ANAVEX LIFE SCIENCES CORP.
For the period ended Jun 30, 2025. Filed Aug 12, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Aug 12, 2025
AVXL$1.22+6.1%Stored close · as of Nov 9, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-13.
0001731122-25-000724
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-12.
0001731122-25-001105
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 149 previous paragraphs and 154 current paragraphs.
121 unchanged; 25 reworded; 7 added; 3 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 12 previous and 10 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (7)
Current report
These decreases were partially offset by an increase of approximately $1.1 million in stock-based compensation charges due to a new grant of milestone-based options to existing staff in March 2025, which expense is being recorded over the expected vesting period.
Current report
Research and development expenses were consistent during the nine-month period as related to the comparable nine-month period. An increase of approximately $3.6 million over the comparable period relating to expenditures on the ANAVEX®3-71-SZ-001 clinical trial, which commenced in March 2024 was offset by (i) a decrease of approximately $3.0 million in expenditures over the comparable period relating to our Alzheimer’s program, as a result of the completion of the Phase 2b/3 clinical trial open label extension in June 2024 and (ii) a decrease of approximately $0.7 million relating to the manufacturing activities for Anavex®3-71 completed in the comparable period, for use in future clinical trials.
Current report
Net cash used in operating activities for the nine-months ended June 30, 2025 was $30.4 million, compared to $24.2 million during the comparable period ended June 30, 2024. The principal reason for this is due to a net increase in net loss over the comparable period, as described above, as well as a decrease in working capital balances during the period, as compared to the prior period.
Current report
Sales Agreement
Current report
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.
Current report
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.
Current report
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.
Removed paragraphs (3)
Previous report
These increases were partially offset by (i) a decrease of approximately $0.6 million in the three-month period and $1.2 million in the six-month period in expenditures over the comparable periods relating to our Alzheimer’s program, as a result of the completion of the Phase 2b/3 clinical trial open label extension and (ii) a decrease in stock based compensation charges of $0.8 million in the three-month period and $0.9 million in the six-month period due to a change in estimates associated with milestone-based options.
Previous report
Net other income for the six months ended March 31, 2025 was $2.8 million as compared to $4.8 million for the comparable six months ended March 31, 2024. The decrease in other income for the six-month period is also primarily related to a decrease in interest income associated with a change in market wide rates and principal balances held, as well as decrease in research and development incentive income, as a result of the completion of the open label extensions of our Australian clinical trials
Previous report
Net cash used in operating activities for the six-months ended March 31, 2025 was $18.0 million, compared to $19.0 million during the comparable period ended March 31, 2024. The principal reason for this is due to changes in working capital as a result of (i) the receipt of the annual research and development incentive tax refund during the current quarter, whereas such amount was received in third quarter of fiscal 2024 and (ii) an increase in accrued liabilities related to activities associated with a large manufacturing run for ANAVEX®2-73, which work was not yet invoiced at March 31, 2025.
Reworded paragraphs (25)
Previous wording
We have based these forward-looking statements largely on our current expectations and projections about future events, including the responses we expect from the FDA and other regulatory authorities and financial trends that we believe may affect our financial condition, results of operations, business strategy, preclinical studies and clinical trials, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions including without limitation the risks described in “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K filed with the Securities and Exchange
Current wording
We have based these forward-looking statements largely on our current expectations and projections about future events, including the responses we expect from the FDA and other regulatory authorities and financial trends that we believe may affect our financial condition, results of operations, business strategy, preclinical studies and clinical trials, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions including without limitation the risks described in “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K filed with the Securities and Exchange Commission on December 23, 2024 and the risks described in Part II, Item 1A of this Quarterly Report on Form 10-Q. These risks are not exhaustive. Other sections of this Quarterly Report on Form 10-Q include additional factors which could adversely impact our business and financial performance. Moreover,
Previous wording
Commission on December 23, 2024. These risks are not exhaustive. Other sections of this Quarterly Report on Form 10-Q include additional factors which could adversely impact our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. We cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable laws including the securities laws of the United States, we assume no obligation to update or supplement forward-looking statements.
Current wording
we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. We cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable laws including the securities laws of the United States, we assume no obligation to update or supplement forward-looking statements.
