Cover
Cover - shares | 3 Months Ended | |
Dec. 31, 2023 | Feb. 07, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Dec. 31, 2023 | |
Document Fiscal Period Focus | Q1 | |
Document Fiscal Year Focus | 2024 | |
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 | |
Title of 12(b) Security | Common Stock Par Value $0.001 | |
Trading Symbol | AVXL | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 82,112,511 |
Condensed Consolidated Interim
Condensed Consolidated Interim Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2023 | Sep. 30, 2023 |
Current | ||
Cash and cash equivalents | $ 143,765 | $ 151,024 |
Incentive and tax receivables | 3,549 | 2,709 |
Prepaid expenses and other current assets | 756 | 653 |
Total Assets | 148,070 | 154,386 |
Current Liabilities | ||
Accounts payable | 4,292 | 4,322 |
Accrued liabilities - Note 4 | 7,286 | 7,295 |
Deferred grant income - Note 3 | 917 | 917 |
Total Liabilities | 12,495 | 12,534 |
Commitments and Contingencies - Note 6 | ||
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 82,086,511 common shares (September 30, 2023 - 82,066,511) | 82 | 82 |
Additional paid-in capital | 437,184 | 434,839 |
Accumulated deficit | (301,691) | (293,069) |
Total Stockholders' Equity | 135,575 | 141,852 |
Total Liabilities and Stockholders' Equity | $ 148,070 | $ 154,386 |
Condensed Consolidated Interi_2
Condensed Consolidated Interim Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2023 | Sep. 30, 2023 |
Statement of Financial Position [Abstract] | ||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares issued | 82,086,511 | 82,066,511 |
Common stock, shares outstanding | 82,086,511 | 82,066,511 |
Condensed Consolidated Interi_3
Condensed Consolidated Interim Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating expenses | ||
General and administrative | $ 2,609 | $ 3,317 |
Research and development | 8,684 | 12,067 |
Total operating expenses | 11,293 | 15,384 |
Operating loss | (11,293) | (15,384) |
Other income | ||
Grant income | 25 | |
Research and development incentive income | 592 | 733 |
Interest income, net | 2,008 | 1,268 |
Foreign exchange gain | 156 | 366 |
Total other income, net | 2,756 | 2,392 |
Net loss before provision for income taxes | (8,537) | (12,992) |
Income tax recovery (expense), current | (85) | 20 |
Net loss and comprehensive loss | $ (8,622) | $ (12,972) |
Condensed Consolidated Interi_4
Condensed Consolidated Interim Statements of Operations and Comprehensive Loss (Unaudited) (Parenthetical) - $ / shares | 3 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Statement [Abstract] | ||
Net Loss per share, Basic | $ (0.11) | $ (0.17) |
Net Loss per share, Diluted | $ (0.11) | $ (0.17) |
Weighted average number of shares outstanding, Basic | 82,077,815 | 77,977,112 |
Weighted average number of shares outstanding, Diluted | 82,077,815 | 77,977,112 |
Condensed Consolidated Interi_5
Condensed Consolidated Interim Statements of Changes in Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Beginning balance, value at Sep. 30, 2022 | $ 78 | $ 387,977 | $ (245,564) | $ 142,491 |
Beginning balance, shares at Sep. 30, 2022 | 77,942,815 | |||
Shares issued pursuant to exercise of stock options | 258 | 258 | ||
Shares issued upon exercise of stock options, shares | 89,320 | |||
Share based compensation | 5,347 | 5,347 | ||
Net loss | (12,972) | (12,972) | ||
Ending balance, value at Dec. 31, 2022 | $ 78 | 393,582 | (258,536) | 135,124 |
Ending balance, shares at Dec. 31, 2022 | 78,032,135 | |||
Beginning balance, value at Sep. 30, 2023 | $ 82 | 434,839 | (293,069) | 141,852 |
Beginning balance, shares at Sep. 30, 2023 | 82,066,511 | |||
Shares issued pursuant to exercise of stock options | 59 | 59 | ||
Shares issued pursuant to exercise of stock options, shares | 20,000 | |||
Share based compensation | 2,286 | 2,286 | ||
Net loss | (8,622) | (8,622) | ||
Ending balance, value at Dec. 31, 2023 | $ 82 | $ 437,184 | $ (301,691) | $ 135,575 |
Ending balance, shares at Dec. 31, 2023 | 82,086,511 |
Condensed Consolidated Interi_6
Condensed Consolidated Interim Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Cash Flows used in Operating Activities | ||
Net loss | $ (8,622) | $ (12,972) |
Adjustments to reconcile net loss to net cash used in operations: | ||
Share based compensation | 2,286 | 5,347 |
Changes in working capital balances related to operations: | ||
Incentive and tax receivables | (840) | (902) |
Prepaid expenses and deposits | (103) | (301) |
Accounts payable | (30) | 1,463 |
Accrued liabilities | (9) | 1,098 |
Deferred grant income | 473 | |
Net cash used in operating activities | (7,318) | (5,794) |
Cash Flows provided by Financing Activities | ||
