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 fourth quarter and fiscal year ended September 30, 2024.

“We are excited about the potential to advance a novel treatment for early Alzheimer’s disease with convenient oral dosing and our team remains deeply committed to executing on our momentum,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “I am proud of the strides the Anavex team has made in the recent quarter 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 December 23, 2024, Anavex announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for blarcamesine (ANAVEX®2-73), an investigational drug for the treatment of Alzheimer’s disease.
• On December 9, 2024, Anavex announced its upcoming presentation of topline long-term data from the Phase IIb/III ATTENTION-AD Open-Label-Extension (OLE) trial at the J.P. Morgan 2025 Healthcare Conference, taking place January 13–16, 2025, in San Francisco, CA.
• On December 2, 2024, Anavex announced its participation in a fireside chat which was held December 4th, 2024, at the 7th Annual Evercore ISI HealthCONx Conference 2024 in Coral Gables, FL.
• On November 26, 2024, Anavex announced the submission of the blarcamesine (ANAVEX®2-73) MAA (Marketing Authorization Application) to the European Medicines Agency (EMA). The MAA submission is for the treatment of Alzheimer’s Disease. There are an estimated 7 million people in Europe with Alzheimer’s disease, a number expected to double by 2030, according to the European Brain Council.1
• On November 25, 2024, Anavex reported the acceptance of a peer-reviewed manuscript titled “Blarcamesine for the treatment of Early Alzheimer’s Disease: Results from the ANAVEX2-73-AD-004 Phase IIB/III trial,” in a medical journal with focus on Alzheimer’s disease. The publication date is expected around Q4 2024/Q1 2025.
• On October 31, 2024, Anavex presented new data from the Phase IIb/III study showing blarcamesine (ANAVEX®2-73), once daily orally, demonstrates pre-specified clinical efficacy through upstream SIGMAR1 activation. Clinical data confirmed the mechanism of action by pre-specified SIGMAR1 gene analysis in people with early Alzheimer's disease. The data were presented by Marwan Noel Sabbagh, MD, Professor of Neurology at Barrow Neurological Institute and Chairman of the Anavex Scientific Advisory Board at the Clinical Trials on Alzheimer’s Disease (CTAD) conference, in Madrid, Spain.
• On October 17, 2024, Anavex announced encouraging preliminary electroencephalography (EEG) biomarker results from Part A of the ongoing placebo-controlled Phase 2 clinical study of ANAVEX®3-71 for the treatment of schizophrenia. Preliminary results demonstrated a dose-dependent effect of ANAVEX®3-71 on two key EEG biomarkers in patients with schizophrenia.  Anavex expects data from Part B of the placebo-controlled Phase 2 study, which includes more participants and a longer treatment duration, in the first half of 2025.

Financial Highlights:

• Cash and cash equivalents of $132.2 million at September 30, 2024 compared to $151.0 million at September 30, 2023. As of fiscal year end, the Company anticipates at the current cash utilization rate, a runway of approximately 4 years.
• General and administrative expenses for the fourth quarter of $2.8 million compared to $2.6 million for the comparable quarter of fiscal 2023.
• Research and development expenses for the fourth quarter of $11.6 million compared to $10.1 million for the comparable quarter of fiscal 2023.
• Net loss for the fourth quarter of $11.6 million, or $0.14 per share, compared to a net loss of $10.1 million, or $0.12 per share for the comparable quarter of fiscal 2023.

The financial information for the fiscal year ended September 30, 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# 814 6482 4038 and reference passcode 336064. 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.
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
	Three months ended September 30,
		2024			2023
Operating Expenses
General and administrative	$	2,781		$	2,592
Research and development		11,555			10,061
Total operating expenses		14,336			12,653
Operating loss		(14,336	)		(12,653	)
Other income (expense)
Grant income		75			-
Research and development incentive income		700			670
Interest income, net		1,759			1,958
Foreign exchange gain (loss)		117			(186	)
Gain on write-off of accounts payable		(59	)		-
Total other income, net		2,592			2,442
Net loss before provision for income taxes		(11,744	)		(10,211	)
Income tax recovery, current		124			64
Net loss and comprehensive loss	$	(11,620	)	$	(10,147	)
Net loss per share
Basic and diluted	$	(0.14	)	$	(0.12	)
Weighted average number of shares outstanding
Basic and diluted		84,795,517			81,973,250

Anavex Life Sciences Corp.
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
	Twelve months ended September 30,
		2024			2023
Operating Expenses
General and administrative	$	11,039		$	12,039
Research and development		41,838			43,717
Total operating expenses		52,877			55,756
Operating loss		(52,877	)		(55,756	)
Other income (expense)
Grant income		75			25
Research and development incentive income		2,291			2,718
Interest income, net		7,320			6,519
Other financing expense		-			(964	)
Foreign exchange gain (loss)		189			(40	)
Total other income, net		9,875			8,258
Net loss before provision for income taxes		(43,002	)		(47,498	)
Income tax expense, current		-			(7	)
Net loss and comprehensive loss	$	(43,002	)	$	(47,505	)
Net loss per share
Basic and diluted	$	(0.52	)	$	(0.60	)
Weighted average number of shares outstanding
Basic and diluted		83,468,049			79,787,596

Anavex Life Sciences Corp.
Consolidated Balance Sheets
(in thousands, except share and per share amounts)
	September 30,
		2024			2023
Assets
Current
Cash and cash equivalents	$	132,187		$	151,024
Incentive and tax receivables		2,449			2,709
Prepaid expenses and other current assets		931			653
Total Assets	$	135,567		$	154,386
Liabilities and stockholders' equity
Current Liabilities
Accounts payable	$	9,627		$	4,322
Accrued liabilities		4,835			7,295
Deferred grant income		842			917
Total Liabilities		15,304			12,534
Capital Stock		85			82
Additional paid-in capital		456,249			434,839
Accumulated deficit		(336,071	)		(293,069	)
Total Stockholders' Equity		120,263			141,852
Total Liabilities and Stockholders' Equity	$	135,567		$	154,386

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

1 https://www.braincouncil.eu/projects/rethinking-alzheimers-disease/