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Anavex Life Sciences (AVXL)

Cover

Cover - USD ($)12 Months Ended
Sep. 30, 2021Nov. 19, 2021Mar. 31, 2021
Cover [Abstract]
Document Type10-K
Amendment Flagfalse
Document Annual Reporttrue
Document Transition Reportfalse
Document Period End DateSep. 30,
2021
Document Fiscal Period FocusFY
Document Fiscal Year Focus2021
Current Fiscal Year End Date--09-30
Entity File Number001-37606
Entity Registrant NameANAVEX LIFE SCIENCES CORP.
Entity Central Index Key0001314052
Entity Tax Identification Number98-0608404
Entity Incorporation, State or Country CodeNV
Entity Address, Address Line One630 5th Avenue
Entity Address, Address Line Two20th Floor
Entity Address, City or TownNew York
Entity Address, State or ProvinceNY
Entity Address, CountryUS
Entity Address, Postal Zip Code10111
City Area Code844
Local Phone Number689-3939
Entity Well-known Seasoned IssuerYes
Entity Voluntary FilersNo
Entity Current Reporting StatusYes
Entity Interactive Data CurrentYes
Entity Filer CategoryLarge Accelerated Filer
Entity Small Businesstrue
Entity Emerging Growth Companyfalse
Entity Shell Companyfalse
Entity Public Float $ 1,011,843,276
Entity Common Stock, Shares Outstanding76,018,053
ICFR Auditor Attestation Flagtrue

CONSOLIDATED BALANCE SHEETS

CONSOLIDATED BALANCE SHEETS - USD ($)Sep. 30, 2021Sep. 30, 2020
Current
Cash and cash equivalents $ 152,107,745 $ 29,249,018
Incentive and tax receivables9,136,831 4,849,340
Prepaid expenses and deposits355,549 443,839
Deferred financing charges16,365 0
Total Assets161,616,490 34,542,197
Current Liabilities
Accounts payable4,739,781 3,989,054
Accrued liabilities - Note 35,614,774 3,316,574
Deferred grant income443,831 0
Total Liabilities10,798,386 7,305,628
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 (2020: 100,000,000 common stock, par value $0.001 per share) Issued and outstanding: 75,918,465 common shares (2020 - 62,045,198)75,920 62,047
Additional paid-in capital348,328,048 186,851,752
Accumulated deficit(197,585,864)(159,677,230)
Total Stockholders' Equity150,818,104 27,236,569
Total Liabilities and Stockholders' Equity $ 161,616,490 $ 34,542,197

CONSOLIDATED BALANCE SHEETS (Pa

CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / sharesSep. 30, 2021Sep. 30, 2020
Statement of Financial Position [Abstract]
Preferred stock, authorized10,000,000 10,000,000
Preferred stock, par value (in dollars per share) $ 0.001 $ 0.001
Common shares, authorized200,000,000 100,000,000
Common shares, par value (in dollars per share) $ 0.001 $ 0.001
Common shares, issued75,918,465 62,045,198
Common shares, outstanding75,918,465 62,045,198

CONSOLIDATED STATEMENTS OF OPER

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($)12 Months Ended
Sep. 30, 2021Sep. 30, 2020
Operating expenses
General and administrative $ 9,017,511 $ 5,856,609
Research and development32,983,674 25,231,623
Total operating expenses(42,001,185)(31,088,232)
Other income (expenses)
Grant income54,100 149,888
Research and development incentive income4,547,099 4,375,025
Interest income, net26,261 179,973
Foreign exchange gain (loss), net(267,344)125,540
Total other income, net4,360,116 4,830,426
Net loss before provision for income taxes(37,641,069)(26,257,806)
Income tax expense, current(267,565)(22,664)
Net loss and comprehensive loss $ (37,908,634) $ (26,280,470)
Net Loss per share
Basic and diluted $ (0.54) $ (0.45)
Weighted average number of shares outstanding
Basic and diluted69,802,960 58,194,894

CONSOLIDATED STATEMENTS OF CASH

CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)12 Months Ended
Sep. 30, 2021Sep. 30, 2020
Cash Flows used in Operating Activities
Net loss $ (37,908,634) $ (26,280,470)
Adjustments to reconcile net loss to net cash used in operations:
Stock-based compensation8,231,403 4,876,906
Changes in non-cash working capital balances related to operations:
Incentive and tax receivables(4,287,491)(2,206,595)
Prepaid expenses and deposits88,290 57,159
Accounts payable750,727 465,722
Accrued liabilities2,298,200 1,800,232
Deferred grant income443,831 0
Net cash used in operating activities(30,383,674)(21,287,046)
Cash Flows provided by Financing Activities
Issuance of common shares153,218,762 28,754,198
Share issue costs(5,550,921)(403,764)
Proceeds from exercise of warrants1,466,500 0
Proceeds from exercise of stock options4,108,060 0
Net cash provided by financing activities153,242,401 28,350,434
Increase in cash and cash equivalents during the period122,858,727 7,063,388
Cash and cash equivalents, beginning of period29,249,018 22,185,630
Cash and cash equivalents, end of period152,107,745 29,249,018
Cash paid for state and local minimum income taxes $ 139,531 $ 22,664

CONSOLIDATED STATEMENT OF CHANG

CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($)Common Stock [Member]Additional Paid-in Capital [Member]Retained Earnings [Member]Total
Beginning balance, value at Sep. 30, 2019 $ 52,652 $ 153,633,807 $ (133,396,760) $ 20,289,699
Balance at beginning, shares at Sep. 30, 201952,650,521
Shares issued under 2019 purchase agreement Purchase shares $ 7,565 21,246,733 21,254,298
Shares issued under 2019 Purchase Agreement - Purchase shares (in shares)7,564,584
Commitment shares $ 69 $ (69)
Commitment shares68,943
Shares issued pursuant to cashless exercise of stock options1 (1)
Shares issued pursuant to cashless exercise of options (in shares)721
Shares issued under Sales Agreement, net of share issuance costs $ 1,760 $ 7,094,376 $ 7,096,136
Shares issued under Sales Agreement, net of shares issue costs (in shares)1,760,429
Share based compensation 4,876,906 4,876,906
Net loss (26,280,470)(26,280,470)
Ending balance, value at Sep. 30, 2020 $ 62,047 186,851,752 (159,677,230)27,236,569
Balance at ending, shares at Sep. 30, 202062,045,198
Shares issued under 2019 purchase agreement Purchase shares $ 4,008 24,107,190 24,111,198
Shares issued under 2019 Purchase Agreement - Purchase shares (in shares)4,007,996
Commitment shares $ 78 (78)
Commitment shares78,213
Shares issued pursuant to exercise of stock options $ 1,421 4,106,639 4,108,060
Shares issued pursuant to exercise of stock options (in shares)1,421,529
Shares issued pursuant to registered direct offering, net of share issue costs $ 2,381 46,900,600 46,902,981
Shares issued pursuant to registered direct offering, net of share issue costs (in shares)2,380,953
Shares issued pursuant to exercise of warrants $ 350 1,466,150 1,466,500
Shares issued pusuant to exercise of warrants (in shares)350,000
Shares issued under Sales Agreement, net of share issuance costs $ 5,635 76,664,392 76,670,027
Shares issued under Sales Agreement, net of shares issue costs (in shares)5,634,576
Share based compensation 8,231,403 8,231,403
Net loss (37,908,634)(37,908,634)
Ending balance, value at Sep. 30, 2021 $ 75,920 $ 348,328,048 $ (197,585,864) $ 150,818,104
Balance at ending, shares at Sep. 30, 202175,918,465

