Core Viewpoint - Can-Fite BioPharma Ltd. reported financial results and clinical updates for the first half of 2025, highlighting advancements in its drug candidates and financial performance. Clinical & Development Milestones - The Phase 2a study of Namodenoson for advanced pancreatic cancer has achieved over 50% enrollment, focusing on safety, clinical activity, and pharmacokinetics [2] - Namodenoson, an A3 adenosine receptor agonist, has shown a favorable safety profile and anti-tumor activity in preclinical models [3] - The drug has received Orphan Drug Designation from the FDA, providing potential market exclusivity for seven years post-approval [4] - Following FDA Compassionate Use Approval, interest from leading U.S. medical centers has increased for treating pancreatic cancer patients with Namodenoson [5] - Piclidenoson has shown promise in treating vascular dementia, with a study from UCLA demonstrating its ability to restore tissue integrity in a mouse model [6][7] - The global market for vascular dementia is estimated at $6 billion in 2025, with a projected CAGR of 5% through 2035 [7] - Piclidenoson has a strong safety profile and has demonstrated anti-inflammatory activity in previous clinical studies [8] Financial Results - Revenues for H1 2025 were $0.20 million, a decrease of $0.11 million or 36.07% compared to $0.31 million in H1 2024, primarily due to lower advance payments from distribution agreements [10] - Research and development expenses increased to $3.03 million, up $0.15 million or 5.16% from $2.88 million in H1 2024, driven by ongoing studies for Namodenoson and Piclidenoson [11] - General and administrative expenses rose to $2.07 million, an increase of $0.54 million or 35.47% compared to $1.52 million in H1 2024, mainly due to investor relationship expenses [12] - Net loss for H1 2025 was $4.87 million, compared to a net loss of $3.95 million in H1 2024, attributed to increased R&D and administrative expenses [14] - As of June 30, 2025, cash and cash equivalents totaled $6.45 million, down from $7.88 million at the end of 2024, with a public offering completed in July 2025 raising $5 million [15] Company Overview - Can-Fite BioPharma Ltd. is focused on developing drugs for cancer, liver, and inflammatory diseases, with lead candidates Piclidenoson and Namodenoson in advanced clinical trials [23]

Core Insights - Can-Fite BioPharma Ltd. has achieved over 50% enrollment in its Phase 2a trial of Namodenoson for pancreatic cancer, indicating strong interest from both investigators and patients [1][3] - The primary endpoint of the trial is safety, and Namodenoson has demonstrated a favorable safety profile to date [2][3] - Namodenoson is a selective A3 adenosine receptor agonist showing anti-tumor activity in preclinical models and is also being evaluated for advanced liver cancer [3][4] Company Overview - Can-Fite BioPharma is a clinical-stage biotechnology company focused on developing small molecule drugs for cancer and inflammatory diseases, targeting multi-billion dollar markets [5] - The company’s lead drug candidate, Piclidenoson, has recently reported topline results in a Phase 3 trial for psoriasis and is advancing in clinical trials for other indications [5] - Namodenoson has received Orphan Drug Designation from the FDA for pancreatic cancer and is also being evaluated in trials for hepatocellular carcinoma and other cancers [4][5]

Group 1 - Can-Fite BioPharma Ltd. announced a public offering of 8,333,333 American Depositary Shares (ADSs) at a price of $0.60 per ADS, with short-term warrants to purchase up to 16,666,666 additional ADSs [1][3] - The gross proceeds from the offering are expected to be approximately $5.0 million, with potential additional proceeds of up to $10.0 million from the exercise of short-term warrants [3] - The offering is expected to close on or about July 29, 2025, subject to customary closing conditions [1][3] Group 2 - H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering [2] - The proceeds from the offering will be used for funding research and development, clinical trials, and other working capital and general corporate purposes [3] Group 3 - Can-Fite is a clinical-stage biotechnology company focused on developing small molecule drugs for cancer and inflammatory diseases, with a lead drug candidate, Piclidenoson, currently in Phase 3 trials [6] - The company’s liver drug, Namodenoson, is being evaluated in multiple trials for hepatocellular carcinoma and has received Orphan Drug Designation and Fast Track Designation from the FDA [6] - Can-Fite's drug candidates have shown efficacy in various conditions and have been tested in over 1,600 patients in clinical studies [6]

