Ramat Gan, Israel, Sept. 15, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, today announced a significant new clinical finding under its compassionate use program in decompensated liver cirrhosis. The patient, previously reported by Can-Fite to have experienced the disappearance of end-stage liver disease complications while receiving Namode ...

[Condensed Consolidated Balance Sheets](index=2&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The company's financial position shows a decrease in total assets and shareholders' equity, primarily driven by reduced short-term deposits and accumulated deficit [Assets](index=2&type=section&id=Assets) The company's total assets decreased from $9,120 thousand as of December 31, 2024, to $7,720 thousand as of June 30, 2025, primarily driven by a reduction in short-term deposits and cash and cash equivalents | ASSETS (U.S. dollars in thousands) | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :------------ | :---------------- | | Cash and cash equivalents | $6,454 | $4,825 | | Short-term investment | $2 | $5 | | Short term deposits | $- | $3,057 | | Prepaid expenses and other current assets | $1,168 | $1,095 | | **Total current assets** | **$7,624** | **$8,982** | | Operating lease right of use assets | $91 | $111 | | Property, plant and equipment, net | $5 | $27 | | **Total non-current assets** | **$96** | **$138** | | **Total assets** | **$7,720** | **$9,120** | - Total assets decreased by **$1,400 thousand (15.3%)** from December 31, 2024, to June 30, 2025[4](index=4&type=chunk) - Short-term deposits decreased significantly from **$3,057 thousand to $0**, while cash and cash equivalents increased by **$1,629 thousand**[4](index=4&type=chunk) [Liabilities and Shareholders' Equity](index=3&type=section&id=Liabilities%20and%20Shareholders'%20Equity) Total liabilities decreased slightly, while shareholders' equity saw a notable reduction, primarily due to the accumulated deficit from net losses, despite increases in additional paid-in capital from share issuances | LIABILITIES AND SHAREHOLDERS' EQUITY (U.S. dollars in thousands) | June 30, 2025 | December 31, 2024 | | :------------------------------------------------- | :------------ | :---------------- | | Trade payables | $1,152 | $618 | | Current maturity of operating lease liability | $57 | $53 | | Deferred revenues (current) | $405 | $405 | | Other accounts payable | $506 | $976 | | **Total current liabilities** | **$2,120** | **$2,052** | | Long - term operating lease liability | $33 | $51 | | Deferred revenues (non-current) | $1,383 | $1,581 | | **Total long-term liabilities** | **$1,416** | **$1,632** | | **Total liabilities** | **$3,536** | **$3,684** | | Additional paid-in capital | $174,294 | $170,670 | | Accumulated other comprehensive income | $1,127 | $1,127 | | Accumulated deficit | $(171,237) | $(166,361) | | **Total shareholders' equity** | **$4,184** | **$5,436** | | **Total liabilities and shareholders' equity** | **$7,720** | **$9,120** | - Total shareholders' equity decreased by **$1,252 thousand (23.0%)** from December 31, 2024, to June 30, 2025[7](index=7&type=chunk) - Additional paid-in capital increased by **$3,624 thousand**, while the accumulated deficit worsened by **$4,876 thousand**[7](index=7&type=chunk) [Condensed Consolidated Statements of Net Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Net%20Loss) The company reported an increased net loss for the six months ended June 30, 2025, driven by higher operating expenses despite reduced revenues [Operating Results](index=4&type=section&id=Operating%20Results) The company experienced an increased net loss for the six months ended June 30, 2025, compared to the same period in 2024, driven by higher research and development and general and administrative expenses, despite a decrease in revenues | (U.S. dollars in thousands) | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------------------- | :----------------------------- | :----------------------------- | | Revenues | $202 | $316 | | Research and development expenses | $(3,034) | $(2,885) | | General and administrative expenses | $(2,066) | $(1,525) | | Operating loss | $(4,898) | $(4,094) | | Financial income, net | $22 | $137 | | Net loss | $(4,876) | $(3,957) | | Basic and diluted net loss per share | $(0.00) | $(0.00) | | Weighted average number of ordinary shares | 3,411,909,670 | 1,821,304,184 | - Net loss increased by **$919 thousand (23.2%)** from **$3,957 thousand** in H1 2024 to **$4,876 thousand** in H1 2025[9](index=9&type=chunk) - Revenues decreased by **$114 thousand (36.1%)** year-over-year[9](index=9&type=chunk) - Research and development expenses increased by **$149 thousand (5.2%)**, and general and administrative expenses increased by **$541 thousand (35.5%)**[9](index=9&type=chunk) [Condensed Consolidated Statements of Changes in Shareholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Shareholders'%20Equity) Total shareholders' equity decreased due to net loss, partially offset by capital raised from various share issuances during the period [Equity Changes](index=5&type=section&id=Equity%20Changes) Total shareholders' equity decreased from $5,436 thousand at January 1, 2025, to $4,184 thousand at June 30, 2025, primarily due to the net loss, partially offset by proceeds from share issuances | (U.S. dollars in thousands) | Ordinary shares (Number) | Additional paid-in capital | Accumulated other comprehensive income | Accumulated deficit | Total shareholders' equity | | :-------------------------- | :----------------------- | :------------------------- | :------------------------------------- | :------------------ | :------------------------- | | Balance as of January 1, 2025 | 2,983,181,793 | $170,670 | $1,127 | $(166,361) | $5,436 | | Net loss | - | - | - | $(4,876) | $(4,876) | | Issuance of ordinary shares and warrants, net | 750,000,000 | $2,548 | | | $2,548 | | Issuance of ordinary shares due to ATM, net | 204,225,600 | $825 | - | - | $825 | | Share-based payments | 30,000,000 | $251 | - | - | $251 | | Balance as of June 30, 2025 | 3,967,407,393 | $174,294 | $1,127 | $(171,237) | $4,184 | - Total ordinary shares outstanding increased significantly from **2,983,181,793** at January 1, 2025, to **3,967,407,393** at June 30, 2025, due to various issuances[12](index=12&type=chunk) - Additional paid-in capital increased by **$3,624 thousand** during the six months ended June 30, 2025, from share issuances and share-based payments[12](index=12&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash and cash equivalents increased significantly, driven by financing activities, which compensated for continued cash usage in operations [Cash Flow Activities](index=6&type=section&id=Cash%20Flow%20Activities) The company's cash and cash equivalents increased significantly in the first half of 2025, primarily due to substantial cash inflows from financing activities, which offset the continued net cash used in operating activities | (U.S. dollars in thousands) | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(4,752) | $(4,036) | | Net cash provided by investing activities | $2,999 | $4,496 | | Net cash provided by financing activities | $3,373 | $- | | Exchange differences on balances of cash and cash equivalents | $9 | $(19) | | Increase in cash and cash equivalents | $1,629 | $441 | | Cash and cash equivalents at the beginning of the period | $4,825 | $4,278 | | Cash and cash equivalents at the end of the period | $6,454 | $4,719 | - Net cash used in operating activities increased by **$716 thousand (17.7%)** year-over-year[15](index=15&type=chunk) - Net cash provided by financing activities was **$3,373 thousand** in H1 2025, compared to **$0** in H1 2024, primarily from issuance of ordinary shares and warrants[17](index=17&type=chunk) - Cash and cash equivalents at period end increased to **$6,454 thousand** in H1 2025 from **$4,719 thousand** in H1 2024[17](index=17&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes provide detailed explanations of the company's accounting policies, financial statement line items, and significant events [NOTE 1: General Information and Going Concern](index=8&type=section&id=NOTE%201%3A%20General%20Information%20and%20Going%20Concern) Can-Fite Biopharma Ltd. is a clinical-stage biopharmaceutical company developing small molecule therapeutic products. The company's financial statements are prepared assuming a going concern, despite a history of net losses and negative operating cash flows, which raised substantial doubt. Management's plans to alleviate this doubt include reducing non-essential expenses, deferring R&D programs, and seeking additional financing - Can-Fite Biopharma Ltd. is a clinical-stage biopharmaceutical company focused on developing orally bioavailable small molecule therapeutic products for conditions like psoriasis, liver cancer, MASH, pancreatic cancer, and erectile dysfunction, utilizing the A3AR therapeutic target[19](index=19&type=chunk) - Substantial doubt about the company's ability to continue as a going concern was raised due to net losses of **$4,876 thousand** (H1 2025) and **$3,957 thousand** (H1 2024), net operating cash outflows of **$4,752 thousand** (H1 2025) and **$4,036 thousand** (H1 2024), and reliance on additional financing[20](index=20&type=chunk)[21](index=21&type=chunk) - Management's plans to address going concern include reducing non-essential expenses, deferring/reprioritizing R&D programs, and raising additional funds through equity or debt financings, or strategic partnerships[22](index=22&type=chunk)[25](index=25&type=chunk) [NOTE 2: Significant Accounting Policies](index=10&type=section&id=NOTE%202%3A%20Significant%20Accounting%20Policies) This