Anavex Life Sciences (AVXL) 10-Q 9 Feb 22 2022 Q1 Quarterly report Financial data

Cover

Cover - shares	3 Months Ended
	Dec. 31, 2021	Feb. 08, 2022
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Dec. 31, 2021
Document Fiscal Period Focus	Q1
Document Fiscal Year Focus	2022
Current Fiscal Year End Date	--09-30
Entity File Number	001-37606
Entity Registrant Name	ANAVEX LIFE SCIENCES CORP.
Entity Central Index Key	0001314052
Entity Tax Identification Number	98-0608404
Entity Incorporation, State or Country Code	NV
Entity Address, Address Line One	630 5th Avenue
Entity Address, Address Line Two	20th Floor
Entity Address, City or Town	New York
Entity Address, State or Province	NY
Entity Address, Country	US
Entity Address, Postal Zip Code	10111
City Area Code	844
Local Phone Number	689-3939
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		76,174,887

INTERIM CONDENSED CONSOLIDATED

INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($)	Dec. 31, 2021	Sep. 30, 2021
Current assets
Cash and cash equivalents	$ 151,146,355	$ 152,107,745
Incentive and tax receivables	5,372,153	9,136,831
Prepaid expenses and other current assets	377,860	371,914
Total assets	156,896,368	161,616,490
Current Liabilities
Accounts payable	4,634,791	4,739,781
Accrued liabilities (Note 4)	5,450,040	5,614,774
Deferred grant income	443,831	443,831
Total liabilities	10,528,662	10,798,386
Stockholders’ equity
10,000,000 preferred stock, par value $0.001 per share
(September 30, 2021 - 75,918,465)	76,156	75,920
Additional paid-in capital	354,759,781	348,328,048
Accumulated deficit	(208,468,231)	(197,585,864)
Total stockholders’ equity	146,367,706	150,818,104
Total liabilities and stockholders’ equity	$ 156,896,368	$ 161,616,490

INTERIM CONDENSED CONSOLIDATE_2

INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares	Dec. 31, 2021	Sep. 30, 2021
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	76,155,187	75,918,465
Common stock, shares outstanding	76,155,187	75,918,465

INTERIM CONDENSED CONSOLIDATE_3

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($)	3 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Operating expenses
General and administrative	$ 3,066,951	$ 1,470,656
Research and development	8,656,439	7,925,519
Total operating expenses	(11,723,390)	(9,396,175)
Other income (expenses)
Research and development incentive income	810,730	1,269,316
Interest income (expense), net	4,910	(1,559)
Foreign exchange gain, net	55,363	332,634
Total other income, net	871,003	1,600,391
Net loss before provision for income taxes	(10,852,387)	(7,795,784)
Income tax expense, current	(29,980)	(59,281)
Net loss and comprehensive loss	$ (10,882,367)	$ (7,855,065)
Net Loss per share
Basic and diluted	$ (0.14)	$ (0.12)
Weighted average number of shares outstanding
Basic and diluted	75,997,738	64,295,143

INTERIM CONDENSED CONSOLIDATE_4

INTERIM CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDER'S EQUITY (Unaudited) - USD ($)	Common Stock [Member]	Additional Paid-in Capital [Member]	Retained Earnings [Member]	Total
Beginning balance, value at Sep. 30, 2020	$ 62,047	$ 186,851,752	$ (159,677,230)	$ 27,236,569
Balance beginning, shares at Sep. 30, 2020	62,045,198
Shares issued under 2019 purchase agreement
Purchase shares	$ 3,346	17,458,056		17,461,402
Purchase shares ,shares	3,346,288
Commitment shares	$ 56	(56)
Commitment shares, shares	56,642
Shares issued under Sales Agreement, net of share issuance costs	$ 1,515	8,517,042		8,518,557
Shares issued under Sales Agreement, net of shares issue costs, shares	1,514,829
Share based compensation		939,314		939,314
Net loss			(7,855,065)	(7,855,065)
Ending balance, value at Dec. 31, 2020	$ 66,964	213,766,108	(167,532,295)	46,300,777
Balance ending, shares at Dec. 31, 2020	66,962,957
Beginning balance, value at Sep. 30, 2021	$ 75,920	348,328,048	(197,585,864)	150,818,104
Balance beginning, 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 shares issue 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
Balance ending, shares at Dec. 31, 2021	76,155,187

