Exhibit 99.1 Can-Fite Reports Third Quarter 2023 Financial Results and Clinical Update Advanced liver cancer patient in prior Phase II study remains cancer-free 6.9 years after starting treatment with Namodenoson PETACH TIKVA, Israel, November 30, 2023 -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced financial results for the nine months ended Sep ...

PETACH TIKVA, Israel, June 1, 2023 -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncology, inflammatory and liver diseases, today announced financial results for the three months ended March 31, 2023. Pivotal Phase 3 Liver Cancer Study—Can-Fite's ongoing pivotal Phase 3 liver cancer study is designed to assess Namodenoson in the treatment of patients with advanced hepatocellular carcinoma (HCC) and ...

Exhibit 99.1 PETACH TIKVA, Israel, March 30, 2023 -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced financial results for the year ended December 31, 2022. PICLIDENOSON Pivotal Phase III Psoriasis Registration Plan for Piclidenoson Submitted to EMA – Can-Fite submitted a market registration plan to the European Medicines Agency (EMA) for Picliden ...

● any patents that are issued may not provide meaningful protection; ● we may not be able to develop additional proprietary technologies that are patentable; ● other companies may challenge patents licensed or issued to us; ● other companies may independently develop similar or alternative technologies, or duplicate our technologies; Washington, D.C. 20549 ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Or Commission File No. 001-36203 (Name, Telephone, E-mail and/or F ...

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]

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].

[Overview and 2021 Highlights](index=1&type=section&id=Can-Fite%20Reports%202021%20Financial%20Results%20%26%20Provides%20Clinical%20Update) 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](index=1&type=section&id=2021%20Highlights) 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](index=2&type=chunk) - Signed a significant out-licensing deal with Ewopharma worth up to **$42.7 million**[2](index=2&type=chunk) - Topline data for the Phase III psoriasis study is expected in **Q2 2022**[2](index=2&type=chunk) - 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](index=2&type=chunk) - The Phase IIb study for NASH is currently enrolling patients[2](index=2&type=chunk) [Corporate and Clinical Development Highlights](index=1&type=section&id=Corporate%20and%20Clinical%20Development%20Highlights%20Include:) 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](index=1&type=section&id=Fortified%20Balance%20Sheet) 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](index=3&type=chunk) - 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](index=3&type=chunk) - 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](index=4&type=chunk) - Total potential future milestone payments from all existing out-licensing deals amount to **$130 million**[4](index=4&type=chunk) [Clinical Pipeline Update](index=1&type=section&id=Clinical%20Pipeline%20Update) Can-Fite reported significant progress across its clinical pipeline, with key advancements in liver cancer, NASH, and psoriasis programs [Namodenoson (Liver Cancer & NASH)](index=1&type=section&id=Namodenoson%20(Liver%20Cancer%20%26%20NASH)) 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](index=5&type=chunk) - A pivotal Phase III study for advanced liver cancer (HCC) is expected to commence enrollment of approximately **450 patients** in **H1 2022**[5](index=5&type=chunk) - A Phase IIb study for NASH has commenced enrollment, targeting **140 subjects** with biopsy-confirmed NASH[7](index=7&type=chunk) [Piclidenoson (Psoriasis)](index=1&type=section&id=Piclidenoson%20(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](index=6&type=chunk) - Topline results are expected in **Q2 2022**[6](index=6&type=chunk) - The study aims to establish superiority to placebo at **16 weeks** and non-inferiority to Apremilast (Otezla®) at **32 weeks**[6](index=6&type=chunk) [Intellectual Property and Preclinical Research](index=2&type=section&id=Several%20Patents%20Granted%20for%20Liver%20Diseases) 