NEW YORK, Aug. 17, 2015 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (OTCQX:AVXL), a clinical-stage biopharmaceutical company developing drug candidates to treat 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, 2015.
Financial Highlights:
- Anavex had cash and cash equivalents of approximately $8.0 million as of June 30, 2015, compared with approximately $6.3 million as at March 31, 2015. Approximately $3.0 million was raised as a result of warrants exercised during the quarter. Cash was used in operations and for the advancement of clinical trial work. The Company has sufficient cash for approximately two years.
- Operating expenses for the third quarter of fiscal year 2015 were approximately $1.5 million, compared to approximately $1.0 million for the quarter ended June 30, 2014. The increase was primarily attributable to higher research and development expenses in the current period, mainly related to the ongoing Phase 2a clinical trial of ANAVEX 2-73 and ANAVEX PLUS.
“We are pleased with our progress to date,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “Our Phase 2a clinical trial of ANAVEX 2-73 for the treatment of Alzheimer’s disease is progressing on schedule, with PART A expected to be completed by the end of the year. Additionally, we are expanding PART B, the extension period, from 26 to 52 weeks based on positive initial clinical data and at the request of study participants. In parallel, we are conducting preclinical work with other disease indications including Parkinson’s, which is being funded by a grant from the Michael J. Fox Foundation for Parkinson’s Research.”
Recent Achievements
On August 12, 2015, Anavex announced that it has 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. Upon issuance, the patent will provide intellectual property protection until at least 2030. The allowed patent claims cover formulations and treatments that provide particular coverage relating to improved sigma receptor ligands and their use.
On August 10, 2015, Anavex announced that it has been awarded a research grant from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) to develop ANAVEX 2-73 for the treatment of Parkinson’s disease. The MJFF grant is expected to fully fund a preclinical study worth $286,456 on the effect of ANAVEX 2-73 in a Parkinson’s disease animal model, which seeks to provide a solid dataset that will justify moving forward to clinical development. The study may also provide further evidence for the involvement of sigma-1 receptors in potentially disease-modifying therapies for Parkinson’s disease.
On July 22, 2015, Anavex announced initial Phase 2a study data for ANAVEX 2-73, the Company’s lead investigational oral treatment for Alzheimer’s targeting sigma-1 and muscarinic receptors, which is believed to reduce protein misfolding including reduction of beta amyloid, tau and inflammation. ANAVEX 2-73 showed positive cognitive effects in 83 percent (10/12) of patients during PART A of the study, which consists of a 36-day on-off-on not-yet-optimized dosing regimen to assess bioavailability. At day 36, the amplitude of the cognitive EEG/ERP biomarker P300 increased 38 percent from baseline. Published data suggests that a 38 percent increase is approximately four times higher than donepezil (Aricept®), the current standard of care, in the same timeframe.
On June 18, 2015, Anavex announced the appointment of Steffen Thomas, PhD, to its Board of Directors. Dr. Thomas has 15 years of experience in intellectual property, patent law and proprietary technology rights as well as significant expertise in small molecule pharmaceuticals. Dr. Thomas is currently a patent attorney, European patent attorney and European trademark attorney at Epping Hermann Fischer, a major European intellectual property law firm.
On May 21, 2015, Anavex said it is encouraged by recent data published in the Proceedings of the National Academy of Sciences. The research determines that activating the sigma-1 receptor with agonists can potentially reduce the devastating impact of tau dysfunction. Alzheimer’s is the most widely recognized neurodegenerative disease associated with the aggregation of tau protein in the brain, with others including progressive supranuclear palsy (PSP) and frontotemporal dementia. It has been previously reported that ANAVEX 2-73, targeting the sigma-1 receptor in a dose-dependent study, blocked tau and amyloid-beta proteins as well as memory deficits in a mouse model of Alzheimer’s disease.
On May 18, 2015, Anavex announced that full preclinical anti-seizure data for ANAVEX 2-73 was revealed in a presentation on Friday, May 15, 2015 at the Antiepileptic Drug Trials XIII Conference. ANAVEX 2-73 demonstrated convincing data in three well-established and, according to experts, highly predictive preclinical anti-seizure models with a potentially more favorable side effect profile than currently marketed epilepsy drugs. The cognitive-enhancing features of ANAVEX 2-73 might be a differentiating factor since seizures cause neuro-cognitive impairments, which can be worsened by current epilepsy medications. The strong performance of ANAVEX 2-73 was also confirmed in combination with three generations of epilepsy drugs currently on the market.
The financial information for the three and nine months ended June 30, 2015 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. (OTCQX:AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel drug candidates to treat central nervous system (CNS) diseases 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. 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. 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. 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, | |||||||||
| 2015 | 2014 | |||||||||
| Current | ||||||||||
| Cash | $ | 7,961,331 | $ | 7,262,138 | ||||||
| Prepaid expenses | 16,054 | 89,117 | ||||||||
| Total current assets | 7,977,385 | 7,351,255 | ||||||||
| Equipment | 1,501 | 2,247 | ||||||||
| Total assets | $ | 7,978,886 | $ | 7,353,502 | ||||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||||
| Current | ||||||||||
| Accounts payable and accrued liabilities | $ | 1,259,051 | $ | 1,249,084 | ||||||
| Promissory notes payable | 92,516 | 192,065 | ||||||||
| Total current liabilities | 1,351,567 | 1,441,149 | ||||||||
| Non-interest bearing liabilities | 57,962 | 5,719,727 | ||||||||
| Total liabilities | 1,409,529 | 7,160,876 | ||||||||
| Common stock | 86,217 | 47,201 | ||||||||
| Additional paid-in capital | 65,030,871 | 52,078,750 | ||||||||
| Common stock to be issued | 777,415 | 640,000 | ||||||||
| Accumulated deficit | (59,325,146 | ) | (52,573,325 | ) | ||||||
| Total stockholders' equity | 6,569,357 | 192,626 | ||||||||
| Total liabilities and stockholders' equity | $ | 7,978,886 | $ | 7,353,502 | ||||||
| ANAVEX LIFE SCIENCES CORP. | |||||||||
| INTERIM STATEMENTS OF OPERATIONS | |||||||||
| THREE MONTHS ENDED JUNE 30, 2015 | |||||||||
| 2015 | 2014 | ||||||||
| OPERATING EXPENSES | |||||||||
| Research and development | $ | 799,462 | $ | 265,015 | |||||
| General and administrative | 713,498 | 733,818 | |||||||
| Total operating expenses | 1,512,960 | 998,833 | |||||||
| OPERATING LOSS | (1,512,960 | ) | (998,833 | ) | |||||
| OTHER INCOME | |||||||||
| Interest and finance expenses, net | 1,254 | (8,492 | ) | ||||||
| Financing related charges and adjustments | (2,716,640 | ) | 5,420 | ||||||
| Foreign exchange loss | (11,898 | ) | (7,185 | ) | |||||
| Total other income | (2,727,284 | ) | (10,257 | ) | |||||
| NET LOSS | $ | (4,240,244 | ) | $ | (1,009,090 | ) | |||
| NET LOSS PER COMMON SHARE | |||||||||
| BASIC | $ | (0.06 | ) | $ | (0.03 | ) | |||
| DILUTED | $ | (0.06 | ) | $ | (0.03 | ) | |||
| WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING | |||||||||
| BASIC | 76,380,219 | 39,260,098 | |||||||
| DILUTED | 76,380,219 | 39,260,098 | |||||||
| 2015 | 2014 | ||||||||
| Net loss and comprehensive loss - GAAP basis | $ | (4,240,244 | ) | $ | (1,009,090 | ) | |||
| Add back: | |||||||||
| Non-cash financing related charges and adjustments | 2,716,640 | (5,420 | ) | ||||||
| Net loss and comprehensive loss - Non-GAAP basis | $ | (1,523,604 | ) | $ | (1,014,510 | ) | |||
| NET LOSS PER COMMON SHARE | |||||||||
| BASIC | $ | (0.02 | ) | $ | (0.03 | ) | |||
| DILUTED | $ | (0.02 | ) | $ | (0.03 | ) | |||
| ANAVEX LIFE SCIENCES CORP. | |||||||||
| INTERIM STATEMENTS OF OPERATIONS | |||||||||
| NINE MONTHS ENDED JUNE 30, 2015 | |||||||||
| 2015 | 2014 | ||||||||
| OPERATING EXPENSES | |||||||||
| Research and development | $ | 1,525,233 | $ | 388,347 | |||||
| General and administrative | 1,616,744 | 1,941,261 | |||||||
| Total operating expenses | 3,141,977 | 2,329,608 | |||||||
| OPERATING LOSS | (3,141,977 | ) | (2,329,608 | ) | |||||
| OTHER INCOME | |||||||||
| Interest and finance expenses, net | (73,527 | ) | (16,858 | ) | |||||
| Financing related charges and adjustments | (3,591,346 | ) | 687,409 | ||||||
| Foreign exchange loss | 55,029 | (10,256 | ) | ||||||
| Total other income | (3,609,844 | ) | 660,295 | ||||||
| NET LOSS | $ | (6,751,821 | ) | $ | (1,669,313 | ) | |||
| NET LOSS PER COMMON SHARE | |||||||||
| BASIC | $ | (0.11 | ) | $ | (0.04 | ) | |||
| DILUTED | $ | (0.11 | ) | $ | (0.04 | ) | |||
| WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING | |||||||||
| BASIC | 61,752,000 | 38,218,237 | |||||||
| DILUTED | 61,752,000 | 38,218,237 | |||||||
| 2015 | 2014 | ||||||||
| Net loss and comprehensive loss - GAAP basis | $ | (6,751,821 | ) | $ | (1,669,313 | ) | |||
| Add back: | |||||||||
| Non-cash financing related charges and adjustments | 3,591,346 | (687,409 | ) | ||||||
| Net loss and comprehensive loss - Non-GAAP basis | $ | (3,160,475 | ) | $ | (2,356,722 | ) | |||
| NET LOSS PER COMMON SHARE | |||||||||
| BASIC | $ | (0.05 | ) | $ | (0.06 | ) | |||
| DILUTED | $ | (0.05 | ) | $ | (0.06 | ) | |||