INTERIM CONDENSED CONSOLIDATE_5

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($)	3 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Cash flows used in operating activities
Net loss	$ (10,882,367)	$ (7,855,065)
Adjustments to reconcile net loss to net cash used in operations:
Stock-based compensation	3,908,771	939,314
Changes in non-cash working capital balances related to operations:
Incentive and tax receivables	3,764,678	(1,728,467)
Prepaid expenses and other current assets	(22,311)	44,999
Accounts payable	(104,992)	227,894
Accrued liabilities	(164,734)	499,947
Net cash used in operating activities	(3,500,955)	(7,871,378)
Cash flows provided by financing activities
Issuance of common shares	2,312,785	26,243,419
Share issue costs	(146,717)	(263,460)
Proceeds from exercise of stock options	373,497
Net cash provided by financing activities	2,539,565	25,979,959
(Decrease) increase in cash and cash equivalents during the period	(961,390)	18,108,581
Cash and cash equivalents, beginning of period	152,107,745	29,249,018
Cash and cash equivalents, end of period	151,146,355	47,357,599
Supplemental Cash Flow Information
Cash paid for state and local minimum income taxes

Description of Business and Bas

Description of Business and Basis of Presentation	3 Months Ended
	Dec. 31, 2021
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Description of Business and Basis of Presentation	Note 1 Description of Business and Basis of Presentation Description of Business Anavex Life Sciences Corp. (“Anavex” or the “Company”) is a clinical stage biopharmaceutical company engaged in the development of differentiated therapeutics by applying precision medicine to central nervous system (“CNS”) diseases with high unmet need. Anavex analyzes genomic data from clinical studies to identify biomarkers, which are used to select patients that will receive the therapeutic benefit for the treatment of neurodegenerative and neurodevelopmental diseases. The Company’s lead compound ANAVEX ® Basis of Presentation These 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, 2021 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, 2021 filed with the SEC on November 24, 2021. The Company follows the same accounting policies in the preparation of interim reports. Operating results for the three months ended December 31, 2021 are not necessarily indicative of the results that may be expected for the year ending September 30, 2022. 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 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 is uncertain. The assumptions upon which the Company has based its estimates are routinely evaluated and may be subject to change. The actual amount of the Company’s expenditures will vary depending upon a number of factors including but not limited to the design, timing and duration of future clinical trials, the progress of the Company’s research and development programs and the level of financial resources available. The Company has the ability to adjust its operating plan spending levels based on the timing of future clinical trials. Other than our rights related to the Sales Agreement (as defined below in Note 5), there can be no assurance that additional financing will be available to us when needed or, if available, that it can be obtained on commercially reasonable terms. If the Company is not able to obtain the additional financing on a timely basis, if and when it is needed, it will be forced to delay or scale down some or all of its research and development activities. Coronavirus Disease 2019 (COVID-19) The recent global outbreak of COVID-19 has not had a material impact on the Company’s result of operations or financial condition as of December 31, 2021. However, the pandemic continues to rapidly evolve as of the date these consolidated financial statements are issued and has created a dynamic and uncertain situation in the global economy. As such, it is uncertain as to the full magnitude that the outbreak will have on the Company’s financial condition and future results of operations. Management is actively monitoring the global situation on its business, including on its clinical trials and operations and financial condition. Given the daily evolution of the COVID-19 situation, and the global responses to curb its spread, the Company is not able to estimate the effects COVID-19 may have on its future results of operations or financial condition. 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, asset impairment, 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. 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. The book value of cash and cash equivalents and accounts payable and accrued liabilities approximate their fair values due to the short-term maturity of those instruments. At December 31, 2021 and September 30, 2021, 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, 2021, loss per share excludes 11,403,769 11,540,903

