20-F: Can-Fite BioPharma Reports Continued Losses, Advances Pipeline

Can-Fite BioPharma Ltd. reported a net loss of $9.8 million for 2025, continuing its history of operating losses, while advancing its clinical pipeline and securing additional capital.

Summary

• Can-Fite BioPharma Ltd. incurred a net loss of $9.8 million for the fiscal year ended December 31, 2025, an increase from $7.9 million in 2024 and $7.6 million in 2023.
• The company has an accumulated deficit of approximately $176.2 million as of December 31, 2025.
• Revenues for 2025 decreased by 40% to $0.41 million, down from $0.67 million in 2024, primarily due to lower recognition of advance payments from distribution agreements.
• Research and development expenses increased by 16.26% to $6.69 million in 2025, up from $5.75 million in 2024, driven by accelerated expenses for Namodenoson and Piclidenoson studies.
• General and administrative expenses rose by 20.2% to $3.66 million in 2025, compared to $3.04 million in 2024, mainly due to increased investor relations expenses.
• Cash and cash equivalents stood at $5.5 million, with short-term deposits of $3.0 million, totaling $8.5 million as of December 31, 2025.
• A 1-for-3,000 reverse split of ordinary shares and a change in ADS ratio (1 ADS to 2 ordinary shares) were effected on January 2, 2026, and January 5, 2026, respectively.
• The company initiated pivotal Phase III studies for Piclidenoson in psoriasis and Namodenoson in advanced liver cancer, both currently enrolling patients.
• Enrollment was completed for an exploratory Phase II study of Namodenoson in pancreatic cancer, which met its primary safety endpoint.
• Pre-clinical data supports Piclidenoson's potential for Lowe Syndrome and Namodenoson's potential as an anti-obesity drug, with patent allowances received in Canada and Israel for Namodenoson's anti-obesity use.
• The company terminated its in-licensing agreement with Leiden University for CF602 in January 2026.
• A warrant inducement transaction in March 2026 generated approximately $4.3 million in gross proceeds.

Sentiment

Score: 4

Explanation: StockSavvy.ai views this filing with cautious optimism. While the company continues to face significant financial challenges, including ongoing losses and a need for capital, the advancement of multiple drug candidates into pivotal clinical stages and positive preclinical data for new indications provide potential future value. However, the history of clinical trial setbacks and the substantial accumulated deficit temper enthusiasm.

Positives

• Piclidenoson is in pivotal Phase III studies for moderate to severe psoriasis, following positive responses from the FDA and EMA for its registration plan and study protocol.
• Namodenoson is in a pivotal Phase III trial for advanced liver cancer (HCC) in Child-Pugh B7 patients, with interim analysis data expected in Q2 2027.
• Namodenoson received Fast Track designation from the FDA for advanced HCC and orphan drug designation for HCC and pancreatic cancer.
• An exploratory Phase II study of Namodenoson for pancreatic cancer met its primary safety endpoint, showing good tolerability in heavily pretreated patients.
• Pre-clinical studies support Namodenoson's potential as an anti-obesity drug, with patent allowances received in Canada and Israel for this indication.
• Piclidenoson showed efficacy in preclinical studies for Lowe Syndrome, a rare genetic disease with no current treatment, and preparatory work for a Phase II study is underway.
• Vetbiolix exercised its option to license Piclidenoson for canine osteoarthritis after positive clinical study results, leading to upfront and milestone payments.
• Namodenoson demonstrated a potential supportive role in patients with decompensated liver cirrhosis awaiting transplantation, with one patient surviving eight years with complete response under compassionate use.
• The company successfully raised approximately $4.3 million in gross proceeds from a warrant inducement transaction in March 2026, bolstering liquidity.