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](index=8&type=chunk) - Patents specific to NASH and NAFLD were granted in **37 countries**, with recent issuances in Japan, Hong Kong, and Mexico[8](index=8&type=chunk) - Preclinical studies showed that a CBD-rich T3/C15 cannabis fraction inhibits liver cancer cell growth, leveraging the company's A3AR platform technology[9](index=9&type=chunk) [2021 Financial Results](index=2&type=section&id=Financial%20Results) This section provides an analysis of Can-Fite's financial performance and cash position for the year ended December 31, 2021 [Income Statement Analysis](index=2&type=section&id=Income%20Statement%20Analysis) 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](index=12&type=chunk) - The increase in G&A expenses was primarily due to higher salaries, employee bonuses, public relations, and insurance expenses[13](index=13&type=chunk) [Balance Sheet and Cash Position](index=3&type=section&id=Balance%20Sheet%20and%20Cash%20Position) 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](index=17&type=chunk) [Consolidated Financial Statements](index=4&type=section&id=CONSOLIDATED%20FINANCIAL%20STATEMENTS) This section presents Can-Fite's consolidated balance sheets and statements of comprehensive loss for the periods presented [Consolidated Balance Sheets](index=4&type=section&id=CONSOLIDATED%20BALANCE%20SHEETS) 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](index=6&type=section&id=CONSOLIDATED%20STATEMENTS%20OF%20COMPREHENSIVE%20LOSS) 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](index=7&type=section&id=Company%20Information%20and%20Disclosures) This section provides an overview of Can-Fite BioPharma and includes important forward-looking statements and risk factor disclosures [About Can-Fite BioPharma Ltd.](index=7&type=section&id=About%20Can-Fite%20BioPharma%20Ltd.) 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](index=27&type=chunk) - Lead drug candidate Piclidenoson is in a Phase III trial for psoriasis[27](index=27&type=chunk) - 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](index=27&type=chunk) [Forward-Looking Statements](index=7&type=section&id=Forward-Looking%20Statements) 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](index=28&type=chunk) - Key risk factors include a history of losses, need for additional capital, clinical trial uncertainties, and regulatory approval processes[28](index=28&type=chunk)

SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 Or ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of event requiring this shell company report________________________ For the transition period from__________ to _ ...

[Can-Fite Q3 2021 Report](index=1&type=section&id=Can-Fite%20Q3%202021%20Report) [Corporate and Clinical Development Highlights](index=1&type=section&id=Corporate%20and%20Clinical%20Development%20Highlights) 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](index=3&type=chunk) - Strategically ended the Phase II COVID-19 trial for Piclidenoson to focus resources on other advanced clinical programs[4](index=4&type=chunk) - Expanded its intellectual property portfolio for NASH, with patents granted in Japan, Hong Kong, and Mexico, bringing the total to **37 countries**[5](index=5&type=chunk) - Presented and published positive data on its drug candidates for liver diseases at AASLD and in a peer-reviewed journal[6](index=6&type=chunk)[7](index=7&type=chunk) [Financial Results](index=2&type=section&id=Financial%20Results) 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](index=11&type=chunk) - The increase in G&A expenses was primarily attributed to higher salaries, benefits, public relations, and insurance costs[12](index=12&type=chunk) 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](index=15&type=chunk) [Financial Statements](index=3&type=section&id=Financial%20Statements) 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](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) 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](index=6&type=section&id=About%20Can-Fite%20BioPharma%20Ltd.) 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](index=26&type=chunk) - 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](index=26&type=chunk)

