Can-Fite BioPharma Ltd.

https://www.canfite.com

Can-Fite BioPharma Ltd. is an Israeli clinical-stage biopharmaceutical company focused on developing orally bioavailable small molecule therapeutic products. The company's core mission is to address significant unmet medical needs in multi-billion dollar markets, primarily in the treatment of cancer, liver, and inflammatory diseases. Its headquarters are located in Petah-Tikva, Israel.

The company's pipeline features proprietary drug candidates that target the Gi protein associated A3 adenosine receptor (A3AR). Key product candidates include Piclidenoson (CF101), which is in a pivotal Phase III clinical study for psoriasis, and Namodenoson (CF102), currently in a pivotal Phase III trial for advanced liver cancer (hepatocellular carcinoma), a Phase IIb trial for metabolic dysfunction-associated steatohepatitis (MASH), and a Phase IIa study for pancreatic cancer. Additionally, CF602 is in pre-clinical development for erectile dysfunction.

Recent developments in early 2026 include positive Phase 2a data for Namodenoson in pancreatic cancer, with 35% of patients remaining on therapy. The company also reported its 2025 financial results and ongoing clinical progress in March 2026, highlighting a patient with decompensated liver cirrhosis successfully undergoing liver transplantation after Namodenoson treatment. Leadership includes Motti Farbstein as CEO, CFO, and COO, and Dr. Pnina Fishman as the Scientific Founder and Executive Chairman of the Board.

Latest updates

Can-Fite Pancreatic Cancer Data Shows Durable Response, Extended Treatment

Event summary

  • Can-Fite BioPharma reported Phase 2a data for namodenoson in advanced pancreatic cancer.
  • The study showed stable disease in over 30% of evaluable patients.
  • A notable 35% of patients remained on the therapy, with one patient extending treatment beyond 16 months.
  • The trial, enrolling 20 evaluable patients, met its primary endpoint of safety and tolerability.
  • Full efficacy analyses, including progression-free survival and overall survival, are expected in coming months.

The big picture

Pancreatic cancer represents a significant unmet medical need with limited treatment options, particularly for patients who have progressed on first-line therapies. Can-Fite’s data, while preliminary, suggest namodenoson may offer a durable response in this challenging patient population. The extended treatment duration observed is a positive signal, but the ultimate success hinges on confirming efficacy in the planned full analysis and navigating a competitive landscape.

What we're watching

Efficacy Confirmation
The upcoming full efficacy analyses will be critical to determine if the observed disease stabilization translates into meaningful improvements in progression-free and overall survival, which are key value drivers.
Regulatory Pathway
Given the Orphan Drug Designation, the FDA's appetite for clinical data will be a key factor in determining the drug’s regulatory pathway, particularly if efficacy data are compelling.
Competitive Landscape
The success of namodenoson will be weighed against the existing and emerging therapies for pancreatic cancer, a field with significant unmet need and increasing competition.

Can-Fite Vetbiolix Partnership Advances Canine Osteoarthritis Drug Trial

Event summary

  • Can-Fite’s veterinary partner, Vetbiolix, has completed enrollment in a Phase 2 clinical trial of Piclidenoson for osteoarthritis in dogs.
  • The trial involves 118 client-owned dogs and will run for 90 days, with top-line data expected in Q3 2026.
  • Vetbiolix has exercised an option for a full licensing agreement, entitling Can-Fite to up to $325 million in payments.
  • The global canine osteoarthritis market is estimated at $3 billion by 2028.

The big picture

The partnership between Can-Fite and Vetbiolix represents a strategic move to capitalize on the growing $3 billion canine osteoarthritis market. Vetbiolix’s focus on in-licensing and clinical development contrasts with Can-Fite’s broader pipeline, creating a revenue-sharing model that could provide significant financial benefit if the drug proves successful. The deal underscores the increasing trend of specialized veterinary pharmaceutical companies partnering with human biotech firms to address unmet needs in the companion animal space.

