NEW YORK, Aug. 13, 2014 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. ("Anavex" or the "Company") (OTCQB: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 financial results for the three and nine months ended June 30, 2014.
Upcoming Near-Term Milestones:
- Start Phase 2a study for ANAVEX 2-73 and ANAVEX PLUS in 2014
- Safety and exploratory efficacy
- Report data from Phase 2a study in first half of 2015
- Start Phase 2/3 study in 2015
- Ongoing safety and efficacy
- Potential to be first registration study
- Complement current pipeline through in-licensing – ongoing
- Advance preclinical research with ANAVEX PLUS, ANAVEX 2-73, ANAVEX 3-71 and ANAVEX 1-41 in Parkinson's disease and ALS – ongoing
Financial Highlights:
- Anavex had cash and cash equivalents of $8.2 million as of June 30, 2014, compared with $0.3 million as at September 30, 2013.
- Operating expenses for the third quarter of fiscal year 2014 were $1.0 million, compared to $0.1 million for the quarter ended June 30, 2013. The increase was primarily attributable to higher research and development expenses as the Company prepares to enter clinical Phase 2a studies with ANAVEX 2-73 and ANAVEX PLUS for the treatment of Alzheimer's disease.
- The net loss for the third quarter of fiscal year 2014 was $1.0 million or $0.03 per share, compared to a net loss of $0.2 million or $0.01 for the same period in 2013.
- Operating expenses for the nine months ended June 30, 2014 were $2.3 million, compared to $0.7 million for the comparable period in fiscal year 2013.
- The net loss for the first nine-months of fiscal year 2014 was $1.7 million or $0.04 per share, compared to a net loss of $0.7 million or $0.02 per share for the first nine months of fiscal year 2013.
- Anavex used $1.7 million in cash to fund operations during the first nine-months of fiscal year 2014.
"We have made exceptional progress in advancing our clinical and business strategies and are pleased with the progress to date," said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. "With our Phase 2a Alzheimer's trial on track to commence in 2014 and data from the first part of the trial expected to be reported in mid-2015, we remain enthusiastic about our prospects. Clearly we continue to execute on our growth strategy as we enter the clinic with ANAVEX 2-73 and ANAVEX PLUS and conduct additional preclinical work with other pipeline products."
Recent Achievements
On August 7, 2014, Anavex announced the appointment of Tasos Zografidis, PhD, an experienced pharmaceutical executive, as Vice President of Clinical Operations. Dr. Zografidis will be responsible for managing Anavex's clinical programs, including our upcoming Phase 2a trial for ANAVEX 2-73 and ANAVEX PLUS, the Company's lead drug candidate combination in Alzheimer's disease.
On July 21, 2014, Anavex announced that it had secured cGMP manufacturing of ANAVEX 2-73 for its drug candidate trial supplies. The active drug product (API) has been manufactured and is available for the Phase 2a Alzheimer's trial.
On July 14, 2014, in a presentation at the 2014 Alzheimer's Association International Conference (AAIC), Anavex revealed that ANAVEX 3-71 is highly effective and disease-modifying against all major Alzheimer's hallmarks in preclinical disease model.
On June 30, 2014 Anavex announced that a paper in peer-reviewed scientific journal Neurochemical Research revealed for the first time that sigma-1 receptors functionally downregulate certain proteins that play a major role in various pathophysiological conditions including depression, anxiety, epilepsy and brain injury following ischemic stroke.
On June 4, 2014, Anavex announced that it had been issued U.S. Patent No. 8,673,931 (the "Patent"). The composition and method Patent covers ANAVEX 3-71 for treating Alzheimer's disease, type 2 diabetes and insulin resistance. Anavex obtained exclusive rights to worldwide patents and patent applications for ANAVEX 3-71, a unique and promising preclinical Alzheimer's drug candidate, plus related compounds in March 2014. The Patent has a term that expires no earlier than April 29, 2030.
On May 28, 2014, Anavex announced the appointment of Abraham Fisher, PhD to its Scientific Advisory Board. With nearly 40 years of experience in drug design and discovery, Dr. Fisher has taken lead compounds including AF102B (EVOXAC®, cevimeline HCl) from concept to approval. AF102B was the first muscarinic agonist approved for sale in the U.S. (2000) and in Japan (2001) to treat dry mouth in patients with Sjoergen's Syndrome. He is also the inventor of ANAVEX 3-71 (formerly AF710B).
On May 22, 2014, Anavex welcomed new data published in The Journal of Neuroscience , which has favorable implications for ANAVEX PLUS, the Company's Alzheimer's disease drug candidate combination. The scientific findings indicate that too much calcium signaling in neurons may be involved in causing Alzheimer's disease (AD). These calcium alterations can be modulated directly through the inositol triphosphate (IP3) receptor, representing a potential new therapeutic approach to treating AD. The findings indirectly confirm the therapeutic opportunity in Alzheimer's disease for ANAVEX PLUS, an agonist of the sigma-1 receptor (S1R), because the S1R acts as a calcium signaling modulator via IP3.
On May 12, 2014, Anavex announced the appointment of Norman Relkin, MD, PhD to the Company's Scientific Advisory Board. Dr. Relkin is a Weill Cornell Medical College neurologist and an internationally recognized expert on Alzheimer's disease and related disorders, with over 20 years of clinical trial experience.
On May 8, 2014, Anavex announced the appointment of Bernd Metzner, PhD and Elliot Favus, MD to its board of directors, joining existing directors Christopher Missling, PhD and Tom Skarpelos. As former Head of Finance of Bayer Schering Pharma AG with corporate CFO responsibility at other large companies, Dr. Metzner has extensive experience from early-stage research to commercialization of innovations.
