Anavex Life Sciences Reports Fiscal 2025 First Quarter Financial Results and Provides Business Update
Anavex Life Sciences (NASDAQ: AVXL) reported its fiscal 2025 Q1 financial results, highlighting significant developments in its Alzheimer's disease treatment program. The company's oral treatment blarcamesine demonstrated a 36.3% slowdown in clinical progression at 48 weeks, and 49.8% in patients with SIGMAR1 wild-type gene.
Financial results show cash and equivalents of $120.8 million as of December 31, 2024, providing an estimated 4-year runway. Q1 net loss increased to $12.1 million ($0.14 per share) compared to $8.6 million ($0.11 per share) in the previous year. R&D expenses rose to $10.4 million from $8.7 million, while G&A expenses increased to $3.1 million from $2.7 million.
The company secured a new composition of matter U.S. Patent for ANAVEX®2-73, valid until July 2039, covering crystalline forms and various delivery methods.
Anavex Life Sciences (NASDAQ: AVXL) ha riportato i risultati finanziari del primo trimestre dell'anno fiscale 2025, evidenziando sviluppi significativi nel suo programma di trattamento per la malattia di Alzheimer. Il trattamento orale dell'azienda, blarcamesine, ha dimostrato un rallentamento del 36,3% nella progressione clinica a 48 settimane, e del 49,8% nei pazienti con il gene SIGMAR1 di tipo selvatico.
I risultati finanziari mostrano un patrimonio liquido e equivalenti di $120,8 milioni al 31 dicembre 2024, fornendo una stima di 4 anni di operatività. La perdita netta del primo trimestre è aumentata a $12,1 milioni ($0,14 per azione) rispetto agli $8,6 milioni ($0,11 per azione) dell'anno precedente. Le spese per ricerca e sviluppo sono aumentate a $10,4 milioni da $8,7 milioni, mentre le spese generali e amministrative sono aumentate a $3,1 milioni da $2,7 milioni.
L'azienda ha ottenuto un nuovo brevetto statunitense per la composizione di materia di ANAVEX®2-73, valido fino a luglio 2039, che copre forme cristalline e vari metodi di somministrazione.
Anavex Life Sciences (NASDAQ: AVXL) informó sobre sus resultados financieros del primer trimestre del año fiscal 2025, destacando desarrollos significativos en su programa de tratamiento para la enfermedad de Alzheimer. El tratamiento oral de la compañía, blarcamesine, demostró una desaceleración del 36,3% en la progresión clínica a las 48 semanas, y del 49,8% en pacientes con el gen SIGMAR1 de tipo salvaje.
Los resultados financieros muestran un efectivo y equivalentes de $120,8 millones al 31 de diciembre de 2024, proporcionando una estimación de 4 años de operación. La pérdida neta del primer trimestre aumentó a $12,1 millones ($0,14 por acción) en comparación con $8,6 millones ($0,11 por acción) del año anterior. Los gastos de I+D aumentaron a $10,4 millones desde $8,7 millones, mientras que los gastos generales y administrativos aumentaron a $3,1 millones desde $2,7 millones.
La compañía obtuvo una nueva patente de composición de materia en EE. UU. para ANAVEX®2-73, válida hasta julio de 2039, que cubre formas cristalinas y varios métodos de entrega.
Anavex Life Sciences (NASDAQ: AVXL)는 2025 회계연도 1분기 재무 결과를 발표하며 알츠하이머병 치료 프로그램의 중요한 발전을 강조했습니다. 회사의 경구 치료제 blarcamesine은 48주 차에 임상 진행 속도가 36.3% 느려졌으며, SIGMAR1 야생형 유전자를 가진 환자에서는 49.8% 느려졌습니다.
재무 결과에 따르면, 2024년 12월 31일 기준 현금 및 현금성 자산은 $120.8 million으로, 약 4년의 운영 자금을 제공합니다. 1분기 순손실은 $12.1 million ($0.14 주당)으로 증가했으며, 이는 지난해의 $8.6 million ($0.11 주당)과 비교됩니다. 연구개발 비용은 $10.4 million으로 증가했으며, 일반 및 관리 비용은 $3.1 million으로 증가했습니다.
회사는 ANAVEX®2-73에 대한 새로운 물질 조성 미국 특허를 확보했으며, 이는 2039년 7월까지 유효하며 결정 형태와 다양한 전달 방법을 포함합니다.