[PART I](index=8&type=section&id=PART%20I) [Key Information](index=8&type=section&id=ITEM%203.%20Key%20Information) Selected financial data highlights a history of net losses, alongside a comprehensive list of business and financial risks [Selected Financial Data](index=8&type=section&id=A.%20Selected%20Financial%20Data) The company reports a history of operating losses, with fluctuating revenues and a net loss of $14.4 million in 2020 Selected Consolidated Financial Data (2018-2020) | Financial Metric | 2020 (USD in thousands) | 2019 (USD in thousands) | 2018 (USD in thousands) | | :--- | :--- | :--- | :--- | | **Revenues** | 763 | 2,032 | 3,820 | | **Operating Loss** | (14,139) | (12,007) | (5,414) | | **Net Loss** | (14,443) | (12,625) | (6,571) | | **Net Loss per Share** | (0.04) | (0.14) | (0.17) | | **Total Assets** | 9,523 | 8,174 | 7,952 | | **Total Shareholders' Equity** | 6,074 | 2,442 | 3,015 | - Effective January 1, 2018, the company changed its functional and reporting currency to the **U.S. dollar**[32](index=32&type=chunk) [Risk Factors](index=9&type=section&id=D.%20Risk%20Factors) The company faces significant risks from its history of losses, uncommercialized products, and geopolitical instability - The company has incurred operating losses since its inception, with an **accumulated deficit of approximately $125.5 million** as of December 31, 2020[44](index=44&type=chunk) - The pipeline's reliance on the **A3AR platform technology** and key molecules like Piclidenoson and Namodenoson presents significant development risk[39](index=39&type=chunk)[64](index=64&type=chunk) - Operations in Israel expose the company to **regional political, economic, and military instability**, which could adversely affect business[42](index=42&type=chunk)[146](index=146&type=chunk) - As a foreign private issuer, the company follows home country governance practices, potentially offering **less investor protection** than NYSE American rules[42](index=42&type=chunk)[179](index=179&type=chunk) [Information on the Company](index=43&type=section&id=ITEM%204.%20Information%20on%20the%20Company) This section details the company's history, A3AR platform technology, drug pipeline, business strategy, and regulatory environment [History and Development of the Company](index=43&type=section&id=A.%20History%20and%20Development%20of%20the%20Company) Founded in 1994, the company is an Israeli biopharmaceutical firm listed on the TASE and NYSE American - The company was founded on September 11, 1994, by Dr. Pnina Fishman and Dr. Ilan Cohn[185](index=185&type=chunk) - The company's ADSs began trading on the NYSE American under the symbol **"CANF"** on November 19, 2013[185](index=185&type=chunk) - Capital expenditures were minimal, totaling **$26,000 in 2020**, primarily for computer equipment[186](index=186&type=chunk) [Business Overview](index=43&type=section&id=B.%20Business%20Overview) The company develops small molecule drugs targeting the A3 adenosine receptor for inflammatory and cancer indications - The company's platform technology is based on targeting the **A3 adenosine receptor (A3AR)**, which is highly expressed in cancer and inflammatory cells[188](index=188&type=chunk)[189](index=189&type=chunk) Product Pipeline Status | Product Candidate | Indication | Status | | :--- | :--- | :--- | | **Piclidenoson (CF101)** | Psoriasis | Phase III | | | COVID-19 | Phase II | | **Namodenoson (CF102)** | Liver Cancer (HCC) | Preparing for Phase III | | | NASH | Preparing for Phase IIb | | **CF602** | Erectile Dysfunction | Preclinical | | **Cannabinoids** | Various | Preclinical | - The company's strategy is to build an integrated biotechnology company by developing its portfolio and commercializing products through **out-licensing arrangements**[198](index=198&type=chunk)[202](index=202&type=chunk) - As of March 15, 2020, the company owned or exclusively licensed **15 patent families** containing approximately 163 issued patents and pending applications worldwide[321](index=321&type=chunk) [Organizational Structure](index=85&type=section&id=C.