HC Wainwright Analyst Update today:
We believe simufilam's prospects for successful advancement
through Phase 3 study are strong. After recently conducting a 1x1
virtual meeting with Cassava Sciences management, we came away
confident in the company's ability to navigate controversy and advance simufilam through Phase 3 studies in Alzheimer’s disease (AD). Recall, simufilam is Cassava's oral drug candidate for proposed treatment ofmild-to-moderate AD. Specifically, the first Phase 3 Study (RETHINKALZ) (n = 500) of simufilam 100 mg and the second Phase 3 Study(REFOCUS-ALZ) of simufilam 100 mg and 50 mg both in mild-tomoderate Alzheimer’s disease are designed to evaluate the safety and efficacy of oral simufilam in enhancing cognition and slowing cognitive and functional decline over 52 weeks and 76 weeks, respectively.Notably, due to clinical trial site staffing issues, the Omicron COVID-19
variant has affected patient recruitment sites. However, based on health data from South Africa's Omicron peak, management is optimistic that in the long term, recruitment should not be affected much longer.Importantly, Cassava’s new clinical website supporting recruitment for Phase 3 studies is aiding in the screening of patients for the trial. Additionally, we learned that there is high interest in study participation
by AD patients, as well as high interest in neurologists that treat AD patients at clinical trial sites with an opportunity to enroll their AD patients into the company's Phase 3 studies. We look for further progress with Phase 3 study enrollment, as well as updates on the open-label and cognitive maintenance studies with simufilam as positive catalysts in 2022. We reiterate our Buy rating and PT of $124. With the shareshaving pulled back near levels seen prior to the announcement of 9-month ADAS-Cog results in July 2021, we believe Cassava stockrepresents an attractive value proposition.
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