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ANAVEX LIFE SCIENCES CORP. (AVXL) FY 2025 MD&A

Verbatim Item 7 Management's Discussion and Analysis from ANAVEX LIFE SCIENCES CORP.'s 10-K for fiscal year 2025. Filing date: 2025-11-25. Report date: 2025-09-30. Accession: 0001731122-25-001596.

This page reproduces the company's own Item 7 MD&A text from the linked SEC filing. It is filer text, not grepcent analysis, scoring, or investment advice.

Extracted structurally from real Item 7 body heading to real Item 7A/8 boundary. Published MD&A gate trimmed front/tail over-capture. Confidence: high.

Company profile: AVXL · All MD&A years: index · Previous year: FY 2024

ITEM 7 MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION

The following discussion should be read in conjunction
with our consolidated financial statements and related notes thereto included elsewhere in this report. Past operating results are not
necessarily indicative of results that may occur in future periods. This discussion contains forward-looking statements, which involve
a number of risks and uncertainties. See “Forward Looking Statements” included elsewhere in this report. For discussion and
analysis pertaining to 2024 overview and highlights as compared to 2023, please refer to the Company’s Annual Report on Form 10-K,
filed with the Securities and Exchange Commission (“SEC”) on December 23, 2024.

Financial Operations Overview

We are in
the pre-revenue stage and have not earned any revenues since our inception in 2004. We do not anticipate earning any revenues until we
can establish an alliance with other companies to develop, co-develop, license, acquire or market our products.

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Our operating costs consist primarily of research and development
activities including the cost of clinical studies and clinical supplies as well as clinical drug manufacturing and formulation. Research
and development expenses also include personnel related costs such as salaries and wages, and third-party contract research organization
(CRO) expenses in support of these clinical studies. Personnel costs include salaries and wages, benefits, and non-cash share-based compensation
charges associated with options and other equity awards granted to employees and consultants who are directly engaged in support of our
research and development activities.

General and administrative expenses consist of personnel costs,
expenses for outside professional services and expenses associated with operating as a public company. Personnel costs consist of salaries
and wages, benefits and share-based compensation for general and administrative personnel. Outside professional services and public company
expenses include expenses related to compliance and reporting, additional insurance expenses, audit and SOX compliance, expenses associated
with patent research, applications and filings, investor and stockholder relations activities and other administrative expenses and professional
services.

Comparison of fiscal year 2025 to fiscal years 2024

Operating Expenses

Our operating expenses for fiscal 2025 decreased to $51.4 million,
from $52.9 million in fiscal 2024. The decrease is attributable to research and development expenses, as more fully described below.

The following table summarizes our research and development expenses for
the years ended September 30, 2025, 2024, and 2023 (in thousands):

202520242023
Costs of external service providers$16,348$21,974$22,542
Personnel costs13,46613,67610,264
Share-based compensation7,0135,81310,812
Other common costs76537599
Total research and development costs$37,592$41,838$43,717

External service provider cost by product candidate
was as follows (in thousands):

202520242023
ANAVEX®2-73$10,292$17,572$19,540
ANAVEX®3-715.4083,7482,624
All other product candidates2971506
Other external service provider costs351504372
Total external service provider costs$16,348$21,974$22,542

During fiscal 2025, we experienced an overall decrease
in total research and development expenses over the comparable fiscal 2024 financial year. The main factors driving this decrease were
as follows:

Column 1Column 2Column 3
(i)a decrease of approximately $3.6 million related to the Alzheimer’s program due to the completion of the ATTENTION-AD trial in the third quarter of fiscal 2024 and an overall decrease in related trial data analysis activities;
Column 1Column 2Column 3
(ii)a decrease of approximately $1.7 million associated with the Parkinson’s program related to planning activities for a future clinical trial in the comparable period;
Column 1Column 2Column 3
(iii)a decrease of approximately $1.5 million over the comparable period relating to manufacturing activities of ANAVEX®2-73 for potential commercial use, and to support the MAA;

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Column 1Column 2Column 3
(iv)a decrease of approximately $0.9 million related to the completion of a production run of ANAVEX®3-71 in fiscal 2024.
Column 1Column 2Column 3
(v)a decrease of approximately $0.8 million associated with our Rett syndrome program, due to the completion of the ANAVEX®2-73 EXCELLENCE OLE in the third quarter of fiscal 2024.

