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Anavex Life Sciences Reports Fiscal 2019 Third Quarter Financial Results And Provides Clinical Study Updates

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NEW YORK, Aug. 07, 2019 (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 2019 third quarter.

"We remain focused on our core strategic goal of bringing novel biomarker driven CNS precision medicine therapies to patients with devastating rare diseases, as well as the largest unmet medical need of aging population, Alzheimer's and Parkinson disease, as quickly as possible. We are very pleased with the execution of advancing our pipeline and look forward to providing updates on four clinical programs by year end," said, Christopher U Missling, PhD, President and Chief Executive Officer of Anavex.

ANAVEX®2-73 (blarcamesine) Program Update:

  • Enrollments for the U.S. Phase 2 Rett syndrome study1 and the AVATAR Rett syndrome study2 of ANAVEX®2-73 (blarcamesine) are advancing with high priority.
  • The independent Data Safety Monitoring Board (DSMB) for the U.S. Phase 2 Rett syndrome study of ANAVEX®2-73 (blarcamesine) completed its recent pre-planned review of the preliminary Phase 2 efficacy and safety data. Upon review of the most recent data, the DSMB made the recommendation to continue the study without modification.
  • The enrollment of the Phase 2 ANAVEX®2-73 (blarcamesine) Parkinson's disease dementia (PDD) study3 is proceeding well and is getting closer to reach completion. At the request of investigators in order to offer all participants of the clinical study access to ANAVEX®2-73 (blarcamesine) a voluntary extension of this study is in preparation including microbiome assessment.
  • Enrollment for the Phase 2b/3 ANAVEX®2-73 (blarcamesine) Alzheimer's disease (AD) study4 is proceeding as scheduled. At the request of investigators in order to offer all participants of the clinical study access to ANAVEX®2-73 (blarcamesine) a voluntary extension of this study is planned.
  • A recent peer-reviewed scientific publication titled, Neuronal Sigma-1 receptors: signaling functions and protective roles in neurodegenerative diseases, details the mechanism of action of Sigma-1 receptors (S1R) and references ANAVEX®2-73 among the relevant S1R ligands. The paper summarizes: "In conclusion, S1R is incredibly versatile in its ability to foster neuronal homeostasis in the context of several neurodegenerative disorders."5

Financial Highlights:

  • Cash and cash equivalents of $21.2 million at June 30, 2019, compared to $22.9 million at September 30, 2018.
  • Existing cash and cash equivalents, along with existing financial commitments from third parties, are sufficient to meet cash utilization for in excess of two years.
  • Operating expenses for third quarter fiscal 2019 of $7.1 million compared to $4.6 million for the comparative fiscal quarter. Research and development expenses have increased in the current fiscal year as a result of expenses incurred in connection with the advancement of clinical studies for ANAVEX®2-73 (blarcamesine).
  • Net loss for the quarter of $7.1 million, or $0.14 per share, compared to a net loss of $2.8 million, or $0.06 per share for the third quarter of fiscal 2018.

The financial information for the fiscal quarter ended June 30, 2019 should be read in conjunction with the Company's consolidated interim financial statements, which will appear on EDGAR and will be available on the Anavex website at www.anavex.com.

Conference Call / Webcast Information

The live webcast of the conference call can be accessed online at http://www.wsw.com/webcast/cc/avxl10.

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 48906457, followed by the pound sign (#).

A replay of the conference call will also be available on www.anavex.com approximately one hour after the call.

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), recently completed a successful Phase 2a clinical trial for Alzheimer's disease. ANAVEX®2-73 (blarcamesine) 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 (blarcamesine) 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 (blarcamesine) for the treatment of Parkinson's disease. ANAVEX®3-71, which targets sigma-1 and M1 muscarinic receptors, is a promising preclinical 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 neuroinflammation and mitochondrial dysfunction. Further information is available at www.anavex.com. You can also connect with the company on Twitter, Facebook 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.
  CONDENSED CONSOLIDATED INTERIM BALANCE SHEETS
  (Unaudited)
  Expressed in US Dollars    
    June 30,
2019
September 30,
2018
  ASSETS    
  Current    
  Cash and cash equivalents $ 21,249,206   $ 22,930,638  
  Sales tax recoverable   93,314     40,171  
  Prepaid expenses and deposits   459,618     1,251,798  
  Deposits   15,000     -  
  Total current assets   21,817,138     24,222,607  
  Deferred costs   151,133     101,133  
  Deposits   -     52,396  
  Total assets $ 21,968,271   $ 24,376,136  
       
