NEW YORK, May 11, 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 and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer, today reported financial results for the three and six months ended March 31, 2016.
Financial Highlights:
- Cash and cash equivalents of approximately $12.0 million at March 31, 2016, compared to approximately $15.3 million at September 30, 2015.
- Operating expenses for the second quarter of approximately $2.2 million compared to approximately $0.9 million for the second quarter of fiscal 2015. This increase was primarily attributable to ongoing clinical trial activities, preclinical work and expansion of the Company’s management team.
- Net loss for the second quarter of approximately $2.0 million, or $0.06 per share, compared to a net loss of approximately $1.7 million, or $0.12 per share, for the same period in fiscal 2015.
“We are encouraged by the ongoing Phase 2a Alzheimer’s trial data, as well as the two-year trial extension granted after a request from patients and caregivers. We are especially impressed with our compounds showing pre-clinical efficacy in rare and orphan diseases, including Rett syndrome and Frontotemporal dementia,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “In the meantime, we continue to advance our plans to execute a larger Phase 2/3 Alzheimer’s trial with our lead compound, ANAVEX 2-73, in addition to preparing to explore ANAVEX 2-73 in a Phase 2 clinical study for the treatment of Rett syndrome.”
Recent Corporate Highlights
- April 8, 2016 - Anavex granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration for ANAVEX 3-71 for the treatment of Frontotemporal dementia.
- March 14, 2016 - Reported positive preclinical data for sigma-1 agonist ANAVEX 3-71, which showed a statistically significant reduction in the rate of cognitive deficit, inflammation and Alzheimer’s-like amyloid pathology with the administration of ANAVEX 3-71.
- March 12, 2016 - Presented positive, detailed dose-response analysis of data from the ongoing Phase 2a Alzheimer’s trial of ANAVEX 2-73 PART A at the 14th International Symposium on Advances in Alzheimer Therapy.
- March 10, 2016 - Received approval from the Ethics Committee in Australia to extend the ongoing Phase 2a Alzheimer’s trial at the request of patients and their caregivers. The trial extension is designed to allow participants who complete 52 weeks in PART B to roll-over into a new trial and continue taking ANAVEX 2-73 for an additional 104 weeks, providing an opportunity to gather longitudinal safety data. The trial is independent of the Company’s planned larger Phase 2/3 double-blinded, placebo-controlled study of ANAVEX 2-73 in Alzheimer’s disease.
- February 26, 2016 - Presented positive data for ANAVEX 2-73 from an exploratory study in a Rett syndrome model at the 2016 Epilepsy Pipeline Conference. The data demonstrated dose-related and significant improvements in an array of behavioral and gait paradigms in a mouse model with a MECP2-null mutation, which causes neurological symptoms that mimic Rett syndrome.
The financial information for the three and six months ended March 31, 2016, should be read in conjunction with the Company’s interim consolidated financial statements, which have been filed on the 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 and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer. Anavex’s lead drug candidate, ANAVEX 2-73, is 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 safety 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 animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. The 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 | ||||||||||
| March 31, | September 30, | |||||||||
| 2016 | 2015 | |||||||||
