Cover
Cover - USD ($) $ in Thousands | 12 Months Ended | ||
Sep. 30, 2022 | Nov. 28, 2022 | Mar. 31, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Sep. 30, 2022 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2022 | ||
Current Fiscal Year End Date | --09-30 | ||
Entity File Number | 001-37606 | ||
Entity Registrant Name | ANAVEX LIFE SCIENCES CORP. | ||
Entity Central Index Key | 0001314052 | ||
Entity Tax Identification Number | 98-0608404 | ||
Entity Incorporation, State or Country Code | NV | ||
Entity Address, Address Line One | 630 5th Avenue | ||
Entity Address, Address Line Two | 20th Floor | ||
Entity Address, City or Town | New York | ||
Entity Address, State or Province | NY | ||
Entity Address, Country | US | ||
Entity Address, Postal Zip Code | 10111 | ||
City Area Code | 844 | ||
Local Phone Number | 689-3939 | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 921,000 | ||
Entity Common Stock, Shares Outstanding | 77,961,815 | ||
ICFR Auditor Attestation Flag | true | ||
Auditor Name | GRANT THORNTON LLP | ||
Auditor Location | Hartford, Connecticut | ||
Auditor Firm ID | 248 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Sep. 30, 2022 | Sep. 30, 2021 |
Current | ||
Cash and cash equivalents | $ 149,157,861 | $ 152,107,745 |
Incentive and tax receivables | 3,192,580 | 9,136,831 |
Prepaid expenses and other current assets | 354,162 | 371,914 |
Total Assets | 152,704,603 | 161,616,490 |
Current Liabilities | ||
Accounts payable | 3,824,777 | 4,739,781 |
Accrued liabilities (Note 3) | 5,944,953 | 5,614,774 |
Deferred grant income (Note 4) | 443,831 | 443,831 |
Total Liabilities | 10,213,561 | 10,798,386 |
Capital stock Authorized:10,000,000 preferred stock, par value $0.001 per share | ||
Capital stock Authorized: 200,000,000 common stock, par value $0.001 per share Issued and outstanding:77,942,568 common shares (September 30, 2021 - 75,918,465) | 77,944 | 75,920 |
Additional paid-in capital | 387,976,881 | 348,328,048 |
Accumulated deficit | (245,563,783) | (197,585,864) |
Total Stockholders' Equity | 142,491,042 | 150,818,104 |
Total Liabilities and Stockholders' Equity | $ 152,704,603 | $ 161,616,490 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2022 | Sep. 30, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred stock, authorized | 10,000,000 | 10,000,000 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common shares, authorized | 200,000,000 | 200,000,000 |
Common shares, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common shares, issued | 77,942,815 | 75,918,465 |
Common shares, outstanding | 77,942,815 | 75,918,465 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) | 12 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2020 | |
Operating expenses | |||
General and administrative | $ 13,070,068 | $ 9,017,511 | $ 5,856,609 |
Research and development | 37,915,747 | 32,983,674 | 25,231,623 |
Total operating expenses | 50,985,815 | 42,001,185 | 31,088,232 |
Operating loss | (50,985,815) | (42,001,185) | (31,088,232) |
Other income (expenses) | |||
Grant income | 54,100 | 149,888 | |
Research and development incentive income | 3,323,011 | 4,547,099 | 4,375,025 |
Interest income, net | 946,988 | 26,261 | 179,973 |
Foreign exchange (loss) gain, net | (903,611) | (267,344) | 125,540 |
Total other income, net | 3,366,388 | 4,360,116 | 4,830,426 |
Net loss before provision for income taxes | (47,619,427) | (37,641,069) | (26,257,806) |
Income tax expense, current | (358,492) | (267,565) | (22,664) |
Net loss and comprehensive loss | $ (47,977,919) | $ (37,908,634) | $ (26,280,470) |
Net Loss per share | |||
Basic and diluted | $ (0.62) | $ (0.54) | $ (0.45) |
Weighted average number of shares outstanding | |||
Basic and diluted | $ 76,909,993 | $ 69,802,960 | $ 58,194,894 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2020 | |
Cash Flows used in Operating Activities | |||
Net loss | $ (47,977,919) | $ (37,908,634) | $ (26,280,470) |
Adjustments to reconcile net loss to net cash used in operations: | |||
Stock-based compensation | 18,379,242 | 8,231,403 | 4,876,906 |
Changes in working capital balances related to operations: | |||
Incentive and tax receivables | 5,944,251 | (4,287,491) | (2,206,595) |
Prepaid expenses and deposits | 1,387 | 88,290 | 57,159 |
Accounts payable | (915,004) | 750,727 | 465,722 |
Accrued liabilities | 330,179 | 2,298,200 | 1,800,232 |
Deferred grant income | 443,831 | ||
Net cash used in operating activities | (24,237,864) | (30,383,674) | (21,287,046) |
Cash Flows provided by Financing Activities | |||
Issuance of common shares | 20,984,667 | 153,218,762 | 28,754,198 |
Share issue costs | (706,877) | (5,550,921) | (403,764) |
Proceeds from exercise of warrants | 1,466,500 | ||
Proceeds from exercise of stock options | 1,010,190 | 4,108,060 | |
Net cash provided by financing activities | 21,287,980 | 153,242,401 | 28,350,434 |
Increase (decrease) in cash and cash equivalents during the period | (2,949,884) | 122,858,727 | 7,063,388 |
Cash and cash equivalents, beginning of period | 152,107,745 | 29,249,018 | 22,185,630 |
Cash and cash equivalents, end of period | 149,157,861 | 152,107,745 | 29,249,018 |
Cash paid for state and local minimum income taxes | $ 326,903 | $ 139,531 | $ 22,664 |
CONSOLIDATED STATEMENTS OF CHAN
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Beginning balance, value at Sep. 30, 2019 | $ 52,652 | $ 153,633,807 | $ (133,396,760) | $ 20,289,699 |
Balance at beginning, shares at Sep. 30, 2019 | 52,650,521 | |||
Purchase shares | $ 7,565 | 21,246,733 | 21,254,298 | |
Purchase shares (in shares) | 7,564,584 | |||
Commitment shares | $ 69 | $ (69) | ||
Commitment shares (in shares) | 68,943 | |||
Shares issued pursuant to cashless exercise of stock options | 1 | (1) | ||
Shares issued pursuant to cashless exercise of options (in shares) | 721 | |||
Shares issued under Sales Agreement | $ 1,760 | $ 7,498,140 | $ 7,499,900 | |
Shares issued under Sales Agreement (in shares) | 1,760,429 | |||
Less: share issue costs | (403,764) | (403,764) | ||
Share based compensation | 4,876,906 | 4,876,906 | ||
Net loss | (26,280,470) | (26,280,470) | ||
Ending balance, value at Sep. 30, 2020 | $ 62,047 | 186,851,752 | (159,677,230) | 27,236,569 |
Balance at ending, shares at Sep. 30, 2020 | 62,045,198 | |||
Purchase shares | $ 4,008 | 24,107,190 | 24,111,198 | |
Purchase shares (in shares) | 4,007,996 | |||
Commitment shares | $ 78 | (78) | ||
Commitment shares (in shares) | 78,213 | |||
Shares issued pursuant to exercise of stock options | $ 1,421 | 4,106,639 | 4,108,060 | |
Shares issued pursuant to exercise of stock options (in shares) | 1,421,529 | |||
Shares issued under Sales Agreement | $ 5,635 | 79,101,915 | 79,107,550 | |
Shares issued under Sales Agreement (in shares) | 5,634,576 | |||
Less: share issue costs | (2,437,523) | (2,437,523) | ||
Shares issued pursuant to registered direct offering | $ 2,381 | 49,997,632 | 50,000,013 | |
Shares issued pursuant to registered direct offering (in shares) | 2,380,953 | |||
Less: share issue costs | (3,097,032) | (3,097,032) | ||
Shares issued pusuant to exercise of warrants | $ 350 | 1,466,150 | 1,466,500 | |
Shares issued pusuant to exercise of warrants (in shares) | 350,000 | |||
Share based compensation | 8,231,403 | 8,231,403 | ||
Net loss | (37,908,634) | (37,908,634) | ||
Ending balance, value at Sep. 30, 2021 | $ 75,920 | 348,328,048 | (197,585,864) | 150,818,104 |
Balance at ending, shares at Sep. 30, 2021 | 75,918,465 | |||
Shares issued pursuant to exercise of stock options | $ 401 | 1,009,789 | 1,010,190 | |
Shares issued pursuant to exercise of stock options (in shares) | 400,537 | |||
Shares issued under Sales Agreement | $ 1,623 | 20,983,044 | 20,984,667 | |
Shares issued under Sales Agreement (in shares) | 1,623,813 | |||
Less: share issue costs | (723,242) | (723,242) | ||
Share based compensation | 18,379,242 | 18,379,242 | ||
Net loss | (47,977,919) | (47,977,919) | ||
Ending balance, value at Sep. 30, 2022 | $ 77,944 | $ 387,976,881 | $ (245,563,783) | $ 142,491,042 |
Balance at ending, shares at Sep. 30, 2022 | 77,942,815 |
Business Description and Basis
Business Description and Basis of Presentation | 12 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Business Description and Basis of Presentation | Note 1 Business Description and Basis of Presentation Business Anavex Life Sciences Corp. (“Anavex” or the “Company”) is a clinical stage biopharmaceutical company engaged in the development of differentiated therapeutics by applying precision medicine to central nervous system (“CNS”) diseases with high unmet need. Anavex analyzes genomic data from clinical studies to identify biomarkers, which are used to select patients that will receive the therapeutic benefit for the treatment of neurodegenerative and neurodevelopmental diseases. The Company’s lead compound ANAVEX ® Basis of Presentation These consolidated financial statements have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) and the instructions to Form 10-K and have been prepared under the accounting principles generally accepted in the United States of America (“U.S. GAAP”). Liquidity All of the Company’s potential drug compounds are in the clinical development stage and the Company cannot be certain that its research and development efforts will be successful or, if successful, that its potential drug compounds will ever be approved for sale or generate commercial revenues. To date, we have not generated any revenues from our operations. The Company expects the business to continue to experience negative cash flows for the foreseeable future and cannot predict when, if ever, its business might become profitable. Management believes that the current working capital position will be sufficient to meet the Company’s working capital requirements beyond the next 12 months after the date that these consolidated financial statements are issued. The process of drug development can be costly, and the timing and outcomes of clinical trials is uncertain. The assumptions upon which the Company has based its estimates are routinely evaluated and may be subject to change. The actual amount of the Company’s expenditures will vary depending upon a number of factors including but not limited to the design, timing and duration of future clinical trials, the progress of the Company’s research and development programs and the level of financial resources available. The Company has the ability to adjust its operating plan spending levels based on the timing of future clinical trials. Other than our rights related to the Sales Agreement (as defined below in Note 5), there can be no assurance that additional financing will be available to us when needed or, if available, that it can be obtained on commercially reasonable terms. If the Company is not able to obtain the additional financing on a timely basis, if and when it is needed, it will be forced to delay or scale down some or all of its research and development activities. Coronavirus Disease 2019 (COVID-19) The recent global outbreak of COVID-19 did not have a material impact on the Company’s result of operations or financial condition for the year ended September 30, 2022. However, the future course of the pandemic could have adverse effects in the U.S and global economies and thus negatively impact our business and financial results. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 2 Summary of Significant Accounting Policies Use of Estimates The preparation of financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses in the reporting period. The Company regularly evaluates estimates and assumptions related to accounting for research and development costs, incentive income receivable, valuation and recoverability of deferred tax assets, stock-based compensation and loss contingencies. The Company bases its estimates and assumptions on current facts, historical experience and various other factors that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the book values of assets and liabilities and the accrual of costs and expenses that are not readily apparent from other sources. The actual results experienced by the Company may differ materially and adversely from the Company’s estimates. To the extent there are material differences between the estimates and the actual results, future results of operations will be affected. Principles of Consolidation These consolidated financial statements include the accounts of Anavex Life Sciences Corp. and its wholly owned subsidiaries, Anavex Australia Pty Limited. (“Anavex Australia”), a company incorporated under the laws of Australia, Anavex Germany GmbH, a company incorporated under the laws of Germany, and Anavex Canada Ltd., a company incorporated under the laws of the Province of Ontario, Canada. All inter-company transactions and balances have been eliminated. Cash and equivalents The Company considers only those investments which are highly liquid, readily convertible to cash and that mature within three months from the date of purchase to be cash equivalents Highly liquid investments that are considered cash equivalents include money market accounts, money market funds and certificates of deposit. The carrying value of cash equivalents approximates fair value due to the short-term maturity of these securities. The Company’s investment policy allows for investments in domestic money market certificates, certificates of deposit, money market funds, bonds or commercial papers, and establishes diversification and credit quality requirements and limits investments by maturity and issuer. The Company currently maintains its investments at one large well known financial institution. The Company maintains its cash in bank deposit accounts which, at times, may exceed federally insured limits. Accounts are guaranteed by the Federal Deposit Insurance Corporation (FDIC) up to $ 250,000 Research and Development Expenses Research and development costs are expensed as incurred. These expenses are comprised of the costs of the Company’s proprietary research and development efforts, including preclinical studies, clinical trials, manufacturing costs, employee salaries and benefits and stock-based compensation expense, contract services including external research and development expenses incurred under arrangements with third parties such as contract research organizations (“CROs”), facilities costs, overhead costs and other related expenses. Milestone payments made by the Company to third parties are expensed when the specific milestone has been achieved. Manufacturing costs are expensed as incurred in accordance with Accounting Standard Codification (“ASC”) 730, Research and Development, as these materials have no alternative future use outside of their intended use. Nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities are deferred and amortized over the period that the goods are delivered, or the related services are performed, subject to an assessment of recoverability. The Company makes estimates of costs incurred in relation to external CROs, and clinical site costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the studies including the phase or completion of events, invoices received and contracted costs. Judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates. The Company’s historical accrual estimates have not been materially different from actual costs. In addition, the Company incurs expenses in respect of intellectual property costs relating to patents and trademarks. The probability of success and length of time to develop commercial applications of the drugs subject to the underlying patent and trademark costs is difficult to determine and numerous risks and uncertainties exist with respect to the timely completion of the development projects. There is no assurance the drugs subject to the underlying patents and trademarks will ever be successfully commercialized. Due to these risks and uncertainties, the patent and trademark costs do not meet the definition of an asset and thus are expensed as incurred within general and administrative expenses. Research and Development Incentive Income The Company is eligible to obtain certain research and development tax credits, including the Australian research and development tax incentive credit (the “Australia R&D credit”) through a program administered through the Australian Tax Office (the “ATO”) and AusIndustry, a division of the Australian Government’s Department of Industry, Innovation and Science (“AusIndustry”), which provides for a cash refund based on a percentage of eligible research and development activities undertaken in Australia by the Company’s wholly owned subsidiary, Anavex Australia. Anavex Australia is also eligible under the Australia R&D credit program to receive the cash refund for certain research and development expenses incurred by Anavex Australia outside of Australia, to the extent such expenses are pre-approved by AusIndustry pursuant to an advanced overseas finding application. The Australia R&D credit program is available to eligible companies with an annual aggregate revenue of less than $20.0 million Australian during the reimbursable period. The tax incentives are available on the basis of specific criteria with which the Company must comply. Although the tax incentive may be administered through the local tax authority, the Company has accounted for the incentives outside of the scope of ASC Topic 740, Income Taxes (“ASC 740”), since the incentives are not linked to the Company’s taxable income and can be realized regardless of whether the Company has generated taxable income in the respective jurisdictions. With respect to the Australia R&D credit, as there is no authoritative guidance under GAAP for accounting for grants to for-profit business entities, the Company accounts for the grant by analogy to IAS20 Accounting for Government Grants and Disclosure of Government Assistance In addition, Anavex Australia and Anavex Canada incur Goods and Services Tax (GST) on certain services provided by local vendors. As a domestic entity in those jurisdictions, Anavex Australia and Anavex Canada are entitled to a refund of the GST paid. Similarly, Anavex Germany incurs Value Added Tax (VAT) on certain services provided by local vendors, to which it is entitled to a refund of such VAT paid. The Company’s estimate of the amount of cash refund it expects to receive related to GST and VAT incurred is included in Incentive and tax receivables in the accompanying consolidated balance sheets. Basic and Diluted Loss per Share Basic income/(loss) per common share is computed by dividing net income/(loss) available to common stockholders by the weighted average number of common shares outstanding during the period. Diluted income/(loss) per common share is computed by dividing net income/(loss) available to common stockholders by the sum of (1) the weighted-average number of common shares outstanding during the period, (2) the dilutive effect of the assumed exercise of options and warrants using the treasury stock method and (3) the dilutive effect of other potentially dilutive securities. For purposes of the diluted net loss per share calculation, options and warrants are potentially dilutive securities and are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive. As of September 30, 2022, diluted loss per share excludes 13,329,616 11,540,903 10,576,266 Financial Instruments The book value of the Company’s financial instruments, consisting of cash and equivalents, incentive and tax receivables, accounts payable and accrued liabilities approximate their fair value due to the short-term maturity of such instruments. Unless otherwise noted, it is management’s opinion that the Company is not exposed to significant interest, currency or credit risks arising from these financial instruments. Foreign Currency Translation The functional currency of the Company is the US dollar. Monetary items denominated in a foreign currency are translated into US dollars at exchange rates prevailing at the balance sheet date and non-monetary items are translated at exchange rates prevailing when the assets were acquired, or obligations incurred. Foreign currency denominated expense items are translated