Proceeds from exercise of stock options | 59 | 258 |
Net cash provided by financing activities | 59 | 258 |
Decrease in cash and cash equivalents during the period | (7,259) | (5,536) |
Cash and cash equivalents, beginning of period | 151,024 | 149,158 |
Cash and cash equivalents, end of period | 143,765 | 143,622 |
Supplemental Cash Flow Information | ||
Cash paid for state and local minimum income taxes | $ 47 | $ 50 |
Business Description
Business Description | 3 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Business Description | Note 1 Business Description 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 trials to identify biomarkers, which are used in the analysis of its clinical trials for the treatment of neurodegenerative and neurodevelopmental diseases. The Company’s lead compound ANAVEX ® |
Basis of Presentation
Basis of Presentation | 3 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Presentation | Note 2 Basis of Presentation Basis of Presentation These accompanying unaudited condensed consolidated interim financial statements have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) and accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim reporting. Accordingly, certain information and note disclosures normally included in the annual financial statements in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. In the opinion of management, the disclosures are adequate to make the information presented not misleading. These accompanying unaudited condensed consolidated interim financial statements reflect all adjustments, consisting of normal recurring adjustments, which in the opinion of management are necessary for fair presentation of the information contained herein. The consolidated balance sheet as of September 30, 2023 was derived from the audited annual financial statements but does not include all disclosures required by U.S. GAAP. The accompanying unaudited condensed consolidated interim financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s annual report on Form 10-K for the year ended September 30, 2023 filed with the SEC on November 27, 2023. The Company follows the same accounting policies in the preparation of interim reports. Operating results for the three months ended December 31, 2023 are not necessarily indicative of the results that may be expected for the year ending September 30, 2024. 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 sales to pharmaceutical companies 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 from operations for the foreseeable future and cannot predict when, if ever, our 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 condensed consolidated interim financial statements are issued. The process of drug development can be costly, and the timing and outcomes of clinical trials are 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 2023 Purchase 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. 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, share 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 carrying 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. Fair Value Measurements The fair value hierarchy under GAAP is based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value which are the following: Level 1 - quoted prices (unadjusted) in active markets for identical assets or liabilities; 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 December 31, 2023 and September 30, 2023, the Company did not have any Level 3 assets or liabilities. 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 December 31, 2023 loss per share excludes 14,269,363 13,525,296 Recently Adopted Accounting Pronouncements In November 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2023-07, “Segment Reporting: Improvements to Reportable Segment Disclosures.” This guidance requires disclosure of incremental segment information on an annual and interim basis. This amendment is effective for our fiscal year ending September 30, 2025 and our interim periods within the fiscal year ending September 30, 2026. The Company is currently assessing the impact of this guidance on its disclosures. In December 2023, the FASB issued ASU No. 2023-09, “Income Taxes: Improvements to Income Tax Disclosures.” This guidance requires consistent categories and greater disaggregation of information in the rate reconciliation and disclosures of income taxes paid by jurisdiction. This amendment is effective for our fiscal year ending September 30, 2026. The Company is currently assessing the impact of this guidance on its disclosures. |
Other Income
Other Income | 3 Months Ended |
Dec. 31, 2023 | |
Other Income | |
