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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

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

For the quarterly period ended June 30, 2024

 

OR

 

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

For the transition period from              to

 

Commission file number: 001-37619

 

EDESA BIOTECH, INC.

(Exact name of registrant as specified in its charter)

 

British Columbia, Canada N/A
(State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.)

 

100 Spy Court, Markham, ON, Canada L3R 5H6 (289)800-9600
(Address of principal executive offices and 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

               

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 ☒ No ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted 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 such files). Yes ☒ 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         ☒ Smaller reporting company         
  Emerging growth company         

 

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

 

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

 

As of August 9, 2024, the registrant had 3,247,389 common shares issued and outstanding.

 



 

 

 

 

EDESA BIOTECH, INC.

QUARTERLY REPORT ON FORM 10-Q

Quarter Ended June 30, 2024

 

Table of Contents

 

   

Page

PART I

FINANCIAL STATEMENTS

 
     

Item 1.

Financial Statements (Unaudited)

3
 

Condensed Interim Consolidated Balance Sheets – June 30, 2024 and September 30, 2023

3
 

Condensed Interim Consolidated Statements of Operations – Three and Nine Months Ended June 30, 2024 and 2023

4
 

Condensed Interim Consolidated Statements of Cash Flows – Three and Nine Months Ended June 30, 2024 and 2023

5
 

Condensed Interim Consolidated Statements of Changes in Shareholders' Equity – Three and Nine Months Ended June 30, 2024 and 2023

6
 

Notes to Condensed Interim Consolidated Financial Statements

7
     

Item 2.

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

15
     

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

21
     

Item 4.

Controls and Procedures

21
     

PART II

OTHER INFORMATION

 
     

Item 1.

Legal Proceedings

22
     

Item 1A.

Risk Factors

22
     

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

22
     

Item 3.

Defaults Upon Senior Securities

22
     

Item 4.

Mine Safety Disclosures

22
     

Item 5.

Other Information

22
     

Item 6.

Exhibits

23

 

 

 

 

2

 

 

PART 1 FINANCIAL INFORMATION

Item 1. Financial Statements

 

 

Edesa Biotech, Inc.

Condensed Interim Consolidated Balance Sheets

 

   

June 30, 2024

   

September 30, 2023

 
                 

Assets:

               
                 

Current assets:

               

Cash and cash equivalents

  $ 2,040,884     $ 5,361,397  

Accounts and other receivable

    551,064       626,543  

Prepaid expenses and other current assets

    454,686       448,912  
                 

Total current assets

    3,046,634       6,436,852  
                 

Non-current assets:

               

Property and equipment, net

    -       8,702  

Long-term deposits

    40,661       173,490  

Intangible asset, net

    2,104,141       2,180,020  

Right-of-use assets

    36,286       91,373  
                 

Total assets

  $ 5,227,722     $ 8,890,437  
                 
                 

Liabilities and shareholders' equity:

               
                 

Current liabilities:

               

Accounts payable and accrued liabilities

  $ 2,321,810     $ 1,747,150  

Short-term right-of-use lease liabilities

    38,817       74,714  
                 

Total current liabilities

    2,360,627       1,821,864  
                 

Non-current liabilities:

               

Long-term right-of-use lease liabilities

    -       19,773  
                 

Total liabilities

    2,360,627       1,841,637  
                 

Commitments (Note 5)

               
                 

Shareholders' equity:

               

Capital shares

               
Authorized unlimited common and preferred shares without par value                

Issued and outstanding:

               

3,247,389 common shares (September 30, 2023 - 3,075,473)

    47,236,024       46,643,151  

Additional paid-in capital

    13,482,824       13,039,265  

Accumulated other comprehensive loss

    (224,791 )     (214,648 )

Accumulated deficit

    (57,626,962 )     (52,418,968 )
                 

Total shareholders' equity

    2,867,095       7,048,800  
                 

Total liabilities and shareholders' equity

  $ 5,227,722     $ 8,890,437  

 

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

 

3

 

 

 

Edesa Biotech, Inc.

Condensed Interim Consolidated Statements of Operations

 

   

Three Months Ended

   

Nine Months Ended

 
   

June 30, 2024

   

June 30, 2023

   

June 30, 2024

   

June 30, 2023

 
                                 

Expenses:

                               

Research and development

  $ 897,305     $ 1,025,622     $ 2,778,100     $ 3,841,150  

General and administrative

  $ 1,035,140     $ 1,038,587     $ 3,232,248       3,011,945  
                                 

Loss from operations

    (1,932,445 )     (2,064,209 )     (6,010,348 )     (6,853,095 )
                                 

Other income (loss):

                               

Reimbursement grant income

    236,226       -       661,062       -  

Interest income

    32,848       82,754       137,007       217,901  

Misc other income

    -       -       14,766       -  

Foreign exchange loss

    (4,841 )     (3,451 )     (9,681 )     (18,078 )
                                 
      264,233       79,303       803,154       199,823  
                                 

Loss before income taxes

    (1,668,212 )     (1,984,906 )     (5,207,194 )     (6,653,272 )
                                 

Income tax expense

    -       -       800       800  
                                 

Net loss

    (1,668,212 )     (1,984,906 )     (5,207,994 )     (6,654,072 )
                                 

Exchange differences on translation

    1,612       39,839       (10,143 )     23,415  
                                 

Net comprehensive loss

  $ (1,666,600 )   $ (1,945,067 )   $ (5,218,137 )   $ (6,630,657 )
                                 

Weighted average number of common shares

    3,221,806       2,930,681       3,180,647       2,802,793  
                                 

Loss per common share - basic and diluted

  $ (0.52 )   $ (0.68 )   $ (1.64 )   $ (2.37 )

 

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

 

4

 

 

 

Edesa Biotech, Inc.

Condensed Interim Consolidated Statements of Cash Flows

 

   

Nine Months Ended

 
   

June 30, 2024

   

June 30, 2023

 
                 

Cash flows from operating activities:

               

Net loss

  $ (5,207,994 )   $ (6,654,072 )

Adjustments for:

               

Depreciation and amortization

    141,843       137,501  

Share-based compensation

    443,559       729,380  

Gain on payable forgiveness

    (14,766 )     -  

Changes in working capital items:

               

Accounts and other receivable

    71,501       1,149,129  

Prepaid expenses and other current assets

    109,647       339,031  

Accounts payable and accrued liabilities

    533,044       (869,430 )
                 

Net cash used in operating activities

    (3,923,166 )     (5,168,461 )
                 

Cash flows from financing activities:

               

Proceeds from issuance of common shares and warrants

    729,387       3,861,245  

Proceeds from exercise of warrants

    -       770,531  

Payments for issuance costs of common shares and warrants

    (76,389 )     (214,130 )

Repayment of debt

    (29,532 )     -  
                 

Net cash provided by financing activities

    623,466       4,417,646  
                 

Effect of exchange rate changes on cash and cash equivalents

    (20,813 )     117,066  
                 

Net change in cash and cash equivalents

    (3,320,513 )     (633,749 )

Cash and cash equivalents, beginning of period

    5,361,397       7,090,919  
                 

Cash and cash equivalents, end of period

  $ 2,040,884     $ 6,457,170  

 

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

 

5

 

 

 

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 June 30, 2024

                                               

Balance - March 31, 2024

    3,215,968     $ 47,136,168     $ 13,373,318     $ (226,403 )   $ (55,958,750 )   $ 4,324,333  
                                                 

Issuance of common shares

    31,421       138,421       -       -       -       138,421  

Issuance costs

    -       (38,565 )     -       -       -       (38,565 )

Share-based compensation

    -       -       109,506       -       -       109,506  

Net loss and comprehensive loss

    -       -       -       1,612       (1,668,212 )     (1,666,600 )
                                                 

Balance - June 30, 2024

    3,247,389     $ 47,236,024     $ 13,482,824     $ (224,791 )   $ (57,626,962 )   $ 2,867,095  
                                                 

Three Months Ended June 30, 2023

                                               

Balance - March 31, 2023

    2,865,517     $ 45,453,733     $ 12,489,949     $ (230,026 )   $ (48,713,719 )   $ 8,999,937  
                                                 

Issuance of common shares upon exercise of warrants

    115,441       833,749       -       -       -       833,749  

Issuance costs

    -       (146,295 )     -       -       -       (146,295 )

Share-based compensation

    -       -       108,159       -       -       108,159  

Net loss and comprehensive loss

    -       -       -       39,839       (1,984,906 )     (1,945,067 )
                                                 

Balance - June 30, 2023

    2,980,958     $ 46,141,187     $ 12,598,108     $ (190,187 )   $ (50,698,625 )   $ 7,850,483  
                                                 

Nine Months Ended June 30, 2024

                                               

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

    171,916       729,387       -       -       -       729,387  

Issuance costs

    -       (136,514 )     -       -       -       (136,514 )

Share-based compensation

    -       -       443,559       -       -       443,559  

Net loss and comprehensive loss

    -       -       -       (10,143 )     (5,207,994 )     (5,218,137 )
                                                 

Balance - June 30, 2024

    3,247,389     $ 47,236,024     $ 13,482,824     $ (224,791 )   $ (57,626,962 )   $ 2,867,095  
                                                 

Nine Months Ended June 30, 2023

                                               

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 in equity offering

    499,918       2,916,418       944,827       -       -       3,861,245  

Issuance of common shares upon exercise of warrants

    100,760       994,618       (224,087 )     -       -       770,531  

Issuance costs

    -       (242,948 )     (28,357 )     -       -       (271,305 )

Share-based compensation

    -       -       729,380       -       -       729,380  

Net loss and comprehensive loss

    -       -       -       23,415       (6,654,072 )     (6,630,657 )
                                                 

Balance - June 30, 2023

    2,980,958     $ 46,141,187     $ 12,598,108     $ (190,187 )   $ (50,698,625 )   $ 7,850,483  

 

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

 

6

 

 

Edesa Biotech, Inc.

Notes to Condensed Interim Consolidated Financial Statements

(Unaudited)

 

 

 

1. Nature of Operations

 

Edesa Biotech, Inc. (the 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 and is headquartered in Markham, Ontario. It operates under its wholly owned subsidiaries, Edesa Biotech Research, Inc., an Ontario, Canada corporation, and Edesa Biotech USA, Inc., a California, USA corporation.

 

The Company’s common shares trade on The Nasdaq Capital Market in the United States under the symbol “EDSA”.

 

 

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 year ended September 30, 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. All intercompany balances and transactions have been eliminated on consolidation. All adjustments (consisting of normal recurring adjustments and accruals) considered necessary for a fair presentation of the results of operations for the periods presented have been included in the interim periods. Operating results for the three and nine months ended June 30, 2024 are not necessarily indicative of the results that may be expected for other interim periods or the fiscal year ending September 30, 2024.

 

Use of estimates

 

The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the period or year. Actual results could differ from those 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 and reporting currencies

 

The 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.

