Cover
Cover - USD ($) | 12 Months Ended | ||
Sep. 30, 2023 | Dec. 13, 2023 | Nov. 24, 2023 | |
Cover [Abstract] | |||
Entity Registrant Name | EDESA BIOTECH, INC. | ||
Entity Central Index Key | 0001540159 | ||
Document Type | 10-K | ||
Amendment Flag | false | ||
Entity Voluntary Filers | No | ||
Current Fiscal Year End Date | --09-30 | ||
Entity Well Known Seasoned Issuer | No | ||
Entity Small Business | true | ||
Entity Shell Company | false | ||
Entity Emerging Growth Company | false | ||
Entity Current Reporting Status | Yes | ||
Document Period End Date | Sep. 30, 2023 | ||
Entity Filer Category | Non-accelerated Filer | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2023 | ||
Entity Common Stock Shares Outstanding | 3,164,722 | ||
Entity Public Float | $ 0 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Fin Stmt Error Correction Flag | false | ||
Entity File Number | 001-37619 | ||
Entity Incorporation State Country Code | Z4 | ||
Entity Address Address Line 1 | 100 Spy Court | ||
Entity Address City Or Town | Markham | ||
Entity Address State Or Province | ON | ||
Entity Address Country | CA | ||
Entity Address Postal Zip Code | L3R 5H6 | ||
City Area Code | 289 | ||
Icfr Auditor Attestation Flag | false | ||
Auditor Name | MNP LLP | ||
Auditor Location | Toronto, Canada | ||
Auditor Firm Id | 1930 | ||
Local Phone Number | 800-9600 | ||
Security 12b Title | Common Shares, without par value | ||
Trading Symbol | EDSA | ||
Security Exchange Name | NASDAQ | ||
Entity Interactive Data Current | Yes |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Sep. 30, 2023 | Sep. 30, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 5,361,397 | $ 7,090,919 |
Accounts and other receivable | 626,543 | 1,255,451 |
Prepaid expenses and other current assets | 448,912 | 745,543 |
Total current assets | 6,436,852 | 9,091,913 |
Non-current assets: | ||
Property and equipment, net | 8,702 | 12,694 |
Long-term deposits | 173,490 | 171,464 |
Intangible asset, net | 2,180,020 | 2,281,192 |
Right-of-use assets | 91,373 | 18,465 |
Total assets | 8,890,437 | 11,575,728 |
Current liabilities: | ||
Accounts payable and accrued liabilities | 1,747,150 | 2,121,802 |
Short-term right-of-use lease liabilities | 74,714 | 18,975 |
Total current liabilities | 1,821,864 | 2,140,777 |
Non-current liabilities: | ||
Long-term payables | 0 | 43,662 |
Long-term right-of-use lease liabilities | 19,773 | 0 |
Total liabilities | 1,841,637 | 2,184,439 |
Shareholders' equity: | ||
Capital shares Authorized unlimited common and preferred shares without par value Issued and outstanding: 3,075,473 common shares (September 30, 2022 - 2,380,280) | 46,643,151 | 42,473,099 |
Additional paid-in capital | 13,039,265 | 11,176,345 |
Accumulated other comprehensive loss | (214,648) | (213,602) |
Accumulated deficit | (52,418,968) | (44,044,553) |
Total shareholders' equity | 7,048,800 | 9,391,289 |
Total liabilities and shareholders' equity | $ 8,890,437 | $ 11,575,728 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2023 | Sep. 30, 2022 |
Consolidated Balance Sheets | ||
Capital Shares, Par Value | $ 0 | $ 0 |
Capital Shares, Issued | 3,075,473 | 2,380,280 |
Capital Shares, Outstanding | 2,380,280 | 2,380,280 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Expenses: | ||
Research and development | $ 4,794,549 | $ 13,335,334 |
General and administrative | 4,428,209 | 5,035,456 |
Loss from operations | (9,222,758) | (18,370,790) |
Other income (loss): | ||
Reimbursement grant income | 581,039 | 780,257 |
Interest income | 289,846 | 63,523 |
Foreign exchange loss | (21,742) | (21,114) |
Total other income loss | 849,143 | 822,666 |
Loss before income taxes | (8,373,615) | (17,548,124) |
Income tax expense | 800 | 800 |
Net loss | (8,374,415) | (17,548,924) |
Exchange differences on translation | (1,046) | (8,340) |
Net comprehensive loss | $ (8,375,461) | $ (17,557,264) |
Weighted average number of common shares | 2,858,929 | 2,096,446 |
Loss per common share - basic and diluted | $ (2.93) | $ (8.37) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (8,374,415) | $ (17,548,924) |
Adjustments for: | ||
Depreciation and amortization | 183,471 | 118,188 |
Share-based compensation | 1,246,457 | 2,260,634 |
Changes in working capital items: | ||
Accounts and other receivable | 562,770 | 2,027,454 |
Prepaid expenses and other current assets | 301,504 | (19,497) |
Accounts payable and accrued liabilities | (556,270) | 882,843 |
Net cash used in operating activities | (6,636,483) | (12,279,302) |
Cash flows from investing activities: | ||
Purchase of property and equipment | 0 | (5,656) |
Net cash used in investing activities | 0 | (5,656) |
Cash flows from financing activities: | ||
Proceeds from issuance of common shares and warrants | 4,345,017 | 11,957,687 |
Proceeds from exercise of warrants | 770,532 | 0 |
Payments for issuance costs of common shares and warrants | (285,438) | (328,059) |
Net cash provided by financing activities | 4,830,111 | 11,629,628 |
Effect of exchange rate changes on cash and cash equivalents | 76,850 | (93,010) |
Net change in cash and cash equivalents | (1,729,522) | (748,340) |
Cash and cash equivalents, beginning of year | 7,090,919 | 7,839,259 |
Cash and cash equivalents, end of year | 5,361,397 | 7,090,919 |
Supplemental Disclosure of Noncash Financing Activities: | ||
Issuance costs withheld from gross proceeds from issuance of common shares and warrants | 0 | 393,461 |
Fair value of placement agent warrants | $ 0 | $ 408,059 |
Condensed Interim Consolidated
Condensed Interim Consolidated Statements of Changes in Shareholders' Equity - USD ($) | Total | Additional Paid-In Capital | Accumulated other comprehensive loss | Retained Earnings (Accumulated Deficit) | Common Shares |
Balance, shares at Sep. 30, 2021 | 1,899,333 | ||||
Balance, amount at Sep. 30, 2021 | $ 13,058,291 | $ 4,871,461 | $ (205,262) | $ (26,495,629) | $ 34,887,721 |
Issuance of common shares and warrants in equity offering, shares | 309,558 | ||||
Issuance of common shares and warrants in equity offering, amount | $ 12,941,474 | $ 6,702,293 | 0 | 0 | $ 6,239,181 |
Issuance costs including fair value of placement agent warrants, shares | 0 | 0 | 0 | ||
Issuance costs including fair value of placement agent warrants, amount | $ (1,311,966) | $ (448,739) | 0 | 0 | $ (863,227) |
Issuance of common shares upon exercise of pre-funded warrants, net of costs, shares | 171,389 | ||||
Issuance of common shares upon exercise of pre-funded warrants, net of costs, amount | 120 | (2,209,304) | 0 | 0 | $ 2,209,424 |
Share-based compensation | 2,260,634 | 2,260,634 | 0 | 0 | 0 |
Net loss and comprehensive loss | (17,557,264) | 0 | (8,340) | (17,548,924) | 0 |
Net loss and comprehensive loss | (17,557,264) | ||||
Balance, amount at Sep. 30, 2022 | 9,391,289 | 11,176,345 | (213,602) | (44,044,553) | $ 42,473,099 |
Balance shares at Sep. 30, 2022 | 2,380,280 | ||||
Issuance of common shares and warrants in equity offering, shares | 580,876 | ||||
Issuance of common shares and warrants in equity offering, amount | 4,345,019 | 944,828 | 0 | 0 | $ 3,400,191 |
Share-based compensation | 1,246,457 | 1,246,457 | 0 | 0 | $ 0 |
Issuance of common shares upon exercise of warrants, shares | 100,760 | ||||
Issuance of common shares upon exercise of warrants, amount | 770,531 | (224,087) | 0 | 0 | $ 994,618 |
Issuance of common shares upon exercise of restricted stock share, shares | 13,557 | ||||
Issuance of common shares upon exercise of restricted stock share, amount | 0 | (75,920) | 0 | 0 | $ 75,920 |
Issuance costs, amount | (329,035) | (28,358) | 0 | 0 | 300,677 |
Net loss and comprehensive loss | (8,375,461) | 0 | (1,046) | (8,374,415) | 0 |
Balance, amount at Sep. 30, 2023 | $ 7,048,800 | $ 13,039,265 | $ (214,648) | $ (52,418,968) | $ 46,643,151 |
Balance shares at Sep. 30, 2023 | 3,075,473 |
Nature of operations
Nature of operations | 12 Months Ended |
Sep. 30, 2023 | |
Nature of operations | |
Nature Of Operations | 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”. Liquidity The Company’s 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. At September 30, 2023, the Company had an accumulated deficit of $52.4 million and working capital of $4.6 million, including $5.4 million in cash and cash equivalents. In August 2022 the Company filed a $150.0 million shelf registration statement, under which the Company entered into an equity distribution agreement with Canaccord for $20.0 million in gross proceeds, subject to certain offering limitations that currently allows the Company to offer and sell common shares having an aggregate gross sales price of up to $8.4 million (Canaccord ATM). There was approximately $7.1 million of available capacity on the Canaccord ATM as of September 30, 2023. The Company’s primary use of cash and cash equivalents is to fund our operating expenses, which consist of research and development (R&D) and general and administrative (G&A) expenditures. Cash used to fund operating expenses is impacted by the timing of when the Company pays these expenses, as reflected in the change in accounts payable and accrued expenses. Net cash used in operating activities was $6.6 million and $12.3 million for the years ended September 30, 2023 and 2022, respectively. The Company incurred net losses of $8.4 million and $17.6 million for the years ended September 30, 2023 and 2022. Subsequent to the year end, in October 2023, the Company entered into a multi-year contribution agreement (2023 SIF Agreement) with the Canadian Government’s Strategic Innovation Fund (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 the Company. The remaining C$17.2 million is conditionally repayable starting in 2029 only if and when the Company earns gross revenue. See Note 9. In February 2021, the Company signed a contribution agreement with the Canadian government’s SIF (2021 SIF Agreement), the Company was 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 years ended September 30, 2023 and 2022, the Company recorded grant income of $0.6 million and $0.8 million respectively related to both the 2023 SIF Agreement and the 2021 SIF Agreement. Subsequent to the year end, in October 2023, the Company entered into $10.0 million revolving credit agreement with Pardeep Nijhawan Medicine Professional Corporation (Credit Agreement), providing an unsecured revolving credit facility, with a credit limit of $3.5 million (Credit Limit) which is 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. No amounts have been drawn upon from the Credit Agreement. In March 2023, the Company entered into an equity distribution agreement with Canaccord, as sales agent, pursuant to which the Company may offer and sell, from time to time, common shares through an at-the-market equity offering program for up to $20 million in gross proceeds, subject to certain offering limitations that currently allows the Company to offer and sell common shares having an aggregate gross sales price of up to $8.4 million. At September 30, 2023, the Company sold a total of 196,401 common shares pursuant to the agreement for gross proceeds of approximately $1.3 million. In November 2022, the Company 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 are approximately $3.0 million, before offering expenses. In March 2022, the Company completed a registered direct offering of 220,000 common shares, no par value, and pre-funded warrants to purchase up to an aggregate of 171,390 common shares. In a concurrent private placement, the Company issued common share purchase warrants to purchase an aggregate of up to 391,390 common shares. Net proceeds to the Company were approximately $9.0 million. During the year ended September 30, 2022, the Company sold a total of 89,558 common shares for net proceeds of $2.6 million, under an at-the-market equity offering program. The Company plans to finance operations for at least the next twelve months with cash and cash equivalents on hand, utilization of the Canaccord ATM, drawing upon the Credit Agreement and reimbursements of eligible R&D expenses under the Company’s 2023 SIF Agreement. |
