Conference Call and Webcast Today at 4:30 p.m. ET
NEW YORK, Aug. 09, 2018 (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, Rett syndrome and other central nervous system (CNS) diseases, today reported financial results for its third fiscal quarter ended June 30, 2018.
Financial Highlights:
- Cash and equivalents of $25.8 million at June 30, 2018, compared to $27.4 million at September 30, 2017.
- Cash used to fund operations in the third fiscal quarter was $2.1 million, which is net of grant and research and development incentive income of $1.7 million, compared to $3.0 million for the comparative quarter last year. This is in line with the Company’s cash utilization guidance.
- Operating expenses in the third fiscal quarter of $4.6 million compared to $3.7 million for the comparative quarter last year. This increase was a result of increased spending on research and development, related to clinical trial preparatory activities, as well as an expanded scientific team.
- Net loss for the third fiscal quarter of $2.8 million, or $0.06 per share, compared to a net loss of $3.6 million, or $0.04 per share for the comparative quarter.
“In order to identify the key biomarkers for the design of our late-stage CNS precision medicine trials, we have taken a data driven, hypothesis free approach to the systematic analysis of our ongoing Phase 2a trial in Alzheimer’s disease. Using the Artificial Intelligence (AI) technology KEM, the relation between all parameters, both clinical and genomic, and their impact on outcome was ranked in an unbiased mode,” said Christopher U Missling, PhD President and Chief Executive Officer of Anavex. “We believe this unbiased and systematic approach to identifying our biomarkers is likely to increase the chance of success in our follow-up, genomic marker driven late-stage CNS precision medicine trials in Parkinson’s disease dementia, Alzheimer’s disease and Rett syndrome.”
Recent Corporate Highlights:
- July 25, 2018 – Anavex reported the results of an entire genome DNA and RNA evaluation of study participants in a 57-week Phase 2a Alzheimer’s disease study investigating ANAVEX®2-73, a selective sigma-1 receptor agonist, resulting in the analysis of 33,311 genes and 860 pathways. Additionally, direct target occupancy of ANAVEX®2-73 at the sigma-1 receptor using quantitative Positron emissions tomography (PET) scanning was presented.
- July 9, 2018 – Anavex announced that it had received approval from the Spanish Agency for Medicinal Products and Medical Devices (AEMPS) to initiate its Phase 2, double-blind, placebo-controlled 14-week trial of the safety and efficacy of ANAVEX®2-73 for the treatment of Parkinson’s disease dementia (PDD).
- July 3, 2018 – Anavex announced that the Company had received approval by the Australian Human Research Ethics Committee to initiate its Phase 2b/3 double-blind, randomized, placebo-controlled, 48-week safety and efficacy trial of ANAVEX®2-73 for the treatment of Alzheimer’s disease.
The financial information for fiscal quarter ended June 30, 2018, 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.
Conference Call / Webcast Information
Anavex will host a conference call at 4:30 p.m. ET today, August 9, 2018.
The live webcast of the conference call can be accessed online at http://www.wsw.com/webcast/cc/avxl6/. To listen to the live call by phone, interested parties within the U.S. should dial, toll-free, 1 (866) 939-3921 and international callers should dial 1 (678) 302-3550. Please use confirmation number 47394949. A replay of the call will be available approximately one hour after the end of the call 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, recently completed a successful 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. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson’s Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 for the treatment of Parkinson’s disease. ANAVEX®3-71, which targets sigma-1 and M1 muscarinic receptors, is a promising preclinical drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer’s disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on neuroinflammation and mitochondrial dysfunction. 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. | ||||||||
