Core Insights - Silexion Therapeutics is pioneering RNA interference (RNAi) therapies targeting KRAS-driven cancers, which are notoriously difficult to treat with traditional methods [2][3] - The lead candidate, SIL204, has shown promising preclinical results in reducing tumor growth and metastasis across various cancer types, including pancreatic, colorectal, and lung cancers [2][5] Technological Platform - Silexion's technology targets KRAS mutations at the genetic level, differing from conventional small molecule inhibitors, aiming to prevent oncogenic protein production [4] - SIL204 can target multiple KRAS mutations, which are prevalent in various cancers: approximately 90% in pancreatic cancers, 45% in colorectal cancers, and 35% in non-squamous non-small-cell lung cancers [5] Preclinical Developments - A significant milestone was reached in March 2025 with the completion of studies using orthotopic pancreatic cancer models, providing a more accurate representation of cancer progression [6] - SIL204 demonstrated notable efficacy in reducing tumor cell numbers across different pancreatic cancer cell lines, indicating a nuanced understanding of therapeutic interventions [7] Strategic Approach - Silexion focuses on two primary drug delivery methods: systemic delivery for metastatic progression and intratumoral delivery for primary tumors, collaborating with Catalent to enhance formulation and manufacturing processes [8] - The company's research extends beyond pancreatic cancer, exploring applications in colorectal and lung cancers, reflecting a comprehensive understanding of KRAS-driven malignancies [9] The Road Ahead - Silexion's development roadmap includes continued preclinical studies, toxicology and pharmacodynamic investigations, potential regulatory submissions, and plans to initiate human clinical trials in the first half of 2026 [10] - The scientific community is closely monitoring Silexion's progress, as successful outcomes could significantly impact cancer therapeutics and precision oncology [11]

Core Insights - Silexion Therapeutics is advancing its next-generation RNA interference (RNAi) therapeutic candidate, SIL204, targeting KRAS-driven cancers beyond pancreatic cancer, with treatment markets estimated at over $30 billion annually [1][3]. 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 [4]. - The company's first-generation product, LODER™, has shown promising results in Phase 2 trials for non-resectable pancreatic cancer [4]. Study Details - The completed preclinical studies evaluated SIL204 in cancer cell lines with KRAS mutations, including colorectal cancer (GP2D), lung cancer (A427), and pancreatic cancer (Panc-1), chosen for their high prevalence of KRAS mutations and significant unmet medical needs [2][3]. - KRAS mutations are found in approximately 90% of pancreatic cancers, 45% of colorectal cancers, and 35% of non-squamous non-small-cell lung cancers, highlighting the potential market for SIL204 [3]. Future Prospects - The completion of the expanded preclinical evaluation is seen as a significant milestone for the SIL204 development program, with expectations for positive results that could broaden the company's development strategy [3].

Financial Performance - Silexion raised over $9 million in gross funds during Q1 2025, strengthening its financial position[1] - The company reported a net loss of $1.7 million for Q1 2025, compared to a net loss of $1.4 million in Q1 2024, primarily due to increased general and administrative expenses[7] - Cash and cash equivalents increased to $6.2 million as of March 31, 2025, up from $1.2 million as of December 31, 2024[7] - Total operating expenses for Q1 2025 were $1.7 million, an increase from $1.3 million in the same period of 2024[7] - Research and development expenses decreased to $0.6 million in Q1 2025 from $1.0 million in Q1 2024, reflecting reduced subcontractor costs[7] - Total assets increased to $8.3 million as of March 31, 2025, compared to $2.9 million as of December 31, 2024[9] Product Development - SIL204 demonstrated a ~70% reduction in tumor cell numbers in the AsPC-1 model and ~80% reduction in the BxPC-3 model by day 28 in preclinical studies[3] - The company unveiled an expanded dual-route development strategy for SIL204, targeting both primary tumors and metastases, with clinical trials planned to start in the first half of 2026[3] - Silexion announced a strategic collaboration with Catalent for formulation development and clinical manufacturing activities for SIL204[3] - The company completed a public offering raising approximately $5.0 million in gross proceeds during Q1 2025[3]

