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Anavex Life Sciences Provides Business Update and Reports Fiscal 2021 Third Quarter Financial Results

  • Total of 509 Patients Enrolled in Confirmatory Late-stage Precision Medicine ANAVEX®2-73 (blarcamesine) Phase 2b/3 Clinical Trial in Patients with Alzheimer’s Disease

  • Exceeding of Enrollment Target for the Precision Medicine ANAVEX®2-73 (blarcamesine) Phase 2/3 AVATAR Clinical Trial in Patients with Rett Syndrome

  • Current Cash Position of $157.6 million

  • Webcast and Conference Call Today at 4:30 p.m. EDT

NEW YORK, Aug. 12, 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 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, 2021.

“We are pleased with the rigorous and efficient execution of the confirmatory late-stage Precision Medicine ANAVEX®2-73 Phase 2b/3 randomized, double-blind, placebo-controlled clinical trial with a total of 509 patients with Alzheimer’s disease and are excited to be able to provide top-line data by 2H 2022. The steadfast clinical trial execution capabilities of the Anavex team also extend to the Precision Medicine ANAVEX®2-73 Phase 2/3 AVATAR clinical trial in patients with Rett syndrome, which exceeded the enrollment target, and currently topline results from this study are expected by 2H 2021,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “We are excited about the potential of our SIGMAR1 platform, and we continue working to advance new programs to the clinic, all with the aim of meeting the unmet clinical needs of patients with both degenerative and developmental neurological disorders around the world.”

Recent Business Highlights:

  • On May 25, 2021, Anavex announced the appointment of Ms. Jiong Ma, PhD to its Board of Directors. Ms. Ma is a Senior Board executive with over 25 years of experience in investing, building, and scaling of companies with a focus on innovative product launches in digital health, technology, and new energy transition.
  • On June 8, 2021, Anavex announced that it exceeded its enrollment target for the confirmatory late-stage ANAVEX®2-73 Phase 2b/3 randomized, double-blind, placebo-controlled trial in Alzheimer’s disease. The Company expects to announce topline results from this study by 2H 2022.
  • On June 21, 2021, Anavex reported complete data from its ANAVEX®2-73 U.S. Rett syndrome Phase 2 study. Predictive biomarker of response established with SIGMAR1 mRNA expression correlates significantly with responses in primary clinical efficacy endpoints from the U.S. Phase 2 randomized, double-blind, placebo-controlled trial of ANAVEX®2-73 in patients with Rett syndrome.
  • On June 24, 2021, Anavex announced the closing of $50 million registered direct offering to Deep Track Capital, an investment firm focused exclusively on the life sciences industry.
  • On June 28, 2021, Anavex reported complete data from its ANAVEX®2-73 Parkinson’s disease dementia (PDD) Phase 2 study. Predictive biomarker of response established with SIGMAR1 mRNA expression correlates significantly with responses in primary and secondary clinical efficacy endpoints from the proof-of-concept randomized, double-blind, placebo-controlled Phase 2 trial of 132 patients with Parkinson’s disease dementia.
  • Further clinical milestones are provided in Anavex Life Sciences’ latest corporate presentation, available on www.anavex.com.

Financial Highlights:

  • Cash and cash equivalents of $157.6 million on June 30, 2021, an increase of over $128 million compared to $29.2 million from September 30, 2020.
  • Net loss of $10.2 million, or $0.14 per share for the quarter, compared to net loss of $6.5 million, or $0.11 per share in comparative quarter of fiscal 2020.
  • Research and development expenses of $9.0 million for the quarter, compared to $6.7 million for comparable quarter of fiscal 2020.
  • General and administrative expenses of $2.4 million for the quarter, compared to $1.4 million for comparable quarter of fiscal 2020.

The financial information for the fiscal quarter ended June 30, 2021, 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 can be accessed online at https://wsw.com/webcast/cc/avxl19/1500606.

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 50210582, 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 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), successfully completed a Phase 2a clinical trial for Alzheimer’s disease and recently a Phase 2 proof-of-concept study in Parkinson’s disease dementia and a Phase 2 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 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 
For the three months ended June 30, 2021 and 2020 
(Unaudited) 
Expressed in US Dollars   
  2021  2020  
Operating Expenses   
General and administrative$2,434,127 $1,381,477  
Research and development 8,964,528  6,725,002  
Total operating expenses (11,398,655) (8,106,479) 
    
Other income (expenses)   
Grant income 43,280  -  
Research and development incentive income 1,363,661  1,319,913  
Interest income, net 11,453  56,096  
Foreign exchange gain (loss), net (160,880) 248,665  
Total other income, net 1,257,514  1,624,674  
Net loss before provision for income taxes (10,141,141) (6,481,805) 
Income tax expense, current (39,000) (4,817) 
Net loss and comprehensive loss$ (10,180,141)$ (6,486,622) 
    
Net loss per share   
Basic and diluted$(0.14)$(0.11) 
    
Weighted average number of shares outstanding  
Basic and diluted 70,589,561  59,105,399  
    


ANAVEX LIFE SCIENCES CORP. 
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS 
For the nine months ended June 30, 2021 and 2020 
(Unaudited) 
Expressed in US Dollars   
  2021  2020  
Operating Expenses   
General and administrative$6,138,528 $4,453,654  
Research and development 23,610,888  19,126,717  
Total operating expenses (29,749,416) (23,580,371) 
    
Other income (expenses)   
Grant income 54,100  149,888  
Research and development incentive income 3,593,856  2,980,456  
Interest income, net 19,110  172,996  
Foreign exchange gain (loss), net 17,191  (24,182) 
Total other income, net 3,684,257  3,279,158  
Net loss before provision for income taxes (26,065,159) (20,301,213) 
Income tax expense, current (125,269) (14,031) 
Net loss and comprehensive loss$ (26,190,428)$ (20,315,244) 
    
Net loss per share   
Basic and diluted$(0.39)$(0.35) 
    
Weighted average number of shares outstanding  
Basic and diluted 67,810,774  57,401,387  
    


ANAVEX LIFE SCIENCES CORP. 
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS 
As at June 30, 2021 and September 30, 2020 
Expressed in US Dollars   
 June 30, 2021September 30, 2020 
ASSETS(Unaudited)  
Current    
Cash and cash equivalents$157,560,045 $29,249,018  
Incentive and tax receivables 8,601,258  4,849,340  
Prepaid expenses and deposits 258,198  443,839  
Total Assets$166,419,501 $34,542,197  
    
LIABILITIES AND STOCKHOLDERS' EQUITY  
Current Liabilities   
Accounts payable$4,176,707 $3,989,054  
Accrued liabilities 4,653,234  3,316,574  
Deferred grant income 443,831  -  
Total Liabilities 9,273,772  7,305,628  
Capital Stock 75,151  62,047  
Additional paid-in capital 342,938,236  186,851,752  
Accumulated deficit (185,867,658) (159,677,230) 
Total Stockholders' Equity 157,145,729  27,236,569  
Total Liabilities and Stockholders' Equity$166,419,501 $34,542,197  
    

For Further Information:

Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com

Investors:
Andrew J. Barwicki
Investor Relations
Tel: 516-662-9461
Email: andrew@barwicki.com