Significant regulatory milestone marks advancement into clinical-stage development of next-generation RNAi therapy featuring an innovative, integrated systemic treatment delivery approach targeting highly prevalent KRAS-driven cancers with significant unmet medical need Company reported strong positive preclinical study results demonstrating significant anti-tumor activity in multiple models and announced successful completion of toxicology studies, and constructive regulatory engagement supporting the Phas ...

Throughout the year, the Company reported significant positive preclinical findings for SIL204 across eight KRAS mutations and four cancer types, including first evidence of activity in gastric cancer, reinforcing broad therapeutic potential During the fourth quarter, Silexion achieved key clinical readiness milestones including completing two-species toxicology studies, written Scientific Advice from Germany's BfArM, and submission of Phase 2/3 clinical trial application to the Ministry of Health in Israel ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to _______________ Commission File Number 001-39157 Silexion Therapeutics Corp (Exact name of registrant as specified in its charter) Cayman Islands 001-42253 N/ ...

Grand Cayman, Cayman Island, March 05, 2026 (GLOBE NEWSWIRE) -- Silexion Therapeutics Corp. (“Silexion” or the “Company”), a clinical-stage, oncology-focused biotechnology company, reminds its shareholders of the upcoming Extraordinary General Meeting of Shareholders (the "EGM"), scheduled to be held on March 16, 2026. At the EGM, shareholders will be asked to vote on proposals relating to: Authorized Share Capital Increase Proposal: An increase to the authorized share capital of the Company by 50,000,000 ...

Core Insights - Silexion Therapeutics Corp. is attending the 7th RNAi-Based Therapeutics Summit to discuss advancements in RNA-based therapeutics, particularly in oncology [1][2][3] Company Overview - Silexion is a clinical-stage biotechnology company focused on developing treatments for solid tumor cancers associated with mutated KRAS oncogenes, which are prevalent in human cancers [4] - The company is advancing its lead product candidate, SIL204, a next-generation siRNA therapy aimed at silencing mutated KRAS oncogenes, with plans to initiate a Phase 2/3 clinical study in locally advanced pancreatic cancer by mid-2026 [2][4] Event Participation - Silexion management, including CEO Ilan Hadar, will host one-on-one meetings during the RNAi-Based Therapeutics Summit, indicating a proactive approach to engage with potential investors and partners [3] - The company is an official partner of the RNAi-Based Therapeutics Summit for 2026, highlighting its commitment to the field of RNA-based therapeutics [3]

Core Insights - Silexion Therapeutics has made significant progress in 2025, positioning its lead asset SIL204 for human clinical trials in the first half of 2026, targeting KRAS-driven cancers [2][9] - The company aims to address a global market exceeding $30 billion for KRAS-driven cancer treatments, particularly focusing on pancreatic, colorectal, and lung cancers [4][3] Company Developments - In 2025, Silexion demonstrated exceptional preclinical efficacy of SIL204, achieving over 90% inhibition of cancer cell growth across multiple human cancer cell line models [5][6] - The company validated SIL204's activity against eight distinct KRAS mutations, including G12D, G12V, and G12C, and showed efficacy in five cancer types [5][6] - Silexion completed toxicology studies confirming no systemic organ toxicity and received positive feedback from Germany's BfArM on its Phase 2/3 trial design [7][8] Clinical Trial Plans - The initiation of the Phase 2/3 clinical trial for SIL204 in locally advanced pancreatic cancer (LAPC) is planned for the first half of 2026, with regulatory submissions already completed in Israel [9][10] - The trial will utilize a dual-route strategy combining intratumoral delivery and systemic administration, with an initial safety run-in involving approximately 18 patients [10][11] Market Context - The KRAS inhibitor market is projected to reach approximately $10 billion by 2032, yet current therapies are mutation-specific and do not address the majority of KRAS-driven cancers [3] - Over 80% of pancreatic cancer mortality is attributed to metastatic disease, highlighting the unmet need that SIL204 aims to address [4]