 

 

3. Intangible Assets

 

Acquired license

 

In April 2020, the Company entered into a license agreement with a pharmaceutical development company to obtain exclusive world-wide rights to know-how, patents and data relating to certain monoclonal antibodies (the Constructs), including sublicensing rights. Unless earlier terminated, the term of the license agreement will remain in effect for 25 years from the date of first commercial sale of licensed products containing the Constructs. Subsequently, the license agreement will automatically renew for five-year periods unless either party terminates the agreement in accordance with its terms.

 

Under the license agreement, the Company is exclusively responsible, at its expense, for the research, development, manufacture, marketing, distribution and commercialization of the Constructs and licensed products and to obtain all necessary licenses and rights. The Company is required to use commercially reasonable efforts to develop and commercialize the Constructs in accordance with the terms of a development plan established by the parties.

 

7

 

The Company has determined that the license has multiple alternative future uses in research and development projects and sublicensing in other countries or for other disease indications. The value of the acquired license is recorded as an intangible asset with amortization over the estimated useful life of 25 years and evaluation for impairment at the end of each reporting period.

 

The 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 license includes acquisition legal costs. See Note 5 for license commitments.

 

Intangible assets, net consisted of the following:

 

   

June 30, 2024

   

September 30, 2023

 
                 

The Constructs

  $ 2,529,483     $ 2,529,483  
                 

Less: accumulated amortization

    (425,342 )     (349,463 )
                 

Total intangible assets, net

  $ 2,104,141     $ 2,180,020  

 

Amortization expense amounted to $0.03 million for each of the three months ended June 30, 2024 and 2023 and $0.08 million for each of the nine months ended June 30, 2024 and 2023.

 

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

 

Year Ending

       

September 30, 2024

    25,293  

September 30, 2025

    101,172  

September 30, 2026

    101,172  

September 30, 2027

    101,172  

September 30, 2028

    101,172  

Thereafter

    1,674,160  
         
    $ 2,104,141  

 

 

4. Right-of-Use Lease with Related Party

 

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

   

Nine Months Ended

 
   

June 30, 2024

   

June 30, 2023

   

June 30, 2024

   

June 30, 2023

 

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

  $ 19,299     $ 21,188     $ 59,208     $ 61,530  

 

8

 

Lease terms and discount rates were as follows:

 

   

June 30, 2024

   

September 30,2023

 

Remaining lease term (months):

    6       15  

Estimated incremental borrowing rate:

    9.2 %     9.2 %

 

The future minimum lease payments under right-of-use leases at June 30, 2024 were as follows:

 

Year Ending

       

September 30, 2024

  $ 19,781  

September 30, 2025

    19,781  
         

Total lease payments

    39,562  

Less imputed interest

    745  
         

Present value of right-of-use lease liabilities

    38,817  

Present value included in current liabilities

    38,817  
         

Present value included in long-term liabilities

  $ -  

 

Cash flow information was as follows:

 

   

Nine Months Ended

 
   

June 30, 2024

   

June 30, 2023

 

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.

  $ 59,732     $ 59,045  

 

 

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 June 30, 2024 are as follows:

 

Year Ending

       
         

September 30, 2024

  $ 301,000  

September 30, 2025

    49,000  

September 30, 2026

    36,000  

September 30, 2027

    42,000  

September 30, 2028

    -  
         
    $ 428,000  

 

License and royalty commitments

 

In April 2020, through its Ontario subsidiary, the Company entered into a license agreement with a third party to obtain exclusive world-wide rights to the Constructs, including sublicensing rights. An intangible asset for the acquired license has been recognized. See Note 3 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 or sublicensing payments were made to the third party during the three and nine months ended June 30, 2024 and 2023.

 

9

 

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 $0.04 million and $0.16 million were to the third party during the three and nine months ended June 30, 2023 and no milestone payments were made during the three and nine months ended June 30, 2024.

 

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 is 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 the 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 and nine months ended June 30, 2024, the Company recorded an expense of $25,000 and $75,000 as a result of meeting milestones outlined in the 2021 license agreement. There were no milestones achieved in the three and nine months ended June 30, 2023 and no expenses were incurred.

 

In June 2024, the Company’s drug candidate, EB05, was selected by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, for evaluation in a U.S. government-funded clinical study. The Phase 2 platform trial will be a randomized, double-blinded, placebo-controlled, multi-center U.S. clinical trial to investigate novel threat-agnostic host-directed therapeutics, including EB05, in hospitalized adult patients with ARDS due to a variety of causes. For the EB05 cohort of the study, patients will be randomized one-to-one to either EB05 plus Standard of Care (SOC) or to a placebo plus SOC control arm. The Company plans to provide drug product for the study as well as technical support. The Company is responsible for providing drug product and placebo for the Phase 2 platform trial.

 

 

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 nine months ended June 30, 2024, the Company sold a total of 171,916 common shares pursuant to the agreement for net proceeds of approximately $0.6 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 the fair value of warrants issued. Option valuation models require the input of highly subjective assumptions including the expected price volatility. The Company calculates expected volatility based on historical 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

 

Warrants

 

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

 

   

Number of Warrant Shares (#)

   

Weighted Average Exercise Price

 

Nine Months Ended June 30, 2024

               

Balance - September 30, 2023

    720,909     $ 19.51  
                 

Expired

    (111,192 )     7.26  
                 

Balance - June 30, 2024

    609,717     $ 21.74  
                 

Nine Months Ended June 30, 2023

               

Balance - September 30, 2022

    521,718     $ 28.00  
                 

Issued

    384,496       8.75  

Exercised

    (100,760 )     7.63  

Expired

    (4,018 )     111.30  
                 

Balance - June 30, 2023

    801,436     $ 20.93  

 

The weighted average contractual life remaining on the outstanding warrants at June 30, 2024 is 32 months.

 

The following table summarizes information about the warrants outstanding at June 30, 2024:

 

Number of Warrants (#)

   

Exercise Prices

   

Expiry Dates

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

609,717              

 

The fair value of warrants granted during the nine months ended June 30, 2023 was estimated using the Black-Scholes option valuation model using the following assumptions:

 

   

Nine Months Ended

June 30, 2023

   

Class A Warrants

    Class B Warrants  
               

Risk free interest rate

    4.54 %   4.76 %

Expected life (years)

 

3.14

    1.14  

Expected share price volatility

    90.73 %   89.70 %

Expected dividend yield

    0.00 %   0.00 %

 

 

11

 

Share options

 

The Company adopted an Equity Incentive Compensation Plan in 2019 (the 2019 Plan) administered by the independent members of the Board of Directors, which amended and restated prior plans. Options, restricted shares and restricted share units are eligible for grant under the 2019 Plan. The total number of shares available for issuance under the terms of the 2019 Plan is 642,737. The remaining number of shares available to grant at June 30, 2024 is 156,679.

 

The Company’s 2019 Plan allows options to be granted to directors, officers, employees and certain external consultants and advisers. Under the 2019 Plan, the option term is not to exceed 10 years and the exercise price of each option is determined by the independent members of the Board of Directors.

 

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

 

   

Number of Options (#)

   

Weighted Average Exercise Price

   

Weighted Average Grant Date Fair Value

 

Nine Months Ended June 30, 2024

                       

Balance - September 30, 2023

    420,615     $ 25.60     $ 18.84  
                         

Granted

    500       4.10       3.10  

Forfeited

    (2,401 )     15.00       10.70  

Expired

    (35,674 )     33.18       24.63  
                         

Balance - June 30, 2024

    383,040     $ 24.93     $ 18.33  
                         

Nine Months Ended June 30, 2023

                       

Balance - September 30, 2022

    314,853     $ 32.62     $ 23.94  
                         

Granted

    47,571       10.01       7.49  

Forfeited

    (12,779 )     22.96       16.38  

Expired

    (34 )     2,129       2,129  
                         

Balance - June 30, 2023

    349,611     $ 29.61     $ 21.77  

 

During the three and nine months ended June 30, 2024, the independent members of the Board of Directors granted 500 employee options and no director options. During the three and nine months ended June 30, 2024 and 2023, there were no employee or director options granted. 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 June 30, 2024 is 83 months.

 

The following table summarizes information about the options under the 2019 Plan outstanding and exercisable at June 30, 2024:

 

Number of Options (#)

   

Exercisable at
June 30, 2024 (#)

   

Range of Exercise Prices

   

Expiry Dates

374       374     $ 246.96 - 596.82    

June 2024 - Mar 2025

37,719       37,719     C$ 15.12    

May 2024 - Dec 2028

43,031       43,031     $ 22.12    

May 2024 - Feb 2030

51,006       51,006     $ 52.08 - 56.49    

May 2024 - Oct 2030

81,041       80,971     $ 36.75 - 40.18    

Apr 2024 - Sep 2031

58,753       48,610     $ 25.97    

Apr 2024 - Feb 2032

111,116       54,551     $ 4.10 - 10.01    

Apr 2024 - Oct 2033

383,040       316,262              

 

The options exercisable at June 30, 2024 had a weighted average exercise price of $28.05, $22.00 intrinsic value and a weighted average remaining life of 78 months. There were 66,778 options at June 30, 2024 that had not vested with a weighted average exercise price of $10.15, $68.00 intrinsic value and a weighted average remaining life of 104 months.

 

12

 

The fair value of options granted during the nine months ended June 30, 2024 and 2023 was estimated using the Black-Scholes option valuation model using the following assumptions:

 

   

Nine Months Ended

June 30, 2024

   

Nine Months Ended

June 30, 2023

 
                 

Risk free interest rate

    4.92 %     3.62% - 4.18 %

Expected life (years)

    5       5  

Expected share price volatility

    97.26 %     95.3% - 97.34 %

Expected dividend yield

    0.00 %     0.00 %

 

The Company recorded $0.1 million and $0.1 million of share-based compensation expenses for the three months ended June 30, 2024 and 2023, respectively and $0.4 million and $0.7 million for the nine months ended June30, 2024 and 2023.

 

As of June 30, 2024, the Company had approximately $0.1 million of unrecognized share-based compensation expense, which is expected to be recognized over a period of 27 months.

 

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. There were no RSUs granted in the comparative period.

 

The following is a summary of changes in the status of RSUs from October 1, 2023 through June 30, 2024:

 

   

Number of RSU (#)

   

Weighted Average Grant Date Fair Value

 

Nine Months Ended June 30, 2024

               

Balance - September 30, 2023

    33,045     $ 5.60  
                 

Granted

    19,772       4.52  
                 

Balance - June 30, 2024

    52,817     $ 5.20  

 

The following table summarizes information about the RSUs under the 2019 Plan outstanding and exercisable at June 30, 2024:

 

   

Number of RSU (#)

   

Expiry Date

Fully-vested RSUs

    52,817    

August 2033 - June 2034

 

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 is no future 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.

 

13

 

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.

 

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 $0.2 million and $0.6 million for the three and nine months ended June 30, 2024. No grant income was recorded under the 2023 SIF Agreement for the three and nine months ended June 30, 2023.

 

 

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.

 

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

 

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

 

Level 3 – Unobservable inputs for the asset or liability that are supported by little or no market activity.

