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

1. Anavex reports $12.1 million net loss for Q1 fiscal 2025. 2. The company holds $120.8 million in cash, providing a 4-year runway. 3. ANAVEX®2-73 shows significant clinical benefits for early Alzheimer's patients. 4. New U.S. patent extends protection for ANAVEX®2-73 until 2039. 5. Stakeholder support increases for innovative Alzheimer's treatment options.

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Why Bullish?

The strong clinical results and patent protection could enhance investor sentiment, similar to past patent approvals that positively impacted biopharma stocks like Biogen.

How important is it?

The article highlights significant clinical and financial developments that could directly influence AVXL's future stock price trajectory, making it crucial for potential investors.

Why Long Term?

The patent and sustained clinical benefits suggest a positive impact on AVXL's prospects over time, similar to long-term successes seen in other biotech companies.

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February 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, Feb. 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) diseases, today reported financial results for its first quarter of fiscal 2025. “We are receiving growing support from stakeholders for the potential to advance a novel treatment for early Alzheimer’s disease with convenient oral dosing with potential clinical meaningful benefit,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “We are excited to potentially making a difference for individuals suffering from Alzheimer’s disease, by presenting a scalable treatment alternative alongside the ease of oral administration.” Recent Highlights: On January 27, 2025, Anavex announced it was issued a new composition of matter U.S. Patent, expected to remain in force at least until July 2039, entitled “A2-73 CRYSTALLINE POLYMORPH COMPOSITIONS OF MATTER AND METHODS OF USE THEREOF” from the United States Patent and Trademark Office (USPTO). This new patent claims crystalline forms of the dihydrogen phosphate salt of ANAVEX®2-73 (blarcamesine), freebase, transdermal patches and enteric coated oral dosage forms including the same for neuroprotection and treatment of neurodegenerative disorders, including Alzheimer’s disease, Parkinson’s disease and other disorders.On January 15, 2025, Anavex announced that The Journal of Prevention of Alzheimer’s Disease (JPAD)  published peer-reviewed detailed results from the Phase IIb/III study evaluating oral blarcamesine (ANAVEX®2-73) for the treatment of early Alzheimer’s Disease (AD). Once daily oral blarcamesine, demonstrating a safety profile with no associated neuroimaging adverse events, significantly slowed clinical progression by 36.3% at 48 weeks with blarcamesine group as well as the prespecified SIGMAR1 wild-type gene group by 49.8% at 48 weeks on the prespecified primary cognitive endpoint ADAS-Cog13, respectively.On January 13, 2025, Anavex provided topline long-term data from the Phase IIb/III ATTENTION-AD Open-Label-Extension (OLE) trial. The data demonstrated that over three years of continuous treatment with blarcamesine (ANAVEX®2-73) significantly reduced clinical decline showing continued clinically and meaningful benefit for early Alzheimer’s disease patients. Financial Highlights: Cash and cash equivalents of $120.8 million at December 31, 2024 compared to $132.2 million at September 30, 2024. As of quarter end, the Company anticipates at current cash utilization rates and ranges, a runway of approximately 4 years.General and administrative expenses for the first quarter of $3.1 million compared to $2.7 million for the comparable first quarter of fiscal 2024.Research and development expenses for the first quarter of $10.4 million compared to $8.7 million for the comparable first quarter of fiscal 2024.Net loss for the first quarter of $12.1 million, or $0.14 per share, compared to a net loss of $8.6 million, or $0.11 per share for the comparable first quarter of fiscal 2024. The financial information for the quarter ended December 31, 2024, 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# 828 2995 9982 and reference passcode 308966. 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 December 31, 20242023Operating Expenses  General and administrative$3,146 $2,694 Research and development 10,446  8,684 Total operating expenses  13,592    11,378  Operating loss  (13,592)  (11,378)   Other income (expense)  Grant income 12  - Research and development incentive income 412  592 Interest income, net 1,394  2,008 Foreign exchange gain (loss) (337) 156 Total other income, net  1,481   2,756  Net loss and comprehensive loss$ (12,111)$ (8,622)   Net loss per share  Basic and diluted$(0.14)$(0.11)   Weighted average number of shares outstanding Basic and diluted 84,805,974  82,077,815          Anavex Life Sciences Corp.Condensed Consolidated Balance Sheets(in thousands, except share and per share amounts)      December 31,September 30, 20242024Assets  Current  Cash and cash equivalents$120,775 $132,187 Incentive and tax receivables 2,557  2,449 Prepaid expenses and other current assets 711  931 Total Assets$124,043 $135,567    Liabilities and stockholders' equity  Current Liabilities  Accounts payable$4,567 $9,627 Accrued liabilities 7,732  4,835 Deferred grant income 829  842 Total Liabilities 13,128  15,304 Capital Stock 85  85 Additional paid-in capital 459,012  456,249 Accumulated deficit (348,182) (336,071)Total Stockholders' Equity 110,915  120,263 Total Liabilities and Stockholders' Equity$124,043 $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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