Full Press Release Details
Anavex Life Sciences Reports
Fiscal 2024 Second Quarter Financial Results and
Provides Business Update
Company to host a webcast
today at 8:30 a.m. Eastern Time
NEW YORK - May 9, 2024 - Anavex
Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing
differentiated therapeutics for the treatment of neurodegenerative, neurodevelopmental and neuropsychiatric disorders including Alzheimer's
disease, Parkinson's disease, Rett syndrome, schizophrenia, and other central nervous system (CNS) diseases, today reported financial
results for its fiscal quarter ended March 31, 2024.
"We are encouraged by the very recently issued
FDA guidance for Early Alzheimer's disease, which states that one cognitive measurement alone, like ADAS-Cog13, could
be a sufficient primary endpoint for early Alzheimer's disease.[1] We appreciate this new guidance and believe this
opens another possible pathway for us to move forward in parallel to the initiated process of Marketing Authorisation application to
the European Medicines Agency (EMA) for blarcamesine related to the treatment of Alzheimer's disease, which is underway. We are
also pleased to report that the first cohort of schizophrenia patients in the ongoing ANAVEX 3-71-SZ-001 Phase 2 trial of ANAVEX 3-71
has been fully enrolled," said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. "Moreover, we
remain committed to the development of our programs within neurodegenerative, neurodevelopmental disorders, which could further expand
our portfolio of transformative investigational therapies and utilizing
our differentiated precision medicine platform to deliver easy access and scalable treatment options for brain disorders."
Business Highlights:
[3] Fadiran EO, Hammond E, Tran J, Missling
CU, Ette E. Population-Based Characterization of the Pharmacokinetics and Food Effect of ANAVEX3-71, a Novel Sigma-1 Receptor and Allosteric
M1 Muscarinic Receptor Agonist in Development for Treatment of Frontotemporal Dementia, Schizophrenia, and Alzheimer Disease. Clin
Pharmacol Drug Dev. 2024;13(1):21-31. doi:10.1002/cpdd.1323
Financial Highlights:
financial information for the fiscal quarter ended March 31, 2024, should be read in conjunction with the Company's condensed consolidated
interim financial statements, which will appear on EDGAR, www.sec.gov and will be available on the Anavex website at www.anavex.com.
/ 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# 815 2682 8440 and reference passcode 121725. 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, neurodevelopmental,
and neuropsychiatric disorders, including Alzheimer's disease, Parkinson's disease, Rett syndrome, schizophrenia 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 and one Phase 2/3 in pediatric patients
with Rett syndrome. ANAVEX 2-73 is an orally available drug candidate that restores cellular homeostasis by targeting SIGMAR1 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.
We believe that ANAVEX 3-71,
which targets SIGMAR1 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. | ||||||||
| Condensed Consolidated Interim Statements of Operations and Comprehensive Loss | ||||||||
| (in thousands, except share and per share amounts) | ||||||||
| Three months ended March 31, | ||||||||
| 2024 | 2023 | |||||||
| Operating Expenses | ||||||||
| General and administrative | $ | 2,790 | $ | 2,883 | ||||
| Research and development | 9,729 | 11,307 | ||||||
| Total operating expenses | 12,519 | 14,190 | ||||||
| Operating loss | (12,519 | ) | (14,190 | ) | ||||
| Other income | ||||||||
| Research and development incentive income | 472 | 750 | ||||||
| Interest income, net | 1,756 | 1,465 | ||||||
| Other financing expense | - | (964 | ) | |||||
| Foreign exchange gain (loss), net | (150 | ) | (118 | ) | ||||
| Total other income, net | 2,078 | 1,133 | ||||||
| Net loss before provision for income taxes | (10,441 | ) | (13,057 | ) | ||||
| Income tax expense, current | (105 | ) | (50 | ) | ||||
| Net loss and comprehensive loss | $ | (10,546 | ) | $ | (13,107 | ) | ||
| Net loss per share | ||||||||
| Basic and diluted | $ | (0.13 | ) | $ | (0.17 | ) | ||
| Weighted average number of shares outstanding | ||||||||
| Basic and diluted | 82,464,226 | 78,304,363 |
| Anavex Life Sciences Corp. | ||||||||
| Condensed Consolidated Interim Statements of Operations and Comprehensive Loss | ||||||||
| (in thousands, except share and per share amounts) | ||||||||
| Six months ended March 31, | ||||||||
| 2024 | 2023 | |||||||
| Operating Expenses | ||||||||
| General and administrative | $ | 5,399 | $ | 6,200 | ||||
| Research and development | 18,413 | 23,373 | ||||||
| Total operating expenses | 23,812 | 29,573 | ||||||
| Operating loss | (23,812 | ) | (29,573 | ) | ||||
| Other income | ||||||||
| Grant income | - | 25 | ||||||
| Research and development incentive income | 1,064 | 1,483 | ||||||
| Interest income, net | 3,764 | 2,733 | ||||||
| Other financing expense | - | (964 | ) | |||||
| Foreign exchange gain (loss), net | 7 | 247 | ||||||
| Total other income, net | 4,835 | 3,524 | ||||||
| Net loss before provision for income taxes | (18,977 | ) | (26,049 | ) | ||||
| Income tax expense, current | (191 | ) | (30 | ) | ||||
| Net loss and comprehensive loss | $ | (19,168 | ) | $ | (26,079 | ) | ||
| Net loss per share | ||||||||
| Basic and diluted | $ | (0.23 | ) | $ | (0.33 | ) | ||
| Weighted average number of shares outstanding | ||||||||
| Basic and diluted | 82,269,965 | 78,138,940 |
| Anavex Life Sciences Corp. | ||||||||
| Condensed Consolidated Interim Balance Sheets | ||||||||
| (in thousands, except share and per share amounts) | ||||||||
| March 31, | September 30, | |||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| Current | ||||||||
| Cash and cash equivalents | $ | 139,386 | $ | 151,024 | ||||
| Incentive and tax receivables | 3,785 | 2,709 | ||||||
| Prepaid expenses and other current assets | 1,345 | 653 | ||||||
| Total Assets | $ | 144,516 | $ | 154,386 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current Liabilities | ||||||||
| Accounts payable | $ | 3,726 | $ | 4,322 | ||||
| Accrued liabilities | 4,915 | 7,295 | ||||||
| Deferred grant income | 917 | 917 | ||||||
| Total Liabilities | 9,558 | 12,534 | ||||||
| Capital Stock | 84 | 82 | ||||||
| Additional paid-in capital | 447,345 | 434,839 | ||||||
| Share proceeds receivable | (234 | ) | - | |||||
| Accumulated deficit | (312,237 | ) | (293,069 | ) | ||||
| Total Stockholders' Equity | 134,958 | 141,852 | ||||||
| Total Liabilities and Stockholders' Equity | $ | 144,516 | $ | 154,386 |
For Further Information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com