Other Income | Note 3 Other Income Grant Income As of December 31, 2023, the Company had received a $ 1 ® 0.5 0.5 The grant income has been deferred when received and is being amortized to other income as the related research and development expenditures are incurred. During the three months ended December 31, 2023, the Company recognized $ 0 25,000 0.9 0.9 Research and development incentive incom e Research and development incentive income represents the income earned by Anavex Australia of the Australia R&D credit. This cash incentive is received by Anavex Australia, upon filing of a claim in connection with Anavex Australia’s annual income tax return. During the three months ended December 31, 2023 the Company recorded research and development incentive income of $ 0.6 0.9 0.7 1.1 At December 31, 2023, Incentive and tax receivables includes $ 3.3 4.9 2.5 3.9 The Australia R&D credit program is a self-assess program whereby the Company must assess its eligibility each year to determine (i) if the entity is eligible (ii) if the specific R&D activities are eligible and (iii) if the individual R&D expenditures have nexus to such R&D activities. 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. Anavex Australia is able to continue to claim the R&D tax incentive for as long as it remains eligible and continues to incur eligible research and development expenditures. Although the Company believes that it has complied with all the relevant conditions of eligibility under the program for all periods claimed, the Australian Tax Office (ATO) has the right to review the Company’s qualifying programs and related expenditures for a period of four years. If such a review were to occur, the ATO may have different interpretations of certain eligibility requirements. If the ATO disagreed with the Company’s assessments and any related subsequent appeals, it could require adjustment to and repayment of current or previous years’ claims already received. Additionally, if the Company was unable to demonstrate a reasonably arguable position taken on such claims, the ATO could also assess penalties and interest on such adjustment. Currently, the Company’s tax incentive claims from 2019 to 2022 are open to potential review by the ATO. Additionally, the period open for review is indefinite if the ATO suspects fraud. The Company has not provided any allowance for any such potential adjustments, should they occur in the future. |
Accrued Liabilities
Accrued Liabilities | 3 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Liabilities | Note 4 Accrued Liabilities The principal components of accrued liabilities consist of (in thousands): Schedule of accrued liabilities December 31 September 30 2023 2023 Accrued clinical site and patient visits costs $ 2,058 $ 2,006 Accrued compensation and benefits 1,785 1,360 Fixed contract accruals 364 38 Milestone based contract accruals 989 1,267 All other accrued liabilities 2,090 2,624 Total accrued liabilities $ 7,286 $ 7,295 |
Equity Offerings
Equity Offerings | 3 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
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 (the “Board”). Preferred Stock The Company’s 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. 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 (“Shares”) 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 agent 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 no 142.4 142.4 2023 Purchase Agreement On February 3, 2023, the Company entered into a $150.0 million purchase agreement (the “2023 Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which the Company has the right to sell and issue to Lincoln Park, and Lincoln Park is obligated to purchase, up to $150.0 150,000,000 In consideration for entering into the 2023 Purchase Agreement, the Company issued to Lincoln Park 75,000 75,000 150 0.8 0.1 During the three months ended December 31, 2023 and 2022, the Company did no At December 31, 2023, an amount of $ 122.1 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 6 Commitments and Contingencies Leases The Company leases office space under an operating lease with an initial term of 12 months or less. Under the terms of the office lease, the Company is required to pay its proportionate share of operating costs. During the three months ended December 31, 2023 and 2022, operating lease costs were as follows (in thousands): Schedule of operating lease costs 2023 2022 Operating lease costs $ 30 $ 30 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 three months ended December 31, 2023 and 2022, the Company made matching contributions under the 401(k) plan as follows (in thousands): Schedule of contribution plan 2023 2022 Contributions to 401(k) plan $ 73 $ 44 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 