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 ...

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]

Cayman Islands, July 31, 2025 (GLOBE NEWSWIRE) -- Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion Therapeutics" or the "Company"), a clinical-stage biotech company developing RNA interference (RNAi) therapies for KRAS-driven cancers, today announced the entry into definitive agreements for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 152,106 of the Company's ordinary shares originally issued in January 2025 at a reduced exercise price of $11.57 per share. Th ...

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 is advancing its next-generation RNA interference (RNAi) therapeutic candidate, SIL204, targeting KRAS-driven cancers beyond pancreatic cancer, with treatment markets estimated at over $30 billion annually [1][3]. Company Overview - Silexion Therapeutics is a clinical-stage biotechnology company focused on developing RNAi therapies for solid tumors driven by KRAS mutations, which are prevalent in various cancers [4]. - The company's first-generation product, LODER™, has shown promising results in Phase 2 trials for non-resectable pancreatic cancer [4]. Study Details - The completed preclinical studies evaluated SIL204 in cancer cell lines with KRAS mutations, including colorectal cancer (GP2D), lung cancer (A427), and pancreatic cancer (Panc-1), chosen for their high prevalence of KRAS mutations and significant unmet medical needs [2][3]. - KRAS mutations are found in approximately 90% of pancreatic cancers, 45% of colorectal cancers, and 35% of non-squamous non-small-cell lung cancers, highlighting the potential market for SIL204 [3]. Future Prospects - The completion of the expanded preclinical evaluation is seen as a significant milestone for the SIL204 development program, with expectations for positive results that could broaden the company's development strategy [3].

Core Insights - Silexion Therapeutics Corp. has made significant advancements in its preclinical pipeline for SIL204, demonstrating efficacy against both primary tumors and metastases in orthotopic models, which could represent a paradigm shift in treating KRAS-driven cancers [1][2] - The company has strengthened its financial position by raising over $9 million in gross funds during Q1 2025, enhancing its ability to advance its clinical development pipeline [1][2] Recent Milestones & Business Highlights - Positive data from orthotopic pancreatic cancer models showed that SIL204 reduced primary tumor growth by approximately 70% in the AsPC-1 model and 80% in the BxPC-3 model by day 28, along with significant reductions in metastases [5] - A single systemic dose of SIL204 maintained effective drug levels for over 56 days, indicating potential for long-term therapeutic exposure [5] - An expanded dual-route development strategy for SIL204 was unveiled, integrating systemic and intratumoral administration to target both primary tumors and metastatic progression [5] - A strategic collaboration with Catalent was announced to conduct formulation development and clinical manufacturing activities for SIL204 [5] Financial Results Highlights - Cash and cash equivalents increased to $6.2 million as of March 31, 2025, from $1.2 million as of December 31, 2024, primarily due to successful financing activities [10] - Total operating expenses for Q1 2025 were $1.7 million, compared to $1.3 million in Q1 2024, with research and development expenses decreasing to $0.6 million [6][10] - The net loss for Q1 2025 was $1.7 million, compared to $1.4 million for the same period in 2024, attributed to higher general and administrative expenses [10][14]