Core Insights - Cassava Sciences, Inc. is focused on developing simufilam as a treatment for Alzheimer's disease, with top-line results from its Phase 3 trial, RETHINK-ALZ, expected by the end of 2024 [1][2][9] Financial Overview - As of September 30, 2024, the company reported cash and cash equivalents of $149.0 million, which is expected to support operations into 2026 [1][11] - The net loss for the third quarter of 2024 was $27.9 million, or $0.58 per share, compared to a net loss of $25.7 million, or $0.61 per share, for the same period in 2023 [11][21] - Research and development expenses decreased to $17.7 million from $23.6 million in the same period last year, primarily due to the completion of patient screening and enrollment for the Phase 3 program [11][20] - General and administrative expenses increased significantly to $12.9 million from $4.3 million in the same period last year, driven by higher legal expenses and increased compensation costs [11][20] Clinical Trial Updates - The Phase 3 program includes two studies: RETHINK-ALZ and REFOCUS-ALZ, both fully enrolled with approximately 1,900 patients [4][5] - The RETHINK-ALZ study evaluates the safety and efficacy of simufilam 100 mg tablets administered twice daily over 52 weeks, while REFOCUS-ALZ assesses two doses (100 mg and 50 mg) over 76 weeks [4][5] - The Data and Safety Monitoring Board (DSMB) has recommended that both Phase 3 studies continue as planned without modification [7] Patient Enrollment and Completion - Approximately 800 patients are enrolled in RETHINK-ALZ and about 1,100 in REFOCUS-ALZ, with a dropout rate of 21% for RETHINK-ALZ and 25% for REFOCUS-ALZ [5][6] - The last patient visit for RETHINK-ALZ occurred recently, with around 635 patients completing the study, while over 550 have completed REFOCUS-ALZ [6] Future Plans - An open-label extension study is available for patients who completed the Phase 3 trials, with over 1,040 patients opting to enter this study [10] - The company plans to add cognition and plasma biomarker monitoring to the open-label extension trial to gather long-term data on simufilam's impact [10]

Group 1 - Cassava Sciences, Inc. will hold a conference call on November 7th at 8:30 a.m. Eastern Time [1] - The audio webcast of the conference call will be available on the company's website and can be replayed for 90 days [1] Group 2 - Cassava Sciences is a clinical-stage biotechnology company based in Austin, Texas, focused on detecting and treating neurodegenerative diseases, particularly Alzheimer's disease [2] - The company's drug candidate, Simufilam, is currently in Phase 3 clinical trials for Alzheimer's treatment and targets a specific site on filamin A [3] - Simufilam is believed to interrupt amyloid-β42 binding to receptors in the brain, potentially affecting the Alzheimer's disease process [3] - Cassava Sciences holds exclusive, worldwide rights to its investigational product candidates and related technologies without royalty obligations to third parties [3]

Cassava Sciences Today SAVA Cassava Sciences $26.52 -0.21 (-0.79%) 52-Week Range $8.79 ▼ $42.20 Price Target $111.50 Add to Watchlist Cassava Sciences Inc. NASDAQ: SAVA is a biotech developing treatments for Alzheimer's disease. The company has a lot of controversy over its lead drug, simufilam, which attempts to go further than alleviate symptoms but actually modify the underlying biology of the disease. While the concept sounds fascinating, the problems for the medical sector company lie in the credibilit ...

Cassava Sciences (SAVA) has agreed to pay a $40 million fine to settle charges from the U.S. Securities and Exchange Commission (SEC) over allegedly misleading statements about the results of its 2020 mid-stage study of simufilam for Alzheimer's disease. Despite settling, the company did not admit to or deny the SEC's allegations. The SEC also brought charges against two former senior executives, including founder and ex-CEO Remi Barbier and former senior vice president of Neuroscience, Dr. Lindsay Burns. T ...