Negatives

• The company has a history of significant operating losses, with a net loss of $9.8 million in 2025 and an accumulated deficit of $176.2 million.
• Revenues decreased by 40% in 2025 compared to 2024, indicating a decline in income from existing out-licensing agreements.
• Past clinical trials for Piclidenoson in dry-eye syndrome and glaucoma failed to meet primary efficacy endpoints.
• Two Phase IIb studies of Piclidenoson in rheumatoid arthritis, including one in combination with MTX, failed to reach primary endpoints.
• A Phase II/III study of Piclidenoson for psoriasis did not meet its primary endpoint, although further analysis showed positive data.
• A Phase II study of Namodenoson for advanced HCC in Child-Pugh B patients did not meet its primary endpoint of overall survival in the whole population.
• The company will need to raise substantial additional capital to fund its operations and strategic objectives, with no assurance of availability on acceptable terms.
• The termination of the in-licensing agreement with Leiden University for CF602 removes a potential drug candidate from the pipeline, though the company is investigating other compounds for erectile dysfunction.

Risks

• Continued operating losses and the need for additional capital, which may be costly or difficult to obtain and will dilute current shareholders' ownership interests.
• Uncertainties of cash flows and inability to meet working capital needs.
• Product candidates are at various stages of clinical and preclinical development and may never be commercialized or achieve profitability.
• Results of earlier clinical trials may not be predictive of later-stage clinical trials, leading to potential failures or delays.
• Dependence on a platform technology (A3AR) and a limited number of molecules (Piclidenoson, Namodenoson, CF602); failure to develop these will have a material adverse effect.
• Clinical trials are expensive, time-consuming, and difficult to design and implement, potentially leading to delays or suspensions.
• Reliance on third-party manufacturers and suppliers, which could face problems causing production and shipment delays.
• Lack of internal sales, marketing, or distribution capabilities, requiring reliance on third parties who may not perform effectively.
• Dependence on key management and consultants; failure to retain or attract leading experts could harm the business.
• Product candidates will remain subject to ongoing regulatory requirements even if approved; failure to comply could lead to loss of approvals or suspension of sales.
• Inability to successfully grow and expand the business, leading to ineffective management of growth.
• Adverse effects from natural disasters, health epidemics, or cybersecurity breaches could disrupt operations and development programs.
• Loss of composition of matter exclusivity for Piclidenoson and Namodenoson due to patent expiry, potentially diminishing proprietary position.
• Difficulty in obtaining or maintaining patents, licensing agreements, and other intellectual property, impacting competitive ability.
• Uncertainty of international patent protection and potential for substantial costs in opposition proceedings in foreign countries.
• Inability to enforce covenants not to compete under U.S. and Israeli law, allowing competitors to benefit from former employees' expertise.
• Exposure to product liability claims if product candidates cause harm to patients, potentially leading to substantial liabilities.
• Increased limitations on reimbursement due to healthcare reform, affecting third-party coverage and pricing of products.
• Risk of misconduct or improper activities by employees, principal investigators, consultants, commercial partners, or vendors, leading to enforcement actions and penalties.
• Adverse effects from political, economic, and military instability in Israel and its region, including the ongoing security situation.
• Harm to results of operations from currency fluctuations and inflation, as a portion of expenses are incurred in non-U.S. dollar currencies.
• Potential for being classified as a Passive Foreign Investment Company (PFIC) for U.S. federal income tax purposes, leading to negative tax consequences for U.S. Holders.
• Provisions of charter documents and Israeli law may discourage, delay, or prevent mergers or acquisitions, even if favorable to shareholders.
• Negative impact from unsolicited takeover proposals, shareholder activism, or proxy contests.
• Dilution of existing shareholders' ownership interests from the issuance of additional equity securities.
• Fluctuation in the market price of ordinary shares and ADSs, potentially resulting in substantial losses for investors.
• Risk of not satisfying NYSE American requirements for continued listing, leading to delisting.
• As a foreign private issuer, following home country corporate governance practices may result in less protection for investors than under rules applicable to domestic issuers.
• Difficulty attracting research analysts due to not becoming a reporting company through an underwritten initial public offering in the United States.
• Inability to satisfy Section 404 of the Sarbanes-Oxley Act requirements or ineffective internal control over financial reporting, impacting financial statement reliability and share price.

