UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

þ

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

For the quarterly period ended December 31, 20172023

 

OR

 

¨

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

For the transition period from                  to

 

Commission File Number:file number: 001-37619

 

Stellar Biotechnologies, Inc.

(Exact name of registrant as specified in its charter)

EDESA BIOTECH, INC.

(Exact name of registrant as specified in its charter)

   

British Columbia, Canada

N/A

(State or other jurisdiction of

(I.R.S. Employer
incorporation or organization)

(I.R.S. Employer Identification No.)

332 E. Scott Street

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

(289) 800-9600

Port Hueneme, California93041

(Address of principal executive offices)offices and zip code)

(Zip Code)Registrant’s telephone number, including area code)

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

Title of each class

Trading

Symbol

Name of each exchange

on which registered

Common Shares, without par value

EDSA

The Nasdaq Stock Market LLC

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

 

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

 

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

 

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

 

Large accelerated filer

¨

Accelerated filer

¨

Non-accelerated filer

x

Smaller reporting company

¨

Emerging growth company

x

 

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

 

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

 

As of February 7, 2018,9, 2024, the registrant had 10,520,0963,171,760 common shares issued and outstanding.

 

 

Stellar Biotechnologies, Inc.EDESA BIOTECH, INC.

Quarterly Report on FormQUARTERLY REPORT ON FORM 10-Q

For the Quarter Ended December 31, 20172023

 

Table of Contents

 

PART I — FINANCIAL INFORMATION

3

Page

PART I

FINANCIAL STATEMENTS

3

Item 1.

Financial Statements (Unaudited).

3

Condensed Interim Consolidated Balance Sheets – December 31, 20172023 and September 30,2017 2023

3

Condensed Interim Consolidated Statements of Operations – Three Months Ended December 31, 20172023 and 20162022

4

Condensed Interim Consolidated Statements of Cash Flows – Three Months Ended December 31, 20172023 and 20162022

5

Condensed Interim Consolidated Statements of Changes in Shareholders' Equity – Three Months Ended December 31, 2023 and 2022

6

Notes to Condensed Interim Consolidated Financial Statements

6

7

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations.Operations

14

16

Item 3.

Quantitative and Qualitative Disclosures About Market Risk.Risk

17

20

Item 4.

Controls and Procedures.Procedures

17

20

PART II

OTHER INFORMATION

18

21

Item 1. Legal Proceedings.

18

Item 1A. Risk Factors.1.

18Legal Proceedings

21

Item 1A.

Risk Factors

21

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds.Proceeds

18

21

Item 3.

Defaults Upon Senior Securities.Securities

18

21

Item 4.

Mine Safety Disclosures.Disclosures

18

21

Item 5. Other Information.

18

Item 5.

Other Information

21

Item 6. Exhibits.

18Exhibits

22

 

PART I — FINANCIAL INFORMATION

Item 1.Financial Statements.
2

Table of Contents

 

Stellar Biotechnologies,PART 1 – FINANCIAL INFORMATION

Item 1. Financial Statements

Edesa Biotech, Inc.

Condensed Interim Consolidated Balance Sheets

(Unaudited)

  

  December 31,  September 30, 
  2017  2017 
       
Assets:        
         
Current assets:        
Cash and cash equivalents $4,369,671  $4,570,951 
Accounts receivable  10,977   1,287 
Short-term investments  998,575   1,994,401 
Inventory  118,540   68,114 
Prepaid expenses  159,543   123,694 
         
Total current assets  5,657,306   6,758,447 
         
Noncurrent assets:        
         
Equity investment in joint venture  66,695   66,695 
Property, plant and equipment, net  854,053   879,523 
Deposits  15,340   15,340 
         
Total noncurrent assets  936,088   961,558 
         
Total Assets $6,593,394  $7,720,005 
         
Liabilities and Shareholders' Equity:        
         
Current liabilities:        
Accounts payable and accrued liabilities $574,376  $320,947 
         
Total Current Liabilities  574,376   320,947 
         
Commitments(Note 7)        
         
Shareholders' equity:        
Common shares, unlimited common shares authorized,
no par value, 10,520,096 issued and outstanding
 at December 31, 2017 and September 30, 2017
  48,351,701   48,351,701 
Accumulated share-based compensation  4,460,106   4,439,400 
Accumulated deficit  (46,792,789)  (45,392,043)
         
Total Shareholders' Equity  6,019,018   7,399,058 
         
Total Liabilities and Shareholders' Equity $6,593,394  $7,720,005 

 

 

December 31, 2023

 

 

September 30, 2023

 

 

 

 

 

 

 

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$4,267,787

 

 

$5,361,397

 

Accounts and other receivable

 

 

743,569

 

 

 

626,543

 

Prepaid expenses and other current assets

 

 

404,903

 

 

 

448,912

 

 

 

 

 

 

 

 

 

 

Total current assets

 

 

5,416,259

 

 

 

6,436,852

 

 

 

 

 

 

 

 

 

 

Non-current assets:

 

 

 

 

 

 

 

 

Property and equipment, net

 

 

8,188

 

 

 

8,702

 

Long-term deposits

 

 

177,731

 

 

 

173,490

 

Intangible asset, net

 

 

2,154,727

 

 

 

2,180,020

 

Right-of-use assets

 

 

74,885

 

 

 

91,373

 

 

 

 

 

 

 

 

 

 

Total assets

 

$7,831,790

 

 

$8,890,437

 

 

 

 

 

 

 

 

 

 

Liabilities and shareholders' equity:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable and accrued liabilities

 

$1,908,598

 

 

$1,747,150

 

Short-term right-of-use lease liabilities

 

 

78,314

 

 

 

74,714

 

 

 

 

 

 

 

 

 

 

Total current liabilities

 

 

1,986,912

 

 

 

1,821,864

 

 

 

 

 

 

 

 

 

 

Non-current liabilities:

 

 

 

 

 

 

 

 

Long-term right-of-use lease liabilities

 

 

-

 

 

 

19,773

 

 

 

 

 

 

 

 

 

 

Total liabilities

 

 

1,986,912

 

 

 

1,841,637

 

 

 

 

 

 

 

 

 

 

Commitments (Note 5)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shareholders' equity:

 

 

 

 

 

 

 

 

Capital shares

 

 

 

 

 

 

 

 

Authorized unlimited common and preferred shares without par value

 

 

 

 

 

 

 

 

Issued and outstanding:

 

 

 

 

 

 

 

 

3,164,722 common shares (September 30, 2023 - 3,075,473)

 

 

46,933,895

 

 

 

46,643,151

 

Additional paid-in capital

 

 

13,223,622

 

 

 

13,039,265

 

Accumulated other comprehensive loss

 

 

(215,220)

 

 

(214,648)

Accumulated deficit

 

 

(54,097,419)

 

 

(52,418,968)

 

 

 

 

 

 

 

 

 

Total shareholders' equity

 

 

5,844,878

 

 

 

7,048,800

 

 

 

 

 

 

 

 

 

 

Total liabilities and shareholders' equity

 

$7,831,790

 

 

$8,890,437

 

 

The accompanying notes are an integral part of these condensed interim consolidated financial statements.


Stellar Biotechnologies, Inc.

3

Table of Contents

Edesa Biotech, Inc.

Condensed Interim Consolidated Statements of Operations

(Unaudited)

  Three Months Ended 
  December 31,  December 31, 
  2017  2016 
       
Revenues:        
Product sales $20,487  $141,856 
   20,487   141,856 
         
Expenses:        
Cost of sales  2,801   78,565 
Costs of aquaculture  98,050   84,835 
Research and development  631,034   460,865 
General and administrative  678,481   932,067 
   1,410,366   1,556,332 
         
Loss from Operations  (1,389,879)  (1,414,476)
         
Other Income (Loss)        
Foreign exchange loss  (17,929)  (77,390)
Investment income  7,862   6,994 
   (10,067)  (70,396)
         
Loss Before Income Tax  (1,399,946)  (1,484,872)
         
Income tax expense  800   800 
         
Net Loss $(1,400,746) $(1,485,672)
         
Loss per common share:        
Basic and diluted $(0.13) $(0.15)
Weighted average number of common shares outstanding:        
Basic and diluted  10,520,096   10,136,258 

 

 

Three Months Ended

 

 

 

December 31, 2023

 

 

December 31, 2022

 

 

 

 

 

 

 

 

Expenses:

 

 

 

 

 

 

Research and development

 

$704,458

 

 

$1,357,338

 

General and administrative

 

 

1,152,971

 

 

 

1,020,967

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

 

(1,857,429)

 

 

(2,378,305)

 

 

 

 

 

 

 

 

 

Other income (loss):

 

 

 

 

 

 

 

 

Reimbursement grant income

 

 

120,834

 

 

 

-

 

Interest income

 

 

60,966

 

 

 

49,429

 

Foreign exchange loss

 

 

(2,822)

 

 

(5,941)

 

 

 

 

 

 

 

 

 

 

 

 

178,978

 

 

 

43,488

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

(1,678,451)

 

 

(2,334,817)

 

 

 

 

 

 

 

 

 

Exchange differences on translation

 

 

(572)

 

 

(25,067)

 

 

 

 

 

 

 

 

 

Net comprehensive loss

 

$(1,679,023)

 

$(2,359,884)

 

 

 

 

 

 

 

 

 

Weighted average number of common shares

 

 

3,128,024

 

 

 

2,626,847

 

 

 

 

 

 

 

 

 

 

Loss per common share - basic and diluted

 

$(0.54)

 

$(0.89)

 

The accompanying notes are an integral part of these condensed interim consolidated financial statements.


Stellar Biotechnologies, Inc.

4

Table of Contents

Edesa Biotech, Inc.

