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]

Core Insights - Silexion Therapeutics has completed the data collection phase for its first evaluation of SIL-204 in clinically relevant orthotopic pancreatic cancer models, marking a significant milestone in its development program [1][2][3] Company Overview - Silexion Therapeutics is a clinical-stage biotechnology company focused on developing RNA interference (RNAi) therapies for KRAS-driven cancers, with its first-generation product, LODER™, showing promising results in Phase 2 trials for non-resectable pancreatic cancer [4] - The company is advancing its next-generation siRNA candidate, SIL-204, which targets a broader range of KRAS mutations [4] Study Details - The study evaluated SIL-204's ability to reduce primary tumor growth and metastatic spread in orthotopic pancreatic cancer models, which better reflect human pancreatic cancer biology compared to traditional subcutaneous xenograft models [2][6] - The orthotopic models allow for a more accurate assessment of tumor behavior and therapeutic efficacy against both primary and metastatic disease [2] Future Expectations - Initial results from the study are expected to be reported in March 2025, which will inform Silexion's development strategy for SIL-204 [3]

Core Viewpoint - Silexion Therapeutics Corp. has entered into agreements for the immediate exercise of warrants to purchase 2,221,523 ordinary shares at an exercise price of $1.35 per share, expecting gross proceeds of approximately $3.3 million, which will be used for working capital and general corporate purposes [1][3]. Group 1: Financial Details - The gross proceeds from the exercise of the warrants are expected to be approximately $3.3 million before deducting fees and expenses [1]. - The company will issue new unregistered warrants to purchase the same number of ordinary shares at an exercise price of $1.50 per share, with a term of twenty-four months [3]. - The additional payment for the new warrants totals $277,690.38, included in the gross proceeds [3]. Group 2: Regulatory and Compliance - The new warrants and the shares issuable upon their exercise are not registered under the Securities Act of 1933 and may not be sold in the U.S. without registration or an exemption [4]. - The company has agreed to file a registration statement with the SEC for the resale of the ordinary shares from the new warrants [4]. Group 3: Company Overview - Silexion Therapeutics is focused on developing RNA interference therapies for KRAS-driven cancers, with its first-generation product, LODER™, showing promise in Phase 2 trials for non-resectable pancreatic cancer [6]. - The company is advancing its next-generation siRNA candidate, SIL-204, which targets a broader range of KRAS mutations and has shown significant potential in preclinical studies [6].

Core Insights - Silexion Therapeutics Corp. announced promising preclinical data for SIL-204, demonstrating significant tumor growth reduction in orthotopic pancreatic cancer models, validating systemic administration as an effective delivery method [1][2][5] Preclinical Data Highlights - SIL-204 reduced tumor growth by approximately 50% after 30 days, with around 50% of tumors showing complete necrosis in human pancreatic tumors with a G12D mutation xenografted into mice [7] - A single systemic administration of SIL-204 maintained effective drug levels in rat plasma and tissues for over 56 days [7] - SIL-204 inhibits key oncogenic KRAS mutations, including G12D, G12V, G12R, Q61H, and G13D [7] - Intratumoral administration of SIL-204 microparticles reduced tumor cell numbers by approximately 3-fold and increased tumor necrosis by approximately 5-fold after 15 days in human pancreatic cancer xenograft harboring a KRAS G12V mutation in mice [7] Future Development Plans - The company is exploring how the new data can inform an expanded treatment strategy for KRAS-driven cancers and plans to announce details of its expanded development plan shortly [3]

Company Overview - Silexion Therapeutics is a clinical-stage biotechnology company focused on developing RNA interference (RNAi) therapies for KRAS-driven cancers, which are the most common oncogenic drivers in human cancers [7] - The company's first-generation product, LODER™, has shown promising results in a Phase 2 trial for non-resectable pancreatic cancer [7] - Silexion is advancing its next-generation siRNA candidate, SIL-204, designed to target a broader range of KRAS mutations and showing significant potential in preclinical studies [7] Public Offering Details - Silexion Therapeutics announced the pricing of a public offering of 3,703,703 ordinary shares (or equivalents) and warrants to purchase up to 3,703,703 ordinary shares at a combined public offering price of $1.35 per share [5] - The warrants have an exercise price of $1.35 per share, are exercisable immediately upon issuance, and will expire five years from the date of issuance [5] - The gross proceeds from the offering, before deducting fees and expenses, are expected to be approximately $5.0 million [6] - The net proceeds will be used to advance the company's pre-clinical studies and for general corporate purposes [6] Regulatory and Offering Information - The securities are being offered pursuant to a registration statement on Form S-1 (File No. 333-282932), which was declared effective by the SEC on January 15, 2025 [2] - H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering [6] - The closing of the offering is expected to occur on or about January 17, 2025, subject to customary closing conditions [5]

Core Insights - Silexion Therapeutics Corp. has announced new preclinical results showing the synergistic efficacy of its siRNA candidate SIL-204 in combination with first-line chemotherapy agents for pancreatic cancer, specifically 5-fluorouracil and irinotecan, as well as gemcitabine [2][4] Group 1: Preclinical Results - SIL-204 demonstrates significant synergistic activity with 5-fluorouracil and irinotecan in human pancreatic tumor cell lines with KRAS G12D mutations, which are the most common mutations in pancreatic cancer [2][3] - The combination of SIL-204 with 5-fluorouracil and irinotecan resulted in a significant reduction in cancer cell confluence after approximately three days, with a p-value of less than 0.0005, indicating strong statistical significance [3] Group 2: Clinical Development Plans - Silexion plans to initiate toxicology studies for SIL-204 in the upcoming months and aims to advance it into Phase 2/3 clinical trials in the first half of 2026, focusing on locally advanced pancreatic cancer (LAPC) [5] - The company is also preparing to conduct preclinical studies for SIL-204 in colorectal cancer models [5] Group 3: Company Overview - Silexion Therapeutics is a clinical-stage biotechnology company focused on developing RNA interference therapies targeting 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, indicating a strong foundation for its ongoing research and development efforts [6]