 

The 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 is also exposed to credit risk at period end from the carrying value of its cash and cash equivalents and accounts and other receivable. The Company manages this risk by maintaining bank accounts with Canadian Chartered Banks and a U.S. banks believed to be credit worthy and money market mutual funds of U.S. government securities. The Company’s cash is not subject to any external restrictions. The Company assesses 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.

 

14

 

(c) Foreign exchange risk

 

The Company and its subsidiary have balances in Canadian dollars that give rise to exposure to foreign 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 while a weakening U.S. dollar will lead to a FX gain. The Company has not entered into any agreements or purchased any instruments to hedge possible currency risks. At June 30, 2024, the Company and its Canadian subsidiary had assets denominated in Canadian dollars of approximately C$1.0 million and the U.S. dollar exchange rate at this date was equal to 1.3680 Canadian dollars. Based on the exposure at June 30, 2024, a 10% annual change in the Canadian/U.S. exchange rate would impact the Company’s loss and other comprehensive loss by approximately $0.1 million.

 

(d) Liquidity risk

 

Liquidity risk is the risk that the Company will encounter difficulty raising liquid funds to meet commitments as they fall due. In meeting its liquidity requirements, the Company closely monitors its forecasted cash requirements with expected cash drawdown.

 

 

9. Loss per Share

 

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

 

 

10. Related Party Transactions

 

During the three and nine months ended June 30, 2024 and 2023, the Company paid cash of $20,000 and $60,000, respectively, for a ROU lease from a company controlled by the Company’s CEO. These transactions are in the normal 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 executed a two-year lease extension through December 31, 2024 in accordance with the terms of the original lease agreement. Rent of approximately $7,000 was payable at June 30, 2024. There was no rent payable at June 30, 2023.

 

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 has not drawn any funds from the Credit Agreement. During the three and nine months ended June 30, 2024 the Company incurred a standby charge of $13,000 and $38,000. There was no standby charge in the three and nine months ended June 30, 2023.

 

 

 

Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations.

 

The following managements 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 June 30, 2024 and our audited consolidated financial statements for the year ended September 30, 2023 included in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission, or the SEC, on December 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, 2023 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.

 

15

 

The discussion and analysis of our financial condition and results of operations are based on our unaudited condensed interim consolidated financial statements for the three months ended June 30, 2024 and 2023, and for the nine months ended June 30, 2024 and 2023 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 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.

 

DISCLOSURE 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 number 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

 

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 forward-looking statements. You should refer to the “Risk Factors” section of our Annual Report on Form 10-K for the fiscal year ended September 30, 2023, filed with the SEC, on December 15, 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.

 

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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 approved 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 in the fields of respiratory diseases and medical dermatology.

 

Our most advanced drug candidate is EB05 (paridiprubart). EB05 represents a new class of 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. EB05 has also been included in a U.S. government funded platform study of HDTs.

 

In addition to EB05, we are developing product candidates for a number of chronic inflammatory and dermatological conditions. We intend to file an investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) for a future Phase 2 study of paridiprubart as a potential treatment for patients with progressive pulmonary fibrosis, a serious chronic disease that causes lung inflammation and scarring. 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 plan to seek regulatory approval for this vitiligo study in the U.S. as well. In addition, we are developing an sPLA2 inhibitor, EB01 (daniluromer), as a topical treatment for chronic Allergic Contact Dermatitis (ACD), a common occupational skin condition. We intend to seek strategic arrangements to further develop and/or monetize this late-stage clinical asset, following favorable Phase 2b results of 1.0% EB01 cream.

 

Recent Developments

 

Government-Funded Platform Study in General ARDS

 

In June 2024, our drug candidate, EB05, was selected by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, for evaluation in a U.S. government-funded clinical study. The Phase 2 platform trial will be a randomized, double-blinded, placebo-controlled, multi-center U.S. clinical trial to investigate novel threat-agnostic host-directed therapeutics, including EB05, in hospitalized adult patients with ARDS due to a variety of causes. For the EB05 cohort of the study, patients will be randomized one-to-one to either EB05 plus Standard of Care (SOC) or to a placebo plus SOC control arm. Edesa plans to provide drug product for the study as well as technical support.

 

Given this opportunity, we are currently evaluating our broader development strategy for the development of EB05 to align our activities with sources of government funding and the greater market opportunity for general ARDS, including amending our Canadian government supported Phase 3 ARDS study, which is exclusively recruiting patients hospitalized with Covid-19. Potential options include, but are not limited to, expanding the enrollment criteria of the Phase 3 study, refocusing the project on manufacturing scale-up, extending the project timeline and/or pausing recruitment while awaiting results of the BARDA study. Should we decide to make changes to our ongoing Phase 3 trial and manufacturing plans, we may be required to renegotiate the terms of our 2023 SIF Agreement.

 

Significant Accounting Policies and Estimates

 

See Note 2 to our financial statements included in our Annual Report on Form 10-K for the year ended September 30, 2023 for a discussion of our significant accounting policies and estimates. There have been no material changes to such significant accounting policies or estimates.

 

17

 

Results of Operations

 

Comparison of the Three Months Ended June 30, 2024 and 2023

 

Total operating expenses decreased by $0.2 million to $1.9 million for the three months ended June 30, 2024 compared to $2.1 million for the same period last year:

 

 

Research and development (R&D) expenses decreased by $0.1 million to $0.9 million for the three months ended June 30, 2024 compared to $1.0 million for the same period last year primarily due to decreased external research expenses related to our ongoing EB05 phase 3 clinical study and the completed EB01 phase 2 study, partially offset by an increase in expenses related to manufacturing of our investigational drug, paridiprubart. Our R&D expenses consist primarily of employee-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 product candidates, including regulatory consultants.

 

 

General and administrative (G&A) expenses were unchanged at $1.0 million for the three months ended June 30, 2024 and June 30, 2023. 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 $185,000 to $264,000 for the three months ended June 30, 2024 compared to $79,000 for the same period last year and was composed of the following:

 

 

Grant income increased by $0.2 million to $0.2 million for the three months ended June 30, 2024. 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 decreased by $50,000 to $33,000 for the three months ended June 30, 2024 compared to $83,000 for the same period last year primarily due to lower cash balances.

 

 

Foreign exchange loss was $5,000 for the three months ended June 30, 2024 compared to a loss of $3,000 for the three months ended June 30, 2023.

 

For the three months ended June 30, 2024, our net loss was $1.7 million, or $0.52 per common share, compared to a net loss of $2.0 million, or $0.68 per common share for the three months ended June 30, 2023.

 

Comparison of the Nine Months Ended June 30, 2024 and 2023

 

Total operating expenses decreased by $0.9 million to $6.0 million for the nine months ended June 30, 2024 compared to $6.9 million for the same period last year:

 

 

R&D expenses decreased by $1.0 million to $2.8 million for the nine months ended June 30, 2024 compared to $3.8 million for the same period last year primarily due to decreased external research expenses related to our completed EB01 phase 2 study and a decrease in non-cash share-based compensation and labor costs, partially offset by an increase in expenses for our ongoing EB05 phase 3 clinical study and for manufacturing of our investigational drug, paridiprubart. Our R&D expenses consist primarily of employee-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 product candidates, including regulatory consultants.

 

 

G&A expenses increased by $0.2 million to $3.2 million for the nine months ended June 30, 2024 compared to $3.0 million for the same period last year primarily due to increased fees for professional services, partially offset by a decrease in non-cash 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.

 

18

 

Total other income increased by $0.6 million to $0.8 million for the nine months ended June 30, 2024 compared to $0.2 million for the same period last year and was composed of the following:

 

 

Grant income increased by $0.6 million to $0.6 million for the nine months ended June 30, 2024. 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 decreased by $81,000 to $137,000 for the nine months ended June 30, 2024 compared to $218,000 for the same period last year primarily due to a decrease in cash balances.

 

 

Miscellaneous other income was $15,000 for the nine months ended June 30, 2024 related to loan forgiveness on the CEBA loan that was repaid in the quarter.

 

 

Foreign exchange loss was $9,700 for the nine months ended June 30, 2024 compared to a loss of $18,100 for the nine months ended June 30, 2023.

 

For the nine months ended June 30, 2024, our net loss was $5.2 million, or $1.64 per common share, compared to a net loss of $6.7 million, or $2.37 per common share for the nine months ended June 30, 2023.

 

Capital Expenditures

 

Our capital expenditures primarily consist of computer and office equipment. There were no significant capital expenditures for the three and nine months ended June 30, 2024 and 2023.

 

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 the 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 $3.9 million and $5.2 million for the nine months ended June 30, 2024 and 2023, respectively. We incurred net losses of $5.2 million and $6.7 million for the nine months ended June 30, 2024 and 2023.

 

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 and nine months ended June 30, 2024 we recorded grant income of $0.2 million and $0.6 million respectively, related to the 2023 SIF Agreement. There was no grant income recognized in the comparative periods.

 

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 $6.3 million of available capacity on the Canaccord ATM as of June 30, 2024. 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 June 30, 2024, we sold a total of 31,421 common shares pursuant to the agreement for net proceeds of $0.1 million after deducting commissions and costs of $40,000. For the nine months ended June 30, 2024, we sold a total of 171,916 common shares pursuant to the agreement for net proceeds of $0.6 million after deducting commissions and costs of $140,000.

 

19

 

In November 2022, we completed a private placement of units consisting of 384,475 common shares, 12-month warrants to purchase up to an aggregate of 192,248 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 June 30, 2024, we had an accumulated deficit of $57.6 million and working capital of $0.7 million, including $2.0 million in cash and cash equivalents. Subsequent to the quarter, we collected the receivable from 2023 SIF Agreement for $0.3 million from Canadian government. 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 next 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 $3.9 million for the nine months ended June 30, 2024 compared to $5.2 million for the nine months ended June 30, 2023, primarily due to a decrease in R&D expenses of $1.0 million and an investment in working capital of $0.1 million, partially offset by a reduction in non-cash stock based compensation of $0.3 million.

 

Net cash used in investing activities

 

There was no cash used in investing activities for the nine months ended June 30, 2024 and 2023, respectively.

 

Net cash provided by financing activities

 

Net cash provided by financing activities was $0.6 million for the nine months ended June 30, 2024 as compared to $4.4 million for the nine months ended June 30, 2023. In the current period, we received proceeds of $0.7 million from the Canaccord ATM, partially offset by issuance costs of $76,000 and the repayment of debt of $29,500. In the comparative period, we received proceeds of $3.0 million from a private placement in November 2022, offset by issuance costs of $0.1 million for net proceeds of $2.9 million; we received $0.8 million in proceeds from the exercise of warrants and $0.7 million in net proceeds from the Canaccord ATM.

 

20

 

Research and 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 $0.9 million and $2.8million for the three and nine months ended June 30, 2024 compared to $1.0 million and $3.8 million for the three and nine months ended June 30, 2023. The decrease was due primarily to lower external research expenses related to our ongoing clinical studies.

 

Off-Balance Sheet Arrangements

 

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

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

 

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 our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of June 30, 2024. 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 June 30, 2024, 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 June 30, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

 

 

 

21

 

PART II OTHER INFORMATION

 

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.