Condensed Interim Consolidated Statements of Cash Flows

(Unaudited)

 

  Three Months Ended 
  December 31,  December 31, 
  2017  2016 
       
Cash Flows Used In Operating Activities:        
Net loss $(1,400,746) $(1,485,672)
         
Adjustments to reconcile net loss to net cash used in operating activities:        
Depreciation and amortization  49,309   45,470 
Share-based compensation  20,706   36,442 
Foreign exchange loss  17,929   77,390 
Transfer equipment to research and development  10,835   - 
         
Changes in working capital items:        
Accounts receivable  (9,712)  72,666 
Inventory  (50,426)  (80,153)
Prepaid expenses  (35,919)  (9,885)
Accounts payable and accrued liabilities  253,561   (21,292)
         
Net cash used in operating activities  (1,144,463)  (1,365,034)
         
Cash Flows From Investing Activities:        
Acquisition of property, plant and equipment  (34,767)  (84,424)
Purchase of short-term investments  (4,174)  (4,804)
Proceeds on sales and maturities of short-term investments  1,000,000   - 
         
Net cash provided by (used in) investing activities  961,059   (89,228)
         
Effect of exchange rate changes on cash and cash equivalents  (17,876)  (77,233)
         
Net change in cash and cash equivalents  (201,280)  (1,531,495)
         
Cash and cash equivalents - beginning of period  4,570,951   7,416,904 
         
Cash and cash equivalents - end of period $4,369,671  $5,885,409 
         
Cash (demand deposits) $4,090,861  $4,549,089 
Cash equivalents  278,810   1,336,320 
         
Cash and cash equivalents $4,369,671  $5,885,409 
         
Supplemental cash flow information:        
         
Cash paid during the period for taxes $800  $800 

 

 

Three Months Ended

 

 

 

December 31, 2023

 

 

December 31, 2022

 

 

 

 

 

 

 

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$(1,678,451)

 

$(2,334,817)

Adjustments for:

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

45,031

 

 

 

27,197

 

Share-based compensation

 

 

184,357

 

 

 

333,675

 

Changes in working capital items:

 

 

 

 

 

 

 

 

Accounts and other receivable

 

 

(99,585)

 

 

1,060,378

 

Prepaid expenses and other current assets

 

 

38,664

 

 

 

57,722

 

Accounts payable and accrued liabilities

 

 

103,456

 

 

 

(935,250)

 

 

 

 

 

 

 

 

 

Net cash used in operating activities

 

 

(1,406,528)

 

 

(1,791,095)

 

 

 

 

 

 

 

 

 

Cash flows from investing activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net cash used in investing activities

 

 

 -

 

 

 

 -

 

 

 

 

 

 

 

 

 

 

Cash flows from financing activities:

 

 

 

 

 

 

 

 

Proceeds from issuance of common shares and warrants

 

 

315,201

 

 

 

3,027,496

 

Payments for issuance costs of common shares and warrants

 

 

(9,459)

 

 

(115,721)

 

 

 

 

 

 

 

 

 

Net cash provided by financing activities

 

 

305,742

 

 

 

2,911,775

 

 

 

 

 

 

 

 

 

 

Effect of exchange rate changes on cash and cash equivalents

 

 

7,176

 

 

 

58,608

 

 

 

 

 

 

 

 

 

 

Net change in cash and cash equivalents

 

 

(1,093,610)

 

 

1,179,288

 

Cash and cash equivalents, beginning of period

 

 

5,361,397

 

 

 

7,090,919

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents, end of period

 

$4,267,787

 

 

$8,270,207

 

  

The accompanying notes are an integral part of these condensed interim consolidated financial statements.


Stellar Biotechnologies, Inc.
Notes to Condensed Interim Consolidated Financial Statements (Unaudited)5

1.NatureTable of OperationsContents

 

Stellar Biotechnologies,Edesa Biotech, Inc.

Condensed Interim Consolidated Statements of Changes in Shareholders' Equity

 

 

Shares #

 

 

Common Shares

 

 

Additional  Paid-in Capital

 

 

 Accumulated Other Comprehensive Loss

 

 

Accumulated Deficit

 

 

Total Shareholders' Equity

 

Three Months Ended December 31, 2023

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance - September 30, 2023

 

 

3,075,473

 

 

$46,643,151

 

 

$13,039,265

 

 

$(214,648)

 

$(52,418,968)

 

$7,048,800

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common shares

 

 

89,249

 

 

 

315,201

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

315,201

 

Issuance costs

 

 

-

 

 

 

(24,457)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(24,457)

Share-based compensation

 

 

-

 

 

 

-

 

 

 

184,357

 

 

 

-

 

 

 

-

 

 

 

184,357

 

Net loss and comprehensive loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(572)

 

 

(1,678,451)

 

 

(1,679,023)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance - December 31, 2023

 

 

3,164,722

 

 

$46,933,895

 

 

$13,223,622

 

 

$(215,220)

 

$(54,097,419)

 

$5,844,878

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended December 31, 2022

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance - September 30, 2022

 

 

2,380,280

 

 

$42,473,099

 

 

$11,176,345

 

 

$(213,602)

 

$(44,044,553)

 

$9,391,289

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common shares and warrants

 

 

384,477

 

 

 

2,082,669

 

 

 

944,827

 

 

 

-

 

 

 

-

 

 

 

3,027,496

 

Issuance costs

 

 

-

 

 

 

(81,945)

 

 

(37,175)

 

 

-

 

 

 

-

 

 

 

(119,120)

Share-based compensation

 

 

-

 

 

 

-

 

 

 

333,675

 

 

 

-

 

 

 

-

 

 

 

333,675

 

Net loss and comprehensive loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(25,067)

 

 

(2,334,817)

 

 

(2,359,884)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance - December 31, 2022

 

 

2,764,757

 

 

$44,473,823

 

 

$12,417,672

 

 

$(238,669)

 

$(46,379,370)

 

$10,273,456

 

The accompanying notes are an integral part of these condensed interim consolidated financial statements.

6

Table of Contents

Edesa Biotech, Inc.

Notes to Condensed Interim Consolidated Financial Statements

(Unaudited)

1. Nature of Operations

Edesa Biotech, Inc. (the Company)Company or Edesa) is a biopharmaceutical company focused on acquiring, developing and commercializing clinical stage drugs for inflammatory and immune-related diseases with clear unmet medical needs. The Company is organized under the laws of British Columbia, Canada. The Company’s businessCanada and is the aquaculture, researchheadquartered in Markham, Ontario. It operates under its wholly owned subsidiaries, Edesa Biotech Research, Inc., an Ontario, Canada corporation, and development, manufacture and commercialization of Keyhole Limpet Hemocyanin (KLH). The Company markets and distributes its KLH products to biotechnology and pharmaceutical companies, academic institutions, and clinical research organizations primarily in Europe, Asia, and the United States. Edesa Biotech USA, Inc., a California, USA corporation.

The Company’s common shares have been listed for tradingtrade on The Nasdaq Capital Market in the United States under the symbol “SBOT” since November 5, 2015.“EDSA”.

 

In April 2010, the Company changed its name from CAG Capital, Inc. to Stellar Biotechnologies, Inc. and completed a reverse merger transaction with Stellar Biotechnologies, Inc., a California corporation, which was founded in September 1999, and remains the Company’s wholly-owned subsidiary and principal operating entity. In January 2017, the California subsidiary and the Company established a wholly-owned Mexican subsidiary under the name BioEstelar, S.A. de C.V. in Ensenada, Baja California to perform aquaculture research and development activities in Mexico. The Company’s executive offices are located at 332 E. Scott Street, Port Hueneme, California, 93041, USA, and its registered and records office is Royal Centre, 1055 West Georgia Street, Suite 1500, Vancouver, BC, V6E 4N7, Canada.

Management Plans

Company operations have historically been funded by the issuance2. Basis of common shares, exercise of warrants, grant revenues, contract services revenue and product sales. For the three months ended December 31, 2017 and 2016, the Company reported net losses of approximately $1.4 million and $1.5 million, respectively. As of December 31, 2017, the Company had an accumulated deficit of approximately $46.8 million and working capital of approximately $5.1 million. While the Company plans to finance company operations for the next twelve months with cash on hand and product sales, management expects to continue incurring losses for the foreseeable future and will need to raise additional capital to pursue our business plan beyond February 2019. Management is taking action to ensure the Company will continue as a going concern for at least one year beyond the date of the issuance of the Company’s financial statements. First, management has flexibility to adjust planned expenditures based on a number of factors including the size and timing of capital expenditures, staffing levels, inventory levels, and the status of customer clinical trials. Management also seeks to expand the customer base for existing marketed products, and intends to secure additional financing through debt and/or equity financings, including transactions with strategic customers and partners that may include debt and/or equity arrangements.Presentation

2.Basis of Presentation

 

The accompanying unaudited condensed interim consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP) for interim financial information and with the instructions to Form 10-Q. They do not include all information and footnotes necessary for a fair presentation of financial position, results of operations and cash flows in conformity with U.S. GAAP for complete financial statements. These unaudited condensed interim consolidated financial statements should be read in conjunction with the consolidated financial statements and related notes contained in the Company’s Annual Report on Form 10-K for the fiscal year ended September 30, 2017.2023, which was filed with the Securities and Exchange Commission (SEC) on December 15, 2023.

 

The accompanying unaudited condensed interim consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Stellar Biotechnologies, Inc., a California corporation in the U.S. and BioEstelar, S.A. de C.V. a Baja California corporation in Mexico.wholly owned subsidiaries. All significant intercompany balances and transactions have been eliminated inon consolidation. In the opinion of management, allAll adjustments (consisting of normal recurring adjustments and accruals) considered necessary for a fair presentation of the results of operations for the periodperiods presented have been included in the interim period.periods. Operating results for the three months ended December 31, 20172023 are not necessarily indicative of the results that may be expected for other interim periods or the fiscal year ending September 30, 2018. The condensed interim consolidated financial data at September 30, 2017 is derived from audited financial statements included in the Company’s Annual Report on Form 10-K for the fiscal year ended September 30, 2017, as filed on December 1, 2017 with the SEC.2024.

Use of estimates

 

The preparation of consolidated financial statements in conformity with U.S. GAAP for interim financial information requires management to make estimates and assumptions that affect the reported amounts reported inof assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and accompanying notes.the reported amounts of revenue and expenses during the period or year. Actual results could differ from thesethose estimates. Areas where significant judgment is involved in making estimates are valuation of accounts and other receivable; valuation and useful lives of property and equipment; intangible assets; right-of-use assets; deferred income taxes; the determination of fair value of share-based compensation; the determination of fair value of warrants in order to allocate proceeds from equity issuances; and forecasting future cash flows for assessing the going concern assumption.

 

Functional Currencyand reporting currencies

 

The condensed interim consolidated financial statements of the Company are presented in U.S. dollars, unless otherwise stated, which is the Company’s and its wholly owned subsidiary’s, Edesa Biotech USA, Inc., functional currency. The functional currency of the Company’s wholly owned subsidiary, Edesa Biotech Research, Inc., as determined by management, is Canadian dollars.

 


Stellar Biotechnologies, Inc.
Notes to Condensed Interim Consolidated Financial Statements (Unaudited)

3. Intangible Assets

 

3.Significant Accounting Policies

Recent Accounting PronouncementsAcquired license

 

In May 2014,April 2020, the Financial Accounting Standards Board (FASB) issued guidance codified in Accounting Standards Codification (ASC) 606Revenue Recognition – Revenue from Contracts with Customerswhich amends the guidance in ASC 605,Revenue Recognition and addsCompany entered into a new Subtopic to the Codification, ASC 340-40,Other Assets and Deferred Costs: Contracts with Customers.The standard’s core principle is that a company will recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. To achieve that core principle, an entity should apply the following steps: Step 1: Identify the contract(s)license agreement with a customer; Step 2: Identifypharmaceutical development company to obtain exclusive world-wide rights to know-how, patents and data relating to certain monoclonal antibodies (the Constructs), including sublicensing rights. Unless earlier terminated, the performance obligationsterm of the license agreement will remain in the contract;Step 3: Determine the transaction price; Step 4: Allocate the transaction price to the performance obligations in the contract; and Step 5: Recognize revenue when (or as) the entity satisfies a performanceobligation. ASC 606 permits two methods of adoption: retrospectively to each prior reporting period presented (full retrospective method), or retrospectively with the cumulative effect of initially applying the guidance recognized atfor 25 years from the date of initial application (the modified retrospective method). In August 2015,first commercial sale of licensed products containing the FASB issued an accounting update to defer the effective date by one year for public entities such that it is now effective for public entities for annual reporting periods beginning after December 15, 2017, including interim periodswithin those years, with early application permitted by one year.Constructs. Subsequently, the FASB issued supplemental adoption guidance and clarification to ASC 606 related to principal vs. agent considerations, identifying performance obligations and licensing, technical corrections and improvements, which must be adoptedlicense agreement will automatically renew for five-year periods unless either party terminates the agreement in accordance with its terms.

