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Anavex Life Sciences Reports Fiscal 2019 Second Quarter Financial Results and Provides Clinical Study Updates

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

NEW YORK, May 08, 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 diseases including Alzheimer's disease, Parkinson's disease, Rett syndrome and other central nervous system (CNS) diseases, today reported financial results for its fiscal 2019 second quarter.

"We are very pleased with the progress we made related to enrollment for the novel genomic marker driven CNS precision medicine clinical studies in Parkinson's disease dementia and Alzheimer's disease and initiating a second Rett syndrome study," said, Christopher U Missling, PhD, President and Chief Executive Officer of Anavex.

ANAVEX®2-73 Program Update:

  • 70% of the total patient enrollment target has been achieved to date for the Phase 2 ANAVEX®2-73 Parkinson's disease dementia (PDD) study1.
  • Enrollment for the Phase 2b/3 ANAVEX®2-73 Alzheimer's disease (AD) study2 is proceeding as planned with over 20% patients enrolled to date.
  • 40% of the total patient enrollment target has been achieved to date for the Phase 2 ANAVEX®2-73 Rett syndrome (RTT) study3.
  • Anavex received approval by the Australian Human Research Ethics Committee to initiate an approximately 30 patient Phase 2 double-blind, randomized, placebo-controlled, study of ANAVEX®2-73 for the treatment of Rett syndrome, called AVATAR study4. The AVATAR study is scheduled to initiate this quarter.

Financial Highlights:

  • Cash and equivalents of $19.5 million at March 31, 2019, compared to $22.9 million at September 30, 2018.
  • Cash used to fund operations for second quarter fiscal 2019 was $4.3 million, compared to $2.8 million for the comparative second quarter in fiscal 2018.
  • Operating expenses for second quarter fiscal 2019 of $8.1 million compared to $4.7 million for the comparative fiscal quarter. Research and development expenses increased as a result of expenses incurred in connection with the advancement of clinical studies for ANAVEX®2-73.
  • Net loss for the quarter of $8.0 million, or $0.17 per share, compared to a net loss of $4.8 million, or $0.11 per share for the second quarter of fiscal 2018. The fiscal quarter in 2019 contains non-cash expenses of approximately $1.9 million.

The financial information for the fiscal quarter ended March 31, 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/avxl9.

To join the conference call live via telephone, interested parties within the U.S. should dial, toll-free, 1-866-866-1333 and international callers should dial 1-404-260-1421. Please use confirmation number 48595200, 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 diseases 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, recently completed a successful Phase 2a clinical trial for Alzheimer's disease. 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 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 March 31 September 30,
  ASSETS   2019     2018  
  Current    
  Cash and cash equivalents $   19,457,845   $   22,930,638  
  Sales tax recoverable     76,160       40,171  
  Prepaid expenses and deposits     849,642       1,251,798  
  Deferred financing charges     151,133       101,133  
  Deposits     15,000       -  
  Total current assets     20,549,780       24,323,740  
  Deposits     -       52,396  
  Total assets $   20,549,780   $   24,376,136  
       
  LIABILITIES AND STOCKHOLDERS' EQUITY    
  Current    
  Accounts payable and accrued liabilities  $   6,370,604   $   3,884,626  
  Total liabilities     6,370,604       3,884,626  
  Common stock     48,175       45,935  
  Additional paid-in capital     138,696,975       129,377,542  
  Subscriptions receivable     (292,700 )     -  
  Accumulated deficit     (124,273,274 )     (108,931,967 )
  Total stockholders' equity     14,179,176       20,491,510  
  Total liabilities and stockholders' equity $   20,549,780   $   24,376,136  
       

 

         
  ANAVEX LIFE SCIENCES CORP.  
  CONDENSED CONSOLIDATED INTERIM STATEMENT OF OPERATIONS  
  THREE MONTHS ENDED MARCH 31, 2019 AND 2018  
  (Unaudited)  
  Expressed in US Dollars      
      2019     2018    
  Operating Expenses      
  General and administrative $   2,061,251   $   1,489,450    
  Research and development     6,078,786       3,245,023    
  Total operating expenses     8,140,037       4,734,473    
         
  Operating Loss     (8,140,037 )     (4,734,473 )  
  Other income      
  Grant income     74,527       -    
  Interest income, net     51,465       28,647    
  Foreign exchange gain (loss)     54,199       (18,337 )  
  Total other income      180,191       10,310    
  Net loss before income taxes     (7,959,846 )     (4,724,163 )  
  Income tax expense - current     (48,048 )     (27,861 )  
  Net loss $    (8,007,894 ) $    (4,752,024 )  
         
  Net loss per Share      
  Basic and Diluted $   (0.17 ) $   (0.11 )  
         
  Weighted Average Number of Shares Outstanding    
  Basic and Diluted     47,134,686       44,545,523    

 

         
  ANAVEX LIFE SCIENCES CORP.  
  CONDENSED CONSOLIDATED INTERIM STATEMENT OF OPERATIONS  
  SIX MONTHS ENDED MARCH 31, 2019 AND 2018  
  (Unaudited)  
  Expressed in US Dollars      
      2019     2018    
  Operating Expenses      
  General and administrative $   3,822,559   $   2,887,253    
  Research and development     11,790,996       5,939,335    
  Total operating expenses     15,613,555       8,826,588    
         
  Operating Loss     (15,613,555 )     (8,826,588 )  
  Other income      
  Grant income     149,055       -    
  Interest income, net     130,265       59,023    
  Foreign exchange gain (loss)     49,693       (6,358 )  
  Total other income      329,013       52,665    
  Net loss before income taxes     (15,284,542 )     (8,773,923 )  
  Income tax expense - current     (56,765 )     (37,266 )  
  Net loss $    (15,341,307 ) $    (8,811,189 )  
         
  Net loss per Share      
  Basic and Diluted $   (0.33 ) $   (0.20 )  
         
  Weighted Average Number of Shares Outstanding    
  Basic and Diluted     46,726,649       44,210,591    

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: NCT03774459

2 ClinicalTrials.gov Identifier: NCT03790709

3 ClinicalTrials.gov Identifier: NCT03758924

4 ANAVEX®2-73 assessment of safety and efficacy in Rett syndrome patients

Anavex Life Sciences Corp.

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