Core Insights - Silexion Therapeutics has initiated a regulatory application in Israel for its Phase 2/3 clinical trial of SIL204 targeting locally advanced pancreatic cancer, marking a significant milestone in its clinical development program [1][2][4] - The application is supported by successful toxicology studies and positive feedback from German regulatory authorities, with plans for further regulatory filings in Germany and the EU in Q1 2026 [1][2][4] - The planned Phase 2/3 trial aims to evaluate SIL204's dual-route administration strategy, which combines intratumoral delivery and systemic administration [4] Company Overview - Silexion Therapeutics is a clinical-stage biotechnology company focused on RNA-based therapies for oncology, particularly targeting cancers with mutated KRAS oncogenes [5] - The company previously conducted a Phase 2a clinical trial for its first-generation product, which showed a positive trend compared to chemotherapy alone [5] Clinical Development - The Phase 2/3 trial is set to begin in Q2 2026, following the completion of a safety run-in in Israel and Germany [2][4] - The collaboration with Sheba Medical Center, a top-ranked hospital, is integral to the Israeli portion of the clinical trial [3]

Core Insights - Silexion Therapeutics is progressing towards initiating its Phase 2/3 clinical trial for SIL204, aimed at treating locally advanced pancreatic cancer, with plans to submit regulatory documents in Israel by the end of Q4 2025 and in Germany by Q1 2026 [1][2][3] Regulatory Developments - The company received formal written Scientific Advice from the German Federal Institute for Drugs and Medical Devices (BfArM), which provides clarity on the proposed trial design, including clinical design, dosing plans, patient population strategy, and manufacturing considerations [1][2] - This positive feedback is seen as a significant milestone that supports the acceptability of the proposed study design based on safety data and manufacturing specifications [2] Company Strategy and Operations - Silexion is on track to initiate the Phase 2/3 clinical trial in the first half of 2026, pending regulatory clearance, and is focused on advancing operational activities necessary for trial launch, including manufacturing readiness and clinical site preparations [3] - The company aims to address critical unmet needs in KRAS-mutated cancers, which are prevalent in solid tumor cancers [4]

Core Insights - Silexion Therapeutics Corp. is a clinical-stage biotechnology company focused on oncology, specifically targeting solid tumor cancers with the mutated KRAS oncogene [3]. Group 1: Company Presentation - Silexion management will present at the Noble Capital Markets' 21st Annual Emerging Growth Equity Conference on December 3, 2025, from 2:30 to 2:55 PM ET [2]. - The presentation will be led by Ilan Hadar, CEO, and Mirit Horenshtein-Hadar, CFO, at Florida Atlantic University Conference Center, Boca Raton, FL [2]. - Management will be available for one-on-one meetings during the conference, and interested parties can arrange meetings through their conference representative [2]. Group 2: Clinical Development - Silexion is dedicated to developing innovative treatments for solid tumor cancers, particularly those with the mutated KRAS oncogene, which is the most common oncogenic gene driver in human cancers [3]. - The company has conducted a Phase 2a clinical trial for its first-generation product, which showed a positive trend compared to chemotherapy alone [3]. - Silexion is focused on advancing its lead product candidate for locally advanced pancreatic cancer [3].

Core Insights - Silexion Therapeutics has successfully completed toxicology studies for SIL204, confirming no systemic organ toxicity, which supports the company's plans for regulatory submissions in Israel and Germany [1][2][3] - The company is on track to initiate a Phase 2/3 clinical trial for SIL204 in locally advanced pancreatic cancer (LAPC) in Q2 2026 [1][3] Company Overview - Silexion Therapeutics is a clinical-stage biotechnology company focused on developing RNA interference therapies for KRAS-driven cancers, particularly targeting mutated KRAS oncogenes [4] - The company previously conducted a Phase 2a clinical trial for its first-generation product, which showed a positive trend compared to chemotherapy alone [4] Product Development - SIL204 is designed as a next-generation siRNA therapy aimed at abolishing the expression of mutated KRAS proteins, which are known to drive aggressive cancers [2] - Preclinical data for SIL204 indicates significant inhibition of cancer cell growth in vitro across various KRAS mutated cell lines and positive anti-tumor activity in pancreatic cancer sites following systemic administration [2] Clinical Trial Preparation - The company has secured a contract research organization (CRO) partner for the upcoming clinical trial and is preparing regulatory submissions to health authorities in Israel and Germany [3] - The favorable safety results from the toxicology studies support Silexion's integrated treatment regimen approach, which combines intratumoral and systemic administration [3]