Actual outcomes could differtaxes; classification of convertible preferred shares as liability or equity; the determination of fair value of share-based compensation; the determination of fair value of shares and replacement warrants for reverse acquisition; the determination of fair value of Class A Warrants, Class B Warrants and placement agent warrants in order to allocate proceeds from these estimates. Theseequity issuances; and forecasting future cash flows for assessing the going concern assumption.

Functional and reporting currencies
The consolidated financial statements include estimates,of the Company are presented in U.S. dollars, unless otherwise stated, which is the Company’s and its wholly- owned subsidiary’s, Edesa Biotech USA, Inc., functional currency. The functional currency of the Company’s wholly-owned subsidiary, Edesa Biotech Research, Inc., as determined by their nature are uncertain. The impacts of such estimates are pervasive throughout the consolidated financial statements,management, is Canadian dollars.
Cash and may require accounting adjustments based on future periods if the revision affects both current and future periods. These estimates are based on historical experience, current and future economic conditions and other factors, including expectations of future events that are believed to be reasonable under the circumstances.

b)Cash and Cash Equivalents

cash equivalents

Cash and cash equivalents consist of demand deposits with financial institutions and highly liquid investments which are readily convertible into cash with maturities of three months or less when purchased.

c)Investments

The carrying amount of cash and cash equivalents approximates its fair value due to its short-term nature.

Investments
Investments at September 30, 2017 and 2016during the year consisted of U.S. Treasury bills with original maturities between 13 and 52 weeks. They are classified as held-to-maturity and are reported at amortized cost, which approximates fair value. The Company regularly reviews these investments to determine whether any decline in fair value below the amortized cost basis has occurred that is other than temporary. If a decline in fair value has occurred that is determined to be other than temporary, the cost basis of the investment is written down to fair value.

d)Allowance for Doubtful Accounts Receivable

There were no investments outstanding at September 30, 2020 and 2019.

Accounts and other receivable
The Company assesses the collectability of its accounts receivable through a review of its current aging, as well as an analysis of its historical collection rate, general economic conditions and credit status of its customers.  Accounts and other receivable include Harmonized Sales Tax (HST) refunds receivable. As of September 30, 2017 and 2016,2020, all outstanding accounts and HST refunds receivable were deemed to be fully collectible, and therefore, no allowance for doubtful accounts was recorded.

e)Inventory

The Company records inventory at the lower of cost or market, with market not in excess of net realizable value. Raw materials are measured using FIFO (first-in first-out) cost. Work in process

Property and finished goods are measured using average cost.

f)equipment
Property Plant and Equipment

Property, plant and equipment are recorded at historical cost less accumulated depreciation and any accumulated impairment losses, if any.losses. Depreciation is recorded to write off the cost of assets less their residual values over their useful lives, using the declining balance and straight-line methods. Assets not in use and on consignment for sale are carried at the expected net proceeds value. Maintenance and repair expenditures that do not improve or extend the life are expensed in the period incurred. Any gain or loss arising on the straight-line method overdisposal or retirement of an item of property and equipment is recognized as the difference between the sales proceeds and the carrying amount of the asset. The estimated useful lives, ranging from 1.5residual values and depreciation methods are reviewed at the end of each year, with the effect of any changes in estimate accounted for on a prospective basis.

The depreciation policy for the principal asset categories are calculated as follows:

Computer equipment
30% declining balance methodor straight line 3 years
Furniture and equipment
20% declining balance method



Edesa Biotech, Inc.
Notes to Consolidated Financial Statements
For the Year Ended September 30, 2020 and Nine-month Period Ended September 30, 2019

Intangible assets
Intangible assets represent the exclusive world-wide rights to 15 years. Leasehold improvements are depreciated over know-how, patents and data relating to certain monoclonal antibodies (“the shorterConstructs”), including sublicensing rights, acquired by entering into a license agreement with a pharmaceutical development company. Unless earlier terminated, the term of the license agreement will remain in effect for 25 years from the date of first commercial sale of licensed products containing the Constructs. Subsequently, the license agreement will automatically renew for five-year periods unless either party terminates the agreement in accordance with its terms. Intangible assets are stated at their historical cost, amortized on a straight-line basis over their expected useful lifelives, which is 25 years, and subject to impairment review at the end of each reporting period.
Impairment of long-lived assets
Long-lived assets are tested for impairment when indicators of impairment exist. When a significant change in the expected timing or amount of the future cash flows of the financial asset is identified, the carrying amount of the financial asset is reduced and the amount of the write-down is recognized as a loss. A previously recognized impairment loss may be reversed to the extent of the improvement, or remaining term of lease. Maintenance and repairs are charged to operations as incurred.

g)Impairment of Long-Lived Assets

If indicators of impairment exist,provided it is not greater than the Company assessesamount that would have been reported at the recoverabilitydate of the affected long-lived assets by determining whetherreversal had the carrying value of such assets can be recovered through undiscounted future operating cash flows. If impairment is indicated,not been recognized previously, and the amount of such impairmentthe reversal is measured by comparing the carryingrecognized in net income (loss).

Fair value of the asset to the fair value of the asset and the Company records the impairment as a reduction in the carrying value of the related asset and a charge to operating results. Estimating the undiscounted future cash flows associated with long-lived assets requires judgment, and assumptions could differ materially from actual results.

h)Fair Value of Financial Instruments

measurement

The Company uses the fair value measurement framework for valuing financial assets and liabilities measured on a recurring basis in situations where other accounting pronouncements either permit or require fair value measurements.liabilities. See Note 10 for fair value measurements.

 F-9
11.

Stellar Biotechnologies, Inc.
Notes to Consolidated Financial Statements
For the Years Ended September 30, 2017, 2016 and 2015

i)Revenue Recognition

Product Sales

Revenue Recognition
The Company recognizes product salesrevenue when KLH product is shipped (for which the risk is typically transferred upon deliverycustomer obtains control of promised goods or services, in an amount that reflects the consideration the Company expects to the shipping carrier) and there is persuasive evidence of an arrangement, the fee is fixedreceive in exchange for those goods or determinable, and collectability is reasonably assured. The Company documents arrangements with customers with purchase orders and sales agreements. 

Product sales include sales made under supply agreements with customers for a fixed price per gram of KLH products based on quantities ordered. Supply agreements are typically on a non-exclusive basis except within that customer’s field of use.

Contract services revenue

services. The Company recognizes contract services revenue when contract services have been performed and reasonable assurance exists regarding measurement and collectability. An appropriate amount will be recognized as revenuefollowing the five-step model prescribed under ASC Topic 606: (1) identify contract(s) with a customer; (2) identify the performance obligations in the period thatcontract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenues when (or as) the Company is assuredsatisfies the performance obligation(s). Revenues consist of fulfillingsales of product inventory obtained in the contract requirements. Amounts receivedreverse acquisition completed in advanceJune 2019, which are recognized upon shipment when the customer obtains control of the product and the Company has no further performance of contract services are recorded as deferred revenue.

Contract services include services performed under collaboration agreementsobligations.

Research and technology transfer and purchase agreement.

j)Research and Development

development

Research and development expenses principally consist of personnel costs related to (i) contract research organizations for clinical trial management services, (ii) contract manufacturing organizations for manufacturing the Company’sdrug compound(s) for use in clinical trials and (iii) salaries of employees directly involved in research and development staff as well as depreciation of research and development assets. Research and development expenses also include costs incurred for laboratory supplies,KLH designated for internal research use only,efforts. reimbursable costs associated with collaborative agreements, third-party contract payments, consultants, facility and related overhead costs.Research and development costs are expensed as incurred.

k)Share-Based Compensation

Share-based compensation
The Company measures the cost of equity-settled transactions by reference to the fair value of the equity instruments at the date at which they are granted since the fair value of the goods or services received by the Company cannot be reliably estimated.
The Company grants options to buy common shares of the Company to its directors, officers, employees and consultants, and grants other equity-based instruments such as warrants to non-employees.

The fair value of share-based compensation is measured on the date of grant, using the Black-Scholes option valuation model and is recognized over the vesting period net of estimated forfeitures for employees or the service period for non-employees. The provisions of the Company's share-based compensation plans do not require the Company to settle any options by transferring cash or other assets, and therefore the Company classifies the awards as equity. The Black-Scholes option valuation model requires the input of subjective assumptions, including price volatility of the underlying stock, risk-free interest rate, dividend yield, and expected life of the option.

l)Foreign Exchange

Items included in

Translation of foreign currency transactions
The Company's reporting currency is the U.S. dollar. The financial statements of the wholly-owned Canadian subsidiary is measured using the Canadian dollar as the functional currency. Assets and liabilities of the Canadian operation have been translated at year-end exchange rates and related revenue and expenses have been translated at average exchange rates for the year. Accumulated gains and losses resulting from the translation of the financial statements of the Company’s subsidiariesCanadian operation are measured using the currencyincluded as part of the primary economic environment in which the entity operates (the functional currency). The functional currencyaccumulated other comprehensive loss, a separate component of the parent and its subsidiaries is the U.S. dollar.

Transactionsshareholders' equity.

For other transactions denominated in currencies other than the U.S. dollarCompany’s functional currency, the monetary assets and liabilities are recordedtranslated at the year-end rates. Revenue and expenses are translated at rates of exchange rates prevailing on the datestransaction dates. Non-monetary balance sheet and related income statement accounts are remeasured into U.S. dollar using historical exchange rates. All of the transactions.

m)Income Taxes

Income tax expense comprises current and deferred tax. Income tax isexchange gains or losses resulting from these other transactions are recognized in income or loss except to the extent that it relates to items recognized directly in equity. Current tax expense is the expected tax payable on taxable income for the year, using tax rates enacted or substantively enacted at year-end, adjusted for amendments to tax payable with regards to previous years.