The above decreases were partially offset by an increase
of approximately $3.0 million related to completion of Part B of the ANAVEX®3-71-SZ-001
trial during fiscal 2025, which was substantially larger in size than the preceding Part A during fiscal 2024.

General and administrative expenses were $13.8 million
for the fiscal 2025 financial year, as compared to $11.0 million in fiscal 2024. The primary reason for the increase in general and administrative
expenses was an increase in legal fees of $1.7 million, related to legal/regulatory matters, a new shelf registration statement, and various
class action lawsuits.

We expect to see our research and development expenditures increase
from current levels as we continue to advance our pipeline compounds.

Other income (net)

Net other income for the year ended September 30, 2025 was $5.0
million as compared to $9.9 million for fiscal 2024. The primary reason for the decrease in other income was due to a decrease of $2.6
million in interest income as a result of withdrawals in principal balance applied to excess funds invested in a money market as well
as a market wide decrease in interest rates.

During fiscal 2025, we recorded $0.6 million in research and development incentive
income, consisting of the Australian research and development incentive credit administered through the ATO, in connection with fiscal
2025 eligible expenditures. In comparison, research and development incentive income for fiscal 2024 was $2.3 million in connection with
fiscal 2024 eligible expenditures. This income is driven by the clinical trial expenditures incurred in Australia, and the decrease year
over year is a result of the completion of eligible R&D clinical trials in Australia. We expect to continue to receive support from
the Australian government for future clinical trials which we plan to conduct, in part, within Australia.

Net loss

Net loss for fiscal 2025 was $46.4 million, or $0.54
per share, compared to a net loss of approximately $43.0 million, or $0.52 per share for fiscal 2024.

Liquidity and Capital Resources

Working Capital (in thousands)

20252024
Current Assets$103,815$135,567
Current Liabilities8,94615,304
Working Capital$94,869$120,263

At September 30, 2025, we had $102.6 million in cash and cash
equivalents, a decrease from $132.2 million at September 30, 2024.

We intend to continue to use our capital resources to advance
our clinical trials for ANAVEX®2-73 and ANAVEX®3-71, and to perform work necessary to prepare for future
development of our pipeline compounds.

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Cash Flows

Following is a summary
of sources of cash flows for the years ended September 30, 2025, 2024 and 2023 (in thousands):

202520242023
Cash flows used in operating activities$(39,044)$(30,812)$(27,785)
Cash flows provided by financing activities9,43411,97529,651
(Decrease)/increase in cash$(29,610)$(18,837)$1,866

Cash flow used in operating activities

There was an increase in cash used in operating activities of
$8.2 million during fiscal 2025. The principal reason for this is due to a large decrease in accounts payable during the year, as compared
to a large increase in the comparable financial year, principally due to timing of payments for a large manufacturing campaign of ANAVEX®2-73.

Cash flow provided by financing activities

Cash provided by financing activities in fiscal 2025 was $9.4
million, comprised primarily of net cash received of $9.2 million related to the issuance of common shares pursuant to the at-the-market
offering and $2.9 million in cash from the exercise of stock options by our employees. We utilized $2.7 million to satisfy tax withholding
obligations associated with the net exercise of two expiring employee stock options to our CEO, in exchange for the withholding of shares.

Cash provided by financing activities in fiscal 2024 was $12.0
million, comprised of $11.3 million attributable to cash received from the issuance of common shares under the 2023 Purchase Agreement
and $0.7 million received pursuant to the exercise of stock options.

Other Financings

Sales Agreement

On July 25, 2025, we entered into a Sales Agreement
(the “Sales Agreement”) with TD Securities (USA) LLC (the “Sales Agent”). Pursuant to the Sales Agreement, the
Company may offer and sell up to an aggregate offering price of $150 million (the “Offering”) in shares of common stock from
time to time through the Sales Agent.