What we're watching

Clinical Efficacy
The trial’s outcome will be critical, as the current treatment landscape relies on symptomatic relief with associated safety concerns, and Piclidenoson’s success hinges on demonstrating a superior profile.
Commercial Execution
Vetbiolix’s ability to navigate regulatory approvals and commercialize Piclidenoson will be key to realizing the potential $325 million revenue stream for Can-Fite.
Pipeline Diversification
Can-Fite’s reliance on this partnership for near-term revenue highlights the need to advance its other drug candidates, particularly Namodenoson, to mitigate risk.

Can-Fite Shows Clinical Promise, Financials Reflect R&D Investment

Event summary

  • Can-Fite's Phase 2a pancreatic cancer study met its primary safety endpoint, with over 30% of patients alive at the last data cut-off.
  • A patient treated with Namodenoson for advanced hepatocellular carcinoma (HCC) has demonstrated over 9 years of cancer-free survival following a complete response.
  • Revenues decreased by 40% year-over-year to $0.41 million, primarily due to lower advance payment recognition from distribution agreements.
  • Research and development expenses increased by 16.26% to $6.69 million, driven by ongoing Phase 3 trials for psoriasis and HCC, and a Phase 2b study for MASH.
  • The company received approximately $4.3 million from warrant exercises and inducement in March 2026.

The big picture

Can-Fite's progress in pancreatic and liver cancer, coupled with expansion into metabolic diseases, represents a strategic pivot towards higher-value therapeutic areas. However, the company's financial performance highlights the inherent challenges of clinical-stage drug development, where significant investment is required before revenue generation. The long-term survival data for Namodenoson, if replicated in larger trials, could establish a significant competitive advantage in the crowded liver oncology market.

What we're watching

Clinical Efficacy
The long-term survival data in the HCC patient, while compelling, requires broader validation across the Phase 3 trial to confirm Namodenoson's efficacy and potential for accelerated approval.
Financial Sustainability
Can-Fite’s revenue decline and increased R&D spending necessitate careful monitoring of cash burn and potential need for further financing rounds.
Regulatory Pathway
The FDA's Fast Track and Orphan Drug designations for HCC will be critical to observe, as any shifts in regulatory expectations could significantly impact Namodenoson's commercial prospects.

Can-Fite Bolsters Obesity Franchise with Israeli Patent Grant

Event summary

  • Can-Fite BioPharma secured an Israeli patent (No. 284463) covering the use of A3 adenosine receptor (A3AR) agonists, including Namodenoson, for fat loss and obesity treatment.
  • This patent allowance complements existing IP protection in the US, Canada, and Australia, strengthening Can-Fite’s global intellectual property portfolio.
  • A peer-reviewed study published in the International Journal of Obesity demonstrated the anti-obesity effect of Namodenoson.
  • The global obesity therapeutics market is projected to reach $60.5 billion by 2030, with a CAGR of approximately 22%.

The big picture

Can-Fite is attempting to carve out a niche in the rapidly expanding obesity therapeutics market, currently dominated by GLP-1 agonists. The newly granted patent strengthens their IP position, but the company faces the challenge of demonstrating Namodenoson’s differentiated benefits and navigating a competitive landscape with established players. The $60.5 billion market size by 2030 represents a significant opportunity, but requires substantial investment and execution.

What we're watching

Clinical Trials
The success of Namodenoson’s ongoing Phase III trial for advanced liver cancer and Phase IIb trial for MASH will be critical in establishing its overall clinical value and justifying further investment in its obesity franchise.
Competitive Landscape
The market is dominated by GLP-1 receptor agonists; Can-Fite must demonstrate a clear advantage—either in efficacy, safety, or cost—to gain significant market share.
Partnering Strategy
Given the capital intensity of drug development, Can-Fite’s ability to secure strategic partnerships to co-develop and commercialize Namodenoson will be a key determinant of its long-term success.

Can-Fite Boosts Cash Reserves with Warrant Exercise, Issues New Warrants

Event summary

  • Can-Fite BioPharma has secured approximately $4.0 million in gross proceeds through the exercise of outstanding warrants.
  • The exercise price was reduced to $5.00 per ADS from the original $9.34, impacting existing warrant holders.
  • In exchange, Can-Fite issued new warrants for 1,591,738 ADSs, exercisable for 24 months.
  • Proceeds will be used for R&D, clinical trials, and general corporate purposes.
  • The closing of the offering is expected on March 5, 2026.

