ANAVEX2-73-RS-003 is a Phase 2/3, double-blind, randomized, placebo-controlled dose escalation safety, tolerability and efficacy study in patients 5-17 years of age with RTT using endpoints including multiple clinical and exploratory molecular and biochemical measures.

Start Date01 Jul 2020

Sponsor / Collaborator

Anavex Life Sciences Corp.

[+2]

NCT04575259

/ CompletedPhase 2

Open Label Extension Study for Patients With Parkinson's Disease With Dementia Enrolled in Study ANAVEX2-73-PDD-001

This is a Phase 2 open-label extension study to evaluate the effects of ANAVEX2-73 on safety and efficacy of daily treatment.

Start Date10 Oct 2019

Sponsor / Collaborator

Anavex Life Sciences Corp.

[+2]

NCT04314934

/ CompletedPhase 2/3

Open Label Extension Study for Patients With Early Alzheimer's Disease (AD) Enrolled in Study ANAVEX2-73-AD-004

This is a Phase 2b/3 open-label extension study to evaluate the effects of ANAVEX2-73 on safety and effficacy of daily treatment.

Start Date10 Oct 2019

Sponsor / Collaborator

Anavex Life Sciences Corp.

[+2]

100 Clinical Results associated with Blarcamesine

100 Translational Medicine associated with Blarcamesine

100 Patents (Medical) associated with Blarcamesine

Literatures (Medical) associated with Blarcamesine

01 Apr 2026·EUROPEAN NEUROPSYCHOPHARMACOLOGY

Emerging neurobiological targets in psychiatric treatment

Review

Author: Berk, Michael ; Govinnage, Janani ; Giorlando, Frank ; De Zoysa, Agampodi Ishan ; Narayanaswamy, J C ; Dodd, Seetal

Despite significant advancements in psychopharmacology, there are inadequate treatment options for many psychiatric disorders, including major depressive disorder, bipolar disorder, schizophrenia, and anxiety disorders. This review explores emerging neurobiological targets beyond conventional monoaminergic approaches, focusing on sodium channels, Neuropeptide Y (NPY), Neurokinin 1 (NK1) receptors, P2 × 7 purinergic receptors, Sigma-1 receptors, and Orexin. Recent evidence suggests that sodium channel modulators, such as evenamide, may offer therapeutic benefits for treatment-resistant schizophrenia by stabilizing glutamatergic neurotransmission. NPY-based therapies have potential in stress-related disorders, foreshadowing rapid anxiolytic and antidepressant effects through modulation of the stress response. NK1 receptor antagonists, although inconsistent in mood disorders, show promise in addiction treatment by reducing substance cravings. The P2 × 7 receptor, a key regulator of neuroinflammation, has been implicated in mood disorders, and its pharmacological inhibition may provide neuroprotective benefits. Additionally, Sigma-1 receptor agonists, including Blarcamesine and Pridopidine, have shown neuroprotective and cognitive-enhancing properties, making them attractive candidates for psychiatric and neurodegenerative disorders. Orexin receptor antagonists, such as suvorexant and seltorexant, have potential in mood disorders and substance dependence, highlighting the broader therapeutic applications of targeting the orexinergic system. While these emerging therapeutic targets hold promise, challenges remain in translating preclinical findings into effective clinical applications. Large-scale, placebo-controlled trials are necessary to establish their efficacy and safety. The identification of biomarkers for patient stratification will be critical in the hitherto elusive goal of developing precision medicine approaches. Targeted pharmacological interventions offer a path toward more effective, well-tolerated, and potentially individualized treatment options for patients with severe mental illness.

01 Dec 2025·Alzheimers & Dementia

Precision Medicine in Alzheimer’s Disease (AD): Observed Efficacy Treatment Effects from Blarcamesine Clinical AD Trials

Article

Author: Gueddou, Ayoub ; Courreges, Olivier ; Missling, Christopher U ; Guizard, Nicolas ; Lopez‐Talavera, Juan Carlos ; Sabbagh, Marwan N. ; Villa, Luca ; Jin, Kun ; Gabelle, Audrey ; Gordon, Elizabeth ; Chezem, William R. ; Grimmer, Timo ; Borrot, Mathilde

Abstract:

Background:

Precision Medicine represents a transformative approach in treating Alzheimer’s disease (AD), focusing on tailoring interventions based on individual genetic, molecular, clinical and environmental profiles in addition to confirm clear Mechanism of Action (MoA). This strategy aims to optimize treatment outcomes by identifying patient subgroups that are most likely to benefit or benefit at a higher degree from specific therapies, thus reducing inefficacies and potentially adverse effects associated with generalized treatment regimens.