 

There have been no material changes to the risk factors discussed in Item 1A. Risk Factors in our Annual Report on Form 10-K for the year ended September 30, 2023, filed with the Securities and Exchange Commission on December 15, 2023.

 

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

 

None.

 

Item 3. Defaults Upon Senior Securities.

 

None.

 

Item 4. Mine Safety Disclosures.

 

Not applicable.

 

 

Item 5. Other Information.

 

None of the Company's directors and officers adopted, modified, or terminated a Rule 10b-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the Company's fiscal quarter ended June 30, 2024 (each as defined in Item 408 of Regulation S-K under the Securities Exchange Act of 1934, as amended).

 

 

 

 

 

 

 

 

 

 

 

 

 

22

 

Item 6. Exhibits

EXHIBIT INDEX

 

Exhibit No.

 

Description 

     
10.1^   Amendment No. 3 to Edesa Biotech, Inc. 2019 Equity Incentive Compensation Plan (included as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on May 30, 2024, 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

 

Inline XBRL Instance Document

     

101.SCH

 

Inline XBRL Taxonomy Extension Schema Document

     

101.CAL

 

Inline XBRL Taxonomy Calculation Linkbase Document

     

101.DEF

 

Inline XBRL Taxonomy Extension Definition Linkbase Document

     

101.LAB

 

Inline XBRL Taxonomy Label Linkbase Document

     

101.PRE

 

Inline XBRL Taxonomy Presentation Linkbase Document

     
104   Cover Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101)

 

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

 

 

^ Management contract or compensatory plan or arrangement.

 

 

 

 

 

 

23

 

 

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: August 9, 2024

/s/ Pardeep Nijhawan

 

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

(Principal Executive Officer)

   

Date: August 9, 2024

/s/ Stephen Lemieux

 

Stephen Lemieux, Chief Financial Officer

(Principal Financial Officer)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

24

EXHIBIT 31.1

 

CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT TO SECTION 302(a) OF THE SARBANES-OXLEY ACT OF 2002

(18 U.S.C. SECTION 1350)

 

I, Pardeep Nijhawan, certify that:

 

1.

I have reviewed this Quarterly Report on Form 10-Q of Edesa Biotech, Inc.;

   

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

   

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

   

4.

The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

   
 

a.

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

     
 

b.

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

     
 

c.

Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

     
 

d.

Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.

The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

 

a.

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

     
 

b.

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: August 9, 2024

By:

 /s/ Pardeep Nijhawan

 
   

Pardeep Nijhawan

Director, Chief Executive Officer and Corporate Secretary

(Principal Executive Officer)

 

 

 

EXHIBIT 31.2

 

CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT TO SECTION 302(a) OF THE SARBANES-OXLEY ACT OF 2002

(18 U.S.C. SECTION 1350)

 

I, Stephen Lemieux, certify that:

 

1.

I have reviewed this Quarterly Report on Form 10-Q of Edesa Biotech, Inc.;

   

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

   

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

   

4.

The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

   
 

a.

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

     
 

b.

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

     
 

c.

Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

     
 

d.

Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.

The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

 

a.

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

     
 

b.

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: August 9, 2024

By:

 /s/ Stephen Lemieux

 
   

Stephen Lemieux

Chief Financial Officer

(Principal Financial Officer)

 

 

 

EXHIBIT 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

 

In connection with the Quarterly Report of Edesa Biotech, Inc. (the Company) on Form 10-Q for the quarter ended June 30, 2024, as filed with the Securities and Exchange Commission on the date hereof (the Report), I, Pardeep Nijhawan, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

 

1.

The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

   

2.

The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

 

Date: August 9, 2024

By:

/s/ Pardeep Nijhawan

   

Pardeep Nijhawan

   

Director, Chief Executive Officer and Corporate Secretary

   

(Principal Executive Officer)

 

 

 

 

 

EXHIBIT 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

 

In connection with the Quarterly Report of Edesa Biotech, Inc. (the Company) on Form 10-Q for the quarter ended June 30, 2024, as filed with the Securities and Exchange Commission on the date hereof (the Report), I, Stephen Lemieux, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

 

1.

The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

   

2.

The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Date: August 9, 2024

By:

/s/ Stephen Lemieux

   

Stephen Lemieux

   

Chief Financial Officer

   

(Principal Financial Officer)

 

 

 

 

 
v3.24.2.u1
Document And Entity Information - shares
9 Months Ended
Jun. 30, 2024
Aug. 09, 2024
Document Information [Line Items]    
Document Type 10-Q  
Document Quarterly Report true  
Document Period End Date Jun. 30, 2024  
Document Transition Report false  
Entity File Number 001-37619  
Entity Registrant Name EDESA BIOTECH, INC.  
Entity Incorporation, State or Country Code CA  
Entity Address, Address Line One 100 Spy Court  
Entity Address, City or Town Markham  
Entity Address, Country CA  
Entity Address, Postal Zip Code L3R 5H6  
City Area Code 289  
Local Phone Number 800-9600  
Title of 12(b) Security Common Shares, without par value  
Trading Symbol EDSA  
Security Exchange Name NASDAQ  
Entity Current Reporting Status Yes  
Entity Interactive Data Current Yes  
Entity Filer Category Non-accelerated Filer  
Entity Small Business true  
Entity Emerging Growth Company false  
Entity Shell Company false  
Entity Common Stock, Shares Outstanding (in shares)   3,247,389
Entity Central Index Key 0001540159  
Current Fiscal Year End Date --09-30  
Document Fiscal Year Focus 2024  
Document Fiscal Period Focus Q3  
Amendment Flag false  
v3.24.2.u1
Condensed Interim Consolidated Balance Sheets (Current Period Unaudited) - USD ($)
Jun. 30, 2024
Sep. 30, 2023
Current assets:    
Cash and cash equivalents $ 2,040,884 $ 5,361,397
Accounts and other receivable 551,064 626,543
Prepaid expenses and other current assets 454,686 448,912
Total current assets 3,046,634 6,436,852
Non-current assets:    
Property and equipment, net 0 8,702
Long-term deposits 40,661 173,490
Intangible asset, net 2,104,141 2,180,020
Right-of-use assets 36,286 91,373
Total assets 5,227,722 8,890,437
Current liabilities:    
Accounts payable and accrued liabilities 2,321,810 1,747,150
Short-term right-of-use lease liabilities 38,817 74,714
Total current liabilities 2,360,627 1,821,864
Non-current liabilities:    
Long-term right-of-use lease liabilities 0 19,773
Total liabilities 2,360,627 1,841,637
Shareholders' equity:    
Capital shares Authorized unlimited common and preferred shares without par value Issued and outstanding: 3,247,389 common shares (September 30, 2023 - 3,075,473) 47,236,024 46,643,151
Additional paid-in capital 13,482,824 13,039,265
Accumulated other comprehensive loss (224,791) (214,648)
Accumulated deficit (57,626,962) (52,418,968)
Total shareholders' equity 2,867,095 7,048,800
Total liabilities and shareholders' equity $ 5,227,722 $ 8,890,437
v3.24.2.u1
Condensed Interim Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares
$ / shares in Thousands
9 Months Ended 12 Months Ended
Jun. 30, 2024
Sep. 30, 2023
Common Stock, Shares Authorized, Unlimited [Fixed List] Unlimited Unlimited
Common Stock, No Par Value (in dollars per share) $ 0 $ 0
Common Stock, Shares, Issued (in shares) 3,247,389 3,075,473
Common Stock, Shares, Outstanding (in shares) 3,247,389 3,075,473
v3.24.2.u1
Condensed Interim Consolidated Statements of Operations (Unaudited) - USD ($)
3 Months Ended 9 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Expenses:        
Research and development $ 897,305 $ 1,025,622 $ 2,778,100 $ 3,841,150
General and administrative 1,035,140 1,038,587 3,232,248 3,011,945
Loss from operations (1,932,445) (2,064,209) (6,010,348) (6,853,095)
Other income (loss):        
Reimbursement grant income 236,226 0 661,062 0
Interest income 32,848 82,754 137,007 217,901
Misc other income 0 0 14,766 0
Foreign exchange loss (4,841) (3,451) (9,681) (18,078)
Nonoperating Income (Expense) 264,233 79,303 803,154 199,823
Loss before income taxes (1,668,212) (1,984,906) (5,207,194) (6,653,272)
Income tax expense 0 0 800 800
Net loss (1,668,212) (1,984,906) (5,207,994) (6,654,072)
Exchange differences on translation 1,612 39,839 (10,143) 23,415
Net comprehensive loss $ (1,666,600) $ (1,945,067) $ (5,218,137) $ (6,630,657)
Weighted average number of common shares (in shares) 3,221,806 2,930,681 3,180,647 2,802,793
Loss per common share - basic and diluted (in dollars per share) $ (0.52) $ (0.68) $ (1.64) $ (2.37)
v3.24.2.u1
Condensed Interim Consolidated Statements of Cash Flows (Unaudited) - USD ($)
9 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Cash flows from operating activities:    
Net loss $ (5,207,994) $ (6,654,072)
Adjustments for:    
Depreciation and amortization 141,843 137,501
Share-based compensation 443,559 729,380
Gain on payable forgiveness (14,766) 0
Changes in working capital items:    
Accounts and other receivable 71,501 1,149,129
Prepaid expenses and other current assets 109,647 339,031
Accounts payable and accrued liabilities 533,044 (869,430)
Net cash used in operating activities (3,923,166) (5,168,461)
Cash flows from financing activities:    
Proceeds from issuance of common shares and warrants 729,387 3,861,245
Proceeds from exercise of warrants 0 770,531
Payments for issuance costs of common shares and warrants (76,389) (214,130)
Repayment of debt (29,532) 0
Net cash provided by financing activities 623,466 4,417,646
Effect of exchange rate changes on cash and cash equivalents (20,813) 117,066
Net change in cash and cash equivalents (3,320,513) (633,749)
Cash and cash equivalents, beginning of period 5,361,397 7,090,919
Cash and cash equivalents, end of period $ 2,040,884 $ 6,457,170
v3.24.2.u1
Condensed Interim Consolidated Statements of Changes in Shareholders' Equity (Unaudited) - USD ($)
Common Stock [Member]
Additional Paid-in Capital [Member]
AOCI Attributable to Parent [Member]
Retained Earnings [Member]
Total
Balance (in shares) at Sep. 30, 2022 2,380,280        
Balance at Sep. 30, 2022 $ 42,473,099 $ 11,176,345 $ (213,602) $ (44,044,553) $ 9,391,289
Issuance of common shares (in shares) 499,918        
Issuance of common shares $ 2,916,418 944,827 0 0 3,861,245
Issuance costs $ (242,948) (28,357) 0 0 (271,305)
Share-based compensation   729,380 0   729,380
Net loss and comprehensive loss   0 23,415 (6,654,072) (6,630,657)
Issuance of common shares upon exercise of warrants (in shares) 100,760        
Issuance of common shares upon exercise of warrants $ 994,618 (224,087) 0 0 770,531
Balance (in shares) at Jun. 30, 2023 2,980,958        
Balance at Jun. 30, 2023 $ 46,141,187 12,598,108 (190,187) (50,698,625) 7,850,483
Balance (in shares) at Mar. 31, 2023 2,865,517        
Balance at Mar. 31, 2023 $ 45,453,733 12,489,949 (230,026) (48,713,719) 8,999,937
Issuance costs (146,295) 0 0 0 (146,295)
Share-based compensation 0 108,159 0   108,159
Net loss and comprehensive loss $ 0 0 39,839 (1,984,906) (1,945,067)
Issuance of common shares upon exercise of warrants (in shares) 115,441        
Issuance of common shares upon exercise of warrants $ 833,749 0 0 0 833,749
Balance (in shares) at Jun. 30, 2023 2,980,958        
Balance at Jun. 30, 2023 $ 46,141,187 12,598,108 (190,187) (50,698,625) 7,850,483
Balance (in shares) at Sep. 30, 2023 3,075,473        
Balance at Sep. 30, 2023 $ 46,643,151 13,039,265 (214,648) (52,418,968) 7,048,800
Issuance of common shares (in shares) 171,916        
Issuance of common shares $ 729,387 0 0 0 729,387
Issuance costs (136,514) 0 0 0 (136,514)
Share-based compensation   443,559 0   443,559
Net loss and comprehensive loss $ 0 0 (10,143) (5,207,994) (5,218,137)
Balance (in shares) at Jun. 30, 2024 3,247,389        
Balance at Jun. 30, 2024 $ 47,236,024 13,482,824 (224,791) (57,626,962) 2,867,095
Balance (in shares) at Mar. 31, 2024 3,215,968        
Balance at Mar. 31, 2024 $ 47,136,168 13,373,318 (226,403) (55,958,750) 4,324,333
Issuance of common shares (in shares) 31,421        
Issuance of common shares $ 138,421 0 0 0 138,421
Issuance costs $ (38,565) 0 0 0 (38,565)
Share-based compensation   109,506 0   109,506
Net loss and comprehensive loss   0 1,612 (1,668,212) (1,666,600)
Balance (in shares) at Jun. 30, 2024 3,247,389        
Balance at Jun. 30, 2024 $ 47,236,024 $ 13,482,824 $ (224,791) $ (57,626,962) $ 2,867,095
v3.24.2.u1
Note 1 - Nature of Operations
9 Months Ended
Jun. 30, 2024
Notes to Financial Statements  
Nature of Operations [Text Block]