section details the company's revenue recognition policies, specifically regarding contract balances and remaining performance obligations, and outlines recently issued accounting pronouncements that have not yet been adopted - Contract liabilities, representing amounts received for which revenue has not yet been recognized, amounted to **$1,788 thousand** as of June 30, 2025, down from **$1,986 thousand** as of December 31, 2024[29](index=29&type=chunk) - The aggregate amount of transaction price allocated to remaining performance obligations was **$1,788 thousand** as of June 30, 2025, with **22%** expected to be recognized as revenue over the next 12 months and the remainder over the following 3.5 years[30](index=30&type=chunk) - The company is evaluating the impact of recently issued accounting pronouncements, ASU 2023-09 (Income Taxes) effective January 1, 2025, and ASU 2024-03 (Income Statement - Expense Disaggregation) effective after December 15, 2026[30](index=30&type=chunk)[31](index=31&type=chunk) [NOTE 3: Fair Value Measurements](index=11&type=section&id=NOTE%203%3A%20Fair%20Value%20Measurements) The company measures its short-term investment at fair value, classifying it as Level 1 due to the use of quoted prices in active markets for identical assets - The company's short-term investment, consisting of an equity investment in a publicly traded company, is classified within **Level 1** of the fair value hierarchy[33](index=33&type=chunk) Fair Value Measurements (U.S. dollars in thousands) | Description | Fair value (June 30, 2025) | Level 1 (June 30, 2025) | Fair value (December 31, 2024) | Level 1 (December 31, 2024) | | :------------------ | :------------------------- | :---------------------- | :----------------------------- | :-------------------------- | | Short-term investment | $2 | $2 | $5 | $5 | [NOTE 4: Earnings Per Share](index=11&type=section&id=NOTE%204%3A%20Earnings%20Per%20Share) Basic and diluted net loss per share remained at $(0.00) for both periods, despite a significant increase in the weighted average number of ordinary shares outstanding, as all outstanding share options and warrants were anti-dilutive | (U.S. dollars in thousands) | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------------------- | :----------------------------- | :----------------------------- | | Net loss applicable to shareholders | $(4,876) | $(3,957) | | Weighted average shares used in computing basic and diluted net loss per share | 3,411,909,670 | 1,821,304,184 | | Net loss per share, basic and diluted | $(0.00) | $(0.00) | - The weighted average number of ordinary shares used in computing basic and diluted net loss per share increased by **87.3%** from **1,821,304,184** in H1 2024 to **3,411,909,670** in H1 2025[36](index=36&type=chunk) - All outstanding share options and warrants (excluding prefunded warrants) were excluded from diluted EPS calculation as they were anti-dilutive for both periods[37](index=37&type=chunk) [NOTE 5: Contingent Liabilities and Commitments](index=12&type=section&id=NOTE%205%3A%20Contingent%20Liabilities%20and%20Commitments) The company has a patent license agreement with Leiden University for compounds including CF602, which involves various royalty payments based on milestones, net sales, and sublicensing, with no material accrual recorded as of June 30, 2025 - The company holds an exclusive license from Leiden University for patents of several compounds, including CF602, in certain territories[39](index=39&type=chunk) - Commitments include a one-time **€25 thousand** concession commission, annual royalties of **€10 thousand** until clinical trials commence, **2%-3%** of net sales, and milestone-based royalties up to **€850 thousand** (e.g., **€50k** for Phase I, **€100k** for Phase II, **€200k** for Phase III, **€500k** for marketing approval)[41](index=41&type=chunk) - A **10%** royalty rate applies if the agreement is sublicensed to another company[41](index=41&type=chunk) [NOTE 6: Shareholders' Equity Details](index=13&type=section&id=NOTE%206%3A%20Shareholders'%20Equity%20Details) This section details significant changes in shareholders' equity, including multiple share issuances through registered direct offerings and ATM programs, an increase in authorized share capital, and the adoption of new share option plans, alongside a summary of outstanding warrants - In April 2025, the company completed a registered direct offering of **750,000,000 ordinary shares** at **$0.004 per share**, generating approximately **$3,000 thousand** in gross proceeds, and issued warrants to the placement agent[43](index=43&type=chunk)[44](index=44&type=chunk)[47](index=47&type=chunk) - During January through June 2025, the company issued **204,225,600 ordinary shares** for net proceeds of **$825 thousand** through its ATM program[47](index=47&type=chunk) - The