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, 2023.

“We are very excited to be entering a new phase of the Company’s history. For the first time we initiated the process of submitting a Marketing Authorisation application to the European Medicines Agency (EMA) for blarcamesine related to the treatment of Alzheimer’s disease. Relatedly, we are starting to explore possible commercial activities and examining innovative strategies to effectively engage patients, providers and payers,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “There is a high demand from Alzheimer’s disease patients and families for easy access and scalable treatment options. We are striving to work towards presenting a drug that will potentially improve patients' lives with our precision medicine oral blarcamesine, which is intended to reduce the need for complex procedures for the treatment of people with Alzheimer’s disease.”

Key Pipeline Updates:

  • Alzheimer’s disease: Full data from the blarcamesine in Alzheimer’s disease Phase 2b/3 randomized clinical trial will be published in an upcoming peer-reviewed journal. The Company has initiated the process for submitting a Marketing Authorisation application to the European Medicines Agency (EMA) under the Centralised Procedure. The Marketing Authorisation would allow direct market access throughout the European Union for oral blarcamesine for the treatment of Alzheimer’s disease. There are an estimated 7 million people in Europe with Alzheimer’s disease, a number expected to double by 2030, according to the European Brain Council.1
  • Alzheimer’s disease: Ongoing ATTENTION-AD open-label extension 96-week trial.
  • Rett syndrome: On track for top-line data of potentially pivotal ANAVEX®2-73-RS-003 Phase 2/3 EXCELLENCE pediatric clinical trial.
  • Parkinson’s disease: Initiation of ANAVEX®2-73 imaging-focused trial and Phase 2b/3 6 months trial.
  • Schizophrenia: Initiation of ANAVEX®3-71 Phase 2 clinical trial.
  • Fragile X: Initiation of potentially pivotal ANAVEX®2-73 Phase 2/3 clinical trial.
  • New Rare disease: Initiation of potentially pivotal ANAVEX®2-73 Phase 2/3 clinical trial.
  • Publications: Continued clinical publications involving ANAVEX®2-73 and ANAVEX®3-71.

1 https://www.braincouncil.eu/projects/rethinking-alzheimers-disease/

Recent Business Highlights:

  • On November 22, 2023, the Company announced that the United States Patent and Trademark Office (USPTO) granted U.S. Patent No. 11,813,242 entitled “A2-73 AS A THERAPEUTIC FOR INSOMNIA, ANXIETY, AND AGITATION”. This patent expands Anavex’s existing patent coverage of blarcamesine (ANAVEX®2-73), including U.S. Patent No. 11,337,953 to cover Anavex’s leading drug candidate, blarcamesine (ANAVEX®2-73), ANAVEX®1-41 and ANAVEX®19-144, for treating insomnia, anxiety or agitation.
  • On November 20, 2023, the Company announced the initiation of the process for submitting a Marketing Authorisation application under the Centralised Procedure. The Marketing Authorisation would allow direct market access throughout the European Union for oral blarcamesine (ANAVEX®2-73) for the treatment of Alzheimer’s disease.
  • On November 6, 2023, the Company announced the appointment of David Goldberger, RPh, MLS as Senior Vice President Regulatory Affairs. Mr. Goldberger brings over 40 years of pharmacy practice and pharmaceutical industry experience to the Company.
  • On October 25, 2023, the Company announced a new peer-reviewed publication in the journal Neurobiology of Aging, titled “Early treatment with an M1 and sigma-1 receptor agonist prevents cognitive decline in a transgenic rat model displaying Alzheimer-like amyloid pathology”, featuring the orally available small molecule ANAVEX®3-71 (AF710B). This preclinical study describes the potential disease-modifying properties of ANAVEX®3-71 on Alzheimer’s disease pathology as a possible drug candidate for a once daily oral preventive strategy for Alzheimer’s disease.
  • On September 14, 2023, the Company announced that the Phase 2b/3 clinical trial to treat Alzheimer’s disease with blarcamesine (ANAVEX®2-73) demonstrated a statistically significant slowing in cognitive decline associated with Alzheimer's disease. The clinical effect was complemented by two independent biomarkers: A significant reduction in pathological amyloid beta levels in plasma, as well as a significant slowing in the rate of pathological brain volume loss.
  • On September 12, 2023, the Company announced the appointment of Prof. Dr. Marwan N Sabbagh, MD as Chairman of the Scientific Advisory Board. Dr. Sabbagh is a behavioral neurologist in the Alzheimer’s and Memory Disorders Program at Barrow Neurological Institute and is also a professor and the Vice Chair of Research in the Institute’s Department of Neurology. He is board certified in neurology by the American Board of Psychiatry and Neurology and is a fellow of the American Academy of Neurology. Dr. Sabbagh is also a prolific author who has written and edited books on Alzheimer’s disease and has contributed to hundreds of medical and scientific articles.

