Cassava Sciences(US:SAVA)2025-05-08 12:15Business Update 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 20263 - The Alzheimer's disease program with simufilam will be completely discontinued by end of Q2 2025 after Phase 3 study failures6 Portfolio Highlights 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 202636 - The Alzheimer's disease program is being completely discontinued by end of Q2 2025 due to Phase 3 study failures6 - A license agreement for TSC program intellectual property was established with Yale University in February 202536 Corporate Highlights 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 program36 - Implemented a cost curtailment program, reducing the workforce by 10 employees (approximately 33%) in Q16 - Dr. James W. Kupiec retired as Chief Medical Officer, effective May 9, 20256 Financial Results for First Quarter 2025 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 debt110 - The increase in G&A expenses was primarily driven by a $3.0 million estimated loss accrual for legal-related expenses10 Condensed Consolidated Statements of Operations 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 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 |