Recent Accounting Pronouncement

Recent Accounting Pronouncements	3 Months Ended
	Dec. 31, 2021
Accounting Changes and Error Corrections [Abstract]
Recent Accounting Pronouncements	Note 2 Recent Accounting Pronouncements Recently Adopted Accounting Pronouncements Effective October 1, 2021, the Company adopted ASU 2019-12, “Simplifying the Accounting for Income Taxes (ASC 740)”, which is intended to simplify various aspects related to accounting for income taxes by removing certain exceptions to the general principles in Topic 740 and clarifying and amending existing guidance to improve consistent application. There was no material impact on the Company’s operations, financial condition, or cash flows.

Other Income

Other Income	3 Months Ended
	Dec. 31, 2021
Other Income
Other Income	Note 3 Other Income Grant Income During the year ended September 30, 2021, the Company received $ 497,931 ® The grant income is being deferred when received and amortized to other income as the related research and development expenditures are incurred. During the three months ended December 31, 2021 and 2020, the Company did not recognize any of this grant on its statements of operations. At December 31, 2021, an amount of $ 443,831 443,831 Research and development incentive income Research and development incentive income represents the receipt by Anavex Australia, of the Australian research and development incentive credit, (the “R&D Incentive Credit”). During the three months ended December 31, 2021, the Company recorded research and development incentive income of $ 810,730 1,116,362 1,269,316 1,735,962

Accrued liabilities

Accrued liabilities	3 Months Ended
	Dec. 31, 2021
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, 2021 2021 Clinical site costs and patient visits $ 1,689,740 $ 2,035,800 Accrued compensation and benefits 1,205,186 1,201,903 Fixed contract accruals 359,424 649,649 All other accrued liabilities 2,195,690 1,727,422 Total accrued liabilities $ 5,450,040 $ 5,614,774

Equity Offerings

Equity Offerings	3 Months Ended
	Dec. 31, 2021
Equity Offerings
Equity Offerings	Note 5 Equity Offerings Common Stock Common shares are voting and are entitled to dividends as declared at the discretion of the Board of Directors. Preferred Stock The Company’s Board of Directors (the “Board”) has the authority to issue preferred stock in one or more series and to fix the rights, preferences, privileges, restrictions and the number of shares constituting any series 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% of the gross proceeds from the sale of the Shares pursuant to the Sales Agreement. The Company also agreed to provide the Sales Agents with customary indemnification and contribution rights. During the three months ended December 31, 2021, 99,588 2,312,785 2,149,701 1,514,829 8,782,017 8,518,557 161,079,765 163,392,550 2019 Purchase Agreement On June 7, 2019, the Company entered into a $ 50,000,000 50,000,000 In consideration for entering into the 2019 Purchase Agreement, the Company issued to Lincoln Park 324,383 shares of common stock as a commitment fee during the year ended September 30, 2019 and agreed to issue up to 162,191 At December 31, 2021 and September 30, 2021, no shares remained available for issuance under the 2019 Purchase Agreement. During the three months ended December 31, 2020, the Company issued to Lincoln Park an aggregate of 3,402,930 3,346,288 17,461,402 56,642