Core Insights - Can-Fite BioPharma Ltd. announced that Piclidenoson demonstrated efficacy in an experimental model of vascular dementia, as shown by a study from UCLA [1][2] Company Overview - Can-Fite BioPharma Ltd. is a clinical-stage biotechnology company focused on developing small molecule drugs for cancer and inflammatory diseases [1][6] - The company's lead drug candidate, Piclidenoson, has shown a compelling safety profile in clinical studies and is currently in pivotal Phase 3 trials for psoriasis [5][6] Vascular Dementia Market - Vascular dementia is the second most common cause of dementia, with no FDA-approved therapies available, leading to a significant unmet medical need [3][4] - The global market for vascular dementia is estimated at $6 billion in 2025, with a projected CAGR of 5% through 2035 [3] Drug Mechanism and Potential - Piclidenoson is a selective A3 adenosine receptor agonist that has shown neuroprotective effects and the potential to improve vascular health, addressing a significant gap in the current treatment landscape for vascular dementia [4][5]

As filed with the Securities and Exchange Commission on July 25, 2025. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 CAN-FITE BIOPHARMA LTD. (Exact name of registrant as specified in its charter) State of Israel 2834 Not Applicable (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification No.) 26 Ben Gurion ...

Core Viewpoint - Can-Fite BioPharma Ltd. is advancing its clinical pipeline, particularly focusing on the Phase IIa study of Namodenoson for advanced pancreatic cancer, which addresses a significant unmet medical need in this area [1][4]. Company Overview - Can-Fite BioPharma Ltd. is a clinical-stage biotechnology company developing small molecule drugs for cancer and inflammatory diseases, with a focus on multi-billion dollar markets [5]. - The company's lead drug candidate, Piclidenoson, has recently reported topline results in a Phase 3 trial for psoriasis and is progressing to a pivotal Phase 3 trial [5]. - Namodenoson, another key drug, is being evaluated in multiple trials, including a Phase III trial for hepatocellular carcinoma (HCC) and a Phase 2a study for pancreatic cancer [5]. Clinical Trial Details - The Phase IIa clinical trial of Namodenoson is an open-label study involving patients with advanced pancreatic adenocarcinoma who have progressed after at least one prior therapy [2]. - The trial is assessing the safety, clinical activity, and pharmacokinetics of Namodenoson, administered at a dose of 25 mg twice daily in 28-day cycles, with approximately 20 evaluable patients expected to be enrolled [2]. - The trial is led by Prof. Salomon Stemmer, a prominent oncologist, and Namodenoson has received Orphan Drug Designation from the FDA for pancreatic cancer treatment [3]. Enrollment and Safety Profile - As of the latest update, 50% of the planned patient cohort has been enrolled, and Namodenoson has shown a favorable safety profile [4]. - The study aims to provide a novel therapeutic approach for patients with advanced pancreatic cancer who have exhausted standard treatment options [4].

Core Insights - Can-Fite BioPharma Ltd. has raised $175 million in funding to advance its lead drug candidates, Namodenoson and Piclidenoson, into pivotal Phase III studies for liver cancer and psoriasis respectively [1][6] Group 1: Company Overview - Can-Fite is a biotechnology company focused on developing small-molecule drugs targeting oncological and inflammatory diseases, specifically through the A3 adenosine receptor (A3AR) [2][6] - The company is currently conducting pivotal Phase III trials for Namodenoson in advanced liver cancer and Piclidenoson in moderate-to-severe psoriasis [2][6] Group 2: Drug Development and Trials - Namodenoson has shown selective targeting of liver and pancreatic tumor cells while sparing healthy tissue, and is currently enrolling patients for its Phase III study [2][3] - Piclidenoson is also in a pivotal Phase III trial for psoriasis, with both candidates demonstrating favorable safety profiles and promising efficacy in previous Phase II trials [3][4] Group 3: Funding and Commercialization - The cumulative funding has supported drug manufacturing, regulatory activities with the FDA and EMA, and the development of a broad patent portfolio [3] - Can-Fite has signed seven commercialization agreements with strategic partners for future marketing of its drug candidates upon regulatory approval [5] Group 4: Future Prospects - The company is also conducting a Phase IIa study of Namodenoson in pancreatic cancer and a Phase IIb trial in metabolic dysfunction-associated steatohepatitis (MASH) [4][6] - Namodenoson has received Orphan Drug Designation in the U.S. and Europe and Fast Track Designation for hepatocellular carcinoma by the FDA [6]

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]