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NEW YORK, May 10, 2017 -- 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 March 31, 2017.
Financial Highlights:
- Cash and equivalents of $23.4 million at March 31, 2017, compared to $9.2 million at September 30, 2016.
- During the first six months of fiscal year 2017, Anavex used $3.9 million in cash to fund operations, after receipt of $2.1 million in research and development incentive income.
- Operating expenses of approximately $3.6 million compared to approximately $2.2 million for the comparative quarter. This increase was a result of increased spending on research and development and clinical preparatory activities.
- Net loss for the quarter of approximately $1.5 million, or $0.04 per share, compared to a net loss of approximately $2.0 million, or $0.06 per share for the comparative quarter.
“We are continuing 2017 with a stronger balance sheet than the previous quarter and a strengthened corporate team,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “We are on track to initiate placebo-controlled efficacy and safety trials this year in Alzheimer’s and Parkinson’s disease as well as Rett syndrome, for which ANAVEX 2-73 was granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA).”
Corporate Highlights
- May 1, 2017 – Anavex announced the appointment of Emmanuel O. Fadiran, RPh, PhD, as Senior Vice President of Regulatory Affairs. Dr. Fadiran has 24 years of regulatory experience within the U.S. Food and Drug Administration (FDA), having held leadership positions at the FDA’s Center for Drug Evaluation and Research (CDER).
- April 3, 2017 – Anavex announced the presentation of new mechanism of action data related to ANAVEX compounds targeting the sigma-1 receptor at the 13th International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD 2017).
- Preclinical data was presented indicating that in addition to reducing oxidative stress, ANAVEX 2-73, ANAVEX 3-71 and ANAVEX 1-41 demonstrate protective effects of the mitochondrial enzyme complexes I and IV during pathological conditions, which, if impaired, are believed to play a role in the pathogenesis of neurodegenerative and neurodevelopmental diseases.
- Additional data was presented for ANAVEX 3-71 indicating that during pathological conditions, ANAVEX 3-71 demonstrated the formation of new synapses between neurons (synaptogenesis) without causing an abnormal increase in the number of astrocytes. In neurodegenerative diseases such as Alzheimer’s and Parkinson’s, synaptogenesis is believed to be impaired. - February 13, 2017 – Anavex announced the appointment of Peter Donhauser, D.O. to its Board of Directors. Mr. Donhauser has more than 20 years of expertise in clinical research followed by practicing osteopathic medicine with an integrated medical approach in private practice since 2000.
The financial information for the three and six months ended March 31, 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, ANAVEX 2-73, recently completed successfully 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. 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 and 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) | ||||||
| March 31, | September 30, | |||||
| ASSETS | 2017 | 2016 | ||||
| Current | ||||||
| Cash | $ | 23,351,567 | $ | 9,186,814 | ||
| Sales Tax Recoverable | 60,636 | 79,347 | ||||
| Prepaid expenses and deposits | 141,989 | 180,124 | ||||
| Total current assets | 23,554,192 | 9,446,285 | ||||
| Deposits | 52,396 | 52,396 | ||||
| Total assets | $ | 23,606,588 | $ | 9,498,681 | ||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||
| Current | ||||||
| Accounts payable and accrued liabilities | $ | 2,033,692 | $ | 3,119,993 | ||
| Deferred grant income | 86,205 | 70,532 | ||||
| Total liabilities | 2,119,897 | 3,190,525 | ||||
| Common stock | 41,377 | 36,169 | ||||
| Additional paid-in capital | 104,159,213 | 84,290,140 | ||||
| Accumulated deficit | (82,713,899 | ) | (78,018,153 | ) | ||
| Total stockholders' equity | 21,486,691 | 6,308,156 | ||||
| Total liabilities and stockholders' equity | $ | 23,606,588 | $ | 9,498,681 | ||
| ANAVEX LIFE SCIENCES CORP. | ||||||
| CONSOLIDATED INTERIM STATEMENTS OF OPERATIONS | ||||||
| THREE MONTHS ENDED MARCH 31, 2017 AND 2016 | ||||||
| (Unaudited) | ||||||
| 2017 | 2016 | |||||
| Operating Expenses | ||||||
| General and administrative | $ | 1,116,014 | $ | 1,089,641 | ||
| Research and development | 2,492,933 | 1,090,527 | ||||
| Total operating expenses | 3,608,947 | 2,180,168 | ||||
| Operating Loss | (3,608,947 | ) | (2,180,168 | ) | ||
| Other income (expenses) | ||||||
| Grant income | 16,684 | 26,879 | ||||
| Research and development incentive income | 2,022,902 | - | ||||
| Interest income, net | 18,147 | 2,064 | ||||
| Financing related charges and adjustments | - | 151,330 | ||||
| Foreign exchange gain (loss) | 11,722 | (30,906 | ) | |||
| Total other income (expenses) | 2,069,455 | 149,367 | ||||
| Net loss before income taxes | (1,539,492 | ) | (2,030,801 | ) | ||
| Income tax expense - current | (9,595 | ) | - | |||
| Net loss | $ | (1,549,087 | ) | $ | (2,030,801 | ) |
| Net loss per Share | ||||||
| Basic | $ | (0.04 | ) | $ | (0.06 | ) |
| Diluted | $ | (0.04 | ) | $ | (0.06 | ) |
| Weighted Average Number of Shares Outstanding | ||||||
| Basic | 41,159,707 | 35,214,793 | ||||
| Diluted | 41,159,707 | 35,214,793 | ||||
| ANAVEX LIFE SCIENCES CORP. | ||||||
| CONSOLIDATED INTERIM STATEMENTS OF OPERATIONS | ||||||
| SIX MONTHS ENDED MARCH 31, 2017 AND 2016 | ||||||
| (Unaudited) | ||||||
| 2017 | 2016 | |||||
| Operating Expenses | ||||||
| General and administrative | $ | 2,242,198 | $ | 3,982,746 | ||
| Research and development | 4,535,423 | 2,729,856 | ||||
| Total operating expenses | 6,777,621 | 6,712,602 | ||||
| Operating Loss | (6,777,621 | ) | (6,712,602 | ) | ||
| Other income (expenses) | ||||||
| Grant income | 51,970 | 65,934 | ||||
| Research and development incentive income | 2,022,902 | 571,093 | ||||
| Interest income, net | 21,802 | 4,206 | ||||
| Financing related charges and adjustments | - | 150,235 | ||||
| Foreign exchange gain (loss) | 25,804 | (46,561 | ) | |||
| Total other income | 2,122,478 | 744,907 | ||||
| Net loss before income taxes | (4,655,143 | ) | (5,967,695 | ) | ||
| Income tax expense - current | (40,603 | ) | (17,615 | ) | ||
| Net loss | $ | (4,695,746 | ) | $ | (5,985,310 | ) |
| Net loss per Share | ||||||
| Basic | $ | (0.12 | ) | $ | (0.17 | ) |
| Diluted | $ | (0.12 | ) | $ | (0.17 | ) |
| Weighted Average Number of Shares Outstanding | ||||||
| Basic | 39,761,612 | 34,589,957 | ||||
| Diluted | 39,761,612 | 34,589,957 | ||||
For Further Information: Anavex Life Sciences Corp. Research & Business Development Toll-free: 1-844-689-3939 Email: [email protected] Investors: Matthew Haines River East Investor Relations, LLC 917-733-9297 [email protected] Media: Dennis Dobson, Jr. Dobson Media Group 203-258-0159 [email protected] Social Media: Bill Douglass Gotham Communications 646-504-0890 [email protected]