at exchange rates prevailing on the transaction date. Unrealized gains or losses arising from the translations are credited or charged to income in the period in which they occur. The Company has determined that the functional currency of Anavex Australia Pty Limited, Anavex Germany GmbH, and Anavex Canada Ltd. is also the US dollar. Segment and Geographic Reporting Operating segments are defined as components of an enterprise for which separate discrete information is available for evaluation by the chief operating decision maker or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business as one operating segment, which is the business of developing novel therapies for the management of CNS diseases. Grant Income Grant income is recognized at the fair value of the grant when it is received, and all substantive conditions have been satisfied. Grants received from government and other agencies in advance of the specific research and development costs to which they relate are deferred and recognized in the consolidated statement of operations in the period they are earned and when the related research and development costs are incurred. Income Taxes The Company follows the provisions of ASC 740, which requires the asset and liability method of accounting for income taxes. Under the asset and liability method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the financial statements carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The Company follows the provisions of ASC 740 regarding accounting for uncertainty in income taxes. The Company initially recognizes tax positions in the financial statements when it is more likely than not the position will be sustained upon examination by the tax authorities. Such tax positions are initially and subsequently measured as the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate settlement with the tax authority assuming full knowledge of the position and all relevant facts. Application requires numerous estimates based on available information. The Company considers many factors when evaluating and estimating its tax positions and tax benefits, and its recognized tax positions and tax benefits may not accurately anticipate actual outcomes. As additional information is obtained, there may be a need to periodically adjust the recognized tax positions and tax benefits. These periodic adjustments may have a material impact on the consolidated statements of operations. At September 30, 2022 the Company did no The Company recognizes interest and penalties related to current income tax expense on the interest income, net line, in the accompanying consolidated statement of operations. Accrued interest and penalties, if any, are included in accrued liabilities on the consolidated balance sheets. There were no Stock-based Compensation The Company accounts for all stock-based payments and awards under the fair value method. The fair value of all share purchase options and warrants are expensed over their contractual vesting period, or over the expected performance period for only the portion of awards expected to vest, in the case of milestone-based vesting, with a corresponding increase to additional paid-in capital. Compensation costs for stock-based payments with graded vesting are recognized on a straight-line basis. Stock based compensation expense is adjusted for actual forfeitures of unvested awards as they occur. The Company has granted share purchase option awards that vest upon achievement of certain performance criteria, or milestone-based awards. The Company estimates an implicit service period for achieving performance criteria for each award and recognizes the resulting fair value as expense over the implicit service period when it concludes that achieving the performance criteria is probable. The Company periodically reviews and updates as appropriate its estimates of implicit service periods and conclusions on achieving the performance criteria. Performance awards vest upon achievement of the performance criteria. The Company uses the Black-Scholes option valuation model to calculate the fair value of share purchase options and warrants at the date of the grant. This model requires the input of subjective assumptions, including the expected price volatility and expected life of each award. The Company uses the U.S. Treasury daily treasury yield curve rates for the expected term of the option as the risk-free rate. The expected term represents the period that options granted are expected to be outstanding using the simplified method. The Company’s historical share option exercise experience does not provide a reasonable basis for estimating the expected term. Expected volatility is based on the average of the daily share price changes over the expected term. The Company does not estimate forfeitures and elects to record actual forfeitures as they occur. The Company has not paid any dividends on its common stock historically, therefore no assumption of dividend payments is made in the model. These assumptions consist of estimates of future market conditions, which are inherently uncertain, and therefore, are subject to management’s judgment. Changes in these assumptions can materially affect the fair value estimates. The purchase price of options or warrants may be paid in cash or, if approved by the Company’s compensation committee in advance, “net settled” in shares of the Company’s common stock. In a net settlement of an option or warrant, the Company does not receive payment of the exercise price from the holder but reduces the number of shares of common stock issued upon the exercise of the stock option or warrant by the smallest number of whole shares that have an aggregate fair market value equal to or over the aggregate exercise price for the option shares covered by the option or warrant exercised. Shares issued pursuant to the exercise of options and warrants are issued from the Company’s treasury. Fair Value Measurements Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. Assets and liabilities that are measured at fair value are reported using a three-level fair value hierarchy that prioritizes the inputs used to measure fair value. This hierarchy maximizes the use of observable inputs and minimizes the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows: Level 1 - quoted prices (unadjusted) in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date; Level 2 - observable inputs other than Level 1, quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, and model-derived prices whose inputs are observable or whose significant value drivers are observable; and Level 3 - assets and liabilities whose significant value drivers are unobservable by little or no market activity and that are significant to the fair value of the assets or liabilities. At September 30, 2022 and 2021, the Company did not have any Level 2 or Level 3 assets or liabilities. Recently Adopted Accounting Pronouncements Effective October 1, 2021, the Company adopted Accounting Standards Update (“ASU”) 2019-12, “Simplifying the Accounting for Income Taxes (ASC 740)”, which is intended to simplify various aspects related to accounting for income taxes by removing certain exceptions to the general principles in Topic 740 and clarifying and amending existing guidance to improve consistent application. There was no material impact on the Company’s operations, financial condition, or cash flows. In November 2021, the Financial Accounting Standards Board (“FASB”) issued ASU 2021-10, “Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance” (“ASU 2021-10”). ASU 2021-10 increases the transparency of government assistance including the disclosure of (1) the types of assistance, (2) an entity’s accounting for the assistance, and (3) the effect of the assistance on an entity’s financial statements. ASU 2021-10 is effective for fiscal years beginning after December 15, 2021, with early adoption permitted. Upon implementation, the Company may use either a prospective or retrospective method of adoption when adopting the ASU. The adoption of ASU 2021-10 will impact the disclosures related to the research and development incentive income that the Company receives from the ATO for its clinical trials in Australia. The Company currently plans to adopt the provisions of this ASU on October 1, 2022. |
Accrued Liabilities
Accrued Liabilities | 12 Months Ended |
Sep. 30, 2022 | |
Accrued Liabilities | |
Accrued Liabilities | Note 3 Accrued Liabilities The principal components of accrued liabilities consist of: Schedule of components of accrued liabilities 2022 2021 Accrued clinical site and patient visits costs $ 2,031,105 $ 2,035,800 Accrued compensation and benefits 1,297,337 1,201,903 Fixed contract accruals 417,414 649,649 All other accrued liabilities 2,199,097 1,727,422 Total accrued liabilities $ 5,944,953 $ 5,614,774 |
Other Income
Other Income | 12 Months Ended |
Sep. 30, 2022 | |
Other Income | |
Other Income | Note 4 Other Income Grant income During the year ended September 30, 2022, the Company received $ 0 497,931 0 995,862 ® The grant income is being deferred when received and amortized to other income as the related research and development expenditures are incurred. During the year ended September 30, 2022, the Company recognized $Nil 0 54,100 0 443,831 443,831 During the year ended September 30, 2017, the Company was awarded grant funding in the amount of $ 597,886 The grant income was deferred when received and amortized to other income as the related research and development expenditures were incurred. During the year ended September 30, 2020, the Company recognized $ 149,888 Research and development incentive income Research and development incentive income represents income earned by the Company’s Australian subsidiary, of the Australian research and development tax incentive credit (the “tax incentive credit”). During the year ended September 30, 2022, the Company recorded research and development incentive income of $ 3,323,011 4,468,246 4,547,099 6,068,993 4,375,025 6,392,266 The Company evaluates its eligibility under the tax incentive program as of each balance sheet date based on the most current and relevant data available. Although the Company believes that it complies with all the relevant conditions of the program, as a matter of course, the Company may be subject to pre-issue review or audit by the ATO and, the ATO may have different interpretations of certain eligibility requirements. Currently, the Company’s tax incentive claims from 2018 to 2022 are open to potential review or audit by the ATO. |
