Anavex Life Sciences Reports Fiscal 2023 Second Quarter Financial Results

Newly available preliminary efficacy results of surrogate biomarkers from the ANAVEX®2-73-AD-004 study; allowing initiation of discussions with regulatory agencies for Accelerated Approval Pathway for ANAVEX®2-73 (blarcamesine) in Alzheimer’s disease with convenient oral treatment

On track to release top-line data of potentially pivotal ANAVEX®2-73-RS-003 Phase 2/3 EXCELLENCE pediatric clinical trial in the second half of 2023

Company to host a webcast today at 8:30 a.m. Eastern Time

NEW YORK, May 09, 2023 (GLOBE NEWSWIRE) -- 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 March 31, 2023.

“Recent positive clinical study results and FDA approvals through the Accelerated Approval Pathway are positive for the Alzheimer’s disease community, especially for the patients, families and caregivers who fight everyday against this devastating disease. We look forward to presenting the complete dataset of the Phase 2b/3 Alzheimer’s disease trial of ANAVEX®2-73 (blarcamesine), an orally available, small-molecule activator of the upstream sigma-1 receptor (SIGMAR1), involved in restoring neural cell homeostasis and promoting neuroplasticity, which might be at the forefront of patient-centric, next-generation biomarker-guided precision medicine Alzheimer’s disease treatments. With newly available preliminary efficacy results of surrogate biomarkers, we consider initiating discussions with regulatory agencies for Accelerated Approval Pathway for ANAVEX®2-73 (blarcamesine),” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. "We also look forward to making meaningful advances in our neurodevelopmental and other neurodegenerative precision medicine portfolio this year with the expected topline data from the potentially pivotal ANAVEX®2-73-RS-003 Phase 2/3 EXCELLENCE pediatric clinical trial in the second half of 2023. Additionally, we continue to focus on initiating our pivotal study of ANAVEX®2-73 (blarcamesine) in patients with Parkinson’s disease, the second largest neurodegenerative disease after Alzheimer’s disease.”

Key Near Term Pipeline Updates:

• Alzheimer’s disease: Full data ANAVEX®2-73-AD-004, including newly available preliminary results of surrogate biomarkers of pivotal Phase 2b/3 clinical trial. The Company intends to discuss these findings with regulatory authorities in the context of the ongoing clinical development of ANAVEX®2-73 in this indication, with the goal of providing a much-needed treatment to the millions of patients living with Alzheimer’s disease with a convenient once-daily oral treatment. The Company plans to proceed in parallel with the initiation of a confirmatory Alzheimer’s disease study.
• Rett syndrome: Top-line data of potentially pivotal ANAVEX®2-73-RS-003 Phase 2/3 EXCELLENCE pediatric clinical trial. Company expects to announce topline results from this study in the second half of 2023.
• Parkinson’s disease: Initiation of ANAVEX®2-73 pivotal clinical trial.
• 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 May 2^nd, 2023, the Company participated in a fireside chat at the H.C.Wainright BioConnect Investor Conference at NASDAQ World Headquarters in New York.
• On May 1^st, 2023, the Company announced that it was granted a new U.S. Patent No. 11,622,955 entitled “SIGMA-1 RECEPTOR AGONIST SYSTOLIC BLOOD PRESSURE THERAPY,” from the United States Patent and Trademark Office (USPTO), expanding Anavex’s coverage of treatment methods for ANAVEX®2-73 (blarcamesine), to the treatment of systolic hypertension, or lowering systolic blood pressure.
• On April 17^th, 2023, the Company presented at the 22^nd Annual Needham Virtual Healthcare Conference 2023.
• On March 30^th, 2023, the Company reported the preliminary 48-week open label extension Parkinson’s disease dementia ANAVEX2-73-PDD-EP-001 Phase 2 clinical trial data, which demonstrated longitudinal beneficial effects of ANAVEX®2-73 on the prespecified primary and secondary objectives, as well as planned primary and key secondary endpoints which will be utilized in a forthcoming pivotal study of ANAVEX®2-73 in Parkinson’s disease.
• On March 9^th, 2023, Anavex announced the appointment of Kun Jin, PhD, as Vice President, Head of Biostatistics. Dr. Jin will draw on his extensive experience, including recently as the Statistical Team Leader at the U.S. Food and Drug Administration (FDA).
  

