AVXL

Anavex Life Sciences (NASDAQ:AVXL) is advancing Alzheimer’s Phase 3 planning with the FDA after submitting its clinical trial data to a newly opened Alzheimer’s IND, while reporting $118.3 million in cash and an expected operating runway into mid to late fiscal 2028. Anavex has submitted its Alzheimer’s clinical trial data to its new IND as it prepares for FDA discussions over its U.S. development programme and Phase 3 study design. Anavex Life Sciences (NASDAQ:AVXL) ended June with $118.3 million in cash and cash equivalents, up from $102.6 million at September 2025 fiscal year-end. Management expects existing cash to fund operations into mid to late fiscal 2028, providing capital coverage as several clinical programmes advance. The company is moving ahead with an adult Phase 3 Rett syndrome study and has requested an FDA meeting about adding paediatric patients. A Fragile X syndrome IND is expected to be submitted in September, creating another near-term regulatory milestone. Anavex’s near-term regulatory strategy is increasingly concentrated on blarcamesine across Alzheimer’s disease, Rett syndrome and Fragile X syndrome. For Alzheimer’s, the company has submitted all clinical trial data to its newly opened IND and plans further discussions with the FDA covering its U.S. clinical development programme and proposed ANAVEX2-73-AD-005 Phase 3 trial. Anavex received scientific advice from the EMA in June covering areas including the proposed study population, endpoint hierarchy, treatment duration, statistical framework and subgroup strategy. Management intends to incorporate that feedback into its FDA discussions, with the U.S. now its near-term regulatory priority. A European Phase 3 study is not currently being pursued. Two clinical pharmacology studies required across the blarcamesine pipeline are also progressing. The first participant visit in the ADME study has taken place, while the final participant visit in the DDI study is expected by the end of September. In Rett syndrome, Anavex is moving towards initiation of an approximately 170-participant adult Phase 3 trial while seeking FDA agreement to include paediatric patients. Separately, the company expects to submit its Fragile X IND in September. The Alzheimer’s programme is moving into a regulatory alignment phase rather than directly into a newly launched Phase 3 trial. That makes the outcome of discussions with the FDA particularly important for determining the design and path of the next pivotal study. The company’s decision to concentrate on three indications may also provide investors with a clearer view of its clinical priorities. Alzheimer’s, Rett syndrome and Fragile X now form the core development strategy, potentially focusing resources on programmes management considers to have the strongest regulatory paths. Funding visibility is another significant element of the quarter. The $118.3 million cash position is expected by management to support operations into mid to late fiscal 2028, which could provide room to advance these programmes without an immediate funding requirement based on the company’s current forecast. Anavex reported third-quarter net income of $7.8 million, or $0.08 per share, compared with a $13.2 million loss, or $0.16 per share, a year earlier. However, the improvement was primarily driven by reversals of stock-based compensation associated with employee terminations, including the former CEO, rather than a change in the underlying economics of a commercial-stage business. Investors also have a corporate reporting issue to monitor. Anavex still needs to file its outstanding second- and third-quarter fiscal 2026 Forms 10-Q and said it is working with Nasdaq to fully regain compliance. FDA discussions around the proposed Alzheimer’s Phase 3 protocol are a central upcoming catalyst, particularly any clarity on the design of ANAVEX2-73-AD-005. Other milestones include completion of clinical conduct for the DDI study after the expected final participant visit by the end of September, the planned September Fragile X IND submission and FDA feedback on potentially adding paediatric patients to the Rett syndrome Phase 3 programme. Investors can also watch for the outstanding Form 10-Q filings and confirmation that Anavex has fully regained Nasdaq compliance. Anavex Life Sciences stock price

Clinical Development Strategy for Alzheimer’s Disease Remains the Focus as Anavex Advances Regulatory Progress Across All Three Programs Anavex Submits Completed Alzheimer’s Disease Clinical Study Data and Rett Syndrome Formal Meeting Request to FDA, with an IND Submission for Fragile X Syndrome Planned for September NEW YORK, Aug. 25, 2026 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for central nervous system (“CNS”) diseases with high unmet medical needs, today reported a business update and financial results for its third fiscal quarter ended June 30, 2026. “I am delighted to report on the continued regulatory momentum we are building across our pipeline. We have submitted all data from our Alzheimer’s disease clinical trials to our newly opened Alzheimer’s IND.  These clinical data will serve as the foundation to advance our discussions with the U.S. Food and Drug Administration (“FDA”) regarding our U.S. clinical development program and Phase 3 protocol design for Alzheimer’s disease,” stated Terrie Kellmeyer, Ph.D., Interim Chief Executive Officer. “At the same time, we continue to advance our two essential clinical pharmacology studies, which are required for all indications across our pipeline.  We are moving quickly to complete both: the first participant visit occurred in the Absorption, Distribution, Metabolism and Elimination (ADME) study, and the last participant visit is expected by the end of September in the ongoing Drug-drug Interaction (DDI) study. For Rett syndrome, we are moving our adult Phase 3 study forward as quickly as possible, and we have submitted a meeting request to the FDA to discuss adding pediatric patients to the study. In Fragile X syndrome, we expect to submit our IND to the FDA in September. We remain focused on the three indications that we believe demonstrate the most promising regulatory paths forward, serving both our patients and shareholders. We are taking a methodical, financially disciplined, stepwise approach to advance each of our programs along an FDA-aligned regulatory and clinical path.” Business Update, Recent and Upcoming Milestones The Company’s primary focus is advancing its lead compound ANAVEX®2-73 (blarcamesine) for the treatment of mild cognitive impairment due to Alzheimer’s disease (“AD”) and mild AD (collectively known as “early AD”), and for Rett syndrome and Fragile X syndrome. These three indications are the Company’s core focus. Anavex will be attending the following upcoming 2026 events: Alzheimer’s Disease Program Anavex has submitted all data from its Alzheimer's disease clinical trials to its newly opened Alzheimer's IND. The Company is using feedback from the European Medicines Agency's (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) on its Marketing Authorization Application (“MAA”), together with the EMA’s scientific advice described below and feedback from its Type C meeting with the FDA held in November 2025, to properly position these completed studies within its overall clinical development plan. In June 2026, Anavex received Scientific Advice from the EMA, addressing the overall design of the proposed Phase 3 study (ANAVEX2-73-AD-005), including study population, endpoint hierarchy, treatment duration, statistical framework and subgroup strategy. The Company has completed its review of the EMA CHMP assessment report, which clearly outlined the foundational clinical pharmacology studies and nonclinical work that are required for a potential future approval of blarcamesine, and we anticipate the FDA will have the same requirements. The foundational clinical pharmacology studies for blarcamesine under the IND - the ADME study and the DDI study - will provide critical support across the Company’s pipeline programs, with the first participant visit in the ADME study recently completed and the last participant in the DDI study expected to complete the last study visit by the end of September. This will then represent the completion of the clinical conduct of the DDI study. Anavex has refreshed and streamlined its Scientific Advisory Board to a focused group of Alzheimer’s disease key opinion leaders and treating physicians, who have confirmed their continued interest in supporting the Company’s efforts.  