Cassava Sciences(SAVA) - 2025 Q2 - Quarterly Results

Q2 2025 Financial Results and Business Update Overview Executive Summary of Q2 2025 Performance Cassava Sciences reported a $44.2 million net loss for Q2 2025, a significant shift from prior year net income, with $16.3 million net cash used in operations for H1 2025 Net Income (Loss) Comparison (in millions) | Period | Net Income (Loss) (in millions) | | :----- | :------------------------------ | | Q2 2025 | ($44.2) | | Q2 2024 | $6.2 | Net Cash Used in Operations (in millions) | Period | Net Cash Used in Operations (in millions) | | :----- | :---------------------------------------- | | H1 2025 | $16.3 | | H2 2025 (Expected) | $47 - $51 | Corporate Highlights The company advances simufilam for TSC-related epilepsy with positive preclinical data, strategic neuroscience appointments, and addresses securities litigation with a recorded loss contingency TSC-related Epilepsy Program Development - Simufilam is being advanced as a potential first-in-class treatment for TSC-related epilepsy, with positive preclinical results showing alleviation of neuronal abnormalities and a 60% reduction in seizure frequency in a mouse model[5][6][9] - A proof-of-concept clinical study for TSC-related epilepsy is planned for H1 2026, following positive preclinical data and a Yale University license agreement in February 2025[6][8][9] Key Neuroscience Appointments - Dr. Joseph Hulihan has been appointed as Chief Medical Officer (CMO) to advise on the clinical development of simufilam for TSC-related epilepsy[7] - Dr. Angélique Bordey joined as Senior Vice President (SVP), Neuroscience, and Dr. Jack Moore as SVP, Clinical Development, to guide the clinical development strategy[7][10] Financial Position and Litigation Update Cash and Cash Equivalents (in millions) | As of | Amount (in millions) | | :---- | :------------------- | | June 30, 2025 | $112.4 | | December 31, 2024 | $128.6 | - An estimated loss contingency of $31.25 million was recorded in Q2 2025 related to the potential settlement of certain securities litigation[3][8][15] Detailed Financial Results for Second Quarter 2025 Key Financial Metrics Cassava Sciences reported a Q2 2025 net loss of $44.2 million ($0.92 per share), a decline from Q2 2024 net income, with cash and cash equivalents at $112.4 million as of June 30, 2025 Net Income (Loss) and EPS (in millions, except per share amounts) | Metric | Q2 2025 | Q2 2024 | | :----- | :------ | :------ | | Net Income (Loss) (in millions) | ($44.2) | $6.2 | | EPS (Basic & Diluted) | ($0.92) | $0.13 | Cash and Cash Equivalents (in millions) | Date | Amount (in millions) | | :--- | :------------------- | | June 30, 2025 | $112.4 | | December 31, 2024 | $128.6 | Net Cash Used in Operations (in millions) | Period | Amount (in millions) | | :----- | :------------------- | | H1 2025 | $16.3 | | H2 2025 (Expected) | $47 - $51 | | Year-end 2025 (Estimated Cash) | $61 - $65 | - The Q2 2025 net loss included a $31.25 million estimated loss contingency for securities litigation and $4.6 million in non-cash stock-based compensation expense[15] - Net income in Q2 2024 was primarily driven by a non-cash gain from the change in fair value of warrant liabilities[15] Operating Expenses Analysis R&D expenses decreased by 66% due to Alzheimer's program completion, while G&A expenses fell 13%, influenced by varying litigation loss contingencies Research and Development (R&D) Expenses (in millions) | Period | Q2 2025 (in millions) | Q2 2024 (in millions) | Change (YoY) | | :----- | :-------------------- | :-------------------- | :----------- | | R&D Expenses | $5.1 | $15.2 | -66% | | Stock-based Compensation | $1.2 | $1.0 | +20% | - The 66% decrease in R&D expenses was primarily due to the phase-out and completion of the Alzheimer's disease development program in Q2 2025[15] General and Administrative (G&A) Expenses (in millions) | Period | Q2 2025 (in millions) | Q2 2024 (in millions) | Change (YoY) | | :----- | :-------------------- | :-------------------- | :----------- | | G&A Expenses | $40.3 | $46.2 | -13% | | Stock-based Compensation | $3.4 | $1.6 | +112.5% | | Legal-related Costs (Q2 2025) | ~$3.6 | N/A | N/A | - The 13% decrease in G&A expenses was mainly due to a $40.0 million SEC-related loss contingency recorded in 2024, compared to a $31.25 million securities litigation estimated loss contingency recorded in 2025[15] About Tuberous Sclerosis Complex (TSC) and TSC-related Epilepsy - Tuberous Sclerosis Complex (TSC) is a rare genetic disorder caused by mutations in TSC1 or TSC2 genes, affecting approximately 50,000 people in the US and involving multiple organs, including the brain, leading to severe manifestations like epileptic seizures[9][12][13] - Epilepsy is the most common medical condition in TSC patients, affecting 80-90%, with two-thirds experiencing refractory epilepsy. Current therapies are often not fully effective and are associated with serious adverse events[13] About Cassava Sciences, Inc. - Cassava Sciences, Inc. is a biotechnology company focused on developing novel, investigational treatments for central nervous system disorders, with a primary focus on simufilam for TSC-related epilepsy[14] - Simufilam is a proprietary, investigational oral small molecule believed to modulate the activity of the filamin A protein, which regulates diverse aspects of neuronal development[14] Financial Tables Condensed Consolidated Statements of Operations This table presents unaudited condensed consolidated statements of operations for Cassava Sciences for the three and six months ended June 30, 2025 and 2024 Condensed Consolidated Statements of Operations (unaudited, in thousands, except per share amounts) | Metric | 3 Months Ended June 30, 2025 (in thousands) | 3 Months Ended June 30, 2024 (in thousands) | 6 Months Ended June 30, 2025 (in thousands) | 6 Months Ended June 30, 2024 (in thousands) | | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | | Operating expenses | | | | | | Research and development | $5,116 | $15,198 | $18,782 | $31,431 | | General and administrative | $40,276 | $46,204 | $51,196 | $49,905 | | Total operating expenses | $45,392 | $61,402 | $69,978 | $81,336 | | Operating loss | ($45,392) | ($61,402) | ($69,97