Successful completion of two-species toxicology studies confirms no systemic organ toxicity, advancing the Company towards its planned regulatory submissions to Israel and Germany Company remains on track to initiate Phase 2/3 clinical trial in locally advanced pancreatic cancer in Q2 2026 Grand Cayman, Cayman Islands, Nov. 25, 2025 (GLOBE NEWSWIRE) -- Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company developing RNA interference (RNAi) therapies ...

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]

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]

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].