At December 31, 2023 and September 30, 2023, the Company had 160,000 3.72 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 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 December 31, 2023, 3,892,000 6,643,952 The following summarizes information about stock option activity during the year ended September 30, 2023 and three months ended December 31, 2023: Schedule of outstanding stock purchase options Number of Options Weighted Average Exercise Price Weighted Average Grant Date Fair Value Aggregate intrinsic value Outstanding, September 30, 2022 13,169,616 6.61 4.96 62,267,309 Granted 1,959,000 9.30 6.60 — Exercised (759,753 ) 2.34 0.95 4,629,026 Forfeited (257,083 ) 12.00 6.74 — Outstanding, September 30, 2023 14,111,780 7.12 5.27 22,290,069 Granted 155,000 7.40 4.88 — Exercised (20,000 ) 2.96 2.23 58,600 Forfeited (137,417 ) 12.19 6.78 — Outstanding, December 31, 2023 14,109,363 7.08 47,674,002 Exercisable, December 31, 2023 9,663,446 5.26 45,388,166 The following summarizes information about stock options at December 31, 2023 by a range of exercise prices: Schedule of summarized information about stock options Range of exercises prices Number of outstanding Weighted average remaining contractual life Weighted average Number of vested Weighted average From To options (in years) exercise price options exercise price $ 0.92 $ 3.00 3,260,309 4.47 $ 2.38 3,260,309 $ 2.38 $ 3.01 $ 5.00 2,017,500 4.07 $ 3.28 2,017,500 $ 3.28 $ 5.01 $ 9.00 5,375,054 6.00 $ 6.91 3,329,970 $ 6.11 $ 9.01 $ 13.00 1,909,000 8.10 $ 10.53 496,083 $ 11.36 $ 13.01 $ 25.00 1,547,500 7.23 $ 18.24 559,584 $ 18.64 14,109,363 5.79 $ 7.08 9,663,446 $ 5.26 The weighted average grant date fair value of options vested at December 31, 2023 was $ 4.00 3.94 5.8 6.0 4.5 4.75 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 December 31, 2023. During the three months ended December 31, 2023, the Company recognized stock-based compensation expense of $ 2.3 5.3 Schedule of general and administrative expenses and research and development expenses December 31 2023 2022 General and administrative $ 926 $ 1,743 Research and development 1,360 3,604 Total stock-based compensation $ 2,286 $ 5,347 An amount of approximately $ 27.7 The fair value of each option award granted during the three months ended December 31, 2023 and 2022 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 2023 2022 Risk-free interest rate 4.47 % 4.07 % Expected life of options (years) 5.29 4.98 Annualized volatility 80.61 % 84.01 % Dividend rate 0.00 % 0.00 % The fair value of stock compensation charges recognized during the three months ended December 31, 2023 and 2022 was determined with reference to the quoted market price of the Company’s shares on the grant date. |
Basis of Presentation (Policies
Basis of Presentation (Policies) | 3 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Presentation | Basis of Presentation These accompanying unaudited condensed consolidated interim financial statements have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) and accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim reporting. Accordingly, certain information and note disclosures normally included in the annual financial statements in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. In the opinion of management, the disclosures are adequate to make the information presented not misleading. These accompanying unaudited condensed consolidated interim financial statements reflect all adjustments, consisting of normal recurring adjustments, which in the opinion of management are necessary for fair presentation of the information contained herein. The consolidated balance sheet as of September 30, 2023 was derived from the audited annual financial statements but does not include all disclosures required by U.S. GAAP. The accompanying unaudited condensed consolidated interim financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s annual report on Form 10-K for the year ended September 30, 2023 filed with the SEC on November 27, 2023. The Company follows the same accounting policies in the preparation of interim reports. Operating results for the three months ended December 31, 2023 are not necessarily indicative of the results that may be expected for the year ending September 30, 2024. |
Liquidity | 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 sales to pharmaceutical companies 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 from operations for the foreseeable future and cannot predict when, if ever, our 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 condensed consolidated interim financial statements are issued. The process of drug development can be costly, and the timing and outcomes of clinical trials are 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 2023 Purchase 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. |