Previous wording
**Source: Reyes Setal., Sci Rep. 2021 Aug 25; 11(1):17150
Current wording
Source: Reyes S et al., Sci Rep. 2021 Aug 25; 11(1):17150
Previous wording
In November 2024, we announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA), under the centralized procedure, for ANAVEX®2-73 for the treatment of Alzheimer’s disease and, in December 2024, the EMA accepted the submission for scientific review. The MAA, if approved, would allow direct market access throughout the European Union for oral ANAVEX®2-73 (blarcamesine) for the treatment of Alzheimer’s disease. A company seeking to market a new pharmaceutical product through the centralized procedure must file safety data and efficacy data as part of the MAA. After the EMA evaluates the MAA, it provides a recommendation to the European Commission (“EC”) and the EC then approves or denies the MAA. Throughout the scientific review process with the EMA, we may receive feedback or comments which, while not a conclusive decision, could suggest the application provided is insufficient to support the marketing authorization. We may not be able to sufficiently address these comments or requests. Alternatively, these comments or requests could lead us to decide, after consultation with our advisors or the regulatory authorities, to withdraw our MAA for blarcamesine. The Company plans to announce the results when the EMA review and decision-making is finished and does not plan to provide interim updates.
Current wording
In November 2024, we announced the submission of a Marketing Authorisation Application (“MAA”) to the European Medicines Agency (EMA), under the centralized procedure, for ANAVEX®2-73 for the treatment of Alzheimer’s disease and, in December 2024, the EMA accepted the submission for scientific review. The MAA, if approved, would allow direct market access throughout the European Union for oral ANAVEX®2-73 (blarcamesine) for the treatment of Alzheimer’s disease. A company seeking to market a new pharmaceutical product through the centralized procedure must file safety data and efficacy data as part of the MAA. After the EMA evaluates the MAA, it provides a recommendation to the European Commission (“EC”) and the EC then approves or denies the MAA. Throughout the scientific review process with the EMA, we may receive feedback or comments which, while not a conclusive decision, could suggest the application provided is insufficient to support the marketing authorization. We may not be able to sufficiently address these comments or requests. Alternatively, these comments or requests could lead us to decide, after consultation with our advisors or the regulatory authorities, to withdraw or amend our MAA for blarcamesine. The Company plans to announce the results when the EMA review and decision-making is finished and does not plan to provide interim updates.
Previous wording
We hold ownership or exclusive rights to twenty-seven (27) issued U.S. patents, twenty-two (22) pending U.S. patent applications, and numerous PCT and ex-U.S. patent applications relating to our drug candidates, methods associated therewith, and to our research programs.
Current wording
We hold ownership or exclusive rights to thirty (30) issued U.S. patents, twenty (20) pending U.S. patent applications, and numerous PCT and ex-U.S. patent applications relating to our drug candidates, methods associated therewith, and to our research programs.
Previous wording
We own five issued U.S. patents each with claims directed to crystalline forms of ANAVEX®2-73. The first of these five patents claims crystalline forms of ANAVEX®2-73, dosage forms and compositions containing crystalline ANAVEX®2-73, and methods of treatment for Alzheimer’s disease using them. This patent is expected to expire in July 2036, absent any patent term extension for regulatory delays. The second of these five patents claims pharmaceutical compositions containing a crystalline form of ANAVEX®2-73, and methods of treatment for Alzheimer’s disease using the compositions. This patent is expected to expire in June 2036, absent any patent term extension for regulatory delays. The third of these five patents claims pharmaceutical compositions containing a crystalline form of ANAVEX®2-73, and methods of treating for Alzheimer’s disease using the compositions. This patent is expected to expire in June 2037, absent any patent term extension for regulatory delays. The fourth patent claims method of making certain crystalline forms of ANAVEX®2-73. This patent is expected to expire in October 2036, absent any patent term extension for regulatory delays. The fifth patent claims crystalline forms of the dihydrogen phosphate salt of ANAVEX®2-73 and dosage forms (including transdermal and oral dosage forms) and pharmaceutical compositions containing the same. This patent is expected to expire in July 2039, absent any patent term extension for regulatory delays.