  LIABILITIES AND STOCKHOLDERS' EQUITY    
  Current    
  Accounts payable and accrued liabilities $ 4,336,607   $ 3,884,626  
  Total liabilities   4,336,607     3,884,626  
  Common stock   51,511     45,935  
  Accumulated deficit   (131,347,535 )   (108,931,967 )
  Total stockholders' equity   17,631,664     20,491,510  
  Total liabilities and stockholders' equity $ 21,968,271   $ 24,376,136  
       


         
  ANAVEX LIFE SCIENCES CORP.  
  CONDENSED CONSOLIDATED INTERIM STATEMENT OF OPERATIONS  
  THREE MONTHS ENDED JUNE 30, 2019 AND 2018  
  (Unaudited)  
  Expressed in US Dollars      
      2019     2018    
  Operating Expenses      
  General and administrative $ 1,388,729   $ 1,620,379    
  Research and development   5,758,446     2,997,634    
  Total operating expenses   7,147,175     4,618,013    
         
  Operating Loss   (7,147,175 )   (4,618,013 )  
  Other income      
  Grant income   74,944     74,528    
  Research and development incentive income   -     1,629,513    
  Interest income, net   34,838     112,226    
  Gain on settlement of accounts payable   36,978     -    
  Financing related charges   -     (30,943 )  
  Foreign exchange gain (loss)   (54,546 )   (16,475 )  
  Total other income   92,214     1,768,849    
  Net loss before income taxes   (7,054,961 )   (2,849,164 )  
  Income tax expense - current   (19,300 )   -    
  Net loss $ (7,074,261 ) $ (2,849,164 )  
         
  Net loss per Share      
  Basic and Diluted $ (0.14 ) $ (0.06 )  
         
  Weighted Average Number of Shares Outstanding    
  Basic and Diluted   49,622,465     45,212,074    
         


       
  ANAVEX LIFE SCIENCES CORP.
  CONDENSED CONSOLIDATED INTERIM STATEMENT OF OPERATIONS
  NINE MONTHS ENDED JUNE 30, 2019 AND 2018
  (Unaudited)
  Expressed in US Dollars    
      2019     2018  
  Operating Expenses    
  General and administrative $ 5,211,287   $ 4,507,632  
  Research and development   17,549,442     8,936,969  
  Total operating expenses   22,760,729     13,444,601  
       
  Operating Loss   (22,760,729 )   (13,444,601 )
  Other income    
  Grant income   223,999     74,528  
  Research and development incentive income   -     1,629,513  
  Interest income, net   165,103     171,249  
  Gain on settlement of accounts payable   36,978     -  
  Financing related charges   -     (30,943 )
  Foreign exchange gain (loss)   (4,854 )   (22,833 )
  Total other income   421,226     1,821,514  
  Net loss before income taxes   (22,339,503 )   (11,623,087 )
  Income tax expense - current   (76,065 )   (37,266 )
  Net loss $ (22,415,568 ) $ (11,660,353 )
       
  Net loss per Share    
  Basic and Diluted $ (0.47 ) $ (0.26 )
       
  Weighted Average Number of Shares Outstanding  
  Basic and Diluted   47,691,921     44,365,683  
       

For Further Information:

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

Investors & Media:
Email: ir@anavex.com


1 ClinicalTrials.gov Identifier: NCT03758924 
2 ClinicalTrials.gov Identifier: NCT03941444 
3 ClinicalTrials.gov Identifier: NCT03774459 
4 ClinicalTrials.gov Identifier: NCT03790709 
5 www.frontiersin.org/articles/10.3389/fnins.2019.00862/abstract

Anavex Life Sciences Corp.

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