Method:

Blarcamesine, a selective modulator of the Sigma‐1 receptor (SIGMAR1), has garnered attention due to its role in autophagy, cellular stress response, protein homeostasis, and neuroprotection. Recent clinical studies have confirmed its effects in the majority of AD patients who carry the homozygous wild‐type (WT) SIGMAR1 genotype (∼70% of the whole population) (Hampel et al., 2020).

Result:

In the Phase IIb/III ANAVEX2‐73‐AD‐004 trial, a clear MoA of oral once daily blarcamesine, a pre‐specified efficacy analysis confirmed the importance of SIGMAR1 to clinical response. While all trial participants improved significantly versus placebo after 48 Weeks, 36.3% for ADAS‐Cog13 and 27.6% for CDR‐SB, respectively, a further, also significant, improvement was observed in the prespecified analysis of SIGMAR1 carriers. Compared to the ITT group, participants carrying the SIGMAR1 WT gene observed further improvement versus placebo of 49.8% and 33.7% for the primary and secondary key endpoints ADAS‐Cog13 and CDR‐SB, respectively (Macfarlane et al., 2025).

Conclusion:

Thus, the specificity of blarcamesine to this genotype underscores the importance of understanding clear MoA and potential for further improved personalized medicine in AD treatment, as therapies targeting individual molecular profiles could achieve more substantial and sustained benefits. While Precision Medicine holds great promise for improving the treatment paradigm of AD by offering more personalized, likely more effective therapies, it also introduces challenges related to potential cost, data privacy, ethical concerns, and inequities in access. Addressing these issues is crucial to ensure that the benefits of Precision Medicine can be realized for all patients.

01 Dec 2025·Alzheimers & Dementia

A Patient‐Centric, Digital Multimodal Post‐Market Approval Continuous Monitoring of Drug Safety & Efficacy Platform for Blarcamesine

Article

Author: Gueddou, Ayoub ; Courreges, Olivier ; Missling, Christopher U ; Gabelle, Audrey ; Guizard, Nicolas ; Sabbagh, Marwan N. ; Lopez‐Talavera, Juan Carlos ; Villa, Luca ; Jin, Kun ; Gordon, Elizabeth ; Chezem, William R. ; Borrot, Mathilde ; Grimmer, Timo

Abstract:

Background:

There is a critical need to establish robust Real‐World Evidence (RWE) platform for monitoring both clinically relevant benefits and potential mid/long‐term side effects of Alzheimer’s disease (AD) drugs at an individual level, with the ambition to enhance personalized medicine in AD. However, there are no standards for digital post‐market approval continuous monitoring of drug safety and efficacy. Oral blarcamesine, a novel convenient scalable precision medicine treatment was submitted and accepted for Marketing Authorisation Application (MAA) review by the European Medicines Agency. To innovate the monitoring of blarcamesine, we built a patient‐centric, digital multimodal platform based on three pillars consisting of digital Patient Reported Outcomes (PRO), digital clinical and cognitive assessments, and automated MRI Brain Imaging exams.

Method:

The digital PRO includes regularly administered surveys via wearable device data to provide a comprehensive view of treatment impact. The digital clinical and cognitive assessment integrates interactive applications for clinical and cognitive training and performance tracking and historical comparisons. The brain imaging pillar implements automated MRI image quality control and automated monitoring of brain volume changes using the QyScore ® neuroimaging analysis platform from Qynapse.

Result:

Such a platform would enable continuous, real‐time data collection from patients, facilitating more precise tracking of drug efficacy, patient individual responses, and the emergence of potential side effects.

Conclusion:

This post‐market approval continuous monitoring platform may benefit all stakeholders, including patients, clinicians, regulators, service providers and payors. This modularly digital platform can be customized to fit also other post‐market approval monitoring.