Current wording
We own five issued U.S. patents each with claims directed to crystalline forms of ANAVEX®2-73. The first of these five patents claims crystalline forms of ANAVEX®2-73, dosage forms and compositions containing crystalline ANAVEX®2-73, and methods of treatment for Alzheimer’s disease using them. This patent is expected to expire in July 2036, absent any patent term extension for regulatory delays. The second of these five patents claims pharmaceutical compositions containing a crystalline form of ANAVEX®2-73, and methods of treatment for Alzheimer’s disease using the compositions. This patent is expected to expire in June 2036, absent any patent term extension for regulatory delays. The third of these five patents claims pharmaceutical compositions containing a crystalline form of ANAVEX®2-73,
Previous wording
Comparison of the three- and six- months ended March 31, 2025 and 2024
Current wording
Comparison of the three- and nine- months ended June 30, 2025 and 2024
Previous wording
Total operating expenses for the three months ended March 31, 2025 were $12.5 million, compared to $12.6 million for the comparable three months ended March 31, 2024. Total operating expenses for the six months ended March 31, 2025 were $26.1 million, compared to $24.0 million for the comparable six months ended March 31, 2024.
Current wording
Total operating expenses for the three months ended June 30, 2025 were $14.5 million, compared to $14.6 million for the comparable three months ended June 30, 2024. Total operating expenses for the nine months ended June 30, 2025 were $40.6 million, compared to $38.6 million for the comparable nine months ended June 30, 2024.
Previous wording
Our research and development expenses for the three months ended March 31, 2025 were $9.9 million, as compared to $9.7 million for the three months ended March 31, 2024. Our research and development expenses for the six months ended March 31, 2025 were $20.3 million, compared to $18.4 million in the comparable six months ended March 31, 2024.
Current wording
Our research and development expenses for the three months ended June 30, 2025 were $10.0 million, as compared to $11.8 million for the three months ended June 30, 2024. Our research and development expenses for the nine months ended June 30, 2025 were $30.3 million, compared to $30.2 million in the comparable nine months ended June 30, 2024.
Previous wording
The increase in research and development expenses during the three- and six-month periods is primarily related to the following:
Current wording
The decrease in research and development expenses during the three-month period is primarily related to the following:
Previous wording
The following table summarizes our research and development expenses for the three- and six-months ended March 31, 2025 and 2024 (in thousands):
Current wording
The following table summarizes our research and development expenses for the three- and nine-months ended June 30, 2025 and 2024 (in thousands):
Previous wording
During the three- and six-months ended March 31, 2025 and 2024, external service provider costs by product candidate was as follows (in thousands):
Current wording
During the three- and nine-months ended June 30, 2025 and 2024, external service provider costs by product candidate was as follows (in thousands):
Previous wording
General and administrative expenses were $2.6 million for the three months ended March 31, 2025, as compared to $2.9 million for the same quarter of fiscal 2024. General and administrative expenses were $5.8 million for the six months ended March 31, 2025, as compared to $5.6 million for the six months ended March 31, 2024. In both periods, increases in legal fees were offset by a decrease in stock based compensation charges.
Current wording
General and administrative expenses were $4.5 million for the three months ended June 30, 2025, as compared to $2.8 million for the same quarter of fiscal 2024. General and administrative expenses were $10.3 million for the nine months ended June 30, 2025, as compared to $8.4 million for the nine months ended June 30, 2024. In both periods the increases were primarily related to corporate legal fees and intellectual property legal fees associated with legal matters and patent filings and maintenance. In the three month period, the increase was also related to an increase in non-cash stock based compensation charges associated with a new grant of milestone-based options to existing staff in March 2025.
Previous wording
Net other income for the three-months ended March 31, 2025 was $1.3 million, as compared to $2.1 million for the comparable three-months ended March 31, 2024. The decrease in other income is primarily related to a decrease in interest income associated with a change in market wide rates and principal balances held, as well as decrease in research and development incentive income, as a result of the completion of the open label extensions of our Australian clinical trials.
Current wording
Net other income for the three-months ended June 30, 2025 was $1.2 million, as compared to $2.4 million for the comparable three-months ended June 30, 2024. Net other income for the nine months ended June 30, 2025 was $4.0 million as compared to $7.2 million for the comparable nine months ended June 30, 2024. In both periods, the decrease in other income is related to a decrease of research and development incentive income, as a result of the completion of Australian clinical trials, as well as a decrease in interest income as a result of lower cash balances and market interest rates.
Previous wording
Net loss for the three-months ended March 31, 2025, was $11.2 million, or $0.13 per share, as compared to $10.5 million, or $0.13 per share in the comparative quarter of fiscal 2024.
Current wording
Net loss for the three-months ended June 30, 2025, was $13.2 million, or $0.16 per share, as compared to $12.2 million, or $0.14 per share in the comparative quarter of fiscal 2024.
