Silexion Therapeutics Reports $16.5 Million Net Loss for 2024, Plans Phase 2/3 Trial for SIL204

Silexion Therapeutics Corp (formerly Biomotion Sciences), a clinical-stage oncology biotechnology company, reported a net loss of $16.5 million for the year ended December 31, 2024, compared to a net loss of $5.1 million in 2023. This increase is primarily attributed to higher research and development expenses ($5.8 million vs. $3.7 million), general and administrative expenses ($6.8 million vs. $1.0 million), and net financial expenses ($3.9 million vs. $0.4 million). The significant increase in expenses reflects the costs associated with becoming a public company following a business combination completed on August 15, 2024, including non-cash share-based compensation expenses and transaction costs.

The company's lead product candidate, SIL204, is a second-generation siRNA therapeutic targeting KRAS-driven cancers, specifically locally advanced pancreatic cancer (LAPC). SIL204 is designed to improve upon the company's first-generation candidate, siG12D-LODER (Loder), by optimizing uptake into tumor cells and broadening silencing activity. A Phase 2 clinical trial with Loder showed a trend toward improved overall survival in patients with KRAS G12D/V mutations, informing the design of the planned Phase 2/3 trial for SIL204. Pre-clinical studies for SIL204 demonstrated broad silencing activity against various KRAS mutations and synergistic effects with standard-of-care chemotherapy.

Silexion plans to initiate toxicology studies for SIL204 in 2025, followed by a regulatory submission in the first quarter of 2026 to begin a Phase 2/3 clinical trial in the first half of 2026. The company anticipates applying for Orphan Drug Designation in the U.S. and EU in 2026. As of December 31, 2024, the company had 11 full-time and 3 part-time employees, all based in Israel. The company's principal executive offices are located in Ramat Gan, Israel.

Significant financing activities occurred during the year. The company raised $2 million through a PIPE financing at closing and utilized an equity line of credit (ELOC) with White Lion Capital, LLC, raising an additional $3.1 million through December 31, 2024. A public offering in January 2025 generated approximately $5 million in gross proceeds, further supplemented by approximately $3.3 million from an induced warrant exercise transaction. As of December 31, 2024, the company's cash and cash equivalents totaled $1.2 million. The company's independent registered public accounting firm expressed substantial doubt about its ability to continue as a going concern due to recurring operating losses and negative cash flows.

The company's future financial performance is subject to numerous risks, including the uncertainties inherent in clinical drug development, the need for substantial additional funding, competition from established pharmaceutical companies, and the complexities of obtaining regulatory approvals. The company's financial statements include an explanatory paragraph expressing substantial doubt about its ability to continue as a going concern.