Silexion Therapeutics (SLXN) launches Phase 2/3 SIL204 trial in pancreatic cancer
Rhea-AI Filing Summary
Silexion Therapeutics Corp. announced the successful initiation of its Phase 2/3 clinical trial of SIL204, a small interfering RNA (siRNA) candidate, in locally advanced pancreatic cancer at Tel Aviv Sourasky Medical Center, formally activating the first clinical site and clearing it to begin patient screening, with first dosing anticipated afterward.
The trial evaluates SIL204 plus standard-of-care chemotherapy using a dual-route strategy that combines intratumoral delivery to overcome stromal barriers with systemic administration to address metastatic disease. It begins with an initial safety run-in of approximately 18 patients, then expands globally to a randomized cohort of approximately 166 patients. SIL204 is designed to silence a broad range of KRAS mutations, which occur in about 90% of pancreatic cancers, 45% of colorectal cancers, and 30–35% of lung adenocarcinomas, supporting potential use across multiple KRAS-driven tumors.
Positive
- Phase 2/3 SIL204 trial initiated with first site active, enabling patient screening and future dosing in locally advanced pancreatic cancer and marking a transition from regulatory preparation into active clinical execution with a planned randomized cohort of approximately 166 patients.
Negative
- None.
Filing Explained
Approvals and clinical supply are in place at the first active site, but treatment has not started; first dosing and added sites remain pending.
The company reports that Tel Aviv Sourasky Medical Center is the first active site for the SIL204 Phase 2/3 study after required regulatory and institutional approvals, with investigational supply available for screening; first dosing and additional sites are still future milestones.
Because this is an Item 7.01 Regulation FD disclosure, the 8-K furnishes the release and says it is not treated as filed under Section 18; that filing status does not change the site's operational activation described in the release.
As of
The next named operational checkpoint is first patient dosing, while the company says other Israeli and German sites are progressing through activation.
Sources and calculations
- Silexion Therapeutics Corp Form 8-K and Exhibit 99.1 (2026-07-29)
- Form 8-K purpose (current)
- Silexion Therapeutics Corp latest quarterly fundamentals (2026-03-31)
- Cash and equivalents vs quarterly operating cash outflow, in days of cash use $2,413,000 / ($3,646,000 / 90) = [object Object]
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
Safety run-in cohort size: approximately 18 patients
Randomized cohort size: approximately 166 patients
KRAS prevalence in pancreatic cancer: approximately 90%
+5 more
8 metrics
Safety run-in cohort size
approximately 18 patients
Initial safety run-in cohort in the Phase 2/3 SIL204 trial
Randomized cohort size
approximately 166 patients
Planned randomized cohort in the SIL204 Phase 2/3 trial
KRAS prevalence in pancreatic cancer
approximately 90%
Share of pancreatic cancers with KRAS mutations
KRAS prevalence in colorectal cancer
45%
Share of colorectal cancers with KRAS mutations
KRAS prevalence in lung adenocarcinoma
30–35%
Share of lung adenocarcinomas with KRAS mutations
Five-year survival in pancreatic cancer
below 13%
Five-year survival rate for pancreatic cancer
Warrant exercise price
$15,525.00 per share
Exercise price of SLXNW warrants for ordinary shares
Nasdaq market value requirement
$5 million
New minimum market value of listed securities for Nasdaq listing
Key Terms
Phase 2/3 clinical trial, small interfering RNA (siRNA), intratumoral delivery, EU Clinical Trials Regulation, +2 more
6 terms
Phase 2/3 clinical trial medical
"Successful initiation of the Phase 2/3 clinical trial of SIL204"
A phase 2/3 clinical trial is a single, combined study that first tests whether a treatment works and is safe in a modest number of patients, then expands seamlessly into a larger, confirmatory stage if early results are promising. Think of it like a prototype test that can quickly move into full production without starting over; for investors, it concentrates risk and time, because positive results can speed regulatory approval while negative results can be a major setback.
small interfering RNA (siRNA) medical
"SIL204, the Company’s lead small interfering RNA (siRNA) product candidate"
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.
intratumoral delivery medical
"combining intratumoral delivery designed to overcome the stromal barrier"
A method of giving a medicine or therapeutic agent directly into a solid tumor, rather than into the bloodstream, to concentrate the treatment where cancer is located. Like putting a watering can on the plant instead of spraying the whole garden, it can increase local effectiveness and reduce side effects elsewhere in the body, which matters to investors because it can influence clinical success, safety profiles, regulatory approval chances and commercial value.