Deferred tax is recorded using the liability method, providing for temporary differences between the carrying amountsstatements of assetsoperations and liabilities for financial reporting purposes and the amounts used for taxation purposes. Temporary differences are not provided for relating to goodwill not deductible for tax purposes. The amount of deferred tax provided is based on the expected manner of realization or settlement of the carrying amount of assets and liabilities, using tax rates enacted or substantively enacted at the balance sheet date.

comprehensive loss.


 F-10

Stellar Biotechnologies,Edesa Biotech, Inc.
Notes to Consolidated Financial Statements
For the YearsYear Ended September 30, 2017, 20162020 and 2015Nine-month Period Ended September 30, 2019

Income taxes
Deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the tax bases of assets and liabilities and their financial statement reported amounts using enacted tax rates and laws in effect in the year in which the differences are expected to reverse. A valuation allowance is provided against deferred tax assets when it is determined to be more likely than not that the deferred tax asset iswill not be realized.
The Company assesses the likelihood of the financial statement effect of a tax position that should be recognized only to the extent thatwhen it is more likely than not that future taxable profits will be available against which the asset can be utilized. To the extent that the Company does not consider it more likely than not that a deferred tax asset will be recovered, it provides a valuation allowance against that excess.

The Company periodically evaluates its tax positions to determine whether it is more likely than not that a tax position will be sustained upon examination by a taxing authority based on the appropriate taxing authorities. The Company has not incurred any interest or penaltiestechnical merits of the tax position, circumstances, and information available as of September 30, 2017 with respect to uncertain income tax matters. The Company does not expect that there will be unrecognized tax benefits of a significant nature that will increase or decrease within 12 months of the reporting date.

The Company is subject to examination by taxing authorities in Canada and the U.S. Management does not believe that there are any uncertain tax positions that would result in an asset or liability for taxes being recognized in the accompanying financial statements. The Company recognizes tax-related interest and penalties, if any, as a component of income tax expense.

The Company accounts for income taxes on a tax jurisdictional basis. The Company files income tax returns in Canada, the provinces of British Columbia and Ontario, the U.S. federal and the state jurisdictions and in Canada. Mexico tax returns are on a calendar year basis. Management believes that there are no material uncertain tax positions that would impact the accompanying consolidated financial statements. The Company's policy is to recognize interest and penalties related to unrecognized tax benefits in income tax expense. The Company may be subject to examination by the Internal Revenue Service for tax years 2013 through 2016 and by the Canada Revenue Agency for tax years 2013 through 2017. The Company may also be subject to examination on certain state, local and other foreign jurisdictions for the tax years 2012 through 2017.

n)Earnings (Loss) Per Share

of California.

Earnings (loss) per share
Basic earnings (loss) per share is calculated by dividing net income (loss) available to common shareholders by the weighted average number of common shares outstanding during the period.

The computation of diluted earnings (loss) per share assumes the conversion, exercise or contingent issuance of securities only when such conversion, exercise or issuance would have a dilutive effect on earnings (loss) per share. The dilutive effect of convertible securities iswould be reflected in diluted earnings per share by application of the “if converted” method. The dilutive effect of outstanding options and warrants and their equivalents iswould be reflected in diluted earnings per share by application of the treasury stock method. ConversionHowever, conversion of outstanding warrants, broker unitsconvertible preferred shares, options and optionswarrants would have an antidilutive effect on loss per share for the yearsyear ended September 30, 2017, 20162020 and 2015nine-month period ended September 30, 2019 and are therefore excluded from the computation of diluted loss per share.

o)Segments

See Notes 8 and 9 for outstanding convertible preferred shares, options and warrants at September 30, 2020 and 2019.

Segmented Information
The Company operates in oneCompany's operations comprise a single reportable segment engaged in the research and accordingly, nodevelopment, manufacturing and commercialization of innovative pharmaceutical products. As the operations comprise a single reportable segment, disclosures have been presented. All equipment, leasehold improvementsamounts disclosed in the consolidated financial statements for net loss, comprehensive loss, depreciation and other fixedtotal assets owned byalso represent segmented amounts.
Adoption of Recent Accounting Pronouncements
On October 1, 2019, the Company are physically located within the United States (except for insignificant leasehold improvements under evaluation in Baja California, Mexico), and all supply, collaboration and licensing agreements are denominated in U.S. dollars.

p)Recent Accounting Pronouncements

In May 2014, the Financial Accounting Standards Board (FASB) issued guidance codified inadopted Accounting Standards Codification (ASC) 606Revenue Recognition – Revenue from Contracts with Customerswhich amendsTopic 842 Leases using the guidance in ASC 605,Revenue Recognition and adds a new Subtopic to the Codification, ASC 340-40,Other Assets and Deferred Costs: Contracts with Customers.The standard’s core principle is that a company will recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. To achieve that core principle, an entity should apply the following steps: Step 1: Identify the contract(s) with a customer; Step 2: Identify the performance obligations in the contract;Step 3: Determine the transaction price; Step 4: Allocate the transaction price to the performance obligations in the contract; and Step 5: Recognize revenue when (or as) the entity satisfies a performanceobligation. ASC 606 permits two methods of adoption: retrospectively to each prior reporting period presented (fullmodified retrospective method), or retrospectively with the cumulative effect of initiallytransition method, applying the guidance recognizednew standard to all leases existing at the date of initial application (the modified retrospective method).application. In August 2015,addition, the FASB issued an accounting updateCompany elected the package of practical expedients in transition, which permitted the Company not to deferreassess prior conclusions about lease identification, lease classification and initial direct costs on leases that commenced prior to adoption of the effective date bynew standard. The Company also elected the ongoing practical expedient not to recognize operating lease right-of-use assets and operating lease liabilities for short-term leases. As a result of adopting the new standard, the Company recognized operating lease right-of-use (“ROU”) assets of approximately $234,000 and operating lease liabilities of approximately $234,000 on the balance sheet for one year for public entities suchoperating lease with a term longer than 12 months at adoption. There was no impact to opening accumulated deficit. The Company had three short-term operating leases upon adoption that it is now effective for public entities for annual reporting periods beginning after December 15, 2017, including interim periodswithin those years, with early application permitted by one year. Subsequently,did not follow the FASB issued supplemental adoption guidanceROU model. The ROU assets are initially measured at cost and clarification to ASC 606 related to principal vs. agent considerations, identifying performance obligations and licensing, technical corrections and improvements, which must be adoptedamortized using the straight-line method through the end of the lease term. The lease liabilities are measured at the same time as ASC 606. These standardspresent value of the lease payments that are effective fornot paid at the Company during the fiscal year ending September 30, 2019. Management is in the process of assessing the impact this guidance will have oncommencement date, discounted using the Company’s consolidated financial statements.We anticipate adoption of ASC 606 using the modified retrospective method with a cumulative catch-up adjustment to the opening balance sheet of retained earnings at the effective date, during the first quarter of fiscal 2019. The Company will continue to review separate performance obligations, potential disclosures, and the method of adoption in order to complete the evaluation of the impact on the consolidated financial statements.

incremental borrowing rate.


 F-11

Stellar Biotechnologies,Edesa Biotech, Inc.
Notes to Consolidated Financial Statements
For the YearsYear Ended September 30, 2017, 20162020 and 2015Nine-month Period Ended September 30, 2019

In July 2015, FASB issued ASU 2015-11,Inventory (Topic 330): Simplifying the Measurement of Inventory. ASU 2015-11 indicates that an entity should measure inventory at the lower of cost and net realizable value. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. The ASU does not apply to inventory measured using LIFO or the retail inventory method. It does apply to all other inventory, including inventory measured using FIFO or average cost. The guidance in ASU 2015-11 is effective for public entities for annual reporting periods beginning after December 15, 2016, including interim periodswithin those years. The provisions should be applied prospectively with early application permitted as of the beginning of an interim or annual reporting period. These standards are effective for the Company during the fiscal year ending September 30, 2018. Management believes ASU 2015-11 will not have a significant impact on the Company’s consolidated financial statements. 

In January 2016, the FASB issued ASU 2016-01,Financial Instruments-Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities, whichprimarily affects the

Future accounting for equity investments, financial liabilities under the fair value option, and the presentation and disclosure requirements for financial instruments. In addition,ASU 2016-01clarified guidance related to the valuation allowance assessment when recognizing deferred tax assets resulting from unrealized losses on available-for-sale debt securities.The guidance is effective for public entities for fiscal years beginning after December 15, 2017, including interim periods within those years, with early adoption permitted. These standards are effective for the Company during the fiscal year ending September 30, 2019.Management is in the process of assessing the impact of ASU 2016-01 on the Company’s consolidated financial statements.

In February 2016, the FASB issued ASU 2016-02,Leases (Topic 842), which establishes a new lease accounting model for lessees. The updated guidance requires an entity to recognize assets and liabilities on the balance sheet arising from a lease for both financing and operating leases, along with additional qualitative and quantitative disclosures. The amended guidance is effective for public entities for fiscal years beginning after December 15, 2018, including interim periods within those years, with early adoption permitted. These standards are effective for the Company during the fiscal year ending September 30, 2020.Management is in the process of assessing the impact of ASU 2016-02 on the Company’s consolidated financial statements.We anticipate adoption ofASU 2016-02,will result in lease liabilities and right-of-use assets onthe Company’s consolidatedfinancial statements for several long-term operating leases.