Under the license agreement, the Company is exclusively responsible, at the same time as ASC 606. These standards are effectiveits expense, for the Company duringresearch, development, manufacture, marketing, distribution and commercialization of the fiscal year ending September 30, 2019. Management is in the process of assessing the impact this guidance will have on the Company’s consolidated financial statements.We anticipate adoption of ASC 606 using the modified retrospective method with a cumulative catch-up adjustmentConstructs and licensed products and to the opening balance sheet of retained earnings at the effective date, during the first quarter of fiscal 2019.obtain all necessary licenses and rights. The Company will continueis required to review separate performance obligations, potential disclosures,use commercially reasonable efforts to develop and commercialize the methodConstructs in accordance with the terms of adoptiona development plan established by the parties.

7

Table of Contents

The Company has determined that the license has multiple alternative future uses in order to complete the evaluationresearch and development projects and sublicensing in other countries or for other disease indications. The value of the impact onacquired license is recorded as an intangible asset with amortization over the consolidated financial statements.

In January 2016, the FASB issued ASU 2016-01,Financial Instruments-Overall (Subtopic 825-10): Recognitionestimated useful life of 25 years and Measurement of Financial Assets and Financial Liabilities, whichprimarily affects the accountingevaluation for equity investments, financial liabilities under the fair value option, and the presentation and disclosure requirements for financial instruments. In addition,ASU 2016-01clarified guidance related to the valuation allowance assessment when recognizing deferred tax assets resulting from unrealized losses on available-for-sale debt securities.The guidance is effective for public entities for fiscal years beginning after December 15, 2017, including interim periods within those years, with early adoption permitted. These standards are effective for the Company during the fiscal year ending September 30, 2019.Management is in the process of assessing the impact of ASU 2016-01 on the Company’s consolidated financial statements.

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

In June 2016, the FASB issued ASU 2016-13,Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which includes provisions that require financial assets measured at amortized cost basis to be presented at the net amount expected to be collected and credit losses relating to available-for-sale debt securities to be recorded through an allowance for credit losses, which requires recognition of an estimate of all current expected credit losses. The guidance is effective for public entities for fiscal years beginning after December 15, 2019, including interim periods within those years, with early adoption permitted for fiscal years beginning after December 15, 2018. These standards are effective for the Company during the fiscal year ending September 30, 2021.Management is in the process of assessing the impact of ASU 2016-13 on the Company’s consolidated financial statements.

In May 2017, the FASB issued ASU 2017-09, Scope of Modification Accounting, which provides new guidance on changes to the terms or conditions of share-based payment awards that would be required to apply modification accounting under ASC 718,Compensation-Stock Compensation. The amendments are effective for annual reporting periods beginning after December 15, 2017 with early adoption permitted. These standards are effective for the Company during the fiscal year ending September 30, 2019.  Management is in the process of assessing the impact of ASU 2017-09 on the Company's consolidated financial statements.

4.Investments

Short-term investments consisted of U.S. Treasury Bills at December 31, 2017 and September 30, 2017.

U.S. Treasury Bills are carried at amortized cost which approximates fair value and are classified as held-to-maturity investments.


Stellar Biotechnologies, Inc.
Notes to Condensed Interim Consolidated Financial Statements (Unaudited)

5.Inventory

Raw materials include inventory of manufacturing supplies. Work in process includes manufacturing supplies, direct and indirect labor, contracted manufacturing and testing, and allocated manufacturing overhead for inventory in processimpairment at the end of theeach reporting period. Finished goods include products that are complete and available for sale. At December 31, 2017 and September 30, 2017, the Company recorded work in process and finished goods inventory only for those products with recent sales levels to evaluate net realizable value.

 

Inventory consistedThe required upfront license payment of $2.5 million was paid by issuance of Series A-1 Convertible Preferred Shares, which have been fully converted to common shares. The value of the following:license includes acquisition legal costs. See Note 5 for license commitments.

 

  December 31,  September 30, 
  2017  2017 
       
Raw materials $30,628  $21,761 
Work in process  51,933   - 
Finished goods  35,979   46,353 
         
  $118,540  $68,114 

6.Property, Plant and Equipment, net

Property, plant and equipment,Intangible assets, net consisted of the following:

 

  December 31,  September 30, 
  2017  2017 
       
Aquaculture system $126,257  $126,257 
Laboratory facilities  62,033   62,033 
Computer and office equipment  117,840   117,840 
Tools and equipment  1,035,604   982,439 
Vehicles  77,994   77,994 
Leasehold improvements  342,935   337,060 
   1,762,663   1,703,623 
Less: accumulated depreciation  (1,008,777)  (969,418)
         
Depreciable assets, net  753,886   734,205 
Construction in progress  100,167   145,318 
         
  $854,053  $879,523 

 

 

 December 31,

2023

 

 

September 30,

2023

 

 

 

 

 

 

 

 

The Constructs

 

$2,529,483

 

 

$2,529,483

 

 

 

 

 

 

 

 

 

 

Less: accumulated amortization

 

 

(374,756)

 

 

(349,463)

 

 

 

 

 

 

 

 

 

Total intangible assets, net

 

$2,154,727

 

 

$2,180,020

 

 

Depreciation and amortizationAmortization expense amounted to approximately $49,000 and $45,000 for the three months ended December 31, 2017 and 2016, respectively.

7.Commitments

Operating leases

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

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

The Company leases undeveloped land in Baja California, Mexico to assess the potential development of an additional aquaculture locale and expansion of production. The lease term is three years from June 2015 with options to extend the lease for 30 years. The Company may terminate early with 30 days’ notice. The rent has been prepaid through June 2018, and is not included in the future minimum lease payments below. The Company has a related agreement with the lessor to collaborate on the design, expansion and development of marine aquaculture resources and KLH production facilities on the leased property. Under that agreement, the Company was responsible for certain leasehold improvements including construction of structures and a power-generating facility, which are owned by the Company. The Company reimburses the lessor for local operational support. The collaboration agreement expires in June 2018, unless terminated earlier.


Stellar Biotechnologies, Inc.
Notes to Condensed Interim Consolidated Financial Statements (Unaudited)

Aggregate future minimum lease payments at December 31, 2017 are as follows:

Nine Months Ending September 30, 2018  115,000 
Year Ending September 30, 2019  106,000 
Year Ending September 30, 2020  106,000 
Year Ending September 30, 2021  6,000 
     
  $333,000 

Rent expense on these lease agreements amounted to approximately $60,000 and $59,000 for the three months ended December 31, 2017 and 2016, respectively.

Purchase obligations

The Company has commitments totaling approximately $133,000 at December 31, 2017 for signed agreements with contract research organizations, consultants, construction contractors and equipment suppliers. All purchase obligations are expected to be fulfilled within the next 12 months.

Supply agreements

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

Joint venture agreement

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

The Company holds a 30% equity interest in the joint venture in exchange for an initial capital contribution of €120,000. One-half of the initial contribution, approximately $67,000, was paid during the year ended September 30, 2016 with the balance due upon the occurrence of certain defined future events. The Company will also provide the joint venture additional financing as may be required, on a pro rata basis in line with our equity interest. According to the joint venture agreement, if certain milestones are not achieved by December 31, 2017, the joint venture will be dissolved, unless (i) the parties mutually agree to pursue the joint venture arrangement, or (ii) either party decides to purchase the equity interests of the other party. This deadline has passed and the parties have expressed their mutual desire to renew and amend the agreement to extend the timeline. Each of the parties is entitled, upon the occurrence of certain defined events, to acquire the interest of the other party. Except as described herein, the joint venture has an initial ten-year term, renewable for successive five-year terms. If either party provides notice at least six months prior to the expiration date of an applicable term that it does not wish to continue its participation in the joint venture, the other party will have a right to acquire all of such terminating party’s equity interests in the joint venture.

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

Licensing agreement and technology transfer agreement

In July 2013, the Company acquired the exclusive, worldwide license to certain patented technology for the development of human immunotherapies againstClostridium difficile infection (C. diff) under a written agreement (the License Agreement) with a University (the Licensor) which required payments of license fees, patent cost reimbursements and other contingent fees. In March 2017, (i) the Company entered into an agreement to terminate the License Agreement, (ii) the Company concurrently entered into a technology transfer and purchase agreement (the Transfer Agreement) with a vaccine biotechnology company (the Transferee), and (iii) the Licensor and Transferee entered into a direct licensing arrangement relating to the patented C. diff technology. Under the Transfer Agreement, the Company transferred to the Transferee its proprietary rights and know-how of immunogens and vaccine technology for C. diff, in exchange for an upfront payment and a percentage of future fees, milestone payments, sublicensing income and royalties, if any, paid by the Transferee or its assigns to the Licensor.

As a result of the termination of the License Agreement, there are no early termination penalties and no further annual licensing fees, contingent milestone payments, royalties, sub-licensing fees or other financial obligations payable by the Company to the Licensor. 


Stellar Biotechnologies, Inc.
Notes to Condensed Interim Consolidated Financial Statements (Unaudited)

Retirement savings plan 401(k) contributions

The Company sponsors a 401(k) retirement savings plan that requires an annual non-elective safe harbor employer contribution of 3% of eligible employee wages. All employees over 21 years of age are eligible beginning the first payroll after 3 consecutive months of employment. Employees are 100% vested in employer contributions and in any voluntary employee contributions. Contributions to the 401(k) plan were approximately $19,000 and $18,000$0.03 million for each of the three months ended December 31, 20172023 and 2016,2022 , respectively.

 

Total estimated future amortization of intangible assets for each fiscal year is as follows:

Year Ending

 

 

 

September 30, 2024

 

 

75,879

 

September 30, 2025

 

 

101,172

 

September 30, 2026

 

 

101,172

 

September 30, 2027

 

 

101,172

 

September 30, 2028

 

 

101,172

 

Thereafter

 

 

1,674,160

 

 

 

 

 

 

 

 

$2,154,727

 

4. Right-of-Use Lease with Related party commitmentsParty

 

On August 14, 2002,The Company leases a facility used for executive offices from a related company. The original lease expired in December 2022 and the Company executed a two-year extension through December 2024.

The components of right-of-use lease cost were as follows:

 

 

Three Months Ended

 

 

 

December 31,

2023

 

 

December 31,

2022

 

Right-of-use lease cost, included in general and administrative on the Statements of Operations

 

$20,116

 

 

$18,898

 

Lease terms and discount rates were as follows:

December 31,

2023

September 30,

2023

Remaining lease term (months):

12

15

Estimated incremental borrowing rate:

9.2%

9.2%

8

Table of Contents

The future minimum lease payments under right-of-use leases at December 31, 2023 were as follows:

Year Ending

 

 

 

 

 

 

September 30, 2024

 

 

 

 

$61,234

 

September 30, 2025

 

 

 

 

 

20,411

 

 

 

 

 

 

 

 

 

Total lease payments

 

 

 

 

 

81,645

 

Less imputed interest

 

 

 

 

 

3,331

 

 

 

 

 

 

 

 

 

Present value of right-of-use lease liabilities

 

 

 

 

 

78,314

 

Present value included in current liabilities

 

 

 

 

 

78,314

 

 

 

 

 

 

 

 

 

 

Present value included in long-term liabilities

 

 

 

 

$-

 

Cash flow information was as follows:

 

 

Three Months Ended

 

 

 

December 31,

2023

 

 

December 31,

2022

 

Cash paid for amounts included in the measurement of right-of-use lease liabilities, included in accounts payable and accrued liabilities on the Statements of Cash Flow.

