Silexion (NASDAQ: SLXN) advances SIL204 with GMP batches and Phase 2/3 ethics approval
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Silexion Therapeutics Corp is advancing its lead RNAi cancer drug SIL204 by starting Good Manufacturing Practice (GMP) clinical batch manufacturing with Catalent at its Limoges, France facility. These clinical batches will be used as investigational medicinal product for the safety run-in segment of a planned Phase 2/3 trial in locally advanced pancreatic cancer.
The company also received approval from the Helsinki Ethics Committee of Tel Aviv Sourasky Medical Center for the planned Phase 2/3 study at this leading Israeli oncology site, following prior authorization from the Israeli Ministry of Health and a Clinical Trial Application submission in Germany. Together, the manufacturing progress and multi-country regulatory steps move SIL204 closer to first patient dosing in a Phase 2/3 trial combining SIL204 with standard chemotherapy and using a dual-route (intratumoral and systemic) administration strategy.
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Insights
Silexion moves SIL204 closer to first dosing with GMP supply and ethics approval milestones.
Silexion is transitioning SIL204 from preclinical work toward human testing by initiating GMP clinical batch manufacturing with Catalent. Producing validated drug product at a specialized injectable facility in Limoges is a critical CMC step before any Phase 2/3 dosing can begin.
On the regulatory side, ethics approval at Tel Aviv Sourasky Medical Center, combined with earlier Israeli Ministry of Health authorization and a Clinical Trial Application submitted in Germany, shows parallel progress across jurisdictions. These developments support the planned Phase 2/3 trial in locally advanced pancreatic cancer using dual intratumoral and systemic delivery alongside standard chemotherapy.
The impact ultimately depends on successful completion of manufacturing, stability testing, and final trial clearances. Future disclosures on full regulatory approvals, site activations, and actual first patient dosing in the Phase 2/3 study will further clarify SIL204’s clinical trajectory.
8-K Event Classification
2 items: 7.01, 9.01
2 items
Item 7.01
Regulation FD Disclosure
Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
Announcement date: May 13, 2026
Planned trial phase: Phase 2/3
Drug substance manufacture year: 2025
+2 more
5 metrics
Announcement date
May 13, 2026
Press release and 8-K disclosure date
Planned trial phase
Phase 2/3
Upcoming SIL204 trial in locally advanced pancreatic cancer
Drug substance manufacture year
2025
SIL204 drug substance manufactured by specialist oligonucleotide CDMO
Prior trial stage
Phase 2a
Earlier trial with first-generation product showing positive trend vs chemotherapy alone
Manufacturing site
Limoges, France
Catalent European center of excellence for clinical biologics and drug product
Key Terms
Good Manufacturing Practice (GMP), Contract Development and Manufacturing Organization (CDMO), Investigational Medicinal Product (IMP), Clinical Trial Application (CTA), +2 more
6 terms
Good Manufacturing Practice (GMP) technical
"announced the initiation of Good Manufacturing Practice (GMP) clinical batch manufacturing of SIL204"
Good Manufacturing Practice (GMP) is a set of government-enforced standards that ensure medicines, medical devices, and related products are produced consistently, safely, and with the quality claimed on the label. Think of it as a strict recipe and hygiene checklist for a factory that prevents contamination, errors, and product variations. Investors care because GMP compliance affects a company’s ability to sell products, avoid costly recalls or regulatory shutdowns, and maintain reliable revenue and reputation.
Contract Development and Manufacturing Organization (CDMO) technical
"a specialist global oligonucleotide contract development and manufacturing organization"
A contract development and manufacturing organization (CDMO) is a company that develops and produces drugs, vaccines or other medical products for other firms, handling steps from formulation and testing to large-scale manufacturing and quality control. Investors care because CDMOs function like outsourced specialized factories and development partners: their revenue grows when many clients need production capacity or development expertise, so their performance signals broader industry demand and is tied to regulatory approvals and client programs.
Investigational Medicinal Product (IMP) regulatory
"will serve as the Investigational Medicinal Product (IMP) supply used to treat the first patients"
Clinical Trial Application (CTA) regulatory
"the Company's Clinical Trial Application (CTA) submitted to Germany"
A clinical trial application (CTA) is the formal request a company files with health regulators asking permission to begin testing a new drug or medical device in people. It matters to investors because approval is a key development milestone—like getting a building permit to start construction—signaling reduced regulatory risk, unlocking the next phase of data generation and timelines for potential commercial value, while rejection or delay can push back prospects and increase costs.
