On August 14, 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 six-month periods ended June 30, 2026, and provided a business update.
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Ilan Hadar, Chairman and Chief Executive Officer of Silexion, commented: "The second quarter of 2026 and the period since that time have represented the most consequential stretch in Silexion’s history, as we have transitioned SIL204 from a preclinical and regulatory-preparation asset into an active Phase 2/3 clinical program. With clinical trial authorization from Germany’s BfArM added to the previously received approval from the Israeli Ministry of Health, and the successful initiation of our first clinical site at Tel Aviv Sourasky Medical Center at the end of July, our focus has shifted entirely to clinical execution. In parallel, we continued to expand the scientific profile of SIL204 with new immuno-oncology data supporting a coordinated immune-sensitization signature across four KRAS mutations, reinforcing the rationale for future combination with anti-PD-(L)1 checkpoint inhibitors. We believe this combination of clinical, regulatory, manufacturing, and translational progress positions Silexion at the beginning of what should be a defining stretch for the Company."
Mirit Horenshtein Hadar, Chief Financial Officer of Silexion, added: "During the second quarter and subsequent to quarter end, we successfully executed a series of financing transactions. Most recently, we closed a public offering with gross proceeds of approximately $2.5 million. All of those transactions were designed to strengthen our balance sheet and support the transition of SIL204 into its recently initiated Phase 2/3 Clinical Trial, bringing new hope to the patients who need it most, alongside supporting compliance with applicable Nasdaq continued listing requirements."
Recent Milestones & Business Highlights
Phase 2/3 Clinical Program Advanced Across Israel and Germany, and Successfully Initiated at Tel Aviv Sourasky Medical Center: During the second quarter and subsequent to quarter end, Silexion advanced SIL204 into active Phase 2/3 clinical evaluation in locally advanced pancreatic cancer. In April 2026, the Company submitted its Clinical Trial Application to Germany’s Federal Institute for Drugs and Medical Devices (BfArM) through the EU Clinical Trials Information System, with Germany serving as Reference Member State for the European program. In June 2026, the Company received CTA approval from BfArM, accompanied by a positive opinion from the Ethics Committee of the North Rhine Medical Association, adding Germany to the previously received approval from the Israeli Ministry of Health. In May 2026, the Company initiated GMP clinical supply manufacturing of SIL204 with a leading global contract development and manufacturing organization (CDMO), further supporting the operational readiness of the program. On July 29, 2026, subsequent to quarter end, Silexion successfully initiated the Phase 2/3 clinical trial at Tel Aviv Sourasky Medical Center ("TASMC" or "Ichilov"), one of Israel’s largest and most prominent academic medical centers, clearing the site to commence patient screening, with first patient dosing anticipated to follow. Additional Israeli and German trial sites are progressing through activation and are expected to join the program in the coming months.
Expanded Immuno-Oncology Profile for SIL204 – Coordinated Immune-Sensitization Signature Across Three Pathways and Four KRAS Mutations: During and subsequent to the second quarter, Silexion reported preclinical findings that extended SIL204’s therapeutic profile beyond direct anti-tumor activity into immune sensitization. In May 2026, the Company reported statistically significant upregulation of MHC-I following SIL204 treatment in human KRAS-mutant pancreatic and non-small cell lung cancer cells, supporting potential future evaluation alongside anti-PD-1 therapies including pembrolizumab (Keytruda). In August 2026, the Company reported additional statistically significant upregulation of FAS (CD95), the immune "death receptor," and downregulation of HLA-G, an established immune checkpoint, across three distinct KRAS mutations in pancreatic and non-small cell lung cancer cell lines. Taken together, these findings support a coordinated immune-sensitization signature across three key immune pathways — increased antigen presentation, restored susceptibility to immune-mediated apoptosis, and reduced immune checkpoint activity — observed across four KRAS mutations (G12D, G12V, G12C, and G12R), reinforcing the scientific rationale for combining SIL204 with anti-PD-(L)1 checkpoint inhibitor therapies.