Their input will be critical in designing a practical and clear protocol, helping guide the development of blarcamesine from a physician and patient perspective. Rett Syndrome Program The FDA has granted Orphan Drug Designation, Rare Pediatric Disease Designation and Fast Track Designation for blarcamesine in Rett syndrome. Fragile X Syndrome Program The Company is preparing to initiate the Fragile X clinical program. The IND for Fragile X syndrome is expected to be submitted in September, supported by the Orphan Drug Designation already granted by the FDA. Nasdaq Compliance The Company plans to file its outstanding Form 10-Q filings for the second and third fiscal quarters of 2026 in the near term and continues to work diligently with Nasdaq to officially fully regain compliance as quickly as possible. Webcast / Conference Call Information Anavex intends to host its next webcast and conference call with its 2026 fourth quarter and full year fiscal financial results. Management will be available for select meetings. Please email Investor Relations for further details. Fiscal Third Quarter 2026 Highlights Cash and cash equivalents were $118.3 million as of June 30, 2026, compared to $102.6 million as of fiscal year end September 30, 2025. The Company’s cash balance at the end of the third fiscal quarter of 2026 is expected to fund operations into mid to late fiscal 2028. General and administrative expenses (recovery) were $(2.0) million for the third fiscal quarter of 2026 compared to $4.5 million for the third fiscal quarter of 2025. The decrease in expenses resulting in a net recovery was primarily related to the reversal of $7.5 million in stock-based compensation expense during the period associated with the termination of employees, primarily the former Chief Executive Officer. Research and development expenses (recovery) were $(4.7) million for the third fiscal quarter of 2026 compared to $10.0 million for the third fiscal quarter of 2025. The decrease in expenses resulting in a net recovery was primarily related to the reversal of $9.9 million in stock-based compensation expense during the period associated with the termination of employees, primarily the former Chief Executive Officer. Net income for the third fiscal quarter was $7.8 million, or $0.08 per share, compared to a net loss of $13.2 million, or $0.16 per share, for the third fiscal quarter of 2025. The decrease in net loss was primarily related to the recovery of stock-based compensation expense, as more fully described above. About Anavex Life Sciences Corp. Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded clinical stage biopharmaceutical company engaged in the development of novel therapeutics for the treatment of central nervous system (“CNS”) diseases with high unmet medical need. Further information is available at www.anavex.com. Forward-Looking Statements Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include, but are not limited to, statements relating to the Company’s plans to prioritize engagement with the U.S. FDA to align on a clear, data-driven regulatory and clinical development strategy; the Company’s plans to continue to execute on its mission of developing targeted, orally delivered therapies for a specific range of CNS-related diseases; the timing, progress and results of advancement of ANAVEX 2-73 in clinical programs for the treatment of early Alzheimer’s disease, Rett syndrome and Fragile X syndrome; the Company’s plans to align with the FDA on a U.S. clinical development strategy for early Alzheimer's disease, align on a Phase 3 protocol for Rett syndrome that includes pediatric patients, and align on a clinical development strategy for the Fragile X clinical program; the Company’s plans to file its outstanding Form 10-Q filings for the second and third fiscal quarters of 2026 in the near term; and the Company’s expectations regarding its cash runway. These statements are based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such forward-looking statements due to various factors, including, but not limited to, risks related to the Company’s ability to regain compliance with Nasdaq Listing Rule 5250(c)(1);  the Company’s failure to timely file its Form 10-Q for the quarterly period ended March 31, 2026 and June 30, 2026; the duration and outcomes of any current or future litigation related to the termination of the Company’s former Chief Executive Officer and any related matters; volatility in the Company’s stock price and the market in general; the Company’s ability to raise additional capital; challenges seeking, and ultimately obtaining, regulatory approval for the Company’s product candidates; the ability of Fast Track designation or breakthrough therapy designation to lead to a faster FDA review and approval process; the Company’s ability to maintain any benefits associated with Orphan Drug Designation, including market exclusivity; undesirable side effects caused by the Company’s product candidates; the Company’s ability to attract and retain highly qualified personnel; the Company’s reliance on third-parties; the Company’s ability to obtain and maintain sufficient intellectual property protection for our product candidates; the Company’s ability to defend against claims of intellectual property infringement; the Company’s ability to compete in the highly competitive biotechnology and pharmaceutical industries; and other risks and uncertainties set forth in the Company’s Annual Report on Form 10-K for the fiscal year ended September 30, 2025, and subsequent filings and furnishings with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof except as required by law. Investor Relations & Media Contact: SCR Partners, LLCAlex ArzenoTel: 203-550-3972Email: [email protected] Tripp SullivanTel: 615-942-7077Email: [email protected] Company Contact: Sandra BoenischPrincipal Financial OfficerAnavex Life Sciences Corp.Tel: 1-844-689-3939Email: [email protected]

Establishing Disciplined, Data-Driven Strategy with Focus on FDA Engagement for Alzheimer’s Disease NEW YORK, July 30, 2026 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (Anavex or the Company) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for central nervous system (CNS) diseases with high unmet medical needs, today reported preliminary financial results for its fiscal second quarter ended March 31, 2026. The Company’s primary focus is on advancing its lead compound ANAVEX®2-73 (blarcamesine) in the Company’s clinical program for the treatment of mild cognitive impairment (“MCI”) due to Alzheimer’s disease (“AD”) and mild AD (collectively known as “early AD”), and for Rett syndrome and Fragile X syndrome, both of which are neurodevelopmental rare diseases. “Anavex remains firmly committed to our lead candidate oral blarcamesine (ANAVEX®2-73) for patients with Alzheimer's disease, and we are prioritizing engagement with the U.S. FDA to align on a clear, data-driven regulatory and clinical development strategy,” stated Terrie Kellmeyer, PhD, Interim Chief Executive Officer. “A qualified data-driven approach will guide every decision we make. I have spent nearly three decades building and leading clinical and regulatory functions in drug development, and I’m bringing that experience to bear every day as we implement a disciplined regulatory strategy and build the right foundation for our programs. We are committed to advancing blarcamesine towards a clear regulatory path. I also want to recognize our employees, who have continued to show up for the patients who are counting on us, and the patients and families living with Alzheimer’s disease, Rett syndrome and Fragile X, who are depending on us to continue this important work on these urgent unmet medical needs. We are continuing to execute on the mission of developing targeted, orally delivered therapies for a specific range of CNS related diseases.” Business Update & Anticipated Upcoming Milestones Anavex is prioritizing programs that the Company believes have the greatest potential for success. The strategy concentrates resources on blarcamesine across three CNS indications: early Alzheimer's disease and Rett syndrome, where the Company’s clinical and regulatory foundation is most advanced, and Fragile X, where FDA Orphan Drug Designation, supportive preclinical and