Future Outlook

The company expects to continue incurring losses for the foreseeable future as it advances its preclinical and clinical development programs and seeks regulatory approvals. Future revenues are anticipated from existing and potential new out-licensing arrangements and capital raising activities. Management believes existing financial resources, supplemented by a contingency plan including cost reduction and potential additional financing, will be sufficient for at least the next twelve months. Interim analysis data for Piclidenoson's Phase III psoriasis study and Namodenoson's Phase III HCC study are expected in Q2 2027. Top-line data for Namodenoson's Phase IIa pancreatic cancer study is expected in Q3 2026.

Management Comments

• Management believes existing financial resources, based on current projections and plans, will be sufficient to meet requirements for the next twelve months from the date of issuance of this Annual Report.
• Management has committed to implement a contingency plan, including cost reduction and reprioritization of R&D programs, and reduction in compensation to key management personnel, until additional financing is obtained.
• Management believes the characteristics of Piclidenoson, including its good safety profile, clinical activity, oral administration, and low production cost, position it well against competition in psoriasis markets.
• Management believes Namodenoson's good safety profile, oral administration, and low cost of goods may position it well in the HCC market, especially for Child Pugh B7 patients where no FDA-approved drug exists.

Industry Context

StockSavvy.ai notes that Can-Fite BioPharma operates in highly competitive biopharmaceutical markets for cancer, liver, and inflammatory diseases. The psoriasis drug market is projected to reach $39 billion by 2030, and the HCC treatment market nearly $34 billion by 2035, indicating significant commercial opportunities if the company's drug candidates achieve regulatory approval and market acceptance. However, the industry is characterized by rapidly evolving technology, intense competition from large pharmaceutical and biotechnology companies (e.g., Amgen, J&J, Pfizer, Novartis in psoriasis; Bayer, Merck, Roche in HCC; Madrigal, Novo Nordisk in MASH), and a costly, lengthy R&D process. The company's focus on A3AR agonists and allosteric modulators represents a unique mechanism of action, but it faces challenges from established therapies and advanced pipeline candidates from competitors. The increasing scrutiny on drug pricing and healthcare reform measures in the U.S. and EU could also impact future profitability and market access.

Comparison to Industry Standards

• Piclidenoson's Phase III COMFORT study for psoriasis showed statistically significant improvement over placebo in PASI 75 response (9.7% vs. 2.6% at Week 16 for 3mg dose), but was inferior to the active control Otezla (apremilast) in PASI 75 (17% vs. 26.2%) and PASI 50 (34.1% vs. 49.5%) at Week 32. However, Piclidenoson showed superiority in Psoriasis Disability Index (PDI) improvement (20.5% vs. 10.3%) and a better tolerability profile (1% GI-related adverse events vs. 6% for Otezla).
• Namodenoson's Phase II HCC study did not meet its primary endpoint of overall survival in the whole population (median OS 4.1 months vs. 4.3 months for placebo), but showed superiority in the largest subpopulation of Child-Pugh B7 patients (median OS 6.8 months vs. 4.3 months for placebo, 1-year survival 44% vs. 18%). This suggests a niche for Namodenoson in a patient group with high unmet need, as no drug is FDA-approved for Child-Pugh B7 patients with advanced liver cancer.
• CF602's preclinical efficacy in erectile dysfunction in diabetic rats, with 118% improvement in ICP/MAP ratio over placebo and superior effects on erection compared to sildenafil in animal studies, positions it against market leaders like Pfizer's Viagra and Eli Lilly's Cialis, particularly for patients contraindicated for PDE5 inhibitors.
• The company's reliance on out-licensing agreements for commercialization is a common strategy for smaller biopharmaceutical companies, but success depends on partners' capabilities and market conditions, similar to other development-stage firms.

