Can-Fite(CANF) - 2021 Q4 - Annual Report

Overview and 2021 Highlights Can-Fite concluded 2021 with a fortified financial standing and significant clinical progress, anticipating key Phase III data and new study initiations in 2022 2021 Highlights Can-Fite reported a strong 2021 financial position with $18.9 million cash, a $42.7 million Ewopharma deal, and anticipated key Phase III clinical milestones in 2022 - Cash balance stood at $18.9 million as of December 31, 2021[2] - Signed a significant out-licensing deal with Ewopharma worth up to $42.7 million[2] - Topline data for the Phase III psoriasis study is expected in Q2 2022[2] - A pivotal Phase III study for Namodenoson in advanced liver cancer is expected to begin enrollment in H1 2022, following a complete response observed in a Phase II patient[2] - The Phase IIb study for NASH is currently enrolling patients[2] Corporate and Clinical Development Highlights This section details Can-Fite's strengthened financial position, advancements across its clinical pipeline, and expansion of its intellectual property portfolio Financial Position and Partnerships Can-Fite significantly strengthened its balance sheet in 2021 through strategic funding and a major out-licensing deal, securing substantial future milestone payments - As of December 31, 2021, Can-Fite had $18.9 million in cash, cash equivalents, and short-term deposits[3] - Funding in 2021 included a $2.25 million non-dilutive payment from Ewopharma, $2.74 million from warrant exercises, and $10 million from a registered direct offering[3] - The out-licensing agreement with Ewopharma is valued at up to $42.7 million, comprising a $2.25 million upfront payment and up to $40.45 million in milestones, plus 17.5% royalties on net sales[4] - Total potential future milestone payments from all existing out-licensing deals amount to $130 million[4] Clinical Pipeline Update Can-Fite reported significant progress across its clinical pipeline, with key advancements in liver cancer, NASH, and psoriasis programs Namodenoson (Liver Cancer & NASH) Namodenoson showed a complete response in a liver cancer patient, supporting an upcoming pivotal Phase III HCC study, while a Phase IIb NASH study has commenced enrollment - A patient from a prior Phase II liver cancer study treated with Namodenoson has survived five years and experienced complete clearance of all cancer lesions[5] - A pivotal Phase III study for advanced liver cancer (HCC) is expected to commence enrollment of approximately 450 patients in H1 2022[5] - A Phase IIb study for NASH has commenced enrollment, targeting 140 subjects with biopsy-confirmed NASH[7] Piclidenoson (Psoriasis) The Phase III Comfort™ study for psoriasis has completed enrollment, with topline results expected in Q2 2022, aiming for superiority to placebo and non-inferiority to Otezla® - The Phase III Comfort™ study for psoriasis has completed enrollment of over 400 patients[6] - Topline results are expected in Q2 2022[6] - The study aims to establish superiority to placebo at 16 weeks and non-inferiority to Apremilast (Otezla®) at 32 weeks[6] Intellectual Property and Preclinical Research Can-Fite expanded its intellectual property for Namodenoson in liver diseases and reported positive preclinical findings on A3AR-based cannabis compounds for liver cancer - A broad U.S. patent was allowed for Namodenoson, covering the treatment of all advanced liver fibrosis indications, including NASH and NAFLD[8] - Patents specific to NASH and NAFLD were granted in 37 countries, with recent issuances in Japan, Hong Kong, and Mexico[8] - Preclinical studies showed that a CBD-rich T3/C15 cannabis fraction inhibits liver cancer cell growth, leveraging the company's A3AR platform technology[9] 2021 Financial Results This section provides an analysis of Can-Fite's financial performance and cash position for the year ended December 31, 2021 Income Statement Analysis Can-Fite reported increased revenues and a reduced net loss in 2021, primarily driven by decreased research and development expenses Income Statement Summary | Metric | 2021 (USD millions) | 2020 (USD millions) | Change | | :--- | :--- | :--- | :--- | | Revenues | $0.85 | $0.76 | +11.8% | | R&D Expenses | $9.85 | $11.95 | -17.6% | | G&A Expenses | $3.84 | $2.95 | +30.2% | | Net Loss | $12.6 | $14.4 | -12.5% | - The decrease in R&D expenses was mainly due to the completion of the Univo research project and a Phase III rheumatoid arthritis study that incurred costs in 2020[12] - The increase in G&A expenses was primarily due to higher salaries, employee bonuses, public relations, and insurance expenses[13] Balance Sheet and Cash Position Can-Fite significantly improved its cash position to $18.9 million by year-end 2021, driven by capital raises and an upfront payment from a distribution agreement Cash, Cash Equivalents, & Short-term Deposits | Date | Cash, Cash Equivalents, & Short-term Deposits (USD millions) | | :--- | :--- | | Dec 31, 2021 | $18.9 | | Dec 31, 2020 | $8.3 | - The increase in cash was driven by $2.74 million from warrant exercises, a $2.25 million advance payment from Ewopharma, and a $10 million registered direct offering[17] Consolidated Financial Statements This section presents Can-Fite's consolidated balance sheets and statements of comprehensive loss for the periods presented Consolidated Balance Sheets Can-Fite's total assets and shareholders' equity significantly increased by December 31, 2021, primarily due to a substantial rise in cash and capital raised Consolidated Balance Sheet Summary | Metric (in thousands USD) | Dec 31, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $4,390 | $8,268 | | Short-term deposits | $14,512 | $0 | | Total current assets | $20,068 | $9,400 | | Total Assets | $20,253 | $9,523 | | Liabilities & Equity | | | | Total current liabilities | $2,730 | $1,269 | | Total Liabilities | $5,871 | $3,449 | | Total Shareholders' Equity | $14,382 | $6,074 | Consolidated Statements of Comprehensive Loss For 2021, Can-Fite reported a reduced net loss of $12.62 million and a basic and diluted net loss per share of $0.03, indicating improved financial performance Consolidated Statements of Comprehensive Loss Summary | Metric (in thousands USD, except per share data) | 2021 | 2020 | | :--- | :--- | :--- | | Revenues | $853 | $763 | | Operating Loss | $(12,842) | $(14,139) | | Net Loss | $(12,615) | $(14,443) | | Total Comprehensive Loss | $(15,205) | $(15,158) | | Basic and Diluted Net Loss Per Share | $(0.03) | $(0.04) | Company Information and Disclosures This section provides an overview of Can-Fite BioPharma and includes important forward-looking statements and risk factor disclosures About Can-Fite BioPharma Ltd. Can-Fite BioPharma is a clinical-stage drug development company focused on cancer, liver, and inflammatory diseases, with lead candidates Piclidenoson and Namodenoson in advanced trials - Can-Fite is a clinical-stage company focused on cancer, liver, and inflammatory diseases[27] - Lead drug candidate Piclidenoson is in a Phase III trial for psoriasis[27] - Namodenoson is being evaluated for NASH (Phase IIb) and HCC (Phase III), and has received Orphan Drug and Fast Track Designations from the FDA for HCC[27] Forward-Looking Statements This section includes a standard disclaimer for forward-looking statements, highlighting inherent risks and uncertainties that could materially affect future results - The press release contains forward-looking statements that are not guarantees of future performance and are subject to risks and uncertainties[28] - Key risk factors include a history of losses, need for additional capital, clinical trial uncertainties, and regulatory approval processes[28]