SLXN

Israeli Ministry of Health approved the initiation of Silexion's Phase 2/3 clinical trial of SIL204 in locally advanced pancreatic cancer Clinical Trial Application subsequently submitted to Germany through the EU Clinical Trials Information System Phase 2/3 clinical trial initiation remains on track for the second quarter of 2026 Grand Cayman, May 18, 2026 (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 provided an update on recent business developments following the release of its financial results for the first quarter ended March 31, 2026, which were reported on May 15, 2026. Recent Milestones & Business Highlights Israeli Ministry of Health Approval to Initiate Phase 2/3 Clinical Trial of SIL204: On March 24, 2026, Silexion announced that it had received formal approval from the Israeli Ministry of Health to initiate its Phase 2/3 clinical trial evaluating the Company’s lead product candidate SIL204 for the treatment of locally advanced pancreatic cancer. The approval represented a defining regulatory milestone for the Company, marking the transition of SIL204 into clinical-stage development of a next-generation siRNA therapy designed to silence mutated KRAS - a driver present in approximately 90% of pancreatic cancers - and positioning Silexion as a clinical-stage biotechnology company focused on KRAS-driven cancers. The approval followed strong positive anti-tumor activity demonstrated across multiple preclinical models, successful completion of two-species toxicology studies, and constructive regulatory engagement supporting the Phase 2/3 trial design. Phase 2/3 Clinical Trial Application Submitted to Germany: On April 28, 2026, subsequent to quarter end, the Company announced the successful submission of a Clinical Trial Application (CTA) to Germany for the planned Phase 2/3 clinical trial of SIL204 in patients with locally advanced pancreatic cancer. The CTA was submitted through the EU Clinical Trials Information System (CTIS), with Germany serving as the Reporting Member State leading the scientific assessment of the trial across the European Union. The submission was informed by the positive written Scientific Advice received from Germany's Federal Institute for Drugs and Medical Devices...

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 for SIL204 in locally advanced pancreatic cancer The Company remains on track to initiate Phase 2/3 clinical trial in the first half of 2026, with Israel regulatory feedback anticipated by the end of Q1 2026 Grand Cayman, Cayman Islands, March 17, 2026 (GLOBE NEWSWIRE) -- Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage, oncology-focused biotechnology company, today reported its financial results for the fourth quarter and full year ended December 31, 2025, and provided an update on recent business developments. Recent Milestones & Business Highlights Expanding Preclinical Validation Across KRAS-Driven Cancers: Throughout 2025, Silexion generated additional preclinical data supporting the broad therapeutic potential of SIL204. In human KRAS-mutated cancer cell line models, SIL204 demonstrated very high inhibition levels of cancer cell growth across multiple models and showed activity against eight distinct KRAS mutations: G12D, G12V, G12R, G12C, G13C, G12A, Q61H, and G13D. Preclinical efficacy was observed across four cancer types, including pancreatic, colorectal, lung, and gastric cancers. In orthotopic pancreatic cancer models, systemic administration of SIL204 resulted in significant reductions in primary tumor growth and metastatic spread to secondary organs. Completion of Toxicology Studies and Clinical Trial Infrastructure Build-Out: In the fourth quarter of 2025, the Company completed two-species GLP toxicology studies for SIL204, supporting planned regulatory submissions and Phase 2/3 clinical readiness. During the year, Silexion also announced it has engaged AMS Advanced Medical Services GmbH as contract research organization (CRO) for its planned Phase 2/3 program and advanced manufacturing and operational partnerships to support scaled clinical execution. Regulatory Advancement Toward Phase 2/3 Initiat...