Equity Offerings
Equity Offerings | 12 Months Ended |
Sep. 30, 2022 | |
Equity Offerings | |
Equity Offerings | Note 5 Equity Offerings Common Stock Common shares are voting and are entitled to dividends as declared at the discretion of the Board of Directors. Preferred Stock The Company’s Board of Directors (the “Board”) has the authority to issue preferred stock in one or more series and to fix the rights, preferences, privileges, restrictions and the number of shares constituting any series or the designation of the series. Registered Direct Offering On June 22, 2021, the Company and Deep Track Capital entered into a securities purchase agreement pursuant to which the Company sold to Deep Track Capital an aggregate of 2,380,953 shares of common stock at $21 per share in a registered direct offering, for gross proceeds of $50,000,013. Net proceeds of the offering were $46,902,981 after deducting offering fees and expenses. Sales Agreement The Company entered into a Controlled Equity Offering Sales Agreement on July 6, 2018, which was amended and restated on May 1, 2020 (the “Sales Agreement”) with Cantor Fitzgerald & Co. and SVB Leerink LLC (together the “Sales Agents”), pursuant to which the Company may offer and sell shares of common stock registered under an effective registration statement from time to time through the Sales Agents (the “Offering”). Upon delivery of a placement notice based on the Company’s instructions and subject to the terms and conditions of the Sales Agreement, the Sales Agents may sell the Shares by methods deemed to be an “at the market offering” offering, in negotiated transactions at market prices prevailing at the time of sale or at prices related to such prevailing market prices, or by any other method permitted by law, including negotiated transactions, subject to the prior written consent of the Company. The Company is not obligated to make any sales of Shares under the Sales Agreement. The Company or Sales Agents may suspend or terminate the offering of Shares upon notice to the other party, subject to certain conditions. The Sales Agents will act as agents on a commercially reasonable efforts basis consistent with their normal trading and sales practices and applicable state and federal law, rules and regulations and the rules of Nasdaq. The Company has agreed to pay the Sales Agents commissions for their services of up to 3.0 1,623,813 20,984,667 20,261,425 5,634,576 79,107,550 76,670,027 1,760,429 7,499,900 7,096,136 142,407,882 163,392,550 2019 Purchase Agreement On June 7, 2019, the Company entered into a $50,000,000 purchase agreement (the “2019 Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), as amended on July 1, 2020, pursuant to which the Company had the right to sell and issue to Lincoln Park, and Lincoln Park was obligated to purchase, up to $ 50,000,000 In consideration for entering into the 2019 Purchase Agreement, the Company issued to Lincoln Park 324,383 162,191 50,000,000 During the year ended September 30, 2022, the Company did not issue any shares to Lincoln Park under the 2019 Purchase Agreement. During the year ended September 30, 2021, the Company issued to Lincoln Park an aggregate of 4,086,209 7,633,527 4,007,996 7,564,584 24,111,198 21,254,298 78,213 68,943 At September 30, 2022 and 2021, no |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 6 Commitments and Contingencies Lease During the year ended September 30, 2022, the Company incurred office lease expense of $ 72,865 130,784 233,423 Employee 401(k) Benefit Plan The Company has a defined-contribution savings plan under Section 401(k) of the Internal Revenue Code. The plan covers all United States based employees. United States based employees eligible to participate in the plan may contribute up to the current statutory limits under the Internal Revenue Service regulations. The 401(k) plan permits the Company to make additional matching contributions on behalf of contributing employees. During the year ended September 30, 2022, the Company made $ 158,112 128,856 98,058 Litigation The Company is subject to claims and legal proceedings that arise in the ordinary course of business. Such matters are inherently uncertain, and there can be no guarantee that the outcome of any such matter will be decided favorably to the Company or that the resolution of any such matter will not have a material adverse effect upon the Company’s consolidated financial statements. The Company does not believe that any of such pending claims and legal proceedings will have a material adverse effect on its consolidated financial statements. Share Purchase Warrants The following table summarizes the warrant activity during the years ended September 30, 2022: Schedule of exercisable share purchase warrants outstanding Weighted Average Number of Exercise Shares Price ($) Balance, September 30, 2021 210,000 5.69 Forfeited (50,000 ) 12.00 Balance, September 30, 2022 160,000 3.72 On September 30, 2022, the Company had share purchase warrants outstanding as follows: Schedule of share purchase warrants outstanding Number Exercise Price Expiry Date 150,000 $ 3.17 May 6, 2024 10,000 $ 12.00 April 21, 2026 160,000 Stock–based Compensation Plan 2015 Stock Option Plan On September 18, 2015, the Company’s board of directors approved a 2015 Omnibus Incentive Plan (the “2015 Plan”), which provided for the grant of stock options and restricted stock awards to directors, officers, employees and consultants of the Company. The maximum number of our common shares reserved for issue under the plan was 6,050,553 2019 Stock Option Plan On January 15, 2019, the Board approved the 2019 Omnibus Incentive Plan (the “2019 Plan”), which provides for the grant of stock options and restricted stock awards to directors, officers, employees, consultants and advisors of the Company. The maximum number of our common shares reserved for issue under the plan was 6,000,000 During the year ended September 30, 2022, 406,453 2022 Stock Option Plan On March 25, 2022, the Board approved the 2022 Omnibus Incentive Plan (the “2022 Plan”). The 2022 Plan was approved by stockholders on May 24, 2022. Under the terms of the 2022 Plan, 10,000,000 The 2022 Plan provides that it may be administered by the Board, or the Board may delegate such responsibility to a committee. The exercise price will be determined by the Board at the time of grant shall be at least equal to the fair market value on such date. If the grantee is a 10% stockholder on the grant date, then the exercise price shall not be less than 110% of fair market value of the Company’s shares of common stock on the grant date. Stock options may be granted under the 2022 Plan for an exercise period of up to ten years from the date of grant of the option or such lesser periods as may be determined by the Board, subject to earlier termination in accordance with the terms of the 2022 Plan. At September 30, 2022, 2,058,000 8,363,453 The following summarizes information about stock option activity during the year ended September 30, 2022: Schedule of outstanding stock purchase options Weighted Weighted Average Average Grant Number of Exercise Price Date Fair Value Aggregate Shares ($) ($) intrinsic value ($) Outstanding, September 30, 2021 11,330,903 5.74 140,132,451 Granted 2,358,000 10.13 7.07 — Forfeited (118,750 ) 6.86 5.23 — Exercised (400,537 ) 2.52 1.88 4,201,015 Outstanding, September 30, 2022 13,169,616 6.61 62,267,309 Exercisable, September 30, 2022 8,777,113 4.40 55,173,997 The following summarizes information about stock options at September 30, 2022 by a range of exercise prices: Summarizes information about stock options Weighted average Weighted Weighted Number of remaining average average Range of exercise prices outstanding contractual life exercise Number of exercise From To options (in years) price ($) vested options price ($) $ 0.92 $ 2.96 3,903,762 5.12 2.30 3,883,345 2.30 $ 3.15 $ 4.80 2,078,800 5.34 3.30 2,063,800 3.29 $ 5.04 $ 8.98 3,957,054 6.07 6.28 2,365,387 6.31 $ 9.20 $ 13.01 1,698,000 9.58 10.50 109,581 12.40 $ 13.22 $ 24.58 1,532,000 8.44 18.23 355,000 18.66 13,169,616 8,777,113 The weighted average per share fair value of options vested during the year ended September 30, 2022 was $ 4.69 2.54 2.55 6.4 6.8 5.1 5.5 The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying awards and the quoted market price of the Company’s stock for the options that were in-the-money at September 30, 2022. The Company recognized stock-based compensation expense of $ 18,379,242 8,231,403 4,876,906 Schedule of general and administrative expenses and research and development expenses 2022 2021 2020 General and administrative $ 7,129,412 $ 3,571,335 $ 2,210,789 Research and development 11,249,830 4,660,068 2,666,117 Total stock-based compensation $ 18,379,242 $ 8,231,403 $ 4,876,906 An amount of approximately $ 19,032,000 The fair value of each option and warrant award is estimated on the date of grant using the Black Scholes option pricing model based on the following weighted average assumptions: Schedule of weighted average assumptions for fair value of each option award 2022 2021 2020 Risk-free interest rate 3.11 % 0.73 % 1.57 % Expected life of options (years) 5.57 5.74 5.53 Annualized volatility 84.17 % 93.43 % 95.99 % Dividend rate 0.00 % 0.00 % 0.00 % The fair value of stock compensation charges recognized during the years ended September 30, 2022, 2021 and 2020 was determined with reference to the quoted market price of the Company’s shares on the grant date. |
Income Taxes
Income Taxes | 12 Months Ended |
