Throughout the year, the Company reported significant positive preclinical findings for SIL204 across eight KRAS mutations and four cancer types, including first evidence of activity in gastric cancer, reinforcing broad therapeutic potential
During the fourth quarter, Silexion achieved key clinical readiness milestones including completing two-species toxicology studies, written Scientific Advice from Germany's BfArM, and submission of Phase 2/3 clinical trial application to the Ministry of Health in Israel for SIL204 in locally advanced pancreatic cancer
The Company remains on track to initiate Phase 2/3 clinical trial in the first half of 2026, with Israel regulatory feedback anticipated by the end of Q1 2026
Grand Cayman, Cayman Islands, March 17, 2026 (GLOBE NEWSWIRE) -- Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage, oncology-focused biotechnology company, today reported its financial results for the fourth quarter and full year ended December 31, 2025, and provided an update on recent business developments.
Recent Milestones & Business Highlights
Expanding Preclinical Validation Across KRAS-Driven Cancers: Throughout 2025, Silexion generated additional preclinical data supporting the broad therapeutic potential of SIL204. In human KRAS-mutated cancer cell line models, SIL204 demonstrated very high inhibition levels of cancer cell growth across multiple models and showed activity against eight distinct KRAS mutations: G12D, G12V, G12R, G12C, G13C, G12A, Q61H, and G13D. Preclinical efficacy was observed across four cancer types, including pancreatic, colorectal, lung, and gastric cancers. In orthotopic pancreatic cancer models, systemic administration of SIL204 resulted in significant reductions in primary tumor growth and metastatic spread to secondary organs.
Completion of Toxicology Studies and Clinical Trial Infrastructure Build-Out: In the fourth quarter of 2025, the Company completed two-species GLP toxicology studies for SIL204, supporting planned regulatory submissions and Phase 2/3 clinical readiness. During the year, Silexion also announced it has engaged AMS Advanced Medical Services GmbH as contract research organization (CRO) for its planned Phase 2/3 program and advanced manufacturing and operational partnerships to support scaled clinical execution.
Regulatory Advancement Toward Phase 2/3 Initiation: Silexion received written Scientific Advice from Germany's Federal Institute for Drugs and Medical Devices (BfArM) regarding the design of its planned Phase 2/3 clinical trial. The Company subsequently submitted its Phase 2/3 clinical trial application to the Ministry of Health in Israel for SIL204 in locally advanced pancreatic cancer and anticipates receiving initial regulatory feedback in the first quarter of 2026. The Company also plans to submit a Phase 2/3 clinical trial application in Germany by the end of the first quarter of 2026, with additional regulatory filings across the European Union planned in early 2027.
Strengthened Financial Position and Nasdaq Compliance: During 2025, the Company raised over $18.6 million in aggregate gross proceeds through public offerings and warrant exercises transactions. In September 2025, Nasdaq confirmed that Silexion had regained full compliance with Listing Rules 5550(a)(2) and 5550(b)(1), securing continued listing on the Nasdaq Capital Market.
Phase 2/3 Clinical Trial Planned for the Second Quarter of 2026: The planned Phase 2/3 clinical study is expected to begin in the second quarter of 2026 and will include an initial safety run-in cohort of approximately 18 patients, followed by expansion into a randomized cohort of approximately 166 patients. The study is designed to evaluate SIL204's dual-route administration approach in combination with standard chemotherapy in patients with locally advanced pancreatic cancer.
Ilan Hadar, Chairman and Chief Executive Officer of Silexion, commented: "We made meaningful progress during the fourth quarter and throughout 2025 as we executed across scientific, operational, and regulatory priorities to advance SIL204 toward the clinic. With our toxicology package completed, written Scientific Advice from Germany, and the submission of our Phase 2/3 clinical trial application in Israel, we believe we are well-positioned to continue advancing toward our planned Phase 2/3 clinical program initiation in 2026. We remain focused on disciplined execution as we work to bring an RNAi-based approach to patients with KRAS-driven cancers."
Mirit Horenshtein Hadar, Chief Financial Officer of Silexion, added: "During 2025, we strengthened our financial position while maintaining a determined operating approach. We ended the year with approximately $6.0 million in cash and cash equivalents, and we believe our capital structure and focus on clinical progress support our planned development and regulatory and clinical milestones as we advance SIL204."
Financial Results for the Three Months Ended December 31, 2025
-- Research and development ("R&D") expenses for the three months ended
December 31, 2025, were approximately $3.4 million, compared to
approximately $0.9 million for the same period in 2024.This
quarter-over-quarter increase primarily reflected the Company's continued
progression toward clinical readiness, including increased development
and external program execution activities.
-- General and administrative ("G&A") expenses for the three months ended
December 31, 2025, were approximately $1.0 million, compared to
approximately $1.0 million for the same period in 2024.
-- Net loss for the three months ended December 31, 2025, was approximately
$4.4 million, compared to approximately $1.7 million in the same period
of 2024.
Financial Results for the Year Ended December 31, 2025:
-- R&D expenses for the year ended December 31, 2025, were $7.1 million,
compared to $5.8 million for the year ended December 31, 2024. The
increase was primarily driven by higher subcontractor and consultant
expenses related to GMP production batches of the active pharmaceutical
ingredient (API) and formulation development intended to support
initiation of the planned human clinical trial expected in the second
quarter of 2026, partially offset by the absence of non-cash share-based
compensation expenses recognized in the prior-year period in connection
with grants issued during the August 2024 Business Combination.
-- G&A expenses for the year ended December 31, 2025, were $4.5 million,
compared to $6.8 million for the year ended December 31, 2024.The
decrease primarily reflecting the absence of significant non-cash
share-based compensation expenses and transaction costs recognized in the
prior-year period in connection with grants issued during the August 2024
Business Combination, partially offset by higher professional services
costs including director compensation, legal and other expenses
associated with the transition to a public company subsequent to the
Closing of the Business Combination, and more.
-- Net loss for the year ended December 31, 2025, was $11.9 million,
compared to a net loss of $16.5 million for the year ended December 31,
2024.
Balance Sheet Highlights:
-- As of December 31, 2025, the Company had cash and cash equivalents of
$6.0 million, compared to $1.2 million as of December 31, 2024. The
Company believes that its current cash balance will support in its
continued advancement toward the initiation of Phase 2/3 clinical trial
expected in the second quarter of 2026.
-- Total shareholders' equity was $2.6 million as of December 31, 2025,
compared to a capital deficiency of $(4.0) million as of December 31,
2024. During 2025, the Company completed multiple financing transactions,
including approximately $11.0 million in gross proceeds from public
offerings in January and September, approximately $2.6 million from
warrant exercises, and approximately $5.0 million from warrant exercise
inducement transactions (before related issuance costs).
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 which 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. 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:
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