small interfering RNA (siRNA) technical
"SIL204, a small interfering RNA (siRNA), towards clinical trials"
Small interfering RNA (siRNA) are short, lab-designed molecules that act like a targeted mute button for specific genes, binding to and prompting the cell to destroy matching genetic messages so a particular protein is not produced. For investors, siRNA represents a therapeutic technology platform: its ability to precisely switch off disease-causing genes can create new drug candidates, shape clinical and regulatory risk, and influence long-term commercial potential in biotechnology and pharma.
locally advanced pancreatic cancer (LAPC) medical
"upcoming Phase 2/3 clinical trial in locally advanced pancreatic cancer (LAPC)"
Locally advanced pancreatic cancer (LAPC) is cancer that has grown beyond the pancreas into nearby tissues or major blood vessels but has not spread to distant organs, making surgical removal impractical. It matters to investors because this stage defines the need for medical treatments, clinical trials and longer-term care rather than a one-time cure; successful therapies can represent substantial, sustained market opportunity while setbacks can delay approvals and reduce projected revenues, like fixing a critical but hard-to-reach section of a vital pipeline.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant
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Securities Exchange Act of 1934
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-3-756-4999
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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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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 May 13, 2026, Silexion Therapeutics
Corp issued a press release entitled “Silexion Therapeutics Announces Initiation of GMP Clinical Supply Manufacturing of SIL204 with Leading
Global CDMO”. 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 this Item 7.01 of Form 8-K, including the information in the press release furnished pursuant to
this Item 7.01, 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 this Item 7.01, 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
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99.1
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Press Release dated May
13, 2026
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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: May 13, 2026
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/s/ Ilan Hadar
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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 Announces Initiation of GMP Clinical Supply Manufacturing of SIL204 with
Leading Global CDMO, and New Approval of Phase 2/3 Trial From Tel Aviv Sourasky Medical Center
Leading Global CDMO, and New Approval of Phase 2/3 Trial From Tel Aviv Sourasky Medical Center
Silexion advances toward Phase 2/3 trial in KRAS-driven pancreatic cancer, as SIL204 begins GMP clinical
manufacturing in collaboration with global leading manufacturing partner Catalent at its European
center of excellence
Tel Aviv Sourasky Medical Center’s Helsinki Ethics Committee approves planned Phase 2/3 trial of SIL204
in locally advanced pancreatic cancer, marking an important clinical site activation milestone at a leading
Israeli oncology center; Underscores continued regulatory momentum in preparation for trial initiation
Grand Cayman, Cayman Islands, May 13, 2026 --
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 the initiation of Good Manufacturing Practice
(GMP) clinical batch manufacturing of SIL204, the Company's next-generation siRNA therapy targeting mutated KRAS, in support of the planned upcoming Phase 2/3 clinical trial in locally advanced pancreatic cancer (LAPC). Additionally, the Company was pleased to announce that it has received approval from the Helsinki Ethics Committee of Tel Aviv Sourasky Medical Center for the planned Phase 2/3 trial of SIL204 at
its site, a leading Israeli oncology center.
The clinical batches currently in production will serve as the Investigational Medicinal Product (IMP) supply used to treat the first
patients to be enrolled in the safety run-in segment of the Phase 2/3 trial. The drug substance (active pharmaceutical ingredient) for SIL204 was successfully manufactured in 2025 by a specialist global oligonucleotide contract development and
manufacturing organization, enabling seamless progression into drug product manufacturing. The drug product, the finished clinical formulation administered to patients, is now being manufactured by Catalent, Inc., a leading global CDMO championing the missions that help people live better and healthier lives, at its state-of-the-art facility in Limoges, France, Catalent's European center of excellence for
clinical biologics formulation development and drug product manufacturing. The Limoges facility specializes in complex injectable formulations, and all activities are conducted in full compliance with applicable GMP standards.
This manufacturing milestone represents a key step in Silexion's CMC (Chemistry, Manufacturing, and Controls) readiness ahead of the
planned Phase 2/3 trial and materially advances the Company's preparedness for first patient dosing. With the Israeli Ministry of Health's recent approval of the Phase 2/3 trial and the Company's Clinical Trial Application (CTA) submitted to
Germany, Silexion is continuing to advance the operational steps to bring SIL204 into human trials. The Sourasky Medical Center Helsinki Ethics Committee approval, issued
by one of Israel’s leading academic medical centers, reflects on the solid scientific basis attributed to the Company’s SIL 204 product candidate, and builds upon the foregoing Israeli Ministry of Health authorization and ongoing CTA review in
Germany, reflecting multi-front regulatory progress towards the Company’s planned Phase 2/3 clinical trial.
