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]

Core Insights - Silexion Therapeutics has announced a strategic collaboration with Catalent to advance its RNA interference (RNAi) cancer therapies, specifically targeting KRAS-driven cancers [1][4] - The collaboration will focus on the formulation development and clinical manufacturing of Silexion's siRNA candidate, SIL204, at Catalent's facility in Limoges, France [2][4] - Silexion aims to initiate human clinical trials for SIL204 in the first half of 2026, following promising preclinical results [4][5] Company Overview - Silexion Therapeutics is a clinical-stage biotechnology company focused on developing RNAi therapies for solid tumors driven by KRAS mutations, which are prevalent in various cancers [6] - The company's first-generation product, LODER™, has shown promising results in Phase 2 trials for non-resectable pancreatic cancer [6] - SIL204 is designed to target a broader range of KRAS mutations and has demonstrated significant efficacy in preclinical studies [3][6] Collaboration Details - Catalent will optimize both systemic and intratumoral delivery formulations of SIL204, supporting Silexion's dual-route development strategy [2][4] - The collaboration leverages Catalent's expertise in complex formulation development to enhance SIL204's stability, bioavailability, and delivery precision [4] - Silexion plans to conduct additional toxicology and pharmacodynamic studies throughout 2025, with regulatory submissions anticipated in late 2025 and early 2026 [5]

Grand Cayman, Cayman Islands, April 23, 2025 (GLOBE NEWSWIRE) -- Silexion Therapeutics Corp. (NASDAQ:SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, today announced a strategic collaboration with Catalent, a global leader in advanced delivery technologies, clinical development, and manufacturing solutions for therapeutics. Under the agreement, Catalent will conduct formulation development and clinical manufactu ...

Core Insights - Silexion Therapeutics Corp. has announced an expanded development plan for its next-generation siRNA candidate, SIL204, targeting KRAS-driven pancreatic cancer through both systemic and intratumoral administration [1][2][3] Development Strategy - The expanded plan is based on promising preclinical findings that show SIL204 significantly inhibits tumor growth in relevant models of pancreatic cancer [2][5] - The dual-route approach aims to tackle the aggressive nature of KRAS-driven cancers, which have high mortality rates and limited treatment options [2] Clinical Development Timeline - Silexion plans to initiate human trials in the first half of 2026, following additional toxicology and pharmacodynamic studies throughout 2025 [3][5] - Regulatory submissions are expected to be made to the Israel Ministry of Health in the second half of 2025 and to the European Union in the first half of 2026 [3] Preclinical Data Support - The first-generation product, siG12DLoder, demonstrated an overall survival benefit in Phase 2 clinical trials, providing a foundation for SIL204 [5] - Recent studies indicate that subcutaneous administration of SIL204 significantly reduces metastases to secondary organs in orthotopic models, with sustained drug levels observed for approximately two months post-administration [5] Industry Engagement - The expanded development plan and recent preclinical developments will be presented at the Cancer Advocacy Group of Louisiana NeauxCancer 2025 Conference [6][7] Company Overview - Silexion Therapeutics is focused on developing RNA interference therapies for solid tumors driven by KRAS mutations, with a commitment to improving outcomes for patients with difficult-to-treat cancers [8]

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].

