As filed with the Securities and Exchange Commission on June 5, 2018April 11, 2022

Registration No. 333-

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM S-1

REGISTRATION STATEMENT

 

FORM S-1
REGISTRATION STATEMENT
UNDER

THE SECURITIES ACT OF 1933

 

EDESA BIOTECH, INC.

Stellar Biotechnologies, Inc.
(Exact name of registrant as specified in its charter)charter)

 

British Columbia, Canada2834N/A
(State or other jurisdiction of
Incorporationincorporation or organization)
(Primary Standard Industrial
Classification Code Number)
(IRSI.R.S. Employer
Identification Number)No.)

 

332 E. Scott Street100 Spy Court

Port Hueneme, California 93041Markham, Ontario, Canada L3R 5H6

(805) 488-2800Telephone: (289) 800-9600

(Address, including zip code, and telephone number,

including area code, of registrant’s principal executive officesoffices))

 

Kathi Niffenegger

Chief Financial Officer

Stellar Biotechnologies, Inc.100 Spy Court

332 E. Scott StreetMarkham, Ontario, Canada L3R 5H6

Port Hueneme, California 93041Telephone: (289) 800-9600

(805) 488-2800

(Address, including zip code, and telephone number,

including area code, of agent for serviceservice))

 

CopiesCopy to:

Barbara A. Jones,Steven M. Skolnick, Esq.

Greenberg Traurig,Michael J. Lerner, Esq.

Lowenstein Sandler LLP

1840 Century Park East,1251 Avenue of the Americas

Los Angeles, CA 90067New York, New York 10020

(310) 586-7773Telephone: (212) 262-6700

 

Approximate date of commencement of proposed sale to the public: As soon as practicableFrom time to time after the effective date of this Registration Statement becomes effective.registration statement.

 

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box.x

 

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.¨

 

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.¨

 

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.¨

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”filer” and “smaller reporting company,” and “emerging growth company” in Rule 12b-2 under the Securities Exchange Act of the Exchange Act.1934. (Check one):

 

Large accelerated filer¨Accelerated Filer¨Accelerated filer¨Filer¨
Non-accelerated filerxFilerxSmaller reporting company¨Reporting CompanyEmerging growth companyx
 (Do not check if a smaller reporting company)Emerging Growth Company¨

 

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)7(a)(2)(B) of the ExchangeSecurities Act.x¨

CALCULATION OF REGISTRATION FEE

Title of Each Class of
Securities to be Registered(1)
 Amount to be
Registered(2)
  Proposed Maximum
Aggregate
Offering Price Per Share(3)
  Proposed Maximum
Aggregate
Offering Price(3)
  Amount of
Registration Fee(3)
 
Common shares, no par value  3,366,228  $2.65  $8,920,504.20     
Common shares, no par value  78,545  $3.3125  $

260,180.31

     
      Total  $

9,180,684.51

  $

1,143.00

 

(1)Pursuant to Rule 416 under the Securities Act, the securities being registered hereunder include such indeterminate number of additional common shares as may be issued after the date hereof as a result of stock splits, stock dividends or similar transactions.
(2)Represents common shares issuable upon the exercise of warrants by the selling shareholders named herein.
(3)Estimated solely for the purpose of calculating the registration fee in accordance with Rule 457(o) under the Securities Act of 1933, as amended, based on the price at which the warrants may be exercised.

 

The Registrant hereby amends this Registration Statementregistration statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment whichthat specifically states that this Registration Statementregistration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the Registration Statementregistration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

 

 

 

 

The information in this prospectus is not complete and may be changed. The selling shareholdersWe may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any jurisdictionstate where the offer or sale is not permitted.

 

SUBJECT TO COMPLETION, DATED JUNE 5, 2018APRIL 11, 2022

 

PRELIMINARY PROSPECTUS

 

Stellar Biotechnologies, Inc.

3,444,773 Common Shares

 

2,739,727 common shares

Issuable upon Exercise of Outstanding Warrants

This prospectus relates to the resale from time to time, by the selling shareholder identified in this prospectus under the caption “Selling Shareholder,” of up to 2,739,727 of our common shares, no par value, it may acquire upon the exercise of outstanding warrants, which we refer to as the “Warrants.” We are registeringissued the Warrants to the selling shareholder in a private placement concurrent with a registered direct offering of 1,540,000 of our common shares and pre-funded warrants to purchase up to an aggregate of 3,444,7731,199,727 common shares, for resale by certainwhich was completed on March 24, 2022.

The selling shareholder may, from time to time, sell, transfer or otherwise dispose of our shareholders identifiedany or all of their common shares or interests in their common shares on any stock exchange, market or trading facility on which the common shares are traded or in private transactions. These dispositions may be at fixed prices, at prevailing market prices at the time of sale, at prices related to the prevailing market price, at varying prices determined at the time of sale, or at negotiated prices. See “Plan of Distribution” in this prospectus. The 3,444,773 common shares consist of (i) 1,122,076 common shares underlying outstanding Series A Common Share Purchase Warrants exercisable at $2.65 per share (subject to customary adjustmentsprospectus for share splits and dividends), (ii) 78,545 common shares underlying outstanding Series A Common Share Purchase Warrants exercisable at $3.3125 per share (subject to customary adjustments for share splits and dividends) and (iii) 2,244,152 common shares underlying outstanding Series B Common Share Purchase Warrants exercisable at $2.65 per share (subject to customary adjustments for share splits and dividends).more information. We will not receive any proceeds from the resale or other disposition of the common shares by the selling shareholders. Anyshareholder. However, we will receive the proceeds received by us from theof any cash exercise of the warrants will be used for general corporate purposes.

The selling shareholders may offer our common shares from time to time in a numberWarrants. See “Use of different methodsProceeds” beginning on page 7 and at varying prices. For more information on possible methods of offer and sale by the selling shareholders, please see the section entitled “Plan of Distribution” beginning on page 2613 of this prospectus.prospectus for more information.

 

Our common shares are listed on the Nasdaq Capital Market under the symbol “SBOT.“EDSA.TheOn April 6, 2022, the last reported sale price of our common shares as reported on June 1, 2018the Nasdaq Capital Market was $1.79$2.80 per share.

We are an “emerging growth company” as that term is used in the Jumpstart Our Business Startups Act of 2012 and, as such, we have elected to comply with certain reduced public company reporting requirements for this prospectus and future filings. See “Prospectus Summary – Implications of Being an Emerging Growth Company.”

 

You should read this prospectus, together with additional information described under the headings “Incorporation of Certain Information“Information Incorporated by Reference” and “Where You Can Find More Information,” carefully before you invest in any of our securities.

 

InvestingAn investment in our securities involves a high degree of risk. TheseBefore deciding whether to invest in our securities, you should consider carefully the risks areand uncertainties described in the section captioned “Risk Factors” sectioncontained in our Annual Report on page 9 of this prospectus. You should also considerForm 10-K for the risk factors described or referredfiscal year ended September 30, 2021 filed with the Securities and Exchange Commission on December 28, 2021 and our Quarterly Report on Form 10-Q for the fiscal quarter ended December 31, 2021 filed with the Securities and Exchange Commission on February 14, 2022 and other filings we make with the Securities and Exchange Commission from time to in any documentstime, which are incorporated by reference herein in their entirety, together with other information in this prospectus and in an applicable prospectus supplement, before investing in these securities.the information incorporated by reference herein.

 

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

 

The date of this prospectusProspectus is      2018., 2022

 

 

 

TABLE OF CONTENTS

 

PROSPECTUS SUMMARYSummary12
Risk Factors5
The OfferingCautionary Note Regarding Forward-Looking Statements6
Use of Proceeds7
RISK FACTORSSelling Shareholder98
Description of Securities10
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTSPlan of Distribution2113
Legal Matters16
USE OF PROCEEDSExperts2116
Information Incorporated by Reference16
SELLING SHAREHOLDERSWhere You Can Find More Information21
DESCRIPTION OF THE SECURITIES WE ARE OFFERING25
PLAN OF DISTRIBUTION27
LEGAL MATTERS28
EXPERTS28
WHERE YOU CAN FIND ADDITIONAL INFORMATION28
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE2817

 

You should rely only on the information contained in this prospectus or in any related free writing prospectus filed by us with the Securities and Exchange Commission, or the SEC.

ABOUT THIS PROSPECTUS

We have not authorized anyone to provide you with any information or to make any representation notthat is different from that contained in this prospectus or incorporated by reference. We doin any free writing prospectus we may authorize to be delivered or made available to you. When you make a decision about whether to invest in our securities, you should not take any responsibility for, and can provide no assurance as to the reliability of,rely upon any information other than the information in this prospectus or in any free writing prospectus that otherswe may provideauthorize to be delivered or made available to you. Neither the delivery of this prospectus nor the sale of our securities means that the information contained in this prospectus or any free writing prospectus is correct after the date of this prospectus or such free writing prospectus. This prospectus is not an offer to sell or the solicitation of an offer to buy our securities in any jurisdiction where offers and sales are not permitted. The information in this prospectuscircumstances under which the offer or solicitation is accurate only as of its date, regardless of the time of delivery of this prospectus or any sale of common shares. You should not assume that the information contained in this prospectus or any prospectus supplement or free writing prospectus is accurate as of any date other than the date on the front cover of those documents, or that the information contained in any document incorporated by reference is accurate as of any date other than the date of the document incorporated by reference, regardless of the time of delivery of this prospectus or any sale of a security. Our business, financial condition, results of operations and prospects may have changed since those dates.unlawful.

 

For investors outside the United States: We have not done anythingtaken any action that would permit a publicthis offering of the common shares or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States. Persons outside the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of common sharesthe securities covered hereby and the distribution of this prospectus outside of the United States.

 

This prospectus contain summaries of certain provisions contained in some of the documents described herein, but reference is made to the actual documents for complete information. All of the summaries are qualified in their entirety by the full text of the actual documents, some of which have been filed or will be filed and incorporated by reference herein. See “Information Incorporated by Reference” and “Where You Can Find More Information” in this prospectus. We further note that the representations, warranties and covenants made by us in any agreement that is filed as an exhibit to any document that is incorporated by reference into this prospectus were made solely for the benefit of the parties to such agreement, including, in some cases, for the purpose of allocating risk among the parties to such agreements, and should not be deemed to be a representation, warranty or covenant to you. Moreover, such representations, warranties or covenants were accurate only as of the date when made. Accordingly, such representations, warranties and covenants should not be relied on as accurately representing the current state of our affairs.

 

This prospectus contains and incorporates by reference certain market data and industry statistics and forecasts that are based on studies sponsored by us, independent industry publications and other publicly available information. Although we believe these sources are reliable, estimates as they relate to projections involve numerous assumptions, are subject to risks and uncertainties, and are subject to change based on various factors, including those discussed under “Risk Factors” in this prospectus and under similar headings in the documents incorporated by reference herein and therein. Accordingly, investors should not place undue reliance on this information.


PROSPECTUS SUMMARY

 

This summary highlights information contained elsewhere orin this prospectus and the documents incorporated by reference in this prospectus andherein. This summary does not contain all of the information that you should consider before deciding to invest in making your investment decision.our securities. You should read this summary together withentire prospectus carefully, including the more detailed information, includingsection entitled “Risk Factors” beginning on page 5 and our consolidated financial statements and the related notes contained orand the other information incorporated by reference ininto this prospectus. You should carefully consider, among other things,prospectus before making an investment decision.

All references to the matters discussed in “Risk Factors” included elsewhereterms “Edesa Biotech,” the “Company,” “we,” “us” or “our” in this prospectus refer to Edesa Biotech, Inc., a British Columbia corporation, and its consolidated subsidiaries, unless the sections titled “Risk Factors”context requires otherwise.

This prospectus and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and related notes, each included in our Annual Report on Form 10-K for the year ended September 30, 2017, filed with the SEC on December 1, 2017, which isinformation incorporated by reference herein contain references to trademarks, service marks and trade names owned by us or other companies. Solely for convenience, trademarks, service marks and trade names referred to in this prospectus and the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our unaudited consolidated financial statements and related notes, each included in our Quarterly Reports on Form 10-Q filed with the SEC on February 7, 2018 and May 7, 2018, each of which isinformation incorporated by reference herein, before making an investment decision. You should also read and consider the information in the documents to which we have referred you in “Where You Can Find Additional Information” And “Incorporation of Certain Information by Reference.” As used in this prospectus, “Stellar,” “the Company,” “we,” “us,” and “our” refer to Stellar Biotechnologies, Inc. and our consolidated subsidiaries, except where the context otherwise requires.

Summary of Risks

Our business is subject to a number of risks and uncertainties that you should understand before making an investment decision. For example, we have a history of net losses, we expect to continue to incur net losses and we may not achieve or maintain profitability. Furthermore, we have limited cash flow to sustain our operations. We have historically relied upon the sale of common shares to help fund our operations and meet our obligations and presently expect to continue to do so in the future as and when we consider appropriate, subject to market conditions and the availability of favorable terms. In the near term 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. At present, KLH is used only for research and clinical trial purposes, and there is no commercially approved drug product or drug product submitted in a pending marketing application that incorporates KLH as an ingredient. As a result, no marketing authority has reviewed our drug master file (DMF) for KLH as a product ingredient or inspected Stellar. As of March 31, 2018, we have an accumulated deficit of $48.1 million since inception. We have incurred substantial net losses since our inception, including net losses of $5.03 million, $5.03 million and $2.84 million for the years ended September 30, 2017, 2016 and 2015, respectively. We expect to incur additional losses as we continue to invest in our research and development programs and move forward with our scale-up plans and commercialization activities. Additional risks are discussed more fully in the section entitled “Risk Factors” following this prospectus summary. These risks include, but are not limited to, the following:

·We have a history of net losses and limited cash flow to sustain our operations.

·We will require additional financing or financings in the future, including sales of our common shares, which is likely to result in substantial dilution to existing shareholders.

·We depend heavily on the success and market acceptance of KLH and we may never recoup our investment into its research and development.

·Our customers are drug developers and pharmaceutical companies, which themselves face substantial uncertainties related to regulatory approval of their products, which could reduce the market opportunity for our products.

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

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


·Our business is geographically concentrated and if a catastrophic event were to impact our facilities, our business may be disrupted which could result in serious harm to our business, results of operations and financial condition.

·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, if we decide to proceed with its development.

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

·We compete with other companies in KLH production and manufacturing that may have greater resources or manufacturing capabilities than we do.

·We rely on the significant experience and specialized expertise of our Chief Executive Officer and other members of our senior management team.

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

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

·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.

·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.

·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. 

Business Overview

Our Company

We are 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 treatments that involve using the body’s own immune system to target and treat disease. Today, multiple companies and institutions are developing drugs that combine disease-targeting agents with KLH. These disease-targeting agents do not evoke a robust immune response by themselves and thus require a carrier molecule like KLH.

The versatility 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 clinical or pre-clinical development for Alzheimer’s disease, metastatic breast cancer, type 1 diabetes, dermatomyositis, systemic lupus erythematous, ovarian cancer and 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 mollusk 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, we believe that aquaculture production methods, like the methods we practice, will be required to provide scalable, fully traceable supplies of KLH.


