Cassava Sciences Stock Price, News & Analysis

Cassava Sciences, Inc. (Nasdaq: SAVA) announced its financial results for 2021, reporting a net loss of $32.4 million ($0.82 per share), up from $6.3 million ($0.24 per share) in 2020. The firm has $233.4 million in cash, anticipating expenses of $25 to $35 million in H1 2022. In the second half of 2021, Cassava initiated two Phase 3 studies for its Alzheimer’s drug simufilam, aiming to enroll over 1,700 patients across North America. Research and development expenses surged to $24.8 million due to clinical trial costs, reflecting its commitment to tackling Alzheimer’s disease.

Cassava Sciences (Nasdaq: SAVA) announced the FDA's denial of multiple Citizen Petitions regarding allegations against the company. The petitions, filed by an attorney for short-selling clients, were dismissed, confirming the company's stance that the claims are false. Cassava is advancing its lead drug, simufilam, into Phase 3 clinical trials for Alzheimer’s, which are under Special Protocol Assessments by the FDA. Both trials are currently enrolling patients, marking significant progress in their Alzheimer's disease research.

Cassava Sciences announced the launch of Rethink-ALZ.com, a new clinical website aimed at enhancing visibility and information for participants in its Phase 3 studies of simufilam, an oral treatment for Alzheimer’s disease.

The site connects patients to nearby clinical sites and includes a pre-qualification questionnaire for potential participants. The Phase 3 studies, now active at over 25 clinical sites, aim to assess the efficacy of simufilam in approximately 1,750 patients across the U.S., Canada, and beyond.

Cassava Sciences (Nasdaq: SAVA) announced that the Neuroscience journal found no evidence of data manipulation in a 2005 article authored by the company. This clearance comes from an independent third party and reinforces the company’s stance against false allegations of scientific misconduct. Previously, the Journal of Neuroscience also cleared Cassava of similar accusations. The company continues testing its lead drug candidate, simufilam, for Alzheimer’s disease in Phase 3 clinical studies. Cassava emphasizes the importance of integrity in scientific research.

Cassava Sciences has initiated a second Phase 3 study of simufilam, its investigational drug for Alzheimer’s disease. This study, REFOCUS-ALZ, aims to evaluate the safety and efficacy of simufilam in about 1,000 patients over 78 weeks across the U.S. and Canada. Conducted under a Special Protocol Assessment from the FDA, the trial is a response to the growing need for effective Alzheimer’s treatments. Simufilam aims to restore the normal function of altered proteins in the brain, addressing underlying Alzheimer's pathology.

Cassava Sciences, Inc. (SAVA) reported a net loss of $9.6 million, or $0.24 per share, for Q3 2021, significantly widening from a loss of $1.4 million, or $0.06 per share, in Q3 2020. Total cash and equivalents rose to $241.5 million from $93.5 million at year-end 2020. The company anticipates full-year operational cash use will be $25 to $30 million, up from prior estimates, driven by prepayments for its Phase 3 clinical program on simufilam. R&D costs surged to $8.0 million due to clinical trial preparations, while G&A expenses increased to $1.7 million, attributed to legal fees and depreciation.

Cassava Sciences has confirmed there is no evidence of data manipulation in a 2012 study regarding Alzheimer's treatment, as stated by the Journal of Neuroscience. This study supports the development of simufilam, their lead drug candidate. A duplicated figure was identified, but it did not affect the study's conclusions. The company continues its focus on a Phase 3 clinical program for simufilam. Additionally, a second Citizen Petition requesting FDA approval for simufilam has been submitted, although no engagement has occurred from the FDA.

Cassava Sciences (SAVA) has initiated its first Phase 3 study for simufilam, an investigational drug targeting Alzheimer’s disease. This study, named RETHINK-ALZ, will assess the safety and efficacy of simufilam over 52 weeks in approximately 750 patients. A second Phase 3 study, REFOCUS-ALZ, is expected to start by year-end, evaluating the drug over 78 weeks with around 1,000 patients. Both studies have received Special Protocol Assessments from the FDA, confirming their design features. The company's commitment to transparency and ethical standards in research is emphasized.

Cassava Sciences (Nasdaq: SAVA) announced top-line results from a 12-month interim analysis of its open-label study with simufilam, showing an average improvement of 3.2 points in ADAS-Cog scores (p<0.001). Conducted with funding from the NIH, 68% of participants improved significantly, while over 50% exhibited no neuropsychiatric symptoms by month 12. The FDA's Special Protocol Assessment for the upcoming Phase 3 program remains on track for Q4 2021. No serious adverse events related to the drug were reported, highlighting its safety profile.