Anavex Life Sciences Reports Fiscal 2024 Fourth Quarter Financial Results and Provides Business Update
Anavex Life Sciences (NASDAQ: AVXL) reported its fiscal 2024 Q4 results, highlighting key developments in its Alzheimer's disease treatment program. The company's cash position stood at $132.2 million as of September 30, 2024, projecting a 4-year runway. Q4 financial results showed a net loss of $11.6 million ($0.14 per share), compared to $10.1 million ($0.12 per share) in Q4 2023.
Notable achievements include the EMA's acceptance of the Marketing Authorization Application (MAA) for blarcamesine in Alzheimer's disease treatment, and promising preliminary EEG biomarker results from the Phase 2 study of ANAVEX®3-71 for schizophrenia. Research and development expenses increased to $11.6 million from $10.1 million year-over-year.
Anavex Life Sciences (NASDAQ: AVXL) ha riportato i risultati del quarto trimestre fiscale 2024, evidenziando sviluppi chiave nel suo programma di trattamento per la malattia di Alzheimer. La posizione di cassa dell'azienda si attestava a $132,2 milioni al 30 settembre 2024, con una previsione di copertura di 4 anni. I risultati finanziari del quarto trimestre hanno mostrato una perdita netta di $11,6 milioni ($0,14 per azione), rispetto ai $10,1 milioni ($0,12 per azione) del quarto trimestre del 2023.
Tra i risultati notevoli si evidenzia l'accettazione da parte dell'EMA della domanda di autorizzazione al commercio (MAA) per blarcamesina nel trattamento della malattia di Alzheimer e promettenti risultati preliminari dei biomarcatori EEG dallo studio di Fase 2 di ANAVEX®3-71 per la schizofrenia. Le spese per ricerca e sviluppo sono aumentate a $11,6 milioni rispetto ai $10,1 milioni dell'anno precedente.
Anavex Life Sciences (NASDAQ: AVXL) informó sobre los resultados del cuarto trimestre fiscal 2024, destacando desarrollos clave en su programa de tratamiento para la enfermedad de Alzheimer. La posición de efectivo de la empresa se situaba en $132.2 millones al 30 de septiembre de 2024, proyectando un plazo de 4 años. Los resultados financieros del cuarto trimestre mostraron una pérdida neta de $11.6 millones ($0.14 por acción), en comparación con los $10.1 millones ($0.12 por acción) del cuarto trimestre de 2023.
Logros notables incluyen la aceptación por parte de la EMA de la Solicitud de Autorización de Comercialización (MAA) para blarcamesina en el tratamiento de la enfermedad de Alzheimer, y prometedores resultados preliminares de biomarcadores EEG del estudio de Fase 2 de ANAVEX®3-71 para la esquizofrenia. Los gastos en investigación y desarrollo aumentaron a $11.6 millones frente a los $10.1 millones del año anterior.
Anavex Life Sciences (NASDAQ: AVXL)는 2024 회계년도 4분기 실적을 보고하면서 알츠하이머병 치료 프로그램의 주요 개발 사항을 강조했습니다. 회사의 현금 잔고는 2024년 9월 30일 기준으로 $132.2 ล้าน이며, 4년의 자금 여력을 예상하고 있습니다. 4분기 재무 결과는 $11.6 밀리언의 순손실($0.14 주당)을 나타내며, 이는 2023년 4분기의 $10.1 밀리언($0.12 주당)과 비교됩니다.
주요 성과로는 알츠하이머병 치료를 위한 blarcamesine의 마케팅 허가 신청(MAA)이 EMA에 의해 수용된 것과, ANAVEX®3-71의 정신분열증에 대한 2상 연구에서의 유망한 초기 EEG 바이오마커 결과가 있습니다. 연구 및 개발 비용은 작년 $10.1 밀리언에서 $11.6 밀리언으로 증가했습니다.