authorized share capital was increased by **10,000,000,000 ordinary shares** on June 30, 2025, bringing the total authorized to **20,000,000,000 ordinary shares**[47](index=47&type=chunk) Share-based expenses recognized (U.S. dollars in thousands) | (U.S. dollars in thousands) | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------------------- | :----------------------------- | :----------------------------- | | Research and development | $30 | $34 | | General and administrative | $221 | $159 | | **Total** | **$251** | **$193** | Outstanding Warrants to Purchase Ordinary Shares (as of June 30, 2025) | Issuance date | Number of outstanding Warrants | Exercise price per warrant | | :------------ | :----------------------------- | :------------------------- | | January 2020 | 23,838,038 | $0.12 | | December 2021 | 10,500,000 | $0.07 | | January 2023 | 28,636,500 | $0.02 | | November 2023 | 771,366,900 | $0.00 | | August 2024 | 1,774,285,800 | $0.01 | | April 2025 | 52,500,000 | $0.01 | | **Total** | **2,661,127,238** | | [NOTE 7: Segment Reporting](index=16&type=section&id=NOTE%207%3A%20Segment%20Reporting) The company operates as a single operating segment, with the CEO serving as the chief operating decision maker who reviews consolidated financial information to allocate resources and assess performance - The company's business is comprised of **one operating segment**[54](index=54&type=chunk) - The Chief Executive Officer (CEO) acts as the chief operating decision maker (CODM) and reviews financial information on a consolidated basis to measure segment profit or loss, allocate resources, and assess performance[54](index=54&type=chunk) [NOTE 8: Subsequent Events](index=17&type=section&id=NOTE%208%3A%20Subsequent%20Events) Subsequent to the balance sheet date, in July 2025, the company completed a public offering, raising significant gross proceeds and issuing ordinary shares, pre-funded warrants, and common warrants, along with incurring issuance costs - On July 28, 2025, the company completed a public offering, raising aggregate gross proceeds of **$5,000 thousand** (approximately **$4,200 thousand** net of issuance costs)[55](index=55&type=chunk) - The July 2025 Offering included the issuance of **375,000,000 ordinary shares**, **7,083,333 pre-funded warrants** (to purchase up to **2,124,999,900 ordinary shares**), and **16,666,666 common warrants** (to purchase up to **4,999,999,800 ordinary shares**)[55](index=55&type=chunk) - The pre-funded warrants are immediately exercisable at a nominal exercise price (**$0.001 per ADS**), and common warrants have an exercise price of **$0.002 per share** (**$0.60 per ADS**) and expire on the two-year anniversary of issuance[56](index=56&type=chunk) - The company incurred an aggregate issuance cost of **$760 thousand** for the July 2025 Offering and issued warrants to the placement agent[57](index=57&type=chunk)

Core Viewpoint - Can-Fite BioPharma Ltd. reported financial results and clinical updates for the first half of 2025, highlighting advancements in its drug candidates and financial performance. Clinical & Development Milestones - The Phase 2a study of Namodenoson for advanced pancreatic cancer has achieved over 50% enrollment, focusing on safety, clinical activity, and pharmacokinetics [2] - Namodenoson, an A3 adenosine receptor agonist, has shown a favorable safety profile and anti-tumor activity in preclinical models [3] - The drug has received Orphan Drug Designation from the FDA, providing potential market exclusivity for seven years post-approval [4] - Following FDA Compassionate Use Approval, interest from leading U.S. medical centers has increased for treating pancreatic cancer patients with Namodenoson [5] - Piclidenoson has shown promise in treating vascular dementia, with a study from UCLA demonstrating its ability to restore tissue integrity in a mouse model [6][7] - The global market for vascular dementia is estimated at $6 billion in 2025, with a projected CAGR of 5% through 2035 [7] - Piclidenoson has a strong safety profile and has demonstrated anti-inflammatory activity in previous clinical studies [8] Financial Results - Revenues for H1 2025 were $0.20 million, a decrease of $0.11 million or 36.07% compared to $0.31 million in H1 2024, primarily due to lower advance payments from distribution agreements [10] - Research and development expenses increased to $3.03 million, up $0.15 million or 5.16% from $2.88 million in H1 2024, driven by ongoing studies for Namodenoson and Piclidenoson [11] - General and administrative expenses rose to $2.07 million, an increase of $0.54 million or 35.47% compared to $1.52 million in H1 2024, mainly due to investor relationship expenses [12] - Net loss for H1 2025 was $4.87 million, compared to a net loss of $3.95 million in H1 2024, attributed to increased R&D and administrative expenses [14] - As of June 30, 2025, cash and cash equivalents totaled $6.45 million, down from $7.88 million at the end of 2024, with a public offering completed in July 2025 raising $5 million [15] Company Overview - Can-Fite BioPharma Ltd. is focused on developing drugs for cancer, liver, and inflammatory diseases, with lead candidates Piclidenoson and Namodenoson in advanced clinical trials [23]