Basis of presentation
Basis of presentation | 12 Months Ended |
Sep. 30, 2023 | |
Basis of presentation | |
Basis Of Presentation | 1. Basis of preparation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP) and include the accounts of the Company and its wholly owned subsidiaries, Edesa Biotech Research, Inc. and Edesa Biotech USA, Inc. All intercompany balances and transactions have been eliminated upon consolidation. |
Significant accounting policies
Significant accounting policies | 12 Months Ended |
Sep. 30, 2023 | |
Significant accounting policies | |
Significant accounting policies | 2. Significant accounting policies 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. Cash and cash equivalents Cash and cash equivalents consist of demand deposits with financial institutions held in checking, savings and money market mutual funds and highly liquid investments which are readily convertible into cash with maturities of three months or less when purchased. The carrying amount of cash and cash equivalents approximates its fair value due to its short-term nature. Accounts and other receivable The Company assesses the collectability of its accounts receivable through a review of its current aging and payment terms, as well as an analysis of its historical collection rate, general economic conditions and credit status of the government agencies. Accounts and other receivable include reimbursement grant income for the Company’s federal grant with the Canadian government’s SIF and Harmonized Sales Tax (HST) refunds receivable. As of September 30, 2023, all outstanding accounts, grants and HST refunds receivable were deemed to be fully collectible, and therefore, no allowance for doubtful accounts was recorded. Property and equipment Property and equipment are recorded at historical cost less accumulated depreciation and any accumulated impairment losses. Depreciation is recorded to write off the cost of assets less their residual values over their useful lives, using the declining balance and straight-line methods. Maintenance and repair expenditures that do not improve or extend the life are expensed in the period incurred. Any gain or loss arising on the disposal or retirement of an item of property and equipment is recognized as the difference between the sales proceeds and the carrying amount of the asset. The estimated useful lives, residual values and depreciation methods are reviewed at the end of each year, with the effect of any changes in estimate accounted for on a prospective basis. The depreciation policy for the principal asset categories are calculated as follows: · Computer equipment 30% declining balance method or straight line 3 years · Furniture and equipment 20% declining balance method Intangible assets Intangible assets represent the exclusive world-wide rights to know-how, patents and data relating to certain monoclonal antibodies (the Constructs), including sublicensing rights, acquired by entering into a license agreement with a pharmaceutical development company. Unless earlier terminated, the term of the license agreement will remain in effect for 25 years from the date of first commercial sale of licensed products containing the Constructs. Subsequently, the license agreement will automatically renew for five-year periods unless either party terminates the agreement in accordance with its terms. Intangible assets are stated at their historical cost, amortized on a straight-line basis over their expected useful lives, which is 25 years, and subject to impairment review at the end of each reporting period. Impairment of long-lived assets Long-lived assets are tested for impairment when indicators of impairment exist. When a significant change in the expected timing or amount of the future cash flows of the financial asset is identified, the carrying amount of the financial asset is reduced and the amount of the write-down is recognized as a loss. A previously recognized impairment loss may be reversed to the extent of the improvement, provided it is not greater than the amount that would have been reported at the date of the reversal had the impairment not been recognized previously, and the amount of the reversal is recognized in net income (loss). Right-of-Use assets and liabilities The Company recognizes right-of-use (ROU) assets and liabilities on the balance sheet for operating leases with terms longer than 12 months. The Company follows the ongoing practical expedient not to recognize ROU assets and liabilities for short-term leases. The ROU assets are initially measured at cost and amortized using the straight-line method through the end of the lease term. The ROU liabilities are initially measured at the present value of the lease payments that are not paid at the commencement date, discounted using the Company's incremental borrowing rate. Fair value measurement The Company uses the fair value measurement framework for valuing financial assets and liabilities. See Note 11. Revenue recognition Reimbursement grant income is recognized based on the reimbursement rate included in the government contribution agreement when allowable expenses have been incurred. Research and development Research and development expenses principally consist of (i) contract research organizations for clinical trial management services, (ii) contract manufacturing organizations for manufacturing the drug compound(s) for use in clinical trials and (iii) salaries of employees directly involved in research and development efforts. Research and development costs are expensed as incurred. Share-based compensation The Company has equity incentive plans under which various types of equity-based awards including share options, restricted shares and restricted share unit awards may be granted to employees, non-employee directors and non-employee consultants and warrants that may be granted as compensation to non-employees. The Company measures the cost of equity-settled transactions by reference to the fair value of the equity instruments at the date at which they are granted since the fair value of the goods or services received by the Company cannot be reliably estimated. The Company recognizes compensation expense for all share-based awards based on the estimated grant-date fair values. For restricted share unit awards to employees, the fair value is based on the 5-day volume weighted average price (VWAP) of the Company’s common shares up to the date of grant. The value of the portion of the award that is ultimately expected to vest is recognized as expense on a straight-line basis over the requisite service period. The fair value of share options is determined using the Black-Scholes option pricing model. The Company utilizes a dividend yield of zero based on the fact that the Company has never paid cash dividends and has no current intention of paying cash dividends. The Company elected an accounting policy to record forfeitures as they occur. See Note 8 for a discussion of the assumptions used by the Company in determining the grant date fair value of options granted under the Black-Scholes option pricing model, as well as a summary of the share option activity under the Company’s share-based compensation plan for all years presented. The provisions of the Company’s share-based compensation plans do not require the Company to settle any options or restricted share units by transferring cash or other assets, and therefore the Company classifies the awards as equity. Translation of foreign currency transactions The Company’s reporting currency is the U.S. dollar. The financial statements of the wholly owned Canadian subsidiary is measured using the Canadian dollar as the functional currency. Assets and liabilities of the Canadian operation have been translated at year-end exchange rates and related revenue and expenses have been translated at average exchange rates for the year. Accumulated gains and losses resulting from the translation of the financial statements of the Canadian operation are included as part of accumulated other comprehensive loss, a separate component of shareholders’ equity. For other transactions denominated in currencies other than the Company’s functional currency, the monetary assets and liabilities are translated at the year-end rates. Revenue and expenses are translated at rates of exchange prevailing on the transaction dates. Non-monetary balance sheet and related income statement accounts are remeasured into U.S. dollar using historical exchange rates. All of the exchange gains or losses resulting from these other transactions are recognized in the statements of operations and comprehensive loss. Income taxes Deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the tax bases of assets and liabilities and their financial statement reported amounts using enacted tax rates and laws in effect in the year in which the differences are expected to reverse. A valuation allowance is provided against deferred tax assets when it is determined to be more likely than not that the deferred tax asset will not be realized. The Company assesses the likelihood of the financial statement effect of a tax position that should be recognized when it is more likely than not that the position