Core Insights - Can-Fite BioPharma Ltd. has completed a comprehensive analysis of its partnerships and market potential for its lead drug candidates, Piclidenoson and Namodenoson, pending regulatory approvals [1][2] Group 1: Drug Candidates and Market Potential - The company forecasts substantial revenue generation over the next decade from Piclidenoson and Namodenoson, which are in development for psoriasis, advanced liver cancer, pancreatic cancer, and MASH, with expected regulatory approvals and launches between 2027 and 2029 [2][4] - Can-Fite's partnerships include diverse financial components such as development milestones, commercial sales benchmarks, and royalties, which are expected to contribute to significant cumulative income from multiple revenue streams [2][4] Group 2: Company Overview and Drug Development - Can-Fite is an advanced clinical stage drug development company targeting multi-billion dollar markets in cancer, liver, and inflammatory diseases, with Piclidenoson recently reporting positive Phase III trial results for psoriasis [5] - Namodenoson is currently in a Phase III trial for hepatocellular carcinoma and has received Orphan Drug Designation and Fast Track Designation from the FDA, indicating its potential as a second-line treatment [5] Group 3: Strategic Foundation and Future Outlook - The company emphasizes the strategic foundation built through diverse collaborations, highlighting significant commercial opportunities and potential long-term value for shareholders [4] - The safety profile of Can-Fite's drugs has been validated through clinical studies involving over 1,600 patients, reinforcing confidence in their development pipeline [5]