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, share 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 carrying 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. |
Fair Value Measurements | Fair Value Measurements The fair value hierarchy under GAAP is based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value which are the following: Level 1 - quoted prices (unadjusted) in active markets for identical assets or liabilities; 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 December 31, 2023 and September 30, 2023, the Company did not have any Level 3 assets or liabilities. |
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 December 31, 2023 loss per share excludes 14,269,363 13,525,296 |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements In November 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2023-07, “Segment Reporting: Improvements to Reportable Segment Disclosures.” This guidance requires disclosure of incremental segment information on an annual and interim basis. This amendment is effective for our fiscal year ending September 30, 2025 and our interim periods within the fiscal year ending September 30, 2026. The Company is currently assessing the impact of this guidance on its disclosures. In December 2023, the FASB issued ASU No. 2023-09, “Income Taxes: Improvements to Income Tax Disclosures.” This guidance requires consistent categories and greater disaggregation of information in the rate reconciliation and disclosures of income taxes paid by jurisdiction. This amendment is effective for our fiscal year ending September 30, 2026. The Company is currently assessing the impact of this guidance on its disclosures. |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 3 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of accrued liabilities | Schedule of accrued liabilities December 31 September 30 2023 2023 Accrued clinical site and patient visits costs $ 2,058 $ 2,006 Accrued compensation and benefits 1,785 1,360 Fixed contract accruals 364 38 Milestone based contract accruals 989 1,267 All other accrued liabilities 2,090 2,624 Total accrued liabilities $ 7,286 $ 7,295 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of operating lease costs | Schedule of operating lease costs 2023 2022 Operating lease costs $ 30 $ 30 |
Schedule of contribution plan | Schedule of contribution plan 2023 2022 Contributions to 401(k) plan $ 73 $ 44 |
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 Number of Options Weighted Average Exercise Price Weighted Average Grant Date Fair Value Aggregate intrinsic value Outstanding, September 30, 2022 13,169,616 6.61 4.96 62,267,309 Granted 1,959,000 9.30 6.60 — Exercised (759,753 ) 2.34 0.95 4,629,026 Forfeited (257,083 ) 12.00 6.74 — Outstanding, September 30, 2023 14,111,780 7.12 5.27 22,290,069 Granted 155,000 7.40 4.88 — Exercised (20,000 ) 2.96 2.23 58,600 Forfeited (137,417 ) 12.19 6.78 — Outstanding, December 31, 2023 14,109,363 7.08 47,674,002 Exercisable, December 31, 2023 9,663,446 5.26 45,388,166 |
Schedule of summarized information about stock options | Schedule of summarized information about stock options Range of exercises prices Number of outstanding Weighted average remaining contractual life Weighted average Number of vested Weighted average From To options (in years) exercise price options exercise price $ 0.92 $ 3.00 3,260,309 4.47 $ 2.38 3,260,309 $ 2.38 $ 3.01 $ 5.00 2,017,500 4.07 $ 3.28 2,017,500 $ 3.28 $ 5.01 $ 9.00 5,375,054 6.00 $ 6.91 3,329,970 $ 6.11 $ 9.01 $ 13.00 1,909,000 8.10 $ 10.53 496,083 $ 11.36 $ 13.01 $ 25.00 1,547,500 7.23 $ 18.24 559,584 $ 18.64 14,109,363 5.79 $ 7.08 9,663,446 $ 5.26 |
Schedule of general and administrative expenses and research and development expenses | Schedule of general and administrative expenses and research and development expenses December 31 2023 2022 General and administrative $ 926 $ 1,743 Research and development 1,360 3,604 Total stock-based compensation $ 2,286 $ 5,347 |
Schedule of weighted average assumptions | Schedule of weighted average assumptions 2023 2022 Risk-free interest rate 4.47 % 4.07 % Expected life of options (years) 5.29 4.98 Annualized volatility 80.61 % 84.01 % Dividend rate 0.00 % 0.00 % |
Basis of Presentation (Details
Basis of Presentation (Details Narrative) - shares | 3 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Loss per share for potentially dilutive common shares | 14,269,363 | 13,525,296 |
Other Income (Details Narrative
Other Income (Details Narrative) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2021 | |