biomarker data, and the absence of any approved therapy may lead to a promising regulatory path with the FDA. Alzheimer’s Disease Program At the end of March 2026, the Company opened an Investigational New Drug (IND) application for early Alzheimer’s disease with the FDA. This is an important milestone: the IND enables clinical studies to be conducted in the U.S. and provides the basis for substantive discussions with the FDA to align on the Company’s future clinical development for early Alzheimer’s disease. The Company intends to engage with the FDA on a U.S. clinical development strategy for early Alzheimer's disease. The Company continues to review the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) assessment report and intends to use it to inform and support its clinical development strategy with the FDA. In July 2026, Anavex attended the Alzheimer’s Association International Conference (AAIC) in London, England, which provided the Company with an opportunity to engage with clinicians, researchers and the broader Alzheimer’s community and to reinforce the Company’s continued commitment to bringing a treatment option to market for patients with early Alzheimer’s disease. Rett Syndrome Program The FDA has already granted Orphan Drug Designation, Rare Pediatric Disease (RPD) Designation and Fast Track Designation for blarcamesine in Rett syndrome. Fragile X Syndrome Program The FDA has already granted Orphan Drug Designation for Fragile X syndrome. Nasdaq Compliance On July 20, 2026, the Company submitted a plan to regain compliance with Nasdaq Listing Rule 5250(c)(1). Preliminary Fiscal Second Quarter 2026 Highlights The financial results in this press release are preliminary and subject to completion of the Company’s financial closing procedures. Actual results may vary materially from these preliminary financial results due to the completion of the Company’s financial closing procedures and other developments or information that may arise between now and the time of the finalization of the Company’s financial results for three and six months ended March 31, 2026. Preliminary cash and cash equivalents were $127.4 million as of March 31, 2026, compared to $102.6 million as of September 30, 2025. The Company expects the cash balance at the end of the second fiscal quarter of 2026 to fund operations into mid-to-late fiscal 2028. Preliminary general and administrative expenses were $2.3 million for the second fiscal quarter of 2026 compared to $2.6 million for the second fiscal quarter of 2025. The decrease was primarily related to a decrease in legal and professional fees over the comparable period. Preliminary research and development expenses were $4.2 million for the second fiscal quarter of 2026 compared to $9.9 million for the second fiscal quarter of 2025. The decrease was primarily attributable to the completion of the ANAVEX® 3-71 clinical trial for schizophrenia and a decrease in clinical manufacturing activities over the comparable period. Preliminary Net loss for the second fiscal quarter of 2026 was $5.3 million, or $0.06 per share, compared to a net loss of $11.2 million, or $0.13 per share, for the second fiscal quarter of 2025. About Anavex Life Sciences Corp. Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded clinical stage biopharmaceutical company engaged in the development of novel therapeutics for the treatment of central nervous system (“CNS”) diseases with high unmet medical need. Further information is available at www.anavex.com. Forward-Looking Statements Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include, but are not limited to, statements relating to the Company’s preliminary financial results for the second quarter of 2026; the Company’s plans to prioritize engagement with the U.S. FDA to align on a clear, data-driven regulatory and clinical development strategy; the Company’s plans to continue to execute on its mission of developing targeted, orally delivered therapies for a specific range of CNS-related diseases; the timing, progress and results of advancement of ANAVEX®2-73 in clinical programs for the treatment of early Alzheimer’s, Rett syndrome and Fragile X syndrome; the Company’s plans to align with the FDA on a U.S. clinical development strategy for early Alzheimer's disease, align on a Phase 3 protocol for Rett syndrome in both adult and pediatric patients, and align on a clinical development strategy for the Fragile X clinical program; and the Company’s expectations regarding its cash runway. These statements are based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such forward-looking statements due to various factors, including, but not limited to, risks related to the Company’s failure to timely file its Form 10-Q for the quarterly period ended March 31, 2026 and the Company’s ability to regain compliance with Nasdaq Listing Rule 5250(c)(1); that actual financial results may vary materially from the preliminary financial results presented in this press release; volatility in the Company’s stock price and the market in general; the Company’s ability to raise additional capital; Fast Track designation that the Company has received or may seek out may not actually lead to a faster FDA review and approval process; the Company may be unable to maintain any benefits associated with orphan drug designation, including market exclusivity; undesirable side effects caused by the Company’s product candidates; the Company’s ability to attract and retain highly qualified personnel; the Company’s ability to obtain the support of qualified scientific collaborators; the Company’s reliance on third parties; the Company’s ability to obtain and maintain sufficient intellectual property protection for its product candidates; the Company’s ability to defend against claims of intellectual property infringement; the Company’s ability to compete in the highly competitive biotechnology and pharmaceutical industries; and other risks and uncertainties set forth in the Company’s Annual Report on Form 10-K for the fiscal year ended September 30, 2025, and subsequent filings and furnishings with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof except as required by law. Investor Relations & Media Contact: SCR Partners, LLCAlex ArzenoTel: 203-550-3972Email: [email protected] Tripp SullivanTel: 615-942-7077Email: [email protected] Company Contact: Sandra BoenischPrincipal Financial OfficerAnavex Life Sciences Corp.Tel: 1-844-689-3939Email: [email protected]

The clinical-stage biotech highlighted regulatory progress for its lead Alzheimer’s candidate while reporting lower quarterly losses and reaffirming a cash runway extending into fiscal 2028. Anavex Life Sciences (NASDAQ:AVXL) is prioritizing blarcamesine across Alzheimer’s disease, Rett syndrome and Fragile X syndrome. The company opened an Investigational New Drug (IND) application with the FDA for early Alzheimer’s disease, supporting future U.S. clinical development. Preliminary Q2 2026 results showed a narrower net loss as research and development spending declined. Cash and cash equivalents increased to $127.4 million, with management expecting funding into mid-to-late fiscal 2028. Management plans additional FDA discussions that could shape the regulatory pathway for multiple CNS programs. Anavex Life Sciences (NASDAQ:AVXL) reported preliminary second-quarter fiscal 2026 financial results while providing an update on the regulatory strategy for its lead drug candidate, blarcamesine (ANAVEX 2-73), across several central nervous system indications. The company’s primary focus remains early Alzheimer’s disease, where it opened an Investigational New Drug application with the U.S. Food and Drug Administration at the end of March 2026. According to the company, the IND allows clinical studies to proceed in the United States and provides the framework for discussions with the FDA regarding future clinical development. Two supporting clinical pharmacology studies are moving forward under the IND. An absorption, distribution, metabolism and excretion (ADME) study is expected to begin during the third quarter of calendar 2026, while dosing has already started in a drug-drug interaction study. Anavex said these studies are intended to strengthen its regulatory package while broader Alzheimer’s development continues in parallel. Beyond Alzheimer’s disease, the company said it plans further discussions with the FDA regarding Rett syndrome