Business Context and Reporting Period
Silexion Therapeutics Corp (SLXN) is a clinical-stage biotechnology company focused on developing RNA interference (RNAi) therapies for KRAS-driven cancers, primarily locally advanced pancreatic cancer (LAPC). The company's lead product candidate, SIL204, is a second-generation siRNA designed to silence the KRAS oncogene. This Form 10-K covers the fiscal year ended December 31, 2025. The company was formed via a business combination with Moringa Acquisition Corp in August 2024 and operates primarily through its Israeli subsidiary, Silexion Therapeutics Ltd.
Key Financial Metrics
| Metric (in thousands, except per share) | 2025 | 2024 |
|---|---|---|
| Revenue | $0 | $0 |
| Net Loss | $(11,912) | $(16,519) |
| Operating Expenses | $11,632 | $12,571 |
| Cash and Cash Equivalents (Year End) | $5,991 | $1,187 |
| Net Cash Used in Operating Activities | $(10,819) | $(8,396) |
| Net Cash Provided by Financing Activities | $15,640 | $5,104 |
| Accumulated Deficit | $(55,166) | $(43,254) |
| Loss Per Share (Basic & Diluted) | $(8.96) | $(394.94) |
Note: Share and per-share data have been retroactively adjusted for 1-for-9 and 1-for-15 reverse share splits.
Material Changes vs. Prior Period
- Net Loss Reduction: Net loss decreased by approximately 28% (from $16.5M to $11.9M), primarily driven by a significant reduction in non-cash share-based compensation expenses ($5.9M in 2024 vs. $0.1M in 2025) and a decrease in financial expenses related to the one-time loss on the business combination in 2024.
- Operating Expenses: Total operating expenses decreased by 7.5%. While Research and Development (R&D) expenses increased by 22.4% (to $7.1M) due to GMP production and clinical trial preparation, General and Administrative (G&A) expenses decreased by 33.8% (to $4.5M) due to the absence of one-time transaction costs and share-based compensation.
- Liquidity Improvement: Cash and cash equivalents increased significantly from $1.2M to $6.0M, fueled by $15.6M in net financing proceeds from public offerings and warrant exercises in 2025.
- Debt Reduction: The company retired the EarlyBird Convertible Note in March 2025 and converted $1.8M of the A&R Sponsor Promissory Note into equity in September 2025, reducing the outstanding principal to approximately $1.6M.
Guidance, Outlook, and Risks
Outlook and Milestones
- Clinical Trials: The company expects to initiate the first part of its adaptive Phase 2/3 clinical trial for SIL204 in the second quarter of 2026 in Israel and Germany. This trial includes a safety run-in followed by a randomized study.
- Regulatory Filings: An Investigational New Drug (IND) application to the U.S. FDA is expected in Q1 2027. Applications for Orphan Drug Designation in the U.S. and EU are planned for H1 2027.
- Financing: The company has established an At-The-Market (ATM) offering agreement to raise up to $13.2M. No sales were made under the ATM in 2025.
Material Risks and Contingencies
- Going Concern: The independent auditor has expressed substantial doubt about the company's ability to continue as a going concern. Management estimates current cash reserves are sufficient for only "several months" of operations, necessitating additional capital raises.
- Nasdaq Compliance: The company is under a mandatory monitoring period until September 2026 to maintain compliance with Nasdaq shareholders' equity requirements. Failure to maintain compliance could result in immediate delisting.
- Geopolitical Risk: Operations are centered in Israel. Ongoing conflicts in the Middle East pose risks to operations, travel, and the ability to raise capital, though the company states core R&D activities are conducted outside Israel.
- Related Party Dispute: The Moringa Sponsor has disputed the conversion of $1.8M of the Sponsor Promissory Note into shares and demanded repayment in full. The company rejects this claim, asserting the conversion was compliant.
Key Facts for Investor Verification
- Cash Runway: Verify the exact duration of the current cash runway given the "several months" estimate and the high burn rate associated with upcoming clinical trials.
- Financing Strategy: Assess the feasibility of raising additional capital via the ATM or new public offerings given the current market volatility and the company's recent reverse share splits.
- Clinical Timeline: Monitor the Q2 2026 initiation of the Phase 2/3 trial as a critical milestone for valuation and future funding.
- Related Party Note: Track the status of the dispute regarding the $1.6M remaining Sponsor Promissory Note and potential legal or financial implications.
- Nasdaq Status: Confirm continued compliance with Nasdaq Capital Market listing standards, specifically the $2.5M shareholders' equity requirement, throughout the monitoring period.