159

News (Medical) associated with Blarcamesine

03 Aug 2026

·www.biospace.com

Anavex Life Sciences Announces Plans to Refresh Board to Continue Overseeing Critical Progress and Stockholder Value Creation

Nominates Two New Independent Directors, Mr. Gautam Patel and Dr. Adrian Senderowicz, Who Bring Deep, Relevant Experience in Life Sciences Mr. Patel and Dr. Senderowicz to Stand for Election at 2026 Annual Meeting with Independent Directors Dr. Jiong Ma, Dr. Peter Donhauser, Dr. Axel Paeger and Dr. Claus van der Velden Urges Stockholders to Reject Attempt by PVG Asset Management Corporation and Patrick S. Adams to Acquire Control of the Company Issues Open Letter to Stockholders and Files Preliminary Proxy Statement ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); NEW YORK, Aug. 03, 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 announced that the Executive Committee of the Company’s Board of Directors (the “Executive Committee”) has taken significant steps to continue overseeing critical progress to enhance stockholder value. The Executive Committee announced that it is recommending a refreshed slate of directors to the Company’s stockholders through the nomination of two new independent candidates, Mr. Gautam Patel and Dr. Adrian Senderowicz. In identifying these candidates, the Board focused on individuals whose experience aligns with the company’s strategic priorities. Mr. Patel and Dr. Senderowicz bring significant life sciences industry experience across leadership, strategy and drug development at the executive and Board levels, as well as expertise in capital markets, clinical development and FDA regulatory matters that the Board believes will support the Company’s growth and advance programs toward market approval and commercialization. Mr. Patel and Dr. Senderowicz, along with independent chairperson Dr. Jiong Ma, and independent directors Dr. Peter Donhauser, Dr. Axel Paeger and Dr. Claus van der Velden, will comprise the six Anavex nominees standing for reelection at the 2026 Annual Meeting of Stockholders (the “2026 Annual Meeting”). Dr. Christopher Missling, former Chief Executive Officer of Anavex, who refused to step down from the Board upon his termination “for cause”, and independent director Dr. Steffen Thomas, have not been renominated for election and will no longer be members of the Board after the 2026 Annual Meeting. In connection with the 2026 Annual Meeting, Anavex filed its preliminary proxy statement with the Securities and Exchange Commission (the “SEC”) on July 31, 2026. As further described in the preliminary proxy statement, the Anavex Board has established an Executive Committee to exercise the power of the Board in the management of the business and affairs of the Company. The Executive Committee consists of Dr. Jiong Ma, Dr. Axel Paeger and Dr. Claus van der Velden. Anavex’s preliminary proxy statement and, after the filing thereof, its definitive proxy statement can be accessed for free by visiting EDGAR on the SEC website at . Once Anavex files its definitive proxy materials with the SEC, they will also be mailed to stockholders and will include a WHITE proxy card with instructions on how to vote FOR all six Anavex nominees comprising the refreshed Anavex Board. Your vote FOR all six Anavex nominees comprising the refreshed Anavex Board on the WHITE card will be critical. The current Anavex Board members standing for reelection at the 2026 Annual Meeting issued the following open letter to Anavex stockholders: Dear Valued Anavex Stockholders, Your current Board members standing for election at the 2026 Annual Meeting have taken decisive action to stabilize the Company and create value for stockholders, including working with the management team that is executing a strategy focusing on our lead candidate for patients with Alzheimer’s disease, oral blarcamesine (ANAVEX ® 2-73) and identifying and nominating Mr. Patel and Dr. Senderowicz as highly qualified candidates for election to the Board. The Company continues to have a strong cash runway and no long-term debt, and we are focused on ensuring we maximize our use of capital and deliver on our goal of enhancing stockholder value. We are working with urgency while ensuring the Company’s operations continue without disruption following our termination “for cause” of former CEO Christopher Missling and the resulting delay in filing Anavex’s quarterly report with the SEC. We appointed Dr. Terrie Kellmeyer, the Company’s former Senior Vice President of Clinical Development and a Senior Advisor to Anavex, as interim CEO to oversee this period of transition. Dr. Kellmeyer spent her entire career in drug development building and leading clinical and regulatory functions across the full lifecycle of drug development. We are confident she is the right person to support the Company at this time. Your Refreshed Anavex Board Your current Board members standing for reelection are entirely independent and will continue to bring critical institutional knowledge that we believe will advance the right path