Business Description and Basis

Business Description and Basis of Presentation12 Months Ended
Sep. 30, 2021
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Business Description and Basis of PresentationNote 1 Business Description and Basis of
Presentation Business Anavex Life Sciences Corp. (“Anavex”
or the “Company”) is a clinical stage biopharmaceutical company engaged in the development
of differentiated therapeutics by applying precision medicine to central nervous system (“CNS”) diseases with high
unmet need. Anavex analyzes genomic data from clinical studies to identify biomarkers, which are used to select patients that will
receive the therapeutic benefit for the treatment of neurodegenerative and neurodevelopmental diseases. is being developed to treat Alzheimer’s disease, Parkinson’s
disease and potentially other central nervous system diseases, including rare diseases, such as Rett syndrome, a rare severe neurological
monogenic disorder caused by mutations in the X-linked gene, methyl-CpG-binding protein 2 (“MECP2”) On May 25, 2021, the Company filed
a Certificate of Amendment to its Articles of Incorporation with the Secretary of the State of Nevada effecting an amendment to
increase the number of authorized shares of the Company’s common stock, par value $ 0.001 200,000,000 Basis of
Presentation These consolidated financial statements
have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) and the
instructions to Form 10-K and have been prepared under the accounting principles generally accepted in the United States of America
(“U.S. GAAP”). Liquidity All of the Company’s potential
drug compounds are in the clinical development stage and the Company cannot be certain that its research and development efforts
will be successful or, if successful, that its potential drug compounds will ever be approved for sale or generate commercial revenues.
To date, we have not generated any revenues from our operations. The Company expects the business to continue to experience negative
cash flows for the foreseeable future and cannot predict when, if ever, its business might become profitable. Management believes that the current
working capital position will be sufficient to meet the Company’s working capital requirements beyond the next 12 months
after the date that these consolidated financial statements are issued. The process of drug development can be costly, and the
timing and outcomes of clinical trials is uncertain. The assumptions upon which the Company has based its estimates are routinely
evaluated and may be subject to change. The actual amount of the Company’s expenditures will vary depending upon a number
of factors including but not limited to the design, timing and duration of future clinical trials, the progress of the Company’s
research and development programs and the level of financial resources available. The Company has the ability to adjust its operating
plan spending levels based on the timing of future clinical trials. Other than our rights related to
the Sales Agreement (as defined below in Note 5), there can be no assurance that additional financing will be available to us when
needed or, if available, that it can be obtained on commercially reasonable terms. If the Company is not able to obtain the additional
financing on a timely basis, if and when it is needed, it will be forced to delay or scale down some or all of its research and
development activities. The recent global outbreak of COVID-19
has not had a material impact on the Company’s result of operations or financial condition for the year ended September 30,
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.

