Cover
Cover - shares | 3 Months Ended | |
Dec. 31, 2022 | Feb. 07, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Dec. 31, 2022 | |
Document Fiscal Period Focus | Q1 | |
Document Fiscal Year Focus | 2023 | |
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 $0.001 | |
Trading Symbol | AVXL | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 78,032,135 |
Interim Condensed Consolidated
Interim Condensed Consolidated Balance Sheets (Unaudited) - USD ($) | Dec. 31, 2022 | Sep. 30, 2022 |
Current | ||
Cash and cash equivalents | $ 143,621,848 | $ 149,157,861 |
Incentive and tax receivables | 4,094,431 | 3,192,580 |
Prepaid expenses and other current assets | 655,643 | 354,162 |
Total Assets | 148,371,922 | 152,704,603 |
Current Liabilities | ||
Accounts payable | 5,288,261 | 3,824,777 |
Accrued liabilities - Note 4 | 7,042,822 | 5,944,953 |
Deferred grant income - Note 3 | 916,763 | 443,831 |
Total Liabilities | 13,247,846 | 10,213,561 |
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 share78,032,135 common shares (September 30, 2022 - 77,942,815) | 78,033 | 77,944 |
Additional paid-in capital | 393,581,544 | 387,976,881 |
Accumulated deficit | (258,535,501) | (245,563,783) |
Total Stockholders' Equity | 135,124,076 | 142,491,042 |
Total Liabilities and Stockholders' Equity | $ 148,371,922 | $ 152,704,603 |
Interim Condensed Consolidate_2
Interim Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Dec. 31, 2022 | Sep. 30, 2022 |
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 | 78,032,135 | 77,942,815 |
Common stock, shares outstanding | 78,032,135 | 77,942,815 |
Interim Condensed Consolidate_3
Interim Condensed Consolidated Statement of Operations (Unaudited) - USD ($) | 3 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating expenses | ||
General and administrative | $ 3,317,036 | $ 3,066,951 |
Research and development | 12,066,919 | 8,656,439 |
Total operating expenses | 15,383,955 | 11,723,390 |
Operating loss | (15,383,955) | (11,723,390) |
Other income | ||
Grant income | 25,000 | |
Research and development incentive income | 733,590 | 810,730 |
Interest income, net | 1,267,618 | 4,910 |
Foreign exchange gain, net | 365,983 | 55,363 |
Total other income, net | 2,392,191 | 871,003 |
Net loss before provision for income taxes | (12,991,764) | (10,852,387) |
Income tax recovery (expense), current | 20,046 | (29,980) |
Net loss and comprehensive loss | $ (12,971,718) | $ (10,882,367) |
Net Loss per share | ||
Basic and diluted | $ (0.17) | $ (0.14) |
Weighted average number of shares outstanding | ||
Basic and diluted | $ 77,977,112 | $ 75,997,738 |
Interim Condensed Consolidate_4
Interim Condensed Consolidated Statement of Changes in Stockholders' Equity (Unaudited) - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Beginning balance, value at Sep. 30, 2021 | $ 75,920 | $ 348,328,048 | $ (197,585,864) | $ 150,818,104 |
Beginning balance, shares at Sep. 30, 2021 | 75,918,465 | |||
Shares issued pursuant to exercise of stock options | $ 137 | 373,360 | 373,497 | |
Shares issued pursuant to exercise of stock options, shares | 137,134 | |||
Shares issued under Sales Agreement, net of share issuance costs | $ 99 | 2,149,602 | 2,149,701 | |
Shares issued under Sales Agreement, net of share issuance costs, shares | 99,588 | |||
Share based compensation | 3,908,771 | 3,908,771 | ||
Net loss | (10,882,367) | (10,882,367) | ||
Ending balance, value at Dec. 31, 2021 | $ 76,156 | 354,759,781 | (208,468,231) | 146,367,706 |
Ending balance, shares at Dec. 31, 2021 | 76,155,187 | |||
Beginning balance, value at Sep. 30, 2022 | $ 77,944 | 387,976,881 | (245,563,783) | 142,491,042 |
Beginning balance, shares at Sep. 30, 2022 | 77,942,815 | |||
Shares issued pursuant to exercise of stock options | $ 89 | 258,155 | 258,244 | |
Shares issued pursuant to exercise of stock options, shares | 89,320 | |||
Share based compensation | 5,346,508 | 5,346,508 | ||
Net loss | (12,971,718) | (12,971,718) | ||
Ending balance, value at Dec. 31, 2022 | $ 78,033 | $ 393,581,544 | $ (258,535,501) | $ 135,124,076 |
Ending balance, shares at Dec. 31, 2022 | 78,032,135 |
Interim Condensed Consolidate_5
Interim Condensed Consolidated Statement of Cash Flows (Unaudited) - USD ($) | 3 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Cash Flows used in Operating Activities | ||
Net loss | $ (12,971,718) | $ (10,882,367) |