Anavex Life Sciences (NASDAQ: AVXL) a publié les résultats du quatrième trimestre de l'exercice 2024, mettant en avant des développements clés dans son programme de traitement de la maladie d'Alzheimer. La position de trésorerie de l'entreprise se chiffrait à $132,2 millions au 30 septembre 2024, projetant ainsi un horizon de financement de 4 ans. Les résultats financiers du quatrième trimestre ont montré une perte nette de $11,6 millions ($0,14 par action), contre $10,1 millions ($0,12 par action) au quatrième trimestre 2023.
Parmi les réalisations notables, on note l'acceptation par l'EMA de la demande d'autorisation de mise sur le marché (MAA) pour blarcamesine dans le traitement de la maladie d'Alzheimer, ainsi que des résultats préliminaires prometteurs des biomarqueurs EEG de l'étude de phase 2 d'ANAVEX®3-71 pour la schizophrénie. Les dépenses de recherche et développement ont augmenté à $11,6 millions, contre $10,1 millions l'année précédente.
Anavex Life Sciences (NASDAQ: AVXL) hat die Ergebnisse des vierten Quartals des Geschäftsjahres 2024 bekannt gegeben und dabei wichtige Entwicklungen in seinem Behandlungsprogramm für Alzheimer hervorgehoben. Die Barmittel des Unternehmens beliefen sich zum 30. September 2024 auf $132,2 Millionen und prognostizieren eine Laufzeit von 4 Jahren. Die finanziellen Ergebnisse des vierten Quartals zeigten einen Nettoverlust von $11,6 Millionen ($0,14 pro Aktie), verglichen mit $10,1 Millionen ($0,12 pro Aktie) im vierten Quartal 2023.
Zu den bemerkenswerten Erfolgen gehört die Akzeptanz des Antrags auf Marktzulassung (MAA) für blarcamesine zur Behandlung von Alzheimer durch die EMA sowie vielversprechende vorläufige EEG-Biomarkerergebnisse aus der Phase-2-Studie zu ANAVEX®3-71 für Schizophrenie. Die Forschungs- und Entwicklungskosten stiegen im Jahresvergleich von $10,1 Millionen auf $11,6 Millionen.
- Strong cash position of $132.2M with 4-year runway projection
- EMA acceptance of MAA for blarcamesine in Alzheimer's treatment
- Positive preliminary EEG biomarker results in schizophrenia Phase 2 study
- Net loss increased to $11.6M from $10.1M year-over-year
- R&D expenses increased 14.9% to $11.6M
- G&A expenses rose to $2.8M from $2.6M
Insights
Anavex's Q4 fiscal 2024 results reveal a solid financial position with
The net loss widened to
The EMA's acceptance of blarcamesine's MAA for Alzheimer's represents a important milestone. With 7 million potential patients in Europe projected to double by 2030, successful commercialization could generate significant revenue streams. The comprehensive clinical data presentation at CTAD and upcoming long-term data release could catalyze market confidence.
The advancement of blarcamesine through regulatory channels marks a significant development in Alzheimer's treatment landscape. The drug's oral administration route offers a compelling advantage over existing injectable treatments, potentially improving patient compliance and accessibility. The SIGMAR1 activation mechanism represents an innovative approach, differentiated from traditional amyloid-targeting therapies.
The preliminary EEG biomarker results from ANAVEX®3-71's Phase 2 schizophrenia trial demonstrate promising dose-dependent effects. This data-driven approach using objective biomarkers strengthens the scientific validity of their clinical program. The expansion of their CNS pipeline beyond Alzheimer's into schizophrenia and Rett syndrome indicates a robust platform technology with broad therapeutic potential.
Company to host a webcast today at 8:30 a.m. Eastern Time
NEW YORK, Dec. 23, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) diseases, today reported financial results for its fourth quarter and fiscal year ended September 30, 2024.