PART I - FINANCIAL INFORMATION [Financial Statements](index=7&type=section&id=Item%201.%20Financial%20Statements) The company reported an increased net loss for Q1 2025, primarily due to higher G&A expenses, while significantly improving liquidity and balance sheet strength, despite a 'going concern' warning Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $6,152 | $1,187 | | Total Assets | $8,308 | $2,863 | | Total Liabilities | $5,722 | $6,852 | | Total Shareholders' Equity (Deficiency) | $2,586 | $(3,989) | Condensed Consolidated Statements of Operations (Unaudited) | Account | Three months ended March 31, 2025 (in thousands) | Three months ended March 31, 2024 (in thousands) | | :--- | :--- | :--- | | Research and development | $590 | $961 | | General and administrative | $1,060 | $289 | | Operating Loss | $(1,650) | $(1,250) | | Net Loss | $(1,735) | $(1,423) | | Loss Per Share (Basic and Diluted) | $0.26 | $12.29 | Condensed Consolidated Statements of Cash Flows Highlights (Unaudited) | Cash Flow Activity | Three months ended March 31, 2025 (in thousands) | Three months ended March 31, 2024 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | $(2,453) | $(1,752) | | Net cash used in investing activities | $(6) | $(6) | | Net cash provided by financing activities | $7,432 | $* | | Net increase (decrease) in cash | $4,973 | $(1,758) | - 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, due to **recurring losses** and **negative operating cash flows**[45](index=45&type=chunk)[46](index=46&type=chunk)[47](index=47&type=chunk) - In January 2025, the company raised approximately **$5.0 million** in gross proceeds from a public offering of shares and warrants, and an additional **$3.3 million** in gross proceeds from an induced warrant exercise transaction[62](index=62&type=chunk)[67](index=67&type=chunk) - On March 13, 2025, the company settled its outstanding convertible promissory note with EarlyBird by extinguishing the **$880,000** balance through a cash payment of **$551,000** and the issuance of **277,777** ordinary shares[72](index=72&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The clinical-stage biotech company's Q1 2025 net loss increased due to higher G&A expenses, despite improved liquidity from recent financings, but faces a 'going concern' risk with limited cash reserves - The company is a **clinical-stage, oncology-focused biotechnology company** developing treatments for cancers driven by the **KRAS oncogene**. Its lead product candidate is **SIL204**, an **siRNA-based therapeutic** for locally advanced pancreatic cancer[98](index=98&type=chunk) - Research and development expenses **decreased by 40%** to **$0.6 million** in Q1 2025 from **$1.0 million** in Q1 2024, mainly due to a **$0.5 million** reduction in subcontractor costs related to API development activities[114](index=114&type=chunk) - General and administrative expenses **increased by 266.7%** to **$1.1 million** in Q1 2025 from **$0.3 million** in Q1 2024, primarily due to higher payroll and a **$0.4 million** increase in professional services costs associated with being a public company[115](index=115&type=chunk) - Management estimates that existing cash and cash equivalents are sufficient to fund business operations only into the **fourth quarter of 2025**, necessitating **additional financing**[162](index=162&type=chunk) - The company has raised capital through multiple channels since the August 2024 Business Combination, including a **$2.0M PIPE**, **$3.1M** from an Equity Line of Credit (ELOC), a **$5.0M public offering**, and a **$3.3M induced warrant exercise**[100](index=100&type=chunk)[101](index=101&type=chunk) - As of March 31, 2025, the company had received a total of **$5.8 million** in royalty-bearing grants from the Israeli Innovation Authority (IIA), which are repayable at a rate of **3.0% to 5.0%** of future product sales[147](index=147&type=chunk)[148](index=148&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a "smaller reporting company," the company is exempt from market risk disclosures and anticipates no material impact from interest rate fluctuations on its interest-bearing bank accounts - As a **"smaller reporting company"** as defined by the SEC, the company is **exempt** from the disclosures required under Item 3 of Part I of Form 10-Q[174](index=174&type=chunk) [Controls and Procedures](index=39&type=section&id=Item%204.%20Control%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - Based on an evaluation as of March 31, 2025, the company's chief executive officer and chief financial officer concluded that the disclosure controls and procedures were **effective**[177](index=177&type=chunk) - There were **no changes** in the company's internal control over financial reporting during the fiscal quarter ended March 31, 2025, that have **materially affected**, or are reasonably likely to materially affect, internal controls[178](index=178&type=chunk) PART II - OTHER INFORMATION [Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no legal proceedings - None[180](index=180&type=chunk) [Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's 2024 Annual Report on Form 10-K - As of the date of this Quarterly Report, there have been **no material changes** to the risk factors described in the "Part I, Item 1.A Risk Factors" section of the 2024 Annual Report[181](index=181&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=39&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports recent sales of unregistered securities related to an induced warrant exercise and a marketing agreement settlement, conducted in reliance on Section 4(a)(2) of the Securities Act and/or Rule 506 of Regulation D - The company issued **unregistered securities** in connection with the **Induced Warrant Exercise Transaction** and the **Settlement of Amounts Due Under Marketing Agreement with EarlyBirdCapital**. These sales were made in reliance on **Section 4(a)(2) of the Securities Act** and/or **Rule 506 of Regulation D**[183](index=183&type=chunk) [Defaults Upon Senior Securities](index=40&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[185](index=185&type=chunk) [Mine Safety Disclosures](index=40&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[186](index=186&type=chunk) [Other Information](index=40&type=section&id=Item%205.%20Other%20Information) The company reports no other information - None[187](index=187&type=chunk) [Exhibits](index=40&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the quarterly report, including CEO and CFO certifications pursuant to the Sarbanes-Oxley Act and Inline XBRL documents - The report includes exhibits such as **Certifications of the Principal Executive Officer and Principal Financial Officer** (pursuant to **SOX Sections 302 and 906**) and **Inline XBRL data files**[189](index=189&type=chunk)

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].