Adjustments to reconcile net loss to net cash used in operations: | ||
Stock-based compensation | 5,346,508 | 3,908,771 |
Changes in working capital balances related to operations: | ||
Incentive and tax receivables | (901,851) | 3,764,678 |
Prepaid expenses and deposits | (301,481) | (22,311) |
Accounts payable | 1,463,484 | (104,992) |
Accrued liabilities | 1,097,869 | (164,734) |
Deferred grant income | 472,932 | |
Net cash used in operating activities | (5,794,257) | (3,500,955) |
Cash Flows provided by Financing Activities | ||
Issuance of common shares | 2,312,785 | |
Share issue costs | (146,717) | |
Proceeds from exercise of stock options | 258,244 | 373,497 |
Net cash provided by financing activities | 258,244 | 2,539,565 |
Decrease in cash and cash equivalents during the period | (5,536,013) | (961,390) |
Cash and cash equivalents, beginning of period | 149,157,861 | 152,107,745 |
Cash and cash equivalents, end of period | 143,621,848 | 151,146,355 |
Supplemental Cash Flow Information | ||
Cash paid for state and local minimum income taxes | $ 50,077 |
Business Description
Business Description | 3 Months Ended |
Dec. 31, 2022 | |
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, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Presentation | Note 2 Basis of Presentation Basis of Presentation These accompanying unaudited interim condensed consolidated 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 interim condensed consolidated 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, 2022 was derived from the audited annual financial statements but does not include all disclosures required by U.S. GAAP. The accompanying unaudited interim condensed consolidated 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, 2022 filed with the SEC on November 28, 2022. The Company follows the same accounting policies in the preparation of interim reports. Operating results for the three months ended December 31, 2022 are not necessarily indicative of the results that may be expected for the year ending September 30, 2023. 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 interim condensed consolidated 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 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. 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 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. Coronavirus Disease 2019 (COVID-19) The global pandemic resulting from the disease known as COVID-19, caused by a novel strain of coronavirus, did not have a material impact on the Company’s result of operations or financial condition for the quarter ended December 31, 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. 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, 2022 and September 30, 2022, 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, 2022 loss per share excludes 13,525,296 11,403,769 Recently Adopted Accounting Pronouncements In November 2021, the FASB issued ASU 2021-10, “Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance” (“ASU 2021-10”). ASU 2021-10 increases the disclosure requirements for annual reporting periods relating to material government assistance transactions on the entity’s financial statements and any significant terms and conditions of the agreements including commitments and contingencies. The new standard was effective for the Company on October 1, 2022 but only impacts annual financial statement footnote disclosures. The adoption of ASU 2021-10 is expected to impact the disclosures related to the research and development incentive income that the Company receives from the Australian Tax Office (“ATO”) for its clinical trials in Australia. |
Other Income
Other Income | 3 Months Ended |
Dec. 31, 2022 | |
Other Income | |
Other Income | Note 3 Other Income Grant Income As of December 31, 2022, the Company had received $ 995,862 ® 497,931 497,931 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, 2022, the Company recognized $ 25,000 0 916,763 443,831 Research and development incentive income Research and development incentive income represents the income earned by Anavex Australia, of the Australian research and development tax incentive credit (the “Tax Incentive Credit”). During the three months ended December 31, 2022 the Company recorded research and development incentive income of $ 733,590 1,116,618 810,730 1,116,362 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, 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. |