after previously aligning on an adult Phase 3 trial protocol, with the goal of potentially expanding the study to include pediatric patients. It also intends to engage the agency on a development strategy for Fragile X syndrome, where blarcamesine already holds FDA Orphan Drug Designation. Financially, preliminary cash and cash equivalents increased to $127.4 million as of March 31, 2026, from $102.6 million at the end of fiscal 2025. Preliminary net loss narrowed to $5.3 million, or $0.06 per share, compared with $11.2 million, or $0.13 per share, a year earlier, while research and development expenses declined following the completion of the company’s schizophrenia study. The update shifts investor attention from near-term financial performance toward regulatory execution, which remains the key value driver for Anavex. Opening the Alzheimer’s IND establishes the regulatory framework needed for U.S. clinical development and may allow the company to refine its strategy following its review of feedback from European regulators. Planned FDA interactions across Alzheimer’s disease, Rett syndrome and Fragile X could help clarify future development timelines and trial requirements. The improved cash position and lower operating expenses also strengthen the company’s financial outlook. Management’s expectation that existing cash will fund operations into mid-to-late fiscal 2028 suggests reduced near-term financing pressure while regulatory discussions continue. Investors will likely monitor several upcoming milestones: Initiation of the ADME study during the third quarter of calendar 2026. Progress in the ongoing drug-drug interaction study. FDA discussions on the U.S. clinical development strategy for early Alzheimer’s disease. Updates on the Phase 3 Rett syndrome program, including potential inclusion of pediatric patients. Progress toward regaining compliance with Nasdaq listing requirements and further regulatory developments for the Fragile X program. Anavex Life Sciences stock price

Image source: The Motley Fool. Monday, Feb. 9, 2026, at 8:30 a.m. ET President and Chief Executive Officer — Christopher Missling Principal Financial Officer — Sandra Boenisch Head of Corporate Communications — Clint Tomlinson Need a quote from a Motley Fool analyst? Email [email protected] Christopher Missling: Thank you, Clint, and good morning, everyone. Thank you for being with us today to review our first quarter financial results and quarterly business update. As we enter 2026, we continue to progress our innovative clinical pipeline with a particular focus on our lead candidate, oral blarcamesine, in early Alzheimer's disease. Based on our commitment to improving the lives of patients with neurological disorders, we remain excited about the therapeutic potential of oral blarcamesine. We look forward to working with the regulatory agencies in Europe and in the US to advance blarcamesine as a potential new treatment option for patients. We recently announced Anavex's participation as a key industry partner in Access AD, a major new European initiative designed to accelerate the adoption of innovative diagnostic and therapeutic approaches for Alzheimer's disease across real-world clinical settings. The multiyear program is funded by the European Commission's Innovative Health Initiative and unites leading academic centers, technology developers, industry innovators, and patient organizations to strengthen equitable access to timely and effective Alzheimer's disease care. As part of the consortium, blarcamesine will be evaluated in a clinical prediction study. As an update to our regulatory pathway, in January, we announced feedback from an FDA Type C meeting in which the FDA shared their feedback on Anavex's development plans. The meeting discussed the potential pathways to support blarcamesine for Alzheimer's disease. In order to move forward, it is expected that existing data from the Phase 2b/3 Anavex 2-73 AD-004 program be submitted to the FDA. In December, as expected, the CHMP adopted a negative opinion on the marketing authorization application for blarcamesine. Subsequently, on December 18, Anavex announced it had requested the EMA to reexamine its opinion. We are working closely with the EMA during this process, which is being led by a different rapporteur and co-rapporteur. In November, we announced presentations at the 18th CTAD conference in San Diego. The oral late-breaking communication on oral blarcamesine Phase 2b/3 trial confirms identified precision medicine patient population, significant broad clinical and quality of life improvements for early Alzheimer's disease patients, and two poster presentations featuring blarcamesine. Looking forward, we will provide both regulatory and clinical trial updates on blarcamesine in other indications such as Parkinson's disease and fragile X. This will include disclosure of planned future clinical trial designs as we continue to advance our therapeutic pipeline. Additionally, new scientific findings will be presented at upcoming conferences or in upcoming publications. An oral presentation at the 16th Intrinsic Capacity Frailty and Sarcopenia Research Conference for Healthy Longevity to be held March 12 at Johns Hopkins University Bloomberg Center in Washington DC. The new findings on a clinical relationship with a biomarker correlation between clinical endpoints and reduced brain region atrophy with blarcamesine in early Alzheimer's disease. A publication on Alzheimer's disease regarding precision medicine AB-clear populations of the Anavex 2-73 AD-004 Phase 2b/3 trial. Another publication on Alzheimer's disease on the precision medicine gene, collagen 24A1, which with an estimated over 70% prevalence in the early Alzheimer's disease population, has the potential to establish effective treatment of early Alzheimer's disease through the effectiveness of autophagy-enhancing blarcamesine. And a publication regarding fragile X, blarcamesine corrects EEG biomarkers of cortical dysfunction in a mouse model of fragile X syndrome. With regard to Anavex 3-71, we will be advancing Anavex 3-71 towards pivotal clinical studies for the treatment of schizophrenia-related disorders. And now I would like to direct the call to Sandra Boenisch, Principal Financial Officer of Anavex, for a financial summary of the recently reported quarter. Sandra Boenisch: Thanks, Christopher. Good morning to everyone. I am pleased to share with you today our first quarter financial results. Our cash position at December 31 was $131.7 million with no debt. During the quarter, we utilized cash and cash equivalents of $7.1 million in operating activities after taking into account changes in non-cash working capital accounts. As of today, we anticipate that at the current cash utilization rate, our cash runway is more than three years. Our research and development expenses for the quarter were $4.7 million as compared to $10.4 million for the comparable quarter of last year. General and administrative expenses were $2.1 million as compared to $3.1 million for the comparable quarter of last year. And compared to the same quarter of fiscal 2025, we saw a decrease in operating expenses, mostly driven by the completion of a large manufacturing campaign of blarcamesine conducted in fiscal 2025, and a decrease in clinical trial activities as a result of the completion of our Anavex 3-71 Phase II study in schizophrenia. And lastly, we reported a net loss of $5.7 million for the quarter or $0.06 per share. Thanks, and I will turn it back to you, Christopher. Christopher Missling: Thank you, Sandra. In summary, we are focused on continuing to advance the development of our precision medicine compounds and are excited to be potentially making a difference to individuals suffering from neurological diseases by presenting scalable treatment options alongside the ease of oral administration. I would now like to turn the call back to Clint for Q&A. Clint Tomlinson: Thank you, Christopher. We will now begin the Q&A session. If you have a question, please raise your hand or enter it in the Q&A box. And our first question will come from Ram Selvajara from HC Wainwright. You should be connected now, Ram. But I see you muted. Hello? Can you hear me? Ram Selvajara: Yes. Thanks so much for taking our questions. Firstly, I was wondering if you could, at this juncture, provide us with some additional information regarding who the rapporteur and