Silexion Therapeutics Corp(SLXN) - 2025 Q2 - Quarterly Results

Executive Summary Silexion Therapeutics, a clinical-stage biotech, advanced its RNAi therapy for KRAS-driven cancers, secured a key partnership, and strengthened its financial position Company Overview Silexion Therapeutics Corp. is a clinical-stage biotechnology company focused on developing RNA interference (RNAi) therapies specifically for KRAS-driven cancers - Silexion Therapeutics Corp. is a clinical-stage biotechnology company developing RNA interference (RNAi) therapies for KRAS-driven cancers[2] Q2 2025 Business Highlights Silexion Therapeutics reported strong preclinical efficacy data for SIL204 across multiple KRAS-driven cancer types, secured a strategic formulation partnership, maintained its Nasdaq listing, and strengthened its financial position, remaining on track for Phase 2/3 clinical trials in H1 2026 - Continued advancement of SIL204 preclinical program with strong efficacy data across multiple KRAS-driven cancer types[1] - Company strengthened financial position and maintains progress toward clinical trials[1] - Preclinical data demonstrates SIL204's impressive efficacy across pancreatic, colorectal, and lung cancers, with high inhibition rates and coverage of multiple KRAS mutations including Q61H and G13D variants[9] Business Developments Silexion advanced its SIL204 preclinical program, secured a strategic partnership, achieved corporate milestones, and progressed towards clinical trials Preclinical Program Advancement (SIL204) Silexion significantly expanded its preclinical program for SIL204, demonstrating strong efficacy in inhibiting KRAS G12D mutations across pancreatic, colorectal, and lung cancer models, and reported initial evidence of SIL204's efficacy against the clinically significant KRAS Q61H mutation - Significant expansion of preclinical program for SIL204, exploring its potential impact on colorectal and lung cancer[3] - Results demonstrated strong efficacy across multiple KRAS-driven cancer types[3] Efficacy Across Multiple Cancer Types SIL204 showed high inhibition rates in preclinical studies for pancreatic, colorectal, and lung cancers, specifically targeting KRAS G12D mutations SIL204 Efficacy in KRAS G12D Mutations | Cancer Type | KRAS Mutation | Inhibition Rate | | :---------- | :------------ | :-------------- | | Pancreatic Cancer | KRAS G12D | Up to 94% | | Colorectal Cancer | KRAS G12D | Approx. 90% | | Lung Cancer | KRAS G12D | Significant dose-dependent inhibition | New KRAS Mutation Coverage In July 2025, Silexion reported the first evidence of SIL204's efficacy against the clinically significant KRAS Q61H mutation, achieving up to 97% inhibition in pancreatic cancer cells - First evidence of SIL204's efficacy against the clinically significant KRAS Q61H mutation[5] - Achieved up to 97% inhibition in pancreatic cancer cells with KRAS Q61H mutation[5] Strategic Formulation Partnership In April 2025, Silexion partnered with Catalent, a global leader in advanced delivery technologies, for formulation development and clinical manufacturing of SIL204, supporting a dual-route development strategy for primary tumors and metastases - Strategic collaboration with Catalent for formulation development and clinical manufacturing activities for SIL204[4] - Partnership supports the Company's dual-route development strategy targeting both the primary tumor and resulting metastases[4] Regulatory and Clinical Timeline Silexion remains on track to initiate Phase 2/3 clinical trials for SIL204 in the first half of 2026, initially focusing on locally advanced pancreatic cancer, with regulatory submissions planned for Israel in Q4 2025 and the EU in Q1 2026 - Company remains on track to initiate Phase 2/3 clinical trials for SIL204 in the first half of 2026[6] - Initial focus on locally advanced pancreatic cancer[6] - Regulatory submission plans: Israel Ministry of Health in Q4 2025 and European Union in Q1 2026[6] Corporate Milestones Silexion successfully maintained its Nasdaq listing following a favorable decision and completed a 1-for-15 reverse share split, also