In March 2016, the FASB issued ASU 2016-09,Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting, which is part of the FASB’s Simplification Initiative. The updated guidance simplifies the accounting for share-based payment transactions,including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. The amended guidance is effective for public entities for fiscal years beginning after December 15, 2016, including interim periods within those years, with early adoption permitted.These standards are effective for the Company during the fiscal year ending September 30, 2018. Management believesASU 2016-09will not have a significant impactonthe Company’s consolidatedfinancial statements.

pronouncements

In June 2016, the FASB issued ASU 2016-13,Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which includes provisions that require financial assets measured at amortized cost basis to be presented at the net amount expected to be collected and credit losses relating to available-for-sale debt securities to be recorded through an allowance for credit losses, which requires recognition of an estimate of all current expected credit losses. The guidance is effective for public entities for fiscal years beginning after December 15, 2019, including interim periods within those years, with early adoption permitted for fiscal years beginning after December 15, 2018. These standards are effective for the Company during the fiscal year ending September 30, 2021.Management is in the process of assessing the impact ofexpects that ASU 2016-13, as updated, will not have a significant impact on the Company’s consolidated financial statements.statements.

In May 2017,

4.            Property and equipment
Property and equipment, net consisted of the FASB issued ASU 2017-09, Scope of Modification Accounting, which provides new guidancefollowing:  

 
 
 September 30,
2020
 
 
 September 30,
2019
 
 
 
 
 
 
 
 
Computer equipment
 $34,651 
 $42,910 
Furniture and equipment
  5,694 
  7,932 
 
    
    
 
  40,345 
  50,842 
Less: accumulated depreciation
  (25,530)
  (29,194)
 
    
    
Depreciable assets, net
 $14,815 
 $21,648 
 
    
    
Assets not in service
  - 
  51,410 
 
    
    
Total property and equipment, net
 $14,815 
 $73,058 
Assets not in service at September 30, 2019 represented equipment acquired in the reverse acquisition and held for sale on changesconsignment by a third party. All assets not in service were disposed by September 30, 2020.
Depreciation expense amounted to the terms or conditions of share-based payment awards that would be required to apply modification accounting under ASC 718,Compensation-Stock Compensation. The amendments are effective for annual reporting periods beginning after December 15, 2017 with early adoption permitted. These standards are effective$9,602 and $4,779 for the Company during the fiscal year endingended September 30, 2019.  Management is in the process of assessing the impact of ASU 2017-09 on the Company's consolidated financial statements. 

2020 and nine-month period ended September 30, 2019, respectively.


 F-12

Stellar Biotechnologies,Edesa Biotech, Inc.
Notes to Consolidated Financial Statements
For the YearsYear Ended September 30, 2017, 20162020 and 2015Nine-month Period Ended September 30, 2019

4.Investments

Short-term investments consisted

5.            Intangible assets
Acquired License
In April 2020, the Company entered into a license agreement with a pharmaceutical development company to obtain exclusive world-wide rights to know-how, patents and data relating to certain monoclonal antibodies ("the Constructs"), including sublicensing rights. Unless earlier terminated, the term of the following:

  September 30,  September 30, 
  2017  2016 
         
U.S. Treasury Bills $1,994,401  $3,988,794 

U.S. Treasury Bills are carriedlicense agreement will remain in effect for 25 years from the date of first commercial sale of licensed products containing the Constructs. Subsequently, the license agreement will automatically renew for five-year periods unless either party terminates the agreement in accordance with its terms.

Under the license agreement, the Company is exclusively responsible, at amortized cost which approximates fairits expense, for the research, development manufacture, marketing, distribution and commercialization of the Constructs and licensed products and to obtain all necessary licenses and rights. The Company is required to use commercially reasonable efforts to develop and commercialize the Constructs in accordance with the terms of a development plan established by the parties.
The Company has determined that the license has multiple alternative future uses in research and development projects and sublicensing in other countries or for other disease indications. The value of the acquired license is recorded as an intangible asset with amortization over the estimated useful life of 25 years and classified as held-to-maturity investments.

5.Inventory

Raw materials include inventory of manufacturing supplies. Work in process includes manufacturing supplies, direct and indirect labor, contracted manufacturing and testing, and allocated manufacturing overheadevaluation for inventory in processimpairment at the end of the year. Finished goods include products that are complete and available for sale. At September 30, 2017 and 2016, the Company recorded work in process and finished goods inventory only for those products with recent sales levels to evaluate net realizable value.

Inventory consistedeach reporting period.

The required upfront license payment of $2.5 million was paid by issuance of Series A-1 Convertible Preferred Shares. The value of the following:

  September 30,  September 30, 
  2017  2016 
       
Raw materials $21,761  $38,764 
Work in process  -   43,498 
Finished goods  46,353   167,168 
         
  $68,114  $249,430 

6.Property, Plant and Equipment, net

Property, plantlicense includes acquisition legal costs. See Note 7 for license commitments and equipment,Note 8 for temporary equity.

Intangible assets, net consisted of the following:

  September 30,  September 30, 
  2017  2016 
       
Aquaculture system $126,257  $126,257 
Laboratory facilities  62,033   62,033 
Computer and office equipment  117,840   102,030 
Tools and equipment  982,439   894,319 
Vehicles  77,994   49,347 
Leasehold improvements  337,060   282,305 
   1,703,623   1,516,291 
Less: accumulated depreciation  (969,418)  (793,057)
         
Depreciable assets, net  734,205   723,234 
Construction in progress  145,318   32,880 
         
  $879,523  $756,114 

Depreciation

 September 30, 2020
 September 30, 2019
The Constructs
$2,529,483
$
Less: accumulated amortization
(45,947)
Total intangible assets, net
$2,483,536
$
Amortization expense amounted to $179,322, $149,565 and $159,521$45,947 for the yearsyear ended September 30, 2017, 20162020. There was no amortization expense for nine-month period ended September 30, 2019.
Total estimated future amortization of intangible assets for each fiscal year is as follows:
Year Ending
September 30, 2021
$101,172
September 30, 2022
101,172
September 30, 2023
101,172
September 30, 2024
101,172
September 30, 2025
101,172
Thereafter
1,977,676
$2,483,536
6.            Leases
Related party operating lease
The Company leases facilities used for executive offices from a related company for a six-year term through December 2022, with options to renew for another two-year term. The option period is not included in the operating lease right-of-use assets and 2015, respectively.

liabilities.
The gross amounts of assets and liabilities related to operating leases were as follows:

  F-13Balance Sheet Caption
September 30,
2020
Assets: 
Operating lease assetsOperating lease right-of-use assets
$160,006
Liabilities:
Current:
Operating lease liabilitiesShort-term operating lease liabilities
$69,730
Long-term:
Operating lease liabilitiesLong-term operating lease liabilities
94,460
Total lease liabilities
$164,190



Stellar Biotechnologies,Edesa Biotech, Inc.
Notes to Consolidated Financial Statements
For the YearsYear Ended September 30, 2017, 20162020 and 2015Nine-month Period Ended September 30, 2019


The components of lease cost were as follows:
7.Statements of Operations Caption
CommitmentsYear Ended
September 30,
2020
Operating lease costGeneral and administrative
$76,331

Operating leases


Lease terms and discount rates were as follows:

September 30,
2020
Remaining lease term (months):
27
Estimated incremental borrowing rate:
6.5%

The Company leases buildings and facilities used in its operations under two sublease agreements. In June 2015, the Company exercised its option to extend these sublease agreements for an additional five-year term beginning in October and November 2015. The Company negotiated an option to extend the leases for two additional five-year terms.

The Company leases facilities used for executive offices and laboratories. The Company must pay a portion of the common area maintenance. In July 2016, the Company extended this lease for a two-year term, with options to renew for three successive two-year terms.

The Company leases undeveloped land in Baja California, Mexico to assess the potential development of an additional aquaculture locale and expansion of production. The lease term is three years from June 2015 with options to extend the lease for 30 years. The Company may terminate early with 30 days’ notice. The rent has been prepaid, and is not included in theapproximate future minimum lease payments below. under operating leases at September 30, 2020 were as follows:


Year Ending
September 30, 2021
$78,362
September 30, 2022
78,884
September 30, 2023
19,721
Total lease payment
176,967
Less imputed interest
12,777
Present value of lease liabilities
164,190
Less current installments
69,730
Long-term lease liabilities excluding current installments
$94,460
Cash flow information was as follows:


Statements of Cash Flows Caption
Year Ended
September 30,
2020
Cash paid for amounts included in the measurement of lease liabilitiesAccounts payable and accrued liabilities
$76,333
Other operating leases
The Company also leased facilities through its California subsidiary under one operating lease that expired in June 2020 and two operating leases that expired in September 2020. The Company did not exercise options to extend these leases. Total rent under these leases included in general and administrative expenses was $201,421 and $68,508 for the year ended September 30, 2020 and nine-month period ended September 30, 2019, respectively. There was no rent under these leases prior to the completion of the reverse acquisition on June 7, 2019.
7.            Commitments
Research and other commitments
The Company has commitments for contracted research organizations who perform clinical trials for the Company’s ongoing clinical studies, other service providers and the drug substance acquired in connection with a related agreement with the lessor to collaborate on the design, expansion and development of marine aquaculture resources and KLH production facilities on the leased property. Under that agreement, the Company is responsible for certain leasehold improvements including construction of structures and a power-generating facility, which will be owned by the Company. The Company will reimburse the lessor for local operational support. The collaboration agreement expires in June 2018, unless terminated earlier.

license agreement. Aggregate future minimum leasecontractual payments at September 30, 20172020 are as follows:

For The Year Ending September 30,   
2018  160,000 
2019  106,000 
2020  106,000 
2021  6,000 
     
  $378,000 

Rent expense on these lease agreements amounted to approximately $238,000, $235,000 and $192,000 for the years ended September 30, 2017, 2016 and 2015, respectively.

Purchase obligations

The Company has commitments totaling approximately $252,000 at September 30, 2017, for signed agreements with contract research organizations, consultants and construction contractors. All purchase obligations are expected to be fulfilled within the next 12 months, except for approximately $65,100, which is expected to be fulfilled in the following fiscal year.

Supply agreements

The Company has commitments under supply agreements with customers for fixed prices per gram of KLH in connection with clinical trials on a non-exclusive basis except within that customer’s field of use. The expiration dates of these supply agreements range from October 2019 to February 2022, and are generally renewable upon written request of the customer.

