NEW YORK, Feb. 08, 2016 (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 diseases including 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, 2015.
Financial Highlights:
- Anavex had cash and cash equivalents of approximately $13.8 million as of December 31, 2015, compared to approximately $15.3 million as at September 30, 2015.
- Anavex used approximately $1.5 million in net cash during the first three months of fiscal year 2016.
- Operating expenses for the three months ended December 31, 2015 were approximately $4.5 million, compared to approximately $0.8 million for the quarter ended December 31, 2014. The increase was primarily attributable to expenses related to ongoing clinical trials, non-recurring charges and expenses, and an expanded scientific and management team.
- The net loss for the three months ended December 31, 2015 was approximately $4.0 million or $0.12 per share, compared to a net loss of approximately $0.8 million or $0.06 for the same period in 2014. The net loss was partially offset by $0.6 million in grant income.
“The ongoing Phase 2a adaptive trial of ANAVEX 2-73 in mild-to-moderate Alzheimer’s patients continues to move ahead and we look forward to sharing additional results as the year progresses,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “In parallel to the ongoing Phase 2a trial, the Anavex team is also moving forward with plans for a Phase 2/3 trial of ANAVEX 2-73, which would include a larger group of Alzheimer’s patients and an additional control arm. Also this year, we are scheduling a Phase 2 human trial of ANAVEX 2-73 in a non-disclosed indication and other advancements with our pipeline compounds. We continue to be encouraged by the Company’s progress.”
Recent Corporate Highlights
- On January 11, 2016, the Company reported that a significant positive dose-response relationship has been observed with ANAVEX 2-73 in mild-to-moderate Alzheimer’s patients. In a pre-planned interim analysis of data from the ongoing Phase 2a Alzheimer’s trial, cognitive scores measured through MMSE and EEG/ERP-P300 data confirmed that the higher ANAVEX 2-73 doses achieved a statistically significant improvement. These improvements were observed both in the changes of MMSE and EEG/ERP-P300 scores over five weeks compared to the lower doses.
Upcoming Milestones:
- Data updates for 12, 26, 38 and 52-week timeframes for PART B of the ongoing Phase 2a Alzheimer’s trial of ANAVEX 2-73.
- In addition to ongoing Phase 2a trial currently in PART B, initiate larger, double-blinded, randomized, placebo-controlled Phase 2/3 trial of ANAVEX 2-73 for Alzheimer’s disease.
- Commence double-blinded, randomized, placebo-controlled Phase 2 human trial of ANAVEX 2-73 in additional indication.
- Advance preclinical research with ANAVEX pipeline compounds in neurodegenerative diseases, pain and various types of cancer.
The financial information for the three months ended December 31, 2015 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. (Nasdaq:AVXL) is a publicly traded biopharmaceutical company dedicated to the development of differentiated therapeutics for the treatment of neurodegenerative diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain 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. 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. 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. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in convulsive epileptic animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. Michael J. Fox Foundation (MJFF) for Parkinson’s Research has awarded Anavex a research grant to develop ANAVEX 2-73 for the treatment of Parkinson’s disease to fully fund a preclinical study, which could justify moving ANAVEX 2-73 into a Parkinson’s disease clinical trial. ANAVEX 3-71, also targeting sigma-1 and M1 muscarinic receptors, is a promising preclinical drug candidate demonstrating disease modifications against the major Alzheimer’s hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also with beneficial effects on neuroinflammation and mitochondrial dysfunctions. 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, | |||||||||
| 2015 | 2015 | |||||||||
| Current | ||||||||||
| Cash | $ | 13,853,405 | $ | 15,290,976 | ||||||
| GST Recoverable | 92,337 | 76,840 | ||||||||
| Prepaid expenses | 77,215 | 100,845 | ||||||||
| Total current assets | 14,022,957 | 15,468,661 | ||||||||
| Equipment | 1,003 | 1,252 | ||||||||
| Total assets | $ | 14,023,960 | $ | 15,469,913 | ||||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||||
| Current | ||||||||||
| Accounts payable and accrued liabilities | $ | 2,417,431 | $ | 2,503,726 | ||||||
| Deferred grant income | 32,559 | 71,614 | ||||||||
| Promissory notes payable | 82,410 | 85,238 | ||||||||
| Total current liabilities | 2,532,400 | 2,660,578 | ||||||||
| Non-interest bearing liabilities | 265 | 332 | ||||||||
| Total liabilities | 2,532,665 | 2,660,910 | ||||||||
| Common stock | 34,655 | 32,044 | ||||||||
| Additional paid-in capital | 76,127,544 | 74,060,999 | ||||||||
| Common stock to be issued | 2,565,060 | 1,997,415 | ||||||||
| Accumulated deficit | (67,235,964 | ) | (63,281,455 | ) | ||||||
| Total stockholders' equity | 11,491,295 | 12,809,003 | ||||||||
| Total liabilities and stockholders' equity | $ | 14,023,960 | $ | 15,469,913 | ||||||
| ANAVEX LIFE SCIENCES CORP. | |||||||||
| INTERIM STATEMENTS OF OPERATIONS | |||||||||
| THREE MONTHS ENDED DECEMBER 31, 2015 | |||||||||
| (unaudited) | |||||||||
| 2015 | 2014 | ||||||||
| OPERATING EXPENSES | |||||||||
| Research and development | $ | 670,736 | $ | 452,053 | |||||
| General and administrative | 3,861,698 | 318,625 | |||||||
| Total operating expenses | 4,532,434 | 770,678 | |||||||
| OPERATING LOSS | (4,532,434 | ) | (770,678 | ) | |||||
| OTHER INCOME | |||||||||
| Grant income | 610,148 | - | |||||||
| Interest and finance expenses, net | 2,142 | (77,009 | ) | ||||||
| Financing related charges and adjustments | (1,095 | ) | 37,651 | ||||||
| Foreign exchange loss | (15,655 | ) | 23,318 | ||||||
| Total other income | 595,540 | (16,040 | ) | ||||||
| Net loss before income taxes | (3,936,894 | ) | (786,718 | ) | |||||
| Income tax expense | 17,615 | - | |||||||
| NET LOSS | $ | (3,954,509 | ) | $ | (786,718 | ) | |||
| NET LOSS PER COMMON SHARE | |||||||||
| BASIC | $ | (0.12 | ) | $ | (0.06 | ) | |||
| DILUTED | $ | (0.12 | ) | $ | (0.06 | ) | |||
| WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING | |||||||||
| BASIC | 33,971,913 | 12,907,598 | |||||||
| DILUTED | 33,971,913 | 12,907,598 | |||||||