Commitments and Contingencies

Commitments and Contingencies	3 Months Ended
	Dec. 31, 2021
Commitments and Contingencies Disclosure [Abstract]
Commitments and Contingencies	Note 6 Commitments and Contingencies a) Leases During the three months ended December 31, 2021, the Company incurred office lease expense of $ 4,845 68,387 b) 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, 2021, the Company made $ 22,682 16,556 c) 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. d) Share Purchase Warrants A summary of the status of the Company’s outstanding share purchase warrants is presented below: Schedule of exercisable share purchase warrants outstanding Weighted Number of Average Exercise Shares Price ($) Balance, September 30, 2020 500,000 3.88 Granted 60,000 12.00 Exercised (350,000 ) 4.19 Balance, September 30, 2021 210,000 5.69 Forfeited (50,000 ) 12.00 Balance, December 31, 2021 160,000 3.72 At December 31, 2021, the Company had share purchase warrants outstanding as follows: Schedule of share purchase warrants outstanding Number Exercise Price Expiry Date 150,000 $ 3.17 May 6, 2024 10,000 $ 12.00 April 21, 2026 160,000 e) 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 6,050,553 146,371 146,371 e) Stock-based Compensation Plan – (Continued) 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. Under the terms of the 2019 Plan, 6,000,000 The 2019 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 2019 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 2019 Plan. At December 31, 2021, 406,332 456,332 A summary of the status of Company’s outstanding stock options is presented below: Schedule of outstanding stock purchase options Weighted Weighted Average Average Grant Aggregate Number of Exercise Price Date Fair intrinsic value Shares ($) Value ($) ($) Outstanding, September 30, 2020 10,076,266 3.48 14,982,581 Granted 2,732,000 12.55 9.32 Forfeited (55,834 ) 3.04 2.43 Exercised (1,421,529 ) 2.89 2.43 24,446,305 Outstanding, September 30, 2021 11,330,903 5.74 140,132,451 Granted 50,000 19.64 15.52 Exercised (137,134 ) 2.72 2.12 2,276,948 Outstanding, December 31, 2021 11,243,769 5.84 132,001,363 Exercisable, December 31, 2021 8,294,684 3.75 112,870,598 e) Stock-based Compensation Plan – (Continued) The following summarizes information about stock options at December 31, 2021 by a range of exercise prices: Schedule Of Share-based Payment Arrangement, Option, Activity Weighted average Weighted Weighted Range of exercise Number of remaining average average prices outstanding contractual exercise Number of exercise From To options life (in years) price vested options price $ 0.92 $ 2.96 4,172,215 5.94 2.29 4,049,714 2.29 $ 3.15 $ 4.80 2,117,500 6.08 3.30 1,837,500 3.29 $ 5.04 $ 8.98 3,397,054 6.20 6.05 2,347,054 6.30 $ 12.00 $ 13.01 230,000 9.27 12.44 39,166 12.38 $ 17.03 $ 24.58 1,327,000 9.58 19.35 21,250 24.24 11,243,769 8,294,684 The weighted average grant date fair value of options vested during the three months ended December 31, 2021 was $ 2.85 2.40 6.54 6.79 5.31 5.51 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, 2021. During the three months ended December 31, 2021, the Company recognized stock-based compensation expense of $ 3,908,771 939,314 Schedule of general and administrative expenses and research and development expenses 2021 2020 General and administrative $ 1,671,726 $ 422,823 Research and development 2,237,046 516,491 Total stock-based compensation $ 3,908,771 $ 939,314 An amount of approximately $ 18,170,000 e) Stock-based Compensation Plan – (Continued) The fair value of each option award granted during the three months ended December 31, 2021 and 2020 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 2021 2020 Risk-free interest rate 1.37 % 0.62 % Expected life of options (years) 6.50 5.59 Annualized volatility 96.79 % 96.16 % Dividend rate 0.00 % 0.00 % The fair value of stock compensation charges recognized during the three months ended December 31, 2021 and 2020 was determined with reference to the quoted market price of the Company’s shares on the grant date.

Recent Accounting Pronounceme_2

Recent Accounting Pronouncements (Policies)	3 Months Ended
	Dec. 31, 2021
Accounting Changes and Error Corrections [Abstract]
Recently Adopted Accounting Pronouncements	Recently Adopted Accounting Pronouncements Effective October 1, 2021, the Company adopted ASU 2019-12, “Simplifying the Accounting for Income Taxes (ASC 740)”, which is intended to simplify various aspects related to accounting for income taxes by removing certain exceptions to the general principles in Topic 740 and clarifying and amending existing guidance to improve consistent application. There was no material impact on the Company’s operations, financial condition, or cash flows.

