Anavex Life Sciences Reports Fiscal 2024 Third Quarter Financial Results and Provides Business Update

Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of 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 fiscal quarter ended June 30, 2024.

“We continue to meaningfully advance our differentiated precision medicine clinical program, highlighted by the recent presentation of comprehensive results from the Phase 2b/3 clinical trial of blarcamesine (ANAVEX®2-73), which were presented at the Alzheimer’s Association International Conference (AAIC), showing that oral, once daily blarcamesine significantly slowed clinical decline for early Alzheimer's disease patients with good comparative safety profile and no associated neuroimaging adverse events. We are also pleased to report that the clinical team continues to beat the planned timelines in the ongoing ANAVEX®3-71-SZ-001 Phase 2 trial of ANAVEX®3-71 in schizophrenia patients,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “Additionally, we remain dedicated to developing medicines for individuals suffering from brain disorders within neurodegenerative and neurodevelopmental disorders, which could further expand our differentiated precision medicine platform to deliver scalable treatment options coupled with convenient oral dosing.”

Key Pipeline Updates:

Alzheimer’s disease:
- Full data from the blarcamesine in Alzheimer’s disease Phase 2b/3 placebo-controlled clinical trial will be published in an upcoming peer-reviewed journal. The initiated process for submitting a Marketing Authorisation application (MAA) to the European Medicines Agency (EMA) under the Centralised Procedure is underway, with full regulatory submission of blarcamesine expected in Q4 2024. The Marketing Authorisation would allow direct market access throughout the European Union for oral blarcamesine 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
- Analysis of RNA sequencing (RNA-seq), which would reveal which genes are actively transcribed (expressed) in Alzheimer’s patients in comparison between placebo and blarcamesine of the placebo-controlled Phase 2b/3 blarcamesine trial in early Alzheimer’s disease. This data might have relevant value since it may provide insight into Alzheimer’s disease pathology and how cells function in presence of placebo or in presence of blarcamesine, respectively. Interim data expected in the second half of 2024.
- Completed last patient last visit in the ATTENTION-AD open-label extension 96-week trial. Interim data expected in the second half of 2024.
- AAIC 2024 meeting resulted in constructive feedback received coupled with enthusiasm around our Alzheimer’s disease program strengthened by the recent addition of an experienced clinical team, which support Anavex future plans. Educational reach out to continue towards MAA submission and beyond.
Schizophrenia: The placebo-controlled ANAVEX®3-71-SZ-001 Phase 2 clinical trial of ANAVEX®3-71 for the treatment of schizophrenia has completed dosing of the first cohort and is nearing the completion of enrollment of the second cohort of schizophrenia patients in Part A of the trial.
Parkinson’s disease: Initiation of ANAVEX®2-73 Phase 2b/3 >6-month trial, including biomarkers, which we believe may be key to understanding drug effects on Parkinson’s disease pathophysiology and account for the recently changing context in the field of Parkinson’s disease is expected in the second half of 2024.
Rett syndrome: An educational presentation was provided at the 2024 IRSF Rett Syndrome Scientific Meeting, June 18 – June 19, 2024, which demonstrated the commitment of Anavex to the Rett syndrome community through direct engagement with patients and families. Positive and supportive feedback was received from families and investigators about the continued Anavex Rett syndrome program.
Fragile X: New disease-specific, translatable, and objective biomarker data generated with ANAVEX®2-73, supporting the initiation of the ANAVEX®2-73 Phase 2/3 clinical trial was presented at the 19th NFXF International Fragile X Conference. Meeting with NFXF leadership team strengthened Anavex’s relationship with community coupled with increased awareness of Anavex’s Fragile X syndrome (FXS) program by engaging with patients and families in attendance.
New Rare disease: Initiation of ANAVEX®2-73 Phase 2/3 clinical trial.
Medical Affairs: Building Medical Affairs capabilities to expand education and physician support activities to ensure optimal medical impact including continued clinical publications involving ANAVEX®2-73 and ANAVEX®3-71.

