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

Rhea-AI Summary

Silexion Therapeutics (NASDAQ: SLXN) announced initiation of GMP clinical batch manufacturing of SIL204 with Catalent in Limoges, France, to supply its planned Phase 2/3 trial in locally advanced pancreatic cancer.

Tel Aviv Sourasky Medical Center’s Helsinki Ethics Committee also approved the Phase 2/3 trial, following prior Israeli Ministry of Health authorization and a Clinical Trial Application submission in Germany.

Positive

• GMP clinical manufacturing of SIL204 drug product started at Catalent’s Limoges, France facility
• Helsinki Ethics Committee at Tel Aviv Sourasky Medical Center approved SIL204 Phase 2/3 trial site
• Israeli Ministry of Health previously approved the Phase 2/3 trial for SIL204
• Clinical Trial Application for SIL204 submitted to Germany, expanding regulatory progress
• SIL204 will be tested with dual-route administration plus standard-of-care chemotherapy in LAPC

Negative

• None.

News Market Reaction – SLXN

-5.01%

11 alerts

-5.01% Session close to close

+13.1% Peak Tracked

-25.6% Trough Tracked

$2.36M Market Cap

1.3x Rel. Volume

In the May 13 session, SLXN declined 5.01%, reflecting a notable negative market reaction. Argus tracked a peak move of +13.1% during that session. Argus tracked a trough of -25.6% from its starting point during tracking. Our momentum scanner triggered 11 alerts that day, indicating notable trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock moved -5.0% in the session following this news. A negative reaction despite operational pr...

Analysis

The stock moved -5.0% in the session following this news. A negative reaction despite operational progress would fit a history of mixed responses to SIL204 trial milestones, where average clinical-trial headlines moved the stock by -1.21%. Even with GMP supply and additional site approval, investors remain exposed to warrant overhang and an effective resale registration that could facilitate more stock into the market. These structural factors may amplify downside when enthusiasm for clinical updates cools.

Key Figures

Registered warrant shares: 2,710,945 shares Potential warrant proceeds: $11.86 million Shares outstanding pre-offering: 4,074,710 shares +5 more

8 metrics

Registered warrant shares 2,710,945 shares POS AM registration for shares issuable upon exercise of outstanding warrants

Potential warrant proceeds $11.86 million Gross proceeds if all registered warrants in POS AM are exercised for cash

Shares outstanding pre-offering 4,074,710 shares Ordinary shares outstanding prior to POS AM warrant share registration

Pro forma shares 6,785,655 shares Assuming full exercise of registered warrants in POS AM filing

New authorized shares 50,000,000 shares Proposed increase in authorized ordinary shares in PRE 14A

Nasdaq equity requirement $2.5 million Shareholders’ equity threshold cited in PRE 14A

Resale registration shares 1,292,348 shares Ordinary shares covered by effective S-3 resale registration

Shelf warrant proceeds $4.9 million Maximum cash if 344,063 registered warrants under S-3 are exercised

Previous Clinical trial Reports

5 past events · Latest: Apr 28 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Apr 28	Germany CTA submitted	Positive	-12.8%	Submitted Phase 2/3 clinical trial application to Germany’s BfArM for SIL204.
Mar 24	Israel trial approval	Positive	+5.5%	Received Israeli Ministry of Health approval to initiate Phase 2/3 SIL204 trial.
Dec 16	Israel CTA submitted	Positive	+1.2%	Submitted Phase 2/3 clinical trial application in Israel targeting Q2 2026 start.
Dec 2	German feedback	Positive	-7.6%	Received positive Scientific Advice from BfArM on Phase 2/3 SIL204 trial design.
Nov 25	Toxicology completed	Positive	+7.6%	Completed two-species toxicology for SIL204 showing no systemic organ toxicity.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Clinical trial updates have produced mixed reactions, with an average same-tag move of -1.21% and both rallies and pullbacks on positive SIL204 news.

Recent Company History

Over the past several months, Silexion has steadily advanced SIL204 toward a Phase 2/3 trial in locally advanced pancreatic cancer. It completed toxicology with no systemic organ toxicity, secured positive German BfArM feedback, and submitted applications in Israel and Germany. Israel later approved the trial, and a German CTA was filed. Today’s GMP manufacturing and site approval build directly on this sequence, moving from regulatory planning into operational trial readiness.

