KRAS-driven cancers
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Silexion Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-11-12 14:00
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]
Silexion Therapeutics Announces Positive New Human Cell Line Data Confirming Pan-KRAS Activity of SIL204, Demonstrating Up to 99.7% Inhibition and First Evidence in Gastric Cancer
Globenewswire· 2025-09-30 12:40
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]
Silexion Therapeutics Regains Compliance with Nasdaq Listing Requirements
Globenewswire· 2025-09-25 12:45
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]
Silexion Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-05-13 20:45
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]
Silexion Therapeutics Announces Completion of Innovative Expanded Development Plan for SIL204 which will be unveiled at the 2025 NeauxCancer Conference
Globenewswire· 2025-03-21 12:30
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].