Cassava Sciences Stock Price, News & Analysis

Austin-based Cassava Sciences, Inc. (Nasdaq: SAVA) has publicly addressed recent allegations regarding its Alzheimer's disease research, claiming these accusations are false. CEO Remi Barbier stated that the assertions about the company’s science being improbable or fraudulent are misleading. Cassava Sciences aims to defend its integrity and the interests of its stakeholders vigorously. The company has made its full statement available through an audio file and written transcript accessible online. Further details about their mission and developments can be found on their official website.

Cassava Sciences, Inc. (Nasdaq: SAVA) announced plasma p-tau analysis results from its Phase 2b clinical study on Alzheimer’s disease. The study's testing was conducted by Quanterix Corp., an independent laboratory, focusing on p-tau levels in plasma samples. CEO Remi Barbier emphasized data integrity, asserting that all testing was performed blind. Cassava Sciences has refuted allegations regarding scientific integrity made by a party holding a short position in its stock, insisting that claims are misleading and unfounded.

Cassava Sciences (Nasdaq: SAVA), a biotech firm focused on Alzheimer's disease, issued a response to recent online claims about its scientific integrity, labeling them as false and misleading. The company asserts that its biomarker data was independently generated and stands firm in the credibility of its research. Key clarifications include the accurate increase of plasma p-tau levels in a patient, the legitimacy of Western blot techniques, and FDA agreement on Phase 3 study protocols for simufilam. Cassava emphasizes the importance of distinguishing fact from fiction to uphold stakeholder trust.

Cassava Sciences announced the FDA's agreement under a Special Protocol Assessment (SPA) for its Phase 3 studies of simufilam in treating Alzheimer’s disease. This agreement validates the study protocols aimed at ensuring regulatory compliance and effective design. The company reaffirms its plan to initiate the Phase 3 program in Fall 2021. Two pivotal clinical studies will evaluate simufilam's safety and efficacy in subjects with mild-to-moderate Alzheimer's. CEO Remi Barbier emphasized that this milestone aligns the company with FDA requirements.

Cassava Sciences, focused on Alzheimer's disease, reported a net loss of $5.1 million for Q2 2021, translating to $0.13 per share, compared to a net loss of $1.1 million or $0.05 per share in Q2 2020. Cash and cash equivalents increased to $278.3 million as of June 30, 2021, with no debt. The expected cash usage for the full year is $20-25 million, driven by R&D and operational costs. R&D expenses surged to $3.9 million from $0.6 million year-over-year, reflecting a focus on clinical trial preparations.

Cassava Sciences, Inc. (Nasdaq: SAVA) will announce its financial results for Q2 2021 on August 3, 2021, before market opening. A conference call led by President & CEO Remi Barbier and CFO Eric Schoen will follow at 9 a.m. ET to discuss the results and growth strategy. Alzheimer's disease affects nearly 50 million people globally, with costs exceeding $1 trillion annually. The company is committed to developing innovative solutions for neurodegenerative conditions. Investors can access the event via the company’s website.

Cassava Sciences announced significant improvements in biomarkers for Alzheimer’s patients after 6 months of treatment with its investigational drug, simufilam. The study, involving 25 patients, showed a reduction in key biomarkers: total tau decreased by 38% and phosphorylated tau by 18% (both p<0.00001). Neurodegeneration markers neurogranin and NfL dropped by 72% and 55%, respectively (both p<0.00001). These biomarker improvements correlate with cognitive enhancements, supporting the drug's potential as a durable treatment.

Cassava Sciences (Nasdaq: SAVA) reported promising interim results from an open-label study of its investigational drug, simufilam, for Alzheimer's treatment. At 9 months, patients showed a significant cognitive improvement of 3.0 points on the ADAS-Cog scale (p<0.001), alongside notable biomarker enhancements. Importantly, over 50% of participants experienced no behavioral disorders, and no safety concerns were raised. The study, funded by NIH, involved 50 patients with mild-to-moderate Alzheimer's. Findings suggest simufilam has potential long-term benefits, warranting further Phase 3 trials set to commence in Fall 2021.

Cassava Sciences (Nasdaq: SAVA) announced positive clinical results from its SavaDx diagnostic in detecting Alzheimer’s disease. In a Phase 2b trial, treatment with simufilam significantly reduced plasma levels of altered filamin A by 48% (p=0.003) for 100 mg and 44% (p=0.02) for 50 mg doses. Additionally, p-tau181 levels decreased by 17% (p=0.01) and 15% (p=0.02) respectively. These findings suggest effective target engagement by simufilam. A poster presentation of these results was made at the Alzheimer’s Association International Conference (AAIC).