EU Clinical Trials Regulation regulatory
"German oncology centers approved under the EU Clinical Trials Regulation framework"
A legal framework that sets the rules for running clinical drug and device tests across the European Union, covering how trials are approved, monitored, and reported. It streamlines applications through a single online portal and raises transparency and patient safety standards, much like a unified building permit system speeds construction and enforces inspections. Investors care because it can change how quickly trials start, how costly they are, and how much regulatory risk a drug developer faces.
investigational medicinal product regulatory
"confirms that Silexion’s investigational medicinal product (“IMP”) for SIL204 is available"
An investigational medicinal product is a drug, biologic or therapy that is still being tested in clinical trials and has not yet received regulatory approval for general use. Think of it as a prototype being road‑tested: trial results determine whether it is safe and effective, which directly affects potential market size, approval timelines, and investment risk and reward for stakeholders.
KRAS mutations medical
"KRAS mutations are present in approximately 90% of pancreatic cancers"
A KRAS mutation is a change in the KRAS gene that makes a cell’s growth-control protein act like a gas pedal stuck down, driving uncontrolled cell division that can cause cancer. For investors, KRAS mutations matter because they determine whether certain drugs or tests will work, influence clinical trial outcomes and regulatory decisions, and shape the commercial size and timing of oncology product opportunities.
AI-generated analysis. How Rhea-AI works. Not financial advice.
FAQ
What did Silexion Therapeutics (SLXN) announce regarding the SIL204 program?
Silexion Therapeutics announced the successful initiation of its Phase 2/3 clinical trial of SIL204 in locally advanced pancreatic cancer at Tel Aviv Sourasky Medical Center, activating the first clinical site and clearing it to start patient screening and subsequent dosing.
How is the Phase 2/3 SIL204 trial for SLXN designed?
The Phase 2/3 trial starts with an initial safety run-in of approximately 18 patients, then expands worldwide to obtain a randomized cohort of approximately 166 patients, testing SIL204 combined with standard-of-care chemotherapy in patients with locally advanced pancreatic cancer.
What is unique about SIL204 in Silexion Therapeutics’ (SLXN) pipeline?
SIL204 is a small interfering RNA (siRNA) designed to silence a broad range of KRAS mutations, rather than a single variant, potentially enabling application across multiple KRAS-driven cancers beyond pancreatic cancer, including colorectal and lung adenocarcinomas.
Which administration strategy is SLXN using for SIL204 in the Phase 2/3 trial?
The trial uses a dual-route administration strategy: intratumoral delivery intended to overcome the stromal barrier in the primary tumor, combined with systemic administration to address metastatic disease, alongside standard-of-care chemotherapy in locally advanced pancreatic cancer.
What prior regulatory milestones support SLXN’s SIL204 Phase 2/3 trial?
Key milestones include Israeli Ministry of Health authorization on March 24, 2026, initiation of GMP clinical supply manufacturing with Catalent in May 2026, TASMC ethics approval in May 2026, and German BfArM authorization in June 2026, culminating in site activation on July 29, 2026.
How prevalent are KRAS mutations in cancers targeted by Silexion Therapeutics (SLXN)?
KRAS mutations occur in approximately 90% of pancreatic cancers, 45% of colorectal cancers, and 30–35% of lung adenocarcinomas. This high prevalence underpins Silexion’s strategy to develop SIL204 for multiple KRAS-driven solid tumors.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
SECURITIES AND EXCHANGE COMMISSION
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If an emerging growth company, indicate by check mark if 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 July 29, 2026, Silexion Therapeutics
Corp issued a press release entitled “Silexion Therapeutics Successfully Initiates Phase 2/3 Clinical Trial of SIL204 in Locally Advanced
Pancreatic Cancer at Tel Aviv Sourasky Medical Center”. 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 July
29, 2026
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104
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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: July 29, 2026
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By:
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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 Successfully Initiates Phase 2/3 Clinical Trial of SIL204 in Locally
Advanced Pancreatic Cancer at Tel Aviv Sourasky Medical Center
Successful initiation of the Phase 2/3 clinical trial of SIL204— at Tel Aviv Sourasky Medical Center
(“TASMC” or “Ichilov”), one of Israel’s largest and most prominent academic medical centers, clears the
site to commence patient screening
Milestone marks the start of Silexion’s transition of the SIL204 program from regulatory preparation into
active clinical execution, following the Company’s previously announced regulatory authorizations from
the Israeli Ministry of Health and Germany’s Federal Institute for Drugs and Medical Devices (BfArM)
With site initiation complete, patient screening at TASMC is expected to commence in the coming weeks,
with first patient dosing anticipated to follow
Additional Israeli and German trial sites are progressing through activation and are expected to join the
Phase 2/3 program in the coming months
Grand Cayman, Cayman Islands, July 29, 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 successful initiation of its
Phase 2/3 clinical trial of SIL204, the Company’s lead small interfering RNA (siRNA) product candidate, at Tel Aviv Sourasky Medical Center (“TASMC” or “Ichilov”), formally activating the first clinical site for the study in patients with locally
advanced pancreatic cancer (“LAPC”). With the trial now initiated at TASMC, the site is cleared to commence patient screening.