Accrued Liabilities
Accrued Liabilities | 3 Months Ended |
Dec. 31, 2022 | |
Payables and Accruals [Abstract] | |
Accrued Liabilities | Note 4 Accrued Liabilities The principal components of accrued liabilities consists of: Schedule of Accrued Liabilities December 31, September 31, 2022 2022 Accrued clinical site and patient visits costs $ 2,212,464 $ 2,031,105 Accrued compensation and benefits 1,249,205 1,297,337 Fixed contract accruals 1,076,630 417,414 All other accrued liabilities 2,504,523 2,199,097 Total accrued liabilities $ 7,042,822 $ 5,944,953 |
Equity Offerings
Equity Offerings | 3 Months Ended |
Dec. 31, 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 (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 of 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 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 99,588 2,312,785 2,149,701 142,407,882 142,407,882 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 6 Commitments and Contingencies Leases During the three months ended December 31, 2022, the Company incurred office lease expense of $ 30,070 4,845 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, 2022, the Company made $ 43,646 22,682 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. Anavex Life Sciences Corp. Share Purchase Warrants At December 31, 2022 and September 30, 2022, 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 and 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, 2022 2,378,000 8,078,453 A summary of the status of Company’s outstanding stock options is presented below: Schedule of outstanding stock purchase options Weighted Weighted Average Average Aggregate Number of Exercise Grant Date intrinsic value Shares Price ($) Fair Value ($) ($) 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 Granted 325,000 12.43 8.17 Forfeited (40,000 ) 7.51 2.52 Exercised (89,320 ) 2.89 2.44 591,993 Outstanding, December 31, 2022 13,365,296 6.78 50,676,617 Exercisable, December 31, 2022 8,795,293 4.51 45,930,627 The following summarizes information about stock options at December 31, 2022 by a range of exercise prices: Schedule Of Share-based Payment Arrangement, Option, Activity Weighted Weighted average average exercise Number of remaining Weighted price Range of exercise prices outstanding contractual average Number of options From To options life (in years) exercise price vested options vested $ 0.92 2.96 3,850,742 4.86 2.29 3,844,908 2.29 $ 3.15 4.80 2,042,500 5.09 3.30 2,032,500 3.29 $ 5.04 8.98 3,927,054 5.80 6.29 2,374,554 6.31 $ 9.20 13.01 1,968,000 9.04 10.73 154,581 12.27 $ 13.22 24.58 1,577,000 8.24 18.51 388,750 18.80 13,365,296 8,795,293 The weighted average grant date fair value of options vested during the three months ended December 31, 2022 was $ 4.40 2.85 6.18 6.40 4.83 5.1 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, 2022. During the three months ended December 31, 2022, the Company recognized stock-based compensation expense of $ 5,346,508 3,908,771 Schedule of general and administrative expenses and research and development expenses 2022 2021 General and administrative $ 1,742,524 $ 1,671,725 Research and development 3,603,984 2,237,046 Total stock-based compensation $ 5,346,508 $ 3,908,771 An amount of approximately $ 16,340,941 The fair value of each option award granted during the three months ended December 31, 2022 and 2021 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 Risk-free interest rate 4.07 % 1.37 % Expected life of options (years) 4.98 6.50 Annualized volatility 84.01 % 96.79 % Dividend rate 0.00 % 0.00 % The fair value of stock compensation charges recognized during the three months ended December 31, 2022 and 2021 was determined with reference to the quoted market price of the Company’s shares on the grant date. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Dec. 31, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 7 Subsequent Events Subsequent to December 31, 2022, the Company entered into a Purchase Agreement (the “Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“LPC”), whereby the Company has the right, in its sole discretion, to sell to LPC up to $150,000,000 in value of shares of the Company’s common stock from time to time over a 36-month period pursuant to the terms of the Purchase Agreement. |
