Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 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, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ Commission File Number: 000-29959 Filana Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 91-191 ...

Financial Performance - Net loss for 2025 was $91.0 million, or $1.88 per share, compared to a net loss of $24.3 million, or $0.53 per share in 2024[2] - Cash and cash equivalents were $95.5 million as of December 31, 2025, down from $128.6 million at the end of 2024[7] - The company estimates net cash use in operations for the first half of 2026 to be in a range from $14 to $17 million, plus a $31.25 million estimated loss contingency related to securities litigation[3] Expenses - Research and development expenses decreased to $26.6 million in 2025, a 62% reduction from $69.6 million in 2024[8] - General and administrative expenses decreased to $68.8 million in 2025, down 4% from $71.8 million in 2024[8] - The total operating expenses for 2025 were $95.4 million, compared to $141.4 million in 2024[20] Future Plans - The company plans to submit a response to the FDA regarding the clinical hold on its TSC-related epilepsy program as soon as practicable[4] - The company is focused on developing novel medicines to modulate the filamin A protein for CNS disorders, including TSC-related epilepsy[7] Share Information - Total shares outstanding as of March 9, 2026, were 48.3 million[7] - The company estimates cash at June 30, 2026, to be in a range from $47 to $50 million[3]

New corporate identity reflects the Company’s mission to develop novel medicines to modulate filamin A and address unmet needs in treating TSC-related epilepsy Filana Therapeutics to begin trading under “FLNA” effective March 11, 2026 AUSTIN, Texas, March 10, 2026 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (NASDAQ: SAVA) today announced the rebranding of the Company, with a name change to Filana Therapeutics, Inc. (“Filana Therapeutics”, or the “Company”). The new name and corporate brand reflect the Compa ...

Core Viewpoint - The U.S. Department of Justice has concluded its investigation into Cassava Sciences regarding allegations of research misconduct related to its Alzheimer's drug simufilam [1] Company Summary - Cassava Sciences announced the end of the DOJ probe, which focused on allegations concerning the integrity of research conducted for simufilam [1]

Core Viewpoint - Cassava Sciences, Inc. has resolved investigations by the U.S. Department of Justice and the U.S. Securities and Exchange Commission regarding allegations of research misconduct and negligence-based disclosure charges, allowing the company to refocus on its development of treatments for CNS disorders [1][2][3] Group 1: Investigations and Resolutions - The U.S. Department of Justice closed its inquiry into Cassava Sciences regarding allegations of research misconduct, with the related indictment dismissed with prejudice on October 23, 2025 [1] - The company reached a settlement with the U.S. Securities and Exchange Commission in September 2024, paying a monetary penalty without admitting or denying the allegations [2] - Both investigations have concluded, allowing the company to move forward without these legal concerns [2] Group 2: Company Focus and Future Plans - Cassava Sciences remains committed to maintaining stakeholder trust and will continue to focus on developing novel treatments for TSC-related epilepsy [3] - The company is engaged in developing investigational treatments, including simufilam, for CNS disorders [4]

Core Insights - The studies RETHINK-ALZ and REFOCUS-ALZ did not meet their pre-specified co-primary, secondary, or exploratory biomarker endpoints, but exploratory post-hoc analyses provided informative insights regarding the treatment effects of simufilam in specific patient subgroups [1][2][5] Study Overview - RETHINK-ALZ (NCT04994483) randomized 804 participants, while REFOCUS-ALZ (NCT05026177) included 1,125 patients, both focusing on mild to moderate Alzheimer's disease [3][9] - The trials were multi-center, double-blinded, placebo-controlled studies designed to evaluate the safety and efficacy of simufilam compared to placebo [9] Safety and Efficacy Findings - Simufilam demonstrated a favorable safety profile in the studies, with detailed safety observations reported [1][4] - In the predefined mild subgroup (MMSE score 21-27), simufilam (100 mg) was associated with slower cognitive decline compared to placebo at various weeks, with nominal significance at p = 0.01, 0.01, 0.02, 0.02, and 0.02 for Weeks 4, 28, 40, 52, and 64 respectively [5][6] Exploratory Analyses - Exploratory findings indicated potential treatment differences in the mild subgroup, with a prespecified pooled analysis showing nominal significance at p < 0.01 for Weeks 4 and 28 [5][6] - A post hoc analysis using a plasma p-tau181 cutoff of ≥ 67 showed significant differences in cognitive decline at Weeks 4, 28, and 40 (p = 0.03, 0.001, 0.006 respectively) [6] Future Directions - The company has discontinued the development of simufilam for Alzheimer's disease but aims to leverage the safety observations for ongoing development in TSC-related epilepsy [3][4][8] - Cassava Sciences plans to initiate a proof-of-concept study for simufilam in TSC-related epilepsy, collaborating with leading investigators [4][12]

