Silence Therapeutics PLC(SLN) - 2025 Q2 - Quarterly Results

Executive Summary Silence Therapeutics reported positive Phase 1 data for divesiran in Polycythemia Vera, with the SANRECO Phase 2 trial on track, and maintained a strong financial position with $114.2 million in cash, extending its runway into 2028 Q2 2025 Business and Strategic Highlights The second quarter of 2025 was marked by positive updated Phase 1 data for divesiran in Polycythemia Vera, reinforcing its therapeutic potential. The SANRECO Phase 2 trial remains a top priority, progressing towards full enrollment by year-end 2025 - Presented updated SANRECO Phase 1 data at EHA 2025, further supporting divesiran's potential as a first-in-class siRNA in PV[1][2] - The SANRECO Phase 2 study for divesiran is on-track for complete enrollment by year-end 2025 and remains the company's top priority[1][2] Q2 2025 Financial Overview Silence Therapeutics maintained a strong financial position, ending Q2 2025 with approximately $114.2 million in cash and cash equivalents and short-term investments, which is expected to fund operational plans into 2028 | Metric | Value (as of June 30, 2025) | | :----- | :-------------------------- | | Cash and cash equivalents and short-term investments | $114.2 million | | Cash runway guidance | Into 2028 | Business and R&D Updates The company advanced divesiran for Polycythemia Vera with positive Phase 1 data and ongoing Phase 2 enrollment, completed Phase 3 readiness for zerlasiran, and prioritized extra-hepatic siRNA targeting while pausing SLN548 development Divesiran for Polycythemia Vera (PV) Divesiran continues to show compelling therapeutic potential for Polycythemia Vera, with updated Phase 1 data demonstrating durable hematocrit control and improved iron deficiency. The Phase 2 SANRECO trial is progressing well, exceeding 50% enrollment and remaining on track for year-end completion - Divesiran is being developed as a first-in-class siRNA for Polycythemia Vera (PV)[2][3] - The SANRECO Phase 2 trial for divesiran in PV patients is a top priority and continues to progress towards full enrollment this year[2][6] SANRECO Phase 1 Data Presentation Updated Phase 1 data for divesiran demonstrated durable hematocrit control, reduced phlebotomy needs, and improved iron deficiency, with good tolerability - Divesiran treatment led to durable hematocrit control (<45%) and essentially eliminated the need for phlebotomies in the targeted population[6] - Divesiran increased hepcidin and ferritin, resulting in elevation of iron body content and improved iron deficiency[6] - Divesiran was well tolerated with no dose-limiting toxicities[6] SANRECO Phase 2 Study Progress The SANRECO Phase 2 trial has exceeded 50% enrollment and remains on schedule for completion by year-end 2025 - Exceeded 50% enrollment in the Phase 2 portion of the SANRECO trial[6] - Remains on-track to complete enrollment by year-end 2025[6] Zerlasiran for Cardiovascular Disease Silence Therapeutics has completed core Phase 3 readiness activities for zerlasiran, including manufacturing and supply scale-up, and is actively seeking third-party partners for its Phase 3 development and potential commercialization - Completed core Phase 3 readiness activities for zerlasiran, including manufacturing and supply scale up[4] - Actively in dialogues with potential third-party partners for Phase 3 development of zerlasiran as well as potential future commercialization activities[4] Other Research & Development Activities The company is prioritizing extra-hepatic cell targeting of siRNA due to promising initial preclinical activity in mice models, leading to the decision to pause the initiation of a Phase 1 study for SLN548, an siRNA for complement-mediated diseases - Prioritizing extra-hepatic activities due to promising initial preclinical activity in mice models for extra-hepatic cell targeting of siRNA[5] - Decided to pause initiating a Phase 1 study of SLN548, a wholly owned siRNA for complement-mediated diseases[5] Collaborations A Phase 1 study for SLN312, a siRNA product candidate licensed to AstraZeneca, is currently ongoing, indicating continued progress in external partnerships - A Phase 1 study of our siRNA product candidate, SLN312, which is licensed to AstraZeneca, is ongoing[7] Financial Performance Silence Therapeutics reported an increased net loss in Q2 2025 due to higher R&D expenses and foreign currency losses, while maintaining a strong cash position with a runway into 2028 Second Quarter 2025 Financial Highlights Silence Therapeutics reported a net loss of $27.4 million for Q2 2025, an increase from $19.8 million in Q2 2024, primarily due to higher R&D expenses driven by clinical trial advancements and contract manufacturing. G&A expenses decreased due to efficiency efforts. The company ended the quarter with $114.2 million in cash and short-term investments, projecting a cash runway into 2028 | Financial Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | Change (YoY) | | :--------------- | :-------------------- | :-------------------- | :----------- | | R&D