Silexion (NASDAQ: SLXN) advances SIL204 with German CTA step
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Silexion Therapeutics Corp furnished an update that it has successfully submitted a Clinical Trial Application in Germany for a planned Phase 2/3 trial of its lead siRNA therapy, SIL204, in KRAS-driven locally advanced pancreatic cancer. Germany will act as the Reporting Member State for the European Union review under the CTIS system, following earlier approval from the Israeli Ministry of Health for the same Phase 2/3 trial. The company plans to start the global Phase 2/3 study in the second quarter of 2026, combining intratumoral and systemic administration of SIL204 with standard chemotherapy at leading oncology centers in Germany, other EU states and Israel.
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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
Trial phase: Phase 2/3
Planned trial start: Q2 2026
Pancreatic cancer 5-year survival: Below 13%
+4 more
7 metrics
Trial phase
Phase 2/3
Planned clinical trial of SIL204 in LAPC
Planned trial start
Q2 2026
Overall Phase 2/3 trial initiation
Pancreatic cancer 5-year survival
Below 13%
Lethality context for pancreatic cancer
KRAS mutation rate in pancreatic cancer
Approximately 90%
Prevalence of KRAS mutations in pancreatic cancer
KRAS mutation rate in colorectal cancer
45%
KRAS prevalence in colorectal cancers
KRAS mutation rate in lung adenocarcinoma
30–35%
KRAS prevalence in lung adenocarcinomas
Pancreatic cancer metastatic mortality share
More than 80%
Portion of pancreatic cancer deaths from metastatic disease
Key Terms
Clinical Trial Application (CTA), BfArM, RNA interference (RNAi), small interfering RNA (siRNA), +2 more
6 terms
Clinical Trial Application (CTA) regulatory
"announced the recent successful submission of a Clinical Trial Application (CTA) 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.
BfArM regulatory
"Scientific Advice received from Germany's Federal Institute for Drugs and Medical Devices (BfArM"
Germany’s Federal Institute for Drugs and Medical Devices (BfArM) is the national regulator that evaluates, approves and monitors medicines, medical devices and related safety information. For investors, BfArM rulings act like traffic signals for healthcare companies: clearances speed products to market and revenue, while rejections, restrictions or safety warnings can delay launches, reduce sales and change a company’s risk profile and valuation.
RNA interference (RNAi) medical
"a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers"
A natural cellular process in which small RNA molecules shut down the production of a specific protein by blocking the instructions that make it, like flipping a precise light switch to silence one appliance without affecting others. For investors, RNA interference is important because it underpins a class of highly targeted therapies and research tools that can create new drugs, shorten development paths, and change the potential market and regulatory risks for companies working on gene-based treatments.
small interfering RNA (siRNA) medical
"lead, small interfering RNA (siRNA) product candidate, SIL204"
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
"SIL204, in patients with 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.
Reporting Member State regulatory
"Germany serving as the Reporting Member State — the country that will lead the scientific assessment"
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant
to Section 13 or 15(d) of the
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) |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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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).
Emerging growth company
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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 April 28, 2026, Silexion Therapeutics
Corp issued a press release entitled “Silexion Therapeutics Announces Successful Submission of Phase 2/3 Clinical Trial Application to Germany’s
BfArM for SIL204 in KRAS-Driven 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 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
(d) Exhibits
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99.1
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Press Release dated April
28, 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: April 28, 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 Announces Successful Submission of Phase 2/3 Clinical Trial Application to
Germany’s BfArM for SIL204 in KRAS-Driven Locally Advanced Pancreatic Cancer
CTA submission positions Silexion for European Phase 2/3 trial of SIL204 in KRAS-driven pancreatic
cancer, with Germany serving as Reference Member State for the EU program
Grand Cayman, Cayman Islands, April 28, 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 recent successful submission of a Clinical
Trial Application (CTA) to Germany for its planned Phase 2/3 clinical trial of its lead, small interfering RNA (siRNA) product candidate, SIL204, in patients with locally advanced pancreatic cancer (LAPC). The CTA was submitted through the EU
Clinical Trials Information System (CTIS), with Germany serving as the Reporting Member State — the country that will lead the scientific assessment of the trial across the European Union.
The submission represents a pivotal regulatory milestone in Silexion's clinical development program and marks the Company's entry into the
European regulatory process for its next-generation siRNA therapy targeting mutated KRAS. The filing was informed by the positive Scientific Advice received from Germany's Federal Institute for Drugs and Medical Devices (BfArM, Bundesinstitut für Arzneimittel und Medizinprodukte) announced in December 2025, and follows the recent approval from the Israeli Ministry of Health
to initiate the same Phase 2/3 trial in Israel.
The application is supported by a comprehensive regulatory package, including completed two-species toxicology studies confirming no
systemic organ toxicity, and extensive preclinical data. Upon approval, Silexion plans to conduct the trial at leading oncology centers in Germany and across additional EU member states, in parallel with its previously announced Israeli sites led by
Sheba Medical Center. Overall Phase 2/3 trial initiation remains planned for the second quarter of 2026.
"The successful submission of our Phase 2/3 clinical trial application to Germany is a defining milestone that extends SIL204's development
into Europe and positions Silexion to advance one of the most innovative RNAi programs in KRAS-driven cancer across multiple major jurisdictions," said Ilan Hadar, Chairman and Chief Executive Officer of Silexion Therapeutics. "Germany is widely
regarded as one of the most rigorous and respected regulatory environments in the world, and its role as our Reporting Member State under the EU Clinical Trials Regulation provides a strong foundation for our broader European Phase 2/3 program. With
the recent Israeli Ministry of Health approval in hand and now our European filing successfully in place, we are executing against every pillar of our 2026 regulatory roadmap as we prepare to initiate the Phase 2/3 trial in the second quarter of this
year."
The planned Phase 2/3 trial will evaluate SIL204 in combination with standard-of-care chemotherapy in patients with LAPC, using Silexion's
innovative dual-route administration strategy - combining intratumoral delivery to target primary tumors with systemic administration to address metastatic disease. The study is structured as a safety run-in followed by a randomized cohort.
Pancreatic cancer remains one of the most lethal malignancies, with a five-year survival rate below 13% and more than 80% of pancreatic cancer mortality driven by metastatic disease. KRAS mutations are present in approximately 90% of pancreatic
cancers, 45% of colorectal cancers, and 30-35% of lung adenocarcinomas, representing one of the largest and most persistent unmet needs in oncology.
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 candidate, 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 candidate, 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
Cautionary Note 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 initiation, progress, timing, and outcome of regulatory submission processes in Germany, the European Union, and Israel; the planned initiation and conduct of the Phase 2/3 clinical trial of SIL204 in locally advanced pancreatic cancer; the planned expansion of clinical development to additional jurisdictions; the therapeutic potential of SIL204 and its capacity to address KRAS-driven cancers; and the Company's expectations regarding its regulatory and clinical roadmap— are forward-looking statements. 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 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; (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 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 statements regarding the initiation, progress, timing, and outcome of regulatory submission processes in Germany, the European Union, and Israel; the planned initiation and conduct of the Phase 2/3 clinical trial of SIL204 in locally advanced pancreatic cancer; the planned expansion of clinical development to additional jurisdictions; the therapeutic potential of SIL204 and its capacity to address KRAS-driven cancers; and the Company's expectations regarding its regulatory and clinical roadmap— are forward-looking statements. 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 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; (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 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