Financial Highlights:

• Cash and cash equivalents of $153.5 million at March 31, 2023 compared to $149.2 million at year end September 30, 2022.
• General and administrative expenses for the quarter of $2.9 million compared to $2.9 million for the comparable quarter of fiscal 2022.
• Research and development expenses for the quarter of $11.3 million compared to $8.6 million for the comparable quarter of fiscal 2022.
• Net loss for the quarter of $13.1 million, inclusive of $4.8 million in non-cash items, or $0.17 per share, compared to a net loss of $10.4 million, inclusive of $4.4 million in non-cash items, or $0.14 per share for the comparable quarter of fiscal 2022.

The financial information for the quarter ended March 31, 2023, 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 on Tuesday May 9, 2023, 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 1 929 205 6099 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 March 31,
		2023			2022
Operating Expenses
General and administrative	$	2,882,568		$	2,915,158
Research and development		11,306,591			8,604,589
Total operating expenses		14,189,159			11,519,747
Operating loss		(14,189,159	)		(11,519,747	)
Other income
Research and development incentive income		749,681			835,513
Interest income, net		1,465,221			7,578
Other financing expense		(964,344	)		-
Foreign exchange (loss) gain, net		(118,678	)		268,645
Total other income, net		1,131,880			1,111,736
Net loss before provision for income taxes		(13,057,279	)		(10,408,011	)
Income tax expense, current		(50,000	)		(29,800	)
Net loss and comprehensive loss	$	(13,107,279	)	$	(10,437,811	)
Net loss per share
Basic and diluted	$	(0.17	)	$	(0.14	)
Weighted average number of shares outstanding
Basic and diluted		78,304,363			76,248,603

Anavex Life Sciences Corp.
Interim Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited - Expressed in US Dollars)
	Six months ended March 31,
		2023			2022
Operating Expenses
General and administrative	$	6,199,604		$	5,982,109
Research and development		23,373,510			17,261,028
Total operating expenses		29,573,114			23,243,137
Operating loss		(29,573,114	)		(23,243,137	)
Other income
Grant income		25,000			-
Research and development incentive income		1,483,271			1,646,243
Interest income, net		2,732,839			12,488
Other financing expense		(964,344	)		-
Foreign exchange gain, net		247,305			324,008
Total other income, net		3,524,071			1,982,739
Net loss before provision for income taxes		(26,049,043	)		(21,260,398	)
Income tax expense, current		(29,954	)		(59,780	)
Net loss and comprehensive loss	$	(26,078,997	)	$	(21,320,178	)
Net loss per share
Basic and diluted	$	(0.33	)	$	(0.28	)
Weighted average number of shares outstanding
Basic and diluted		78,138,940			76,121,792

Anavex Life Sciences Corp.
Interim Condensed Consolidated Balance Sheets
At March 31, 2023 and September 30, 2022
(Unaudited – Expressed in US Dollars)
	March 31, 2023			September 30, 2022
Assets
Current
Cash and cash equivalents	$	153,466,962		$	149,157,861
Incentive and tax receivables		4,737,661			3,192,580
Prepaid expenses and other current assets		981,774			354,162
Total Assets	$	159,186,397		$	152,704,603
Liabilities and stockholders' equity
Current Liabilities
Accounts payable	$	6,281,742		$	3,824,777
Accrued liabilities		6,822,838			5,944,953
Deferred grant income		916,763			443,831
Total Liabilities		14,021,343			10,213,561
Capital Stock		80,236			77,944
Additional paid-in capital		416,727,598			387,976,881
Accumulated deficit		(271,642,780	)		(245,563,783	)
Total Stockholders' Equity		145,165,054			142,491,042
Total Liabilities and Stockholders' Equity	$	159,186,397		$	152,704,603

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