Research and development incentive income | $ 600,000 | $ 700,000 | ||
Grant income | 0 | 25,000 | ||
Grant income, amount | 900,000 | $ 900,000 | ||
Incentive and tax receivables | 3,300,000 | 2,500,000 | ||
Australia, Dollars | ||||
Research and development incentive income | 900,000 | $ 1,100,000 | ||
Incentive and tax receivables | 4,900,000 | 3,900,000 | ||
Anavex [Member] | ||||
Research and development incentive income | $ 500,000 | $ 500,000 | ||
Michael J Fox [Member] | ||||
Research and development incentive income | $ 1,000,000 |
Accrued liabilities (Details)
Accrued liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Sep. 30, 2023 |
Payables and Accruals [Abstract] | ||
Accrued clinical site and patient visits costs | $ 2,058 | $ 2,006 |
Accrued compensation and benefits | 1,785 | 1,360 |
Fixed contract accruals | 364 | 38 |
Milestone based contract accruals | 989 | 1,267 |
All other accrued liabilities | 2,090 | 2,624 |
Total accrued liabilities | $ 7,286 | $ 7,295 |
Equity Offerings (Details Narra
Equity Offerings (Details Narrative) - USD ($) | 3 Months Ended | |||
Feb. 03, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | Sep. 30, 2023 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Sales of agreement amount | $ 142,400,000 | $ 142,400,000 | ||
Fair value of the initial commitment | 800,000 | |||
Third Party [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Incurred expenses | $ 100,000 | |||
Equity Offering Sales Agreement [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Number of common stock sold | 0 | 0 | ||
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% | |||
Purchase Agreement 2023 [Member] | Lincoln Park Capital Fund L L C [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Value Of Shares Obligated To Purchase | $ 150,000,000 | |||
Purchase Agreement 1 [Member] | Lincoln Park Capital Fund L L C [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Share issued for offering, shares | 75,000 | 0 | 0 | |
Pro rata basic number of shares obligated to purchase | 75,000 | |||
Proceeds from Issuance or sale of equity | $ 150,000,000 | |||
Amount of shares remain available | $ 122,100,000 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease costs | $ 30 | $ 30 |
Commitments and Contingencies_3
Commitments and Contingencies (Details 1) - USD ($) $ in Thousands | 3 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Contributions to 401(k) plan | $ 73 | $ 44 |
Commitments and Contingencies_4
Commitments and Contingencies (Details 2) | Dec. 31, 2023 $ / shares shares |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number of shares outstanding | 160,000 |
Purchase Warrants [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number of shares outstanding | 150,000 |
Exercise price | $ / shares | $ 3.17 |
Expiry Date | May 06, 2024 |
Purchase Warrants 1 [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number of shares outstanding | 10,000 |
Exercise price | $ / shares | $ 12 |
Expiry Date | Apr. 21, 2026 |
Commitments and Contingencies_5
Commitments and Contingencies (Details 3) - Equity Option [Member] - USD ($) | 3 Months Ended | 12 Months Ended |
Dec. 31, 2023 | Sep. 30, 2023 | |
Offsetting Assets [Line Items] | ||
Number of Options Outstanding at Beginning | 14,111,780 | 13,169,616 |
Weighted Average Exercise Price Outstanding at Beginning | $ 7.12 | $ 6.61 |
Weighted Average Grant Date Fair Value at Beginning | $ 5.27 | $ 4.96 |
Aggregate Intrinsic Value Outstanding at Beginning | $ 22,290,069 | $ 62,267,309 |
Number of Options, Granted | 155,000 | 1,959,000 |
Weighted Average Exercise Price, Granted | $ 7.40 | $ 9.30 |
Weighted Average Grant Date Fair Value, Granted | $ 4.88 | $ 6.60 |
Number of Options, Exercised | (20,000) | (759,753) |
Weighted Average Exercise Price, Exercised | $ 2.96 | $ 2.34 |
Weighted Average Grant Date Fair Value, Exercised | $ 2.23 | $ 0.95 |
Aggregate Intrinsic Value, Exercised | $ 58,600 | $ 4,629,026 |
Number of Options, Forfeited | (137,417) | (257,083) |
Weighted Average Exercise Price, Forfeited | $ 12.19 | $ 12 |
Weighted Average Grant Date Fair Value, Forfeited | $ 6.78 | $ 6.74 |
Number of Options Outstanding at Ending | 14,109,363 | 14,111,780 |
Weighted Average Exercise Price Outstanding at Ending | $ 7.08 | $ 7.12 |
Aggregate Intrinsic Value Outstanding at Ending | $ 47,674,002 | $ 22,290,069 |
Number of Options, Exercisable | 9,663,446 | |
Weighted Average Exercise Price, Exercisable | $ 5.26 | |
Aggregate Intrinsic Value, Exercisable | $ 45,388,166 |
Commitments and Contingencies_6
Commitments and Contingencies (Details 4) - $ / shares | 3 Months Ended | 12 Months Ended | |
