Can-Fite(CANF) - 2021 Q3 - Quarterly Report

Can-Fite Q3 2021 Report Corporate and Clinical Development Highlights The company advanced its clinical pipeline, notably completing enrollment for its Phase III psoriasis study, while strategically reallocating resources and strengthening its NASH IP portfolio - Completed patient enrollment in the Phase III Comfort™ study for psoriasis, with topline results anticipated in Q1 2022[3] - Strategically ended the Phase II COVID-19 trial for Piclidenoson to focus resources on other advanced clinical programs[4] - Expanded its intellectual property portfolio for NASH, with patents granted in Japan, Hong Kong, and Mexico, bringing the total to 37 countries[5] - Presented and published positive data on its drug candidates for liver diseases at AASLD and in a peer-reviewed journal[6][7] Financial Results The company reported a reduced net loss of $8.49 million for the nine-month period, driven by lower R&D expenses, and strengthened its cash position to $13.3 million Financial Performance for the Nine Months Ended September 30 (in millions USD) | Metric | 2021 | 2020 | Change | | :--- | :--- | :--- | :--- | | Revenues | $0.65 | $0.61 | +6.6% | | Research and Development Expenses | $6.75 | $9.06 | -25.5% | | General and Administrative Expenses | $2.71 | $2.14 | +26.6% | | Net Loss | $8.49 | $10.81 | -21.5% | - The decrease in R&D expenses was mainly due to costs incurred in 2020 for Phase II and Phase III studies that were not present in 2021[11] - The increase in G&A expenses was primarily attributed to higher salaries, benefits, public relations, and insurance costs[12] Cash and Cash Equivalents Position (in millions USD) | Date | Amount | | :--- | :--- | | September 30, 2021 | $13.3 | | December 31, 2020 | $8.26 | - The increase in cash was driven by proceeds from warrant exercises ($2.74M), a distribution agreement ($2.25M), and a registered direct offering ($10M), offset by operating activities[15] Financial Statements The financial statements reflect an improved balance sheet with increased total assets and a reduced net loss per share for the nine-month period Condensed Consolidated Balance Sheets The balance sheet shows total assets grew to $14.64 million, driven by a stronger cash position, while total shareholders' equity improved to $9.33 million Assets (in thousands USD) | Asset Category | Sep 30, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | $5,806 | $8,268 | | Short-term deposits | $7,503 | $0 | | Total current assets | $14,474 | $9,400 | | Total assets | $14,639 | $9,523 | Liabilities and Shareholders' Equity (in thousands USD) | Category | Sep 30, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | Total current liabilities | $2,153 | $1,269 | | Total long-term liabilities | $3,152 | $2,180 | | Total liabilities | $5,305 | $3,449 | | Total equity | $9,334 | $6,074 | | Total liabilities and shareholders' equity | $14,639 | $9,523 | Condensed Consolidated Statements of Comprehensive Loss The company's net loss for the nine-month period improved to $8.50 million, or ($0.02) per share, from $10.81 million in the prior year Statement of Comprehensive Loss for the Nine Months Ended September 30 (in thousands USD, except per share data) | Metric | 2021 | 2020 | | :--- | :--- | :--- | | Revenues | $649 | $613 | | Operating loss | $(8,814) | $(10,586) | | Net loss | $(8,497) | $(10,810) | | Basic and diluted net loss per share | $(0.02) | $(0.04) | | Weighted average number of ordinary shares | 515,918,123 | 323,360,926 | Company Overview The company is a clinical-stage biopharma firm with a pipeline targeting cancer, liver, and inflammatory diseases, led by Piclidenoson and Namodenoson - The company's lead drug candidates and their current clinical stages are: - Piclidenoson: Phase III trial for psoriasis - Namodenoson: Heading into a Phase III trial for hepatocellular carcinoma (HCC) and a Phase IIb trial for non-alcoholic steatohepatitis (NASH) - CF602: Has shown efficacy for erectile dysfunction[26] - Namodenoson has received Orphan Drug Designation in the U.S. and Europe, as well as Fast Track Designation from the U.S. FDA as a second-line treatment for HCC[26]