will be sustained upon examination by a taxing authority based on the technical merits of the tax position, circumstances, and information available as of the reporting date. The Company is subject to examination by taxing authorities in Canada and the U.S. Management does not believe that there are any uncertain tax positions that would result in an asset or liability for taxes being recognized in the accompanying financial statements. The Company recognizes tax-related interest and penalties, if any, as a component of income tax expense. The Company accounts for income taxes on a tax jurisdictional basis. The Company files income tax returns in Canada, the provinces of British Columbia and Ontario, the U.S. and the state of California. Earnings (loss) per share Basic earnings (loss) per share is calculated by dividing net income (loss) available to common shareholders by the weighted average number of common shares outstanding during the year. The computation of diluted earnings (loss) per share assumes the conversion, exercise or contingent issuance of securities only when such conversion, exercise or issuance would have a dilutive effect on earnings (loss) per share. The dilutive effect of convertible securities would be reflected in diluted earnings per share by application of the “if converted” method. The dilutive effect of outstanding share options and warrants and their equivalents would be reflected in diluted earnings per share by application of the treasury stock method. However, conversion of outstanding share options and warrants would have an antidilutive effect on loss per share for the years ended September 30, 2023 and 2022 and are therefore excluded from the computation of diluted loss per share. See Note 8 for share options and warrants at September 30, 2023 and 2022. Segmented Information The Company’s operations comprise a single reportable segment engaged in the research and development, manufacturing and commercialization of innovative pharmaceutical products. As the operations comprise a single reportable segment, amounts disclosed in the consolidated financial statements for net loss, comprehensive loss, depreciation and total assets also represent segmented amounts. Adoption of Recent Accounting Pronouncements On October 1, 2022, the Company adopted Accounting Standards Update ASU 2021-10 Disclosure by Business Entities About Government Assistance, modifying ASC Topic 832, Government Assistance. The amendments in ASU 2021-10 require disclosure of information about certain types of government assistance received. The Company expanded its disclosures related to government assistance. Future accounting pronouncements In November 2023, the FASB issued Accounting Standards Update ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires disclosure of incremental segment information on an interim and annual basis. This ASU is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal periods beginning after December 15, 2024, and requires retrospective application to all prior periods presented in the financial statements. The Company is currently evaluating the impact of the guidance on the consolidated financial statements and disclosures. |
Property and equipment
Property and equipment | 12 Months Ended |
Sep. 30, 2023 | |
Property and equipment | |
Property and equipment | 4. Property and equipment Property and equipment, net consisted of the following: September 30, 2023 September 30, 2022 Computer equipment $ 46,945 $ 46,674 Furniture and equipment 5,603 5,538 52,548 52,212 Less: accumulated depreciation (43,846 ) (39,518 ) Total property and equipment, net $ 8,702 $ 12,694 Depreciation expense amounted to $4,328 and $6,991 for the years ended September 30, 2023 and 2022, respectively. |
Intangible assets
Intangible assets | 12 Months Ended |
Sep. 30, 2023 | |
Intangible assets | |
Intangible assets | 5. Intangible assets Acquired License In April 2020, the Company entered into a license agreement with a pharmaceutical development company to obtain exclusive world-wide rights to know-how, patents and data relating to certain monoclonal antibodies (the Constructs), including sublicensing rights. Unless earlier terminated, the term of the 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 7 for license commitments. Intangible assets, net consisted of the following: September 30, 2023 September 30, 2022 The Constructs $ 2,529,483 $ 2,529,483 Less: accumulated amortization (349,463 ) (248,291 ) Total intangible assets, net $ 2,180,020 $ 2,281,192 Amortization expense amounted to $101,172 for each of the years ended September 30, 2023, and 2022, respectively. Total estimated future amortization of intangible assets for each fiscal year is as follows: Year Ending September 30, 2024 101,172 September 30, 2025 101,172 September 30, 2026 101,172 September 30, 2027 101,172 September 30, 2028 101,172 Thereafter 1,674,160 $ 2,180,020 |
Right-of-Use Asset and Liabilit
Right-of-Use Asset and Liabilities | 12 Months Ended |
Sep. 30, 2023 | |
Right-of-Use Asset and Liabilities | |
Right-of-Use Lease with Related Party | 6. Right-of-Use Asset and Liabilities Related party ROU asset and liability 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 term extension through December 31, 2024. The components of lease cost were as follows: September 30, 2023 September 30, 2022 Right-of-use lease cost, included in general and administrative on the Statements of Operations $ 82,358 $ 18,465 Lease terms and discount rates were as follows: September 30, 2023 September 30, 2022 Remaining lease term (months): 15 3 Estimated incremental borrowing rate: 9.2 % 6.5 % The approximate future minimum lease payments under operating leases at September 30, 2023 were as follows: Year Ending September 30, 2024 $ 79,697 September 30, 2025 19,924 Total lease payments 99,621 Less imputed interest 5,134 Present value of right-of-use lease liabilities 94,487 Present value included in current liabilities 74,714 Present value included in long-term liabilities $ 19,773 Cash flow information was as follows: Years Ended September 30, 2023 September 30, 2022 Cash paid for amounts included in the measurement of right-of-use lease liabilities, included in accounts payable and accrued liabilities on the Statements of Cash Flow. $ 79,222 $ 80,377 |
Commitments
Commitments | 12 Months Ended |
Sep. 30, 2023 | |
Commitments | |
Commitments | 7. Commitments Research and other commitments The Company has commitments for contracted research organizations who perform clinical trials for the Company’s ongoing clinical studies and other service providers. Aggregate future contractual payments at September 30, 2023 are as follows: Year Ending September 30, 2024 1,798,000 September 30, 2025 49,000 September 30, 2026 36,000 September 30, 2027 41,000 September 30, 2028 - $ 1,924,000 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 certain know-how, patents and data relating to certain monoclonal antibodies (the Constructs), including sublicensing rights. An intangible asset for the acquired license has been recognized. See Note 5 for intangible assets. Under the license agreement, the Company is committed to payments of up to an aggregate amount of $356 million contingent upon meeting certain milestones outlined in the license agreement, primarily relating to future potential commercial approval and sales milestones. The Company 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 years ended September 30, 2023 and 2022. In connection with this license agreement and pursuant to a purchase agreement entered into in April 2020, the Company acquired drug substance of one of the Constructs for an aggregate purchase price of $5.0 million. The Company recorded an expense of $2.5 million for the second installment payment during the year ended September 30, 2022. No expense was recorded during the year ended September 30, 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. 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. No license or royalty payments were made to the third party during the years ended September 30, 2023 and 2022, respectively. 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. For the years ended September 30, 2023 and 2022, the Company recorded expenses of $50,000 and $25,693, respectively, as a result of meeting milestones outlined in the 2021 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. Retirement savings plan 401(k) contributions Executive officers and employees of our California subsidiary are eligible to receive the Company’s non-elective safe harbor employer contribution of 3% of eligible compensation under a 401(k) plan to provide retirement benefits. Employees are 100% vested in employer contributions and in any voluntary employee contributions. Contributions to the 401(k) plan were $16,872 and $19,740 during the years ended September 30, 2023 and 2022, respectively. |
Capital shares
Capital shares | 12 Months Ended |
Sep. 30, 2023 | |
Capital shares | |
Capital Shares | 8. 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 will expire on December 23, 2023. The warrants are considered contracts on the Company’s own shares and are classified as equity. On March 24, 2022, the Company completed a registered direct offering of 220,000 common shares, no par value, and pre-funded warrants to purchase up to an aggregate of 171,390 common shares. In a concurrent private placement, the Company issued common share purchase warrants to purchase an aggregate of up to 391,390 common shares. Net proceeds from the offering were $9.0 million. The common share purchase warrants were immediately exercisable at an exercise price of $24.64 per share and will expire on September 24, 2027. The pre-funded warrants were immediately exercisable at an exercise price of $0.0007 per share and do not expire. The warrants are considered contracts on the Company’s own shares and are classified as equity. The Company allocated gross proceeds with $5.9 million as the value of common shares and pre-funded warrants and $4.1 million as the value of common share purchase warrants under additional paid-in capital on a relative fair value basis. In connection with the offering, the Company issued warrants to purchase an aggregate of 27,397 common shares to certain affiliated designees of the placement agent as part of the placement agent’s compensation. The placement agent warrants are exercisable on or after March 24, 2022, at an exercise price of $31.9375 per share and will expire on March 21, 2027 with a fair value of $0.4 million. Equity distribution agreements On March 27, 2023, the Company entered into the Canaccord ATM, 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 year ended September 30, 2023, the Company sold a total of 196,401 common shares pursuant to the agreement for gross proceeds of approximately $1.3 million. From November 22, 2021 until terminated on March 21, 2022, the Company had an equity distribution agreement for an at-the-market equity offering program with another sales agent. During the year ended September 30, 2022, the Company sold a total of 89,558 common shares pursuant to the agreement for net proceeds of $2.6 million. 