Workflow
Cassava Sciences(SAVA)
icon
Search documents
Cassava Sciences(SAVA) - 2024 Q4 - Annual Report
2025-03-03 21:20
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification Number) 6801 N. Capital of Texas Highway, Building 1; Suite 300, Austin, TX 78731 Form 10-K (Mark One) ☑ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ...
Cassava Sciences(SAVA) - 2024 Q4 - Annual Results
2025-03-03 12:40
Financial Position - Unaudited cash and cash equivalents balance as of December 31, 2024 was approximately $128.6 million[4] Workforce Reduction - The company reduced its workforce by 10 employees, a reduction of 33%[7] - Estimated one-time costs of approximately $0.4 million related to severance payments for the workforce reduction[8] - Workforce reduction expected to be completed, and associated costs incurred, during the first quarter of 2025[8] Clinical Trials and Study Results - Phase 3 ReThink-ALZ study of simufilam in mild-to-moderate Alzheimer's disease did not meet prespecified co-primary endpoints[6] - The company decided to discontinue its Phase 3 ReFocus-ALZ study and its open-label extension study[6] - The company plans to share detailed study results at a future medical meeting[10] Forward-Looking Statements and Risks - Forward-looking statements include risks related to clinical study timelines, unexpected costs, and drug development uncertainties[11] Regulatory and Reporting - The company's press release dated January 7, 2025, is attached as Exhibit 99.1[12] - The report is signed by Eric J. Schoen, Chief Financial Officer, on January 7, 2025[15]
Cassava Sciences Reports 2024 Financial Results and Provides Business Update
Newsfilter· 2025-03-03 12:30
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].
Cassava Sciences Licenses Simufilam Method of Treatment Patent
Globenewswire· 2025-02-27 12:00
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].
SAVA Deadline Today: SAVA Investors Have Opportunity to Lead Cassava Sciences, Inc. Securities Fraud Lawsuit
Prnewswire· 2025-02-10 20:59
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].
Cassava Sciences, Inc. Securities Fraud Class Action Lawsuit Pending: Contact The Gross Law Firm Before February 10, 2025 to Discuss Your Rights - SAVA
Prnewswire· 2025-02-10 10:45
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].
Lead Plaintiff Deadline on February 10, 2025 for SAVA Investors - Kessler Topaz Meltzer & Check, LLP Encourages Investors with Losses to Contact the Firm
Prnewswire· 2025-02-09 15:45
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].
Shareholders that lost money on Cassava Sciences, Inc.(SAVA) Urged to Join Class Action - Contact Levi & Korsinsky to Learn More
Prnewswire· 2025-02-07 10:45
Core Viewpoint - A class action securities lawsuit has been filed against Cassava Sciences, Inc. due to alleged securities fraud related to its drug candidate simufilam, which failed to meet clinical trial endpoints, leading to significant stock price decline [1][2]. Group 1: Lawsuit Details - The lawsuit aims to recover losses for investors affected by alleged securities fraud between February 7, 2024, and November 24, 2024 [1]. - Defendants allegedly provided misleading information regarding simufilam's efficacy in treating Alzheimer's Disease, expressing confidence that was not substantiated by trial results [2]. - Following the release of disappointing Phase 3 study results on November 25, 2024, Cassava's stock plummeted from $26.48 to $4.30, a drop of approximately 83.76% in one day [2]. Group 2: Next Steps for Investors - Investors who suffered losses during the specified timeframe have until February 10, 2025, to request appointment as lead plaintiff, although participation in recovery does not require this role [3]. - Class members may be eligible for compensation without incurring any out-of-pocket costs or fees [3]. Group 3: Firm Background - Levi & Korsinsky, LLP has a strong track record in securities litigation, having secured hundreds of millions for shareholders over the past 20 years [4]. - The firm has been recognized as one of the top securities litigation firms in the United States for seven consecutive years [4].
Cassava Sciences, Inc. Sued for Securities Law Violations - Investors Should Contact The Gross Law Firm for More Information - SAVA
Prnewswire· 2025-02-06 10:45
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 clinical trial endpoints, leading to a significant stock price decline [1][2]. Group 1: Allegations and Impact - Shareholders who purchased shares of Cassava Sciences (SAVA) between February 7, 2024, and November 24, 2024, are encouraged to contact the Gross Law Firm for potential lead plaintiff appointment [1]. - The complaint alleges that the defendants provided misleading information about simufilam's efficacy in treating Alzheimer's Disease, expressing confidence that was not substantiated by trial results [1]. - Following the release of disappointing Phase 3 study results on November 25, 2024, Cassava's stock plummeted from $26.48 to $4.30 per share, a decline of approximately 83.76% in one day [1]. Group 2: Next Steps for Shareholders - The deadline for shareholders to register for the class action is February 10, 2025, and they will be enrolled in a portfolio monitoring system for updates on the case [2]. - Participation in the case does not incur any costs or obligations for shareholders [2]. Group 3: Firm's Commitment - The Gross Law Firm is recognized for its commitment to protecting investors' rights against deceit and fraud, aiming to hold companies accountable for misleading practices that inflate stock prices [3].
SAVA Deadline: SAVA Investors Have Opportunity to Lead Cassava Sciences, Inc. Securities Fraud Lawsuit
Prnewswire· 2025-02-05 17:48
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 for a class action lawsuit [1][3]. 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 must move the Court to serve as lead plaintiff by February 10, 2025 [3]. - The lawsuit alleges that Cassava Sciences misrepresented the reliability of information regarding its drug prospects and downplayed risks associated with its leading drug candidate, simufilam [5]. Group 2: Legal Representation - The Rosen Law Firm emphasizes the importance of selecting qualified legal counsel with a proven track record in securities class actions, highlighting its own success in recovering significant amounts for investors [4]. - The firm has been recognized for its achievements in securities class action settlements, including a notable settlement against a Chinese company and ranking highly in the number of settlements since 2013 [4]. Group 3: Case Background - The lawsuit claims that Cassava Sciences created a false impression of confidence in simufilam's potential to treat Alzheimer's Disease, despite lacking evidence to support such claims [5]. - When the true nature of the drug's efficacy became known, investors reportedly suffered damages as a result of the misleading information [5].