Anavex Life Sciences ReportsFiscal 2025 Third Quarter Financial Results and Provides Business Update
Anavex Life Sciences (NASDAQ:AVXL) reported its fiscal 2025 Q3 financial results and provided updates on its clinical developments. The company's lead drug candidate blarcamesine demonstrated continued clinical benefits for early-stage Alzheimer's patients over a 4-year period, as presented at AAIC 2025.
Financial highlights include cash position of $101.2 million as of June 30, 2025, providing over 3 years of runway. Q3 net loss was $13.2 million ($0.16 per share), compared to $12.2 million ($0.14 per share) in Q3 2024. R&D expenses decreased to $10.0 million from $11.8 million year-over-year, while G&A expenses increased to $4.5 million from $2.8 million.
Anavex Life Sciences (NASDAQ:AVXL) ha reso noti i risultati finanziari del terzo trimestre dell'esercizio 2025 e ha fornito aggiornamenti sui suoi sviluppi clinici. Il candidato principale, blarcamesine, ha mostrato benefici clinici persistenti nei pazienti con Alzheimer in fase iniziale su un periodo di 4 anni, come presentato all'AAIC 2025.
I punti finanziari rilevanti includono una posizione di cassa pari a $101.2 milioni al 30 giugno 2025, che assicura oltre 3 anni di autonomia finanziaria. La perdita netta del terzo trimestre è stata di $13.2 milioni ($0.16 per azione), rispetto a $12.2 milioni ($0.14 per azione) nel Q3 2024. Le spese per R&S sono diminuite a $10.0 milioni da $11.8 milioni su base annua, mentre le spese G&A sono salite a $4.5 milioni da $2.8 milioni.
Anavex Life Sciences (NASDAQ:AVXL) informó sus resultados financieros del tercer trimestre del ejercicio 2025 y proporcionó actualizaciones sobre sus desarrollos clínicos. El candidato principal, blarcamesine, demostró beneficios clínicos continuos en pacientes con Alzheimer en estadio temprano durante un período de 4 años, según se presentó en el AAIC 2025.
Entre los aspectos financieros destaca una posición de caja de $101.2 millones al 30 de junio de 2025, que ofrece más de 3 años de visibilidad financiera. La pérdida neta del tercer trimestre fue de $13.2 millones ($0.16 por acción), frente a $12.2 millones ($0.14 por acción) en el Q3 de 2024. Los gastos de I+D se redujeron a $10.0 millones desde $11.8 millones interanual, mientras que los gastos G&A aumentaron a $4.5 millones desde $2.8 millones.
Anavex Life Sciences (NASDAQ:AVXL)� 2025 회계연도 3분기 재무 실적� 발표하고 임상 진행 상황� 업데이트했습니다. 주력 후보물질� blarcamesine은 AAIC 2025에서 발표� 바와 같이 경증 알츠하이� 환자들에� 4� 동안 지속적� 임상� 이점� 보였습니�.
재무 요약으로� 2025� 6� 30� 기준 현금 보유� $101.2M으로 3� 이상 운영 자금� 확보되어 있다� 점이 포함됩니�. 3분기 순손실은 $13.2($0.16/�)으로, 2024� Q3� $12.2M($0.14/�)� 비해 증가했습니다. 연구개발비는 전년 동기 대� $11.8M에서 $10.0M으로 감소했으�, G&A 비용은 $2.8M에서 $4.5M으로 증가했습니다.
Anavex Life Sciences (NASDAQ:AVXL) a publié ses résultats financiers du troisième trimestre de l'exercice 2025 et a fourni des informations sur ses avancées cliniques. Son principal candidat-médicament, blarcamesine, a démontré des bénéfices cliniques durables chez des patients atteints d'Alzheimer au stade précoce sur une période de 4 ans, présentés lors de l'AAIC 2025.
Parmi les points financiers, on relève une trésorerie de $101.2 millions au 30 juin 2025, assurant plus de 3 ans d'autonomie. La perte nette du troisième trimestre s'élève à $13.2 millions ($0.16 par action), contre $12.2 millions ($0.14 par action) au T3 2024. Les dépenses R&D ont diminué à $10.0 millions contre $11.8 millions en glissement annuel, tandis que les frais G&A ont augmenté à $4.5 millions contre $2.8 millions.
Anavex Life Sciences (NASDAQ:AVXL) veröffentlichte seine Finanzergebnisse für das dritte Quartal des Geschäftsjahres 2025 und gab Updates zu seinen klinischen Entwicklungen. Der führende Wirkstoffkandidat, blarcamesine, zeigte laut Präsentation auf der AAIC 2025 über einen Zeitraum von vier Jahren anhaltende klinische Vorteile für Patienten mit Frühstadium-Alzheimer.
Zu den finanziellen Eckdaten gehört eine Barmittelposition von $101.2 Millionen zum 30. Juni 2025, was mehr als 3 Jahre Laufzeit ermöglicht. Der Quartalsverlust belief sich auf $13.2 Millionen ($0.16 je Aktie), gegenüber $12.2 Millionen ($0.14 je Aktie) im Q3 2024. Die F&E-Ausgaben sanken auf $10.0 Millionen von $11.8 Millionen im Jahresvergleich, während die G&A-Kosten auf $4.5 Millionen von $2.8 Millionen anstiegen.