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 warrants activity is as follows: Number of Warrant Shares (#) Weighted Average Exercise Price Balance - September 30, 2021 102,929 $ 39.83 Issued 418,789 25.13 September 30, 2022 521,718 $ 28.00 Issued 384,496 8.75 Exercised (100,760 ) 7.65 Expired (84,545 ) 37.29 September 30, 2023 720,909 $ 19.51 The weighted average contractual life remaining on the outstanding warrants at September 30, 2023 is 35 months. The following table summarizes information about the warrants outstanding at September 30, 2023: Number of Warrants (#) Exercise Prices Expiry Dates 110,122 $ 7.00 December 2023 1,070 $ 33.67 June 2024 1,687 $ 22.40 January 2025 173,614 $ 10.50 December 2025 15,627 $ 56.00 February 2026 27,399 $ 31.94 March 2027 391,390 $ 24.64 September 2027 720,909 The fair value of warrants issued during the years ended September 30, 2023 and 2022 was estimated using the Black-Scholes option valuation model using the following assumptions: Year Ended September 30, 2023 Year Ended September 30, 2022 Class A Warrants Class B Warrants Common Warrants Placement Agent Warrants Risk free interest rate 4.54 % 4.76 % 2.37 % 2.37 % Expected life 3.14 years 1.14 years 5.5 years 5 years Expected share price volatility 90.73 % 89.70 % 87.09 % 87.09 % Expected dividend yield 0.00 % 0.00 % 0.00 % 0.00 % Pre-funded Warrants A summary of the Company’s pre-funded warrant activity is as follows: Number of Pre-funded Warrant Shares (#) Balance - September 30, 2021 - Issued 171,389 Exercised (171,389 ) Balance - September 30, 2022 - 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 575,737. The remaining number of shares available to grant at September 30, 2023 is 81,765. 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 Balance - September 30, 2021 253,777 $ 35.42 $ 26.53 Granted 71,451 25.62 17.36 Forfeited (3,851 ) 45.92 34.79 Expired (6,524 ) 56.35 45.36 Balance - September 30, 2022 314,853 $ 32.62 $ 23.94 Granted 118,579 7.47 5.23 Forfeited (12,779 ) 22.76 16.23 Expired (38 ) 1,973.20 1,973.20 Balance - September 30, 2023 420,615 $ 25.60 $ 18.84 There were no options exercised during the years ended September 30, 2023 or September 30, 2022 and there was no intrinsic value of options outstanding at September 30, 2023. The weighted average contractual life remaining on the outstanding options at September 30, 2022 is 85 months. The following table summarizes information about the options under the 2019 Plan outstanding and exercisable at September 30, 2023: Number of Options (#) Exercisable at September 30, 2023 (#) Range of Exercise Prices Expiry Dates 497 497 $ 246.96 - 596.82 Dec 2023 - Mar 2025 42,348 42,348 C$ 15.12 May 2024 - Dec 2028 46,285 46,285 $ 22.12 May 2024 - Feb 2030 56,722 56,702 $ 52.08 - 56.49 May 2024 - Oct 2030 93,344 81,048 $ 36.75 - 40.18 Apr 2024 - Sep 2031 68,777 44,441 $ 20.58 - 25.97 Apr 2024 - Feb 2032 112,642 18,334 $ 5.79 - 10.01 Apr 2024 - Jul 2033 420,615 289,655 The options exercisable at September 30, 2023 had a weighted average exercise price of $31.03, no intrinsic value and a weighted average remaining life of 74 months. There were 130,960 options at September 30, 2023 that had not vested with a weighted average exercise price of $13.61 no intrinsic value and a weighted average remaining life of 111 months. The fair value of options granted during the years ended September 30, 2023 and 2022 was estimated using the Black-Scholes option valuation model using the following assumptions: Years Ended September 30, 2023 September 30, 2022 Risk free interest rate 3.62% - 4.18% 1.71% - 2.54% Expected life 5 years 5 years Expected share price volatility 95.3% - 97.34% 85.91% - 86.59% Expected dividend yield 0.00 % 0.00 % The Company recorded $1.2 million and $2.3 million of share-based compensation expenses for the years ended September 30, 2023 and 2022, respectively. As of September 30, 2023, the Company had approximately $0.5 million of unrecognized share-based compensation expense, which is expected to be recognized over a period of 31 months. Restricted Share Units 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 following is a summary of changes in the status of RSUs from October 1, 2021 through September 30, 2023: Number of RSU (#) Weighted Average Grant Date Fair Value Balance - September 30, 2021 and 2022 - $ - Granted 46,602 5.60 Converted to common shares (13,557 ) 5.60 Balance - September 30, 2023 33,045 $ 5.60 The following table summarizes information about the RSUs under the 2019 Plan outstanding and exercisable at September 30, 2023: Number of RSU(#) Expiry Date Fully-vested RSUs 33,045 August 4, 2033 The RSUs that were granted in the current year were in lieu of cash bonuses for certain employees and in lieu of payments on consulting invoices for services prior to the appointment of the new Chief Financial Officer. All RSUs that were granted in the current year 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. |
Government Contributions
Government Contributions | 12 Months Ended |
Sep. 30, 2023 | |
Government Contributions | |
Government Contributions | 9. 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 the 2021 SIF Agreement with the Canadian Government. 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. Under the February 2021 SIF Agreement the Company recorded grant income of $0.8 million for the year ended September 30, 2022. No grant income was recorded under the 2021 SIF Agreement during the year ended September 30, 2023. No further funding will be received from the 2021 SIF Agreement. In October 2023, the Company entered into the 2023 SIF Agreement with the Canadian Government. 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 October 2023 SIF Agreement the Company recorded grant income of $0.6 million for the year ended September 30, 2023. No grant income was recorded under the 2023 SIF Agreement during the year ended September 30, 2022. |
Income Tax
Income Tax | 12 Months Ended |
Sep. 30, 2023 | |
Income Tax | |
Income Tax | 10. Income Tax The reconciliation of the combined Canadian federal and provincial statutory income tax rate to the approximate effective tax rate is as follows: Years Ended September 30, 2023 September 30, 2022 Net loss before recovery of income taxes $ (8,374,000 ) $ (17,548,000 ) Canadian federal and provincial statutory income tax rate 26.5 % 26.5 % Expected income tax recovery $ (2,219,000 ) $ (4,650,000 ) Effect of foreign currency and foreign tax rate differences (207,200 ) 976,800 Permanent differences 339,000 650,000 Share issuance cost booked through equity or capitalization (89,000 ) (449,000 ) Non-capital losses limitation - U.S. 899,000 - Other (94,000 ) - Change in valuation allowance 1,372,000 3,473,000 Income tax (recovery) expense $ 800 $ 800 Components of the net deferred tax asset or liability Deferred taxes are provided as a result of temporary differences that arise due to the difference between the income tax values and the carrying amount of assets and liabilities. Approximate deferred tax assets and liabilities are as follows: September 30, 2023 September 30, 2022 Non-capital losses carried forward - Canada $ 13,943,000 $ 11,740,000 Non-capital losses carried forward - U.S. 731,000 1,631,000 Research and development tax credits 1,371,000 1,052,000 Share issuance and financing costs 585,000 686,000 Right-of-use lease liabilities 25,000 5,000 Other temporary differences 43,000 15,000 Subtotal $ 16,699,000 $ 15,129,000 Less: valuation allowance (16,466,000 ) (15,093,000 ) Total net deferred tax assets $ 233,000 $ 36,000 Property and equipment $ (3,000 ) $ (15,000 ) Right-of-use assets (24,000 ) (5,000 ) Grant Income receivable (153,000 ) - Deferred share issuance costs (53,000 ) (16,000 ) Total deferred tax liabilities $ (233,000 ) $ (36,000 ) Net deferred taxes $ - $ - Realization of the deferred tax assets is dependent upon the generation of future taxable income, the amount and timing of which are uncertain. It is more likely than not that a tax benefit will not be realized. Accordingly, net deferred tax assets have been fully offset by a valuation allowance. Non-capital losses, capital losses, and research and development credits generated by Edesa Biotech USA, Inc. prior to changes in share ownership that occurred as a result of the reverse acquisition are substantially limited. It is unlikely that tax losses totaling $29.6 million and credits totaling $0.6 million will be utilized to offset potential future taxable income before expiration and they are excluded from deferred tax assets above. The approximate Canadian non-capital losses carried forward at September 30, 2023 expire as follows: 2025 C$ 21,000 2026 56,000 2027 114,000 2028 233,000 2029 688,000 2030 860,000 2031 685,000 2032 673,000 2033 107,000 2034 1,941,000 2035 2,207,000 2036 2,216,000 2037 2,123,000 2038 3,500,000 2039 1,732,000 2040 7,992,000 2041 12,675,000 2042 22,387,000 2043 10,765,000 Total C$ 70,975,000 Share issuance and financing costs will be fully amortized in 2026. The U.S. non-capital losses carried forward at September 30, 2023 totaled approximately $3.4 million, which do not expire for federal taxes. The U.S. state research and development tax credits carried forward at September 30, 2023 totaled approximately $0.6 million, which do not expire for state taxes. The approximate U.S. state non-capital losses carried forward at September 30, 2023 expire as follows: 2039 $ 70,000 2040 150,000 2041 68,000 2042 6,000 Total $ 294,000 |
Financial instruments
Financial instruments | 12 Months Ended |
Sep. 30, 2023 | |
Financial instruments | |
Financial Instruments | 11. 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, 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 September 30, 2023, the Company and its Canadian subsidiary had assets denominated in Canadian dollars of approximately C$3.0 million and the U.S. dollar exchange rate at this date was equal to 1.3581 Canadian dollars. Based on the exposure at September 30, 2023, a 10% annual change in the Canadian/U.S. exchange rate would impact the Company’s loss and other comprehensive loss by approximately $0.2 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. |