forward. Following a thorough search process, we are also nominating two new, independent candidates, Mr. Gautam Patel and Dr. Adrian Senderowicz, who will bring significant, relevant life sciences experience and complementary skills to the Board that are expected to immediately contribute to the Company’s strategy and help create value across the business. Upon election, half of the Anavex Board will have been refreshed since February 2026, and all of the Board members will be independent. The four independent Anavex directors and two independent nominees standing for election are: Dr. Jiong Ma (Independent Chairperson), who has over 30 years of experience investing in, building and scaling technology and life-sciences companies globally and brings deep financial, transactional and capital markets expertise to the Board. She has substantial experience investing in, partnering with and working with management teams to set strategy for disruptive technology and life sciences companies to shape the business, accelerate growth and drive long-term stockholder value. Dr. Peter Donhauser , a physician and clinical research leader with more than 20 years of experience in integrated medical care, clinical trial oversight and private practice leadership, leading research across numerous trials for some of the world’s leading global pharmaceutical companies. He has practiced osteopathic medicine in private practice since 2000, specializing in an integrated approach to patient care, providing the Board with valuable clinical and patient-centered expertise. Dr. Axel Paeger , an experienced healthcare executive and corporate leader with more than 30 years of clinical, operational and executive leadership experience. Dr. Paeger currently serves as Chief Executive Officer of AMEOS Group, which he founded as a start-up in 2002 and scaled into one of Europe’s leading healthcare providers. He is a medically trained executive leader who brings deep experience in healthcare to the Board. Mr. Gautam Patel , an experienced investment executive with over 30 years of corporate finance, investment management and board leadership experience. Mr. Patel brings extensive capital allocation, investment and financial advisory expertise to the Board, with a proven track record of executing growth-focused investments and guiding corporate strategy across the life sciences, financial services and technology sectors. Dr. Adrian Senderowicz , an accomplished pharmaceutical executive and physician-scientist with over 30 years of clinical and regulatory leadership experience across the life sciences industry. Dr. Senderowicz brings deep drug development, clinical research and global regulatory expertise to the Board, with a proven track record of advancing novel therapeutics through critical international approvals to drive growth and long-term value. Dr. Claus van der Velden , an accomplished finance executive with more than two decades of experience leading finance, governance and enterprise oversight functions for publicly traded and technology-driven companies in Germany. Since May 2021, he has served as Chief Financial Officer and Managing Director of NetCologne GmbH, a regional telecommunications provider in Germany. The Current Anavex Board Members Standing for Reelection are Advancing a Clear Plan to Create Stockholder Value We have taken steps to address governance at the Board-level and established interim leadership of the Company. The current Anavex Board members standing for reelection are highly engaged with leadership and helping oversee continued progress of Anavex’s development pipeline. The business update we provided on July 30 underscores that we remain firmly committed to the Company’s 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. With our support, Anavex is prioritizing programs that the Company believes have the greatest potential for success. The Company’s strategy concentrates resources on blarcamesine across three CNS indications: early Alzheimer's disease and Rett syndrome, where the clinical and regulatory foundation is most advanced, and on Fragile X syndrome, where FDA Orphan Drug Designation, supportive preclinical and biomarker data, and the absence of any approved therapy create a promising regulatory path with the FDA. We are highly confident in the path ahead for the Company and the potential of our drug pipeline to improve the lives of patients while driving value for stockholders. We Urge Stockholders to Reject the Attempt by PVG Asset Management Corporation and Patrick Adams to Take Control of the Company On July 24, 2026, Patrick Adams and his firm PVG Asset Management Corporation (“PVG”) filed a preliminary proxy statement with the SEC (the “PVG Proxy Statement”) seeking to replace the entire Board of Anavex. We believe the PVG Proxy Statement is significantly deficient, does not comply with applicable SEC rules and regulations, includes misleading statements and omits material information. Among other things, it provides insufficient information with respect to PVG, Mr. Adams and