%20Organizational%20Structure) The corporate structure consists of the parent company and three wholly-owned, inactive subsidiaries - The company has three wholly-owned subsidiaries: Eye-Fite Limited (Israel), which is being wound up, and Can-Fite Biopharma Europe (France), all of which are currently inactive[417](index=417&type=chunk) [Property, Plants and Equipment](index=85&type=section&id=D.%20Property%2C%20Plants%20and%20Equipment) The company leases approximately 300 square meters of office and lab space in Petah-Tikva, Israel - The company leases its headquarters in Petah-Tikva, Israel, which houses administrative, clinical, and research operations, including a 150-square-meter laboratory[418](index=418&type=chunk) [Operating and Financial Review and Prospects](index=86&type=section&id=ITEM%205.%20Operating%20and%20Financial%20Review%20and%20Prospects) Financial analysis shows decreased revenue, increased R&D expenses, continued net losses, and reliance on equity financing [Results of Operations](index=95&type=section&id=A.%20Results%20of%20Operations) Revenues decreased 63% in 2020 due to lower recognized payments, while R&D expenses rose 8.9% from clinical trial costs Comparison of Results of Operations (2019 vs. 2020) | Item | 2020 (USD in millions) | 2019 (USD in millions) | Change (%) | | :--- | :--- | :--- | :--- | | **Revenues** | $0.76 | $2.03 | -63% | | **R&D Expenses** | $11.95 | $10.97 | +8.9% | | **G&A Expenses** | $2.95 | $3.06 | -3.6% | | **Financial Expense, net** | $0.3 | $0.6 | -50% | Comparison of Results of Operations (2018 vs. 2019) | Item | 2019 (USD in millions) | 2018 (USD in millions) | Change (%) | | :--- | :--- | :--- | :--- | | **Revenues** | $2.0 | $3.8 | -47.3% | | **R&D Expenses** | $10.9 | $6.0 | +81.6% | | **G&A Expenses** | $3.0 | $3.1 | -3.1% | [Liquidity and Capital Resources](index=97&type=section&id=B.%20Liquidity%20and%20Capital%20Resources) Operations are funded by equity offerings and licensing, with existing resources deemed sufficient for the next twelve months - As of December 31, 2020, the company had approximately **$8.3 million in cash and cash equivalents**[491](index=491&type=chunk) - In 2020, the company raised a combined **$18.9 million** from warrant exercises and registered direct offerings[491](index=491&type=chunk) Cash Flow Summary (2018-2020) | Cash Flow Activity | 2020 (USD in millions) | 2019 (USD in millions) | 2018 (USD in millions) | | :--- | :--- | :--- | :--- | | **Net Cash Used in Operating Activities** | ($12.0) | ($11.0) | ($4.1) | | **Net Cash Used in Investing Activities** | ($0.03) | ($0.003) | ($0.03) | | **Net Cash Provided by Financing Activities** | $17.7 | $10.1 | $4.4 | [Contractual Obligations](index=99&type=section&id=F.%20Contractual%20Obligations) Total contractual obligations were $192,716 as of year-end 2020, primarily for milestone and lease payments Contractual Obligations as of December 31, 2020 (USD) | Obligation Type | Total | Less than 1 year | 1-3 years | | :--- | :--- | :--- | :--- | | **Leiden University milestones** | 122,678 | 12,268 | 110,410 | | **Car lease obligations** | 70,038 | 44,932 | 25,106 | | **Total** | **192,716** | **57,200** | **135,516** | [Directors, Senior Management and Employees](index=99&type=section&id=ITEM%206.%20Directors%2C%20Senior%20Management%20and%20Employees) This section details the company's leadership, compensation, board structure, and employee base of eight people [Directors and Senior Management](index=99&type=section&id=A.%20Directors%20and%20Senior%20Management) The leadership team includes co-founders Dr. Ilan Cohn (Chairman) and Dr. Pnina Fishman (CEO) - The key management includes Dr. Ilan Cohn (Chairman), Dr. Pnina Fishman (CEO), Motti Farbstein (COO & CFO), and Dr. Sari Fishman (VP Business Development)[501](index=501&type=chunk) [Compensation](index=101&type=section&id=B.%20Compensation) Aggregate compensation for eight office holders was $1.633 million in 2020, with formal agreements for senior management Aggregate Compensation for Office Holders (2020) | Group | Number of Persons | Total Compensation (USD) | | :--- | :--- | :--- | | All office holders | 8 | 1,633,000 | Compensation of Top 5 Office Holders (2020) | Name | Position | Total Compensation (USD) | | :--- | :--- | :--- | | Pnina Fishman | CEO | 685,000 | | Motti Farbstein | CFO | 468,000 | | Sari Fishman | VP Business Development | 329,000 | | Yaacov Goldman | External Director | 41,000 | | Guy Regev | External Director | 41,000 | [Board Practices](index=105&type=section&id=C.