Joint venture agreement

In May 2016, the Company entered into a joint venture agreement with another party for the formation of a joint venture company to manufacture and sell conjugated therapeutic vaccines. The joint venture is organized as a French simplified corporation.

Year Ending F-14
September 30, 2021
$4,838,000
September 30, 2022
2,572,000
September 30, 2023
27,000
September 30, 2024
24,000
$7,461,000




Stellar Biotechnologies,Edesa Biotech, Inc.
Notes to Consolidated Financial Statements
For the YearsYear Ended September 30, 2017, 20162020 and 2015Nine-month Period Ended September 30, 2019


License and royalty commitments
In April 2020, through its Ontario subsidiary, the Company entered into a license agreement with a third party to obtain exclusive world-wide rights to certain know-how, patents and data relating to certain monoclonal antibodies ("the Constructs"), including sublicensing rights. An intangible asset for the acquired license has been recognized. See Note 5 for intangible assets. Under the license agreement, the Company is committed to payments of up to an aggregate amount of $356 million contingent upon meeting certain milestones outlined in the license agreement, primarily relating to future potential commercial approval and sales milestones. The Company holdsalso has a 30% equity interestcommitment to pay royalties based on any net sales of products containing the Constructs in the joint venturecountries where the Company directly commercializes the products containing the Constructs and a percentage of any sublicensing revenue received by the Company and its affiliates in exchange for an initial capital contribution of €120,000. One-half of the initial contribution, approximately $67,000, was paidcountries where it does not directly commercialize the products containing the Constructs. No royalty or sublicensing payments were made to the third party during the year ended September 30, 2016 with the balance due upon the occurrence of certain defined future events. The Company will also provide the joint venture additional financing as may be required, on a pro rata basis in line with our equity interest. If the joint venture does not achieve certain milestones by December 31, 2017, the joint venture will be dissolved, unless (i) the parties mutually agree to pursue the joint venture arrangement, or (ii) either party decides to purchase the equity interests of the other party. These milestones have not been achieved, and the parties have discussed their mutual desire to extend the deadline. Each of the parties is entitled, upon the occurrence of certain defined events, to acquire the interest of the other party. Except as described herein, the joint venture has an initial ten-year term, renewable for successive five-year terms. If either party provides notice at least six months prior to the expiration date of an applicable term that it does not wish to continue its participation in the joint venture, the other party will have a right to acquire all of such terminating party’s equity interests in the joint venture.

2020. In connection with the formation of the joint venture and the execution of its strategy, the parties intend over time to enter into an exclusive supply agreement within a limited field of use for Stellar to supply KLH to the joint venture, a supply agreement designating the joint venture as the exclusive manufacturer and supplier of the other party’s vaccines, and services agreements for the provision of various knowledge and expertise by each of the parties.

Licensingthis license agreement and technology transferpursuant to a purchase agreement

In July 2013, entered into in April 2020, the Company acquired drug substance of one of the exclusive, worldwide licenseConstructs for an aggregate purchase price of $5.0 million, payable in two future installments, the first when the Company is ready to certain patented technology forinitiate a Phase 2 trial and the development of human immunotherapies againstClostridium difficile infection (C. diff) undersecond when the Company is ready to initiate a written agreement (the License Agreement) with a University (the Licensor). Annual license fees of $20,000 each werePhase 3 trial. The purchase commitment is included in the table above in 2021 and 2022. No amounts have been paid for the yearsdrug substance during the year ended September 30, 2020.

In 2016, and 2015. The Company also reimbursed patent filing, prosecution, and maintenance costs of approximately $12,000, $11,000 and $52,000 for the years ended September 30, 2017, 2016 and 2015, respectively. License fees and patent cost reimbursements have been accounted for as research and development expense in the accompanying consolidated statements of operations.

In March 2017, (i)through its Ontario subsidiary, the Company entered into ana license agreement with a third party to terminateobtain exclusive rights to certain know-how, patents and data relating to a pharmaceutical product. The Company will use the License Agreement, (ii)exclusive rights to develop the product for therapeutic, prophylactic and diagnostic uses in topical dermal applications and anorectal applications. No intangible assets have been recognized under the license agreement with the third party as of September 30, 2020 and 2019. Under the license agreement, the Company concurrently entered into a technology transfer and purchase agreement (the Transfer Agreement) with a vaccine biotechnology company (the Transferee), and (iii) the Licensor and Transferee entered into a direct licensing arrangement relatingis committed to payments of various amounts to the patented C. diff technology. Underthird party upon meeting certain milestones outlined in the Transfer Agreement,license agreement, up to an aggregate amount of $18.6 million. Upon divestiture of substantially all of the assets of the Company, transferredthe Company shall pay the third party a percentage of the valuation of the licensed technology sold as determined by an external objective expert. The Company also has a commitment to pay the Transferee its proprietary rights and know-howthird party a royalty based on net sales of immunogens and vaccine technology for C. diff,the product in exchange forcountries where the Company, or an upfront paymentaffiliate, directly commercializes the product and a percentage of future fees, milestone payments, sublicensing income and royalties, if any, paid by the Transferee or its assigns to the Licensor.

As a result of the termination of the License Agreement, there are no early termination penalties and no further annual licensing fees, contingent milestone payments, royalties, sub-licensing fees or other financial obligations payablerevenue received by the Company and its affiliates in the countries where it does not directly commercialize the product. No license or royalty payments were made to the Licensor.

Retirement savings plan 401(k) contributions

The Company sponsors a 401(k) retirement savings plan that requires an annual non-elective safe harbor employer contribution of 3% of eligible employee wages. All employees over 21 years of age are eligible beginningthird party during the first payroll after 3 consecutive months of employment. Employees are 100% vested in employer contributions and in any voluntary employee contributions. Contributions to the 401(k) plan were approximately $62,000, $64,000 and $58,000 for the yearsyear ended September 30, 2017, 20162020 and 2015, respectively.

nine-month period ended September 30, 2019.

Related party commitments:

Patent royalty agreement

patent royalty commitments

On August 14, 2002, through its California subsidiary, the Company entered into ana patent royalty agreement with a director and officer of the Company, wherewhereby he would receive royalty payments in exchange for assignment of his patent rights to the Company. The royalty is 5% of gross receipts from products using this invention in excess of $500,000 annually. The
Retirement savings plan 401(k) contributions
Executive officers and employees of our California subsidiary are eligible to receive the Company’s current operations utilize this invention. Royalty expense incurred duringnon-electivesafe harbor employercontribution of 3% of eligible compensation under a 401(k) plan to provide retirement benefits.Employees are 100% vested in employer contributions and in any voluntary employee contributions. Contributions to the years ended September 30, 2016401(k) plan were $11,936 and 2015 was approximately $35,500 and $1,500. There was no royalty expense incurred $5,442during the year ended September 30, 2017.

2020 and nine-month period ended September 30, 2019.
There are no 401(k) contributions in the accompanying consolidated financial statements prior to the completion of the reverse acquisition on June 7, 2019.
8.            
Temporary Equity
Series A-1 Convertible Preferred Shares
As described in Notes 5 and 7, in April 2020, the Company entered into a license agreement with a pharmaceutical development company to obtain exclusive world-wide rights to know- how, patents and data relating to certain monoclonal antibodies ("the Constructs"), including sublicensing rights. In exchange for the exclusive rights to develop and commercialize the Constructs, the Company issued 250 convertible preferred shares valued at $2.5 million designated as Series A-1 Convertible Preferred Shares (the “Series A-1 Shares”). The Series A-1 Shares have no par value, a stated value of $10,000 per share and rank, with respect to redemption payments, rights upon liquidation, dissolution or winding-up of the Company, or otherwise, senior in preference and priority to the Company’s common shares.
A holder of Series A-1 Shares is not entitled to receive dividends unless declared by the Company’s Board of Directors. Subject to certain exceptions and adjustments for share splits, each Series A-1 Share is convertible six months after its date of issuance into a number of the Company’s common shares calculated by dividing (i) the sum of the stated value of such Series A-1 Share plus a return equal to 3% of the stated value of such Series A-1 Share per annum (collectively, the “Preferred Amount”) by (ii) a fixed conversion price of $2.26. A holder of Series A-1 Shares will not have the right to convert any portion of its Series A-1 Shares if the holder, together with its affiliates, would beneficially own in excess of 4.99% of the number of common shares outstanding immediately after giving effect to such conversion (the “Beneficial Ownership Limitation”); provided, however, that upon notice to the Company, the holder may increase the Beneficial Ownership Limitation to a maximum of 9.99%. The Series A-1 Shares do not have the right to vote on any matters except as required by law and do not contain any variable pricing features, or any price-based anti-dilutive features.
In the event of any liquidation, dissolution or winding-up of the Company, a holder of Series A-1 Shares shall be entitled to receive, before any distribution or payment may be made with respect to the Company’s common shares, an amount in cash equal to the Preferred Amount per share, plus any unpaid accrued dividends on all such shares.

 F-15

Stellar Biotechnologies,Edesa Biotech, Inc.
Notes to Consolidated Financial Statements
For the YearsYear Ended September 30, 2017, 20162020 and 2015Nine-month Period Ended September 30, 2019

Collaboration agreement

In December 2013,


At any time, the Company entered intomay redeem some or all outstanding Series A-1 Shares for a collaboration agreement with a privately-held Taiwanese biopharmaceuticals manufacturer which expired in accordance with its terms in December 2015. Undercash payment per share equal to the termsPreferred Amount. A holder of the agreement,Series A-1 Shares may require the Company was responsibleto redeem the Series A-1 Shares for cash beginning 18 months after issuance if at any time after such date the production and delivery of GMP grade KLH for evaluation as a carrier molecule in the collaboration partner’s potential manufacture of OBI-822 (Adagloxad Simolenin) active immunotherapy. The Company was also responsible for method development, product formulation, and process qualification for certain KLH reference standards. The collaboration partner was responsible for development objectives and product specifications. The agreement provided for the collaboration partner to pay fees for certain expenses and costs associated with the collaboration. Subject to certain conditions and timing, the collaboration also provided for the parties to negotiate a commercial supply agreement for Stellar KLH which was executed in February 2017.

