Can-Fite BioPharma Ltd. (CANF) Business Model Canvas

Can-Fite BioPharma Ltd. (CANF): Business Model Canvas [Dec-2025 Updated]

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You're looking at the core strategy of Can-Fite BioPharma Ltd., and honestly, it boils down to pushing their A3AR agonist drug pipeline through those critical late-stage hurdles. As an analyst who's seen a few biotech cycles, the key here is their focus: advancing Piclidenoson for psoriasis and Namodenoson for liver cancer, all while sitting on a patent portfolio that stretches out to 2040. Here's the quick math: they had $6.45 million in cash as of June 30, 2025, but they were using about $4.75 million in operating cash in H1 2025, so capital access is always front-of-mind, even after that $5 million equity raise in July 2025. This model is all about de-risking assets through clinical data and locking in big pharma partners via out-licensing. This canvas shows exactly how they plan to turn that R&D spend into future royalties. Dive into the details below to see the full picture.

Can-Fite BioPharma Ltd. (CANF) - Canvas Business Model: Key Partnerships

You're looking at the network that underpins Can-Fite BioPharma Ltd.'s commercial strategy, which relies heavily on out-licensing and distribution deals to bring its pipeline drugs to market globally. This structure is key because, as of June 30, 2025, Can-Fite had an accumulated deficit of approximately $171.24 million and no commercial sales of its product candidates yet. The partnerships provide non-dilutive funding, like the advance payments recognized from these agreements.

Global Licensing and Distribution Partners

Can-Fite BioPharma Ltd. has established several key out-licensing agreements for its drug candidates, Piclidenoson and Namodenoson, across different territories. The total potential value from these pharma indications licensing agreements is up to $130 million. However, financial results for the first half of 2025 showed revenues of $0.20 million, a decrease of 36.07% compared to the $0.31 million in H1 2024. This dip was attributed to recognizing a lower portion of advance payments from several key partners.

Here's a breakdown of the known financial structures with specific partners:

Partner Indication/Territory Upfront Payment (Approximate) Milestone Potential (Approximate) Royalty Rate
Ewopharma AG Piclidenoson (CEE) & Namodenoson (CEE, Switzerland) $2.25 million Up to $40.45 million (plus additional for pancreatic indication) 17.5% on net sales
Cipher Pharmaceuticals Piclidenoson (Canada) $1,292 (or 1,650 CAD) Up to $2,000 Canadian Dollar 16.5% of net sales
CKD (Chong Kun Dang) Namodenoson (South Korea) Up to $3,000 (for HCC) + up to $6,000 (for NASH) Included in upfront/milestone total Cost plus 10% or 23% of net sales

The agreement with Ewopharma, which covers Central Eastern European countries and Switzerland, involved an initial $2.25 million upfront payment and up to an additional $40.45 million in milestones for Piclidenoson and Namodenoson. For the Canadian market, Cipher Pharmaceuticals made an upfront payment of $1,292 (or 1,650 CAD) back in 2015. Can-Fite BioPharma Ltd. has recognized revenues from its agreements with Cipher, CKD, Gebro Holding (for Spain, Switzerland, and Austria), and Ewopharma.

Veterinary Partners for Animal Health Applications

The partnership with Vetbiolix for Piclidenoson in canine osteoarthritis represents a significant, near-term revenue opportunity. Can-Fite BioPharma Ltd. projects an aggregate of $325 million in upfront and royalty payments over the next decade, contingent on regulatory approval, assuming a potential launch in 2029. This deal includes a 15% royalty on worldwide sales for this indication. The target market for companion animal arthritis was valued at $3.8 billion in 2023, expected to reach $6.3 billion by 2030. Can-Fite and Vetbiolix model that Piclidenoson could capture up to 6% of this market, leading to peak worldwide sales of $445 million by 2034. Furthermore, Can-Fite BioPharma Ltd. is looking to advance a second veterinary partnership for its drug Namodenoson, targeting the veterinary oncology market projected to reach $3.1 billion by 2030.

Academic and Medical Institutions for Clinical Studies

Clinical development is managed through collaborations with various medical centers, though specific institution names like UCLA or Bambino Gesù Children's Hospital aren't detailed in the latest financial updates. The focus is on advancing the pipeline through pivotal human trials. The research and development expenses for the first half of 2025 were $3.03 million, covering these ongoing studies.

