Regulators clear Silexion (NASDAQ: SLXN) to begin SIL204 pancreatic cancer trial
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Silexion Therapeutics Corp reports that the Israeli Ministry of Health has formally approved a Phase 2/3 clinical trial of its RNAi therapy SIL204 in locally advanced pancreatic cancer. SIL204 is designed to silence a broad range of KRAS mutations, which occur in over 90% of pancreatic cancers, and has shown significant anti-tumor activity in multiple preclinical models with supportive toxicology data. The company expects to begin the Phase 2/3 trial in the second quarter of 2026, subject to site activation and standard readiness steps, and plans additional regulatory filings in Germany by the end of the current quarter and across the European Union in early 2027.
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Insights
Regulatory clearance moves SIL204 into a pivotal pancreatic cancer trial, but clinical risk and funding needs remain high.
Silexion Therapeutics has received Israeli Ministry of Health approval to initiate a Phase 2/3 trial of SIL204 in locally advanced pancreatic cancer. The therapy uses RNA interference to broadly target KRAS mutations, supported by preclinical anti-tumor activity and completed toxicology studies.
This step effectively transitions the company into a clinical-stage, KRAS-focused oncology developer. However, pancreatic cancer trials are complex, and success will depend on demonstrating meaningful benefit versus chemotherapy in humans and sustaining capital to run a pivotal-scale program.
The company expects to start the trial in the second quarter of 2026 and to seek additional approvals in Germany by the end of the current quarter and in the European Union in early 2027. Future clinical readouts and regulatory interactions will determine whether SIL204’s broad KRAS targeting translates into real patient benefit.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 7.01 Regulation FD Disclosure.
On March 24, 2026, Silexion Therapeutics
Corp issued a press release entitled “Silexion Therapeutics Receives Approval from Israeli Ministry of Health to Initiate Phase 2/3 Clinical Trial of SIL204 in Locally Advanced Pancreatic Cancer”. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K (this “Form 8-K”) and is incorporated herein by reference.
The information in Item 7.01 of this Form 8-K, including the information in the press release furnished pursuant to
this Item 7.01 of Form 8-K, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. Furthermore, the information in Item 7.01 of this Form
8-K, including the information in the press release, shall not be deemed to be incorporated by reference in the filings of the registrant under the Securities Act of 1933, as amended.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
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99.1
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Press Release dated March
24, 2026
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Cover Page Interactive Data File (formatted in Inline XBRL)
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be
signed on its behalf by the undersigned hereunto duly authorized.
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SILEXION THERAPEUTICS CORP
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Date: March 24, 2026
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/s/ Ilan Hadar
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Name:
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Ilan Hadar
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Title:
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Chief Executive Officer
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Exhibit 99.1
Silexion Therapeutics Receives Approval from Israeli Ministry of Health to Initiate Phase 2/3
Clinical Trial of SIL204 in Locally Advanced Pancreatic Cancer
Significant regulatory milestone marks advancement into clinical-stage development of next-
generation RNAi therapy featuring an innovative, integrated systemic treatment delivery
approach targeting highly prevalent KRAS-driven cancers with significant unmet medical need
Company reported strong positive preclinical study results demonstrating significant anti-tumor
activity in multiple models and announced successful completion of toxicology studies, and
constructive regulatory engagement supporting the Phase 2/3 trial design
Silexion expects to initiate human clinical trials in the second quarter of 2026
Grand Cayman, Cayman Islands, March 24, 2026 (GLOBE NEWSWIRE) - Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"),
a clinical-stage, oncology-focused biotechnology company, today announced that it has received formal approval from the Israeli Ministry of Health to initiate its Phase 2/3 clinical trial evaluating SIL204 for the treatment of locally advanced
pancreatic cancer, following positive preclinical results that demonstrated significant anti-tumor activity in mulitple models alongside successful completion of toxicology studies.
This approval represents a major regulatory milestone and a critical advancement for the Company, enabling the transition of SIL204 into
human clinical evaluation and positioning Silexion as a clinical-stage biotechnology company focused on KRAS-driven cancers.
SIL204 is designed to silence KRAS mutations, which are present in over 90% of pancreatic cancers and are widely recognized as one of the
most challenging targets in oncology. Unlike mutation-specific approaches, SIL204 is engineered to target a broad range of KRAS mutations, supporting its potential applicability across multiple high-value cancer indications.
