Cassava Sciences, Inc. - SAVA STOCK NEWS

Cassava Sciences (NASDAQ: SAVA) announced it will host a corporate update via conference call and webcast on Monday, November 25th at 8:00 AM ET. The biotechnology company, which focuses on developing novel Alzheimer's disease treatments, will make the webcast available through their website, with a replay accessible for 90 days following the event on the Company Presentations page.

Cassava Sciences (NASDAQ: SAVA) has appointed Freda Nassif as Chief Commercial Officer, effective immediately. Nassif, who brings extensive experience in developing commercial strategies for FDA-approved drugs, will report to President and CEO Rick Barry. This appointment comes as Cassava prepares for its first Phase 3 topline data readout for simufilam, their novel Alzheimer's disease treatment, expected before the end of 2024. The company views this strategic hire as important for potential product launch preparations, pending positive trial results and FDA approval.

Cassava Sciences reported Q3 2024 financial results and provided updates on its Phase 3 clinical program for simufilam in Alzheimer's disease. The company maintains $149.0 million in cash with no debt, reporting a net loss of $27.9 million ($0.58 per share). The RETHINK-ALZ Phase 3 trial has completed with approximately 635 patients, while REFOCUS-ALZ has over 550 completers. Top-line data for RETHINK-ALZ is expected before end of 2024, with REFOCUS-ALZ results anticipated mid-2025. About 88% of Phase 3 completers have entered the open-label extension study, which now includes over 1,040 patients.

Cassava Sciences (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer's disease, has announced it will hold a conference call and webcast on Thursday, November 7th, 2024, at 8:30 a.m. Eastern Time to report its third quarter 2024 results. The audio webcast will be accessible through the company's website and will remain available for replay for 90 days following the event.

Cassava Sciences, Inc. (Nasdaq: SAVA) has reached a settlement with the SEC to resolve a previously-disclosed investigation. The company agreed to pay a $40 million penalty for negligence-based disclosure charges related to its 2020 Phase 2b clinical trial of simufilam. Two former senior employees also settled charges. Cassava cooperated with the investigation and implemented remedial measures.

The company does not anticipate charges from the DOJ's Criminal Division. On July 17, 2024, Cassava appointed Richard Barry as Executive Chairman, who became CEO on September 6, 2024. The company remains focused on completing ongoing Phase 3 trials of simufilam for Alzheimer's disease.

Cassava's expected net cash use in operations for the second half of 2024 is $80 to $90 million, including the penalty. The company maintains its estimate of $117 to $127 million cash at year-end 2024.

Cassava Sciences (Nasdaq: SAVA) has announced the completion of a third interim safety review for simufilam in ongoing Phase 3 clinical trials for Alzheimer's disease. An independent Data and Safety Monitoring Board (DSMB) recommended that both Phase 3 studies continue without modification. The company's Chief Medical Officer expressed satisfaction with the safety review and anticipates announcing top-line efficacy, safety, and biomarker data for the 12-month Phase 3 study before the end of 2024.

The Phase 3 program consists of two fully enrolled trials with over 1,900 patients. The first trial (52-week treatment) expects top-line results by year-end 2024, while the second trial (76-week treatment) anticipates results around mid-year 2025. This news follows previous interim safety data suggesting simufilam is not associated with treatment-emergent amyloid-related imaging abnormalities (ARIA).

Cassava Sciences, Inc. (Nasdaq: SAVA) has named Richard (Rick) Barry as its new Chief Executive Officer. Barry, who has been a director since June 2021, was previously appointed Executive Chairman and principal executive officer in July 2024. In a move to separate the CEO and Chairman roles, Claude Nicaise, M.D. has been appointed as Chairman of the Board.

Dr. Nicaise brings extensive experience in clinical and regulatory leadership, having held senior positions at Alexion Pharmaceuticals and Bristol-Myers Squibb. The company is focused on developing treatments for Alzheimer's disease, with two ongoing Phase 3 trials for their drug simufilam. The first trial, involving 804 patients, is expected to report results by the end of 2024, while the second trial with 1,125 patients is anticipated to conclude by mid-2025.

Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer's disease, has been invited to present at the H.C. Wainwright 26th Annual Global Investment Conference in New York. Rick Barry, Cassava's Executive Chairman, will participate in a 'fireside chat' with Vernon T. Bernardino, PhD., Managing Director of Biotechnology Equity Research at H.C. Wainwright.

The event is scheduled for Monday, September 9th, from 3:00pm to 3:30pm Eastern Time. A live webcast will be available on Cassava Sciences' website, with an archived replay accessible for 90 days following the event. Registered institutional investors can request meetings with Cassava Sciences through the conference website.

Cassava Sciences (NASDAQ: SAVA) reported Q2 2024 financial results, showing $207.3 million in cash and cash equivalents as of June 30, 2024. The company recorded a net income of $6.2 million, compared to a net loss of $26.4 million in Q2 2023. Cassava is in advanced discussions to resolve an SEC investigation, with a $40 million estimated loss contingency recorded in Q2. The company's Phase 3 clinical program for Alzheimer's treatment is progressing, with both RETHINK-ALZ and REFOCUS-ALZ studies fully enrolled. Top-line data readout for the 52-week study is expected by end of 2024, and for the 76-week study by mid-2025. Cash use in the second half of 2024 is projected to be $80-90 million, including the SEC-related contingency.