The big picture

This financing provides a near-term liquidity boost for Can-Fite, which has historically relied on capital raises to fund its clinical pipeline. The warrant exercise at a discounted price suggests a lack of investor confidence at the original strike price, potentially reflecting concerns about the company's pipeline progress or overall market sentiment. The issuance of new warrants, while providing immediate capital, creates a future overhang of potential dilution.

What we're watching

Capital Structure
The issuance of new warrants dilutes existing shareholders, and the market will scrutinize whether the new capital justifies this dilution and the terms of the new warrants.
Clinical Progress
The stated use of proceeds for R&D and clinical trials suggests an acceleration of ongoing programs; investors should monitor progress in Phase III trials for psoriasis and HCC.
Regulatory Risk
The need to file a Resale Registration Statement with the SEC introduces regulatory risk and potential delays in the ability to freely trade the shares issued upon warrant exercise.

Can-Fite Phase 2a Pancreatic Cancer Study Hits Primary Endpoint on Safety

Event summary

  • Can-Fite’s namodenoson met the primary endpoint of safety in a Phase 2a study for advanced pancreatic ductal adenocarcinoma (PDAC).
  • The study enrolled 20 patients who had progressed after prior systemic therapies.
  • Secondary endpoints, overall survival (OS) and progression-free survival (PFS), are still being evaluated with ongoing follow-up.
  • Namodenoson has received Orphan Drug Designation from the FDA for pancreatic cancer.
  • Prof. Salomon Stemmer, a key opinion leader, highlighted the favorable safety profile.

The big picture

While a safety win is a positive step, pancreatic cancer has a notoriously poor prognosis and high unmet need. Namodenoson’s success hinges on demonstrating meaningful efficacy, as safety alone is unlikely to drive regulatory approval or commercial viability. The company’s broader pipeline, including Piclidenoson, will be under increased scrutiny as investors assess the overall value proposition.

What we're watching

Survival Outcomes
The maturation of survival data (OS and PFS) will be crucial in determining the clinical benefit of namodenoson beyond safety, and the upcoming scientific meetings will be key venues for this information.
Regulatory Pathway
Given the Orphan Drug Designation, the FDA’s appetite for further development will depend heavily on the emerging survival data and the overall risk-benefit profile.
Pipeline Synergy
Can-Fite’s broader pipeline strategy, particularly the Phase 3 trial for HCC and the MASH Phase 2b trial, will be influenced by the success or failure of namodenoson in pancreatic cancer, potentially impacting resource allocation.

Can-Fite Data Suggests Obesity Treatment Potential for Liver Drug

Event summary

  • Can-Fite published a peer-reviewed study in the International Journal of Obesity demonstrating anti-obesity effects of namodenoson.
  • The study, based on in vitro and murine models, showed namodenoson inhibited adipocyte proliferation and reduced weight gain.
  • Findings align with previous Phase IIa data suggesting namodenoson’s impact on liver fat and body weight in MASH patients.
  • The global obesity treatment market is projected to reach $60.5 billion by 2030, with a 22% CAGR.

The big picture

Can-Fite’s data represents a potential strategic pivot for namodenoson, expanding its therapeutic scope beyond liver diseases into the massive obesity market. This repurposing strategy could accelerate revenue generation, but also introduces complexities in clinical development and regulatory approval. The company's existing pipeline and patent portfolio provide a foundation, but success hinges on demonstrating efficacy and safety in a new patient population.

What we're watching

Clinical Trials
The success of the ongoing Phase IIb MASH study will be critical in validating namodenoson’s broader therapeutic potential and influencing its obesity development pathway.
Regulatory Pathway
How regulatory agencies will view the repurposing of namodenoson for obesity, given its existing development for MASH and HCC, will shape the speed and cost of future trials.
Market Adoption
Whether Can-Fite can effectively position namodenoson within the competitive obesity treatment landscape, given the presence of established therapies and emerging novel approaches, will determine its commercial viability.