Summary of Significant Accounti

Summary of Significant Accounting Policies12 Months Ended
Sep. 30, 2021
Accounting Policies [Abstract]
Summary of Significant Accounting PoliciesNote 2 Summary of Significant Accounting Policies
a) 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 book values of assets
and liabilities and the accrual of costs and expenses that are not readily apparent from other sources. The actual results experienced
by the Company may differ materially and adversely from the Company’s estimates. To the extent there are material differences
between the estimates and the actual results, future results of operations will be affected.
b) 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.
c) Cash and equivalents The
Company considers only those investments which are highly liquid, readily convertible to cash and that mature within three months
from the date of purchase to be cash equivalents Highly liquid investments
that are considered cash equivalents include money market accounts, money market funds and certificates of
deposit. The carrying value of cash equivalents approximates fair value due to the short-term maturity of these securities. The
Company s investment policy allows for investments in domestic money market certificates, certificates of deposit,
money market funds, commercial papers, bonds or commercial papers, and establishes diversification and credit quality requirements
and limits investments by maturity and issuer. The Company currently maintains its investments at one large well known financial
institution. The Company maintains
its cash in bank deposit accounts which, at times, may exceed federally insured limits. Accounts are guaranteed by the Federal
Deposit Insurance Corporation (FDIC) up to $ 250,000 The Company has not experienced any losses in such accounts.
d) Research and Development Expenses Research and development costs
are expensed as incurred. These expenses are comprised of the costs of the Company’s proprietary research and development
efforts, including preclinical studies, clinical trials, manufacturing costs, employee salaries and benefits and stock-based compensation
expense, contract services including external research and development expenses incurred under arrangements with third parties
such as contract research organizations (“CROs”), facilities costs, overhead costs and other related expenses. Milestone
payments made by the Company to third parties are expensed when the specific milestone has been achieved. Manufacturing costs are
expensed as incurred in accordance with Accounting Standard Codification (“ASC”) 730, Research and Development, as
these materials have no alternative future use outside of their intended use. Nonrefundable
advance payments for goods or services that will be used or rendered for future research and development activities are deferred
and amortized over the that the goods are delivered, or the related services are performed,
subject to an assessment of recoverability. The Company makes estimates of costs incurred in relation to external CROs, and clinical
site costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the studies including the
phase or completion of events, invoices received and contracted costs. Judgments and estimates are made in determining
the accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates. The Company’s
historical accrual estimates have not been materially different from actual costs. In addition, the Company incurs
expenses in respect of intellectual property costs relating to patents and trademarks. The probability of success and length of
time to develop commercial applications of the drugs subject to the underlying patent and trademark costs is difficult to determine
and numerous risks and uncertainties exist with respect to the timely completion of the development projects. There is no assurance
the drugs subject to the underlying patents and trademarks will ever be successfully commercialized. Due to these risks and uncertainties,
the patent and trademark costs do not meet the definition of an asset and thus are expensed as incurred within general and administrative
expenses.
e) Research and Development Incentive Income The Company is eligible to obtain
certain research and development tax credits, including the Australian research and development tax incentive credit (the “Australia
R&D credit”) through a program administered through the Australian Tax Office (the “ATO”), which provides
for a cash refund based on a percentage of certain research and development activities undertaken in Australia by the Company’s
wholly owned subsidiary, Anavex Australia Pty Ltd. (“Anavex Australia”). The cash refund is available to eligible companies
with an annual aggregate revenue of less than $20.0 million Australian during the reimbursable period. The tax incentives are available
on the basis of specific criteria with which the Company must comply. Although the tax incentive may be administered through the
local tax authority, the Company has accounted for the incentives outside of the scope of ASC Topic 740, Income Taxes (“ASC
740”), since the incentives are not linked to the Company’s taxable income and can be realized regardless of whether
the Company has generated taxable income in the respective jurisdictions. With respect to the Australia R&D
credit, Anavex Australia may be eligible to receive the cash refund for certain research and development expenses incurred by Anavex
Australia outside of Australia, to the extent such expenses are pre-approved by the Australian authority pursuant to an advanced
overseas finding application. The Company accrues for the amount of cash refund it expects to receive in relation to research and
development expenses outside of Australia only to the extent it has received advanced approval from the Department of Industry,
Innovation and Science in Australia, pursuant to an approved advanced overseas finding application. In addition, Anavex Australia and
Anavex Canada incur Goods and Services Tax (GST) on certain services provided by local vendors. As a domestic entity in those jurisdictions,
Anavex Australia and Anavex Canada are entitled to a refund of the GST paid. Similarly, Anavex Germany incurs Value Added Tax (VAT)
on certain services provided by local vendors, to which it is entitled to a refund of such VAT paid. The Company’s estimate
of the amount of cash refund it expects to receive related to GST and VAT incurred is included in Incentive and tax receivables
in the accompanying consolidated balance sheets.
f) Basic and Diluted Loss per Share Basic income/(loss) per common
share is computed by dividing net income/(loss) available to common stockholders by the weighted average number of common shares
outstanding during the period. Diluted income/(loss) per common share is computed by dividing net income/(loss) available to common
stockholders by the sum of (1) the weighted-average number of common shares outstanding during the period, (2) the dilutive effect
of the assumed exercise of options and warrants using the treasury stock method and (3) the dilutive effect of other potentially
dilutive securities. For purposes of the diluted net loss per share calculation, options and warrants are potentially dilutive
securities and are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive. As of September 30, 2021, diluted
loss per share excludes 11,540,903 10,576,266
g) Financial
Instruments The book value of the Company’s
financial instruments, consisting of cash and equivalents, incentive and tax receivables, and accounts payable and accrued liabilities
approximate their fair value due to the short-term maturity of such instruments. Unless otherwise noted, it is management’s
opinion that the Company is not exposed to significant interest, currency or credit risks arising from these financial instruments.
h) Foreign Currency Translation The functional currency of the
Company is the US dollar. Monetary items denominated in a foreign currency are translated into US dollars at exchange rates prevailing
at the balance sheet date and non-monetary items are translated at exchange rates prevailing when the assets were acquired, or
obligations incurred. Foreign currency denominated expense items are translated at exchange rates prevailing on the transaction
date. Unrealized gains or losses arising from the translations are credited or charged to income in the period in which they occur. The Company has determined that
the functional currency of Anavex Australia Pty Limited, Anavex Germany GmbH, and Anavex Canada Ltd. is also the US dollar.
i) Segment and Geographic Reporting Operating segments are defined
as components of an enterprise for which separate discrete information is available for evaluation by the chief operating decision
