SLXN

Silexion Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update

Silexion Sees Progress with SIL204 Ahead of 2026 Clinical Trials

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    <h3>Information</h3>
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    <h3>AI Summary</h3>
    <p>Silexion Therapeutics reported significant preclinical progress for its KRAS-focused therapy SIL204, leading to a Phase 2/3 trial application in Israel for pancreatic cancer. The company anticipates regulatory feedback by Q1 2026 and is set to commence trials mid-year, bolstering its valuation and investor interest.</p>
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    <h3>Key Points</h3>
    <ul><li>Silexion achieved positive preclinical findings for SIL204 in cancer treatment.</li><li>Clinical trial application submitted for locally advanced pancreatic cancer in Israel.</li><li>Anticipated regulatory feedback from Israel by Q1 2026.</li><li>Silexion completed critical toxicology studies and plans Phase 2/3 trial in 2026.</li><li>Company raised over $18.6 million in 2025, improving financial stability.</li></ul>
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  <section data-block="companies-mentioned">
    <h3>Companies Mentioned</h3>
    <ul><li><strong>Silexion Therapeutics (SLXN)</strong>: Focusing on oncology therapies; recent milestones signal progress.</li></ul>
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    <h3>Corporate Developments</h3>
    <p>This news falls under &#039;Corporate Developments&#039; due to ongoing clinical advancements and regulatory processes, which are critical for biotechnology companies as they drive future revenue potential and valuation.</p>
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  <section data-block="market-moving">
    <h3>Market-Moving</h3>
    <ul><li>Regulatory feedback from Israel could impact stock performance significantly.</li><li>Phase 2/3 trial results in mid-2026 may boost investor confidence.</li><li>Strong preclinical findings enhance investment viability and interest.</li><li>Upcoming trials provide opportunities for partnership or acquisition discussions.</li></ul>
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    <h3>Key Facts</h3>
    <ul><li>Silexion raised $18.6 million through offerings in 2025.</li><li>Completed two-species toxicology studies for SIL204 in Q4 2025.</li><li>SIL204 shows efficacy against eight KRAS mutations in preclinical studies.</li><li>Net loss reduced to $11.9 million in 2025 from $16.5 million in 2024.</li><li>Current cash position stands at $6.0 million as of December 31, 2025.</li></ul>
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  <section data-block="trading-thesis">
    <h3>Trading Thesis</h3>
    <p>Investors should look for potential upside in SLXN as clinical trials progress in mid-2026.</p>
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<article>
    <h2>Silexion Therapeutics Reports Financial Results and Business Update for 2025</h2>
    <p>Grand Cayman, Cayman Islands, March 17, 2026 – Silexion Therapeutics Corp. (NASDAQ: <a href="https://www.benzinga.com/quote/SLXN">SLXN</a>), a clinical-stage biotechnology company specializing in oncology, has released its financial results for the fourth quarter and the full year ended December 31, 2025. The Company also provided an update on its recent business developments and advancements in clinical readiness for its lead candidate, SIL204.</p>

    <section>
        <h3>Key Business Milestones Achieved</h3>
        <p>Silexion has made significant strides in expanding the therapeutic potential of SIL204 throughout 2025. The Company reported positive preclinical findings across eight KRAS mutations and four major cancer types, including the first evidence of activity in gastric cancer, highlighting extensive therapeutic applicability.</p>
        
        <h4>Preclinical Validation Across KRAS-Driven Cancers</h4>
        <p>In 2025, Silexion demonstrated considerable efficacy of SIL204 in human KRAS-mutated cancer cell line models, achieving high levels of inhibition against cancer cell growth across various KRAS mutations: 
        <ul>
            <li>G12D</li>
            <li>G12V</li>
            <li>G12R</li>
            <li>G12C</li>
            <li>G13C</li>
            <li>G12A</li>
            <li>Q61H</li>
            <li>G13D</li>
        </ul>
        Additionally, SIL204 showed effectiveness in pancreatic, colorectal, lung, and gastric cancers. In pancreatic cancer models, systemic administration led to significant tumor size reduction and decreased metastasis.</p>