We produce clinical-grade KLH using Current Good Manufacturing Practices (GMP) and market and sell our 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 KLHlogos, artwork, and other technology in exchange for fees, revenuesvisual displays, may appear without the ® or royalties. Our customers manage and fund all product development and regulatory submissions for their respective drug products that utilize our KLH protein. We® symbols, but such references are in the process of upgrading and scaling our manufacturing operations and plan to produce KLH suitable for commercial drugs by the time our customers are ready to file marketing applications referencing our DMFs.

Competitive Strengths

We believe that we possess a number of competitive strengths that position us to become the world leader in the sustainable manufacture of GMP grade KLH and KLH-conjugated vaccines, including:

·Fully permitted, land-based aquaculture facility produces a barrier to market entry. Our proprietary 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 obtain water discharge permits, among other limitations, 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. 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.

·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 help build customer trust and loyalty.

·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. In addition, we have established a model via our joint venture, Neostell, S.A.S., to participate in the profits from manufacturing of KLH-conjugated vaccines.

·Intellectual property portfolio includes protection for specialized systems and technologies. We have intellectual property related to KLH development and manufacturing, including one U.S. patent and foreign counterparts, trade secrets and know-how related to specialized aquaculture systems and technologies.

·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.

·Sustainability practices protect marine source and promote scalability. Our KLH protein is produced using environmentally sound, sustainable practices intended to protect and renew the live marine source.

·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 Strategy

We intend to develop and expand the market for KLH and KLH-conjugated vaccines. Our near-term focus is to support the further development of third party 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 of product candidates utilizing our licensed KLH products. In addition to fees, revenues or royalties we may receive, we believe that the development of third-party drug candidates, if any are ultimately approved for human use, will further validate our technologies, increase awareness and promote broader adoption of our products by additional third parties. Key elements of our business strategy include:


·Expand infrastructure and capacity while prudently managing our working capital. 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.

·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.

·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 participate in the manufacture and sale of KLH-based immunotherapies for third party customers.

·Continue innovation and new product development. We plan to expand our KLH technology portfolio through ongoing research and development. We believe that these activities provide long-term strategic, revenue and clinical opportunities by potentially 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.

Our Technology

We have spent more than 15 years developing and optimizing sustainable KLH production methods, specifically focused on protection 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. Currently, our technology allows us to produce clinical-grade KLH using GMP to support our customers at their current stages of development.

Our proprietary aquaculture technology involves methods we developed and optimized to control the reproduction and growth of the Giant Keyhole Limpet. 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.

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 demand in the near term.

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. To date, we have completed process development studies and implemented new optimized manufacturing methods. We also initiated construction of approximately 10,000 square feet of renovated Pacific Ocean-front space for aquaculture production and related activities.


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 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. Our aquaculture operations include a fully permitted seawater supply and discharge system, which we believe is a competitive strength due in part to the time required and uncertainties related to the public review process required to obtain new water discharge permits in the State of California.

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, in anticipation of the increased demand for our KLH products, among other considerations.

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. 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.

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 products suitable for our customers’ Phase 1 and Phase 2 clinical studies as well as 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 are in the process of upgrading and scaling our manufacturing operations and plan to produce KLH suitable for commercial drugs by the time our customers are ready to file marketing applications referencing our DMFs.

Supply Agreements

We have entered into, and intend to continue to enter into, agreements with third parties that will allow us to supply Stellar KLH in exchange for fees, revenues or royalties. Our current supply agreements are limited to clinical trials, and typically provide us with first negotiation rights for the supply of KLH in connection with potential future commercialization of a customer’s products.

Intellectual Property and License Agreements

We hold important proprietary intellectual property related to KLH development and manufacture and to the environmental protection of the Giant Keyhole Limpet including, but not limited to, one U.S. patent and foreign counterparts and trade secrets related to specialized aquaculture systems 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.


The Offering

The following summary contains basic information about the offering and the securities the selling shareholders are offering and is not intended to be complete. It doesindicate, in any way, that we will not contain allassert, to the information that is important to you. For a more complete understandingfullest extent under applicable law, our rights or the rights of the securities the selling shareholders are offering, please referapplicable licensor to the section of this prospectus titled “Description of Securities.”

Common shares being offering by the selling shareholdersThe selling shareholders are offering up to 3,444,773 common shares consisting of (i) 1,122,076 common shares underlying outstanding Series A Common Share Purchase Warrants exercisable at $2.65 per share (subject to customary adjustments for share splits and dividends), (ii) 78,545 common shares underlying outstanding Series A Common Share Purchase Warrants exercisable at $3.3125 per share (subject to customary adjustments for share splits and dividends) and (iii) 2,244,152 common shares underlying outstanding Series B Common Share Purchase Warrants exercisable at $2.65 per share (subject to customary adjustments for share splits and dividends).
Warrant exercisability and expirationThe Series A Common Purchase Warrants are exercisable immediately and expire on May 29, 2023. The Series B Common Share Purchase Warrants are exercisable immediately and expire on December 31, 2018.
Common shares outstanding prior to this offering5,118,519 common shares as of June 1, 2018.
Common shares to be outstanding after this offering8,563,292 common shares.
Use of proceedsAll proceeds from the sale of the common shares under this prospectus will be for the account of the selling shareholders. We will not receive any proceeds from the sale of our common shares offered pursuant to this prospectus. Any proceeds received by us from the exercise of the warrants will be used for general corporate purposes, which may include working capital, capital expenditures and research and development expenses. See the section entitled “Use of Proceeds” in this prospectus.
Nasdaq Capital Market trading symbolSBOT
ListingOur common shares are listed for trading on the Nasdaq Capital Market. There is no established trading market for the warrants and we do not intend to list the warrants on any exchange or other trading or quotation system.
Risk FactorsSee “Risk Factors” on page 9 of this prospectus to read about factors you should consider before buying common shares.

The number of common shares that will be outstanding after this offering is based on 5,118,519 shares outstanding as of June 1, 2018, and excludes:

·80,787 common shares issuable upon exercise of options to purchase our common shares outstanding as of June 1, 2018 at a weighted average exercise price of $26.46 per share;
·180,805 common shares issuable upon exercise of warrants to purchase our common shares outstanding as of June 1, 2018 at an exercise price of $31.50 per share;
·147,356 additional common shares reserved as of June 1, 2018 for future issuance under our 2017 Incentive Compensation Plan;
·145,283 common shares issuable upon exercise of warrants to purchase our common shares as of June 1, 2018 at an exercise price of $3.31 per share; and
·535,295 common shares issuable upon exercise of warrants to purchase our common shares as of June 1, 2018 at an exercise price of $2.65 per share.


Implications of Being an Emerging Growth Company

As a company with less than $1.07 billion in revenue during our last fiscal year, we qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act, or JOBS Act, enacted in April 2012. An “emerging growth company” may take advantage of reduced reporting requirements that are otherwise applicable to public companies. These provisions include, but are not limited to:

·not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act;
·reduced disclosure obligations regarding executive compensation in our periodic reports, proxy statements and registration statements; and
·exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved.

We may take advantage of these provisions until September 30, 2021. However, if certain events occur prior to September 30, 2021, including if we become a “large accelerated filer,” our annual gross revenues exceed $1.07 billion or we issue more than $1.0 billion of non-convertible debt in any three-year period, we will cease to be an emerging growth company before such date.

We have elected to take advantage of certain of the reduced disclosure obligations and may elect to take advantage of other reduced reporting requirements in future filings. As a result, the information that we provide to our shareholders may be different than the information you might receive from other public reporting companies in which you hold equity interests.

Corporate Information

We operate through our wholly-owned subsidiary, Stellar Biotechnologies, Inc., a California corporation which was organized September 9, 1999. Our executive offices are located at 332 East Scott Street, Port Hueneme, California 93041. Our phone number is (805) 488-2800. Our website address is www.stellarbiotechnologies.com. The contents of our website are not part of this prospectus for any purpose or otherwise incorporated by reference. Our website address is included for information only.

Our logo, Stellar KLH™ and other trademarks, or service marks of ours appearing in this prospectus are our property. This prospectus contains additionaland trade names, trademarks and service marks of other companies.names. We do not intend our use or display of other companies’ trade names, trademarks or service marks or trademarks to imply relationshipsa relationship with, or endorsement or sponsorship of us by, theseany other companies. Other trademarks, trade names and service marks appearing in this prospectus and the documents incorporated by reference herein are the property of their respective owners.

Overview

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 monoclonal antibody therapy that we are developing as 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 has 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 poor outcomes and disease progression in COVID-19 patients. Since EB05 has demonstrated the ability to block signaling irrespective of the presence or concentration of the various molecules that frequently bind with TLR4, we believe that EB05 could ameliorate TLR4-mediated inflammation cascades in ARDS patients, thereby reducing lung injury, ventilation rates and mortality. In September 2021, an independent data and safety monitoring board preemptively unblinded the Phase 2 part of a Phase 2/3 study of EB05 in hospitalized COVID-19 patients and identified “a clinically important” mortality benefit. The monitoring board further recommended continuation of the study into a Phase 3 confirmatory trial. The Phase 2 part of the study was funded primarily by a $11 million (C$14 million) reimbursement grant that was awarded by the Canadian government's Strategic Innovation Fund (SIF) following a multi-disciplinary technical review of our drug technology and plans.

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. EB01 is currently being evaluated in a Phase 2b clinical study.

In addition to our current clinical programs, we intend to expand the utility of our technologies and clinical-stage assets across other indications.

 


7Recent Developments

 

Summary Consolidated Financial DataRegistered Direct Offering and Private Placement

On March 21, 2022, we entered into a securities purchase agreement with the selling shareholder for the issuance and sale of 1,540,000 common shares and pre-funded warrants to purchase up to an aggregate of 1,199,727 common shares in a registered direct offering (the “RD Offering”) and warrants (the “Warrants”) to purchase 2,739,727 common shares in a concurrent private placement (the “2022 Private Placement”). The public offering price was $3.65 for each common share and related Warrant and $3.6499 for each pre-funded warrant and related Warrant. The Warrants have an exercise price of $3.52 per share, were immediately exercisable upon issuance and have a term of exercise of five and one-half years. The closing of the issuance and sale of these securities was consummated on March 24, 2022. The gross proceeds from the offering, prior to deducting offering expenses and placement agent fees and expenses payable by us, were approximately $10.0 million. This prospectus covers the resale or other disposition by the selling shareholder of the common shares issuable upon the exercise of the Warrants.

Corporate Information

We were incorporated in Canada in 2007 and operate through our wholly-owned subsidiaries, Edesa Biotech Research, Inc., an Ontario corporation incorporated in 2015, formerly known as Edesa Biotech Inc., which we acquired on June 7, 2019, and Edesa Biotech USA, Inc., a California, corporation founded in 1999, formerly known as Stellar Biotechnologies, Inc. prior to November 2020, which we acquired on April 9, 2010. Our common shares are traded on the Nasdaq Capital Market under the symbol “EDSA”. Our executive offices are located at 100 Spy Court, Markham, Ontario L3R 5H6 Canada and our telephone number at this location is (289) 800-9600. Our website address is www.edesabiotech.com. The information contained on, or that can be accessed through, our website is not a part of this prospectus. Our trademarks and trade names include, but may not be limited to, “Edesa Biotech,” and the Edesa logo.


The Offering

This prospectus relates to the resale or other disposition from time to time by the selling shareholder identified in this prospectus of up to 2,739,727 common shares issuable upon exercise of the Warrants. None of the shares registered hereby are being offered for sale by us.

Common shares offered by the selling shareholderUp to 2,739,727 common shares issuable upon exercise of the Warrants.
Common shares outstanding after this offering18,202,014 shares, assuming the exercise in full of the Warrants.
Use of proceedsWe will not receive any proceeds from the common shares offered by the selling shareholder under this prospectus. However, we will receive the proceeds of any cash exercise of the Warrants. We intend to use the net proceeds from any cash exercise of the Warrants for working capital and general corporate purposes. See “Use of Proceeds.”
Listing InformationOur common shares are listed on the Nasdaq Capital Market under the symbol “EDSA.”
Risk FactorsAn investment in our securities involves a high degree of risk. Before deciding whether to invest in our securities, you should consider carefully the risks and uncertainties described in the section captioned “Risk Factors” contained in our Annual Report on Form 10-K for the fiscal year ended September 30, 2021 filed with the Securities and Exchange Commission on December 28, 2021 and our Quarterly Report on Form 10-Q for the fiscal quarter ended December 31, 2021 filed with the Securities and Exchange Commission on February 14, 2022 and other filings we make with the Securities and Exchange Commission from time to time, which are incorporated by reference herein in their entirety, together with other information in this prospectus and the information incorporated by reference herein. 

 

The summary data presented below for eachnumber of common shares to be outstanding upon completion of this offering is based on 15,462,287 of our common shares outstanding as of April 7, 2022 and excludes, as of that date, the yearsfollowing:

2,261,334 of our common shares issuable upon exercise of outstanding options granted under our equity incentive plans at a weighted average exercise price of $4.70 per share;

364,617 of our common shares available for issuance or future grant pursuant to our equity incentive plan;

912,226 of our common shares issuable upon exercise of outstanding warrants at a weighted average exercise price of $5.46 per share; and

1,199,727 of our common shares issuable upon exercise of outstanding pre-funded warrants at a weighted average exercise price of $0.0001 per share.


RISK FACTORS

An investment in our securities involves a high degree of risk. Before deciding whether to invest in our securities, you should consider carefully the risks and uncertainties described in the three-year period ended September 30, 2017 have been derived from our consolidated financial statements, which financial statements have been audited by Moss Adams LLP, an independent registered public accounting firm. The historical financial data for the six months ended March 31, 2018 and 2017 has been derived from our unaudited condensed interim consolidated financial statements. You should read the summary of our consolidated financial data set forth below together with the more detailed informationsection captioned “Risk Factors” contained in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financial statements and the related notes, each included in our Annual Report on Form 10-K for the fiscal year ended September 30, 2017,2021 filed with the SECSecurities and Exchange Commission on December 1, 2017, which is incorporated by reference herein.

  Six Months Ended 
  

March 31,

2018

  

March 31,

2017

 
Revenues:        
Product sales $84,539  $154,875 
Contract services revenue  -   50,000 
Total revenues  84,539   204,875 
         
Loss from Operations  (2,733,736)  (2,562,033)
         
Net Loss $(2,753,273) $(2,589,349)
         
Loss per common share:        
Basic and diluted $(1.83) $(1.79)
Weighted average number of common shares outstanding:        
Basic and diluted  1,502,870   1,448,036 

  Fiscal Year Ended 
  

September 30,

2017

  

September 30,

2016

  

September 30,

2015

 
          
Revenues:            
Product sales $178,287  $1,239,689  $563,689 
Contract services revenue  50,000   32,000   195,000 
Total revenues  228,287   1,271,689   758,689 
             
Loss from Operations  (5,224,546)  (4,908,356)  (4,338,592)
             
Net Loss $(5,030,648) $(5,026,080) $(2,843,029)
             
Loss per common share:            
Basic and diluted $(3.44) $(3.99) $(2.50)
Weighted average number of common shares outstanding:            
Basic and diluted  1,462,459   1,260,902   1,136,709 

8

RISK FACTORS

Investing in28, 2021 and our securities involves a high degree of risk. You should carefully consider the risks and uncertainties set forth below, together with all of the other information set forth in this prospectus and incorporated by reference, before investing in our securities. If any of these risks actually occur, our business, financial condition, results of operations and future prospects could be materially and adversely affected. In that event, the price of our securities could decline, and you could lose part or all of your investment.