Loss per Share
Loss per Share | 12 Months Ended |
Sep. 30, 2023 | |
Loss per Share | |
Loss per Share | 12. 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. |
Related party transactions
Related party transactions | 12 Months Ended |
Sep. 30, 2023 | |
Related party transactions | |
Related Party Transactions | 13. Related party transactions During each of the years ended September 30, 2023 and 2022, the Company paid cash of $82,000 and $81,000, 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. Rents of approximately $15,000 and $22,000 were payable at September 30, 2023 and September 30, 2022, respectively. |
Subsequent events
Subsequent events | 12 Months Ended |
Sep. 30, 2023 | |
Subsequent events | |
Subsequent events | 14. Subsequent events Subsequent to the year end, equity sales under the Company’s at-the-market offering program have resulted in the issuance of 89,241 common shares and receipt of net cash proceeds of $0.3 million after deducting sales agent commissions. In October 2023, the Company entered into $10.0 million revolving credit agreement with a company controlled by the Company's CEO, providing an unsecured revolving credit facility, with a credit limit of $3.5 million. No amounts have been drawn on the credit agreement subsequent to the year end. |
Significant accounting polici_2
Significant accounting policies (Policies) | 12 Months Ended |
Sep. 30, 2023 | |
Significant accounting policies | |
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. |
Cash and cash equivalents | Cash and cash equivalents consist of demand deposits with financial institutions held in checking, savings and money market mutual funds and highly liquid investments which are readily convertible into cash with maturities of three months or less when purchased. The carrying amount of cash and cash equivalents approximates its fair value due to its short-term nature. |
Accounts and other receivable | The Company assesses the collectability of its accounts receivable through a review of its current aging and payment terms, as well as an analysis of its historical collection rate, general economic conditions and credit status of the government agencies. Accounts and other receivable include reimbursement grant income for the Company’s federal grant with the Canadian government’s SIF and Harmonized Sales Tax (HST) refunds receivable. As of September 30, 2023, all outstanding accounts, grants and HST refunds receivable were deemed to be fully collectible, and therefore, no allowance for doubtful accounts was recorded. |
Property and equipment | Property and equipment are recorded at historical cost less accumulated depreciation and any accumulated impairment losses. Depreciation is recorded to write off the cost of assets less their residual values over their useful lives, using the declining balance and straight-line methods. Maintenance and repair expenditures that do not improve or extend the life are expensed in the period incurred. Any gain or loss arising on the disposal or retirement of an item of property and equipment is recognized as the difference between the sales proceeds and the carrying amount of the asset. The estimated useful lives, residual values and depreciation methods are reviewed at the end of each year, with the effect of any changes in estimate accounted for on a prospective basis. The depreciation policy for the principal asset categories are calculated as follows: · Computer equipment 30% declining balance method or straight line 3 years · Furniture and equipment 20% declining balance method |
Intangible assets | Intangible assets represent the exclusive world-wide rights to know-how, patents and data relating to certain monoclonal antibodies (the Constructs), including sublicensing rights, acquired by entering into a license agreement with a pharmaceutical development company. Unless earlier terminated, the term of the license agreement will remain in effect for 25 years from the date of first commercial sale of licensed products containing the Constructs. Subsequently, the license agreement will automatically renew for five-year periods unless either party terminates the agreement in accordance with its terms. Intangible assets are stated at their historical cost, amortized on a straight-line basis over their expected useful lives, which is 25 years, and subject to impairment review at the end of each reporting period. |
Impairment of long-lived assets | Long-lived assets are tested for impairment when indicators of impairment exist. When a significant change in the expected timing or amount of the future cash flows of the financial asset is identified, the carrying amount of the financial asset is reduced and the amount of the write-down is recognized as a loss. A previously recognized impairment loss may be reversed to the extent of the improvement, provided it is not greater than the amount that would have been reported at the date of the reversal had the impairment not been recognized previously, and the amount of the reversal is recognized in net income (loss). |
Right-of-Use assets | The Company recognizes right-of-use (ROU) assets and liabilities on the balance sheet for operating leases with terms longer than 12 months. The Company follows the ongoing practical expedient not to recognize ROU assets and liabilities for short-term leases. The ROU assets are initially measured at cost and amortized using the straight-line method through the end of the lease term. The ROU liabilities are initially measured at the present value of the lease payments that are not paid at the commencement date, discounted using the Company's incremental borrowing rate. |
Fair value measurement | The Company uses the fair value measurement framework for valuing financial assets and liabilities. See Note 11. |
Revenue recognition | Reimbursement grant income is recognized based on the reimbursement rate included in the government contribution agreement when allowable expenses have been incurred. |
Research and development | Research and development expenses principally consist of (i) contract research organizations for clinical trial management services, (ii) contract manufacturing organizations for manufacturing the drug compound(s) for use in clinical trials and (iii) salaries of employees directly involved in research and development efforts. Research and development costs are expensed as incurred. |
Share-based compensation | The Company has equity incentive plans under which various types of equity-based awards including share options, restricted shares and restricted share unit awards may be granted to employees, non-employee directors and non-employee consultants and warrants that may be granted as compensation to non-employees. The Company measures the cost of equity-settled transactions by reference to the fair value of the equity instruments at the date at which they are granted since the fair value of the goods or services received by the Company cannot be reliably estimated. The Company recognizes compensation expense for all share-based awards based on the estimated grant-date fair values. For restricted share unit awards to employees, the fair value is based on the 5-day volume weighted average price (VWAP) of the Company’s common shares up to the date of grant. The value of the portion of the award that is ultimately expected to vest is recognized as expense on a straight-line basis over the requisite service period. The fair value of share options is determined using the Black-Scholes option pricing model. The Company utilizes a dividend yield of zero based on the fact that the Company has never paid cash dividends and has no current intention of paying cash dividends. The Company elected an accounting policy to record forfeitures as they occur. See Note 8 for a discussion of the assumptions used by the Company in determining the grant date fair value of options granted under the Black-Scholes option pricing model, as well as a summary of the share option activity under the Company’s share-based compensation plan for all years presented. The provisions of the Company’s share-based compensation plans do not require the Company to settle any options or restricted share units by transferring cash or other assets, and therefore the Company classifies the awards as equity. |
Translation of foreign currency transactions | The Company’s reporting currency is the U.S. dollar. The financial statements of the wholly owned Canadian subsidiary is measured using the Canadian dollar as the functional currency. Assets and liabilities of the Canadian operation have been translated at year-end exchange rates and related revenue and expenses have been translated at average exchange rates for the year. Accumulated gains and losses resulting from the translation of the financial statements of the Canadian operation are included as part of accumulated other comprehensive loss, a separate component of shareholders’ equity. For other transactions denominated in currencies other than the Company’s functional currency, the monetary assets and liabilities are translated at the year-end rates. Revenue and expenses are translated at rates of exchange prevailing on the transaction dates. Non-monetary balance sheet and related income statement accounts are remeasured into U.S. dollar using historical exchange rates. All of the exchange gains or losses resulting from these other transactions are recognized in the statements of operations and comprehensive loss. |
Income taxes | Deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the tax bases of assets and liabilities and their financial statement reported amounts using enacted tax rates and laws in effect in the year in which the differences are expected to reverse. A valuation allowance is provided against deferred tax assets when it is determined to be more likely than not that the deferred tax asset will not be realized. The Company assesses the likelihood of the financial statement effect of a tax position that should be recognized when it is more likely than not that the position will be sustained upon examination by a taxing authority based on the technical merits of the tax position, circumstances, and information available as of the reporting date. The Company is subject to examination by taxing authorities in Canada and the U.S. Management does not believe that there are any uncertain tax positions that would result in an asset or liability for taxes being recognized in the accompanying financial statements. The Company recognizes tax-related interest and penalties, if any, as a component of income tax expense. The Company accounts for income taxes on a tax jurisdictional basis. The Company files income tax returns in Canada, the provinces of British Columbia and Ontario, the U.S. and the state of California. |
