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 quarter ended March 31, 2022.

"We are pleased with the continued advancement regarding our lead product candidate ANAVEX®2-73 in Alzheimer’s disease and Rett syndrome as we maintain our attention on execution across each of our clinical programs and overall business operations," said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. "We are also looking forward to next month’s R&D Day’s event, where we will present our broad SIGMAR1 platform portfolio, which allows us to expand further within the neurodegenerative and rare disease space. We remain on track to deliver data readouts, as well as presentations at medical meetings and initiating biomarker-driven precision medicine clinical studies through the rest of the year as planned."

ANAVEX®2-73 Program and other Near-Term Pipeline Data Updates:

  • Top-line results from the randomized, placebo-controlled Phase 2b/3 study ANAVEX®2-73-AD-004 for the treatment of Alzheimer’s disease are expected 2H 2022.
  • Top-line results from the randomized, placebo-controlled EXCELLENCE Phase 2/3 study ANAVEX®2-73-RS-003 for the treatment of pediatric patients with Rett syndrome are expected 2H 2022.
  • ANAVEX will host a R&D Day for investors and analysts on Tuesday, June 21, 2022. Anavex’s R&D Day will include presentations from the Company’s leadership team with a focus on the Company’s clinical development pipeline. Additional details will follow closer to the event.
  • Oral presentation of ‘Effects of the Sigma-1 receptor agonist blarcamesine (ANAVEX®2-73) in a murine model of fragile X syndrome: Neurobehavioral phenotypes and receptor occupancy’ to be presented at 18th NFXF International Fragile X Conference, July 14-17, 2022, in San Diego, California.
  • Pipeline expansion of the ANAVEX platform using gene biomarkers of response, applying precision medicine for neurological disorders with unmet medical need are expected 2022: 
    • Meeting with FDA for discussing ANAVEX®2-73 Parkinson’s disease program including pivotal Phase 3 study.
    • Planned initiation of ANAVEX®2-73 imaging-focused Parkinson’s disease clinical study.
    • Planned initiation of a potentially 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.
    • Planned initiation of ANAVEX®3-71 Phase 2 clinical trials for FTD, schizophrenias and Alzheimer’s disease indications.

Recent Business Highlights:

  • Anavex presented Phase 2 clinical biomarker data from the ANAVEX®2-73-PDD-001 Parkinson’s Disease Dementia (PDD) study at the AD/PDTM 2022 International Conference on Alzheimer’s & Parkinson’s Diseases and related neurological disorders in Barcelona, Spain, March 15–20, 2022.
  • Anavex announced presentations of Psychometric Evaluation of the Rett Syndrome Behaviour Questionnaire (RSBQ) and Burden of Illness (BOI) study in Rett syndrome by the respective working groups, at the 2022 International Rett Syndrome Foundation (IRSF) Rett Syndrome Scientific Meeting in Nashville, TN, April 26–27, 2022.

Financial Highlights:

  • Continued fiscal responsible management of cash utilization.
  • Cash and cash equivalents of $153.3 million on March 31, 2022, compared to $152.1 million at fiscal year end September 30, 2021.
  • Net loss of $10.4 million, or $0.14 per share for the quarter compared to net loss of $8.1 million, or $0.12 per share for the comparable quarter of fiscal 2021.
  • Research and development expenses of $8.6 million compared to $6.7 million for the comparable quarter of fiscal 2021.
  • General and administrative expenses of $2.9 million compared to $2.2 million for the comparable quarter of fiscal 2021.

The financial information for the fiscal quarter ended March 31, 2022, should be read in conjunction with the Company’s 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.

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 reference passcode 911357. 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 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), has successfully completed a Phase 2a 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 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 M1 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.  
Interim Condensed Consolidated Statements of Operations and Comprehensive Loss  
For the three months ended March 31, 2022 and 2021  
(Unaudited)  
Expressed in US Dollars      
    2022     2021    
Operating Expenses      
General and administrative $ 2,915,158   $ 2,233,745    
Research and development   8,604,589     6,720,841    
Total operating expenses   (11,519,747 )   (8,954,586 )  
       
Other income (expenses)      
Grant income   -     10,820    
Research and development incentive income   835,513     960,879    
Interest income, net   7,578     9,216    
Foreign exchange gain (loss), net   268,645     (154,563 )  
Total other income, net   1,111,736     826,352    
Net loss before provision for income taxes   (10,408,011 )   (8,128,234 )  
Income tax expense, current   (29,800 )   (26,988 )  
Net loss and comprehensive loss $ (10,437,811 ) $ (8,155,222 )  
       
Net loss per share      
Basic and diluted $ (0.14 ) $ (0.12 )  
       
Weighted average number of shares outstanding    
Basic and diluted   76,248,603     68,594,867    
       

Anavex Life Sciences Corp.  
Interim Condensed Consolidated Statements of Operations and Comprehensive Loss  
For the six months ended March 31, 2022 and 2021  
(Unaudited)  
   
Expressed in US Dollars      
    2022     2021    
Operating Expenses      
General and administrative $ 5,982,109   $ 3,704,401    
Research and development   17,261,028     14,646,360    
Total operating expenses   (23,243,137 )   (18,350,761 )  
       
Other income (expenses)      
Grant income   -     10,820    
Research and development incentive income   1,646,243     2,230,195    
Interest income, net   12,488     7,657    
Foreign exchange gain (loss), net   324,008     178,071    
Total other income, net   1,982,739     2,426,743    
Net loss before provision for income taxes   (21,260,398 )   (15,924,018 )  
Income tax expense, current   (59,780 )   (86,269 )  
Net loss and comprehensive loss $ (21,320,178 ) $ (16,010,287 )  
       
Net loss per share      
Basic and diluted $ (0.28 ) $ (0.24 )  
       
Weighted average number of shares outstanding    
Basic and diluted   76,121,792     66,421,380    
       

Anavex Life Sciences Corp.  
Interim Condensed Consolidated Balance Sheets  
Unaudited  
Expressed in US Dollars      
  March 31, September 30,  
    2022     2021    
Assets      
Current      
Cash and cash equivalents $ 153,342,556   $ 152,107,745    
Incentive and tax receivables   6,468,987     9,136,831    
Prepaid expenses and other current assets   464,605     371,914    
Total Assets $ 160,276,148   $ 161,616,490    
       
Liabilities and stockholders' equity      
Current Liabilities      
Accounts payable $ 2,631,888   $ 4,739,781    
Accrued liabilities   4,995,388     5,614,774    
Deferred grant income   443,831     443,831    
Total Liabilities   8,071,107     10,798,386    
Capital Stock   77,163     75,920    
Additional paid-in capital   371,437,616     348,328,048    
Share proceeds receivable   (403,696 )   -    
Accumulated deficit   (218,906,042 )   (197,585,864 )  
Total Stockholders' Equity   152,205,041     150,818,104    
Total Liabilities and Stockholders' Equity $ 160,276,148   $ 161,616,490    
       

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 

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