Cassava Sciences (SAVA) recently suffered yet another setback, which raises concern regarding its prospects. Nonetheless, simufilam is being evaluated for the treatment of Tuberous sclerosis complex (TSC)-related epilepsy. The company also has an investigational diagnostic product candidate, SavaDx, in its portfolio. SavaDX is a novel biomarker assay being studied for the detection of Alzheimer's disease from a small blood sample. Last week, the company announced that the phase III study REFOCUS-ALZ on lead ...

Core Viewpoint - Cassava Sciences' lead drug candidate simufilam has failed to meet primary endpoints in two late-stage studies for Alzheimer's disease, leading to a significant drop in the company's stock price by 32.1% [1][2]. Company Summary - The phase III REFOCUS-ALZ study, which involved 1,125 patients with mild-to-moderate Alzheimer's disease, did not show a significant reduction in cognitive and functional decline compared to placebo over 76 weeks [2][3]. - The study also failed to meet any pre-specified secondary and exploratory biomarker endpoints, and the drug demonstrated an acceptable safety profile [2][3]. - Following the disappointing results, Cassava has decided to discontinue the REFOCUS-ALZ study and the open-label extension study [6]. Future Steps - Cassava plans to phase out its Alzheimer's disease program by the end of Q2 2025 and has initiated preclinical studies to explore simufilam's potential for treating tuberous sclerosis complex-related epilepsy [7]. - The company is also reducing its workforce by 33% in Q1 2025 as part of cost management efforts, which will incur a one-time cost of approximately $0.4 million [8]. Industry Context - Currently, there are two FDA-approved drugs for Alzheimer's disease: Leqembi and Kisunla, both targeting early symptomatic stages of the disease [9]. - These drugs work by reducing the accumulation of amyloid beta plaque in the brain, which is associated with cognitive decline in Alzheimer's patients [10].

Simufilam did not show a significant reduction in co-primary endpoints of cognitive or functional decline versus placebo in patients with mild-to-moderate Alzheimer’s diseaseSimufilam continued to demonstrate an overall favorable safety profileCassava’s Alzheimer’s disease development program with simufilam will be completely discontinued by the end of Q2 2025 AUSTIN, Texas, March 25, 2025 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (NASDAQ: SAVA, “Cassava”, the “Company”), a clinical-stage biotechnology com ...

Cassava Sciences, Inc. (SAVA) could be a solid addition to your portfolio given its recent upgrade 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 Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.Individual inve ...