Accrued liabilities (Tables)

Accrued liabilities (Tables)	3 Months Ended
	Dec. 31, 2021
Payables and Accruals [Abstract]
Schedule of Accrued Liabilities	Schedule of Accrued Liabilities December 31, September 31, 2021 2021 Clinical site costs and patient visits $ 1,689,740 $ 2,035,800 Accrued compensation and benefits 1,205,186 1,201,903 Fixed contract accruals 359,424 649,649 All other accrued liabilities 2,195,690 1,727,422 Total accrued liabilities $ 5,450,040 $ 5,614,774

Commitments and Contingencies (

Commitments and Contingencies (Tables)	3 Months Ended
	Dec. 31, 2021
Commitments and Contingencies Disclosure [Abstract]
Schedule of exercisable share purchase warrants outstanding	Schedule of exercisable share purchase warrants outstanding Weighted Number of Average Exercise Shares Price ($) Balance, September 30, 2020 500,000 3.88 Granted 60,000 12.00 Exercised (350,000 ) 4.19 Balance, September 30, 2021 210,000 5.69 Forfeited (50,000 ) 12.00 Balance, December 31, 2021 160,000 3.72
Schedule of share purchase warrants outstanding	Schedule of share purchase warrants outstanding Number Exercise Price Expiry Date 150,000 $ 3.17 May 6, 2024 10,000 $ 12.00 April 21, 2026 160,000
Schedule of outstanding stock purchase options	Schedule of outstanding stock purchase options Weighted Weighted Average Average Grant Aggregate Number of Exercise Price Date Fair intrinsic value Shares ($) Value ($) ($) Outstanding, September 30, 2020 10,076,266 3.48 14,982,581 Granted 2,732,000 12.55 9.32 Forfeited (55,834 ) 3.04 2.43 Exercised (1,421,529 ) 2.89 2.43 24,446,305 Outstanding, September 30, 2021 11,330,903 5.74 140,132,451 Granted 50,000 19.64 15.52 Exercised (137,134 ) 2.72 2.12 2,276,948 Outstanding, December 31, 2021 11,243,769 5.84 132,001,363 Exercisable, December 31, 2021 8,294,684 3.75 112,870,598
Schedule Of Share-based Payment Arrangement, Option, Activity	Schedule Of Share-based Payment Arrangement, Option, Activity Weighted average Weighted Weighted Range of exercise Number of remaining average average prices outstanding contractual exercise Number of exercise From To options life (in years) price vested options price $ 0.92 $ 2.96 4,172,215 5.94 2.29 4,049,714 2.29 $ 3.15 $ 4.80 2,117,500 6.08 3.30 1,837,500 3.29 $ 5.04 $ 8.98 3,397,054 6.20 6.05 2,347,054 6.30 $ 12.00 $ 13.01 230,000 9.27 12.44 39,166 12.38 $ 17.03 $ 24.58 1,327,000 9.58 19.35 21,250 24.24 11,243,769 8,294,684
Schedule of general and administrative expenses and research and development expenses	Schedule of general and administrative expenses and research and development expenses 2021 2020 General and administrative $ 1,671,726 $ 422,823 Research and development 2,237,046 516,491 Total stock-based compensation $ 3,908,771 $ 939,314
Schedule of weighted average assumptions for fair value of each option award	Schedule of weighted average assumptions for fair value of each option award 2021 2020 Risk-free interest rate 1.37 % 0.62 % Expected life of options (years) 6.50 5.59 Annualized volatility 96.79 % 96.16 % Dividend rate 0.00 % 0.00 %

Description of Business and B_2

Description of Business and Basis of Presentation (Details Narrative) - shares	3 Months Ended	12 Months Ended
	Dec. 31, 2021	Sep. 30, 2021
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Loss per share for potentially dilutive common shares	11,403,769	11,540,903

Other Income (Details Narrative

Other Income (Details Narrative) - USD ($)	3 Months Ended		12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Sep. 30, 2021
Defined Benefit Plan Disclosure [Line Items]
Research and development incentive income	$ 810,730	$ 1,269,316
Grant income	443,831		$ 443,831
Australia, Dollars
Defined Benefit Plan Disclosure [Line Items]
Research and development incentive income	1,116,362	$ 1,735,962
Parkinson [Member]
Defined Benefit Plan Disclosure [Line Items]
Research and development incentive income	$ 497,931

Accrued liabilities (Details)

