MALVERN, PA — Annovis Bio, Inc. (NYSE: ANVS) reported that enrollment in its pivotal Phase 3 Alzheimer’s disease trial has reached 85% and remains on track for completion this summer, positioning the biotechnology company for potential New Drug Application filings beginning in 2027 for its lead neurodegenerative therapy candidate, buntanetap.
The company also reported progress in its Parkinson’s disease open-label extension study, where enrollment has reached 40%, while outlining plans for additional clinical and biomarker data expected over the next two years.
“Our Phase 3 AD clinical trial achieved significant enrollment growth, keeping us firmly on track to complete randomization of patients in summer 2026,” President and Chief Executive Officer Maria Maccecchini stated.
Annovis closed enrollment to new Alzheimer’s disease participants on May 15 after reaching a sufficient number of screened patients to satisfy enrollment targets, according to the company.
The trial is evaluating buntanetap in early Alzheimer’s disease patients positive for the pTau217 plasma biomarker and is designed to measure both symptomatic improvement at six months and potential disease-modifying effects at 18 months.
The company also disclosed that an independent Data and Safety Monitoring Board recommended continuation of the study following a six-month safety review.
Annovis expects symptomatic data from the trial approximately six months after the final patient receives treatment, with longer-term disease-modifying data anticipated after 18 months.
Based on study outcomes, the company plans to pursue an FDA New Drug Application for buntanetap as a symptomatic Alzheimer’s treatment in early 2027 and potentially as a disease-modifying therapy in early 2028.
In Parkinson’s disease, Annovis launched an open-label extension study evaluating the long-term safety and efficacy of buntanetap over 36 months.
The study incorporates both skin biopsy biomarkers measuring phosphorylated alpha-synuclein and an AI-enabled digital biomarker platform developed through a partnership with NeuroRPM to continuously monitor motor function.
“We expect to generate substantive clinical data across both indications that will anchor our regulatory path toward an NDA submission for buntanetap,” Maccecchini noted.
During the quarter, Annovis also reported publication of Phase 2/3 Alzheimer’s trial data in Nature NPJ Dementia, which the company stated demonstrated dose-dependent cognitive improvements and biomarker reductions among treated patients.
The company additionally secured a U.S. patent covering the use of buntanetap and related compounds in neurological injuries arising from brain infections.
Financially, Annovis reported cash and cash equivalents totaling $14.2 million as of March 31, compared with $19.5 million at the end of 2025. The figure excludes proceeds from a $10 million registered direct offering completed in April.
Research and development expenses increased to $16.7 million during the quarter from $5.0 million a year earlier, reflecting expanded clinical trial activity.
General and administrative expenses remained flat at approximately $1.3 million.
Annovis reported a net loss of $0.63 per share for the quarter ended March 31, compared with a net loss of $0.32 per share in the prior-year period.
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