Earnings (loss) per share | Basic earnings (loss) per share is calculated by dividing net income (loss) available to common shareholders by the weighted average number of common shares outstanding during the year. The computation of diluted earnings (loss) per share assumes the conversion, exercise or contingent issuance of securities only when such conversion, exercise or issuance would have a dilutive effect on earnings (loss) per share. The dilutive effect of convertible securities would be reflected in diluted earnings per share by application of the “if converted” method. The dilutive effect of outstanding share options and warrants and their equivalents would be reflected in diluted earnings per share by application of the treasury stock method. However, conversion of outstanding share options and warrants would have an antidilutive effect on loss per share for the years ended September 30, 2023 and 2022 and are therefore excluded from the computation of diluted loss per share. See Note 8 for share options and warrants at September 30, 2023 and 2022. |
Segmented Information | The Company’s operations comprise a single reportable segment engaged in the research and development, manufacturing and commercialization of innovative pharmaceutical products. As the operations comprise a single reportable segment, amounts disclosed in the consolidated financial statements for net loss, comprehensive loss, depreciation and total assets also represent segmented amounts. |
Adoption of Recent Accounting Pronouncements | On October 1, 2022, the Company adopted Accounting Standards Update ASU 2021-10 Disclosure by Business Entities About Government Assistance, modifying ASC Topic 832, Government Assistance. The amendments in ASU 2021-10 require disclosure of information about certain types of government assistance received. The Company expanded its disclosures related to government assistance. |
Future accounting pronouncements | In November 2023, the FASB issued Accounting Standards Update ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires disclosure of incremental segment information on an interim and annual basis. This ASU is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal periods beginning after December 15, 2024, and requires retrospective application to all prior periods presented in the financial statements. The Company is currently evaluating the impact of the guidance on the consolidated financial statements and disclosures. |
Property and equipment (Tables)
Property and equipment (Tables) | 12 Months Ended |
Sep. 30, 2023 | |
Property and equipment | |
Schedule of Property and equipment | September 30, 2023 September 30, 2022 Computer equipment $ 46,945 $ 46,674 Furniture and equipment 5,603 5,538 52,548 52,212 Less: accumulated depreciation (43,846 ) (39,518 ) Total property and equipment, net $ 8,702 $ 12,694 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 12 Months Ended |
Sep. 30, 2023 | |
Intangible assets | |
Intangible Assets | September 30, 2023 September 30, 2022 The Constructs $ 2,529,483 $ 2,529,483 Less: accumulated amortization (349,463 ) (248,291 ) Total intangible assets, net $ 2,180,020 $ 2,281,192 |
Estimated Future Amortization Of Intagible Assets | Year Ending September 30, 2024 101,172 September 30, 2025 101,172 September 30, 2026 101,172 September 30, 2027 101,172 September 30, 2028 101,172 Thereafter 1,674,160 $ 2,180,020 |
Right-of-Use Asset and Liabil_2
Right-of-Use Asset and Liabilities (Tables) | 12 Months Ended |
Sep. 30, 2023 | |
Right-of-Use Asset and Liabilities | |
Components of lease cost | September 30, 2023 September 30, 2022 Right-of-use lease cost, included in general and administrative on the Statements of Operations $ 82,358 $ 18,465 |
Lease Terms And Discount Rates | September 30, 2023 September 30, 2022 Remaining lease term (months): 15 3 Estimated incremental borrowing rate: 9.2 % 6.5 % |
Future Minimum Lease Payments | Year Ending September 30, 2024 $ 79,697 September 30, 2025 19,924 Total lease payments 99,621 Less imputed interest 5,134 Present value of right-of-use lease liabilities 94,487 Present value included in current liabilities 74,714 Present value included in long-term liabilities $ 19,773 |
Cash Paid-lease Liabilities | Years Ended September 30, 2023 September 30, 2022 Cash paid for amounts included in the measurement of right-of-use lease liabilities, included in accounts payable and accrued liabilities on the Statements of Cash Flow. $ 79,222 $ 80,377 |
Commitments (Tables)
Commitments (Tables) | 12 Months Ended |
Sep. 30, 2023 | |
Commitments | |
Future Contractual Payments | Year Ending September 30, 2024 1,798,000 September 30, 2025 49,000 September 30, 2026 36,000 September 30, 2027 41,000 September 30, 2028 - $ 1,924,000 |
Capital Shares (Tables)
Capital Shares (Tables) | 12 Months Ended |
Sep. 30, 2023 | |
Capital shares | |
Warrant activity | Number of Warrant Shares (#) Weighted Average Exercise Price Balance - September 30, 2021 102,929 $ 39.83 Issued 418,789 25.13 September 30, 2022 521,718 $ 28.00 Issued 384,496 8.75 Exercised (100,760 ) 7.65 Expired (84,545 ) 37.29 September 30, 2023 720,909 $ 19.51 |
Schedule of fair value of warrants black-Scholes option valuation table | Year Ended September 30, 2023 Year Ended September 30, 2022 Class A Warrants Class B Warrants Common Warrants Placement Agent Warrants Risk free interest rate 4.54 % 4.76 % 2.37 % 2.37 % Expected life 3.14 years 1.14 years 5.5 years 5 years Expected share price volatility 90.73 % 89.70 % 87.09 % 87.09 % Expected dividend yield 0.00 % 0.00 % 0.00 % 0.00 % |
Warrants outstanding | Number of Warrants (#) Exercise Prices Expiry Dates 110,122 $ 7.00 December 2023 1,070 $ 33.67 June 2024 1,687 $ 22.40 January 2025 173,614 $ 10.50 December 2025 15,627 $ 56.00 February 2026 27,399 $ 31.94 March 2027 391,390 $ 24.64 September 2027 720,909 |
Pre-funded warrant activity | Number of Pre-funded Warrant Shares (#) Balance - September 30, 2021 - Issued 171,389 Exercised (171,389 ) Balance - September 30, 2022 - |
Share options | Number of Options (#) Weighted Average Exercise Price Weighted Average Grant Date Fair Value Balance - September 30, 2021 253,777 $ 35.42 $ 26.53 Granted 71,451 25.62 17.36 Forfeited (3,851 ) 45.92 34.79 Expired (6,524 ) 56.35 45.36 Balance - September 30, 2022 314,853 $ 32.62 $ 23.94 Granted 118,579 7.47 5.23 Forfeited (12,779 ) 22.76 16.23 Expired (38 ) 1,973.20 1,973.20 Balance - September 30, 2023 420,615 $ 25.60 $ 18.84 |
Summary of plan outstanding and exercisable | Number of Options (#) Exercisable at September 30, 2023 (#) Range of Exercise Prices Expiry Dates 497 497 $ 246.96 - 596.82 Dec 2023 - Mar 2025 42,348 42,348 C$ 15.12 May 2024 - Dec 2028 46,285 46,285 $ 22.12 May 2024 - Feb 2030 56,722 56,702 $ 52.08 - 56.49 May 2024 - Oct 2030 93,344 81,048 $ 36.75 - 40.18 Apr 2024 - Sep 2031 68,777 44,441 $ 20.58 - 25.97 Apr 2024 - Feb 2032 112,642 18,334 $ 5.79 - 10.01 Apr 2024 - Jul 2033 420,615 289,655 |
Fair value Of warrant granted assumptions | Years Ended September 30, 2023 September 30, 2022 Risk free interest rate 3.62% - 4.18% 1.71% - 2.54% Expected life 5 years 5 years Expected share price volatility 95.3% - 97.34% 85.91% - 86.59% Expected dividend yield 0.00 % 0.00 % |
Summary of changes in Restricted Share Units | Number of RSU (#) Weighted Average Grant Date Fair Value Balance - September 30, 2021 and 2022 - $ - Granted 46,602 5.60 Converted to common shares (13,557 ) 5.60 Balance - September 30, 2023 33,045 $ 5.60 |
summary of information about the RSU | Number of RSU(#) Expiry Date Fully-vested RSUs 33,045 August 4, 2033 |
Income Tax (Tables)
Income Tax (Tables) | 12 Months Ended |
Sep. 30, 2023 | |
Income Tax | |
reconciliation of the combined Canadian federal to the approximate effective tax rate | Years Ended September 30, 2023 September 30, 2022 Net loss before recovery of income taxes $ (8,374,000 ) $ (17,548,000 ) Canadian federal and provincial statutory income tax rate 26.5 % 26.5 % Expected income tax recovery $ (2,219,000 ) $ (4,650,000 ) Effect of foreign currency and foreign tax rate differences (207,200 ) 976,800 Permanent differences 339,000 650,000 Share issuance cost booked through equity or capitalization (89,000 ) (449,000 ) Non-capital losses limitation - U.S. 899,000 - Other (94,000 ) - Change in valuation allowance 1,372,000 3,473,000 Income tax (recovery) expense $ 800 $ 800 |
Deferred taxes | September 30, 2023 September 30, 2022 Non-capital losses carried forward - Canada $ 13,943,000 $ 11,740,000 Non-capital losses carried forward - U.S. 731,000 1,631,000 Research and development tax credits 1,371,000 1,052,000 Share issuance and financing costs 585,000 686,000 Right-of-use lease liabilities 25,000 5,000 Other temporary differences 43,000 15,000 Subtotal $ 16,699,000 $ 15,129,000 Less: valuation allowance (16,466,000 ) (15,093,000 ) Total net deferred tax assets $ 233,000 $ 36,000 Property and equipment $ (3,000 ) $ (15,000 ) Right-of-use assets (24,000 ) (5,000 ) Grant Income receivable (153,000 ) - Deferred share issuance costs (53,000 ) (16,000 ) Total deferred tax liabilities $ (233,000 ) $ (36,000 ) Net deferred taxes $ - $ - |
Canadian non-capital losses | 2025 C$ 21,000 2026 56,000 2027 114,000 2028 233,000 2029 688,000 2030 860,000 2031 685,000 2032 673,000 2033 107,000 2034 1,941,000 2035 2,207,000 2036 2,216,000 2037 2,123,000 2038 3,500,000 2039 1,732,000 2040 7,992,000 2041 12,675,000 2042 22,387,000 2043 10,765,000 Total C$ 70,975,000 |
U.S. state non-capital losses | 2039 $ 70,000 2040 150,000 2041 68,000 2042 6,000 Total $ 294,000 |
Nature of operations (Details N
Nature of operations (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Mar. 31, 2023 | Nov. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Accumulated deficit | $ (52,400,000) | ||||
Working capital | 4,600,000 | ||||
Cash and cash equivalents | $ 5,400,000 | ||||
Description of shelf registration | In August 2022 the Company filed a $150.0 million shelf registration statement, under which the Company entered into an equity distribution agreement with Canaccord for $20.0 million in gross proceeds, subject to certain offering limitations that currently allows the Company to offer and sell common shares having an aggregate gross sales price of up to $8.4 million (Canaccord ATM). There was approximately $7.1 million of available capacity on the Canaccord ATM as of September 30, 2023. | ||||
Net Cash used in operating activities | $ 6,600,000 | $ 12,300,000 | |||