Key trial statuses as of late 2025 include:

  • Namodenoson Phase 3 trial for hepatocellular carcinoma (HCC) was designed to enroll 450 patients globally.
  • The Namodenoson Phase 2a study in pancreatic cancer (NCT06387342) achieved an over 50% Enrollment Milestone as of August 2025.
  • Piclidenoson reported topline results in a Phase III trial for psoriasis.
  • Can-Fite has an upcoming Phase II study planned for Lowe Syndrome.

The regulatory environment in Israel, where many studies are conducted, generally aligns with FDA and EMA protocols, which helps streamline the path to US and EU commercial markets.

Clinical Research Organizations (CROs)

While specific CROs managing the global Phase III trials aren't named in the H1 2025 financial reports, the management of these complex studies is factored into the operating expenses. The R&D expenses for H1 2025 were $3.03 million, which includes costs associated with the ongoing Phase 3 study of Piclidenoson and the two ongoing studies for Namodenoson (Phase 3 HCC and Phase 2b MASH). The company is responsible for conducting product development activities, including the management of clinical studies required for regulatory approvals, as per its agreements.

Can-Fite BioPharma Ltd. (CANF) - Canvas Business Model: Key Activities

You're looking at the core engine of Can-Fite BioPharma Ltd., which is all about pushing drug candidates through the complex clinical and regulatory gauntlet. The key activities here are heavy on science execution and regulatory navigation, which directly ties up capital.

Conducting pivotal Phase III trials for Piclidenoson (psoriasis) and Namodenoson (HCC)

The company is actively managing multiple late-stage trials. For Namodenoson in advanced hepatocellular carcinoma (HCC), Can-Fite BioPharma Ltd. is conducting a pivotal Phase III trial, with the interim analysis data expected during the second half of 2026. This drug candidate also has a Phase IIb study running for MASH and an exploratory Phase IIa study in pancreatic cancer, which achieved over 50% Enrollment Milestone as of August 28, 2025. For Piclidenoson, the lead candidate for psoriasis, Can-Fite BioPharma Ltd. commenced a pivotal Phase III trial following discussions with regulators. As of late 2025, recruitment for this specific psoriasis Phase III study had not yet begun, though the study was first submitted on October 9, 2024, with an update on April 28, 2025. The primary efficacy objective for the psoriasis trial is the proportion of subjects achieving a Psoriasis Area and Severity Index (PASI) score response of $\ge$75% (PASI 75).

Here's a quick look at the pipeline activities as of late 2025:

Drug Candidate Indication Trial Stage Key Status/Milestone
Namodenoson Hepatocellular Carcinoma (HCC) Pivotal Phase III Interim analysis data expected in H2 2026
Namodenoson MASH Phase IIb Ongoing
Namodenoson Pancreatic Cancer Phase IIa Achieved over 50% Enrollment Milestone (as of 8/28/2025)
Piclidenoson Psoriasis Pivotal Phase III Recruitment has not yet begun (as of late 2025)
CF602 Erectile Dysfunction (ED) Preclinical/Development Received Notice of Patent Allowance in Brazil (11/20/2025)

Research and development (R&D) of proprietary A3AR small-molecule drugs

The R&D activity is directly funding these clinical programs. Research and development expenses for the first six months ended June 30, 2025, totaled $3.03 million. This figure represents an increase of 5.16% compared to the same period in 2024, which was $2.88 million. This acceleration in R&D spending is primarily tied to the ongoing studies for both Namodenoson and Piclidenoson. The company's platform technology targets the A3 adenosine receptor (A3AR), which is highly expressed in pathological cells.

Regulatory submissions and compliance with FDA and EMA protocols

Navigating the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) is a constant key activity. Can-Fite BioPharma Ltd. initiated the pivotal Phase III studies for Piclidenoson following meetings with the FDA and EMA. Namodenoson has secured several regulatory advantages:

  • Orphan Drug Designation from the FDA for pancreatic cancer.
  • Orphan Drug Status with both the FDA and EMA for HCC.
  • Fast Track Status with the FDA for HCC as a second-line treatment.