Basis of Presentation (Policies
Basis of Presentation (Policies) | 3 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Presentation | Basis of Presentation These accompanying unaudited interim condensed consolidated 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 interim condensed consolidated 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, 2022 was derived from the audited annual financial statements but does not include all disclosures required by U.S. GAAP. The accompanying unaudited interim condensed consolidated 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, 2022 filed with the SEC on November 28, 2022. The Company follows the same accounting policies in the preparation of interim reports. Operating results for the three months ended December 31, 2022 are not necessarily indicative of the results that may be expected for the year ending September 30, 2023. |
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 interim condensed consolidated 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 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. |
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 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. |
Coronavirus Disease 2019 (COVID-19) | Coronavirus Disease 2019 (COVID-19) The global pandemic resulting from the disease known as COVID-19, caused by a novel strain of coronavirus, did not have a material impact on the Company’s result of operations or financial condition for the quarter ended December 31, 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. |
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, 2022 and September 30, 2022, 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, 2022 loss per share excludes 13,525,296 11,403,769 |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements In November 2021, the FASB issued ASU 2021-10, “Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance” (“ASU 2021-10”). ASU 2021-10 increases the disclosure requirements for annual reporting periods relating to material government assistance transactions on the entity’s financial statements and any significant terms and conditions of the agreements including commitments and contingencies. The new standard was effective for the Company on October 1, 2022 but only impacts annual financial statement footnote disclosures. The adoption of ASU 2021-10 is expected to impact the disclosures related to the research and development incentive income that the Company receives from the Australian Tax Office (“ATO”) for its clinical trials in Australia. |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 3 Months Ended |
Dec. 31, 2022 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Liabilities | Schedule of Accrued Liabilities December 31, September 31, 2022 2022 Accrued clinical site and patient visits costs $ 2,212,464 $ 2,031,105 Accrued compensation and benefits 1,249,205 1,297,337 Fixed contract accruals 1,076,630 417,414 All other accrued liabilities 2,504,523 2,199,097 Total accrued liabilities $ 7,042,822 $ 5,944,953 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
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 Aggregate Number of Exercise Grant Date intrinsic value Shares Price ($) Fair Value ($) ($) 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 Granted 325,000 12.43 8.17 Forfeited (40,000 ) 7.51 2.52 Exercised (89,320 ) 2.89 2.44 591,993 Outstanding, December 31, 2022 13,365,296 6.78 50,676,617 Exercisable, December 31, 2022 8,795,293 4.51 45,930,627 |
Schedule Of Share-based Payment Arrangement, Option, Activity | Schedule Of Share-based Payment Arrangement, Option, Activity Weighted Weighted average average exercise Number of remaining Weighted price Range of exercise prices outstanding contractual average Number of options From To options life (in years) exercise price vested options vested $ 0.92 2.96 3,850,742 4.86 2.29 3,844,908 2.29 $ 3.15 4.80 2,042,500 5.09 3.30 2,032,500 3.29 $ 5.04 8.98 3,927,054 5.80 6.29 2,374,554 6.31 $ 9.20 13.01 1,968,000 9.04 10.73 154,581 12.27 $ 13.22 24.58 1,577,000 8.24 18.51 388,750 18.80 13,365,296 8,795,293 |
Schedule of general and administrative expenses and research and development expenses | Schedule of general and administrative expenses and research and development expenses 2022 2021 General and administrative $ 1,742,524 $ 1,671,725 Research and development 3,603,984 2,237,046 Total stock-based compensation $ 5,346,508 $ 3,908,771 |
