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Anavex Life Sciences Reports Fiscal Year 2018 Financial Results And Provides Clinical Study Update
Conference Call and Webcast Today at 4:30 p.m. ET
NEW YORK, Dec. 12, 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, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today reported financial results for its fiscal year ended September 30, 2018.
“We were able to initiate novel genomic marker driven later-stage CNS precision medicine trials in Parkinson’s disease dementia, Alzheimer’s disease and Rett syndrome for ANAVEX®2-73 entering fiscal 2019. We are looking forward to a swift enrollment in all three studies given the high unmet need in these indications,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex.
ANAVEX®2-73 Program Update:
- Successfully activated 100% of all planned clinical study sites, representing twenty clinical trial sites for the Phase 2 ANAVEX®2-73 Parkinson’s disease dementia (PDD) study. Enrollment and dosing of patients is proceeding as planned.
- Successfully activated 75% of all planned clinical study sites, representing nine clinical trial sites for the Phase 2b/3 ANAVEX®2-73 Alzheimer’s disease (AD) study. Enrollment and dosing of patients is proceeding as planned.
- Successfully initiated first clinical trial site for the Phase 2 ANAVEX®2-73 Rett syndrome (RTT) study.
- Cash and equivalents of $22.9 million at September 30, 2018, compared to $27.4 million at September 30, 2017.
- Cash used to fund operations for fiscal 2018 was $12.6 million, which is net of grant and research and development incentive income of $1.8 million, compared to $9.0 million for the comparative fiscal last year. This is in line with the Company’s current cash utilization guidance.
- Operating expenses for fiscal 2018 of $19.3 million compared to $15.7 million for the comparative fiscal year 2017. Research and development expenses increased as a result of expenses incurred to prepare for three clinical trials, two of which commenced in October 2018, including continuing to expand our scientific team.
- Net loss for the year of $17.5 million, or $0.39 per share, compared to a net loss of $13.5 million, or $0.33 per share for the comparative year.
Recent Corporate Highlights:
- November 8, 2018 – Anavex announced the appointment of Dag Aarsland, MD, PhD to its Scientific Advisory Board. Dr. Aarsland is a distinguished researcher for clinical treatment of Parkinson’s Disease Dementia (PDD). Dr. Aarsland is a Professor and the Head of Department of Old Age Psychiatry at the Institute of Psychiatry, Psychology & Neuroscience, King’s College, London, UK. Dr. Aarsland is also consultant psychiatrist at the Mental Health for Older Adults and Dementia, South London & Maudsley NHS Foundation Trust, where he leads the Parkinson Spectrum Memory Clinic.
- October 30, 2018 – Anavex announced that it had enrolled the first patient in its Phase 2 double-blind, randomized, placebo-controlled, 14-week safety and efficacy trial of ANAVEX®2-73 for the treatment of Parkinson’s disease dementia (PDD). The Phase 2 study will enroll approximately 120 patients, randomized 1:1:1 to two different ANAVEX®2-73 doses or placebo.
- October 26, 2018 – Anavex presented new clinical data for ANAVEX®2-73 in a presentation at the 2018 Clinical Trials on Alzheimer’s Disease (CTAD) Meeting. At 148-weeks into the five-year extended Phase 2a clinical study of ANAVEX®2-73, data confirmed a significant association between ANAVEX®2-73 concentration and both exploratory functional and cognitive endpoints as measured by the Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) evaluation and the Mini Mental State Examination (MMSE), respectively.
- October 19, 2018 – Anavex announced the Company had received confirmation from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) is now open for ANAVEX®2-73 for the treatment of Rett syndrome.
- August 28, 2018 – Anavex announced that it had enrolled its first patient in its Phase 2b/3 double-blind, randomized, placebo-controlled, 48-week safety and efficacy trial of ANAVEX®2-73 for the treatment of early Alzheimer’s disease. The Phase 2b/3 trial will enroll approximately 450 patients, randomized 1:1:1 to two different ANAVEX®2-73 doses or placebo.
The financial information for the year ended September 30, 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/avxl7/.
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 47898736, 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 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.
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|
|Expressed in US Dollars||September 30,|
|Cash and cash equivalents||$||22,930,638||$||27,440,257|
|Sales tax recoverable||40,171||9,748|
|Prepaid expenses and deposits||1,251,798||335,928|
|Deferred financing charges||101,133||-|
|Total current assets||24,323,740||27,785,933|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accounts payable and accrued liabilities||$||3,884,626||$||3,584,334|
|Additional paid-in capital||129,377,542||115,689,221|
|Total stockholders' equity||20,491,510||24,253,995|
|Total liabilities and stockholders' equity||$||24,376,136||$||27,838,329|
|ANAVEX LIFE SCIENCES CORP.|
|CONSOLIDATED STATEMENT OF OPERATIONS|
|YEARS ENDED SEPTEMBER 30, 2018, 2017 and 2016|
|Expressed in US Dollars|
|General and administrative||$||5,989,170||$||5,008,275||$||8,334,740|
|Research and development||13,344,421||10,672,086||7,254,303|
|Total operating expenses||19,333,591||15,680,361||15,589,043|
|Other income (expenses)|
|Research and development incentive income||1,629,513||2,022,902||571,093|
|Interest income, net||255,092||88,098||11,322|
|Gain on settlement of accounts payable||-||75,204||151,402|
|Gain on settlement of debt||-||-||61,205|
|Financing related charges||(30,943||)||-||(5,812||)|
|Foreign exchange gain (loss)||(49,789||)||(47,583||)||(48,445||)|
|Total other income||1,952,928||2,279,563||881,960|
|Net loss before income taxes||(17,380,663||)||(13,400,798||)||(14,707,083||)|
|Income tax expense - current||(72,746||)||(59,607||)||(29,615||)|
|Net loss per Share|
|Basic and Diluted||$||(0.39||)||$||(0.33||)||$||(0.42||)|
|Weighted Average Number of Shares Outstanding|
|Basic and Diluted||44,655,725||40,841,033||35,153,426|
For Further Information:
Anavex Life Sciences Corp.
Research & Business Development