The company is also undertaking preparatory work for an upcoming Phase II study with Piclidenoson for the treatment of Lowe syndrome.

Securing and maintaining a broad patent portfolio for drug candidates

Protecting the intellectual property (IP) is crucial for future revenue streams from out-licensing. As of late 2021, Can-Fite BioPharma Ltd.'s IP estate spanned 15 patent families. More recently, on November 20, 2025, the company received a Notice of Allowance from the National Institute of Industrial Property of Brazil for its CF602 drug candidate targeting erectile dysfunction. This patent expands protection for CF602 beyond the major markets of the U.S. and Europe where patents have already been granted. The potential financial impact from securing these rights is substantial; Can-Fite has existing out-licensing agreements worth up to $130 million for pharma indications and an additional up to $325 million for veterinary indications (Piclidenoson).

Can-Fite BioPharma Ltd. (CANF) - Canvas Business Model: Key Resources

You're looking at the core assets that power Can-Fite BioPharma Ltd.'s strategy right now. These aren't just line items; they are the foundation for their value proposition, especially as they push drug candidates through late-stage trials.

The most critical resource is the proprietary platform technology targeting the A3 adenosine receptor (A3AR). This mechanism is the common thread for their lead assets, Namodenoson and Piclidenoson, which are designed to selectively target cells highly expressing A3AR, found in both cancer and inflammatory conditions. This focus allows for a streamlined development path across multiple indications.

The intellectual property (IP) is what locks in future revenue potential. Can-Fite BioPharma Ltd. has built a broad IP estate around its compounds. Specifically, the patent application No.2020205042, covering methods of treating obese patients by administering Namodenoson in an oral formulation, has been accepted by the Australian Patent Office and expires in 2040.

The clinical evidence supporting the safety and potential efficacy of their drug candidates is a non-negotiable key resource. You need to see the numbers that back up the science.

Here's a breakdown of the clinical and financial backing as of mid-2025:

Resource Detail Metric/Value
Safety Profile Patient Experience close to 2000 patients
Cash and Short-Term Deposits (as of June 30, 2025) $6.45 million
Namodenoson Pancreatic Cancer Trial Enrollment (as of H1 2025) Over 50% Enrollment Milestone Achieved
Piclidenoson Vascular Dementia Market Potential Estimated at $6 billion as of 2025
Total Funding Raised to Date $175 million
Out-licensing Potential (Pharma Indications) Up to $130 million

The clinical data itself is dense with specific achievements. For instance, Namodenoson is currently enrolling patients in a pivotal Phase III study for advanced liver cancer (HCC) and has achieved over 50% enrollment in its Phase 2a study for pancreatic cancer as of the first half of 2025. Also, Piclidenoson is in a pivotal Phase III trial for psoriasis.

You should also note the recent financial activity that bolsters this resource base. Can-Fite BioPharma Ltd. completed a public offering in July 2025, bringing in aggregate gross proceeds of $5 million. Still, the cash position decreased from $7.88 million at the end of 2024 to $6.45 million by June 30, 2025, due to ongoing operations.

The platform's success is also reflected in the regulatory advantages secured for Namodenoson, including Orphan Drug Designation in the U.S. and Europe, plus Fast Track Designation as a second-line treatment for HCC by the U.S. Food and Drug Administration.

The company's IP is further supported by multiple approved patents globally for various clinical applications of the drug candidates.

Finance: review the 13-week cash flow projection incorporating the July 2025 capital raise by next Tuesday.

Can-Fite BioPharma Ltd. (CANF) - Canvas Business Model: Value Propositions

You're looking at the core reasons why Can-Fite BioPharma Ltd.'s platform technology matters to patients and partners. The value here is rooted in the small-molecule, oral delivery format targeting the A3 adenosine receptor (A3AR), which is overexpressed on diseased cells.

Oral, small-molecule drug candidates for chronic diseases (Piclidenoson)

Piclidenoson, one of Can-Fite BioPharma Ltd.'s lead candidates, is an orally administered, highly selective A3 adenosine receptor (A3AR) agonist. This oral formulation is a key value driver, offering convenience over injectables for chronic conditions. The drug has reported topline results in a Phase III trial for psoriasis and has since commenced a pivotal Phase III trial for this indication. Beyond psoriasis, Piclidenoson is also being developed for the rare genetic disease Lowe Syndrome, with a Phase II open-label study design completed. Furthermore, preclinical data from UCLA demonstrated its efficacy in an experimental model of vascular dementia, a condition with a global market estimated at $6 billion as of 2025.