Financial Performance and Expenses - Research and development expenses for the years ended December 31 were $69.6 million in 2024, $89.4 million in 2023, and $68.0 million in 2022, indicating a decrease of 22.1% from 2023 to 2024[130]. - The company has incurred significant net losses since inception and anticipates continuing to incur net losses for the foreseeable future[212]. - The company has not generated any revenue from product sales since its inception in 1998 and has no history of product approvals for commercial sale[224]. - The company expects to incur approximately $0.4 million in one-time costs related to the workforce reduction, primarily for severance payments, with the majority of costs expected to be incurred in Q1 2025[184]. - The company announced a workforce reduction of 10 employees, representing a 33% decrease, to align human capital resources with strategic goals following the discontinuation of ongoing clinical trials for Alzheimer's disease[183]. Product Development and Regulatory Challenges - The drug approval process requires substantial time and financial resources, with no guarantee of timely approvals for future product candidates[146]. - The company does not expect to have any approved product candidates in the near term[159]. - The FDA may conduct pre-approval inspections of manufacturing facilities to ensure compliance with cGMP requirements[158]. - The FDA may require post-market testing (Phase 4 testing) to ensure continued safety or effectiveness of the approved drug[162]. - The company may face challenges in obtaining regulatory approval for its product candidates, which is necessary for commercialization[227]. - The time required to obtain FDA approval is unpredictable and typically takes many years, which may significantly harm the company's business and growth prospects[289]. - The company has never obtained FDA approval for a diagnostic test and may not secure such approval in a timely manner or at all[264]. - The company has not completed long-term safety studies for its product candidate simufilam, which may affect its clinical development and regulatory approval[298]. - The company may face significant competition in the field of clinical laboratory testing, with competitors having greater financial and technical resources[265]. - The company faces significant competition in the central nervous system disorders field, with many competitors having greater financial resources and expertise[277]. Clinical Trials and Research - The topline results from the Phase 3 RETHINK-ALZ study of simufilam did not meet the pre-specified co-primary, secondary, and exploratory biomarker endpoints, leading to the discontinuation of the Phase 3 REFOCUS-ALZ study[223]. - Clinical studies may fail to demonstrate substantial evidence of safety and efficacy due to improper or inadequate study design or enrollment criteria[269]. - The first Phase 3 trial in Alzheimer's disease did not meet pre-specified endpoints, indicating potential challenges in future trials[234]. - Clinical studies may face substantial delays, which could increase costs and impair the ability to generate revenue[241]. - The company plans to conduct exploratory preclinical studies in collaboration with the TSCA to investigate simufilam's potential as a treatment for seizures in TSC[261]. Intellectual Property and Legal Issues - The company currently has no U.S. patents for SavaDx and believes it may only be protected by trade secrets and know-how, complicating enforcement of potential patent infringement claims[315]. - The legal framework for patent eligibility in the U.S. for diagnostic methods is complex and evolving, which may affect the company's ability to obtain effective patent protection for its investigational product candidate, SavaDx[315]. - The company may not be granted patent term extensions under the Hatch-Waxman Act, which could allow competitors to launch similar products after patent expiration, adversely affecting its business[318]. - The company relies on trade secrets and confidentiality agreements to protect its proprietary information, but these can be difficult to enforce and may be compromised[319]. - The patent prosecution process is expensive and complex, and the company may not be able to maintain all necessary patent applications effectively[323]. Management and Corporate Governance - The company appointed Richard J. Barry as President and CEO on September 6, 2024, following his role as Executive Chairman of the Board[192]. - Former CEO Remi Barbier is receiving severance compensation of $1.23 million over twelve months following his resignation[194]. - Dr. Lindsay Burns, former SVP of Neuroscience, is receiving severance compensation of $0.5 million in quarterly installments over twelve months following her separation from the company[198]. - The company is managing inquiries from U.S. government agencies related to its research and development activities[283]. - The company may face litigation or other proceedings that could adversely impact its financial condition and operating results[281]. Market and Competitive Landscape - The competitive factors for product candidates include efficacy, safety, convenience, price, and reimbursement availability[134]. - Approximately 90% to 95% of novel drug candidates under development by the biopharmaceutical industry have failed to achieve regulatory approval and subsequent commercialization[270]. - The potential market opportunities for the product candidate simufilam may be smaller than anticipated, affecting profitability[275]. - Acceptance and use of the drugs by physicians and patients are uncertain, which could impact revenue generation[244]. - If the company fails to identify and develop additional product candidates, its commercial opportunity will be limited[262]. Compliance and Regulatory Environment - The company is subject to various federal and state regulations, including the Clinical Laboratory Improvement Amendments (CLIA) and the Health Insurance Portability and Accountability Act (HIPAA), which impose strict compliance requirements[297]. - The company must comply with anti-kickback and fraud laws, which could expose it to criminal sanctions and civil penalties[311]. - Legislative changes, such as the Affordable Care Act, may impose additional costs and regulatory burdens that could negatively affect the company's profitability[308]. - The company is required to report certain payments and transfers of value to healthcare providers under the federal Physician Payments Sunshine Act[311]. - Regulatory authorities have substantial discretion in the approval process and may refuse to accept applications or require additional studies[274].

Core Viewpoint - Cassava Sciences, Inc. is a clinical-stage biotechnology company focused on developing investigational treatments for CNS disorders, including Alzheimer's disease and TSC-related seizures, and has reported its financial results for the year ended December 31, 2024, along with a business update [1][3]. Financial Results - As of December 31, 2024, the company had cash and cash equivalents of $128.6 million, with no debt [6]. - The net loss for 2024 was $24.3 million, or $0.53 per share, a significant decrease from a net loss of $97.2 million, or $2.32 per share, in 2023 [6]. - Net cash used in operations was $116.9 million in 2024, with an expected cash use of $16 to $20 million for the first half of 2025 [6]. - Research and development (R&D) expenses were $69.6 million in 2024, down from $89.4 million in 2023, primarily due to the completion of enrollment for the Phase 3 Alzheimer's disease clinical program [6]. - General and administrative (G&A) expenses increased to $71.8 million in 2024 from $16.5 million in 2023, largely due to a $40 million settlement with the SEC and increased stock-based compensation [6]. Clinical Trials and Developments - Cassava is preparing to report topline results from the now-discontinued REFOCUS-ALZ Phase 3 study of simufilam in Alzheimer's disease in late Q1/early Q2 2025 [2][5]. - The company has entered a licensing agreement with Yale University to explore simufilam's potential as a treatment for TSC-related seizures [2]. - The REFOCUS-ALZ trial involved approximately 1,125 participants and was designed to evaluate the safety and efficacy of simufilam compared to a placebo [7]. - The RETHINK-ALZ study, which did not meet its prespecified co-primary endpoints, involved 804 participants and was also a Phase 3 trial for simufilam [9][11]. Future Outlook - The company plans to evaluate the next steps for simufilam in Alzheimer's disease after reviewing the results from both the REFOCUS-ALZ and RETHINK-ALZ studies [2]. - Cassava intends to focus on TSC-related seizures, a condition affecting approximately 50,000 people in the U.S. and over one million worldwide [13].