“We are excited about the potential to advance a novel treatment for early Alzheimer’s disease with convenient oral dosing and our team remains deeply committed to executing on our momentum,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “I am proud of the strides the Anavex team has made in the recent quarter to potentially making a difference for individuals suffering from Alzheimer’s disease, by presenting a scalable treatment alternative alongside the ease of oral administration.”
Recent Highlights:
- On December 23, 2024, Anavex announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for blarcamesine (ANAVEX®2-73), an investigational drug for the treatment of Alzheimer’s disease.
- On December 9, 2024, Anavex announced its upcoming presentation of topline long-term data from the Phase IIb/III ATTENTION-AD Open-Label-Extension (OLE) trial at the J.P. Morgan 2025 Healthcare Conference, taking place January 13–16, 2025, in San Francisco, CA.
- On December 2, 2024, Anavex announced its participation in a fireside chat which was held December 4th, 2024, at the 7th Annual Evercore ISI HealthCONx Conference 2024 in Coral Gables, FL.
- On November 26, 2024, Anavex announced the submission of the blarcamesine (ANAVEX®2-73) MAA (Marketing Authorization Application) to the European Medicines Agency (EMA). The MAA submission is for the treatment of Alzheimer’s Disease. There are an estimated 7 million people in Europe with Alzheimer’s disease, a number expected to double by 2030, according to the European Brain Council.1
- On November 25, 2024, Anavex reported the acceptance of a peer-reviewed manuscript titled “Blarcamesine for the treatment of Early Alzheimer’s Disease: Results from the ANAVEX2-73-AD-004 Phase IIB/III trial,” in a medical journal with focus on Alzheimer’s disease. The publication date is expected around Q4 2024/Q1 2025.
- On October 31, 2024, Anavex presented new data from the Phase IIb/III study showing blarcamesine (ANAVEX®2-73), once daily orally, demonstrates pre-specified clinical efficacy through upstream SIGMAR1 activation. Clinical data confirmed the mechanism of action by pre-specified SIGMAR1 gene analysis in people with early Alzheimer's disease. The data were presented by Marwan Noel Sabbagh, MD, Professor of Neurology at Barrow Neurological Institute and Chairman of the Anavex Scientific Advisory Board at the Clinical Trials on Alzheimer’s Disease (CTAD) conference, in Madrid, Spain.
- On October 17, 2024, Anavex announced encouraging preliminary electroencephalography (EEG) biomarker results from Part A of the ongoing placebo-controlled Phase 2 clinical study of ANAVEX®3-71 for the treatment of schizophrenia. Preliminary results demonstrated a dose-dependent effect of ANAVEX®3-71 on two key EEG biomarkers in patients with schizophrenia. Anavex expects data from Part B of the placebo-controlled Phase 2 study, which includes more participants and a longer treatment duration, in the first half of 2025.
Financial Highlights:
- Cash and cash equivalents of
$132.2 million at September 30, 2024 compared to$151.0 million at September 30, 2023. As of fiscal year end, the Company anticipates at the current cash utilization rate, a runway of approximately 4 years. - General and administrative expenses for the fourth quarter of
$2.8 million compared to$2.6 million for the comparable quarter of fiscal 2023. - Research and development expenses for the fourth quarter of
$11.6 million compared to$10.1 million for the comparable quarter of fiscal 2023. - Net loss for the fourth quarter of
$11.6 million , or$0.14 per share, compared to a net loss of$10.1 million , or$0.12 per share for the comparable quarter of fiscal 2023.