A member30-day volume weighted average price of the Company’s Boardcommon shares is below the conversion price of Directors currently serves$2.26. In the event of a required redemption, at the election of the Company, the redemption amount (which is equal to the Preferred Amount) may be paid in full or in up to twelve equal monthly payments with any unpaid redemption amounts accruing interest at a rate of 3% annually, compounded monthly. On the third anniversary of the date of issuance of the Series A-1 Shares, the Company has the right to convert any outstanding Series A-1 Shares into common shares.

Because the convertible preferred shares are redeemable outside the control of the Company, they are presented as the manufacturer’s general managertemporary equity rather than permanent shareholders’ equity.
Issued and chair of its board of directors. 

8.Share Capital

The Company had the following transactions in share capital:

  Years Ended 
  September 30,  September 30,  September 30, 
  2017  2016  2015 
          
Number of common shares issued  383,838   2,151,500   42,773 
             
Issuance of common shares $-  $6,750,000  $- 
Share issuance costs  -   (805,264)  - 
Proceeds from exercise of warrants  -   1,368,260   12,609 
Transfer to common shares on issuance of performance shares  1,070,909   -   - 
Transfer to common shares on exercise of warrants  -   1,853,581   10,000 
Proceeds from exercise of options  -   -   94,168 
Transfer to common shares on exercise of options  -   -   113,561 
Share-based compensation  115,546   259,379   267,222 

outstanding Series A-1 Convertible Preferred Shares:

 
 
Series A-1 Convertible Preferred Shares (#)
 
 
Series A-1 Convertible Preferred Shares
 
Balance – December 31, 2018 and September 30, 2019
  - 
 $- 
 
    
    
Issuance of convertible preferred shares
  250 
 $2,500,000 
Convertible preferred share issuance costs
  - 
  (57,154)
Preferred return on convertible preferred shares
  - 
  34,109 
 
    
    
Balance – September 30, 2020
  250 
 $2,476,955 

9.            Capital shares
Reverse Share Split

On September 2, 2015,June 7, 2019, the Company effected a share consolidation (reverse split)reverse split of the Company's common shares at a ratio of 1-for-10.1-for-6. As a result of the reverse split, every tensix shares of the issued and outstanding common shares, without par value, consolidated into one newly-issuednewly issued outstanding common share, without par value. Eachvalue, after fractional share remaining after the reverse split that was less than one-half of a share was cancelled and each fractional share that was at least one-half of a share was changed to one whole share. The number of warrants, broker units, and options were proportionately adjusted by the split ratio and the exercise prices correspondingly increased by the same split ratio.rounding. All historical shares and exercise prices are presented on a post-split basis in these consolidated financial statements.

Performance Shares

Pursuant to

Equity Offering
On January 8, 2020, the Company closed a performance share plan approved by shareholders in 2010, 1,000,000registered direct offering of 1,354,691 common shares, were reserved for issuanceno par value and a concurrent private placement of Class A Purchase Warrants to purchase an aggregate of up to 1,016,036 common shares and Class B Purchase Warrants to purchase an aggregate of up to 677,358 common shares. Gross proceeds from the offering amounted to $4,360,500.
The Class A Purchase Warrants are exercisable on or after July 8, 2020, at an exercise price of $4.80 per share and will expire on July 8, 2023. The Class B Purchase Warrants are exercisable on or after July 8, 2020, at an exercise price of $4.00 per share and will expire on November 8, 2020. In connection with the offering, the Company also issued warrants to purchase an aggregate of 12,364 common shares to certain officers, directors and employeesaffiliated designees of the placement agent as part of the placement agent’s compensation. The placement agent warrants are exercisable on or after July 6, 2020, at an exercise price of $3.20 per share, and will expire on January 6, 2025.
The warrants are considered contracts on the Company’s own shares and are classified as equity. The Company upon achievementallocated gross proceeds with $3,070,358 as the value of certain milestonescommon shares and $1,008,743 as the value of Class A Purchase Warrants and $281,399 as the value of Class B Purchase Warrants under additional paid-in capital in the consolidated statements of changes in shareholders’ equity on a relative fair value basis.
The direct costs related to completionthe issuance of method developmentthe common shares and warrants were $468,699. These direct costs were recorded as an offset against gross proceeds with $330,025 being recorded under common shares and $138,674 being recorded under additional paid-in capital on a relative fair value basis. The Company also recorded the fair value of placement agent warrants in the amount of $18,051 as share based compensation to nonemployees under additional paid-in capital and an offset against gross proceeds with $12,710 being recorded under common shares and $5,341 being recorded under additional paid-in capital on a relative fair value basis.
Equity Distribution Agreement
On September 28, 2020, the Company entered into an Equity Distribution Agreement with RBC Capital Markets, LLC (“RBCCM”), as sales agent, pursuant to which the Company may offer and sell, from time to time, common shares through an at-the-market equity offering program for commercial-scale manufactureup to $9.2 million in gross cash proceeds. RBCCM will use commercially reasonable efforts to sell the common shares from time to time, based upon the Company’s instructions. The Company has no obligation to sell any of KLH, compilationthe shares, and regulatory submittalmay at any time suspend sales under the distribution agreement or terminate the agreement in accordance with its terms. The total amount of all required chemistry, manufacturingcash that may be generated under this distribution agreement is uncertain and control datadepends on a variety of factors, including market conditions and completionthe trading price of preclinical toxicity and immunogenicity testing of products. Share-based compensation was recorded over the estimated vesting period ending in August 2012.

AtCompany’s common shares. No shares were sold under the distribution agreement prior to September 30, 2017, all vested performance shares under the plan have been issued, and the performance share plan was terminated.

2020.




Edesa Biotech, Inc.
Notes to Consolidated Financial Statements
For the Year Ended September 30, 2020 and Nine-month Period Ended September 30, 2019

Black-Scholes option valuation model

The Company uses the Black-Scholes option valuation model to determine the fair value of share-based compensation for share options and compensation warrants broker unitsgranted and share options.the fair value of warrants issued. Option valuation models require the input of highly subjective assumptions including the expected price volatility. The Company has usedcalculates expected volatility based on historical volatility to estimate the volatility of the Company’s share price. When there is insufficient data available, the Company uses a peer group that is publicly traded to calculate expected volatility. The Company adopted interest-free rates by reference to the U.S. treasury yield rates. The Company calculated the fair value of share options granted based on the expected life of 5 years (2019: 4 years), considering expected forfeitures during the option term of 10 years. Expected life of warrants is based on warrant terms. The Company did not and is not expected to declare any dividends. Changes in the subjective input assumptions can materially affect the fair value estimates, and therefore the existing models do not necessarily provide a reliable single measure of the fair value of the Company’s warrants broker units and share options.

 F-16


Stellar Biotechnologies, Inc.
Notes to Consolidated Financial Statements
For the Years Ended September 30, 2017, 2016 and 2015

Warrants

A summary of the Company’s warrants activity is as follows:

  Number of
Warrants
  Weighted
Average
Exercise Price
  
        
Balance - September 30, 2015  1,022,761  $9.04  
          
Granted  1,265,626   4.50  
Granted  40,000   4.00 CDN $
Exercised  (424,000)  4.00 CDN $
Expired  (598,761)  13.33  
Expired  (40,000)  4.00 CDN $
          
Balance - September 30, 2016 and 2017  1,265,626  $4.50  

There are no outstanding warrants with exercise prices denominated in Canadian dollar at September 30, 2017.

 
 
Number of
Warrants (#)
 
 
Weighted Average Exercise Price
 
Balance – December 31, 2018
  - 
 $- 
 
    
    
Effect of reverse acquisition
  362,430 
  31.60 
Black-Scholes value payout
  (313,516)
  33.01 
 
    
    
Balance – September 30, 2019
  48,914 
 $11.19 
 
    
    
Issued
  1,705,758 
 $4.47 
Exercised 
  (761,951) 
  4.31 
 
    
    
Balance – September 30, 2020
  992,721 
 $4.92 
The weighted average contractual life remaining on the outstanding warrants at September 30, 20172020 is 5127 months.

The following table summarizes information about the warrants outstanding at September 30, 2017:

Exercise Price  Number of
Warrants
  Expiry Date
       
$4.50   1,265,626  January 6, 2022
         
     1,265,626   

Warrant Liability

All warrants with exercise prices denominated in Canadian dollars were exercised or expired. Therefore, there is no outstanding warrant liability at September 30, 2017.

Equity offerings conducted by the Company in prior years included the issuance of warrants with exercise prices denominated in Canadian dollars. The Company’s functional currency is the U.S. dollar. As a result of having exercise prices denominated in other than the Company’s functional currency, those warrants met the definition of derivatives and were therefore classified as derivative liabilities measured at fair value with adjustments to fair value recognized through the consolidated statements of operations. The fair value of those warrants was determined using the Black-Scholes option valuation model at the end of each reporting period. On the date those warrants were exercised, the fair value of warrant liability was reclassified to common shares along with the proceeds from the exercise. If those warrants expired, the related decrease in warrant liability was recognized in profit or loss, as part of the change in fair value of warrant liability. There was no cash flow impact as a result of this accounting treatment.

