Annovis Bio Targets March 2027 Alzheimer’s Readout, Prepares Rolling NDA

Key Points

• Annovis Bio expects six-month Phase III Alzheimer’s results in March 2027, with the final patient visit scheduled for Dec. 31, 2026. The trial will continue to 18 months, with a separate readout planned for March 2028 to assess potential disease-modifying effects of buntanetap.
• The company is preparing a rolling NDA that could begin in May 2027 if the six-month data meet pre-specified efficacy requirements, but it expects to raise about $15 million before year-end to fund operations into spring 2027.
• Annovis is also advancing a 36-month open-label Parkinson’s study, targeting enrollment completion by Dec. 26, 2026, while planning a future Parkinson’s disease dementia study contingent on funding.

Annovis Bio NYSE: ANVS said it expects to report top-line results from the six-month portion of its pivotal Phase III Alzheimer’s disease trial in March 2027, while preparing a rolling new drug application, or NDA, that management said could begin in May if the study meets its efficacy requirements.

Founder, President and Chief Executive Officer Dr. Maria Maccecchini said the company’s Alzheimer’s program is fully enrolled and that the last patient’s final six-month visit is scheduled for Dec. 31, 2026. The company plans to clean, lock and analyze the data before presenting results at the AD/PD conference in March 2027.

The study will continue through 18 months, with a separate top-line readout expected in March 2028. Maccecchini said the longer-term data are intended to evaluate whether buntanetap has disease-modifying effects.

Alzheimer’s Trial Design and Prior Findings

The Phase III Alzheimer’s trial uses ADAS-Cog 13 and ADCS-ADL as primary endpoints at both six and 18 months, according to Maccecchini. Patients were selected using cognitive testing, plasma p-tau217 testing and MRI assessments. The company said it is using p-tau217 rather than the p-tau217/total tau ratio used in an earlier study, following discussions with the FDA.

Maccecchini said the trial’s screening failure rate was 67% through July 2026, while the dropout rate was 8%. She said the company had recorded no drug-related serious adverse events. Annovis said it recruited 200 patients during 2025 and an additional 662 through the end of July 2026, and Maccecchini later cited enrollment of 860 patients.

She said earlier Alzheimer’s data did not show statistically significant cognitive improvement in the overall intent-to-treat population. However, Annovis identified a subgroup of p-tau217-positive patients receiving a 30-milligram dose that showed improvement in cognition and certain biomarker measures, according to the company. The current Phase III population was designed to more closely match that subgroup.

Maccecchini said the 18-month analysis will include volumetric MRI and p-tau217 as secondary endpoints, along with inflammatory and other biomarkers. Annovis also plans an open-label extension for participants completing the 18-month trial. She said the extension would primarily provide safety information for FDA purposes, while potentially offering the company additional observations on patients who switch from placebo to drug treatment.

NDA Preparation and Funding Needs

Maccecchini said Annovis has begun assembling NDA modules in advance of the Alzheimer’s readout. If the six-month data satisfy pre-specified efficacy requirements, she said no additional clinical step would be necessary before submitting an NDA. An independent team behind a firewall from Annovis, the clinical research organization and study investigators will access the blinded data and file the NDA, she said.

However, the company expects to require additional capital. Maccecchini said Annovis had approximately $19 million in the bank but later clarified that the existing cash would only last into the fourth quarter. She said the company needs to raise about $15 million before year-end to fund operations into April or May 2027.

Maccecchini estimated the company’s monthly cash burn at roughly $7 million to $9 million, though she said the figure could change as screening costs decline. She attributed elevated recent spending partly to screening more than 2,000 prospective participants for the Alzheimer’s study.

The CEO said she and Annovis’ chairman had committed to participate in a planned capital raise. She also said the company has not entered into meaningful partnership discussions because potential pharmaceutical partners are waiting for 18-month disease-modification data.

Parkinson’s Open-Label Program

Annovis is also conducting a 36-month open-label Parkinson’s disease study designed to allow prior participants to remain on buntanetap while gathering additional clinical and biomarker data. Maccecchini said the company expects to complete enrollment in the Parkinson’s open-label study by Dec. 26, 2026.

The Parkinson’s study includes movement and cognitive scales, inflammatory biomarkers, neurofilament light measurements, a NeuroRPM watch intended to measure movement, and alpha-synuclein skin biopsies. Maccecchini said Annovis chose skin biopsies because it believes they may provide a way to observe disease progression, unlike a cerebrospinal-fluid precipitation assay that she described as producing a yes-or-no result.

In a prior Phase III Parkinson’s study, Maccecchini said the intent-to-treat population did not meet its endpoint, but per-protocol analyses showed improvements across UPDRS measures. She also said post hoc analyses suggested cognitive benefits in participants with mild cognitive impairment and amyloid pathology.

Annovis plans a Parkinson’s disease dementia study when funding becomes available. The company is also beginning discussions with European regulatory consultants and patient organizations and intends to file information with the European Medicines Agency later in 2026 regarding its ongoing Alzheimer’s study and planned Parkinson’s disease dementia program.

Maccecchini said Annovis does not expect to commercialize buntanetap following the six-month Alzheimer’s readout. Instead, the company intends to use the initial NDA process to prepare for a potential later submission of 18-month data, which she said could shorten the subsequent review period if the application is otherwise complete.

About Annovis Bio (NYSE:ANVS)

Annovis Bio, Inc NYSE: ANVS is a clinical-stage biotechnology company headquartered in Tampa, Florida, focused on the discovery and development of small molecule therapeutics for neurodegenerative and neuroinflammatory disorders. Leveraging a proprietary platform that targets protein trafficking and translational dysregulation, Annovis aims to restore cellular homeostasis by modulating the production and clearance of disease-related proteins. The company's pipeline is designed to address critical pathways implicated in Alzheimer's disease, Parkinson's disease, multiple sclerosis and other central nervous system conditions.

The company's lead asset, ANVS401 (Posiphen®), is an oral small molecule that has been evaluated in Phase 1 and Phase 2 clinical trials to reduce levels of amyloid precursor protein and its toxic fragments in Alzheimer's patients.

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