Key Terms

gmp, investigational medicinal product, cdmo, sirna, +4 more

8 terms

gmp technical

"announced the initiation of Good Manufacturing Practice (GMP) clinical batch manufacturing"

Good Manufacturing Practice (GMP) is a set of regulatory standards and procedures that ensure products—especially medicines, medical devices, and related goods—are consistently made to meet safety, quality, and purity requirements. For investors, GMP compliance is like a factory’s hygiene and checklist system: it reduces the risk of product recalls, regulatory fines, and production stoppages, supports market access, and signals more reliable, lower-risk operations that can protect revenue and reputation.

investigational medicinal product regulatory

"will serve as the Investigational Medicinal Product (IMP) supply used to treat the first patients"

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.

cdmo technical

"manufacturing in collaboration with global leading manufacturing partner Catalent, a leading global CDMO"

A contract development and manufacturing organization (CDMO) is a company that provides specialized services to help develop and produce pharmaceutical products for other businesses. Think of it as a contract factory that takes a company's recipe and makes the product on their behalf. For investors, CDMOs are important because they support the growth of pharmaceutical companies and can be key partners in bringing new medicines to market.

sirna medical

"SIL204 is a next-generation siRNA therapy designed to silence mutated KRAS oncogenes"

Small interfering RNA (siRNA) is a short strand of genetic material that binds to and destroys the messenger RNA that carries instructions for making a specific protein, effectively switching that gene off. Investors care because siRNA is a platform for precise medicines: successful trials or approvals can create high-value drugs, while delivery challenges, manufacturing complexity, patent positions and regulatory risk can sharply affect a biotech company's prospects.

cmc regulatory

"represents a key step in Silexion's CMC (Chemistry, Manufacturing, and Controls) readiness"

Chemistry, Manufacturing, and Controls (CMC) describes the technical documentation and processes that show how a drug or medical product is made, tested for consistent quality, and kept stable from batch to batch. Investors care because strong CMC means a product can be manufactured reliably at scale and meet regulatory standards—similar to proving a recipe can be cooked the same way in any kitchen before restaurants expand—affecting approval, production costs, and potential revenue.

clinical trial application regulatory

"the Company's Clinical Trial Application (CTA) submitted to Germany"

An application submitted to a regulatory authority requesting formal permission to begin testing a new drug, medical device, or treatment in humans. Like asking for a building permit before construction, it summarizes safety data, plans for how the study will be run, and monitoring procedures; investors watch these filings closely because approval lets a program move from lab research to clinical testing, reducing uncertainty and creating value-driving milestones.

intratumoral medical

"dual-route administration strategy that combines intratumoral delivery to target primary tumors"

"Intratumoral" describes something that occurs or exists within a tumor, which is an abnormal growth of tissue. For investors, understanding intratumoral is important because it relates to medical treatments or research aimed at targeting the tumor directly, potentially leading to more effective therapies. Think of it as focusing treatment straight into the problem area, much like fixing a leak by working directly on the pipe itself.

systemic administration medical

"with systemic administration to address metastatic disease"

Systemic administration is giving a drug or biological therapy so it circulates through the bloodstream and reaches tissues throughout the body, rather than being applied to one spot. For investors, this matters because systemic delivery can widen a product’s patient reach and potential sales but also raises higher safety, manufacturing and regulatory hurdles—similar to watering an entire garden versus targeting a single plant, which affects cost, risk and marketability.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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 (GLOBE NEWSWIRE) -- 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

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

Investor Relations Contact
Arx Investor Relation
North American Equities Desk
silexion@arxhq.com

FAQ

What did Silexion (NASDAQ: SLXN) announce on May 13, 2026 about SIL204 manufacturing?

Silexion announced it has begun GMP clinical batch manufacturing of SIL204 at Catalent’s Limoges, France facility. According to Silexion, these batches will supply the safety run-in and subsequent stages of the planned Phase 2/3 trial in locally advanced pancreatic cancer.

What regulatory approvals has SIL204 received for the Phase 2/3 trial in pancreatic cancer?

SIL204’s Phase 2/3 trial received approval from Israel’s Ministry of Health and Tel Aviv Sourasky Medical Center’s Helsinki Ethics Committee. According to Silexion, a Clinical Trial Application has also been submitted in Germany, indicating multi-jurisdictional regulatory progress toward trial initiation.

What is Catalent’s role in Silexion’s SIL204 clinical supply manufacturing?

Catalent is manufacturing the finished clinical drug product for SIL204 at its Limoges, France center. According to Silexion, Catalent provides expertise in complex injectable formulations and sustained-release technologies, supporting validated GMP processes, stability programs, and full quality testing for upcoming clinical use.

How is the planned SIL204 Phase 2/3 trial in LAPC designed?

The SIL204 Phase 2/3 trial in locally advanced pancreatic cancer will use a safety run-in followed by a randomized cohort. According to Silexion, SIL204 will be evaluated in combination with standard-of-care chemotherapy, using a dual-route administration strategy to address primary tumors and metastatic disease.

What is SIL204 and how will it be administered in the Phase 2/3 trial?

SIL204 is a next-generation siRNA therapy targeting mutated KRAS, designed to silence oncogenes before protein expression. According to Silexion, the Phase 2/3 trial will use dual-route administration, combining intratumoral delivery to primary tumors with systemic dosing to reach metastatic lesions.

Why is GMP clinical supply manufacturing of SIL204 important for Silexion (SLXN) investors?

GMP clinical supply manufacturing is a key operational step enabling first patient dosing in the Phase 2/3 trial. According to Silexion, validated processes, stability programs, and quality testing at Catalent’s facility support Chemistry, Manufacturing, and Controls readiness for upcoming clinical evaluation of SIL204.