ANVS - Annovis Bio: Alzheimer's Phase 2/3 Topline Readout Puts Future For Buntanetap Into Question

2024-05-02 00:19:50 ET

Summary

• Annovis reported topline data from a Phase 2/3 trial in Alzheimer's disease, but the trial was a failure.
• The exclusion of 37% of the patient population and the focus on mild AD patients were not pre-specified, raising concerns.
• Annovis faces financial challenges and may see a significant decline in stock prices.

Thesis

I have covered Annovis Bio (ANVS) before with a Hold rating in October 2023. At the time, Annovis had not yet released any topline readout from their Phase 3 trial in Parkinson's and their Phase 2/3 trial in Alzheimer's.

The Phase 2/3 results in Alzheimer's have just been released. The press release, at first glance, looked like the trial was a success, although I believe should have stated that the trial failed to reach both primary endpoints in the tested patients. The trial enrolled mild and moderate AD patients. I deduct from the press release that moderate patients' cognition did not outperform placebo, and most certainly not in a statistically significant manner. Otherwise, the company would have stated so much.

The company has excluded 37% of the patients, in a footnote, without previously alerting investors that it would do so. The company has also made a distinction between mild and moderate AD patients, although that distinction had not been prespecified....

For further details see: