NEW YORK, Dec. 29, 2015 (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 year-end results for fiscal year 2015.
Financial Highlights:
- Anavex had cash and cash equivalents of $15.3 million as of September 30, 2015, compared with $7.3 million as at September 30, 2014.
- During fiscal year 2015 Anavex used $4.2 million in cash to fund operations.
- The net loss for fiscal year 2015 was $12.1 million or $0.65 per share compared to a net loss of $10.0 million or $1.02 for the 2014 fiscal year.
- Operating expenses for the 12 months ended September 30, 2015 were $7.1 million, compared to $3.0 million for the comparable period in fiscal year 2014. The increase was primarily attributable to the Phase 2a clinical trial and expanding the team.
“Anavex had a remarkable year in 2015 with the achievement of several clinical and corporate milestones, including significant advancement of ANAVEX 2-73 for the treatment Alzheimer’s disease,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “We plan to continue to operate in a fiscally responsible manner and we look forward to providing additional updates in 2016 which include the Company’s plan to advance ANAVEX 2-73 for the treatment of Alzheimer’s disease in a larger double-blinded, randomized, placebo-controlled Phase 2/3 trial as well as initiating a human clinical trial with ANAVEX 2-73 in an additional indication.”
Upcoming Milestones:
- PART B data updates for 12, 26, 38, 52 week timeframes of the ongoing Phase 2a Alzheimer’s trial for ANAVEX 2-73.
- Report pharmacokinetics and pharmacodynamics (PK/PD) data for PART A of the Phase 2a trial.
- Initiate double-blinded, randomized, placebo-controlled Phase 2 human trial of ANAVEX 2-73 in non-disclosed indication.
- In addition to ongoing Phase 2a trial currently in PART B, start larger, double-blinded, randomized, placebo-controlled Phase 2/3 trial of ANAVEX 2-73 for Alzheimer’s disease.
- Advance preclinical research with ANAVEX pipeline compounds in neurodegenerative diseases, pain and various types of cancer – ongoing.
- In-licensing to complement current pipeline – ongoing.
Recent Corporate Highlights
On December 8, 2015, Dr. Missling presented an Alzheimer’s case study on the Anavex pipeline and shared his experience in the field of the private sector that can translate to public investment support for brain research at the third annual roundtable on the implementation of the Mental Health Parity Addiction and Equity Act (MHPAEA) of 2008 at the U.S. Capitol Visitor Center in Washington, D.C.
On December 7, 2015, Anavex presented preclinical epilepsy data in a poster at the American Epilepsy Society Annual Meeting, showing that ANAVEX 2-73 demonstrated convincing data in three well-established and predictive preclinical anti-seizure models with potentially more favorable side effect profile than currently marketed epilepsy drugs.
On November 30, 2015, Anavex announced the publication of further data for ANAVEX 3-71 (formerly AF710B) in the peer-reviewed scientific journal Neurodegenerative Diseases. The ANAVEX 3-71 data provides evidence for a positive, more upstream effect on reducing synaptic loss, amyloid and tau pathologies, and neuroinflammation, which is potentially beneficial for the treatment of Alzheimer’s and other neurological diseases. ANAVEX 3-71 is part of the Company’s pipeline including ANAVEX 2-73 targeting sigma-1 and muscarinic receptors.
On November 18, 2015, Anavex announced that it is moving forward with the development program for ANAVEX 2-73 based on formal interaction and guidance from the FDA, which confirmed the Company’s strategy to advance ANAVEX 2-73 for the treatment of Alzheimer’s disease in a larger double-blinded, randomized, placebo-controlled Phase 2/3 trial.
On November 9, 2015, Anavex announced positive safety and cognitive efficacy data from a Phase 2a clinical trial of ANAVEX 2-73 in Alzheimer’s disease. Initial analysis of Phase 2a data demonstrated that the study met the primary objective of safety as ANAVEX 2-73 was well tolerated and results were consistent with prior Phase 1 clinical trial data. The secondary objectives were also met, with ANAVEX 2-73 showing cognitive improvement across all doses in all exploratory cognitive measurements, including the Cogstate battery, Mini Mental State Examination (MMSE), event-related potentials (ERP) and P300 tests, which consistently demonstrated improvements from baseline in the completed PART A portion of the study in 32 mild-to-moderate Alzheimer’s patients.
On October 28, 2015, Anavex began trading its common stock on the Nasdaq Capital market at the opening of market hours under the symbol “AVXL.”
On October 7, 2015, Anavex’s common stock began trading on a post-split one-for-four (1-for-4) basis following a reverse stock split of its authorized, issued and outstanding common shares to meet the conditions of a Nasdaq listing.
On September 21, 2015, Anavex announced the appointment of Harald Hampel, MD, MA, PhD, MSc, to the Company’s Scientific Advisory Board. An internationally recognized expert on Alzheimer’s and related neurodegenerative diseases, Dr. Hampel is Professor and AXA Research Fund Chair at Sorbonne Universities’ Pierre and Marie Curie University (UPMC) in Paris, the leading university in science, technology and medicine in France.
On September 28, 2015, Anavex announced that patient enrollment for the Phase 2a clinical trial of ANAVEX 2-73 had been completed ahead of schedule.
On August 12, 2015, Anavex announced that it had received a Notice of Allowance from the U.S. Patent and Trademark Office for U.S. Pat. App. No. 14/205,637 related to ANAVEX 2-73. The patent was subsequently issued on November 10, 2015 as patent number 9,180,106 and is expected to provide intellectual property protection until at least 2030.
On August 10, 2015, Anavex announced that it was awarded a research grant from The Michael J. Fox Foundation (MJFF) for Parkinson’s Research to develop ANAVEX 2-73 for the treatment of Parkinson’s disease. The MJFF grant is expected to fully fund a preclinical study worth $286,455 on the effect of ANAVEX 2-73 in a Parkinson’s disease animal model. The study may also provide further evidence for the involvement of sigma-1 receptors in potentially disease-modifying therapies for Parkinson’s disease.
Financial information for the fiscal 2015 fourth quarter and year-end results ended September 30, 2015 should be read in conjunction with the Company’s audited consolidated financial statements, which have been filed on EDGAR 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 | ||||||||||
| 2015 | 2014 | |||||||||
| Current | ||||||||||
| Cash | $ | 15,290,976 | $ | 7,262,138 | ||||||
| GST recoverable | 76,840 | - | ||||||||
| Prepaid expenses | 100,845 | 89,117 | ||||||||
| Total current assets | 15,468,661 | 7,351,255 | ||||||||
| Equipment | 1,252 | 2,247 | ||||||||
| Total assets | $ | 15,469,913 | $ | 7,353,502 | ||||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||||
| Current | ||||||||||
| Accounts payable and accrued liabilities | $ | 2,503,726 | $ | 1,249,084 | ||||||
| Deferred grant income | 71,614 | - | ||||||||
| Promissory notes payable | 85,238 | 192,065 | ||||||||
| Total current liabilities | 2,660,578 | 1,441,149 | ||||||||
| Non-interest bearing liabilities | 332 | 5,719,727 | ||||||||
| Total liabilities | 2,660,910 | 7,160,876 | ||||||||
| Common stock | 32,044 | 11,800 | ||||||||
| Additional paid-in capital | 74,060,999 | 50,714,151 | ||||||||
| Common stock to be issued | 1,997,415 | 640,000 | ||||||||
| Accumulated deficit | (63,281,455 | ) | (51,173,325 | ) | ||||||
| Total stockholders' equity | 12,809,003 | 192,626 | ||||||||
| Total liabilities and stockholders' equity | $ | 15,469,913 | $ | 7,353,502 | ||||||
| ANAVEX LIFE SCIENCES CORP. | |||||||||
| STATEMENTS OF OPERATIONS | |||||||||
| YEARS ENDED SEPTEMBER 30, 2015 AND 2014 | |||||||||
| 2015 | 2014 | ||||||||
| OPERATING EXPENSES | |||||||||
| General and administrative | $ | 4,836,978 | $ | 2,236,580 | |||||
| Research and development | 2,271,736 | 732,395 | |||||||
| Total operating expenses | 7,108,714 | 2,968,975 | |||||||
| OPERATING LOSS | (7,108,714 | ) | (2,968,975 | ) | |||||
| OTHER INCOME | |||||||||
| Interest and finance expenses, net | (71,825 | ) | (7,089 | ) | |||||
| Gain on settlement of accounts payable | - | 199,655 | |||||||
| Financing related charges and adjustments | (4,998,145 | ) | (8,624,986 | ) | |||||
| Foreign exchange loss | 70,554 | 33,042 | |||||||
| Total non-operating expenses, net | (4,999,416 | ) | (8,399,378 | ) | |||||
| Net Loss before provision for income taxes | (12,108,130 | ) | (11,368,353 | ) | |||||
| Income tax expense (benefit) - deferred | - | (1,400,000 | ) | ||||||
| NET LOSS | $ | (12,108,130 | ) | $ | (9,968,353 | ) | |||
| NET LOSS PER COMMON SHARE | |||||||||
| BASIC | $ | (0.65 | ) | $ | (1.02 | ) | |||
| DILUTED | $ | (0.65 | ) | $ | (1.02 | ) | |||
| WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING | |||||||||
| BASIC | 18,584,820 | 9,804,539 | |||||||
| DILUTED | 18,584,820 | 9,804,539 | |||||||