Sep. 30, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 7 Income Taxes The Company’s U.S. and foreign loss before income taxes are set forth below: Schedule of Income before Income Tax, Domestic and Foreign 2022 2021 2020 United States $ (40,001,893 ) $ (28,850,926 ) $ (18,096,148 ) Foreign (7,617,534 ) (8,790,143 ) (8,161,658 ) Total $ (47,619,427 ) $ (37,641,069 ) $ (26,257,806 ) The components of net deferred income tax assets as of September 30, 2022 and 2021 are as follows: Schedule of deferred tax asset and liabilities 2022 2021 Net operating loss carryforwards $ 46,208,000 $ 34,982,000 Research and development tax credit carryforwards 2,182,000 1,577,000 Stock-based compensation 13,373,000 10,453,000 Unpaid charges 894,000 89,000 Intangible asset costs 388,000 323,000 Foreign exchange and other 44,000 62,000 Valuation allowance of deferred tax assets (63,089,000 ) (47,486,000 ) Net deferred tax assets $ — $ — A reconciliation of income tax expense at the statutory federal income tax rate and income taxes as reflected in the consolidated financial statements for the years ended September 30, 2022 and 2021 is as follows: Schedule of Effective Income Tax Rate Reconciliation 2022 2021 2020 Income tax benefit at statutory federal rate $ (10,000,000 ) $ (7,934,000 ) $ (5,519,000 ) Foreign income taxed at other rates (170,000 ) (353,000 ) (723,000 ) Permanent differences relating to stock based compensation (714,000 ) (4,379,000 ) — Permanent differences relating to Section 162(m) — 816,000 — Other permanent differences — 741,000 35,000 Adjustment to tax assets based on Section 382 — 3,330,000 — Research and development credits, net 232,000 1,042,000 1,267,000 State and local taxes (4,975,000 ) (7,022,000 ) (2,911,000 ) Adjustment to true up to prior years' tax provision 24,000 48,000 373,000 Effect of change in statutory tax rates — 216,000 36,000 State minimum and excise taxes 358,492 267,565 22,664 Change in valuation allowances 15,603,000 13,495,000 7,442,000 Income tax expense $ 358,492 $ 267,565 $ 22,664 As of September 30, 2022, the Company had U.S. federal net operating loss carryforwards of approximately $ 123.4 101.6 $37.7 million will begin to expire in 2025 and $85.7 million can be carried forward indefinitely 199.0 177.7 2036 2.2 1.6 10.6 14.9 7.9 11.2 The Company evaluates its valuation allowance requirements based on available evidence. When circumstances change, and this causes a change in management’s judgment about the recoverability of deferred tax assets, the impact of the change on the valuation allowance is reflected in current income. Because management of the Company does not currently believe that it is more likely than not that the Company will receive the benefit of these assets, a full valuation allowance has been established at September 30, 2022 and 2021. The Company files income tax returns in the U.S. federal jurisdiction and various state and local and foreign jurisdictions. The Company’s tax returns are subject to tax examinations by U.S. federal and state tax authorities, or examinations by foreign tax authorities until the respective statutes of limitation expire. The Company is subject to tax examinations by tax authorities for all taxation years commencing on or after 2018. Under the provisions of the Internal Revenue Code, the net operating loss (“NOL”) carryforwards are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities. Under Section 382 of the Internal Revenue Code, NOL and tax credit carryforwards may become subject to an annual limitation in the event of an over 50% cumulative change in the ownership interest of significant stockholders over a three-year period, as well as similar state tax provisions. The Company conducted a Section 382 study during the year ended September 30, 2021 and determined that, during the year ended September 30, 2015, there was a change in ownership which resulted in $25.8 million of federal NOLs being subject to an annual limitation of $439,914. During the year ended September 30, 2021, the Company reduced its federal NOLs by $12.1 million and its Research and Development tax credit carryforwards by $0.8 million, which are the amount of tax assets that will expire unutilized pursuant to the Section 382 study. This resulted in a reduction of $2.5 million of NOLs and $0.8 million of research and development credits and a corresponding reduction in the valuation allowance of $ 3.3 . During the year ended September 30, 2022 the Company determined that there were no changes in ownership pursuant to Section 382. As of September 30, 2022, the Company did not provide any foreign withholding taxes related to its foreign subsidiaries’ undistributed earnings, as such earnings have been retained and are intended to be indefinitely reinvested to fund ongoing operations of the foreign subsidiaries. It is not practicable to estimate the amount of taxes that would be payable upon remittance of these earnings, because such tax, if any, is dependent upon circumstances existing if and when remittance occur. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Use of Estimates | Use of Estimates The preparation of financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses in the reporting period. The Company regularly evaluates estimates and assumptions related to accounting for research and development costs, incentive income receivable, valuation and recoverability of deferred tax assets, stock-based compensation and loss contingencies. The Company bases its estimates and assumptions on current facts, historical experience and various other factors that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the book values of assets and liabilities and the accrual of costs and expenses that are not readily apparent from other sources. The actual results experienced by the Company may differ materially and adversely from the Company’s estimates. To the extent there are material differences between the estimates and the actual results, future results of operations will be affected. |
Principles of Consolidation | Principles of Consolidation These consolidated financial statements include the accounts of Anavex Life Sciences Corp. and its wholly owned subsidiaries, Anavex Australia Pty Limited. (“Anavex Australia”), a company incorporated under the laws of Australia, Anavex Germany GmbH, a company incorporated under the laws of Germany, and Anavex Canada Ltd., a company incorporated under the laws of the Province of Ontario, Canada. All inter-company transactions and balances have been eliminated. |
Cash and equivalents | Cash and equivalents The Company considers only those investments which are highly liquid, readily convertible to cash and that mature within three months from the date of purchase to be cash equivalents Highly liquid investments that are considered cash equivalents include money market accounts, money market funds and certificates of deposit. The carrying value of cash equivalents approximates fair value due to the short-term maturity of these securities. The Company’s investment policy allows for investments in domestic money market certificates, certificates of deposit, money market funds, bonds or commercial papers, and establishes diversification and credit quality requirements and limits investments by maturity and issuer. The Company currently maintains its investments at one large well known financial institution. The Company maintains its cash in bank deposit accounts which, at times, may exceed federally insured limits. Accounts are guaranteed by the Federal Deposit Insurance Corporation (FDIC) up to $ 250,000 |
Research and Development Expenses | Research and Development Expenses Research and development costs are expensed as incurred. These expenses are comprised of the costs of the Company’s proprietary research and development efforts, including preclinical studies, clinical trials, manufacturing costs, employee salaries and benefits and stock-based compensation expense, contract services including external research and development expenses incurred under arrangements with third parties such as contract research organizations (“CROs”), facilities costs, overhead costs and other related expenses. Milestone payments made by the Company to third parties are expensed when the specific milestone has been achieved. Manufacturing costs are expensed as incurred in accordance with Accounting Standard Codification (“ASC”) 730, Research and Development, as these materials have no alternative future use outside of their intended use. Nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities are deferred and amortized over the period that the goods are delivered, or the related services are performed, subject to an assessment of recoverability. The Company makes estimates of costs incurred in relation to external CROs, and clinical site costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the studies including the phase or completion of events, invoices received and contracted costs. Judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates. The Company’s historical accrual estimates have not been materially different from actual costs. In addition, the Company incurs expenses in respect of intellectual property costs relating to patents and trademarks. The probability of success and length of time to develop commercial applications of the drugs subject to the underlying patent and trademark costs is difficult to determine and numerous risks and uncertainties exist with respect to the timely completion of the development projects. There is no assurance the drugs subject to the underlying patents and trademarks will ever be successfully commercialized. Due to these risks and uncertainties, the patent and trademark costs do not meet the definition of an asset and thus are expensed as incurred within general and administrative expenses. |