Selective targeting of cancer cells while sparing healthy tissue (Namodenoson)

Namodenoson, the company's oncological drug candidate, offers a critical differentiator from traditional chemotherapy: its selectivity. It binds with high affinity and selectivity to the A3AR, which is highly expressed in diseased cells but minimally in normal cells. This mechanism provides a potential for a strong safety profile with minimal off-target toxicity. A compelling real-life example of this potential is a patient treated in a prior Phase II study for advanced liver cancer who remains cancer-free after 9 years of treatment, meeting the definition of a complete responder. In its Phase IIa trial for pancreatic cancer, the dosing regimen involves 25 mg of oral Namodenoson twice daily in continuous 28-day cycles.

Namodenoson's value proposition is further enhanced by its dual role; beyond its anti-cancer activity, it demonstrates potent anti-ischemic, anti-inflammatory, anti-fibrotic, and anti-toxicity effects, mediated by increasing adiponectin levels.

Orphan Drug Designation (ODD) for Namodenoson in pancreatic cancer

The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to Namodenoson for the potential treatment of pancreatic cancer. This regulatory status is significant because it provides tangible regulatory advantages, including eligibility for tax credits for clinical trials, exemption from user fees, and a potential 7 years of market exclusivity upon approval. The ongoing Phase IIa study for pancreatic cancer is evaluating safety as the primary endpoint.

Potential to address multi-billion dollar markets in oncology and inflammation

Can-Fite BioPharma Ltd.'s platform technology is explicitly designed to address multi-billion-dollar markets across oncology and inflammatory diseases. The company has structured its partnerships to capture value from these large indications, projecting potential substantial cumulative income over the next decade, assuming regulatory approvals and launches between 2027 and 2029. The potential value is further illustrated by specific market projections and existing agreements.

Here's a quick look at the scale of the opportunities Can-Fite BioPharma Ltd. is targeting with its lead candidates:

Indication / Asset Market/Financial Metric Value/Amount
Piclidenoson (Veterinary Osteoarthritis) Estimated Royalty Revenues from Vetbiolix Partnership Up to $325 million
Namodenoson (Veterinary Oncology) Projected Veterinary Market Size by 2030 $3.1 billion
Piclidenoson (Vascular Dementia) Estimated Global Market Size as of 2025 $6 billion
Overall Pharma Indications (Namodenoson & Piclidenoson) Total Value of Existing Out-licensing/Distribution Agreements Up to $130 million
Overall Pipeline (Namodenoson & Piclidenoson) Total Funding Raised to Date $175 million

The company's existing agreements are structured with diverse financial components, including development/regulatory milestones, commercial sales benchmarks, manufacturing transfer payments, and royalties on product sales.

  • Piclidenoson is in a pivotal Phase III trial for psoriasis.
  • Namodenoson is in a pivotal Phase III trial for advanced liver cancer (HCC).
  • Namodenoson is in a Phase IIa study for pancreatic cancer.
  • Piclidenoson is in development for Lowe Syndrome.

Finance: draft $130 million pharma milestone tracking schedule by Friday.

Can-Fite BioPharma Ltd. (CANF) - Canvas Business Model: Customer Relationships

You're looking at how Can-Fite BioPharma Ltd. manages its critical external relationships to drive its development pipeline toward commercialization. For a clinical-stage biotech, these aren't just customers; they are partners, key influencers, and the source of necessary capital.

High-touch, long-term relationships with commercialization partners

Can-Fite BioPharma Ltd. structures its commercial future around a network of established collaborations. As of late 2025, the Company maintains seven partnerships that are key to realizing the value of its drug candidates, Piclidenoson and Namodenoson. These relationships are designed for the long haul, involving complex financial structures that include development and regulatory milestones, commercial sales benchmarks, manufacturing-related transfer payments, and royalties on product sales. The Company projects potential cumulative income from these existing terms, assuming milestones are met and launches occur between 2027 and 2029, which could total up to $685 million in projected future revenues over the next decade. This is separate from other out-licensing and distribution agreements, which are worth up to $130 million for pharma indications and an additional up to $325 million for veterinary indications. To be fair, H1 2025 revenues, which include recognition from these agreements, were only $0.20 million, showing the revenue recognition is heavily back-loaded toward future commercial success.

