UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 001-42253 SILEXION THERAPEUTICS CORP (Exact name of registrant as specified in its charter) Washington, D.C. 20549 | CERTAIN TERMS | Page ii | | --- | --- | | SPE ...

Exhibit 99.1 Silexion Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Update Continued advancement of SIL204 preclinical program with strong ef icacy data across multiple KRAS-driven cancer types; company strengthened financial position and maintains progress toward clinical trials GRAND CAYMAN, Cayman Islands, August 12, 2025 - Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company developing RNA interference (RNAi) ...

Core Insights - Silexion Therapeutics Corp. announced new preclinical data showing unprecedented inhibition rates of up to 97% in pancreatic cancer cells and nearly 90% in colorectal cancer cells, highlighting SIL204's potential as a pan-KRAS therapeutic [1][6][7] - The findings include the first evidence of SIL204's efficacy against the KRAS Q61H mutation, which was previously untested, indicating a significant advancement in the company's research [1][2][8] - Silexion is preparing to initiate a Phase 2/3 clinical trial in Q2 2026 to further investigate SIL204 for treating KRAS-driven solid tumors [1][8] Preclinical Study Findings - The comprehensive CTG analysis demonstrated significantly higher inhibition rates, with SIL204 achieving up to 94% inhibition in pancreatic cancer cells with KRAS G12D mutations and comparable 97% inhibition in cells with KRAS Q61H mutations [2][6] - SIL204 also showed an inhibition rate of nearly 90% in colorectal cancer cells with KRAS G12D mutations, extending its effectiveness beyond pancreatic cancer [6][7] - The results provide compelling evidence of SIL204's potent activity against multiple KRAS mutations across different cancer types, including pancreatic, colorectal, and lung cancers [6][8] Company Overview - Silexion Therapeutics is a clinical-stage biotechnology company focused on developing RNA interference therapies for KRAS-driven cancers, which are among the most common oncogenic drivers in human cancers [9] - The company's first-generation product, LODER™, has shown promising results in a Phase 2 trial for non-resectable pancreatic cancer, while SIL204 is designed to target a broader range of KRAS mutations [9]

Core Viewpoint - Silexion Therapeutics Corp. announced a 1-for-15 reverse share split to comply with NASDAQ requirements, enhance market position, and support strategic growth initiatives [1][4]. Group 1: Reverse Share Split Details - The reverse share split will take effect after market close on July 28, 2025, with trading on a split-adjusted basis starting July 29, 2025 [1]. - Every fifteen ordinary shares will be combined into one share, increasing the par value from $0.0009 to $0.0135 per share, with no fractional shares issued [2]. - Shareholders in book-entry form will see automatic adjustments, and those holding shares through brokers will also have their shares adjusted automatically [3]. Group 2: Strategic Rationale - The reverse share split aims to help Silexion regain compliance with NASDAQ's minimum bid price requirement, thereby enhancing its market position and supporting growth initiatives [4]. - The company is focused on advancing RNA interference (RNAi) therapies for KRAS-driven cancers, with recent preclinical breakthroughs and an expanded development strategy [3][5]. Group 3: Company Overview - Silexion Therapeutics is a clinical-stage biotechnology company developing RNAi therapies targeting solid tumors driven by KRAS mutations, with promising results from its first-generation product, LODER™ [5]. - The next-generation siRNA candidate, SIL204, is designed to target a broader range of KRAS mutations and has shown significant potential in preclinical studies [5].

Core Insights - Silexion Therapeutics Corp. announced positive preclinical data for SIL204, demonstrating significant efficacy in human lung cancer cell lines, particularly those with KRAS G12D mutations [1][4][6] - The company is conducting a new study on an untested KRAS mutation, with results expected soon, which could further validate SIL204 as a potential pan-KRAS treatment [2][3] - Silexion's dual-route administration strategy is progressing, with plans to initiate a Phase 2/3 clinical trial in Q2 2026 for KRAS-driven solid tumors [3] Study Findings - The study showed dose-dependent inhibition in lung cancer cells with KRAS G12D mutations, highlighting SIL204's potential as a versatile therapeutic [4][7] - The lipid-conjugated delivery system enhances SIL204's entry into tumor cells, addressing a significant barrier for siRNA technology [5][6] Market Opportunity - KRAS mutations are prevalent in various cancers, with approximately 90% in pancreatic cancers, 45% in colorectal cancers, and 30% in lung cancers, representing a significant market opportunity [8] - The global treatment market for these cancers exceeds US $30 billion annually, with many KRAS variants challenging to target with conventional therapies, underscoring the potential of Silexion's RNAi-based strategy [8][9] Company Overview - Silexion Therapeutics is focused on developing RNA interference therapies for solid tumors driven by KRAS mutations, with SIL204 as its next-generation candidate showing promise in preclinical studies [10]

Core Insights - Silexion Therapeutics has demonstrated the efficacy of its RNAi therapeutic candidate, SIL204, against KRAS-driven cancers, showing a significant inhibition rate of approximately 90% in GP2D human colorectal cancer cells [1][5] - The company plans to conduct further preclinical studies focusing on lung cancer cell lines to expand the understanding of SIL204's therapeutic potential [2][4] Company Overview - Silexion Therapeutics is a clinical-stage biotechnology company specializing in 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, while SIL204 aims to target a broader range of KRAS mutations [6] Therapeutic Potential - SIL204 has shown significant inhibition of cancer cell proliferation and metabolic activity across multiple cancer types, including pancreatic, colorectal, and lung cancers, indicating its potential as a pan-KRAS therapy [4][5] - KRAS mutations are found in approximately 90% of pancreatic cancers, 45% of colorectal cancers, and 35% of non-squamous non-small-cell lung cancers, representing a substantial market opportunity exceeding US $30 billion annually [4][6]

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)