NEW YORK, May 15, 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 provided a business update including clinical trial plans for its lead drug candidates in Alzheimer's disease (AD).
Business Update
Anavex plans to initiate clinical trials with ANAVEX PLUS for the treatment of Alzheimer's disease. ANAVEX PLUS is the Company's proprietary compound ANAVEX 2-73 administered in combination with donepezil, the generic version of Aricept®. Donepezil's combination with a Sigma 1 receptor agonist (ANAVEX 2-73) is believed to enhance efficacy. The trials will consist of a prospective, multicenter, two-part study involving up to 300 mild-to-moderate AD patients.
The first part is a scheduled Phase 1b/2a trial of approximately 40 patients who will receive either ANAVEX 2-73 or standard of care (donepezil) with ANAVEX 2-73. The study will explore dose and schedule as well as the efficacy of the combination. Patients in this study will have the option to rollover into a single open-label study in order to further accumulate safety, tolerability and efficacy data.
The second part of the study is designed as a double-blind Phase 2 trial and will randomize AD patients to standard of care (donepezil) or standard of care (donepezil) with ANAVEX 2-73 with a primary outcome measure at 26 weeks efficacy based on standard cognitive measures. All patients from this second study will also have the option to rollover into the single open-label study in order to further accumulate safety, tolerability and efficacy data.
The trial is on track to commence in 2014 and data from the first part is expected to be reported in mid 2015.
"We are very excited to be preparing for the start of this two-part trial and will be completing our toxicology studies and readying manufacturing in advance of patient screening," said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. "We expect rapid enrollment as there is a large, ready pool of patients with Alzheimer's disease currently taking donepezil."
Dr. Missling added, "With respect to other compounds in our pipeline, we note that recent published studies on a Sigma-1 receptor agonist have shown a role in providing functional neurorestoration in animal models of Parkinson's disease. Not only is this similar to the mechanism of action of our Alzheimer's disease drug candidate, but it shows additional potential for our pipeline drug candidates ANAVEX 2-73, ANAVEX 3-71 (AF710B) and ANAVEX 1-41 to be disease-modifying treatments for Parkinson's disease."
Financial Results
Anavex also reported financial results for the three and six months ended March 31, 2014.
- Anavex had cash and cash equivalents of $9.2 million as of March 31, 2014, compared with $0.3 million as at September 30, 2013. During the second quarter of fiscal 2014 the Company issued $10.0 million in non-interest-bearing convertible debentures.
- Operating expenses for the second quarter of fiscal year 2014 were $1.0 million, compared to $0.1 million for the quarter ended March 31, 2013. The increase was primarily attributable to higher research and development expenses as the Company prepares to enter clinical studies with ANAVEX PLUS for the treatment of Alzheimer's disease, as well as expenses related to raising capital.
- The net loss for the second quarter of fiscal year 2014 was $1.0 million or $0.03 per share, compared to a net loss of $0.1 million or $0.00 for the same period in 2013.
- Operating expenses for the six months ended March 31, 2014 were $1.3 million, compared to $0.5 million for the comparable period in fiscal year 2013.
- The net loss for the first half of fiscal year 2014 was $0.7 million or $0.04 per share, compared to a net loss of $0.6 million or $0.02 per share for the first half of fiscal year 2013.
- Anavex used $0.8 million in cash to fund operations during the first half of fiscal year 2014.
Dr. Missling added, "We have made exceptional progress in advancing our clinical and business strategies. The capital we raised during the quarter will enable us to enter the clinic with ANAVEX PLUS for the treatment of Alzheimer's disease and to conduct additional preclinical work with our other pipeline products."
The financial information for the three and six months ended March 31, 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 PLUS
ANAVEX PLUS is a "cocktail" of ANAVEX 2-73 and donepezil (Aricept®). ANAVEX 2-73 is an orally available small molecule with multiple modes of action that holds potential to be disease modifying in Alzheimer's disease. In several Alzheimer's disease models including Tg2576, AVANEX 2-73 has shown a reversal of memory loss and neuroprotection. Studies with ANAVEX 2-73 have shown a clear synergistic memory effect of up to 80% in combination with donepezil, and up to 7 points cognition improvement in ADAS-Cog at 12 weeks and 5.5 points at 26 weeks in a human calibrated realistic cortical network computer model. Anavex has filed a patent application for the combination of ANAVEX 2-73 and donepezil.
