ANVS - Annovis: Strong Sell Reiteration Prior To Phase 3 Data In Parkinson's Disease

2024-06-30 11:48:25 ET

Summary

• Annovis Bio's only potential catalyst is the upcoming Phase 3 readout for Parkinson's disease.
• The company's changes to the primary endpoints of that trial, contrary to the FDA's wishes, cause concern.
• There is now more certainty that the Phase 2/3 trial in Alzheimer's disease failed to reach its primary endpoints.
• A recent CFO resignation, lack of funding and the company's wishes to conduct large further trials lead to a Strong Sell rating.

Thesis

These are pivotal times for Annovis Bio (ANVS). Since my last coverage on how the Phase 2 trial in Alzheimer’s disease ((AD)) had missed its primary endpoint, the company’s CFO has resigned, the company has released eight additional press releases, and its stock has been all over the place.

The only potential catalyst that Annovis still has is the Phase 3 readout for Parkinson’s disease ((PD)). The topline readout for this trial was announced for June 2024, although the trial had already ended in December of last year.

Annovis has changed the primary endpoints for that study, after having announced unblinding of the study, excluding the part on motor function which I believe to be the most essential. That change has not been communicated to investors, and more importantly, is not in line with what the FDA had requested....

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