Capital-Structure Actions to Support Clinical Execution and Continued Nasdaq Listing: During the second quarter and subsequent to quarter end, Silexion executed a series of financing transactions in support of the Phase 2/3 clinical program and support compliance with applicable Nasdaq continued listing requirements, including a May 2026 warrant exercise inducement transaction, ongoing sales of ordinary shares under the Company’s at-the-market facility, further partial conversions of principal under its related party promissory note, shareholder-approved successive increases in authorized share capital, and a 1-for-10 reverse share split effected on May 28, 2026. Most recently, on August 13, 2026, the Company closed a registered public offering with aggregate gross proceeds of approximately $2.5 million and net proceeds of approximately $2.1 million.
Financial Results for the Three Months Ended June 30, 2026
Research and development ("R&D") expenses for the three months ended June 30, 2026, were approximately $2.2 million, compared to approximately $1.0 million for the three months ended June 30, 2025, an increase of 120.0%. The increase resulted mainly from an increase in subcontractors’ and consultants’ expenses related to the operational ramp-up and preparations, required to support the initiation of our Phase 2/3 human clinical trial, which was initiated in July 2026.
General and administrative ("G&A") expenses for the three months ended June 30, 2026, were approximately $1.5 million, compared to approximately $1.3 million for the three months ended June 30, 2025, an increase of 15.4%. The increase resulted mainly from an increase in professional services costs, primarily related to consultants and other expenses associated with the costs of operating as a public company.
Financial expenses (income), net for the three months ended June 30, 2026, were approximately $(0.1) million of financial income, net, compared to approximately $0.2 million of financial expenses, net, for the three months ended June 30, 2025. The change was mainly due to the revaluation of the related party promissory note.
Net loss for the three months ended June 30, 2026, was approximately $3.6 million, compared to approximately $2.5 million for the three months ended June 30, 2025, an increase of 44.0%. The increase was mainly due to higher research and development expenses related to preparations for the human clinical trial initiated in July 2026, and higher general and administrative expenses, partly offset by a decrease in financial expenses, net, due to the revaluation of financial instruments.
Financial Results for the Six Months Ended June 30, 2026
R&D expenses for the six months ended June 30, 2026, were approximately $3.6 million, compared to approximately $1.6 million for the six months ended June 30, 2025, an increase of 125.0%. The increase was primarily attributable to higher subcontractors’ and consultants’ expenses related to the operational ramp-up and preparations, required to support the initiation of the Company’s Phase 2/3 human clinical trial, which was initiated in July 2026.
G&A expenses for the six months ended June 30, 2026, were approximately $2.8 million, compared to approximately $2.3 million for the six months ended June 30, 2025, an increase of 21.7%. The increase resulted mainly from an increase in professional services costs, primarily related to legal, consultants, and other expenses associated with the costs of operating as a public company.
Financial expenses (income), net for the six months ended June 30, 2026, were approximately $(0.1) million of financial income, compared to approximately $0.3 million of financial expenses for the six months ended June 30, 2025. The decrease was mainly due to the revaluation of the related party promissory note.
Net loss for the six months ended June 30, 2026, was approximately $6.3 million, compared to approximately $4.2 million for the six months ended June 30, 2025, an increase of 50.0%. The increase was mainly due to higher research and development expenses (mainly related to preparations for the human clinical trial, initiated in July 2026) and higher general and administrative expenses, partly offset by a decrease in financial expenses, net, due to the revaluation of financial instruments.
Balance Sheet
As of June 30, 2026, the Company had cash and cash equivalents of approximately $2.2 million, compared to approximately $6.0 million as of December 31, 2025.
During the second quarter and subsequent to quarter end, the Company strengthened its capital position through a series of financing transactions, most recently the closing on August 13, 2026, of a public offering yielding aggregate gross proceeds of approximately $2.5 million. As a result of these transactions and those detailed in the Company’s Quarterly Report on Form 10-Q, the Company estimates that its shareholders’ equity, as of June 30, 2026 (as adjusted to reflect the foregoing transactions to date), is currently approximately $3.2 million, which exceeds the Nasdaq Capital Market’s $2.5 million minimum shareholders’ equity requirement for continued listing. Accordingly, the Company believes that it has restored compliance with the applicable shareholders’ equity requirement.
(Press release, Silexion Therapeutics, AUG 14, 2026, View Source [SID1234670146])