[Report Overview](index=1&type=section&id=Report%20Overview) This report outlines Can-Fite BioPharma's clinical progress for its drug candidates, its financial results for 2024, and company profile [Clinical & Development Milestones](index=1&type=section&id=Clinical%20%26%20Development%20Milestones) Can-Fite reported significant clinical progress for its two main drug candidates, Namodenoson and Piclidenoson, advancing their development across multiple indications [Namodenoson Drug Candidate](index=1&type=section&id=Namodenoson%20Drug%20Candidate) Namodenoson demonstrated a complete cure in a liver cancer patient, received Orphan Drug Designation for pancreatic cancer, and secured anti-obesity patents - A liver cancer patient treated with Namodenoson in a compassionate use program from a prior Phase II study has shown a complete cure, with disappearance of all metastases after **8 years of overall survival**[2](index=2&type=chunk) - Namodenoson was granted Orphan Drug Designation by the U.S. FDA for pancreatic cancer, providing potential for **seven years of market exclusivity** upon approval[3](index=3&type=chunk) - A Phase IIa clinical trial for advanced pancreatic adenocarcinoma has been initiated to evaluate the safety and efficacy of Namodenoson[3](index=3&type=chunk) - The U.S. Patent Office granted a patent for Namodenoson's use as an anti-obesity drug, expiring in **2042** A similar patent was granted by the Australian Patent Office, expiring in **2040**[4](index=4&type=chunk)[5](index=5&type=chunk) [Piclidenoson Drug Candidate](index=2&type=section&id=Piclidenoson%20Drug%20Candidate) Piclidenoson initiated a pivotal Phase 3 study for psoriasis, advanced development for Lowe Syndrome, and secured a partnership for canine osteoarthritis - A pivotal Phase 3 study for Piclidenoson in moderate to severe plaque psoriasis has been initiated with the FDA and EMA, with patient enrollment starting in Europe[6](index=6&type=chunk) - A Phase II open-label study for the rare genetic disease, Lowe Syndrome, has been designed and is being prepared for initiation[7](index=7&type=chunk) - Partnered with Vetbiolix for canine osteoarthritis, with a successful clinical study completed Peak worldwide sales are projected at **$445 million** by **2034**, with Can-Fite entitled to a **15% royalty**[8](index=8&type=chunk) [Financial Results (Year Ended December 31, 2024)](index=2&type=section&id=Financial%20Results) Can-Fite reported a 9.3% decrease in revenues to $0.67 million, a 3.8% reduction in R&D expenses, and a net loss of $7.88 million for 2024 Financial Performance Summary | Financial Metric | 2024 | 2023 | Change | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Revenues | $0.67M | $0.74M | -$0.07M | -9.3% | | R&D Expenses | $5.75M | $5.98M | -$0.23M | -3.8% | | G&A Expenses | $3.04M | $2.95M | +$0.09M | +3.1% | | Net Loss | $7.88M | $7.63M | +$0.25M | +3.3% | - The decrease in revenue was mainly due to recognizing a lower portion of advance payments from existing distribution agreements[9](index=9&type=chunk) - The reduction in R&D expenses is primarily attributed to lower costs associated with the Piclidenoson psoriasis study[10](index=10&type=chunk) - Cash, cash equivalents, and short-term deposits totaled **$7.88 million** as of December 31, 2024, down from **$8.90 million** at the end of 2023, with the decrease attributed to ongoing operations[13](index=13&type=chunk) [Consolidated Financial Statements](index=4&type=section&id=Consolidated%20Financial%20Statements) The consolidated financial statements show a decrease in total assets to $9.12 million and a net loss of $7.88 million for the year ended December 31, 2024 Consolidated Balance Sheets (U.S dollars in thousands) | | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | **ASSETS** | | | | Total current assets | $8,982 | $9,908 | | Total non-current assets | $138 | $81 | | **Total assets** | **$9,120** | **$9,989** | | **LIABILITIES & EQUITY** | | | | Total current liabilities | $2,052 | $2,020 | | Total long-term liabilities | $1,632 | $1,726 | | Total shareholders' equity | $5,436 | $6,243 | | **Total liabilities and shareholders' equity** | **$9,120** | **$9,989** | Consolidated Statements of Comprehensive Loss (U.S dollars in thousands) | | Year ended Dec 31, 2024 | Year ended Dec 31, 2023 | | :--- | :--- | :--- | | Revenues | $674 | $743 | | Research and development expenses | $(5,757) | $(5,983) | | General and administrative expenses | $(3,047) | $(2,955) | | **Operating loss** | **$(8,130)** | **$(8,195)** | | Total financial income, net | $250 | $561 | | **Net loss** | **$(7,880)** | **$(7,634)** | | Basic and diluted net loss per share | $(0.00) | $(0.01) | [About Can-Fite BioPharma Ltd.](index=7&type=section&id=About%20Can-Fite%20BioPharma%20Ltd.) Can-Fite is an advanced clinical-stage drug development company focused on cancer, liver, and inflammatory diseases, with lead candidates Piclidenoson and Namodenoson - The company's drug pipeline includes Piclidenoson (Phase III for psoriasis), Namodenoson (Phase III for HCC, Phase IIb for MASH, Phase IIa for pancreatic cancer), and CF602 (efficacy shown for erectile dysfunction)[19](index=19&type=chunk) - Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe, and Fast Track Designation by the U.S. FDA as a second-line treatment for HCC[19](index=19&type=chunk)