%20Board%20Practices) The six-member board is staggered into three classes and governed by Israeli law, including audit and compensation committees - In February 2020, shareholders approved a **staggered Board of Directors**, divided into three classes with three-year terms[536](index=536&type=chunk) - Under Israeli Companies Law, the company is required to have at least **two external directors**[548](index=548&type=chunk)[560](index=560&type=chunk) - The company has an **Audit Committee and a Compensation Committee** as required by Israeli law[561](index=561&type=chunk)[571](index=571&type=chunk) [Employees](index=117&type=section&id=D.%20Employees) As of December 31, 2020, the company had eight employees in Israel, none covered by a collective bargaining agreement - As of December 31, 2020, the company had **eight employees** in Israel across management, R&D, and business development[603](index=603&type=chunk) [Share Ownership](index=117&type=section&id=E.%20Share%20Ownership) Intracoastal Capital LLC was the only shareholder with over 5% ownership, while management held less than 1% - As of March 15, 2021, **Intracoastal Capital LLC** was the only beneficial owner of more than 5% of the company's voting securities, holding approximately **6.4%**[606](index=606&type=chunk)[609](index=609&type=chunk) - Senior management and directors as a group beneficially owned **less than 1%** of the company's outstanding ordinary shares as of March 15, 2021[606](index=606&type=chunk) - The company maintains two share option plans, with options to purchase **11,923,400 ordinary shares** outstanding as of December 31, 2020[611](index=611&type=chunk)[613](index=613&type=chunk) [Major Shareholders and Related Party Transactions](index=120&type=section&id=ITEM%207.%20Major%20Shareholders%20and%20Related%20Party%20Transactions) This section details significant ownership and transactions, including management agreements and a settlement with an activist shareholder [Related Party Transactions](index=120&type=section&id=B.%20Related%20Party%20Transactions) Key transactions include a 2017 merger involving a former subsidiary, management employment agreements, and a 2019 settlement - In November 2017, the company's former subsidiary, OphthaliX, completed a merger, and Can-Fite reacquired assets by canceling approximately **$5 million of debt**[626](index=626&type=chunk)[627](index=627&type=chunk) - The company has employment and consulting agreements with its senior management, including CEO Dr. Pnina Fishman and CFO Motti Farbstein[629](index=629&type=chunk) - In October 2019, the company entered into a settlement agreement with **Capital Point Ltd.** to resolve litigation and establish a five-year standstill[634](index=634&type=chunk) [Financial Information](index=122&type=section&id=ITEM%208.%20Financial%20Information) The company is not involved in significant legal proceedings and reinvests all earnings rather than paying dividends [Consolidated Financial Statements and Other Financial Information](index=122&type=section&id=A.%20Consolidated%20Financial%20Statements%20and%20Other%20Financial%20Information) The company is not involved in any material legal proceedings and does not plan to pay cash dividends - The company is not involved in any legal or arbitration proceedings that are expected to have a **significant effect on its financial position**[637](index=637&type=chunk) - The company has **never paid cash dividends** and does not intend to in the foreseeable future, planning to reinvest earnings[638](index=638&type=chunk) [Additional Information](index=123&type=section&id=ITEM%2010.%20Additional%20Information) This section covers corporate governance, articles of association, Israeli acquisition laws, and tax considerations for shareholders [Memorandum and Articles of Association](index=123&type=section&id=B.