GlobeNewswire Inc | Nov 24, 2021 07:00AM EST

November 24, 2021

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 Alzheimers disease, Parkinsons 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 ANAVEX2-73 clinical trial in Alzheimers disease, the Phase 2/3 ANAVEX2-73 clinical trial in Rett syndrome as well as the Phase 1 of ANAVEX3-71. As we look to the remainder of 2021 and into 2022, I am very excited about the Companys 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 ANAVEX2-73-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 ANAVEX3-71-001 study evaluating ANAVEX3-71 in humans are expected around year end 2021. -- A scientific presentation on ANAVEX2-73 for the potential treatment of amyotrophic lateral sclerosis (ALS) will be shared at the 4th Annual ALS ONE Research Symposium, November 29th & 30th, 2021. -- Top-line results from the placebo-controlled EXCELLENCE Phase 2/3 ANAVEX2-73-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 ANAVEX2-73-AD-004 study for the treatment of Alzheimers disease are expected 2H 2022. -- Pipeline expansion for ANAVEX2-73 using gene biomarkers of response, applying precision medicine for neurological disorders with unmet medical need are expected 1H 2022: Planned initiation of ANAVEX2-73 imaging-focused Parkinsons 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 Companys Phase 2b/3 Alzheimers disease study of its investigational compound ANAVEX2-73 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 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 recommendation is to continue the studies without modification. -- On August 26, 2021, Anavex announced that preclinical data of ANAVEX2-73 in Fragile X Syndrome was published in the peer-reviewed journal, Scientific Reports. The study evaluated ANAVEX2-73 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, ANAVEX2-73 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 Companys 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 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, 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 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 OPERATIONS AND COMPREHENSIVE LOSSFor 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 SHEETSAs 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' $ 161,616,490 $ 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