maker or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations
and manages its business as one operating segment, which is the business of developing novel therapies for the management of CNS
diseases.
j) Grant Income Grant
income is recognized at the fair value of the grant when it is received, and all substantive conditions have been satisfied.
k) Income Taxes The Company follows the provisions
of ASC 740, which requires the asset and liability method of accounting for income taxes. Under the asset and liability method,
deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between
the financial statements carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets
and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary
differences are expected to be recovered or settled. The Company follows the provisions
of ASC 740 regarding accounting for uncertainty in income taxes. The Company initially recognizes tax positions in the financial
statements when it is more likely than not the position will be sustained upon examination by the tax authorities. Such tax positions
are initially and subsequently measured as the largest amount of tax benefit that is greater than 50% likely of being realized
upon ultimate settlement with the tax authority assuming full knowledge of the position and all relevant facts. Application requires
numerous estimates based on available information. The Company considers many factors when evaluating and estimating its tax positions
and tax benefits, and its recognized tax positions and tax benefits may not accurately anticipate actual outcomes. As additional
information is obtained, there may be a need to periodically adjust the recognized tax positions and tax benefits. These periodic
adjustments may have a material impact on the consolidated statements of operations. The Company recognizes interest
and penalties related to current income tax expense on the interest income, net line, in the accompanying consolidated statement
of operations. Accrued interest and penalties, if any, are included in accrued liabilities on the consolidated balance sheets.
l) Stock-based Compensation The Company accounts for all stock-based
payments and awards under the fair value method. The fair value of all share purchase
options and warrants are expensed over their contractual vesting period, or over the expected performance period for only the portion
of awards expected to vest, in the case of milestone-based vesting, with a corresponding increase to additional paid-in capital. Compensation costs for stock-based
payments with graded vesting are recognized on a straight-line basis. Stock based compensation expense is adjusted for actual forfeitures
of unvested awards as they occur. The Company has granted share purchase
option awards that vest upon achievement of certain performance criteria, or milestone-based awards. The Company estimates an implicit
service period for achieving performance criteria for each award and recognizes the resulting fair value as expense over the implicit
service period when it concludes that achieving the performance criteria is probable. The Company periodically reviews and updates
as appropriate its estimates of implicit service periods and conclusions on achieving the performance criteria. Performance awards
vest upon achievement of the performance criteria. The Company uses the Black-Scholes
option valuation model to calculate the fair value of share purchase options and warrants at the date of the grant. This model
requires the input of subjective assumptions, including the expected price volatility, expected life and estimated forfeitures of
each award. The Company uses the U.S. Treasury daily treasury yield curve rates for the expected term of the option as the
risk-free rate. The expected term represents the period that options granted are expected to be outstanding using the simplified
method. The Company’s historical share option exercise experience does not provide a reasonable basis for estimating the
expected term. Expected volatility is based on the average of the daily share price changes over the expected term. The Company does
not estimate forfeitures and elects to record actual forfeitures as they occur. The Company has not paid any dividends on its common
stock historically, therefore no assumption of dividend payments is made in the model. These assumptions consist of estimates of
future market conditions, which are inherently uncertain, and therefore, are subject to management’s judgment. Changes in
these assumptions can materially affect the fair value estimates. The purchase price
of options or warrants may be paid in cash or, if approved by the Company’s compensation committee in advance, “net settled”
in shares of the Company’s common stock. In a net settlement of an option or warrant, the Company does not receive payment of the
exercise price from the holder but reduces the number of shares of common stock issued upon the exercise of the stock option or warrant
by the smallest number of whole shares that have an aggregate fair market value equal to or over the aggregate exercise price for the
option shares covered by the option or warrant exercised. Shares issued pursuant to the exercise of options and warrants are issued from
the Company’s treasury.
m) Fair Value Measurements Fair value is defined as the exchange
price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous
market for the asset or liability in an orderly transaction between market participants at the measurement date. Assets and liabilities
that are measured at fair value are reported using a three-level fair value hierarchy that prioritizes the inputs used to measure
fair value. This hierarchy maximizes the use of observable inputs and minimizes the use of unobservable inputs. The three levels
of inputs used to measure fair value are as follows: Level 1 - quoted prices (unadjusted) in active markets
for identical assets or liabilities that the Company has the ability to access at the measurement date; Level 2 - observable inputs other
than Level 1, quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar
assets and liabilities in markets that are not active, and model-derived prices whose inputs are observable or whose significant
value drivers are observable; and Level 3 - assets and liabilities
whose significant value drivers are unobservable by little or no market activity and that are significant to the fair value of
the assets or liabilities. At September 30, 2021 and 2020,
the Company did not have any Level 3 assets or liabilities. n) Recent Accounting Pronouncements In
December 2019, the FASB issued 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. ASU 2019-12 will be effective for the Company on October 1, 2021. The
Company does not expect such guidance to have a material impact on the Company’s operations, financial condition, or cash flows.

Accrued Liabilities

Accrued Liabilities12 Months Ended
Sep. 30, 2021
Accrued Liabilities
Accrued LiabilitiesNote 3 Accrued Liabilities The principal components of accrued liabilities consists
of:
Schedule of components of accrued liabilities
2021 2020
Clinical site costs and patient visits $ 2,035,800 $ 760,900
Accrued compensation and benefits 1,201,903 567,805
Fixed contract accruals 649,649 367,429
All other accrued liabilities 1,727,422 1,620,440
Total accrued liabilities $ 5,614,774 $ 3,316,574 Anavex Life Sciences Corp. Notes to the Consolidated Financial Statements September 30, 2021 – Page 8

Other Income

Other Income12 Months Ended
Sep. 30, 2021
Other Income
Other IncomeNote 4 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 year ended September 30, 2021, the Company recognized $ 54,100 443,831 0 During the
year ended September 30, 2017, the Company was awarded grant funding in the amount of $ 597,886 The grant
income was deferred when received and amortized to other income as the related research and development expenditures were incurred.
During the year ended September 30, 2021, the Company recognized $ 149,888 Research
and development incentive income Research
and development incentive income represents income earned by the Company’s Australian subsidiary, of the Australian
research and development incentive credit, During the
year ended September 30, 2021, the Company recorded research and development incentive income of $ 4,547,099 6,068,993 4,375,025 6,392,266 As
a matter of course, the Company may be subject to pre-issue review or audit by the ATO. The Company was notified that the ATO is performing
a pre-issue review of the 2020 research and development incentive income return. The Company is responding to questions and requests for
information and does not expect an adverse finding.

