NEW YORK, Aug. 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 nine months ended June 30, 2016.
Highlights:
- The SEC staff recently advised Company’s legal counsel that the staff did not intend to recommend enforcement action by the Commission against the Company in connection with the investigation previously described in the Company’s 2015 Report on Form 10-K.
- Cash and cash equivalents of approximately $9.7 million at June 30, 2016, compared to approximately $15.3 million at September 30, 2015.
- Operating expenses for the third quarter of approximately $2.3 million compared to approximately $1.5 million for the third quarter of fiscal 2015. This increase was primarily attributable to ongoing clinical trial activities, preclinical work, an expansion of the Company’s team and increased legal fees.
- Net loss for the third quarter of approximately $2.2 million, or $0.06 per share, compared to a net loss of approximately $4.2 million, or $0.22 per share, for the same period in fiscal 2015.
“We are encouraged by the ongoing Phase 2a Alzheimer’s trial data and are especially excited about the observed reduction in insomnia, a condition correlated with multiple underlying psychiatric diseases,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “We look forward to the upcoming 9-month data release and the update of the clinical development plan for Phase 2 study for the treatment of Rett syndrome with ANAVEX 2-73.”
Recent Corporate Highlights
- July 24 and 27, 2016 - Anavex presented 31-week safety and efficacy data from the ongoing Phase 2a study of ANAVEX 2-73 in Alzheimer’s patients at the Alzheimer’s Association International Conference (AAIC) 2016. Data demonstrated favorable safety, maximum tolerated dose, positive dose response and sustained efficacy response through 31 weeks for both cognitive and functional measures, as well as positive unexpected therapeutic response events. ANAVEX 2-73 continues to demonstrate a favorable adverse event (AE) profile through 31 weeks in a patient population of elderly Alzheimer’s patients with varying degrees of physical fragility. ANAVEX 2-73 data presented allows the Company to progress into Phase 2/3 placebo-controlled studies.
- June 22, 2016 - The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for ANAVEX 2-73 for the treatment of infantile spasms.
- June 6, 2016 - Anavex presented positive preclinical data for ANAVEX 2-73 in Fragile X syndrome and Autism-related disorders at the Gordon Research Conference for Fragile X and Autism-Related Disorders. In a Fragile X model, ANAVEX 2-73 significantly improved all behaviors tested and reversed hyperactivity and impairment in learning and memory (p≤0.0001).
- May 20, 2016 - The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for ANAVEX 2-73 for the treatment of Rett syndrome.
- May 18, 2016 – Anavex reported positive preclinical data for ANAVEX 2-73 in infantile spasms. ANAVEX 2-73 significantly reduced the number of spasms in an animal model with infantile spasms (epileptic spasms) by 55 percent compared to vehicle (p=0.0002).
The financial information for the three and nine months ended June 30, 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 | ||||||||||
| June 30, | September 30, | |||||||||
| 2016 | 2015 | |||||||||
| Current | ||||||||||
| Cash | $ | 9,727,040 | $ | 15,290,976 | ||||||
| Sales Tax Recoverable | 47,953 | 76,840 | ||||||||
| Prepaid expenses and deposits | 68,474 | 100,845 | ||||||||
| Total current assets | 9,843,467 | 15,468,661 | ||||||||