- Strong cash position of $101.2M providing over 3 years of runway
- Blarcamesine showed continued clinical benefits in Alzheimer's patients for up to 4 years
- Reduced R&D expenses by 15.3% year-over-year to $10.0M
- Oral administration of blarcamesine offers potential advantage over injectable alternatives
- Net loss increased to $13.2M from $12.2M year-over-year
- G&A expenses rose 60.7% to $4.5M compared to previous year
- Cash position decreased from $132.2M to $101.2M since September 2024
Insights
Anavex's Q3 shows steady clinical progress for blarcamesine in Alzheimer's, but wider losses and continuing cash burn require monitoring.
Anavex's fiscal Q3 2025 results paint a picture of continued clinical advancement amid growing financial pressures. The company's cash position has declined to
The company's net loss widened to
The clinical narrative centers on blarcamesine, their oral small molecule targeting early Alzheimer's disease. The 4-year extension data presented at AAIC 2025 demonstrated continued benefits measured by standard cognitive and functional assessments (ADAS-Cog13 and ADCS-ADL). Additionally, the company highlighted how their compound works upstream by restoring impaired autophagy, potentially addressing the disease before amyloid-beta and tau accumulation.
Importantly, a European stakeholder survey emphasized market preference for oral therapies like blarcamesine over injectable monoclonal antibodies, suggesting potential commercial advantages if approved. Oral administration could facilitate broader market penetration by reducing monitoring requirements and simplifying administration compared to current antibody treatments.
Blarcamesine shows promising long-term cognitive benefits in Alzheimer's with potential advantages as an oral therapy targeting autophagy mechanisms.
Anavex's blarcamesine data presented at AAIC 2025 represents a potentially significant development in the Alzheimer's treatment landscape. The compound demonstrates two particularly notable characteristics: its oral administration route and its upstream mechanism targeting autophagy.
The 4-year extension data showing continued clinical benefits on both cognitive function (ADAS-Cog13) and activities of daily living (ADCS-ADL) suggests durability of effect—a critical factor in Alzheimer's therapeutics where disease progression typically continues despite intervention. While specific numerical data wasn't provided in the release, the description of "clinically meaningful benefit" indicates the changes likely meet thresholds considered relevant for patients' quality of life.
Mechanistically, blarcamesine's focus on restoring impaired autophagy positions it differently from most approved Alzheimer's therapies. Autophagy—the cellular process that clears damaged proteins and organelles—becomes dysfunctional early in Alzheimer's pathogenesis. By targeting this upstream process before amyloid-beta and tau accumulation, blarcamesine potentially addresses the disease cascade earlier than antibody therapies focused on clearing already-formed plaques and tangles.
The EU stakeholder survey highlighting preferences for oral therapies reflects practical clinical considerations. Current monoclonal antibody treatments require infusion infrastructure, monitoring for ARIA (amyloid-related imaging abnormalities), and specialized administration protocols. An effective oral therapy would significantly reduce these barriers, potentially expanding treatment to broader patient populations, particularly in settings with limited healthcare infrastructure. This modality difference could be crucial for real-world effectiveness even if efficacy in controlled trials were comparable.
Company to host a today at 8:30 a.m. Eastern Time
NEW YORK, Aug. 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) disorders, today reported financial results for its third quarter of fiscal 2025.
“Our development of non-invasive, targeted upstream compounds continues to advance, particularly in the context of Alzheimer’s disease,� said Christopher U. Missling, PhD, President and CEO of Anavex. “Clinical feedback highlights the importance of orally administered therapies that are both accessible and effective. At AAIC 2025, we presented open-label extension data for blarcamesine, which demonstrated continued clinically meaningful benefit in early-stage Alzheimer’s patients—further validating its therapeutic potential.�
Recent Highlights:
- On July 31, 2025, Anavex announced the latest findings for blarcamesine, an oral small molecule for the potential treatment of early Alzheimer’s disease. The data were presented by Marwan Noel Sabbagh, MD, Professor of Neurology, and Chairman of the Anavex Scientific Advisory Board at the 2025 Alzheimer's Association International Conference (AAIC). Blarcamesine-treated patients continue to accrue benefit through up to 4 years, as measured by the prespecified clinical endpoints ADAS-Cog13 and ADCS-ADL, respectively. Further presentations at the AAIC 2025 Conference featured prespecified Precision Medicine Phase IIb/III 48-week ANAVEX®2-73-AD-004 double-blind (DB) clinical trial data on blarcamesine, confirming the upstream mechanism of blarcamesine, restoring impaired autophagy as an early event, preceding amyloid-beta and tau.
- July 27-31, 2025, Anavex was honored to be a part of the program at the 2025 Alzheimer’s Association International Conference (AAIC) in Toronto. The sharing of knowledge at these central events is important to help advance dementia science to better support the millions of individuals, families, and communities impacted by Alzheimer’s disease.