Core Viewpoint - Cassava Sciences has entered into a licensing agreement with Yale University for intellectual property rights related to simufilam, aimed at treating seizures associated with rare neurodevelopmental disorders, particularly tuberous sclerosis complex (TSC) [1][3]. Group 1: Licensing Agreement - The agreement includes an exclusive license to US method of treatment patent (US 12,186,307) for simufilam [1][8]. - The licensed intellectual property is based on research conducted by Dr. Angélique Bordey and her team at Yale, which demonstrated that simufilam significantly reduced seizure frequency in an animal model [2][3]. Group 2: Research and Development - Cassava plans to conduct preclinical studies in collaboration with the TSC Alliance to further evaluate simufilam's potential as a treatment for TSC-related seizures [3]. - Simufilam is a proprietary investigational oral small molecule that targets the filamin A protein [4][9]. Group 3: Tuberous Sclerosis Complex (TSC) - TSC is a neurodevelopmental disorder caused by mutations in the mTOR pathway genes, leading to seizures in 80% to 90% of patients [5][6]. - Approximately two-thirds of TSC patients do not respond to current antiepileptic drugs, resulting in lifelong seizures and associated disabilities [6]. Group 4: Market Potential - TSC affects an estimated 1 in 6,000 live births, with around 50,000 individuals in the United States and over one million worldwide living with the condition [7].

Core Viewpoint - Rosen Law Firm is reminding investors who purchased Cassava Sciences, Inc. securities during the specified Class Period of the upcoming lead plaintiff deadline on February 10, 2025 [1]. Group 1: Class Action Details - Investors who bought Cassava securities between February 7, 2024, and November 24, 2024, may be eligible for compensation without any out-of-pocket fees through a contingency fee arrangement [2]. - A class action lawsuit has already been filed, and interested parties can join by contacting Rosen Law Firm [3][6]. - To serve as lead plaintiff, individuals must file a motion with the Court by February 10, 2025 [3]. Group 2: Law Firm Credentials - Rosen Law Firm specializes in securities class actions and has a strong track record, including the largest securities class action settlement against a Chinese company at the time [4]. - The firm has been ranked No. 1 for securities class action settlements in 2017 and has consistently ranked in the top 4 since 2013, recovering hundreds of millions for investors [4]. - In 2019, the firm secured over $438 million for investors, and its founding partner was recognized as a Titan of Plaintiffs' Bar by Law360 in 2020 [4]. Group 3: Case Background - The lawsuit alleges that Cassava Sciences misled investors regarding the reliability of information about its drug prospects and downplayed risks associated with its leading drug candidate, simufilam [5]. - It is claimed that Cassava's statements about simufilam's potential were misleading, as the drug was not capable of effectively treating Alzheimer's Disease, leading to investor damages when the truth was revealed [5].

Core Viewpoint - The Gross Law Firm is notifying shareholders of Cassava Sciences, Inc. regarding a class action lawsuit related to the company's drug candidate simufilam, which failed to meet key study endpoints, leading to a significant drop in stock price [1][2]. Group 1: Allegations and Impact - The allegations state that Cassava Sciences provided misleading information about simufilam's effectiveness in treating Alzheimer's Disease, expressing confidence that was not supported by clinical results [1]. - On November 25, 2024, Cassava announced that simufilam did not meet any of the primary, secondary, or exploratory endpoints in its Phase 3 "ReThink-ALZ" study, resulting in a dramatic stock price decline of approximately 83.76%, from $26.48 to $4.30 per share in one day [1]. Group 2: Class Action Details - Shareholders who purchased shares of SAVA between February 7, 2024, and November 24, 2024, are encouraged to register for the class action, with a deadline for lead plaintiff appointment set for February 10, 2025 [2]. - Registered shareholders will receive updates through a portfolio monitoring software regarding the status of the case, with no cost or obligation to participate [2]. Group 3: Law Firm's Mission - The Gross Law Firm aims to protect investors' rights against deceit and fraud, ensuring companies adhere to responsible business practices and good corporate citizenship [3].

Core Viewpoint - A securities class action lawsuit has been filed against Cassava Sciences, Inc. for allegedly making false and misleading statements regarding its drug simufilam and its effectiveness in treating Alzheimer's Disease during the specified Class Period from February 7, 2024, to November 24, 2024 [1][2]. Group 1: Lawsuit Details - The lawsuit is on behalf of investors who purchased or acquired Cassava securities during the Class Period [1]. - The lead plaintiff deadline for the lawsuit is February 10, 2025 [1]. - The complaint alleges that Cassava's drug simufilam was not capable of abating the progression of Alzheimer's Disease, which misrepresented the company's business and prospects [2]. Group 2: Legal Process - Investors may seek to be appointed as a lead plaintiff representative by the deadline or may choose to remain absent [3]. - The lead plaintiff will act on behalf of all class members and select counsel to represent the class [3]. Group 3: Firm Background - Kessler Topaz Meltzer & Check, LLP has a reputation for prosecuting class actions and has recovered billions for victims of corporate misconduct [4].