2020:

 
Number of Warrants (#)
 
 
Exercise Prices
 
Expiry Dates
  216,414 
 $4.00 
November 2020
  28,124 
 $15.90 
May 2023
  728,921 
 4.80 
July 2023
  7,484 
 4.81 
June 2024
  11,778 
 $3.20 
January 2025
  992,721 




The fair value of warrants exercisedissued during the year ended September 30, 2020 was determinedestimated using the Black-Scholes option valuation model using the following weighted average assumptions:

  Years Ended 
  September 30,  September 30, 
  2016  2015 
Risk free interest rate  0.48%  0.44%
Expected life (years)  0.04   0.40 
Expected share price volatility  92%  92%

 
 
 Class A Warrants
 
 
 Class B Warrants
 
 
 Placement Agent Warrants
 
Risk free interest rate
  1.61%
  1.55%
  1.61%
Expected life
  3.5 years 
  0.83 years 
  5 years 
Expected share price volatility
  103.81%
  134.15%
  101.89%
Expected dividend yield
  0.00%
  0.00%
  0.00%

There were no warrants exercised duringissued in the yearnine-month period ended September 30, 2017.

 F-17
2019.

Stellar Biotechnologies, Inc.
Notes to Consolidated Financial Statements
For the Years Ended September 30, 2017, 2016 and 2015

The fair value of warrants granted was determined using the Black-Scholes option valuation model, using the following weighted average assumptions at the date of the grant: 

Year Ended
September 30,
2016
Risk free interest rate0.52%
Expected life (years)0.01
Expected share price volatility91%
Expected dividend yield0%

There were no warrants granted during the years ended September 30, 2017 or 2015.

Broker units

Share Options
The Company granted broker units as finders’ feesadopted an Equity Incentive Compensation Plan in conjunction with equity offerings in prior years. Broker units were fully vested when granted and allowed2019 (the “2019 Plan”) administered by the holders to purchase equity units. A unit consistedindependent members of one common share and either one whole warrant or one half warrant.

A summary of broker units activity is as follows:

  Number of
Units
  Weighted
Average
Exercise Price
  
        
Balance - September 30, 2015  46,600  $1.87  
          
Exercised  (40,000)  2.50 CDN $
Expired  (6,600)  2.50 CDN $
          
Balance - September 30, 2016 and 2017  -  $-  

There were no broker units granted during the years ended September 30, 2017, 2016 and 2015.

Options

The Company has an incentive compensation plan adopted in 2017 (the Plan) administered by the Board of Directors, which amended and restated the 2013 fixed share option plan2017 Incentive Compensation Plan (the 2013 Plan)“2017 Plan”). Options, restricted shares and restricted share units are eligible for grantsgrant under the 2019 Plan. The number of shares available for issuance under the 2019 Plan is 1,597,000,1,148,697, including shares available for the exercise of outstanding options under the 20132017 Plan. No restricted shares or restricted share units have been granted as of September 30, 2017.

The exercise price of anOption holders under Edesa Biotech Research, Inc.’s option is set atplan received substitute options under the closing priceCompany’s incentive plan upon completion of the Company’s common shares on the date of grant. Sharereverse acquisition.

The Company's 2019 Plan allows options to be granted to directors, officers, employees and certain individualexternal consultants for past service are subjectand advisers. Under the 2019 Plan, the option term is not to exceed 10 years and the following vesting schedule: (a) one-third shall vest immediately, (b) one-third shall vest at 12 months fromexercise price of each option is determined by the dateindependent members of grant and (c) one-third shall vest at 18 months from the dateBoard of grant.

Share options granted to directors, officers, employees and certain individual consultants for future service are subject to the following vesting schedule: (x) one-third shall vest at 12 months from the date of grant, (y) one-third shall vest at 24 months from the date of grant and (z) one-third shall vest at 36 months from the date of grant.

 F-18
Directors.

Stellar Biotechnologies, Inc.
Notes to Consolidated Financial Statements
For the Years Ended September 30, 2017, 2016 and 2015

Share options granted to certain individual investor relations consultants are subject to the following vesting schedule: (aa) 25% shall vest at 3 months from the date of grant, (bb) 25% shall vest at 6 months from the date of grant, (cc) 25% shall vest at 12 months from the date of grant and (dd) 25% shall vest at 15 months from the date of grant.

Options have been granted under the 2019 Plan allowing the holders to purchase common shares of the Company as follows:

  Number of
Options
  Weighted
Average
Exercise Price
  
        
Balance - September 30, 2015  557,638  $5.17  
          
Granted  56,300   6.47  
Expired  (21,334)  10.70  
Expired  (53,501)  5.22 CDN $
          
Balance - September 30, 2016  539,103  $5.29  
          
Granted  71,600   1.89  
Expired  (28,233)  11.14  
Expired  (171,500)  2.90 CDN $
          
Balance - September 30, 2017  410,970  $5.74  

 
 
Number of Options (#)
 
 
Weighted Average Exercise Price
 
Balance – December 31, 2018
  315,123 
 $1.65 
 
    
    
Effect of reverse acquisition
  7,787 
  124.80 
Expired
  (3,265)
  125.75 
 
    
    
Balance – September 30, 2019
  319,645 
 $3.39 
 
    
    
Granted
  366,365 
  3.35 
Exercised
  (4,450)
  2.60 
Forfeited
  (5,790)
  2.73 
Expired
  (333)
  145.20 
 
    
    
Balance – September 30, 2020
  675,437 
 $3.30 

On February 12, 2020, the independent members of the Board of Directors granted a total of 352,365 options to directors, officers and employees of the Company pursuant to the 2019 Plan. The options have a term of 10 years with 33% vesting on the grant date, with a pro rata amount of the balance vesting monthly for the next 36 months and an exercise price equal to the Nasdaq closing price on the grant date.
On September 30, 2020, the independent members of the Board of Directors granted a total of 14,000 options to employees of the Company pursuant to the 2019 Plan. The options have a term of 10 years vesting monthly for 36 months from November 30, 2020 and an exercise price equal to the Nasdaq closing price on the grant date.
The weighted average contractual life remaining on the outstanding options at September 30, 2020 is 3599 months.



Edesa Biotech, Inc.
Notes to Consolidated Financial Statements
For the Year Ended September 30, 2020 and Nine-month Period Ended September 30, 2019

The following table summarizes information about the options under the 2019 Plan outstanding and exercisable at September 30, 2017:

Number of
Options
  Exercisable at
September 30, 2017
  Range of exercise prices Expiry Dates
 115,110   115,110  CDN$0.01 - 5.00 Apr 2017-Dec 2019
 79,900   17,733  $0.01 - 5.00 Sep 2023-Mar 2024
 139,860   139,860  CDN$5.01 - 10.00 Oct 2017-Jun 2022
 15,100   15,100  $5.01 - 10.00 Dec 2022
 21,500   21,500  CDN$15.01 - 20.00 Nov 2018-Nov 2021
 39,500   39,500  $15.01 - 20.00 Nov 2020
 410,970   348,803     

2020:

 
Number of Options (#)
 
 
 Exercisable at September 30, 2020 (#)
 
 
 Range of Exercise Prices
 
Expiry Dates
 
 
 
 
 
 
 
 
 
 
  238 
  238 
 $768.60 
Nov 2020
  214 
  214 
  C$638.40 
Nov 2021
  238 
  238 
 $304.08 
Dec 2022
  3,499 
  3,499 
 $35.28 - 93.24 
Sep 2023-Mar 2025
  311,883 
  302,343 
  C$2.16 
Aug 2027-Dec 2028
  345,365 
  161,788 
 $3.16 
Feb 2030
  14,000 
  - 
 $8.07 
Sep 2030
  675,437 
  468,320 
    
 
The estimated fair value of the share options granted during the year ended September 30, 2020 and nine-month period ended September 30, 2019 was determinedestimated using athe Black-Scholes option valuation model withusing the following weighted average assumptions:

  Years Ended 
  September 30,  September 30,  September 30, 
  2017  2016  2015 
Risk free interest rate  1.44%  1.01%  1.65%
Expected life (years)  7.00   7.00   7.00 
Expected share price volatility  166%  117%  115%
Expected dividend yield  0%  0%  0%


 
 
Year Ended
September 30,
2020
 
 
Nine-month Period Ended
September 30,
2019
 
 
 
 
 
 
 
 
Risk free interest rate
  0.28%-1.45%
  1.98%
Expected life
  5 years  
  4 years  
Expected share price volatility
  94.42%-104.14%
  79.46%
Expected dividend yield
  0.00%
  0.00%
The weighted average fair valueCompany recorded $598,359 and $35,074 of share options granted duringshare-based compensation expenses for the yearsyear ended September 30, 2017, 20162020 and 2015 was $1.84, $5.56, and $9.48,nine-month period ended September 30, 2019, respectively.

As of September 30, 2017,2020, the Company had approximately $62,000$346,000 of unrecognized share-based compensation expense, which is expected to be recognized over a period of 3037 months.

Issued and outstanding common shares:
 
 
Number of Common Shares (#)
 
 
Common Shares
 
Balance – December 31, 2018
  3,239,902 
 $1,111,253 
 
    
    
Conversion of preferred shares upon reverse acquisition
  3,376,112 
 $6,260,299 
Share consideration transferred upon reverse acquisition
  888,454 
  4,633,499 
 
    
    
Balance – September 30, 2019
  7,504,468 
 $12,005,051 
 
    
    
Common shares issued
  1,354,691 
 $3,070,358 
Common shares issued upon exercise of warrants
  751,510 
  3,754,265 
Common shares issued upon exercise of share options
  4,450 
  20,935 
Share issuance costs
  - 
  (349,756)
 
    
    
Balance – September 30, 2020
  9,615,119 
 $18,500,853 

 F-19

Stellar Biotechnologies,Edesa Biotech, Inc.
Notes to Consolidated Financial Statements
For the YearsYear Ended September 30, 2017, 20162020 and 2015Nine-month Period Ended September 30, 2019

The intrinsic value

Issued and outstanding preferred shares:

 
 
Class A Preferred Shares (#)
 
 
Class A Preferred Shares
 
Balance – December 31, 2018
  1,007,143 
 $6,064,013 
 
    
    
Preferred return on Class A preferred shares
  - 
  196,286 
Conversion upon reverse acquisition
  (1,007,143)
  (6,260,299)
 
    
    
Balance – September 30, 2019 and 2020
  - 
 $- 
Following the completion of the options exercised duringreverse acquisition on June 7, 2019, all the year ended September 30, 2015 was $8.28. Thereoutstanding Class A preferred shares and accumulated accrued preferred return were no options exercised duringfully converted to 3,376,112 common shares based on the years ended September 30, 2017fair market value upon conversion. Prior to conversion, the Class A preferred shares had the following features:
The Class A preferred shares were voting and 2016. There was no intrinsic valueconvertible into common shares at the option of the vested optionsholder at September 30, 2017.