Research and Development Incentive Income | Research and Development Incentive Income The Company is eligible to obtain certain research and development tax credits, including the Australian research and development tax incentive credit (the “Australia R&D credit”) through a program administered through the Australian Tax Office (the “ATO”) and AusIndustry, a division of the Australian Government’s Department of Industry, Innovation and Science (“AusIndustry”), which provides for a cash refund based on a percentage of eligible research and development activities undertaken in Australia by the Company’s wholly owned subsidiary, Anavex Australia. Anavex Australia is also eligible under the Australia R&D credit program to receive the cash refund for certain research and development expenses incurred by Anavex Australia outside of Australia, to the extent such expenses are pre-approved by AusIndustry pursuant to an advanced overseas finding application. The Australia R&D credit program is available to eligible companies with an annual aggregate revenue of less than $20.0 million Australian during the reimbursable period. The tax incentives are available on the basis of specific criteria with which the Company must comply. Although the tax incentive may be administered through the local tax authority, the Company has accounted for the incentives outside of the scope of ASC Topic 740, Income Taxes (“ASC 740”), since the incentives are not linked to the Company’s taxable income and can be realized regardless of whether the Company has generated taxable income in the respective jurisdictions. With respect to the Australia R&D credit, as there is no authoritative guidance under GAAP for accounting for grants to for-profit business entities, the Company accounts for the grant by analogy to IAS20 Accounting for Government Grants and Disclosure of Government Assistance In addition, Anavex Australia and Anavex Canada incur Goods and Services Tax (GST) on certain services provided by local vendors. As a domestic entity in those jurisdictions, Anavex Australia and Anavex Canada are entitled to a refund of the GST paid. Similarly, Anavex Germany incurs Value Added Tax (VAT) on certain services provided by local vendors, to which it is entitled to a refund of such VAT paid. The Company’s estimate of the amount of cash refund it expects to receive related to GST and VAT incurred is included in Incentive and tax receivables in the accompanying consolidated balance sheets. |
Basic and Diluted Loss per Share | Basic and Diluted Loss per Share Basic income/(loss) per common share is computed by dividing net income/(loss) available to common stockholders by the weighted average number of common shares outstanding during the period. Diluted income/(loss) per common share is computed by dividing net income/(loss) available to common stockholders by the sum of (1) the weighted-average number of common shares outstanding during the period, (2) the dilutive effect of the assumed exercise of options and warrants using the treasury stock method and (3) the dilutive effect of other potentially dilutive securities. For purposes of the diluted net loss per share calculation, options and warrants are potentially dilutive securities and are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive. As of September 30, 2022, diluted loss per share excludes 13,329,616 11,540,903 10,576,266 |
Financial Instruments | Financial Instruments The book value of the Company’s financial instruments, consisting of cash and equivalents, incentive and tax receivables, accounts payable and accrued liabilities approximate their fair value due to the short-term maturity of such instruments. Unless otherwise noted, it is management’s opinion that the Company is not exposed to significant interest, currency or credit risks arising from these financial instruments. |
Foreign Currency Translation | Foreign Currency Translation The functional currency of the Company is the US dollar. Monetary items denominated in a foreign currency are translated into US dollars at exchange rates prevailing at the balance sheet date and non-monetary items are translated at exchange rates prevailing when the assets were acquired, or obligations incurred. Foreign currency denominated expense items are translated at exchange rates prevailing on the transaction date. Unrealized gains or losses arising from the translations are credited or charged to income in the period in which they occur. The Company has determined that the functional currency of Anavex Australia Pty Limited, Anavex Germany GmbH, and Anavex Canada Ltd. is also the US dollar. |
Segment and Geographic Reporting | Segment and Geographic Reporting Operating segments are defined as components of an enterprise for which separate discrete information is available for evaluation by the chief operating decision maker or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business as one operating segment, which is the business of developing novel therapies for the management of CNS diseases. |
Grant Income | Grant Income Grant income is recognized at the fair value of the grant when it is received, and all substantive conditions have been satisfied. Grants received from government and other agencies in advance of the specific research and development costs to which they relate are deferred and recognized in the consolidated statement of operations in the period they are earned and when the related research and development costs are incurred. |
Income Taxes | Income Taxes The Company follows the provisions of ASC 740, which requires the asset and liability method of accounting for income taxes. Under the asset and liability method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the financial statements carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The Company follows the provisions of ASC 740 regarding accounting for uncertainty in income taxes. The Company initially recognizes tax positions in the financial statements when it is more likely than not the position will be sustained upon examination by the tax authorities. Such tax positions are initially and subsequently measured as the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate settlement with the tax authority assuming full knowledge of the position and all relevant facts. Application requires numerous estimates based on available information. The Company considers many factors when evaluating and estimating its tax positions and tax benefits, and its recognized tax positions and tax benefits may not accurately anticipate actual outcomes. As additional information is obtained, there may be a need to periodically adjust the recognized tax positions and tax benefits. These periodic adjustments may have a material impact on the consolidated statements of operations. At September 30, 2022 the Company did no The Company recognizes interest and penalties related to current income tax expense on the interest income, net line, in the accompanying consolidated statement of operations. Accrued interest and penalties, if any, are included in accrued liabilities on the consolidated balance sheets. There were no |
Stock-based Compensation | Stock-based Compensation The Company accounts for all stock-based payments and awards under the fair value method. The fair value of all share purchase options and warrants are expensed over their contractual vesting period, or over the expected performance period for only the portion of awards expected to vest, in the case of milestone-based vesting, with a corresponding increase to additional paid-in capital. Compensation costs for stock-based payments with graded vesting are recognized on a straight-line basis. Stock based compensation expense is adjusted for actual forfeitures of unvested awards as they occur. The Company has granted share purchase option awards that vest upon achievement of certain performance criteria, or milestone-based awards. The Company estimates an implicit service period for achieving performance criteria for each award and recognizes the resulting fair value as expense over the implicit service period when it concludes that achieving the performance criteria is probable. The Company periodically reviews and updates as appropriate its estimates of implicit service periods and conclusions on achieving the performance criteria. Performance awards vest upon achievement of the performance criteria. The Company uses the Black-Scholes option valuation model to calculate the fair value of share purchase options and warrants at the date of the grant. This model requires the input of subjective assumptions, including the expected price volatility and expected life of each award. The Company uses the U.S. Treasury daily treasury yield curve rates for the expected term of the option as the risk-free rate. The expected term represents the period that options granted are expected to be outstanding using the simplified method. The Company’s historical share option exercise experience does not provide a reasonable basis for estimating the expected term. Expected volatility is based on the average of the daily share price changes over the expected term. The Company does not estimate forfeitures and elects to record actual forfeitures as they occur. The Company has not paid any dividends on its common stock historically, therefore no assumption of dividend payments is made in the model. These assumptions consist of estimates of future market conditions, which are inherently uncertain, and therefore, are subject to management’s judgment. Changes in these assumptions can materially affect the fair value estimates. The purchase price of options or warrants may be paid in cash or, if approved by the Company’s compensation committee in advance, “net settled” in shares of the Company’s common stock. In a net settlement of an option or warrant, the Company does not receive payment of the exercise price from the holder but reduces the number of shares of common stock issued upon the exercise of the stock option or warrant by the smallest number of whole shares that have an aggregate fair market value equal to or over the aggregate exercise price for the option shares covered by the option or warrant exercised. Shares issued pursuant to the exercise of options and warrants are issued from the Company’s treasury. |
