NEW YORK, Dec. 12, 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 its fiscal year ended September 30, 2016.
Highlights:
- Cash and cash equivalents of $17.3 million as of December 12, 2016, and $9.2 million at September 30, 2016, compared to $15.3 million at September 30, 2015.
- During fiscal year 2016, Anavex used $9.2 million in cash to fund operations, which was within the Company’s spending plan guidance.
- Operating expenses for the year ended September 30, 2016, were $15.6 million, which included $5.1 million non-cash charges, compared to $7.1 million for the comparable period in fiscal year 2015. The increase was primarily attributable to ongoing clinical trial activities, preclinical work, and expansion of the Company’s team.
- Net loss for fiscal year 2016 was $14.7 million, or $0.42 per share, compared to a net loss of $12.1 million, or $0.65 per share, for the 2015 fiscal year.
- “9-Months and 12-Months Safety and Exploratory Efficacy Data of ANAVEX 2-73 in a Phase 2a Study in Mild-to-Moderate Alzheimer’s Disease Patients” was presented at the 9th annual Clinical Trials on Alzheimer's Disease (CTAD) 2016 conference in San Diego, CA. The presentation by Associate Professor Stephen Macfarlane, FRANZCP, is available in the publications section of the Anavex website.
“We are entering into 2017 with a stronger balance sheet and a strengthened corporate and scientific advisory team coupled with recently reported encouraging 57-week safety and tolerability data for ANAVEX 2-73, which restores cellular homeostasis, in a Phase 2a clinical trial in Alzheimer’s disease,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “We are now analyzing the significant correlations observed between cognition, function and behavior in combination with PK/PD modeling of the population as well as of each individual patient in order to derive the optimal parameters for the subsequent planned placebo-controlled efficacy trials. We believe this coherent approach should reduce future clinical development risk.”
Dr. Missling continued, “Given the strengthened financial resources and scientific validation, in 2017, we are able to prepare for a Phase 2/3, placebo-controlled trial in Alzheimer’s disease as well as a Phase 2, placebo-controlled trial in Rett syndrome, for which the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for ANAVEX 2-73 and a Phase 2, placebo-controlled trial in Parkinson’s disease.”
Recent Corporate Highlights
- December 1, 2016 - Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex participated on a panel at the Fourth Annual Mental Health Parity and Addiction Equity Act (MHPAEA) Business Roundtable. The panel focused on implementation of the MHPAEA of 2008.
- November 30, 2016 – Anavex announced addition of three prominent researchers in Parkinson’s and other CNS diseases to the company’s Scientific Advisory Board. The new SAB members include Tanya Simuni, M.D., Professor of Neurology and Director, Parkinson's Disease and Movement Disorders Program at Northwestern University, Chicago, Illinois; Daniel Weintraub, M.D., Professor of Psychiatry at University of Pennsylvania, Philadelphia, Pennsylvania; and Kalpana M. Merchant, Ph.D., Adjunct Professor of Neurology at Northwestern University Feinberg School of Medicine and Adjunct Professor of Biology at Purdue University, Portland, Oregon.
- November 14, 2016 – Anavex reported preclinical efficacy data for the treatment of neuropathic pain and visceral pain with ANAVEX 1066. Data was presented in a poster titled “Mixed sigma-1 / sigma-2 ligands as analgesics: studies with ANAVEX 1066 in animal models of neuropathic pain and visceral pain” at the annual meeting of the Society for Neuroscience 2016.
- October 5, 2016 – Anavex entered into a collaboration with Ariana Pharma to use Ariana’s proprietary KEM® (Knowledge, Extraction, Management) patient stratification technology. KEM® is a comprehensive and FDA-tested clinical data analysis system that enables full exploitation of complex datasets including of smaller numbers of patients.
- September 28, 2016 – Anavex entered into a material transfer agreement with Biogen under which Biogen will test Anavex’s lead drug candidate, ANAVEX 2-73, in an oligodendrocyte precursor cell (OPC) differentiation assay. A satisfactory result from the OPC assay study may lead to an in vivo remyelination study using a chemical demyelination model.
- September 22, 2016 – Anavex presented preclinical data demonstrating that ANAVEX 2-73 restores function in a classic animal model of Parkinson’s disease. Significant improvements were seen on all measures: behavioral, histopathological and neuroinflammatory endpoints.
- July 24 and 27, 2016 – Anavex presented positive safety and efficacy data through 31 weeks from the ongoing ANAVEX 2-73 Phase 2a study in mild-to-moderate Alzheimer’s patients at the Alzheimer’s Association International Conference (AAIC)® 2016.