The initiation on July 29, 2026 follows the receipt of all regulatory and institutional approvals required to open the site — including the
Israeli Ministry of Health authorization received on March 24, 2026, and the institutional ethics approval previously granted by TASMC – and confirms that Silexion’s investigational medicinal product (“IMP”) for SIL204 is available in Israel and
positioned for the site upon initial patient screening. TASMC, commonly known as Ichilov, is one of Israel’s largest teaching hospitals and a leading center for oncology clinical research, and serves as the anchor site for the Israeli arm of
Silexion’s Phase 2/3 program.
Within approximately four months, Silexion completed a rapid sequence of clinical readiness milestones for SIL204: the Israeli Ministry of
Health approval received in March 2026; the initiation of GMP clinical supply manufacturing with Catalent announced in May 2026; TASMC’s own institutional ethics approval for the Phase 2/3 trial announced in May 2026; and the BfArM authorization in
Germany received in June 2026, all of which culminated in the activation of TASMC as the first clinical site for the SIL204 program on July 29, 2026. With the first clinical site now formally active, Silexion’s SIL204 program is moving beyond the
regulatory preparation phase and into active clinical execution, with additional Israeli and German sites progressing through activation in parallel and first patient dosing anticipated as the next milestone.
“Successfully initiating our first clinical site at Tel Aviv Sourasky Medical Center is a defining operational milestone for Silexion and
for the SIL204 program,” said Ilan Hadar, Chairman and Chief Executive Officer of Silexion Therapeutics. “This is the moment where years of preclinical development, GMP manufacturing scale-up, and multi-jurisdictional regulatory work have translated
into an active clinical program. TASMC is one of Israel’s premier oncology research centers and having it as our first active site provides an exceptional foundation as we bring additional Israeli and German centers online in the weeks and months
ahead. We look forward to advancing rapidly toward first patient dosing.”
The Phase 2/3 trial is designed to evaluate SIL204 in combination with standard-of-care chemotherapy in patients with locally advanced
pancreatic cancer, using Silexion’s innovative dual-route administration strategy— combining intratumoral delivery designed to overcome the stromal barrier that can limit systemic drug penetration into the primary tumor, alongside systemic
administration to address metastatic disease. The study is structured as an initial safety run-in cohort of approximately 18 patients, followed by expansion into sites worldwide to obtain a randomized cohort of approximately 166 patients. Additional
Israeli sites, alongside leading German oncology centers approved under the EU Clinical Trials Regulation framework, are advancing through site activation and are expected to join the program in the coming months.
SIL204, which is designed to silence a broad range of KRAS mutations rather than a single variant, supports Silexion’s potential
applicability across multiple high-value cancer indications beyond pancreatic cancer. 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. Pancreatic cancer—which is the subject of the current, initial clinical trial— 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.
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 now advancing its lead, second-generation, product candidate, SIL204, a small interfering RNA (siRNA), into Phase 2/3
clinical evaluation 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 initiation, timing, design, and conduct of the Phase 2/3 clinical trial of SIL204 in locally advanced pancreatic cancer, including the expected timing
of first patient screening and dosing at Tel Aviv Sourasky Medical Center; the anticipated activation of additional clinical trial sites in Israel and Germany; the anticipated expansion of the trial into additional EU member states, the United
States, and other international jurisdictions; the potential therapeutic benefits and clinical utility of SIL204 across KRAS-driven cancers; the Company’s transition of the SIL204 program from regulatory preparation into active clinical execution;
the Company’s plans to potentially advance SIL204 into additional indications, including colorectal and lung cancers; and the Company’s development strategy and anticipated milestones are forward-looking statements. These forward-looking statements
are generally identified by terminology such as “may”, “should”, “could”, “might”, “plan”, “possible”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “prospective”, “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 conduct clinical trials, including the Phase 2/3 trial of SIL204 in locally advanced pancreatic cancer that has been initiated, and to enroll
and dose patients on the anticipated timeline; (ii) the ability of Silexion’s clinical trial sites to complete standard site activation procedures at additional participating medical centers; (iii) Silexion’s strategy, future operations, financial
position, projected costs, prospects, and plans; (iv) the impact of the regulatory environment and compliance complexities, including site-level approvals, conditions and clearances required prior to study commencement at each clinical site in Israel
and Germany, and the timing and outcome of additional regulatory submissions and reviews in further EU member states, the United States, and other jurisdictions; (v) expectations regarding future partnerships or other relationships with third
parties; (vi) Silexion’s future capital requirements and sources and uses of cash, including its ability to obtain additional capital; (vii) Silexion’s ability to maintain its Nasdaq listing (in light of all current Nasdaq listing requirements,
including the new $5 million minimum market value of listed securities); and (viii) 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, and the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the SEC on May 15, 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.
Silexion Therapeutics Corp
Ms. Mirit Horenshtein Hadar, CFO
mirit@silexion.com
Investor Relations Contact
Arx Investor Relations
North American Equities Desk
silexion@arxhq.com