The approval follows a series of major positive developments achieved by the Company, including strong positive anti-tumor activity
demonstrated in multiple preclinical models, successful completion of toxicology studies, and constructive regulatory engagement supporting the Phase 2/3 trial design. Together, these achievements have enabled SIL204 to advance toward clinical-stage
development. The Company also plans to submit a Phase 2/3 clinical trial application in Germany by the end of this current quarter, with additional regulatory filings across the European Union planned in early 2027.
“The receipt of this approval marks a defining and highly significant milestone for Silexion,” said Ilan Hadar, Chairman and Chief Executive
Officer of Silexion Therapeutics. “We are now advancing SIL204 into a pivotal clinical trial with the goal of addressing KRAS-driven cancers at their source. This progress reflects the strength of our data, the safety demonstrated during the Loder
(predecessor to SIL204) clinical trial, the urgency of the unmet need in pancreatic cancer, and our continued execution toward developing a potentially transformative therapy.”
The Company expects to initiate the Phase 2/3 trial in the second quarter of 2026, subject to site activation and standard clinical
readiness procedures, and plans to advance SIL204 as a potential treatment across additional KRAS-driven indications, including colorectal and lung cancers.
About Silexion Therapeutics
Silexion Therapeutics is a pioneering clinical-stage, oncology-focused biotechnology company dedicated to the development of innovative treatments for unsatisfactorily treated solid tumor cancers that have the mutated KRAS oncogene, generally considered to be the most common oncogenic gene driver in human cancers. The Company conducted a Phase 2a clinical trial in its first-generation product, which showed a positive trend in comparison to the control of chemotherapy alone. Silexion is committed to pushing the boundaries of therapeutic advancements in the field of oncology and further developing its lead product candidate for locally advanced pancreatic cancer. For more information, please visit: https://silexion.com
Silexion Therapeutics is a pioneering clinical-stage, oncology-focused biotechnology company dedicated to the development of innovative treatments for unsatisfactorily treated solid tumor cancers that have the mutated KRAS oncogene, generally considered to be the most common oncogenic gene driver in human cancers. The Company conducted a Phase 2a clinical trial in its first-generation product, which showed a positive trend in comparison to the control of chemotherapy alone. Silexion is committed to pushing the boundaries of therapeutic advancements in the field of oncology and further developing its lead product candidate for locally advanced pancreatic cancer. For more information, please visit: https://silexion.com
Notice Regarding Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of the federal securities laws. All statements other than statements of historical fact contained in this communication, including, for example, statements regarding the initiation, timing, design, and conduct of the planned Phase 2/3 clinical trial of SIL204, including expected trial commencement in the second quarter of 2026 and patient enrollment; the timing, content, and outcome of regulatory submissions and interactions with regulatory authorities in Israel, Germany, the European Union, and other jurisdictions; the advancement of SIL204 into clinical-stage development; the potential therapeutic benefits and clinical utility of SIL204 across KRAS-driven cancers; the Company’s plans to expand development into additional indications, including colorectal and lung cancers; the Company’s development strategy and anticipated milestones; its ability to raise additional capital and fund operations; and its ability to maintain its Nasdaq listing, are forward-looking statements. These forward-looking statements are generally identified by terminology such as "may", "should", "could", "might", "plan", "possible", "project", "strive", "budget", "forecast", "expect", "intend", "will", "estimate", "anticipate", "believe", "predict", "potential" or "continue", or the negatives of these terms or variations of them or similar terminology. Forward-looking statements involve a number of risks, uncertainties, and assumptions, and actual results or events may differ materially from those projected or implied in those statements. Important factors that could cause such differences include, but are not limited to: (i) Silexion's ability to successfully complete preclinical studies and initiate clinical trials; (ii) Silexion's strategy, future operations, financial position, projected costs, prospects, and plans; (iii) the impact of the regulatory environment and compliance complexities; (iv) expectations regarding future partnerships or other relationships with third parties; (v) Silexion's future capital requirements and sources and uses of cash, including its ability to obtain additional capital; (vi) Silexion's ability to maintain its Nasdaq listing; and (vii) other risks and uncertainties set forth in the documents filed by the Company with the SEC, including the Company's Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 17, 2026. Silexion cautions you against placing undue reliance on forward-looking statements, which reflect current beliefs and are based on information currently available as of the date a forward-looking statement is made. Forward-looking statements set forth herein speak only as of the date they are made. Silexion undertakes no obligation to revise forward-looking statements to reflect future events, changes in circumstances, or changes in beliefs, except as otherwise required by law.