- In June 2025, a survey of Alzheimer’s Disease stakeholders from European Union (EU) Member States on ‘Current Unmet Needs in Alzheimer Care� was conducted. There is a clear acknowledgment that oral therapies would ‘facilitate things� for many countries and be ‘much more accessible� for the respective healthcare systems, potentially requiring less extensive monitoring and complex administration compared to injectable monoclonal antibodies. This modality difference is seen as a key factor in potential broader market penetration.
Financial Highlights:
- Cash and cash equivalents of
$101.2 million at June 30, 2025 compared to$132.2 million at year ended September 30, 2024. The Company anticipates at current adjusted cash utilization rates and ranges, an approximate cash runway of more than 3 years. - Research and development expenses for the quarter of
$10.0 million compared to$11.8 million for the comparable quarter of fiscal 2024. - General and administrative expenses for the quarter of
$4.5 million compared to$2.8 million for the comparable quarter of fiscal 2024. - An increase in non-cash compensation charges, was offset by a decrease in overall cash operating expenses, as compared to the same quarter of fiscal 2024.
- Net loss for the quarter of
$13.2 million , or$0.16 per share, compared to a net loss of$12.2 million , or$0.14 per share for the comparable quarter of fiscal 2024.
The financial information for the quarter ended June 30, 2025, 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 .
Webcast / Conference Call Information:
The live of the conference call will be available on Anavex’s website at .
The conference call can be also accessed by dialing 1 929 205 6099 for participants in the U.S. using the Meeting ID# 856 5033 5285 and reference passcode 014 352. 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 . You can also connect with the Company on , , and .
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 June 30, | |||||||
2025 | 2024 | ||||||
Operating Expenses | |||||||
General and administrative | $ | 4,500 | $ | 2,792 | |||
Research and development | 9,959 | 11,811 | |||||
Total operating expenses | 14,459 | 14,603 | |||||
Operating loss | (14,459 | ) | (14,603 | ) | |||
Other income | |||||||
Grant income | 25 | - | |||||
Research and development incentive income | 127 | 526 | |||||
Interest income, net | 1,075 | 1,796 | |||||
Foreign exchange gain | (11 | ) | 67 | ||||
Total other income, net | 1,216 | 2,389 | |||||
Net loss and comprehensive loss | $ | (13,243 | ) | $ | (12,214 | ) | |
Net loss per share | |||||||
Basic and diluted | $ | (0.16 | ) | $ | (0.14 | ) | |
Weighted average number of shares outstanding | |||||||
Basic and diluted | 85,380,587 | 84,535,328 |
Anavex Life Sciences Corp. | |||||||
Condensed Consolidated Statements of Operations and Comprehensive Loss | |||||||
(in thousands, except share and per share amounts) (Unaudited) | |||||||
Nine months ended June 30, | |||||||
2025 | 2024 | ||||||
Operating Expenses | |||||||
General and administrative | $ | 10,266 | $ | 8,382 | |||
Research and development | 30,298 | 30,224 | |||||
Total operating expenses | 40,564 | 38,606 | |||||
Operating loss | (40,564 | ) | (38,606 | ) | |||
Other income (expense) | |||||||
Grant income | 37 | - | |||||
Research and development incentive income | 635 | 1,591 | |||||
Interest income, net | 3,679 | 5,561 | |||||
Foreign exchange gain (loss) | (337 | ) | 72 | ||||
Total other income, net | 4,014 | 7,224 | |||||
Net loss and comprehensive loss | $ | (36,550 | ) | $ | (31,385 | ) | |
Net loss per share | |||||||
Basic and diluted | $ | (0.43 | ) | $ | (0.38 | ) | |
Weighted average number of shares outstanding | |||||||
Basic and diluted | 85,085,795 | 83,022,330 |
Anavex Life Sciences Corp. | ||||||
Condensed Consolidated Balance Sheets | ||||||
(in thousands, except share and per share amounts) | ||||||
June 30, | September 30, | |||||
2025 | 2024 | |||||
Assets | ||||||
Current | ||||||
Cash and cash equivalents | $ | 101,164 | $ | 132,187 | ||
Incentive and tax receivables | 820 | 2,449 | ||||
Prepaid expenses and other current assets | 448 | 931 | ||||
Total Assets | $ | 102,432 | $ | 135,567 | ||
Liabilities and stockholders' equity | ||||||
Current Liabilities | ||||||
Accounts payable | $ | 6,740 | $ | 9,627 | ||
Accrued liabilities | 3,929 | 4,835 | ||||
Deferred grant income | 805 | 842 | ||||
Total Liabilities | 11,474 | 15,304 | ||||
Capital Stock | 85 | 85 | ||||
Additional paid-in capital | 463,494 | 456,249 | ||||
Accumulated deficit | (372,621 | ) | (336,071 | ) | ||
Total Stockholders' Equity | 90,958 | 120,263 | ||||
Total Liabilities and Stockholders' Equity | $ | 102,432 | $ | 135,567 |
For Further Information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email:
Investors:
Andrew J. Barwicki
Investor Relations
Tel: 516-662-9461
Email:
