[Business Update](index=1&type=section&id=Business%20Update) Cassava pivots to TSC-related epilepsy with simufilam, discontinues Alzheimer's program, and reduces workforce - The company aims to initiate the first clinical study for simufilam in TSC-related epilepsy in **H1 2026**[3](index=3&type=chunk) - The Alzheimer's disease program with simufilam will be completely discontinued by end of **Q2 2025** after Phase 3 study failures[6](index=6&type=chunk) [Portfolio Highlights](index=1&type=section&id=Portfolio%20Highlights) Portfolio focuses on simufilam for TSC-related epilepsy, with H1 2026 clinical trials planned, following Alzheimer's program termination - **Simufilam** is being developed for Tuberous Sclerosis Complex (TSC)-related epilepsy, with clinical trials planned to start in **H1 2026**[3](index=3&type=chunk)[6](index=6&type=chunk) - The Alzheimer's disease program is being completely discontinued by **end of Q2 2025** due to Phase 3 study failures[6](index=6&type=chunk) - A license agreement for TSC program intellectual property was established with Yale University in **February 2025**[3](index=3&type=chunk)[6](index=6&type=chunk) [Corporate Highlights](index=1&type=section&id=Corporate%20Highlights) Cassava appointed new SVPs for neuroscience and clinical development, and reduced its workforce by 33% through a cost curtailment program - Appointed **Dr. Angélique Bordey** as SVP, Neuroscience, and **Dr. Jack Moore** as SVP, Clinical Development, to advance the new TSC program[3](index=3&type=chunk)[6](index=6&type=chunk) - Implemented a cost curtailment program, reducing the workforce by **10 employees** (approximately **33%**) in Q1[6](index=6&type=chunk) - **Dr. James W. Kupiec** retired as Chief Medical Officer, effective **May 9, 2025**[6](index=6&type=chunk) [Financial Results for First Quarter 2025](index=1&type=section&id=Financial%20Results%20for%20First%20Quarter%202025) Cassava reported a Q1 2025 net loss of **$23.4 million**, contrasting with Q1 2024 net income, while maintaining **$117.3 million** cash and no debt Key Financial Metrics (in millions) | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | **Net Income (Loss)** | **($23.4M)** | **$25.0M** | **-$48.4M** | | R&D Expenses | $13.7M | $16.2M | -16% | | G&A Expenses | $10.9M | $3.7M | +195% | | Cash & Cash Equivalents | $117.3M | - | - | | Net Cash Used in Operations | $11.3M | - | - | - The company ended Q1 2025 with **$117.3 million** in cash and cash equivalents and no debt[1](index=1&type=chunk)[10](index=10&type=chunk) - The increase in G&A expenses was primarily driven by a **$3.0 million** estimated loss accrual for legal-related expenses[10](index=10&type=chunk) [Condensed Consolidated Statements of Operations](index=3&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) For Q1 2025, Cassava reported no revenue, an operating loss of **$24.6 million**, and a net loss of **$23.4 million** or **($0.48) per share**, contrasting with Q1 2024's net income Condensed Consolidated Statements of Operations (in thousands, except per share amounts) | (In thousands, except per share amounts) | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | **Operating Expenses** | | | | Research and development | $13,666 | $16,233 | | General and administrative | $10,920 | $3,701 | | **Total operating expenses** | **$24,586** | **$19,934** | | **Operating loss** | **($24,586)** | **($19,934)** | | Gain from change in fair value of warrant liabilities | $— | $43,041 | | **Net income (loss)** | **($23,403)** | **$25,043** | | **Net income (loss) per share, basic** | **($0.48)** | **$0.58** | [Condensed Consolidated Balance Sheets](index=3&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) As of March 31, 2025, Cassava's total assets were **$140.9 million**, decreasing from **$157.5 million** at year-end 2024, with liabilities at **$13.3 million** and equity at **$127.6 million** Condensed Consolidated Balance Sheets (in thousands) | (In thousands) | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $117,328 | $128,574 | | **Total assets** | **$140,932** | **$157,533** | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $13,237 | $11,750 | | **Total liabilities** | **$13,316** | **$11,829** | | **Total stockholders' equity** | **$127,616** | **$145,704** | | **Total liabilities and stockholders' equity** | **$140,932** | **$157,533** |

Core Insights - Cassava Sciences, Inc. is advancing the development of simufilam for TSC-related epilepsy, with plans to initiate clinical trials in the first half of 2026 following necessary pre-clinical studies and regulatory strategy development [3][6] - The company reported a net loss of $23.4 million for Q1 2025, a significant decrease from a net income of $25.0 million in the same period in 2024, primarily due to the change in fair value of warrant liabilities [6][10] - As of March 31, 2025, Cassava had cash and cash equivalents of $117.3 million, with no debt, indicating a favorable balance sheet for future developments [6][19] Business Update - Cassava has entered a license agreement with Yale University for intellectual property rights related to potential treatments for rare diseases, including TSC-related epilepsy [3][6] - The company has appointed Dr. Angélique Bordey as SVP of Neuroscience and Dr. Jack Moore as SVP of Clinical Development to enhance its team for the new TSC-related epilepsy program [3][6] - The Alzheimer's disease program, which did not meet its co-primary endpoints in Phase 3 studies, will be completely discontinued by the end of Q2 2025 [6][10] Financial Performance - Total operating expenses for Q1 2025 were $24.6 million, compared to $19.9 million in Q1 2024, reflecting increased general and administrative expenses primarily due to legal-related costs [10][17] - Research and development expenses decreased by 16% to $13.7 million in Q1 2025, down from $16.2 million in the same period in 2024, due to the discontinuation of Alzheimer's clinical trials [10][17] - General and administrative expenses rose to $10.9 million in Q1 2025, compared to $3.7 million in Q1 2024, largely due to legal expenses and the absence of insurance recoveries [10][17]

Core Insights - Cassava Sciences, Inc. has appointed Dr. Angélique Bordey as Senior Vice President of Neuroscience to lead research and development efforts, particularly focusing on simufilam for TSC-related epilepsy and other potential indications [1][2][3] Company Overview - Cassava Sciences, Inc. is a clinical-stage biotechnology company that develops investigational treatments for central nervous system disorders, including simufilam for TSC-related epilepsy [7] - Simufilam is a proprietary oral small molecule targeting the filamin A protein [7] Leadership and Expertise - Dr. Bordey brings extensive experience as Vice Chair of the Department of Neurosurgery at Yale School of Medicine and has published over 125 research papers [5][6] - Her research has contributed to a recently granted patent for simufilam's use in treating TSC-related epilepsy, which has led to a licensing agreement with Yale University [3][4] Research Focus - Dr. Bordey will guide the preclinical program to evaluate simufilam as a treatment for TSC-related epilepsy, which is known to be challenging to manage [2][4] - The collaboration with the TSC Alliance and her leadership in the TSC community may facilitate productive study collaborations [3][4]

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].