Continued advancement toward Phase 2/3 clinical trial initiation, on track for the first half of 2026 New preclinical data demonstrated SIL204’s exceptional efficacy across multiple human cancer cell lines, highlighting potential effectiveness against five KRAS-driven cancer types Successfully raised over $9 million during the third quarter, significantly strengthening the Company’s balance sheet Grand Cayman, Cayman Islands, Nov. 12, 2025 (GLOBE NEWSWIRE) -- Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company developing RNA interference (RNAi) therapies for KRAS-driven cancers, today reported its financial results for the third quarter ended September 30, 2025, and provided an update on recent business developments. Recent Milestones & Business Highlights: Clinical Trial Preparation On Track: Silexion continues to advance operational readiness for its planned Phase 2/3 clinical trials of SIL204, with toxicology studies progressing as planned. Regulatory submissions are expected to be filed with the Israel Ministry of Health in Q4 2025 and in Germany and in the European Union in Q1 2026, with clinical trial initiation anticipated in the first half of 2026. Strong Preclinical Results Across Multiple Cancer Types: The Company continues to accumulate positive efficacy preclinical data in various KRAS-driven cancers, further supporting the potential of SIL204 as a platform technology for these oncogene-driven cancers. Silexion announced that SIL204 successfully killed cancer cells across five different cancer types with very high effectiveness. The drug worked against eight different cancer-causing mutations, including the most common ones found in pancreatic, lung, and colorectal cancers. Importantly, this included the first evidence that SIL204 works in gastric (stomach) cancer. These results demonstrate SIL204's potential to treat a wide range of KRAS-driven cancers with a single therapy. CRO Partnership to Support the Phase 2/3 Trials: In September 2025, Silexion announced that it had selected AMS Advanced Medical Services GmbH as its contract research organization (CRO) to support the upcoming Phase 2/3 clinical trials for SIL204. AMS brings over 28 years of oncology clinical development and regulatory experience, including management of Phase 3 trials in pancreatic cancer. This partnership covers...

Continued advancement of SIL204 preclinical program with strong efficacy data across multiple KRAS-driven cancer types; company strengthened financial position and maintains progress toward clinical trials GRAND CAYMAN, Cayman Islands, Aug. 12, 2025 (GLOBE NEWSWIRE) -- Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company developing RNA interference (RNAi) therapies for KRAS-driven cancers, today reported its financial results for the second quarter ended June 30, 2025, and provided an update on recent business developments. Recent Milestones & Business Highlights: Groundbreaking Preclinical Data Across Multiple Cancer Types: Following the completion of studies evaluating the Company’s second-generation drug candidate SIL204 in orthotopic pancreatic cancer models in February 2025, the Company announced a significant expansion of its preclinical program. In May 2025, Silexion announced preclinical studies exploring SIL204's potential impact on colorectal and lung cancer, with results demonstrating strong efficacy across multiple KRAS-driven cancer types: Pancreatic Cancer: SIL204 demonstrated up to 94% inhibition in cancer cells harboring KRAS G12D mutations Colorectal Cancer: Achieved approximately 90% inhibition rate in GP2D colorectal cancer cells with KRAS G12D mutations Lung Cancer: Showed significant dose-dependent inhibition in human lung cancer cell lines harboring KRAS G12D mutations New KRAS Mutation Coverage: In July 2025, the Company reported first evidence of SIL204's efficacy against the clinically significant KRAS Q61H mutation, with up to 97% inhibition in pancreatic cancer cells Strategic Formulation Partnership: In April 2025, Silexion announced a strategic collaboration with Catalent, a global leader in advanced delivery technologies, for formulation development and clinical manufacturing activities for SIL204 at Catalent's facility in Limoges, France. This partnership supports the Company's dual-route development strategy targeting both the primary tumor and resulting metastases. Regulatory and Clinical Timeline: The Company remains on track to initiate Phase 2/3 clinical trials for SIL204 in the first half of 2026, focusing initially on locally advanced pancreatic cancer. Silexion is currently conducting the toxicology studies to initiate the clinical trial, and those are progress...

Company’s New Groundbreaking Preclinical Data in NSCLC Models Provides Further Validation for SIL204's Innovative Delivery System; Company is Currently Conducting Additional Studies into New and Previously Untested KRAS Mutation with Results expected in the Near Future Grand Cayman, Cayman Islands, July 09, 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 new positive preclinical data demonstrating SIL204's significant efficacy in human lung cancer cell lines. The Company is also pleased to announce that it is in the process of conducting a new study examining the efficacy of SIL204 on a new previously untested KRAS mutation, the results of which it plans to release shortly. If positive, such results could further help establish SIL204 as a potential pan-KRAS treatment. In parallel, Silexion's dual-route administration strategy, leveraging both intratumoral and systemic delivery approaches, remains on track. The Company continues to prepare for the initiation of a Phase 2/3 clinical trial in Q2 2026 to investigate SIL204 for the treatment of KRAS-driven solid tumor cancers. Key Study Findings: The study revealed significant dose-dependent inhibition in lung cancer cells harboring KRAS G12D mutations, with notable efficacy, highlighting SIL204's potential as a versatile therapeutic for lung cancer. The results also support Silexion’s lipid-conjugated delivery system for enhancing SIL204 drug entrance into tumor cells; overcoming a known barrier for siRNA technology and one which is critical for therapeutic efficacy in solid tumors. Figure: SIL204 demonstrates dose-dependent inhibition in human lung cancer cells harboring KRAS G12D mutation showing robust efficacy at higher concentrations. "These new findings provide compelling evidence of SIL204's enhanced delivery capabilities in lung cancer models," said Ilan Hadar, Chairman and Chief Executive Officer of Silexion. "The ability of our lipid-conjugated siRNA to enter cancer cells represents a significant advantage for clinical applications, potentially overcoming a major challenge in RNAi therapeutics for solid tumors." In May 2025, Silexion announced the completion of initial studies exploring SIL204's potential impact on colorectal an...