Can-Fite Bolsters Obesity Therapy IP with Canadian Patent Allowance

Event summary

  • Can-Fite BioPharma received a notice of allowance for a Canadian patent application (No. 3,126,002) covering the use of Namodenoson for anti-obesity therapy.
  • The patent protects the use of Namodenoson, an A3 adenosine receptor (A3AR) agonist, for reducing fat mass and body weight in Canada.
  • Can-Fite already holds similar patents in the U.S. and Australia for Namodenoson's use in obesity and metabolic disorders.
  • Data suggests Namodenoson treatment increased adiponectin levels and reduced body weight in animal models, with a 2.3% weight loss observed in a Phase IIa MASH study.

The big picture

The obesity treatment market is experiencing significant growth, projected to reach $60.5 billion by 2030, driven by rising prevalence and demand for oral therapies. Can-Fite’s patent allowance expands its intellectual property portfolio and creates potential for partnerships, but the company faces the challenge of demonstrating clinical efficacy and navigating a competitive market. The company's broader A3 adenosine receptor platform represents a potential diversification strategy beyond its existing oncology and liver disease programs.

What we're watching

Market Adoption
The success of Namodenoson as an anti-obesity therapy will hinge on demonstrating superior efficacy and safety compared to existing treatments, given the competitive landscape and patient expectations.
Regulatory Pathway
The Canadian regulatory pathway for Namodenoson’s obesity indication will be critical to observe, as it may influence the speed and cost of commercialization.
Clinical Data
Further clinical data demonstrating the mechanism of action and long-term effects of Namodenoson on body composition and metabolic health will be essential to validate its therapeutic potential.

Namodenoson Aids Liver Transplant Candidate, Spotlights Treatment Gap

Event summary

  • Can-Fite's Namodenoson facilitated clinical stabilization in a patient with decompensated liver cirrhosis, enabling a successful liver transplantation.
  • The patient received Namodenoson under a compassionate use framework, highlighting its potential as a bridge to transplant.
  • The case underscores the critical need for therapies addressing the shortage of donor organs and the rapid deterioration of patients with advanced cirrhosis.
  • Namodenoson is currently in Phase III trials for HCC, Phase IIb for MASH, and Phase IIa for pancreatic cancer.
  • The global liver cirrhosis treatment market is projected to reach $15 billion by 2031, from $7.6 billion in 2024.

The big picture

This case highlights the significant unmet need in treating advanced liver cirrhosis, where patients often face a desperate wait for donor organs. While a single case is not definitive, it suggests Namodenoson could play a valuable role in stabilizing patients and improving their chances of successful transplantation, potentially impacting the $15 billion liver cirrhosis treatment market. The success hinges on demonstrating broader efficacy and navigating regulatory hurdles for this specific application.

What we're watching

Clinical Validation
Whether this single case can be replicated and validated in broader clinical studies will be crucial for Namodenoson's adoption in transplant bridging protocols.
Regulatory Pathway
The FDA and EMA will likely scrutinize the data from this case and ongoing trials to determine if Namodenoson warrants accelerated approval for this niche application.
Market Adoption
The pace at which physicians integrate Namodenoson into pre-transplant management will depend on cost-effectiveness data and demonstrated impact on transplant outcomes.

Can-Fite Advances Pancreatic Cancer Trial, Awaits Q3 Data

Event summary

  • Can-Fite BioPharma has completed patient enrollment for a Phase 2a clinical trial of Namodenoson in patients with advanced pancreatic adenocarcinoma.
  • The trial is evaluating safety, clinical activity, and pharmacokinetics of Namodenoson, with a primary safety endpoint already demonstrated.
  • Top-line efficacy data is expected in Q3 2026.
  • Namodenoson is an A3 adenosine receptor (A3AR) agonist and has received Orphan Drug Designation for pancreatic cancer treatment.
  • The trial is led by Prof. Salomon Stemmer at the Davidoff Center, Rabin Medical Center.

