New data in human cancer cell lines provides confirmation of pan-KRAS mutation inhibition with inhibition of G12D, G12V, G12R, G12C, G13C, G12A, Q61H, and G13D mutations Company Reports first evidence of gastric cancer activity expands potential therapeutic reach of SIL204 GRAND CAYMAN, Cayman Islands, Sept. 30, 2025 (GLOBE NEWSWIRE) -- Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven ...

Company Successfully Meets Both Minimum Bid Price and Shareholders' Equity Requirements, Securing Continued Listing on the Nasdaq Capital MarketGRAND CAYMAN, Cayman Islands, Sept. 25, 2025 (GLOBE NEWSWIRE) -- Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, today announced that it has received written notification from The Nasdaq Stock Market LLC ("Nasdaq") confirming that th ...

Silexion Therapeutics Corp. SLXN stock is trading higher on Thursday, with a session volume of 16.87 million compared to the average volume of 74.2 thousand as per data from Benzinga Pro.The company released new preclinical data demonstrating that subcutaneously administered SIL204 successfully reaches all primary sites of pancreatic cancer metastasis and shows anti-tumor activity.The study evaluated SIL204’s biodistribution and therapeutic activity following subcutaneous administration in a metastatic panc ...

New Positive Preclinical Data Shows Succesful Drug Distribution to Liver, Peritoneum, and Lung with Measurable Reductions in Tumor Burden at Clinically Relevant Doses Results Provide Further Validation of the Systemic Component of a Dual-Route Administration Strategy Enabeling Potential Targeting of Both Primary Tumors and Metastatic Disease Silexion Remains on Track for Phase 2/3 Trial Initiation in H1 2026 Following Planned Q4 2025 and Q1 2026 Regulatory Submissions GRAND CAYMAN, Cayman Islands, Sept. 1 ...

Core Insights - Silexion Therapeutics Corp has selected AMS Advanced Medical Services GmbH as its contract research organization (CRO) to support upcoming Phase 2/3 clinical trials for SIL204, a next-generation siRNA candidate targeting KRAS-driven solid tumor cancers [1][2][3] - The partnership is expected to enhance Silexion's regulatory submissions to the Israel Ministry of Health in Q4 2025 and to the European Union in Q1 2026, with trials commencing in the first half of 2026 [2][3] - SIL204 has demonstrated up to 97% inhibition rates in preclinical studies across various cancer models, including pancreatic, colorectal, and lung cancers [3][5] Company Overview - Silexion Therapeutics is a clinical-stage biotechnology company focused on developing RNA interference therapies for cancers driven by the mutated KRAS oncogene, which is prevalent in human cancers [6] - The company aims to advance its lead product candidate for locally advanced pancreatic cancer, building on positive trends observed in previous clinical trials [7] Clinical Development Strategy - The upcoming Phase 2/3 trial will evaluate SIL204's dual-route administration strategy, which combines intratumoral delivery to target primary tumors and systemic administration for metastatic disease [5] - Preclinical data supports the efficacy of SIL204 in significantly reducing both primary tumor growth and metastatic spread in relevant pancreatic cancer models [5] CRO Partnership - AMS brings over 28 years of experience in oncology clinical development and regulatory affairs, which is crucial for executing Silexion's clinical program effectively [2][4] - The collaboration will cover regulatory strategy, clinical trial design, site selection and management, and data analysis for the planned Phase 2/3 study [4]

Core Insights - Silexion Therapeutics Corp. has made significant advancements in its preclinical program for SIL204, demonstrating strong efficacy across multiple KRAS-driven cancer types, including pancreatic, colorectal, and lung cancers [1][2][7] - The company has strengthened its financial position and is on track to initiate Phase 2/3 clinical trials for SIL204 in the first half of 2026 [1][4][5] Recent Milestones & Business Highlights - The preclinical data for SIL204 shows up to 94% inhibition in pancreatic cancer cells with KRAS G12D mutations, approximately 90% inhibition in colorectal cancer cells, and significant dose-dependent inhibition in lung cancer cell lines [9] - A strategic partnership with Catalent was established for formulation development and clinical manufacturing of SIL204, supporting a dual-route development strategy [3] Regulatory and Clinical Timeline - Silexion plans to submit regulatory applications to initiate Phase 2/3 trials to the Israel Ministry of Health in Q4 2025 and to the European Union in Q1 2026 [4] Financial Overview - As of June 30, 2025, cash and cash equivalents increased to $3.5 million from $1.2 million at the end of 2024, reflecting successful financing activities [10] - Total operating expenses for Q2 2025 were $2.3 million, a 64.3% increase from Q2 2024, with R&D expenses rising to $1.0 million [11] - The net loss for Q2 2025 was $2.5 million, compared to $1.5 million in Q2 2024, primarily due to increased general and administrative expenses [13]

