Can-Fite(CANF) - 2022 Q1 - Quarterly Report

Financial Performance - As of December 31, 2021, Can-Fite reported a cash balance of $18.9 million, an increase from $8.3 million at the end of 2020[3][17]. - Revenues for the year ended December 31, 2021, were $0.85 million, up from $0.76 million in 2020, primarily due to the recognition of advance payments from the Ewopharma distribution agreement[11]. - The net loss for the year ended December 31, 2021, was $12.6 million, a decrease from a net loss of $14.4 million in 2020, attributed to reduced research and development expenses[16]. - Can-Fite's total liabilities and shareholders' equity as of December 31, 2021, amounted to $20.25 million, compared to $9.52 million at the end of 2020[25]. - The company has received over $20 million in non-dilutive funding to date, supporting its ongoing clinical development efforts[4]. Research and Development - Research and development expenses for 2021 were $9.85 million, down from $11.95 million in 2020, with expectations for an increase in 2022[12]. - The Phase III psoriasis study completed enrollment of over 400 patients, with topline data expected in Q2 2022[6]. - Can-Fite's Phase IIb NASH study commenced enrollment in January 2022, targeting 140 subjects with biopsy-confirmed NASH[7]. - A pivotal Phase III liver cancer study is expected to commence enrollment in H1 2022, with approximately 450 patients anticipated[5]. - Can-Fite BioPharma's lead drug candidate, Piclidenoson, has completed enrollment in a Phase III trial for psoriasis[27]. - Namodenoson, the liver drug, is in a Phase IIb trial for non-alcoholic steatohepatitis (NASH) and is expected to enter a Phase III trial for hepatocellular carcinoma (HCC)[27]. - Namodenoson has received Orphan Drug Designation in the U.S. and Europe and Fast Track Designation for HCC by the FDA[27]. - CF602, the third drug candidate, has shown efficacy in treating erectile dysfunction[27]. - The drugs have an excellent safety profile with over 1,500 patients involved in clinical studies to date[27]. Market and Strategic Position - Can-Fite operates in multi-billion dollar markets targeting cancer, liver, and inflammatory diseases[27]. - The company faces risks including a history of losses and the need for additional capital to fund operations[28]. - Forward-looking statements indicate potential uncertainties in cash flows and regulatory approvals for product candidates[28]. - Can-Fite's business model and strategic plans are subject to competitive pressures and market acceptance[28]. - The company does not undertake any obligation to publicly update forward-looking statements[28]. Licensing and Partnerships - Can-Fite signed a significant out-licensing deal worth $42.7 million with Ewopharma, including a $2.25 million upfront payment and potential milestone payments of up to $40.45 million[4].