Market Overview

Anavex Life Sciences Reports Fiscal Second Quarter 2018 Financial Results

Share:

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

NEW YORK, May 10, 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 the second fiscal quarter ended March 31, 2018.

Clinical Update:

  • The Phase 2a Alzheimer's extension study ANAVEX®2-73-003 has been approved by the Ethics Committee in Australia to continue for a further 104 weeks, i.e. additional two (2) years per request by patients, their caregivers and physicians. The ANAVEX®2-73-003 extension study was the continuation of the 57-week ANAVEX®2-73-002 study and is designed to allow participants who complete the first 104 week extension to continue taking ANAVEX®2-73 for an additional 104 weeks, providing an opportunity to gather extended five (5) years of cumulative safety and tolerability data for orally daily dosed ANAVEX®2-73. The further extension is in addition and independent of the Company's planned larger Phase 2/3 double-blinded, placebo-controlled study of ANAVEX®2-73 in Alzheimer's disease.

Financial Highlights:

  • Cash and equivalents of $25.7 million at March 31, 2018, compared to $27.4 million at September 30, 2017.

  • Cash used to fund operations in the second fiscal quarter was $2.8 million, compared to $0.7 million for the comparative quarter last year. This is in line with the Company's cash utilization guidance.

  • Operating expenses in the second fiscal quarter of $4.7 million compared to $3.6 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.

  • Net loss for the second fiscal quarter of $4.8 million, or $0.11 per share, compared to a net loss of $1.5 million, or $0.04 per share for the comparative quarter.

"We are looking forward, focusing on executing clinical trials using the inclusion of advanced genomic biomarkers into late-stage CNS precision medicine trials, including our Rett syndrome, Alzheimer's disease and Parkinson's disease dementia trials – all indications with high unmet need," said, Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex.
                                                                                                                                                                   
Recent Corporate Highlights:

  • April 17, 2018 – Anavex announced that the Company had submitted to regulatory authorities in Europe a Phase 2 Parkinson's disease dementia study and, pending approval, the Company plans to initiate this clinical trial in calendar H2 2018.
     
  • March 7, 2018 – Anavex announced new data for ANAVEX®2-73 in a genetic mouse model of Tuberous Sclerosis Complex (TSC), a rare genetic disorder characterized by the growth of numerous benign tumors in many parts of the body with a high incidence of seizures. The new preclinical data demonstrate that treatment with ANAVEX®2-73 significantly increases survival and reduces seizures.
     
  • March 5, 2018 –Stephan Toutain, MS, MBA joined Anavex as Senior Vice President Operations and Claus van der Velden, PhD was appointed to the Board of Directors.

The financial information for fiscal quarter ended March 31, 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, May 10, 2018.

The live webcast of the conference call can be accessed online at http://www.wsw.com/webcast/cc/avxl5. 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 46931087. 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 to develop ANAVEX®2-73 for the treatment of Parkinson's disease. The grant fully funded a preclinical study, which could justify moving ANAVEX®2-73 into a Parkinson's disease clinical trial. 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
     
  March 31, September 30,
ASSETS 2018 2017
Current    
Cash and cash equivalents $ 25,656,584   $ 27,440,257  
Sales tax recoverable   5,011     9,748  
Prepaid expenses and deposits   150,660     335,928  
Total current assets   25,812,255     27,785,933  
Deposits   52,396     52,396  
Deferred financing charges   30,943     -  
Total assets $ 25,895,594   $ 27,838,329  
     
LIABILITIES AND STOCKHOLDERS' EQUITY    
Current    
Accounts payable and accrued liabilities $ 3,416,737   $ 3,584,334  
Total liabilities   3,416,737     3,584,334  
Common stock   44,575     43,332  
Additional paid-in capital   122,724,029     115,689,221  
Accumulated deficit   (100,289,747 )   (91,478,558 )
Total stockholders' equity   22,478,857     24,253,995  
Total liabilities and stockholders' equity $ 25,895,594   $ 27,838,329  
     

 

     
ANAVEX LIFE SCIENCES CORP.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF OPERATIONS
THREE MONTHS ENDED MARCH 31, 2018 AND 2017
(Unaudited)
     
  2018
2017
Operating Expenses    
General and administrative $ 1,489,450   $ 1,116,014  
Research and development   3,245,023     2,492,933  
Total operating expenses     4,734,473       3,608,947  
     
Operating Loss     (4,734,473 )     (3,608,947 )
Other income    
Grant income   -     16,684  
Research and development incentive income   -     2,022,902  
Interest income, net   28,647     18,147  
Foreign exchange gain (loss)   (18,337 )   11,722  
Total other income      10,310       2,069,455  
Net loss before income taxes   (4,724,163 )   (1,539,492 )
Income tax expense - current   (27,861 )   (9,595 )
Net loss $    (4,752,024 ) $    (1,549,087 )
     
Net loss per Share    
Basic and Diluted $ (0.11 ) $ (0.04 )
     
Weighted Average Number of Shares Outstanding  
Basic and Diluted   44,545,523     41,159,707  
     

 

     
ANAVEX LIFE SCIENCES CORP.
CONSOLIDATED INTERIM STATEMENTS OF OPERATIONS
SIX MONTHS ENDED MARCH 31, 2018 AND 2017
(Unaudited)
     
  2018 2017
Operating Expenses    
General and administrative $ 2,887,253   $ 2,242,198  
Research and development   5,939,335     4,535,423  
Total operating expenses     8,826,588       6,777,621  
     
Operating Loss     (8,826,588 )     (6,777,621 )
Other income (expenses)    
Grant income   -     51,970  
Research and development incentive income   -     2,022,902  
Interest income, net   59,023     21,802  
Foreign exchange gain (loss)   (6,358 )   25,804  
Total other income     52,665       2,122,478  
Net loss before income taxes   (8,773,923 )   (4,655,143 )
Income tax expense - current   (37,266 )   (40,603 )
Net loss $    (8,811,189 ) $    (4,695,746 )
     
Net loss per Share    
Basic and Diluted $ (0.20 ) $ (0.12 )
     
Weighted Average Number of Shares Outstanding  
Basic and Diluted   44,210,591     39,761,612  
     

For Further Information:

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

Investors & Media:
Meggie Purcell
Solebury Trout
mpurcell@soleburytrout.com

Primary Logo

View Comments and Join the Discussion!