| Current | ||||||||||
| Cash | $ | 11,950,847 | $ | 15,290,976 | ||||||
| Sales Tax Recoverable | 78,670 | 76,840 | ||||||||
| Prepaid expenses and deposits | 84,977 | 100,845 | ||||||||
| Total current assets | 12,114,494 | 15,468,661 | ||||||||
| Equipment | 755 | 1,252 | ||||||||
| Total assets | $ | 12,115,249 | $ | 15,469,913 | ||||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||||
| Current | ||||||||||
| Accounts payable and accrued liabilities | $ | 2,338,137 | $ | 2,503,726 | ||||||
| Deferred grant income | 5,445 | 71,614 | ||||||||
| Promissory notes payable | 88,145 | 85,238 | ||||||||
| Total current liabilities | 2,431,727 | 2,660,578 | ||||||||
| Non-interest bearing liabilities | 337 | 332 | ||||||||
| Total liabilities | 2,432,064 | 2,660,910 | ||||||||
| Common stock | 35,697 | 32,044 | ||||||||
| Additional paid-in capital | 78,914,253 | 74,060,999 | ||||||||
| Common stock to be issued | - | 1,997,415 | ||||||||
| Accumulated deficit | (69,266,765 | ) | (63,281,455 | ) | ||||||
| Total stockholders' equity | 9,683,185 | 12,809,003 | ||||||||
| Total liabilities and stockholders' equity | $ | 12,115,249 | $ | 15,469,913 | ||||||
| ANAVEX LIFE SCIENCES CORP. | |||||||||
| INTERIM STATEMENTS OF OPERATIONS | |||||||||
| THREE MONTHS ENDED MARCH 31, 2016 AND 2015 | |||||||||
| (unaudited) | |||||||||
| 2016 | 2015 | ||||||||
| OPERATING EXPENSES | |||||||||
| Research and development | $ | 1,327,393 | $ | 407,146 | |||||
| General and administrative | 852,775 | 451,193 | |||||||
| Total operating expenses | 2,180,168 | 858,339 | |||||||
| OPERATING LOSS | (2,180,168 | ) | (858,339 | ) | |||||
| OTHER INCOME (EXPENSE) | |||||||||
| Grant income | 26,879 | - | |||||||
| Interest and finance expenses, net | 2,064 | 2,228 | |||||||
| Gain on settlement of accounts payable | 151,402 | - | |||||||
| Financing related charges and adjustments | (72 | ) | (912,357 | ) | |||||
| Foreign exchange loss | (30,906 | ) | 43,609 | ||||||
| Total other income (expenses) | 149,367 | (866,520 | ) | ||||||
| NET LOSS | $ | (2,030,801 | ) | $ | (1,724,859 | ) | |||
| NET LOSS PER COMMON SHARE | |||||||||
| BASIC | $ | (0.06 | ) | $ | (0.12 | ) | |||
| DILUTED | $ | (0.06 | ) | $ | (0.12 | ) | |||
| WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING | |||||||||
| BASIC | 35,214,793 | 14,326,945 | |||||||
| DILUTED | 35,214,793 | 14,326,945 | |||||||
| ANAVEX LIFE SCIENCES CORP. | |||||||||
| INTERIM STATEMENTS OF OPERATIONS | |||||||||
| SIX MONTHS ENDED MARCH 31, 2016 AND 2015 | |||||||||
| (unaudited) | |||||||||
| 2016 | 2015 | ||||||||
| OPERATING EXPENSES | |||||||||
| Research and development | $ | 1,998,129 | $ | 725,771 | |||||
| General and administrative | 4,714,473 | 903,246 | |||||||
| Total operating expenses | 6,712,602 | 1,629,017 | |||||||
| OPERATING LOSS | (6,712,602 | ) | (1,629,017 | ) | |||||
| OTHER INCOME (EXPENSE) | |||||||||
| Grant income | 637,027 | - | |||||||
| Interest and finance expenses, net | 4,206 | (74,781 | ) | ||||||
| Gain on settlement of accounts payable | 151,402 | - | |||||||
| Financing related charges and adjustments | (1,167 | ) | (874,706 | ) | |||||
| Foreign exchange loss | (46,561 | ) | 66,927 | ||||||
| Total other income (expenses) | 744,907 | (882,560 | ) | ||||||
| Net loss before income taxes | (5,967,695 | ) | (2,511,577 | ) | |||||
| Income tax expense | 17,615 | - | |||||||
| NET LOSS | $ | (5,985,310 | ) | $ | (2,511,577 | ) | |||
| NET LOSS PER COMMON SHARE | |||||||||
| BASIC | $ | (0.17 | ) | $ | (0.18 | ) | |||
| DILUTED | $ | (0.17 | ) | $ | (0.18 | ) | |||
| WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING | |||||||||
| BASIC | 34,589,957 | 13,609,473 | |||||||
| DILUTED | 34,589,957 | 13,609,473 | |||||||