MALVERN, PA — Annovis Bio Inc. (NYSE: ANVS) reported its 2025 financial results and said it advanced late-stage clinical development of its investigational drug buntanetap, including launching a Phase 3 trial for early Alzheimer’s disease and initiating a Parkinson’s disease extension study.
The company announced the updates alongside its fiscal year results.
Annovis said it began a pivotal Phase 3 trial in February 2025 evaluating buntanetap in early Alzheimer’s disease patients over 18 months, with 65% of participants enrolled across 83 U.S. sites as of March 2026.
The company also reported that the trial’s Data and Safety Monitoring Board recommended continuing the study without changes following a six-month safety review.
In Parkinson’s disease, Annovis said it launched an open-label extension study in January 2026 to evaluate long-term safety and tolerability over 36 months.
The company added that it met with the U.S. Food and Drug Administration in January 2026 and received a recommendation to proceed with planning a study in Parkinson’s disease dementia.
Annovis reported biomarker data from prior studies indicating reductions in proteins associated with neurodegeneration, including amyloid and tau, and said the findings suggest potential disease-modifying effects.
“The year 2025 was a landmark period for Annovis,” CEO Maria Maccecchini said, citing progress in late-stage trials and data analysis.
The company also said it transferred patents in August 2025 to a new crystal form of buntanetap, extending intellectual property protection through 2047.
Research and development expenses rose to $25.2 million in 2025 from $20.0 million in 2024, while general and administrative expenses decreased to $4.5 million from $6.7 million.
Annovis reported a net loss of $1.40 per share, both basic and diluted, for 2025, compared with a net loss of $2.02 per share basic and $2.31 diluted in 2024.
Cash and cash equivalents totaled $19.5 million at the end of 2025, up from $10.6 million a year earlier.
The company said its current cash position, including proceeds from stock offerings completed in the fourth quarter of 2025, is expected to fund operations into the third quarter of 2026.
Annovis had 27.2 million shares of common stock outstanding as of December 31, 2025.
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