Anavex Reports Fiscal Third Quarter 2017 Financial Results

Date : 08/07/2017 @ 7:00AM
Source : GlobeNewswire Inc.
Stock : Anavex Life Sciences Corp. (MM) (AVXL)
Quote : 4.84  0.17 (3.64%) @ 8:00PM

Anavex Reports Fiscal Third Quarter 2017 Financial Results

Anavex Life Sciences Corp. (NASDAQ:AVXL)
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3 Months : From Jul 2017 to Oct 2017

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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 diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer, today reported financial results for the fiscal quarter ended June 30, 2017.

Financial Highlights:

  • Cash and equivalents of $24.8 million at June 30, 2017, compared to $9.2 million at September 30, 2016.
  • Cash used to fund operations was $3.0 million, compared to $2.2 million for the comparative quarter last year. This is in line with the Company’s cash utilization guidance.
  • Operating expenses of $3.7 million compared to $2.3 million for the comparative quarter last year. This increase was a result of increased spending on research and development, including clinical trial preparatory activities.
  • Net loss for the quarter of $3.6 million, or $0.09 per share, compared to a net loss of $2.2 million, or $0.06 per share, for the comparative quarter.

“We are entering the second half of 2017 with our strongest balance sheet to date, which allows the Company to execute the Phase 2 clinical trial in Rett syndrome, for which ANAVEX™ 2-73 has been granted Orphan Drug Designation by the FDA, as well as the Phase 2/3 clinical trial in Alzheimer’s disease and the Phase 2 clinical trial in Parkinson’s disease,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex Life Sciences. “We look forward to initiating these placebo-controlled clinical trials. The respective trial designs are based on broad genomic and biomarker characterization, pharmacokinetic and pharmacodynamic modeling including data from patients in previous ANAVEX™ 2-73 trials, as well as preclinical translational science. To our knowledge, this is the first use of this approach in the design of clinical trials for Alzheimer’s disease, Parkinson’s disease and Rett syndrome, and marks a shift towards advancing implementation of precision medicine for these and other neurodegenerative and neurodevelopmental diseases."

Corporate Highlights:

•  July 20, 2017 – Anavex further strengthened its Scientific Advisory Board with the appointment of Andrew J. Cole, M.D., F.R.C.P.(C.)  Dr. Cole is Director of the MGH Epilepsy Service, Chief of the Division of Clinical Neurophysiology and Epilepsy and Professor of Neurology at Harvard Medical School.

•  May 22, 2017 – Anavex announced new preclinical data for ANAVEXTM 2-73 in the rare diseases Angelman syndrome, Fragile X syndrome and Rett syndrome.

  • In a study sponsored by the Foundation for Angelman Syndrome, ANAVEXTM 2-73 was assessed in a mouse model for the development of audiogenic seizures.  The results indicated that ANAVEX™ 2-73 administration significantly reduced audiogenic-induced seizures.
  • In a study sponsored by FRAXA Research Foundation, data demonstrated that ANAVEXTM 2-73 restored hippocampal brain-derived neurotrophic factor (BDNF) expression to normal levels. BDNF under-expression has been observed in many neurodevelopmental and neurodegenerative pathologies. BDNF signaling promotes maturation of both excitatory and inhibitory synapses. ANAVEXTM 2-73 normalization of BDNF expression could be a contributing factor for the positive data observed in both neurodevelopmental and neurodegenerative disorders.
  • In an experiment sponsored by Rettsyndrome.org, ANAVEXTM 2-73 was evaluated in automatic visual response and respiration tests in seven-month old mice, an age at which advanced pathology is evident. Vehicle-treated MECP2 mice demonstrated fewer automatic visual responses than wild-type mice. Treatment with ANAVEXTM 2-73 significantly increased the automatic visual response in the MECP2 Rett syndrome disease mouse.

Planned Objectives:

  • Report PK/PD data from Alzheimer’s Phase 2a clinical trial.
  • Initiate Phase 2 clinical trial in Rett syndrome (12-week, randomized, double-blind, placebo-controlled).
  • Initiate Phase 2 clinical trial in Parkinson’s disease (12-week, randomized, double-blind, placebo-controlled).
  • Initiate Phase 2/3 clinical trial in Alzheimer’s disease (6/12-month, randomized, double-blind, placebo-controlled).
  • Potential for several clinical read-outs in 2018.
  • Complement current pipeline through in-licensing – ongoing.

The financial information for the three and nine months ended June 30, 2017, 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.

