Can-Fite(CANF) - 2024 Q4 - Annual Report

Report Overview This report outlines Can-Fite BioPharma's clinical progress for its drug candidates, its financial results for 2024, and company profile Clinical & Development Milestones Can-Fite reported significant clinical progress for its two main drug candidates, Namodenoson and Piclidenoson, advancing their development across multiple indications Namodenoson Drug Candidate 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] - 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] - A Phase IIa clinical trial for advanced pancreatic adenocarcinoma has been initiated to evaluate the safety and efficacy of Namodenoson[3] - 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][5] Piclidenoson Drug Candidate 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] - A Phase II open-label study for the rare genetic disease, Lowe Syndrome, has been designed and is being prepared for initiation[7] - 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] Financial Results (Year Ended December 31, 2024) 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] - The reduction in R&D expenses is primarily attributed to lower costs associated with the Piclidenoson psoriasis study[10] - 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] Consolidated Financial Statements 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. 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] - 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]