Risks Related to this Offering and Ownership of Our Securities

An investment in our common shares is extremely speculative and there can be no assurance of any returnQuarterly Report on any such investment.

An investment in our common shares is extremely speculative and there is no assurance that investors will obtain any return on their investment. Investors will be subject to substantial risks involved in an investment in us, including the risk of losing their entire investment.

The price of our common shares may be subject to substantial volatility.

Although our common shares are listed on 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” for our common shares, the market price for our common shares may fluctuate significantly more than the stock market as a whole. Without a large float, our common shares would be less liquid than the stock of companies with broader public ownership and, as a result, the trading price of our common shares may be more volatile.

Furthermore, the stock market is subject to significant price and volume fluctuations, and the price of our common shares has been in the past, and may continue in the future to be subject to wide fluctuations in response to several factors, including:

·our quarterly or annual operating results;
·our cash 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;
·changes 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 where we transact business.

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 may not be an active, liquid trading market for our common shares.

There is no guarantee that an active trading market for our common shares will 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. 

Without a Nasdaq listing, shareholders may have a difficult time getting a quoteForm 10-Q for the sale or purchase of our shares, the sale or purchase of our shares would likely be made more difficult, and the trading volume and liquidity of our shares could decline. Delisting from Nasdaq could also result in negative publicity and could make it more difficult for us to raise additional capital. If our common shares are delisted by Nasdaq, our common shares may be eligible to trade on an over-the-counter quotation system where an investor may find it more difficult to sell our shares or obtain accurate quotations as to the market value of our common shares. We cannot assure you that our common shares, if delisted from Nasdaq, will be listed on another national securities exchange or quoted on an over-the-counter quotation system.

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 at least the next twelve months with cash on hand and product sales, management expects to continue incurring losses for the foreseeable future and may need to raise additional capital to pursue our business plan. 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 or cease 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 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.


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 BCBCA 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 Our Business

We have a history of net losses and limited cash flow to sustain our operations.

We currently have limited revenue from product sales of Stellar KLH, and anticipate our planned total 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. As of Marchquarter ended December 31, 2018, we have an accumulated deficit of $48.1 million since inception. To date, we have not paid dividends on our common shares and do not anticipate doing so in the foreseeable future. We have historically relied upon the sale of common shares to help fund our operations and meet our obligations. Any future additional equity financing would cause dilution to current shareholders. If we do not have sufficient capital for our operations, management would be forced to reduce or discontinue our activities, which would have a negative effect on our operations and financial condition.

We depend heavily on the success and market acceptance of Stellar KLH and we may never recoup our investment into its research and development.

We have invested a significant portion of our time and financial resources into the development of Stellar KLH. We anticipate that in the near term 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; 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, which are currently under development. The pharmaceutical industry is subject to significant government regulation, which varies from country to country. None of the products being developed by our customers that utilize our Stellar KLH are approved for commercial sale or have been submitted in a marketing application where our KLH DMF was reviewed by a regulatory authority. Before regulatory approvals for the commercial sale of any drug is granted, 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 customers’ 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 our KLH is referenced in a pending marketing application or regulatory approval is granted for any drug or product that utilizes Stellar KLH, it will be subject to ongoing regulatory requirements, which include registration, manufacturing, labeling, advertising and promotion, packaging, distribution, record keeping and reporting, and storage. Because Stellar’s KLH has not been part of a marketing application where our DMF was reviewed, no regulatory authority has inspected Stellar or its manufacturing operations. 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.


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 disrupted which could result in serious harm to 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;
·Neovacs’ products may not receive regulatory approval, have not received regulatory approval to date, and even if they do, they may not be commercially successful;
·we may experience difficulties and delays in manufacturing and production at Neostell;
·we may experience difficulties in manufacturing KLH suitable for 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.

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, including the development of regional marine resources, aquaculture and raw material processing for Stellar’s KLH products, in anticipation of the increased demand for our KLH products, among other considerations. 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 and similar anti-corruption laws outside the U.S. Global enforcement of anti-corruption laws has increased substantially in recent years, with more enforcement proceedings by U.S. and foreign governmental agencies and the imposition of significant fines and penalties. While we have implemented policies and procedures to enhance compliance with these laws, our international operations create the risk that there may be unauthorized payments or offers of payments made by employees, consultants, sales agents or distributors. Any alleged or actual violations of these laws may subject us to government investigations, significant criminal or civil sanctions and other liabilities, and negatively affect our reputation.

Our sales in international markets subject us to foreign currency exchange 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 and financial condition.

We compete with other companies in KLH production and manufacturing that may have greater resources than we do.

The immunotherapy industry is rapidly evolving 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, 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. Some of 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.


We 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 range of the Giant Keyhole Limpet in the wild is limited, and due to the lack of a regulated harvest, the wild stocks of Giant Keyhole Limpets are believed 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 that are GMP compliant. We may encounter difficulties in production or meeting GMP standards, 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, we contract with third party vendors, including contract testing organizations and contract manufacturing organizations for testing of our products and for certain steps in the manufacture of some our products, and may be unable to monitor and establish or 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 and vialing. 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 for the development and sales of Stellar KLH.

In conducting our research and development and commercialization activities, we currently rely, and expect to continue to rely, on collaboration 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 who are subject to regulatory, competitive and other risks, under their respective agreements or arrangements with us, would substantially disrupt or delay our research and development and commercialization activities, including potential commercial sales. Any such loss would likely increase our expenses and materially harm our business, financial condition and results of operation.

We have limited marketing, sales and distribution experience and capabilities. We will need to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our products.

We currently have limited experience in the marketing, sales and distribution of KLH products. Depending on market acceptance of our Stellar KLH products, we may need to expand our capabilities. We may not be able to establish such additional capabilities in-house, and then will need to enter into agreements with third parties to successfully perform these tasks. If we contract or make arrangements with third parties for the sales and marketing of our products, our revenues will be dependent on the efforts of these third parties, whose efforts may not be successful. If we market any of our products directly, we must either internally develop or acquire a marketing and sales force, which would require substantial resources and management attention.


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

Our ability to be successful in the highly competitive biotechnology and pharmaceutical industries depends 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 expertise 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 our future growth needs. We may not be able to attract and retain necessary team members to operate our business.

In addition, our future success depends 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 will need to hire additional personnel 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 leave or be unable to fill new positions, as they become available, requiring key persons with appropriate experience. 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 may 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, we may not be able to obtain or maintain sufficient and affordable insurance coverage for all claims that may occur. The cost of any product liability litigation or other proceeding, even if resolved in our favor, could be substantial. In addition, our inability to obtain or maintain sufficient insurance coverage at an acceptable cost or to otherwise protect against potential product liability claims could prevent or inhibit the development and commercial production and sale of our products, which could adversely affect our business, financial condition and results of operations.

Our activities are subject to regulation in the United States and in the foreign jurisdictions in which we operate. Failure to comply with applicable laws and regulations could adversely impact our operations.

Our operations, including our aquaculture and harvesting activities, and our production activities, are subject to regulation at the local, state and federal levels in the United States by a number of regulatory agencies including, but not limited 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, we may be subject to a variety of foreign regulations related to research, manufacturing, and the commercial sales and distribution of our products, to the extent we choose to manufacture, sell or distribute any products outside of the United States, such as Mexico. If we are unable to comply with laws and regulations in the United States and elsewhere, 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 materials and products, are subject to federal, state and local laws, rules, regulations and policies governing the use, generation, manufacture, storage, air emission, effluent discharge, handling and disposal of certain materials, biological specimens and wastes. We 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.


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 depends on our ability to protect our intellectual property, including by obtaining patent protection in the United States and other countries, or through protection of our trade secrets, including unpatented know-how, technology and other proprietary information. When appropriate, we seek to protect our proprietary position by filing patent applications in the United States 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 regards to our business or to protect or enforce our patents, it may involve substantial expenditures 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 technologies that are patentable.

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

In addition, some of our technologies are not covered by any patent application 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 protect our intellectual property rights and may be found to have violated the intellectual property rights of others if we continue to operate in the absence of a patent issued to us. Many of the substantive changes to patent law associated 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 operation of our business. However, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense 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 lead 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, and will likely continue to make, changes in how the patent laws 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. We have never, and may never, seek to enforce our U.S. patent. 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. We also rely on trade secrets, know-how, continuing technological innovation, and in-licensing opportunities to develop and maintain our proprietary position.

We plan to file other international patent applications directed to patentable features 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 invalidated 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 damages 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.

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.

Competitors may infringe our patents or patent applications, 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. Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe their patents or claiming that our patents are invalid or unenforceable. Grounds for 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 as ex parte reexaminations, inter partes review, 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, in a patent infringement proceeding, a court may decide that our patent applications or patents, if issued, are invalid or unenforceable, in whole or in part, construe the patent’s claims narrowly, or refuse to stop the other party from using the technology at issue on the grounds that our patent applications do not cover the technology. An adverse result in any litigation proceeding could put one or more of our patents at risk of being invalidated or interpreted narrowly.

Our trade secrets are difficult to protect and misappropriation could reduce the market for our products.

We may not be able to obtain adequate remedies for the unauthorized use or disclosure of our proprietary information, including our trade secrets. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time consuming, and the outcome is unpredictable. 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 were to be disclosed to or independently developed by a competitor, our competitive position could be harmed.

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 effect on the success of our business.

Our success depends, in part, on our ability to operate without infringing the patents and other proprietary intellectual property rights of third parties. This is generally referred 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, both in the United States and internationally, involve complex legal and factual questions. As a result, such proceedings are lengthy, costly and time-consuming, and their outcome is highly uncertain. We 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, methods or other claims, we may have to participate in an adversarial proceeding, such as an interference or derivation proceeding in the USPTO or similar proceedings in other countries, to determine the priority of invention. In the event an infringement claim is brought against us, 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 injunctions or damage awards.

In the future, the USPTO 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 determined that we have infringed an issued patent and do not have the freedom to operate, we could be subject to injunctions, and compelled to pay significant damages, including punitive damages, which could harm our business.

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 efforts 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 outcome could have a material adverse effect on our business. Even if we are successful in defending against these claims, litigation could result in substantial cost and be a distraction to our management and employees.

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, as amended (the “Securities Act”), (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 which we are deemed to be a large accelerated filer, which means the market value of our common shares that is held by non-affiliates exceeded $700 million as of the prior March 31st and (ii) 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 became a reporting company following the effectiveness of our Form 20-F,2021 filed with the Securities and Exchange Commission on February 3, 2012, our first sale of common equity securities pursuant to an effective registration statement under14, 2022 and other filings we make with the Securities Act of 1933 was July 6, 2016. We may chooseand Exchange Commission from time to take advantage of some but not alltime, which are incorporated by reference herein in their entirety, together with other information in this prospectus and the information incorporated by reference herein. If any of these reduced reporting burdens.risks actually occurs, our business, financial condition, results of operations or cash flow could suffer materially. In such event, the trading price of our common shares could decline, and you might lose all or part of your investment.

 


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 Securities Exchange Act of 1934, as amended (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.


SPECIALCAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This prospectus and the documents we incorporateincorporated herein by reference contain “forward-looking statements” made pursuant to the safe-harbor provision of the U.S. Private Securities Litigation Reform Act of 1995, which reflect our current expectations regarding future events. All statements other than statements of historical facts included in or incorporated by reference into this prospectus contain certainthat address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. Our forward-looking statements within the meaninggenerally include statements about our plans, objectives, strategies and prospects regarding, among other things, our businesses, results of Section 27A of the Securities Actoperations, liquidity and Section 21E of 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. 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 identifyfinancial condition. In some cases, we have identified these forward-looking statements as those statements containing thewith words “anticipate,”like “believe,” “plan,“may,“estimate,“could,” “might,” “possible,” “potential,” “project,” “will,” “should,” “expect,” “intend,” “may,“plan,“will,“predict,“would,“anticipate,“could,“estimate,“should,“approximate,“might,“contemplate” or “continue,“potential,” “continue”or the negative of these words or other words and terms of similar expressions.

Specifically, this prospectus containsmeaning. Known and unknown risks and uncertainties could cause our actual results to differ materially from those in forward-looking statements regarding:statements. Such risks include, but are not limited to, the following:

 

·our aquaculture production methods;
·our competitive strengths, including, strengths over market entrants and current and potential competitors, quality of product, supply and collaboration agreements and business model;
·our ability to developobtain funding for our operations;

our estimates regarding our expenses, revenues, anticipated capital requirements and expand the marketour needs for KLH and its uses;additional financing;

·the expansiontiming of the commencement, progress and receipt of data from any of our infrastructurepreclinical and manufacturing capabilities and continued commercial growth and research and development;clinical trial

·the broader applicationexpected results of KLHany preclinical or clinical trial and the impact on the likelihood or timing of any regulatory approval;

the therapeutic benefits, effectiveness and safety of our product candidates

the timing or likelihood of regulatory filings and approvals;

changes in other markets;our strategy or development 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 scale capacity to meet anticipated customer demand;protect our intellectual property as well as comply with the terms of license agreements with third parties;

·the proprietary nature of our locations in California and in Mexico and the relative availability and success of each;
·our ability to finance company operations with cashidentify, develop and commercialize additional products or product candidates;

reliance on hand and product sales;
·our financial success;key personnel; and

·our ability to attractgeneral changes in economic or business conditions, including those caused by COVID-19 and retain talented employees.its variants.

 

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, uncertaintiesMore detailed information about these and other unpredictable factors manyis included under “Risk Factors” in this and in other documents incorporated herein by reference. Many of whichthese factors are beyond our control. Our actual results could differ materially and adverselyFuture events may vary substantially from those expressedwhat we currently foresee. You should not place undue reliance on such forward-looking statements. This offering is not available to residents of Canada or persons or entities in anyCanada. We are under no obligation to update or alter such forward-looking statements whether as a result of various factors, some of which are listed under the “Risk Factors” section and elsewhere in this prospectus. Risks and uncertainties include, among others, the availability of funds and resourcesnew information, future results, events, developments or otherwise, unless required to pursue our research and development projects, the successful and timely completion of preclinicaldo so by a governmental authority or clinical studies by third parties in which our products are utilized, our abilityapplicable law. We advise you, however, to meet the goals of our joint ventures 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, changesreview any further disclosures we make on related subjects in our strategy or development plans, our ability to protect our intellectual property, uncertainties related to governmental regulations and regulatory processes,most recent Annual Report on Form 10-K, as well as any amendments thereto reflected in subsequent filings with the volatility of our common share price, the effect of competition, the effect of technological changes, reliance on key personnel, and general changes in economic or business conditions. Except as required by law, we undertake no obligation to update forward-looking statements.SEC.

 


USE OF PROCEEDS

 

We will not receive any proceeds from the sale of common shares offered by the selling shareholder under this prospectus. However, we will receive the proceeds of any cash exercise of the Warrants. If all of the Warrants were exercised for cash, we would receive aggregate proceeds of approximately $9.6 million. We intend to use the net proceeds from any cash exercise of the Warrants for working capital and general corporate purposes.


