Company to host a webcast today at 8:30 a.m. Eastern Time
NEW YORK, Nov. 27, 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 year ended September 30, 2023.
“We are very excited to be entering a new phase of the Company’s history. For the first time we initiated the process of submitting a Marketing Authorisation application to the European Medicines Agency (EMA) for blarcamesine related to the treatment of Alzheimer’s disease. Relatedly, we are starting to explore possible commercial activities and examining innovative strategies to effectively engage patients, providers and payers,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “There is a high demand from Alzheimer’s disease patients and families for easy access and scalable treatment options. We are striving to work towards presenting a drug that will potentially improve patients’ lives with our precision medicine oral blarcamesine, which is intended to reduce the need for complex procedures for the treatment of people with Alzheimer’s disease.”
Key Pipeline Updates:
1 https://www.braincouncil.eu/projects/rethinking-alzheimers-disease/
Recent Business Highlights:
Financial Highlights:
The financial information for the fiscal year ended September 30, 2023, 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:
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# 860 5505 7787 and reference passcode 146807. 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 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. | ||||||
| Consolidated Statements of Operations and Comprehensive Loss | ||||||
| (in thousands, except share and per share amounts) | ||||||
| Three months ended September 30, | ||||||
| 2023 | 2022 | |||||
| Operating Expenses | ||||||
| General and administrative | $ | 2,592 | $ | 3,903 | ||
| Research and development | 10,061 | 11,381 | ||||
| Total operating expenses | 12,653 | 15,284 | ||||
| Operating loss | (12,653 | ) | (15,284 | ) | ||
| Other income | ||||||
| Research and development incentive income | 670 | 994 | ||||
| Interest income, net | 1,958 | 705 | ||||
| Foreign exchange loss, net | (186 | ) | (495 | ) | ||
| Total other income, net | 2,442 | 1,204 | ||||
| Net loss before provision for income taxes | (10,211 | ) | (14,080 | ) | ||
| Income tax recovery (expense), current | 64 | (210 | ) | |||
| Net loss and comprehensive loss | $ | (10,147 | ) | $ | (14,290 | ) |
| Net loss per share | ||||||
| Basic and diluted | $ | (0.12 | ) | $ | (0.18 | ) |
| Weighted average number of shares outstanding | ||||||
| Basic and diluted | 81,973,250 | 77,442,470 | ||||
| Anavex Life Sciences Corp. | ||||||
| Consolidated Statements of Operations and Comprehensive Loss | ||||||
| (in thousands, except share and per share amounts) | ||||||
| Year ended September 30, | ||||||
| 2023 | 2022 | |||||
| Operating Expenses | ||||||
| General and administrative | $ | 12,039 | $ | 13,070 | ||
| Research and development | 43,717 | 37,916 | ||||
| Total operating expenses | 55,756 | 50,986 | ||||
| Operating loss | (55,756 | ) | (50,986 | ) | ||
| Other income | ||||||
| Grant income | 25 | – | ||||
| Research and development incentive income | 2,718 | 3,323 | ||||
| Interest income, net | 6,519 | 947 | ||||
| Other financing expense | (964 | ) | – | |||
| Foreign exchange loss, net | (40 | ) | (904 | ) | ||
| Total other income, net | 8,258 | 3,366 | ||||
| Net loss before provision for income taxes | (47,498 | ) | (47,620 | ) | ||
| Income tax expense, current | (7 | ) | (358 | ) | ||
| Net loss and comprehensive loss | $ | (47,505 | ) | $ | (47,978 | ) |
| Net loss per share | ||||||
| Basic and diluted | $ | (0.60 | ) | $ | (0.62 | ) |
| Weighted average number of shares outstanding | ||||||
| Basic and diluted | 79,787,596 | 76,909,993 | ||||
| Anavex Life Sciences Corp. | ||||||
| Consolidated Balance Sheets | ||||||
| (in thousands, except share and per share amounts) | ||||||
| September 30, | ||||||
| 2023 | 2022 | |||||
| Assets | ||||||
| Current | ||||||
| Cash and cash equivalents | $ | 151,024 | $ | 149,158 | ||
| Incentive and tax receivables | 2,709 | 3,193 | ||||
| Prepaid expenses and other current assets | 653 | 354 | ||||
| Total Assets | $ | 154,386 | $ | 152,705 | ||
| Liabilities and stockholders’ equity | ||||||
| Current Liabilities | ||||||
| Accounts payable | $ | 4,322 | $ | 3,825 | ||
| Accrued liabilities | 7,295 | 5,945 | ||||
| Deferred grant income | 917 | 444 | ||||
| Total Liabilities | 12,534 | 10,214 | ||||
| Capital Stock | 82 | 78 | ||||
| Additional paid-in capital | 434,839 | 387,977 | ||||
| Accumulated deficit | (293,069 | ) | (245,564 | ) | ||
| Total Stockholders’ Equity | 141,852 | 142,491 | ||||
| Total Liabilities and Stockholders’ Equity | $ | 154,386 | $ | 152,705 | ||
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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