%20Memorandum%20and%20Articles%20of%20Association) The articles permit any lawful purpose and include provisions for a staggered board, meeting quorums, and dividend authority - The **Board of Directors is staggered** into three classes, which can make it more difficult for shareholders to replace incumbent directors[655](index=655&type=chunk)[658](index=658&type=chunk) - The quorum for shareholder meetings is at least two shareholders holding at least **25% of the total outstanding voting rights**[668](index=668&type=chunk) - Israeli law requires **special tender offers** for acquisitions that would result in a holding of 25% or 45% of the voting rights[677](index=677&type=chunk) [Taxation](index=129&type=section&id=E.%20Taxation) This summarizes Israeli and U.S. tax rules for shareholders, including capital gains, dividends, and PFIC status - Non-Israeli resident shareholders are **generally exempt from Israeli capital gains tax** on the sale of shares under certain conditions[707](index=707&type=chunk) - Dividends paid to non-residents of Israel are generally subject to a **25% withholding tax**, which may be reduced by a tax treaty[710](index=710&type=chunk)[711](index=711&type=chunk) - The company does not believe it was a **Passive Foreign Investment Company (PFIC)** for U.S. federal income tax purposes in 2020[718](index=718&type=chunk)[730](index=730&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=140&type=section&id=ITEM%2011.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is primarily exposed to interest rate risk and foreign currency risk from expenses in NIS and euros - The company's primary market risks are **interest rate risk** on its cash and investments, and **foreign currency exchange risk**[766](index=766&type=chunk) - Foreign currency risk stems from expenses denominated in **NIS and euros**, while the company's functional currency is the U.S. dollar[768](index=768&type=chunk) [PART II](index=142&type=section&id=PART%20II) [Controls and Procedures](index=142&type=section&id=ITEM%2015.%20Controls%20and%20Procedures) Management concluded that both disclosure controls and internal control over financial reporting were effective as of year-end 2020 - Management, including the CEO and CFO, concluded that the company's **disclosure controls and procedures were effective** as of December 31, 2020[780](index=780&type=chunk) - Based on an assessment using the COSO framework, management concluded that the company's **internal control over financial reporting was effective** as of December 31, 2020[783](index=783&type=chunk)[784](index=784&type=chunk) [Corporate Governance](index=144&type=section&id=ITEM%2016G.%20Corporate%20Governance) As a foreign private issuer, the company follows certain Israeli home country practices instead of NYSE American rules - The company follows Israeli home country practice for shareholder meeting quorum requirements, setting it at **25% of outstanding voting stock**[798](index=798&type=chunk) - The company adheres to Israeli law instead of NYSE American rules regarding shareholder approval for certain **equity compensation plans**[798](index=798&type=chunk) [PART III](index=145&type=section&id=PART%20III) [Financial Statements](index=145&type=section&id=ITEM%2018.%20Financial%20Statements) Audited financial statements show a net loss of $14.4 million for 2020 and highlight the need to raise additional funds Consolidated Balance Sheet Highlights (As of Dec 31, 2020) | Account | Amount (USD in thousands) | | :--- | :--- | | **Total Assets** | 9,523 | | *Cash and cash equivalents* | 8,268 | | **Total Liabilities** | 3,449 | | **Total Shareholders' Equity** | 6,074 | Consolidated Statement of Comprehensive Loss (Year Ended Dec 31) | Account | 2020 (USD in thousands) | 2019 (USD in thousands) | 2018 (USD in thousands) | | :--- | :--- | :--- | :--- | | **Revenues** | 763 | 2,032 | 3,820 | | **Operating Loss** | (14,139) | (12,007) | (5,414) | | **Net Loss** | (14,443) | (12,625) | (6,571) | | **Net Loss Per Share** | (0.04) | (0.14) | (0.17) | - The independent auditor's report identifies the company's liquidity and **need to raise additional capital** as a critical audit matter[819](index=819&type=chunk)[820](index=820&type=chunk)[821](index=821&type=chunk) - Subsequent to year-end, the company received **$2.74 million from warrant exercises** and a **$2.25 million upfront payment** from a new distribution agreement[915](index=915&type=chunk)[916](index=916&type=chunk)[917](index=917&type=chunk)