Recent Business Highlights:

On May 22, 2024, Anavex announced new additions to its leadership team with the appointment of Juan Carlos Lopez-Talavera, MD, PhD as Senior Vice President, Head of Research and Development, Terrie Kellmeyer, PhD as Senior Vice President of Clinical Development, and Jeffrey Edwards, PhD as Vice President of Clinical Pharmacology and Science, all with a track record of successfully bringing drugs to market.
On July 28, 2024, comprehensive results from the Phase 2b/3 clinical trial of ANAVEX®2-73 (blarcamesine) were presented at the Alzheimer’s Association Conference (AAIC), showing that oral, once daily blarcamesine significantly slowed clinical decline for early Alzheimer's disease patients with good comparative safety profile and no associated neuroimaging adverse events. The clinical benefit of blarcamesine was consistently observed for both 30 mg and 50 mg treatment groups, and the results demonstrated benefits of blarcamesine on both cognitive and functional parameters (ADAS-Cog13, CDR-SB, CGI-I), as well as amyloid-beta and brain volume, two underlying pathological hallmarks of Alzheimer’s disease.
On July 30, 2024, Anavex reported positive preclinical results in biomarkers that are directly translatable to humans for individuals with FXS for ANAVEX®2-73 (blarcamesine), in a disease model of Fragile X syndrome (FXS). The findings presented at the 19th NFXF International Fragile X Conference reports positive results for electroencephalogram (EEG) biomarkers that are directly translatable to humans and present in both individuals with FXS and animal models of FXS.

Financial Highlights:

Cash and cash equivalents of $138.8 million at June 30, 2024 compared to $151.0 million at fiscal yearend September 30, 2023. The Company anticipates at the current cash utilization rate a runway of approximately 4 years.
General and administrative expenses for the quarter of $2.9 million compared to $3.2 million for the comparable quarter of fiscal 2023.
Research and development expenses for the quarter of $11.9 million compared to $10.3 million for the comparable quarter of fiscal 2023.
Net loss for the quarter of $12.2 million, or $0.14 per share, compared to a net loss of $11.3 million, or $0.14 per share for the comparable quarter of fiscal 2023.

The financial information for the fiscal quarter ended June 30, 2024, should be read in conjunction with the Company’s condensed consolidated interim 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# 821 9280 7728 and reference passcode 121725. 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.

____________________1 https://www.braincouncil.eu/projects/rethinking-alzheimers-disease/


Anavex Life Sciences Corp.
Condensed Consolidated Interim Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)

	Three months ended June 30,
	2024			2023
Operating Expenses
General and administrative	$	2,859		$	3,248
Research and development		11,870			10,283
Total operating expenses		14,729			13,531
Operating loss		(14,729	)		(13,531	)

Other income
Research and development incentive income		526			565
Interest income, net		1,796			1,828
Foreign exchange gain (loss)		67			(101	)
Gain on settlement of accounts payable		59			-
Total other income, net		2,448			2,292
Net loss before provision for income taxes		(12,281	)		(11,239	)
Income tax recovery (expense), current		67			(41	)
Net loss and comprehensive loss	$	(12,214	)	$	(11,280	)

Net loss per share
Basic and diluted	$	(0.14	)	$	(0.14	)

Weighted average number of shares outstanding
Basic and diluted		84,535,328			80,875,235

Anavex Life Sciences Corp.
Condensed Consolidated Interim Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)

	Nine months ended June 30,
	2024			2023
Operating Expenses
General and administrative	$	8,258		$	9,447
Research and development		30,283			33,657
Total operating expenses		38,541			43,104
Operating loss		(38,541	)		(43,104	)

Other income
Grant income		-			25
Research and development incentive income		1,591			2,048
Interest income, net		5,561			4,561
Other financing expense		-			(964	)
Foreign exchange gain (loss)		72			146
Gain on settlement of accounts payable		59			-
Total other income, net		7,283			5,816
Net loss before provision for income taxes		(31,258	)		(37,288	)
Income tax expense, current		(124	)		(71	)
Net loss and comprehensive loss	$	(31,382	)	$	(37,359	)

Net loss per share
Basic and diluted	$	(0.38	)	$	(0.47	)

Weighted average number of shares outstanding
Basic and diluted		83,022,330			79,051,038


Anavex Life Sciences Corp.
Condensed Consolidated Interim Balance Sheets
(in thousands, except share and per share amounts)

	June 30,			September 30,
	2024			2023
Assets
Current
Cash and cash equivalents	$	138,756		$	151,024
Incentive and tax receivables	1,720			2,709
Prepaid expenses and other current assets	1,059			653
Total Assets	$	141,535		$	154,386

Liabilities and stockholders' equity
Current Liabilities
Accounts payable	$	3,503		$	4,322
Accrued liabilities	7,334			7,295
Deferred grant income	917			917
Total Liabilities	11,754			12,534
Capital Stock	85			82
Additional paid-in capital	454,236			434,839
Share proceeds receivable	(89		)	-
Accumulated deficit	(324,451		)	(293,069		)
Total Stockholders' Equity	129,781			141,852
Total Liabilities and Stockholders' Equity	$	141,535		$	154,386