Net losses | $ (8,400,000) | (17,600,000) | |||
Description of multi year contribution agreement with canadian government | 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 the Company. The remaining C$17.2 million is conditionally repayable starting in 2029 only if and when the Company earns gross revenue. See Note 9. In February 2021, the Company signed a contribution agreement with the Canadian government’s SIF (2021 SIF Agreement), the Company was 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 years ended September 30, 2023 and 2022, the Company recorded grant income of $0.6 million and $0.8 million respectively related to both the 2023 SIF Agreement and the 2021 SIF Agreement. | ||||
Unsecured revolving credit facility, with a credit limit | $ 3,500,000 | ||||
Sale of common shares | 89,558 | ||||
Net proceeds from sale of common shares | $ 2,600,000 | ||||
Net proceeds from sale of common stock | $ 4,345,017 | $ 11,957,687 | |||
Equity distribution agreement with Canaccord [Member] | |||||
Sale of common shares | 196,401 | ||||
Net proceeds from sale of common stock | $ 20,000,000 | ||||
Aggregate gross sales price | $ 8,400,000 | $ 1,300,000 | |||
Private Placement [Member] | |||||
Number of common share direct offer | 384,475 | 220,000 | |||
Pre-funded warrants to purchase up to an aggregate number of common share | 192,248 | 171,390 | |||
Purchase warrants to purchase an aggregate | 192,248 | 391,390 | |||
Net proceeds from common stock | $ 3,000,000 | $ 9,000,000 |
Significant accounting polici_3
Significant accounting policies (Details Narrative) | 12 Months Ended |
Sep. 30, 2023 | |
Operating leases with terms | 12 months |
Computer Equipment | |
Depreciation | 30% |
Useful life | 3 years |
Furniture and equipment | |
Depreciation | 20% |
Intangible Assets | |
Useful life | 25 years |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) | Sep. 30, 2023 | Sep. 30, 2022 |
Property and equipment, gross | $ 52,548 | $ 52,212 |
Less: accumulated depreciation | (43,846) | (39,518) |
Total property and equipment, net | 8,702 | 12,694 |
Computer Equipment | ||
Property and equipment, gross | 46,945 | 46,674 |
Furniture and Equipment | ||
Property and equipment, gross | $ 5,603 | $ 5,538 |
Property and Equipment (Detai_2
Property and Equipment (Details Narrative) - USD ($) $ in Millions | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Property and equipment | ||
Depreciation expense | $ 4,328 | $ 6,991 |
Intangible Assets (Details)
Intangible Assets (Details) - USD ($) | Sep. 30, 2023 | Sep. 30, 2022 |
Intangible assets | ||
The Constructs | $ 2,529,483 | $ 2,529,483 |
Less: Accumulated Amortization | 349,463 | 248,291 |
Intangible Assets, Net | $ 2,180,020 | $ 2,281,192 |
Intagible Assets (Details 1)
Intagible Assets (Details 1) | Sep. 30, 2023 USD ($) |
Intangible assets | |
September 30, 2024 | $ 101,172 |
September 30, 2025 | 101,172 |
September30, 2026 | 101,172 |
September 30, 2027 | 101,172 |
September 30, 2028 | 101,172 |
Thereafter | 1,674,160 |
Total | $ 2,180,020 |
Intangible Assets (Details Narr
Intangible Assets (Details Narrative) - USD ($) | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Intangible assets | ||
Amortization Expense | $ 1,011,720,000 | $ 1,011,720,000 |
Useful Life | 25 years | |
Description Of Licence Agreement | The required upfront license payment of $2.5 million was paid by issuance of Series A-1 Convertible Preferred Shares |
Right-of-Use Asset and Liabil_3
Right-of-Use Asset and Liabilities (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
General and Administrative Expense | ||
Right-of-use lease cost, included in general and administrative on the Statements of Operations | $ 82,358 | $ 18,465 |
Right-of-Use Asset and Liabil_4
Right-of-Use Asset and Liabilities (Details 1) | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Right-of-Use Asset and Liabilities | ||
Remaining Lease Term (months) | 15 years | 3 years |
Estimated Incremental Borrowing Rate | 9.20% | 6.50% |
Right-of-Use Asset and Liabil_5
Right-of-Use Asset and Liabilities (Details 2) - USD ($) | Sep. 30, 2023 | Sep. 30, 2022 |
Year Ending | ||
September 30, 2024 | $ 79,697 | |
September 30, 2025 | 19,924 | |
Total Lease Payment | 99,621 | |
Less Imputed Interest | 5,134 | |
Present value of right-of-use lease liabilities | 94,487 | |
Present value included in current liabilities | 74,714 | $ 18,975 |
Present value included in long-term liabilities | $ 19,773 | $ 0 |
Right-of-Use Asset and Liabil_6
Right-of-Use Asset and Liabilities (Details 3) - USD ($) | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Right-of-Use Asset and Liabilities | ||
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 | $ 79,222 | $ 80,377 |
Commitments (Details)
Commitments (Details) $ in Millions | Jun. 30, 2023 USD ($) |
Year Ending September 30, | |
September 30, 2028 | $ 0 |
September 30, 2024 | 1,798,000 |
September 30, 2025 | 49,000 |
September 30, 2026 | 36,000 |
September 30, 2027 | 41,000 |
Total | $ 1,924,000 |
Commitments (Details Narrative)
Commitments (Details Narrative) - USD ($) | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
2021 [Member] | License Commitments Agreement [Member] | ||
Payments to investors | $ 68,900,000 | |
2021 [Member] | License Commitments [Member] | ||
Risk free interest rate | 100% | |
Payments to investors | $ 50,000 | $ 25,693 |
Payments to third party | 16,872 | $ 19,740 |
2016 [Member] | License Commitments [Member] | ||
Payments to investors | 18,400,000 | |
Payments to third party | $ 40,000,000 | |
Common Shares | ||
Description of aqquire drugs | the Company acquired drug substance of one of the Constructs for an aggregate purchase price of $5.0 million. The Company recorded an expense of $2.5 million for the second installment payment during the year ended September 30, 2022. No expense was recorded during the year ended September 30, 2023 | |
Remaining payments of contingent | $ 356,000,000 |
Capital Shares (Details)
Capital Shares (Details) - $ / shares | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Capital shares | ||
Number of warrants, beginning balance | 521,718 | 102,929 |
Issued | 384,496 | 418,789 |
Exercised | (100,760) | |
Expired | (84,545) | |
Number of warrants, ending balance | 720,909 | 521,718 |
Weighted average exercise price, beginning balance | $ 28 | $ 39.83 |
Issued | 8.75 | 25.13 |
Exercised | 7.65 | |
Expired | 37.29 | |
Weighted average exercise price, ending balance | $ 19.51 | $ 28 |
Capital Shares (Details 1)
Capital Shares (Details 1) - $ / shares | 12 Months Ended | ||||
Sep. 30, 2023 | Jun. 30, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Sep. 30, 2021 | |
Number of warrants | 720,909 | 5,609,845 | 521,718 | 3,651,953 | 102,929 |
Weighted average exercise price | $ 19.51 | $ 28 | $ 39.83 | ||
Warrant 3 [Member] | |||||
Number of warrants | 1,687 | ||||
Weighted average exercise price | $ 22.40 | ||||
Expiry date | January 2025 | ||||
Warrant 1 [Member] | |||||
Number of warrants | 110,122 | ||||
Weighted average exercise price | $ 7 | ||||
Expiry date | December 2023 | ||||
Warrant 2 [Member] | |||||
Number of warrants | 1,070 | ||||
Weighted average exercise price | $ 33.67 | ||||
Expiry date | June 2024 | ||||
Warrant 4 [Member] | |||||
Number of warrants | 173,614 | ||||
Weighted average exercise price | $ 10.50 | ||||
Expiry date | December 2025 | ||||
Warrant 5 [Member] | |||||
Number of warrants | 15,627 | ||||
Weighted average exercise price | $ 56 | ||||
Expiry date | February 2026 | ||||
Warrant 6 [Member] | |||||
Number of warrants | 27,399 | ||||
Weighted average exercise price | $ 31.94 | ||||
Expiry date | March 2027 | ||||
Warrant 7 [Member] | |||||
Number of warrants | 391,390 | ||||
Weighted average exercise price | $ 24.64 | ||||
Expiry date | September 2027 |
Capital Shares (Details 2)
Capital Shares (Details 2) | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Expected life (years) | 5 years | 5 years |
Expected dividend yield | 0% | 0% |
Class A Warrants Member | ||
Risk free interest rate | 4.54% | 2.37% |
Expected life (years) | 3 years 1 month 20 days | 5 years 6 months |
Expected share price volatility | 90.73% | 87.09% |
Expected dividend yield | 0% | 0% |
Class B Warrants [Member] | ||
Risk free interest rate | 4.76% | 2.37% |
Expected life (years) | 1 year 1 month 20 days | 5 years |
Expected share price volatility | 89.70% | 87.09% |
Expected dividend yield | 0% | 0% |
Capital Shares (Details 3)
Capital Shares (Details 3) - shares | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Number of warrants, beginning balance | 521,718 | 102,929 |
Issued | 384,496 | 418,789 |
Exercised | (100,760) | |
Number of warrants, ending balance | 720,909 | 521,718 |
Pre-funded Warrant Shares | ||
Issued | 171,389 | |
Exercised | (171,389) |
Capital Shares (Details 4)
Capital Shares (Details 4) - $ / shares | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Number of options, ending balance | 420,615 | |
Purchase Common Share Options [Member] | ||
Number of options, beginning balance | 314,853 | 253,777 |
Number of options granted | 118,579 | 71,451 |
Number of options forfeited | (12,779) | (3,851) |
Number of options expired | (38) | (6,524) |
Number of options, ending balance | 420,615 | 314,853 |
Weighted Average Exercise Price, beginning balance | $ 32.62 | $ 35.42 |
Weighted average exercise price granted | 7.47 | 25.62 |
Weighted average exercise price forfeited | 22.76 | 45.92 |
Weighted average exercise price expired | 1,973.20 | 56.35 |
Weighted Average Exercise Price, ending balance | 25.60 | 32.62 |
Weighted Average Grant Date Fair Value, beginning balance | 23.94 | 26.53 |
Weighted Average Grant Date Fair Value, Granted | 5.23 | 17.36 |
Weighted Average Grant Date Fair Value, Forfeited | 16.23 | 34.79 |
Weighted Average Grant Date Fair Value, expired | 1,973.20 | 45.36 |
Weighted Average Grant Date Fair Value, ending balance | $ 18.84 | $ 23.94 |
Capital Shares (Details 5)
Capital Shares (Details 5) | 12 Months Ended |
Sep. 30, 2023 $ / shares shares | |
Number of options | 420,615 |
Options exercisable | 289,655 |
Stock Option 1 | |
Number of options | 497 |
Options exercisable | 497 |
Stock Option 1 | Minumum | |
Weighted average exercise price | $ / shares | $ 246.96 |
Expiry dates | Dec 2023 |
Stock Option 1 | Maximum | |
Weighted average exercise price | $ / shares | $ 596.82 |
Expiry dates | Mar 2025 |
Stock Option 2 | |
Number of options | 42,348 |
Options exercisable | 42,348 |
Weighted average exercise price | $ / shares | $ 15.12 |
Expiry dates | May 2024 |
Stock Option 2 | Maximum | |
Expiry dates | Dec 2028 |
Stock Option 3 | |
Number of options | 46,285 |