Financial Performance - The company has incurred net losses of approximately $7.9 million in 2024, $7.6 million in 2023, and $10.1 million in 2022, with an accumulated deficit of approximately $166.4 million as of December 31, 2024[40]. - The company anticipates continuing to incur substantial operating losses for the foreseeable future due to ongoing research and development activities[40]. - The company has incurred significant losses in connection with its research and development efforts since inception[219]. - The company has not declared or paid any cash dividends on its ordinary shares and does not expect to do so in the foreseeable future[193]. Cash and Capital Requirements - As of December 31, 2024, the company had cash and cash equivalents of $4.8 million and short-term deposits of $3.1 million, and raised approximately $5.0 million in gross proceeds in August 2024[42]. - The company has entered into an At The Market Offering Agreement, resulting in approximately $3.06 million in gross proceeds as of March 31, 2025[42]. - The company may need to raise additional capital in the future, which could be costly or difficult to obtain and may dilute current shareholders' ownership interests[42]. - The company’s future capital requirements will depend on various factors, including the progress of clinical trials and regulatory reviews[44]. Product Development and Pipeline - The current product pipeline includes three molecules: Piclidenoson, Namodenoson, and CF602, with Piclidenoson being the most advanced[32]. - The company has not yet commercialized any products or technologies and may never achieve profitability[50]. - The company has not yet achieved market acceptance for its product candidates, which is critical for future profitability[51]. - The company is conducting pivotal Phase III trials for Piclidenoson in psoriasis and Namodenoson in advanced liver cancer, with patient enrollment ongoing[219]. Regulatory Challenges - The company may face challenges in obtaining regulatory approvals for its product candidates, which could impact its ability to commercialize products[50]. - The company has not received regulatory approval for any of its product candidates, which may significantly impact its ability to commercialize products and generate revenue[53]. - Regulatory authorities may require additional pre-clinical testing or clinical trials, delaying the approval process and impacting revenue generation[54]. - The FDA requires completion of clinical trials to establish safety and efficacy before approving a New Drug Application (NDA), and significant delays in testing could increase product development costs[122]. Competition and Market Risks - The company faces significant competition from larger pharmaceutical and biotechnology companies, which have greater financial resources and experience in drug development[77]. - The competitive environment and pricing policies from government and third-party payors could limit the commercial viability of the company's products[52]. - The commercial success of approved products will depend on acceptance by the medical community, influenced by factors such as clinical safety, efficacy, and convenience[130]. Intellectual Property and Legal Risks - The company faces uncertainties regarding patent protection, which could affect competitive positioning and market exclusivity[102]. - Litigation related to intellectual property rights could incur significant costs and impact operational capabilities[107]. - The Brazilian drug regulatory agency, ENVISA, can nullify patents based on public interest, and Indian patent law does not allow patent protection for new uses of pharmaceuticals[113]. Operational and Compliance Risks - The company does not currently have sales, marketing, or distribution capabilities, which could materially adversely affect its business and results of operations[70]. - The company is dependent on third parties for the supply of materials needed for manufacturing, and any issues could delay clinical trials and regulatory approvals[74]. - Compliance with healthcare and data privacy laws is critical, as violations can lead to severe penalties and operational disruptions[157]. Management and Governance - Key management and technical personnel are crucial for the company's success, and failure to retain them could adversely affect operations[75]. - The company amended its articles of association to establish a staggered board, complicating shareholder efforts to replace board members[187]. - As a foreign private issuer, the company is permitted to follow certain home country corporate governance practices, which may provide less protection to investors compared to domestic issuers[205]. Economic and Geopolitical Factors - Inflation has increased costs for commodities, labor, and materials, adversely impacting financial condition and operations[182]. - Political instability in Israel, including recent military conflicts, may adversely affect business conditions and the company's financial performance[169]. - Geopolitical developments and global supply chain disruptions contribute to economic uncertainty, affecting financing costs and availability[181].

Core Insights - Can-Fite BioPharma Ltd. reported financial results and clinical updates for the year ended December 31, 2024, highlighting advancements in its drug candidates and financial performance [1] Clinical & Development Milestones Achieved - Namodenoson has shown promising results in treating liver cancer, with a patient achieving complete cure and normal liver function [1] - The drug has protective effects beyond its anti-cancer activity, as presented at the 2025 ASCO Gastrointestinal Cancers Symposium [1] - Namodenoson received Orphan Drug Designation from the FDA for pancreatic cancer, allowing for potential market exclusivity for seven years post-approval [2] - A Phase IIa clinical trial for advanced pancreatic adenocarcinoma has been initiated [2] - Namodenoson was granted a patent for its use as an anti-obesity drug, with the patent expiring in 2042 [3][4] - Can-Fite initiated a pivotal Phase 3 study for Piclidenoson in treating psoriasis, with patient enrollment starting in Europe [5] - The company is developing Piclidenoson for Lowe Syndrome, with a Phase II study planned [6] - Can-Fite partnered with Vetbiolix to develop Piclidenoson for canine osteoarthritis, with potential peak sales of $445 million by 2034 [7][8] Financial Results - Revenues for 2024 were $0.67 million, a decrease of 9.3% from $0.74 million in 2023 [9] - Research and development expenses were $5.75 million, down 3.8% from $5.98 million in 2023, primarily due to reduced expenses related to Piclidenoson [10] - General and administrative expenses increased by 3.1% to $3.04 million, attributed to higher public relations costs [11] - Net loss for 2024 was $7.88 million, slightly higher than the $7.63 million loss in 2023 [12] - As of December 31, 2024, cash and cash equivalents totaled $7.88 million, down from $8.90 million in 2023 [13] Company Overview - Can-Fite BioPharma is focused on developing drugs for cancer, liver, and inflammatory diseases, with its lead candidates being Piclidenoson and Namodenoson [21]