the other director nominees, their background and security ownership, agreements with third parties with respect to the proxy solicitation and other critical information necessary for our stockholders to evaluate the qualifications of the nominees (or the lack thereof) and conflicts of interest. In addition, the PVG Proxy Statement lacks any discussion of any plan or strategy for Anavex going forward, which leads us to conclude that PVG and Mr. Adams are seeking to gain effective control of the Company without paying you a premium for your investment, despite only owning 0.35% of the Company’s outstanding shares of common stock as of July 30, 2026. We believe that electing Mr. Adams or any of his nominees would be highly risky and potentially value destructive by creating further disruption at this critical time for the Company. Anavex’s preliminary proxy statement and, after the filing thereof, its definitive proxy statement can be accessed for free by visiting EDGAR on the SEC website at . Once Anavex files its definitive proxy materials with the SEC, they will also be mailed to stockholders and include a WHITE proxy card with instructions on how to vote FOR all six directors comprising the refreshed Anavex Board. Your vote FOR all six directors comprising the refreshed Anavex Board on the WHITE card will be critical. We look forward to engaging with investors as we move toward the 2026 Annual Meeting and are unwavering in our commitment to act in the best interests of the Company and all stockholders. Sincerely, Dr. Jiong Ma Independent Chair Dr. Peter Donhauser Independent Director Dr. Axel Paeger Independent Director Dr. Claus van der Velden Independent Director 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. Further information is available at . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements regarding the Company’s plans, strategies and expectations regarding the 2026 Annual Meeting, director nominations, the proxy solicitation, the Company’s go-forward strategy, clinical development programs, business prospects, and potential actions of the Board and the Executive Committee, are forward-looking statements. These statements can be identified by the use of forward-looking terminology, including the words “believes,” “anticipates,” “plans,” “estimates,” “expects,” “intends,” “may,” “will,” “would,” “could” and similar expressions, or the negative thereof. Many factors may cause actual results to differ materially from those projected in any of such forward-looking statements, including the 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 SEC, which should be considered together with any forward-looking statement. 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. Important Additional Information and Where to Find It The Company intends to definitive proxy statement on Schedule 14A, an accompanying WHITE proxy card, and other relevant documents with the SEC in connection with the solicitation of proxies from the Company’s stockholders for the 2026 Annual Meeting. THE COMPANY’S STOCKHOLDERS ARE STRONGLY ENCOURAGED TO READ THE COMPANY’S DEFINITIVE PROXY STATEMENT (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO), THE ACCOMPANYING WHITE PROXY CARD AND OTHER DOCUMENTS FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. Stockholders will be able to obtain the definitive proxy statement, any amendments or supplements to the proxy statement and other documents that the Company files with the SEC at no charge at the SEC’s website at Copies will also be available at no charge at the Company’s website at Certain Information Regarding Participants The Company, its directors and certain of its executive officers may be deemed to be “participants” (as defined in Schedule 14A under the Securities Exchange Act of 1934, as amended) in the solicitation of proxies from the Company’s stockholders in connection with the matters to be considered at the 2026 Annual Meeting. Information regarding the names of the Company’s directors and executive officers and certain other individuals and their direct or indirect interests in the Company, by security holdings or otherwise, is set forth in the sections entitled “Compensation of Directors,” “Executive Compensation,” and “Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters” of the Company’s Annual Report on Form 10-K for the fiscal year ended September 30, 2025 (available here ), and any subsequent filings on Forms 3, 4 and 5 filed with the SEC. Additional information regarding the identity of potential participants, and their direct or indirect interests, by security holdings or otherwise, will be set forth in the Company’s definitive proxy statement for the 2026 Annual Meeting when it is filed with the SEC. These documents are available free of charge at the SEC’s website at Investor Relations: SCR Partners, LLC Alex Arzeno Tel: 203-550-3972 Email: alex@scr-ir.com Tripp Sullivan Tel: 615-942-7077 Email: tsullivan@scr-ir.com For Media: Collected Strategies Nick Lamplough / Dylan O’Keefe AVXL-CS@collectedstrategies.com

