Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. is a clinical-stage biotechnology company developing orally administered small-molecule therapeutics based on its A3 adenosine receptor platform. Its pipeline is focused on oncology, liver disease, and inflammatory diseases, with development and partnering activities centered in Israel and commercial/regulatory interactions in the United States and Europe.
Fiscal year 2025 · change from previous year
Development 2020–2025
Business
Share of revenueClinical-stage therapies for cancer indications, including hepatocellular carcinoma and pancreatic cancer.
Clinical-stage therapies for autoimmune and inflammatory conditions such as psoriasis.
Clinical-stage therapies targeting liver-related diseases including MASH and cirrhosis.
Out-licensing and collaboration agreements that monetize pipeline rights through upfront and milestone payments.
Customers
Can-Fite sells into a business-to-business pharmaceutical ecosystem rather than directly to patients. Its counterparties are mainly large pharmaceutical companies, biotechnology firms, and potential strategic partners that license drug candidates, fund development, or commercialize assets in specific territories. Ultimately, the therapeutic end users are physicians and patients in oncology, hepatology, and inflammatory disease markets.
Large pharma groups that license Namodenoson or Piclidenoson for selected regions or indications to expand pipelines.
Biotech firms that partner on development, shared trials, or co-commercialization of clinical assets.
Companies that take rights in defined territories and handle market access and launch execution.
Hospitals and research centers running the company's Phase II and Phase III studies.
Patients with HCC, psoriasis, MASH, pancreatic cancer, or rare disease indications who benefit from the therapies being tested.
Strategy
Can-Fite’s strategy is to advance a small number of clinical-stage assets through late-stage trials while using partnering and licensing to broaden development reach. The company is also positioning its A3AR platform as a repeatable source of orally administered therapies across oncology, liver disease, and inflammatory disease. Regulatory designations and regional licensing agreements are important because they can reduce development friction and create optionality for future commercialization.
Phase III data are the main value driver for a clinical-stage biotech and determine partnering leverage.
Out-licensing can provide non-dilutive capital and territory-specific commercialization capacity.
FDA and EMA alignment can improve the path to approval and market access for lead assets.
A3AR biology may support additional indications and increase the value of the pipeline.
Geography
The company is incorporated in Israel and has principal executive offices in Ramat Gan, while its securities trade in the United States on NYSE American and in Israel on TASE. Its development programs are designed for regulatory pathways in the United States and Europe, and partnering activity also includes international licensing arrangements. Clinical and conference-related business activity is visible in the United States, particularly through U.S. regulatory engagement and industry events.
Risks
The company depends on successful clinical development of a small number of lead assets, so trial setbacks or weak efficacy data would materially affect valuation. As a biotech with no broad commercial product base, it also faces financing, regulatory, and partnering execution risk, while the biology of oncology and inflammatory disease drug development carries high attrition rates. Any delay in approvals, licensing, or market access would slow the path from pipeline to revenue.
- Late-stage clinical failureImpact: CriticalLikelihood: Medium
Phase III programs are the main value drivers and negative data can sharply reduce future licensing and approval prospects.
Exposure: Namodenoson and Piclidenoson
- Financing and dilution riskImpact: HighLikelihood: High
Clinical-stage development is capital intensive and the company may need external funding before commercialization.
Exposure: Development funding
- Regulatory approval riskImpact: HighLikelihood: Medium
FDA and EMA approval depends on meeting predefined efficacy and safety endpoints and may be delayed or denied.
Exposure: U.S. and Europe
- Partnering and licensing execution riskImpact: MediumLikelihood: Medium
Future monetization depends on finding partners willing to pay upfronts, milestones, and royalties.
Exposure: Global out-licensing
Accounting
Judgemental itemsUpfront and milestone payments from regional agreements must be recognized based on performance obligations and contract terms.
Impact: Affects reported revenue timing and volatility
Trial costs are estimated from patient enrollment, site activity, and vendor progress before invoices arrive.
Impact: Affects R&D expense and liabilities
Private placements can include warrants that require valuation and remeasurement judgments.
Impact: Affects financing-related gains/losses and balance sheet presentation
Employee and director awards are common in biotech and create non-cash expense using valuation assumptions.
Impact: Affects operating expense and diluted share count
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Last updated: 28/09/2026