co-rapporteur are for the reexamination of the CHMP opinion on blarcamesine. Christopher Missling: The 27 countries of the EU decide on two rapporteurs. One of the two countries of the 27 will be rapporteurs. Ram Selvajara: Okay. Can you provide us with additional information regarding the timeline with which the reexamination is likely to occur? My understanding is that, in effect, it starts a new clock, but that this might be as short as six months. Can you confirm that? Christopher Missling: That is correct. It is a sixty-plus-sixty-day period where we respond to the reexamination request. And then the review by the two rapporteurs will take another sixty days. So that's why we stated that we expect this process to last for the first half of this year. Can you provide a timeline regarding when you anticipate potentially filing a formal NDA submission with the FDA? This is a plan we will advance once we are getting closer. But the last meeting was very productive we had with the FDA. And so we continue with this request, which we were given that we will provide the full data package to the FDA for addressing their review and expecting next steps from there. Ram Selvajara: Can you just remind us what type of meeting this was that you held with the FDA, the most recent one? Christopher Missling: That was a Type C meeting. Ram Selvajara: Okay. Thank you. Clint Tomlinson: Thank you, Ram. Next question comes from Tom Bishop of BI Research. Tom, you should be on now. Tom Bishop: Ring. Can you hear me? Clint Tomlinson: Yes. Go ahead. Tom Bishop: Can you go into a little bit more detail about what additional information will be in the resubmission to the EMA in terms of will ABC clear data be in there, varying volume data, follow 24A1, and OLE. Can you just give us a little bit more meat on the bone? Christopher Missling: That's absolutely possible. So for background, in the resubmission, we are able to address and provide feedback on the arguments why this drug should be reexamined for approval for EMA review. And as a reminder, there is a requirement for granting conditional approval if the disease is serious, if there's a major unmet need, if the data shows clinically meaningful effects, if there's a strong mechanistic rationale especially linking genetic variants, and if the supporting evidence from translational data is available and the sponsor is then also committing to a study in executing it and confirming the efficacy during the approval process. And we are including the data of the AD-004 study, the open-label study, the data on the AB-clear study population, as well as the correlation of the efficacy of the clinical efficacy with the brain atrophy reduction. Tom Bishop: Now was none of that actually in the, you know, those last few that you mentioned in the original submission such that this could potentially be more persuasive as it is for me. Christopher Missling: Yeah. It's really like a process, I would say, and we also understand that is something which a counterparty has to digest. And maybe that is the reason also we've seen now in the past several cases where even with drugs which were prior approved already, and with very large companies submitting those, you know, trial data, well, ended up at the same situation where we ended up today as well. But, we can, of course, not guarantee the approval in this reexamination procedure. But it seems to be a question of how to repackage or rearticulate the strength of the package or of the data. Tom Bishop: Okay. And with the FDA, I know the question was asked when might you file this data with the FDA. I mean, it kinda already exists, so I'm was just wondering if you can be any more clear about why we can't they can't why you can't get that data to the FDA very soon? Christopher Missling: It's in process, and you have to also understand the FDA has a certain meeting request which requires some time to schedule. And this is in the process as well. So that's why it's not like you just ship something over, and then you get feedback you have to make it in consistency with a meeting request. And that's what will happen. Tom Bishop: Okay. Are there any correct me if I'm getting the scene out here, but are there any trials currently in progress? The only trial we have ongoing is right now the compassionate use program for Rett syndrome. In three countries, in three continents. In Canada, in the UK, in Australia, and we have also the compassionate use ongoing for Alzheimer's disease. So we are planning now the studies in Parkinson's disease, in fragile X, and another indication which is not disclosed yet, and we also will proceed with the Alzheimer trial which we I mentioned before. Tom Bishop: Okay. Well, is the it's been a little while since the Rett trial finished, the Parkinson's trial was finished several years now, and I'm just wondering if you can give us any near-term timeline for first trial. Some of these schizophrenia, just wrapped up that. Christopher Missling: Yeah. Tom Bishop: As to when something we'll we'll we'll get something in this clinic. Yeah. Yep. Absolutely good question. We also plan a schizophrenia program to continue. As I mentioned this morning, so we are really gonna be very busy with trials, and we are very excited about it. And just to let you know, the Parkinson's disease trial has not been started yet. It was Parkinson's disease dementia. But it's the basis of which we are executing the Parkinson's disease trial. Tom Bishop: Okay. I guess that's it for me for now. Thank you. Clint Tomlinson: Thank you, Tom. The next question will come from Jesse Silveira from Spirit of the Coast Analytics. You can go ahead, Jesse. Hear me alright? Jesse Silveira: Yes. Thank you. Hi. Good morning. This is Jesse Silveira with Spirit of the Coast Analytics. Thank you for taking my questions today. Before we get into some of my, I guess, more elaborate questions, maybe we can start with some quicker pitches. First up, something a lot of people have been kind of scratching their heads on is clarity for CHMP rejection, in particular, we know that blarcamesine works better for patients with sigma-1 wild type. As a part of the CHMP rejection, the agency stated, and I quote, the main study failed to demonstrate effectiveness and safety of blarcamesine Anavex, in patients with early Alzheimer's disease who do not have a mutation in the sigma-1 gene, end quote. So this statement appears contrary to the facts because the drug is effective for patients, who do not have a mutation in the sigma-1 gene, also known as sigma-1 wild type. So is it the company's opinion that the CHMP made an error in how they phrased their rejection, or can you clarify the company's understanding of this statement in particular? Christopher Missling: Yeah. We would not criticize the regulatory bodies, but we would say that in consistency with our interpretation of the trial, we met the ADAS-cog 13 and there was more significant in the wild type sigma-1 population as well as in the from the boxes which also was superior to the ITT in the wild type compared to the ITT population. The ADL ADCS ADL endpoint, was the only one which was not significant, although it was trending positively. And as we and the academic world found out that this scale is not sensitive enough to pick up the changes of activities of the living in forty-eight weeks in an early Alzheimer's population. So that is the maybe the only difference in interpretation of the trial. That was, maybe differently evaluated. But now when you go to the AB-clear population, you will see, and we submitted that for publication. It's already publicly available a preprint that the AB-clear population, which includes sigma-1 wild type, carriers with the collagen 24A1 wild type, gene that those patients have significance reached significance across the board. So for ADAS-cog 13, for ADCS ADL, and for CDR Sum of the Boxes. And they're not only achieving significance, but they're also achieved this with highly clinically meaningful effect sizes, which are sometimes two to three times larger than, what we have seen so far from other compounds. In the pipeline or on the market. So that's kind of, like, why this is intriguing now to also point that out and have that discussion put that forward. Jesse Silveira: Okay. Thank you for that. And I'm gonna have I'm gonna skip around a minute just because you kind of led into it. So stated in your Borrow Capital interview