generating approximately $1.8 million in gross proceeds from a warrant exercise inducement transaction Nasdaq Listing Status Silexion received a favorable decision from a Nasdaq hearings panel in July 2025, allowing it to maintain its listing, and effected a 1-for-15 reverse share split on July 29, 2025, as part of compliance efforts - Received a favorable decision from a Nasdaq hearings panel in July 2025, allowing maintenance of Nasdaq Capital Market listing[7] - Effected a 1-for-15 reverse share split on July 29, 2025, to maintain compliance[7] Recent Financing Activities Subsequent to the quarter end, on July 31, 2025, Silexion generated approximately $1.8 million in gross proceeds from the exercise of 152,106 existing warrants through an inducement transaction - Entered into a warrant exercise inducement transaction on July 31, 2025[8] - Generated approximately $1.8 million in gross proceeds from the exercise of 152,106 existing warrants[8] Second Quarter 2025 Financial Performance Silexion Therapeutics reported a significant increase in cash position, higher operating expenses driven by R&D and G&A, increased net financial expenses, and a larger net loss for Q2 and the six months ended June 30, 2025 Cash Position Cash and cash equivalents increased significantly to $3.5 million as of June 30, 2025, up from $1.2 million at December 31, 2024, primarily due to financing activities completed in early 2025 Cash and Cash Equivalents | Metric | June 30, 2025 | December 31, 2024 | Change | | :----- | :------------ | :---------------- | :----- | | Cash and cash equivalents | $3.5 million | $1.2 million | +$2.3 million | - Increase primarily reflects proceeds from financing activities completed in early 2025, partially offset by ongoing operational expenses[10] Operating Expenses Total operating expenses for Q2 2025 increased by 64.9% year-over-year to $2.3 million, driven by increases in both research and development (32.9% increase) and general and administrative expenses (104.5% increase) due to increased headcount, salary adjustments, bonus accruals, and public company costs Operating Expenses (Three Months Ended June 30, in thousands) | Expense Category | Q2 2025 | Q2 2024 | Change (YoY) | % Change (YoY) | | :--------------- | :------ | :------ | :----------- | :------------- | | Research and development | $1,018 | $766 | +$252 | +32.9% | | General and administrative | $1,266 | $619 | +$647 | +104.5% | | Total Operating Expenses | $2,284 | $1,385 | +$899 | +64.9% | - R&D increase primarily due to increased payroll and payroll-related expenses from additional headcount and salary increases following the business combination, as well as bonus accrual[11] - G&A increase mainly due to increased payroll expenses and professional services costs associated with operating as a public company[11] Financial Expenses, Net Net financial expenses for Q2 2025 increased by 111.8% to $0.2 million from $0.1 million in Q2 2024, primarily due to an increase in revaluation expenses of financial instruments Financial Expenses, Net (Three Months Ended June 30, in thousands) | Metric | Q2 2025 | Q2 2024 | Change (YoY) | % Change (YoY) | | :----- | :------ | :------ | :----------- | :------------- | | Financial expenses, net | $216 | $102 | +$114 | +111.8% | - Increase primarily due to an increase in revaluation expenses of financial instruments[12] Net Loss The net loss for Q2 2025 increased by 68.1% year-over-year to $2.5 million, primarily driven by higher general and administrative expenses related to public company status and increased research and development expenses, with the six-month net loss reaching $4.2 million Net Loss (Three and Six Months Ended June 30, in thousands) | Metric | Q2 2025 | Q2 2024 | Change (YoY) | % Change (YoY) | | :----- | :------ | :------ | :----------- | :------------- | | Net Loss (3 months) | $2,503 | $1,489 | +$1,014 | +68.1% | | Net Loss (6 months) | $4,238 | $2,912 | +$1,326 | +45.5% | - Increase in net loss mainly due to increased general and administrative expenses related to public company status and research and development expenses[13](index=