 

$20,116

 

 

$18,899

 

5. Commitments

Research and other commitments

The Company has commitments for contracted research organizations who perform clinical trials for the Company’s ongoing clinical studies and other service providers. Approximate aggregate future contractual payments at December 31, 2023 are as follows:

Year Ending

 

 

 

 

 

 

 

September 30, 2024

 

$1,540,000

 

September 30, 2025

 

 

49,000

 

September 30, 2026

 

 

36,000

 

September 30, 2027

 

 

42,000

 

September 30, 2028

 

 

-

 

 

 

 

 

 

 

 

$1,667,000

 

License and royalty commitments

In April 2020, through its CaliforniaOntario subsidiary, the Company entered into a patent royaltylicense agreement with a director and officer of the Company, whereby he would receive royalty payments in exchange for assignment of his patentthird party to obtain exclusive world-wide rights to the Company.Constructs, including sublicensing rights. An intangible asset for the acquired license has been recognized. See Note 5 for intangible assets. Under the license agreement, the Company is committed to payments of up to an aggregate amount of $356 million contingent upon meeting certain milestones outlined in the license agreement, primarily relating to future potential commercial approval and sales milestones. The Company also has a commitment to pay royalties based on any net sales of products containing the Constructs in the countries where the Company directly commercializes the products containing the Constructs and a percentage of any sublicensing revenue received by the Company and its affiliates in the countries where it does not directly commercialize the products containing the Constructs. No milestone, royalty is 5% of gross receipts from products using this invention in excess of $500,000 annually. The Company’s current operations utilize this invention. There was no royalty expense incurredor sublicensing payments were made to the third party during the three months ended December 31, 20172023 and 2016.2022.

In 2016, through its Ontario subsidiary, the Company entered into a license agreement with a third party to obtain exclusive rights to certain know-how, patents and data relating to a pharmaceutical product. The Company will use the exclusive rights to develop the product for therapeutic, prophylactic and diagnostic uses in topical dermal applications and anorectal applications. No intangible assets have been recognized under the license agreement with the third party. Under the license agreement, the Company is committed to payments of various amounts to the third party upon meeting certain milestones outlined in the license agreement, up to an aggregate amount of $18.4 million. Upon divestiture of substantially all of the assets of the Company, the Company shall pay the third party a percentage of the valuation of the licensed technology sold as determined by an external objective expert. The Company also has a commitment to pay the third party a royalty based on net sales of the product in countries where the Company, or an affiliate, directly commercializes the product and a percentage of sublicensing revenue received by the Company and its affiliates in the countries where it does not directly commercialize the product. A milestone payment of $0.1 million was made to the third party during the three months ended December 31, 2022 and no milestone payments were made during the three months ended December 31, 2023.

 

8.Share Capital
9

Table of Contents

 

In March 2021, through its Ontario subsidiary, the Company entered into a license agreement with the inventor of the same pharmaceutical product to acquire global rights for all fields of use beyond those named under the 2016 license agreement. The Company hadis committed to remaining payments of up to an aggregate amount of $68.9 million, primarily relating to future potential commercial approval and sales milestones. In addition, if the Company fails to file an investigational new drug application or foreign equivalent (IND) for the product within a certain period of time following transactionsthe date of the agreement, the Company is required to remit to the inventor a fixed license fee quarterly as long as the requirement to file an IND remains unfulfilled. For the three months ended December 31, 2023, the Company recorded an expense of $25,000 as a result of meeting milestones outlined in share capital:the 2021 license agreement. There were no milestones achieved in the three months ended December 31, 2022 and no expenses were incurred.

 

  Three Months Ended 
  December 31,  December 31, 
  2017  2016 
      
Share-based compensation $20,706  $36,442 

6. Capital Shares

 

Equity offerings

On November 2, 2022, the Company completed a private placement of units consisting of 384,475 common shares, Class A warrants to purchase up to an aggregate of 192,248 common shares and Class B warrants to purchase up to an aggregate of 192,248 common shares. Net proceeds from the offering were $2.9 million, which were allocated between the relative fair values of the common shares (using a fair value of $2.7 million) and the common share purchase warrants (using a total fair value of $1.2 million). The warrants became exercisable December 23, 2022. The Class A warrants have an exercise price of $10.50 per share and will expire on December 23, 2025. The Class B warrants have an exercise price of $7.00 per share and expired on December 23, 2023. The warrants are considered contracts on the Company’s own shares and are classified as equity.

Equity distribution agreement

On March 27, 2023, the Company entered into an equity distribution agreement with Canaccord, pursuant to which the Company may offer and sell, from time to time, common shares through an at-the-market equity offering program for up to $20 million in gross proceeds, subject to certain offering limitations that currently allow the Company to offer and sell common shares having an aggregate gross sales price of up to $8.4 million. The Company has no obligation to sell any of the common shares and may at any time suspend sales or terminate the equity distribution agreement in accordance with its terms. During the three months ended December 31, 2023, the Company sold a total of 89,249 common shares pursuant to the agreement for gross proceeds of approximately $0.3 million after deducting commissions and direct costs.

Black-Scholes option valuation model

 

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

 

10

Table of Contents

Warrants

 

There were 1,265,626A summary of the Company’s warrants outstanding at December 31, 2017 with an exercise price of $4.50 and expiry date of January 6, 2022. There were no warrants granted or exercised during the period from September 30, 2016 to December 31, 2017.activity is as follows:

 

 

Number of Warrant Shares (#)

 

 

Weighted Average Exercise Price

 

Three Months Ended December 31, 2023

 

 

 

 

 

 

Balance - September 30, 2023

 

 

720,909

 

 

$19.51

 

 

 

 

 

 

 

 

 

 

Expired

 

 

(110,122

 

 

7.00

 

 

 

 

 

 

 

 

 

 

Balance - December 31, 2023

 

 

610,787

 

 

$21.76

 

 

 

 

 

 

 

 

 

 

Three Months Ended December 31, 2022

 

 

 

 

 

 

 

 

Balance - September 30, 2022

 

 

521,718

 

 

$28.00

 

 

 

 

 

 

 

 

 

 

Issued

 

 

384,496

 

 

 

8.75

 

 

 

 

 

 

 

 

 

 

Balance - December 31, 2022

 

 

906,214

 

 

$19.88

 

 

The weighted average contractual life remaining on the outstanding warrants at December 31, 20172023 is 3338 months.

 

The following table summarizes information about the warrants outstanding at December 31, 2023:

Number of Warrants (#)

 

 

Exercise Prices

 

 

Expiry Dates

 

 

1,070

 

 

$33.67

 

 

June 2024

 

 

1,687

 

 

$22.40

 

 

January 2025

 

 

173,614

 

 

$10.50

 

 

December 2025

 

 

15,627

 

 

$56.00

 

 

February 2026

 

 

27,399

 

 

$31.94

 

 

March 2027

 

 

391,390

 

 

$24.64

 

 

September 2027

 

 

610,787

 

 

 

 

 

 

 

 

The fair value of warrants granted during the three months ended December 31, 2022 was estimated using the Black-Scholes option valuation model using the following assumptions:

 

 

Three Months Ended December 31, 2022

 

 

 

Class A Warrants

 

 

Class B Warrants

 

 

 

 

 

 

 

 

Risk free interest rate

 

 

4.54%

 

 

4.76%

Expected life

 

3.14 years

 

 

1.14 years

 

Expected share price volatility

 

 

90.73%

 

 

89.70%

Expected dividend yield

 

 

0.00%

 

 

0.00%

Share Optionsoptions

The Company hasadopted an incentive compensation plan adoptedEquity Incentive Compensation Plan in 20172019 (the Incentive2019 Plan) administered by the independent members of the Board of Directors, which amended and restated the 2013 fixed share option plan.prior plans. Options, restricted shares and restricted share units are eligible for grantsgrant under the Incentive2019 Plan. The total number of shares available for issuance under the Incentiveterms of the 2019 Plan is 1,597,000, including575,737. The remaining number of shares available for the exercise of outstanding options under the 2013 fixed share option plan. No restricted shares or restricted share units have been granted as ofto grant at December 31, 2017.2023 is 81,371.

 

The exercise price of an option is set at the closing price of the Company’s common shares on the date of grant. Share2019 Plan allows options to be granted to directors, officers, employees and certain individualexternal consultants for past service are subjectand advisers. Under the 2019 Plan, the option term is not to exceed 10 years and the following vesting schedule: (a) one-third shall vest immediately, (b) one-third shall vest at 12 months fromexercise price of each option is determined by the dateindependent members of grant and (c) one-third shall vest at 18 months from the dateBoard of grant.Directors.

 

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

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


Stellar Biotechnologies, Inc.
Notes to Condensed Interim Consolidated Financial Statements (Unaudited)11

Table of Contents

 

Options have been granted under the Incentive2019 Plan allowing the holders to purchase common shares of the Company as follows:

 

 Number of
Options
  Weighted
Average
Exercise Price
   

 

Number of Options (#)

 

 

Weighted Average Exercise Price

 

 

Weighted Average Grant Date Fair Value

 

      
Balance - September 30, 2016  539,103  $5.29   

Three Months Ended December 31, 2023

 

 

 

 

 

 

 

Balance - September 30, 2023

 

420,615

 

$25.60

 

$18.84

 

          

 

 

 

 

 

 

 

Granted  71,600   1.89   

 

500

 

4.10

 

3.10

 

Expired  (28,233)  11.14   

 

 

(106)

 

 

960.00

 

 

 

960.00

 

 

 

 

 

 

 

 

Balance - December 31, 2023

 

 

421,009

 

 

$25.46

 

 

$18.67

 

 

 

 

 

 

 

 

Three Months Ended December 31, 2022

 

 

 

 

 

 

 

Balance - September 30, 2022

 

314,853

 

$32.62

 

$23.94

 

 

 

 

 

 

 

 

Granted

 

500

 

6.72

 

4.97

 

Expired  (171,500)  2.90  CDN $

 

 

(34)

 

 

2,129.00

 

 

 

2,129.00

 

          

 

 

 

 

 

 

 

Balance - September 30, 2017  410,970  $5.74   
          
Expired  (10,667)  17.29   
Expired  (35,250)  4.57  CDN $
          
Balance - December 31, 2017  365,053  $5.58   

Balance - December 31, 2022

 

 

315,319

 

 

$32.27

 

 

$23.73

 

During the three months ended December 31, 2023, the independent members of the Board of Directors granted 500 employee options and no director options. The options have a term of 10 years and an exercise price equal to the Nasdaq closing price on the grant date.

 

The weighted average contractual life remaining on the outstanding options at December 31, 2023 is 3383 months.

