Piclidenoson

RAMAT GAN, Israel, Sept. 08, 2026 (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 clinical updates and financial results for H1 2026. Advances in Clinical Programs Pancreatic Cancer Phase 2a study evaluating Namodenoson in patients with advanced pancreatic ductal adenocarcinoma achieved its primary safety endpoint and demonstrated durable overall survival outcomes. The open-label Phase IIa study enrolled 20 patients with advanced pancreatic ductal adenocarcinoma who had progressed following standard therapies. Fourteen patients received Namodenoson as third-line treatment, five as second-line treatment, and one as fourth-line treatment. Namodenoson was well tolerated. Overall survival findings identify a subset of heavily pretreated pancreatic cancer patients achieving prolonged survival despite receiving Namodenoson as third-line therapy. A Phase IIb study protocol which combines chemotherapy and Namodenoson is under development. An abstract highlighting the positive results has been accepted for poster presentation at the European Society for Medical Oncology (ESMO) Congress 2026. Hepatocellular Carcinoma (HCC) Blinded overall survival observed across the entire patient population in the Company’s ongoing pivotal Phase III study of Namodenoson in advanced hepatocellular carcinoma (HCC) appears longer than originally anticipated based on the assumptions underlying the study design. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); In view of the longer-than-anticipated survival observed in the study population, Can-Fite is evaluating an earlier timing for the study’s planned interim analysis. Clinical Progress in Psoriasis The Company completed enrolment of the first 247 patients in its pivotal Phase 3 study evaluating Piclidenoson for the treatment of moderate-to-severe plaque psoriasis. The study has now reached the pre-specified interim analysis stage under a protocol agreed with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The interim analysis will evaluate efficacy and safety data from the enrolled patients. Results are expected during Q1 2027 . Strengthening of Intellectual Property Portfolio Can-Fite continued to expand its global intellectual property estate with multiple patent allowances across key territories, including Israel, Canada, Brazil, Australia and Japan, covering novel therapeutic uses of Namodenoson and Piclidenoson. These additions further strengthen the Company’s long-term commercial positioning and pipeline value. Motti Farbstein Can-Fite’s CEO&CFO stated: “The first half of 2026 was marked by meaningful progress across our clinical programs. We are particularly encouraged by the longer-than-anticipated overall survival observed to date in our ongoing pivotal Phase III liver cancer study, while recognizing that the study remains blinded. In parallel, the durable survival outcomes observed in heavily pretreated pancreatic cancer patients and the advancement of our pivotal psoriasis study to its interim analysis stage further strengthen our clinical pipeline. We remain focused on disciplined execution of these late-stage programs and on advancing Namodenoson and Piclidenoson toward important clinical and regulatory milestones.” ezstandalone.cmd.push(function () { ezstandalone.showAds(132); }); Financial Results Revenues Revenues for the six months ended June 30, 2026 were $0.20 million compared to $0.20 million for the six months ended June 30, 2025. Revenues for the six months ended June 30, 2026 and for the six months ended June 30, 2026 comprise of a portion of advance payments received under our existing out-licensing agreements with Cipher, CKD Gebro and Ewopharma. Research and development expenses ezstandalone.cmd.push(function () { ezstandalone.showAds(133); }); Research and development expenses for the six months ended June 30, 2026 were $3.45 million, an increase of $0.42 million, or 13.86%, compared to $3.03 million for the six months ended June 30, 2025. Research and development expenses for the first half of 2026 comprised primarily of expenses associated with the ongoing of the Phase 3 study of Piclidenoson for the treatment of psoriasis and two ongoing studies for Namodenoson, a Phase 3 study in the treatment of advanced liver cancer and a Phase 2b study for MASH. The increase is primarily due to acceleration in expenses associated with both the Namodenoson and Piclidenoson programs. General and administrative expenses General and administrative expenses for the six months ended June 30, 2026 were $1.42 million, a decrease of $0.65 million, or 31.40%, compared to $2.07 million for the six months ended June 30, 2025. The decrease is primarily due to lower investors relations expenses. We expect that general and administrative expenses will remain at the same level through 2026. Financial income, net ezstandalone.cmd.push(function () { ezstandalone.showAds(134); }); Financial income, net for the six months ended June 30, 2026 was $0.08 million compared to $0.02 million for the six months ended June 30, 2025. The increase in financial income, net was mainly due to higher interest income from bank deposits. Net loss for the six months period ended June 30, 2026 was $4.60 million compared with a net loss of $4.87 million for the six months period ended June 30, 2025 . The