Financial Performance - The net loss for the nine months ended September 30, 2024, was $14,772,000, compared to a net loss of $3,428,000 for the same period in 2023, indicating an increase in losses of about 331%[13]. - The company reported a basic and diluted loss per share of $50.43 for the nine months ended September 30, 2024, compared to $28.76 for the same period in 2023, representing an increase of about 75%[13]. - The company reported a net loss of $14,696 for the nine-month period ended September 30, 2024, which is a substantial increase from the previous year's loss[19]. - The company experienced a net loss of $11,851 for the three-month period ended September 30, 2024, indicating continued operational challenges[19]. - The net loss for the nine months ended September 30, 2024, was $14,772,000 compared to a loss of $3,428,000 for the same period in 2023, indicating a significant increase in losses[22]. Assets and Liabilities - Total assets decreased from $5,256,000 as of December 31, 2023, to $3,087,000 as of September 30, 2024, representing a decline of approximately 41%[5]. - Current liabilities increased significantly from $2,196,000 to $3,583,000, marking an increase of about 63%[8]. - Total liabilities surged from $2,255,000 to $7,666,000, an increase of approximately 240%[8]. - The accumulated deficit increased from $26,811,000 to $41,583,000, reflecting a rise of about 55%[10]. - Cash and cash equivalents decreased from $4,595,000 as of December 31, 2023, to $1,973,000 as of September 30, 2024, a decline of approximately 57%[5]. Operating Expenses - Operating expenses for the nine months ended September 30, 2024, were $10,671,000, compared to $2,953,000 for the same period in 2023, reflecting a substantial increase of approximately 261%[13]. - Research and development expenses for the nine months ended September 30, 2024, were $4,944,000, up from $2,451,000 in 2023, which is an increase of approximately 102%[13]. - General and administrative expenses for the nine months ended September 30, 2024, totaled $5,727,000, significantly up from $502,000 in the same period of 2023, indicating a 1033.3% increase[84]. - The company recognized a total financial expense of $4,092,000 for the nine months ended September 30, 2024, compared to $449,000 for the same period in 2023, reflecting a substantial increase of 812.5%[84]. Cash Flow - Net cash used in operating activities for the nine months ended September 30, 2024, was $5,470,000, up from $3,272,000 in the prior year[22]. - Cash and cash equivalents at the end of the period were $2,023,000, down from $5,812,000 at the end of the previous year[24]. - The company experienced a decrease in cash and cash equivalents and restricted cash of $2,572,000 for the nine months ended September 30, 2024[22]. - Net cash provided by financing activities for the nine months ended September 30, 2024, was $2,920,000, compared to $522,000 in the same period of 2023[22]. Capital Structure - The company issued 2,413 shares of Series A-4 preferred shares, net of issuance costs, contributing $411 to the capital[16]. - The total amount of additional paid-in capital reached $37,003 as of September 30, 2024, reflecting ongoing capital raising efforts[19]. - The company completed a SPAC merger on August 15, 2024, resulting in the formation of New Silexion, which is now publicly traded on the Nasdaq under the symbols "SLXN" and "SLXNW"[27][33]. - The company has an equity line of credit (ELOC) agreement allowing it to sell up to $15,000,000 of ordinary shares until December 31, 2025[70]. Going Concern - Management has concluded there is substantial doubt about the company's ability to continue as a going concern for at least 12 months from the issuance date of the financial statements[42]. - The company expects to continue incurring losses and negative cash flows from operations, requiring financing for future research and development activities[41]. Shareholder Information - Silexion's shareholders are expected to hold approximately 61.55% of the outstanding voting interests in New Silexion post-merger[33]. - The company received a deficiency letter from Nasdaq on October 29, 2024, indicating that the closing bid price of its Ordinary Shares was below the minimum $1.00 per share for 30 consecutive business days[114]. - The Company has until April 28, 2025, to regain compliance with Nasdaq's listing requirements[114]. Miscellaneous - The company has three subsidiaries as of September 30, 2024, including Silenseed (China) Ltd., which has no significant operations[26]. - The company has pledged $25 thousand as collateral for guarantees related to lease payments as of September 30, 2024[48]. - A 1-for-9 reverse share split of the company's ordinary shares was approved by shareholders on November 19, 2024, and became effective on November 29, 2024[35]. - The company has not generated revenues to date and is still in its development and clinical stage[38].

Core Insights - Silexion Therapeutics Corp. reported significant advancements in its clinical pipeline, particularly for its second-generation candidate SIL204, which shows promise in treating KRAS-driven cancers [2][6] - The company successfully transitioned to a publicly traded entity on Nasdaq, enhancing its capital access for ongoing development [4][6] - Financial results for 2024 indicate a net loss of $16.5 million, primarily due to increased operating expenses associated with becoming a public company [9][14] Recent Business and Clinical Highlights - The completion of the merger with Moringa Acquisition Corp. on August 15, 2024, marked a strategic milestone for Silexion, providing greater access to capital [6] - SIL204 demonstrated significant preclinical efficacy, reducing primary tumor burden and metastatic spread in pancreatic cancer models [6][9] - The company plans to initiate Phase 2/3 clinical trials for SIL204 by the first half of 2026, targeting locally advanced pancreatic cancer (LAPC) [6][9] Financial Highlights - Cash and cash equivalents decreased to $1.2 million as of December 31, 2024, down from $4.6 million in 2023, reflecting operational expenses and investments in clinical development [9][11] - Total operating expenses for 2024 were $12.6 million, a significant increase from $4.7 million in 2023, driven by one-time expenses related to the business combination [9][14] - The company raised approximately $9.1 million in gross proceeds through various financing activities post-reporting date, extending its operational runway [9][12] Clinical Program Progress - The first-generation candidate LODER™ showed a 56% objective response rate in a Phase 2 trial for patients with KRAS G12D/V mutations, with tumor resectability improving to 67% [6][9] - SIL204's preclinical studies confirmed its potential for long-term therapeutic exposure, maintaining effective drug levels for over 56 days [6][9] - The company is also exploring SIL204's applications in colorectal cancer, expanding its focus on KRAS-driven cancers [6][9] Board and Management Updates - Prof. Amnon Peled was appointed to the Board of Directors in December 2024, bringing expertise in cancer therapeutics [6][9]