Fair Value Measurements | Fair Value Measurements Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. Assets and liabilities that are measured at fair value are reported using a three-level fair value hierarchy that prioritizes the inputs used to measure fair value. This hierarchy maximizes the use of observable inputs and minimizes the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows: Level 1 - quoted prices (unadjusted) in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date; Level 2 - observable inputs other than Level 1, quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, and model-derived prices whose inputs are observable or whose significant value drivers are observable; and Level 3 - assets and liabilities whose significant value drivers are unobservable by little or no market activity and that are significant to the fair value of the assets or liabilities. At September 30, 2022 and 2021, the Company did not have any Level 2 or Level 3 assets or liabilities. |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements Effective October 1, 2021, the Company adopted Accounting Standards Update (“ASU”) 2019-12, “Simplifying the Accounting for Income Taxes (ASC 740)”, which is intended to simplify various aspects related to accounting for income taxes by removing certain exceptions to the general principles in Topic 740 and clarifying and amending existing guidance to improve consistent application. There was no material impact on the Company’s operations, financial condition, or cash flows. In November 2021, the Financial Accounting Standards Board (“FASB”) issued ASU 2021-10, “Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance” (“ASU 2021-10”). ASU 2021-10 increases the transparency of government assistance including the disclosure of (1) the types of assistance, (2) an entity’s accounting for the assistance, and (3) the effect of the assistance on an entity’s financial statements. ASU 2021-10 is effective for fiscal years beginning after December 15, 2021, with early adoption permitted. Upon implementation, the Company may use either a prospective or retrospective method of adoption when adopting the ASU. The adoption of ASU 2021-10 will impact the disclosures related to the research and development incentive income that the Company receives from the ATO for its clinical trials in Australia. The Company currently plans to adopt the provisions of this ASU on October 1, 2022. |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 12 Months Ended |
Sep. 30, 2022 | |
Accrued Liabilities | |
Schedule of components of accrued liabilities | Schedule of components of accrued liabilities 2022 2021 Accrued clinical site and patient visits costs $ 2,031,105 $ 2,035,800 Accrued compensation and benefits 1,297,337 1,201,903 Fixed contract accruals 417,414 649,649 All other accrued liabilities 2,199,097 1,727,422 Total accrued liabilities $ 5,944,953 $ 5,614,774 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of exercisable share purchase warrants outstanding | Schedule of exercisable share purchase warrants outstanding Weighted Average Number of Exercise Shares Price ($) Balance, September 30, 2021 210,000 5.69 Forfeited (50,000 ) 12.00 Balance, September 30, 2022 160,000 3.72 |
Schedule of share purchase warrants outstanding | Schedule of share purchase warrants outstanding Number Exercise Price Expiry Date 150,000 $ 3.17 May 6, 2024 10,000 $ 12.00 April 21, 2026 160,000 |
Schedule of outstanding stock purchase options | Schedule of outstanding stock purchase options Weighted Weighted Average Average Grant Number of Exercise Price Date Fair Value Aggregate Shares ($) ($) intrinsic value ($) Outstanding, September 30, 2021 11,330,903 5.74 140,132,451 Granted 2,358,000 10.13 7.07 — Forfeited (118,750 ) 6.86 5.23 — Exercised (400,537 ) 2.52 1.88 4,201,015 Outstanding, September 30, 2022 13,169,616 6.61 62,267,309 Exercisable, September 30, 2022 8,777,113 4.40 55,173,997 |
Summarizes information about stock options | Summarizes information about stock options Weighted average Weighted Weighted Number of remaining average average Range of exercise prices outstanding contractual life exercise Number of exercise From To options (in years) price ($) vested options price ($) $ 0.92 $ 2.96 3,903,762 5.12 2.30 3,883,345 2.30 $ 3.15 $ 4.80 2,078,800 5.34 3.30 2,063,800 3.29 $ 5.04 $ 8.98 3,957,054 6.07 6.28 2,365,387 6.31 $ 9.20 $ 13.01 1,698,000 9.58 10.50 109,581 12.40 $ 13.22 $ 24.58 1,532,000 8.44 18.23 355,000 18.66 13,169,616 8,777,113 |
Schedule of general and administrative expenses and research and development expenses | Schedule of general and administrative expenses and research and development expenses 2022 2021 2020 General and administrative $ 7,129,412 $ 3,571,335 $ 2,210,789 Research and development 11,249,830 4,660,068 2,666,117 Total stock-based compensation $ 18,379,242 $ 8,231,403 $ 4,876,906 |
Schedule of weighted average assumptions for fair value of each option award | Schedule of weighted average assumptions for fair value of each option award 2022 2021 2020 Risk-free interest rate 3.11 % 0.73 % 1.57 % Expected life of options (years) 5.57 5.74 5.53 Annualized volatility 84.17 % 93.43 % 95.99 % Dividend rate 0.00 % 0.00 % 0.00 % |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Sep. 30, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule of Income before Income Tax, Domestic and Foreign | Schedule of Income before Income Tax, Domestic and Foreign 2022 2021 2020 United States $ (40,001,893 ) $ (28,850,926 ) $ (18,096,148 ) Foreign (7,617,534 ) (8,790,143 ) (8,161,658 ) Total $ (47,619,427 ) $ (37,641,069 ) $ (26,257,806 ) |
Schedule of deferred tax asset and liabilities | Schedule of deferred tax asset and liabilities 2022 2021 Net operating loss carryforwards $ 46,208,000 $ 34,982,000 Research and development tax credit carryforwards 2,182,000 1,577,000 Stock-based compensation 13,373,000 10,453,000 Unpaid charges 894,000 89,000 Intangible asset costs 388,000 323,000 Foreign exchange and other 44,000 62,000 Valuation allowance of deferred tax assets (63,089,000 ) (47,486,000 ) Net deferred tax assets $ — $ — |
Schedule of Effective Income Tax Rate Reconciliation | Schedule of Effective Income Tax Rate Reconciliation 2022 2021 2020 Income tax benefit at statutory federal rate $ (10,000,000 ) $ (7,934,000 ) $ (5,519,000 ) Foreign income taxed at other rates (170,000 ) (353,000 ) (723,000 ) Permanent differences relating to stock based compensation (714,000 ) (4,379,000 ) — Permanent differences relating to Section 162(m) — 816,000 — Other permanent differences — 741,000 35,000 Adjustment to tax assets based on Section 382 — 3,330,000 — Research and development credits, net 232,000 1,042,000 1,267,000 State and local taxes (4,975,000 ) (7,022,000 ) (2,911,000 ) Adjustment to true up to prior years' tax provision 24,000 48,000 373,000 Effect of change in statutory tax rates — 216,000 36,000 State minimum and excise taxes 358,492 267,565 22,664 Change in valuation allowances 15,603,000 13,495,000 7,442,000 Income tax expense $ 358,492 $ 267,565 $ 22,664 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details Narrative) - USD ($) | 12 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2020 | |
Accounting Policies [Abstract] | |||
Federal Deposit Insurance Corporation | $ 250,000 | ||
Loss per share for potentially dilutive common shares | 13,329,616 | 11,540,903 | 10,576,266 |
Uncertain tax positions | $ 0 | ||
Interest and penalties | $ 0 | $ 0 |
Accrued Liabilities (Details)
Accrued Liabilities (Details) - USD ($) | Sep. 30, 2022 | Sep. 30, 2021 |
Accrued Liabilities | ||
Accrued clinical site and patient visits costs | $ 2,031,105 | $ 2,035,800 |
Accrued compensation and benefits | 1,297,337 | 1,201,903 |
Fixed contract accruals | 417,414 | 649,649 |
All other accrued liabilities | 2,199,097 | 1,727,422 |
Total accrued liabilities | $ 5,944,953 | $ 5,614,774 |
Other Income (Details Narrative
Other Income (Details Narrative) - USD ($) | 12 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2017 | |
Defined Benefit Plan Disclosure [Line Items] | ||||
Grant income | $ 0 | $ 497,931 | $ 0 | |
Research and development incentive income | 3,323,011 | 4,547,099 | 4,375,025 | |
Grant income | 0 | 54,100 | 0 | $ 597,886 |
Deferred grant income | 443,831 | 443,831 | ||
Grant income | 149,888 | |||
Australia, Dollars | ||||
Defined Benefit Plan Disclosure [Line Items] | ||||
Research and development incentive income | $ 4,468,246 | 6,068,993 | $ 6,392,266 | |
Michael J Fox [Member] | ||||
Defined Benefit Plan Disclosure [Line Items] | ||||
Research and development incentive income | 995,862 | |||
Parkinson [Member] | ||||
Defined Benefit Plan Disclosure [Line Items] | ||||
Research and development incentive income | $ 995,862 |
Equity Offerings (Details Narra
Equity Offerings (Details Narrative) - USD ($) | 12 Months Ended | |||
Jun. 07, 2019 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2020 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Sales of agreement amount | $ 142,407,882 | $ 163,392,550 | ||
Equity Offering Sales Agreement [Member] | Cantor Fitzgerald And Co [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Percentage of gross proceeds from sales | 3% | |||
Number of common stock sold | 1,623,813 | 5,634,576 | 1,760,429 | |
Gross proceeds from Issuance Public Offering | $ 20,984,667 | $ 79,107,550 | $ 7,499,900 | |
Proceeds from Issuance Public Offering | $ 20,261,425 | $ 76,670,027 | $ 7,096,136 | |
2019 Purchase Agreement [Member] | Lincoln Park Capital Fund, LLC [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Value of shares obligated to purchase | $ 50,000,000 | |||
Share issued for offering, shares | 324,383 | 4,086,209 | 7,633,527 | |
Pro rata basic number of shares obligated to purchase | 162,191 | |||
Proceeds from Issuance or Sale of Equity | $ 50,000,000 | |||
Number of shares issued for aggregate purchase price | 4,007,996 | 7,564,584 | ||
Number of shares issued for aggregate purchase price, value | $ 24,111,198 | $ 21,254,298 | ||
Number of shares issued for commitment | 78,213 | 68,943 | ||
Amount of shares remain available | $ 0 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) - Purchase Warrants [Member] | 12 Months Ended |