Here's a look at the potential financial scale tied to these relationships:

Relationship Type Potential Future Value (Cumulative) H1 2025 Revenue Contribution
Projected Future Revenues from Seven Partnerships Up to $685 million Included in total
Out-licensing/Distribution (Pharma Indications) Up to $130 million Portion recognized
Out-licensing/Distribution (Veterinary Indications) Up to $325 million Portion recognized
Total H1 2025 Revenue N/A $0.20 million

These agreements are defintely the backbone of the expected future revenue stream.

Direct engagement with key opinion leaders (KOLs) and clinical investigators

The credibility and progress of Can-Fite BioPharma Ltd.'s pipeline hinge on the engagement with experts who guide research and adoption. This involves securing the involvement of renowned clinicians to lead critical trials. For instance, the ongoing Phase 2a study for Namodenoson in pancreatic cancer is led by Prof. Salomon Stemmer, a recognized key opinion leader at the Davidoff Center, Rabin Medical Center, Israel. The Company's two lead drug candidates, Piclidenoson and Namodenoson, have already accumulated safety and efficacy data across close to 2000 patients in clinical studies to date. This depth of patient experience is a key asset when engaging with the broader medical community. The focus remains on soliciting meaningful insights to steer development, which is crucial given the high-stakes nature of the indications, such as the $6 billion global market for Vascular Dementia where Piclidenoson shows potential.

Key aspects of this relationship focus include:

  • Securing leadership for pivotal trials like the Namodenoson pancreatic cancer Phase 2a study.
  • Leveraging experience from nearly 2000 patients across current clinical programs.
  • Focusing on the potential of Piclidenoson in the $6 billion Vascular Dementia market.
  • Ensuring KOLs see the public benefit in steering drug development optimally.

Investor relations and public presentations to maintain capital access

Sustaining clinical development requires continuous access to capital, which is managed through direct engagement with the investment community. Can-Fite BioPharma Ltd. actively manages these relationships through presentations and capital raises. In July 2025, the Company successfully completed a public offering to bolster its finances, raising aggregate gross proceeds of $5 million. This capital infusion was necessary as cash and equivalents stood at $6.45 million as of June 30, 2025, a decrease from $7.88 million at the end of 2024. The operational costs driving this cash burn are reflected in the H1 2025 General and administrative expenses, which reached $2.07 million, marking an increase of 35.47% compared to the first half of 2024. This increase is specifically attributed to higher investor relations expenses following a one-time project during H1 2025. The Company plans further structural actions, announcing a Special General Meeting for November 3, 2025, to vote on increasing authorized share capital by 22 billion shares and approving a 1:3000 reverse stock split. Furthermore, the CEO is scheduled to present the latest pipeline developments at the Noble Capital Markets 21st Annual Emerging Growth Equity Conference on December 3rd, 2025, to maintain visibility.

Here are the recent financial metrics tied to capital maintenance:

Investor Relations/Capital Metric Amount/Ratio Date/Period
Gross Proceeds from July 2025 Public Offering $5 million July 2025
Cash and Equivalents $6.45 million June 30, 2025
General and Administrative Expenses (H1) $2.07 million H1 2025
Increase in G&A Expenses (YoY) 35.47% H1 2025 vs H1 2024
Proposed Reverse Stock Split Ratio 1:3000 November 2025 Meeting

Finance: draft 13-week cash view by Friday.

Can-Fite BioPharma Ltd. (CANF) - Canvas Business Model: Channels

You're looking at how Can-Fite BioPharma Ltd. gets its value propositions-the drug candidates-out to the world, which for a clinical-stage biotech means partners, regulators, and the capital markets. It's a mix of formal agreements, clinical site networks, and investor outreach.

