NEW YORK, November 25, 2025 — Leads & Copy — Anavex Life Sciences Corp. (Nasdaq: AVXL) has released its financial results for the fourth quarter of fiscal year 2025, reporting a net loss of $9.8 million, or $0.11 per share, compared to a net loss of $11.6 million, or $0.14 per share, for the same period in 2024. The clinical-stage biopharmaceutical company is focused on developing treatments for Alzheimer’s and Parkinson’s diseases, schizophrenia, neurodevelopmental and neurodegenerative diseases, and rare conditions such as Rett syndrome, along with other central nervous system (CNS) disorders.
Christopher U. Missling, PhD, President and CEO of Anavex, stated that the company is dedicated to developing oral, targeted upstream medicines, especially for early-stage Alzheimer’s disease, noting there are an estimated 7.2 million people living with Alzheimer’s in the U.S. and 7 million in Europe. He added that Anavex’s clinical pipeline aims to address critical unmet needs in neurodegenerative and neurodevelopmental disorders through therapeutic options. The oral drug blarcamesine has shown continued clinically meaningful benefits in patients with early-stage Alzheimer’s, validating its therapeutic potential. The company plans to request a re-examination of the CHMP opinion upon its formal adoption.
The company outlined several expected development milestones, including regulatory and clinical trial updates for blarcamesine in early Alzheimer’s and Parkinson’s diseases, as well as Rett syndrome. Anavex will also provide updates on the design of a Phase 2/3 clinical trial for Fragile X development, advance ANAVEX®3-71 towards pivotal clinical studies for schizophrenia-related disorders, and expand collaborative initiatives and strategic partnership activities.
Anavex anticipates presenting new scientific findings at upcoming conferences and publications, including the direct relationship between cognitive function and reduced brain region atrophy with blarcamesine; the robust effect size of oral blarcamesine for early symptomatic Alzheimer’s through precision medicine; the identification of COL24A1 as a new Precision Medicine gene for effective treatment of early Alzheimer’s disease with blarcamesine; and the continued long-term benefit from oral blarcamesine compared to delayed-start analysis and decline compared to natural history studies.
Recent corporate developments include several peer-reviewed publications. A study in Neuroscience Letters showed that pre-treatment with blarcamesine prevented Amyloid beta-induced memory impairment and brain oxidative injury in an Alzheimer’s disease model. A publication in iScience ascertained the precise autophagy mechanism of sigmar-1 receptor (S1R/SIGMAR1) through blarcamesine activation. Additionally, a publication on oral blarcamesine Phase IIb/III trial confirming an identified precision medicine patient population is to be available online as a preprint at medRxiv.
The company reported that findings for blarcamesine, an oral small molecule for the potential treatment of early Alzheimer’s disease, demonstrated minimal decline after 48 weeks in the ABCLEAR31 population, which was comparable to minimally perceptible decline in prodromal aging adults.
Topline results from a placebo-controlled Phase 2 clinical study evaluating ANAVEX®3-71 for the treatment of schizophrenia in adults on stable antipsychotic medication (ANAVEX3-71-SZ-001, NCT06245213) were also released. The study met its primary endpoint, demonstrating that ANAVEX®3-71 was safe and well-tolerated, with positive trends in EEG and ERP biomarkers of schizophrenia.
New data demonstrate continued long-term benefit from oral blarcamesine compared to decline observed in the Alzheimer’s Disease Neuroimaging Initiative (ADNI)2 control group, and Anavex was informed of a negative trend vote on the Marketing Authorisation Application (MAA) for blarcamesine by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The Company intends to request a re-examination of the CHMP opinion upon its formal adoption.
Anavex will present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026, in San Francisco, CA.
The company’s cash and cash equivalents totaled $102.6 million as of September 30, 2025, compared to $132.2 million the previous year. As of today, with a cash balance of over $120 million, Anavex anticipates a cash runway of more than 3 years at its current utilization rate. Research and development expenses for the quarter were $7.3 million, compared to $11.6 million in 2024, while general and administrative expenses rose to $3.5 million from $2.7 million. The net loss for the quarter was $9.8 million, or $0.11 per share, versus $11.6 million, or $0.14 per share, for the comparable period in 2024.
The live webcast of the conference call will be available on Anavex’s website. The conference call can be accessed by dialing 1 929 205 6099 for participants in the U.S. using the Meeting ID# 839 7768 4735 and reference passcode 825109.
Anavex Life Sciences Corp. is focused on developing novel therapeutics for neurodegenerative, neurodevelopmental, and neuropsychiatric disorders, including Alzheimer’s disease, Parkinson’s disease, schizophrenia, and Rett syndrome. Their lead drug candidate, ANAVEX®2-73 (blarcamesine), has completed Phase 2 and Phase 3 clinical trials for Alzheimer’s disease and Rett syndrome, respectively. ANAVEX®3-71 is another promising drug candidate demonstrating disease-modifying activity against Alzheimer’s disease hallmarks in preclinical trials.
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
Source: Anavex Life Sciences Corp.
