NEW YORK, Aug. 07, 2017 (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 fiscal quarter ended June 30, 2017.
Financial Highlights:
- Cash and equivalents of $24.8 million at June 30, 2017, compared to $9.2 million at September 30, 2016.
- Cash used to fund operations was $3.0 million, compared to $2.2 million for the comparative quarter last year. This is in line with the Company’s cash utilization guidance.
- Operating expenses of $3.7 million compared to $2.3 million for the comparative quarter last year. This increase was a result of increased spending on research and development, including clinical trial preparatory activities.
- Net loss for the quarter of $3.6 million, or $0.09 per share, compared to a net loss of $2.2 million, or $0.06 per share, for the comparative quarter.
“We are entering the second half of 2017 with our strongest balance sheet to date, which allows the Company to execute the Phase 2 clinical trial in Rett syndrome, for which ANAVEX™ 2-73 has been granted Orphan Drug Designation by the FDA, as well as the Phase 2/3 clinical trial in Alzheimer’s disease and the Phase 2 clinical trial in Parkinson’s disease,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex Life Sciences. “We look forward to initiating these placebo-controlled clinical trials. The respective trial designs are based on broad genomic and biomarker characterization, pharmacokinetic and pharmacodynamic modeling including data from patients in previous ANAVEX™ 2-73 trials, as well as preclinical translational science. To our knowledge, this is the first use of this approach in the design of clinical trials for Alzheimer’s disease, Parkinson’s disease and Rett syndrome, and marks a shift towards advancing implementation of precision medicine for these and other neurodegenerative and neurodevelopmental diseases."
Corporate Highlights:
• July 20, 2017 – Anavex further strengthened its Scientific Advisory Board with the appointment of Andrew J. Cole, M.D., F.R.C.P.(C.) Dr. Cole is Director of the MGH Epilepsy Service, Chief of the Division of Clinical Neurophysiology and Epilepsy and Professor of Neurology at Harvard Medical School.
• May 22, 2017 – Anavex announced new preclinical data for ANAVEXTM 2-73 in the rare diseases Angelman syndrome, Fragile X syndrome and Rett syndrome.
- In a study sponsored by the Foundation for Angelman Syndrome, ANAVEXTM 2-73 was assessed in a mouse model for the development of audiogenic seizures. The results indicated that ANAVEX™ 2-73 administration significantly reduced audiogenic-induced seizures.
- In a study sponsored by FRAXA Research Foundation, data demonstrated that ANAVEXTM 2-73 restored hippocampal brain-derived neurotrophic factor (BDNF) expression to normal levels. BDNF under-expression has been observed in many neurodevelopmental and neurodegenerative pathologies. BDNF signaling promotes maturation of both excitatory and inhibitory synapses. ANAVEXTM 2-73 normalization of BDNF expression could be a contributing factor for the positive data observed in both neurodevelopmental and neurodegenerative disorders.
- In an experiment sponsored by Rettsyndrome.org, ANAVEXTM 2-73 was evaluated in automatic visual response and respiration tests in seven-month old mice, an age at which advanced pathology is evident. Vehicle-treated MECP2 mice demonstrated fewer automatic visual responses than wild-type mice. Treatment with ANAVEXTM 2-73 significantly increased the automatic visual response in the MECP2 Rett syndrome disease mouse.
Planned Objectives:
- Report PK/PD data from Alzheimer’s Phase 2a clinical trial.
- Initiate Phase 2 clinical trial in Rett syndrome (12-week, randomized, double-blind, placebo-controlled).
- Initiate Phase 2 clinical trial in Parkinson’s disease (12-week, randomized, double-blind, placebo-controlled).
- Initiate Phase 2/3 clinical trial in Alzheimer’s disease (6/12-month, randomized, double-blind, placebo-controlled).
- Potential for several clinical read-outs in 2018.
- Complement current pipeline through in-licensing – ongoing.
The financial information for the three and nine months ended June 30, 2017, should be read in conjunction with the Company’s condensed consolidated interim financial statements, which will appear 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 and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer. Anavex’s lead drug candidate, ANAVEXTM 2-73, recently completed successfully a Phase 2a clinical trial for Alzheimer’s disease. ANAVEXTM 2-73 is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. 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 ANAVEXTM 2-73 for the treatment of Parkinson’s disease to fully fund a preclinical study, which could justify moving ANAVEXTM 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. You can also connect with the company on Twitter, Facebook and LinkedIn.