Core Insights - The psoriasis market is projected to reach $30 billion by 2030, with a significant shift towards oral drugs [1] - Can-Fite BioPharma Ltd. has initiated a pivotal Phase 3 study for its oral drug Piclidenoson, targeting moderate to severe plaque psoriasis [1][3] Company Overview - Can-Fite BioPharma Ltd. is a biotechnology company focused on developing small molecule drugs for oncological and inflammatory diseases [1][5] - The company’s lead drug candidate, Piclidenoson, has shown efficacy in previous clinical studies and is now entering a Phase 3 trial [5] Clinical Study Details - The Phase 3 study is randomized, double-blind, and placebo-controlled, aiming to demonstrate the safety and efficacy of Piclidenoson [2] - Co-primary efficacy objectives include achieving a Psoriasis Area and Severity Index (PASI) score response of ≥75% and a Static Physician's Global Assessment (sPGA) score of 0 or 1 at Week 16 [2] Drug Mechanism and Profile - Piclidenoson is a first-in-class A3 adenosine receptor agonist with a strong safety profile and evidence of efficacy in earlier trials [4] - The drug works by inhibiting inflammatory cytokines IL-17 and IL-23 and inducing apoptosis in skin cell keratinocytes [4]

Industry Overview - The psoriasis market is projected to reach $30 billion by 2030, with a significant shift towards oral drugs [1] Company Developments - Can-Fite BioPharma Ltd. has initiated a pivotal Phase 3 study for its oral drug Piclidenoson, targeting moderate to severe plaque psoriasis, with patient enrollment starting in Europe and expected to follow in the US and Canada [1][3] - The Phase 3 study is randomized, double-blind, and placebo-controlled, focusing on the safety and efficacy of Piclidenoson, with co-primary efficacy objectives including achieving a PASI score response of ≥75% and a sPGA score of 0 or 1 at Week 16 [2] - The FDA has requested two Phase 3 studies and encouraged the enrollment of adolescent patients due to the drug's strong safety profile [2] - Upon successful completion of the Phase 3 program, the company plans to submit a New Drug Application (NDA) to the FDA and a Marketing Authorization Plan (MAA) to the EMA [3] Product Information - Piclidenoson is a first-in-class A3 adenosine receptor agonist, demonstrating an excellent safety profile and efficacy in previous clinical studies, targeting inflammatory cytokines IL-17 and IL-23 [4] - Can-Fite's lead drug candidate, Piclidenoson, is part of a broader pipeline that includes other drugs like Namodenoson, which is being evaluated for various cancers and has received Orphan Drug Designation and Fast Track Designation from the FDA [5]

Core Insights - Can-Fite BioPharma Ltd. is collaborating with Vetbiolix to advance the clinical study of Piclidenoson for treating osteoarthritis in dogs, with projected revenues of $325 million over the next decade upon regulatory approval [1][2][4] Company Overview - Can-Fite BioPharma Ltd. is a biotechnology company focused on developing small molecule drugs for oncological and inflammatory diseases, with a lead drug candidate Piclidenoson showing promise in both human and animal studies [1][7] - The company has a pipeline that includes drugs for various conditions, including cancer and liver diseases, with ongoing clinical trials for its lead candidates [7][8] Market Opportunity - The arthritis market for companion animals is valued at $3.8 billion in 2023 and is expected to grow to $6.3 billion by 2030, with Piclidenoson potentially capturing up to 6% of this market, leading to peak sales of $445 million by 2034 [2][4] - Can-Fite is entitled to a 15% royalty on worldwide sales of Piclidenoson in this indication, indicating a significant revenue potential for the company [2][4] Product Development - Current treatments for canine osteoarthritis are limited and often come with significant side effects, while Piclidenoson offers a safer and potentially more effective oral treatment option [3][5] - Vetbiolix has successfully completed a clinical study for Piclidenoson, which supports its pharmacological profile as a viable treatment for osteoarthritis in pets [2][5] Strategic Partnerships - The collaboration with Vetbiolix is aimed at leveraging the veterinary market, which presents shorter timelines for regulatory approval compared to human medicine, thus enhancing revenue opportunities for Can-Fite [4][6]

