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 ( ...

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]

Financial Performance - Silexion successfully 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] - The net loss for Q3 2025 was $3.3 million, or ($2.88) per share, representing a decrease of approximately 72.3% from a net loss of $11.9 million, or ($274.25) per share, in Q3 2024[10] - Shareholders' equity rose to $7.0 million as of September 30, 2025, a substantial improvement from a capital deficiency of $4.0 million at year-end 2024[5] - The net loss for the nine months ended September 30, 2025, was $7,500,000, a reduction of 49.3% from $14,772,000 in 2024[20] - Loss per share for the nine months ended September 30, 2025, was $10.36, compared to $754.85 in the same period of 2024[20] - The operating loss for the three months ended September 30, 2025, was $3,292,000, down from $8,036,000 in the same period of 2024[20] - The net loss for the three months ended September 30, 2025, was $3,262,000, compared to $11,860,000 in 2024, reflecting a 72.5% improvement[20] - The company reported a loss before income tax of $7,497,000 for the nine months ended September 30, 2025, down from $14,763,000 in 2024[20] Expenses - Research and Development (R&D) expenses for Q3 2025 were $2.2 million, a decrease of 31.3% compared to $3.2 million in Q3 2024, primarily due to the absence of non-cash share-based compensation expenses[10] - General and Administrative (G&A) expenses for Q3 2025 were $1.1 million, down 77.1% from $4.8 million in Q3 2024, mainly due to the absence of non-cash share-based compensation expenses[10] - Total operating expenses for the nine months ended September 30, 2025, were $7,226,000, a decrease of 32.9% from $10,671,000 in the same period of 2024[20] - Research and development expenses for the nine months ended September 30, 2025, were $3,765,000, down 23.8% from $4,944,000 in 2024[20] - General and administrative expenses for the nine months ended September 30, 2025, were $3,461,000, a decrease of 39.7% compared to $5,727,000 in 2024[20] - Financial expenses for the nine months ended September 30, 2025, were $271,000, a decrease from $4,092,000 in 2024[20] Assets and Compliance - Silexion's total assets as of September 30, 2025, were $11.6 million, significantly up from $2.9 million as of December 31, 2024[17] - Silexion regained compliance with Nasdaq listing requirements, confirming continued listing on the Nasdaq Capital Market as of September 23, 2025[6] Clinical Development - The company is on track to initiate Phase 2/3 clinical trials for SIL204 in the first half of 2026, with regulatory submissions expected in Q4 2025 and Q1 2026[2] - SIL204 demonstrated high efficacy against five KRAS-driven cancer types, successfully killing cancer cells across multiple mutations, including those found in pancreatic, lung, colorectal, and gastric cancers[3] - Silexion selected AMS Advanced Medical Services GmbH as its contract research organization to support the upcoming Phase 2/3 clinical trials, leveraging their extensive oncology experience[4]

Financial Performance - The company reported a net loss of $7,500,000 for the nine months ended September 30, 2025, a decrease from a net loss of $14,772,000 for the same period in 2024, reflecting a 49% improvement[30]. - The loss per share for the nine months ended September 30, 2025, was $10.36, significantly lower than the loss per share of $754.85 for the same period in 2024[30]. - The company experienced a net loss of $(7,500,000) for the period ending September 30, 2025[35]. - The company reported a net loss of $11,851,000 for the three months ended September 30, 2024[38]. - The company experienced a net loss of $3,262,000 as of September 30, 2025[39]. - The company reported an accumulated deficit of $50.8 million as of September 30, 2025, reflecting ongoing financial challenges since inception[125]. - Net loss decreased by approximately $7.3 million, or 49.3%, to $7.5 million for the nine-month period ended September 30, 2025, compared to $14.8 million for the same period in 2024[148]. - Net loss decreased by approximately $8.6 million, or 72.3%, to $3.3 million for the three-month period ended September 30, 2025, compared to $11.9 million for the same period in 2024[155]. Assets and Liabilities - As of September 30, 2025, total assets increased to $11,614,000 from $2,863,000 as of December 31, 2024, representing a growth of approximately 305%[25]. - Current assets rose significantly to $11,055,000 compared to $2,250,000 at the end of 2024, marking an increase of about 390%[25]. - The company’s total liabilities decreased to $4,637,000 as of September 30, 2025, from $6,852,000 at the end of 2024, a reduction of approximately 32%[28]. - Shareholders' equity improved to $6,977,000 as of September 30, 2025, compared to a capital deficiency of $3,989,000 at the end of 2024, indicating a positive shift in equity status[28]. - The balance of ordinary shares as of September 30, 2025, is projected to be 3,126,642, with a capital deficiency of $(50,754,000)[35]. - The total capital deficiency was reported at $50,754,000 as of September 30, 2025[39]. - The company has incurred total losses of $16,519,000 for the year ended December 31, 2024, indicating a need for ongoing financial support[52]. Cash Flow and Financing - The company raised $11,000,000 from public offerings in January 2025 and September 2025, and an additional $2,300,000 from SPAC merger transactions[42]. - The company is currently evaluating various financing alternatives to support future research and development activities, as it has not yet generated revenues[51]. - The company anticipates needing to raise additional capital to finance operations and expand the business within the next 12 months[159]. - The company entered into an At-The-Market (ATM) Agreement to raise up to $13.17 million in ordinary shares, with no sales made under this agreement during Q3 2025 due to customary restrictions[177]. - The company plans to finance cash needs through public and private equity offerings, but adequate financing may not be available on acceptable terms[212]. - Reliance on equity financing could lead to significant dilution of current shareholders' equity interests[213]. Research and Development - Research and development expenses decreased to $3,765,000 for the nine months ended September 30, 2025, compared to $4,944,000 in 2024, a decline of about 24%[30]. - The company expects to continue investing in research and development for SIL204, anticipating an increase in related expenses in the future[138]. - The lead product candidate, SIL204, targets the mutated KRAS oncogene, which is present in approximately 92% of pancreatic cancer patients[119]. - The company plans to initiate a clinical trial for SIL204, which is designed to improve clinical outcomes for pancreatic cancer patients[120]. - The company is focused on expanding its intellectual property portfolio and hiring additional personnel to support its operations and product development[130]. Operational Efficiency - Operating expenses for the nine months ended September 30, 2025, totaled $7,226,000, down from $10,671,000 in 2024, indicating a reduction of approximately 32%[30]. - General and administrative expenses for the nine months ended September 30, 2025, were $3,461,000, down 39.6% from $5,727,000 in the same period of 2024[69]. - Financial expenses, net decreased by approximately $3.8 million, or 92.7%, to $0.3 million for the nine-month period ended September 30, 2025, compared to $4.1 million for the same period in 2024[147]. - General and administrative expenses decreased by approximately $3.7 million, or 77.1%, to $1.1 million for the three-month period ended September 30, 2025, compared to $4.8 million for the same period in 2024[153]. Going Concern and Future Outlook - The company has substantial doubt about its ability to continue as a going concern for at least 12 months from the date the financial statements are issued[54]. - The financial statements assume the company will continue as a going concern, which may not be realized if additional funding is not secured[208]. - The company faces uncertainties regarding the timing and costs associated with the development of product candidates, including SIL204[211]. - The company has expressed substantial doubt about its ability to continue as a going concern without additional capital[160].

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]