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 June 30, 2022.

“We are pleased with the progress of our clinical Precision Medicine SIGMAR1 platform pipeline and remain on track for the readout of the placebo-controlled ANAVEX®2-73 Phase 2b/3 Alzheimer’s disease clinical trial, a condition of significant unmet need and economic burden for which there are only limited approved pharmacological treatment options,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “Subsequent data readouts, including the placebo-controlled Phase 2/3 Rett syndrome EXCELLENCE study, which completion is projected by year end as well as initiation of biomarker-driven Precision Medicine clinical studies are expected through the rest of the year as planned.”

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

  • Last patient last visit in the randomized, placebo-controlled Phase 2b/3 study ANAVEX®2-73-AD-004 for the treatment of early Alzheimer’s disease occurred at the end of June 2022 and top line results are expected in the fall of 2022.
  • Last patient last visit of the 48-week open label extension of the Parkinson's Disease Dementia Phase 2 study occurred this quarter and data expected by end of 2022.
  • Completion of the randomized, placebo-controlled EXCELLENCE Phase 2/3 study ANAVEX®2-73-RS-003 for the treatment of pediatric patients with Rett syndrome is expected by end of 2022.
  • Pipeline expansion of the ANAVEX platform using gene biomarkers of response and applying precision medicine for treatment of neurological disorders with high 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 schizophrenia, frontotemporal dementia (FTD) and Alzheimer’s disease indications.

Recent Business Highlights:

  • Anavex presented the first entire clinical human Alzheimer’s disease and Parkinson’s disease gene pathway data from the ANAVEX®2-73-PDD-001 Parkinson’s Disease Dementia (PDD) study at the Alzheimer’s Association International Conference (AAIC), in San Diego, CA on July 31 – August 4, 2022.
  • Anavex presented long-lasting effect of ANAVEX®3-71 preventing cognitive decline in a transgenic rat model of Alzheimer’s disease at the Alzheimer’s Association International Conference (AAIC), in San Diego, CA on July 31 – August 4, 2022.
  • Anavex announced its very first scientific educational video news release of its broad SIGMAR1 platform. The video, published on June 21, 2022 presented an overview of the Company’s biomarker driven precision medicine approach and clinical development programs and was presented by several members of the Anavex management team.
  • Anavex announced a peer-reviewed publication in American Journal of Medical Genetics identifying a blood biomarker for assessing treatment effect of ANAVEX®2-73 in Fragile X syndrome, which provided a strong scientific support for the planned clinical trial of ANAVEX®2-73 in Fragile X syndrome.

Financial Highlights:

  • Cash and cash equivalents of $153.2 million on June 30, 2022, compared to $152.1 million at fiscal year end September 30, 2021.
  • Net loss of $12.4 million, or $0.16 per share for the quarter compared to net loss of $10.2 million, or $0.14 per share for the comparable quarter of fiscal 2021.
  • Research and development expenses of $9.3 million compared to $9.0 million for the comparable quarter of fiscal 2021.
  • General and administrative expenses of $3.2 million compared to $2.4 million for the comparable quarter of fiscal 2021.

The financial information for the fiscal quarter ended June 30, 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.

Economic Burden of Alzheimer’s Disease1

Alzheimer’s disease is the most common cause of dementia and the fifth leading cause of death in adults older than 65 years. The estimated total healthcare costs for the treatment of Alzheimer disease in 2020 is estimated at $305 billion, with the cost expected to increase to more than $1 trillion as the population ages. Most of the direct costs of care for Alzheimer’s disease are attributed to skilled nursing care, home healthcare, and hospice care. Indirect costs of care, including quality of life and informal caregiving, are likely underestimated and are associated with significant negative societal and personal burden.

About Anavex Life Sciences Corp.

Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel 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 June 30, 2022 and 2021  
(Unaudited)  
Expressed in US Dollars      
    2022     2021    
Operating Expenses      
General and administrative $ 3,185,451   $ 2,434,127    
Research and development   9,273,269     8,964,528    
Total operating expenses   (12,458,720 )   (11,398,655 )  
       
Other income (expenses)      
Grant income   -     43,280    
Research and development incentive income   682,432     1,363,661    
Interest income, net   229,917     11,453    
Foreign exchange (loss) gain, net   (732,549 )   (160,880 )  
Total other income, net   179,800     1,257,514    
Net loss before provision for income taxes   (12,278,920 )   (10,141,141 )  
Income tax expense, current   (88,421 )   (39,000 )  
Net loss and comprehensive loss $ (12,367,341 ) $ (10,180,141 )  
       
Net loss per share      
Basic and diluted $ (0.16 ) $ (0.14 )  
       
Weighted average number of shares outstanding          
Basic and diluted   77,442,236     70,589,651    
       
       

Anavex Life Sciences Corp.  
Interim Condensed Consolidated Statements of Operations and Comprehensive Loss  
For the nine months ended June 30, 2022 and 2021  
(Unaudited)  
   
Expressed in US Dollars      
    2022     2021    
Operating Expenses      
General and administrative $ 9,167,560   $ 6,138,528    
Research and development   26,534,297     23,610,888    
Total operating expenses   (35,701,857 )   (29,749,416 )  
       
Other income (expenses)      
Grant income   -     54,100    
Research and development incentive income   2,328,675     3,593,856    
Interest income, net   242,405     19,110    
Foreign exchange (loss) gain, net   (408,541 )   17,191    
Total other income, net   2,162,539     3,684,257    
Net loss before provision for income taxes   (33,539,318 )   (26,065,159 )  
Income tax expense, current   (148,201 )   (125,269 )  
Net loss and comprehensive loss $ (33,687,519 ) $ (26,190,428 )  
       
Net loss per share      
Basic and diluted $ (0.44 ) $ (0.39 )  
       
Weighted average number of shares outstanding          
Basic and diluted   76,561,940     67,810,774    
       

   
Anavex Life Sciences Corp.  
Interim Condensed Consolidated Balance Sheets  
Unaudited  
Expressed in US Dollars      
  June 30, September 30,  
    2022     2021    
Assets      
Current      
Cash and cash equivalents $ 153,199,352   $ 152,107,745    
Incentive and tax receivables   6,559,829     9,136,831    
Prepaid expenses and other current assets   461,963     371,914    
Total Assets $ 160,221,144   $ 161,616,490    
       
Liabilities and stockholders' equity      
Current Liabilities      
Accounts payable $ 3,126,892   $ 4,739,781    
Accrued liabilities   5,913,821     5,614,774    
Deferred grant income   443,831     443,831    
Total Liabilities   9,484,544     10,798,386    
Capital Stock   77,944     75,920    
Additional paid-in capital   381,932,039     348,328,048    
Accumulated deficit   (231,273,383 )   (197,585,864 )  
Total Stockholders' Equity   150,736,600     150,818,104    
Total Liabilities and Stockholders' Equity $ 160,221,144   $ 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 Relations Tel: 516-662-9461 Email: andrew@barwicki.com

______________________________________1 W Wong Economic Burden of Alzheimer Disease and Managed Care Considerations Am J Manag Care. 2020;26:S177-S183

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