with Jason a few weeks ago that the reexamination would be under a CMA path and not a full market authorization. And in the interview, you explained that ADCS ADL one of your co-primary endpoints had been invalidated as a reliable measure during your trial analysis phase due to a lack of sensitivity found within the community despite its previous status as the gold standard in Alzheimer's trials. You then went into detail about new statistical methodology that the company was looking to use featuring a higher p-value threshold of 0.0167. And I know that the company has met ADAS-cog 13 and CDR Sum of the Boxes across all genetic cohorts with this p-value or better. So the question is, does using this new threshold allow the company to circumnavigate the ADCS ADL miss, and will regulators in your view, accept the scientific invalidation of ADCS ADL combined with your new gatekeeping strategy? If you can give any on that. Christopher Missling: Yeah. As I just stated, this is exactly the discussion which is probably ongoing if this ADL is 4. And if you follow science, you would agree with that. Because it's an endpoint which has been earmarked as being useful for overt Alzheimer, for moderate and severe Alzheimer, but not sensitive enough for the early Alzheimer population. And that was confirmed actually in guidances from the regulatory bodies. So you would assume that is a fair argument to have, and, we stated that argument and to make that argument as well. Jesse Silveira: Okay. Thank you for that. And, with that said, you went over the sixty plus sixty day timeline earlier for this reevaluation. We should be, I believe, near sixty days now. Have you already submitted the new strategy and package to CHMP and has a SAG been appointed yet? Christopher Missling: We will update everybody once we have the result of this process. We will not comment on the ongoing process. But the SEC will be part of the review process since we requested that, and we will expect this to be given to us a dialogue involving the SAG, the Scientific Advisory Group from the EMA for from the neurology team. Jesse Silveira: Okay. Thank you. And if I have it correct, you have committed to running a confirmatory phase four trial if approved for CMA using paying patients as a real-world cohort. Isn't is that correct? Christopher Missling: Sorry. What patients? Jesse Silveira: Like, paying patients in the EU. So assuming you are actually approved under CMA, will you be running a phase four trial with these patients? We will. Or how would that look, I guess? Christopher Missling: Yeah. We would run a trial as the regulatory body the CHM guidelines, provides for. That you get approved, and then in parallel, you will run a confirmatory study. Yes. Jesse Silveira: Okay. And I think relevant to additional Alzheimer's trials, is on January 28th of this year, Alzheimer Europe launched the prevalence of dementia in Europe 2025 report which projected a 64% surge in dementia across Europe by 2050. Based on our research, it appears that Europe is not on course to meet projected health strategies, especially those centered on dementia. And it looks like they're kind of, as a as the EU, moving away from social work and dimension favor of defense and economy. In light of these statements, it's our understanding that Anavex is set to participate in Access AD, funded by the European Commission. Can you please give more detail on how blarcamesine, a currently unapproved drug, is to be involved in this program? Like, is the company running this trial? Are endpoints and objectives of this trial? When will the first patient be dosed, or anything else you'd like to offer. Christopher Missling: The Access AD program is really a great opportunity for acknowledging Anavex as a participant and being part of the ecosystem in Europe for Alzheimer's disease, which involves both academic institutions as well as government entities and advocacy groups within Europe. So we're very pleased and excited about being part of that. A specific carve-out or not carve-out, especially part of this very large grant, if you like, is a dedicated clinical trial of blarcamesine as a placebo-controlled trial to look for data of prediction of the effect of blarcamesine in Alzheimer patients, in early Alzheimer patients, and that involves, review of biomarkers, and novel biomarkers, looking at autophagy signals, and, also including efficacy. And we're planning to use this trial also for a regulatory, specific, goal. So we will make this trial part of our package for confirming the efficacy of blarcamesine in early Alzheimer's disease. So it's a very intriguing project to be part of. And the Access AD program consists of multiple features. Among them is also a review of healthy diet. Also, a supplement diet is part of that. And, they're all separate. They're not together. And as I just mentioned, one part is explicitly a trial of blarcamesine. In our placebo-controlled clinical trial. Jesse Silveira: I'm sorry if you mentioned is this an early Alzheimer's patients, or is this is there, like, a preventative component to this trial? Christopher Missling: Yeah. So it's a good question. It could end up being a preventative also, but right now, it's consistent with an early Alzheimer's population as a target population. Jesse Silveira: Okay. And this would be considered AD-006 on your pipeline chart. Is that correct? Christopher Missling: That's correct. Yes. Jesse Silveira: Okay. AD-006. Okay. Great. And I think I'm finishing up here. Is the atrophy to clinical improvement analysis or paper complete? And maybe if you could give any expectations on when we could get eyes on that. Christopher Missling: The yeah. So we have submitted now three papers. We I mentioned this morning. And the atrophy paper is still not submitted, but will be submitted soon as well. Jesse Silveira: Okay. Great. And okay. That's pretty much all I have. Kudos on your JPM presentation and the new website format. They look great. And it's striking how little to lose I think, the CHMP has by granting a CMA considerably considering this, you know, the soundly claimed safety and efficacy the drug on cognition, objective brain atrophy markers, not to mention patient-assessed improvements. Measured by the quality of life AD survey. So we have no further questions, and thank you again for having us. Christopher Missling: We appreciate that. Thank you. Clint Tomlinson: Thank you, Jesse. Christopher Missling: Doctor Missling, we have no more questions at this time. Clint Tomlinson: Thank you. So in closing, we continue to focus on execution as we advance our therapeutic pipeline to potentially improve patients' lives living with these devastating conditions. We are energized by the possibility of making a meaningful impact for people living with neurological diseases offering treatment options that are not only scalable, but also far easier to administer through an oral route. By lowering barriers to access and simplifying delivery, we hope to bring innovative therapies to a broader population and improve quality of life in a tangible way. Thank you. Christopher Missling: Thank you, ladies and gentlemen, for participating in the call today. We appreciate it. And this will conclude the conference. You may now disconnect. Before you buy stock in Anavex Life Sciences, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Anavex Life Sciences wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Anavex (AVXL) Q1 2026 Earnings Call Transcript was originally published by The Motley Fool

