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Anavex Life Sciences Reports Fiscal Third Quarter 2018 Financial Results

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

NEW YORK, Aug. 09, 2018 (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, Rett syndrome and other central nervous system (CNS) diseases, today reported financial results for its third fiscal quarter ended June 30, 2018.

Financial Highlights:

  • Cash and equivalents of $25.8 million at June 30, 2018, compared to $27.4 million at September 30, 2017.
  • Cash used to fund operations in the third fiscal quarter was $2.1 million, which is net of grant and research and development incentive income of $1.7 million, compared to $3.0 million for the comparative quarter last year. This is in line with the Company’s cash utilization guidance.
  • Operating expenses in the third fiscal quarter of $4.6 million compared to $3.7 million for the comparative quarter last year. This increase was a result of increased spending on research and development, related to clinical trial preparatory activities, as well as an expanded scientific team.
  • Net loss for the third fiscal quarter of $2.8 million, or $0.06 per share, compared to a net loss of $3.6 million, or $0.04 per share for the comparative quarter.

“In order to identify the key biomarkers for the design of our late-stage CNS precision medicine trials, we have taken a data driven, hypothesis free approach to the systematic analysis of our ongoing Phase 2a trial in Alzheimer’s disease. Using the Artificial Intelligence (AI) technology KEM, the relation between all parameters, both clinical and genomic, and their impact on outcome was ranked in an unbiased mode,” said Christopher U Missling, PhD President and Chief Executive Officer of Anavex. “We believe this unbiased and systematic approach to identifying our biomarkers is likely to increase the chance of success in our follow-up, genomic marker driven late-stage CNS precision medicine trials in Parkinson’s disease dementia, Alzheimer’s disease and Rett syndrome.”
                                                                                                                                                                   
Recent Corporate Highlights:

  • July 25, 2018 – Anavex reported the results of an entire genome DNA and RNA evaluation of study participants in a 57-week Phase 2a Alzheimer’s disease study investigating ANAVEX®2-73, a selective sigma-1 receptor agonist, resulting in the analysis of 33,311 genes and 860 pathways. Additionally, direct target occupancy of ANAVEX®2-73 at the sigma-1 receptor using quantitative Positron emissions tomography (PET) scanning was presented.
     
  • July 9, 2018 – Anavex announced that it had received approval from the Spanish Agency for Medicinal Products and Medical Devices (AEMPS) to initiate its Phase 2, double-blind, placebo-controlled 14-week trial of the safety and efficacy of ANAVEX®2-73 for the treatment of Parkinson’s disease dementia (PDD). 
     
  • July 3, 2018 – Anavex announced that the Company had received approval by the Australian Human Research Ethics Committee to initiate its Phase 2b/3 double-blind, randomized, placebo-controlled, 48-week safety and efficacy trial of ANAVEX®2-73 for the treatment of Alzheimer’s disease.

The financial information for fiscal quarter ended June 30, 2018, should be read in conjunction with the Company’s condensed 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

Anavex will host a conference call at 4:30 p.m. ET today, August 9, 2018.

The live webcast of the conference call can be accessed online at http://www.wsw.com/webcast/cc/avxl6/. To listen to the live call by phone, 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 47394949. A replay of the call will be available approximately one hour after the end of the call at 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 diseases including Alzheimer’s disease, 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 
     
  June 30,September 30, 
 ASSETS 2018  2017  
 Current   
 Cash and cash equivalents$  25,827,592 $  27,440,257  
 Sales tax recoverable   6,145    9,748  
 Prepaid expenses and deposits   858,560    335,928  
 Deferred financing charges   50,000    -  
 Total current assets   26,742,297    27,785,933  
 Deposits   52,396    52,396  
 Total assets$  26,794,693 $  27,838,329  
     
 LIABILITIES AND STOCKHOLDERS' EQUITY   
 Current   
 Accounts payable and accrued liabilities $  3,209,070 $  3,584,334  
 Total liabilities   3,209,070    3,584,334  
 Common stock   45,315    43,332  
 Additional paid-in capital   126,679,219    115,689,221  
 Accumulated deficit   (103,138,911)   (91,478,558) 
 Total stockholders' equity   23,585,623    24,253,995  
 Total liabilities and stockholders' equity$  26,794,693 $  27,838,329  
     

 

     
 ANAVEX LIFE SCIENCES CORP. 
 CONDENSED CONSOLIDATED INTERIM STATEMENT OF OPERATIONS 
 THREE MONTHS ENDED JUNE 30, 2018 AND 2017 
 (Unaudited) 
     
   2018  2017  
 Operating Expenses   
 General and administrative$  1,620,379 $  1,405,026  
 Research and development   2,997,634    2,300,277  
 Total operating expenses   4,618,013     3,705,303   
     
 Operating Loss   (4,618,013)   (3,705,303) 
 Other income   
 Grant income   74,528    69,146  
 Research and development incentive income   1,629,513    -  
 Interest income, net   112,226    26,677  
 Gain on settlement of accounts payable   -     75,204  
 Financing related charges   (30,943)  
 Foreign exchange gain (loss)   (16,475)   (65,932) 
 Total other income    1,768,849     105,095   
 Net loss before income taxes   (2,849,164)   (3,600,208) 
 Income tax expense - current   -    (9,877) 
 Net loss$   (2,849,164)$   (3,610,085) 
     
 Net loss per Share   
 Basic and Diluted$  (0.06)$  (0.09) 
     
 Weighted Average Number of Shares Outstanding  
 Basic and Diluted   45,212,074    41,509,225  

 

    
 ANAVEX LIFE SCIENCES CORP.
 CONDENSED CONSOLIDATED INTERIM STATEMENT OF OPERATIONS
 NINE MONTHS ENDED JUNE 30, 2018 AND 2017
 (Unaudited)
    
   2018  2017 
 Operating Expenses  
 General and administrative$  4,507,632 $  3,647,224 
 Research and development   8,936,969    6,835,700 
 Total operating expenses   13,444,601     10,482,924  
    
 Operating Loss   (13,444,601)   (10,482,924)
 Other income (expenses)  
 Grant income   74,528    121,116 
 Research and development incentive income   1,629,513    2,022,902 
 Interest income, net   171,249    48,479 
 Gain on settlement of accounts payable   -    75,204 
 Financing related charges   (30,943)   - 
 Foreign exchange gain (loss)   (22,833)   (40,128)
 Total other income   1,821,514     2,227,573  
 Net loss before income taxes   (11,623,087)   (8,255,351)
 Income tax expense - current   (37,266)   (50,480)
 Net loss$   (11,660,353)$   (8,305,831)
    
 Net loss per Share  
 Basic and Diluted$  (0.26)$  (0.21)
    
 Weighted Average Number of Shares Outstanding 
 Basic and Diluted   44,365,683    40,344,149 


For Further Information:

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

Investors:
Scott Gordon
Core IR
scottg@coreir.com

Thursday, August 9, 2018 - 07:00