ANVS News & Events

Annovis Bio announced a partnership with NeuroRPM to implement a new FDA-cleared artificial intelligence platform that collects movement data for symptom and disease management in its ongoing Parkinson's study. Annovis' recently launched open-label study in PD patients is currently enrolling participants across the 25 sites in the United States to test buntanetap for the duration of 36 months. As part of the initiative to advance management, monitoring, and data collection, the Company has entered into a partnership with NeuroRPM to introduce the first FDA-cleared AI-enabled medical device that allows to monitor the primary PD symptoms - bradykinesia, tremor, and dyskinesia. This information will serve as a digital biomarker, capturing real-time evidence of how disease symptoms change during the course of the study. For the open-label study, in addition to the NeuroRPM's digital biomarker assessing PD symptoms, Annovis is also implementing a highly accurate biomarker test for misfolded phosphorylated alpha-synuclein - a defining hallmark of Parkinson's pathology. Measured via a minimally invasive skin procedure, the assay delivers objective pathological evidence of the disease with greater than 90% diagnostic sensitivity and specificity. The combination of cutting-edge digital and biological biomarkers used in tandem opens a unique opportunity to comprehensively record patients' response to treatment - changes in symptoms and potential disease-modification - bringing greater precision and depth to the measurement of outcomes in the ongoing open-label PD trial.

Annovis' cash and cash equivalents totaled $19.5 million as of December 31, 2025 compared to $10.6 million as of December 31, 2024. The Company estimates that its current cash and cash equivalents, including proceeds from its stock offerings in the fourth quarter of 2025, will enable it to fund its operations into the third quarter of 2026. The Company had 27.2 million shares of common stock outstanding as of December 31, 2025.

"The year 2025 was a landmark period for Annovis, one in which we took decisive steps toward bringing buntanetap to patients," said Maria Maccecchini, Ph.D., Founder and CEO of Annovis. "We initiated our pivotal Phase 3 AD study and later launched an OLE PD study, both critical milestones on the path to an NDA submission. Throughout the year, we remained focused on designing, preparing, and executing these studies with the highest standards of rigor while maintaining our scientific presence through key conferences, meetings, and publications. Equally important, we also revealed new biomarker data on buntanetap from our ongoing analysis of the completed studies, reinforcing the drug's therapeutic potential."

Annovis Bio announced that an independent Data and Safety Monitoring Board, DSMB, has issued a positive recommendation regarding the safety of buntanetap at 6 months, supporting the continuation of the ongoing Phase 3 AD clinical trial without modification. Following a comprehensive evaluation, the DSMB concluded that no safety concerns were identified and recommended that the clinical trial continue as planned, without changes. Moreover, the 6-month safety data in Alzheimer's patients were consistent with those observed in Parkinson's patients at the same time point. Subsequent safety evaluations are planned at 12 and 18 months.