Silexion Therapeutics (SLXN) announced compelling preclinical data demonstrating the efficacy of its next-generation RNAi therapeutic candidate, SIL204, against human pancreatic, colorectal and lung, NSCLC, cancer cell lines. These results significantly expand SIL204’s therapeutic potential beyond pancreatic cancer, allowing it to potentially address major KRAS-driven cancers with substantial unmet medical needs. Following the Company’s recent announcement of completion of preclinical studies, a comprehensive analysis of the data has revealed that SIL204 effectively inhibited the proliferation and metabolic activity of human cancer cell lines harboring KRAS G12D mutations across multiple cancer types, resulting in the following obvervations: The data reveals SIL204 successfully inhibited the proliferation and metabolic activity of human cancer cell lines harboring a specific KRAS mutation: GP2D, A427 and Panc-1, in a statistically significant manner. The significant inhibition was observed in a dose-dependent manner down to nanomolar concentrations. As observed in the left hand graph below, a dose-dependent reduction in cell viability was noted in GP2D colorectal cancer cells, even in the absence of external additives, due to the lipid end of SIL204. Notably, as can be seen in the right hand graph below, the Company observed an inhibition rate of approximately 90% in the presence of SIL204 in GP2D colorectal cancer cells. Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See today’s best-performing stocks on TipRanks >> Read More on SLXN: Disclaimer & DisclosureReport an Issue Silexion Therapeutics Receives Nasdaq Delisting Notice Silexion Completes Key Preclinical Studies for SIL204 Silexion Therapeutics completes preclinical studies on SIL204 Silexion Therapeutics’ Promising Future: Buy Rating Backed by Expanding Market Potential and Strong Financial Position Silexion Therapeutics Partners with Catalent for SIL204 Development

Silexion’s Revolutionary RNAi approach demonstrates powerful anti-tumor activity across three major KRAS-driven cancer types; Inhibition rate of ~90% observed in GP2D human colorectal cancer cells; Company to conduct additional preclinical study focused on lung cancer cell lines GRAND CAYMAN, Cayman Islands, May 29, 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 compelling preclinical data demonstrating the efficacy of its next-generation RNAi therapeutic candidate, SIL204, against human pancreatic, colorectal and lung (NSCLC) cancer cell lines. These results significantly expand SIL204's therapeutic potential beyond pancreatic cancer, allowing it to potentially address major KRAS-driven cancers with substantial unmet medical needs. Following the Company's recent announcement of completion of preclinical studies, a comprehensive analysis of the data has revealed that SIL204 effectively inhibited the proliferation and metabolic activity of human cancer cell lines harboring KRAS G12D mutations across multiple cancer types, resulting in the following obvervations: The data reveals SIL204 successfully inhibited the proliferation and metabolic activity of human cancer cell lines harboring a specific KRAS mutation (G12D): GP2D (colorectal), A427 (lung) and Panc-1 (pancreatic), in a statistically significant manner. The significant inhibition was observed in a dose-dependent manner down to nanomolar concentrations. As observed in the left hand graph below (figure 1), a dose-dependent reduction in cell viability was noted in GP2D colorectal cancer cells, even in the absence of external additives, due to the lipid end of SIL204. Notably, as can be seen in the right hand graph below (figure 2), the Company observed an inhibition rate of approximately 90% in the presence of SIL204 in GP2D colorectal cancer cells. The Company plans to conduct an additional study focused on the inhibition effects of SIL204 on lung (NSCLC) cancer cell lines (A427) in the coming weeks to uncover further data. "These results represent a significant expansion of SIL204's potential therapeutic applications and provide further validation to our RNAi approach of targeting KRAS mutations across multiple cancer types," sai...