Core Insights - Silexion Therapeutics Corp. announced new preclinical data showing unprecedented inhibition rates of up to 97% in pancreatic cancer cells and nearly 90% in colorectal cancer cells, highlighting SIL204's potential as a pan-KRAS therapeutic [1][6][7] - The findings include the first evidence of SIL204's efficacy against the KRAS Q61H mutation, which was previously untested, indicating a significant advancement in the company's research [1][2][8] - Silexion is preparing to initiate a Phase 2/3 clinical trial in Q2 2026 to further investigate SIL204 for treating KRAS-driven solid tumors [1][8] Preclinical Study Findings - The comprehensive CTG analysis demonstrated significantly higher inhibition rates, with SIL204 achieving up to 94% inhibition in pancreatic cancer cells with KRAS G12D mutations and comparable 97% inhibition in cells with KRAS Q61H mutations [2][6] - SIL204 also showed an inhibition rate of nearly 90% in colorectal cancer cells with KRAS G12D mutations, extending its effectiveness beyond pancreatic cancer [6][7] - The results provide compelling evidence of SIL204's potent activity against multiple KRAS mutations across different cancer types, including pancreatic, colorectal, and lung cancers [6][8] Company Overview - Silexion Therapeutics is a clinical-stage biotechnology company focused on developing RNA interference therapies for KRAS-driven cancers, which are among the most common oncogenic drivers in human cancers [9] - The company's first-generation product, LODER™, has shown promising results in a Phase 2 trial for non-resectable pancreatic cancer, while SIL204 is designed to target a broader range of KRAS mutations [9]

Core Viewpoint - Silexion Therapeutics Corp. announced a 1-for-15 reverse share split to comply with NASDAQ requirements, enhance market position, and support strategic growth initiatives [1][4]. Group 1: Reverse Share Split Details - The reverse share split will take effect after market close on July 28, 2025, with trading on a split-adjusted basis starting July 29, 2025 [1]. - Every fifteen ordinary shares will be combined into one share, increasing the par value from $0.0009 to $0.0135 per share, with no fractional shares issued [2]. - Shareholders in book-entry form will see automatic adjustments, and those holding shares through brokers will also have their shares adjusted automatically [3]. Group 2: Strategic Rationale - The reverse share split aims to help Silexion regain compliance with NASDAQ's minimum bid price requirement, thereby enhancing its market position and supporting growth initiatives [4]. - The company is focused on advancing RNA interference (RNAi) therapies for KRAS-driven cancers, with recent preclinical breakthroughs and an expanded development strategy [3][5]. Group 3: Company Overview - Silexion Therapeutics is a clinical-stage biotechnology company developing RNAi therapies targeting solid tumors driven by KRAS mutations, with promising results from its first-generation product, LODER™ [5]. - The next-generation siRNA candidate, SIL204, is designed to target a broader range of KRAS mutations and has shown significant potential in preclinical studies [5].

Core Insights - Silexion Therapeutics Corp. announced positive preclinical data for SIL204, demonstrating significant efficacy in human lung cancer cell lines, particularly those with KRAS G12D mutations [1][4][6] - The company is conducting a new study on an untested KRAS mutation, with results expected soon, which could further validate SIL204 as a potential pan-KRAS treatment [2][3] - Silexion's dual-route administration strategy is progressing, with plans to initiate a Phase 2/3 clinical trial in Q2 2026 for KRAS-driven solid tumors [3] Study Findings - The study showed dose-dependent inhibition in lung cancer cells with KRAS G12D mutations, highlighting SIL204's potential as a versatile therapeutic [4][7] - The lipid-conjugated delivery system enhances SIL204's entry into tumor cells, addressing a significant barrier for siRNA technology [5][6] Market Opportunity - KRAS mutations are prevalent in various cancers, with approximately 90% in pancreatic cancers, 45% in colorectal cancers, and 30% in lung cancers, representing a significant market opportunity [8] - The global treatment market for these cancers exceeds US $30 billion annually, with many KRAS variants challenging to target with conventional therapies, underscoring the potential of Silexion's RNAi-based strategy [8][9] Company Overview - Silexion Therapeutics is focused on developing RNA interference therapies for solid tumors driven by KRAS mutations, with SIL204 as its next-generation candidate showing promise in preclinical studies [10]

Core Insights - Silexion Therapeutics has demonstrated the efficacy of its RNAi therapeutic candidate, SIL204, against KRAS-driven cancers, showing a significant inhibition rate of approximately 90% in GP2D human colorectal cancer cells [1][5] - The company plans to conduct further preclinical studies focusing on lung cancer cell lines to expand the understanding of SIL204's therapeutic potential [2][4] Company Overview - Silexion Therapeutics is a clinical-stage biotechnology company specializing in RNA interference therapies targeting KRAS mutations, which are prevalent in various cancers [6] - The company’s first-generation product, LODER™, has shown promising results in Phase 2 trials for non-resectable pancreatic cancer, while SIL204 aims to target a broader range of KRAS mutations [6] Therapeutic Potential - SIL204 has shown significant inhibition of cancer cell proliferation and metabolic activity across multiple cancer types, including pancreatic, colorectal, and lung cancers, indicating its potential as a pan-KRAS therapy [4][5] - KRAS mutations are found in approximately 90% of pancreatic cancers, 45% of colorectal cancers, and 35% of non-squamous non-small-cell lung cancers, representing a substantial market opportunity exceeding US $30 billion annually [4][6]