        <h4>Toxicology Studies and Clinical Preparedness</h4>
        <p>The Company completed GLP toxicology studies for SIL204 during Q4 2025, which supports upcoming regulatory submissions and clinical trial readiness. Silexion also partnered with AMS Advanced Medical Services GmbH for its Phase 2/3 program operations and manufacturing needs.</p>
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        <h3>Regulatory Progress and Future Clinical Trials</h3>
        <p>Silexion received constructive regulatory advice from Germany's Federal Institute for Drugs and Medical Devices (BfArM) regarding its Phase 2/3 clinical trial design. The Company submitted its clinical trial application to Israel's Ministry of Health for locally advanced pancreatic cancer and expects initial feedback by the end of Q1 2026. Furthermore, Silexion plans additional regulatory submissions in Germany and the European Union in 2026.</p>
        
        <h4>Phase 2/3 Clinical Trial Plans</h4>
        <p>The anticipated Phase 2/3 clinical study is set to commence in Q2 2026, including an initial cohort of approximately 18 patients, followed by a randomized cohort of about 166 patients. This study aims to assess SIL204's dual-route administration combined with standard chemotherapy for patients battling locally advanced pancreatic cancer.</p>
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    <section>
        <h3>Financial Overview</h3>
        <p>Silexion's financial position has significantly strengthened, raising over $18.6 million in gross proceeds during 2025 through public offerings and warrant exercises. Nasdaq confirmed the Company’s compliance with listing rules, thereby ensuring its continued presence on the Nasdaq Capital Market.</p>

        <h4>Q4 and Full Year Financial Results</h4>
        <p>Financial results from the last quarter and the full year are as follows:</p>
        <ul>
            <li><strong>Q4 2025 R&D Expenses:</strong> Approximately $3.4 million, a substantial increase from $0.9 million in Q4 2024.</li>
            <li><strong>Q4 2025 G&A Expenses:</strong> Approximately $1.0 million, unchanged from the previous year.</li>
            <li><strong>Q4 2025 Net Loss:</strong> Approximately $4.4 million, compared to $1.7 million in Q4 2024.</li>
        </ul>

        <p>For the full year 2025:</p>
        <ul>
            <li><strong>R&D Expenses:</strong> $7.1 million, up from $5.8 million in 2024.</li>
            <li><strong>G&A Expenses:</strong> $4.5 million, down from $6.8 million in 2024.</li>
            <li><strong>Net Loss:</strong> Approximately $11 million, indicating a strategic focus on clinical development.</li>
        </ul>
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    <section>
        <h3>Leadership Commentary</h3>
        <p>Ilan Hadar, Chairman and CEO of Silexion, remarked on the Company’s progress, stating, “We made significant advancements during the fourth quarter and throughout 2025, executing on our scientific, operational, and regulatory goals for SIL204. With the completion of our toxicology studies and submission of our trial applications, we believe our position is solid as we move towards our planned clinical programs in 2026.”</p>
        
        <p>Mirit Horenshtein Hadar, CFO, added, “In 2025, we not only fortified our financial standing but maintained a focused operational strategy, ending the year with approximately $6.0 million in cash, well-positioned for future clinical and regulatory milestones related to SIL204.”</p>
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Silexion Therapeutics reported significant preclinical progress for its KRAS-focused therapy SIL204, leading to a Phase 2/3 trial application in Israel for pancreatic cancer. The company anticipates regulatory feedback by Q1 2026 and is set to commence trials mid-year, bolstering its valuation and investor interest.

Silexion Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update

AI Summary

Sentiment Rationale

Trading Thesis

Market-Moving

Key Facts

Companies Mentioned

Corporate Developments

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