Equity Offerings

Equity Offerings12 Months Ended
Sep. 30, 2021
Equity Offerings
Equity OfferingsNote 5 Equity Offerings Common Stock Common shares are voting and are
entitled to dividends as declared at the discretion of the Board of Directors. Preferred Stock The Company’s Board of Directors (the
“Board”) has the authority to issue preferred stock in one or more series and to fix the rights, preferences,
privileges, restrictions and the number of shares constituting any series or the designation of the series. Registered Direct Offering On June 22, 2021, the Company and
Deep Track Capital entered into a securities purchase agreement pursuant to which the Company sold to Deep Track Capital an aggregate
of 2,380,953 21 50,000,013 46,902,981 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 5,634,576 79,107,550 76,670,027 1,760,429 7,499,900 7,096,136 163,392,550 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 324,383 162,191 During the year ended September
30, 2021, the Company issued to Lincoln Park an aggregate of 4,086,209 7,633,527 4,007,996 7,564,584 24,111,198 21,254,298 78,213 68,943 At September 30, 2021, no shares
remained available for issuance under the 2019 Purchase Agreement (September 30, 2020: $ 24,111,198

Commitments and Contingencies

Commitments and Contingencies12 Months Ended
Sep. 30, 2021
Commitments and Contingencies Disclosure [Abstract]
Commitments and ContingenciesNote 6 Commitments and Contingencies
a) Lease During the year
ended September 30, 2021 the Company incurred office lease expense of $ 130,784 $ 233,423
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 year ended September 30, 2021, the Company made $ 128,856 98,058
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. The following table summarizes
the warrant activity during the years ended September 30, 2021 and 2020:
Schedule of exercisable share purchase warrants outstanding
Weighted
Average
Exercise Price
Number of Shares ($)
Balance, September 30, 2019 350,000 4.19
Granted 150,000 3.17
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 At September
30, 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
60,000 $ 12.00 April 21, 2026
210,000 2015 Stock Option Plan On September 18, 2015, the Company’s
board of directors approved a 2015 Omnibus Incentive Plan (the “2015 Plan”), which provided for the grant of stock
options and restricted stock awards to directors, officers, employees and consultants of the Company. The maximum number of our common
shares reserved for issue under the plan was 6,050,553 146,371 133,036 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 of directors 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 September 30, 2021, 456,332 3,161,665 A summary of the status of Company’s
outstanding stock purchase option activity during the years ended September 30, 2021 and 2020 is presented below:
Schedule of outstanding stock purchase options
Weighted
Weighted Average Grant Aggregate
Average Exercise Date Fair intrinsic value
Number of Shares Price ($) Value ($) ($)
Outstanding, September 30, 2019 8,462,933 3.58 4,115,032
Granted 1,695,000 2.96 2.27
Forfeited (68,332 ) 3.01 2.44
Exercised (13,335 ) 3.15 2.61 2,400
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
Exercisable, September 30, 2021 7,228,488 3.73 102,786,851 The following summarizes information about
stock options at September 30, 2021 by a range of exercise prices:
Summarizes information about
stock options
Number of Weighted average remaining Weighted average Number of Weighted average
Range of exercise prices outstanding contractual life exercise vested exercise
From To options (in years) price options price
$ 0.92 $ 2.96 4,309,349 6.25 2.31 3,167,682 2.10
$ 3.15 $ 4.80 2,117,500 6.33 3.30 1,830,836 3.29
$ 5.04 $ 8.98 3,397,054 6.45 6.05 2,207,054 6.35
$ 12.00 $ 13.01 230,000 9.52 12.44 22,916 12.42
$ 18.11 $ 24.58 1,277,000 9.82 19.33 — —
11,330,903 7,228,488 The weighted average grant date
fair value of options vested during the year ended September 30, 2021 was $ 2.54 2.55 6.79 6.96 5.51 6.25 The aggregate intrinsic value is
calculated as the difference between the exercise price of the underlying awards and the quoted market price of the Company’s
stock for the options that were in-the-money at September 30, 2021. The Company recognized stock-based
compensation expense of $ 8,231,403 4,876,906
Schedule of general and administrative expenses and research and development expenses
2021 2020
General and administrative $ 3,571,335 $ 2,210,789
Research and development $ 4,660,068 $ 2,666,117
Total stock-based compensation $ 8,231,403 $ 4,876,906 An amount of approximately $ 21,650,000 The fair value
of each option and warrant award is estimated on the date of grant using the Black Scholes option pricing model based on the following
weighted average assumptions:
Schedule of weighted average assumptions for fair value of each option award
2021 2020
Risk-free interest rate 0.73 % 1.57 %
Expected life of options (years) 5.74 5.53
Annualized volatility 93.43 % 95.99 %
Dividend rate 0.00 % 0.00 % The fair value of stock compensation
charges recognized during the years ended September 30, 2021 and 2020 was determined with reference to the quoted market price
of the Company’s shares on the grant date.

Income Taxes

Income Taxes12 Months Ended
Sep. 30, 2021
Income Tax Disclosure [Abstract]
Income TaxesNote 7 Income Taxes The Company’s U.S.
and foreign loss before income taxes are set forth below:
Schedule of Income before Income Tax, Domestic and Foreign
2021 2020
United States $ (28,850,926 ) $ (18,096,148 )
Foreign (8,790,143 ) (8,161,658 )
Total $ (37,641,069 ) $ (26,257,806 ) The components of net deferred income tax assets as
of September 30, 2021 and 2020 are as follows:
Schedule of deferred tax asset and liabilities
2021 2020
Net operating loss carryforwards $ 34,982,000 $ 23,397,000
Research and development tax credit carryforwards 1,577,000 2,069,000
Stock-based compensation 10,453,000 8,283,000
Unpaid charges 89,000 83,000
Intangible asset costs 323,000 132,000
Foreign exchange and other 62,000 27,000
Valuation allowance deferred tax assets (47,486,000 ) (33,991,000 )
Net deferred tax assets $ — $ —
2021 2020
Income tax benefit at statutory federal rate $ (7,934,000 ) $ (5,519,000 )
Foreign income taxed at other rates (353,000 ) (723,000 )
Permanent differences relating to stock based compensation (4,379,000 ) —
Permanent differences relating to Section 162(m) 816,000 —
Other permanent differences 741,000 35,000
Adjustment to tax assets based on Section 382 3,330,000 —
Research and development credits, net 1,042,000 1,267,000
State and local taxes (7,022,000 ) (2,911,000 )
Adjustment and true up to prior years' tax provision 48,000 373,000
Effect of change in statutory rates 216,000 36,000
State minimum and exise taxes 267,565 22,664
Change in valuation allowances 13,495,000 7,442,000
Income tax expense $ 267,565 $ 22,664 As of September 30, 2021, the
Company had U.S. federal net operating loss carryforwards of approximately $ 101.6 77.0 $37.7 will begin to expire in 2025 and $63.9 can be carried forward indefinitely 177.7 103.1 2036 1.6 2.1 7.9 11.2 4.3 The Company evaluates its valuation
allowance requirements based on available evidence. When circumstances change, and this causes a change in management’s judgment
about the recoverability of deferred tax assets, the impact of the change on the valuation allowance is reflected in current income.
Because management of the Company does not currently believe that it is more likely than not that the Company will receive the
benefit of these assets, a valuation allowance has been established at September 30, 2021 and 2020. Uncertain Tax Positions The Company files income tax returns
in the U.S. federal jurisdiction and various state and local and foreign jurisdictions. The Company’s tax returns are subject
to tax examinations by U.S. federal and state tax authorities, or examinations by foreign tax authorities until the respective
statutes of limitation expire. The Company is subject to tax examinations by tax authorities for all taxation years commencing
on or after 2014. Under the provisions of the Internal
Revenue Code, the net operating loss (“NOL”) carryforwards are subject to review and possible adjustment by the Internal
Revenue Service and state tax authorities. Under Section 382 of the Internal Revenue Code, NOL and tax credit carryforwards may
become subject to an annual limitation in the event of an over 50% cumulative change in the ownership interest of significant stockholders
over a three-year, as well as similar state tax provisions. The
Company conducted a Section 382 study during the year ended September 30, 2021 and determined that, during the year ended September
30, 2015, there was a change in ownership which resulted in $25.8 million of federal NOLs being subject to an annual limitation.
During the year ended September 30, 2021, the Company reduced its federal NOLs by $12.1 million and its Research and development tax
credit carryforwards by $0.8 million, which are the amount of tax assets that will expire unutilized pursuant to the Section 382
study. This resulted in a reduction of $2.5 million of NOLs and $0.8 million of research and development credits
and a corresponding reduction in the valuation allowance of $ 3.3 As
of September 30, 2021, the Company did not provide any foreign withholding taxes related to its foreign subsidiaries’
undistributed earnings, as such earnings have been retained and are intended to be indefinitely reinvested to fund ongoing
operations of the foreign subsidiaries. It is not practicable to estimate the amount of taxes that would be payable upon remittance
of these earnings, because such tax, if any, is dependent upon circumstances existing if and when remittance occur.

