Annovis Bio (ANVS) Status Update summary

Clinical program progress

• Pivotal phase III Alzheimer's trial is underway, targeting 760 patients with 52 sites open and 220 patients screened so far; full enrollment is expected by year-end, with a six-month data readout in fall and 18-month data in summer 2027.

• The trial uses MMSE, pTau217, volumetric MRI, and multiple biomarkers to assess both symptomatic and disease-modifying effects.

• Early data show significant cognitive improvement over placebo in both Alzheimer's and Parkinson's patients, with robust efficacy across subgroups and a strong safety profile, including in APOE4 carriers.

• Open-label extension studies are planned for both Alzheimer's and Parkinson's programs, pending funding and regulatory approval.

• Recruitment is challenged by an eight-week screening process and a 38% screen failure rate, but this is lower than comparable trials.

Regulatory and funding status

• NDA filing for symptomatic Alzheimer's is targeted for fall 2027, with disease-modifying claims potentially in fall 2028, depending on data and FDA review timelines.

• Regulatory submission may begin while the 18-month trial is ongoing, subject to FDA guidance.

• Parkinson's pivotal studies and open-label extensions are ready to proceed but are delayed due to funding constraints; $10 million is needed for open-label and $70 million for a full pivotal study.

• Efforts to secure funding include outreach to government, investment firms, and pharmaceutical companies, but large pharma interest is contingent on more definitive data.

Scientific and competitive positioning

• The investigational drug targets multiple neurotoxic proteins, potentially offering broader efficacy than current drugs that focus on single targets like amyloid plaques.

• Biomarker and imaging strategies are designed to demonstrate both symptomatic improvement and disease modification, with volumetric MRI and plasma markers as key endpoints.

• The drug has shown improvement in cognition and nerve cell health in both animal and human studies, with ongoing efforts to expand biomarker validation.

• The company is optimistic about replicating prior positive results in the ongoing phase III trial, with a high probability of success for the six-month endpoint.