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

Rhea-AI Summary

Silexion Therapeutics (NASDAQ: SLXN) submitted a Clinical Trial Application to Germany's BfArM via EU CTIS for a planned Phase 2/3 trial of SIL204 in KRAS-driven locally advanced pancreatic cancer. The filing follows positive BfArM scientific advice and Israeli Ministry of Health approval, and supports planned trial initiation in Q2 2026 across Germany, other EU states, and Israel.

The trial will test SIL204 with standard chemotherapy using a dual-route intratumoral plus systemic administration strategy, starting with a safety run-in then a randomized cohort.

Positive

• Israeli approval obtained to initiate the Phase 2/3 trial
• CTA submitted to Germany with Germany as EU Reporting Member State
• Phase 2/3 initiation planned for Q2 2026
• Preclinical package includes two-species toxicology showing no systemic organ toxicity

Negative

• EU trial approval is pending following the CTA submission
• No clinical efficacy data reported for SIL204 in humans yet

News Market Reaction – SLXN

-12.75% 2.1x vol

9 alerts

-12.75% Session close to close

+4.7% Peak Tracked

-36.5% Trough Tracked

$2.97M Market Cap

2.1x Rel. Volume

In the Apr 28 session, SLXN declined 12.75%, reflecting a significant negative market reaction. Argus tracked a peak move of +4.7% during that session. Argus tracked a trough of -36.5% from its starting point during tracking. Our momentum scanner triggered 9 alerts that day, indicating moderate trading interest and price volatility. Trading volume was elevated at 2.1x the daily average, suggesting increased selling activity.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock dropped -12.8% in the session following this news. A negative reaction despite constructiv...

Analysis

The stock dropped -12.8% in the session following this news. A negative reaction despite constructive regulatory progress would echo past divergence when positive BfArM feedback coincided with a selloff. The program now has multiple green lights, including Israeli approval and a German CTA, yet SLXN trades near its 52-week low and well below its 200-day MA. Financing needs, an effective resale registration tied to up to $4.9 million in warrant exercises, and prior capital actions may weigh on sentiment even after good news.

Key Figures

Trial phase: Phase 2/3 Trial start timing: Q2 2026 5-year survival: <13% +4 more

7 metrics

Trial phase Phase 2/3 Planned SIL204 trial in locally advanced pancreatic cancer

Trial start timing Q2 2026 Overall Phase 2/3 trial initiation remains planned

5-year survival <13% Five-year survival rate in pancreatic cancer

Metastatic mortality share >80% Share of pancreatic cancer mortality driven by metastatic disease

KRAS in pancreatic cancer ≈90% Prevalence of KRAS mutations in pancreatic cancers

KRAS in colorectal cancer 45% Prevalence of KRAS mutations in colorectal cancers

KRAS in lung adenocarcinoma 30–35% Prevalence of KRAS mutations in lung adenocarcinomas

Previous Clinical trial Reports

5 past events · Latest: Mar 24 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Mar 24	Israel trial approval	Positive	+5.5%	Israeli Ministry of Health approved the SIL204 Phase 2/3 LAPC trial.
Dec 16	Israel CTA submission	Positive	+1.2%	Submitted Phase 2/3 clinical trial application in Israel for SIL204.
Dec 02	German feedback	Positive	-7.6%	Received favorable BfArM scientific advice on Phase 2/3 trial design.
Nov 25	Toxicology completion	Positive	+7.6%	Completed two-species toxicology for SIL204 with no systemic organ toxicity.
Sep 11	Preclinical metastasis data	Positive	+9.9%	Reported systemic SIL204 activity at major metastatic sites with p<0.01 effects.

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 for SIL204 have usually led to positive price reactions, with only one notable selloff on otherwise constructive German feedback.

