Business Context and Reporting Period
Company: Can-Fite Biopharma Ltd.
Filing Type: Form 20-F (Annual Report)
Reporting Period: Fiscal year ended December 31, 2025
Business Overview: Can-Fite is an advanced clinical-stage biopharmaceutical company developing orally bioavailable small molecule therapeutics targeting the A3 adenosine receptor (A3AR) for cancer, liver, and inflammatory diseases. The company has no commercial product sales and relies on out-licensing agreements and capital raises for funding.
Key Financial Metrics
| Metric | 2025 | 2024 | 2023 |
|---|---|---|---|
| Revenues | $0.41 million | $0.67 million | $0.74 million |
| Net Loss | $(9.83) million | $(7.88) million | $(7.63) million |
| Research & Development Expenses | $(6.69) million | $(5.76) million | $(5.98) million |
| General & Administrative Expenses | $(3.66) million | $(3.05) million | $(2.96) million |
| Cash and Cash Equivalents (Year End) | $5.53 million | $4.83 million | $4.28 million |
| Short-Term Deposits (Year End) | $3.01 million | $3.06 million | $N/A |
| Accumulated Deficit | $(176.19) million | $(166.36) million | $(158.48) million |
| Net Cash Used in Operating Activities | $(8.95) million | $(7.64) million | $(8.44) million |
| Net Cash Provided by Financing Activities | $9.64 million | $6.71 million | $9.14 million |
Material Changes vs. Prior Period
- Revenue Decline: Revenues decreased 40% to $0.41 million in 2025 compared to $0.67 million in 2024. This was primarily due to the recognition of a lower portion of advance payments from distribution agreements (Ewopharma, Gebro, CKD, Cipher).
- Increased Operating Loss: Net loss widened to $9.83 million in 2025 from $7.88 million in 2024. This increase was driven by a 16% rise in R&D expenses (acceleration of Phase 3 studies for Piclidenoson and Namodenoson) and a 20% rise in G&A expenses (investor relations costs).
- Capital Structure Changes: The company executed a 1-for-3,000 reverse split of ordinary shares in January 2026 (retroactively adjusted in financials) and changed the ADS ratio from 1:300 to 1:2. Significant equity raises occurred in 2025, including a registered direct offering and ATM sales, resulting in $9.64 million of net cash from financing.
Guidance, Outlook, and Risks
Outlook and Clinical Pipeline
- Piclidenoson (Psoriasis): Pivotal Phase III study initiated in Q1 2025; interim data expected Q2 2027.
- Namodenoson (HCC): Pivotal Phase III "Liveration" study enrolling patients; interim data expected Q2 2027.
- Namodenoson (MASH): Phase IIb study enrolling patients.
- Namodenoson (Pancreatic Cancer): Phase IIa study completed enrollment; met primary safety endpoint in March 2026.
- Liquidity: Management projects existing resources ($8.5 million in cash/deposits as of Dec 31, 2025) plus a subsequent $4.35 million warrant exercise in March 2026 will fund operations for at least 12 months. A contingency plan involving cost reductions and R&D reprioritization is in place.
Material Risks
- Going Concern: The company has a history of losses and negative operating cash flows. Continued operations depend on raising additional capital, which may not be available on acceptable terms.
- Geopolitical Instability: Operations are based in Israel. Ongoing security situations (conflicts with Hamas, Hezbollah, Iran) pose risks to personnel availability, supply chains, and regional economic stability.
- Clinical Trial Failure: Historical failures in Phase II/III trials for other indications (e.g., rheumatoid arthritis, glaucoma) highlight the risk that current pivotal trials may not meet endpoints.
- Listing Requirements: Risk of delisting from NYSE American if market capitalization falls below $5 million for 30 consecutive trading days under proposed rules.
Investor Verification Checklist
- Cash Runway: Verify the sufficiency of the $8.5 million cash balance plus the $4.35 million March 2026 proceeds against the projected burn rate for the next 12 months.
- Reverse Split Impact: Assess the impact of the 1-for-3,000 reverse split and ADS ratio change on trading liquidity and market price.
- Clinical Milestones: Monitor the timeline for interim data releases from the Phase III Psoriasis and HCC trials (expected Q2 2027) and the Phase IIa Pancreatic Cancer survival data.
- Revenue Recognition: Review the terms of out-licensing agreements (Ewopharma, CKD, etc.) to understand the timing of future milestone payments versus upfront amortization.
- Geopolitical Exposure: Evaluate the company's contingency plans regarding the security situation in Israel and its impact on clinical trial execution.