GlobeNewswire Inc | Dec 28, 2020 07:00AM EST

December 28, 2020

NEW YORK, Dec. 28, 2020 (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 Alzheimers disease, Parkinsons disease, Rett syndrome and other central nervous system (CNS) diseases, today reported financial results for its fiscal year ended September 30, 2020.

Christopher U Missling, PhD, President and Chief Executive Officer of Anavex said: Despite all of the new challenges, 2020 was an extraordinary year for Anavex, with significant progress across our portfolio, including our first positive, placebo-controlled, U.S. ANAVEX2-73 (blarcamesine) Rett syndrome trial, a positive Parkinsons disease dementia trial, and further progress in Alzheimers disease. I want to thank the patients, doctors, and the Anavex team who made all of this progress possible. We look forward to building on this momentum with key milestones expected from multiple programs, including data on the ongoing late-stage Rett syndrome trials AVATAR and EXCELLENCE, expanding the clinical biomarker-driven ANAVEX2-73 rare disease program into additional late-stage studies with high unmet medical need, completing the late stage ANAVEX2-73 Phase 2b/3 Alzheimers disease trial, and advancing ANAVEX2-73 into clinical disease modifying testing in Parkinsons disease.

Key Clinical Updates:

-- Plan to advance the AVATAR adult Rett syndrome study into a pivotal Phase 2/3 clinical trial. -- Pipeline expansion for ANAVEX2-73 using gene biomarkers of response, applying precision medicine for neurological disorders with unmet medical need: 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. -- Phase 2b/3 ANAVEX2-73 Alzheimers disease (AD) study currently over 80% enrolled with complete enrollment expected in early 2021. -- Planned initiation of ANAVEX2-73 imaging-focused Parkinsons disease clinical study.

Recent Business Highlights:

-- In December 2020, Anavex announced top-line results from a U.S. Phase 2 controlled trial of ANAVEX2-73 in adult female patients with Rett syndrome. Primary safety, pharmacokinetics and secondary efficacy endpoints were met, with statistically significant and clinically meaningful consistent improvements in Rett Syndrome Behaviour Questionnaire (RSBQ) and Clinical Global Impression Improvement (CGI-I) scores. Improvements in RSBQ Total scores were correlated with decreases (improvements) in plasma glutamate. Based on the results, Anavex is planning to meet with the FDA to discuss an accelerated approval pathway. -- In November 2020, Anavex presented data at the 13th Clinical Trials on Alzheimers Disease (CTAD) 2020 Conference, reporting top-line results from the proof-of-concept Phase 2 placebo-controlled trial with primary objectives of safety, tolerability, and efficacy in cognition of ANAVEX2-73 in patients in Parkinsons disease dementia (PDD) compared to placebo. Both primary objectives of the study were met. The results show clinically meaningful, dose-dependent, and statistically significant improvements in the Cognitive Drug Research (CDR) computerized assessment system analysis. The study confirmed the precision medicine approach of targeting SIGMAR1 as a genetic biomarker in response to ANAVEX2-73 supporting progression to further development in upcoming Phase 2/3 studies. -- In November 2020, Anavex received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for its patent application number 16/717,921 expected to remain in force at least until 2037, expanding coverage of treatment methods using its lead drug candidate, ANAVEX2-73, as well as drug candidate ANAVEX1-41 for treating a range neurodevelopmental disorders including Rett syndrome, autism spectrum disorder, Angelman syndrome, cerebral palsy and multiple sclerosis, among other indications.

Financial Highlights:

-- Cash and cash equivalents of $47.6 million as of today and $29.2 million at September 30, 2020, compared to $22.2 million at September 30, 2019. -- Net loss of $26.3 million, or $0.45 per share for the year, compared to net loss of $26.3 million, or $0.54 per share in fiscal 2019. -- Research and development expenses of $25.2 million for the year, compared to $22.3 million for fiscal 2019. -- General and administrative expenses of $5.9 million for the year, compared to $6.8 million for fiscal 2019.

The financial information for the fiscal year ended September 30, 2020 should be read in conjunction with the Companys consolidated financial statements, which will appear on EDGAR, www.sec.gov and will be available on the Anavex website at www.anavex.com.

Conference Call / Webcast Information

The live webcast of the conference call can be accessed online at https://wsw.com/webcast/cc/avxl16/1496358.

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 50061077, 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 Alzheimers disease, Parkinsons disease, Rett syndrome and other central nervous system (CNS) diseases, pain and various types of cancer. Anavexs lead drug candidate, ANAVEX2-73 (blarcamesine), recently completed successfully a Phase 2a clinical trials for Alzheimers disease and a Phase 2 proof-of-concept study in Parkinsons disease dementia and a Phase 2 study in adult patients with Rett syndrome. ANAVEX2-73 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 Alzheimers disease. ANAVEX2-73 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 Parkinsons Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX2-73 for the treatment of Parkinsons disease. ANAVEX3-71, which targets sigma-1 and muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimers disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies. In preclinical trials, ANAVEX3-71 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 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 Companys 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 OPERATIONSFor the years ended September 30, 2020 and 2019

Expressed in US Dollars 2020 2019 Operating Expenses General and administrative $ 5,856,609 $ 6,846,599 Research and development 25,231,623 22,260,349 Total operating expenses (31,088,232 ) (29,106,948 ) Other income (expenses) Grant income 149,888 298,943 Research and development incentive income 4,375,025 2,465,691 Interest income, net 179,973 207,280 Gain on settlement of accounts payable - 115,758 Financing related charges - (151,133 )Foreign exchange gain (loss), net 125,540 (42,389 )Total other income, net 4,830,426 2,894,150 Net loss before provision for income taxes (26,257,806 ) (26,212,798 )Income tax expense, current (22,664 ) (82,181 )Net loss and comprehensive loss $ (26,280,470 ) $ (26,294,979 ) Net loss per share Basic and diluted $ (0.45 ) $ (0.54 ) Weighted average number of shares outstanding Basic and diluted 58,194,894 48,906,470

ANAVEX LIFE SCIENCES CORP.CONSOLIDATED BALANCE SHEETSAs at September 30, 2020 and 2019Expressed in US Dollars 2020 2019 ASSETS Current Cash and cash equivalents $ 29,249,018 $ 22,185,630 Incentive and tax receivables 4,849,340 2,642,745 Prepaid expenses and deposits 443,839 500,998 Total Assets $ 34,542,197 $ 25,329,373 LIABILITIES AND STOCKHOLDERS' EQUITY Current Liabilities Accounts payable $ 3,989,054 $ 3,523,332 Accrued liabilities 3,316,574 1,516,342 Total Liabilities 7,305,628 5,039,674 Capital Stock 62,047 52,652 Additional paid-in capital 186,851,752 153,633,807 Accumulated deficit (159,677,230 ) (133,396,760 )Total Stockholders' Equity 27,236,569 20,289,699 Total Liabilities and Stockholders' $ 34,542,197 $ 25,329,373 Equity



For Further Information:

Anavex Life Sciences Corp.Research & Business DevelopmentToll-free: 1-844-689-3939Email: info@anavex.com

Investors & Media:Clint TomlinsonEmail: ir@anavex.com