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 | ||
| March 31, | September 30, | |
| 2014 | 2013 | |
| Current | ||
| Cash | $ 9,193,558 | $ 345,074 |
| Prepaid expenses | 28,478 | 48,375 |
| Total current assets | 9,222,036 | 393,449 |
| Deferred financing charges | 1,068,541 | -- |
| Equipment | 1,943 | -- |
| Total assets | $ 10,292,520 | $ 393,449 |
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||
| Current | ||
| Accounts payable and accrued liabilities | $ 1,689,605 | $ 1,741,797 |
| Promissory notes payable | 193,720 | 210,863 |
| Total current liabilities | 1,883,325 | 1,952,660 |
| Derivative financial instruments - warrants | -- | 904,000 |
| Convertible debentures, net of debt discounts | 1,011 | -- |
| Total liabilities | 1,884,336 | 2,856,660 |
| Common stock | 38,261 | 37,238 |
| Additional paid-in capital | 49,595,118 | 38,644,523 |
| Common stock to be issued | 640,000 | 60,000 |
| Accumulated deficit | (41,865,195) | (41,204,972) |
| Total stockholders' equity (capital deficit) | 8,408,184 | (2,463,211) |
| Total liabilities and stockholders' equity | $ 10,292,520 | $ 393,449 |
| ANAVEX LIFE SCIENCES CORP. | ||
| STATEMENTS OF OPERATIONS | ||
| THREE MONTHS ENDED MARCH 31, 2014 AND 2013 | ||
| (unaudited) | ||
| 2014 | 2013 | |
| OPERATING EXPENSES | ||
| Research and development | $ 118,152 | $ 560 |
| General and administrative | 903,015 | 126,551 |
| Total operating expenses | 1,021,167 | 127,111 |
| OPERATING LOSS | (1,021,167) | (127,111) |
| OTHER INCOME | ||
| Interest and finance expenses, net | (5,079) | (16,558) |
| Accretion of debt discounts | (1,011) | -- |
| Foreign exchange gain | 8,397 | 37,569 |
| Total other income | 2,307 | 21,011 |
| NET LOSS | $ (1,018,860) | $ (106,100) |
| NET LOSS PER COMMON SHARE | ||
| BASIC | $ (0.03) | $ (0.00) |
| DILUTED | $ (0.03) | $ (0.00) |
| WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING | ||
| BASIC | 37,881,209 | 30,240,687 |
| DILUTED | 37,881,209 | 30,240,687 |
| ANAVEX LIFE SCIENCES CORP. | ||
| STATEMENTS OF OPERATIONS | ||
| SIX MONTHS ENDED MARCH 31, 2014 AND 2013 | ||
| (unaudited) | ||
| 2014 | 2013 | |
| OPERATING EXPENSES | ||
| Research and development | $ 123,332 | $ 127,563 |
| General and administrative | 1,207,443 | 415,415 |
| Total operating expenses | 1,330,775 | 542,978 |
| OPERATING LOSS | (1,330,775) | (542,978) |
| OTHER INCOME | ||
| Interest and finance expenses, net | (8,366) | (26,783) |
| Accretion of debt discounts | (1,011) | -- |
| Change in fair value of derivative financial instruments | 683,000 | -- |
| Foreign exchange gain (loss) | (3,071) | 10,144 |
| Total other income | 670,552 | (16,639) |
| NET LOSS | $ (660,223) | $ (559,617) |
| NET LOSS PER COMMON SHARE | ||
| BASIC | $ (0.02) | $ (0.02) |
| DILUTED | $ (0.04) | $ (0.02) |
| WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING | ||
| BASIC | 37,680,823 | 30,240,687 |
| DILUTED | 37,680,823 | 30,240,687 |