SELLING SHAREHOLDER

This prospectus covers the resale or other disposition by the selling shareholder identified in the table below of up to an aggregate of 2,739,727 of our common shares by the selling shareholders. We cannot predict when or if the warrants will be exercised, and it is possible that the warrants may expire and never be exercised. Any proceeds received by us from the exercise of the warrants will be used for general corporate purposes, which may include working capital, capital expenditures, and research and development expenses.

We have not yet determined the amount of net proceeds to be used specifically for any of the foregoing purposes. Accordingly, our management will have significant discretion and flexibility in applying the net proceeds from the exercise of the warrants. Pending any use, as described above, we intend to invest the net proceeds in high-quality, short-term, interest-bearing securities.

SELLING SHAREHOLDERS

In May 2018, we issued warrants in a private placement financing to “accredited investors” as defined in Rule 501(a) under the Securities Act pursuant to an exemption from registration under the Securities Act, including warrants issued to a placement agent in connection with the private placement. The Series A Common Share Purchase Warrants (the “Series A Warrants”) became exercisable as of May 29, 2018, with an exercise period of five years. 1,122,076 Series A Warrants are exercisable at a price of $2.65 per share (subject to customary adjustments for share splits and dividends) and 78,545 Series A Warrants are exercisable at $3.3125 per share (subject to customary adjustments for share splits and dividends). The Series B Common Share Purchase Warrants (the “Series B Warrants”) became exercisable as of May 29, 2018, with an exercise period of seven months, at an exercise price of $2.65 per share (subject to customary adjustments for share splits and dividends).


We have agreed to register for resale the common shares underlying the Series A Warrants and the Series B Warrants (the “Warrant Shares”) under the Securities Act. Pursuant to the warrant exercise agreements with certain purchasers of the warrants (the “Exercise Agreements”), we have agreed to file a registration statement covering the Warrant Shares and have agreed to use commercially reasonable efforts to cause such registration statement to become effective (the “Registration Rights”). The resale registration statement, of which this prospectus is a part, when declared effective by the SEC, permits the resale of the Warrant Shares by the selling shareholders and their permitted assigns into the market from time to time over an extended period. Such registration statement has been filed pursuant to the Registration Rights to register the common shares the selling shareholders listed in the table below may acquireissuable upon the exercise of our outstanding Warrants.

The selling shareholder acquired its securities in the Series Atransactions described above under the heading “Prospectus Summary – Recent Developments – Registered Direct Offering and Private Placement.”

The Warrants and Series Bheld by the selling shareholder contain limitations which prevent the holder from exercising such Warrants without regardif such exercise would cause the selling shareholder, together with certain related parties, to any restrictions orbeneficially own a number of common shares which would exceed 4.99% of our then outstanding common shares following such exercise, excluding for purposes of such determination, common shares issuable upon exercise of the Warrants which have not been exercised.

The table below sets forth, as of April 4, 2022, the following information regarding the selling shareholder:

the name of the selling shareholder;

the number of common shares owned by the selling shareholder prior to this offering, without regard to any beneficial ownership limitations contained in the Warrants and the Pre-funded Warrants (as defined below);

the number of common shares to be offered by the selling shareholder in this offering;

the number of common shares to be owned by the selling shareholder assuming the sale of all of the common shares covered by this prospectus; and

the percentage of our issued and outstanding common shares to be owned by the selling shareholder assuming the sale of all of the common shares covered by this prospectus based on the number of common shares issued and outstanding as of April 4, 2022.

Except as described above, the number of common shares issuable upon exercise thereof.beneficially owned by the selling shareholder has been determined in accordance with Rule 13d-3 under the Exchange Act and includes, for such purpose, common shares that the selling shareholder has the right to acquire within 60 days of April 4, 2022.

 

When we referAll information with respect to the common share ownership of the selling shareholdersshareholder has been furnished by or on behalf of the selling shareholder. We believe, based on information supplied by the selling shareholder, that except as may otherwise be indicated in this prospectus, we mean those persons listedthe footnotes to the table below, the selling shareholder has sole voting and dispositive power with respect to the common shares reported as beneficially owned by it. Because the selling shareholder identified in the table below, as well as the permitted transferees, pledgees, donees, assignees, successors and others who later come to hold any of the selling shareholders’ interests other than through a public sale.

The selling shareholders may from time to time offer and sell pursuant to this prospectus anysome or all of the common shares set forth inbeneficially owned by it and covered by this prospectus, and because there are currently no agreements, arrangements or understandings with respect to the following table. There is no requirement for the selling shareholders to sell their shares, and we do not know when, or if, or in what amount the selling shareholders may offersale of any of the common shares, no estimate can be given as to the number of common shares available for sale pursuant to this prospectus.

The table below has been prepared based on the information furnished to usresale hereby that will be held by the selling shareholders asshareholder upon termination of June 1, 2018. Thethis offering. In addition, the selling shareholders identified belowshareholder may have sold, transferred or otherwise disposed of, some or allmay sell, transfer or otherwise dispose of, theirat any time and from time to time, the common shares since the date on which the information in the following table is presentedthey beneficially own in transactions exempt from or not subject to the registration requirements of the Securities Act. Information concerningAct after the date on which they provided the information set forth in the table below. We have, therefore, assumed for the purposes of the following table, that the selling shareholders may change from time to time and, if necessary, weshareholder will supplementsell all of the common shares owned beneficially by it that are covered by this prospectus, accordingly. We are unable to confirm whether the selling shareholdersbut will in factnot sell any other common shares that they presently own. The selling shareholder has not held any position or all of their common shares.

To our knowledge and except as noted below, none of the selling shareholdersoffice, or has or within the past three years hasotherwise had anya material relationshipsrelationship, with us or any of our affiliates. Each selling shareholder who is also an affiliate ofsubsidiaries within the past three years other than as a broker dealer, as noted below, has represented that: (1) the selling shareholder purchased in the ordinary course of business; and (2) at the time of purchaseresult of the securities being registered for resale, the selling shareholder had no agreementsownership of our common shares or understandings, directly or indirectly, with any person to distribute theother securities.

 


  Beneficial Ownership Before This Offering  

Shares

Underlying

  Beneficial Ownership After This Offering 
Selling Shareholders 

Number of

Shares Owned

  Percentage  

Warrants

Offered

Hereby

  

Number of

Shares

Owned(1)

  Percentage(1) 

Anson Investments Master Fund LP(2)
190 Elgin Ave

George Town, Grand Cayman KY1-9005

Cayman Islands

  527,297(3)  4.99%  169,114   358,183   4.14%

Intracoastal Capital, LLC(4)
245 Palm Trail

Delray Beach, Florida 33483

  1,624,200(5)  9.99%  1,170,000   453,200   5.23%
Sabby Volatility Warrant Master Fund, Ltd.
c/o Ogier Fiduciary Services (Cayman) Limited
89 Nexus Way, Camana Bay
Grand Cayman KY1-9007
Cayman Islands(6)
  707,555(7)  4.99%  498,114   209,441   2.45%

Mark Viklund*
430 Park Avenue, 3rd Floor

New York, New York

  6,714(8)  *   2,356   4,358   * 

Noam Rubenstein*
430 Park Avenue, 3rd Floor

New York, New York

  56,704(9)  1.10%  24,742   31,962   * 

Charles Worthman*
430 Park Avenue, 3rd Floor

New York, New York

  2,238(10)  *   785   1,453   * 

Michael Vasinkevich*
430 Park Avenue, 3rd Floor

New York, New York

  144,370(11)  2.74%  50,662   93,708   1.1%

*Less than 1% 

Name of Selling Shareholder Shares
Owned
prior to
Offering
  Shares
Offered
by this
Prospectus
  Shares
Owned after
Offering
  Percentage of
Shares
Beneficially Owned after Offering (1)
 
Armistice Capital Master Fund Ltd. (2)  5,378,004   2,739,727   2,638,277   9.99%
                 

 

(1)AssumesPercentage is based on 15,462,287 common shares outstanding as of April 4, 2022, assuming the resale of all of the common shares covered by this prospectus and giving effect to the 9.99% beneficial ownership blockers in the Pre-Funded Warrants (as defined below).  
(2)Consists of (i) 1,438,550 common shares, (ii) pre-funded warrants to purchase up to 1,199,727 common shares (the “Pre-Funded Warrants”), and (iii) Warrants to purchase up to 2,739,727 common shares (the “Warrants”).  The exercise of the Warrants and the Pre-Funded Warrants held by Armistice Capital Master Fund Ltd. (the “Master Fund”) are subject to a 4.99% beneficial ownership limitation and a 9.99% beneficial ownership limitation, respectively, which prohibit the Master Fund from exercising any portion of those warrants to the extent that, following such exercise, the Master Fund would own a number of our common shares exceeding the applicable beneficial ownership limitation.  The number of shares listed in the second and fourth columns are based on the number of common shares, Warrants and Pre-Funded Warrants held by the Master Fund, assuming exercise in full of the Warrants and Pre-Funded Warrants without regard to any limitations on exercise, but the percentage set forth in the fifth column is limited by the 9.99% beneficial ownership blockers in the Pre-Funded Warrants.  The securities are directly held by the Master Fund, a Cayman Islands exempted company, and may be deemed to be sold in this offering are sold.

(2)Votingindirectly beneficially owned by Armistice Capital, LLC (“Armistice”), as the investment manager of the Master Fund; and investment power over(ii) Steven Boyd, as the shares held by Anson Investments Master Fund LP is exercised by the co-investment advisors to Anson Investments Master Fund LP. The co-investment advisorsManaging Member of Anson Investments Master Fund LP consist of Anson Advisors IncArmistice.  Armistice and Anson Funds Management LP. Anson Advisors Inc and Anson Funds Management LP. Bruce Winson is the managing member of Anson Management GP LLC, which is the general partner of Anson Funds Management LP. Moez Kassam and Amin Nathoo are directors of Anson Advisors Inc. Mr. Winson, Mr. Kassam and Mr. Nathoo eachSteven Boyd disclaim beneficial ownership of the common sharesreported securities except to the extent of their respective pecuniary interest therein.

(3)

This amount includes 259,516 common shares issuable upon the exercise  The address of warrants (the “Anson Warrants”), which are currently exercisable. The Anson Warrants, pursuant to their terms, may not be exercised to the extent such exercise would cause the holder, together with its affiliates and attribution parties, to beneficially own a number of common shares which would exceed 4.99% of our then outstanding common shares following such exercise, excluding for purposes of such determination common shares issuable upon exercise of such warrants which have not been exercised.

Armistice Capital Master Fund Ltd. is c/o Armistice Capital, LLC, 510 Madison Avenue, 7th Floor, New York, NY 10022.

 


(4)Voting and investment power over the shares held by Intracoastal Capital, LLC (“Intracoastal”) is exercised by the co-managers of Intracoastal, Mitchell P. Kopin and Daniel P. Asher. As a result, Mr. Kopin and Mr. Asher may be deemed to have beneficial ownership of (as determined under Section 13(d) of the Exchange Act) of the common shares that are held by Intracoastal.

(5)

This amount includes 1,274,300 common shares issuable upon the exercise of warrants (the “Intracoastal Warrants”), which are currently exercisable. The Intracoastal Warrants, pursuant to their terms, may not be exercised to the extent such exercise would cause the holder, together with its affiliates and attribution parties, to beneficially own a number of common shares which would exceed 4.99 or 9.99% of our then outstanding common shares following such exercise, excluding for purposes of such determination common shares issuable upon exercise of such warrants which have not been exercised.

(6)Voting and investment power over the shares is held by Hal Mintz.

(7)This amount includes 498,114 common shares issuable upon the exercise of warrants (the “Sabby Warrants”), which are currently exercisable. The Sabby Warrants, pursuant to their terms, may not be exercised to the extent such exercise would cause the holder, together with its affiliates and attribution parties, to beneficially own a number of common shares which would exceed 4.99% of our then outstanding common shares following such exercise, excluding for purposes of such determination common shares issuable upon exercise of such warrants which have not been exercised.

(8)This amount includes 6,714 common shares issuable upon the exercise of warrants (the “Viklund Warrants”), which are currently exercisable. The Viklund Warrants, pursuant to their terms, may not be exercised to the extent such exercise would cause the holder, together with its affiliates and attribution parties, to beneficially own a number of common shares which would exceed 4.99% of our then outstanding common shares following such exercise, excluding for purposes of such determination common shares issuable upon exercise of such warrants which have not been exercised.

(9)This amount includes 56,704 common shares issuable upon the exercise of warrants (the “Rubenstein Warrants”), which are currently exercisable. The Rubenstein Warrants, pursuant to their terms, may not be exercised to the extent such exercise would cause the holder, together with its affiliates and attribution parties, to beneficially own a number of common shares which would exceed 4.99% of our then outstanding common shares following such exercise, excluding for purposes of such determination common shares issuable upon exercise of such warrants which have not been exercised.

(10)This amount includes 2,238 common shares issuable upon the exercise of warrants (the “Worthman Warrants”), which are currently exercisable. The Worthman Warrants, pursuant to their terms, may not be exercised to the extent such exercise would cause the holder, together with its affiliates and attribution parties, to beneficially own a number of common shares which would exceed 4.99% of our then outstanding common shares following such exercise, excluding for purposes of such determination common shares issuable upon exercise of such warrants which have not been exercised.

(11)This amount includes 144,370 common shares issuable upon the exercise of warrants (the “Vasinkevich Warrants”), which are currently exercisable. The Vasinkevich Warrants, pursuant to their terms, may not be exercised to the extent such exercise would cause the holder, together with its affiliates and attribution parties, to beneficially own a number of common shares which would exceed 4.99% of our then outstanding common shares following such exercise, excluding for purposes of such determination common shares issuable upon exercise of such warrants which have not been exercised.

(12)Those shareholders shown with an asterisk (*) after their name in the “Selling Shareholders” column are registered broker-dealers or affiliates of broker-dealers.

Beneficial ownership of shares and percentage ownership are determined in accordance with the SEC’s rules and are based on 5,118,519 common shares issued and outstanding as of June 1, 2018. In calculating the number of shares beneficially owned by an individual or entity and the percentage ownership of that individual or entity, shares underlying options or warrants that are either currently exercisable or exercisable within 60 days from the date of this prospectus are deemed outstanding. These shares, however, are not deemed outstanding for the purpose of computing the percentage ownership of any other individual or entity.

24

DESCRIPTION OF SECURITIES WE ARE OFFERING

 

The selling shareholders are offering 3,444,773Description of our common shares. The following is a brief description of the securities the selling shareholders are offering. This summary does not purport to be complete in all respects. This description is subject to and qualified entirely by the terms of our Amended and Restated Articles, which we refer to as our Articles, copies of which have been filed with the Commission and are also available upon request from us.

CommonCapital Shares

 

We are authorized to issue an unlimited number of common shares, no par value, and preferred shares, no par value. As of June 1, 2018, we had 5,118,519April 7, 2022, there were 15,462,287 common shares issuedoutstanding and outstanding. Holders of our commonno preferred shares are entitled to one vote per share on all matters to be voted upon by our shareholders. Our Articles do not authorize cumulative voting. A majority of two-thirds of the votes cast is required for the passage of a special resolution or a special separate resolution.outstanding.

