Core Insights - Cassava Sciences shares are experiencing a significant decline, dropping 80% in premarket trading after the failure of its experimental drug Simufilam in a late-stage trial for Alzheimer's disease [2][7] - The drug did not demonstrate a significant reduction in cognitive or functional decline in patients with mild-to-moderate Alzheimer's, which is the most common cause of dementia [2][4] - The company plans to discontinue another late-stage study and an open-label study of Simufilam following the trial's failure [5] Company Actions - CEO Rick Barry expressed disappointment regarding the trial results, highlighting the impact on patients and families seeking new treatment options [3] - The company had previously agreed to a $40 million settlement with the SEC over allegations of manipulating clinical trial data related to Simufilam [6] Market Impact - The sharp decline in share price has reduced the year-to-date gain for Cassava Sciences to approximately 18% [7]

Core Viewpoint - Cassava Sciences Inc. experienced a significant decline in stock price following the release of disappointing topline data from the Phase 3 ReThink-ALZ study of simufilam for mild-to-moderate Alzheimer's disease [1][8]. Study Results - The Phase 3 ReThink-ALZ trial did not meet the pre-specified co-primary, secondary, and exploratory biomarker endpoints, which included changes in cognition and function assessed by ADAS-COG12 and ADCS-ADL scales [2]. - Despite the disappointing results, simufilam maintained an overall favorable safety profile [3]. Impact on Future Trials - The failed results from the ReThink-ALZ trial have led the company to discontinue its second Phase 3 trial, ReFocus-ALZ, as well as the Open Label Extension study [4]. Data Review and Future Plans - The complete 52-week dataset, along with a significant portion of the 76-week data, will be reviewed, and the company plans to share detailed results at a future medical meeting [5]. Regulatory Issues - Cassava Sciences has faced scrutiny for allegedly fabricating data from simufilam drug trials, resulting in a settlement of over $40 million with the SEC regarding misleading statements related to a Phase 2 trial [6]. - The SEC's investigation revealed that manipulated data was disclosed in September 2020, falsely indicating significant improvements in Alzheimer's biomarkers [7].

Core Insights - Simufilam did not demonstrate a significant reduction in cognitive or functional decline compared to placebo in patients with mild-to-moderate Alzheimer's disease in the ReThink-ALZ Phase 3 study [1][2] - The company plans to present the data at an upcoming medical meeting and will hold a webcast to discuss the results [1][7] - The overall safety profile of Simufilam remains favorable despite the study results [1][4] Study Details - The ReThink-ALZ trial involved 804 participants with mild or moderate Alzheimer's disease, randomized to receive either Simufilam 100 mg or a placebo for 52 weeks [8] - Co-primary endpoints included changes in cognition and function assessed by ADAS-COG12 and ADCS-ADL scales, with no statistical significance observed [3][9] - The loss of cognition in the placebo group was less pronounced than in previous studies, prompting further investigation [2] Safety and Demographics - The safety data indicated that 71.2% of Simufilam participants experienced any adverse event, compared to 67.6% in the placebo group [5][6] - The demographic data showed a mean age of 73.7 years for the Simufilam group and 74.3 years for the placebo group, with a balanced gender distribution [5][6] Future Plans - The company has decided to discontinue the ReFocus-ALZ trial and the Open Label Extension study due to the results of the ReThink-ALZ study [2] - Detailed analyses of both studies will be reported in the future [2][7] - Cassava Sciences remains focused on enhancing shareholder value and is well-capitalized with approximately $149 million in cash as of the end of Q3 2024 [7]

Core Viewpoint - Cassava Sciences, Inc. is set to hold a conference call and webcast to discuss developments related to its Alzheimer's disease treatment on November 25, 2024 [1][2]. Company Overview - Cassava Sciences is a clinical-stage biotechnology company based in Austin, Texas, focused on detecting and treating neurodegenerative diseases, particularly Alzheimer's disease [3]. - The company owns exclusive, worldwide rights to its investigational product candidates and related technologies, including Simufilam, without royalty obligations to any third party [4]. Product Information - Simufilam is an investigational oral small molecule drug candidate currently being evaluated in two Phase 3 clinical trials for the potential treatment of Alzheimer's disease [4].

Ms. Nassif brings an extensive track record of successfully developing commercial strategies for multiple FDA-approved drugs Appointment initiates Cassava’s commercial readiness strategy as the Company prepares for first Phase 3 topline data readout before year end 2024 AUSTIN, Texas, Nov. 18, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (NASDAQ: SAVA), a clinical-stage biotechnology company focused on developing a novel treatment for Alzheimer’s disease, today announced the appointment of Freda Nassif a ...

The Medical group has plenty of great stocks, but investors should always be looking for companies that are outperforming their peers. Cassava Sciences, Inc. (SAVA) is a stock that can certainly grab the attention of many investors, but do its recent returns compare favorably to the sector as a whole? By taking a look at the stock's year-to-date performance in comparison to its Medical peers, we might be able to answer that question.Cassava Sciences, Inc. is one of 1024 companies in the Medical group. The M ...

Cassava Sciences, Inc. (SAVA) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #2 (Buy). An upward trend in earnings estimates -- one of the most powerful forces impacting stock prices -- has triggered this rating change.The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by the system.Indivi ...

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]