Executive ChangeOrphan Drug

30 Jul 2026

·www.biospace.com

Anavex Life Sciences Reports Preliminary Second Quarter 2026 Financial Results and Provides Business Update

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 ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); 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. Two foundational clinical pharmacology studies are proceeding under this IND in the U.S.: an absorption, distribution, metabolism, and excretion (ADME) study and a drug-drug interaction (DDI) study with a goal to strengthen and support the Company’s regulatory pathway for all blarcamesine indications. The Company anticipates initiation of the ADME study to take place in the third quarter of the 2026 calendar year, and dosing in the DDI study is already underway. These studies are not sequential requirements. Rather, they support the overall FDA regulatory requirements for blarcamesine while the Company continues to advance its early Alzheimer’s disease program in parallel. 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. The Company has aligned with the FDA on a Phase 3 clinical trial protocol for Rett syndrome for adults only. The Company intends to discuss with the FDA adding pediatric patients to the protocol, with a more detailed program update expected at a future date. Fragile X Syndrome Program The FDA has already granted Orphan Drug Designation for Fragile X syndrome. The Company plans to initiate discussions with the FDA on the clinical development strategy for the Fragile X syndrome clinical program building on this designation, with further details to be shared as the program advances. 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 . 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 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, LLC Alex Arzeno Tel: 203-550-3972 Email: alex@scr-ir.com Tripp Sullivan Tel: 615-942-7077 Email: tsullivan@scr-ir.com Company Contact: Sandra Boenisch Principal Financial Officer Anavex Life Sciences Corp. Tel: 1-844-689-3939 Email: ir@anavexcorp.com Anavex Life Sciences Corp. Preliminary Condensed Consolidated Interim Statements of Operations and Comprehensive Loss 1 (in thousands, except share and per share amounts) (Unaudited) Three months ended March 31, 2026 2025 Operating Expenses General and administrative $ 2,292 $ 2,621 Research and development 4,192 9,892 Total operating expenses 6,484 12,513 Operating loss (6,484 ) (12,513 ) Other income Research and development incentive income 27 96 Interest income, net 1,061 1,210 Foreign exchange gain (loss) 58 11 Total other income, net 1,146 1,317 Net loss before provision for income taxes (5,338 ) (11,196 ) Income tax expense, current - - Net loss and comprehensive loss $ (5,338 ) $ (11,196 ) Net loss per share Basic and diluted $ (0.06 ) $ (0.13 ) Weighted average number of shares outstanding Basic and diluted 92,675,753 85,073,769 1 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. Anavex Life Sciences Corp. Preliminary Condensed Consolidated Interim Statements of Operations and Comprehensive Loss 2 (in thousands, except share and per share amounts) (Unaudited) Six months ended March 31, 2026 2025 Operating Expenses General and administrative $ 4,417 $ 5,767 Research and development 8,849 20,338 Total operating expenses 13,266 26,105 Operating loss (13,266 ) (26,105 ) Other income Grant income - 12 Research and development incentive income 60 508 Interest income, net 2,140 2,604 Foreign exchange gain (loss) 65 (326 ) Total other income, net 2,265 2,798 Net loss before provision for income taxes (11,001 ) (23,307 ) Income tax expense, current (18 ) - Net loss and comprehensive loss $ (11,019 ) $ (23,307 ) Net loss per share Basic and diluted $ (0.12 ) $ (0.27 ) Weighted average number of shares outstanding Basic and diluted 90,832,571 84,938,400 2 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. Anavex Life Sciences Corp. Preliminary Condensed Consolidated Interim Balance Sheets 3 (in thousands, except share and per share amounts) (Unaudited) March 31, 2026 September 30, 2025 Assets (unaudited) Current Cash and cash equivalents $ 127,422 $ 102,577 Incentive and tax receivables 932 809 Prepaid expenses and other current assets 412 429 Total Assets $ 128,766 $ 103,815 Liabilities and stockholders' equity Current Liabilities Accounts payable $ 2,520 $ 4,249 Accrued liabilities 3,734 3,892 Deferred grant income 805 805 Total Liabilities 7,059 8,946 Capital Stock 93 87 Additional paid-in capital 515,081 477,230 Accumulated deficit (393,467 ) (382,448 ) Total Stockholders' Equity 121,707 94,869 Total Liabilities and Stockholders' Equity $ 128,766 $ 103,815 3 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.