Without admitting wrongdoing, the company put a regulatory controversy to rest, but this was expensive. Cassava Sciences (SAVA -10.62%) ended the week with a piece of dispiriting news. It's going to reach deep into its coffers to settle charges brought by the most important financial-markets regulator governing its affairs. Many investors had enough of the company and sold off its stock to the point where it lost nearly 11% of its value across the Friday trading session. That was a far steeper fall than the ...

Core Viewpoint - Cassava Sciences Inc and its executives have agreed to pay over $40 million to resolve SEC charges related to misleading statements about the efficacy of their Alzheimer's drug, simufilam, during a Phase 2 trial [1][4]. Group 1: SEC Investigation Findings - The SEC's investigation revealed that Cassava disclosed manipulated data in September 2020, which falsely indicated significant improvements in Alzheimer's biomarkers such as total tau and phosphorylated tau [2]. - Dr. Hoau-Yan Wang, a consultant and co-developer of the drug, was found to have manipulated trial results by selecting a subset of patients based on unblinded data, creating an illusion of efficacy [2][3]. - Cassava and its executives misled investors by promoting the drug's cognitive benefits while failing to disclose that the complete dataset showed no measurable cognitive improvement [3]. Group 2: Settlement Details - As part of the settlement, Cassava will pay $40 million, while founder Remi Barbier and former Senior VP Lindsay Burns will pay $175,000 and $85,000, respectively [4]. - Barbier and Burns will be banned from serving as officers or directors for three and five years, respectively [4]. - Dr. Wang agreed to cease future violations and pay a $50,000 fine without admitting or denying the charges [4]. Group 3: Company Updates - CEO Rick Barry indicated that the company is in the final stages of testing simufilam, emphasizing significant financial and emotional stakes [5]. - Cassava Sciences recently completed its third interim safety review for simufilam, with the Data and Safety Monitoring Board recommending that both Phase 3 trials continue without changes [5]. Group 4: Stock Performance - Following the news, SAVA stock experienced a decline of 10.90%, trading at $28.40 during the premarket session [6].

AUSTIN, Texas, Sept. 26, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. ("Cassava" or the "Company") (Nasdaq: SAVA), a biotechnology company focused on Alzheimer's disease, today announced that it has reached a settlement with the U.S. Securities and Exchange Commission ("SEC") of negligence-based disclosure charges that resolve a previously-disclosed SEC investigation into statements made by the Company pertaining to the results of its 2020 Phase 2b clinical trial of simufilam and related matters. Two for ...

Washington, D.C.--(Newsfile Corp. - September 26, 2024) - The Securities and Exchange Commission today announced Cassava Sciences, Inc., its founder and former CEO, Remi Barbier, and its former Senior Vice President of Neuroscience, Dr. Lindsay Burns, will pay more than $40 million to settle charges related to misleading statements made in September 2020 about the results of a Phase 2 clinical trial for the company's purported therapeutic for the treatment of Alzheimer's disease. In a related order, the SEC ...

An Independent Data and Safety Monitoring Board (DSMB) Recently Evaluated the Interim Patient Safety Database for Oral Simufilam in On-going Phase 3 Trials. The DSMB Recommended Both Phase 3 Trials Continue as Planned, Without Modification. Final Clinical Safety Data for Simufilam Are Expected at the Conclusion of the Phase 3 Program. AUSTIN, Texas, Sept. 24, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company focused on Alzheimer's disease, today announced the completion ...

Cassava Sciences Today SAVA Cassava Sciences $21.85 -4.17 (-16.03%) 52-Week Range $8.79 ▼ $42.20 Price Target $119.00 Add to Watchlist Cassava Sciences NASDAQ: SAVA has become a hot topic among traders and active market participants thanks to its recent surge in volatility, liquidity, and overall market performance. Over the past month, shares have climbed 133% and are now more than 190% above their 52-week low. With its recent spike and increasing volatility and popularity in the headlines, the question ar ...