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

Date : 08/07/2019 @ 11:00AM
Source : GlobeNewswire Inc.
Stock : Anavex Life Sciences Corporation (AVXL)
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Anavex Life Sciences Reports Fiscal 2019 Third Quarter Financial Results And Provides Clinical Study Updates

Anavex Life Sciences (NASDAQ:AVXL)
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6 Months : From Jun 2019 to Dec 2019

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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, 2019September 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 DevelopmentToll-free: 1-844-689-3939Email:  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

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