Orphan DrugFast TrackFinancial StatementPhase 3

22 May 2026

·anavex.com

Anavex Life Sciences Receives Expected Nasdaq Delinquency Notification

About UsTeam Careers ConditionsAlzheimer’s Disease Parkinson’s Disease Schizophrenia Angelman Syndrome Depression Fragile X Syndrome Frontotemporal Dementia Infantile Spasms Pain Rett Syndrome Stroke Therapeutic CandidatesBlarcamesine (ANAVEX® 2-73) ANAVEX® 3-71 ANAVEX® 1-41 ANAVEX® 1066 PatientsSIGMACEPTOR InvestorsInvestor Resources Events Analyst Coverage Corporate Governance Share Data News Team Careers Alzheimer’s Disease Parkinson’s Disease Schizophrenia Angelman Syndrome Depression Fragile X Syndrome Frontotemporal Dementia Infantile Spasms Pain Rett Syndrome Stroke Blarcamesine (ANAVEX® 2-73) ANAVEX® 3-71 ANAVEX® 1-41 ANAVEX® 1066 SIGMACEPTOR Investor Resources Events Analyst Coverage Corporate Governance Share Data About UsTeam Careers ConditionsAlzheimer’s Disease Parkinson’s Disease Schizophrenia Angelman Syndrome Depression Fragile X Syndrome Frontotemporal Dementia Infantile Spasms Pain Rett Syndrome Stroke Therapeutic CandidatesBlarcamesine (ANAVEX® 2-73) ANAVEX® 3-71 ANAVEX® 1-41 ANAVEX® 1066 PatientsSIGMACEPTOR InvestorsInvestor Resources Events Analyst Coverage Corporate Governance Share Data News Team Careers Alzheimer’s Disease Parkinson’s Disease Schizophrenia Angelman Syndrome Depression Fragile X Syndrome Frontotemporal Dementia Infantile Spasms Pain Rett Syndrome Stroke Blarcamesine (ANAVEX® 2-73) ANAVEX® 3-71 ANAVEX® 1-41 ANAVEX® 1066 SIGMACEPTOR Investor Resources Events Analyst Coverage Corporate Governance Share Data About UsTeam Careers ConditionsAlzheimer’s Disease Parkinson’s Disease Schizophrenia Angelman Syndrome Depression Fragile X Syndrome Frontotemporal Dementia Infantile Spasms Pain Rett Syndrome Stroke Therapeutic CandidatesBlarcamesine (ANAVEX® 2-73) ANAVEX® 3-71 ANAVEX® 1-41 ANAVEX® 1066 PatientsSIGMACEPTOR InvestorsInvestor Resources Events Analyst Coverage Corporate Governance Share Data News Team Careers Alzheimer’s Disease Parkinson’s Disease Schizophrenia Angelman Syndrome Depression Fragile X Syndrome Frontotemporal Dementia Infantile Spasms Pain Rett Syndrome Stroke Blarcamesine (ANAVEX® 2-73) ANAVEX® 3-71 ANAVEX® 1-41 ANAVEX® 1066 SIGMACEPTOR Investor Resources Events Analyst Coverage Corporate Governance Share Data About UsTeam Careers ConditionsAlzheimer’s Disease Parkinson’s Disease Schizophrenia Angelman Syndrome Depression Fragile X Syndrome Frontotemporal Dementia Infantile Spasms Pain Rett Syndrome Stroke Therapeutic CandidatesBlarcamesine (ANAVEX® 2-73) ANAVEX® 3-71 ANAVEX® 1-41 ANAVEX® 1066 PatientsSIGMACEPTOR InvestorsInvestor Resources Events Analyst Coverage Corporate Governance Share Data News Team Careers Alzheimer’s Disease Parkinson’s Disease Schizophrenia Angelman Syndrome Depression Fragile X Syndrome Frontotemporal Dementia Infantile Spasms Pain Rett Syndrome Stroke Blarcamesine (ANAVEX® 2-73) ANAVEX® 3-71 ANAVEX® 1-41 ANAVEX® 1066 SIGMACEPTOR Investor Resources Events Analyst Coverage Corporate Governance Share Data NEW YORK, NY, May 22, 2026 – 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) disorders, today announced it received an expected delinquency notification letter (the “Notice”) from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) on May 20, 2026. The Notice indicates that the Company is not in compliance with Nasdaq Listing Rule 5250(c)(1) (the “Nasdaq Listing Rule”) as a result of the Company’s inability to timely file its Form 10-Q for the quarterly period ended March 31, 2026. As indicated in the Notice, the Company has until July 20, 2026, to submit a plan to regain compliance. The Company is working prudently to complete and file the Form 10-Q and submit a plan to regain compliance with the Nasdaq Listing Rule. This notification has no immediate effect on the Company’s common stock listed on Nasdaq. 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. 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 complete and file its Form 10-Q and to submit a plan to regain compliance with Nasdaq Listing Rule 5250(c)(1). 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 file the Form 10-Q and the Company’s ability to regain compliance with Nasdaq Listing Rule 5250(c)(1) 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, LLC Alex Arzeno Tel: 203-550-3972 Email: alex@scr-ir.com Tripp Sullivan Tel: 615-942-7077 Email: tsullivan@scr-ir.com Company Contact: Sandra Boenisch Principal Financial Officer Anavex Life Sciences Corp. Tel: 1-844-689-3939 Email: ir@anavexcorp.com Anavex is dedicated to advancing brain health by developing innovative oral medicines designed to improve patients lives. Alzheimer’s Disease Parkinson’s Disease Schizophrenia Rett Syndrome Angelman Syndrome Depression Fragile X Syndrome Frontotemporal Dementia Infantile Spasms Alzheimer’s Disease Parkinson’s Disease Schizophrenia Rett Syndrome Angelman Syndrome Depression Fragile X Syndrome Frontotemporal Dementia Infantile Spasms Corporate Presentation Therapeutic Candidates Investor Resources Share Data Events Careers Our Values A Letter from the CEO Corporate Presentation Therapeutic Candidates Investor Resources Share Data Events Careers Our Values A Letter from the CEO Receive updates directly to your inbox on company announcements, clinical progress, and regulatory developments. Forward Looking Statement Code of Conduct Legal Notice Privacy Policy Contact Forward Looking Statement Code of Conduct Legal Notice Privacy Policy Contact