Company to host a webcast today at 8:30 am Eastern Time NEW YORK, Feb. 09, 2026 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, today reported financial results for its first quarter of fiscal 2026. “As we have entered 2026, we continue to progress our innovative clinical pipeline with particular focus on our lead candidate, oral blarcamesine in early Alzheimer's disease. Based on our commitment to improving the lives of patients with neurological disorders, we remain excited about the therapeutic potential of oral blarcamesine. We look forward to working with the regulatory agencies in Europe and the U.S. to advance oral blarcamesine as a potential new treatment option for patients.” said Christopher U. Missling, PhD, President and CEO of Anavex. “An estimated 7.2 million people in the U.S. and 7 million in Europe are living with Alzheimer’s disease. Our mission is to develop targeted, orally delivered therapies aimed at a range of CNS related diseases, and specifically early-stage Alzheimer’s, where intervention may have the greatest impact.” Expected Development Milestones: Update on regulatory pathway for blarcamesine in early Alzheimer’s disease Progress on clinical development program in Parkinson’s disease through targeted approach, potentially addressing the highest disease burden in Parkinson’s disease Regulatory and clinical trial update for blarcamesine in Parkinson’s disease Regulatory and clinical trial update for blarcamesine in Rett syndrome Fragile X development update: Design of Phase 2/3 clinical trial Advancing ANAVEX®3-71 towards pivotal clinical studies for the treatment of schizophrenia related disorders Progressing collaborative initiatives and strategic partnership activities New scientific findings to be presented at upcoming conferences or publications: Oral Presentation at 16th Intrinsic Capacity, Frailty and Sarcopenia Research Conference for Healthy Longevity (ICFSR26), to be held on March 10-12, 2026 at Johns Hopkins University Bloomberg Center Washington, D.C.: “Exploring Treatment for Older Adults with Pre-Frailty to Mitigate Cognitive and Physical Decline Targeting Autophagy with Oral Blarcamesine” Clinical relationship with biomarker: Correlation between clinical endpoints and reduced brain region atrophy with blarcamesine in early Alzheimer’s disease Publication Alzheimer’s disease: Precision Medicine ABCLEAR populations of the ANAVEX®2-73-AD-004 Phase 2b/3 trial Publication Alzheimer’s disease: Precision Medicine gene, COL24A1, with estimated >70% prevalence in the early AD population has the potential to establish effective treatment of early Alzheimer’s disease through effectiveness of autophagy-enhancing blarcamesine Publication Fragile X: Blarcamesine corrects EEG biomarkers of cortical dysfunction in a mouse model of fragile X syndrome Recent Corporate Developments: On January 13, 2026, Anavex announced its participation as a key industry partner in ACCESS-AD, a major new European initiative designed to accelerate the adoption of innovative diagnostic and therapeutic approaches for Alzheimer’s disease across real-world clinical settings. The multi-year program is funded by the European Commission’s Innovative Health Initiative (IHI) and unites leading academic centers, technology developers, industry innovators and patient organizations to strengthen equitable access to timely and effective Alzheimer’s disease care. On January 8, 2026, Anavex announced the appointment of Wolfgang Liedtke, MD PhD, as Senior Vice President, Global Head of Neurology. Dr. Liedtke is a board-certified neurologist, who brings more than 25 years of extensive experience in developing and delivering innovative medicines in a broad range of CNS diseases, including genetic medicines and global therapeutic development. Most recently he was Chair of Neurology at Regeneron, where he oversaw the integration of discovery into 45 clinical trials (14 Phase 3 studies). On January 6, 2026, Anavex announced feedback from the FDA Type C meeting, in which the FDA shared their interest and collaborative approach to Anavex’ development plans. The meeting discussed the potential pathways to support an NDA (New Drug Application) for the treatment of Alzheimer’s disease. In order to move forward, existing data from the Phase IIb/III ANAVEX2-73-AD-004 program requested by the Agency will be submitted. On December 12, 2025, Anavex provided an update on the regulatory review in the EU for blarcamesine to treat early Alzheimer’s disease. The CHMP has adopted a negative opinion on the marketing authorisation application for blarcamesine and, on December 18, 2025, Anavex announced it had requested the EMA to re-examine its opinion. Anavex intends to work closely with the EMA during the process, which is led by a different rapporteur and co-rapporteur. On November 26, 2025, Anavex announced the presentations at the 18th Clinical Trials on Alzheimer’s Disease (CTAD) Conference in San Diego, CA. The oral late breaking communication: ‘Oral Blarcamesine Phase IIb/III Trial Confirms Identified Precision Medicine Patient Population – Significant Broad Clinical and Quality of Life Improvements for Early Alzheimer’s Disease Patients’, and two poster presentations, titled: ‘Oral Blarcamesine Comparison to Normal Cognitive Aging: Demonstrating Alignment with Prodromal Cognitive Aging Trajectories in Precision Medicine Patient Population Phase IIb/III Trial – for Early Alzheimer’s Disease Patients’ and ‘Advancing Alzheimer’s Disease Care: Convenience for Both Patients and Families with Oral Blarcamesine’ featuring blarcamesine’. Financial Highlights: Cash and cash equivalents of $131.7 million at December 31, 2025 compared to $102.6 million at September 30, 2025. The Company anticipates at its current cash utilization rate, an approximate cash runway of more than 3 years. Research and development expenses for the quarter of $4.7 million compared to $10.4 million for the comparable quarter of fiscal 2025. General and administrative expenses for the quarter of $2.1 million compared to $3.1 million for the comparable quarter of fiscal 2025. Net loss for the quarter of $5.7 million, or $0.06 per share, compared to a net loss of $12.1 million, or $0.14 per share for the comparable fourth quarter of fiscal 2025. The financial information for the fiscal quarter should be read in conjunction with the Company’s condensed consolidated interim financial statements, which will appear on EDGAR, www.sec.gov. Webcast / Conference Call Information: The live webcast of the conference call will be available on Anavex’s website at www.anavex.com. The conference call can be also accessed by dialing 1 929 205 6099 for participants in the U.S. using the Meeting ID# 844 4149 6344 and reference passcode 789539. A replay of the conference call will be available on Anavex’s website for up to 30 days. About Anavex Life Sciences Corp. Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative, neurodevelopmental, and neuropsychiatric disorders, including Alzheimer's disease, Parkinson's disease, schizophrenia, Rett syndrome, and other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex's lead drug candidate, ANAVEX®2-73 (blarcamesine), has successfully completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer's disease, a Phase 2 proof-of-concept study in Parkinson's disease dementia, and both a Phase 2 and a Phase 3 study in adult patients and one Phase 2/3 study in pediatric patients with Rett syndrome. ANAVEX®2-73 is an orally available drug candidate designed to restore cellular homeostasis by targeting SIGMAR1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer's disease. ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson's Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 for the treatment of Parkinson's disease. We believe that ANAVEX®3-71, which targets SIGMAR1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer's disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at www.anavex.com. You can also connect with the Company on Twitter, Facebook, Instagram, and LinkedIn. Forward-Looking Statements Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. For Further Information: Anavex Life Sciences Corp. Research & Business Development Toll-free: 1-844-689-3939 Email: [email protected] Investors: Andrew J. Barwicki Investor Relations Tel: 516-662-9461 Email: [email protected]

