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 2020 second quarter.

“We are pleased to report that we are approaching the conclusion of the double-blind Phase 2 Parkinson’s disease dementia trial with ANAVEX®2-73 (blarcamesine) and we expect to report top line results by mid-2020,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “Both the Alzheimer’s disease Phase 2b/3 trial and clinical Rett syndrome programs are also proceeding as planned. Our focus on Precision Medicine studies for neurological disorders remains persistent.”

Program Updates:

  • Enrollment for the two randomized, double-blind, placebo-controlled Phase 2 ANAVEX®2-73 (blarcamesine) U.S. Phase 2 Rett syndrome trial1 and the AVATAR Rett syndrome trial2 each have surpassed the 50% mark and continue to enroll.
  • Despite the outbreak of COVID-19, all clinical trial programs continue to proceed. While Rett syndrome protocols have always by default allowed at-home visits, Anavex implemented contingency plans as recommended by local regulatory authorities for the Phase 2b/3 ANAVEX®2-73 (blarcamesine) Alzheimer’s disease (AD) study3 and the Phase 2 study in Parkinson’s Disease Dementia (PDD) study4 to ensure remote or virtual assessments for all active patients and all respective extension studies. Because ANAVEX®2-73 (blarcamesine) is an oral formulation, study participants are able to receive shipments of their study medication in a controlled and compliant fashion, and direct-to-patient delivery is occurring in multiple countries.
  • In January 2020, Anavex announced achieving the enrollment target for the ANAVEX®2-73 (blarcamesine) Phase 2 study in Parkinson’s disease dementia (PDD). Topline results from this randomized, double-blind, placebo-controlled study are expected by mid-2020.
  • In February 2020, Anavex announced a publication in the peer-reviewed Journal of Neuroimmunology titled “Sigma-1 Receptor Agonists as Potential Protective Therapies in Multiple Sclerosis“ featuring preclinical data of ANAVEX®2-73 (blarcamesine) relevant to multiple sclerosis.
  • In April 2020, Anavex announced a publication in the peer-reviewed journal Alzheimer’s & Dementia: Translational Research & Clinical Interventions, entitled, “A precision medicine framework using Artificial Intelligence for the identification and confirmation of genomic biomarkers of response to an Alzheimer’s disease therapy: Analysis of the Blarcamesine (ANAVEX2-73) Phase 2a clinical study” highlights the relevance of phenotypic and genotypic precision medicine analyses of Whole Exome Sequencing (WES) and gene expression (RNAseq) data in drug development and in particular the potential to identify patients’ genetic variants and gene expression changes that may predict increased chances of success of Alzheimer’s disease treatments.

Financial Highlights:

  • Cash and cash equivalents of $26.6 million at March 31, 2020, compared to $22.2 million at fiscal year ended September 30, 2019.
  • Research and development expenses of $6.1 million for both the current quarter as well as the comparable quarter in 2019. 
  • General and administrative expenses of $1.7 million for the quarter as compared to $2.1 million for the comparable quarter in 2019.
  • Net loss of $7.2 million, or $0.12 per share for the quarter, compared to net loss of $7.2 million, or $0.15 per share in the comparable quarter of 2019.

The financial information for the fiscal quarter ended March 31, 2020 should be read in conjunction with the Company’s consolidated interim financial statements, which will appear on EDGAR, www.sec.gov and will be available on the Anavex website at www.anavex.com.

Conference Call / Webcast Information

Anavex will host a conference call and webcast today at 4:30 p.m. ET.

The live webcast of the conference call can be accessed online at http://www.wsw.com/webcast/cc/avxl13.

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 49673201, followed by the pound sign (#).

A replay of the conference call will also be available on 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 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 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 mitochondrial dysfunction and neuroinflammation. 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  
As at March 31, 2020 and September 30, 2019  
Expressed in US Dollars      
  March 31, 2020 September 30, 2019  
  (Unaudited)    
ASSETS      
Current      
Cash and cash equivalents $ 26,563,071   $ 22,185,630    
Incentives and taxes receivable   4,151,947     2,642,745    
Prepaid expenses and deposits   305,559     500,998    
Total assets $ 31,020,577   $ 25,329,373    
       
LIABILITIES AND STOCKHOLDERS' EQUITY      
Current      
Accounts payable $ 3,649,734   $ 3,523,332    
Accrued liabilities   2,579,097     1,516,342    
Total liabilities   6,228,831     5,039,674    
Common stock   58,666     52,652    
Additional paid-in capital   171,958,462     153,633,807    
Accumulated deficit   (147,225,382 )   (133,396,760 )  
Total stockholders' equity   24,791,746     20,289,699    
Total liabilities and stockholders' equity $ 31,020,577   $ 25,329,373    
       

       
ANAVEX LIFE SCIENCES CORP.  
CONDENSED CONSOLIDATED INTERIM STATEMENT OF OPERATIONS  
THREE MONTHS ENDED MARCH 31, 2020 and 2019  
(Unaudited)  
Expressed in US Dollars      
    2020     2019    
Operating Expenses      
General and administrative $ 1,720,142   $ 2,061,251    
Research and development   6,053,047     6,078,786    
Total operating expenses   7,773,189     8,140,037    
       
Operating Loss   (7,773,189 )   (8,140,037 )  
Other income      
Grant income   74,944     74,527    
Research and development incentive income   717,328     760,990    
Interest income, net   70,180     51,465    
Foreign exchange gain (loss)   (325,960 )   54,199    
Total other income   536,492     941,181    
Net loss before income taxes   (7,236,697 )   (7,198,856 )  
Income tax expense - current   -     (48,048 )  
Net loss $ (7,236,697 ) $ (7,246,904 )  
       
Net loss per Share      
Basic and Diluted $ (0.12 ) $ (0.15 )  
       
Weighted Average Number of Shares Outstanding    
Basic and Diluted   58,353,954     47,134,686    

       
ANAVEX LIFE SCIENCES CORP.  
CONSOLIDATED STATEMENT OF OPERATIONS  
SIX MONTHS ENDED MARCH 31, 2020 AND 2019  
(Unaudited)  
Expressed in US Dollars      
    2020     2019    
Operating Expenses      
General and administrative $ 3,072,176   $ 3,822,559    
Research and development   12,401,715     11,790,996    
Total operating expenses   15,473,891     15,613,555    
       
Other income      
Grant income   149,888     149,055    
Research and development incentive income   1,660,543     1,174,672    
Interest income, net   116,900     130,265    
Foreign exchange gain (loss)   (272,848 )   49,693    
Total other income   1,654,483     1,503,685    
Net loss before income taxes   (13,819,408 )   (14,109,870 )  
Income tax expense - current   (9,214 )   (56,765 )  
Net loss $ (13,828,622 ) $ (14,166,635 )  
       
Net loss per Share      
Basic and Diluted $ (0.24 ) $ (0.30 )  
       
Weighted Average Number of Shares Outstanding    
Basic and Diluted   56,554,037     46,726,649    
               
               

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: NCT037589242 ClinicalTrials.gov Identifier: NCT039414443 ClinicalTrials.gov Identifier: NCT037907094 ClinicalTrials.gov Identifier: NCT03774459

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