Expenses | $17.6 | $13.8 | +$3.8 (+27.5%) | | G&A Expenses | $5.1 | $7.0 | -$1.9 (-27.1%) | | Net Loss | $27.4 | $19.8 | +$7.6 (+38.4%) | - The increase in R&D expenses was primarily driven by the advancement of clinical trials and an increase in contract manufacturing activities[11] - The decrease in G&A expenses was primarily due to a reduction in reporting and compliance requirements, as well as efforts to increase operating efficiencies[11] | Metric | Value (as of June 30, 2025) | | :----- | :-------------------------- | | Cash and cash equivalents, and short-term investments | $114.2 million | | Expected cash runway | Into 2028 | Condensed Consolidated Balance Sheets As of June 30, 2025, total assets decreased to $165.2 million from $202.6 million at December 31, 2024, primarily driven by a reduction in cash and cash equivalents. Total liabilities increased slightly, while total shareholders' equity improved from a larger deficit | Balance Sheet Item | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | Change | | :----------------- | :--------------------------- | :------------------------------- | :----- | | Total assets | $165,233 | $202,635 | -$37,402 | | Total liabilities | $(71,078) | $(68,612) | -$2,466 (increase in absolute value) | | Total shareholders' equity | $(94,155) | $(134,023) | +$39,868 (reduction in deficit) | | Cash and cash equivalents | $41,739 | $121,330 | -$79,591 | | Short-term investments | $72,416 | $26,004 | +$46,412 | Condensed Consolidated Statements of Operations and Comprehensive Loss For the three months ended June 30, 2025, Silence Therapeutics reported a net loss of $27.4 million, an increase from $19.8 million in the prior year period. This was influenced by a significant foreign currency loss and increased R&D costs, despite a decrease in G&A expenses | Income Statement Item | Three months ended June 30, 2025 (in thousands) | Three months ended June 30, 2024 (in thousands) | Change (YoY) | | :-------------------- | :---------------------------------------------- | :---------------------------------------------- | :----------- | | Revenue | $224 | $756 | -$532 (-70.4%) | | Gross profit | $139 | $(2,577) | +$2,716 (swing to profit) | | Research and development costs | $(17,647) | $(13,802) | -$(3,845) (+27.9%) | | General and administrative expenses | $(5,131) | $(7,009) | +$1,878 (-26.8%) | | Operating loss | $(23,963) | $(23,388) | -$(575) (+2.5%) | | Foreign currency (loss)/gain, net | $(6,613) | $(222) | -$(6,391) (significant increase in loss) | | Net Loss | $(27,354) | $(19,755) | -$(7,599) (+38.5%) | | Loss per share (basic and diluted) | $(0.19) | $(0.14) | -$(0.05) (+35.7%) | - The company incurred a significant foreign currency loss of $6.6 million in Q2 2025, compared to a loss of $0.2 million in Q2 2024[17] Corporate Information Silence Therapeutics is a clinical-stage biotechnology company focused on siRNA therapies for cardiovascular, hematology, and rare diseases, with forward-looking statements subject to inherent risks About Silence Therapeutics Silence Therapeutics is a global clinical-stage biotechnology company dedicated to transforming lives through precision-engineered siRNA medicines. It utilizes its mRNAi GOLD™ platform to target disease-associated genes, primarily in the liver, focusing on cardiovascular, hematology, and rare diseases - Silence Therapeutics is a global clinical-stage biotechnology company focused on developing novel siRNA therapies[9] - The company leverages its mRNAi GOLD™ platform to create siRNAs designed to precisely target and silence disease-associated genes, primarily in the liver[9] - Focuses on areas of high unmet medical need, with programs advancing in cardiovascular disease, hematology, and rare diseases[9] Forward-Looking Statements The report contains forward-looking statements regarding business strategy, clinical development, therapeutic benefits, trial timelines, collaborations, value delivery, and cash runway. These statements are subject to risks and uncertainties, including operating losses, capital needs, regulatory approvals, side effects, reliance on third parties, and intellectual property, as detailed in SEC filings - The press release contains forward-looking statements regarding business strategy, clinical development activities and timelines, therapeutic benefits, trial enrollment timing, collaborations, value delivery, and anticipated cash runway[10] - Forward-looking statements are subject to risks and uncertainties, including net operating losses, ability to obtain capital, early stages of clinical development, regulatory approval, undesirable side effects, reliance on third-party suppliers, and intellectual property rights[10][12] - The company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law[12] Inquiries Contact information for investor relations and corporate communications is provided for inquiries regarding Silence Therapeutics - Inquiries can be directed to Gem Hopkins, VP, IR and Corporate Communications, via email or phone[13]