Summary of Significant Accoun_2

Summary of Significant Accounting Policies (Policies)12 Months Ended
Sep. 30, 2021
Accounting Policies [Abstract]
Use of Estimatesa) 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 book values of assets
and liabilities and the accrual of costs and expenses that are not readily apparent from other sources. The actual results experienced
by the Company may differ materially and adversely from the Company’s estimates. To the extent there are material differences
between the estimates and the actual results, future results of operations will be affected.
Principles of Consolidationb) Principles of Consolidation These consolidated financial statements
include the accounts of Anavex Life Sciences Corp. and its wholly-owned subsidiaries, Anavex Australia Pty Limited. (“Anavex
Australia”), a company incorporated under the laws of Australia, Anavex Germany GmbH, a company incorporated under the laws
of Germany, and Anavex Canada Ltd., a company incorporated under the laws of the Province of Ontario, Canada. All inter-company
transactions and balances have been eliminated.
Cash and equivalentsc) Cash and equivalents The
Company considers only those investments which are highly liquid, readily convertible to cash and that mature within three months
from the date of purchase to be cash equivalents Highly liquid investments
that are considered cash equivalents include money market accounts, money market funds and certificates of
deposit. The carrying value of cash equivalents approximates fair value due to the short-term maturity of these securities. The
Company s investment policy allows for investments in domestic money market certificates, certificates of deposit,
money market funds, commercial papers, bonds or commercial papers, and establishes diversification and credit quality requirements
and limits investments by maturity and issuer. The Company currently maintains its investments at one large well known financial
institution. The Company maintains
its cash in bank deposit accounts which, at times, may exceed federally insured limits. Accounts are guaranteed by the Federal
Deposit Insurance Corporation (FDIC) up to $ 250,000 The Company has not experienced any losses in such accounts.
Research and Development Expensesd) Research and Development Expenses Research and development costs
are expensed as incurred. These expenses are comprised of the costs of the Company’s proprietary research and development
efforts, including preclinical studies, clinical trials, manufacturing costs, employee salaries and benefits and stock-based compensation
expense, contract services including external research and development expenses incurred under arrangements with third parties
such as contract research organizations (“CROs”), facilities costs, overhead costs and other related expenses. Milestone
payments made by the Company to third parties are expensed when the specific milestone has been achieved. Manufacturing costs are
expensed as incurred in accordance with Accounting Standard Codification (“ASC”) 730, Research and Development, as
these materials have no alternative future use outside of their intended use. Nonrefundable
advance payments for goods or services that will be used or rendered for future research and development activities are deferred
and amortized over the that the goods are delivered, or the related services are performed,
subject to an assessment of recoverability. The Company makes estimates of costs incurred in relation to external CROs, and clinical
site costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the studies including the
phase or completion of events, invoices received and contracted costs. Judgments and estimates are made in determining
the accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates. The Company’s
historical accrual estimates have not been materially different from actual costs. In addition, the Company incurs
expenses in respect of intellectual property costs relating to patents and trademarks. The probability of success and length of
time to develop commercial applications of the drugs subject to the underlying patent and trademark costs is difficult to determine
and numerous risks and uncertainties exist with respect to the timely completion of the development projects. There is no assurance
the drugs subject to the underlying patents and trademarks will ever be successfully commercialized. Due to these risks and uncertainties,
the patent and trademark costs do not meet the definition of an asset and thus are expensed as incurred within general and administrative
expenses.
Research and Development Incentive Incomee) Research and Development Incentive Income The Company is eligible to obtain
certain research and development tax credits, including the Australian research and development tax incentive credit (the “Australia
R&D credit”) through a program administered through the Australian Tax Office (the “ATO”), which provides
for a cash refund based on a percentage of certain research and development activities undertaken in Australia by the Company’s
wholly owned subsidiary, Anavex Australia Pty Ltd. (“Anavex Australia”). The cash refund is available to eligible companies
with an annual aggregate revenue of less than $20.0 million Australian during the reimbursable period. The tax incentives are available
on the basis of specific criteria with which the Company must comply. Although the tax incentive may be administered through the
local tax authority, the Company has accounted for the incentives outside of the scope of ASC Topic 740, Income Taxes (“ASC
740”), since the incentives are not linked to the Company’s taxable income and can be realized regardless of whether
the Company has generated taxable income in the respective jurisdictions. With respect to the Australia R&D
credit, Anavex Australia may be eligible to receive the cash refund for certain research and development expenses incurred by Anavex
Australia outside of Australia, to the extent such expenses are pre-approved by the Australian authority pursuant to an advanced
overseas finding application. The Company accrues for the amount of cash refund it expects to receive in relation to research and
development expenses outside of Australia only to the extent it has received advanced approval from the Department of Industry,
Innovation and Science in Australia, pursuant to an approved advanced overseas finding application. In addition, Anavex Australia and
Anavex Canada incur Goods and Services Tax (GST) on certain services provided by local vendors. As a domestic entity in those jurisdictions,
Anavex Australia and Anavex Canada are entitled to a refund of the GST paid. Similarly, Anavex Germany incurs Value Added Tax (VAT)
on certain services provided by local vendors, to which it is entitled to a refund of such VAT paid. The Company’s estimate
of the amount of cash refund it expects to receive related to GST and VAT incurred is included in Incentive and tax receivables
in the accompanying consolidated balance sheets.
Basic and Diluted Loss per Sharef) Basic and Diluted Loss per Share Basic income/(loss) per common
share is computed by dividing net income/(loss) available to common stockholders by the weighted average number of common shares
outstanding during the period. Diluted income/(loss) per common share is computed by dividing net income/(loss) available to common
stockholders by the sum of (1) the weighted-average number of common shares outstanding during the period, (2) the dilutive effect
of the assumed exercise of options and warrants using the treasury stock method and (3) the dilutive effect of other potentially
dilutive securities. For purposes of the diluted net loss per share calculation, options and warrants are potentially dilutive
securities and are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive. As of September 30, 2021, diluted
loss per share excludes 11,540,903 10,576,266
Financial Instrumentsg) Financial
Instruments The book value of the Company’s
financial instruments, consisting of cash and equivalents, incentive and tax receivables, and accounts payable and accrued liabilities
approximate their fair value due to the short-term maturity of such instruments. Unless otherwise noted, it is management’s
opinion that the Company is not exposed to significant interest, currency or credit risks arising from these financial instruments.
Foreign Currency Translationh) Foreign Currency Translation The functional currency of the
Company is the US dollar. Monetary items denominated in a foreign currency are translated into US dollars at exchange rates prevailing
at the balance sheet date and non-monetary items are translated at exchange rates prevailing when the assets were acquired, or
obligations incurred. Foreign currency denominated expense items are translated at exchange rates prevailing on the transaction
date. Unrealized gains or losses arising from the translations are credited or charged to income in the period in which they occur. The Company has determined that
the functional currency of Anavex Australia Pty Limited, Anavex Germany GmbH, and Anavex Canada Ltd. is also the US dollar.
Segment and Geographic Reportingi) Segment and Geographic Reporting Operating segments are defined
as components of an enterprise for which separate discrete information is available for evaluation by the chief operating decision
maker or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations
and manages its business as one operating segment, which is the business of developing novel therapies for the management of CNS
diseases.
Grant Incomej) Grant Income Grant
income is recognized at the fair value of the grant when it is received, and all substantive conditions have been satisfied.
Income Taxesk) Income Taxes The Company follows the provisions
of ASC 740, which requires the asset and liability method of accounting for income taxes. Under the asset and liability method,
deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between
the financial statements carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets
and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary
differences are expected to be recovered or settled. The Company follows the provisions
of ASC 740 regarding accounting for uncertainty in income taxes. The Company initially recognizes tax positions in the financial
statements when it is more likely than not the position will be sustained upon examination by the tax authorities. Such tax positions
are initially and subsequently measured as the largest amount of tax benefit that is greater than 50% likely of being realized
upon ultimate settlement with the tax authority assuming full knowledge of the position and all relevant facts. Application requires
numerous estimates based on available information. The Company considers many factors when evaluating and estimating its tax positions
and tax benefits, and its recognized tax positions and tax benefits may not accurately anticipate actual outcomes. As additional
information is obtained, there may be a need to periodically adjust the recognized tax positions and tax benefits. These periodic
adjustments may have a material impact on the consolidated statements of operations. The Company recognizes interest
and penalties related to current income tax expense on the interest income, net line, in the accompanying consolidated statement
of operations. Accrued interest and penalties, if any, are included in accrued liabilities on the consolidated balance sheets.
Stock-based Compensationl) Stock-based Compensation The Company accounts for all stock-based
payments and awards under the fair value method. The fair value of all share purchase
options and warrants are expensed over their contractual vesting period, or over the expected performance period for only the portion
of awards expected to vest, in the case of milestone-based vesting, with a corresponding increase to additional paid-in capital. Compensation costs for stock-based
payments with graded vesting are recognized on a straight-line basis. Stock based compensation expense is adjusted for actual forfeitures
of unvested awards as they occur. The Company has granted share purchase
option awards that vest upon achievement of certain performance criteria, or milestone-based awards. The Company estimates an implicit
service period for achieving performance criteria for each award and recognizes the resulting fair value as expense over the implicit
service period when it concludes that achieving the performance criteria is probable. The Company periodically reviews and updates
as appropriate its estimates of implicit service periods and conclusions on achieving the performance criteria. Performance awards
vest upon achievement of the performance criteria. The Company uses the Black-Scholes
option valuation model to calculate the fair value of share purchase options and warrants at the date of the grant. This model
requires the input of subjective assumptions, including the expected price volatility, expected life and estimated forfeitures of
each award. The Company uses the U.S. Treasury daily treasury yield curve rates for the expected term of the option as the
risk-free rate. The expected term represents the period that options granted are expected to be outstanding using the simplified
method. The Company’s historical share option exercise experience does not provide a reasonable basis for estimating the
expected term. Expected volatility is based on the average of the daily share price changes over the expected term. The Company does
not estimate forfeitures and elects to record actual forfeitures as they occur. The Company has not paid any dividends on its common
stock historically, therefore no assumption of dividend payments is made in the model. These assumptions consist of estimates of
future market conditions, which are inherently uncertain, and therefore, are subject to management’s judgment. Changes in
these assumptions can materially affect the fair value estimates. The purchase price
of options or warrants may be paid in cash or, if approved by the Company’s compensation committee in advance, “net settled”
in shares of the Company’s common stock. In a net settlement of an option or warrant, the Company does not receive payment of the
exercise price from the holder but reduces the number of shares of common stock issued upon the exercise of the stock option or warrant
by the smallest number of whole shares that have an aggregate fair market value equal to or over the aggregate exercise price for the
option shares covered by the option or warrant exercised. Shares issued pursuant to the exercise of options and warrants are issued from
the Company’s treasury.
Fair Value Measurementsm) Fair Value Measurements Fair value is defined as the exchange
price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous
market for the asset or liability in an orderly transaction between market participants at the measurement date. Assets and liabilities
that are measured at fair value are reported using a three-level fair value hierarchy that prioritizes the inputs used to measure
fair value. This hierarchy maximizes the use of observable inputs and minimizes the use of unobservable inputs. The three levels
of inputs used to measure fair value are as follows: Level 1 - quoted prices (unadjusted) in active markets
for identical assets or liabilities that the Company has the ability to access at the measurement date; Level 2 - observable inputs other
than Level 1, quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar
assets and liabilities in markets that are not active, and model-derived prices whose inputs are observable or whose significant
value drivers are observable; and Level 3 - assets and liabilities
whose significant value drivers are unobservable by little or no market activity and that are significant to the fair value of
the assets or liabilities. At September 30, 2021 and 2020,
the Company did not have any Level 3 assets or liabilities.
Recent Accounting Pronouncementsn) Recent Accounting Pronouncements In
December 2019, the FASB issued 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. ASU 2019-12 will be effective for the Company on October 1, 2021. The
Company does not expect such guidance to have a material impact on the Company’s operations, financial condition, or cash flows.

