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 Development

Toll-free: 1-844-689-3939

Email: info@anavex.com

Investors:

Andrew J. Barwicki

Investor Relations

Tel: 516-662-9461

Email: andrew@barwicki.com

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