Common Shares

 

The holders of our common shares are entitled to one vote for each share held of record on all matters submitted to a vote of the shareholders. Our shareholders do not have cumulative voting rights in the election of directors. Subject to preferences that may be applicable to any outstanding preferred shares, the holders of common shares are entitled to receive ratably only those dividends if any, as may be declared from time to time by our Boardboard of Directorsdirectors out of funds legally available for the payment of dividends, subject to the rights of any series of preferred shares. In the event of afunds. Upon our liquidation, dissolution or winding up, the holders of our common shares are entitled to share ratably in all assets remaining after payment of liabilities and the preferential amounts, ifliquidation preferences of any to which the holdersoutstanding preferred shares. Holders of our preferred shares, if any, are entitled. Our common shares have no preemptive conversion or other subscription or conversion rights. There are no redemption or sinking fund provisions applicable to our common shares. All of ourCommon shares outstanding, common sharesand to be issued, are, and will be, fully paid and non-assessable. Additional shares of authorized common shares may be issued, as authorized by our board of directors from time to time, without shareholder approval, except as may be required by applicable stock exchange requirements.

 

DescriptionCertain Provisions of Outstanding Warrants to Purchase Common Shares pursuant to which the Warrant Shares may be IssuedOur Charter Documents and British Columbia Law

 

Anti-takeover Provisions of our Articles

In addition to the board of directors’ ability to issue preferred shares, our Articles, as amended, contain other provisions that are intended to enhance the likelihood of continuity and stability in the composition of our board of directors and which may have the effect of delaying, deferring or preventing a future takeover or change in control of our Company unless such takeover or change in control is approved by our board of directors. These provisions include a supermajority vote requirement for business combinations.

Advance Notice Procedures for Shareholder Proposals

Effective October 31, 2013, our board of directors adopted an advance notice policy (the “Advance Notice Policy”) with immediate effect for the purpose of providing our shareholders, directors and management with a clear framework for nominating our directors in connection with any annual or special meeting of shareholders. The following summary of certain terms and provisionsAdvance Notice Policy was approved by the shareholders at our annual meeting on February 13, 2014.

Purpose of the Series A WarrantsAdvance Notice Policy. Our directors are committed to: (i) facilitating an orderly and Series B Warrantsefficient annual general or, where the need arises, special meeting, process; (ii) ensuring that all shareholders receive adequate notice of the director nominations and sufficient information with respect to all nominees; and (iii) allowing shareholders to register an informed vote having been afforded reasonable time for appropriate deliberation. The purpose of the Advance Notice Policy is not completeto provide our shareholders, directors and is subjectmanagement with a clear framework for nominating directors. The Advance Notice Policy fixes a deadline by which holders of record of our common shares must submit director nominations to the Company prior to any annual or special meeting of shareholders and qualifiedsets forth the information that a shareholder must include in its entiretythe notice to the Company for the notice to be in proper written form in order for any director nominee to be eligible for election at any annual or special meeting of shareholders.

Terms of the Advance Notice Policy. The Advance Notice Policy provides that advance notice to the Company must be made in circumstances where nominations of persons for election to our board of directors are made by shareholders of the Company other than pursuant to: (i) a “proposal” made in accordance with Division 7 of Part 5 of the British Columbia Business Corporations Act, or “the Act”; or (ii) a requisition of the shareholders made in accordance with section 167 of the Act. Among other things, the Advance Notice Policy fixes a deadline by which holders of record of our common shares must submit director nominations to the secretary of the Company prior to any annual or special meeting of shareholders and sets forth the specific information that a shareholder must include in the written notice to the secretary of the Company for an effective nomination to occur. No person will be eligible for election as a director of the Company unless nominated in accordance with the provisions of the warrants,Advance Notice Policy.


In the formscase of which are filed as exhibitan annual meeting of shareholders, notice to our Current Report on Form 8-K filed with the SEC on May 29, 2018. Prospective investors should carefully reviewCompany must be made not less than 30 nor more than 65 days prior to the terms and provisionsdate of the form of warrant for a complete description of the terms and conditions of the warrants.

Duration and Exercise Price

1,122,076 Series A Warrants have an initial exercise price per share equal to $2.65 and 78,545 Series A Warrants have an initial exercise price per share equal to $3.3125 per share. Each Series A Warrant became exercisable on May 29, 2018 and expires on May 29, 2023. Each Series B Warrant has an initial exercise price per share equal to $2.65 and became exercisable on May 29, 2018. The Series B Warrants expire on December 31, 2018. The exercise price and number of common shares issuable upon exercise of the Series A Warrants and Series B Warrants is subject to appropriate adjustmentannual meeting; provided, however, that in the event that the annual meeting is to be held on a date that is less than 50 days after the date on which the first public announcement of share dividends, share splits, reorganizationsthe date of the annual meeting was made, notice may be made not later than the close of business on the 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 15th day following the day on which the first public announcement of the date of the special meeting was made.

Our board of directors may, in its sole discretion, waive any requirement of the Advance Notice Policy.

Provisions of British Columbia Law Governing Business Combinations

All provinces of Canada have adopted National Instrument 62-104 entitled “Take-Over Bids and Issuer Bids” and related forms to harmonize and consolidate take-over bid and issuer bid regimes nationally (“NI 62-104”). The Canadian Securities Administrators, or similar events affectingCSA, have also issued National Policy 62-203 entitled “Take-Over Bids and Issuer Bids” (the “National Policy”) which contains regulatory guidance on the interpretation and application of NI 62-104 and on the conduct of parties involved in a bid. The National Policy and NI 62-104 are collectively referred to as the “Bid Regime.” The National Policy does not have the force of law, but is an indication by the CSA of what the intentions and desires of the regulators are in the areas covered by their policies. Unlike some regimes where the take-over bid rules are primarily policy-driven, in Canada the regulatory framework for take-over bids is primarily rules-based, which rules are supported by policy.

A “take-over bid” or “bid” is an offer to acquire outstanding voting or equity securities of a class made to any person who is in one of the provinces of Canada or to any securityholder of an offeree issuer whose last address as shown on the books of a target is in such province, where the securities subject to the offer to acquire, together with the securities “beneficially owned” by the offeror, or any other person acting jointly or in concert with the offeror, constitute in the aggregate 20% or more of the outstanding securities of that class of securities at the date of the offer to acquire. For the purposes of the Bid Regime, a security is deemed to be “beneficially owned” by an offeror as of a specific date if the offeror is the beneficial owner of a security convertible into the security within 60 days following that date, or has a right or obligation permitting or requiring the offeror, whether or not on conditions, to acquire beneficial ownership of the security within 60 days by a single transaction or a series of linked transactions. Offerors are also subject to early warning requirements, where an offeror who acquires “beneficial ownership of”, or control or direction over, voting or equity securities of any class of a reporting issuer or securities convertible into, voting or equity securities of any class of a target that, together with the offeror’s securities, would constitute 10% or more of the outstanding securities of that class must promptly publicly issue and file a news release containing certain prescribed information, and, within two business days, file an early warning report containing substantially the same information as is contained in the news release.

In addition, where an offeror is required to file an early warning report or a further report as described and the offeror acquires or disposes of beneficial ownership of, or the power to exercise control or direction over, an additional 2% or more of the outstanding securities of the class, or disposes of beneficial ownership of outstanding securities of the class below 10%, the offeror must issue an additional press release and file a new early warning report. Any material change in a previously filed early warning report also triggers the issuance and filing of a new press release and early warning report. During the period commencing on the occurrence of an event in respect of which an early warning report is required and terminating on the expiry of one business day from the date that the early warning report is filed, the offeror may not acquire or offer to acquire beneficial ownership of any securities of the class in respect of which the early warning report was required to be filed or any securities convertible into securities of that class. This requirement does not apply to an offeror that has beneficial ownership of, or control or direction over, securities that comprise 20% of more of the outstanding securities of the class.


Related party transactions, issuer bids and insider bids are subject to additional regulation that may differ depending on the particular jurisdiction of Canada in which it occurs.

Warrants

The Warrants were issued in the 2022 Private Placement on March 24, 2022 in connection with a registered direct offering of our common shares and pre-funded warrants to purchase common shares. As of April 7, 2022, the exercise price.

Cashless ExerciseWarrants were exercisable for an aggregate of 2,739,727 common shares.

 

If, at the time a holder exercises its Series AExercisability.   The Warrants or Series Bwere exercisable immediately upon issuance and expire on September 24, 2027. The Warrants a registration statement registering the issuance of the common shares underlying the warrants under the Securities Act is not then effective or available for the issuance of such shares, then in lieu of making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of common shares determined according to a formula set forth in the Series A Warrant or Series B Warrant, as applicable.

Exercisability

The Series A Warrants and Series B Warrants will beare exercisable, at the option of each holder, in whole or in part by delivering to us a duly executed exercise notice accompaniedand, at any time a registration statement registering the issuance of the common shares underlying the Warrants under the Securities Act is effective and available for the issuance of such shares, or an exemption from registration under the Securities Act is available for the issuance of such shares, by payment in full in immediately available funds for the number of our common shares purchased upon such exercise. If at the time of exercise (exceptthere is no effective registration statement registering, or the prospectus contained therein is not available for the issuance of the common shares underlying the Warrants, then the Warrants may also be exercised, in the casewhole or in part, at such time by means of a cashless exercise, as discussed below).in which case the holder would receive upon such exercise the net number of common shares determined according to the formula set forth in the Warrant.

Exercise Limitation. A holder will not have the right to exercise any portion of the Warrant if the holder (together with its affiliates) may not exercise any portionwould beneficially own in excess of 4.99% (or 9.99% upon the request of the warrant to the extent that the holder would own more than 4.99% (or, at the election of a purchaser prior to issuance of the warrant, 9.99%) of the outstanding common shares immediately after exercise, except that upon at least 61 days’ prior notice from the holder to us, the holder may increase the amount of ownership of outstanding shares after exercising the holder’s warrant up to 9.99%investor) of the number of our common shares outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the warrants.

25

Fractional SharesWarrants. However, any holder may increase or decrease such percentage, provided that any increase will not be effective until the 61st day after such election.

 

No fractionalExercise Price. The Warrants have an exercise price of $3.52 per share. The exercise price is subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting our common shares willand also upon any distributions of assets, including cash, stock or other property to our shareholders.

Transferability. Subject to applicable laws, the Warrants may be issuedoffered for sale, sold, transferred or assigned without our consent.

Exchange Listing. There is no established public trading market for the Warrants. We do not intend to apply for listing of the Warrants on any securities exchange or other nationally recognized trading system. Without an active trading market, the liquidity of the Warrants is limited.

Fundamental Transactions. In the event of any fundamental transaction, as described in the Warrants and generally including any merger with or into another entity, sale of all or substantially all of our assets, tender offer or exchange offer, or reclassification of our common shares, then upon theany subsequent exercise of a  Warrant, the Series A Warrants or Series B Warrants. Rather,holder will have the right to receive as alternative consideration, for each common share that would have been issuable upon such exercise immediately prior to the occurrence of such fundamental transaction, the number of common shares to be issued will, atof the successor or acquiring corporation or of our election, either be rounded up tocompany, if it is the nearest whole numbersurviving corporation, and any additional consideration receivable upon or we will payas a cash adjustment in respectresult of such final fraction in an amount equaltransaction by a holder of the number of common shares for which the Warrant is exercisable immediately prior to such fraction multiplied by the exercise price.

Transferabilityevent.

 

SubjectRights as a Shareholder. Except as otherwise provided in the Warrants or by virtue of such holder’s ownership of our common shares, the holder of a Warrant does not have the rights or privileges of a holder of our common shares, including any voting rights, until the holder exercises the Warrant.

Registration Rights. We have filed this registration statement with the SEC that includes this prospectus to applicable laws,register for resale under the Series A Warrants and Series B Warrants may be transferred atSecurities Act of 1933, the optioncommon shares issuable upon exercise of the holder upon surrender of the warrant(s)Warrants to us togethersatisfy our obligations in connection with the appropriate instruments of transfer.

Fundamental Transaction

In2022 Private Placement. We will use commercially reasonable efforts to keep registration statement effective at all times until the event of a fundamental transaction which is approved by our Board, the holders of the Series Aselling shareholder no longer owns any Warrants and Series B Warrants have the right to require us or a successor entity to redeem the warrants for cash in the amount of the Black-Scholes value of the unexercised portion of the warrant on the date of the consummation of the fundamental transaction. In the event of a fundamental transaction which is not approved by our Board, the holders of the Series A Warrants and Series B Warrants have the right to require us or a successor entity to redeem the warrant(s) for the consideration paid in the fundamental transaction in the amount of the Black Scholes value of the unexercised portion of the warrant(s) on the date of the consummation of the fundamental transaction.shares issuable upon exercise thereof.

 

26


PLAN OF DISTRIBUTION

 

EachThe selling shareholder, and anywhich as used herein includes donees, pledgees, transferees or other successors-in-interest selling the common shares, or interests in the common shares received after the date of their pledgees, assignees and successors-in-interestthis prospectus from a selling shareholder as a gift, pledge, partnership distribution or other transfer, may, from time to time, sell, transfer or otherwise dispose of any or all of their common shares includedor interests in the registration statement of which this prospectus is a party,common shares on the Nasdaq Capital Market or any other stock exchange, market or trading facility on which the common shares are traded or in private transactions. The selling shareholder may sell all or a portion of the common shares held by it and offered hereby from time to time directly or through one or more underwriters, broker-dealers or agents. If the common shares are sold through underwriters or broker-dealers, the selling shareholder will be responsible for underwriting discounts or commissions or agent’s commissions. The common shares may be sold in one or more transactions at fixed prices, at prevailing market prices at the time of the sale, at varying prices determined at the time of sale or at negotiated prices. These sales may be at fixedeffected in transactions, which may involve crosses or negotiated prices.

A selling shareholder may use anyblock transactions, pursuant to one or more of the following methods when selling securities:methods:

 

·on any national securities exchange or quotation service on which the securities may be listed or quoted at the time of sale;

in the over-the-counter market;

in transactions otherwise than on these exchanges or systems or in the over-the-counter market;

through the writing or settlement of options or other hedging transactions, whether such options are listed on an options exchange or otherwise;

ordinary brokerage transactions and transactions in which the broker-dealer solicits purchases;purchasers;

·block trades in which the broker-dealer will attempt to sell the securitiesshares as agent but may position and resell a portion of the block as principal to facilitate the transaction;

·purchases by a broker-dealer as principal and resale by the broker-dealer for its account;

·an exchange distribution in accordance with the rules of the applicable exchange;

·privately negotiated transactions;

·settlementshort sales effected after the date the registration statement of short sales;which this prospectus is a part was declared effective by the SEC;

·in transactions through broker-dealers thatmay agree with thea selling shareholder to sell a specified number of such securitiesshares at a stipulated price per security;share;

·through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise;
·a combination of any such methods of sale; orand

·any other method permitted pursuant to applicable law.

 

The aggregate proceeds to the selling shareholdersshareholder from the sale of the common shares offered by it will be the purchase price of the common shares less discounts or commissions, if any. The selling shareholder reserves the right to accept and, together with their agents from time to time, to reject, in whole or in part, any proposed purchase of common shares to be made directly or through agents. We will not receive any of the proceeds from sales of shares by the selling shareholder.


The selling shareholder may also sell our common shares under Rule 144 promulgated under the Securities Act, or any other exemption from registration, if available, rather than under this prospectus.

