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Anavex Life Sciences Reports Fiscal 2025 Third Quarter Financial Results and Provides Business Update

1. Anavex focuses on Alzheimer's disease therapies, showcasing clinical trial success. 2. Blarcamesine shows meaningful benefits in early Alzheimer's patients over four years. 3. Financial results reveal a net loss of $13.2 million for Q3 2025. 4. Cash reserves are strong, with $101.2 million and a 3-year runway. 5. Oral medications are seen as more accessible than injectables in Europe.

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Why Bullish?

The positive clinical data on blarcamesine may boost investor confidence, akin to previous trends for biopharmaceuticals with promising trial results.

How important is it?

The article presents significant advancements and successful trial results affecting AVXL's future market presence and valuation.

Why Long Term?

The ongoing positive data from trials and potential market expansion suggest sustained interest and growth over time.

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August 12, 2025 07:30 ET  | Source: Anavex Life Sciences Corp. Company to host a webcast today at 8:30 a.m. Eastern Time NEW YORK, Aug. 12, 2025 (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 third quarter of fiscal 2025. “Our development of non-invasive, targeted upstream compounds continues to advance, particularly in the context of Alzheimer’s disease,” said Christopher U. Missling, PhD, President and CEO of Anavex. “Clinical feedback highlights the importance of orally administered therapies that are both accessible and effective. At AAIC 2025, we presented open-label extension data for blarcamesine, which demonstrated continued clinically meaningful benefit in early-stage Alzheimer’s patients—further validating its therapeutic potential.” Recent Highlights: On July 31, 2025, Anavex announced the latest findings for blarcamesine, an oral small molecule for the potential treatment of early Alzheimer’s disease. The data were presented by Marwan Noel Sabbagh, MD, Professor of Neurology, and Chairman of the Anavex Scientific Advisory Board at the 2025 Alzheimer's Association International Conference (AAIC). Blarcamesine-treated patients continue to accrue benefit through up to 4 years, as measured by the prespecified clinical endpoints ADAS-Cog13 and ADCS-ADL, respectively. Further presentations at the AAIC 2025 Conference featured prespecified Precision Medicine Phase IIb/III 48-week ANAVEX®2-73-AD-004 double-blind (DB) clinical trial data on blarcamesine, confirming the upstream mechanism of blarcamesine, restoring impaired autophagy as an early event, preceding amyloid-beta and tau.July 27-31, 2025, Anavex was honored to be a part of the program at the 2025 Alzheimer’s Association International Conference (AAIC) in Toronto. The sharing of knowledge at these central events is important to help advance dementia science to better support the millions of individuals, families, and communities impacted by Alzheimer’s disease.In June 2025, a survey of Alzheimer’s Disease stakeholders from European Union (EU) Member States on ‘Current Unmet Needs in Alzheimer Care’ was conducted. There is a clear acknowledgment that oral therapies would ‘facilitate things’ for many countries and be ‘much more accessible’ for the respective healthcare systems, potentially requiring less extensive monitoring and complex administration compared to injectable monoclonal antibodies. This modality difference is seen as a key factor in potential broader market penetration. Financial Highlights: Cash and cash equivalents of $101.2 million at June 30, 2025 compared to $132.2 million at year ended September 30, 2024. The Company anticipates at current adjusted cash utilization rates and ranges, an approximate cash runway of more than 3 years.Research and development expenses for the quarter of $10.0 million compared to $11.8 million for the comparable quarter of fiscal 2024.General and administrative expenses for the quarter of $4.5 million compared to $2.8 million for the comparable quarter of fiscal 2024.An increase in non-cash compensation charges, was offset by a decrease in overall cash operating expenses, as compared to the same quarter of fiscal 2024.Net loss for the quarter of $13.2 million, or $0.16 per share, compared to a net loss of $12.2 million, or $0.14 per share for the comparable quarter of fiscal 2024. The financial information for the quarter ended June 30, 2025, should be read in conjunction with the Company’s consolidated financial statements, which will appear on EDGAR, www.sec.gov and will be available on the Anavex website at www.anavex.com. 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# 856 5033 5285 and reference passcode 014 352. A replay of the conference call will also 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. Anavex Life Sciences Corp.Condensed Consolidated Statements of Operations and Comprehensive Loss(in thousands, except share and per share amounts)(Unaudited)  Three months ended June 30,  2025   2024 Operating Expenses  General and administrative$4,500  $2,792 Research and development 9,959   11,811 Total operating expenses 14,459   14,603 Operating loss (14,459)  (14,603)   Other income   Grant income 25   - Research and development incentive income 127   526 Interest income, net 1,075   1,796 Foreign exchange gain (11)  67 Total other income, net 1,216   2,389 Net loss and comprehensive loss$(13,243) $(12,214)   Net loss per share  Basic and diluted$(0.16) $(0.14)   Weighted average number of shares outstanding Basic and diluted         85,380,587              84,535,328   Anavex Life Sciences Corp.Condensed Consolidated Statements of Operations and Comprehensive Loss(in thousands, except share and per share amounts)(Unaudited)  Nine months ended June 30,  2025   2024 Operating Expenses  General and administrative$                10,266  $                8,382 Research and development                30,298                    30,224 Total operating expenses                40,564                     38,606  Operating loss  (40,564)   (38,606)   Other income (expense)  Grant income                       37   - Research and development incentive income                     635                      1,591 Interest income, net                  3,679                      5,561 Foreign exchange gain (loss)                   (337)                        72 Total other income, net                  4,014                      7,224  Net loss and comprehensive loss$                (36,550) $                (31,385)   Net loss per share  Basic and diluted$                (0.43) $                (0.38)   Weighted average number of shares outstanding Basic and diluted 85,085,795   83,022,330   Anavex Life Sciences Corp.Condensed Consolidated Balance Sheets(in thousands, except share and per share amounts)   June 30,September 30,  2025  2024 Assets  Current  Cash and cash equivalents$101,164 $132,187 Incentive and tax receivables                            820                     2,449 Prepaid expenses and other current assets                            448                        931 Total Assets$102,432 $135,567    Liabilities and stockholders' equity  Current Liabilities  Accounts payable$6,740 $9,627 Accrued liabilities                      3,929                     4,835 Deferred grant income                           805                        842 Total Liabilities                      11,474                   15,304 Capital Stock                           85  85 Additional paid-in capital                    463,494                 456,249 Accumulated deficit (372,621) (336,071)Total Stockholders' Equity                       90,958                 120,263 Total Liabilities and Stockholders' Equity$102,432 $135,567  For Further Information:Anavex Life Sciences Corp.Research & Business DevelopmentToll-free: 1-844-689-3939Email: info@anavex.com Investors:Andrew J. BarwickiInvestor RelationsTel: 516-662-9461Email: andrew@barwicki.com

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