9.Income Taxes

any time. Upon the occurrence of a liquidation event, as defined in the resolutions of the shareholders dated August 28, 2017, the Class A preferred shares had a liquidation amount preference over the rights of holders of common shares or any class of shares ranking junior to Class A preferred shares. The breakdownClass A preferred shares also contained an 8% preferred return that accrued daily and compounds annually and was payable in shares upon conversion.

The Company evaluated the Class A preferred shares and the embedded conversion option. The embedded conversion option did not meet the criteria for bifurcation and was therefore classified to equity.
10.            Income Tax
The reconciliation of loss beforethe combined Canadian federal and provincial statutory income tax by jurisdictionrate to the approximate effective tax rate is as follows:

  Years Ended 
  September 30,  September 30,  September 30, 
  2017  2016  2015 
          
U.S. $(4,540,094) $(4,001,206) $(3,258,355)
Canadian  (464,990)  (1,026,520)  405,203 
Other foreign  (24,764)  8,846   46,923 
             
Total Loss Before Income Tax $(5,029,848) $(5,018,880) $(2,806,229)

 
 
Year Ended September 30,
2020
 
 
Nine-month Period Ended September 30, 2019
 
 
 
 
 
 
 
 
Net loss before recovery of income taxes
 $(6,363,430)
 $(2,776,734)
Canadian federal and provincial statutory income tax rate
  26.5%
  26.5%
 
    
    
Expected income tax recovery
 $(1,686,000)
 $(736,000)
Permanent differences
  159,000 
  11,000 
Effect of foreign currency and foreign tax rate differences
  23,800 
  (60,000)
Share issuance cost booked through equity or capitalization 
  (144,000)
  - 
Change in valuation allowance
  1,648,000 
  785,000 
 
    
    
Income tax (recovery) expense
 $800 
 $- 

Components of the net deferred tax asset or liability
Deferred taxes are provided as a result of temporary differences that arise due to the difference between the income tax values and the carrying amount of assets and liabilities. Approximate deferred tax assets and liabilities of the Company are as follows:

  September 30,
2017
  September 30,
2016
  September 30,
2015
 
          
Deferred income tax assets:            
Non-capital loss carry-forwards $12,164,100  $10,000,000  $8,028,900 
Research and development tax credits  947,300   808,000   716,400 
Deferred expenses  34,300   70,000   82,900 
Property, plant and equipment  2,200   400   1,700 
Share issuance costs  142,600   207,200   67,800 
Deferred income tax liabilities:            
U.S. federal benefit net of state taxes  (923,700)  (764,500)  (628,800)
Valuation allowance  (12,366,800)  (10,321,100)  (8,268,900)
             
Net deferred income tax asset (liability) $-  $-  $- 




Edesa Biotech, Inc.
Notes to Consolidated Financial Statements
For the Year Ended September 30, 2020 and Nine-month Period Ended September 30, 2019
 
 
September 30,
2020
 
 
September 30,
2019
 
 
 
 
 
 
 
 
Non-capital losses carried forward - Canada
 $4,881,000 
 $3,592,000 
Non-capital losses carried forward - U.S.
  1,609,000 
  1,587,000 
Research and development tax credits
  1,253,000 
  626,000 
Share issuance and financing costs
  473,000 
  517,000 
Operating lease liabilities
  43,000 
  - 
Other temporary differences
  16,000 
  28,000 
 
    
    
Subtotal
 $8,275,000 
 $6,350,000 
Less: valuation allowance
  (8,173,000)
  (6,350,000)
 
    
    
Total net deferred tax assets
 $102,000 
 $- 
 
    
    
Property and equipment
 $(17,000)
 $- 
Operating lease right-of-use assets
  (42,000)
  - 
Deferred share issuance costs
  (43,000)
  - 
 
    
    
Total deferred tax liabilities
 $(102,000)
 $- 
 
    
    
Net deferred taxes
 $- 
 $- 
Realization of the deferred tax assets is dependent upon the generation of future taxable income, the amount and timing of which are uncertain. It is more likely than not that a tax benefit will not be realized.  Accordingly, the net deferred tax assets have been fully offset by a valuation allowance.

As

Non-capital losses, capital losses, and research and development credits generated by Edesa Biotech USA, Inc. prior to changes in share ownership that occurred as a result of September 30, 2017, the Company had federal net operating loss (NOL) carryforwards of approximately $25.3reverse acquisition are substantially limited. It is unlikely that tax losses totaling $25.6 million expiring 2030 through 2037, California NOL carryforwards of approximately $25.0and credits totaling $0.6 million expiring 2018 through 2037, and Canadian federal and provincial NOL carryforwards of approximately CDN$6.8 million expiring 2028 through 2037. Portions of these NOL carryforwards maywill be usedutilized to offset potential future taxable income if any.

As ofbefore expiration and they are excluded from deferred tax assets above.

The approximate Canadian non-capital losses carried forward at September 30, 2017, the Company also has2020 expire as follows:
2028
 C$21,000 
2029
  56,000 
2030
  346,000 
2031
  688,000 
2032
  860,000 
2033
  685,000 
2034
  780,000 
2035
  1,374,000 
2036
  1,415,000 
2037
  2,269,000 
2038
  3,243,000 
2039
  6,059,000 
2040 
  6,546,000 
 
    
Total
 C$24,342,000 
Share issuance and financing costs will be fully amortized in 2024.
The U.S. non-capital losses carried forward at September 30, 2020 totaled approximately $7,587,000, which do not expire for federal and California research and development tax credit carryforwards of approximately $.45 million and $.50 million, respectively, available to offset future taxes. The federal credits begin expiring in 2030 and continue expiring through 2037. Theapproximate U.S. state tax credits do not expire.

Under the provisions of Section 382 of the Internal Revenue Code, substantial changes in the Company's ownership limit the amount of net operating loss carryforwards and tax credit carryforwards that can be utilized annually in the future to offset taxable income. A valuation allowance has been established to reserve the potential benefits of these carryforwards in the Company's consolidated financial statements to reflect the uncertainty of future taxable income required to utilize available tax loss carryforwards and other deferred tax assets.

non-capital losses carried forward at September 30, 2020 expire as follows:
2039
 $70,000 
2040
  150,000 
 
    
Total
 $220,000 

 F-20

Stellar Biotechnologies,Edesa Biotech, Inc.
Notes to Consolidated Financial Statements
For the YearsYear Ended September 30, 2017, 20162020 and 2015Nine-month Period Ended September 30, 2019


11.             Financial instruments
(a)              Fair values

The recovery of incomeU.S. non-capital losses carried forward at September 30, 2020 totaled approximately $7,587,000, which do not expire for federal taxes shownand include approximately $220,000 that expires in the consolidated statements of operations differs from the amounts obtained by applying statutory rates to the loss before provision2040 for income taxes due to the following:

  September 30,
2017
  September 30,
2016
  September 30,
2015
 
          
Combined Canadian federal and provincial tax rates  26.0%  26.0%  26.0%
             
Expected income tax (recovery)/expense $(1,307,800) $(1,304,900) $(729,600)
             
Nondeductible share-based payments  30,000   (67,400)  69,500 
Nondeductible change in fair value of warrant liability  -   (55,100)  (554,100)
Effect of higher income tax rate in U.S.  (624,400)  (550,600)  (445,800)
Foreign currency differences  (42,200)  20,000   169,900 
Other  (174,500)  (2,800)  (43,300)
Change in valuation allowance on deferred tax assets  2,119,700   1,968,000   1,570,200 
             
Income tax expense $800  $7,200  $36,800 

The components of income tax provision (benefits) are as follows:

  September 30,
2017
  September 30,
2016
  September 30,
2015
 
          
Current tax provision            
U.S. federal $-  $-  $- 
Canadian  -   -   - 
Other foreign  -   6,400   36,000 
State  800   800   800 
             
Deferred tax provision            
U.S. federal  (1,447,100)  (1,265,700)  (1,032,200)
Canadian  (199,100)  (303,300)  (209,300)
Other foreign  (5,200)  -   - 
State  (468,300)  (399,000)  (328,700)
             
Change in valuation allowance on deferred tax assets  2,119,700   1,968,000   1,570,200 
             
Total $800  $7,200  $36,800 

10.Fair Value of Financial Instruments

state taxes.


The Company uses the fair value measurement framework for valuing financial assets and liabilities measured on a recurring basis in situations where other accounting pronouncements either permit or require fair value measurements.

Fair value of a financial instrument is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The carrying value of certain financial instruments such as accounts receivable, accounts payable, accrued liabilities, and deferred revenue approximates fair value due to the short-term nature of such instruments. Short-term investments in U.S. Treasury Bills are recorded at amortized cost, which approximates fair value.

 F-21

Stellar Biotechnologies, Inc.
Notes to Consolidated Financial Statements
For the Years Ended September 30, 2017, 2016 and 2015

The Company follows the fair value hierarchy which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Observable inputs are inputs that reflect assumptions market participants would use in pricing the asset or liability developed based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company's own assumptions about the assumptions market participants would use in pricing the asset or liability developed based on the best information available in the circumstances.
There are three levels of inputs that may be used to measure fair value:

Level 1:Quoted prices in active markets for identical or similar assets and liabilities. 
Level 2:Quoted prices for identical or similar assets and liabilities in markets that are not active or observable inputs other than quoted prices in active markets for identical or similar assets and liabilities. 
Level 3:Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. 

