SIL204 Demonstrated Significant Tumor Inhibition in Positive Pre Clinical Studies with Activity Across Pancreatic, Colorectal, and Lung Cancer Models Company’s Platform Seeks to Address an Estimated $30+ Billion Global KRAS-Driven Cancer Market with Pan-KRAS Therapeutic Platform Initiation of Phase 2/3 Clinical Trial in LAPC Planned for H1 2026 Following Positive Regulatory Feedback and Successful Toxicology Studies Grand Cayman, Cayman Islands, Jan. 06, 2026 (GLOBE NEWSWIRE) -- Silexion Therapeutics Corp ( ...

Regulatory submission marks a significant milestone as the Company advances toward Phase 2/3 trial initiation in Q2 2026 at full speed Application follows recent successful toxicology studies, positive German regulatory feedback, and strong preclinical data demonstrating up to 99.7% cancer cell inhibition Regulatory filings in Germany and the EU are planned for Q1 2026, with U.S. expansion anticipated following the safety run-in Grand Cayman, Cayman Islands, Dec. 16, 2025 (GLOBE NEWSWIRE) -- Silexion Therap ...

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 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]

Core Insights - Silexion Therapeutics is advancing towards the initiation of Phase 2/3 clinical trials for its RNA interference therapy SIL204, targeting KRAS-driven cancers, with a timeline set for the first half of 2026 [1][2] - The company has successfully raised over $9 million in the third quarter of 2025, significantly improving its financial position [1][5] Clinical Development - Silexion is on track with its operational readiness for the planned Phase 2/3 clinical trials of SIL204, with toxicology studies progressing as scheduled [2] - Regulatory submissions are expected to be filed with the Israel Ministry of Health in Q4 2025 and in Germany and the EU in Q1 2026 [2] - New preclinical data shows SIL204's high efficacy against multiple human cancer cell lines, demonstrating effectiveness against five KRAS-driven cancer types, including pancreatic, lung, colorectal, and gastric cancers [3] Financial Performance - The company raised approximately $9.5 million in gross proceeds during Q3 2025, increasing cash and cash equivalents to $9.2 million, up from $3.5 million at the end of Q2 2025 [5][10] - Shareholders' equity rose to $7.0 million, a significant improvement from a capital deficiency of $4.0 million at year-end 2024 [5] - The net loss for Q3 2025 was $3.3 million, or ($2.88) per share, a decrease of approximately 72.3% compared to a net loss of $11.9 million, or ($274.25) per share, for the same period in 2024 [11] Strategic Partnerships - Silexion has selected AMS Advanced Medical Services GmbH as its contract research organization (CRO) to support the upcoming Phase 2/3 clinical trials, leveraging AMS's extensive experience in oncology clinical development [4] Compliance and Governance - The company has regained compliance with Nasdaq's listing requirements, confirming its continued listing on the Nasdaq Capital Market [6]

Core Insights - Silexion Therapeutics has confirmed the efficacy of SIL204 as a pan-KRAS inhibitor, demonstrating high inhibition rates across various KRAS mutations in human cancer cell lines [1][2][3] - The company has expanded its therapeutic reach to include gastric cancer, with SIL204 showing activity against multiple cancer types, including pancreatic and colorectal cancers [1][5][6] Summary by Sections Company Overview - Silexion Therapeutics is a clinical-stage biotechnology company focused on developing RNA interference therapies for KRAS-driven cancers [7] Therapeutic Development - SIL204 has shown inhibition rates between 83.5% to 99.7% across eleven human cancer cell lines with specific KRAS mutations [1][7] - The drug has demonstrated significant activity against clinically relevant mutations, including G12R, which is present in 17% of pancreatic cancer cases [2][5] Clinical Trials and Future Plans - The company plans to advance SIL204 into Phase 2/3 clinical trials in the first half of 2026, with regulatory submissions expected in Q4 2025 for Israel and Q1 2026 for the European Union [6][8] Key Findings - SIL204's activity encompasses KRAS mutation variants that represent nearly all KRAS-driven cancers, with mutations found in approximately 90% of pancreatic cancers, 45% of colorectal cancers, and 35% of non-small cell lung cancers [5][6] - The highest inhibition reported was 99.7% in NCIH2009 lung cancer cells with a G12A mutation, marking SIL204's strongest activity to date [7]