Anavex Life Sciences (NASDAQ: AVXL) a annoncé ses résultats financiers du premier trimestre de l'exercice 2025, mettant en avant des développements significatifs dans son programme de traitement de la maladie d'Alzheimer. Le traitement oral de l'entreprise, blarcamesine, a montré un ralentissement de 36,3 % de la progression clinique à 48 semaines, et de 49,8 % chez les patients porteurs du gène SIGMAR1 de type sauvage.
Les résultats financiers indiquent des liquidités et équivalents de $120,8 millions au 31 décembre 2024, offrant une estimation de 4 ans de fonctionnement. La perte nette du premier trimestre a augmenté à $12,1 millions ($0,14 par action) contre $8,6 millions ($0,11 par action) l'année précédente. Les dépenses de R&D ont augmenté à $10,4 millions contre $8,7 millions, tandis que les dépenses générales et administratives ont augmenté à $3,1 millions contre $2,7 millions.
L'entreprise a obtenu un nouveau brevet américain pour la composition de matière d'ANAVEX®2-73, valable jusqu'en juillet 2039, couvrant des formes cristallines et divers modes de livraison.
Anavex Life Sciences (NASDAQ: AVXL) berichtete über die finanziellen Ergebnisse des ersten Quartals des Geschäftsjahres 2025 und hob bedeutende Entwicklungen in seinem Programm zur Behandlung von Alzheimer hervor. Die orale Behandlung des Unternehmens, blarcamesine, zeigte eine Verlangsamung der klinischen Progression um 36,3% nach 48 Wochen und um 49,8% bei Patienten mit dem SIGMAR1 Wildtyp-Gen.
Die finanziellen Ergebnisse zeigen, dass das Unternehmen zum 31. Dezember 2024 über liquide Mittel und Äquivalente in Höhe von $120,8 Millionen verfügte, was eine geschätzte Betriebsdauer von 4 Jahren ermöglicht. Der Nettoverlust im ersten Quartal stieg auf $12,1 Millionen ($0,14 pro Aktie) im Vergleich zu $8,6 Millionen ($0,11 pro Aktie) im Vorjahr. Die F&E-Ausgaben stiegen auf $10,4 Millionen von $8,7 Millionen, während die allgemeinen und administrativen Ausgaben auf $3,1 Millionen von $2,7 Millionen stiegen.
Das Unternehmen sicherte sich ein neues US-Patent für die Zusammensetzung von ANAVEX®2-73, das bis Juli 2039 gültig ist und kristalline Formen sowie verschiedene Verabreichungsmethoden abdeckt.
- Clinical trial showed 36.3% slowdown in Alzheimer's disease progression
- Strong cash position of $120.8M providing 4-year runway
- New patent protection secured until 2039
- Long-term data showed continued clinical benefits over three years
- Net loss increased 40.7% YoY to $12.1M
- R&D expenses increased 19.5% to $10.4M
- G&A expenses rose 14.8% to $3.1M
- Cash position decreased from $132.2M to $120.8M quarter-over-quarter
Insights
The Q1 FY2025 financial results reveal a strategic acceleration in Anavex's development programs, evidenced by a
The company's robust cash position of
The newly secured patent protection until 2039 for ANAVEX®2-73's crystalline forms strengthens the company's intellectual property portfolio and potential market exclusivity. When combined with the positive clinical data showing sustained benefits over three years, this positions Anavex favorably for potential partnerships or licensing agreements, which could significantly impact future revenue streams.
Company to host a webcast today at 8:30 a.m. Eastern Time
NEW YORK, Feb. 12, 2025 (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 first quarter of fiscal 2025.
“We are receiving growing support from stakeholders for the potential to advance a novel treatment for early Alzheimer’s disease with convenient oral dosing with potential clinical meaningful benefit,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “We are excited 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 January 27, 2025, Anavex announced it was issued a new composition of matter U.S. Patent, expected to remain in force at least until July 2039, entitled “A2-73 CRYSTALLINE POLYMORPH COMPOSITIONS OF MATTER AND METHODS OF USE THEREOF” from the United States Patent and Trademark Office (USPTO). This new patent claims crystalline forms of the dihydrogen phosphate salt of ANAVEX®2-73 (blarcamesine), freebase, transdermal patches and enteric coated oral dosage forms including the same for neuroprotection and treatment of neurodegenerative disorders, including Alzheimer’s disease, Parkinson’s disease and other disorders.
