Silexion Therapeutics Reports Third Quarter 2026 Financial Results and Provides Business Update


First patient dosed in the Phase 2/3 clinical trial of SIL204 in locally advanced pancreatic cancer at Tel Aviv Sourasky Medical Center, moving SIL204 into active patient treatment

New translational data expanded SIL204’s profile, including a coordinated immune-sensitization signature across four KRAS mutations and a native lipoprotein-mediated uptake mechanism that supports systemic administration

Third quarter financings increased cash and cash equivalents to $4.8 million and shareholders’ equity to $3.0 million as of September 30, 2026

Grand Cayman, Cayman Islands, Nov. 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 financial results for the three-month and nine-month periods ended September 30, 2026, and provided a business update.

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.

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), through Phase 2/3 clinical evaluation. 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

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 are forward-looking statements, including, for example, statements regarding the development of SIL204; the conduct, enrollment and timing of the ongoing Phase 2/3 clinical trial of SIL204 in locally advanced pancreatic cancer, including enrollment of the safety run-in cohort and expansion into a randomized cohort; the timing of activation of additional clinical trial sites in Israel and Germany and the potential expansion of the trial into additional jurisdictions; the timing and results of ongoing translational, pharmacokinetic, cellular uptake and biodistribution studies, and the potential to evaluate SIL204 in combination with anti-PD-(L)1 checkpoint inhibitor therapies; the potential therapeutic benefits, mutation coverage, mechanism of action and clinical utility of SIL204 across KRAS-driven cancers; Silexion’s business strategy and development plans; Silexion’s ability to raise additional capital and its future capital requirements, including through its at-the-market facility, public and private offerings, warrant exercises, warrant inducement transactions and other financing arrangements; the outcome of litigation; and Silexion’s ability to restore and maintain compliance with Nasdaq continued listing requirements. 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) the degree of success of Silexion’s ongoing and planned clinical trials, including the Phase 2/3 clinical trial of SIL204, and the risk that early observations may not be predictive of later results; (ii) Silexion’s ability to enroll and treat patients, and to complete the activation of additional clinical sites, on anticipated timelines; (iii) whether Silexion is able to successfully execute upon its strategy and plans via its future operations, and maintain a positive financial position; (iv) the impact of the regulatory environment and compliance complexities; (v) whether Silexion is able to develop future partnerships or other relationships with third parties; (vi) Silexion’s future capital requirements and sources and uses of cash, and the potential impact on the Company’s operations of any inability to secure such capital; (vii) the substantial doubt about the Company’s ability to continue as a going concern described in Note 1(e) to the Company’s unaudited condensed consolidated financial statements for the three-month and nine-month periods ended September 30, 2026; (viii) whether Silexion succeeds at maintaining its Nasdaq listing, including the determination of the Nasdaq hearings panel, compliance with the shareholders’ equity and minimum bid price requirements, and any potential increase to the market value of listed securities requirement; and (ix) 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 September 30, 2026, filed with the SEC on November 12, 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.

Company Contact
Silexion Therapeutics Corp
Ms. Mirit Horenshtein Hadar, CFO
info@silexion.com

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


SILEXION THERAPEUTICS CORP
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share and per share data)

 September 30,December 31,
 20262025
ASSETS  
CURRENT ASSETS:  
Cash and cash equivalents$4,760$5,991
Restricted cash2827
Prepaid expenses1,221570
Other current assets10249
TOTAL CURRENT ASSETS6,1116,637
   
NON-CURRENT ASSETS:  
Restricted cash6157
Long-term deposit and other non-current assets32084
Property and equipment, net2125
Operating lease right-of-use asset314412
TOTAL NON-CURRENT ASSETS716578
   
TOTAL ASSETS$6,827$7,215


SILEXION THERAPEUTICS CORP
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS (continued)
(U.S. dollars in thousands, except share and per share data)

 September 30,December 31,
 20262025
LIABILITIES AND SHAREHOLDERS’ EQUITY  
CURRENT LIABILITIES:  
Trade payables$1,244$787
Current maturities of operating lease liability196182
Employee related obligations460879
Other account payable1,781910
Private warrants to purchase ordinary shares (including $* due to related party, as of September 30, 2026 and December 31, 2025)**
TOTAL CURRENT LIABILITIES3,6812,758
   
NON-CURRENT LIABILITIES:  
Long-term operating lease liability178286
Related Party Promissory Note-1,568
TOTAL NON-CURRENT LIABILITIES$178$1,854
TOTAL LIABILITIES$3,859$4,612
   
SHAREHOLDERS’ EQUITY:  
Ordinary shares ($3.24 par value per share, 662,500 and 37,500 shares authorized as of September 30, 2026 and December 31, 2025, respectively; 603,055 and 13,028 shares issued and outstanding as of September 30, 2026 and December 31, 2025, respectively)1,95442
Additional paid-in capital64,99757,727
Accumulated deficit(63,983)(55,166)
TOTAL SHAREHOLDERS’ EQUITY$2,968$2,603
   
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY$6,827$7,215

All share amounts, and par value per share, reflect a 1-for-10 reverse share split effected on May 28, 2026, and a 1-for-24 reverse share split effected on November 10, 2026, as described in Notes 1(d) and 13 to the Company’s condensed consolidated financial statements included in the Company’s quarterly report on Form 10-Q for the quarter ended September 30, 2026.

* Represents an amount less than $1 thousand.


SILEXION THERAPEUTICS CORP
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)

 Nine months ended September 30,Three months ended September 30,
 2026202520262025
OPERATING EXPENSES:    
Research and development (including $176 and $0 from related party for the nine-month periods ended September 30, 2026 and 2025, respectively, and $0 from related party for the three-month periods ended September 30, 2026 and 2025)$4,868$3,765$1,286$2,157
General and administrative (including $298 and $96 from related party for the nine-month periods ended September 30, 2026 and 2025, respectively, and $16 and $38 from related party for the three-month periods ended September 30, 2026 and 2025, respectively)4,2453,4611,3981,135
TOTAL OPERATING EXPENSES9,1137,2262,6843,292
OPERATING LOSS9,1137,2262,6843,292
Financial expenses (income), net (including $(307) and $203 from related party for the nine-month periods ended September 30, 2026 and 2025, respectively, and $(138) and $(26) from related party for the three-month periods ended September 30, 2026 and 2025, respectively)(296)271(151)(30)
LOSS BEFORE INCOME TAX$8,817$7,497$2,533$3,262
INCOME TAX*3*-
NET LOSS$8,817$7,500$2,533$3,262
     
LOSS PER SHARE, BASIC AND DILUTED$115.56$2,486.20$13.70$691.14
     
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE**76,3053,017184,9274,720

* Represents an amount less than $1 thousand.

** All share and per share amounts reflect (for periods preceding the relevant reverse share split, on a retroactive basis) the 1-for-10 reverse share split effected on May 28, 2026 and the 1-for-24 reverse share split effected on November 10, 2026, as described in Notes 1(d) and 13 to the Company’s condensed consolidated financial statements included in the Company’s quarterly report on Form 10-Q for the quarter ended September 30, 2026.


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