Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 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: 001-41905 Cassava Sciences, Inc. (Exact name of registrant as specified in its charter) De ...

EXHIBIT 99.1 Cassava Reports Q2 2025 Financials Results and Provides Business Update AUSTIN, Texas, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (NASDAQ: SAVA, "Cassava", the "Company"), a biotechnology company focused on developing novel, investigational treatments for central nervous system (CNS) disorders such as Tuberous Sclerosis Complex (TSC)-related epilepsy, today reported financial results for the second quarter ended June 30, 2025 and provided a business update. Net loss was $44.2 mill ...

Core Viewpoint - Cassava Sciences, Inc. reported positive preclinical results for simufilam in treating tuberous sclerosis complex (TSC)-related epilepsy, indicating its potential as a novel treatment option [1][2][6] Company Summary - Cassava Sciences is a clinical-stage biotechnology company focused on developing treatments for central nervous system disorders, including TSC-related epilepsy [13] - Simufilam is a proprietary oral small molecule believed to modulate the activity of the filamin A protein, which is crucial for neuronal development [13] - The company plans to initiate a proof-of-concept study for simufilam in TSC-related epilepsy in the first half of 2026 [6][9] Research Findings - The study utilized the Tsc1 conditional knockout (CKO) mouse model, which is recognized for evaluating the effectiveness of therapeutics for TSC-related epilepsy [3][4] - Simufilam demonstrated a beneficial effect on seizure activity, showing a statistically significant correlation between the dose of simufilam and the number of seizures [4] - The results align with previous findings from Yale School of Medicine, reinforcing the potential of simufilam as a first-in-class treatment for TSC-related epilepsy [2][5] Industry Context - Tuberous sclerosis complex affects approximately 50,000 individuals in the US, with epilepsy being the most common condition associated with TSC [12] - Between 80% and 90% of TSC patients experience seizures, and two-thirds have refractory epilepsy, highlighting the urgent need for new treatment options [12] - Current therapies are not fully effective and can lead to serious adverse events, emphasizing the potential market opportunity for simufilam [12]

Core Insights - Cassava Sciences, Inc. presented promising preclinical data on simufilam, showing a significant reduction in seizure activity in a mouse model, which supports its potential as a treatment for Tuberous Sclerosis Complex (TSC)-related epilepsy [1][3][4] - The company plans to initiate human clinical studies in the first half of 2026 to further evaluate simufilam's efficacy in treating TSC-related epilepsy [2][3][10] Preclinical Data - Simufilam reduced seizure frequency by 60% in a mouse model compared to vehicle-treated mice, with significant results (p<0.0001) [7][9] - The effective dose in mice was 20 mg/kg/day, and no adverse effects were observed at doses up to 50 mg/kg/day in rats and 1250 mg/kg/day in mice [7] - The treatment also led to a higher rate of seizure freedom in mice, with 11 out of 32 simufilam-treated mice achieving seizure freedom compared to 3 out of 29 vehicle-treated mice (p=0.0343) [9] Clinical Safety Data - Data from two Phase 3 studies involving 1,929 patients with mild-to-moderate Alzheimer's disease demonstrated a favorable safety profile for simufilam [11][15] - Non-serious adverse events were typically mild and not considered related to simufilam, with no serious adverse events assessed as study-drug related [15] Background on TSC - Tuberous Sclerosis Complex (TSC) affects approximately 50,000 patients in the US, leading to lifelong epilepsy and severe neurological issues [3][12] - Current treatments for TSC-related epilepsy are often ineffective, with nearly two-thirds of patients not responding to antiepileptic drugs [13][14] Future Directions - Additional preclinical studies are planned in collaboration with the TSC Alliance to explore simufilam's mechanism of action and its potential for treating TSC-related epilepsy [10]

