Annovis Bio (ANVS) investor relations material

Clinical program progress and milestones

• Pivotal phase III Alzheimer's trial is fully enrolled, with last patient visit for the six-month study set for December and top-line data to be presented in March at ADPD.

• Open label extensions are ongoing for Parkinson's and planned for Alzheimer's, focusing on long-term safety and efficacy.

• Over 1,600 patients have been treated across 13 completed studies, with two large ongoing studies expected to bring the total to 1,700-1,800 patients by NDA filing.

• Stringent inclusion criteria and biomarker-based selection have improved study quality and reduced dropout rates to 8%.

• NDA filing is planned to begin in May 2027, with disease modification data to be added in April 2028.

Financial status and funding plans

• Current cash position is $19 million, but additional $15 million is needed before April-May to continue operations.

• Cash burn rate peaked during heavy screening periods but will decrease slightly; ongoing costs remain significant due to continuous patient monitoring.

• Management and insiders, including the chairman and CEO, plan to participate in the upcoming capital raise.

• Philanthropic funding is not sufficient to cover the high costs of clinical trials; strategic partnerships are not expected until disease-modifying data is available.

Regulatory and commercialization strategy

• NDA submission will follow the six-month efficacy readout, with most modules prepared in advance for rapid filing.

• FDA-required endpoints and independent data review processes are in place to ensure regulatory compliance.

• EMA filings for both Alzheimer's and Parkinson's are planned for later in the year, with ongoing discussions with EU regulatory consultants.

• Commercialization is targeted after the 18-month disease modification data, with a streamlined NDA supplement process expected to shorten approval timelines.