Financial Performance - The company incurred net losses of $16.5 million and $5.1 million for the years ended December 31, 2024 and December 31, 2023, respectively, with an accumulated deficit of $43.3 million as of December 31, 2024[205]. - As of December 31, 2024, the company's cash and cash equivalents were $1.2 million, raising substantial doubt about its ability to continue as a going concern[215]. - The company has never generated any revenue from product sales and does not anticipate doing so for the foreseeable future[210]. - Future net losses will depend on the rate of expenditures and the ability to obtain funding through equity or debt financings, strategic collaborations, or grants[206]. - The company expects to continue incurring significant expenses and increasing operating losses as it expands research and clinical development[208]. Product Development and Regulatory Challenges - The company has not yet commenced pivotal clinical studies for any product candidate, and it may take several years before any product candidate is approved for commercialization[206]. - The regulatory approval process for RNAi-based therapeutics is complex and uncertain, which may lengthen the timeline for product candidates[226]. - The company has concentrated its efforts on RNAi technology, which is unproven for oncology and may never lead to marketable products[223]. - The company may be required to change its product development strategy if it is not successful in developing a product candidate using RNAi technology[227]. - The company has invested significantly in developing product candidates, including preclinical and clinical studies, but currently generates no revenue from drug sales[228]. Clinical Trials and Patient Recruitment - The first-generation Loder Phase II study has concluded, and the company plans to initiate the next clinical trial with SIL204 for locally advanced pancreatic cancer in the first half of 2026[229]. - Patient recruitment for clinical studies may be challenging, particularly for rare diseases like pancreatic cancer, which had approximately 61,000 diagnoses in the U.S. in 2020[241]. - Clinical drug development is expensive and time-consuming, with a high failure rate in later-stage studies despite promising early results[237]. Regulatory Compliance and Risks - The company must comply with varying regulatory requirements across jurisdictions, and success in one does not guarantee success in others[231]. - Undesirable side effects from product candidates could delay or prevent regulatory approval and impact market acceptance[244]. - If approved, products will be subject to ongoing regulatory scrutiny and may require post-marketing studies to confirm safety and efficacy[248]. - Regulatory authorities may impose restrictions or withdraw approvals if unknown problems arise post-approval, significantly affecting the company's operations[252]. - The company has never produced a commercially approved pharmaceutical product and lacks the necessary regulatory authority approvals[254]. Manufacturing and Supply Chain Risks - The company relies on third-party manufacturers for raw materials and products, increasing the risk of supply disruptions and quality issues[266]. - The company does not currently have the infrastructure to produce product candidates at commercial levels and has not entered into binding agreements with manufacturers for commercialization[271]. - Manufacturing processes are complex and highly regulated, with risks including contamination and equipment failure that could disrupt supply[260]. Market Competition and Commercialization - The biotechnology and pharmaceutical industries are highly competitive, with numerous existing therapies that may compete with the company's product candidates[274]. - The company currently lacks a marketing and sales organization, which is essential for generating revenue from product candidates[276]. - The company may face challenges in estimating the size of the required sales force for effective commercialization, potentially leading to excess costs[277]. - The market acceptance of Silexion's product candidates will depend on factors such as safety, efficacy, pricing, and reimbursement availability[281]. - The company faces significant risks related to the competitive landscape, particularly in the RNAi therapeutic space, which may become more competitive[280]. Intellectual Property and Patent Risks - The company has pending PCT applications for patent protection in multiple international jurisdictions, which is crucial for maintaining a competitive edge[299]. - The ability to obtain and maintain effective patent rights is essential for the company to compete effectively in its markets[299]. - The company faces significant uncertainties regarding its patent applications, which may not result in issued patents that adequately cover its product candidates[302]. - The natural expiration of patents in the United States is generally 20 years after filing, and the company may not have sufficient patent terms to protect its products effectively[306]. - The company may encounter earlier-than-expected competition from generic and biosimilar manufacturers due to challenges against its patents[308]. Financial and Market Risks - The company received two letters from Nasdaq regarding non-compliance with listing requirements, specifically a Market Value of Listed Securities (MVLS) below $50 million and a Market Value of Publicly Held Shares (MVPHS) below $15 million[366]. - The company has outstanding amounts under the A&R Sponsor Promissory Note totaling $3,433,000, which could lead to further dilution of existing shareholders[374]. - The company’s ordinary shares and warrants may experience significant price volatility due to various factors, including market conditions and operational results[370]. - The company may consider transferring its listing to the Nasdaq Capital Market if it meets the necessary requirements, but there is no assurance of qualifying for such a transfer[367]. Operational and Strategic Risks - The company may face challenges in enforcing non-competition agreements with former employees, potentially impacting its competitive position[363]. - The company is at risk of economic boycotts and restrictive laws that could adversely affect its operating results and expansion efforts[358]. - Strategic alliances and acquisitions may present unforeseen integration challenges and could divert management's focus from ongoing operations[351]. - The company may face significant product liability risks, which could lead to substantial liabilities and limit commercialization of approved products[346]. Miscellaneous Risks - Cybersecurity risks are increasing, with potential disruptions to operations that could materially affect research and development programs and financial results[344]. - Political instability in Israel may adversely impact the company’s operations and financial condition, as it has faced multiple elections and judicial changes since 2019[361]. - Conditions in the Middle East, including armed conflicts, may pose risks to the company's operations in Israel[354].

