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 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]

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]

Core Insights - Silexion Therapeutics has announced a strategic collaboration with Catalent to advance its RNA interference (RNAi) cancer therapies, specifically targeting KRAS-driven cancers [1][4] - The collaboration will focus on the formulation development and clinical manufacturing of Silexion's siRNA candidate, SIL204, at Catalent's facility in Limoges, France [2][4] - Silexion aims to initiate human clinical trials for SIL204 in the first half of 2026, following promising preclinical results [4][5] 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 [6] - The company's first-generation product, LODER™, has shown promising results in Phase 2 trials for non-resectable pancreatic cancer [6] - SIL204 is designed to target a broader range of KRAS mutations and has demonstrated significant efficacy in preclinical studies [3][6] Collaboration Details - Catalent will optimize both systemic and intratumoral delivery formulations of SIL204, supporting Silexion's dual-route development strategy [2][4] - The collaboration leverages Catalent's expertise in complex formulation development to enhance SIL204's stability, bioavailability, and delivery precision [4] - Silexion plans to conduct additional toxicology and pharmacodynamic studies throughout 2025, with regulatory submissions anticipated in late 2025 and early 2026 [5]

Core Viewpoint - Silexion Therapeutics is set to present an expanded development plan for its siRNA candidate SIL204 at the upcoming NeauxCancer Conference, following promising preclinical data related to KRAS-driven cancers [1][2][4]. Company Overview - Silexion Therapeutics is a clinical-stage biotechnology company focused on developing RNA interference (RNAi) therapies for solid tumors driven by KRAS mutations, which are prevalent in human cancers [5]. - The company's first-generation product, LODER™, has shown promising results in a Phase 2 clinical trial for non-resectable pancreatic cancer [5]. - Silexion is advancing its next-generation siRNA candidate, SIL204, which targets a broader range of KRAS mutations and has demonstrated significant potential in preclinical studies [5]. Development Plan - The newly completed strategic plan aims to maximize SIL204's potential through various delivery approaches to tackle the challenges posed by KRAS-driven cancers [2]. - Further details regarding the expanded development plan will be disclosed during the presentation at the conference [2][3]. Conference Presentation - A presentation by Silexion will occur during the conference's Innovation track on March 28th at 1:00 PM, where the company will share its strategic vision and recent preclinical findings related to SIL204 [3]. - The management team will be available for one-on-one meetings with interested investors during the conference [4].

Core Insights - Silexion Therapeutics announced positive data indicating that SIL204, when administered subcutaneously, effectively reduces both primary tumor growth and metastatic spread in orthotopic pancreatic cancer models [1][4] Group 1: Efficacy of SIL204 - SIL204 demonstrated significant efficacy in orthotopic xenograft models, which better mimic human disease progression compared to previous models [2][3] - In AsPC-1 models with KRAS G12D mutation, SIL204 achieved approximately 70% reduction in overall bioluminescence by day 28 compared to control [3] - In Panc-1 models, tumor cell numbers decreased significantly in a dose-dependent manner, with a 12% decrease in bioluminescence compared to baseline by day 14, while control increased by over 100% [3] - In BxPC-3 models, SIL204 resulted in around 80% reduction in overall bioluminescence by day 28 compared to control [3] Group 2: Metastasis Reduction - For the first time, SIL204 treatment showed a significant reduction in metastatic spread to secondary organs, lowering metastatic burden in the liver, intestine, spleen, and stomach [3][4] Group 3: Systemic Delivery Validation - Subcutaneous administration of SIL204 confirmed its effectiveness in treating pancreatic tumors and their metastases, validating systemic delivery as a viable route [4] - The company is exploring an expanded development plan for SIL204 based on these findings, with an updated strategy expected soon [4][5] Group 4: Company Overview - Silexion Therapeutics is focused on developing RNA interference therapies for KRAS-driven cancers, with SIL204 being a next-generation candidate targeting a broader range of KRAS mutations [5]