NEW YORK, Feb. 18, 2015 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. ("Anavex" or the "Company") (OTCQX:AVXL), a clinical-stage biopharmaceutical company developing drug candidates to treat Alzheimer's disease, other central nervous system (CNS) diseases, pain and various types of cancer, today reported financial results for the three months ended December 31, 2014.
Financial Highlights:
- Anavex had cash and cash equivalents of approximately $7.0 million as of December 31, 2014, compared with approximately $7.3 million as at September 30, 2014. Cash was used in operations and for the advancement of clinical trial work, offset by funds received from a private placement during the quarter.
- Anavex used approximately $0.7 million in cash to fund operations during the first three months of fiscal year 2015 and has sufficient cash for approximately two years.
- Operating expenses for the three months ended December 31, 2014 were approximately $0.8 million, compared to approximately $0.3 million for the quarter ended December 31, 2013. The increase was primarily attributable to research and development (R&D) expenses related to the Company's Phase 2a clinical trial for ANAVEX 2-73, which commenced in December 2014. R&D expenses are expected to continue to increase over the remaining quarters in the current fiscal year as a result of this clinical trial and other auxiliary research and development activities.
- The net loss for the three months ended December 31, 2014 was approximately $0.8 million or $0.02 per share, compared to a net income of approximately $0.4 million or $0.01 for the same period in 2013.
"Our lead drug ANAVEX 2-73, which is active by itself and in combination with donepezil (Aricept®), is currently in an ongoing clinical trial Phase 2a. We expect to report initial data by Q3 2015. We anticipate that we currently have sufficient funding to complete the entire Phase 2a trial," said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. "ANAVEX 2-73 is orally available and has so far shown strong preclinical data relating to improved memory and the ability to potentially reverse and halt Alzheimer's disease. Also, recent preclinical epilepsy data validates ANAVEX 2-73 as a prospective platform drug for other neurodegenerative diseases beyond Alzheimer's. Anavex also has compounds in the pipeline for other CNS indications as well as pain and cancer. We remain extremely encouraged by our progress to date and look forward to exploring additional indications, including epilepsy, in parallel with our Phase 2a Alzheimer's study."
Recent Achievements
On February 9, 2015, Anavex confirmed positive preclinical data for its lead drug candidate ANAVEX 2-73 for the potential treatment of epilepsy, validating it also as a prospective platform drug for the treatment of other neurodegenerative diseases beyond Alzheimer's. The data demonstrates significant improvement in the reduction of seizures in the test subjects relative to three generations of epilepsy drugs currently on the market, as well as potential significant synergy with each of these drugs.
On January 12, 2015, Anavex announced dosing of the first patient in the Phase 2a clinical trial of ANAVEX 2-73 and ANAVEX PLUS, which are being developed as an oral therapy and oral drug combination for the potential treatment of Alzheimer's disease. The approved Phase 2a clinical trial is the first study of ANAVEX 2-73 in Alzheimer's patients.
On January 6, 2015, Anavex announced that a paper in the current issue of the International Journal of Neuropsychopharmacology (IJNP) revealed that the sigma-1 receptor, the Company's drug target, interacts positively and directly with the cannabinoid receptor. The scientific findings indicate that sigma-1 receptor modulation may protect against psychosis possibly connected to cannabis (marijuana) abuse, especially among the young, whose nervous systems are still maturing, or individuals with a genetic predisposition, which could potentially lead to schizophrenia.
The financial information for the three months ended December 31, 2014 should be read in conjunction with the Company's interim consolidated financial statements, which have been filed on U.S. Securities and Exchange Commission's EDGAR system 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 central nervous system (CNS) diseases, pain and various types of cancer. The Company's lead drug candidates, ANAVEX 2-73 and ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil (Aricept®), are currently being evaluated 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 has successfully completed a Phase 1 study with a clean data profile. Preclinical studies demonstrate 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. Recent positive preclinical data indicates that ANAVEX 2-73 also exhibits anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties. Further information is available at www.anavex.com.
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 | ||
| ASSETS | ||
| December 31, | September 30, | |
| 2014 | 2014 | |
| Current | ||
| Cash | $ 6,980,924 | $ 7,262,138 |
| Prepaid expenses | 67,576 | 89,117 |
| Total current assets | 7,048,500 | 7,351,255 |
| Equipment | 1,998 | 2,247 |
| Total assets | $ 7,050,498 | $ 7,353,502 |
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||
| Current | ||
| Accounts payable and accrued liabilities | $ 1,319,840 | $ 1,249,084 |
| Promissory notes payable | 98,312 | 192,065 |
| Total current liabilities | 1,418,152 | 1,441,149 |
| Non-interest bearing liabilities | 5,159,220 | 5,719,727 |
| Total liabilities | 6,577,372 | 7,160,876 |
| Common stock | 54,807 | 47,201 |
| Additional paid-in capital | 53,138,362 | 52,078,750 |
| Common stock to be issued | 640,000 | 640,000 |
| Accumulated deficit | (53,360,043) | (52,573,325) |
| Total stockholders' equity (capital deficit) | 473,126 | 192,626 |
| Total liabilities and stockholders' equity | $ 7,050,498 | $ 7,353,502 |
| ANAVEX LIFE SCIENCES CORP. | ||
| INTERIM STATEMENTS OF OPERATIONS | ||
| THREE MONTHS ENDED DECEMBER 31, 2014 AND 2013 | ||
| 2014 | 2013 | |
| OPERATING EXPENSES | ||
| Research and development | $ 318,625 | $ 5,180 |
| General and administrative | 452,053 | 304,428 |
| Total operating expenses | 770,678 | 309,608 |
| OPERATING LOSS | (770,678) | (309,608) |
| OTHER INCOME | ||
| Interest and finance expenses, net | (77,009) | (3,287) |
| Financing related charges and adjustments | 37,651 | 683,000 |
| Foreign exchange loss | 23,318 | (11,468) |
| Total other income | (16,040) | 668,245 |
| NET LOSS | $ (786,718) | $ 358,637 |
| NET LOSS PER COMMON SHARE | ||
| BASIC | $ (0.02) | $ 0.01 |
| DILUTED | $ (0.02) | $ (0.01) |
| WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING | ||
| BASIC | 51,630,390 | 37,484,793 |
| DILUTED | 51,630,390 | 43,933,759 |