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 year ended September 30, 2022.

“This is an exciting time in neuroscience and rare disease drug development and we 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. “Our recent progress highlights the potential of our clinical Precision Medicine SIGMAR1 platform and portfolio, and we look forward to sharing additional program and data updates.”

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

  • Late breaking oral communication presentation of top line data of randomized, double-blind, multicenter, placebo-controlled Phase 2b/3 study ANAVEX®2-73-AD-004 for the treatment of early Alzheimer’s disease at the upcoming Clinical Trials on Alzheimer’s Disease (CTAD) Congress 2022, December 1, 2022, at 4:30pm PT in San Francisco, CA.
  • Nearing the enrollment 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.
  • Guidance received from the FDA confirms the Company’s strategy to advance ANAVEX®2-73 for the treatment of Fragile X syndrome in a double-blind, randomized, placebo-controlled Phase 2/3 development program.
  • Upcoming 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:
    • Meeting with FDA to discuss 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 Phase 2/3 clinical trial for the treatment of a new rare-disease indication.
    • Planned initiation of ANAVEX®3-71 Phase 2 clinical trial for schizophrenia.

Recent Business Highlights:

  • Anavex announced a peer-reviewed publication in the journal of Science Translational Medicine, titled “Widespread cell stress and mitochondrial dysfunction occur in patients with early Alzheimer’s disease”, which provided further scientific evidence of the relevance of sigma-1 receptor (SIGMAR1) activation as a compensatory mechanism to chronic CNS diseases.
  • Anavex announced that the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 11,446,275 to Anavex, with claims to treatment methods using its leading drug candidate, ANAVEX®2-73 (blarcamesine) and its analogs, for ameliorating biochemical and functional abnormalities associated with methyl-CpG binding protein 2 defects (MeCP2 defects). Such defects encompass a range of neurodevelopmental and neurological disorders, including but not limited to, Rett syndrome, Angelman syndrome, Williams syndrome, cerebral palsy, autism spectrum disorder, and multiple sclerosis.
  • Anavex announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to ANAVEX®2-73 (blarcamesine) for the treatment of Fragile X syndrome. Fragile X syndrome is the most common form of inherited intellectual disability and the most frequent single gene cause of autism spectrum disorder with an estimated population of approximately 62,500 in the US and 1,088,500 worldwide.1

Financial Highlights:

  • Cash and cash equivalents of $149.2 million at September 30, 2022, compared to $152.1 million at September 30, 2021.
  • Net loss for the fourth quarter of $14.3 million, or $0.18 per share, compared to a net loss of $11.7 million, or $0.15 per share for the same period in fiscal 2021.
  • Net loss for the full fiscal year ended September 30, 2022 of $48.0 million, or $0.62 per compared to net loss of $37.9 million, or $0.54 per share for the full fiscal 2021 year.
  • Research and development expenses for the fourth quarter of $11.4 million compared to $9.4 million for the same period in fiscal 2021.
  • General and administrative expenses of $3.9 million for fiscal 2022 compared to $2.9 million for the comparable quarter of fiscal 2021.

The financial information for the fiscal year ended September 30, 2022, should be read in conjunction with the Company’s 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:

Management will host a conference call today at 8:30 am ET. 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 511901. A replay of the conference call will also be available on Anavex’s website for up to 30 days.

Economic Burden of Alzheimer’s Disease2

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 M1 muscarinic 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.
Consolidated Statements of Operations and Comprehensive Loss
(Unaudited - Expressed in US Dollars)
 
    Three months ended September 30, Years ended September 30,
           
      2022     2021     2022     2021  
Operating Expenses          
General and administrative   $ 3,902,508   $ 2,878,983   $ 13,070,068   $ 9,017,511  
Research and development     11,381,450     9,372,786     37,915,747     32,983,674  
Total operating expenses     15,283,958     12,251,769     50,985,815     42,001,185  
Operating loss     (15,283,958 )   (12,251,769 )   (50,985,815 )   (42,001,185 )
                           
Other income (expenses)                          
Grant income     -     -     -     54,100  
Research and development incentive income     994,336     953,243     3,323,011     4,547,099  
Interest income, net     704,583     7,151     946,988     26,261  
Foreign exchange (loss) gain, net     (495,070 )   (284,535 )   (903,611 )   (267,344 )
Total other income, net     1,203,849     675,859     3,366,388     4,360,116  
Net loss before provision for income taxes     (14,080,109 )   (11,575,910 )   (47,619,427 )   (37,641,069 )
Income tax expense, current     (210,291 )   (142,296 )   (358,492 )   (267,565 )
Net loss and comprehensive loss   $ (14,290,400 ) $ (11,718,206 ) $ (47,977,919 ) $ (37,908,634 )
           
Net loss per share          
Basic and diluted   $ (0.18 ) $ (0.15 ) $ (0.62 ) $ (0.54 )
           
Weighted average number of shares outstanding              
Basic and diluted     77,442,470     75,714,558     76,909,993     69,802,960  

   
Anavex Life Sciences Corp.  
Consolidated Balance Sheets  
At September 30, 2022 and 2021  
Expressed in US Dollars        
      2022     2021    
Assets        
Current        
Cash and cash equivalents   $ 149,157,861   $ 152,107,745    
Incentive and tax receivables     3,192,580     9,136,831    
Prepaid expenses and other current assets     354,162     371,914    
Total Assets   $ 152,704,603   $ 161,616,490    
         
Liabilities and stockholders' equity        
Current Liabilities        
Accounts payable   $ 3,824,777   $ 4,739,781    
Accrued liabilities     5,944,953     5,614,774    
Deferred grant income     443,831     443,831    
Total Liabilities     10,213,561     10,798,386    
Capital Stock     77,944     75,920    
Additional paid-in capital     387,976,881     348,328,048    
Accumulated deficit     (245,563,783 )   (197,585,864 )  
Total Stockholders' Equity     142,491,042     150,818,104    
Total Liabilities and Stockholders' Equity   $ 152,704,603   $ 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

____________________________1 https://fragilex.org/understanding-fragile-x/fragile-x-101/prevalence/2 W Wong Economic Burden of Alzheimer Disease and Managed Care Considerations Am J Manag Care. 2020;26:S177-S183

 

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