Management Changes

Corporate Governance

Related Party Transactions

• Zivit Harpaz, daughter of Pnina Fishman (Executive Chairman and Chief Scientific Officer), is employed as Director of Regulatory and Clinical Operations. She received approximately $296,000 in salary, bonus, and benefits in 2025, and was awarded options to purchase 1,333 ordinary shares in 2025.
• Pnina Fishman, through F.D. Consulting, receives a gross monthly fee of NIS 100,000 (approximately $31,348 as of Dec 31, 2025) and is entitled to options. As of March 25, 2026, she has outstanding options to purchase 6,356 ordinary shares (adjusted for reverse split) that are currently exercisable or vest within 60 days.
• Motti Farbstein, CEO, CFO, and COO, receives a gross monthly salary of NIS 80,000 (approximately $25,078 as of Dec 31, 2025) and is entitled to options. As of March 25, 2026, he has outstanding options to purchase 5,029 ordinary shares (adjusted for reverse split) that are currently exercisable or vest within 60 days.
• Sari Fishman, VP Business Development and daughter of Pnina Fishman, received approximately $389,000 in salary, bonus, and benefits in 2025, and was awarded options to purchase 417 ordinary shares in 2025. As of March 25, 2026, she has outstanding options to purchase 3,919 ordinary shares (adjusted for reverse split) that are currently exercisable or vest within 60 days.

Stakeholder Impact

• **Shareholders**: Face continued dilution from ongoing capital raises and warrant exercises. The reverse stock split and ADS ratio change may impact trading liquidity and perception. The company's ability to achieve profitability and generate product revenues is critical for long-term shareholder value.
• **Employees**: The company's contingency plan includes potential reductions in compensation for key management personnel if additional financing is not obtained, which could affect morale and retention. However, the company generally provides benefits beyond minimums and has good employee relations.
• **Customers/Patients**: Continued advancement of drug candidates (Piclidenoson for psoriasis, Namodenoson for HCC, MASH, pancreatic cancer, Lowe Syndrome) offers potential new therapeutic options, especially for unmet medical needs. The safety profile of the drugs is a key factor for patient acceptance.
• **Suppliers/CROs**: The company relies heavily on third-party contract manufacturers and CROs for preclinical and clinical development. Delays or issues with these partners could impact the company's ability to advance its pipeline.
• **Creditors**: The company's history of losses and reliance on external financing pose a risk to creditors, although management believes current liquidity is sufficient for the next 12 months and has a contingency plan.

Next Steps

• Continue enrolling patients in the pivotal Phase III study for Piclidenoson in psoriasis.
• Continue enrolling patients in the pivotal Phase III trial for Namodenoson in advanced liver cancer.
• Continue enrolling patients in the Phase IIb study of Namodenoson in MASH.
• Undertake preparatory work for a Phase II study with Piclidenoson for the treatment of Lowe Syndrome.
• Submit the study protocol for Piclidenoson in Lowe Syndrome to regulatory authorities in Italy and EMA during Q2 2026.
• Investigate additional compounds targeting the A3 adenosine receptor for the treatment of erectile dysfunction.
• Vetbiolix is initiating an advanced clinical study in dogs with osteoarthritis, with data expected in Q3 2026.
• Survival follow-up for the Namodenoson Phase IIa pancreatic cancer study is ongoing, with outcomes to be announced at upcoming scientific meetings.
• The company plans to submit a New Drug Application (NDA) to the FDA and Marketing Authorization Application (MAA) to the EMA upon positive conclusion of the Piclidenoson Phase III program.

Key Dates

Recommendation

Can-Fite BioPharma is a high-risk, high-reward clinical-stage biopharmaceutical company. While it faces significant financial challenges, including persistent losses and a need for substantial future capital, its pipeline features several drug candidates in pivotal clinical stages with orphan drug and Fast Track designations. The recent capital raises and positive preclinical data for new indications offer potential upside. However, the history of clinical trial failures and the inherent uncertainties of drug development warrant a cautious approach. A 'hold' recommendation reflects the balance between the significant risks and the potential for substantial value creation if key clinical trials succeed and lead to regulatory approvals and commercialization.

Keywords

Biopharmaceutical, Clinical-stage, Piclidenoson, Namodenoson, CF602, A3 Adenosine Receptor, Psoriasis, Hepatocellular Carcinoma, MASH, Pancreatic Cancer, Lowe Syndrome, Obesity, Erectile Dysfunction, Clinical Trials, Orphan Drug, Fast Track Designation, SEC Filing, Form 20-F, Drug Development, Biotech