Sangamo Therapeutics(US:SGMO)2025-11-06 13:07Financial Performance - Revenues for the three months ended September 30, 2025, were $581,000, a decrease of $48.8 million (98.8%) compared to $49.4 million in 2024 [181]. - Revenues for the nine months ended September 30, 2025, were $25.3 million, down $24.9 million (50%) from $50.2 million in 2024 [181]. - A net loss of $85.5 million was reported, adjusted for non-cash expenses, with significant changes in liabilities and assets impacting cash flow [213]. Research and Development - The Phase 1/2 STAND study for ST-503, an investigational epigenetic regulator for chronic neuropathic pain, has commenced patient enrollment and recruitment [168]. - A positive mean annualized estimated glomerular filtration rate (eGFR) slope of 1.965 mL/min/1.73m²/year was observed across all 32 dosed patients in the registrational Phase 1/2 STAAR study for isaralgagene civaparvovec, a gene therapy for Fabry disease [168]. - The company expects research and development expenses to increase in the near term due to activities related to the Fabry disease program [189]. Liquidity and Capital Resources - As of September 30, 2025, the company's cash and cash equivalents, along with the $6.0 million from Pfizer and $9.1 million generated through its at-the-market offering program, are estimated to be sufficient to meet liquidity requirements only into the first quarter of 2026 [162]. - Cash and cash equivalents as of September 30, 2025, were $29.6 million, down from $41.9 million as of December 31, 2024 [200]. - The company has approximately $148.7 million remaining available under its Open Market Sale Agreement as of September 30, 2025 [201]. Operating Expenses - Research and development expenses for the three months ended September 30, 2025, were $28.1 million, an increase of $0.4 million (1%) compared to $27.7 million in 2024 [184]. - General and administrative expenses for the three months ended September 30, 2025, were $8.0 million, a decrease of $3.1 million (28%) from $11.0 million in 2024 [184]. - Total operating expenses for the nine months ended September 30, 2025, were $108.4 million, a decrease of $19.9 million (15%) compared to $128.2 million in 2024 [184]. Future Outlook and Concerns - The company has incurred significant losses and expects to continue doing so for at least the next several years as it continues its research and development activities [174]. - The company has substantial doubt about its ability to continue as a going concern for at least the next 12 months, primarily due to significant losses and dependence on additional financing [204]. - The company anticipates continuing to incur operating losses for several years and needs to raise substantial additional capital to fund operations and development [211]. Capital Raising Efforts - The company is actively seeking additional capital through strategic collaborations and other financing sources to support its operations and research [162]. - The company is engaged in discussions for a commercialization agreement for its Fabry disease program but has not yet secured a partner [204]. - The company may face challenges in raising additional capital due to macroeconomic conditions, including the ongoing conflict between Russia and Ukraine [206]. Compliance and Regulatory Matters - The company has been granted a 180-day extension until April 27, 2026, to regain compliance with the minimum bid price requirement on The Nasdaq Capital Market [161]. - The company is preparing for a Biologics License Application (BLA) submission for isaralgagene civaparvovec as early as the first quarter of 2026 [171]. - Future capital requirements could exceed hundreds of millions of dollars per product for regulatory approvals from the FDA [206].