1. Nature of Operations

 

Edesa Biotech, Inc. (the 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 and is headquartered in Markham, Ontario. It operates under its wholly owned subsidiaries, Edesa Biotech Research, Inc., an Ontario, Canada corporation, and Edesa Biotech USA, Inc., a California, USA corporation.

 

The Company’s common shares trade on The Nasdaq Capital Market in the United States under the symbol “EDSA”.

 

v3.24.2.u1
Note 2 - Basis of Presentation
9 Months Ended
Jun. 30, 2024
Notes to Financial Statements  
Business Description and Basis of Presentation [Text Block]

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 year ended September 30, 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. All intercompany balances and transactions have been eliminated on consolidation. All adjustments (consisting of normal recurring adjustments and accruals) considered necessary for a fair presentation of the results of operations for the periods presented have been included in the interim periods. Operating results for the three and nine months ended June 30, 2024 are not necessarily indicative of the results that may be expected for other interim periods or the fiscal year ending September 30, 2024.

 

Use of estimates

 

The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the period or year. Actual results could differ from those 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 and reporting currencies

 

The 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.

 

v3.24.2.u1
Note 3 - Intangible Assets
9 Months Ended
Jun. 30, 2024
Notes to Financial Statements  
Intangible Assets Disclosure [Text Block]

3. Intangible Assets

 

Acquired license

 

In April 2020, the Company entered into a license agreement with a pharmaceutical development company to obtain exclusive world-wide rights to know-how, patents and data relating to certain monoclonal antibodies (the Constructs), including sublicensing rights. Unless earlier terminated, the term of the license agreement will remain in effect for 25 years from the date of first commercial sale of licensed products containing the Constructs. Subsequently, the license agreement will automatically renew for five-year periods unless either party terminates the agreement in accordance with its terms.

 

Under the license agreement, the Company is exclusively responsible, at its expense, for the research, development, manufacture, marketing, distribution and commercialization of the Constructs and licensed products and to obtain all necessary licenses and rights. The Company is required to use commercially reasonable efforts to develop and commercialize the Constructs in accordance with the terms of a development plan established by the parties.

 

The Company has determined that the license has multiple alternative future uses in research and development projects and sublicensing in other countries or for other disease indications. The value of the acquired license is recorded as an intangible asset with amortization over the estimated useful life of 25 years and evaluation for impairment at the end of each reporting period.

 

The 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 license includes acquisition legal costs. See Note 5 for license commitments.

 

Intangible assets, net consisted of the following:

 

   

June 30, 2024

   

September 30, 2023

 
                 

The Constructs

  $ 2,529,483     $ 2,529,483  
                 

Less: accumulated amortization

    (425,342 )     (349,463 )
                 

Total intangible assets, net

  $ 2,104,141     $ 2,180,020  

 

Amortization expense amounted to $0.03 million for each of the three months ended June 30, 2024 and 2023 and $0.08 million for each of the nine months ended June 30, 2024 and 2023.

 

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

 

Year Ending

       

September 30, 2024

    25,293  

September 30, 2025

    101,172  

September 30, 2026

    101,172  

September 30, 2027

    101,172  

September 30, 2028

    101,172  

Thereafter

    1,674,160  
         
    $ 2,104,141  

 

v3.24.2.u1
Note 4 - Right-of-use Lease With Related Party
9 Months Ended
Jun. 30, 2024
Notes to Financial Statements  
Lessee, Operating Leases [Text Block]

4. Right-of-Use Lease with Related Party

 

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

   

Nine Months Ended

 
   

June 30, 2024

   

June 30, 2023

   

June 30, 2024

   

June 30, 2023

 

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

  $ 19,299     $ 21,188     $ 59,208     $ 61,530  

 

Lease terms and discount rates were as follows:

 

   

June 30, 2024

   

September 30,2023

 

Remaining lease term (months):

    6       15  

Estimated incremental borrowing rate:

    9.2 %     9.2 %

 

The future minimum lease payments under right-of-use leases at June 30, 2024 were as follows:

 

Year Ending

       

September 30, 2024

  $ 19,781  

September 30, 2025

    19,781  
         

Total lease payments

    39,562  

Less imputed interest

    745  
         

Present value of right-of-use lease liabilities

    38,817  

Present value included in current liabilities

    38,817  
         

Present value included in long-term liabilities

  $ -  

 

Cash flow information was as follows:

 

   

Nine Months Ended

 
   

June 30, 2024

   

June 30, 2023

 

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.

  $ 59,732     $ 59,045  

 

v3.24.2.u1
Note 5 - Commitments
9 Months Ended
Jun. 30, 2024
Notes to Financial Statements  
Commitments and Contingencies Disclosure [Text Block]

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 June 30, 2024 are as follows:

 

Year Ending

       
         

September 30, 2024

  $ 301,000  

September 30, 2025

    49,000  

September 30, 2026

    36,000  

September 30, 2027

    42,000  

September 30, 2028

    -  
         
    $ 428,000  

 

License and royalty commitments

 

In April 2020, through its Ontario subsidiary, the Company entered into a license agreement with a third party to obtain exclusive world-wide rights to the Constructs, including sublicensing rights. An intangible asset for the acquired license has been recognized. See Note 3 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 or sublicensing payments were made to the third party during the three and nine months ended June 30, 2024 and 2023.

 

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 $0.04 million and $0.16 million were to the third party during the three and nine months ended June 30, 2023 and no milestone payments were made during the three and nine months ended June 30, 2024.

 

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 is 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 the 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 and nine months ended June 30, 2024, the Company recorded an expense of $25,000 and $75,000 as a result of meeting milestones outlined in the 2021 license agreement. There were no milestones achieved in the three and nine months ended June 30, 2023 and no expenses were incurred.

 

In June 2024, the Company’s drug candidate, EB05, was selected by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, for evaluation in a U.S. government-funded clinical study. The Phase 2 platform trial will be a randomized, double-blinded, placebo-controlled, multi-center U.S. clinical trial to investigate novel threat-agnostic host-directed therapeutics, including EB05, in hospitalized adult patients with ARDS due to a variety of causes. For the EB05 cohort of the study, patients will be randomized one-to-one to either EB05 plus Standard of Care (SOC) or to a placebo plus SOC control arm. The Company plans to provide drug product for the study as well as technical support. The Company is responsible for providing drug product and placebo for the Phase 2 platform trial.

 

v3.24.2.u1
Note 6 - Capital Shares
9 Months Ended
Jun. 30, 2024
Notes to Financial Statements  
Equity [Text Block]

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 nine months ended June 30, 2024, the Company sold a total of 171,916 common shares pursuant to the agreement for net proceeds of approximately $0.6 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 the fair value of warrants issued. Option valuation models require the input of highly subjective assumptions including the expected price volatility. The Company calculates expected volatility based on historical 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.

 

Warrants

 

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

 

   

Number of Warrant Shares (#)

   

Weighted Average Exercise Price

 

Nine Months Ended June 30, 2024

               

Balance - September 30, 2023

    720,909     $ 19.51  
                 

Expired

    (111,192 )     7.26  
                 

Balance - June 30, 2024

    609,717     $ 21.74  
                 

Nine Months Ended June 30, 2023

               

Balance - September 30, 2022

    521,718     $ 28.00  
                 

Issued

    384,496       8.75  

Exercised

    (100,760 )     7.63  

Expired

    (4,018 )     111.30  
                 

Balance - June 30, 2023

    801,436     $ 20.93  

 

The weighted average contractual life remaining on the outstanding warrants at June 30, 2024 is 32 months.

 

The following table summarizes information about the warrants outstanding at June 30, 2024:

 

Number of Warrants (#)

   

Exercise Prices

   

Expiry Dates

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

609,717              

 

The fair value of warrants granted during the nine months ended June 30, 2023 was estimated using the Black-Scholes option valuation model using the following assumptions:

 

   

Nine Months Ended

June 30, 2023

   

Class A Warrants

    Class B Warrants  
               

Risk free interest rate

    4.54 %   4.76 %

Expected life (years)

 

3.14

    1.14  

Expected share price volatility

    90.73 %   89.70 %

Expected dividend yield

    0.00 %   0.00 %

 

 

Share options

 

The Company adopted an Equity Incentive Compensation Plan in 2019 (the 2019 Plan) administered by the independent members of the Board of Directors, which amended and restated prior plans. Options, restricted shares and restricted share units are eligible for grant under the 2019 Plan. The total number of shares available for issuance under the terms of the 2019 Plan is 642,737. The remaining number of shares available to grant at June 30, 2024 is 156,679.