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 | ||||||||
| (Unaudited) | ||||||||
| June 30, | September 30, | |||||||
| ASSETS | 2017 | 2016 | ||||||
| Current | ||||||||
| Cash | $ | 24,793,424 | $ | 9,186,814 | ||||
| Sales Tax Recoverable | 8,216 | 79,347 | ||||||
| Prepaid expenses and deposits | 52,694 | 180,124 | ||||||
| Total current assets | 24,854,334 | 9,446,285 | ||||||
| Deposits | 52,396 | 52,396 | ||||||
| Total assets | $ | 24,906,730 | $ | 9,498,681 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current | ||||||||
| Accounts payable and accrued liabilities | $ | 1,435,498 | $ | 3,119,993 | ||||
| Deferred grant income | 19,073 | 70,532 | ||||||
| Total liabilities | 1,454,571 | 3,190,525 | ||||||
| Common stock | 42,173 | 36,169 | ||||||
| Additional paid-in capital | 109,733,970 | 84,290,140 | ||||||
| Accumulated deficit | (86,323,984 | ) | (78,018,153 | ) | ||||
| Total stockholders' equity | 23,452,159 | 6,308,156 | ||||||
| Total liabilities and stockholders' equity | $ | 24,906,730 | $ | 9,498,681 | ||||
| ANAVEX LIFE SCIENCES CORP. | |||||||
| CONSOLIDATED INTERIM STATEMENTS OF OPERATIONS | |||||||
| THREE MONTHS ENDED JUNE 30, 2017 AND 2016 | |||||||
| (Unaudited) | |||||||
| 2017 | 2016 | ||||||
| Operating Expenses | |||||||
| General and administrative | $ | 1,405,026 | $ | 1,134,845 | |||
| Research and development | 2,300,277 | 1,158,820 | |||||
| Total operating expenses | 3,705,303 | 2,293,665 | |||||
| Operating Loss | (3,705,303 | ) | (2,293,665 | ) | |||
| Other income (expenses) | |||||||
| Grant income | 69,146 | 47,767 | |||||
| Gain on settlement of accounts payable | 75,204 | - | |||||
| Interest income, net | 26,677 | 2,626 | |||||
| Financing related charges and adjustments | (8 | ) | |||||
| Foreign exchange gain (loss) | (65,932 | ) | 8,924 | ||||
| Total other income (expenses) | 105,095 | 59,309 | |||||
| Net loss before income taxes | (3,600,208 | ) | (2,234,356 | ) | |||
| Income tax expense - current | (9,877 | ) | (6,000 | ) | |||
| Net loss | $ | (3,610,085 | ) | $ | (2,240,356 | ) | |
| Net loss per Share | |||||||
| Basic and Diluted | $ | (0.09 | ) | $ | (0.06 | ) | |
| Weighted Average Number of Shares Outstanding | |||||||
| Basic and Diluted | 41,509,225 | 35,709,686 | |||||
| ANAVEX LIFE SCIENCES CORP. | |||||||
| CONSOLIDATED INTERIM STATEMENTS OF OPERATIONS | |||||||
| NINE MONTHS ENDED JUNE 30, 2017 AND 2016 | |||||||
| (Unaudited) | |||||||
| 2017 | 2016 | ||||||
| Operating Expenses | |||||||
| General and administrative | $ | 3,647,224 | $ | 5,117,591 | |||
| Research and development | 6,835,700 | 3,888,676 | |||||
| Total operating expenses | 10,482,924 | 9,006,267 | |||||
| Operating Loss | (10,482,924 | ) | (9,006,267 | ) | |||
| Other income (expenses) | |||||||
| Grant income | 121,116 | 113,701 | |||||
| Research and development incentive income | 2,022,902 | 571,093 | |||||
| Gain on settlement of accounts payable | 75,204 | 151,402 | |||||
| Interest income, net | 48,479 | 6,832 | |||||
| Financing related charges and adjustments | - | (1,175 | ) | ||||
| Foreign exchange gain (loss) | (40,128 | ) | (37,637 | ) | |||
| Total other income | 2,227,573 | 804,216 | |||||
| Net loss before income taxes | (8,255,351 | ) | (8,202,051 | ) | |||
| Income tax expense - current | (50,480 | ) | (23,615 | ) | |||
| Net loss | $ | (8,305,831 | ) | $ | (8,225,666 | ) | |
| Net loss per Share | |||||||
| Basic and Diluted | $ | (0.21 | ) | $ | (0.24 | ) | |
| Weighted Average Number of Shares Outstanding | |||||||
| Basic and Diluted | 40,344,149 | 34,961,838 | |||||