Anavex has requested an EMA CHMP re-examination for oral blarcamesine after a negative opinion, a process requested Dec. 18 and expected to run through the first half of the year under a new rapporteur/co‑rapporteur; the re‑examination package will include Phase IIB/III AD‑004 data, open‑label extension data, Aβ‑Clear analyses and correlations with reduced brain atrophy to support conditional approval criteria. The company said a January FDA Type C meeting was “very productive” and plans to submit existing ANAVEX2‑73‑AD‑004 data as part of a coordinated U.S. regulatory path, while also participating in the EU‑funded ACCESS‑AD program (AD006) to provide placebo‑controlled confirmatory and biomarker evidence. Anavex ended the quarter with $131.7 million in cash, no debt, and used $7.1 million in operating cash this quarter, saying the lower R&D and G&A run rate gives it a cash runway of “more than three years”; net loss for the quarter was $5.7 million (‑$0.06 per share). Interested in Anavex Life Sciences Corp.? Here are five stocks we like better. Short-Squeeze Target Anavex Life Sciences Gains Traction Anavex Life Sciences (NASDAQ:AVXL) executives used the company’s fiscal 2026 first-quarter earnings call to outline regulatory next steps for oral blarcamesine in early Alzheimer’s disease and to review a lower quarterly cash burn and operating expense base following the completion of prior-year manufacturing and certain clinical activities. Chief Executive Officer Dr. Christopher Missling said Anavex remains focused on advancing its clinical pipeline, with oral blarcamesine positioned as the lead program in early Alzheimer’s disease. Missling said the company is “excited about the therapeutic potential” of the drug and intends to work with regulators in Europe and the U.S. to advance it as a potential treatment option. → 3 ETFs Designed to Survive the Next Market Crash On the European front, management revisited the timeline following a negative opinion from the Committee for Medicinal Products for Human Use (CHMP) on the marketing authorization application for blarcamesine. Missling noted that Anavex requested a re-examination of the CHMP opinion on December 18, and said the re-examination is being led by a different rapporteur and co-rapporteur. In response to an analyst question, he described the process as a “60 + 60 day period” for the company to respond, followed by another approximately 60 days for review by the rapporteurs, adding that Anavex expects the re-examination process to last through the first half of the year. Missling did not identify the new rapporteur and co-rapporteur, stating only that two countries among the 27 EU member states serve in those roles. → 3 Consumer Staples Stocks Breaking Out This Month During the Q&A, Missling said the re-examination package will seek to address criteria related to conditional approval, including seriousness of the disease, unmet need, clinically meaningful effects, mechanistic rationale (including genetic variants), and translational support, as well as the sponsor’s commitment to confirmatory study execution. He said Anavex is including multiple data components in the re-examination, including: Data from the Phase IIB/III ANAVEX2-73-AD-004 study Data from the open-label extension (described as an “open-label study”) Data related to the Aβ-Clear study population Correlation between clinical efficacy and reduced brain atrophy → 2 Subscription Economy Winners That Still Dominate Their Niches Missling characterized the re-examination as, in part, a question of how to “repackage or re-articulate the strength of the package or of the data,” while also noting the company cannot guarantee an approval outcome. In the U.S., Missling referenced feedback from a January FDA Type C meeting. He said the meeting covered potential pathways to support blarcamesine for Alzheimer’s disease and that “existing data” from the ANAVEX2-73-AD-004 program is expected to be submitted to the FDA as part of moving forward. When asked about timing for a formal NDA submission, Missling said the company plans to advance its regulatory plan “once we are getting closer,” adding that the Type C meeting was “very productive.” He also said the FDA has meeting-request and scheduling requirements, and described the submission as being coordinated with a meeting request rather than simply sending data and receiving feedback. Several questions focused on the CHMP’s stated rationale and Anavex’s view of the AD-004 results in genetic subgroups. Missling said the company would not criticize regulators, but reiterated Anavex’s interpretation that the trial met ADAS-Cog13, with greater significance in the SIGMAR1 wild-type population, and that CDR-SB was also superior in the wild-type group compared with the intent-to-treat population. He said the ADCS-ADL endpoint was “the only one which was not significant,” though trending positively, and argued that the scale is not sensitive enough to detect changes in activities of daily living over 48 weeks in an early Alzheimer’s population. He also said that in the company’s described Aβ-Clear 3 population—referencing SIGMAR1 wild-type carriers with the COL24A1 wild-type gene—significance was reached “across the board” on ADAS-Cog13, ADCS-ADL, and CDR-SB, with what he called clinically meaningful effect sizes. Missling added that Anavex requested involvement of the EMA’s Scientific Advisory Group (SAG) in the ongoing review process. He said the company will update the public once the process concludes and would not comment further while the re-examination is ongoing. Missling highlighted Anavex’s participation as an industry partner in ACCESS-AD, a European Commission Innovative Health Initiative-funded program intended to accelerate adoption of diagnostic and therapeutic approaches for Alzheimer’s in real-world settings. He said blarcamesine will be evaluated in a placebo-controlled clinical prediction study within the program, including biomarker review (including autophagy signals) and efficacy assessments, and that Anavex plans to use the trial as part of its regulatory package to confirm efficacy in early Alzheimer’s disease. He indicated the target population is currently early Alzheimer’s disease, though it “could end up being a preventative also.” He confirmed the study corresponds to “AD006” on the company’s pipeline chart. Regarding clinical activity underway, Missling said the only ongoing trial is a compassionate use program for Rett syndrome in Canada, the U.K., and Australia, along with compassionate use in Alzheimer’s disease. He said the company is planning studies in Parkinson’s disease, Fragile X syndrome, and another undisclosed indication, and also said it plans to continue a schizophrenia program. He clarified that a Parkinson’s disease trial has not yet started, distinguishing it from prior work in Parkinson’s disease dementia that he described as a basis for the planned Parkinson’s trial. Missling also pointed to upcoming scientific communications, including an oral presentation at a March conference at Johns Hopkins University on findings that he said relate to biomarker relationships, correlations between clinical endpoints, and reduced brain-region atrophy with blarcamesine in early Alzheimer’s disease. He also cited planned publications on precision medicine patient populations from the AD-004 trial (including Aβ-Clear), a publication focused on the COL24A1 gene, and a Fragile X-related publication in a mouse model. In addition, he said ANAVEX3-71 is expected to be advanced toward pivotal clinical studies for schizophrenia-related disorders. Principal Financial Officer Sandra Boenisch reported that Anavex ended the quarter with $131.7 million in cash at December 31 and no debt. The company used $7.1 million in cash and cash equivalents in operating activities during the quarter, after changes in non-cash working capital accounts. Boenisch said Anavex expects its cash runway to be “more than three years” at the current cash utilization rate. Research and development expense was $4.7 million, down from $10.4 million in the comparable quarter of the prior year. General and administrative expense was $2.1 million, compared with $3.1 million a year earlier. Boenisch said the decrease in operating expenses was mainly due to the completion of a large blarcamesine manufacturing campaign in fiscal 2025 and lower clinical trial activity following completion of the ANAVEX3-71 Phase II study in schizophrenia. Anavex reported a net loss of $5.7 million for the quarter, or $0.06 per share. Anavex Life Sciences Corp is a clinical‐stage biopharmaceutical company focused on the development of novel therapeutics for central nervous system (CNS) disorders. The company applies a proprietary drug discovery platform that targets sigma‐1 and muscarinic receptors to modulate cellular stress pathways and support neuronal function. Headquartered in New York City, Anavex is dedicated to advancing treatments for neurodegenerative and neurodevelopmental diseases with high unmet medical need. The company's lead product candidate, blarcamesine (ANAVEX2‐73), is a small‐molecule activator of the sigma‐1 receptor currently being evaluated in clinical trials for Alzheimer's disease and Parkinson's disease dementia. The article "Anavex Life Sciences Q1 Earnings Call Highlights" was originally published by MarketBeat.