 

The following table summarizes information about the options under the Incentive2019 Plan outstanding and exercisable at December 31, 2017:2023:

 

Number of
Options
  Exercisable at
December 31, 2017
  Range of exercise prices Expiry Dates
 94,360   94,360   CDN$0.01 - 5.00 Apr 2017-Dec 2019
 69,233   32,533   $0.01 - 5.00 Sep 2023-Mar 2024
 125,360   125,360   CDN$5.01 - 10.00 Oct 2017-Jun 2022
 15,100   15,100   $5.01 - 10.00 Dec 2022
 21,500   21,500   CDN$15.01 - 20.00 Nov 2018-Nov 2021
 39,500   29,500   $15.01 - 20.00 Nov 2020
 365,053   318,353     

Number of Options (#)

 

 

 Exercisable at

December 31, 2023 (#) 

 

 

 Range of Exercise Prices

 

 

Expiry Dates

 

 

391

 

 

 

391

 

 

$

  246.96 - 596.82

 

 

June 2024 - Mar 2025

 

 

42,348

 

 

 

42,348

 

 

C$15.12

 

 

May 2024 - Dec 2028

 

 

46,285

 

 

 

46,285

 

 

$22.12

 

 

May 2024 - Feb 2030

 

 

56,722

 

 

 

56,722

 

 

$

  52.08 - 56.49

 

 

May 2024 - Oct 2030

 

 

93,344

 

 

 

87,090

 

 

$

  36.75 - 40.18

 

 

Apr 2024 - Sep 2031

 

 

68,777

 

 

 

49,004

 

 

$

  20.58 - 25.97

 

 

Apr 2024 - Feb 2032

 

 

113,142

 

 

 

30,585

 

 

$

  5.79 - 10.01

 

 

Apr 2024 - Jul 2033

 

 

421,009

 

 

 

312,425

 

 

 

 

 

 

 

 

 

The estimatedoptions exercisable at December 31, 2023 had a weighted average exercise price of $29.99, $245 intrinsic value and a weighted average remaining life of 74 months. There were 108,584 options at December 31, 2023 that had not vested with a weighted average exercise price of $12.43, no intrinsic value and a weighted average remaining life of 109 months.

The fair value of the share options granted during the three months ended December 31, 20162023 and 2022 was determinedestimated using athe Black-Scholes option valuation model withusing the following weighted average assumptions:

 

Three Months Ended
December 31,
2016
Risk free interest rate1.49%
Expected life (years)7.00
Expected share price volatility166%
Expected dividend yield0%

 

 

Three Months Ended December 31, 2023

 

 

Three Months Ended December 31, 2022

 

 

 

 

 

 

 

 

Risk free interest rate

 

 

4.92%

 

 

3.62%

Expected life

 

5 years

 

 

5 years

 

Expected share price volatility

 

 

97.26%

 

 

95.30%

Expected dividend yield

 

 

0.00%

 

 

0.00%

 

There were no share options granted duringThe Company recorded $0.2 million and $0.3 million of share-based compensation expenses for the three months ended December 31, 2017.

The weighted average fair value of share options granted during the three months ended December 31, 2016 was $1.98.2023 and 2022, respectively.

 

As of December 31, 2017,2023, the Company had approximately $40,000$0.3 million of unrecognized share-based compensation expense, which is expected to be recognized over a period of 27 months.31months.

12

Table of Contents

Restricted Share Units (RSU)

 

The Company’s 2019 Plan allows restricted share units (RSUs) to be granted to directors, officers, employees and certain external consultants and advisers. Under the 2019 Plan, the RSU term is not to exceed 10 years. The fair value is based on the 5-day VWAP of the Company’s common shares up to the date of grant. The initial grant of RSUs was in August 2023. 

The following is a summary of changes in the status of RSUs from October 1, 2023 through December 31, 2023:

 

 

Number of RSU (#)

 

 

Weighted Average Grant Date Fair Value

 

Three Months Ended December 31, 2023

 

 

 

 

 

 

Balance - September 30, 2023 and December 31, 2023

 

 

33,045

 

 

$5.60

 

The following table summarizes information about the RSUs under the 2019 Plan outstanding and exercisable at December 31, 2023:

Number of RSU (#)

Expiry Date

Fully-vested RSUs

33,045

August 4, 2033

All RSUs that were granted vested immediately upon the grant date. The outstanding RSUs can be converted to common shares by the holder at any time prior to the expiry date. There wereis no options exercised duringfuture unrecorded compensation expense for the RSUs.

7. Government Contributions

Reimbursement grant income for the Company’s federal grant with the Canadian government’s SIF is recorded based on the claim period of eligible costs.

In February 2021, the Company entered into a multi-year contribution agreement (the 2021 SIF Agreement) with the Canadian Government’s Strategic Innovation Fund. Under the 2021 SIF Agreement, the Government of Canada committed up to C$14.1 million in nonrepayable funding which was intended to support research and development related to our EB05 clinical program. No further funding will be received from the 2021 SIF Agreement.

In October 2023, the Company entered into a multi-year contribution agreement (the 2023 SIF Agreement) with the Canadian Government’s Strategic Innovation Fund. Under the 2023 SIF Agreement, the Government of Canada committed up to C$23 million in partially repayable funding toward (i) conducting and completing the Company’s Phase 3 clinical study of its experimental drug EB05 in critical-care patients with Acute Respiratory Distress Syndrome (ARDS) caused by COVID-19 or other infectious agents, (ii) submitting EB05 for governmental approvals and manufacturing scale-up, following, and subject to, completing the Phase 3 study and (iii) conducting two non-clinical safety studies to assess the potential long-term impact of EB05 exposure (the Project). Of the C$23 million committed by SIF, up to C$5.8 million is not repayable by the Company. The remaining C$17.2 million is conditionally repayable starting in 2029 only if and when the Company earns gross revenue. The repayable portion would be payable over fifteen (15) years based on a percentage rate of the Company’s annual revenue growth. The maximum amount repayable under the Agreement is 1.4 times the original repayable amount. In addition, the Company is entitled to partial reimbursement of certain eligible expenses under the Agreement.

Under the Agreement, the Company agreed to certain financial and non-financial covenants and other obligations in relation to the Project. Pursuant to the Agreement, certain customary events of default, such as the Company’s or Edesa Biotech Research’s breach of their covenants and obligations under the Agreement, their insolvency, winding up or dissolution, and other similar events, may permit the Government of Canada to declare an event of default under the Agreement. Upon an event of default, subject to applicable cure, the Government of Canada may exercise a number of remedies, including suspending or terminating funding under the Agreement, demanding repayment of funding previously received and/or terminating the Agreement.

13

Table of Contents

The funding and any associated conditional repayments are not secured by any assets of Edesa Biotech Research or the Company.

The Agreement will expire on the later of December 31, 2042 or the date of the last repayment, unless earlier terminated, subject to certain provisions that extend three (3) years beyond the term or early termination of the Agreement.

Under the 2023 SIF Agreement the Company recorded grant income of $0.1 million for the three months ended December 31, 2017 and 2016. There2023. No grant income was no intrinsic value ofrecorded under the vested options at2023 SIF Agreement for the three months ended December 31, 2017.

2022.

 

9.Fair Value of Financial Instruments

8. Financial Instruments

(a) Fair values

 

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


Stellar Biotechnologies, Inc.
Notes to Condensed Interim Consolidated Financial Statements (Unaudited)

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

 

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

There are three levels of inputs that may be used to measure fair value:

 

·

Level 1:1 – Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets.

Quoted

·

Level 2 – Inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs include quoted prices for similar assets or liabilities in active markets, for identical or similar assets and liabilities. 
Level 2:Quotedquoted prices for identical or similar assets and liabilities in markets that are not active or observable inputs other than quoted prices in active markets for identical or similar assets and liabilities. active.

·

Level 3:3 – Unobservable inputs for the asset or liability that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. activity.

The carrying value of certain financial instruments such as cash and cash equivalents, accounts and other receivable, accounts payable and accrued liabilities approximates fair value due to the short-term nature of such instruments.

(b) Interest rate and credit risk

Interest rate risk is the risk that the value of a financial instrument might be adversely affected by a change in interest rates. The Company does not believe that the results of operations or cash flows would be affected to any significant degree by a significant change in market interest rates, relative to interest rates on cash and cash equivalents due to the short-term nature of these balances.

 

The Company reports its short-term investments in U.S. Treasury Bills at fair value using Level 1 inputs in the fair value hierarchy.

The following table summarizes fair values for those assets and liabilities with fair value measured on a recurring basis.

  Fair Value Measurements Using    
  Quoted Prices in
Active Markets
for Identical
Instruments
 (Level 1)
  Significant
Other
Observable
Inputs
(Level 2)
  Significant
Unobservable
Inputs
(Level 3)
  Total Fair Value 
December 31, 2017                
Assets                
Short-term investments in U.S. Treasury Bills $998,575  $-  $-  $998,575 
                 
September 30, 2017                
Assets                
Short-term investments in U.S. Treasury Bills $1,994,401  $-  $-  $1,994,401 

10.Concentrations of Credit Risk

Credit risk is the risk of an unexpected loss if a customer or third partyalso exposed to a financial instrument fails to meet its contractual obligations. Financial instruments that potentially subject the Company to a concentration of credit risk consist primarilyat period end from the carrying value of its cash and cash equivalents U.S Treasury Bills, and accounts and other receivable. The Company estimates its maximum creditmanages this risk at the amount recorded on the balance sheet.

Management’s assessment of the Company’s credit risk for cashby maintaining bank accounts with a Canadian Chartered Bank and cash equivalents is low as they are held in major financial institutionsa U.S. bank believed to be credit worthy orand money market mutual funds of U.S. Treasury Bills with maturities of 90 days or less.government securities. The Company’s cash is not subject to any external restrictions. The Company limitsassesses the collectability of accounts receivable through a review of the current aging and terms, as well as an analysis of historical collection rates, general economic conditions and credit status of government agencies. Credit risk for the reimbursement grant and HST refunds receivable are not considered significant since amounts are due from the Canadian government’s SIF and the Canada Revenue Agency.

(c) Foreign exchange risk

The Company and its subsidiary have balances in Canadian dollars that give rise to exposure to creditforeign exchange (FX) risk relating to the impact of translating certain non-U.S. dollar balance sheet accounts as these statements are presented in U.S. dollars. A strengthening U.S. dollar will lead to a FX loss for short-term investments by holdingwhile a weakening U.S. Treasury Bills with maturitiesdollar will lead to a FX gain. The Company has not entered into any agreements or purchased any instruments to hedge possible currency risks. At December 31, 2023, the Company and its Canadian subsidiary had assets denominated in Canadian dollars of 1 year or less.approximately C$1.9 million and the U.S. dollar exchange rate at this date was equal to 1.3257 Canadian dollars. Based on credit monitoringthe exposure at December 31, 2023, a 10% annual change in the Canadian/U.S. exchange rate would impact the Company’s loss and history,other comprehensive loss by approximately $0.1 million.

(d) Liquidity risk

Liquidity risk is the risk that the Company considerswill encounter difficulty raising liquid funds to meet commitments as they fall due. In meeting its liquidity requirements, the risk of credit losses due to customer non-performance on accounts receivable to be low.Company closely monitors its forecasted cash requirements with expected cash drawdown.

14

Table of Contents

9. Loss per Share

 

The Company had securities outstanding which could potentially dilute basic earnings per share in the following concentrationsfuture but were excluded from the computation of revenues by customers,diluted loss per share in the periods presented, as their effect would have been anti-dilutive.