Broker-dealers engaged by In addition, the selling shareholdersshareholder may arrange fortransfer the common shares by other means not described in this prospectus. If the selling shareholder effects such transactions by selling common shares to or through underwriters, broker-dealers to participate in sales. Broker-dealersor agents, such underwriters, broker-dealers or agents may receive commissions in the form of discounts, concessions or discountscommissions from the selling shareholders (or, if any broker-dealer actsor commissions from purchasers of the common shares for whom they may act as agent foror to whom they may sell as principal (which discounts, concessions or commissions as to particular underwriters, broker-dealers or agents may be in excess of those customary in the purchasertypes of our common shares, from the purchaser) in amounts to be negotiated,transactions involved but, except as set forth in a supplement to this prospectus to the extent required, in the case of an agency transaction will not be in excess of a customary brokerage commission in compliance with FINRA Rule 2121.5110).

 

In connection with the salesales of the common shares or interests therein,otherwise, the selling shareholdersshareholder may enter into hedging transactions with broker-dealers or other financial institutions, which may in turn engage in short sales of the common shares in the course of hedging thein positions they assume. The selling shareholdersshareholder may also sell common shares short and deliver these common shares covered by this prospectus to close out their short positions orand to return borrowed shares in connection with such short sales. The selling shareholder may also loan or pledge the common shares to broker-dealers that in turn may sell these commonsuch shares. The selling shareholdersshareholder may also enter into option or other transactions with broker-dealers or other financial institutions or createthe creation of one or more derivative securities which require the delivery to such broker-dealer or other financial institutionsinstitution of common shares offered by this prospectus, which common shares such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).

 

The selling shareholder may pledge or grant a security interest in some or all of the common shares owned by it and, if they default in the performance of their secured obligations, the pledgees or secured parties may offer and sell the common shares from time to time pursuant to this prospectus or any amendment to this prospectus under Rule 424(b)(3) or other applicable provision of the Securities Act amending, if necessary, the list of selling shareholders to include the pledgee, transferee or other successors in interest as selling shareholders under this prospectus. The selling shareholder also may transfer and donate the common shares in other circumstances as permitted by applicable law, in which case the transferees, donees, pledgees or other successors in interest will be the selling beneficial owners for purposes of this prospectus.

To the extent required by the Securities Act and the rules and regulations thereunder, the selling shareholder and any broker-dealers or agents that are involvedbroker-dealer participating in sellingthe distribution of the common shares may be deemed to be “underwriters” within the meaning of the Securities Act in connection with such sales.Act. In such event, any commissions received bycommission paid, or any discounts or concessions allowed to, any such broker-dealers or agents and any profit on the resale of the common shares purchased by thembroker-dealer may be deemed to be underwriting commissions or discounts under the Securities Act. Selling shareholders who are deemed to be “underwriters” under the Securities Act (if any) will be subject to the prospectus delivery requirements of the Securities Act and may be subject to certain statutory liabilities of, including but not limited to, Sections 11, 12 and 17 of the Securities Act and Rule 10b-5 under the Exchange Act.

Each selling shareholder has informed the Companyus that it is not a registered broker-dealer and does not have any written or oral agreement or understanding, directly or indirectly, with any person to distributeengage in a distribution of the common shares. Upon us being notified in writing by a selling shareholder that any material arrangement has been entered into with a broker-dealer for the distribution of common shares, a prospectus supplement, if required, will be distributed, which will set forth the aggregate amount of common shares being distributed and the terms of the offering, including the name or names of any broker-dealers or agents, any discounts, commissions and other terms constituting compensation from the selling shareholder and any discounts, commissions or concessions allowed or re-allowed or paid to broker-dealers.

Under the securities laws of some states, the common shares may be sold in such states only through registered or licensed brokers or dealers. In addition, in some states the common shares may not be sold unless such shares have been registered or qualified for sale in such state or an exemption from registration or qualification is available and is complied with.


The selling shareholder may sell all, some or none of the common shares registered pursuant to the registration statement of which this prospectus forms a part. If sold under the registration statement of which this prospectus forms a part, the common shares registered hereunder will be freely tradable in the hands of persons other than our affiliates that there is no underwriteracquire such shares.

We have advised the selling shareholder that the anti-manipulation rules of Regulation M under the Exchange Act may apply to sales of common shares in the market and to the activities of the selling shareholder and its affiliates. In addition, to the extent applicable, we will make copies of this prospectus (as it may be supplemented or coordinating broker actingamended from time to time) available to the selling shareholder for the purpose of satisfying the prospectus delivery requirements of the Securities Act. The selling shareholder may indemnify any broker-dealer that participates in connection withtransactions involving the proposed sale of the common shares offered hereby by the selling shareholders.

The Company is required to pay certain fees and expenses incurred by it incident to the registration of the common shares. The Company has agreed to indemnify the selling shareholders against certain losses, claims, damages and liabilities, including liabilities arising under the Securities Act.

 


Under applicable rules and regulations under the Exchange Act, any person engaged in the distribution of the common shares offered hereby may not simultaneously engage in market making activities with respect to the common shares for the applicable restricted period, as defined by Regulation M, prior to the commencement of the distribution. In addition, the selling shareholders will be subject to applicable provisions of the Exchange Act and the rules and regulations thereunder, including Regulation M, which may limit the timing of purchases and sales of the common shares by the selling shareholders or any other person. We will make copies of this prospectus available to the selling shareholders and have informed them of the need to deliver a copy of this prospectus to each purchaser at or prior to the time of the sale (including by compliance with Rule 172 under the Securities Act).

Listing

Our common shares are listed on the Nasdaq Capital Market under the symbol “SBOT.”

Transfer Agent and Registrar

The transfer agent and registrar for our common shares is Computershare Investor Services, Inc.

LEGAL MATTERS

 

The validity of the securitiescommon shares offered by this prospectushereby will be passed upon for us by McMillan LLP, Vancouver, British Columbia, and certain other matters will be passed upon for us by Greenberg Traurig, LLP, Los Angeles, California.Fasken Martineau DuMoulin, LLP.

 

EXPERTS

 

The consolidated financial statements of Stellar Biotechnologies, Inc. incorporated ininto this Registration Statementprospectus by reference to our Annual Report on Form S-1 by reference have been audited by Moss Adams LLP, an independent registered public accounting firm, as stated in their report, which is incorporated by reference herein.  Such consolidated10-K for the financial statementsyear ended September 30, 2021, have been so incorporated in reliance uponon the report of suchMNP LLP, independent auditors, given on the authority of said firm given upon their authority as experts in accountingauditing and auditing.accounting.

 

WHERE YOU CAN FIND ADDITIONAL INFORMATION

We have filed a registration statement on Form S-1 with the SEC covering the common shares that the selling shareholders are offering by this prospectus. This prospectus does not include all of the information contained in the registration statement. You should refer to the registration statement and its exhibits for additional information. Whenever we make reference in this prospectus to any of our contracts, agreements or other documents, the references are not necessarily complete and you should refer to the exhibits filed or documents incorporated by reference as part of the registration statement for copies of the actual contract, agreement or other document.

We file annual, quarterly and other periodic reports, proxy statements and other information with the Securities and Exchange Commission. You can read our Securities and Exchange Commission filings, including this registration statement, over the Internet at the Securities and Exchange Commission’s website at www.sec.gov. You may also read and copy any document we file with the Securities and Exchange Commission at its public reference facilities at 100 F Street NE, Washington, D.C. 20549. You may also obtain copies of these documents at prescribed rates by writing to the Public Reference Section of the Securities and Exchange Commission at 100 F Street NE, Washington, D.C. 20549. Please call the Securities and Exchange Commission at 1-800-SEC-0330 for further information on the operation of the public reference facilities.

Our Internet address is www.stellarbiotechnologies.com. There we make available free of charge, on or through the investor relations section of our website, annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to those reports filed pursuant to Section 13(a) or 15(d) of the Exchange Act as soon as reasonably practicable after we electronically file such material with the Securities and Exchange Commission. The information found on our website is not part of this prospectus and investors should not rely on any such information in deciding whether to invest.

INCORPORATION OF CERTAIN INFORMATION INCORPORATED BY REFERENCE

 

The SEC allows us to “incorporate by reference” information from other documents that we file with it into this prospectus, which means that we can disclose important information to you by referring you to those documents. The information incorporated by reference is considered to bean important part of this prospectus. The information incorporated by reference is considered to be a part of this prospectus, and information that we file later with the SEC will automatically update and supersede information contained in this prospectus.

 


We incorporate by reference into this prospectus and the registration statement of which this prospectus is a part the information or documents listed below that we have previously filed with the SEC (Commission File No. 001-37619):SEC:

 

·our Annual Report on Form 10-K for the fiscal year ended September 30, 2017, which was2021 filed with the SEC on December 1, 2017;28, 2021;

 

·our Quarterly ReportsReport on Form 10-Q for the quartersquarter ended December 31, 2017 and March 31, 2018, which were2021 filed with the SEC on February 7, 2018 and May 7, 2018;14, 2022;

 

·our Definitive Proxy Statement on Schedule 14A filed with the SEC on April 1, 2022;
our Current Reports on Form 8-K which were filed with the SEC on December 1, 2017, January 25, 2018, FebruaryNovember 22, 2021March 2, 2018, February 7, 2018, April 3, 2018, April 11, 2018, April 27, 2018, May 7, 2018, May 15, 2018, May 16, 2018, May2022March 4, 2022March 4, 2022,  March 23, 20182022 and May 30, 2018;March 29, 2022 (other than any portions thereof deemed furnished and not filed); and

 

·our definitive proxy statement relating to our 2018 Annual Meeting of Stockholders, which was filed with the SEC on February 13, 2018;

·our preliminary proxy statement, which was filed with the SEC on February 2, 2018;

·our consolidated financial statements contained in Amendment No. 1 to Registration Statement on Form S-1 (Registration No. 333-224314), together with the notes thereto and the auditor’s report thereon, and the related management’s discussion and analysis, which was filed with the SEC on May 8, 2018; and

·the description of our common shares contained in theour Registration Statement on Form 8-A12B, which was8-A filed with the SEC on November 3, 2015.2015, including any amendment or report filed for the purpose of updating such description.

 

DocumentsAll reports and other documents that we file with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act after the date of this prospectus but prior to the termination of the offering of the securities hereunder will also be considered to be incorporated by reference are availableinto this prospectus from us without charge. the date of the filing of these reports and documents, and will supersede the information herein; provided, however, that all reports, exhibits and other information that we “furnish” to the SEC will not be considered incorporated by reference into this prospectus. Any statement contained in a document incorporated by reference in this prospectus shall be deemed to be modified or superseded to the extent that a statement contained herein, therein or in any other subsequently filed document that also is incorporated by reference herein or therein modifies or supersedes such statement. Any statement so modified or superseded shall not be deemed, except as so modified or superseded, to constitute a part of this prospectus or the registration statement.

We will provide to any person, including any beneficial owner, to whom a prospectus is delivered,you without charge, upon your oral or written request, with a copy of any or all reports, proxy statements and other documents we file with the SEC, as well as any or all of the reports or documents that have been incorporated by reference in this prospectus or the registration statement (other than exhibits to such documents unless such exhibits are specifically incorporated by reference into such documents). Requests for such copies should be directed to


Edesa Biotech, Inc.
Attention: Investor Relations
100 Spy Court
Markham

Ontario L3R 5H6 Canada
Tel. (289) 800-9600


WHERE YOU CAN FIND MORE INFORMATION

We have filed with the SEC a registration statement on Form S-1 under the Securities Act with respect to the common shares offered by this prospectus. This prospectus, containedwhich is part of the registration statement, omits certain information, exhibits, schedules and undertakings set forth in the registration statement but not delivered in the prospectus. Any such requests should be directedstatement. For further information pertaining to us and our common shares, reference is made to our Corporate Secretary (writtenSEC filings and the registration statement and the exhibits and schedules to the registration statement. Statements contained in this prospectus as to the contents or oral)provisions of any documents referred to in this prospectus are not necessarily complete, and in each instance where a copy of the document has been filed as an exhibit to the registration statement, reference is made to the exhibit for a more complete description of the matters involved.

In addition, registration statements and certain other filings made with the SEC electronically are publicly available through the SEC’s web site at our executive officeshttp://www.sec.gov. The registration statement, including all exhibits and amendments to the registration statement, has been filed electronically with the SEC.

We are subject to the information and periodic reporting requirements of the Securities Exchange Act of 1934, as amended, and, in accordance with such requirements, will file periodic reports, proxy statements, and other information with the SEC. These periodic reports, proxy statements, and other information will be available for inspection and copying at 332 E. Scott Street, Port Hueneme, California 93041, telephone: (805) 488-2800. Youthe web site of the SEC referred to above. We also maintain a website at https://www.edesabiotech.com, at which you may also access these documents onmaterials free of charge as soon as reasonably practicable after they are electronically filed with, or furnished to, the SEC. The information contained in, or that can be accessed through, our Internet site at www.stellarbiotechnologies.com.website is not part of, and is not incorporated into, this prospectus. We have included our website address in this prospectus solely as an inactive textual reference.


Stellar Biotechnologies, Inc.

 

 3,444,7732,739,727 Common Shares

 

PRELIMINARY PROSPECTUS

 

, 20182022


 

PART II

INFORMATION NOT REQUIRED IN PROSPECTUS

 

Item 13.ITEM 13.Other Expenses of Issuance and Distribution.Distribution

 

The following table sets forth the estimated costs and expenses, other than placement agent fees, paid or payable by Edesa Biotech, Inc., or the CompanyRegistrant, in connection with the registrationsale and saledistribution of the common shares, warrants and pre-funded warrants to purchase common sharessecurities being registered other thanregistered. All amounts are estimated fees and commissions in connection with our public offering.except the SEC registration fee.

 

 Amount 
Item Amount 
SEC registration fee $1,143.00  $719 
Legal fees and expenses  33,000 
Accounting fees and expenses  10,000.00   17,000 
Legal fees and expenses  70,000.00 
Transfer agent fees and expenses  2,500.00 
Printing and mailing expenses  5,000.00 
Printing and engraving expenses  3,000 
Transfer agent and registrar fees and expenses  1,000 
Miscellaneous fees and expenses  10,000.00   1,281 
Total expenses $98,643.00 
Total $56,000 

 

Item 14.ITEM 14.Indemnification of Directors and Officers.Officers

 

Subject to the British Columbia Business Corporations Act, or the Act,“the Act”, our directors, former directors and alternate directors and their heirs and legal personal representatives are indemnified against any judgment, penalty or fine awarded or imposed in, or an amount paid in settlement of, a stipulated legal or investigative proceeding, as set forth in our Articles. In addition, our Articles provide that we may, subject to any restrictions in the Act, indemnify any person.

