New York, NY – December 30, 2014
Anavex Life Sciences Corp. (“Anavex” or the “Company”) (OTCQX: AVXL), a clinical-stage biopharmaceutical company developing novel drug candidates to treat Alzheimer’s disease, other diseases of the central nervous system (CNS) and various types of cancer, today reported fourth quarter and year-end results for fiscal year 2014.
Upcoming Near-Term Milestones:
First patient dosed for Phase 2a study for ANAVEX 2-73 and ANAVEX PLUS
Report topline data from Phase 2a study in Q3 2015
Preparation for Phase 3 study in 2015
In-licensing to complement current pipeline – ongoing
Advance preclinical research with ANAVEX pipeline compounds in Parkinson’s disease, epilepsy, depression, ALS (Lou Gehrig’s disease), and various types of cancer – ongoing
Anavex had cash and cash equivalents of $7.3 million as of September 30, 2014, compared with $0.3 million as at September 30, 2013.
The net loss for fiscal year 2014 was $11.4 million or $0.30 per share, and $2.8 million or $0.09 per share on a pro-forma basis, compared to a net loss of $3.7 million or $0.12 for the 2013 fiscal year.
Operating expenses for the 12 months ended September 30, 2014 were $3.0 million, compared to $2.1 million for the comparable period in fiscal year 2013. The increase was primarily attributable to expenses related to the initiation of a Phase 2a clinical trial for ANAVEX 2-73 and ANAVEX PLUS for the treatment of Alzheimer’s disease, as well as professional fees and other expenses related to a $10.0 million financing completed during the year.
Anavex used $2.7 million in cash to fund operations during fiscal year 2014.
“Over the past year we significantly advanced our clinical and operational strategies, creating a solid foundation for growth in our business and development in our proprietary programs. We are also pleased to be fully funded through completion of our Phase 2a trial of ANAVEX 2-73 and ANAVEX PLUS,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “Anavex is well positioned to build on this success in 2015, as we proceed toward key milestones that we believe will lead to value creation for the Company’s stakeholders.”
On December 16, 2014, Anavex began enrollment of Alzheimer’s patients for the Phase 2a clinical trial of ANAVEX 2-73 and ANAVEX PLUS. The randomized trial is designed to assess the safety and exploratory efficacy of ANAVEX 2-73, which is being evaluated for the treatment of Alzheimer’s disease. The trial also plans to evaluate ANAVEX 2-73 in combination with donepezil (ANAVEX PLUS) in patients with mild to moderate Alzheimer’s disease.
On December 12, 2014, Anavex announced an upgrade to the OTCQX marketplace under the Company’s existing stock ticker AVXL. OTCQX is the best marketplace for established, global and growth companies operated by OTC Markets Group Inc., with fewer than 400 companies currently trading on this top-level tier. To qualify for trading on OTCQX, companies must meet high financial standards, demonstrate compliance with U.S. securities laws, be current in their disclosure, and be sponsored by a professional third-party advisor.
On November 17, 2014, in a poster presentation at CNS Summit 2014, Anavex announced full data results from the Phase 1 clinical trial of ANAVEX 2-73. Observed adverse events included moderate and reversible headache and dizziness, which is common in drugs that target central nervous system (CNS) conditions, including Alzheimer’s. No serious side effects were reported in the randomized, double-blind, placebo-controlled study, there was no study discontinuation due to adverse events, ANAVEX 2-73 was found to be safe and well tolerated, and the results indicate a favorable pharmacokinetics profile.
On November 3, 2014, Anavex announced that it had received regulatory approval from the Ethics Committee in Australia to initiate a Phase 2a clinical trial of ANAVEX 2-73 and ANAVEX PLUS for Alzheimer’s disease, which has since commenced.
On October 27, 2014, it was announced that Lincoln Park Capital Fund, LLC (“Lincoln Park”), a long time investor in Anavex, had increased its ownership in the Company. Lincoln Park paid a premium of over 25% to the closing price on the day it signed a $500,000 Securities Purchase Agreement to acquire 2,000,000 shares of common stock.
On August 26, Anavex announced that it had selected The Alfred Hospital in Melbourne, Australia as the lead site for its Phase 2a Alzheimer’s clinical trial.
On August 19, 2014, Anavex welcomed new data published in the scientific journal Cell Death and Disease revealing that the antidepressant Fluvoxamine, a commonly used selective serotonin reuptake inhibitor (SSRI), has a high affinity for sigma-1 receptor (S1R) and thus can alleviate cell stress. The findings provided added encouragement for the Phase 2a trial of ANAVEX 2-73 and ANAVEX PLUS, which is currently underway.
Financial information for the fiscal 2014 fourth quarter and year-end results ended September 30, 2014 should be read in conjunction with the Company’s audited consolidated financial statements, which have been filed on EDGAR and will be available on the Anavex website at www.anavex.com.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (OTCQX: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel drug candidates to treat Alzheimer’s disease, other Central Nervous System (CNS) diseases, and various types of cancer. Anavex’s lead drug candidates, ANAVEX 2-73 and ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil (Aricept®), are currently in a Phase 2a clinical trial for Alzheimer’s disease. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean data profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. The drug combination ANAVEX PLUS produced up to 80% greater reversal of memory loss in Alzheimer’s disease models versus when the drugs were used individually. Further information is available at www.anavex.com.
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.
We are presenting modified pro forma net income available to common stockholders and modified pro forma EPS, which are not measurements determined in accordance with U.S. generally accepted accounting principles, or GAAP, because we believe these measures provide additional metrics to evaluate our operations and which we believe, when considered with both our GAAP results and the reconciliation to net income available to common stockholders, provide a more complete understanding of our business than could be obtained absent this disclosure. We use modified pro forma net income available to common stockholders and modified pro forma EPS, together with financial measures prepared in accordance with GAAP, such as revenue and cash flows from operations, to assess our historical and prospective operating performance and to enhance our understanding of our core operating performance. The use of modified pro forma net income available to common stockholders and modified pro forma EPS as performance measures permits a comparative assessment of our operating performance relative to our performance based upon our GAAP results while isolating the effects of some items that vary from period to period without any correlation to core operating performance or that vary widely among similar companies.
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