On April 29, 2014, Anavex announced the findings of a research study published in peer-reviewed scientific journal Brain . For the first time, scientific data showed that a sigma-1 receptor (S1R) agonist produces functional neurorestoration in animal models of Parkinson's disease. Anavex is encouraged by the report because its results point to the potential for the Company's S1R drug candidates ANAVEX 2-73, ANAVEX 3-71 and ANAVEX 1-41 of being disease-modifying treatments for Parkinson's disease.
The financial information for the three and nine months ended June 30, 2014 should be read in conjunction with the Company's interim 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. ( www.anavex.com ) is a clinical-stage biopharmaceutical company engaged in the development of novel drug candidates to treat Alzheimer's disease, other CNS diseases and various types of cancer. ANAVEX 2-73, an orally available drug candidate developed to treat Alzheimer's disease through potential disease modification, has undergone an initial Phase 1 human clinical trial and was well tolerated in doses up to 55mg. Results from preclinical studies indicate that ANAVEX 2-73 demonstrates anti-amnesic and neuroprotective properties. A highly encouraging synergistic effect has also been observed between ANAVEX 2-73 and donepezil (Aricept®). The combined therapeutic, called ANAVEX PLUS, produced up to 80% greater reversal of memory loss in Alzheimer's disease models versus when the drugs were used individually. Anavex is a publicly traded corporation quoted as AVXL.
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. | ||
| INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS | ||
| (Unaudited) | ||
| ASSETS | ||
| June 30, | September 30, | |
| 2014 | 2013 | |
| Current | ||
| Cash | $ 8,179,681 | $ 345,074 |
| Prepaid expenses | 18,919 | 48,375 |
| Total current assets | 8,198,600 | 393,449 |
| Deferred financing charges | 1,113,565 | -- |
| Equipment | 1,751 | -- |
| Total assets | $ 9,313,916 | $ 393,449 |
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||
| Current | ||
| Accounts payable and accrued liabilities | $ 1,703,307 | $ 1,741,797 |
| Promissory notes payable | 200,835 | 210,863 |
| Total current liabilities | 1,904,142 | 1,952,660 |
| Derivative financial instruments - warrants | -- | 904,000 |
| Convertible debentures, net of debt discounts | 1,091 | -- |
| Total liabilities | 1,905,233 | 2,856,660 |
| Common stock | 38,261 | 37,238 |
| Additional paid-in capital | 49,604,707 | 38,644,523 |
| Common stock to be issued | 640,000 | 60,000 |
| Accumulated deficit | (42,874,285) | (41,204,972) |
| Total stockholders' equity (capital deficit) | 7,408,683 | (2,463,211) |
| Total liabilities and stockholders' equity | $ 9,313,916 | $ 393,449 |
| ANAVEX LIFE SCIENCES CORP. | ||
| STATEMENTS OF OPERATIONS | ||
| THREE MONTHS ENDED JUNE 30, 2014 AND 2013 | ||
| (unaudited) | ||
| 2014 | 2013 | |
| OPERATING EXPENSES | ||
| Research and development | $ 733,818 | $ 86,961 |
| General and administrative | 265,015 | 39,021 |
| Total operating expenses | 998,833 | 125,982 |
| OPERATING LOSS | (998,833) | (125,982) |
| OTHER INCOME | ||
| Interest and finance expenses, net | (8,492) | (14,855) |
| Accretion of debt discounts | (80) | -- |
| Gain on settlement of accounts payable | 5,500 | -- |
| Foreign exchange gain | (7,185) | (11,087) |
| Total other income | (10,257) | (25,942) |
| NET LOSS | $ (1,009,090) | $ (151,924) |
| NET LOSS PER COMMON SHARE | ||
| BASIC | $ (0.03) | $ (0.01) |
| DILUTED | $ (0.03) | $ (0.01) |
| WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING | ||
| BASIC | 39,260,098 | 30,240,687 |
| DILUTED | 39,260,098 | 30,240,687 |
| ANAVEX LIFE SCIENCES CORP. | ||
| STATEMENTS OF OPERATIONS | ||
| NINE MONTHS ENDED JUNE 30, 2014 AND 2013 | ||
| (unaudited) | ||
| 2014 | 2013 | |
| OPERATING EXPENSES | ||
| Research and development | $ 1,941,261 | $ 502,376 |
| General and administrative | 388,347 | 166,584 |
| Total operating expenses | 2,329,608 | 668,960 |
| OPERATING LOSS | (2,329,608) | (668,960) |
| OTHER INCOME | ||
| Interest and finance expenses, net | (16,858) | (41,638) |
| Accretion of debt discounts | (1,091) | -- |
| Change in fair value of derivative financial instruments | 683,000 | -- |
| Gain on settlement of accounts payable | 5,500 | -- |
| Foreign exchange gain (loss) | (10,256) | (943) |
| Total other income | 660,295 | (42,581) |
| NET LOSS | $ (1,669,313) | $ (711,541) |
| NET LOSS PER COMMON SHARE | ||
| BASIC | $ (0.04) | $ (0.02) |
| DILUTED | $ (0.06) | $ (0.02) |
| WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING | ||
| BASIC | 38,218,237 | 30,240,687 |
| DILUTED | 38,218,237 | 30,240,687 |
Anavex Life Sciences Corp. Research & Business Development Toll-free: 1-844-689-3939 Email: Shareholder & Media Relations Toll-free: 1-866-505-2895 Outside North America: +1 (416) 489-0092 Email: www.anavex.com