Level 1 - Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets.
Level 2 - Inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs include quoted prices for similar assets or liabilities in active markets, or quoted prices for identical or similar assets and liabilities in markets that are not active.
Level 3 - Unobservable inputs for the asset or liability that are supported by little or no market activity.
The Company reports itscarrying value of certain financial instruments such as cash and cash equivalents, accounts and other receivable, accounts payable and accrued liabilities approximates fair value due to the short-term nature of such instruments. Short-term investments in U.S. Treasury Bills are recorded at amortized cost, which approximates fair value using Levellevel 1 inputs in the fair value hierarchy.

The following table summarizes fair values for those assetsinputs.

(b)             Interest rate and liabilities with fair value measured on a recurring basis.

  Fair Value Measurements Using    
  Quoted Prices in
Active Markets
for Identical
Instruments
(Level 1)
  Significant
Other
Observable
Inputs
(Level 2)
  Significant
Unobservable
Inputs
(Level 3)
  Total Fair Value 
             
September 30, 2017                
Assets                
Short-term investments in U.S. Treasury Bills $1,994,401  $-  $-  $1,994,401 
                 
September 30, 2016                
Assets                
Short-term investments in U.S. Treasury Bills $3,988,794  $-  $-  $3,988,794 

11.Concentrations of Credit Risk

Creditcredit risk

Interest rate risk is the risk that the value of an unexpected loss if a customer or third party to a financial instrument failsmight be adversely affected by a change in interest rates. The Company does not believe that the results of operations or cash flows would be affected to meet its contractual obligations. Financial instruments that potentially subject the Companyany significant degree by a significant change in market interest rates, relative to a concentration of credit risk consist primarily ofinterest rates on cash and cash equivalents U.S Treasury Bills, and accounts receivable. due to the short-term nature of these balances.
The Company estimates its maximumis also exposed to credit risk at period end from the amount recorded on the balance sheet.

Management’s assessmentcarrying value of the Company’s credit risk forits cash and cash equivalents is low as they are held in major financial institutionsand accounts and other receivable. The Company manages this risk by maintaining bank accounts with Canadian Chartered Banks, U.S. banks believed to be credit worthy, or U.S. Treasury Bills with maturitiesand money market mutual funds of 90 days or less.U.S. government securities. The Company’s cash is not subject to any external restrictions. The Company limitsassesses the collectability of accounts receivable through a review of the current aging, as well as an analysis of historical collection rates, general economic conditions and credit status of customers.  Credit risk for HST refunds receivable is not considered significant since amounts are due from the Canada Revenue Agency.

(c)             Foreign exchange risk
The Company and its subsidiary have balances in Canadian dollars that give rise to exposure to creditforeign exchange (“FX”) risk relating to the impact of translating certain non-U.S. dollar balance sheet accounts as these statements are presented in U.S. dollars. A strengthening U.S. dollar will lead to a FX loss for short-term investments by holdingwhile a weakening U.S. Treasury Bills with maturitiesdollar will lead to a FX gain. The Company has not entered into any agreements or purchased any instruments to hedge possible currency risks. At September 30, 2020, the Company and its Canadian subsidiary had assets denominated in Canadian dollars of 1 year or less.approximately C$3.2 million and the U.S. dollar exchange rate as at this date was equal to 1.3365 Canadian dollars. Based on credit monitoringthe exposure at September 30, 2020, a 10% annual change in the Canadian/U.S. exchange rate would impact the Company’s loss and history,other comprehensive loss by approximately $242,000.
(d)            Liquidity risk
Liquidity risk is the risk that the Company considerswill encounter difficulty raising liquid funds to meet commitments as they fall due. In meeting its liquidity requirements, the risk of credit losses due to customer non-performance on accounts receivable to be low.

Company closely monitors its forecasted cash requirements with expected cash drawdown.

 F-22

Stellar Biotechnologies,Edesa Biotech, Inc.
Notes to Consolidated Financial Statements
For the YearsYear Ended September 30, 2017, 20162020 and 2015Nine-month Period Ended September 30, 2019

The

12.            Related party transactions
During the periods presented, the Company hadincurred the following concentrationsrelated party transactions:
During the year ended September 30, 2020 and nine-month period ended September 30, 2019, the Company incurred rent expense of revenues by customers, each of which accounted for more than 10% of revenues$76,331 and $57,911 from a related company, respectively. These transactions are in the applicable period:

  Years Ended
  September 30, September 30, September 30,
  2017 2016 2015
       
Product sales and contract services revenue 79% from
2 customers
 76% from
3 customers
 86% from
5 customers

normal course of operations and are measured at the exchange amount, which is the amount of consideration established and agreed to by both parties.

No royalty expenses to a director related to legacy product sales by the California subsidiary were incurred during the year ended September 30, 2020. Patent royalties of $20,471 were incurred during the nine-month period ended September 30, 2019, and royalties payable of $23,457 were outstanding at September 30, 2019, which were subsequently paid.
13.            Business Combination
On June 7, 2019, the Edesa Biotech Research, Inc., formerly known as Edesa Biotech Inc., a company organized under the laws of the province of Ontario, Canada (“Edesa Research”), completed its business combination with Stellar Biotechnologies, Inc. a company organized under the laws of British Columbia, Canada (“Stellar”), in accordance with the terms of the Share Exchange Agreement, dated March 7, 2019 (the “Exchange Agreement”), by and among Stellar, Edesa Research and the shareholders of Edesa Research (the “Edesa Research Shareholders”). At the closing of the transaction (the “Closing”), Stellar acquired the entire issued share capital of Edesa Research, with Edesa Research becoming a wholly-owned subsidiary of Stellar (the “Exchange”). The Edesa Research Shareholders exchanged their shares for 88% of the outstanding shares of Stellar on a fully diluted basis. Edesa Research is considered the accounting acquirer of Stellar. Upon closing, Stellar changed its name to Edesa Biotech, Inc. Edesa Research entered into the Exchange primarily to provide greater liquidity to its shareholders, broaden its investment base, increase its profile, and facilitate the process of raising capital as the Company hadcontemplates pursuing new growth opportunities including acquisition of new clinical assets. For the following concentrationsperiod of June 7, 2019 to September 30, 2019, Stellar, the acquiree for accounting purposes, recorded revenues by geographic areas:

  Years Ended 
  September 30, September 30, September 30, 
  2017 2016 2015 
        
Europe  64% 43% 53%
North America  33% 12% 9%
Asia  3% 45% 38%

of $410,870 and a net loss of $452,416. These operating results are included within the accompanying consolidated statements of operations and comprehensive loss.

The Company had the following concentrationsfair value of accounts receivable from its customers, each of which accounted for more than 10%consideration transferred in the applicable period:

reverse acquisition is calculated as follows:
Fair value of 888,454 share consideration transferred, net of liquidity discountSeptember 30,
$4,633,499
 
Excess fair value of replacement warrants
2016
61,902
 
Accounts receivable
Total acquisition date fair value of consideration transferred
$4,695,401
The fair value of the replacement warrants was determined using Black-Scholes valuation model based on exercise price of C$6.45, expected life of 5 years, risk free rate of 1.34% and volatility of 130%.
The major classes of assets acquired and liabilities assumed in the reverse acquisition are as follows:
Cash and cash equivalents
$6,389,322
Other current assets
418,837
Noncurrent assets
42,045
Fair value of warrants payable
(1,187,124)
Other current liabilities
(967,679)
  100% from
1 customer
Net assets of Stellar
$4,695,401

There were no customer accounts receivable at


The following are the unaudited supplemental pro forma results of operations for the nine-month period ended September 30, 2017.

2019, as if the reverse acquisition had been completed on January 1, 2018 and include estimates and assumptions that management believes are reasonable. Since these pro forma results include all one-time reverse acquisition costs and do not include any anticipated cost savings or other effects of the planned integration of the entities, they are not necessarily indicative of the actual results that would have occurred if the combined business had been in effect beginning January 1, 2018.
  F-23
(Unaudited) Supplemental Pro Forma Combined Financial Information Nine-month Period Ended September 30, 2019
Total Revenues
$930,565
Net Loss
$(8,126,749)
Weighted average number of common shares
7,504,468
Loss per common share - basic and diluted
$(1.08)
 14.            
Subsequent events
The Series A-1 Convertible Preferred Shares became convertible in October 2020. Subsequently, 110 convertible preferred shares were converted to 494,846 common shares, reducing temporary equity and increasing shareholders’ equity.
Class A Purchase Warrants to purchase an aggregate of up to 1,016,036 common shares and Class B Purchase Warrants to purchase an aggregate of up to 677,358 common shares became exercisable on July 8, 2020, and placement agent warrants to purchase an aggregate of 12,364 common shares became exercisable on July 6, 2020. Subsequent to September 30, 2020 and through December 2, 2020, 243,369 shares have been issued upon exercise of Class A and Class B warrants with proceeds of approximately $1.0 million.
Subsequent to September 30, 2020 and through December 2, 2020, 169,753 common shares have been issued under the equity distribution agreement with RBCCM with gross proceeds of approximately $1.03 million and commissions of approximately $0.04 million.
Following these transactions, there were 10,523,087 common shares and 140 convertible preferred shares issued and outstanding at December 2, 2020.
On October 13, 2020, the independent members of the Board of Directors granted a total of 430,000 options to directors, officers and employees of the Company pursuant to the 2019 Plan. The options have a term of 10 years vesting monthly for 36 months from the grant date and an exercise price equal to the Nasdaq closing price on the grant date.
F-23