MALVERN, PA — Annovis Bio Inc. (NYSE: ANVS) unveiled significant progress in its efforts to combat neurodegenerative diseases with updates on its pivotal Phase 3 clinical trial and solid financial standing for the first quarter of 2025.
The company’s Phase 3 clinical trial for buntanetap, its lead candidate for treating Alzheimer’s disease (AD), began enrolling participants on February 5, 2025. This dual 6/18-month study is designed to assess both symptomatic benefits over six months and potential long-term disease-modifying effects over an additional 12 months. With approximately 760 participants expected to be enrolled, the trial is currently onboarding clinical sites across the U.S.
“We are advancing as planned with our pivotal Phase 3 Alzheimer’s study, making steady progress every day,” said Melissa Gaines, Senior Vice President of Clinical Operations at Annovis Bio. “Our team is grateful to all collaborators for helping make this process efficient and to our community for their ongoing support. We look forward to providing continued updates on the current trial and other initiatives we have planned for this year.”
The first quarter also saw Annovis actively participate in key industry conferences, including presentations at the AD/PD™ 2025 conference in Vienna, where the company highlighted data from its Phase 3 Parkinson’s trial and previous studies of buntanetap in ApoE4 carriers. Founder and CEO Maria Maccecchini, Ph.D., played a critical role in various forums, presenting on advancements in treatments targeting Alzheimer’s, Parkinson’s disease, and alpha-synuclein.
“In these times of great uncertainty, we are choosing resilience and discipline, putting one foot in front of the other as we stay focused on advancing the Phase 3 AD study,” said Dr. Maccecchini. “Our mission remains clear: to deliver a potentially life-changing treatment to patients as soon as possible.”
On the financial front, Annovis reported cash and cash equivalents of $22.2 million as of March 31, 2025, an improvement compared to $10.6 million a year earlier. Research and development expenses for Q1 2025 decreased to $5.0 million from $6.5 million in Q1 2024, while general and administrative expenses remained flat at $1.3 million over the same periods. The company reported a net loss of $0.32 per share for the quarter, reflecting continued investment in research and development.
Annovis also secured a U.S. patent in January for the use of buntanetap in treating acute brain and nerve injuries, further solidifying its intellectual property portfolio.
With its Phase 3 Alzheimer’s trial advancing, a pipeline of promising treatments, and active engagement with the scientific and investment communities, Annovis Bio is positioned as a leading figure in addressing neurodegenerative diseases. By targeting therapeutic breakthroughs in conditions like Alzheimer’s and Parkinson’s, the company is delivering on its mission to transform patient outcomes in a space with critical unmet needs.
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