The company currently has two clinical-stage biopharmaceutical assets that are under development. This includes the company’s lead therapeutic product, simufilam, a novel treatment for Alzheimer’s disease (AD), and SavaDx, an investigational diagnostic product to detect the presence of AD from a blood sample.
Mid-Year Update on Simufilam
Last month, SAVA provided a mid-year update regarding the clinical development progress of simufilam.
In March last year, Cassava kicked off a long-term, open-label study to evaluate the efficacy of simufilam in patients with Alzheimer’s disease. This study is funded by a research grant awarded by the National Institutes of Health (NIH).
SAVA was able to complete the targeted enrollment of 150 patients for this study last month. The study’s two objectives include monitoring the “long-term safety and tolerability of simufilam 100 mg twice daily for 12 months or longer in patients with Alzheimer’s disease” and measuring cognitive changes on ADAS-Cog, a standard test of cognition in Alzheimer’s disease.
Meanwhile, the efficacy of SavaDx was examined “for its ability to detect treatment effects of simufilam versus placebo in a randomized, controlled study,” which was completed last year. This was a Phase 2b study, and included the enrollment of 64 patients with Alzheimer’s disease.
Funding for the Simufilam Phase 3 Clinical Program
SAVA plans to initiate a Phase 3 clinical program for simufilam in the second half of this year. As of March 31, the company had around $282 million in cash on its balance sheet. Cassava expects that this cash will support its simufilam clinical program.
In addition, the company revealed a research grant of $2.7 million that was awarded by NIH in May this year, which is likely to fund clinical readiness activities for the simufilam program. (See Cassava Sciences stock chart on TipRanks)
Presentation of Clinical Data for Simufilam and SavaDx
On July 21, the company announced that it will present two new clinical datasets for simufilam and SavaDx at the 2021 Alzheimer’s Association International Conference (AAIC), to be held virtually from July 26 through July 30.
The clinical data for simufilam will detail the results of “an interim analysis on safety and cognition for the first 50 patients with Alzheimer’s disease to complete 9 months of open-label treatment.” In the case of SavaDx, the new clinical data is likely to reveal the results of the Phase 2b study.
The news pushed the stock 29.5% higher on July 21.
Analyst Weighs In
On July 20, H.C. Wainwright analyst Vernon Bernardino told clients that he’s confident about the efficacy of simufilam after hosting management during a virtual meeting with investors. To this end, the analyst raised the price target from $97 to $124 (5.4% upside) and reiterated a Buy rating on the stock.
Bernardino notes that the presentation of the simufilam clinical data could be a “positive catalyst for the stock.”
The analyst added that “significant potential exists for simufilam to demonstrate that it can alter the course of cognitive decline and show what still may be possible in mild-to-moderate AD patients…”
According to the analyst, most of the biopharmaceutical companies focused on drug development for Alzheimer’s disease have analyzed the defects in the processes that control the production, accumulation and disposal of amyloid beta (Aβ) protein.
However, simufilam is different in that it targets filamin A (FLNA), “a scaffolding protein highly expressed in the brain and found in altered form in AD patients.”
Bernardino points out that simufilam targets this altered FLNA and restores this protein’s proper shape and function as well as slows down neurodegeneration. The analyst added, “We believe this is supported by ten-plus years of inhouse early discovery and development conducted by Cassava Sciences, which showed simufilam reduced amyloid deposits…”
Furthermore, the analyst highlights that other than simufilam, “no investigational drug has previously demonstrated positive direction in all of these outcomes, which we believe further supports our view that simufilam has potential to change the trajectory of cognitive decline in AD patients.”
Turning to the rest of the Street, consensus is that SAVA is a Strong Buy based on 4 Buys and 1 Hold. The average Cassava Sciences price target of $127 implies 8% upside potential to current levels.
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