Out-licensing and distribution agreements with pharmaceutical companies

Can-Fite BioPharma Ltd. relies heavily on strategic partnerships to handle regional development and commercialization. They fund operations through these deals, alongside equity sales. As of H1 2025, they had existing out-licensing and distribution deals with KD, Cipher, CKD Gebro, CMS, and Kyongbo, plus a historic agreement with SKK. They also have an arrangement with Ewopharma. The revenue recognition from these deals is lumpy; for the six months ended June 30, 2025, revenues were $0.20 million, a 36.07% decrease compared to H1 2024, mainly due to recognizing a lower portion of advance payments from Ewopharma, Gebro, CKD, and Cipher.

The potential value locked in these channels is substantial, though not yet realized as revenue.

Agreement Type Indication Focus Maximum Potential Value (USD)
Out-licensing and Distribution Pharma Indications Up to $130 million
Out-licensing and Distribution Veterinary Indications Up to $325 million

The company expects to fund operations over the next several years through existing cash resources and potential future milestone payments from these agreements.

Clinical trial sites (multicenter, global) for patient enrollment

The clinical trial network is the channel for generating the data needed for regulatory submissions and eventual market approval. This involves setting up multicenter trials globally. The company has experience across close to 2000 patients in clinical studies to date with their lead candidates, Piclidenoson and Namodenoson.

Key ongoing or recently initiated trials define this channel:

  • Phase III liver cancer (Namodenoson) is currently enrolling patients.
  • Phase IIb MASH (Namodenoson) is enrolling patients.
  • Phase 2a pancreatic cancer (Namodenoson) achieved over 50% enrollment milestone.
  • Pivotal Phase III psoriasis (Piclidenoson) is underway, starting enrollment in Europe.
  • Upcoming Phase II in Lowe Syndrome (Piclidenoson) has a completed Phase II design.

The potential market size for a new indication, like vascular dementia where Piclidenoson is showing preclinical promise, is estimated at $6 billion as of 2025.

Regulatory agencies (FDA, EMA) for drug approval and market access

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are critical gatekeepers. Can-Fite BioPharma Ltd. uses successful trial data to gain designations that streamline this channel.

Specific regulatory channel achievements include:

  • Piclidenoson received a green light from both the FDA and EMA to proceed with a pivotal Phase III trial for psoriasis.
  • Namodenoson received Orphan Drug Designation from the FDA for pancreatic cancer.
  • Namodenoson holds Fast Track Designation from the FDA as a second-line treatment for Hepatocellular Carcinoma (HCC).
  • Namodenoson received FDA compassionate use approval for pancreatic carcinoma.

These designations provide regulatory advantages, such as potential market exclusivity for seven years after approval for the Orphan Drug indication.

Investor conferences and press releases for capital markets

Access to capital is a vital channel for funding the clinical development pipeline. Can-Fite BioPharma Ltd. uses public and private offerings, and investor events to maintain liquidity. The company completed a public offering in July 2025, raising aggregate gross proceeds of $5 million.

Key financial and market data points for this channel as of late 2025:

Metric Value (as of June 30, 2025, or late 2025)
Cash and Cash Equivalents (H1 2025) $6.45 million
Total Valuation (Market Cap) $15.84 million
Shares Outstanding 3.97 billion
Net Loss (H1 2025) $4.87 million
General and Administrative Expenses (H1 2025) $2.07 million

The CEO, Motti Farbstein, is scheduled to present at the Noble Capital Markets 21st Annual Emerging Growth Equity Conference on December 3rd, 2025, where he will discuss the pipeline developments. The next earnings release is anticipated on November 27, 2025, before market open. Honestly, investor relations expenses contributed to the 35.47% increase in General and administrative expenses for H1 2025.

Can-Fite BioPharma Ltd. (CANF) - Canvas Business Model: Customer Segments

You're looking at the specific groups Can-Fite BioPharma Ltd. (CANF) targets with its platform technology, which centers on A3 adenosine receptor (A3AR) agonists like Namodenoson and Piclidenoson.

Global pharmaceutical companies seeking late-stage assets (licensees)

This segment represents potential partners who can take on late-stage development and commercialization. Can-Fite BioPharma Ltd. (CANF) has already secured agreements that show the structure of these deals.