Accrued Liabilities (Tables)

Accrued Liabilities (Tables)12 Months Ended
Sep. 30, 2021
Accrued Liabilities
Schedule of components of accrued liabilitiesSchedule of components of accrued liabilities
2021 2020
Clinical site costs and patient visits $ 2,035,800 $ 760,900
Accrued compensation and benefits 1,201,903 567,805
Fixed contract accruals 649,649 367,429
All other accrued liabilities 1,727,422 1,620,440
Total accrued liabilities $ 5,614,774 $ 3,316,574

Commitments and Contingencies (

Commitments and Contingencies (Tables)12 Months Ended
Sep. 30, 2021
Commitments and Contingencies Disclosure [Abstract]
Schedule of exercisable share purchase warrants outstandingSchedule of exercisable share purchase warrants outstanding
Weighted
Average
Exercise Price
Number of Shares ($)
Balance, September 30, 2019 350,000 4.19
Granted 150,000 3.17
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
Schedule of share purchase warrants outstandingSchedule of share purchase warrants outstanding
Number Exercise Price Expiry Date
150,000 $ 3.17 May 6, 2024
60,000 $ 12.00 April 21, 2026
210,000
Schedule of outstanding stock purchase optionsSchedule of outstanding stock purchase options
Weighted
Weighted Average Grant Aggregate
Average Exercise Date Fair intrinsic value
Number of Shares Price ($) Value ($) ($)
Outstanding, September 30, 2019 8,462,933 3.58 4,115,032
Granted 1,695,000 2.96 2.27
Forfeited (68,332 ) 3.01 2.44
Exercised (13,335 ) 3.15 2.61 2,400
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
Exercisable, September 30, 2021 7,228,488 3.73 102,786,851
Summarizes information about stock optionsSummarizes information about
stock options
Number of Weighted average remaining Weighted average Number of Weighted average
Range of exercise prices outstanding contractual life exercise vested exercise
From To options (in years) price options price
$ 0.92 $ 2.96 4,309,349 6.25 2.31 3,167,682 2.10
$ 3.15 $ 4.80 2,117,500 6.33 3.30 1,830,836 3.29
$ 5.04 $ 8.98 3,397,054 6.45 6.05 2,207,054 6.35
$ 12.00 $ 13.01 230,000 9.52 12.44 22,916 12.42
$ 18.11 $ 24.58 1,277,000 9.82 19.33 — —
11,330,903 7,228,488
Schedule of general and administrative expenses and research and development expensesSchedule of general and administrative expenses and research and development expenses
2021 2020
General and administrative $ 3,571,335 $ 2,210,789
Research and development $ 4,660,068 $ 2,666,117
Total stock-based compensation $ 8,231,403 $ 4,876,906
Schedule of weighted average assumptions for fair value of each option awardSchedule of weighted average assumptions for fair value of each option award
2021 2020
Risk-free interest rate 0.73 % 1.57 %
Expected life of options (years) 5.74 5.53
Annualized volatility 93.43 % 95.99 %
Dividend rate 0.00 % 0.00 %

Income Taxes (Tables)

Income Taxes (Tables)12 Months Ended
Sep. 30, 2021
Income Tax Disclosure [Abstract]
Schedule of Income before Income Tax, Domestic and ForeignSchedule of Income before Income Tax, Domestic and Foreign
2021 2020
United States $ (28,850,926 ) $ (18,096,148 )
Foreign (8,790,143 ) (8,161,658 )
Total $ (37,641,069 ) $ (26,257,806 )
Schedule of deferred tax asset and liabilitiesSchedule of deferred tax asset and liabilities
2021 2020
Net operating loss carryforwards $ 34,982,000 $ 23,397,000
Research and development tax credit carryforwards 1,577,000 2,069,000
Stock-based compensation 10,453,000 8,283,000
Unpaid charges 89,000 83,000
Intangible asset costs 323,000 132,000
Foreign exchange and other 62,000 27,000
Valuation allowance deferred tax assets (47,486,000 ) (33,991,000 )
Net deferred tax assets $ — $ —
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block]2021 2020
Income tax benefit at statutory federal rate $ (7,934,000 ) $ (5,519,000 )
Foreign income taxed at other rates (353,000 ) (723,000 )
Permanent differences relating to stock based compensation (4,379,000 ) —
Permanent differences relating to Section 162(m) 816,000 —
Other permanent differences 741,000 35,000
Adjustment to tax assets based on Section 382 3,330,000 —
Research and development credits, net 1,042,000 1,267,000
State and local taxes (7,022,000 ) (2,911,000 )
Adjustment and true up to prior years' tax provision 48,000 373,000
Effect of change in statutory rates 216,000 36,000
State minimum and exise taxes 267,565 22,664
Change in valuation allowances 13,495,000 7,442,000
Income tax expense $ 267,565 $ 22,664

Business Description and Basi_2

Business Description and Basis of Presentation (Details Narrative) - $ / sharesSep. 30, 2021May 25, 2021Sep. 30, 2020
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Common Stock, Par or Stated Value Per Share $ 0.001 $ 0.001 $ 0.001
Common Stock, Shares Authorized200,000,000 200,000,000 100,000,000

Summary of Significant Accoun_3

Summary of Significant Accounting Policies (Details Narrative) - USD ($)12 Months Ended
Sep. 30, 2021Sep. 30, 2020
Accounting Policies [Abstract]
Federal Deposit Insurance Corporation $ 250,000
Loss per share for potentially dilutive common shares11,540,903 10,576,266

Accrued Liabilities (Details)

Accrued Liabilities (Details) - USD ($)Sep. 30, 2021Sep. 30, 2020
Accrued Liabilities
Clinical site costs and patient visits $ 2,035,800 $ 760,900
Accrued compensation and benefits1,201,903 567,805
Fixed contract accruals649,649 367,429
All other accrued liabilities1,727,422 1,620,440
 Total accrued liabilities $ 5,614,774 $ 3,316,574

Other Income (Details Narrative

Other Income (Details Narrative) - USD ($)12 Months Ended
Sep. 30, 2021Sep. 30, 2020Sep. 30, 2017
Defined Benefit Plan Disclosure [Line Items]
Research and development incentive income $ 4,547,099 $ 4,375,025
Grant income54,100 149,888 $ 597,886
Other income443,831 0
Australia, Dollars
Defined Benefit Plan Disclosure [Line Items]
Research and development incentive income6,068,993 $ 6,392,266
Parkinson [Member]
Defined Benefit Plan Disclosure [Line Items]
Research and development incentive income $ 497,931

Equity Offerings (Details Narra

Equity Offerings (Details Narrative) - USD ($)Jun. 07, 2019Jun. 22, 2021Sep. 30, 2021Sep. 30, 2020
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Sales of agreement amount $ 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 offering, shares2,380,953 5,634,576 1,760,429
Common stock price $ 21
Gross proceeds from sale of common stock $ 50,000,013 $ 79,107,550 $ 7,499,900
Proceed from offering $ 46,902,981 $ 76,670,027 $ 7,096,136
Percentage of gross proceeds from sales3.00%
2019 Purchase Agreement [Member] | Lincoln Park Capital Fund, LLC [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Share issued for offering, shares324,383 4,086,209 7,633,527
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 purchase162,191
Number of shares issued for aggregate purchase price4,007,996 7,564,584
Number of shares issued for aggregate purchase price, value $ 24,111,198 $ 21,254,298
Number of shares issued for commitment78,213 68,943
Amount of shares remain available $ 24,111,198

Commitments and Contingencies_2

Commitments and Contingencies (Details) - Purchase Warrants [Member] - $ / shares12 Months Ended
Sep. 30, 2021Sep. 30, 2020
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share Purchase Warrants Balance, at beginning500,000 350,000
Weighted Average Exercise Price Balance, at beginning $ 3.88 $ 4.19
Share Purchase Warrants Granted60,000 150,000
Weighted Average Exercise Price, Granted $ 12 $ 3.17
Share Purchase Warrants Exercised(350,000)
Weighted Average Exercise Price, Exercised $ 4.19
Share Purchase Warrants Balance, at ending210,000 500,000
Weighted Average Exercise Price Balance, at ending $ 5.69 $ 3.88

Commitments and Contingencies_3

Commitments and Contingencies (Details 1)Sep. 30, 2021$ / sharesshares
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number210,000
Purchase Warrants 1 [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number150,000
Exercise Price | $ / shares $ 3.17
Expiry DateMay 6,
2024
Purchase Warrants 2 [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number60,000
Exercise Price | $ / shares $ 12
Expiry DateApr. 21,
2026