"Initiating GMP clinical supply manufacturing for SIL204 is a defining operational milestone that brings us materially closer to first
patient dosing," said Ilan Hadar, Chairman and Chief Executive Officer of Silexion Therapeutics. "With our drug product formulation now in production with Catalent under full GMP controls at its European center of excellence, we are translating years
of preclinical science into regulator-ready clinical supply. This milestone reflects the strength of our CMC execution, much as our recent regulatory approval and submission in Israel and Germany, respectively, exhibit our strong progress on the
regulatory front."
Silexion's manufacturing relationship with Catalent at its Limoges, France, site, originally announced in April 2025, was established to
optimize both the systemic and intratumoral delivery formulations of SIL204 in support of the Company's dual-route administration strategy. The collaboration leverages Catalent's extensive experience in complex injectable formulations and
sustained-release technologies to enhance SIL204's stability, bioavailability, and delivery precision.
The GMP clinical batches are being manufactured in accordance with validated production processes, controlled raw material sourcing,
comprehensive in-process controls, and full quality testing and documentation, in preparation for final batch release and clinical use. Stability programs consistent with applicable regulatory guidelines have been initiated to support the clinical
use of the material.
SIL204 is a next-generation siRNA therapy designed to silence mutated KRAS oncogenes, the most common oncogenic driver in human cancers,
before cancer-driving proteins are expressed. The upcoming Phase 2/3 trial in LAPC will evaluate SIL204 in combination with standard-of-care chemotherapy, using the Company's innovative dual-route administration strategy that combines intratumoral
delivery to target primary tumors with systemic administration to address metastatic disease. The trial is structured as a safety run-in followed by a randomized cohort.
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, and is currently advancing its lead, second-generation, product candidate, SIL204, a small interfering RNA (siRNA), towards clinical trials in Israel and the European Union. 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, and is currently advancing its lead, second-generation, product candidate, SIL204, a small interfering RNA (siRNA), towards clinical trials in Israel and the European Union. 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 statements regarding the Company's CMC readiness, potential clinical site activation, the
supply of clinical trial material for the planned Phase 2/3 clinical trial of SIL204 in locally advanced pancreatic cancer, and the planned initiation and conduct of the Phase 2/3 clinical trial of SIL204, 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 and conduct
clinical trials, including the Phase 2/3 trial of SIL204 in locally advanced pancreatic cancer; (ii) Silexion's strategy, future operations, financial position, projected costs, prospects, and plans; (iii) the impact of the regulatory environment
and compliance complexities, including the outcome of the CTA review in Germany and other jurisdictions, as well as site-level approvals, conditions and clearances
(including outstanding regulatory forms and any initial participant caps) required prior to study commencement at each clinical site; (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. 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 Contact
Arx Investor Relation
North American Equities Desk
silexion@arxhq.com
Arx Investor Relation
North American Equities Desk
silexion@arxhq.com
FAQ
What did Silexion Therapeutics (SLXN) announce about SIL204 manufacturing?
Silexion began GMP clinical batch manufacturing of SIL204 with Catalent in Limoges, France. These batches will serve as the investigational medicinal product for the safety run-in portion of the planned Phase 2/3 trial in locally advanced pancreatic cancer.
What regulatory milestone did Silexion Therapeutics (SLXN) achieve for the SIL204 trial?
Silexion received approval from the Helsinki Ethics Committee of Tel Aviv Sourasky Medical Center for its planned Phase 2/3 SIL204 trial. This follows prior Israeli Ministry of Health authorization and supports clinical site activation at a leading Israeli oncology center.
What cancer indication will Silexion’s SIL204 Phase 2/3 trial target?
The planned Phase 2/3 trial will evaluate SIL204 in locally advanced pancreatic cancer. SIL204 is a next-generation siRNA therapy designed to silence mutated KRAS oncogenes, which are described as a common oncogenic driver in human cancers.
How will SIL204 be administered in Silexion’s planned Phase 2/3 trial?
Silexion plans a dual-route administration strategy for SIL204, combining intratumoral delivery to target primary pancreatic tumors with systemic administration to address metastatic disease. The study will pair SIL204 with standard-of-care chemotherapy in a structured Phase 2/3 design.
What prior clinical experience does Silexion report before SIL204?
Silexion previously conducted a Phase 2a trial with a first-generation product that showed a positive trend versus chemotherapy alone. The company is now advancing SIL204, its second-generation siRNA candidate, toward clinical trials in Israel and the European Union.
What risks does Silexion highlight in its forward-looking statements about SIL204?
Silexion notes risks around completing preclinical work, initiating and conducting the Phase 2/3 trial, complex regulatory outcomes, capital needs, partnership expectations, and maintaining its Nasdaq listing. These factors could cause actual results to differ from current forward-looking statements.