 

Under the Act, we may indemnify (a) a current or former director or officer of the Company; (b) a current or former director or officer of another corporation at a time when that corporation is or was an affiliate of the Company; (c) a current or former director or officer of another corporation who holds or held such position at the request of the Company; or (d) an individual who at the request of the Company, is or was, or holds or held a position equivalent to that of, a director, or officer of a partnership, trust, joint venture or other unincorporated entity (collectively, an “Eligible Party”). In certain circumstances an Eligible Party will include the heirs and personal or other legal representatives of an Eligible Party. We may indemnify an Eligible Party against any Eligible Penalty (defined below) to which the Eligible Party is or may be liable. After the final disposition of an Eligible Proceeding (defined below), we may pay all Expenses (defined below) actually and reasonably incurred by the Eligible Party in connection with such Proceeding (defined below) and must pay all such Expenses actually and reasonably incurred by the Eligible Party in connection with such Proceeding if the Eligible Party has not been reimbursed for those Expenses and is wholly successful on the merits or otherwise in the outcome of the Proceeding, or is substantially successful on the merits in the outcome of the Proceeding. Among other circumstances, we shall not indemnify or cover the Expenses of an Eligible Party if the Eligible Party did not act honestly and in good faith with a view to the best interests of the Company or if the Eligible Party (other than in connection with a civil Proceeding) did not have reasonable grounds for believing that the Eligible Party’s conduct in respect of which the Proceeding was brought was lawful. Further, we cannot indemnify or cover the Expenses of an Eligible Party in respect of any Proceeding brought by or on behalf of the Company against an Eligible Party. The Supreme Court of British Columbia may, among other things, on the applications of a corporation or an Eligible Party, order indemnification by the Company of any liability or expense incurred by an Eligible Party.

 

Eligible Penalty” means a judgment, penalty or fine awarded or imposed in, or an amount paid in settlement of, an Eligible Proceeding.

 

“Eligible Proceeding” means any legal proceeding or investigative action, whether current, threatened, pending or completed (each, a “Proceeding”), in which an Eligible Party, or any of the Eligible Party’s heirs and personal or other legal representatives (i) is or may be joined as a party, or (ii) is or may be liable for or in respect of a judgment, penalty or fine in, or Expenses related to, such Proceeding, in each case by reason of the Eligible Party’s being or having been a director or officer of, or holding or having held a position equivalent to that of a director or officer of, the Company, oneor is or was a director or officer of its currentany corporation at a time when the corporation is or former subsidiaries or affiliates,was an affiliate of the Company, or another entity at the Company’s request.

II-1

 

“Expenses” includes costs, charges and expenses, including legal and other fees, but does not include judgments, penalties, fines or amounts paid in settlement of a Proceeding.

 


We have also entered into separate indemnification agreements with each of our directors and executive officers, which are intended to indemnify our directors and executive officers to the fullest extent permitted under the Securities Act,laws of the Province of British Columbia, subject to certain exceptions. Our obligations under such separate indemnification agreements are in addition to our indemnification obligations under the Act and our charter documents.

 

We maintain a directors’ and officers’ liability insurance policy, which insures directors and officers of the Company and its subsidiaries for losses as a result of claims based upon the directors’ and officers’ acts or omissions, including liabilities arising under the Securities Act. The policy also reimburses us for payments made pursuant to the indemnity provisions under the Act and our charter documents.

 

Item 15.ITEM 15.Recent Sales of Unregistered Securities.

 

Set forth below is information regarding our securities granted inIn the three years preceding the filing of this registration statement, thatthe Company made sales of the following unregistered securities:

Business Combination Transaction

On June 7, 2019, we completed a business combination with Edesa Biotech Research, Inc., formerly known as Edesa Biotech Inc. (“Edesa Biotech Research”), in accordance with the terms of the Share Exchange Agreement, dated March 7, 2019, by and among us, Edesa Biotech Research and the shareholders of Edesa Biotech Research. At the closing of the transaction, we acquired the entire issued share capital of Edesa Biotech Research, with Edesa Biotech Research becoming a wholly-owned subsidiary of ours.

At the closing of the transaction, Edesa Biotech Research shareholders received 6,249,780 of our common shares in exchange for the capital shares of Edesa Biotech Research and the holders of unexercised Edesa Biotech Research share options immediately prior to the closing of the transaction were not registeredissued substitute share options (“Substitute Options”) to purchase an aggregate of 297,422 of our common shares. On July 26, 2019, pursuant to the post-closing adjustment contemplated by the Share Exchange Agreement, we issued an additional 366,234 of our common shares to the Edesa Biotech Research shareholders and the holders of unexercised Edesa Biotech Research stock options immediately prior to the closing of the transaction were issued 17,701 additional Substitute Options to purchase our common shares.

Our common shares issued in the exchange transaction were issued in a transaction exempt from registration under Regulation S promulgated under the Securities Act.Act, because the offer and sale of such securities was made to non-U.S. persons (as that term is defined in Regulation S under the Securities Act) in an offshore transaction.

II-2

January 2020 Private Placement

 

On May 24, 2018,January 6, 2020, we entered into a Warrant Exercise Agreement pursuant to which warrant holders exercised warrants to purchase 1,122,076 of our common shares at an exercise price of $2.65 per share. In consideration, we issued 1,122,076 Series A Warrants and 2,244,152 Series B Warrants. In connection with the Warrant Exercise Agreement, we also issued 78,545 Series A Warrants to H.C. Wainwright & Co., LLC. We received gross proceeds of approximately $3 million. Our issuance of our warrants was made in reliance on Section 4(a)(2) of the Securities Act.

On June 26, 2017, the Board issued an aggregate of 54,834 performance shares remaining under its performance share plan to the Company’s President, CEO and Chairman, a director of the company and another eligible participant in the plan. Since all performance shares under the plan have been issued, the plan was terminated. Our issuance of performance shares was made in reliance on Section 4(a)(2) of the Securities Act.

On June 30, 2016, we entered into Securities Purchase Agreement (the “Securities Purchase Agreement”) with certain United States resident investors and Subscription Agreements (the “Subscription Agreements”) with certain non-U.S. investors providing for the issuance and sale by us of an aggregate of 241,0711,354,691 of our common shares, no par value, at a price of $28.00 per share in a registered direct offering.offering (the “Offering”). In a concurrent private placement (the “Private Placement”), we agreed to sell to such investors warrants(i) Class A Purchase Warrants to purchase up to an aggregate of 180,805up to 1,016,036 common shares, or 0.75 of a common share for each common share purchased in the Offering (the “Class A Purchase Warrants”), and (ii) Class B Purchase Warrants to purchase an aggregate of up to 677,358 common shares, or 0.50 of a common share for each common share purchased in the offering (the “Class B Purchase Warrants,” and together with the Class A Purchase Warrants, the “Purchase Warrants”). The price per common share and associated Purchase Warrants was (i) $3.20 for investors other than investors that are officers, directors, employees or consultants of the company and (ii) $4.11 for each investor that is an officer, director, employee or consultant of the company. The closing of the Offering and concurrent Private Placement occurred on January 8, 2020. The Class A Purchase Warrants were exercisable at any time on or after July 8, 2020, the six (6) month anniversary of the closing date of the Private Placement (the “Class A Purchase Warrant Initial Exercise Date”), at an exercise price of $31.50$4.80 per share. share and will expire on the third anniversary of the Class A Purchase Warrant Initial Exercise Date. The Class B Purchase Warrants were exercisable at any time on or after July 8, 2020, the six (6) month anniversary of the closing date of the Private Placement (the “Class B Purchase Warrant Initial Exercise Date”), at an exercise price of $4.00 per share and will expire on the four month anniversary of the Class B Purchase Warrant Initial Exercise Date. The exercise price and number of common shares issuable upon the exercise of the Purchase Warrants will be subject to adjustment in the event of any share dividends and splits, reverse share split, recapitalization, reorganization or similar transaction. Subject to limited exceptions, a holder of Purchase Warrants will not have the right to exercise any portion of its Purchase Warrants if the holder, together with its affiliates, would beneficially own in excess of 9.99% of the number of common shares outstanding immediately after giving effect to such exercise (the “Beneficial Ownership Limitation”); provided, however, that upon 61 days’ prior notice to us, the holder may increase the Beneficial Ownership Limitation, provided that in no event shall the Beneficial Ownership Limitation exceed 9.99%.

We received gross proceeds of $6.75 million. Our issuanceapproximately $4.36 million from the sale of ourthese securities, before deducting placement agent fees and offering expenses, and excluding the exercise of any warrants.

Brookline Capital Markets, a division of Arcadia Securities, LLC (“Brookline”), acted as placement agent in the United States in connection with the Offering and Private Placement pursuant to a Financial Advisory Agreement between us and Brookline dated November 5, 2019, as amended. Upon the closing of the Offering and Private Placement, Brookline received a placement agent fee equal to 6.5% of the gross proceeds from sales arranged by Brookline (or 3.5% in the case of sales to investors introduced by the company, or Company Investors). Brookline did not receive any cash placement fee with respect to non-U.S. investors.  As additional compensation, the company issued to Brookline a warrant to purchase 12,364 common shares, which is equal to 1.25% of the number of common shares sold in the Offering and warrants was madeconcurrent Private Placement to investors introduced by Brookline (the “Brookline Warrant”). The Brookline Warrant has a term of five years and is exercisable at a price of $3.20 per share. Brookline did not receive any warrant compensation for securities issued to non-U.S investors. The company also reimbursed Brookline $55,000 for certain expenses incurred by Brookline.

The Purchase Warrants, Warrant Shares, Brookline Warrant and the common shares issuable upon exercise of the Brookline Warrant were offered pursuant to an exemption from the registration requirement of the Securities Act provided in reliance on Section 4(a)(2) of the Securities Act.Act and Rule 506(b) promulgated thereunder.

 

DuringNovImmune SA License Agreement

On April 17, 2020, we, through our wholly-owned subsidiary Edesa Biotech Research, entered into an exclusive license agreement with NovImmune SA, which operates under the three months ended December 31, 2015, warrant holders exercised warrantsbrand Light Chain Bioscience (“Light Chain”). Pursuant to the license agreement, we obtained exclusive rights throughout the world to certain know-how, patents and data relating to the monoclonal antibodies targeting TLR4 and CXCL10 (the “Constructs”).  In connection with the license agreement, we issued to Light Chain $2.5 million of our Series A-1 Convertible Preferred Shares (the “Series A-1 Shares”) pursuant to the terms of a securities purchase 60,572agreement. Series A-1 Shares issued to Light Chain were issued in a transaction exempt from registration under Regulation S promulgated under the Securities Act because the offer and sale of such securities was made to a non-U.S. person (as that term is defined in Regulation S under the Securities Act) in an offshore transaction.

March 2022 Private Placement

In connection with a registered direct offering of our common shares atand pre-funded warrants to purchase common shares, on March 21, 222, we entered into a securities purchase agreement with an exercise priceinstitutional investor (the “Purchaser”), pursuant to which, among other things, we sold to the Purchaser warrants (the “Warrants”) to purchase up to 2,739,727 common shares in a private placement. No separate consideration was paid for the issuance of CDN $28.00. We received an aggregate of $1,291,183 as consideration for the Warrants. The Warrants and the common shares issuable upon exercise of the previously-issued warrants. Our issuanceWarrants were offered pursuant to an exemption from the registration requirement of our warrants was madethe Securities Act provided in reliance on Section 4(a)(2) of the Securities Act.Act and Rule 506(b) promulgated thereunder.

 

On October 22, 2015, a holder exercised 5,714 broker units at an exercise price of CDN $17.50 and we received an aggregate of $77,077. Each broker unit consisted of one common share and one warrant to purchase a common share. Accordingly, we issued 5,714 common shares and 5,714 warrants with an exercise price of CDN $28.00. The broker units were granted as finder’s fees in accordance with an option agreement entered into on October 25, 2012 concurrent with the closing of a private placement. The warrants were not exercised and expired on October 25, 2015. Our issuance of our common shares and warrants was made in reliance on Section 4(a)(2) of the Securities Act.

II-3

 

On August 7, 2015, a warrant holder exercised warrants to purchase 549 of our common shares, at an exercise price of CDN $28.00. We received an aggregate of $11,671 as consideration for the exercise of the previously-issued warrants. Our issuance of our warrants was made in reliance on Section 4(a)(2) of the Securities Act.

 

Item 16.ITEM 16.Exhibits and Financial Statement Schedules.

(a)Exhibits

 

(a)           The exhibits listed underSee the caption “Exhibit Index” following the signature page are filed herewith orExhibit Index attached to this Registration Statement, which is incorporated by reference herein.

 

(b)Financial Statement Schedules

(b)          All

No financial statement schedules have been omittedare provided because the information required to be set forth in the schedulescalled for is either not applicablerequired or is shown either in the financial statements or the notes thereto incorporated by reference herein.thereto.

32

 

Item 17.ITEM 17.Undertakings.Undertakings

 

The undersigned Registrantregistrant hereby undertakes:

 

(1)To file, during any period in which offers or sales are being made, a post-effective amendment to this Registration Statement:

1. To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:

 

(i)i.toTo include any prospectus required by Sectionsection 10(a)(3) of the Securities Act;Act of 1933;

 

(ii)ii.toTo reflect in the prospectus any facts or events arising after the effective date of the Registration Statementregistration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the Registration Statement.registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Securities and Exchange Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than 20% change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective Registration Statement; andregistration statement.

 

(iii)iii.toTo include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement;

statement, provided, however, that paragraphs (1)(i), (1)(ii) and (1)(iii) do not apply if the registration statement is on Form S-1, Form S-3, Form SF-3 or Form F-3 and the information required to be included in a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the Commission by the Registrant pursuant to Section 13 or Section 15(d) of the Exchange Act that are incorporated by reference in the Registration Statement;

(2)That, for the purpose of determining any liability under the Securities Act, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

(3)To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.

(4)That, for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser:

(i)each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be partSection 13 or 15(d) of the registration statement as of the date the filed prospectus was deemed part of and includedExchange Act that are incorporated by reference in the registration statement; andstatement.

 

2. That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

3. To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.

4. That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser, each prospectus filed pursuant to Rule 424(b) as part of a registration statement relating to an offering, other than registration statements relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A, shall be deemed to be part of and included in the registration statement as of the date it is first used after effectiveness. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such first use, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such date of first use.

(ii)II-4each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(l)(i), (vii), or (x) for the purpose of providing the information required by Section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof;provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date.

5. That, for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial distribution of the securities, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:

 

(5)That, for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial distribution of the securities, the undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:


(i)any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424;

 

(ii)any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant;

 

(iii)the portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and

 

(iv)any other communication that is an offer in the offering made by the undersigned registrant to the purchaser.

 

(6)That:

(i)6. That, for purposes of determining any liability under the Securities Act of 1933, each filing of the registrant’s annual report pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Securities Exchange Act of 1934) that is incorporated by reference in the Securities Act of 1933, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule 424(b) (1) or (4) or 497(h) under the Securities Act of 1933 shall be deemed to be part of this registration statement as of the time it was declared effective; and

(ii)for the purpose of determining any liability under the Securities Act of 1933, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

(7)That, for purposes of determining any liability under the Securities Act of 1933, each filing of the registrant’s annual report pursuant to Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Securities Exchange Act of 1934) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof; and

(8)Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act and is, therefore, unenforceable.  In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Act and will be governed by the final adjudication of such issue.

SIGNATURES

 

7. Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Act and will be governed by the final adjudication of such issue.

II-5

SIGNATURES

Pursuant to the requirements of the Securities Act of 1933, as amended, the Registrantregistrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form S-1 and has duly caused this Registration Statement on Form S-1 to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Port Hueneme, State of California, June 5, 2018.Markham, Ontario on April 11, 2022.