Recent Company History

Over the past year, Silexion has advanced SIL204 steadily toward Phase 2/3. Key steps included positive metastatic-site preclinical data on Sep 11, 2025, completion of two-species toxicology with no systemic organ toxicity on Nov 25, 2025, and favorable BfArM scientific advice on Dec 2, 2025. Regulatory momentum continued with an Israeli CTA submission on Dec 16, 2025 and full Israeli trial approval on Mar 24, 2026. Today’s German CTA submission fits this progression into a multinational Phase 2/3 program.

Key Terms

rna interference, rnai, clinical trial application, cta, +4 more

8 terms

rna interference medical

"a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies"

RNA interference is a natural cellular process that acts like a mute switch to reduce or silence the activity of a specific gene by targeting its messenger RNA, the blueprint used to make a protein. For investors, it matters because therapies and diagnostics that harness this mechanism can precisely block disease-causing proteins, creating new drug classes with high potential reward but also scientific, manufacturing and regulatory risks that affect company value.

rnai medical

"biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers"

RNAi, short for RNA interference, is a natural cellular process that acts like a mute button for specific genes by using small RNA molecules to stop a target gene from producing its protein. For investors, RNAi matters because it is the underlying mechanism behind a class of precision medicines that can silence disease-causing genes, offering high potential returns but also scientific, regulatory and manufacturing risks unique to novel drug platforms.

clinical trial application regulatory

"announced the recent successful submission of a Clinical Trial Application (CTA) 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.

cta regulatory

"successful submission of a Clinical Trial Application (CTA) to Germany"

A CTA (Commodity Trading Advisor) is a professional or firm that manages and advises clients on trading futures, options and other derivatives, similar to a coach who designs and runs strategies using these instruments. It matters to investors because CTAs make decisions that can affect portfolio risk and returns, and they operate under regulatory oversight, so knowing a CTA’s strategy, performance and compliance helps assess potential reward and risk.

siRNA medical

"lead, small interfering RNA (siRNA) product candidate, SIL204"

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.

kras medical

"RNAi therapies for KRAS-driven cancers"

KRAS is a gene that makes a protein acting like a switch to control cell growth; certain changes (mutations) can lock that switch on and drive uncontrolled cell multiplication, which is a common cause of many cancers. Investors care because drugs or tests targeting KRAS mutations can create large markets or avoidable risks depending on trial results and regulatory decisions, much like a key product feature deciding a gadget’s commercial success.

bfarm regulatory

"Germany's Federal Institute for Drugs and Medical Devices (BfArM, Bundesinstitut ...)"

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.

eu clinical trials information system regulatory

"The CTA was submitted through the EU Clinical Trials Information System (CTIS)"

A central online database and portal used by European regulators to manage clinical trial applications, approvals, safety reports and public study information across the EU. For investors it acts like a public scoreboard: it increases transparency about which drugs or devices are being tested, regulatory progress and outcomes, helping assess development timelines, regulatory risk and competitive positioning without needing private company disclosures.

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

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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 (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 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

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.

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 (SLXN) submit to Germany on April 28, 2026?

Silexion submitted a Clinical Trial Application (CTA) to Germany as Reporting Member State for a Phase 2/3 SIL204 trial. According to the company, the CTA was filed through the EU Clinical Trials Information System to start the European review.

Has SIL204 received any regulatory approvals for the Phase 2/3 trial?

SIL204 received approval from the Israeli Ministry of Health to initiate the Phase 2/3 trial. According to the company, the EU CTA submission to Germany is now pending regulatory review.

When does Silexion plan to start the SIL204 Phase 2/3 trial (SLXN)?

Silexion plans to initiate the Phase 2/3 trial in Q2 2026. According to the company, sites are planned in Germany, additional EU member states, and previously announced Israeli sites.

What is the SIL204 trial design announced by Silexion (SLXN)?

The trial uses a safety run-in followed by a randomized cohort, combining SIL204 with standard chemotherapy. According to the company, it uses a dual-route intratumoral plus systemic administration strategy.

What preclinical safety data supports Silexion's SIL204 submission?

The submission is supported by completed two-species toxicology studies reporting no systemic organ toxicity. According to the company, extensive preclinical data informed the regulatory package and BfArM scientific advice.