 

The Company’s 2019 Plan allows options to be granted to directors, officers, employees and certain external consultants and advisers. Under the 2019 Plan, the option term is not to exceed 10 years and the exercise price of each option is determined by the independent members of the Board of Directors.

 

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

 

   

Number of Options (#)

   

Weighted Average Exercise Price

   

Weighted Average Grant Date Fair Value

 

Nine Months Ended June 30, 2024

                       

Balance - September 30, 2023

    420,615     $ 25.60     $ 18.84  
                         

Granted

    500       4.10       3.10  

Forfeited

    (2,401 )     15.00       10.70  

Expired

    (35,674 )     33.18       24.63  
                         

Balance - June 30, 2024

    383,040     $ 24.93     $ 18.33  
                         

Nine Months Ended June 30, 2023

                       

Balance - September 30, 2022

    314,853     $ 32.62     $ 23.94  
                         

Granted

    47,571       10.01       7.49  

Forfeited

    (12,779 )     22.96       16.38  

Expired

    (34 )     2,129       2,129  
                         

Balance - June 30, 2023

    349,611     $ 29.61     $ 21.77  

 

During the three and nine months ended June 30, 2024, the independent members of the Board of Directors granted 500 employee options and no director options. During the three and nine months ended June 30, 2024 and 2023, there were no employee or director options granted. 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 June 30, 2024 is 83 months.

 

The following table summarizes information about the options under the 2019 Plan outstanding and exercisable at June 30, 2024:

 

Number of Options (#)

   

Exercisable at
June 30, 2024 (#)

   

Range of Exercise Prices

   

Expiry Dates

374       374     $ 246.96 - 596.82    

June 2024 - Mar 2025

37,719       37,719     C$ 15.12    

May 2024 - Dec 2028

43,031       43,031     $ 22.12    

May 2024 - Feb 2030

51,006       51,006     $ 52.08 - 56.49    

May 2024 - Oct 2030

81,041       80,971     $ 36.75 - 40.18    

Apr 2024 - Sep 2031

58,753       48,610     $ 25.97    

Apr 2024 - Feb 2032

111,116       54,551     $ 4.10 - 10.01    

Apr 2024 - Oct 2033

383,040       316,262              

 

The options exercisable at June 30, 2024 had a weighted average exercise price of $28.05, $22.00 intrinsic value and a weighted average remaining life of 78 months. There were 66,778 options at June 30, 2024 that had not vested with a weighted average exercise price of $10.15, $68.00 intrinsic value and a weighted average remaining life of 104 months.

 

The fair value of options granted during the nine months ended June 30, 2024 and 2023 was estimated using the Black-Scholes option valuation model using the following assumptions:

 

   

Nine Months Ended

June 30, 2024

   

Nine Months Ended

June 30, 2023

 
                 

Risk free interest rate

    4.92 %     3.62% - 4.18 %

Expected life (years)

    5       5  

Expected share price volatility

    97.26 %     95.3% - 97.34 %

Expected dividend yield

    0.00 %     0.00 %

 

The Company recorded $0.1 million and $0.1 million of share-based compensation expenses for the three months ended June 30, 2024 and 2023, respectively and $0.4 million and $0.7 million for the nine months ended June30, 2024 and 2023.

 

As of June 30, 2024, the Company had approximately $0.1 million of unrecognized share-based compensation expense, which is expected to be recognized over a period of 27 months.

 

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. There were no RSUs granted in the comparative period.

 

The following is a summary of changes in the status of RSUs from October 1, 2023 through June 30, 2024:

 

   

Number of RSU (#)

   

Weighted Average Grant Date Fair Value

 

Nine Months Ended June 30, 2024

               

Balance - September 30, 2023

    33,045     $ 5.60  
                 

Granted

    19,772       4.52  
                 

Balance - June 30, 2024

    52,817     $ 5.20  

 

The following table summarizes information about the RSUs under the 2019 Plan outstanding and exercisable at June 30, 2024:

 

   

Number of RSU (#)

   

Expiry Date

Fully-vested RSUs

    52,817    

August 2033 - June 2034

 

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 is no future unrecorded compensation expense for the RSUs.

 

v3.24.2.u1
Note 7 - Government Contributions
9 Months Ended
Jun. 30, 2024
Notes to Financial Statements  
Government Assistance [Text Block]

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.

 

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 $0.2 million and $0.6 million for the three and nine months ended June 30, 2024. No grant income was recorded under the 2023 SIF Agreement for the three and nine months ended June 30, 2023.

 

v3.24.2.u1
Note 8 - Financial Instruments
9 Months Ended
Jun. 30, 2024
Notes to Financial Statements  
Financial Instruments Disclosure [Text Block]

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.

 

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

 

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

 

Level 3 – Unobservable inputs for the asset or liability that are supported by little or no market activity.

 

The 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 is also exposed to credit risk at period end from the carrying value of its cash and cash equivalents and accounts and other receivable. The Company manages this risk by maintaining bank accounts with Canadian Chartered Banks and a U.S. banks believed to be credit worthy and money market mutual funds of U.S. government securities. The Company’s cash is not subject to any external restrictions. The Company assesses 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 foreign 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 while a weakening U.S. dollar will lead to a FX gain. The Company has not entered into any agreements or purchased any instruments to hedge possible currency risks. At June 30, 2024, the Company and its Canadian subsidiary had assets denominated in Canadian dollars of approximately C$1.0 million and the U.S. dollar exchange rate at this date was equal to 1.3680 Canadian dollars. Based on the exposure at June 30, 2024, a 10% annual change in the Canadian/U.S. exchange rate would impact the Company’s loss and other comprehensive loss by approximately $0.1 million.

 

(d) Liquidity risk

 

Liquidity risk is the risk that the Company will encounter difficulty raising liquid funds to meet commitments as they fall due. In meeting its liquidity requirements, the Company closely monitors its forecasted cash requirements with expected cash drawdown.

 

v3.24.2.u1
Note 9 - Loss Per Share
9 Months Ended
Jun. 30, 2024
Notes to Financial Statements  
Earnings Per Share [Text Block]

9. Loss per Share

 

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

 

v3.24.2.u1
Note 10 - Related Party Transactions
9 Months Ended
Jun. 30, 2024
Notes to Financial Statements  
Related Party Transactions Disclosure [Text Block]

 

During the three and nine months ended June 30, 2024 and 2023, the Company paid cash of $20,000 and $60,000, respectively, for a ROU lease from a company controlled by the Company’s CEO. These transactions are in the normal 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 executed a two-year lease extension through December 31, 2024 in accordance with the terms of the original lease agreement. Rent of approximately $7,000 was payable at June 30, 2024. There was no rent payable at June 30, 2023.

 

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 has not drawn any funds from the Credit Agreement. During the three and nine months ended June 30, 2024 the Company incurred a standby charge of $13,000 and $38,000. There was no standby charge in the three and nine months ended June 30, 2023.

 

v3.24.2.u1
Insider Trading Arrangements
3 Months Ended 9 Months Ended
Jun. 30, 2024
Jun. 30, 2024
Insider Trading Arr Line Items    
Material Terms of Trading Arrangement [Text Block]  

Item 5. Other Information.

 

None of the Company's directors and officers adopted, modified, or terminated a Rule 10b-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the Company's fiscal quarter ended June 30, 2024 (each as defined in Item 408 of Regulation S-K under the Securities Exchange Act of 1934, as amended).

 

Rule 10b5-1 Arrangement Adopted [Flag] false  
Rule 10b5-1 Arrangement Terminated [Flag] false  
Non-Rule 10b5-1 Arrangement Adopted [Flag] false  
Non-Rule 10b5-1 Arrangement Terminated [Flag] false  
v3.24.2.u1
Significant Accounting Policies (Policies)
9 Months Ended
Jun. 30, 2024
Accounting Policies [Abstract]  
Basis of Accounting, Policy [Policy Text Block]

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 year ended September 30, 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. All intercompany balances and transactions have been eliminated on consolidation. All adjustments (consisting of normal recurring adjustments and accruals) considered necessary for a fair presentation of the results of operations for the periods presented have been included in the interim periods. Operating results for the three and nine months ended June 30, 2024 are not necessarily indicative of the results that may be expected for other interim periods or the fiscal year ending September 30, 2024.

 

Use of Estimates, Policy [Policy Text Block]

Use of estimates

 

The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the period or year. Actual results could differ from those 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.

 

Foreign Currency Transactions and Translations Policy [Policy Text Block]

Functional and reporting currencies

 

The 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.

 

v3.24.2.u1
Note 3 - Intangible Assets (Tables)
9 Months Ended
Jun. 30, 2024
Notes Tables  
Schedule of Finite-Lived Intangible Assets [Table Text Block]
   

June 30, 2024

   

September 30, 2023

 
                 

The Constructs

  $ 2,529,483     $ 2,529,483  
                 

Less: accumulated amortization

    (425,342 )     (349,463 )
                 

Total intangible assets, net

  $ 2,104,141     $ 2,180,020  
Schedule of Finite-Lived Intangible Assets, Future Amortization Expense [Table Text Block]

Year Ending

       

September 30, 2024

    25,293  

September 30, 2025

    101,172  

September 30, 2026

    101,172  

September 30, 2027

    101,172  

September 30, 2028

    101,172  

Thereafter

    1,674,160  
         
    $ 2,104,141  
v3.24.2.u1
Note 4 - Right-of-use Lease With Related Party (Tables)
9 Months Ended
Jun. 30, 2024
Notes Tables  
Lease, Cost [Table Text Block]
   

Three Months Ended

   

Nine Months Ended

 
   

June 30, 2024

   

June 30, 2023

   

June 30, 2024

   

June 30, 2023

 

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

  $ 19,299     $ 21,188     $ 59,208     $ 61,530  
Lease Term and Discount Rate [Table Text Block]
   

June 30, 2024

   

September 30,2023

 

Remaining lease term (months):

    6       15  

Estimated incremental borrowing rate:

    9.2 %     9.2 %
Lessee, Operating Lease, Liability, to be Paid, Maturity [Table Text Block]

Year Ending

       

September 30, 2024

  $ 19,781  

September 30, 2025

    19,781  
         

Total lease payments

    39,562  

Less imputed interest

    745  
         

Present value of right-of-use lease liabilities

    38,817  

Present value included in current liabilities

    38,817  
         

Present value included in long-term liabilities

  $ -  
Leases, Cash Flow Information [Table Text Block]
   

Nine Months Ended

 
   

June 30, 2024

   

June 30, 2023

 

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.