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 Risk-free interest rate 4.07 % 1.37 % Expected life of options (years) 4.98 6.50 Annualized volatility 84.01 % 96.79 % Dividend rate 0.00 % 0.00 % |
Basis of Presentation (Details
Basis of Presentation (Details Narrative) - shares | 3 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Loss per share for potentially dilutive common shares | 13,525,296 | 11,403,769 |
Other Income (Details Narrative
Other Income (Details Narrative) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Sep. 30, 2021 | Sep. 30, 2022 | |
Research and development incentive income | $ 733,590 | $ 810,730 | ||
Grant income | 25,000 | 0 | ||
Deferred grant income | 916,763 | $ 443,831 | ||
Australia, Dollars | ||||
Research and development incentive income | 1,116,618 | $ 1,116,362 | ||
Anavex [Member] | ||||
Research and development incentive income | 497,931 | $ 497,931 | ||
Michael J Fox [Member] | ||||
Research and development incentive income | $ 995,862 |
Accrued liabilities (Details)
Accrued liabilities (Details) - USD ($) | Dec. 31, 2022 | Sep. 30, 2022 |
Payables and Accruals [Abstract] | ||
Accrued clinical site and patient visits costs | $ 2,212,464 | $ 2,031,105 |
Accrued compensation and benefits | 1,249,205 | 1,297,337 |
Fixed contract accruals | 1,076,630 | 417,414 |
All other accrued liabilities | 2,504,523 | 2,199,097 |
Total accrued liabilities | $ 7,042,822 | $ 5,944,953 |
Equity Offerings (Details Narra
Equity Offerings (Details Narrative) - USD ($) | 3 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Sep. 30, 2022 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Sales of agreement amount | $ 142,407,882 | $ 142,407,882 | |
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 | 0 | 99,588 | |
Gross proceeds from Issuance Public Offering | $ 2,312,785 | ||
Proceeds from Issuance Public Offering | $ 2,149,701 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) | Dec. 31, 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_3
Commitments and Contingencies (Details 1) - Equity Option [Member] - USD ($) | 3 Months Ended | 12 Months Ended |
Dec. 31, 2022 | Sep. 30, 2022 | |
Offsetting Assets [Line Items] | ||
Options Outstanding at beginning | 13,169,616 | 11,330,903 |
Weighted Average Exercise Price Outstanding at beginning | $ 6.61 | $ 5.74 |
Aggregate intrinsic value Outstanding at beginning | $ 62,267,309 | $ 140,132,451 |
Options Granted | 325,000 | 2,358,000 |
Weighted Average Exercise Price Granted | $ 12.43 | $ 10.13 |
Weighted Average Grant Date Fair Value Granted | $ 8.17 | $ 7.07 |
Options Forfeited | (40,000) | (118,750) |
Weighted Average Exercise Price Forfeited | $ 7.51 | $ 6.86 |
Weighted Average Grant Date Fair Value Forfeited | $ 2.52 | $ 5.23 |
Options Exercised | (89,320) | (400,537) |
Weighted Average Exercise Price Exercised | $ 2.89 | $ 2.52 |
Weighted Average Grant Date Fair Value Exercised | $ 2.44 | $ 1.88 |
Aggregate intrinsic value Exercised | $ 591,993 | $ 4,201,015 |
Options Outstanding at ending | 13,365,296 | 13,169,616 |
Weighted Average Exercise Price Outstanding at ending | $ 6.78 | $ 6.61 |
Aggregate intrinsic value Outstanding at ending | $ 50,676,617 | $ 62,267,309 |
Options Exercisable at ending | 8,795,293 | |
Weighted Average Exercise Price Exercisable at ending | $ 4.51 | |
Aggregate intrinsic value Exercisable at ending | $ 45,930,627 |
Commitments and Contingencies_4
Commitments and Contingencies (Details 2) - $ / shares | 3 Months Ended | 12 Months Ended | |
Dec. 31, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | |
Offsetting Assets [Line Items] | |||
Weighted average remaining contractual life (in years) | 6 years 2 months 4 days | 6 years 4 months 24 days | |
Equity Option [Member] | |||
Offsetting Assets [Line Items] | |||
Number of outstanding options | 13,365,296 | 13,169,616 | 11,330,903 |
Weighted average exercise price | $ 6.78 | $ 6.61 | $ 5.74 |
Number of vested options | 8,795,293 | ||
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 | $ 2.96 | ||
Number of outstanding options | 3,850,742 | ||
Weighted average remaining contractual life (in years) | 4 years 10 months 9 days | ||
Weighted average exercise price | $ 2.29 | ||
Number of vested options | 3,844,908 | ||