PART I. FINANCIAL INFORMATION [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The company reported a net loss of **$23.4 million** for Q1 2025, a significant shift from a net income of **$25.0 million** in Q1 2024, primarily due to a **$43.0 million** gain from warrant liabilities in the prior year Condensed Consolidated Balance Sheets Condensed Consolidated Balance Sheets (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $117,328 | $128,574 | | Total current assets | $120,151 | $136,532 | | Total assets | $140,932 | $157,533 | | **Liabilities & 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 | Condensed Consolidated Statements of Operations Condensed Consolidated Statements of Operations (in thousands, except per share data) | Metric | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | 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 loss per share, diluted | $(0.48) | $(0.43) | Condensed Consolidated Statements of Cash Flows Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(11,336) | $(19,127) | | Net cash used in investing activities | $— | $— | | Net cash provided by financing activities | $90 | $22,160 | | Net increase (decrease) in cash | $(11,246) | $3,033 | | Cash and cash equivalents at end of period | $117,328 | $124,169 | Notes to Condensed Consolidated Financial Statements - The company has a history of significant net losses, with an accumulated deficit of **$428.5 million** as of March 31, 2025. Management believes current working capital is sufficient to meet needs for at least the next 12 months[23](index=23&type=chunk) - On February 26, 2025, the company entered into an exclusive worldwide license agreement with Yale University for the development and commercialization of simufilam for Tuberous Sclerosis Complex (TSC)-related epilepsy. The agreement includes up to **$4.5 million** in milestone payments and tiered royalties[75](index=75&type=chunk) - The company is involved in multiple legal proceedings, including government investigations and securities class action lawsuits. It settled with the SEC in September 2024, paying a **$40 million** penalty. A reserve of **$3.0 million** has been accrued for potential litigation settlements[90](index=90&type=chunk)[92](index=92&type=chunk)[107](index=107&type=chunk) - In January 2024, the company distributed warrants which, through their redemption in May 2024, generated total gross proceeds of approximately **$126.3 million**[114](index=114&type=chunk) - In January 2025, the company implemented a workforce reduction of **10 employees** (**33%**), incurring approximately **$0.4 million** in one-time severance costs[120](index=120&type=chunk)[121](index=121&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the strategic pivot from Alzheimer's disease to Tuberous Sclerosis Complex (TSC)-related epilepsy following the failure of Phase 3 trials, with R&D expenses decreasing and G&A expenses rising due to legal costs Overview and Business Update - The company has discontinued its Alzheimer's disease development program for simufilam after two **Phase 3 studies** (RETHINK-ALZ and REFOCUS-ALZ) failed to meet their co-primary endpoints. The phase-out is expected to be complete by the end of Q2 2025[132](index=132&type=chunk)[151](index=151&type=chunk)[154](index=154&type=chunk) - The company is now focusing on developing simufilam for **Tuberous Sclerosis Complex (TSC)-related epilepsy**, supported by an exclusive license agreement with Yale University[132](index=132&type=chunk)[135](index=135&type=chunk)[145](index=145&type=chunk) - The company intends to conduct exploratory **preclinical studies** in collaboration with the Tuberous Sclerosis Alliance (TSCA) to assess simufilam's potential for TSC-related seizures before considering an IND application[144](index=144&type=chunk)[165](index=165&type=chunk) Results of Operations - Research and Development (R&D) expenses **decreased by 16%** to **$13.7 million** in Q1 2025 from **$16.2 million** in Q1 2024, primarily due to the discontinuation of Alzheimer's clinical trials[185](index=185&type=chunk) - General and Administrative (G&A) expenses **increased to $10.9 million** in Q1 2025 from **$3.7 million** in Q1 2024. The increase was driven by a **$3.0 million** estimated legal loss accrual and the absence of a **$3.0 million** insurance recovery that occurred in the prior-year period[189](index=189&type=chunk) - A **gain of $43.0 million** from the change in fair value of warrants was recognized in Q1 2024, which was the primary reason for the net income in that period. No such gain occurred in Q1 2025 as there were no warrants outstanding[192](index=192&type=chunk)[193](index=193&type=chunk) Liquidity and Capital Resources - As of March 31, 2025, the company had cash and cash equivalents of **$117.3 million**[196](index=196&type=chunk) - The company believes its current cash and cash equivalents will be **sufficient to fund operations for at least the next 12 months**[209](index=209&type=chunk) - Net cash used in operating activities was **$11.3 million** for the three months ended March 31, 2025, compared to **$19.1 million** in the same period of 2024[204](index=204&type=chunk)[205](index=205&type=chunk) - The 2024 warrant distribution generated total net proceeds of approximately **$123.6 million** after expenses and commissions[114](index=114&type=chunk)[201](index=201&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=44&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Cassava Sciences, Inc. is not required to provide quantitative and qualitative disclosures about market risk - The company is **not required to provide information on market risk** as it qualifies as a **smaller reporting company** under Regulation S-K[210](index=210&type=chunk) [Controls and Procedures](index=44&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of March 31, 2025 - The CEO and CFO concluded that the company's disclosure controls and procedures were **effective** as of March 31, 2025[211](index=211&type=chunk) - There were **no changes in internal control over financial reporting** during the quarter that materially affected, or are reasonably likely to materially affect, these controls[213](index=213&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=44&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in various legal proceedings, including government inquiries and shareholder lawsuits, with detailed information provided in Note 10 of the financial statements - The company is involved in **ongoing litigation, government inquiries, and investigations**. Detailed information is provided in Note 10 to the condensed consolidated financial statements[214](index=214&type=chunk) [Risk Factors](index=44&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2024 - **No material changes** in risk factors have occurred since the filing of the 2024 Annual Report on Form 10-K[215](index=215&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=46&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - **None**[217](index=217&type=chunk) [Defaults Upon Senior Securities](index=46&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - **None**[218](index=218&type=chunk) [Mine Safety Disclosures](index=46&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - **Not applicable**[219](index=219&type=chunk) [Other Information](index=46&type=section&id=Item%205.%20Other%20Information) During the quarter, no directors or officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement - **No directors or officers informed the company of the adoption or termination of a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement** during the quarter[220](index=220&type=chunk) [Exhibits](index=46&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including certifications by the CEO and CFO