The financial information for the fiscal year ended September 30, 2024, 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# 814 6482 4038 and reference passcode 336064. 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, schizophrenia, 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 and one Phase 2/3 study in pediatric patients with Rett syndrome. ANAVEX®2-73 is an orally available drug candidate designed to restore 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. | ||||||
| Consolidated Statements of Operations and Comprehensive Loss | ||||||
| (in thousands, except share and per share amounts) | ||||||
| Three months ended September 30, | ||||||
| 2024 | 2023 | |||||
| Operating Expenses | ||||||
| General and administrative | $ | 2,781 | $ | 2,592 | ||
| Research and development | 11,555 | 10,061 | ||||
| Total operating expenses | 14,336 | 12,653 | ||||
| Operating loss | (14,336 | ) | (12,653 | ) | ||
| Other income (expense) | ||||||
| Grant income | 75 | - | ||||
| Research and development incentive income | 700 | 670 | ||||
| Interest income, net | 1,759 | 1,958 | ||||
| Foreign exchange gain (loss) | 117 | (186 | ) | |||
| Gain on write-off of accounts payable | (59 | ) | - | |||
| Total other income, net | 2,592 | 2,442 | ||||
| Net loss before provision for income taxes | (11,744 | ) | (10,211 | ) | ||
| Income tax recovery, current | 124 | 64 | ||||
| Net loss and comprehensive loss | $ | (11,620 | ) | $ | (10,147 | ) |
| Net loss per share | ||||||
| Basic and diluted | $ | (0.14 | ) | $ | (0.12 | ) |
| Weighted average number of shares outstanding | ||||||
| Basic and diluted | 84,795,517 | 81,973,250 | ||||
| Anavex Life Sciences Corp. | ||||||
| Consolidated Statements of Operations and Comprehensive Loss | ||||||
| (in thousands, except share and per share amounts) | ||||||
| Twelve months ended September 30, | ||||||
| 2024 | 2023 | |||||
| Operating Expenses | ||||||
| General and administrative | $ | 11,039 | $ | 12,039 | ||
| Research and development | 41,838 | 43,717 | ||||
| Total operating expenses | 52,877 | 55,756 | ||||
| Operating loss | (52,877 | ) | (55,756 | ) | ||
| Other income (expense) | ||||||
| Grant income | 75 | 25 | ||||
| Research and development incentive income | 2,291 | 2,718 | ||||
| Interest income, net | 7,320 | 6,519 | ||||
| Other financing expense | - | (964 | ) | |||
| Foreign exchange gain (loss) | 189 | (40 | ) | |||
| Total other income, net | 9,875 | 8,258 | ||||
| Net loss before provision for income taxes | (43,002 | ) | (47,498 | ) | ||
| Income tax expense, current | - | (7 | ) | |||
| Net loss and comprehensive loss | $ | (43,002 | ) | $ | (47,505 | ) |
| Net loss per share | ||||||
| Basic and diluted | $ | (0.52 | ) | $ | (0.60 | ) |
| Weighted average number of shares outstanding | ||||||
| Basic and diluted | 83,468,049 | 79,787,596 | ||||
| Anavex Life Sciences Corp. | ||||||
| Consolidated Balance Sheets | ||||||
| (in thousands, except share and per share amounts) | ||||||
| September 30, | ||||||
| 2024 | 2023 | |||||
| Assets | ||||||
| Current | ||||||
| Cash and cash equivalents | $ | 132,187 | $ | 151,024 | ||
| Incentive and tax receivables | 2,449 | 2,709 | ||||
| Prepaid expenses and other current assets | 931 | 653 | ||||
| Total Assets | $ | 135,567 | $ | 154,386 | ||
| Liabilities and stockholders' equity | ||||||
| Current Liabilities | ||||||
| Accounts payable | $ | 9,627 | $ | 4,322 | ||
| Accrued liabilities | 4,835 | 7,295 | ||||
| Deferred grant income | 842 | 917 | ||||
| Total Liabilities | 15,304 | 12,534 | ||||
| Capital Stock | 85 | 82 | ||||
| Additional paid-in capital | 456,249 | 434,839 | ||||
| Accumulated deficit | (336,071 | ) | (293,069 | ) | ||
| Total Stockholders' Equity | 120,263 | 141,852 | ||||
| Total Liabilities and Stockholders' Equity | $ | 135,567 | $ | 154,386 | ||
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
1 https://www.braincouncil.eu/projects/rethinking-alzheimers-disease/
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