- On January 15, 2025, Anavex announced that The Journal of Prevention of Alzheimer’s Disease (JPAD) published peer-reviewed detailed results from the Phase IIb/III study evaluating oral blarcamesine (ANAVEX®2-73) for the treatment of early Alzheimer’s Disease (AD). Once daily oral blarcamesine, demonstrating a safety profile with no associated neuroimaging adverse events, significantly slowed clinical progression by
36.3% at 48 weeks with blarcamesine group as well as the prespecified SIGMAR1 wild-type gene group by49.8% at 48 weeks on the prespecified primary cognitive endpoint ADAS-Cog13, respectively. - On January 13, 2025, Anavex provided topline long-term data from the Phase IIb/III ATTENTION-AD Open-Label-Extension (OLE) trial. The data demonstrated that over three years of continuous treatment with blarcamesine (ANAVEX®2-73) significantly reduced clinical decline showing continued clinically and meaningful benefit for early Alzheimer’s disease patients.
Financial Highlights:
- Cash and cash equivalents of
$120.8 million at December 31, 2024 compared to$132.2 million at September 30, 2024. As of quarter end, the Company anticipates at current cash utilization rates and ranges, a runway of approximately 4 years. - General and administrative expenses for the first quarter of
$3.1 million compared to$2.7 million for the comparable first quarter of fiscal 2024. - Research and development expenses for the first quarter of
$10.4 million compared to$8.7 million for the comparable first quarter of fiscal 2024. - Net loss for the first quarter of
$12.1 million , or$0.14 per share, compared to a net loss of$8.6 million , or$0.11 per share for the comparable first quarter of fiscal 2024.
The financial information for the quarter ended December 31, 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# 828 2995 9982 and reference passcode 308966. 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. | ||||||
| Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||||
| (in thousands, except share and per share amounts) (Unaudited) | ||||||
| Three months ended December 31, | ||||||
| 2024 | 2023 | |||||
| Operating Expenses | ||||||
| General and administrative | $ | 3,146 | $ | 2,694 | ||
| Research and development | 10,446 | 8,684 | ||||
| Total operating expenses | 13,592 | 11,378 | ||||
| Operating loss | (13,592 | ) | (11,378 | ) | ||
| Other income (expense) | ||||||
| Grant income | 12 | - | ||||
| Research and development incentive income | 412 | 592 | ||||
| Interest income, net | 1,394 | 2,008 | ||||
| Foreign exchange gain (loss) | (337 | ) | 156 | |||
| Total other income, net | 1,481 | 2,756 | ||||
| Net loss and comprehensive loss | $ | (12,111 | ) | $ | (8,622 | ) |
| Net loss per share | ||||||
| Basic and diluted | $ | (0.14 | ) | $ | (0.11 | ) |
| Weighted average number of shares outstanding | ||||||
| Basic and diluted | 84,805,974 | 82,077,815 | ||||
| Anavex Life Sciences Corp. | ||||||
| Condensed Consolidated Balance Sheets | ||||||
| (in thousands, except share and per share amounts) | ||||||
| December 31, | September 30, | |||||
| 2024 | 2024 | |||||
| Assets | ||||||
| Current | ||||||
| Cash and cash equivalents | $ | 120,775 | $ | 132,187 | ||
| Incentive and tax receivables | 2,557 | 2,449 | ||||
| Prepaid expenses and other current assets | 711 | 931 | ||||
| Total Assets | $ | 124,043 | $ | 135,567 | ||
| Liabilities and stockholders' equity | ||||||
| Current Liabilities | ||||||
| Accounts payable | $ | 4,567 | $ | 9,627 | ||
| Accrued liabilities | 7,732 | 4,835 | ||||
| Deferred grant income | 829 | 842 | ||||
| Total Liabilities | 13,128 | 15,304 | ||||
| Capital Stock | 85 | 85 | ||||
| Additional paid-in capital | 459,012 | 456,249 | ||||
| Accumulated deficit | (348,182 | ) | (336,071 | ) | ||
| Total Stockholders' Equity | 110,915 | 120,263 | ||||
| Total Liabilities and Stockholders' Equity | $ | 124,043 | $ | 135,567 | ||
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
FAQ
What were the clinical results of AVXL's blarcamesine in Alzheimer's treatment?
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What was AVXL's net loss per share in Q1 fiscal 2025?
When does AVXL's new patent for ANAVEX®2-73 expire?
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