Core Viewpoint - Can-Fite BioPharma Ltd. is advancing its clinical study for Piclidenoson, targeting the rare genetic disease Lowe Syndrome, with a Phase II trial set to begin soon [1][3]. Company Overview - Can-Fite BioPharma Ltd. is a biotechnology company focused on developing small molecule drugs for oncological and inflammatory diseases [1][11]. - The company’s lead drug candidate, Piclidenoson, is currently in pivotal Phase III trials for psoriasis and has shown efficacy in preclinical studies for Lowe Syndrome [6][11]. Clinical Study Details - The Phase II study for Lowe Syndrome will enroll 5 patients, who will receive 3 mg of Piclidenoson twice daily for 12 months, with the primary endpoint being the efficacy in increasing renal uptake [2][3]. - The study is led by Dr. Franchesca Emma from Bambino Gesù Children's Hospital in Rome, Italy [2]. Disease Background - Lowe Syndrome, an X-linked genetic condition, primarily affects males and is characterized by vision problems, kidney issues, and intellectual disabilities, with a prevalence of approximately 1 in 500,000 [4][5]. - There are currently no available drugs for Lowe Syndrome, highlighting the medical need for effective treatments [3][4]. Research Collaboration - Can-Fite has partnered with Fondazione Telethon for the clinical development of Piclidenoson, leveraging their expertise in rare genetic diseases [3][8]. Piclidenoson Overview - Piclidenoson is a first-in-class A3 adenosine receptor agonist with a strong safety profile and evidence of efficacy in both Phase II and Phase III studies [7][11]. - The drug works by inhibiting inflammatory cytokines IL-17 and IL-23 and inducing apoptosis in skin cell keratinocytes [7]. Fondazione Telethon Contributions - Fondazione Telethon has invested over 660 million euros in research, funding nearly 3,000 projects and studying 630 diseases, aiming to develop therapies for rare genetic conditions [9][10].

Core Insights - Can-Fite BioPharma Ltd. has received FDA approval for compassionate use of its anti-cancer drug Namodenoson for a pancreatic cancer patient in the U.S. [1][3] - Namodenoson is currently undergoing multiple clinical trials, including a pivotal Phase III study for advanced liver cancer and a Phase IIa study for pancreatic cancer [3][5] - The drug has been granted Orphan Drug Designation by the FDA for pancreatic cancer, which may provide market exclusivity for seven years post-approval [4][6] Company Overview - Can-Fite BioPharma is a clinical-stage biotechnology company focused on developing small molecule drugs for oncological and inflammatory diseases [1][6] - The company’s lead drug candidate, Piclidenoson, has recently reported positive results in a Phase III trial for psoriasis [6] - Namodenoson has shown potential efficacy in treating various cancers, including colon, prostate, and melanoma, and has an excellent safety profile based on clinical studies involving over 1,600 patients [5][6]

Core Insights - Can-Fite BioPharma Ltd. announced the publication of a study on Namodenoson, highlighting its protective effects against toxicity compared to traditional chemotherapy [1][2][3] - The study demonstrates Namodenoson's anti-ischemic, anti-inflammatory, anti-fibrotic, and anti-toxicity effects across multiple body systems, particularly the liver, central nervous system, and cardiovascular system [2][3] - Namodenoson is currently undergoing pivotal Phase III trials for advanced liver cancer, with Orphan Drug and Fast Track designations from the FDA and EMA [4][5] Company Overview - Can-Fite BioPharma is focused on developing small molecule drugs for oncological and inflammatory diseases, targeting multi-billion-dollar markets [6] - The company’s lead drug candidate, Piclidenoson, has shown promising results in a Phase III trial for psoriasis and is expected to enter another pivotal Phase III trial [6] - Namodenoson has shown potential in treating various cancers, including hepatocellular carcinoma, metabolic dysfunction-associated steatohepatitis, and pancreatic cancer, with a strong safety profile demonstrated in over 1,600 patients [5][6]