Grand Cayman, Cayman Islands, Nov. 26, 2025 (GLOBE NEWSWIRE) -- Silexion Therapeutics Corp. (“Silexion” or the “Company”), a clinical-stage, oncology-focused biotechnology company, today announced that Company management will be attending and presenting at the Noble Capital Markets' 21st Annual Emerging Growth Equity Conference (NobleCon21). Presentation details:Type: Company presentationDate: December 3, 2025Time: 2:30 – 2:55pm ETSpeakers: Ilan Hadar, Chief Executive Officer and Mirit Horenshtein-Hadar, Ch ...

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 ...

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]

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 Viewpoint - Silexion Therapeutics Corp. has announced a public offering of 1,500,000 ordinary shares and accompanying warrants at a price of $4.00 per share, aiming to raise approximately $6.0 million to advance its pre-clinical studies and for general corporate purposes [1][2]. Group 1: Offering Details - The public offering includes 1,500,000 ordinary shares, series A warrants, and series B warrants, all priced at $4.00 per share [1]. - Series A warrants will have an exercise price of $4.00, exercisable immediately, and will expire five years from issuance [1]. - Series B warrants will also have an exercise price of $4.00, exercisable immediately, but will expire twelve months from issuance [1]. - The offering is expected to close on or about September 12, 2025, pending customary closing conditions [1]. Group 2: Financial Aspects - The gross proceeds from the offering are expected to be $6.0 million before deducting fees and expenses [2]. - The net proceeds will be utilized to advance pre-clinical studies and for general corporate purposes [2]. Group 3: Company Background - Silexion Therapeutics is focused on developing RNA interference therapies for KRAS-driven cancers, particularly targeting solid tumors with mutated KRAS oncogenes [5]. - The company has conducted a Phase 2a clinical trial for its first-generation product, showing a positive trend compared to chemotherapy alone [5]. - Silexion is committed to advancing therapeutic options in oncology, specifically for locally advanced pancreatic cancer [5].

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]