Core Insights - Can-Fite BioPharma Ltd. has achieved over 50% enrollment in its Phase 2a trial of Namodenoson for pancreatic cancer, indicating strong interest from both investigators and patients [1][3] - The primary endpoint of the trial is safety, and Namodenoson has demonstrated a favorable safety profile to date [2][3] - Namodenoson is a selective A3 adenosine receptor agonist showing anti-tumor activity in preclinical models and is also being evaluated for advanced liver cancer [3][4] Company Overview - Can-Fite BioPharma is a clinical-stage biotechnology company focused on developing small molecule drugs for cancer and inflammatory diseases, targeting multi-billion dollar markets [5] - The company’s lead drug candidate, Piclidenoson, has recently reported topline results in a Phase 3 trial for psoriasis and is advancing in clinical trials for other indications [5] - Namodenoson has received Orphan Drug Designation from the FDA for pancreatic cancer and is also being evaluated in trials for hepatocellular carcinoma and other cancers [4][5]

Group 1 - Can-Fite BioPharma Ltd. announced a public offering of 8,333,333 American Depositary Shares (ADSs) at a price of $0.60 per ADS, with short-term warrants to purchase up to 16,666,666 additional ADSs [1][3] - The gross proceeds from the offering are expected to be approximately $5.0 million, with potential additional proceeds of up to $10.0 million from the exercise of short-term warrants [3] - The offering is expected to close on or about July 29, 2025, subject to customary closing conditions [1][3] Group 2 - H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering [2] - The proceeds from the offering will be used for funding research and development, clinical trials, and other working capital and general corporate purposes [3] Group 3 - Can-Fite is a clinical-stage biotechnology company focused on developing small molecule drugs for cancer and inflammatory diseases, with a lead drug candidate, Piclidenoson, currently in Phase 3 trials [6] - The company’s liver drug, Namodenoson, is being evaluated in multiple trials for hepatocellular carcinoma and has received Orphan Drug Designation and Fast Track Designation from the FDA [6] - Can-Fite's drug candidates have shown efficacy in various conditions and have been tested in over 1,600 patients in clinical studies [6]

Ramat Gan, Israel, July 28, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs for the treatment of cancer and inflammatory diseases, today announced that a leading group from University of Los Angeles (UCLA), demonstrate that Piclidenoson showed efficacy in an experimental model of vascular dementia. This press release may contain forward-looking statements, about Can-Fite's ex ...

Core Viewpoint - Can-Fite BioPharma Ltd. is advancing its clinical pipeline, particularly focusing on the Phase IIa study of Namodenoson for advanced pancreatic cancer, which addresses a significant unmet medical need in this area [1][4]. Company Overview - Can-Fite BioPharma Ltd. is a clinical-stage biotechnology company developing small molecule drugs for cancer and inflammatory diseases, with a focus on multi-billion dollar markets [5]. - The company's lead drug candidate, Piclidenoson, has recently reported topline results in a Phase 3 trial for psoriasis and is progressing to a pivotal Phase 3 trial [5]. - Namodenoson, another key drug, is being evaluated in multiple trials, including a Phase III trial for hepatocellular carcinoma (HCC) and a Phase 2a study for pancreatic cancer [5]. Clinical Trial Details - The Phase IIa clinical trial of Namodenoson is an open-label study involving patients with advanced pancreatic adenocarcinoma who have progressed after at least one prior therapy [2]. - The trial is assessing the safety, clinical activity, and pharmacokinetics of Namodenoson, administered at a dose of 25 mg twice daily in 28-day cycles, with approximately 20 evaluable patients expected to be enrolled [2]. - The trial is led by Prof. Salomon Stemmer, a prominent oncologist, and Namodenoson has received Orphan Drug Designation from the FDA for pancreatic cancer treatment [3]. Enrollment and Safety Profile - As of the latest update, 50% of the planned patient cohort has been enrolled, and Namodenoson has shown a favorable safety profile [4]. - The study aims to provide a novel therapeutic approach for patients with advanced pancreatic cancer who have exhausted standard treatment options [4].