Significant advancements in preclinical pipeline for SIL204, with groundbreaking data demonstrating efficacy against both primary tumors and metastases in orthotopic models; strengthened financial position with over $9 million gross funds raised in Q1 2025 GRAND CAYMAN, Cayman Islands, May 13, 2025 (GLOBE NEWSWIRE) -- Silexion Therapeutics Corp. (NASDAQ: SLXN) (“Silexion” or the “Company”), a clinical-stage biotech company developing RNA interference (RNAi) therapies for KRAS-driven cancers, today reported its financial results for the first quarter ended March 31, 2025, and provided an update on recent business developments. “The first quarter of 2025 highlighted our continued clinical traction and saw a number of major developments for Silexion, marked by strong preclinical data from our SIL204 program and successful financing activities that strengthened our balance sheet,” said Ilan Hadar, Chairman and CEO of Silexion. “Our latest orthotopic model data demonstrated SIL204’s ability to significantly reduce both primary tumor burden and metastatic spread when administered systemically, representing a potential paradigm shift in treating KRAS-driven cancers. Building on this success, we unveiled our expanded dual-route development strategy for SIL204, positioning us to potentially address both primary tumors and metastases in challenging oncology indications. With our enhanced financial position and strategic collaborations announced in the recent weeks, we believe we are well-positioned to advance our pipeline toward clinical development.” Recent Milestones & Business Highlights: Breakthrough Anti-Tumor and Anti-Metastatic Activity in Orthotopic Models: On March 5, 2025, Silexion announced positive data from orthotopic pancreatic cancer models demonstrating that subcutaneously administered SIL204 effectively reduces both primary tumor growth and metastatic spread. These findings showed a ~70% reduction in tumor cell numbers in the AsPC-1 (KRAS G12D) model and ~80% reduction in the BxPC-3 model by day 28, along with a substantial reduction in metastases to secondary organs. Extended Therapeutic Exposure and Chemotherapy Synergy Data: Earlier in the quarter, on January 28, 2025, the Company reported that a single systemic dose of SIL204 maintained effective drug levels for over 56 days in preclinical models, highlighting its potential for long-term therapeut...

Significant progress in preclinical pipeline targeting KRAS-driven solid tumor cancers with systemic administration demonstrating robust anti-tumor and anti-metastasis activity in orthotopic mouse models; Recent funding strengthens the company’s ability to deliver long term value Grand Cayman, Cayman Islands, March 18, 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 reported its financial results for the fourth quarter and full year ended December 31, 2024, and provided a corporate update. Ilan Hadar, Chairman and CEO of Silexion, commented: “2024 was a transformative year for Silexion, marked by our Nasdaq listing and the advancement of our clinical and preclinical pipeline. Over the past year, we made important progress, culminating in significant milestones especially for our second-generation candidate SIL204. In early 2025, we reported breakthrough findings from orthotopic pancreatic cancer models demonstrating SIL204’s ability to significantly reduce both primary tumor burden and metastatic spread. These results reinforce SIL204’s potential as a novel therapeutic for KRAS-driven cancers, bringing us closer to clinical development. We remain focused on advancing SIL204 towards trials and expanding its potential applications to address unmet needs in oncology.” Recent Business and Clinical Highlights Merger Completion: On August 15, 2024, Silexion completed its business combination with Moringa Acquisition Corp, becoming a publicly traded company on Nasdaq under the ticker “SLXN.” This strategic milestone provides Silexion with greater access to capital to advance its clinical pipeline Clinical Program Progress: The Company's first-generation candidate, LODER™, has previously demonstrated promise in clinical settings for non-resectable pancreatic cancer. As previously reported on September 24, 2024, the Phase 2 trial of LODER showed a 56% objective response rate (ORR) in patients with KRAS G12D/V mutations, with tumor resectability improving to 67% for some non-resectable cases. The trial data underscore LODER’s potential to improve surgical outcomes and overall survival for patients with locally advanced pancreatic cancer (LAPC). Significant Preclinical Advancements for SIL204: As previousl...