  • Can-Fite BioPharma Ltd. (CANF) has numerous out-licensing and global distribution agreements in place worth up to $130 million for pharma indications.
  • There is an additional potential value of up to $325 million tied to veterinary indications from existing agreements.
  • The Ewopharma distribution agreement for CEE countries and Switzerland included an upfront payment of $2.25 million, with up to an additional $40.45 million payable upon regulatory and sales milestones.
  • This Ewopharma deal also stipulates 17.5% royalties on net sales.
  • Industry-wide, licensing activity is high; in the first half of 2025, oncology licensing agreements alone totaled 78 deals worth $46.9 billion, which included $4.7 billion in upfront payments.

Here's a quick look at the financial context of Can-Fite BioPharma Ltd. (CANF) as of mid-2025, which influences its need for licensing partners:

Financial Metric Amount as of June 30, 2025
Cash and Cash Equivalents $6.45 million
Revenues (Six Months Ended June 30, 2025) $0.20 million
Gross Proceeds from July 2025 Public Offering $5 million
Total Cumulative Funding to Date $175 million

Patients with advanced liver cancer (HCC) and pancreatic cancer

These oncology segments are targeted primarily by Namodenoson. The company has achieved significant regulatory advantages for HCC.

  • Namodenoson is currently being evaluated in a pivotal Phase III trial for advanced hepatocellular carcinoma (HCC).
  • For HCC, Namodenoson has received Orphan Drug Designation (ODD) in the U.S. and Europe, plus Fast Track Status with the U.S. Food and Drug Administration (FDA) as a second line treatment.
  • Namodenoson is also being evaluated in a Phase IIa study for patients with advanced pancreatic adenocarcinoma whose disease has progressed following at least one line of prior therapy.
  • Namodenoson has received Orphan Drug Designation from the FDA for the treatment of pancreatic cancer.
  • The market for HCC treatments in G8 countries is estimated to reach $6.1 billion by 2027.

The Phase 2a pancreatic cancer study (NCT06387342) evaluates oral Namodenoson at a dose of 25 mg, administered twice daily in continuous 28-day cycles. Still, the primary endpoint is safety.

Patients with moderate-to-severe psoriasis and MASH

These inflammatory and liver disease segments are targeted by Piclidenoson and Namodenoson, respectively.

  • Piclidenoson is in a pivotal Phase III trial for patients with moderate-to-severe plaque psoriasis.
  • Namodenoson is being evaluated in a Phase IIb trial for the treatment of Metabolic dysfunction-associated steatohepatitis (MASH).

These drugs have an excellent safety profile with experience in over 1,600 patients in clinical studies to date.

Patients with rare diseases like Lowe Syndrome and Vascular Dementia

This represents an expansion area for the platform technology, targeting smaller, often underserved populations.

  • Can-Fite BioPharma Ltd. (CANF) has an upcoming Phase II study planned for Piclidenoson in the treatment of Lowe Syndrome.
  • The global market for Vascular Dementia is estimated at $6 billion as of 2025.

If you're assessing the company's valuation, remember that the value of these rare disease programs is often tied to the potential for premium pricing and faster regulatory pathways, even if the patient pool is smaller.

Can-Fite BioPharma Ltd. (CANF) - Canvas Business Model: Cost Structure

You're looking at the core expenditures for Can-Fite BioPharma Ltd. as of the middle of 2025. For a clinical-stage biotech, the cost structure is almost entirely driven by the expensive, multi-year process of drug development.

The Net cash used in operating activities for the first half of 2025 (six months ended June 30, 2025) was $4.75 million. This represents an increase from the $4.04 million used in the same period of 2024, showing that operational cash burn is accelerating as clinical programs advance.

The major components of this cash usage are detailed below, primarily focusing on the expenses reported through the first half of 2025.

Cost Category Amount (Six Months Ended June 30, 2025) Year-over-Year Change (vs. H1 2024)
Research and Development (R&D) Expenses $3.03 million Increase of 5.16%
General and Administrative (G&A) Expenses $2.07 million Increase of 35.47%
Net Cash Used in Operating Activities $4.75 million Increase of $0.71 million

High research and development (R&D) expenses are the lifeblood cost for Can-Fite BioPharma Ltd., directly funding the clinical trials for its drug candidates. The R&D expenses for the first half of 2025 totaled $3.03 million. This increase, up 5.16% from $2.88 million in H1 2024, is directly tied to the acceleration of expenses across their pipeline programs.

General and administrative (G&A) costs also saw a significant jump. For the six months ended June 30, 2025, G&A totaled $2.07 million, which is an increase of $0.54 million, or 35.47%, compared to $1.52 million in the prior year period. The company expects G&A expenses to remain at this level through the remainder of 2025.

The R&D spending is allocated across several key clinical efforts, which are the most significant cost drivers beyond basic overhead. You can see the focus of this spending:

  • Ongoing Phase 3 study of Piclidenoson for psoriasis treatment.
  • Ongoing Phase 3 study of Namodenoson in advanced liver cancer.
  • Ongoing Phase 2b study of Namodenoson for MASH (Metabolic Dysfunction-Associated Steatohepatitis).

While specific line items for manufacturing, regulatory filings, and intellectual property maintenance aren't broken out separately in the H1 2025 summary, these activities are inherently embedded within the $3.03 million R&D expense figure, especially costs associated with ongoing patient treatment in trials. Furthermore, the company's net loss for the period was $4.87 million, reflecting these substantial development costs against minimal revenue of $0.20 million.

Financing activities provided a buffer, with net cash provided by financing activities reaching $3.37 million for H1 2025, largely due to proceeds from equity issuances, including a public offering in July 2025. As of June 30, 2025, Can-Fite BioPharma Ltd. held $6.45 million in cash and short-term deposits.

Finance: draft 13-week cash view by Friday.

Can-Fite BioPharma Ltd. (CANF) - Canvas Business Model: Revenue Streams

You're looking at the core ways Can-Fite BioPharma Ltd. brings in cash right now, which is critical given the R&D burn rate. The revenue streams are a mix of upfront cash from deals and the promise of future payments tied to clinical success.

Advance payments and milestones from existing distribution agreements represent a key, albeit fluctuating, part of current recognized revenue. For the six months ended June 30, 2025, the recognized revenue was $0.20 million, which was a 36.07% drop compared to the $0.31 million recognized in the first half of 2024. This dip in H1 2025 revenue stemmed from recognizing a lower portion of advance payments received under existing distribution agreements, specifically mentioning the Ewopharma agreement entered in 2021 and agreements with Gebro, CKD, and Cipher.

The company actively supplements its cash position through capital raises, which is a distinct revenue stream for a clinical-stage firm. Can-Fite BioPharma Ltd. completed a public offering in July 2025, securing aggregate gross proceeds of approximately $5.0 million. After deducting issuance costs, the net proceeds were approximately $4.2 million. This financing is intended to fund research and development, clinical trials, and general corporate purposes.

Revenues from licensing agreements are recognized over time as advance payments are earned. As noted, the total recognized revenue for the first half of 2025 was $0.20 million. The company expects to continue funding operations partly through potential future milestone payments from its licensees.

The largest potential revenue component lies in future royalties on drug sales upon regulatory approval. Can-Fite BioPharma Ltd. has seven partnerships structured to include royalties on product sales, alongside development and regulatory milestones. Based on internal modeling and external advisor insights, the Company forecasts potential cumulative income from these partnerships over the next decade to reach $685 million, assuming regulatory approval and launches for its drug candidates between 2027 and 2029.

Here's a look at the key financial figures related to the revenue-generating activities as of late 2025:

Revenue Component/Metric Amount/Value Period/Date
Total Revenue $0.20 million H1 2025
Revenue Change YoY -36.07% H1 2025 vs. H1 2024
Gross Proceeds from July 2025 Public Offering $5.0 million July 2025
Net Proceeds from July 2025 Public Offering (Approximate) $4.2 million July 2025
Projected Cumulative Future Revenues from Partnerships $685 million Forecasted over next decade
Cash and Equivalents (Excluding July Offering) $6.45 million June 30, 2025

The structure of these expected future payments is detailed in the partnership terms:

  • Development and regulatory milestones.
  • Commercial sales benchmarks.
  • Manufacturing-related transfer payments.
  • Royalties on product sales.

To be fair, these long-term projections are heavily dependent on achieving regulatory approval and market penetration for Piclidenoson and Namodenoson in indications like psoriasis, advanced liver cancer, pancreatic cancer, and MASH, which are assumed to occur between 2027 and 2029. Finance: draft 13-week cash view by Friday.


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