Core Points - Silexion Therapeutics Corp has regained compliance with Nasdaq's minimum bid price and shareholders' equity requirements, ensuring its continued listing on the Nasdaq Capital Market [1][2][3] Company Overview - Silexion Therapeutics is a clinical-stage biotechnology company focused on developing RNA interference therapies for KRAS-driven cancers, particularly targeting solid tumors with mutated KRAS oncogenes [4] - The company has conducted a Phase 2a clinical trial for its first-generation product, showing a positive trend compared to chemotherapy alone [4] Financial Compliance - The company met the minimum bid price requirement of $1.00 per share and the minimum shareholders' equity requirement of $2.5 million, as confirmed by Nasdaq [2][3] - This compliance reinforces the company's strong financial foundation as it prepares for Phase 2/3 clinical trials for its lead product SIL204 in the first half of 2026 [3] Clinical Development - Recent preclinical data indicated up to 97% inhibition rates across multiple KRAS-driven cancer types, supporting the company's clinical development strategy [3] - The company is focused on delivering transformative RNAi therapies to patients with difficult-to-treat cancers [3]

Core Insights - Silexion Therapeutics Corp. has released promising preclinical data for its drug SIL204, which shows effective targeting and anti-tumor activity against pancreatic cancer metastasis [1][3][4] Group 1: Study Findings - SIL204 demonstrated successful biodistribution to all major metastatic sites after a single subcutaneous injection at a dose of 5 mg/mouse, which is a mid-range human equivalent dose for planned clinical trials [2][3] - Significant reductions in tumor burden were observed at day 7 across evaluated organs, with statistically significant reductions (p<0.01) noted in the peritoneum, lung, and intestine [3] - The liver, a common site for pancreatic cancer metastasis, also showed measurable tumor burden reduction, validating the drug's potential for clinical application [4] Group 2: Future Plans - The company is expanding tissue culture studies across various cancer types and KRAS mutations to further explore SIL204's pan-KRAS potential, with results anticipated soon [5] - Silexion is on track to initiate Phase 2/3 clinical trials for its dual-route administration approach in the first half of 2026, with regulatory submissions planned for late 2025 and early 2026 [5] Group 3: Financial Actions - Silexion Therapeutics has priced a public offering of 1.5 million shares along with series A and B warrants, each at $4 per share, which will also have an exercise price of $4.00 per share [6] - Following the news, SLXN stock increased by 14.83%, reaching $5.15 [6]

Core Insights - Silexion Therapeutics Corp. announced new preclinical data showing that SIL204 effectively targets primary and metastatic sites in pancreatic cancer, demonstrating measurable reductions in tumor burden at clinically relevant doses [1][4][5] Group 1: Study Findings - SIL204 was administered subcutaneously in a metastatic pancreatic cancer mouse model, confirming its distribution to key organs and significant reductions in tumor burden across multiple sites [2][5] - A single subcutaneous injection of 5 mg/mouse resulted in statistically significant reductions in tumor burden in the peritoneum, lung, and intestine, with the liver also showing measurable reductions [5] - The study utilized human pancreatic cancer cells with the KRAS G12D mutation, validating the relevance of the dosing for planned clinical use [5] Group 2: Clinical Development Plans - Silexion is on track to initiate Phase 2/3 clinical trials for SIL204 in the first half of 2026, with regulatory submissions planned for Q4 2025 and Q1 2026 [1][9] - The company is expanding tissue culture studies across various cancer types and KRAS mutations to further explore SIL204's potential [8] Group 3: Company Overview - Silexion Therapeutics focuses on developing RNA interference therapies for KRAS-driven cancers, aiming to address the challenges of treating solid tumors with mutated KRAS oncogenes [10]