The inflammatory mediator peroxynitrite, when generated in excess, may damage cells by oxidizing and nitrating cellular components. Defense against this reactive species may be at the level of prevention of the formation of peroxynitrite, at the level of interception, or at the levelRetired history instructor. Alzheimer's disease researcher for the past two decades.My goal is to give investors solid advice based on the mechanisms of action of Alzheimer's drugs. This advice is informed by a background in bio ...

Financial Data and Key Metrics Changes - The company ended Q3 2024 with $149 million in cash, which is expected to be sufficient for operations through the conclusion of ongoing Phase 3 trials and into calendar 2026 [26] - The net loss for Q3 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 [28] - Research and development expenses for Q3 were $17.7 million, down from $23.6 million for the same period last year, indicating a decrease as more patients complete Phase 3 studies [29] - General and administrative expenses for Q3 were $12.9 million, significantly up from $4.3 million in the same quarter last year, primarily due to higher legal-related expenses and increased compensation costs [29] Business Line Data and Key Metrics Changes - The company is currently focused on the Phase 3 trial, RETHINK-ALZ, with database cleanup ongoing and top-line results expected before the end of the year [6][7] - Biomarker data from a subset of patients from the RETHINK study will be reported alongside cognition data, involving approximately 100 patients [8] Market Data and Key Metrics Changes - There are approximately 7 million patients currently diagnosed with Alzheimer's disease in the United States, with 1.2 million new diagnoses each year, but only about 55% of Alzheimer's patients are treated with an approved prescription drug [21][22] Company Strategy and Development Direction - The company is planning to significantly expand its manufacturing capabilities and is developing a commercial plan with the help of an experienced industry consultant [15] - The vision includes providing a treatment option that is superior to cholinesterase inhibitors and does not have the challenges posed by new monoclonal antibody-based drugs [19][20] - The company aims to transform the way Alzheimer's disease is diagnosed and treated, focusing on the primary care physician's role in patient care [24] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about the potential for simufilam to be a best-in-class treatment for Alzheimer's, but acknowledges the uncertainty until trial results are revealed [7] - The company is prepared for the challenges ahead and is committed to ensuring accurate reporting of trial results, regardless of the outcome [9][24] - The anticipated timeline for potential market entry of simufilam is late summer to early fall of 2026, contingent on successful trial results [48] Other Important Information - The company has $40 million of restricted cash held in escrow for a settlement with the SEC, which is still subject to court approval [26] - The statistical analysis plan for the Phase 3 trial has been submitted to the FDA and is locked down, with both primary endpoints needing to be met for trial success [38][39] Q&A Session Summary Question: Update on SavaDx status - Management indicated that while SavaDx will still be pursued, the focus may shift based on the results of the ongoing trials and resource allocation [34] Question: Detail on topline results regarding biomarkers - The company will measure p-tau217, NfL, GFAP, and total-tau, with results expected from baseline to last visit [35][36] Question: Confirmation of statistical analysis plan with FDA - The statistical analysis plan has been locked down with the FDA, requiring success on both primary endpoints for the trial to be deemed successful [38][39] Question: Potential market entry timeline for simufilam - The anticipated timeline for market entry is late summer to early fall of 2026, depending on trial outcomes [48] Question: Other indications for simufilam - Management mentioned a potential indication related to Tuberous Sclerosis, which could be pursued after the Phase 3 trials for Alzheimer's [49]

Financial Position - As of September 30, 2024, Cassava Sciences reported cash and cash equivalents of $149.0 million, expected to support operations into 2026[1] - Total assets increased to $223,753,000 in September 2024 from $151,663,000 in December 2023, representing a growth of approximately 47.4%[24] - Current liabilities rose significantly to $57,034,000 in September 2024 from $14,195,000 in December 2023, indicating an increase of about 301.5%[24] - Total stockholders' equity improved to $166,639,000 in September 2024 compared to $137,468,000 in December 2023, reflecting an increase of approximately 21.3%[25] - Cash and cash equivalents stood at $148,978,000 in September 2024, a substantial rise from $40,000,000 in December 2023[24] - The accumulated deficit decreased to $377,514,000 in September 2024 from $380,769,000 in December 2023, showing a reduction of about 0.6%[25] - Accounts payable and accrued expenses surged to $52,244,000 in September 2024 from $10,573,000 in December 2023, marking an increase of approximately 393.5%[24] - The company reported a total of $202,549,000 in current assets as of September 2024, up from $129,633,000 in December 2023, which is an increase of about 56.2%[24] - The total liabilities increased to $57,114,000 in September 2024 from $14,195,000 in December 2023, reflecting a growth of approximately 302.5%[25] Operational Performance - The net loss for Q3 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] - Research and development (R&D) expenses for Q3 2024 were $17.7 million, down from $23.6 million in Q3 2023, primarily due to the completion of patient screening and enrollment[13] - General and administrative (G&A) expenses increased significantly to $12.9 million in Q3 2024, compared to $4.3 million in Q3 2023, driven by higher legal expenses and increased compensation costs[14] - Net cash used in operations for the first nine months of 2024 was $55.7 million, with an expected range of $40 to $50 million for the second half of 2024[12] - The company plans to pay a $40 million SEC investigation settlement, which has been placed in escrow and excluded from cash and cash equivalents[12] Clinical Trials - Both Phase 3 studies, RETHINK-ALZ and REFOCUS-ALZ, are fully enrolled with approximately 1,900 patients randomized, including 800 in RETHINK-ALZ and 1,100 in REFOCUS-ALZ[5] - The Data and Safety Monitoring Board (DSMB) recommended that both Phase 3 studies continue as planned, with no modifications, following their September 2024 meeting[7] - Top-line data for the RETHINK-ALZ trial is expected to be reported before the end of 2024, with REFOCUS-ALZ data anticipated around mid-2025[9] - Approximately 88% of patients who completed treatment in the Phase 3 studies opted to enter the open-label extension study, totaling over 1,040 patients[10]

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 ...

Alzheimer's drug developer Cassava Sciences Inc SAVA, its founder Remi Barbier, and former Senior VP of Neuroscience Lindsay Burns have agreed to pay over $40 million to resolve SEC charges over misleading statements related to a Phase 2 trial of the company's controversial Alzheimer's drug, simufilam. The SEC also charged Hoau-Yan Wang, a consultant and co-developer of the drug, with manipulating trial results. The SEC's investigation found that in September 2020, Cassava disclosed manipulated data from th ...

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 ...