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Company to host awebcasttoday at 8:30 a.m. Eastern Time
NEW YORK, Nov. 28, 2022 (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 disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today reported financial results for its fiscal year ended September 30, 2022.
“This is an exciting time in neuroscience and rare disease drug development and we remain on track for the readout of the placebo-controlled ANAVEX®2-73 Phase 2b/3 Alzheimer’s disease clinical trial, a condition of significant unmet need and economic burden for which there are only limited approved pharmacological treatment options,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “Our recent progress highlights the potential of our clinical Precision Medicine SIGMAR1 platform and portfolio, and we look forward to sharing additional program and data updates.”
ANAVEX®2-73 Program and other Near-Term Pipeline Data Updates:
Recent Business Highlights:
Financial Highlights:
The financial information for the fiscal year ended September 30, 2022, should be read in conjunction with the Company’s consolidated financial statements, which will appear on EDGAR, www.sec.gov and will be available on the Anavex website at www.anavex.com.
Webcast / Conference Call Information:
Management will host a conference call today at 8:30 am ET. The live webcast of the conference call will be available on Anavex’s website at www.anavex.com.
The conference call can be also accessed by dialing +1 929 205 6099 for participants in the U.S. using the reference passcode 511901. A replay of the conference call will also be available on Anavex’s website for up to 30 days.
Economic Burden of Alzheimer’s Disease2
Alzheimer’s disease is the most common cause of dementia and the fifth leading cause of death in adults older than 65 years. The estimated total healthcare costs for the treatment of Alzheimer disease in 2020 is estimated at $305 billion, with the cost expected to increase to more than $1 trillion as the population ages. Most of the direct costs of care for Alzheimer’s disease are attributed to skilled nursing care, home healthcare, and hospice care. Indirect costs of care, including quality of life and informal caregiving, are likely underestimated and are associated with significant negative societal and personal burden.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders, including Alzheimer's disease, Parkinson's disease, Rett syndrome, and other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex's lead drug candidate, ANAVEX®2-73 (blarcamesine), has successfully completed a Phase 2a clinical trial for Alzheimer's disease, a Phase 2 proof-of-concept study in Parkinson's disease dementia, and both a Phase 2 and a Phase 3 study in adult patients with Rett syndrome. 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 clinical stage 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 mitochondrial dysfunction and neuroinflammation. Further information is available at www.anavex.com. You can also connect with the company on Twitter,Facebook, Instagram, 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 Statements of Operations and Comprehensive Loss | |||||||||||||
| (Unaudited - Expressed in US Dollars) | |||||||||||||
| Three months ended September 30, | Years ended September 30, | ||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||
| Operating Expenses | |||||||||||||
| General and administrative | $ | 3,902,508 | $ | 2,878,983 | $ | 13,070,068 | $ | 9,017,511 | |||||
| Research and development | 11,381,450 | 9,372,786 | 37,915,747 | 32,983,674 | |||||||||
| Total operating expenses | 15,283,958 | 12,251,769 | 50,985,815 | 42,001,185 | |||||||||
| Operating loss | (15,283,958 | ) | (12,251,769 | ) | (50,985,815 | ) | (42,001,185 | ) | |||||
| Other income (expenses) | |||||||||||||
| Grant income | - | - | - | 54,100 | |||||||||
| Research and development incentive income | 994,336 | 953,243 | 3,323,011 | 4,547,099 | |||||||||
| Interest income, net | 704,583 | 7,151 | 946,988 | 26,261 | |||||||||
| Foreign exchange (loss) gain, net | (495,070 | ) | (284,535 | ) | (903,611 | ) | (267,344 | ) | |||||
| Total other income, net | 1,203,849 | 675,859 | 3,366,388 | 4,360,116 | |||||||||
| Net loss before provision for income taxes | (14,080,109 | ) | (11,575,910 | ) | (47,619,427 | ) | (37,641,069 | ) | |||||
| Income tax expense, current | (210,291 | ) | (142,296 | ) | (358,492 | ) | (267,565 | ) | |||||
| Net loss and comprehensive loss | $ | (14,290,400 | ) | $ | (11,718,206 | ) | $ | (47,977,919 | ) | $ | (37,908,634 | ) | |
| Net loss per share | |||||||||||||
| Basic and diluted | $ | (0.18 | ) | $ | (0.15 | ) | $ | (0.62 | ) | $ | (0.54 | ) | |
| Weighted average number of shares outstanding | |||||||||||||
| Basic and diluted | 77,442,470 | 75,714,558 | 76,909,993 | 69,802,960 | |||||||||
| Anavex Life Sciences Corp. | ||||||||
| Consolidated Balance Sheets | ||||||||
| At September 30, 2022 and 2021 | ||||||||
| Expressed in US Dollars | ||||||||
| 2022 | 2021 | |||||||
| Assets | ||||||||
| Current | ||||||||
| Cash and cash equivalents | $ | 149,157,861 | $ | 152,107,745 | ||||
| Incentive and tax receivables | 3,192,580 | 9,136,831 | ||||||
| Prepaid expenses and other current assets | 354,162 | 371,914 | ||||||
| Total Assets | $ | 152,704,603 | $ | 161,616,490 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current Liabilities | ||||||||
| Accounts payable | $ | 3,824,777 | $ | 4,739,781 | ||||
| Accrued liabilities | 5,944,953 | 5,614,774 | ||||||
| Deferred grant income | 443,831 | 443,831 | ||||||
| Total Liabilities | 10,213,561 | 10,798,386 | ||||||
| Capital Stock | 77,944 | 75,920 | ||||||
| Additional paid-in capital | 387,976,881 | 348,328,048 | ||||||
| Accumulated deficit | (245,563,783 | ) | (197,585,864 | ) | ||||
| Total Stockholders' Equity | 142,491,042 | 150,818,104 | ||||||
| Total Liabilities and Stockholders' Equity | $ | 152,704,603 | $ | 161,616,490 | ||||
For Further Information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Investors:
Andrew J. Barwicki
Investor Relations
Tel: 516-662-9461
Email: andrew@barwicki.com
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1 https://fragilex.org/understanding-fragile-x/fragile-x-101/prevalence/
2 W Wong Economic Burden of Alzheimer Disease and Managed Care Considerations Am J Manag Care. 2020;26:S177-S183