Financial Highlights:

  • Cash and cash equivalents of $151.0 million at September 30, 2023 compared to $149.2 million at September 30, 2022.
  • General and administrative expenses for the fourth quarter of $2.6 million compared to $3.9 million for the comparable fourth quarter of fiscal 2022.
  • Research and development expenses for the fourth quarter of $10.0 million compared to $11.4 million for the comparable fourth quarter of fiscal 2022.
  • Net loss for the fourth quarter of $10.1 million, inclusive of $3.2 million in non-cash items, or $0.12 per share, compared to a net loss of $14.3 million, inclusive of $6.0 million in non-cash items, or $0.18 per share for the comparable fourth quarter of fiscal 2022.

The financial information for the fiscal year ended September 30, 2023, 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:

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 Meeting ID# 860 5505 7787 and reference passcode 146807. 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 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 and a Phase 2b/3 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 StatementsStatements 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
(in thousands, except share and per share amounts)
 
  Three months ended September 30,
    2023     2022  
Operating Expenses    
General and administrative $ 2,592   $ 3,903  
Research and development   10,061     11,381  
Total operating expenses   12,653     15,284  
Operating loss   (12,653 )   (15,284 )
     
Other income    
Research and development incentive income   670     994  
Interest income, net   1,958     705  
Foreign exchange loss, net   (186 )   (495 )
Total other income, net   2,442     1,204  
Net loss before provision for income taxes   (10,211 )   (14,080 )
Income tax recovery (expense), current   64     (210 )
Net loss and comprehensive loss $ (10,147 ) $ (14,290 )
     
Net loss per share    
Basic and diluted $ (0.12 ) $ (0.18 )
     
Weighted average number of shares outstanding  
Basic and diluted   81,973,250     77,442,470  
             
Anavex Life Sciences Corp.
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
 
  Year ended September 30,
    2023     2022  
Operating Expenses    
General and administrative $ 12,039   $ 13,070  
Research and development   43,717     37,916  
Total operating expenses   55,756     50,986  
Operating loss   (55,756 )   (50,986 )
     
Other income    
Grant income   25     -  
Research and development incentive income   2,718     3,323  
Interest income, net   6,519     947  
Other financing expense   (964 )   -  
Foreign exchange loss, net   (40 )   (904 )
Total other income, net   8,258     3,366  
Net loss before provision for income taxes   (47,498 )   (47,620 )
Income tax expense, current   (7 )   (358 )
Net loss and comprehensive loss $ (47,505 ) $ (47,978 )
     
Net loss per share    
Basic and diluted $ (0.60 ) $ (0.62 )
     
Weighted average number of shares outstanding  
Basic and diluted   79,787,596     76,909,993  
             
Anavex Life Sciences Corp.
Consolidated Balance Sheets
(in thousands, except share and per share amounts)
     
  September 30,
    2023     2022  
Assets    
Current    
Cash and cash equivalents $ 151,024   $ 149,158  
Incentive and tax receivables   2,709     3,193  
Prepaid expenses and other current assets   653     354  
Total Assets $ 154,386   $ 152,705  
     
Liabilities and stockholders' equity    
Current Liabilities    
Accounts payable $ 4,322   $ 3,825  
Accrued liabilities   7,295     5,945  
Deferred grant income   917     444  
Total Liabilities   12,534     10,214  
Capital Stock   82     78  
Additional paid-in capital   434,839     387,977  
Accumulated deficit   (293,069 )   (245,564 )
Total Stockholders' Equity   141,852     142,491  
Total Liabilities and Stockholders' Equity $ 154,386   $ 152,705  
     

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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