Can-Fite(CANF) - 2022 Q3 - Quarterly Report

Financial Performance - Revenues for the nine months ended September 30, 2022 were $0.61 million, a decrease of $0.04 million, or 6.1%, compared to $0.65 million for the same period in 2021[9] - Research and development expenses for the nine months ended September 30, 2022 were $5.31 million, a decrease of $1.44 million, or 21.3%, compared to $6.75 million for the same period in 2021[10] - General and administrative expenses for the nine months ended September 30, 2022 were $2.31 million, a decrease of $0.40 million, or 14.7%, compared to $2.71 million for the same period in 2021[11] - Net loss for the nine months ended September 30, 2022 was $7.15 million, compared with a net loss of $8.50 million for the same period in 2021, reflecting a decrease in losses[13] - As of September 30, 2022, cash and cash equivalents and short-term deposits totaled $10.79 million, down from $18.90 million at December 31, 2021[14] Product Development and Clinical Trials - Can-Fite's pivotal Phase III liver cancer study for Namodenoson is open for enrollment of approximately 450 patients diagnosed with HCC[4] - The latest Phase III findings for Piclidenoson showed a significantly better tolerability profile compared to Otezla, with GI-related adverse events at 1% for Piclidenoson versus 6% for Otezla[5] - Can-Fite is preparing to submit the pivotal Phase III psoriasis study protocol to the FDA and EMA for Piclidenoson[6] - The canine osteoarthritis market is projected to reach $3 billion by 2028, with Piclidenoson set to enter efficacy studies in this area[7] Strategic Partnerships and Market Position - Can-Fite maintains full distribution rights for Piclidenoson and Namodenoson in the U.S., the largest market in the world, while evaluating strategic partnerships[8] - Can-Fite emphasizes the importance of strategic partnerships and corporate collaborations[25] Risks and Challenges - The company acknowledges a history of losses and the need for additional capital to fund operations[25] - Risks include uncertainties in cash flows and the ability to meet working capital needs[25] - The initiation and results of preclinical studies and clinical trials are critical for advancing product candidates[25] - Regulatory approvals and the timing of filings are essential for product candidate development[25] - The company faces competition and risks related to the COVID-19 pandemic and geopolitical issues[25] - There are risks associated with not meeting NYSE American continued listing requirements[25] - Investors are cautioned against placing undue reliance on forward-looking statements due to inherent uncertainties[25] Forward-Looking Statements - Can-Fite's forward-looking statements include expectations regarding product development, financial condition, and business strategies[25] - The company must maintain intellectual property rights to protect its product candidates[25]