Sep. 30, 2022 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Share Purchase Warrants Balance, at beginning | shares | 210,000 |
Weighted Average Exercise Price Balance, at beginning | $ / shares | $ 5.69 |
Share Purchase Warrants Forfeited | shares | (50,000) |
Weighted Average Exercise Price, Forfeited | $ / shares | $ 12 |
Share Purchase Warrants Balance, at ending | shares | 160,000 |
Weighted Average Exercise Price Balance, at ending | $ / shares | $ 3.72 |
Commitments and Contingencies_3
Commitments and Contingencies (Details 1) | Sep. 30, 2022 $ / shares shares |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number | 160,000 |
Purchase Warrants 1 [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number | 150,000 |
Exercise Price | $ / shares | $ 3.17 |
Expiry Date | May 06, 2024 |
Purchase Warrants 2 [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number | 10,000 |
Exercise Price | $ / shares | $ 12 |
Expiry Date | Apr. 21, 2026 |
Commitments and Contingencies_4
Commitments and Contingencies (Details 2) - Equity Option [Member] | 12 Months Ended |
Sep. 30, 2022 USD ($) $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Options Outstanding at beginning | shares | 11,330,903 |
Weighted Average Exercise Price Outstanding at beginning | $ 5.74 |
Aggregate intrinsic value Outstanding at beginning | $ | $ 140,132,451 |
Options Granted | shares | 2,358,000 |
Weighted Average Exercise Price Granted | $ 10.13 |
Weighted Average Grant Date Fair Value Granted | $ 7.07 |
Options Forfeited | shares | (118,750) |
Weighted Average Exercise Price Forfeited | $ 6.86 |
Weighted Average Grant Date Fair Value Forfeited | $ 5.23 |
Options Exercised | shares | (400,537) |
Weighted Average Exercise Price Exercised | $ 2.52 |
Weighted Average Grant Date Fair Value Exercised | $ 1.88 |
Aggregate intrinsic value Exercised | $ | $ 4,201,015 |
Options Outstanding at ending | shares | 13,169,616 |
Weighted Average Exercise Price Outstanding at ending | $ 6.61 |
Aggregate intrinsic value Outstanding at ending | $ | $ 62,267,309 |
Options Exercisable at ending | shares | 8,777,113 |
Weighted Average Exercise Price Exercisable at ending | $ 4.40 |
Aggregate intrinsic value Exercisable at ending | $ | $ 55,173,997 |
Commitments and Contingencies_5
Commitments and Contingencies (Details 3) - $ / shares | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Weighted average remaining contractual life (in years) | 6 years 4 months 24 days | 6 years 9 months 18 days |
Equity Option [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Number of outstanding options | 13,169,616 | 11,330,903 |
Weighted average exercise price | $ 6.61 | $ 5.74 |
Number of vested options | 8,777,113 | |
Equity Option [Member] | Option Price 1 [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Range of exercise prices, lower range limit | $ 0.92 | |
Range of exercise prices, upper range limit | $ 2.96 | |
Number of outstanding options | 3,903,762 | |
Weighted average remaining contractual life (in years) | 5 years 1 month 13 days | |
Weighted average exercise price | $ 2.30 | |
Number of vested options | 3,883,345 | |
Weighted average exercise price | $ 2.30 | |
Equity Option [Member] | Option Price 2 [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Range of exercise prices, lower range limit | 3.15 | |
Range of exercise prices, upper range limit | $ 4.80 | |
Number of outstanding options | 2,078,800 | |
Weighted average remaining contractual life (in years) | 5 years 4 months 2 days | |
Weighted average exercise price | $ 3.30 | |
Number of vested options | 2,063,800 | |
Weighted average exercise price | $ 3.29 | |
Equity Option [Member] | Option Price 3 [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Range of exercise prices, lower range limit | 5.04 | |
Range of exercise prices, upper range limit | $ 8.98 | |
Number of outstanding options | 3,957,054 | |
Weighted average remaining contractual life (in years) | 6 years 25 days | |
Weighted average exercise price | $ 6.28 | |
Number of vested options | 2,365,387 | |
Weighted average exercise price | $ 6.31 | |
Equity Option [Member] | Option Price 4 [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Range of exercise prices, lower range limit | 9.20 | |
Range of exercise prices, upper range limit | $ 13.01 | |
Number of outstanding options | 1,698,000 | |
Weighted average remaining contractual life (in years) | 9 years 6 months 29 days | |
Weighted average exercise price | $ 10.50 | |
Number of vested options | 109,581 | |
Weighted average exercise price | $ 12.40 | |
Equity Option [Member] | Option Price 5 [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Range of exercise prices, lower range limit | 13.22 | |
Range of exercise prices, upper range limit | $ 24.58 | |
Number of outstanding options | 1,532,000 | |
Weighted average remaining contractual life (in years) | 8 years 5 months 8 days | |
Weighted average exercise price | $ 18.23 | |
Number of vested options | 355,000 | |
Weighted average exercise price | $ 18.66 |
Commitments and Contingencies_6
Commitments and Contingencies (Details 4) - USD ($) | 12 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2020 | |
Loss Contingencies [Line Items] | |||
Total share based compensation | $ 18,379,242 | $ 8,231,403 | $ 4,876,906 |
General and Administrative Expense [Member] | |||
Loss Contingencies [Line Items] | |||
Total share based compensation | 7,129,412 | 3,571,335 | 2,210,789 |
Research and Development Expense [Member] | |||
Loss Contingencies [Line Items] | |||
Total share based compensation | $ 11,249,830 | $ 4,660,068 | $ 2,666,117 |
Commitments and Contingencies_7
Commitments and Contingencies (Details 5) | 12 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |||
Risk-free interest rate | 3.11% | 0.73% | 1.57% |
Expected life of options (years) | 5 years 6 months 25 days | 5 years 8 months 26 days | 5 years 6 months 10 days |
Annualized volatility | 84.17% | 93.43% | 95.99% |
Dividend rate | 0% | 0% | 0% |
Commitments and Contingencies_8
Commitments and Contingencies (Details Narrative) - USD ($) | 12 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2020 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Operating Leases, Rent Expense | $ 72,865 | $ 130,784 | $ 233,423 |
Contribution amount | $ 158,112 | $ 128,856 | $ 98,058 |
Option issued | 2,058,000 | ||
Weighted average grant date fair value of options vested | $ 4.69 | $ 2.54 | $ 2.55 |
Weighted average contractual life of options outstanding | 6 years 4 months 24 days | 6 years 9 months 18 days | |
Options exercisable | 5 years 1 month 6 days | 5 years 6 months | |
Share based compensation | $ 18,379,242 | $ 8,231,403 | $ 4,876,906 |
Remaining stock based compensation | $ 19,032,000 | ||
2015 Omnibus Incentive Plan [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Maximum number of common shares reserved for future issuance | 6,050,553 | ||
2019 Omnibus Incentive Plan [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Additional shares of common stock available for issuance | 6,000,000 | ||
Stock Option Plan 2022 [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Additional shares of common stock available for issuance | 10,000,000 | ||
Option granted | 406,453 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 8,363,453 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 12 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2020 | |
Income Tax Disclosure [Abstract] | |||
United States | $ (40,001,893) | $ (28,850,926) | $ (18,096,148) |
Foreign | (7,617,534) | (8,790,143) | (8,161,658) |
Total | $ (47,619,427) | $ (37,641,069) | $ (26,257,806) |
Income Taxes (Details 1)
Income Taxes (Details 1) - USD ($) | Sep. 30, 2022 | Sep. 30, 2021 |
Income Tax Disclosure [Abstract] | ||
Net operating loss carryforwards | $ 46,208,000 | $ 34,982,000 |
Research and development tax credit carryforwards | 2,182,000 | 1,577,000 |
Stock-based compensation | 13,373,000 | 10,453,000 |
Unpaid charges | 894,000 | 89,000 |
Intangible asset costs | 388,000 | 323,000 |
Foreign exchange and other | 44,000 | 62,000 |
Valuation allowance of deferred tax assets | (63,089,000) | (47,486,000) |
Net deferred tax assets |
Income Taxes (Details 2)
Income Taxes (Details 2) - USD ($) | 12 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2020 | |
Income Tax Disclosure [Abstract] | |||
Income tax benefit at statutory federal rate | $ (10,000,000) | $ (7,934,000) | $ (5,519,000) |
Foreign income taxed at other rates | (170,000) | (353,000) | (723,000) |
Permanent differences relating to stock based compensation | (714,000) | (4,379,000) | |
Permanent differences relating to Section 162(m) | 816,000 | ||
Other permanent differences | 741,000 | 35,000 | |
Adjustment to tax assets based on Section 382 | 3,330,000 | ||
Research and development credits, net | 232,000 | 1,042,000 | 1,267,000 |
State and local taxes | (4,975,000) | (7,022,000) | (2,911,000) |
Adjustment to true up to prior years' tax provision | 24,000 | 48,000 | 373,000 |
Effect of change in statutory tax rates | 216,000 | 36,000 | |
State minimum and excise taxes | 358,492 | 267,565 | 22,664 |
Change in valuation allowances | 15,603,000 | 13,495,000 | 7,442,000 |
Income tax expense | $ 358,492 | $ 267,565 | $ 22,664 |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) - USD ($) | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Operating Loss Carryforwards [Line Items] | ||
Operating loss carry forwards expiration year | 2036 | |
Research and Development tax credits | $ 2,200,000 | $ 1,600,000 |
Decrease in vaution allowance | 3,300,000 | |
Federal [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | $ 123,400,000 | 101,600,000 |
Operating loss carryforwards description | $37.7 million will begin to expire in 2025 and $85.7 million can be carried forward indefinitely | |
State and Local Jurisdiction [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | $ 199,000,000 | 177,700,000 |
Foreign Tax Authority [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | 10,600,000 | 7,900 |
Foreign Tax Authority [Member] | Australia, Dollars | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | $ 14,900 | $ 11,200,000 |