  $ 59,732     $ 59,045  
v3.24.2.u1
Note 5 - Commitments (Tables)
9 Months Ended
Jun. 30, 2024
Notes Tables  
Contractual Obligation, Fiscal Year Maturity [Table Text Block]

Year Ending

       
         

September 30, 2024

  $ 301,000  

September 30, 2025

    49,000  

September 30, 2026

    36,000  

September 30, 2027

    42,000  

September 30, 2028

    -  
         
    $ 428,000  
v3.24.2.u1
Note 6 - Capital Shares (Tables)
9 Months Ended
Jun. 30, 2024
Notes Tables  
Schedule of Stockholders' Equity Note, Warrants or Rights [Table Text Block]
   

Number of Warrant Shares (#)

   

Weighted Average Exercise Price

 

Nine Months Ended June 30, 2024

               

Balance - September 30, 2023

    720,909     $ 19.51  
                 

Expired

    (111,192 )     7.26  
                 

Balance - June 30, 2024

    609,717     $ 21.74  
                 

Nine Months Ended June 30, 2023

               

Balance - September 30, 2022

    521,718     $ 28.00  
                 

Issued

    384,496       8.75  

Exercised

    (100,760 )     7.63  

Expired

    (4,018 )     111.30  
                 

Balance - June 30, 2023

    801,436     $ 20.93  

Number of Warrants (#)

   

Exercise Prices

   

Expiry Dates

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

609,717              
Fair Value Measurement Inputs and Valuation Techniques [Table Text Block]
   

Nine Months Ended

June 30, 2023

   

Class A Warrants

    Class B Warrants  
               

Risk free interest rate

    4.54 %   4.76 %

Expected life (years)

 

3.14

    1.14  

Expected share price volatility

    90.73 %   89.70 %

Expected dividend yield

    0.00 %   0.00 %
Share-Based Payment Arrangement, Option, Activity [Table Text Block]
   

Number of Options (#)

   

Weighted Average Exercise Price

   

Weighted Average Grant Date Fair Value

 

Nine Months Ended June 30, 2024

                       

Balance - September 30, 2023

    420,615     $ 25.60     $ 18.84  
                         

Granted

    500       4.10       3.10  

Forfeited

    (2,401 )     15.00       10.70  

Expired

    (35,674 )     33.18       24.63  
                         

Balance - June 30, 2024

    383,040     $ 24.93     $ 18.33  
                         

Nine Months Ended June 30, 2023

                       

Balance - September 30, 2022

    314,853     $ 32.62     $ 23.94  
                         

Granted

    47,571       10.01       7.49  

Forfeited

    (12,779 )     22.96       16.38  

Expired

    (34 )     2,129       2,129  
                         

Balance - June 30, 2023

    349,611     $ 29.61     $ 21.77  
Share-Based Payment Arrangement, Option, Exercise Price Range [Table Text Block]

Number of Options (#)

   

Exercisable at
June 30, 2024 (#)

   

Range of Exercise Prices

   

Expiry Dates

374       374     $ 246.96 - 596.82    

June 2024 - Mar 2025

37,719       37,719     C$ 15.12    

May 2024 - Dec 2028

43,031       43,031     $ 22.12    

May 2024 - Feb 2030

51,006       51,006     $ 52.08 - 56.49    

May 2024 - Oct 2030

81,041       80,971     $ 36.75 - 40.18    

Apr 2024 - Sep 2031

58,753       48,610     $ 25.97    

Apr 2024 - Feb 2032

111,116       54,551     $ 4.10 - 10.01    

Apr 2024 - Oct 2033

383,040       316,262              
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions [Table Text Block]
   

Nine Months Ended

June 30, 2024

   

Nine Months Ended

June 30, 2023

 
                 

Risk free interest rate

    4.92 %     3.62% - 4.18 %

Expected life (years)

    5       5  

Expected share price volatility

    97.26 %     95.3% - 97.34 %

Expected dividend yield

    0.00 %     0.00 %
Schedule of Unvested Restricted Stock Units Roll Forward [Table Text Block]
   

Number of RSU (#)

   

Weighted Average Grant Date Fair Value

 

Nine Months Ended June 30, 2024

               

Balance - September 30, 2023

    33,045     $ 5.60  
                 

Granted

    19,772       4.52  
                 

Balance - June 30, 2024

    52,817     $ 5.20  
Share-Based Payment Arrangement, Restricted Stock Unit, Activity [Table Text Block]
   

Number of RSU (#)

   