Accrued liabilities (Details) - USD ($)	Dec. 31, 2021	Sep. 30, 2021
Payables and Accruals [Abstract]
Clinical site costs and patient visits	$ 1,689,740	$ 2,035,800
Accrued compensation and benefits	1,205,186	1,201,903
Fixed contract accruals	359,424	649,649
All other accrued liabilities	2,195,690	1,727,422
Total accrued liabilities	$ 5,450,040	$ 5,614,774

Equity Offerings (Details Narra

Equity Offerings (Details Narrative) - USD ($)	Jun. 07, 2019	Dec. 31, 2021	Dec. 31, 2020	Sep. 30, 2021
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Sales of agreement amount		$ 161,079,765		$ 163,392,550
Equity Offering Sales Agreement [Member] | Cantor Fitzgerald And Co [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Share issued for aggregate, shares		99,588	1,514,829
Gross proceeds from sale of common stock		$ 2,312,785	$ 8,782,017
Proceed from offering		$ 2,149,701	$ 8,518,557
2019 Purchase Agreement [Member] | Lincoln Park Capital Fund, LLC [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Share issued for aggregate, shares			3,402,930
Total number of shares obligated to purchase	$ 50,000,000
Proceeds from Issuance or Sale of Equity	$ 50,000,000
Pro rata basic number of shares obligated to purchase	162,191
Additional common shares			3,346,288
Number of shares issued for aggregate purchase price, value			$ 17,461,402
Number of shares issued for commitment			56,642

Commitments and Contingencies_2

Commitments and Contingencies (Details) - Purchase Warrants [Member] - $ / shares	3 Months Ended	12 Months Ended
	Dec. 31, 2021	Sep. 30, 2021
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share Purchase Warrants Balance, at beginning	210,000	500,000
Weighted Average Exercise Price Balance, at beginning	$ 5.69	$ 3.88
Share Purchase Warrants Granted		60,000
Weighted Average Exercise Price, Granted		$ 12
Share Purchase Warrants Exercised		(350,000)
Weighted Average Exercise Price, Exercised		$ 4.19
Share Purchase Warrants Forfeited	(50,000)
Weighted Average Exercise Price, Forfeited	$ 12
Share Purchase Warrants Balance, at ending	160,000	210,000
Weighted Average Exercise Price Balance, at ending	$ 3.72	$ 5.69

Commitments and Contingencies_3

Commitments and Contingencies (Details 1)	Dec. 31, 2021$ / sharesshares
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 6, 2024
Purchase Warrants 2 [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number	10,000
Exercise Price | $ / shares	$ 12
Expiry Date	Apr. 21, 2026

Commitments and Contingencies_4

Commitments and Contingencies (Details 2) - 2015 Omnibus Incentive Plan [Member] - USD ($)	3 Months Ended	12 Months Ended
	Dec. 31, 2021	Sep. 30, 2021
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Options Outstanding at beginning	11,330,903	10,076,266
Weighted Average Exercise Price Outstanding at beginning	$ 5.74	$ 3.48
Aggregate intrinsic value Outstanding at beginning	$ 140,132,451	$ 14,982,581
Options Granted	50,000	2,732,000
Weighted Average Exercise Price Granted	$ 19.64	$ 12.55
Weighted Average Grant Date Fair Value Granted	$ 15.52	$ 9.32
Options Forfeited		(55,834)
Weighted Average Exercise Price Forfeited		$ 3.04
Weighted Average Grant Date Fair Value Forfeited		$ 2.43
Options Exercised	(137,134)	(1,421,529)
Weighted Average Exercise Price Exercised	$ 2.72	$ 2.89
Weighted Average Grant Date Fair Value Exercised	$ 2.12	$ 2.43
Aggregate intrinsic value Exercised	$ 2,276,948	$ 24,446,305
Options Outstanding at ending	11,243,769	11,330,903
Weighted Average Exercise Price Outstanding at ending	$ 5.84	$ 5.74
Aggregate intrinsic value Outstanding at ending	$ 132,001,363	$ 140,132,451
Options Exercisable at ending	8,294,684
Weighted Average Exercise Price Exercisable at ending	$ 3.75
Aggregate intrinsic value Exercisable at ending	$ 112,870,598

