Annovis Bio Reports Significant Progress in Phase 3 Alzheimer's Trial and Strengthens Intellectual Property Position

Annovis Bio Inc. (NYSE: ANVS), a late-stage clinical drug platform company developing therapies for neurodegenerative diseases, reported substantial progress in its third quarter 2025 operations, highlighted by the complete activation of all 84 clinical sites in its pivotal Phase 3 Alzheimer's study (NCT06709014). The company has maintained steady patient enrollment across the United States as it advances toward completion of this critical trial, which represents a significant milestone in the development pathway for buntanetap, the company's lead investigational drug candidate.

The company also announced compelling biomarker data from its Phase 2/3 Alzheimer's trial demonstrating strong reductions in both inflammation and neurodegeneration markers. These findings provide important scientific validation of buntanetap's disease-modifying potential, suggesting the drug may address fundamental pathological processes in Alzheimer's disease rather than merely treating symptoms. The biomarker results offer promising indications that buntanetap could represent a meaningful advancement in the treatment landscape for Alzheimer's patients, who currently face limited therapeutic options.

Annovis Bio has strengthened its intellectual property position by transferring all patents related to the new crystal form of buntanetap, securing protection through 2046. This extended IP protection provides substantial commercial security and enhances the long-term value proposition of the drug candidate. The company has also published supportive pharmacokinetic data that further characterizes buntanetap's profile and supports its continued clinical development. Additional corporate developments include the appointment of veteran finance executive Mark Guerin as Chief Financial Officer, bringing extensive financial management experience to the leadership team during this pivotal period.

Maria Maccecchini, Ph.D., president and CEO of Annovis Bio, stated that every element is now aligned as the company moves toward its data readouts, which represent the final step before submitting a New Drug Application to regulatory authorities. The convergence of clinical progress, supportive biomarker data, strengthened intellectual property, and enhanced corporate leadership positions Annovis Bio for potential regulatory milestones in the coming periods. For additional information about the company's developments, visit https://www.annovisbio.com.

The progress reported by Annovis Bio carries significant implications for the neurodegenerative disease treatment landscape and the millions of patients and families affected by Alzheimer's disease worldwide. Successful development of buntanetap could address substantial unmet medical needs in a therapeutic area where effective disease-modifying treatments remain limited. The company's advancements also demonstrate the continued evolution of Alzheimer's research toward targeting underlying disease mechanisms rather than symptomatic approaches alone.