| Equipment | 506 | 1,252 | ||||||||
| Total assets | $ | 9,843,973 | $ | 15,469,913 | ||||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||||
| Current | ||||||||||
| Accounts payable and accrued liabilities | $ | 2,057,531 | $ | 2,503,726 | ||||||
| Deferred grant income | 27,124 | 71,614 | ||||||||
| Promissory notes payable | 87,887 | 85,238 | ||||||||
| Total current liabilities | 2,172,542 | 2,660,578 | ||||||||
| Non-interest bearing liabilities | 345 | 332 | ||||||||
| Total liabilities | 2,172,887 | 2,660,910 | ||||||||
| Common stock | 35,712 | 32,044 | ||||||||
| Additional paid-in capital | 79,142,495 | 74,060,999 | ||||||||
| Common stock to be issued | - | 1,997,415 | ||||||||
| Accumulated deficit | (71,507,121 | ) | (63,281,455 | ) | ||||||
| Total stockholders' equity | 7,671,086 | 12,809,003 | ||||||||
| Total liabilities and stockholders' equity | $ | 9,843,973 | $ | 15,469,913 | ||||||
| ANAVEX LIFE SCIENCES CORP. | |||||||||
| INTERIM STATEMENTS OF OPERATIONS | |||||||||
| THREE MONTHS ENDED JUNE 30, 2016 AND 2015 | |||||||||
| (unaudited) | |||||||||
| 2016 | 2015 | ||||||||
| OPERATING EXPENSES | |||||||||
| Research and development | $ | 917,303 | $ | 799,462 | |||||
| General and administrative | 1,376,362 | 713,498 | |||||||
| Total operating expenses | 2,293,665 | 1,512,960 | |||||||
| OPERATING LOSS | (2,293,665 | ) | (1,512,960 | ) | |||||
| OTHER INCOME (EXPENSE) | |||||||||
| Grant income | 47,767 | - | |||||||
| Interest and finance expenses, net | 2,626 | 1,254 | |||||||
| Financing related charges and adjustments | (8 | ) | (2,716,640 | ) | |||||
| Foreign exchange loss | 8,924 | (11,898 | ) | ||||||
| Total other income (expenses) | 59,309 | (2,727,284 | ) | ||||||
| Net loss before income taxes | (2,234,356 | ) | (4,240,244 | ) | |||||
| Income tax expense | 6,000 | - | |||||||
| NET LOSS | $ | (2,240,356 | ) | $ | (4,240,244 | ) | |||
| NET LOSS PER COMMON SHARE | |||||||||
| BASIC | $ | (0.06 | ) | $ | (0.22 | ) | |||
| DILUTED | $ | (0.06 | ) | $ | (0.22 | ) | |||
| WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING | |||||||||
| BASIC | 35,709,686 | 19,095,055 | |||||||
| DILUTED | 35,709,686 | 19,095,055 | |||||||
| ANAVEX LIFE SCIENCES CORP. | |||||||||
| INTERIM STATEMENTS OF OPERATIONS | |||||||||
| NINE MONTHS ENDED JUNE 30, 2016 AND 2015 | |||||||||
| (unaudited) | |||||||||
| 2016 | 2015 | ||||||||
| OPERATING EXPENSES | |||||||||
| Research and development | $ | 2,915,432 | $ | 1,525,233 | |||||
| General and administrative | 6,090,835 | 1,616,744 | |||||||
| Total operating expenses | 9,006,267 | 3,141,977 | |||||||
| OPERATING LOSS | (9,006,267 | ) | (3,141,977 | ) | |||||
| OTHER INCOME (EXPENSE) | |||||||||
| Grant income | 684,794 | - | |||||||
| Interest and finance expenses, net | 6,832 | (73,527 | ) | ||||||
| Gain on settlement of accounts payable | 151,402 | - | |||||||
| Financing related charges and adjustments | (1,175 | ) | (3,591,346 | ) | |||||
| Foreign exchange loss | (37,637 | ) | 55,029 | ||||||
| Total other income (expenses) | 804,216 | (3,609,844 | ) | ||||||
| Net loss before income taxes | (8,202,051 | ) | (6,751,821 | ) | |||||
| Income tax expense | 23,615 | - | |||||||
| NET LOSS | $ | (8,225,666 | ) | $ | (6,751,821 | ) | |||
| NET LOSS PER COMMON SHARE | |||||||||
| BASIC | $ | (0.24 | ) | $ | (0.44 | ) | |||
| DILUTED | $ | (0.24 | ) | $ | (0.44 | ) | |||
| WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING | |||||||||
| BASIC | 34,961,838 | 15,438,000 | |||||||
| DILUTED | 34,961,838 | 15,438,000 | |||||||