This press release contains forward-looking statements within the meaning of the federal securities laws. All statements other than statements of historical fact contained in this communication, including, for example, statements regarding the initiation, timing, design, and conduct of the planned Phase 2/3 clinical trial of SIL204, including expected trial commencement in the second quarter of 2026 and patient enrollment; the timing, content, and outcome of regulatory submissions and interactions with regulatory authorities in Israel, Germany, the European Union, and other jurisdictions; the advancement of SIL204 into clinical-stage development; the potential therapeutic benefits and clinical utility of SIL204 across KRAS-driven cancers; the Company’s plans to expand development into additional indications, including colorectal and lung cancers; the Company’s development strategy and anticipated milestones; its ability to raise additional capital and fund operations; and its ability to maintain its Nasdaq listing, are forward-looking statements. These forward-looking statements are generally identified by terminology such as "may", "should", "could", "might", "plan", "possible", "project", "strive", "budget", "forecast", "expect", "intend", "will", "estimate", "anticipate", "believe", "predict", "potential" or "continue", or the negatives of these terms or variations of them or similar terminology. Forward-looking statements involve a number of risks, uncertainties, and assumptions, and actual results or events may differ materially from those projected or implied in those statements. Important factors that could cause such differences include, but are not limited to: (i) Silexion's ability to successfully complete preclinical studies and initiate clinical trials; (ii) Silexion's strategy, future operations, financial position, projected costs, prospects, and plans; (iii) the impact of the regulatory environment and compliance complexities; (iv) expectations regarding future partnerships or other relationships with third parties; (v) Silexion's future capital requirements and sources and uses of cash, including its ability to obtain additional capital; (vi) Silexion's ability to maintain its Nasdaq listing; and (vii) other risks and uncertainties set forth in the documents filed by the Company with the SEC, including the Company's Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 17, 2026. Silexion cautions you against placing undue reliance on forward-looking statements, which reflect current beliefs and are based on information currently available as of the date a forward-looking statement is made. Forward-looking statements set forth herein speak only as of the date they are made. Silexion undertakes no obligation to revise forward-looking statements to reflect future events, changes in circumstances, or changes in beliefs, except as otherwise required by law.
Company Contact:
Silexion Therapeutics Corp
Ms. Mirit Horenshtein Hadar, CFO
mirit@silexion.com
Silexion Therapeutics Corp
Ms. Mirit Horenshtein Hadar, CFO
mirit@silexion.com
Investor Relations
Arx Investor Relations
North American Equities Desk
silexion@arxhq.com
Arx Investor Relations
North American Equities Desk
silexion@arxhq.com
FAQ
What key milestone did Silexion Therapeutics (SLXN) announce for SIL204?
Silexion announced formal approval from the Israeli Ministry of Health to initiate a Phase 2/3 clinical trial of SIL204 in locally advanced pancreatic cancer, marking its transition into clinical-stage development after positive preclinical anti-tumor results and completed toxicology studies.
What is SIL204 and which cancers is Silexion (SLXN) targeting?
SIL204 is an RNAi-based therapy designed to silence KRAS mutations, present in over 90% of pancreatic cancers. It targets a broad range of KRAS variants, with planned development for locally advanced pancreatic cancer and potential expansion into additional KRAS-driven tumors like colorectal and lung cancers.
When does Silexion expect to start the SIL204 Phase 2/3 trial?
Silexion expects to initiate the Phase 2/3 clinical trial of SIL204 in locally advanced pancreatic cancer in the second quarter of 2026, subject to site activation and standard clinical readiness procedures, following the recent regulatory approval in Israel and prior supportive preclinical data.
What additional regulatory plans did Silexion (SLXN) outline beyond Israel?
The company plans to submit a Phase 2/3 clinical trial application in Germany by the end of the current quarter, with further regulatory filings across the European Union expected in early 2027, aiming to broaden the geographic footprint of SIL204’s development program.
How does SIL204 differ from mutation-specific KRAS therapies?
SIL204 is engineered to target a broad range of KRAS mutations rather than a single variant, potentially making it applicable across multiple high-value KRAS-driven cancer indications. This contrasts with mutation-specific drugs that focus on limited KRAS subtypes, potentially narrowing their eligible patient populations.
What prior clinical experience supports Silexion’s KRAS program?
Silexion previously conducted a Phase 2a clinical trial with a first-generation product, Loder, which showed a positive trend versus chemotherapy alone. Safety data from that predecessor trial, along with current preclinical and toxicology results, supported advancing SIL204 into the new Phase 2/3 program.
Filing Exhibits & Attachments
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Silexion Therapeutics Corp