Previous wording
Net loss for the six-months ended March 31, 2025, was $23.3 million, or $0.27 per share, as compared to $19.2 million, or $0.23 per share for the six-months ended March 31, 2024. The increase in net loss for the quarter and year-to-date periods is primarily related to an increase in research and development expenditures and a decrease in other income, as discussed above.
Current wording
Net loss for the nine-months ended June 30, 2025, was $36.6 million, or $0.43 per share, as compared to $31.4 million, or $0.38 per share for the nine-months ended June 30, 2024. The increase in net loss is primarily related to the net increases in operating expenses and net decreases in other income, as more fully described above.
Previous wording
On March 31, 2025, we had net current assets of $99.8 million, a decrease of approximately $20.5 million from our year ended September 30, 2024. The decrease in net current assets primarily relates to cash utilized in operations during the period.
Current wording
On June 30, 2025, we had net current assets of $91.0 million, a decrease of approximately $29.3 million from our year ended September 30, 2024. The decrease in net current assets primarily relates to cash utilized in operations during the period.
Previous wording
The following table summarizes cash flows during the six months ended March 31, 2025 and 2024 (in thousands):
Current wording
The following table summarizes cash flows during the nine months ended June 30, 2025 and 2024 (in thousands):
Previous wording
Cash flows from financing activities for the six-month period ended March 31, 2025 was $1.6 million, compared to cash provided from financing activities of $7.3 million during the comparable six-month period ended March 31, 2024.
Current wording
Cash flows used in financing activities for the nine-month period ended June 30, 2025 was $0.6 million, compared to cash provided from financing activities of $11.9 million during the comparable nine-month period ended June 30, 2024.
Previous wording
During the six months ended March 31, 2025, we received $1.6 million in cash from the exercise of stock options by our employees.
Current wording
During the nine months ended June 30, 2025, we received $1.7 million in cash from the exercise of stock options by our employees. We utilized $2.3 million to satisfy tax withholding obligations associated with the net exercise of an employee stock option to our CEO, in exchange for the withholding of shares.
Previous wording
During the six months ended March 31, 2024, cash provided by financing activities was primarily attributable to cash received from the issuance of common shares at various market prices under the 2023 Purchase Agreement.
Current wording
During the nine months ended June 30, 2024, cash provided by financing activities was primarily attributable to cash received from the issuance of common shares at various market prices under the 2023 Purchase Agreement.
Previous wording
On February 3, 2023, the Company entered into a $150,000,000 purchase agreement (the “2023 Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which the Company has the right to sell and issue to Lincoln Park, and Lincoln Park is obligated to purchase, up to $150.0 million in value of its shares of Common Stock from time to time over a three-year period until February 3, 2026.
Current wording
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.
Previous wording
On any business day and subject to having an effective registration statement and subject to certain customary conditions, the Company 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 the Company has directed Lincoln Park to purchase the full amount of Common Stock available as a Regular Purchase on a given day, it may direct Lincoln Park to purchase additional amounts as “accelerated purchases” and “additional accelerated purchases,” each as set forth in the 2023 Purchase Agreement.
Current wording
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.
Previous wording
During the six-months ended March 31, 2025, the Company did not issue any shares of common stock under the 2023 Purchase Agreement. During the six-month period ended March 31, 2024, the Company issued to Lincoln Park an aggregate of 1,503,707 shares of Common Stock under the 2023 Purchase Agreement, including 1,500,000 shares of Common Stock for an aggregate purchase price of $7,411,700 and 3,707 commitment shares.
Current wording
During the nine-months ended June 30, 2025, the Company did not issue any shares of common stock under the 2023 Purchase Agreement. During the nine-month period ended June 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.
Previous wording
On March 31, 2025, there was an unused amount of $110.8 million under the 2023 Purchase Agreement. The Company will need to obtain effectiveness of a new registration statement in order to access funds under the 2023 Purchase Agreement.
Current wording
On June 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.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
and methods of treating for Alzheimer’s disease using the compositions. This patent is expected to expire in June 2037, absent any patent term extension for regulatory delays. The fourth patent claims method of making certain crystalline forms of ANAVEX®2-73. This patent is expected to expire in October 2036, absent any patent term extension for regulatory delays. The fifth patent claims crystalline forms of the dihydrogen phosphate salt of ANAVEX®2-73 and dosage forms (including transdermal and oral dosage forms) and pharmaceutical compositions containing the same. This patent is expected to expire in July 2039, absent any patent term extension for regulatory delays.