Weighted average exercise price options vested | $ 2.29 | ||
Equity Option [Member] | Option Price 2 [Member] | |||
Offsetting Assets [Line Items] | |||
Range of exercise prices, lower range limit | 3.15 | ||
Range of exercise prices, upper range limit | $ 4.80 | ||
Number of outstanding options | 2,042,500 | ||
Weighted average remaining contractual life (in years) | 5 years 1 month 2 days | ||
Weighted average exercise price | $ 3.30 | ||
Number of vested options | 2,032,500 | ||
Weighted average exercise price options vested | $ 3.29 | ||
Equity Option [Member] | Option Price 3 [Member] | |||
Offsetting Assets [Line Items] | |||
Range of exercise prices, lower range limit | 5.04 | ||
Range of exercise prices, upper range limit | $ 8.98 | ||
Number of outstanding options | 3,927,054 | ||
Weighted average remaining contractual life (in years) | 5 years 9 months 18 days | ||
Weighted average exercise price | $ 6.29 | ||
Number of vested options | 2,374,554 | ||
Weighted average exercise price options vested | $ 6.31 | ||
Equity Option [Member] | Option Price 4 [Member] | |||
Offsetting Assets [Line Items] | |||
Range of exercise prices, lower range limit | 9.20 | ||
Range of exercise prices, upper range limit | $ 13.01 | ||
Number of outstanding options | 1,968,000 | ||
Weighted average remaining contractual life (in years) | 9 years 14 days | ||
Weighted average exercise price | $ 10.73 | ||
Number of vested options | 154,581 | ||
Weighted average exercise price options vested | $ 12.27 | ||
Equity Option [Member] | Option Price 5 [Member] | |||
Offsetting Assets [Line Items] | |||
Range of exercise prices, lower range limit | 13.22 | ||
Range of exercise prices, upper range limit | $ 24.58 | ||
Number of outstanding options | 1,577,000 | ||
Weighted average remaining contractual life (in years) | 8 years 2 months 26 days | ||
Weighted average exercise price | $ 18.51 | ||
Number of vested options | 388,750 | ||
Weighted average exercise price options vested | $ 18.80 |
Commitments and Contingencies_5
Commitments and Contingencies (Details 3) - USD ($) | 3 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Loss Contingencies [Line Items] | ||
Total share based compensation | $ 5,346,508 | $ 3,908,771 |
General and Administrative Expense [Member] | ||
Loss Contingencies [Line Items] | ||
Total share based compensation | 1,742,524 | 1,671,725 |
Research and Development Expense [Member] | ||
Loss Contingencies [Line Items] | ||
Total share based compensation | $ 3,603,984 | $ 2,237,046 |
Commitments and Contingencies_6
Commitments and Contingencies (Details 4) | 3 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Risk-free interest rate | 4.07% | 1.37% |
Expected life of options (years) | 4 years 11 months 23 days | 6 years 6 months |
Annualized volatility | 84.01% | 96.79% |
Dividend rate | 0% | 0% |
Commitments and Contingencies_7
Commitments and Contingencies (Details Narrative) - USD ($) | 3 Months Ended | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | Sep. 30, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Operating Leases, Rent Expense | $ 30,070 | $ 4,845 | |
Contribution amount | $ 43,646 | $ 22,682 | |
Warrants outstanding | 160,000 | 160,000 | |
Warrants outstanding weighted average exercise | $ 3.72 | $ 3.72 | |
Option issued | 2,378,000 | ||
Weighted average grant date fair value of options vested | $ 4.40 | $ 2.85 | |
Weighted average contractual life of options outstanding | 6 years 2 months 4 days | 6 years 4 months 24 days | |
Options exercisable | 4 years 9 months 29 days | 5 years 1 month 6 days | |
Share based compensation | $ 5,346,508 | $ 3,908,771 | |
Remaining stock based compensation | $ 16,340,941 | ||
Stock Option Plan 2015 [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Maximum number of 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 issue | 8,078,453 |
Subsequent Events (Details Narr
Subsequent Events (Details Narrative) | 3 Months Ended |
Dec. 31, 2022 | |
Subsequent Events [Abstract] | |
Purchase agreement, description | the Company entered into a Purchase Agreement (the “Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“LPC”), whereby the Company has the right, in its sole discretion, to sell to LPC up to $150,000,000 in value of shares of the Company’s common stock from time to time over a 36-month period pursuant to the terms of the Purchase Agreement. |