| CONDENSED CONSOLIDATED INTERIM BALANCE SHEETS | ||||||||
| June 30, | September 30, | |||||||
| ASSETS | 2018 | 2017 | ||||||
| Current | ||||||||
| Cash and cash equivalents | $ | 25,827,592 | $ | 27,440,257 | ||||
| Sales tax recoverable | 6,145 | 9,748 | ||||||
| Prepaid expenses and deposits | 858,560 | 335,928 | ||||||
| Deferred financing charges | 50,000 | - | ||||||
| Total current assets | 26,742,297 | 27,785,933 | ||||||
| Deposits | 52,396 | 52,396 | ||||||
| Total assets | $ | 26,794,693 | $ | 27,838,329 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current | ||||||||
| Accounts payable and accrued liabilities | $ | 3,209,070 | $ | 3,584,334 | ||||
| Total liabilities | 3,209,070 | 3,584,334 | ||||||
| Common stock | 45,315 | 43,332 | ||||||
| Additional paid-in capital | 126,679,219 | 115,689,221 | ||||||
| Accumulated deficit | (103,138,911 | ) | (91,478,558 | ) | ||||
| Total stockholders' equity | 23,585,623 | 24,253,995 | ||||||
| Total liabilities and stockholders' equity | $ | 26,794,693 | $ | 27,838,329 | ||||
| ANAVEX LIFE SCIENCES CORP. | ||||||||
| CONDENSED CONSOLIDATED INTERIM STATEMENT OF OPERATIONS | ||||||||
| THREE MONTHS ENDED JUNE 30, 2018 AND 2017 | ||||||||
| (Unaudited) | ||||||||
| 2018 | 2017 | |||||||
| Operating Expenses | ||||||||
| General and administrative | $ | 1,620,379 | $ | 1,405,026 | ||||
| Research and development | 2,997,634 | 2,300,277 | ||||||
| Total operating expenses | 4,618,013 | 3,705,303 | ||||||
| Operating Loss | (4,618,013 | ) | (3,705,303 | ) | ||||
| Other income | ||||||||
| Grant income | 74,528 | 69,146 | ||||||
| Research and development incentive income | 1,629,513 | - | ||||||
| Interest income, net | 112,226 | 26,677 | ||||||
| Gain on settlement of accounts payable | - | 75,204 | ||||||
| Financing related charges | (30,943 | ) | ||||||
| Foreign exchange gain (loss) | (16,475 | ) | (65,932 | ) | ||||
| Total other income | 1,768,849 | 105,095 | ||||||
| Net loss before income taxes | (2,849,164 | ) | (3,600,208 | ) | ||||
| Income tax expense - current | - | (9,877 | ) | |||||
| Net loss | $ | (2,849,164 | ) | $ | (3,610,085 | ) | ||
| Net loss per Share | ||||||||
| Basic and Diluted | $ | (0.06 | ) | $ | (0.09 | ) | ||
| Weighted Average Number of Shares Outstanding | ||||||||
| Basic and Diluted | 45,212,074 | 41,509,225 | ||||||
| ANAVEX LIFE SCIENCES CORP. | |||||||
| CONDENSED CONSOLIDATED INTERIM STATEMENT OF OPERATIONS | |||||||
| NINE MONTHS ENDED JUNE 30, 2018 AND 2017 | |||||||
| (Unaudited) | |||||||
| 2018 | 2017 | ||||||
| Operating Expenses | |||||||
| General and administrative | $ | 4,507,632 | $ | 3,647,224 | |||
| Research and development | 8,936,969 | 6,835,700 | |||||
| Total operating expenses | 13,444,601 | 10,482,924 | |||||
| Operating Loss | (13,444,601 | ) | (10,482,924 | ) | |||
| Other income (expenses) | |||||||
| Grant income | 74,528 | 121,116 | |||||
| Research and development incentive income | 1,629,513 | 2,022,902 | |||||
| Interest income, net | 171,249 | 48,479 | |||||
| Gain on settlement of accounts payable | - | 75,204 | |||||
| Financing related charges | (30,943 | ) | - | ||||
| Foreign exchange gain (loss) | (22,833 | ) | (40,128 | ) | |||
| Total other income | 1,821,514 | 2,227,573 | |||||
| Net loss before income taxes | (11,623,087 | ) | (8,255,351 | ) | |||
| Income tax expense - current | (37,266 | ) | (50,480 | ) | |||
| Net loss | $ | (11,660,353 | ) | $ | (8,305,831 | ) | |
| Net loss per Share | |||||||
| Basic and Diluted | $ | (0.26 | ) | $ | (0.21 | ) | |
| Weighted Average Number of Shares Outstanding | |||||||
| Basic and Diluted | 44,365,683 | 40,344,149 | |||||
For Further Information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Investors:
Scott Gordon
Core IR
scottg@coreir.com