NEW YORK, May 09, 2023 (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 quarter ended March 31, 2023.
“Recent positive clinical study results and FDA approvals through the Accelerated Approval Pathway are positive for the Alzheimer’s disease community, especially for the patients, families and caregivers who fight everyday against this devastating disease. We look forward to presenting the complete dataset of the Phase 2b/3 Alzheimer’s disease trial of ANAVEX®2-73 (blarcamesine), an orally available, small-molecule activator of the upstream sigma-1 receptor (SIGMAR1), involved in restoring neural cell homeostasis and promoting neuroplasticity, which might be at the forefront of patient-centric, next-generation biomarker-guided precision medicine Alzheimer’s disease treatments. With newly available preliminary efficacy results of surrogate biomarkers, we consider initiating discussions with regulatory agencies for Accelerated Approval Pathway for ANAVEX®2-73 (blarcamesine),” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. "We also look forward to making meaningful advances in our neurodevelopmental and other neurodegenerative precision medicine portfolio this year with the expected topline data from the potentially pivotal ANAVEX®2-73-RS-003 Phase 2/3 EXCELLENCE pediatric clinical trial in the second half of 2023. Additionally, we continue to focus on initiating our pivotal study of ANAVEX®2-73 (blarcamesine) in patients with Parkinson’s disease, the second largest neurodegenerative disease after Alzheimer’s disease.”
Key Near Term Pipeline Updates:
Recent Business Highlights:
Financial Highlights:
The financial information for the quarter ended March 31, 2023, should be read in conjunction with the Company’s interim condensed 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 on Tuesday May 9, 2023, 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 Meeting ID# 891 9995 1143 and reference passcode 511901. A replay of the conference call will also be available on Anavex’s website for up to 30 days.
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 and recently a Phase 2b/3 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. | ||||||
| Interim Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||||
| (Unaudited - Expressed in US Dollars) | ||||||
| Three months ended March 31, | ||||||
| 2023 | 2022 | |||||
| Operating Expenses | ||||||
| General and administrative | $ | 2,882,568 | $ | 2,915,158 | ||
| Research and development | 11,306,591 | 8,604,589 | ||||
| Total operating expenses | 14,189,159 | 11,519,747 | ||||
| Operating loss | (14,189,159 | ) | (11,519,747 | ) | ||
| Other income | ||||||
| Research and development incentive income | 749,681 | 835,513 | ||||
| Interest income, net | 1,465,221 | 7,578 | ||||
| Other financing expense | (964,344 | ) | - | |||
| Foreign exchange (loss) gain, net | (118,678 | ) | 268,645 | |||
| Total other income, net | 1,131,880 | 1,111,736 | ||||
| Net loss before provision for income taxes | (13,057,279 | ) | (10,408,011 | ) | ||
| Income tax expense, current | (50,000 | ) | (29,800 | ) | ||
| Net loss and comprehensive loss | $ | (13,107,279 | ) | $ | (10,437,811 | ) |
| Net loss per share | ||||||
| Basic and diluted | $ | (0.17 | ) | $ | (0.14 | ) |
| Weighted average number of shares outstanding | ||||||
| Basic and diluted | 78,304,363 | 76,248,603 | ||||
| Anavex Life Sciences Corp. | ||||||
| Interim Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||||
| (Unaudited - Expressed in US Dollars) | ||||||
| Six months ended March 31, | ||||||
| 2023 | 2022 | |||||
| Operating Expenses | ||||||
| General and administrative | $ | 6,199,604 | $ | 5,982,109 | ||
| Research and development | 23,373,510 | 17,261,028 | ||||
| Total operating expenses | 29,573,114 | 23,243,137 | ||||
| Operating loss | (29,573,114 | ) | (23,243,137 | ) | ||
| Other income | ||||||
| Grant income | 25,000 | - | ||||
| Research and development incentive income | 1,483,271 | 1,646,243 | ||||
| Interest income, net | 2,732,839 | 12,488 | ||||
| Other financing expense | (964,344 | ) | - | |||
| Foreign exchange gain, net | 247,305 | 324,008 | ||||
| Total other income, net | 3,524,071 | 1,982,739 | ||||
| Net loss before provision for income taxes | (26,049,043 | ) | (21,260,398 | ) | ||
| Income tax expense, current | (29,954 | ) | (59,780 | ) | ||
| Net loss and comprehensive loss | $ | (26,078,997 | ) | $ | (21,320,178 | ) |
| Net loss per share | ||||||
| Basic and diluted | $ | (0.33 | ) | $ | (0.28 | ) |
| Weighted average number of shares outstanding | ||||||
| Basic and diluted | 78,138,940 | 76,121,792 | ||||
| Anavex Life Sciences Corp. | ||||||
| Interim Condensed Consolidated Balance Sheets | ||||||
| At March 31, 2023 and September 30, 2022 | ||||||
| (Unaudited – Expressed in US Dollars) | ||||||
| March 31, 2023 | September 30, 2022 | |||||
| Assets | ||||||
| Current | ||||||
| Cash and cash equivalents | $ | 153,466,962 | $ | 149,157,861 | ||
| Incentive and tax receivables | 4,737,661 | 3,192,580 | ||||
| Prepaid expenses and other current assets | 981,774 | 354,162 | ||||
| Total Assets | $ | 159,186,397 | $ | 152,704,603 | ||
| Liabilities and stockholders' equity | ||||||
| Current Liabilities | ||||||
| Accounts payable | $ | 6,281,742 | $ | 3,824,777 | ||
| Accrued liabilities | 6,822,838 | 5,944,953 | ||||
| Deferred grant income | 916,763 | 443,831 | ||||
| Total Liabilities | 14,021,343 | 10,213,561 | ||||
| Capital Stock | 80,236 | 77,944 | ||||
| Additional paid-in capital | 416,727,598 | 387,976,881 | ||||
| Accumulated deficit | (271,642,780 | ) | (245,563,783 | ) | ||
| Total Stockholders' Equity | 145,165,054 | 142,491,042 | ||||
| Total Liabilities and Stockholders' Equity | $ | 159,186,397 | $ | 152,704,603 | ||
For Further Information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Investors:
Andrew J. Barwicki
Investor Relations
Tel: 516-662-9461
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
| Last Trade: | US$8.98 |
| Daily Change: | -0.34 -3.65 |
| Daily Volume: | 565,347 |
| Market Cap: | US$761.500M |
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