Core Viewpoint - Halper Sadeh LLC is investigating potential breaches of fiduciary duties by certain officers and directors of Cassava Sciences, Inc. which may affect shareholder rights [1] Group 1: Legal Actions and Shareholder Rights - Long-term shareholders of Cassava may seek corporate governance reforms, return of funds, court-approved financial incentives, or other benefits [2] - Shareholder involvement is crucial for improving company policies and enhancing shareholder value through better oversight [3] Group 2: Firm's Background and Services - Halper Sadeh LLC represents global investors affected by securities fraud and corporate misconduct, recovering millions for defrauded investors [4]

Core Viewpoint - Cassava Sciences, Inc. has reached a definitive agreement to settle a consolidated securities class action litigation for $31.25 million, allowing the company to focus on the development of its investigational treatment simufilam for TSC-related epilepsy [1][2][3] Financial Settlement - The settlement amount of $31.25 million will resolve all claims from plaintiffs who purchased or acquired the company's common stock or options between September 14, 2020, and October 12, 2023 [2] - The company fully reserved this loss contingency in the second quarter of 2025 [3] Company Focus and Product Development - Cassava is dedicated to the continued development of simufilam, a proprietary investigational oral small molecule aimed at treating TSC-related epilepsy [3][5] - The company is planning a Phase 2 proof-of-concept study for simufilam in collaboration with the TSC Alliance and key opinion leaders, based on a treatment patent issued in 2025 [5]

Core Viewpoint - Cassava Sciences Inc. is facing a full clinical hold from the FDA regarding its trial for simufilam, impacting its timeline for initiating a proof-of-concept clinical trial for TSC-related epilepsy [1][2]. Group 1: FDA Communication - The FDA has formally communicated that Cassava must provide additional information, including pre-clinical data, and modify the trial protocol design [2]. - The company confirmed the full clinical hold on its investigational new drug application for simufilam [1]. Group 2: Clinical Trial Timeline - Cassava no longer expects to initiate the proof-of-concept clinical trial for simufilam in TSC-related epilepsy in the first half of 2026, as previously planned [2]. - The updated timing for the clinical trial initiation will depend on the company's ability to provide the requested information and the satisfactory completion of the FDA's review [3]. Group 3: Financial Position - As of September 30, 2025, the company reported $106.1 million in cash and cash equivalents, which is expected to support operations into 2027 [3]. Group 4: Previous Study Results - In March, Cassava shared topline results from the Phase 3 REFOCUS-ALZ study of simufilam in mild-to-moderate Alzheimer's disease, which did not meet the prespecified co-primary, secondary, and exploratory biomarker endpoints [4]. - Following these results, the company has discontinued the development of simufilam for Alzheimer's disease [4]. Group 5: Market Reaction - Following the news, Cassava Sciences shares fell by 25.26%, trading at $2.13 at the time of publication [5].

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential investment opportunities before the market opens [1] Premarket Gainers - WhiteFiber, Inc. (WYFI) is up 21% at $17.35 [3] - Rising Dragon Acquisition Corp. (RDAC) is up 21% at $12.63 [3] - Julong Holding Limited (JLHL) is up 13% at $3.45 [3] - Linkhome Holdings Inc. (LHAI) is up 11% at $12.50 [3] - A SPAC III Acquisition Corp. (ASPC) is up 9% at $13.09 [3] - Intuitive Machines, Inc. (LUNR) is up 7% at $11.61 [3] - Ascent Solar Technologies, Inc. (ASTI) is up 7% at $3.31 [3] - Bitmine Immersion Technologies, Inc. (BMNR) is up 6% at $30.39 [3] - Velo3D, Inc. (VELO) is up 5% at $12.10 [3] - Gain Therapeutics, Inc. (GANX) is up 4% at $2.36 [3] Premarket Losers - cbdMD, Inc. (YCBD) is down 17% at $1.60 [4] - Mega Fortune Company Limited (MGRT) is down 16% at $7.33 [4] - Cassava Sciences, Inc. (SAVA) is down 14% at $2.43 [4] - NIKE, Inc. (NKE) is down 10% at $59.01 [4] - InMed Pharmaceuticals Inc. (INM) is down 6% at $1.21 [4] - Datacentrex, Inc. (DTCX) is down 5% at $3.23 [4] - Abundia Global Impact Group Inc (AGIG) is down 5% at $1.50 [4] - PSQ Holdings, Inc. (PSQH) is down 5% at $1.00 [4] - Paranovus Entertainment Technology Ltd. (PAVS) is down 4% at $2.34 [4] - Worksport Ltd. (WKSP) is down 4% at $2.09 [4]