Financial Performance - Revenues for the year ended December 31, 2022 were $0.81 million, a decrease of $0.04 million, or 4.7%, compared to $0.85 million in 2021[8] - Total revenues for the year ended December 2022 were $810 million, a decrease of 31% compared to $853 million in 2021[37] - Can-Fite's net loss for the year ended December 31, 2022 was $10.17 million, compared with a net loss of $12.61 million for the same period in 2021[26] - Net loss for the year was $10.173 million, compared to a net loss of $12.615 million in 2021, indicating a reduction of about 19%[37] - Basic and diluted net loss per share improved to $0.01 from $0.03 in the previous year[37] - The operating loss for the year was $10.096 million, an improvement from the $12.842 million loss reported in 2021[37] Expenses - Research and development expenses for the year ended December 31, 2022 were $7.76 million, a decrease of $2.09 million, or 21.2%, compared to $9.85 million in 2021[24] - Research and development expenses decreased to $7.763 million from $9.850 million in the previous year, reflecting a reduction of approximately 21%[37] - General and administrative expenses were $3.14 million for the year ended December 31, 2022, a decrease of $0.70 million, or 18.2%, compared to $3.84 million in 2021[25] Cash and Assets - As of December 31, 2022, Can-Fite had cash, cash equivalents, and short-term deposits of $7.97 million, down from $18.90 million at the end of 2021[11] - Total liabilities and shareholders' equity amounted to $9.283 billion, a decrease from $20.253 billion[36] Product Development and Regulatory Approvals - The pivotal Phase III psoriasis trial for Piclidenoson met its primary endpoint, showing a statistically significant improvement in patients compared to placebo[19] - Can-Fite is advancing Namodenoson in a Phase IIb study for NASH, with a focus on its efficacy in treating liver diseases[6] - The company has submitted a market registration plan for Piclidenoson to the EMA and plans to submit to the FDA[3] - Can-Fite's veterinary partner, Vetbiolix, is developing Piclidenoson for canine osteoarthritis, a market projected to reach $3 billion by 2028[4] - Namodenoson has been approved for compassionate use in Romania for patients with advanced liver cancer, following a complete response in a prior study[7] Risks and Future Outlook - The company continues to face risks related to cash flow uncertainties and the need for additional capital to fund operations[38] - Forward-looking statements indicate potential challenges in product development and regulatory approvals, which may impact future performance[38] - The company has not provided specific guidance for future revenues or operational milestones in the current report[38]

● 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)

Financial Data and Key Metrics Changes - Revenues for the nine months ended September 30, 2020, were $0.61 million compared to $1.84 million for the same period in 2019, indicating a decrease due to lower recognition of advance payments under distribution agreements [19] - Net loss for the nine months ended September 30, 2020, was $10.81 million, compared with a net loss of $7.84 million for the same period in 2019 [24] - Cash and cash equivalents as of September 30, 2020, were $10.22 million, up from $2.69 million at December 31, 2019 [24][25] Business Line Data and Key Metrics Changes - Research and development expenses for the nine months ended September 30, 2020, were $9.05 million, up from $7.01 million for the same period in 2019, primarily due to increased costs associated with the Phase III studies of Piclidenoson [20][21] - General and administrative expenses were $2.14 million for the nine months ended September 30, 2020, compared to $2.22 million for the same period in 2019, reflecting a decrease mainly due to lower professional services and travel expenses [22] Market Data and Key Metrics Changes - The company has out-licensed Piclidenoson for psoriasis in nine countries, which includes milestone payments and royalties upon regulatory approval, indicating a strategic market positioning [9] Company Strategy and Development Direction - The company is focusing on clinical programs with promising data, including psoriasis, NASH, and liver cancer [12] - Can-Fite is preparing for a Phase II study of Piclidenoson in the treatment of COVID-19, expecting to enroll the first patient before the end of the year [13][14] - The company aims to initiate a pivotal Phase III study in liver cancer and the next study in NAFLD/NASH in 2021 [37] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the positive results from the psoriasis Comfort trial and the potential for an earlier conclusion of the study [7][8] - The company is encouraged by the interest in Namodenoson for NASH treatment from both scientific and business communities, with a patent issued in Europe [17][16] Other Important Information - The company completed the development of a cell-based assay to identify clinically active cannabis-derived compounds, which will be marketed on a fee-for-service basis [18][33] Q&A Session Summary Question: When do you think the psoriasis study will be completed? - Management anticipates that enrollment will be completed in a couple of months, with the study potentially concluding in ten to twelve months [27] Question: What was the total cost of the RA study? - The costs for the RA study were between $5 million to $6 million [30] Question: Will there be a patent filing for Namodenoson in the U.S.? - Management confirmed plans to include the U.S. in future filings as progress is made [31] Question: Can you elaborate on the fee-for-service basis for the cannabis assay? - The company developed a unique assay to determine the clinical efficacy of cannabis or its derivatives, which will be offered on a fee-for-service basis [32][33] Question: How is the partnership development going? - Management indicated ongoing efforts to create partnerships and expressed positive feedback from recent presentations [34]

Company Overview - Can-Fite is a clinical-stage drug development company focusing on small molecule drug products in Phase II and Phase III clinical studies[3] - The company has secured corporate partnerships and licensing deals, receiving approximately $18 million to date[3, 7] - Can-Fite's platform technology mimics the body's natural mechanisms to combat cancer and inflammation, targeting the A3 adenosine receptor (A3AR)[4] Drug Development Pipeline - **Piclidenoson:** - Rheumatoid Arthritis: Phase III study with 50% enrollment completed; interim analysis expected in Q4 2020; targets a market estimated at $50.5 billion by 2025[6, 10, 33] - Psoriasis: Phase III study with 50% enrollment completed; interim analysis expected in Q4 2020; addresses a market projected at $11.5 billion by the end of 2020[6, 14, 33] - COVID-19: Filed IND with the FDA for a Phase II study[6, 16] - **Namodenoson:** - Liver Cancer: Phase III study under preparation; targets a market estimated at $3.8 billion in 2027[6, 20, 33] - NASH: Phase II study achieved primary and secondary endpoints; aims for a market valued at $35 billion to $40 billion by 2025[6, 22, 33] - **CF602:** - Erectile Dysfunction: Ongoing development; targets a market estimated at $3.2 billion by 2022[6] - **Cannabinoid-Based Pharmaceuticals:** - Targeting autoimmune, cancer, and metabolic indications through collaboration; addresses a market projected to grow to $56.7 billion by 2026[6, 30, 31] Namodenoson NASH Phase II Study Results - All NASH cases were resolved in patients treated with 25 mg Namodenoson, compared to new NASH that developed in 5% of the placebo group (p<0.009)[28] - Patients treated with 25 mg of Namodenoson had a statistically significant reduction in hepatic fibrosis as measured by the Fibrosis-4 (FIB-4) score, as compared to placebo[25] - In the Namodenoson 25 mg treated group, the proportion of patients with high steatosis scores declined from 37.5% to 13.3% of the population, as compared to the placebo treated group in which the proportion of patients with high steatosis scores decreased from 37.5% to 35.3% of the population, with p=0.08[26]