Anavex Life Sciences Reports Fiscal 2023 First Quarter Financial Results

Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today reported financial results for its fiscal quarter ended December 31, 2022.

“Alzheimer’s disease represents a growing burden to healthcare systems and societies worldwide. This disease is often multifactorial and complex in nature, and we believe that our precision medicine platform and novel central nervous system mechanism improve the chance of clinical success. We are pleased by the results of the placebo-controlled Phase 2b/3 Alzheimer’s disease trial which data suggest that ANAVEX®2-73 (blarcamesine), an orally available, small-molecule activator of the upstream sigma-1 receptor (SIGMAR1), is pivotal to restoring neural cell homeostasis and promoting neuroplasticity and might be at the forefront of biomarker-guided pathway-based targeted precision medicine drug development,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “We look forward to presenting the complete dataset of the study as well as other long-term study data of the other programs, including Parkinson’s disease dementia and Rett syndrome. With a deep portfolio of promising therapies, we believe that Anavex remains well positioned to address the urgent needs of patients affected by neurodegenerative and rare neurodevelopmental diseases.”

Key Near Term Pipeline Updates:

• Alzheimer’s disease: Full data ANAVEX®2-73-AD-004: Potentially pivotal Phase 2b/3 clinical trial
• Parkinson’s disease dementia: Data of 48-week OLE Phase 2 study
• Parkinson’s disease: Initiation of ANAVEX®2-73 imaging-focused clinical trial
• Fragile X: Initiation of potentially pivotal ANAVEX®2-73 Phase 2/3 clinical trial
• Schizophrenia: Initiation of ANAVEX®3-71 Phase 2 clinical trial
• New Rare disease: Initiation of potentially pivotal ANAVEX®2-73 Phase 2/3 clinical trial
• Publications: Several clinical publications involving ANAVEX®2-73, ANAVEX®3-71 and Rett syndrome Burden of Illness study

Recent Business Highlights:

• On February 2nd, 2023, the Company announced completion of enrollment of the randomized, placebo-controlled EXCELLENCE Phase 2/3 study ANAVEX®2-73-RS-003 for the treatment of pediatric patients with Rett syndrome. Company expects to announce topline results from this study in the second half of 2023.
• On January 12th, 2023, Anavex presented at the 41st Annual J.P. Morgan Healthcare Conference, in San Francisco, CA.
• On December 14th, 2022, Anavex strengthened its Scientific Advisory Board with the appointment of Prof. Dr. Timo Grimmer, MD. Prof. Dr. Grimmer served as National Coordinating Investigator for the ANAVEX®2-73 Phase 2b/3 ANAVEX®2-73-AD-004 clinical trial.
• On December 1st, 2022, the Company announced, in a late breaking oral presentation at the Clinical Trials on Alzheimer’s Disease (CTAD) Congress 2022, the top line data of its randomized, double-blind, multicenter, placebo-controlled Phase 2b/3 study ANAVEX®2-73-AD-004 for the treatment of early Alzheimer’s disease. The trial met both its co-primary and key secondary endpoints, showing statistically significant and clinically meaningful improvement in cognition and function as measured by ADAS-Cog, ADCS-ADL, and CDR-SB, respectively.

Financial Highlights:

• Cash and cash equivalents of $143.6 million at December 31, 2022 compared to $149.2 million at year end September 30, 2022.
• General and administrative expenses for the quarter of $3.3 million compared to $3.1 million for the comparable quarter of fiscal 2022.
• Research and development expenses for the quarter of $12.1 million compared to $8.7 million for the comparable quarter of fiscal 2022.
• Net loss for the quarter of $13.0 million, inclusive of $5.3 million in non-cash items, or $0.17 per share, compared to a net loss of $10.9 million, or $0.14 per share for the comparable quarter of fiscal 2022.

The financial information for the quarter ended December 31, 2022, should be read in conjunction with the Company’s interim condensed 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:

Management will host a conference call today at 8:30 am ET. 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 1-305-224-1968 for participants in the U.S. using the Meeting ID# 891 9995 1143 and reference passcode 511901. 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 and neurodevelopmental disorders, including Alzheimer's disease, Parkinson's disease, 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 recently 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 with Rett syndrome. ANAVEX®2-73 is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 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. ANAVEX®3-71, which targets sigma-1 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.
Interim Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited - Expressed in US Dollars)
	Three months ended December 31,
		2022			2021
Operating Expenses
General and administrative	$	3,317,036		$	3,066,951
Research and development		12,066,919			8,656,439
Total operating expenses		15,383,955			11,723,390
Operating loss		(15,383,955	)		(11,723,390	)
Other income
Grant income		25,000			-
Research and development incentive income		733,590			810,730
Interest income, net		1,267,618			4,910
Foreign exchange gain, net		365,983			55,363
Total other income, net		2,392,191			871,003
Net loss before provision for income taxes		(12,991,764	)		(10,852,387	)
Income tax recovery (expense), current		20,046			(29,980	)
Net loss and comprehensive loss	$	(12,971,718	)	$	(10,882,367	)
Net loss per share
Basic and diluted	$	(0.17	)	$	(0.14	)
Weighted average number of shares outstanding
Basic and diluted		77,977,112			75,997,738

Anavex Life Sciences Corp.
Interim Condensed Consolidated Balance Sheets
At December 31, 2022 and September 30, 2022
(Unaudited)
Expressed in US Dollars
	December 31,2022			September 30, 2022
Assets
Current
Cash and cash equivalents	$	143,621,848		$	149,157,861
Incentive and tax receivables		4,094,431			3,192,580
Prepaid expenses and other current assets		655,643			354,162
Total Assets	$	148,371,922		$	152,704,603
Liabilities and stockholders' equity
Current Liabilities
Accounts payable	$	5,288,261		$	3,824,777
Accrued liabilities		7,042,822			5,944,953
Deferred grant income		916,763			443,831
Total Liabilities		13,247,846			10,213,561
Capital Stock		78,033			77,944
Additional paid-in capital		393,581,544			387,976,881
Accumulated deficit		(258,535,501	)		(245,563,783	)
Total Stockholders' Equity		135,124,076			142,491,042
Total Liabilities and Stockholders' Equity	$	148,371,922		$	152,704,603

For Further Information:Anavex Life Sciences Corp.Research & Business DevelopmentToll-free: 1-844-689-3939Email: [e-mail]

Investors:Andrew J. BarwickiInvestor RelationsTel: 516-662-9461Email: [e-mail]