Dec. 31, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | |
Offsetting Assets [Line Items] | |||
Weighted average remaining contractual life (in years) | 5 years 9 months 18 days | 6 years | |
Equity Option [Member] | |||
Offsetting Assets [Line Items] | |||
Number of outstanding options | 14,109,363 | 14,111,780 | 13,169,616 |
Weighted average remaining contractual life (in years) | 5 years 9 months 14 days | ||
Weighted average exercise price | $ 7.08 | $ 7.12 | $ 6.61 |
Number of vested options | 9,663,446 | ||
Weighted average exercise price options vested | $ 5.26 | ||
Equity Option [Member] | Option Price 1 [Member] | |||
Offsetting Assets [Line Items] | |||
Range of exercise prices, lower range limit | 0.92 | ||
Range of exercise prices, upper range limit | $ 3 | ||
Number of outstanding options | 3,260,309 | ||
Weighted average remaining contractual life (in years) | 4 years 5 months 19 days | ||
Weighted average exercise price | $ 2.38 | ||
Number of vested options | 3,260,309 | ||
Weighted average exercise price options vested | $ 2.38 | ||
Equity Option [Member] | Option Price 2 [Member] | |||
Offsetting Assets [Line Items] | |||
Range of exercise prices, lower range limit | 3.01 | ||
Range of exercise prices, upper range limit | $ 5 | ||
Number of outstanding options | 2,017,500 | ||
Weighted average remaining contractual life (in years) | 4 years 25 days | ||
Weighted average exercise price | $ 3.28 | ||
Number of vested options | 2,017,500 | ||
Weighted average exercise price options vested | $ 3.28 | ||
Equity Option [Member] | Option Price 3 [Member] | |||
Offsetting Assets [Line Items] | |||
Range of exercise prices, lower range limit | 5.01 | ||
Range of exercise prices, upper range limit | $ 9 | ||
Number of outstanding options | 5,375,054 | ||
Weighted average remaining contractual life (in years) | 6 years | ||
Weighted average exercise price | $ 6.91 | ||
Number of vested options | 3,329,970 | ||
Weighted average exercise price options vested | $ 6.11 | ||
Equity Option [Member] | Option Price 4 [Member] | |||
Offsetting Assets [Line Items] | |||
Range of exercise prices, lower range limit | 9.01 | ||
Range of exercise prices, upper range limit | $ 13 | ||
Number of outstanding options | 1,909,000 | ||
Weighted average remaining contractual life (in years) | 8 years 1 month 6 days | ||
Weighted average exercise price | $ 10.53 | ||
Number of vested options | 496,083 | ||
Weighted average exercise price options vested | $ 11.36 | ||
Equity Option [Member] | Option Price 5 [Member] | |||
Offsetting Assets [Line Items] | |||
Range of exercise prices, lower range limit | 13.01 | ||
Range of exercise prices, upper range limit | $ 25 | ||
Number of outstanding options | 1,547,500 | ||
Weighted average remaining contractual life (in years) | 7 years 2 months 23 days | ||
Weighted average exercise price | $ 18.24 | ||
Number of vested options | 559,584 | ||
Weighted average exercise price options vested | $ 18.64 |
Commitments and Contingencies_7
Commitments and Contingencies (Details 5) - USD ($) $ in Thousands | 3 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Loss Contingencies [Line Items] | ||
Total share based compensation | $ 2,286 | $ 5,347 |
General and Administrative Expense [Member] | ||
Loss Contingencies [Line Items] | ||
Total share based compensation | 926 | 1,743 |
Research and Development Expense [Member] | ||
Loss Contingencies [Line Items] | ||
Total share based compensation | $ 1,360 | $ 3,604 |
Commitments and Contingencies_8
Commitments and Contingencies (Details 6) | 3 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Risk-free interest rate | 4.47% | 4.07% |
Expected life of options (years) | 5 years 3 months 14 days | 4 years 11 months 23 days |
Annualized volatility | 80.61% | 84.01% |
Dividend rate | 0% | 0% |
Commitments and Contingencies_9
Commitments and Contingencies (Details Narrative) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Warrants outstanding | 160,000 | 160,000 | ||
Warrants outstanding weighted average exercise | $ 3.72 | $ 3.72 | ||
Option issued | 3,892,000 | |||
Weighted average grant date fair value of options vested | $ 4 | $ 3.94 | ||
Weighted average contractual life of options outstanding | 5 years 9 months 18 days | 6 years | ||
Weighted average contractual life of options exercisable | 4 years 6 months | 4 years 9 months | ||
Share based compensation expense | $ 2.3 | $ 5.3 | ||
Remaining stock based compensation | $ 27.7 | |||
Stock Option Plan 2015 [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Common shares reserved for future issuance | 6,050,553 | |||
Stock Option Plan 2019 [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 | |||
Option available issuance | 6,643,952 |