Upon delivery of a placement notice based on our instructions
and subject to the terms and conditions of the Sales Agreement, the Sales Agent may sell shares of common stock by methods deemed to be
an “at the market 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 our prior written
consent. We are not obligated to make any sales of shares under the Sales Agreement. We or the Sales Agent may suspend or terminate the
Offering upon notice to the other party, subject to certain conditions. The Sales Agent will act as sales agent on a commercially reasonable
efforts basis consistent with its normal trading and sales practices, applicable state and federal law, rules and regulations and the
rules of Nasdaq.

We have agreed to pay the Sales Agent commissions
for its services of up to 3.0% of the gross proceeds from the sale of shares of Common Stock pursuant to the Sales Agreement. We have
also agreed to provide the Sales Agent with customary indemnification and contribution rights.

During the year ended September 30, 2025, the Company
issued an aggregate of 927,910 shares of Common Stock under the Sales Agreement for net proceeds of $9.2 million, after deducting commissions
and offering expenses.

At September 30, 2025, there was an unused amount
of $140.4 million under the Sales Agreement.

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2023 Purchase Agreement

On February 3, 2023, we entered into a $150,000,000
purchase agreement (the “2023 Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant
to which we have the right to sell and issue to Lincoln Park, and Lincoln Park is obligated to purchase, up to $150.0 million in value
of our shares of Common Stock from time to time over a three-year period until February 3, 2026.

On any business day and subject to having an effective
registration statement and subject to certain customary conditions, we may direct Lincoln Park to purchase up to 200,000 shares of Common
Stock (such purchases, “Regular Purchases”). The amount of a Regular Purchase may increase under certain circumstances based
on the market price of the Common Stock; provided, however, that Lincoln Park’s committed obligation under any Regular Purchase
shall not exceed $4.0 million. The purchase price of shares of Common Stock will be based on the then prevailing market prices of such
shares at the time of sales as described in the 2023 Purchase Agreement. There are no limits on the price per share that Lincoln Park
may pay to purchase Common Stock under the 2023 Purchase Agreement. In addition, if we have directed Lincoln Park to purchase the full
amount of Common Stock available as a Regular Purchase on a given day, we may direct Lincoln Park to purchase additional amounts as “accelerated
purchases” and “additional accelerated purchases,” each as set forth in the 2023 Purchase Agreement.

The 2023 Purchase Agreement limits the Company’s
sale of shares of Common Stock to Lincoln Park to 15,606,426 shares of Common Stock, representing 19.99% of the shares of the Common Stock
outstanding on the date of the 2023 Purchase Agreement unless (i) stockholder approval is obtained to issue more than such amount or (ii)
the average price of all applicable sales of Common Stock to Lincoln Park under the 2023 Purchase Agreement equals or exceeds the lower
of (A) the closing price of the Common Stock on the Nasdaq Capital Market immediately preceding the Execution Date or (B) the average
of the closing price of the Common Stock on the Nasdaq Capital Market for the five Business Days immediately preceding the Execution Date.

The 2023 Purchase Agreement also prohibits the Company
from directing Lincoln Park to purchase any shares of Common Stock if those shares, when aggregated with all other shares of Common Stock
then beneficially owned by Lincoln Park and its affiliates, would result in Lincoln Park and its affiliates having beneficial ownership,
at any single point in time, of more than 4.99% of the then total outstanding shares of Common Stock, as calculated pursuant to Section
13(d) of the Securities Exchange Act of 1934, as amended, and Rule 13d-3 thereunder.

In consideration for entering into the 2023 Purchase
Agreement, the Company issued to Lincoln Park 75,000 shares of Common Stock as a commitment fee (the “initial commitment shares”)
during the year ended September 30, 2023 and agreed to issue up to 75,000 shares pro rata (collectively with the initial commitment shares,
the “commitment shares”), when and if, Lincoln Park purchased, at the Company’s discretion, the $150.0 million aggregate
commitment.

During the year ended September 30, 2025, the Company
did not issue any shares of common stock under the 2023 Purchase Agreement. During the year ended September 30, 2024, the Company issued
to Lincoln Park an aggregate of 2,455,646 shares of Common Stock under the 2023 Purchase Agreement, including 2,450,000 shares of Common
Stock for an aggregate purchase price of $11.3 million and 5,646 commitment shares.

On September 30, 2025, there was an unused amount
of $110.8 million under the 2023 Purchase Agreement. The Company will need to file a prospectus supplement in order to access funds under
the 2023 Purchase Agreement.