[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, Inc. announces the retirement of Chief Medical Officer James W. Kupiec, MD, effective May 9, 2025, and the appointment of Jack Moore, PhD, as Senior Vice President of Clinical Development, effective April 28, 2025, to advance the clinical evaluation of simufilam for CNS disorders, including TSC-related epilepsy [1][3][8] Company Leadership Changes - James W. Kupiec, MD, retires after a notable career in Alzheimer's disease drug development, contributing to high-quality clinical trials at Cassava [2] - Jack Moore, PhD, brings extensive experience in CNS drug development and will focus on advancing simufilam in new indications [3][4] Clinical Development Focus - Dr. Moore will be responsible for the clinical evaluation of simufilam, targeting TSC-related epilepsy and exploring additional applications [3][5] - The company aims to identify potential clinical collaborators and study sites as part of its strategy for the TSC program [4] Background of Jack Moore - Jack Moore has a strong background in biopharmaceuticals, with experience in CNS and neurodegenerative diseases, having held leadership roles at major pharmaceutical companies [6] - He holds a PhD in Neuroscience and has a history of engaging with key opinion leaders and patient advocacy groups [7] Company Overview - Cassava Sciences, Inc. is a clinical-stage biotechnology company focused on developing investigational treatments for CNS disorders, including simufilam, which targets the filamin A protein [8]

Core Viewpoint - Cassava Sciences, Inc. (SAVA) has experienced a significant downtrend, with a 39.5% decline in stock price over the past four weeks, but it is now in oversold territory, suggesting a potential turnaround due to improved earnings expectations from analysts [1]. Group 1: Technical Indicators - The Relative Strength Index (RSI) is a key technical indicator used to identify oversold stocks, with a reading below 30 typically indicating oversold conditions [2]. - SAVA's current RSI reading is 24.25, indicating that the heavy selling pressure may be exhausting, which could lead to a price rebound [5]. Group 2: Fundamental Analysis - There is strong consensus among sell-side analysts regarding SAVA's earnings potential, with a reported 11.3% increase in the consensus EPS estimate over the last 30 days [7]. - An upward trend in earnings estimate revisions is generally associated with price appreciation in the near term, supporting the case for a potential turnaround for SAVA [7]. Group 3: Analyst Ratings - SAVA holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, indicating a strong potential for a near-term turnaround [8].