100 Deals associated with Blarcamesine

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KEGG	Wiki	ATC	Drug Bank
D11383	Blarcamesine	-	DB05592

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Alzheimer Disease	NDA/BLA	European Union	Anavex Life Sciences Corp.	20 Nov 2023
Cognitive Dysfunction	NDA/BLA	European Union	Anavex Germany GmbH	20 Nov 2023
Rett Syndrome	Phase 3	Australia	Anavex Life Sciences Corp.	06 May 2019
Rett Syndrome	Phase 3	United Kingdom	Anavex Life Sciences Corp.	06 May 2019
Fragile X Syndrome	Phase 3	United States	Anavex Life Sciences Corp.	-
Dementia due to Parkinson's disease	Phase 2	Australia	Anavex Life Sciences Corp.	09 Jul 2018
Dementia due to Parkinson's disease	Phase 2	Spain	Anavex Life Sciences Corp.	09 Jul 2018
Parkinson Disease	Phase 2	Australia	Anavex Life Sciences Corp.	09 Jul 2018
Parkinson Disease	Phase 2	Spain	Anavex Life Sciences Corp.	09 Jul 2018
Angelman Syndrome	Phase 1	-	Anavex Life Sciences Corp.	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ANAVEX2-73-AD-004 (CTAD2025)	Phase 2/3	Alzheimer Disease	150	Blarcamesine	jchamgmbkg(fpzttbzank) = exrzhaobqr jdgwsjvagd (nsxdgrqilp )	Positive	01 Dec 2025
NCT04314934 (ATTENTION-AD, GlobeNewswire) Manual	Phase 2/3	Alzheimer Disease	-	Blarcamesine (the early-start treatment groups)	fdyerjgmql(djyazottut): Difference (LS Mean) = -3.83, P-Value = 0.0165 View more	Positive	31 Jul 2025
				Blarcamesine (the late-start treatment groups)
NCT04314934 (ATTENTION-AD, GlobeNewswire) Manual	Phase 2/3	Alzheimer Disease	-	blarcamesine (early start treatment)	yskliftson(lpupihqrwa) = from previously 25.2% in the ANAVEX®2-73-AD-004 trial to 9.6% in the ATTENTION-AD trial. wcdqluzdmd (leofipvdnk ) View more	Positive	13 Jan 2025
				blarcamesine (late start treatment)
NCT04314934 (GlobeNewswire) Manual	Phase 2/3	Alzheimer Disease	-	Blarcamesine 50 mg	ztzefolmoa(gmgjblgkny) = hrgrcxsgsy ewvasnoybz (zcshhfirdf ) View more	Positive	28 Jul 2024
				Blarcamesine 30 mg	ztzefolmoa(gmgjblgkny) = lgbprkpyfi ewvasnoybz (zcshhfirdf ) View more
NCT04304482 (EXCELLENCE, GlobeNewswire) Manual	Phase 2/3	Rett Syndrome	92	ANAVEX2-73	mndrysulkl(xgwdvurzjr) = idegnmmxqo bwzhurrovr (zaknmobuvb, 2.150) View more	Positive	02 Jan 2024
				Placebo	mndrysulkl(xgwdvurzjr) = dcwziroziv bwzhurrovr (zaknmobuvb, 2.537) View more
NCT03790709 (Corporate Publications) Manual	Phase 2/3	Alzheimer Disease	508	ANAVEX2-73	dhicjmvhcz(fwfgglwqvb): Difference = -1.783 (95% CI, −3.314 - −0.251), P-Value = 0.0226 Met View more	Positive	14 Sep 2023
				Placebo
NCT03790709 (ANAVEX2-73-AD-004, GlobeNewswire) Manual	Phase 2/3	Alzheimer Disease	509	Blarcamesine	azobrfgyji(ylteeapxjk): OR = 1.84, P-Value = 0.015 View more	Positive	01 Dec 2022
				Placebo
NCT03758924 (Biospace) Manual	Phase 2	Rett Syndrome SIGMAR1	-	Blarcamesine	vpucguvhgx(lynylgphna) = jasamgfiue wafqklmlzw (hpzqoacebx ) View more	Positive	21 Jun 2021
				Placebo	-
CTAD2015	Phase 2	-	-	ANAVEX 2-73	wudisjgleq(jifbwigpyv) = The average Cogstate test improved across the test batteries iiacffntvo (mwpmehrouf ) View more	Positive	04 Nov 2015

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