Ramat Gan, Israel, June 16, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs for the treatment of cancer and inflammatory diseases, today announced that Dr. Sari Fishman, Vice President of Business Development, will present an update on the Company’s ongoing Phase IIa study in pancreatic cancer during partnering meetings at the 2025 BIO International Convention, taking place J ...

Core Insights - Can-Fite BioPharma Ltd. is advancing its oncology drug Namodenoson, which is being sought for compassionate use approval by leading U.S. medical centers for treating pancreatic carcinoma [1][2][4] - Namodenoson has received FDA approval for its first single-patient compassionate use treatment, indicating significant progress in its clinical development [2] - The company is conducting a Phase IIa study in Israel for advanced pancreatic adenocarcinoma patients, focusing on safety, clinical activity, and pharmacokinetics [3] Company Overview - Can-Fite BioPharma Ltd. is a clinical-stage biotechnology company targeting multi-billion-dollar markets in cancer, liver, and inflammatory diseases [5] - 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 [5] - Namodenoson is also being evaluated in multiple trials, including a Phase III trial for hepatocellular carcinoma and a Phase IIb trial for Metabolic Dysfunction-associated Steatohepatitis [5] Drug Mechanism and Designation - Namodenoson is an orally bioavailable drug that selectively binds to the A3 adenosine receptor, which is highly expressed in diseased cells, contributing to its favorable safety profile [4] - The drug has received Orphan Drug Designation from the U.S. FDA, highlighting its potential as a therapeutic option for underserved patient populations [3][5]

Core Viewpoint - Can-Fite BioPharma Ltd. has announced a registered direct offering of 2,500,000 American Depositary Shares (ADSs) at a price of $1.20 per ADS, aiming to raise approximately $3.0 million for research, development, and general corporate purposes [1][2]. Group 1: Offering Details - The offering is expected to close on or about April 15, 2025, pending customary closing conditions [1]. - H.C. Wainwright & Co. is acting as the exclusive placement agent for this offering [2]. - The gross proceeds from the offering, before deducting fees and expenses, are anticipated to be $3.0 million [2]. Group 2: Company Overview - Can-Fite BioPharma is focused on developing small-molecule drugs for oncological and inflammatory diseases, targeting multi-billion dollar markets [5]. - The lead drug candidate, Piclidenoson, has recently reported topline results in a Phase III trial for psoriasis and is commencing another pivotal Phase III trial [5]. - Namodenoson, another key drug, is being evaluated in multiple trials for hepatocellular carcinoma (HCC) and has received Orphan Drug Designation and Fast Track Designation from the FDA [5]. - The company has a strong safety profile with over 1,600 patients involved in clinical studies to date [5].

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]

Exhibit 99.1 Can-Fite Reports 2024 Financial Results and Clinical Update Cancer-Free Survival of 8 Years in Liver Cancer Patient Treated with Namodenoson in Prior Phase II Study Ramat Gan, Israel, April 14, 2025 -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, today announced financial results and clinical updates for the year ended December 31, 2024. Clinical & De ...

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]

The psoriasis market is estimated at $30 Billion by 2030 and has shifted significantly to oral drugs Ramat Gan, Israel, March 24, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, today announced that it initiated a pivotal phase 3 psoriasis study of its oral drug Piclidenoson with the U.S. Food and Drug Administration (FDA) and the European Me ...

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]