 

 Stellar Biotechnologies, Inc.EDESA BIOTECH, INC.
   
 By: /s/ Frank R. OatesPardeep Nijhawan
 Name: Frank R. OakesPardeep Nijhawan
 Title:President,Director, Chief Executive Officer and ChairmanCorporate Secretary

 

POWER OF ATTORNEY AND SIGNATURES

 

Each person whose signature to this registration statement appears below hereby constitutes and appoints each of Frank R. OakesPardeep Nijhawan and Kathi Niffenegger as such person’sand each of them singly, his or her true and lawful attorney-in-factattorneys-in-fact and agent,agents, with full power of substitution and resubstitution, for such personhim or her and in such person’shis or her name, place and stead, in any and all capacities, to sign any and all amendments (including, without limitation, post-effective amendments) to thethis registration statement including post-effective amendments, and any and all additional registration statements filed pursuant to Rule 462 under462(b) of the Securities Act of 1933, and to file the same, with all exhibits thereto and all other documents in connection therewith, with the Securities and Exchange Commission, and does hereby grantSEC, granting unto each said attorney-in-fact and agent full power and authority to do and perform each and every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as such person might or could do in person, hereby ratifying and confirming all that each said attorney-in-factattorneys-in-fact and agents or anyeither of them or their, his or her substitute or substitutes may lawfully do or cause to be done by virtue hereof.

 

Pursuant to the requirements of the Securities Act of 1933, as amended, this reportRegistration Statement has been signed by the following persons on behalf of the Registrant andregistrant in the capacities and on the dates indicated.

 

SignaturePerson TitleCapacity Date
     
/s/ Frank R. Oakes /s/ Pardeep Nijhawan President,Director, Chief Executive Officer, and Corporate   April 11, 2022
Frank R. OakesPardeep Nijhawan ChairmanSecretary (Principal Executive Officer)  June 5, 2018
     
 /s//s/ Kathi Niffenegger Chief Financial Officer and Corporate Secretary April 11, 2022
Kathi Niffenegger CPA (Principal Financial and Accounting Officer)  June 5, 2018
     
 /s/ Deborah F. Aghib/s/Jennifer Chao Director  June 5, 2018April 11, 2022
Deborah F. Aghib, Ph.D.Jennifer Chao    
     
 /s/ Tessie M. Che/s/ Lorin Johnson Director June 5, 2018April 11, 2022
Tessie M. Che, Ph.D.Lorin Johnson    
     
 /s/ Paul Chun/s/ Sean MacDonald Director Chairman of the Board of Directors June 5, 2018April 11, 2022
Paul ChunSean MacDonald    
     
 /s/ David L. Hill/s/ Frank Oakes Director June 5, 2018April 11, 2022
David L. Hill, Ph.D.Frank Oakes    
     
 /s/ Daniel E. Morse/s/ Paul Pay Director June 5, 2018April 11, 2022 
Daniel E. Morse, Ph.D.Paul Pay    
     
/s/ Charles V. OlsonCarlo Sistilli Director June 5, 2018April 11, 2022
Charles V. Olson, D. Sc.
 /s/ Mayank D. SampatDirectorJune 5, 2018
Mayank D. SampatCarlo Sistilli    

 

 II-6 

 

 

EXHIBIT INDEX

 

Exhibit No. Description
1.12.1* Engagement Letter,Share Exchange Agreement, dated as of April 9, 2018,March 7, 2019, by and between Stellar Biotechnologies Inc., Edesa Biotech Inc. and the Company and H.C. Wainwright & Co., LLC.Edesa Shareholders (included as Exhibit 1.12.1 to the Company’s Registration StatementCompany's Current Report on Form S-18-K filed on April 17, 2018,March 8, 2019, and incorporated herein by reference).
   
3.1 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).
   
3.2 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).
   
3.3 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).
   
3.4 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).
   
3.5 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).
   
3.6 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, 2015 (included as Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on October 30, 2015, and incorporated herein by reference).
3.8Amended and Restated Articles of the Company, dated April 9, 2018Edesa Biotech, Inc. (included as Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on April 11, 2018,23, 2020, and incorporated herein by reference).
   
3.7 **Notice of Articles of Edesa Biotech, Inc.
4.1 FormSpecimen of Warrant dated June 30, 2016common share certificate (included as Exhibit 4.1 to the Company’s Current ReportRegistration Statement on Form 8-KS-3 filed on JuneAugust 30, 2016,2019 and incorporated herein by reference).
   
4.2 Form of Class A Purchase Warrant issued to investors (included as Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on January 6, 2020 and incorporated herein by reference)
4.3Form 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)
4.4Form 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)
4.5Form of Warrant (included as Exhibit 4.2 to the Company’sCompany's Registration Statement on Form S-1 filed on May 8, 2018, and incorporated herein by reference).

 II-7 

4.34.6 Form of Pre-FundedUnderwriter Warrant (included as Exhibit 4.3 to the Company’s Registration Statement on Form S-1 filed on May 8, 2018, and incorporated herein by reference).
4.4Form of Placement Agent Warrant (included as Exhibit 4.4 to the Company’s Registration Statement on Form S-1 filed on May 8, 2018, and incorporated herein by reference).
4.5Form of Series A Common Share Purchase Warrant (included as Exhibit 10.24.1 to the Company’s Current Report on Form 8-K8-K/A filed on May 29, 2018, and incorporated herein by reference).
4.6Form of Series B Common Share Purchase Warrant (included as Exhibit 10.3 to the Company’s Current Report on Form 8-K filed on May 29, 2018,February 26, 2021 and incorporated herein by reference).
   
4.7 Form of Placement AgentPre-Funded Warrant (included as Exhibit 10.44.1 to the Company’s Current Report on Form 8-K filed on May 29, 2018,March 23, 2022 and incorporated herein by reference).
4.8Form of Private Placement Warrant (included as Exhibit 4.2 to the Company’s Current Report on Form 8-K filed on March 23, 2022 and incorporated herein by reference).
4.9Form of Placement Agent Warrant (included as Exhibit 4.3 to the Company’s Current Report on Form 8-K filed on March 23, 2022 and incorporated herein by reference).
   
5.1** Opinion of McMillan, LLP.Fasken Martineau DuMoulin, LLP
   
10.1 Patent Assignment and Royalty Agreement between the Company and Frank Oakes, dated August 6, 2002Advance Notice Policy, adopted October 31, 2013 (included as Exhibit 4(a)10.14 to the Company’s Registration StatementCompany's Annual Report on Form 20-F10-K filed on February 3, 2012, and incorporated herein by reference).

10.2Sublease Agreement (Units 3, 4 and 5) between the Company and the Port Hueneme Surplus Property Authority, dated October 2, 2000 (included as Exhibit 4(j) to the Company’s Registration Statement on Form 20-F filed on February 3, 2012,November 14, 2014, and incorporated herein by reference).
   
10.310.2@ SubleaseEmployment Agreement (Unit 7)by and between the Company and the Port Hueneme Surplus Property Authority,Kathi Niffenegger, dated March 21, 2005June 7, 2019 (included as Exhibit 4(k)10.1 to the Company’s Registration StatementCompany's Current Report on Form 20-F8-K filed on February 3, 2012,June 10, 2019, and incorporated herein by reference).
   
10.410.3@ LeaseEmployment Agreement by and between the Company and Beachport Center,Pardeep Nijhawan, dated March 29, 2011June 14, 2019 (included as Exhibit 4(l)10.2 to the Company’s Registration StatementCompany's Current Report on Form 20-F8-K/A filed on February 3, 2012,June 20, 2019, and incorporated herein by reference).
   
10.510.4@ Research CollaborationEmployment Agreement by and between the Company and Bayer Innovation GmbH,Michael Brooks, dated August 27, 2009June 14, 2019 (included as Exhibit 4(16)10.3 to the Company’s Amendment No. 2 to its Registration StatementCompany's Current Report on Form 20-F8-K/A filed on July 5, 2012,June 20, 2019, and incorporated herein by reference).
   
10.6 #10.5@ Joint VentureForm of Indemnification Agreement, dated May 11, 2016, by and amongbetween the Company and Neovacs, S.A.each of its directors and executive officers (included as Exhibit 10.110.4 to the Company’sCompany's Current Report on Form 8-K8-K/A filed on May 17, 2016,June 20, 2019, and incorporated herein by reference).
   
10.7License Agreement between the Company and University of Guelph, dated July 24, 2013 (included as Exhibit 99.1 to the Company’s Report on Form 6-K filed on August 30, 2013, and incorporated herein by reference).
10.8 @10.6@ 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).
   
10.9 @10.7@ 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).
   
10.10 @10.8@ Performance Share2019 Equity Incentive Compensation Plan dated April 9, 2010 (included as Exhibit 10(d)10.1 to the Company’s Registration StatementCurrent Report on Form 20-F8-K filed on February 3, 2012,October 25, 2019, and incorporated herein by reference).
10.9Lease, dated as of January 1, 2017, by and between the Registrant and 1968160 Ontario Inc. (included as Exhibit 10.1 to the Company's Current Report on Form 8-K filed on August 30, 2019, and incorporated herein by reference).

II-8

10.10+Exclusive License Agreement, dated as of June 29, 2016, by and between the Registrant and Yissum Research Development Company (included as Exhibit 10.2 to the Company's Current Report on Form 8-K filed on August 30, 2019, and incorporated herein by reference).
   
10.11 Advance Notice Policy, adopted October 31, 2013First Amendment to Exclusive License Agreement, dated April 3, 2017, by and between the Registrant and Yissum Research Development Company (included as Exhibit 10.1410.3 to the Company’s AnnualCompany's Current Report on Form 10-K8-K filed on November 14, 2014,August 30, 2019, and incorporated herein by reference).
   
10.12 Second Amendment One to LeaseExclusive License Agreement, dated May 7, 2017, by and between the CompanyRegistrant and Beachport Center, dated June 24, 2014Yissum Research Development Company (included as Exhibit 10.1510.4 to the Company’s AnnualCompany's Current Report on Form 10-K8-K filed on November 14, 2014,August 30, 2019, and incorporated herein by reference).
   
10.1310.13+ Sublease Amendment No. 2 (Units 4License and 5) to SubleaseDevelopment Agreement, dated as of August 27, 2017, by and between the CompanyRegistrant and the Port Hueneme Surplus Property Authority, dated October 2, 2010Pendopharm, a division of Pharmascience Inc. (included as Exhibit 10.1610.6 to the Company’s AnnualCompany's Current Report on Form 10-K8-K filed on November 14, 2014,August 30, 2019, and incorporated herein by reference).
   
10.14 Sublease Amendment No. 1 (Unit 7) to SubleaseForm of Securities Purchase Agreement between the CompanyEdesa Biotech, Inc. and the Port Hueneme Surplus Property Authority, dated March 21, 2010certain investors (included as Exhibit 10.1710.1 to the Company’s AnnualCurrent Report on Form 10-K8-K filed on November 14, 2014,January 6, 2020 and incorporated herein by reference)
10.15Form 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)
10.16+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).
   
10.1510.17+ CollaborationPurchase Agreement by and between Stellar Biotechnologies,Edesa Biotech Research, Inc. and Amaran BiotechnologyNovImmune SA dated December 7, 2013April 17, 2020 (included as Exhibit 10.1810.2 to Amendment No. 2 of the Company’s AnnualCurrent Report on Form 10-K8-K filed on September 9, 2015,April 23, 2020, and incorporated herein by reference).
   
10.1610.18+ CollaborationSecurities Purchase Agreement dated July 27, 2015, by and between Stellar Biotechnologies,Edesa Biotech, Inc. and Ostiones GuerreroNovImmune SA de CVdated April 17, 2020 (included as Exhibit 10.110.3 to the Company’s Current Report on Form 8-K filed on July 30, 2015, and incorporated herein by reference).

10.17Sublease Amendment No. 1 (Units 4 and 5) to Sublease Agreement between the Company 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, 2005 (included as Exhibit 10.20 to the Company’s Annual Report on Form 10-K filed on December 14, 2015,April 23, 2020, and incorporated herein by reference).
   
10.1810.19@ Sublease Amendment No. 3 (Units 4Employment Agreement by and 5) to Sublease Agreement between the Company and the Port Hueneme Surplus Property Authority,Kathi Niffenegger, dated June 4, 2015December 1, 2020 (included as Exhibit 10.21 to the Company’s Annual Report on Form 10-K filed on December 14, 2015,7, 2020, and incorporated herein by reference).
   
10.1910.20+ Sublease Amendment No.Strategic Innovation Fund Agreement among Edesa Biotech Research, Inc., Edesa Biotech, Inc., and her Majesty the Queen in right of Canada as represented by the Minister of Industry, dated February 2, (Unit 7) to Sublease Agreement between the Company and the Port Hueneme Surplus Property Authority, dated June 4, 20152021 (included as Exhibit 10.2210.1 to the Company’s AnnualCurrent Report on Form 10-K8-K filed on December 14, 2015,February 3, 2021, and incorporated herein by reference).
   
10.2010.21+ Form of Securities PurchaseExclusive License Agreement, dated June 30, 2016as of March 16, 2021, by and between the Edesa Biotech Research, Inc. and Dr. Saul Yedgar (included as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on June 30, 2016,March 22, 2021, and incorporated herein by reference).

II-9

10.22@Amendment No. 1 to Edesa Biotech, Inc. 2019 Equity Incentive Compensation Plan (included as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on April 23, 2021, and incorporated herein by reference).
   
10.2110.23@ Form of Securities PurchaseAmendment to Employment Agreement, entered into on March 19, 2021, by and between Par Nijhawan and Edesa Biotech, Inc. (included as Exhibit 10.2110.3 to the Company’s Registration StatementQuarterly Report on Form S-110-Q filed on May 8, 2018,14, 2021, and incorporated herein by reference).
   
10.2210.24@Amendment to Employment Agreement, entered into on March 19, 2021, by and between Kathi Niffenegger and Edesa Biotech USA, Inc.  (included as Exhibit 10.4 to the Company’s Quarterly Report on Form 10-Q filed on May 14, 2021, and incorporated herein by reference).
10.25@Amendment to Employment Agreement, entered into on March 19, 2021, by and between Michael Brooks and Edesa Biotech, Inc. (included as Exhibit 10.5 to the Company’s Quarterly Report on Form 10-Q filed on May 14, 2021, and incorporated herein by reference).
10.26 Form of Warrant ExerciseSecurities Purchase Agreement, dated May 24, 2018March 21, 2022, by and between the Company and the Purchaser (included as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on May 29, 2018,March 23, 2022 and incorporated herein by reference).
   
21 Subsidiaries of Stellar Biotechnologies,Edesa Biotech, Inc. (included as Exhibit 21 to the Company’s Annual Report on Form 10-K for the fiscal year ended September 30, 2017, filed on December 1, 2017,7, 2020, and incorporated herein by reference).
   
23.1** Consent of Moss AdamsMNP LLP.
   
23.3*23.2** Consent of McMillanFasken Martineau DuMoulin, LLP (contained(included in Exhibit 5.1 hereto)5.1).
   
24.1** Power of Attorney (included on the signature page of this Registration Statement)page).

**Filed herewith

@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.

 

* 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.

** Filed herewith.

@ 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.

 

II-10