Core Findings - Silexion Therapeutics Corp. has released data indicating that SIL204 effectively reduces primary tumor growth and metastatic spread in orthotopic pancreatic cancer models [1][4] - The study validates SIL204's efficacy in a clinically relevant setting, where human pancreatic tumor cells are implanted directly into the pancreas [1][4] Efficacy of SIL204 - SIL204 demonstrated significant efficacy in orthotopic xenograft models, showing robust activity across multiple pancreatic cancer cell lines with different KRAS mutation profiles [4] - In AsPC-1 (KRAS G12D mutation), there was approximately a 70% reduction in overall bioluminescence by day 28 compared to the control group [4] - In Panc-1 (KRAS G12D mutation), bioluminescence decreased in a dose-dependent manner, with the highest-dose group showing the most significant effect, while the control group saw an increase of over 100% [4] - In BxPC-3 (KRAS wild-type model), there was an approximately 80% reduction in overall bioluminescence by day 28 compared to the control group [4] Metastatic Spread and Administration - SIL204 treatment significantly reduced metastatic spread to secondary organs, confirming its effectiveness in treating pancreatic tumors and their metastases [4] - The subcutaneous administration of SIL204 proved effective in reaching pancreatic tumors, supporting systemic delivery as a viable administration route [4] Market Reaction - Following the release of the data, SLXN stock increased by 25.23%, reaching $1.39 [3]

Core Insights - Silexion Therapeutics announced positive data indicating that SIL204, when administered subcutaneously, effectively reduces both primary tumor growth and metastatic spread in orthotopic pancreatic cancer models [1][4] Group 1: Efficacy of SIL204 - SIL204 demonstrated significant efficacy in orthotopic xenograft models, which better mimic human disease progression compared to previous models [2][3] - In AsPC-1 models with KRAS G12D mutation, SIL204 achieved approximately 70% reduction in overall bioluminescence by day 28 compared to control [3] - In Panc-1 models, tumor cell numbers decreased significantly in a dose-dependent manner, with a 12% decrease in bioluminescence compared to baseline by day 14, while control increased by over 100% [3] - In BxPC-3 models, SIL204 resulted in around 80% reduction in overall bioluminescence by day 28 compared to control [3] Group 2: Metastasis Reduction - For the first time, SIL204 treatment showed a significant reduction in metastatic spread to secondary organs, lowering metastatic burden in the liver, intestine, spleen, and stomach [3][4] Group 3: Systemic Delivery Validation - Subcutaneous administration of SIL204 confirmed its effectiveness in treating pancreatic tumors and their metastases, validating systemic delivery as a viable route [4] - The company is exploring an expanded development plan for SIL204 based on these findings, with an updated strategy expected soon [4][5] Group 4: Company Overview - Silexion Therapeutics is focused on developing RNA interference therapies for KRAS-driven cancers, with SIL204 being a next-generation candidate targeting a broader range of KRAS mutations [5]