Financial information for the fiscal year ended September 30, 2016 should be read in conjunction with the Company’s audited consolidated financial statements, which will appear on EDGAR and will be available on the Anavex website at www.anavex.com.
Conference Call / Webcast Information
To join the conference call, dial the toll-free number: (866) 939-3921. Please use confirmation number 43930140, followed by the pound sign (#). The live webcast of the conference call can be accessed online at http://wsw.com/webcast/cc/avxl. Investors may also listen to an archived version of the webcast on 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 restores cellular homeostasis by targeting 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 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.
TABLES FOLLOW
| ANAVEX LIFE SCIENCES CORP. | |||||||||
| CONSOLIDATED BALANCE SHEETS | |||||||||
| AS AT SEPTEMBER 30, 2016 AND 2015 | |||||||||
| ASSETS | |||||||||
| 2016 | 2015 | ||||||||
| Current | |||||||||
| Cash | $ | 9,186,814 | $ | 15,290,976 | |||||
| Sales Tax Recoverable | 79,347 | 76,840 | |||||||
| Prepaid expenses and deposits | 180,124 | 100,845 | |||||||
| Total current assets | 9,446,285 | 15,468,661 | |||||||
| Deposits | 52,396 | - | |||||||
| Equipment | - | 1,252 | |||||||
| Total assets | $ | 9,498,681 | $ | 15,469,913 | |||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||||
| Current | |||||||||
| Accounts payable and accrued liabilities | $ | 3,119,993 | $ | 2,503,726 | |||||
| Deferred grant income | 70,532 | 71,614 | |||||||
| Promissory notes payable | - | 85,238 | |||||||
| Total current liabilities | 3,190,525 | 2,660,578 | |||||||
| Senior Convertible Debentures | - | 332 | |||||||
| Total liabilities | 3,190,525 | 2,660,910 | |||||||
| Common stock | 36,169 | 32,044 | |||||||
| Additional paid-in capital | 84,290,140 | 74,060,999 | |||||||
| Common stock to be issued | - | 1,997,415 | |||||||
| Accumulated deficit | (78,018,153 | ) | (63,281,455 | ) | |||||
| Total stockholders' equity | 6,308,156 | 12,809,003 | |||||||
| Total liabilities and stockholders' equity | $ | 9,498,681 | $ | 15,469,913 | |||||
| ANAVEX LIFE SCIENCES CORP. | |||||||||||
| CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||
| TWELVE MONTHS ENDED SEPTEMBER 30, 2016, 2015 AND 2014 | |||||||||||
| 2016 | 2015 | 2014 | |||||||||
| OPERATING EXPENSES | |||||||||||
| General and administrative | $ | 8,334,740 | $ | 4,836,978 | $ | 2,236,580 | |||||
| Research and development | 7,254,303 | 2,271,736 | 732,395 | ||||||||
| Total operating expenses | 15,589,043 | 7,108,714 | 2,968,975 | ||||||||
| OPERATING LOSS | (15,589,043 | ) | (7,108,714 | ) | (2,968,975 | ) | |||||
| OTHER INCOME (EXPENSE) | |||||||||||
| Grant income | 712,288 | - | - | ||||||||
| Interest income (expense), net | 11,322 | (71,825 | ) | (7,089 | ) | ||||||
| Other income | 212,607 | - | 199,655 | ||||||||
| Financing related charges and adjustments | (5,812 | ) | (4,998,145 | ) | (8,624,986 | ) | |||||
| Foreign exchange loss | (48,445 | ) | 70,554 | 33,042 | |||||||
| Total other income (expenses) | 881,960 | (4,999,416 | ) | (8,399,378 | ) | ||||||
| Net loss before income taxes | (14,707,083 | ) | (12,108,130 | ) | (11,368,353 | ) | |||||
| Income tax expense - current | (29,615 | ) | - | - | |||||||
| Income tax benefit - deferred | - | - | 1,400,000 | ||||||||
| NET LOSS | $ | (14,736,698 | ) | $ | (12,108,130 | ) | $ | (9,968,353 | ) | ||
| NET LOSS PER COMMON SHARE | |||||||||||
| BASIC | $ | (0.42 | ) | $ | (0.65 | ) | $ | (1.02 | ) | ||
| DILUTED | $ | (0.42 | ) | $ | (0.65 | ) | $ | (1.02 | ) | ||
| WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING | |||||||||||
| BASIC | 35,153,426 | 18,584,820 | 9,804,539 | ||||||||
| DILUTED | 35,153,426 | 18,584,820 | 9,804,539 | ||||||||