GlobeNewswire Inc | May 13, 2021 07:00AM EDT

May 13, 2021

NEW YORK, May 13, 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 Alzheimers disease, Parkinsons disease, Rett syndrome and other central nervous system (CNS) diseases, today reported financial results for its fiscal quarter ended March 31, 2021.

"Positive momentum continues to build this quarter and affirms the strength of our pipeline and execution capabilities," said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. "For our lead drug candidate, ANAVEX2-73 in Alzheimers disease, we are close to complete enrollment for our Phase 2b/3 study, and we expect a very data-rich current quarter with data readouts from multiple clinical trials and the remainder of 2021 to be a catalyst-rich year for Anavex. This is an exciting time for Anavex and I look forward to advancing our impressive pipeline of mid- and late-stage clinical trials with a commitment to bringing innovative therapies to patients in need around the globe.

Anavex Life Sciences Business and Near-Term Clinical Outlook:

ANAVEX2-73 Program and other Near-Term Pipeline Data Updates:

-- Complete data ANAVEX2-73 U.S. Rett syndrome Phase 2 study. -- Complete data ANAVEX2-73 Parkinsons disease dementia (PDD) Phase 2 study. -- Top-line data AVATAR: Potentially pivotal Phase 2/3 ANAVEX2-73 adult Rett syndrome clinical trial. -- Top-line data Phase 1 ANAVEX3-71 clinical trial. -- Complete enrollment of Phase 2b/3 ANAVEX2-73 Alzheimers disease clinical trial.

Recent Business Highlights:

-- In March 2021, Anavex announced that the Independent Data Safety Monitoring Board (DSMB) for the Companys Phase 2b/3 Alzheimers disease study of its investigational compound ANAVEX2-73 (blarcamesine) has 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 ANAVEX2-73 Phase 2b/3 Alzheimers disease clinical study ANAVEX2-73-AD-004 and its Open Label Extension (OLE) ANAVEX2-73-AD-EP-004 ATTENTION-AD study. Upon review of the interim safety data, the DSMB made the following recommendation: The DSMB recommendation is to continue the studies without modification. -- In April 2021, Anavex announced that the Independent Data Safety Monitoring Board (DSMB) for the Companys ongoing clinical trial program, including the late-stage AVATAR (ANAVEX2-73-RS-002), EXCELLENCE (ANAVEX2-73-RS-003) and the U.S. Rett syndrome extension study (ANAVEX2-73-RS-EP-001) of its investigational compound ANAVEX2-73 (blarcamesine) has completed its recent pre-planned review of the respective interim safety data for these three separate clinical studies. Upon review of the interim safety data, the DSMB made the following recommendation for each of the three studies: The DSMB recommendation is to continue the studies without modification. -- In March 2021, Anavex announced that ANAVEX2-73 (blarcamesine) is featured in a recent peer-reviewed publication in the journal of Neuropharmacology, titled Future avenues for Alzheimers disease detection and therapy: liquid biopsy, intracellular signaling modulation, systems pharmacology drug discovery from the series of the special issue on The Quest for Disease-Modifying Therapies for Neurodegenerative Disorders. -- In May 2021, Anavex announced the appointment of former FDA officer as Senior Vice President for Nonclinical Development. -- Further clinical milestones are provided in Anavex Life Sciences latest corporate presentation, available on www.anavex.com.

Financial Highlights:

-- Continued fiscal responsible management of cash utilization. -- Cash and cash equivalents at March 31, 2021 of approximately $75.9 million, sufficient cash runway for up to three (3) years. -- Net loss of $8.2 million, or $0.12 per share for the quarter, compared to net loss of $7.2 million, or $0.12 per share in comparative quarter of fiscal 2020. -- Research and development expenses of $6.7 million for the quarter, compared to $6.1 million for comparable quarter of fiscal 2020. -- General and administrative expenses were $2.2 million for the quarter, as compared to $1.7 million for the prior year period.

The financial information for the fiscal quarter ended March 31, 2021 should be read in conjunction with the Companys 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.

Conference Call / Webcast Information:

The live webcast of the conference call can be accessed online at https://wsw.com/webcast/cc/avxl18/1499544.

To join the conference call, live via telephone, interested parties within the U.S. should dial, toll-free, 1 (866) 866-1333 and international callers should dial 1 (404) 260-1421. Please use confirmation number 50162864, 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), successfully completed a Phase 2a clinical trial for Alzheimers disease and recently 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. INTERIM CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS For the three months ended March 31, 2021 and 2020 (Unaudited) Expressed in US Dollars 2021 2020 Operating Expenses General and administrative $ 2,233,745 $ 1,720,142 Research and development 6,720,841 6,053,047 Total operating expenses (8,954,586 ) (7,773,189 ) Other income (expenses) Grant income 10,820 74,944 Research and development incentive income 960,879 717,328 Interest income, net 9,216 70,180 Foreign exchange gain (loss), net (154,563 ) (325,960 ) Total other income, net 826,352 536,492 Net loss before provision for income taxes (8,128,234 ) (7,236,697 ) Income tax expense, current (26,988 ) - Net loss and comprehensive loss $ (8,155,222 ) $ (7,236,697 ) Net loss per share Basic and diluted $ (0.12 ) $ (0.12 ) Weighted average number of shares outstanding Basic and diluted 68,594,867 58,353,954

ANAVEX LIFE SCIENCES CORP. INTERIM CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS For the six months ended March 31, 2021 and 2020 (Unaudited) Expressed in US Dollars 2021 2020 Operating Expenses General and administrative $ 3,704,401 $ 3,072,176 Research and development 14,646,360 12,401,715 Total operating expenses (18,350,761 ) (15,473,891 ) Other income (expenses) Grant income 10,820 149,888 Research and development incentive 2,230,195 1,660,543 incomeInterest income, net 7,657 116,900 Foreign exchange gain (loss), net 178,071 (272,848 ) Total other income, net 2,426,743 1,654,483 Net loss before provision for income (15,924,018 ) (13,819,408 ) taxesIncome tax expense, current (86,269 ) (9,214 ) Net loss and comprehensive loss $ (16,010,287 ) $ (13,828,622 ) Net loss per share Basic and diluted $ (0.24 ) $ (0.24 ) Weighted average number of shares outstanding Basic and diluted 66,421,380 56,544,037

ANAVEX LIFE SCIENCES CORP. INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS As at March 31, 2021 and September 30, 2020 Expressed in US Dollars March 31, 2021 September 30, 2020ASSETS (Unaudited) Current Cash and cash equivalents $ 75,859,339 $ 29,249,018 Incentive and tax receivables 7,328,090 4,849,340 Prepaid expenses and deposits 386,809 443,839 Total Assets $ 83,574,238 $ 34,542,197 LIABILITIES AND STOCKHOLDERS' EQUITY Current Liabilities Accounts payable $ 3,658,052 $ 3,989,054 Accrued liabilities 3,618,779 3,316,574 Deferred grant income 487,111 - Total Liabilities 7,763,942 7,305,628 Capital Stock 70,032 62,047 Additional paid-in capital 251,427,781 186,851,752 Accumulated deficit (175,687,517 ) (159,677,230 ) Total Stockholders' Equity 75,810,296 27,236,569 Total Liabilities and Stockholders' $ 83,574,238 $ 34,542,197 Equity

For Further Information:

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

Investors:Andrew J. BarwickiInvestor RelationsTel: 516-662-9461Email: andrew@barwicki.com