Sangamo Therapeutics(SGMO) - 2025 Q2 - Quarterly Results

Sangamo Therapeutics Q2 2025 Earnings Release Sangamo Therapeutics reports significant Q2 2025 progress in its Fabry disease and neurology pipelines, alongside improved financial results driven by increased revenues and reduced net loss Business Highlights Sangamo Therapeutics announced significant progress across its pipeline in Q2 2025, including positive Fabry disease study results, new clinical site initiation for neuropathic pain, and productive discussions for its prion disease program, alongside a $21 million equity offering Corporate Updates The company successfully raised approximately $21 million in net proceeds from a recent equity offering - Raised approximately $21 million in net proceeds from an underwritten registered equity offering[5] Fabry Disease Program (isaralgagene civaparvovec / ST-920) Positive topline results from the STAAR study for Fabry disease gene therapy support an accelerated approval pathway with the FDA - Announced positive topline results from the registrational Phase 1/2 STAAR study for isaralgagene civaparvovec (ST-920) in adults with Fabry disease[1][6] Key Efficacy Endpoints from STAAR Study | Endpoint | Result | Follow-up Period | Patient Count | | :--- | :--- | :--- | :--- | | Mean Annualized eGFR Slope | +1.965 mL/min/1.73m²/year | 52 weeks | 32 | | Mean Annualized eGFR Slope | +1.747 mL/min/1.73m²/year | 104 weeks | 19 | | α-Gal A Activity | Maintained elevated expression | Up to 4.5 years | Longest treated patient | | Plasma lyso-Gb3 Levels | Remained generally stable | Post-ERT withdrawal | N/A | - The FDA has agreed that the positive mean annualized eGFR slope at 52 weeks will serve as the primary basis for a Biologics License Application (BLA) submission under the Accelerated Approval pathway, anticipated as early as Q1 2026[1][6][11] - The treatment demonstrated a favorable safety and tolerability profile without the need for preconditioning, with most adverse events being grade 1-2[11] Core Neurology Pipeline Sangamo initiated its first clinical site for chronic neuropathic pain and aligned on study design for its prion disease program - Chronic Neuropathic Pain (ST-503): The first clinical site has been initiated for the Phase 1/2 STAND study, with the first patient expected to be dosed in fall 2025 and preliminary efficacy data anticipated in Q4 2026[2][11] - Prion Disease (ST-506): Held a productive meeting with the UK's MHRA, aligning on study design, with a Clinical Trial Application (CTA) submission expected as early as mid-2026[2][11] Second Quarter 2025 Financial Results For Q2 2025, Sangamo reported significantly increased revenues to $18.3 million and a narrowed net loss, with cash and equivalents of $38.3 million expected to fund operations into Q4 2025 Key Financial Metrics Sangamo's Q2 2025 revenues significantly increased to $18.3 million, leading to a reduced net loss of $20.0 million Q2 2025 vs. Q2 2024 Performance | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Revenues | $18.3 million | $0.3 million | | Net Loss | ($20.0 million) | ($36.1 million) | | Net Loss per Share | ($0.08) | ($0.18) | - The $18.0 million increase in revenues was primarily attributable to an upfront license payment received under a capsid license agreement with Eli Lilly and Company[10] Operating Expenses GAAP operating expenses decreased in Q2 2025 due to strategic realignment, while non-GAAP expenses slightly increased Operating Expenses for Q2 (in millions) | Expense Type | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | GAAP Operating Expenses | $36.2 | $37.4 | | Non-GAAP Operating Expenses | $33.0 | $31.9 | - The decrease in GAAP operating expenses was mainly due to cost reductions from strategic realignment, including lower headcount and facilities costs, partially offset by increased expenses for BLA readiness activities for the Fabry disease program[13] Cash Position and Financial Guidance Sangamo's cash and equivalents of $38.3 million are projected to fund operations into Q4 2025, with full-year 2025 operating expense guidance reiterated - Cash and cash equivalents were $38.3 million as of June 30, 2025, sufficient to fund planned operations into the fourth quarter of 2025 with recent at-the-market offering proceeds[14] Reiterated Full-Year 2025 Financial Guidance | Metric | Expected Range (in millions) | | :--- | :--- | | GAAP Total Operating Expenses | $135 - $155 | | Non-GAAP Total Operating Expenses | $125 - $145 | Corporate Information and Events Sangamo Therapeutics will participate in two investor conferences in September 2025 and held a conference call on August 7, 2025, to provide updates - Sangamo plans to participate in the Cantor Global Healthcare Conference and the Wells Fargo Healthcare Conference from September 3-5, 2025[17][19] - The management team held a conference call on August 7, 2025, to discuss program and financial updates[18] Financial Statements The consolidated financial statements detail Sangamo's Q2 2025 performance, showing increased revenues, reduced net loss, and a cash position of $38.3 million Statement of Operations The Statement of Operations shows a significant increase in revenues and a reduction in net loss for both the three and six months ended June 30, 2025 Consolidated Statement of Operations Data (Unaudited, in thousands) | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | :--- | :--- | | | 2025 | 2024 | 2025 | 2024 | | Revenues | $18,306 | $356 | $24,743 | $837 | | Total operating expenses | $36,161 | $37,440 | $72,226 | $89,447 | | Loss from operations | ($17,855) | ($37,084) | ($47,483) | ($88,610) | | Net loss | ($19,986) | ($36,128) | ($50,583) | ($85,217) | | Net loss per share | ($0.08) | ($0.18) | ($0.21) | ($0.44) | Balance Sheet The Balance Sheet indicates total assets of $97.6 million and cash and cash equivalents of $38.3 million as of June 30, 2025 Selected Balance Sheet Data (Unaudited, in thousands) | | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $38,344 | $41,918 | | Total assets | $97,558 | $101,635 | | Total stockholders' equity | $19,602 | $22,770 | Disclosures This section outlines forward-looking statements regarding financial risks and clinical uncertainties, and explains the rationale for using non-GAAP financial measures - Forward-Looking Statements: Key risks highlighted include the company's lack of capital resources, the need for substantial additional funding to continue as a going concern, the uncertain R&D process, and the unpredictable regulatory approval process[23] - Non-GAAP Financial Measures: The company presents non-GAAP operating expenses, which exclude items like depreciation, stock-based compensation, and impairment charges, to provide what it believes is a more meaningful comparison of its operational performance over time[25]