Options exercisable | 46,285 |
Weighted average exercise price | $ / shares | $ 22.12 |
Expiry dates | Feb 2030 |
Stock Option 3 | Minumum | |
Expiry dates | May 2024 |
Stock Option 4 | |
Number of options | 56,722 |
Options exercisable | 56,702 |
Stock Option 4 | Minumum | |
Weighted average exercise price | $ / shares | $ 52.08 |
Expiry dates | May 2024 |
Stock Option 4 | Maximum | |
Weighted average exercise price | $ / shares | $ 56.49 |
Expiry dates | Oct 2030 |
Stock Option 5 | |
Number of options | 93,344 |
Options exercisable | 81,048 |
Stock Option 5 | Minumum | |
Weighted average exercise price | $ / shares | $ 36.75 |
Expiry dates | Apr 2024 |
Stock Option 5 | Maximum | |
Weighted average exercise price | $ / shares | $ 40.18 |
Expiry dates | Sep 2031 |
Stock Option 6 | |
Number of options | 68,777 |
Options exercisable | 44,441 |
Stock Option 6 | Minumum | |
Weighted average exercise price | $ / shares | $ 20.58 |
Expiry dates | Apr 2024 |
Stock Option 6 | Maximum | |
Weighted average exercise price | $ / shares | $ 25.97 |
Expiry dates | Feb 2032 |
Stock Option 7 Member | |
Number of options | 112,642 |
Options exercisable | 18,334 |
Stock Option 7 Member | Minumum | |
Weighted average exercise price | $ / shares | $ 5.79 |
Expiry dates | Apr 2024 |
Stock Option 7 Member | Maximum | |
Weighted average exercise price | $ / shares | $ 10.01 |
Expiry dates | Jul 2033 |
Capital Shares (Details 6)
Capital Shares (Details 6) | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Capital shares | ||
Risk Free Interest Rate, Minimum | 3.62% | 1.71% |
Risk Free Interest Rate, Maximum | 4.18% | 2.54% |
Expected Life (years) | 5 years | 5 years |
Expected Share Price Volatility, Minimum | 95.30% | 85.91% |
Expected Share Price Volatility, Maximum | 97.34% | 86.59% |
Expected Dividend Yield | 0% | 0% |
Capital Shares (Details 7)
Capital Shares (Details 7) - $ / shares | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Number of options, ending balance | 420,615 | |
Restricted Share Units [Member] | ||
Number of options, beginning balance | 0 | 0 |
Number of RSU granted | 46,602 | 0 |
Converted to common shares | (13,557) | 0 |
Number of options, ending balance | 33,045 | 0 |
Weighted Average Grant Date Fair Value, beginning balance | $ 0 | $ 0 |
Weighted Average Grant Date Fair Value, Granted | 5.60 | 0 |
Weighted Average Grant Date Fair Value, Converted To Common Shares | 5.60 | 0 |
Weighted Average Grant Date Fair Value, ending balance | $ 5.60 | $ 0 |
Capital Shares (Details 8)
Capital Shares (Details 8) | 12 Months Ended |
Sep. 30, 2023 shares | |
Number of RSU | 33,045 |
Restricted Share Units 1 | |
Expiry dates | August 4, 2033 |
Capital Shares (Details Narrati
Capital Shares (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |||||
Nov. 02, 2022 | Mar. 27, 2023 | Nov. 22, 2022 | Mar. 24, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based compensation | $ 12 | $ 2,300 | |||||
Unrecognized share-based compensation | $ 500 | ||||||
Gross Proceeds | $ 20,000 | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 19.51 | $ 28 | $ 39.83 | ||||
Aggregate gross sales price | $ 84 | $ 1,300 | |||||
Common share sold during period | 196,401 | ||||||
Affiliated Designees [Member] | |||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 31.9375 | ||||||
Warrant expiry date | Mar. 21, 2027 | ||||||
Warrants to purchase common shares | 391,390 | ||||||
Fair value | $ 400 | ||||||
Black Scholes Option [Member] | |||||||
Expected term | 10 months | ||||||
Grant date | 5 months | ||||||
March 24, 2022 [Member] | |||||||
Net proceeds from the offering | $ 9,000 | ||||||
Offering Common Shares | 220,000 | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 24.64 | ||||||
Warrant expiry date | Sep. 24, 2027 | ||||||
November 2, 2022[Member] | |||||||
Gross Proceeds | $ 2,600 | ||||||
Warrant expiry date | Dec. 23, 2025 | ||||||
Units of Common Shares | 384,475 | 89,558 | |||||
Warrants Additional Paid In Capital [Member] | |||||||
Gross Proceeds | $ 4,100 | ||||||
Employees [Member] | |||||||
Granted option shares | 130,960 | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 31.03 | ||||||
Expected Option Forfeitures Term | 111 years | ||||||
2019 Plan [Member] | |||||||
Weighted average contractual life remaining on outstanding options | 85 months | ||||||
Unrecognized share-based compensation recognition period | 35 months | ||||||
Number Of Shares Available For Issuance | 575,737 | ||||||
Option Term | 10 years | ||||||
Remaining Number Of Options Available For Grant | 81,765 | ||||||
Class A Warrants Member | |||||||
Gross Proceeds | $ 2,900 | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 10.50 | ||||||
Warrants to purchase common shares | 192,248 | ||||||
Class B Warrants [Member] | |||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 7 | ||||||
Warrant expiry date | Dec. 23, 2022 | ||||||
Warrants to purchase common shares | 192,248 | ||||||
Pre-Funded Warrants [Member] | |||||||
Gross Proceeds | $ 5,900 | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.0007 | $ 13.61 | |||||
Warrants To Purchase Common Stock | 171,390 |
Government Contributions (Detai
Government Contributions (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Oct. 31, 2023 | Feb. 28, 2021 | Sep. 30, 2023 | Sep. 30, 2022 | |
Grant income | $ 800,000 | |||
Description of expiry of agreement | 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 | |||
SIF Agreement Member | February 2021 | ||||
Grant income | $ 600,000 | |||
Non repayable funding amount support R&D | $ 14,100,000 | |||
SIF Agreement Member | October 2023 | ||||
Repayable Funding Amount | $ 23,000,000 | |||
Description of SIF Agreement | (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$17.2 million is conditionally repayable starting in 2029 only if and when the Company earns gross revenue | |||
Repayable payment duration | 15 years |
Income Tax (Details)
Income Tax (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Income Tax | ||
Net loss before recovery of income taxes | $ (8,374,000) | $ (17,548,000) |
Canadian federal and provincial statutory income tax rate | 26.50% | 26.50% |
Expected income tax recovery | $ (2,219,000) | $ (4,650,000) |
Effect of foreign currency and foreign tax rate differences | (207,200) | 976,800 |
Permanent differences | 339,000 | 650,000 |
Non-capital losses limitations - US | 899,000 | 0 |
Other | (94,000) | 0 |
Share issuance cost booked through equity or capitalization | (89,000) | (449,000) |
Change in valuation allowance | 1,372,000 | 3,473,000 |
Income tax (recovery) expense | $ 800 | $ 800 |
Income Tax (Details 1)
Income Tax (Details 1) - USD ($) | Sep. 30, 2023 | Sep. 30, 2022 |
Income Tax | ||
Non-capital losses carried forward - Canada | $ 13,943,000 | $ 11,740,000 |
Non-capital losses carried forward - US | 731,000 | 1,631,000 |
Research and development tax credits | 1,371,000 | 1,052,000 |
Share issuance and financing costs | 585,000 | 686,000 |
Right-of-use lease liabilities | 25,000 | 5,000 |
Other temporary differences | 43,000 | 15,000 |
Subtotal | 16,699,000 | 15,129,000 |
Less: valuation allowance | (16,466,000) | (15,093,000) |
Total net deferred tax assets | 233,000 | 36,000 |
Property and equipment | (3,000) | (15,000) |
Right-of-use assets | 24,000 | 5,000 |
Grant Income receivable | (153,000) | 0 |
Deferred share issuance costs | (53,000) | (16,000) |
Total deferred tax liabilities | (233,000) | (36,000) |
Net deferred taxes | $ 0 | $ 0 |
Income Tax (Details 2)
Income Tax (Details 2) - Sep. 30, 2023 | CAD ($) | USD ($) |
Canada | ||
Non-capital income tax losses | $ 70,975,000 | |
Canada | 2027 | ||
Non-capital income tax losses | 114,000 | |
Canada | 2026 | ||
Non-capital income tax losses | 56,000 | |
Canada | 2025 | ||
Non-capital income tax losses | 21,000 | |
Canada | 2028 | ||
Non-capital income tax losses | 233,000 | |
Canada | 2029 | ||
Non-capital income tax losses | 688,000 | |
Canada | 2030 | ||
Non-capital income tax losses | 860,000 | |
Canada | 2031 | ||
Non-capital income tax losses | 685,000 | |
Canada | 2032 | ||
Non-capital income tax losses | 673,000 | |
Canada | 2033 | ||
Non-capital income tax losses | 107,000 | |
Canada | 2034 | ||
Non-capital income tax losses | 1,941,000 | |
Canada | 2035 | ||
Non-capital income tax losses | 2,207,000 | |
Canada | 2036 | ||
Non-capital income tax losses | 2,216,000 | |
Canada | 2037 | ||
Non-capital income tax losses | 2,123,000 | |
Canada | 2038 | ||
Non-capital income tax losses | 3,500,000 | |
Canada | 2039 | ||
Non-capital income tax losses | 1,732,000 | |
Canada | 2040 | ||
Non-capital income tax losses | 7,992,000 | |
Canada | 2041 | ||
Non-capital income tax losses | 12,675,000 | |
Canada | 2042 | ||
Non-capital income tax losses | 22,387,000 | |
Canada | 2043 | ||
Non-capital income tax losses | 10,765,000 | |
United States | ||
Non-capital income tax losses | $ 294,000 | |
United States | 2039 | ||
Non-capital income tax losses | 70,000 | |
United States | 2040 | ||
Non-capital income tax losses | 150,000 | |
United States | 2042 | ||
Non-capital income tax losses | $ 6,000 | |
United States | 2041 | ||
Non-capital income tax losses | $ 68,000 |
Income Tax (Details Narrative)
Income Tax (Details Narrative) $ in Millions | 12 Months Ended |
Sep. 30, 2023 USD ($) | |
Income Tax | |
U.S. non-capital losses carried forward | $ 3.4 |
The U.S. state research and development tax credits carried forward | 0.6 |
Credits totaling | 0.6 |
Tax losses totaling future income | $ 29.6 |
Financial Instruments (Details
Financial Instruments (Details Narrative) $ / shares in Units, $ in Millions | 12 Months Ended | ||
Sep. 30, 2023 USD ($) $ / shares | Sep. 30, 2023 CAD ($) | Sep. 30, 2022 USD ($) | |
Assets | $ 8,890,437 | $ 11,575,728 | |
USD to CAD [Member] | |||
Currency exchange rate | $ / shares | $ 1.3581 | ||
Ontario Subsidary [Member] | |||
Assets | $ 3 | ||
Currency exchange rate description | Based on the exposure at September 30, 2023, a 10% annual change in the Canadian/U.S. exchange rate would impact the Company’s loss and other comprehensive loss by approximately $0.2 million |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - USD ($) | 12 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Related party transactions | ||
Rent expense | $ 82,000 | $ 81,000 |
Royalty payable | $ 15,000 | $ 22,000 |
Subsequent events (Details Narr
Subsequent events (Details Narrative) - USD ($) $ in Millions | 12 Months Ended | |
Sep. 30, 2023 | Oct. 31, 2023 | |
Common shares issued | 89,241 | |
Gross proceeds | $ 0.3 | |
Subsequent Event [Member] | Revolving Credit Facility [Member] | ||
Revolving credit | $ 10 | |
Credit limit | $ 3.5 |