AVXL Anavex Life Sciences Corporation

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,
	2024			2023
Operating 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,
	2024			2024
Assets
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