Expiry Date

Fully-vested RSUs

    52,817    

August 2033 - June 2034

v3.24.2.u1
Note 3 - Intangible Assets (Details Textual) - USD ($)
$ in Thousands
1 Months Ended 3 Months Ended 9 Months Ended
Apr. 30, 2020
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Amortization of Intangible Assets   $ 30 $ 30 $ 80 $ 80
The Constructs [Member]          
License Agreement, Term 25 years        
License Agreement, Renewal Period 5 years        
Finite-Lived Intangible Asset, Useful Life 25 years        
Upfront License Payment $ 2,500        
v3.24.2.u1
Note 3 - Intangible Assets - Schedule of Intangible Assets (Details) - USD ($)
Jun. 30, 2024
Sep. 30, 2023
Less: accumulated amortization $ (425,342) $ (349,463)
Total intangible assets, net 2,104,141 2,180,020
The Constructs [Member]    
The Constructs $ 2,529,483 $ 2,529,483
v3.24.2.u1
Note 3 - Intangible Assets - Estimated Future Amortization (Details) - USD ($)
Jun. 30, 2024
Sep. 30, 2023
September 30, 2024 $ 25,293  
September 30, 2025 101,172  
September 30, 2026 101,172  
September 30, 2027 101,172  
September 30, 2028 101,172  
Thereafter 1,674,160  
Total intangible assets, net $ 2,104,141 $ 2,180,020
v3.24.2.u1
Note 4 - Right-of-use Lease With Related Party (Details Textual)
Dec. 31, 2022
Related Party [Member]  
Lessee, Operating Lease, Renewal Term 2 years
v3.24.2.u1
Note 4 - Right-of-use Lease With Related Party - Lease Cost (Details) - USD ($)
3 Months Ended 9 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Right-of-use lease cost, included in general and administrative on the Statements of Operations $ 19,299 $ 21,188 $ 59,208 $ 61,530
v3.24.2.u1
Note 4 - Right-of-use Lease With Related Party - Lease Terms and Discount Rates (Details)
Jun. 30, 2024
Sep. 30, 2023
Remaining lease term (months): (Month) 6 months 15 months
Estimated incremental borrowing rate: 9.20% 9.20%
v3.24.2.u1
Note 4 - Right-of-use Lease With Related Party - Future Minimum Lease Payments (Details) - USD ($)
Jun. 30, 2024
Sep. 30, 2023
September 30, 2024 $ 19,781  
September 30, 2025 19,781  
Total lease payments 39,562  
Less imputed interest 745  
Present value of right-of-use lease liabilities 38,817  
Present value included in current liabilities 38,817 $ 74,714
Present value included in long-term liabilities $ 0 $ 19,773
v3.24.2.u1
Note 4 - Right-of-use Lease With Related Party - Cash Flow Information (Details) - USD ($)
9 Months Ended
Jun. 30, 2024
Jun. 30, 2023
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. $ 59,732 $ 59,045
v3.24.2.u1
Note 5 - Commitments (Details Textual) - USD ($)
3 Months Ended 9 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Mar. 31, 2021
Apr. 30, 2020
Dec. 31, 2016
The Constructs [Member]              
Maximum Contingent Obligation           $ 356,000,000  
Payments for Milestone, Royalty and Sublicensing $ 0 $ 0 $ 0 $ 0      
License Agreement Related to Pharmaceutical Products [Member]              
Maximum Contingent Obligation             $ 18,400,000
Finite-Lived License Agreements, Gross           $ 0  
Payments for Milestones 0 40,000.00 0 160,000      
License Agreement to Acquire Global Rights of Pharmaceutical Product [Member]              
Maximum Contingent Obligation         $ 68,900,000    
Milestone Expense $ 25,000 $ 0 $ 75,000 $ 0      
v3.24.2.u1
Note 5 - Commitments - Commitments for Contractual Research (Details)
Jun. 30, 2024
USD ($)
September 30, 2024 $ 301,000
September 30, 2025 49,000
September 30, 2026 36,000
September 30, 2027 42,000
September 30, 2028 0
Contractual Obligation $ 428,000
v3.24.2.u1
Note 6 - Capital Shares (Details Textual) - USD ($)
3 Months Ended 9 Months Ended
Nov. 02, 2022
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Sep. 30, 2023
Mar. 27, 2023
Sep. 30, 2022
Stock Issued During Period, Value, New Issues   $ 138,421   $ 729,387 $ 3,861,245      
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)   $ 21.74 $ 20.93 $ 21.74 $ 20.93 $ 19.51   $ 28
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Expected Term       5 years 5 years      
Class of Warrant or Right, Outstanding, Weighted Average Remaining Contractual Term       32 months        
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross       500 47,571      
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term       83 months        
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercisable, Weighted Average Exercise Price   28.05   $ 28.05        
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercisable, Intrinsic Value Per Share   $ 22   $ 22        
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercisable, Weighted Average Remaining Contractual Term       78 months        
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Nonvested, Number of Shares   66,778   66,778        
Share-Based Compensation Arrangement by Share-Based Payment Award, Option, Nonvested, Weighted Average Exercise Price   $ 10.15   $ 10.15        
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Nonvested, Intrinsic Value Per Share   $ 68   $ 68        
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Nonvested, Weighted Average Remaining Contractual Term       104 months        
Share-Based Payment Arrangement, Employee [Member]                
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross   500 0 500 0      
Share-Based Payment Arrangement, Nonemployee [Member]                
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross   0 0 0 0      
The 2019 Plan [Member]                
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized   642,737   642,737        
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant   156,679   156,679        
Share-Based Payment Arrangement, Option [Member]                
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Expected Term       5 years        
Share-Based Compensation Arrangement by Share-Based Payment Award, Expiration Period       10 years        
Share-Based Payment Arrangement, Expense   $ 100,000 $ 100,000 $ 400,000 $ 700,000      
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount   100,000   $ 100,000        
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition       27 months        
Restricted Stock Units (RSUs) [Member]                
Share-Based Compensation Arrangement by Share-Based Payment Award, Expiration Period       10 years        
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount   $ 0   $ 0        
Canaccord [Member]                
Stock Issued During Period, Shares, New Issues       171,916        
Stock Issued During Period, Value, New Issues       $ 600,000        
Equity Offering, Maximum Amount             $ 20,000,000  
Equity Offering, Limitation Amount             $ 8,400,000  
Class A Warrants [Member]                
Class of Warrant or Right, Number of Securities Called by Warrants or Rights 192,248              
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) $ 10.5              
Warrants and Rights Outstanding, Maturity Date Dec. 23, 2025              
Class B Warrants [Member]                
Class of Warrant or Right, Number of Securities Called by Warrants or Rights 192,248              
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) $ 7              
Warrants and Rights Outstanding, Maturity Date Dec. 23, 2023              
Warrants Issued in Private Placement [Member]                
Warrants and Rights Outstanding $ 1,200,000              
Private Placement [Member]                
Stock Issued During Period, Shares, New Issues 384,475              
Proceeds from Issuance or Sale of Equity $ 2,900,000              
Stock Issued During Period, Value, New Issues $ 2,700,000              
v3.24.2.u1
Note 6 - Capital Shares - Schedule of Warrants (Details) - $ / shares
9 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Class of Warrant or Right, Outstanding (in shares) 609,717 801,436
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) $ 21.74 $ 20.93
Balance, number of warrant shares (in shares) 720,909 521,718
Balance, warrants, weighted average exercise price (in dollars per share) $ 19.51 $ 28
Expired, number of warrant shares (in shares) (111,192) (4,018)
Expired, warrants, weighted average exercise price (in dollars per share) $ 7.26 $ 111.3
Issued, number of warrant shares (in shares)   384,496
Issued, warrants, weighted average exercise price (in dollars per share)   $ 8.75
Exercised, number of warrant shares (in shares)   (100,760)
Exercised, warrants, weighted average exercise price (in dollars per share)   $ 7.63
Balance, number of warrant shares (in shares) 609,717 801,436
Balance, warrants, weighted average exercise price (in dollars per share) $ 21.74 $ 20.93
Warrant One [Member]    
Class of Warrant or Right, Outstanding (in shares) 1,687  
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) $ 22.4  
Warrants and Rights Outstanding, Maturity Date Jan. 31, 2025  
Balance, number of warrant shares (in shares) 1,687  
Balance, warrants, weighted average exercise price (in dollars per share) $ 22.4  
Warrant Two [Member]    
Class of Warrant or Right, Outstanding (in shares) 173,614  
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) $ 10.5  
Warrants and Rights Outstanding, Maturity Date Dec. 31, 2025  
Balance, number of warrant shares (in shares) 173,614  
Balance, warrants, weighted average exercise price (in dollars per share) $ 10.5  
Warrant Three [Member]    
Class of Warrant or Right, Outstanding (in shares) 15,627  
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) $ 56  
Warrants and Rights Outstanding, Maturity Date Feb. 28, 2026  
Balance, number of warrant shares (in shares) 15,627  
Balance, warrants, weighted average exercise price (in dollars per share) $ 56  
Warrant Four [Member]    
Class of Warrant or Right, Outstanding (in shares) 27,399  
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) $ 31.94  
Warrants and Rights Outstanding, Maturity Date Mar. 31, 2027  
Balance, number of warrant shares (in shares) 27,399  
Balance, warrants, weighted average exercise price (in dollars per share) $ 31.94  
Warrant Five [Member]    
Class of Warrant or Right, Outstanding (in shares) 391,390  
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) $ 24.64  
Warrants and Rights Outstanding, Maturity Date Sep. 30, 2027  
Balance, number of warrant shares (in shares) 391,390  
Balance, warrants, weighted average exercise price (in dollars per share) $ 24.64  
v3.24.2.u1
Note 6 - Capital Shares - Warrants Assumptions (Details)
Jun. 30, 2023
Class A Warrants [Member] | Measurement Input, Risk Free Interest Rate [Member]  
Warrant assumption 0.0454
Class A Warrants [Member] | Measurement Input, Expected Term [Member]  
Warrant assumption 3.14
Class A Warrants [Member] | Measurement Input, Price Volatility [Member]  
Warrant assumption 0.9073
Class A Warrants [Member] | Measurement Input, Expected Dividend Rate [Member]  
Warrant assumption 0
Class B Warrants [Member] | Measurement Input, Risk Free Interest Rate [Member]  
Warrant assumption 0.0476
Class B Warrants [Member] | Measurement Input, Expected Term [Member]  
Warrant assumption 1.14
Class B Warrants [Member] | Measurement Input, Price Volatility [Member]  
Warrant assumption 0.897
Class B Warrants [Member] | Measurement Input, Expected Dividend Rate [Member]  
Warrant assumption 0
v3.24.2.u1
Note 6 - Capital Shares - Option Activity (Details) - $ / shares
9 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Sep. 30, 2023
Sep. 30, 2022
Balance, number of options (in shares) 420,615 314,853    
Balance, options, weighted average exercise price (in dollars per share) $ 25.6 $ 32.62    
Balance, options, weighted average grant date fair value (in dollars per share) $ 18.33 $ 21.77 $ 18.84 $ 23.94
Granted, number of options (in shares) 500 47,571    
Granted, options, weighted average exercise price (in dollars per share) $ 4.1 $ 10.01    
Granted, options, weighted average grant date fair value (in dollars per share) $ 3.1 $ 7.49    
Forfeited, number of options (in shares) (2,401) (12,779)    
Forfeited, options, weighted average exercise price (in dollars per share) $ 15 $ 22.96    
Forfeited, options, weighted average grant date fair value (in dollars per share) $ 10.7 $ 16.38    
Expired, number of options (in shares) (35,674) (34)    
Expired, options, weighted average exercise price (in dollars per share) $ 33.18 $ 2,129    
Expired, options, weighted average grant date fair value (in dollars per share) $ 24.63 $ 2,129    
Balance, number of options (in shares) 383,040 349,611    
Balance, options, weighted average exercise price (in dollars per share) $ 24.93 $ 29.61    
v3.24.2.u1
Note 6 - Capital Shares - (Details) - $ / shares
9 Months Ended
Jun. 30, 2024
Sep. 30, 2023
Jun. 30, 2023
Sep. 30, 2022
Number of options (in shares) 383,040 420,615 349,611 314,853
Options exercisable (in shares) 316,262      
Weighted average exercise price (in dollars per share) $ 24.93 $ 25.6 $ 29.61 $ 32.62
Range One [Member]        
Number of options (in shares) 374      
Options exercisable (in shares) 374      
Lower limit (in dollars per share) $ 246.96      
Upper limit (in dollars per share) $ 596.82      
Range Two [Member]        
Number of options (in shares) 37,719      
Options exercisable (in shares) 37,719      
Weighted average exercise price (in dollars per share) $ 15.12      
Range Three [Member]        
Number of options (in shares) 43,031      
Options exercisable (in shares) 43,031      
Weighted average exercise price (in dollars per share) $ 22.12      
Range Four [Member]        
Number of options (in shares) 51,006      
Options exercisable (in shares) 51,006      
Lower limit (in dollars per share) $ 52.08      
Upper limit (in dollars per share) $ 56.49      
Range Five [Member]        
Number of options (in shares) 81,041      
Options exercisable (in shares) 80,971      
Lower limit (in dollars per share) $ 36.75      
Upper limit (in dollars per share) $ 40.18      
Range Six [Member]        
Number of options (in shares) 58,753      
Options exercisable (in shares) 48,610      
Weighted average exercise price (in dollars per share) $ 25.97      
Range Seven [Member]        
Number of options (in shares) 111,116      
Options exercisable (in shares) 54,551      
Lower limit (in dollars per share) $ 4.1      
Upper limit (in dollars per share) $ 10.01      
v3.24.2.u1
Note 6 - Capital Shares - Option Assumptions (Details)
9 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Risk free interest rate 4.92%  
Risk free interest rate, minimum   3.62%
Risk free interest rate, maximum   4.18%
Expected life (years) (Year) 5 years 5 years
Expected share price volatility 97.26%  
Expected share price volatility, minimum   95.30%
Expected share price volatility, maximum   97.34%
Expected dividend yield 0.00% 0.00%
v3.24.2.u1
Note 6 - Capital Shares - Restricted Stock Units (Details) - Restricted Stock Units (RSUs) [Member]
9 Months Ended
Jun. 30, 2024
$ / shares
shares
Balance, number of RSU (in shares) | shares 33,045
Balance, weighted average grant date fair value (in dollars per share) | $ / shares $ 5.6
Granted, number of RSU (in shares) | shares 19,772
Granted, weighted average grant date fair value (in dollars per share) | $ / shares $ 4.52
Balance, number of RSU (in shares) | shares 52,817
Balance, weighted average grant date fair value (in dollars per share) | $ / shares $ 5.2
v3.24.2.u1
Note 6 - Capital Shares - Vested Restricted Stock Units (Details)
Jun. 30, 2024
shares
Restricted Stock Units (RSUs) [Member]  
Fully-vested RSUs (in shares) 52,817
v3.24.2.u1
Note 7 - Government Contributions (Details Textual)
$ in Thousands
3 Months Ended 9 Months Ended
Jun. 30, 2024
CAD ($)
Jun. 30, 2024
USD ($)
Jun. 30, 2023
USD ($)
Jun. 30, 2024
USD ($)
Jun. 30, 2023
USD ($)
Oct. 31, 2023
CAD ($)
Feb. 28, 2021
CAD ($)
Government Assistance, Nonoperating Income, Increase (Decrease)   $ 236,226 $ 0 $ 661,062 $ 0    
The 2021 SIF Agreement [Member]              
Government Assistance, Award Amount             $ 14,100
Government Assistance, Asset $ 0            
The 2023 SIF Agreement [Member]              
Government Assistance, Award Amount           $ 23,000  
Government Assistance, Award Amount, Not Repayable           5,800  
Government Assistance, Award Amount, Repyable           $ 17,200  
Government Assistance, Period of Repayment 15 years            
Government Assistance, Maximum Amount Repayable, Factor of Original 1.4            
Government assistance, Expiration, Period After Last Repayment 3 years            
Government Assistance, Nonoperating Income, Increase (Decrease)   $ 200,000 $ 0 $ 600,000 $ 0    
v3.24.2.u1
Note 8 - Financial Instruments (Details Textual)
$ in Millions, $ in Millions
Jun. 30, 2024
USD ($)
Jun. 30, 2024
CAD ($)
Currency Exchange Rate 1.368 1.368
Sensitivity Analysis, Ten Percent Change to Foreign Currency Exchange, Impact to Net Income (Loss) and Other Comprehensive Income (Loss) $ 0.1  
Ontario Subsidiary [Member]    
Net Assets   $ 1
v3.24.2.u1
Note 10 - Related Party Transactions (Details Textual) - USD ($)
1 Months Ended 3 Months Ended 9 Months Ended
Oct. 31, 2023
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Dec. 31, 2022
Debt Instrument, Variable Interest Rate, Type [Extensible Enumeration] Canadian Imperial Bank of Commerce US Base-interest Rate [Member]          
Revolving Credit Facility [Member] | Pardeep Nijhawan Medicine Professional Corporation [Member]            
Line of Credit Facility, Maximum Borrowing Capacity $ 10,000,000          
Debt Instrument, Covenant, Maximum Percentage of Borrowing Base for Outstanding Principal 85.00%          
Long-Term Line of Credit   $ 0   $ 0    
Line of Credit Facility, Commitment Fee Amount   13,000 $ 0 38,000 $ 0  
Revolving Credit Facility [Member] | Pardeep Nijhawan Medicine Professional Corporation [Member] | Canadian Imperial Bank of Commerce US Base-interest Rate [Member]            
Debt Instrument, Basis Spread on Variable Rate 3.00%          
Unsecured Line of Credit [Member] | Pardeep Nijhawan Medicine Professional Corporation [Member]            
Line of Credit Facility, Maximum Borrowing Capacity $ 3,500,000          
Chief Executive Officer [Member]            
Operating Lease, Expense   20,000 20,000 60,000 60,000  
Lessee, Operating Lease, Renewal Term           2 years
Accrued Rent   $ 7,000 $ 0 $ 7,000 $ 0  

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