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, ANAVEXTM 2-73, recently completed successfully a Phase 2a clinical trial for Alzheimer’s disease. ANAVEXTM 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. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. The Michael J. Fox Foundation for Parkinson’s Research has awarded Anavex a research grant to develop ANAVEXTM 2-73 for the treatment of Parkinson’s disease to fully fund a preclinical study, which could justify moving ANAVEXTM 2-73 into a Parkinson’s disease clinical trial. ANAVEX 3-71, also targeting sigma-1 and M1 muscarinic receptors, is a promising preclinical drug candidate demonstrating disease modifications against the major Alzheimer’s hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also with beneficial effects on neuroinflammation and mitochondrial dysfunctions. 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. 
 CONSOLIDATED BALANCE SHEETS 
 (Unaudited) 
     
     
  June 30,September 30, 
 ASSETS 2017  2016  
 Current   
 Cash$  24,793,424 $  9,186,814  
 Sales Tax Recoverable   8,216    79,347  
 Prepaid expenses and deposits   52,694    180,124  
 Total current assets   24,854,334    9,446,285  
 Deposits   52,396    52,396  
 Total assets$  24,906,730 $  9,498,681  
     
 LIABILITIES AND STOCKHOLDERS' EQUITY   
 Current   
 Accounts payable and accrued liabilities $  1,435,498 $  3,119,993  
 Deferred grant income   19,073    70,532  
 Total liabilities   1,454,571    3,190,525  
 Common stock   42,173    36,169  
 Additional paid-in capital   109,733,970    84,290,140  
 Accumulated deficit   (86,323,984)   (78,018,153) 
 Total stockholders' equity   23,452,159    6,308,156  
 Total liabilities and stockholders' equity$  24,906,730 $  9,498,681  
     

 

    
 ANAVEX LIFE SCIENCES CORP.
 CONSOLIDATED INTERIM STATEMENTS OF OPERATIONS
 THREE MONTHS ENDED JUNE 30, 2017 AND 2016
 (Unaudited)
    
   2017  2016 
 Operating Expenses  
 General and administrative$  1,405,026 $  1,134,845 
 Research and development   2,300,277    1,158,820 
 Total operating expenses   3,705,303     2,293,665  
    
 Operating Loss   (3,705,303)   (2,293,665)
 Other income (expenses)  
 Grant income   69,146    47,767 
 Gain on settlement of accounts payable   75,204    - 
 Interest income, net   26,677    2,626 
 Financing related charges and adjustments    (8)
 Foreign exchange gain (loss)   (65,932)   8,924 
 Total other income (expenses)   105,095     59,309  
 Net loss before income taxes   (3,600,208)   (2,234,356)
 Income tax expense - current   (9,877)   (6,000)
 Net loss$   (3,610,085)$   (2,240,356)
    
 Net loss per Share  
 Basic and Diluted$  (0.09)$  (0.06)
    
 Weighted Average Number of Shares Outstanding 
 Basic and Diluted   41,509,225    35,709,686 
    

 

    
 ANAVEX LIFE SCIENCES CORP.
 CONSOLIDATED INTERIM STATEMENTS OF OPERATIONS
 NINE MONTHS ENDED JUNE 30, 2017 AND 2016
 (Unaudited)
    
   2017  2016 
 Operating Expenses  
 General and administrative$  3,647,224 $  5,117,591 
 Research and development   6,835,700    3,888,676 
 Total operating expenses   10,482,924     9,006,267  
    
 Operating Loss   (10,482,924)   (9,006,267)
 Other income (expenses)  
 Grant income   121,116    113,701 
 Research and development incentive income   2,022,902    571,093 
 Gain on settlement of accounts payable   75,204    151,402 
 Interest income, net   48,479    6,832 
 Financing related charges and adjustments   -    (1,175)
 Foreign exchange gain (loss)   (40,128)   (37,637)
 Total other income   2,227,573     804,216  
 Net loss before income taxes   (8,255,351)   (8,202,051)
 Income tax expense - current   (50,480)   (23,615)
 Net loss$   (8,305,831)$   (8,225,666)
    
 Net loss per Share  
 Basic and Diluted$  (0.21)$  (0.24)
    
 Weighted Average Number of Shares Outstanding 
 Basic and Diluted   40,344,149    34,961,838 
    
For Further Information:

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

Investors:
Matthew Haines
River East Investor Relations, LLC
917-733-9297
mhaines@rivereastir.com

Media:
Dennis Dobson, Jr.
Dobson Media Group
203-258-0159
dennisdobsonjr@dobsonmediagroup.com

Social Media:
Bill Douglass
Gotham Communications, LLC
646-504-0890
bill@gothamcomm.com

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