The big picture

Pancreatic cancer represents a significant unmet medical need with limited treatment options. Can-Fite's Phase 2a trial represents a potential advancement in targeted therapies for this aggressive disease, but the small sample size and open-label design limit the conclusions that can be drawn. The Orphan Drug Designation provides incentives for development, but successful commercialization will depend on demonstrating meaningful efficacy and a favorable safety profile.

What we're watching

Efficacy Readout
The Q3 2026 efficacy data release will be critical in determining the potential of Namodenoson as a treatment option for pancreatic cancer, a disease with high unmet need.
Regulatory Pathway
How the FDA will interpret the Phase 2a data, particularly given the Orphan Drug Designation, will influence the potential for accelerated approval or further development.
Competitive Landscape
The success of Namodenoson will be weighed against the progress of other novel therapies targeting pancreatic cancer, which remains a challenging therapeutic area.

Can-Fite Secures Brazilian Patent for Sexual Dysfunction Treatment

Event summary

  • Can-Fite BioPharma has been granted Brazilian Patent No. BR112015002697-4 covering the use of its A3 adenosine receptor agonists for treating sexual dysfunction.
  • The patent strengthens Can-Fite’s intellectual property portfolio in Brazil, a significant pharmaceutical market in Latin America.
  • The patent is based on preclinical and clinical data suggesting A3 adenosine receptor activation may modulate signaling mechanisms related to erectile and sexual function.
  • Pnina Fishman, Chairperson and Chief Scientific Officer, highlighted the patent’s potential for future partnerships and commercialization in Latin America.
  • The company is advancing its A3AR agonist platform across multiple indications, including oncology, inflammatory diseases, and other non-oncologic conditions.

The big picture

This patent grant represents a modest but incremental step for Can-Fite, expanding its IP protection in a growing pharmaceutical market. While sexual dysfunction treatments represent a substantial market, competition is fierce, and success will hinge on effective commercialization strategies and potential partnerships. The move underscores the company's broader strategy of diversifying applications for its A3 adenosine receptor agonist platform beyond its core oncology focus.

What we're watching

Market Penetration
The success of this patent will depend on Can-Fite’s ability to navigate Brazil’s regulatory landscape and compete with established players in the sexual dysfunction treatment market, which is often sensitive to cultural and social factors.
Pipeline Synergy
How the company integrates this sexual dysfunction indication into its broader A3 adenosine receptor agonist platform and prioritizes development resources across oncology, inflammation, and other conditions will be a key indicator of strategic focus.
Partnering Potential
Whether Can-Fite can leverage this patent to attract partnerships or licensing deals in Latin America, given the region's preference for local or regional pharmaceutical companies, will be crucial for commercialization.

Can-Fite Initiates Reverse Split to Bolster NYSE American Listing

Event summary

  • Can-Fite BioPharma Ltd. approved a 1-for-3,000 reverse stock split of its ordinary shares, effective January 2, 2026, on the Tel-Aviv Stock Exchange.
  • The company will simultaneously adjust the ADS ratio from 300 ordinary shares per ADS to 2 ordinary shares per ADS, effective January 5, 2026, on the NYSE American.
  • This change is equivalent to a 1-for-20 split for ADS holders, requiring an exchange of 20 ADSs for 1 new ADS.
  • The reverse split will reduce the total number of outstanding ordinary shares to approximately 500,000 and decrease the authorized number of ordinary shares from 42 billion to 14 billion.

The big picture

The reverse split signals a strategic effort by Can-Fite to improve its visibility and attractiveness to US investors, likely driven by a desire to meet minimum listing requirements and potentially increase its share price. This move is a common tactic for companies facing low share prices, but its long-term success hinges on underlying business performance and clinical trial outcomes. The change in ADS ratio also suggests a desire to make the stock more accessible to a broader range of investors.

What we're watching

Price Volatility
The immediate impact on the ADS price will be closely watched, as the market assesses whether it reaches the anticipated 20x multiple or experiences a correction.
Trading Volume
Reduced share count could lead to lower trading volume and liquidity, potentially impacting institutional investor interest and price discovery.
Listing Compliance
Can-Fite must maintain compliance with NYSE American listing requirements, and the reverse split is likely intended to support this effort, requiring ongoing monitoring of share price and trading metrics.
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