Commitments and Contingencies_5

Commitments and Contingencies (Details 3) - $ / shares	3 Months Ended	12 Months Ended
	Dec. 31, 2021	Sep. 30, 2021
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Weighted average remaining contractual life (in years)	6 years 6 months 14 days	6 years 9 months 14 days
Equity Option [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of outstanding options	11,243,769
Number of vested options	8,294,684
Equity Option [Member] | Option Price 1 [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Range of exercise prices, lower range limit	$ 0.92
Range of exercise prices, upper range limit	$ 2.96
Number of outstanding options	4,172,215
Weighted average remaining contractual life (in years)	5 years 11 months 8 days
Weighted average exercise price	$ 2.29
Number of vested options	4,049,714
Weighted average exercise price	$ 2.29
Equity Option [Member] | Option Price 2 [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Range of exercise prices, lower range limit	3.15
Range of exercise prices, upper range limit	$ 4.80
Number of outstanding options	2,117,500
Weighted average remaining contractual life (in years)	6 years 29 days
Weighted average exercise price	$ 3.30
Number of vested options	1,837,500
Weighted average exercise price	$ 3.29
Equity Option [Member] | Option Price 3 [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Range of exercise prices, lower range limit	5.04
Range of exercise prices, upper range limit	$ 8.98
Number of outstanding options	3,397,054
Weighted average remaining contractual life (in years)	6 years 2 months 12 days
Weighted average exercise price	$ 6.05
Number of vested options	2,347,054
Weighted average exercise price	$ 6.30
Equity Option [Member] | Option Price 4 [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Range of exercise prices, lower range limit	12
Range of exercise prices, upper range limit	$ 13.01
Number of outstanding options	230,000
Weighted average remaining contractual life (in years)	9 years 3 months 7 days
Weighted average exercise price	$ 12.44
Number of vested options	39,166
Weighted average exercise price	$ 12.38
Equity Option [Member] | Option Price 5 [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Range of exercise prices, lower range limit	17.03
Range of exercise prices, upper range limit	$ 24.58
Number of outstanding options	1,327,000
Weighted average remaining contractual life (in years)	9 years 6 months 29 days
Weighted average exercise price	$ 19.35
Number of vested options	21,250
Weighted average exercise price	$ 24.24

Commitments and Contingencies_6

Commitments and Contingencies (Details 4) - USD ($)	3 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Loss Contingencies [Line Items]
Total share based compensation	$ 3,908,771	$ 939,314
General and Administrative Expense [Member]
Loss Contingencies [Line Items]
Total share based compensation	1,671,726	422,823
Research and Development Expense [Member]
Loss Contingencies [Line Items]
Total share based compensation	$ 2,237,046	$ 516,491

Commitments and Contingencies_7

Commitments and Contingencies (Details 5)	3 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Commitments and Contingencies Disclosure [Abstract]
Risk-free interest rate	1.37%	0.62%
Expected life of options (years)	6 years 6 months	5 years 7 months 2 days
Annualized volatility	96.79%	96.16%
Dividend rate	0.00%	0.00%

Commitments and Contingencies_8

Commitments and Contingencies (Details Narrative) - USD ($)	3 Months Ended		12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Sep. 30, 2021
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Operating Leases, Rent Expense	$ 4,845	$ 68,387
Contribution amount	$ 22,682	$ 16,556
weighted average grant date fair value of options vested	$ 2.85	$ 2.40
Weighted average contractual life of options outstanding	6 years 6 months 14 days		6 years 9 months 14 days
Options exercisable	5 years 3 months 21 days		5 years 6 months 3 days
Share based compensation	$ 3,908,771	$ 939,314
Remaining stock based compensation	$ 18,170,000
2015 Omnibus Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Maximum number of common shares reserved for future issuance	6,050,553
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant	146,371		146,371
2019 Omnibus Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Additional shares of common stock available for issuance	6,000,000
Remaining stock options	$ 406,332		$ 456,332