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

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

NEW YORK, Feb. 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 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 first quarter.

“We are very pleased with the pace of enrollment for the novel genomic marker driven later-stage CNS precision medicine clinical studies in Parkinson’s disease dementia and Alzheimer’s disease. We are looking forward to continuous updates on enrollment for these studies as we advance into 2019,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex.

ANAVEX®2-73 Program Update:

  • Since enrollment started on October 30, 2018 for the Phase 2 ANAVEX®2-73 Parkinson’s disease dementia (PDD) study1, over one-third of the total patient enrollment target has been achieved to date.
  • Enrollment for the Phase 2b/3 ANAVEX®2-73 Alzheimer’s disease (AD) study2 is proceeding as planned with over 80 patients screened to date.
  • Successfully submitted Phase 2 ANAVEX®2-73 Rett syndrome (RTT) study3 to respective United States Institutional Review Boards (IRB) of the first three clinical trial sites.

1 ClinicalTrials.gov Identifier: NCT03774459
2 ClinicalTrials.gov Identifier: NCT03790709
3 ClinicalTrials.gov Identifier: NCT03758924

Financial Highlights:

  • Cash and equivalents of $20.7 million at December 31, 2018, compared to $22.9 million at September 30, 2018.
  • Cash used to fund operations for first quarter fiscal 2019 was $4.2 million, compared to $3.6 million for the comparative first quarter in fiscal 2018.
  • Operating expenses for first quarter fiscal 2019 of $7.5 million compared to $4.1 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, and non-recurring expenses of approximately $1.0 million associated with large-scale manufacturing of ANAVEX®2-73 in quantities reserved for potential future commercial use.
  • Net loss for the quarter of $7.3 million, or $0.16 per share, compared to a net loss of $4.1 million, or $0.09 per share for the first quarter of fiscal 2018. The fiscal quarter in 2019 contains non-cash expenses of approximately $2.1 million and non-recurring expenses of approximately $1.0 million.

Recent Corporate Highlights:

  • January 2, 2019 – Anavex announced the appointment of Walter E. Kaufmann, MD as Chief Medical Officer (CMO). Dr. Kaufmann’s clinical focus is on developing novel therapies for genetic disorders associated with intellectual disability. A major focus of Dr. Kaufmann’s research has been Rett syndrome, a field where he has published extensively on neurobiology and clinical aspects.

The financial information for the fiscal quarter ended December 31, 2018 should be read in conjunction with the Company’s consolidated 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/avxl8.

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 48199094, 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 DollarsDecember 31,September 30,
ASSETS 2018 2018
Current  
Cash and cash equivalents$  20,715,169 $  22,930,638 
Sales tax recoverable   30,372    40,171 
Prepaid expenses and deposits   1,155,958    1,251,798 
Deferred financing charges   151,133    101,133 
Deposits   43,047    - 
Total current assets   22,095,679    24,323,740 
Deposits   -    52,396 
Total assets$  22,095,679 $  24,376,136 
   
LIABILITIES AND STOCKHOLDERS' EQUITY  
Current  
Accounts payable and accrued liabilities $  4,875,895 $  3,884,626 
Total liabilities   4,875,895    3,884,626 
Common stock   46,888    45,935 
Additional paid-in capital   133,438,276    129,377,542 
Accumulated deficit   (116,265,380)   (108,931,967)
Total stockholders' equity   17,219,784    20,491,510 
Total liabilities and stockholders' equity$  22,095,679 $  24,376,136 
   

 

   
ANAVEX LIFE SCIENCES CORP.
CONDENSED CONSOLIDATED INTERIM STATEMENT OF OPERATIONS
THREE MONTHS ENDED DECEMBER 31, 2018 AND 2017
(Unaudited)
   
  2018  2017 
Operating Expenses  
General and administrative$  1,761,307 $  1,397,803 
Research and development   5,712,210    2,694,312 
Total operating expenses   7,473,517     4,092,115  
   
Operating Loss   (7,473,517)   (4,092,115)
Other income  
Grant income   74,528    - 
Interest income, net   78,800    30,376 
Foreign exchange gain (loss)   (4,507)   11,979 
Total other income    148,821     42,355  
Net loss before income taxes   (7,324,696)   (4,049,760)
Income tax expense - current   (8,717)   (9,405)
Net loss$   (7,333,413)$   (4,059,165)
   
Net loss per Share  
Basic and Diluted$  (0.16)$  (0.09)
   
Weighted Average Number of Shares Outstanding 
Basic and Diluted   46,327,482    43,882,939 
       

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, February 7, 2019 - 07:00