Anavex Life Sciences Provides Business Update and Reports Fiscal 2021 Year End Financial Results

NEW YORK, Nov. 24, 2021 (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 year ended September 30, 2021.

"Anavex concluded an exceptional fiscal year 2021 while continuing its momentum, highlighted by the efficient execution and full enrollment of three Precision Medicine clinical trials, including the Phase 2b/3 ANAVEX®2-73 clinical trial in Alzheimer’s disease, the Phase 2/3 ANAVEX®2-73 clinical trial in Rett syndrome as well as the Phase 1 of ANAVEX®3-71. As we look to the remainder of 2021 and into 2022, I am very excited about the Company’s potential as we continue to advance and expand our Precision Medicine clinical programs," said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. "As we look ahead, we will continue to focus on driving meaningful growth across our broad SIGMAR1 platform portfolio to deliver transformational treatments for patients with both degenerative and developmental neurological disorders around the world.”

Key Company Updates:

• Top-line results from the second placebo-controlled AVATAR Phase 2/3 ANAVEX®2-73-RS-002 study for the treatment of adult patients with Rett syndrome are expected around year end 2021.
• Top-line results from the placebo-controlled Phase 1 ANAVEX®3-71-001 study evaluating ANAVEX®3-71 in humans are expected around year end 2021.
• A scientific presentation on ANAVEX®2-73 for the potential treatment of amyotrophic lateral sclerosis (ALS) will be shared at the 4^th Annual ALS ONE Research Symposium, November 29^th & 30^th, 2021.
• Top-line results from the placebo-controlled EXCELLENCE Phase 2/3 ANAVEX®2-73-RS-003 study for the treatment of pediatric patients with Rett syndrome are expected 1H 2022.
• Top-line results from the placebo-controlled Phase 2b/3 ANAVEX®2-73-AD-004 study for the treatment of Alzheimer’s disease are expected 2H 2022.
• Pipeline expansion for ANAVEX®2-73 using gene biomarkers of response, applying precision medicine for neurological disorders with unmet medical need are expected 1H 2022:
  • Planned initiation of ANAVEX®2-73 imaging-focused Parkinson’s disease clinical study.
  • Planned initiation of a pivotal Phase 2/3 study in Fragile X Syndrome, the most frequent genetic cause of autism spectrum disorder.
  • Planned initiation of a Phase 2/3 clinical trial for the treatment of a new, rare-disease indication.
    

Recent Business Highlights:

• On October 13, 2021, Anavex announced that the Independent Data Safety Monitoring Board (DSMB) for the Company’s Phase 2b/3 Alzheimer’s disease study of its investigational compound ANAVEX®2-73 completed its recent pre-planned review of the preliminary Phase 2b/3 study data. As specified in the protocol, the DSMB reviewed the interim safety data for the ANAVEX®2-73 Phase 2b/3 Alzheimer’s disease clinical study ANAVEX®2-73-AD-004 and its Open Label Extension (OLE) ANAVEX®2-73-AD-EP-004 ATTENTION-AD study. Upon review of the interim safety data, the DSMB recommendation is to continue the studies without modification.
• On August 26, 2021, Anavex announced that preclinical data of ANAVEX®2-73 in Fragile X Syndrome was published in the peer-reviewed journal, Scientific Reports. The study evaluated ANAVEX®2-73 in Fmr1 knockout (KO) mice, a validated animal model for the disease, which resulted in the reversal of hyperactivity and restoration of associative learning. Furthermore, ANAVEX®2-73 demonstrated dose dependent SIGMAR1 receptor occupancy in a Positron Emission Tomography (PET) study.

Financial Highlights:

• Cash and cash equivalents of $152.1 million on September 30, 2021, an increase of $122.9 million compared to $29.2 million from September 30, 2020.
• Net loss of $37.9 million, or $0.54 per share for the year, compared to net loss of $26.3 million, or $0.45 per share in fiscal 2020.
• Research and development expenses of $33.0 million for the year, compared to $25.2 million in fiscal 2020.
• General and administrative expenses of $9.0 million for the year, compared to $5.9 million in fiscal 2020.

The financial information for the year ended September 30, 2021, 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 can be accessed online at https://wsw.com/webcast/cc/avxl20/1492110.

To join the conference call, live via telephone, interested parties within the U.S. should dial, toll-free, 1 (866) 939-3921 and international callers should dial 1 (678) 302-3550. Please use confirmation number 50258076, followed by the pound sign (#).

A replay of the conference call will also be available on www.anavex.com.

About Anavex Life Sciences Corp.

Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of 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, pain, and various types of cancer. Anavex’s lead drug candidate, ANAVEX®2-73 (blarcamesine), successfully completed a Phase 2a clinical trial for Alzheimer’s disease and recently a Phase 2 proof-of-concept study in Parkinson’s disease dementia and a Phase 2 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 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
For the years ended September 30, 2021 and 2020
Expressed in US Dollars
		2021			2020
Operating Expenses
General and administrative	$	9,017,511		$	5,856,609
Research and development		32,983,674			25,231,623
Total operating expenses		(42,001,185	)		(31,088,232	)
Other income (expenses)
Grant income		54,100			149,888
Research and development incentive income		4,547,099			4,375,025
Interest income, net		26,261			179,973
Foreign exchange gain (loss), net		(267,344	)		125,540
Total other income, net		4,360,116			4,830,426
Net loss before provision for income taxes		(37,641,069	)		(26,257,806	)
Income tax expense, current		(267,565	)		(22,664	)
Net loss and comprehensive loss	$	(37,908,634	)	$	(26,280,470	)
Net loss per share
Basic and diluted	$	(0.54	)	$	(0.45	)
Weighted average number of shares outstanding
Basic and diluted		69,802,960			58,194,894

ANAVEX LIFE SCIENCES CORP.
CONSOLIDATED BALANCE SHEETS
As at September 30, 2021 and 2020
Expressed in US Dollars
		2021			2020
ASSETS
Current
Cash and cash equivalents	$	152,107,745		$	29,249,018
Incentive and tax receivables		9,136,831			4,849,340
Prepaid expenses and deposits		355,549			443,839
Deferred financing charges		16,365			-
Total Assets	$	161,616,490		$	34,542,197
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities
Accounts payable	$	4,739,781		$	3,989,054
Accrued liabilities		5,614,774			3,316,574
Deferred grant income		443,831			-
Total Liabilities		10,798,386			7,305,628
Capital Stock		75,920			62,047
Additional paid-in capital		348,328,048			186,851,752
Accumulated deficit		(197,585,864	)		(159,677,230	)
Total Stockholders' Equity		150,818,104			27,236,569
Total Liabilities and Stockholders' Equity	$	161,616,490		$	34,542,197

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