Company to host a webcast today at
“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
Key Pipeline Updates:
- Alzheimer’s disease:
- Full data from the blarcamesine in Alzheimer’s disease Phase 2b/3 placebo-controlled clinical trial will be published in an upcoming peer-reviewed journal. The initiated process for submitting a Marketing Authorisation application to the
European Medicines Agency (EMA) under the Centralised Procedure is underway. The Marketing Authorisation would allow direct market access throughout theEuropean Union for oral blarcamesine for the treatment of Alzheimer’s disease. There are an estimated 7 million people inEurope with Alzheimer’s disease, a number expected to double by 2030, according to theEuropean Brain Council .2 - Analysis of RNA sequencing (RNA-seq) of the placebo-controlled Phase 2b/3 blarcamesine trial in early Alzheimer’s disease is underway. Interim data expected by mid 2024.
- Ongoing ATTENTION-AD open-label extension 96-week trial. Interim data expected in the second half of 2024.
- Full data from the blarcamesine in Alzheimer’s disease Phase 2b/3 placebo-controlled clinical trial will be published in an upcoming peer-reviewed journal. The initiated process for submitting a Marketing Authorisation application to the
- Schizophrenia: The placebo-controlled ANAVEX®3-71-SZ-001 Phase 2 clinical study of ANAVEX®3-71 for the treatment of schizophrenia is well underway with the first cohort of schizophrenia patients fully enrolled.
- Parkinson’s disease: Initiation of ANAVEX®2-73 imaging-focused trial and Phase 2b/3 6 month trial is expected in the second half of 2024.
- Rett syndrome: Continued positive Real World Evidence (RWE) feedback from Rett syndrome patients and caregivers from the ongoing open-label extension trial and Compassionate Use Program for patients who participated in the Phase 2/3 EXCELLENCE trial encourages us to continue our partnership with the Rett syndrome community and to proceed with a Phase 3 12-week efficacy study. An educational presentation will be provided at the 2024 IRSF Rett Syndrome Scientific Meeting, taking place
June 18 –June 19, 2024 . ANAVEX®2-73 had previously received Fast Track designation, Rare Pediatric Disease designation and Orphan Drug designation from the FDA for the treatment of Rett syndrome. - Fragile X: New disease-specific, translatable, and objective biomarker data generated with ANAVEX®2-73, supporting the initiation of the potentially pivotal ANAVEX®2-73 Phase 2/3 clinical trial will be presented at the 19th
National Fragile X Foundation Conference , taking placeJuly 25 –July 28, 2024 . - New Rare disease: Initiation of potentially pivotal ANAVEX®2-73 Phase 2/3 clinical trial.
- Publications: Continued clinical publications involving ANAVEX®2-73 and ANAVEX®3-71.
Recent Business Highlights:
- On
March 18, 2024 , the Company announced that the first patient in itsU.S. FDA cleared placebo-controlled Phase 2 clinical study of ANAVEX®3-71 for the treatment of schizophrenia had been screened, ahead of schedule. - On
January 24, 2024 , the Company announced a peer-reviewed publication in Clinical Pharmacology in Drug Development, findings from the ANAVEX®3-71 first-in-human study which achieved its safety objectives. The publication is entitled, ‘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’.3 The publication reports pharmacokinetic (PK) dose proportionality of ANAVEX®3-71 in humans and food had no effect on the PK of ANAVEX®3-71. This data also expands the safety objectives met in this first-in-human study of ANAVEX®3-71, further supporting its drug development program. - On
January 8, 2024 , the Company announced that the United States Patent and Trademark Office (USPTO) grantedU.S. Patent No. 11,839,600 entitled “NEURODEVELOPMENTAL DISORDER THERAPY” from the United States Patent and Trademark Office (USPTO) for its patent application number 17/890,083. Anavex’s newest patent expands coverage of ANAVEX®2-73 (blarcamesine) therapy to ameliorate various conditions associated with loss-of-function mutations of the gene encoding methyl-CpG binding protein (MeCP2).
Financial Highlights:
- Cash and cash equivalents of
$139.4 million atMarch 31, 2024 compared to$151.0 million at fiscal yearendSeptember 30, 2023 . The Company anticipates at the current cash utilization rate a runway of approximately 4 years. - General and administrative expenses for the quarter of
$2.8 million compared to$2.9 million for the comparable quarter of fiscal 2023. - Research and development expenses for the quarter of
$9.7 million compared to$11.3 million for the comparable quarter of fiscal 2023. - Net loss for the quarter of
$10.5 million , or$0.13 per share, compared to a net loss of$13.1 million , or$0.17 per share for the comparable quarter of fiscal 2023.
The financial information for the fiscal quarter ended
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
About
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
Condensed Consolidated Interim Statements of Operations and Comprehensive Loss | ||||||
(in thousands, except share and per share amounts) | ||||||
Three months ended | ||||||
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 | ||||
Condensed Consolidated Interim Statements of Operations and Comprehensive Loss | ||||||
(in thousands, except share and per share amounts) | ||||||
Six months ended | ||||||
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 | ||||
Condensed Consolidated Interim Balance Sheets | ||||||
(in thousands, except share and per share amounts) | ||||||
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:
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Investors:
Investor Relations
Tel: 516-662-9461
Email: andrew@barwicki.com
_______________________
1 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/early-alzheimers-disease-developing-drugs-treatment
2 https://www.braincouncil.eu/projects/rethinking-alzheimers-disease/
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
Source:
2024 GlobeNewswire, Inc., source