10. Related Party Transactions

During each of which accountedthe three months ended December 31, 2023 and 2022, the Company paid cash of $20,000 and $19,000, respectively, for more than 10% of revenuesa ROU lease from a company controlled by the Company’s CEO. These transactions are in the applicable period:

  Three Months Ended 
  December 31,  December 31, 
  2017  2016 
       
Product sales and contract services revenue   98% from
3 customers
    92% from
1 customer
 

Thenormal course of operations and are measured at the exchange amount, which is the amount of consideration established and agreed to by both parties. On December 31, 2022, the Company hadexecuted a two-year lease extension through December 31, 2024 in accordance with the following concentrationsterms of revenues by geographic areas:

  Three Months Ended 
  December 31,  December 31, 
  2017  2016 
       
Europe  73%  94%
North America  27%  6%


Stellar Biotechnologies, Inc.
Notes to Condensed Interim Consolidated Financial Statements (Unaudited)

the original lease agreement. Rent of approximately $15,000 was payable at December 31, 2023. There was no rent payable at December 31, 2022.

 

In October 2023, we entered into $10.0 million revolving credit agreement with Pardeep Nijhawan Medicine Professional Corporation, an entity controlled by Dr. Pardeep Nijhawan, MD, our Chief Executive Officer and Secretary and member of our board of directors (Credit Agreement), providing an unsecured revolving credit facility, with a credit limit of $3.5 million (Credit Limit) which was available immediately. The line of credit bears interest at the Canadian Imperial Bank of Commerce US Base-Interest Rate plus 3% per annum and has a maturity date of March 31, 2026, unless terminated earlier by either party with 90 days’ notice. Advances under the line of credit are tied to a borrowing base (Borrowing Base) consisting of eligible grant receivables from SIF, future potential license fee receivables and any other accounts receivable. At no time shall the aggregate principal amount of all advances outstanding exceed the lesser of (i) the Credit Limit and (ii) an amount equal to 85% of the Borrowing Base. The Company hadhas not drawn any funds from the following concentrationsCredit Agreement. During the three months ended December 31, 2023 the Company incurred a standby charge of accounts receivable from its customers, each of which accounted for more than 10%$12,000. There was no standby charge in the applicable period:three months ended December 31, 2022.

11. Subsequent Events

Subsequent to December 31, 2023, equity sales under the Company’s at-the-market offering program have resulted in the issuance of 7,038 common shares and receipt of net cash proceeds of $0.03 million after deducting sales agent commissions.

 

December 31, 
201715

Accounts receivable 49% from
1 customer
Table of Contents

 

There were no customer accounts receivable at September 30, 2017.Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

 


Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following management’s discussion and analysis of our financial condition and results of operations should be read in conjunction with the unaudited condensed interim consolidated financial statements and notes thereto included in Part I, Item 1 of this Quarterly Report on Form 10-Q as of December 31, 20172023 and our audited consolidated financial statements for the year ended September 30, 20172023 included in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission, or the SEC, on December 1, 2017.15, 2023.

This Quarterly Report on Form 10-Q contains forward-looking statements. When used in this report, the words “expects,” “anticipates,” “suggests,” “believes,” “intends,” “estimates,” “plans,” “projects,” “continue,” “ongoing,” “potential,” “expect,” “predict,” “believe,” “intend,” “may,” “will,” “should,” “could,” “would” and similar expressions are intended to identify forward-looking statements. You should not place undue reliance on these forward-looking statements. Our actual results could differ materially from those anticipated in the forward-looking statements for many reasons, including the risks described in our Annual Report on Form 10-K for the year ended September 30, 20172023 and other reports we file with the Securities and Exchange Commission. Although we believe the expectations reflected in the forward-looking statements are reasonable, they relate only to events as of the date on which the statements are made. We do not intend to update any of the forward-looking statements after the date of this report to conform these statements to actual results or to changes in our expectations, except as required by law.

The discussion and analysis of our financial condition and results of operations are based on our unaudited condensed interim consolidated financial statements as of December 31, 20172023 and September 30, 2017,2023, and for the three months ended December 31, 20172023 and 20162022 included in Part I, Item 1 of this Quarterly Report on Form 10-Q, which we have prepared in accordance with U.S. generally accepted accounting principles.principles for interim financial information and with the instructions to Form 10-Q. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported revenues and expenses during the reporting periods. On an ongoing basis, we evaluate such estimates and judgments, including those described in greater detail below. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

Overview

 

Stellar Biotechnologies, Inc. isDISCLOSURE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 under Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include statements with respect to our beliefs, plans, objectives, goals, expectations, anticipations, assumptions, estimates, intentions, and future performance, and involve known and unknown risks, uncertainties, and other factors, which may be beyond our control, and which may cause our actual results, performance, or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. All statements other than statements of historical fact are statements that could be forward-looking statements. You can identify these forward-looking statements through our use of words such as “may,” “can,” “anticipate,” “assume,” “should,” “indicate,” “would,” “believe,” “contemplate,” “expect,” “seek,” “estimate,” “continue,” “plan,” “point to,” “project,” “predict,” “could,” “intend,” “target,” “potential” and other similar words and expressions of the future.

There are a biotechnology company engagednumber of important factors that could cause the actual results to differ materially from those expressed in any forward-looking statement made by us. These factors include, but are not limited to:

·

our ability to obtain funding for our operations;

·

our estimates regarding our expenses, revenues, anticipated capital requirements and our needs for additional financing;

·

the timing of the commencement, progress and receipt of data from any of our preclinical and clinical trials;

·

the expected results of any 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 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 protect our intellectual property as well as comply with the terms of license agreements with third parties;

·

our ability to identify, develop and commercialize additional products or product candidates;

·

reliance on key personnel;

·

general changes in economic or business conditions; and

·

other risks and uncertainties, including those listed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended September 30, 2023

16

Table of Contents

Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected 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. 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. 

We extract and manufacture KLH from the hemolymph of a scarce ocean mollusk, the Giant Keyhole Limpet. Based upon our specialized knowledge of aquaculture science and KLH, we have built unique land-based aquaculture, laboratory and production facilities in Port Hueneme, California, and developed production and manufacturing processes to produce medical-grade KLH using Current Good Manufacturing Practices (GMP).

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


Recent Developments

Neostell Joint Venture

In May 2016, we entered into a joint venture agreement with Neovacs S.A, a Paris-based biotechnology company, for the formation of a joint venture company to manufacture and sell conjugated therapeutic vaccines.  In July 2016, Neostell S.A.S., a French simplified stock corporation (Neostell), was formed to carry out the business of the joint venture.  Neostell is expected to produce Neovacs’ product candidates that utilize Stellar KLH as a carrier molecule and may also manufacture and sell other KLH-based immunotherapy products for third-party customers. We hold a 30% equity interest in the joint venture in exchange for an initial capital contribution of €120,000. One-half of the initial contribution, approximately $67,000, was paid in June 2016 with the balance due upon the occurrence of certain defined future events. We will also provide additional financing to Neostell, as may be required, on a pro rata basis in line with our equity interest. Accordingforward-looking statements. You should refer to the joint venture agreement, if certain milestones are not achieved by December 31, 2017, Neostell will be dissolved, unless the parties mutually agree to pursue the joint venture arrangement, or either party decides to purchase the equity interests“Risk Factors” section of the other party. This deadline has passed and the parties have expressed their mutual desire to renew and amend the agreement to extend the timeline.

Significant Accounting Policies and Estimates

For a discussion of our significant accounting policies and estimates, refer to Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our Annual Report on Form 10-K for the fiscal year ended September 30, 2017, as2023, filed with the Securities and Exchange Commission (SEC) SEC,on December 1, 2017. There15, 2023, for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. We operate in an evolving environment and new risk factors and uncertainties may emerge from time to time. It is not possible for management to predict all risk factors and uncertainties. As a result of these factors, we cannot assure you that the forward-looking statements in this report will prove to be accurate. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. You should review the factors and risks and other information we describe in the reports we will file from time to time with the SEC.

Overview

We are a biopharmaceutical company developing innovative ways to treat inflammatory and immune-related diseases.

Our approach is to acquire, develop and commercialize drug candidates based on mechanisms of action that have demonstrated proof-of-concept in human subjects. We prioritize our efforts on disease indications where there is compelling scientific rationale, no material changesapproved therapies or where there are unmet medical needs, and where there are large addressable market opportunities, among other factors. We have multiple late-stage product candidates in our development pipeline.

Our most advanced drug candidate is EB05. EB05 represents a new class of emerging therapies called Host-Directed Therapeutics (HDTs) that are designed to modulate the body’s own immune response when confronted with infectious diseases or even chemical agents. Importantly, these therapies are designed to work across multiple infectious diseases and threats, and could be stockpiled preemptively ahead of outbreaks. Because they are threat agnostic, HDTs like paridiprubart have the potential to become standard of care in Intensive Care Units (ICUs) and critical countermeasures for both pandemic preparedness and biodefense. We are currently evaluating EB05 as a potential treatment for Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory failure. Recruitment in a Phase 3 study is ongoing.

In addition to EB05, we are developing product candidates for a number of chronic dermatological and inflammatory conditions. In November 2023, we reported final results from a Phase 2b clinical study evaluating multiple concentrations of our drug candidate, EB01 , as a monotherapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD), a common occupational skin condition. Among the findings, 1.0% EB01 cream demonstrated statistically significant accounting policiesimprovement over placebo for the primary endpoint and estimates froma key secondary endpoint. For our EB06 monoclonal candidate, we have received regulatory approval by Health Canada to conduct a future Phase 2 study in patients with moderate to severe nonsegmental vitiligo, a common autoimmune disorder that causes skin to lose its color in patches. We are also preparing an investigational new drug application (IND) in the disclosure providedUnited States (U.S.) for our EB07 product candidate to conduct a future Phase 2 study in patients with certain fibrotic diseases.

17

Table of Contents

Recent Developments

·

In November 2023, we reported final results from a Phase 2b clinical study evaluating multiple concentrations of our drug candidate, EB01, as a monotherapy for moderate-to-severe chronic ACD, Among the findings, 1.0% EB01 cream demonstrated statistically significant improvement over placebo for the primary endpoint and a key secondary endpoint.

·

In October 2023, we announced that Health Canada approved the company's proposal to harmonize clinical trial designs in the U.S. and Canada for an ongoing Phase 3 study of EB05 (paridiprubart). Our monoclonal antibody is currently being evaluated as a treatment for Covid-19 induced ARDS. We are also exploring various approaches to evaluate our EB05 drug candidate in a general, all-cause ARDS population.

·

In October 2023, we secured a $10 million credit facility with our Founder (see Liquidity and Capital Resources); and

·

In October 2023, we announced up to C$23 million in partially repayable funding from the Canadian government (see Liquidity and Capital Resources).

SIGNIFICANT ACCOUNTING POLICIES AND ESTIMATES

See Note 2 to our financial statements included in our Annual Report on Form 10-K for the fiscal year ended September 30, 2017.2023 for a discussion of our significant accounting policies and estimates. There have been no material changes to such significant accounting policies or estimates.

 

Results of Operations

 

Comparison of the Three Months Ended December 31, 20172023 and 20162022

 

Our total revenuesTotal operating expenses decreased by $.12$0.5 million to $.02$1.9 million for the three months ended December 31, 20172023 compared to $.14 million for the three months ended December 31, 2016 due to a decrease in our product sales. While our customer base has not changed significantly, product sales volumes are subject to variability associated with the rate of development and progression of clinical studies of third-party products that utilize Stellar KLH. The rate of progression toward later stage studies is expected to continue to affect the timing and volume of future product sales. During both periods, product mix was similar, consisting of various grades of KLH for clinical and pre-clinical studies and immune system assays.