Commitments and Contingencies_4

Commitments and Contingencies (Details 2) - 2015 Omnibus Incentive Plan [Member] - USD ($)12 Months Ended
Sep. 30, 2021Sep. 30, 2020
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Options Outstanding at beginning10,076,266 8,462,933
Weighted Average Exercise Price Outstanding at beginning $ 3.48 $ 3.58
Aggregate intrinsic value Outstanding at beginning $ 14,982,581 $ 4,115,032
Options Granted2,732,000 1,695,000
Weighted Average Exercise Price Granted $ 12.55 $ 2.96
Weighted Average Grant Date Fair Value Granted $ 9.32 $ 2.27
Options Forfeited(55,834)(68,332)
Weighted Average Exercise Price Forfeited $ 3.04 $ 3.01
Weighted Average Grant Date Fair Value Forfeited $ 2.43 $ 2.44
Options Exercised(1,421,529)(13,335)
Weighted Average Exercise Price Exercised $ 2.89 $ 3.15
Weighted Average Grant Date Fair Value Exercised $ 2.43 $ 2.61
Aggregate intrinsic value Exercised $ 24,446,305 $ 2,400
Options Outstanding at ending11,330,903 10,076,266
Weighted Average Exercise Price Outstanding at ending $ 5.74 $ 3.48
Aggregate intrinsic value Outstanding at ending $ 140,132,451 $ 14,982,581
Options Exercisable at ending7,228,488
Weighted Average Exercise Price Exercisable at ending $ 3.73
Aggregate intrinsic value Exercisable at ending $ 102,786,851

Commitments and Contingencies_5

Commitments and Contingencies (Details 3) - $ / shares12 Months Ended
Sep. 30, 2021Sep. 30, 2020
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Weighted average remaining contractual life (in years)6 years 9 months 14 days6 years 11 months 15 days
Equity Option [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of outstanding options11,330,903
Number of vested options7,228,488
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 options4,309,349
Weighted average remaining contractual life (in years)6 years 3 months
Weighted average exercise price $ 2.31
Number of vested options3,167,682
Weighted average exercise price $ 2.10
Equity Option [Member] | Option Price 2 [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Range of exercise prices, lower range limit3.15
Range of exercise prices, upper range limit $ 4.80
Number of outstanding options2,117,500
Weighted average remaining contractual life (in years)6 years 3 months 29 days
Weighted average exercise price $ 3.30
Number of vested options1,830,836
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 limit5.04
Range of exercise prices, upper range limit $ 8.98
Number of outstanding options3,397,054
Weighted average remaining contractual life (in years)6 years 5 months 12 days
Weighted average exercise price $ 6.05
Number of vested options2,207,054
Weighted average exercise price $ 6.35
Equity Option [Member] | Option Price 4 [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Range of exercise prices, lower range limit12
Range of exercise prices, upper range limit $ 13.01
Number of outstanding options230,000
Weighted average remaining contractual life (in years)9 years 6 months 7 days
Weighted average exercise price $ 12.44
Number of vested options22,916
Weighted average exercise price $ 12.42
Equity Option [Member] | Option Price 5 [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Range of exercise prices, lower range limit18.11
Range of exercise prices, upper range limit $ 24.58
Number of outstanding options1,277,000
Weighted average remaining contractual life (in years)9 years 9 months 25 days
Weighted average exercise price $ 19.33
Number of vested options
Weighted average exercise price

Commitments and Contingencies_6

Commitments and Contingencies (Details 4) - USD ($)12 Months Ended
Sep. 30, 2021Sep. 30, 2020
Loss Contingencies [Line Items]
Total share based compensation $ 8,231,403 $ 4,876,906
General and Administrative Expense [Member]
Loss Contingencies [Line Items]
Total share based compensation3,571,335 2,210,789
Research and Development Expense [Member]
Loss Contingencies [Line Items]
Total share based compensation $ 4,660,068 $ 2,666,117

Commitments and Contingencies_7

Commitments and Contingencies (Details 5)12 Months Ended
Sep. 30, 2021Sep. 30, 2020
Commitments and Contingencies Disclosure [Abstract]
Risk-free interest rate0.73%1.57%
Expected life of options (years)5 years 8 months 26 days5 years 6 months 10 days
Annualized volatility93.43%95.99%
Dividend rate0.00%0.00%

Commitments and Contingencies_8

Commitments and Contingencies (Details Narrative) - USD ($)12 Months Ended
Sep. 30, 2021Sep. 30, 2020
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Operating Leases, Rent Expense $ 130,784 $ 233,423
Contribution amount $ 128,856 $ 98,058
weighted average grant date fair value of options vested $ 2.54 $ 2.55
Weighted average contractual life of options outstanding6 years 9 months 14 days6 years 11 months 15 days
Options exercisable5 years 6 months 3 days6 years 3 months
Share based compensation $ 8,231,403 $ 4,876,906
Remaining stock based compensation $ 21,650,000
2015 Omnibus Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Maximum number of common shares reserved for future issuance6,050,553
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant146,371 133,036
2019 Omnibus Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant456,332 3,161,665
Additional shares of common stock available for issuance6,000,000

Income Taxes (Details)

Income Taxes (Details) - USD ($)12 Months Ended
Sep. 30, 2021Sep. 30, 2020
Income Tax Disclosure [Abstract]
United States $ (28,850,926) $ (18,096,148)
Foreign(8,790,143)(8,161,658)
Total $ (37,641,069) $ (26,257,806)

Income Taxes (Details 1)

Income Taxes (Details 1) - USD ($)Sep. 30, 2021Sep. 30, 2020
Income Tax Disclosure [Abstract]
Net operating loss carryforwards $ 34,982,000 $ 23,397,000
Research and development tax credit carryforwards1,577,000 2,069,000
Stock-based compensation10,453,000 8,283,000
Unpaid charges89,000 83,000
Intangible asset costs323,000 132,000
Foreign exchange and other62,000 27,000
Valuation allowance deferred tax assets(47,486,000)(33,991,000)
Net deferred tax assets

Income Taxes (Details 2)

Income Taxes (Details 2) - USD ($)12 Months Ended
Sep. 30, 2021Sep. 30, 2020
Income Tax Disclosure [Abstract]
Income tax benefit at statutory federal rate $ (7,934,000) $ (5,519,000)
Foreign income taxed at other rates(353,000)(723,000)
Permanent differences relating to stock based compensation  (4,379,000)
Permanent differences relating to Section 162(m) 816,000
Other permanent differences741,000 35,000
Adjustment to tax assets based on Section 3823,330,000
Research and development credits, net1,042,000 1,267,000
State and local taxes(7,022,000)(2,911,000)
Adjustment and true up to prior years' tax provision48,000 373,000
Effect of change in statutory rates216,000 36,000
State minimum and exise taxes267,565 22,664
Change in valuation allowances13,495,000 7,442,000
Income tax expense $ 267,565 $ 22,664

Income Taxes (Details Narrative

Income Taxes (Details Narrative) - USD ($)12 Months Ended
Sep. 30, 2021Sep. 30, 2020
Operating Loss Carryforwards [Line Items]
Operating loss carry forwards expiration year2036
Research and Development tax credits $ 1,600,000 $ 2,100,000
Decrease in vaution allowance3,300
Federal [Member]
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards $ 101,600,000 77,000,000
Operating loss carryforwards description$37.7 will begin to expire in 2025 and $63.9 can be carried forward indefinitely
State and Local Jurisdiction [Member]
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards $ 177,700,000 103,100,000
Foreign Tax Authority [Member]
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards7,900,000 $ 4,300,000
Foreign Tax Authority [Member] | Australia, Dollars
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards $ 11,200,000