On November 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, reported financial results for the three-month and nine-month periods ended September 30, 2026, and provided a business update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Ilan Hadar, Chairman and Chief Executive Officer of Silexion, commented: "In the third quarter, we began treating patients with SIL204 in our Phase 2/3 trial in pancreatic cancer. After opening our first clinical site at Tel Aviv Sourasky Medical Center in July, we dosed the first patient at the end of September. At the same time, our laboratory work continued to strengthen the case for SIL204, with new data suggesting it may help the immune system recognize cancer cells, and showing that it uses natural carriers in the blood to enter cancer cells. Our focus now is on enrolling the first group of patients and bringing more hospitals in Israel and Germany into the trial."

Mirit Horenshtein Hadar, Chief Financial Officer of Silexion, added: "During the third quarter, we completed a public offering and a warrant inducement transaction and continued sales under our at-the-market facility, increasing our cash and cash equivalents to $4.8 million and shareholders’ equity to approximately $3.0 million as of September 30, 2026. This financial progress strengthens our balance sheet and supports the continued advancement of SIL204 as we enroll patients in the Phase 2/3 trial."

Recent Milestones & Business Highlights

First Patient Dosed in Phase 2/3 Clinical Trial of SIL204: On July 29, 2026, Silexion initiated its Phase 2/3 clinical trial of SIL204 in locally advanced pancreatic cancer ("LAPC") at Tel Aviv Sourasky Medical Center ("TASMC" or "Ichilov"), and on September 30, 2026, announced that the first patient worldwide had been dosed at TASMC. The prospective, randomized, controlled, multinational, open-label Phase 2/3 study is evaluating SIL204 in combination with standard-of-care chemotherapy, versus chemotherapy alone, in newly diagnosed, treatment-naïve patients with unresectable Stage 3 LAPC whose tumors harbor a confirmed KRAS mutation. SIL204 is administered via a dual-route regimen combining direct EUS-guided intratumoral delivery to the primary tumor with subcutaneous injections designed to provide systemic exposure. The study is structured as an initial safety run-in cohort of approximately 18 patients, followed by expansion into a randomized cohort of approximately 166 patients.

Clinical Site Expansion in Israel and Germany: In Israel, following the approval of the Israeli Ministry of Health, TASMC was activated as the trial’s first clinical site in July 2026, and the first patient was dosed there on September 30, 2026. Additional Israeli oncology centers, alongside leading academic medical institutions in Germany, are progressing through site activation and are expected to join the trial in the coming months.

Expanded Translational Profile of SIL204: In August 2026, Silexion reported preclinical findings showing statistically significant upregulation of FAS (CD95), an immune "death receptor," and downregulation of HLA-G, an established immune checkpoint, in human KRAS-mutant pancreatic and non-small cell lung cancer cell lines. Together with the MHC-I upregulation reported in May 2026, the findings support a coordinated immune-sensitization signature across three immune pathways and four KRAS mutations (G12D, G12V, G12C and G12R), reinforcing the scientific rationale for combining SIL204 with anti-PD-(L)1 checkpoint inhibitor therapies. In September 2026, the Company reported that SIL204 uses naturally circulating lipoproteins to enter cancer cells and silence mutant KRAS without synthetic transfection reagents or artificial carriers, supporting the systemic administration of SIL204. Pharmacokinetic, cellular uptake kinetics and biodistribution studies are ongoing.

Financing Activities: During the third quarter, Silexion completed a registered public offering in August 2026 with gross proceeds of approximately $2.5 million and a warrant inducement transaction in September 2026 with gross proceeds of approximately $0.84 million, and continued sales of ordinary shares under its at-the-market facility for gross proceeds of approximately $1.9 million. Subsequent to quarter end, on November 10, 2026, the Company effected a 1-for-24 reverse share split.

Financial Results for the Three Months Ended September 30, 2026

Research and development ("R&D") expenses for the three months ended September 30, 2026, were approximately $1.3 million, compared to approximately $2.2 million for the three months ended September 30, 2025, a decrease of 40.9%.

General and administrative ("G&A") expenses for the three months ended September 30, 2026, were approximately $1.4 million, compared to approximately $1.1 million for the three months ended September 30, 2025, an increase of 27.3%.

Net loss for the three months ended September 30, 2026, was approximately $2.5 million, compared to approximately $3.3 million for the three months ended September 30, 2025, a decrease of 24.2%.

Financial Results for the Nine Months Ended September 30, 2026

R&D expenses for the nine months ended September 30, 2026, were approximately $4.9 million, compared to approximately $3.8 million for the nine months ended September 30, 2025, an increase of 28.9%. The increase related to the operational ramp-up for the Phase 2/3 clinical trial of SIL204.

G&A expenses for the nine months ended September 30, 2026, were approximately $4.2 million, compared to approximately $3.5 million for the nine months ended September 30, 2025, an increase of 20.0%.

Net loss for the nine months ended September 30, 2026, was approximately $8.8 million, compared to approximately $7.5 million for the nine months ended September 30, 2025, an increase of 17.3%. The increase was mainly due to higher R&D expenses related to the Phase 2/3 clinical trial of SIL204.

Balance Sheet Highlights

As of September 30, 2026, Silexion had cash and cash equivalents of $4.8 million, compared to $6.0 million as of December 31, 2025, and $2.2 million as of June 30, 2026.
Total shareholders’ equity was $3.0 million as of September 30, 2026, compared to $2.6 million as of December 31, 2025.

(Press release, Silexion Therapeutics, NOV 13, 2026, View Source [SID1234674769])