Off-Balance Sheet Arrangements

We have no off-balance sheet arrangements that have
or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses,
results of operations, liquidity, capital expenditures or capital resources that are material to our stockholders.

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Application
of Critical Accounting Policies

Our
financial statements and accompanying notes are prepared in accordance with generally accepted accounting principles in the United States.
Preparing financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities,
revenue and expenses. These estimates and assumptions are affected by management’s
application of accounting policies. We believe that understanding the basis and nature of the estimates and assumptions involved with
the following aspects of our financial statements is critical to an understanding of our financial statements.

We base our assumptions and estimates on historical experience
and other sources that we believe to be reasonable at the time. Actual results may vary from our estimates due to changes in circumstances,
politics, global economics, general business conditions and other factors. Our significant estimates are related to the valuation of warrants
and options.

There are accounting policies that we believe are significant
to the presentation of our financial statements. The most significant of these accounting policies relates to the accounting for our research
and development expenses and share-based compensation expense.

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 share-based compensation expense, contract services including external research and development expenses incurred under arrangements
with third parties such as contract research organizations (“CROs”),
facilities costs, overhead costs and other related expenses. Milestone payments made by the Company to third parties are expensed when
the specific milestone has been achieved. Manufacturing costs are expensed as incurred in accordance with Accounting Standard Codification
(“ASC”)
730, Research and Development, as these materials have no alternative future use outside of their intended use.

Nonrefundable advance payments for goods or services that will
be used or rendered for future research and development activities are deferred and amortized over the period that the goods are delivered,
or the related services are performed, subject to an assessment of recoverability. The Company makes estimates of costs incurred in relation
to external CROs, and clinical site costs. The Company analyzes the progress of clinical trials, including levels of patient enrollment,
invoices received and contracted costs when evaluating the adequacy of the amount expensed and the related prepaid asset and accrued liability.
Significant judgments and estimates must be made and used in determining the accrued balance and expense in any accounting period. The
Company reviews and accrues CRO expenses and clinical trial study expenses based on work performed and relies upon estimates of those
costs applicable to the stage of completion of a study. Accrued CRO costs are subject to revisions as such trials progress to completion.
Revisions are charged to expense in the period in which the facts that give rise to the revision become known. With respect to clinical
site costs, the financial terms of these agreements are subject to negotiation and vary from contract to contract. Payments under these
contracts may be uneven and depend on factors such as the achievement of certain events, the successful recruitment of patients, the completion
of portions of the clinical trial or similar conditions. The objective of our policy is to record expenses in our financial statements
based on actual services received and efforts expended. As such, expense accruals related to clinical site costs are recognized based
on our estimate of the degree of completion of the event or events specified in the specific clinical trial contract.

In addition, we incur expenses in respect of the acquisition
of intellectual property relating to patents and trademarks. The probability of success and length of time to develop commercial applications
of the drugs subject to the acquired patents and trademarks 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 acquired patents and trademarks will ever be successfully
commercialized. Due to these risks and uncertainties, we expense the acquisition of patents and trademarks.

Share-based Compensation

We account for all share-based payments and awards under the
fair value-based 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.

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Compensation costs for share-based payments with graded vesting
are recognized on a straight-line basis. Share-based compensation expense is adjusted for actual forfeitures of unvested awards as they
occur.

We have granted share purchase option awards that vest upon
achievement of certain performance criteria, or milestone-based awards. We estimate an implicit service period for achieving performance
criteria for each award and recognize the resulting fair value as expense over the implicit service period when we conclude that achieving
the performance criteria is probable. We periodically review and update as appropriate our estimates of implicit service periods and conclusions
on achieving the performance criteria. Performance awards vest upon achievement of the performance criteria.

We
use the Black-Scholes option valuation model to calculate the fair value of share purchase options and warrants at the date of the grant.
This model requires the input of subjective assumptions, including the expected price volatility, and expected life of each award.
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.

RECENT ACCOUNTING PRONOUNCEMENTS

For a discussion of recent accounting pronouncements and their
possible effect on our results, see Note 2 to our Consolidated Financial Statements found elsewhere in this Annual Report.

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