Core Insights - Can-Fite BioPharma Ltd. has raised $175 million in funding to advance its lead drug candidates, Namodenoson and Piclidenoson, into pivotal Phase III studies for liver cancer and psoriasis respectively [1][6] Group 1: Company Overview - Can-Fite is a biotechnology company focused on developing small-molecule drugs targeting oncological and inflammatory diseases, specifically through the A3 adenosine receptor (A3AR) [2][6] - The company is currently conducting pivotal Phase III trials for Namodenoson in advanced liver cancer and Piclidenoson in moderate-to-severe psoriasis [2][6] Group 2: Drug Development and Trials - Namodenoson has shown selective targeting of liver and pancreatic tumor cells while sparing healthy tissue, and is currently enrolling patients for its Phase III study [2][3] - Piclidenoson is also in a pivotal Phase III trial for psoriasis, with both candidates demonstrating favorable safety profiles and promising efficacy in previous Phase II trials [3][4] Group 3: Funding and Commercialization - The cumulative funding has supported drug manufacturing, regulatory activities with the FDA and EMA, and the development of a broad patent portfolio [3] - Can-Fite has signed seven commercialization agreements with strategic partners for future marketing of its drug candidates upon regulatory approval [5] Group 4: Future Prospects - The company is also conducting a Phase IIa study of Namodenoson in pancreatic cancer and a Phase IIb trial in metabolic dysfunction-associated steatohepatitis (MASH) [4][6] - Namodenoson has received Orphan Drug Designation in the U.S. and Europe and Fast Track Designation for hepatocellular carcinoma by the FDA [6]

Core Insights - Can-Fite BioPharma Ltd. is advancing its oncology drug Namodenoson, which is being sought for compassionate use approval by leading U.S. medical centers for treating pancreatic carcinoma [1][2][4] - Namodenoson has received FDA approval for its first single-patient compassionate use treatment, indicating significant progress in its clinical development [2] - The company is conducting a Phase IIa study in Israel for advanced pancreatic adenocarcinoma patients, focusing on safety, clinical activity, and pharmacokinetics [3] Company Overview - Can-Fite BioPharma Ltd. is a clinical-stage biotechnology company targeting multi-billion-dollar markets in cancer, liver, and inflammatory diseases [5] - The company’s lead drug candidate, Piclidenoson, has shown promising results in a Phase III trial for psoriasis and is expected to enter another pivotal Phase III trial [5] - Namodenoson is also being evaluated in multiple trials, including a Phase III trial for hepatocellular carcinoma and a Phase IIb trial for Metabolic Dysfunction-associated Steatohepatitis [5] Drug Mechanism and Designation - Namodenoson is an orally bioavailable drug that selectively binds to the A3 adenosine receptor, which is highly expressed in diseased cells, contributing to its favorable safety profile [4] - The drug has received Orphan Drug Designation from the U.S. FDA, highlighting its potential as a therapeutic option for underserved patient populations [3][5]

Core Viewpoint - Can-Fite BioPharma Ltd. has announced a registered direct offering of 2,500,000 American Depositary Shares (ADSs) at a price of $1.20 per ADS, aiming to raise approximately $3.0 million for research, development, and general corporate purposes [1][2]. Group 1: Offering Details - The offering is expected to close on or about April 15, 2025, pending customary closing conditions [1]. - H.C. Wainwright & Co. is acting as the exclusive placement agent for this offering [2]. - The gross proceeds from the offering, before deducting fees and expenses, are anticipated to be $3.0 million [2]. Group 2: Company Overview - Can-Fite BioPharma is focused on developing small-molecule drugs for oncological and inflammatory diseases, targeting multi-billion dollar markets [5]. - The lead drug candidate, Piclidenoson, has recently reported topline results in a Phase III trial for psoriasis and is commencing another pivotal Phase III trial [5]. - Namodenoson, another key drug, is being evaluated in multiple trials for hepatocellular carcinoma (HCC) and has received Orphan Drug Designation and Fast Track Designation from the FDA [5]. - The company has a strong safety profile with over 1,600 patients involved in clinical studies to date [5].