Annovis Bio Inc (ANVS)

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The 8k reports

Annovis Bio, Inc. (NYSE: ANVS) (the “Company”) has received the interim analysis for sample size re-estimation for its Phase 3 clinical trial for the treatment of early Parkinson’s Disease (“PD”). This trial, which was initiated in August 2022, is a randomized, double-blind, placebo-controlled trial investigating the efficacy, safety, and tolerability of Buntanetap in patients with early PD.

The Phase 3 trial is designed to enroll 450 early PD patients, which are separated into three cohorts of 150 patients. Patients are randomly assigned to receive either 10 or 20 mg of Buntanetap or placebo once per day. The trial’s primary endpoints will be evaluated after patients have been treated for six months using the following measures: the MDS-Unified PD Rating Scale (MDS-UPDRS) Part II and III, which is a 42-item rating scale designed to assess PD-related disability and impairment, and evaluates activities of daily living and motor function; and safety and tolerability, which is assessed using physical examinations, vital signs, clinical laboratory test results, electrocardiogram findings, adverse events leading to study discontinuation, drug related adverse events, severity of adverse events and adverse events.

The Company has received the results of the pre-planned interim analysis conducted by a data analytics provider based on 132 patients from all cohorts collectively for which baseline and two-month data was available. As the interim analysis was conducted at two months of the six-month endpoint and only on 132 patients, it may not be indicative of the results at six months for the full patient population because as the trial progresses, clinical outcomes may materially change as patient enrollment continues and more patient data become available, or different conclusions or considerations may qualify such results once additional data have been received and fully evaluated. Based on the results of the interim analysis, the Company intends to proceed with the trial as planned in accordance with the previously established protocol. The Company remains blinded to the Phase 3 trial and does not have safety or efficacy data from the trial. A separate safety interim analysis is in process and the Company expects that interim analysis to be released in the second quarter of 2023.

With non-adaptive studies, the vast majority of time, DSMB reviews are followed by a recommendation to continue the study as planned. It would be surprising to stop a study in a neurodegenerative disease for either profound success or complete failure (treated would have to be worse than placebo). So there is no surprise. The SP reaction today may be due to a realization that the company has insufficient cash to complete the study as planned (not a reduced n) and still have enough cash to fund continuing operations and fund a reserve. They need a larger cushion of cash in this environment of higher rates and cautious investors. It would be unwise to allow cash to get too low and I suspect they will need to raise funds by the end of the year. Coupled with what is certain, now, to be a nonevent presentation, the price is going to be range bound. In retropspect, its easy to say that they should have raised more cash May-July 2021. I hold no current position, just an observation.