Our total expenses decreased by $.15 million to $1.41 for the three months ended December 31, 2017 compared to $1.56$2.4 million for the same period last year:

 

·

Our cost of sales

Research and development (R&D) expenses decreased by $.08$0.7 million to less than $.01$0.7 million for the three months ended December 31, 20172023 compared to $.08$1.4 million for the same period last year primarily due to decreased product sales volume as well as reducedexternal research expenses related to salesour EB01 study, which was completed during the current period, while expenses for our ongoing EB05 clinical study remained relatively unchanged from the prior period. Our R&D expenses consist primarily of KLH that was produced as a byproductemployee-related expenses, including salaries, benefits, taxes, travel, and share-based compensation expense for personnel in R&D functions; expenses related to process development and production of product candidates paid to contract manufacturing organizations, including the cost of acquiring, developing, and manufacturing research material; costs associated with clinical activities, including expenses for contract research organizations; and clinical trials and activities related to regulatory filings for our research and development activities.product candidates, including regulatory consultants.

 

·

Our research

General and developmentadministrative (G&A) expenses increased by $.17$0.1 million to $.63$1.1 million for the three months ended December 31, 20172023 compared to $.46$1.0 million for the same period last year. The increase wasyear primarily due to researchincreased fees for professional services and development activities intendednoncash share-based compensation. Our G&A expenses consist primarily of salaries and related costs for our employees in administrative, executive and finance functions. G&A expenses also include professional fees for legal, accounting, audit, tax and consulting services, insurance, office, and travel expenses.

·

Total other income increased by $136,000 to increase the scalability and throughput capacity of existing manufacturing systems, including engineering lots of KLH produced under our optimization initiative. Additional research and development in aquaculture as well as process,  analytical and product formulation development also contributed to the increase.

·Our general and administrative expenses decreased by $.25 million to $.68 million$179,000 for the three months ended December 31, 20172023 compared to $.93 million$43,000 for the same period last year and was composed of the following:

·

Grant income increased by $0.1 million to $0.1 million the three months ended December 31, 2023. There was no grant income in the comparative period. The increase is related to the grant income associated with the activities under the 2023 SIF Agreement.

·

Interest income increased by $12,000 to $61,000 the three months ended December 31, 2023 compared to $49,000 for the same period last year primarily due to management’s continued actionsan increase in interest rates.

·

Foreign exchange gain was $2,800 for the three months ended December 31, 2023 compared to reduce corporate expenses, including salaries, professional fees and travel, as well as lower legal fees and public company expenses.a gain of $5,900 for the three months ended December 31, 2022.

For the three months ended December 31, 2023, our net loss was $1.7 million, or $0.54 per common share, compared to a net loss of $2.3 million, or $0.89 per common share for the three months ended December 31, 2022.

Capital Expenditures

 

Our total other income (loss) decreasedcapital expenditures primarily consist of computer and office equipment. There were no significant capital expenditures for the three months ended December 31, 2023 and 2022.

Liquidity and Capital Resources

As a clinical-stage company we have not generated significant revenue, and we expect to incur operating losses as we continue our efforts to acquire, develop, seek regulatory approval for and commercialize product candidates and execute on our strategic initiatives. Our operations have historically been funded through issuances of common shares, exercises of common share purchase warrants, convertible preferred shares, convertible loans, government grants and tax incentives.

Our primary use of cash is to fund our operating expenses, which consist of R&D and G&A expenditures. Cash used to fund operating expenses is impacted by $.06the timing of when we pay these expenses, as reflected in the change in accounts payable and accrued expenses. Net cash used in operating activities was $1.4 million to an overall loss of $.01and $1.8 million for the three months ended December 31, 2017 compared2023 and 2022, respectively. We incurred net losses of $1.7 million and $2.3 million for those same quarters.

18

Table of Contents

In October 2023, we entered into the 2023 SIF Agreement with the Canadian Government’s SIF. Under the 2023 SIF Agreement, the Government of Canada committed up to C$23 million in partially repayable funding. Of the C$23 million committed by SIF, up to C$5.8 million is not repayable by us. The remaining C$17.2 million is conditionally repayable starting in 2029 only if and when we earn gross revenue. In February 2021, we entered into the 2021 SIF Agreement, pursuant to which we were eligible to receive cash reimbursements up to C$14.1 million in the aggregate for certain R&D expenses related to our EB05 clinical development program. All potential funding available under the 2021 SIF Agreement has been received. For the three months ended December 31, 2023 we recorded grant income of $0.1 million related to the 2023 SIF Agreement. The was no grant income recognized in the comparative period.

In October 2023, we entered into $10.0 million revolving credit agreement with Pardeep Nijhawan Medicine Professional Corporation, an entity controlled by Dr. Pardeep Nijhawan, MD, our Chief Executive Officer and Secretary and member of our board of directors (Credit Agreement), providing an unsecured revolving credit facility, with a credit limit of $3.5 million (Credit Limit) which was available immediately. The line of credit bears interest at the Canadian Imperial Bank of Commerce US Base-Interest Rate plus 3% per annum and has a maturity date of March 31, 2026, unless terminated earlier by either party with 90 days’ notice. Advances under the line of credit are tied to a borrowing base (Borrowing Base) consisting of eligible grant receivables from SIF, future potential license fee receivables and any other accounts receivable. At no time shall the aggregate principal amount of all advances outstanding exceed the lesser of (i) the Credit Limit and (ii) an amount equal to 85% of the Borrowing Base. We have not drawn any funds from the Credit Agreement.

In August 2022, we filed a $150.0 million shelf registration statement. In March 2023, we entered into an equity distribution agreement with Canaccord, as sales agent, pursuant to which we may offer and sell, from time to time, common shares through an at-the-market equity offering program for up to $20 million in gross proceeds, subject to certain offering limitations that currently allow us to offer and sell common shares having an aggregate gross sales price of up to $8.4 million (Canaccord ATM). There was approximately $6.7 million of available capacity on the Canaccord ATM as of December 31, 2023.We have no obligation to sell any of the common shares and may at any time suspend sales or terminate the equity distribution agreement in accordance with its terms. For the three months ended December 31, 2023, we sold a total of 89,249 common shares pursuant to the agreement for net proceeds of $0.3 million after deducting commissions and costs of $24,000. Subsequent to December 31, 2023, we sold a total of 7,038 common shares pursuant to the agreement for net proceeds of $33,000 after deducting sales agent commissions.

In November 2022, we completed a private placement of units consisting of 384,475 common shares, 12-month warrants to purchase up to an overall lossaggregate of $.07192,248 common shares and 3-year warrants to purchase up to an aggregate of 192,248 common shares. The gross proceeds from this offering were approximately $3.0 million, before offering expenses.

At December 31, 2023, we had an accumulated deficit of $54.1 million and working capital of $3.4 million, including $4.3 million in cash and cash equivalents. We plan to finance company operations over the course of the next twelve months with cash and cash equivalents on hand, including net proceeds from the Canaccord ATM, advances under the Credit Agreement and reimbursements of eligible R&D expenses under the 2023 SIF Agreement with the Canadian government. Management has flexibility to adjust this timeline by making changes to planned expenditures related to, among other factors, the size and timing of clinical trial expenditures and manufacturing campaigns, staffing levels, and the acquisition or in-licensing of new product candidates. To help fund our operations and meet our obligations in the future, we plan to seek additional financing through the sale of equity, government grants, debt financings or other capital sources, including potential future licensing, collaboration or similar arrangements with third parties or other strategic transactions. If we raise additional funds by issuing equity securities, our shareholders will experience dilution. Debt financing, if available, would result in increased fixed payment obligations and may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Any debt financing or additional equity that we raise may contain terms, such as liquidation and other preferences that are not favorable to us or our existing shareholders. If we raise additional funds through collaboration and licensing arrangements with third parties, it may be necessary to relinquish valuable rights to our technologies, future revenue streams or product candidates or to grant licenses on terms that may not be favorable to us. Adequate funding may not be available to us on acceptable terms, or at all. If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, scale back or discontinue the development of our product candidates.

We expect to continue to incur substantial additional operating losses for at least the same period last year. Foreign exchange lossnext several years as we continue to develop our product candidates and seek marketing approval and, subject to obtaining such approval, the eventual commercialization of our product candidates. If we obtain marketing approval for our product candidates, we will incur significant sales, marketing and outsourced manufacturing expenses. In addition, we expect to incur additional expenses to add operational, financial and information systems and personnel, including personnel to support our planned product commercialization efforts. We also expect to incur significant costs to comply with corporate governance, internal controls and similar requirements applicable to us as a public company. To continue to grow our business over the longer term, we plan to commit substantial resources to research and development, clinical trials of our product candidates, and other operations and potential product acquisitions and in licensing. We have evaluated and expect to continue to evaluate a wide array of strategic transactions as part of our plan to acquire or in license and develop additional products and product candidates to augment our internal development pipeline. Strategic transaction opportunities that we may pursue could materially affect our liquidity and capital resources and may require us to incur additional indebtedness, seek equity capital or both. In addition, we may pursue development, acquisition or in licensing of approved or development products in new or existing therapeutic areas or continue the expansion of our existing operations. Accordingly, we expect to continue to opportunistically seek access to additional capital to license or acquire additional products, product candidates or companies to expand our operations, or for general corporate purposes. Strategic transactions may require us to raise additional capital through one or more public or private debt or equity financings or could be structured as a collaboration or partnering arrangement. We have no arrangements, agreements, or understandings in place at the present time to enter into any acquisition, in licensing or similar strategic business transaction.

Cash Flows

Net cash used in operating activities

Net cash used in operating activities was $.02$1.4 million for the three months ended December 31, 20172023 compared to a loss of $.08$1.8 million for the same period last year due to fluctuations in exchange rates and decreased amounts held in Canadian cash and cash equivalents.

Our net loss for the three months ended December 31, 2017 was $1.40 million, or $0.13 per basic share, compared2022, primarily due to a net lossdecrease in R&D expenses of $1.49$0.7 million, or $0.15 per basic share,partially offset by a reduction in non-cash stock based compensation of $0.1 million and the reduction in the recovery of working capital of $0.1 million.

Net cash used in investing activities

There was no cash used in investing activities for the three months ended December 31, 2016.2023 and 2022, respectively.


Capital Expenditures

19

Table of Contents

Net cash provided by financing activities

 

Our capital expenditures, which primarily consist of scientific, manufacturing, and aquaculture equipment, and facility leasehold improvements were $34,767 and $84,424Net cash provided by financing activities was $0.3 million for the three months ended December 31, 2017 and 2016, respectively.

Liquidity and Capital Resources

Company operations have historically been funded by the issuance of common shares, exercise of warrants, grant revenues, contract services revenue and product sales. For the three months ended December 31, 2017 and 2016, the Company reported net losses of approximately $1.42023 as compared to $2.9 million and $1.5 million, respectively. As of December 31, 2017, the Company had an accumulated deficit of approximately $46.8 million and working capital of approximately $5.1 million. While the Company plans to finance company operations for the next twelve months with cash on hand and product sales, management expects to continue incurring losses for the foreseeable future and will need to raise additional capital to pursue our business plan beyond February 2019. Management is taking action to ensure the Company will continue as a going concern for at least one year beyond the date of the issuance of the Company’s financial statements. First, management has flexibility to adjust planned expenditures based on a number of factors including the size and timing of capital expenditures, staffing levels, inventory levels, and the status of customer clinical trials. Management also seeks to expand the customer base for existing marketed products, and is currently evaluating opportunities to secure additional financing through debt and/or equity financings, including transactions with strategic customers and partners that may include debt and/or equity arrangements. We have not secured any commitment for new financing at this time, nor can we provide any assurance that new financing will be available on commercially acceptable terms, if needed.

We have filed with the Securities and Exchange Commission, and the Securities and Exchange Commission declared effective, a universal shelf registration statement of up to $100 million worth of registered equity securities, of which we utilized approximately $6.75 million in our July 2016 offering. Under this effective registration statement, we may issue registered securities, from time to time, in one or more separate offerings or other transactions with the size, price and terms to be determined at the time of issuance. Pursuant to General Instruction I.B.6 of Form S-3, in no event will we sell securities in a public primary offering with a value of more than one-third of the aggregate market value of our common shares held by non-affiliates in any twelve-month period, so long as the aggregate market value of our common shares held by non-affiliates remains below $75 million. Registered securities issued using our existing shelf may be used to raise additional capital to fund our working capital, R&D and other corporate needs.

Geographic Concentrations

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

  Three Months Ended 
  December 31,  December 31, 
  2017  2016 
       
Europe  73%  94%
North America  27%  6%

The geographic concentration of our product sales revenue fluctuates quarter over quarter, sometimes significantly, depending on the volume of sales from our customers in each of our principal geographic markets.

Research and Development

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

Research and development costs, including materials, KLH designated for internal research use only and salaries of employees directly involved in research and development efforts, are expensed as incurred. From time to time, we produce saleable KLH as a byproduct of our research and development activities. The cost of this KLH is not assigned to inventory.

Our research and development costs were $631,034 and $460,865 for the three months ended December 31, 20172022. In the current quarter, we received proceeds of $0.3 million from the Canaccord ATM, partially offset by issuance costs of $9,500. In the comparative quarter, we received proceeds of $3.0 million from a private placement in November 2022 and 2016, respectively.incurred issuance costs of $0.1 million for net proceeds of $2.9 million.

 

The increase from the comparable period was primarily due to researchResearch and development activities intended to increase the scalability and throughput capacity of existing manufacturing systems, including engineering lots of KLH produced under our optimization initiative.Development

 

Our primary business is the development of innovative therapeutics for inflammatory and immune-related diseases with clear unmet medical needs. We focus our resources on R&D activities, including the conduct of clinical studies and product development, and expense such costs as they are incurred. R&D expenses, which have historically varied based on the level of activity in our clinical programs, are significantly influenced by study initiation expenses and patient recruitment rates, and as a result are expected to continue to fluctuate, sometimes substantially. Our R&D expenses were $0.7 million and $1.4 million for the three months ended December 31, 2023 and 2022, respectively. The decrease was due primarily to lower external research expenses related to our ongoing clinical studies.

16 

 

Disclosure of Contractual ObligationsOff-Balance Sheet Arrangements

 

We currently lease 4,300 square feet of executive office and laboratory space in Port Hueneme, California under a lease which was renewed in July 2016 for a two-year term, with options to renew for three successive two-year terms.

Our aquaculture and KLH manufacturing operations are located on approximately 37,000 square feet of oceanfront land in the Port Hueneme Aquaculture Business Park. Our facilities here include specialized aquaculture infrastructure, seawater supply and discharge systems, laboratories, manufacturing and administrative offices. Wedo not have two sublease agreements which expire in September and October 2020, respectively, with options to extend the leases for two additional five-year terms.

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

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

There have been no material changes in our contractual obligations previously disclosed in our Annual Report on Form 10-K for the fiscal year ended September 30, 2017, as filed with the SEC on December 1, 2017.

Off-Balance Sheet Arrangements

We have no off-balance sheet arrangements that have or are reasonably likely to have a current or future material effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital resources.

 

Item 3.Quantitative and Qualitative Disclosures About Market Risk.

We are exposed to financial market risks associated with foreign exchange rates, concentration of credit, and liquidity. In accordance with our policies, we manage our exposure to various market-based risks and where material, these risks are reviewed and monitored by our Board of Directors. For a discussion of our market risk exposure, refer to Item 7A, “Quantitative3. Quantitative and Qualitative Disclosures About Market Risk,” in our Annual Report on Form 10-K for the fiscal year ended September 30, 2017, as filed with the SEC on December 1, 2017. There are no material changes in market risk from the disclosure provided in our Annual Report on Form 10-K for the fiscal year ended September 30, 2017.Risk.

 

Item 4.Controls and Procedures.

We are a smaller reporting company and are not required to provide disclosure under this item.

 

Item 4. Controls and Procedures.

Disclosure Controls and Procedures

 

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

 

We carried out an evaluation, under the supervision and with the participation of our management, including our Principal Executive Officer and our Principal Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e)) under the Securities and Exchange Act of 1934, as amended)Act) as of December 31, 2017.2023. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Our Chief Executive Officer and Chief Financial Officer concluded that the disclosure controls and procedures as of December 31, 2017,2023, were effective.

 

Changes in Internal Control over Financial Reporting

 

There were no changes in our internal control over financial reporting that occurred during the quarter ended December 31, 20172023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

17 

20

Table of Contents

 

PART II — OTHER INFORMATION

 

Item 1.Legal Proceedings.

Item 1. Legal Proceedings.

 

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

 

Item 1A.Risk Factors.  

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.Item 1A. Risk Factors.

 

On January 30, 2018,There have been no material changes to the Company received a letter from The Nasdaq Stock Market LLC (Nasdaq) notifying the Company that, basedrisk factors discussed in Item 1A. Risk Factors in our Annual Report on the Company’s closing bid priceForm 10-K for the lastyear ended September 30, consecutive business days, the Company is not in compliance2023, filed with the minimum bid price requirement of $1.00 per share for continued listing, as set forth in Nasdaq Listing Rule 5550(a)(2). The Company has an initial period of 180 calendar days, or until July 30, 2018 to regain compliance with the minimum bid price requirement for continued listingSecurities and Exchange Commission on Nasdaq. Although the Nasdaq notification has no immediate impact on the listing of the Company’s common shares, which will continue to trade on the Nasdaq Capital Market under the symbol “SBOT”, we can make no assurances that the Company will regain compliance with the Nasdaq listing requirements.December 15, 2023.

 

We intend to continue to actively monitor the bid priceItem 2. Unregistered Sales of our common shares. If our common shares do not trade at a level that is likely to regain compliance with the Nasdaq listing requirements, our BoardEquity Securities and Use of Directors will consider available options to resolve the deficiency and regain compliance. If at any time before July 30, 2018, the closing bid price of our common shares is at least $1.00 per share for at least ten consecutive business days, we will regain compliance with the minimum bid price requirement. If we cannot demonstrate compliance by July 30, 2018 or if we are not afforded an additional grace period beyond July 30, 2018 by which to demonstrate compliance with the Nasdaq listing requirements, our common shares may then be delisted from Nasdaq, which could make trading our common shares more difficult for investors, potentially leading to declines in our share price and liquidity. Without a Nasdaq listing, shareholders may have a difficult time getting a quote 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.Proceeds.

Item 2.Unregistered Sales of Equity Securities and Use of Proceeds.

 

None.

 

Item 3.Defaults Upon Senior Securities.

Item 3. Defaults Upon Senior Securities.

 

None.

 

Item 4.Mine Safety Disclosures.

Item 4. Mine Safety Disclosures.

 

Not applicable.

 

Item 5.Other Information.

Item 5. Other Information.

 

None.

 

Item 6.Exhibits.
21

Table of Contents

 

Item 6. Exhibits

EXHIBIT INDEX

Exhibit No.

Description

10.1+

Strategic Innovation Fund Agreement, dated October 12, 2023, by and among Edesa Biotech Research, Inc., Edesa Biotech, Inc., and his Majesty the King in right of Canada as represented by the Minister of Industry (included as Exhibit 10.33 to the Company’s Annual Report on Form 10-K filed on December 15, 2023, and incorporated herein by reference).

10.2

Credit Agreement, effective as of October 20, 2023, by and between the Company and Pardeep Nijhawan Medicine Professional Corporation (included as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on October 23, 2023, and incorporated herein by reference).

10.3+

First Amendment to Exclusive License Agreement, dated as of September 21, 2023, by and between Edesa Biotech Research, Inc. and Dr. Saul Yedgar (included as Exhibit 10.35 to the Company’s Annual Report on Form 10-K filed on December 15, 2023, and incorporated herein by reference).

10.4@

First Amendment to Amended and Restated Employment Agreement, by and between the Company and Pardeep Nijhawan, dated December 7, 2023 (included as Exhibit 10.36 to the Company’s Annual Report on Form 10-K filed on December 15, 2023, and incorporated herein by reference).

31.1

Certification of the Chief Executive Officer pursuant to Rule 13a-14(a) under the Securities and Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith). 

31.2

Certification of the Chief Financial Officer pursuant to Rule 13a-14(a) under the Securities and Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith). 

32.1*

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

32.2*

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

101.INS

XBRL Instance Document

101.SCH

XBRL Taxonomy Extension Schema Document

101.CAL

XBRL Taxonomy Calculation Linkbase Document

101.DEF

XBRL Taxonomy Extension Definition Linkbase Document

101.LAB

XBRL Taxonomy Label Linkbase Document

101.PRE

XBRL Taxonomy Presentation Linkbase Document

* The Exhibits listedinformation in the Exhibit Index immediately preceding such Exhibits arethis exhibit is furnished and deemed not filed with orthe Securities and Exchange Commission for purposes of section 18 of the Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of Edesa Biotech, Inc. under the Securities Act of 1933, as amended, or the Exchange Act of 1934, as amended, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

@ Management contract or compensatory plan or arrangement.

+ Portions of this Quarterly Report.exhibit have been omitted pursuant to Rule 601(b)(10)(iv) of Regulation S-K.


22

Table of Contents

SIGNATURES

 

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

 

EDESA BIOTECH, INC.

Date: February 7, 20189, 2024

STELLAR BIOTECHNOLOGIES, INC.

/s/ Pardeep Nijhawan

Pardeep Nijhawan, MD, Director, Chief Executive Officer and Corporate Secretary

(Principal Executive Officer)

Date: February 9, 2024

/s/ Stephen Lemieux

Stephen Lemieux, Chief Financial Officer

(Principal Financial Officer)

 
/s/ Kathi Niffenegger23
Kathi Niffenegger
Chief Financial Officer
(Principal Financial Officer and Duly Authorized Officer)

 

19 

EXHIBIT INDEX

Exhibit
Number
Description
31.1Certification of the Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2Certification of the Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1Certification of the Principal Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. (*)
32.2Certification of the Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. (*)
101.INSXBRL Instance Document
101.SCHXBRL Taxonomy Extension Schema Document
101.CALXBRL Taxonomy Calculation Linkbase Document
101.DEFXBRL Taxonomy Extension Definition Linkbase Document
101.LABXBRL Taxonomy Label Linkbase Document
101.PREXBRL Taxonomy Presentation Linkbase Document

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

20