decrease in net loss for the six months period ended June 30, 2026 was primarily attributable to a decrease in general and administrative expenses which was offset by an increase in research and development expenses . As of June 30, 2026, Can-Fite had cash and cash equivalents and short term deposits of $7.03 million as compared to $8.53 million at December 31, 2025. The decrease in cash during the six months period ended June 30, 2026 is mainly due to the Company's operating loss which was offset by proceeds from issuance of shares and warrants. During September 2026, the Company received aggregate gross proceeds of approximately $4.0 million from warrant exercises and a warrant inducement. The Company's consolidated financial results for the six months period ended June 30, 2026 are presented in accordance with US GAAP Reporting Standards. ezstandalone.cmd.push(function () { ezstandalone.showAds(135); }); CONDENSED CONSOLIDATED BALANCE SHEETS U.S. dollars in thousands (except for share and per share data) June 30, December 31, 2026 2025 Unaudited ASSETS CURRENT ASSETS: Cash and cash equivalents $ 2,985 $ 5,528 Short term deposits 4,052 3,011 Prepaid expenses and other current assets 960 900 Short-term investment 6 1 Total current assets 8,003 9,440 NON-CURRENT ASSETS: Operating lease right of use assets 47 69 Property, plant and equipment, net 5 5 Total non-current assets 52 74 Total assets $ 8,055 $ 9,514 CONDENSED CONSOLIDATED BALANCE SHEETS U.S. dollars in thousands (except for share and per share data) June 30, December 31, 2026 2025 Unaudited LIABILITIES AND SHAREHOLDERS’ EQUITY CURRENT LIABILITIES: Trade payables $ 681 $ 1,161 Current maturity of operating lease liability 48 56 Deferred revenues 405 405 Other accounts payable 1,091 1,109 Total current liabilities 2,225 2,731 NON-CURRENT LIABILITIES: Long - term operating lease liability 1 15 Deferred revenues 974 1,176 Total long-term liabilities 975 1,191 CONTINGENT LIABILITIES AND COMMITMENTS SHAREHOLDERS’ EQUITY: Ordinary shares of no-par value - Authorized: 30,000,000 and 14,000,000 shares at June 30, 2026 and December 31, 2025, respectively; Issued and outstanding: 4,285,093 and 2,618,425 shares as of June 30, 2026 and December 31, 2025, respectively - - Additional paid-in capital 184,518 180,654 Accumulated other comprehensive income 1,127 1,127 Accumulated deficit (180,790 ) (176,189 ) Total shareholders’ equity 4,855 5,592 Total liabilities and shareholders’ equity $ 8,055 $ 9,514 CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS U.S. dollars in thousands (except for share and per share data) Six months ended June 30, 2026 2025 Unaudited Revenues $ 202 $ 202 Research and development expenses (3,456 ) (3,034 ) General and administrative expenses (1,426 ) (2,066 ) Operating loss (4,680 ) (4,898 ) Financial income, net 79 22 Operating loss (4,601 ) (4,876 ) Basic and diluted net loss per share (1.24 ) (4.29 ) Weighted average number of ordinary shares used in computing basic and diluted net loss per share 3,711,018 1,137,303 About Can-Fite BioPharma Ltd. Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company's lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis and is expected to commence a pivotal Phase III. Can-Fite's cancer and liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of steatotic liver disease (SLD), a Phase III pivotal trial for hepatocellular carcinoma (HCC), and the Company is planning a Phase IIa study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety pro experience in over 1,600 patients in clinical studies to date. For more information please visit: . Forward-Looking Statements This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, its product development efforts, business, financial condition, results of operations, strategies or prospects. All statements in this communication, other than those relating to historical facts, are “forward looking statements”. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause Can-Fite’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause actual results, performance or achievements to differ materially from those anticipated in these forward-looking statements include, among other things, our history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; risks related to the security situation in Israel; risks related to not satisfying the continued listing requirements of NYSE American; and statements as to the impact of the political and security situation in Israel on our business. More information on these risks, uncertainties and other factors is included from time to time in the “Risk Factors” section of Can-Fite’s Annual Report on Form 20-F filed with the SEC on March 26, 2026 and other public reports filed with the SEC and in its periodic filings with the TASE. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Can-Fite undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. Contact Can-Fite BioPharma Motti Farbstein info@canfite.com +972-3-9241114

RAMAT GAN, Israel, Sept. 02, 2026 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) (“Can-Fite” or the “Company”), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, today announced the entry into a definitive agreement for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 1,591,738 American Depositary Shares (ADSs), having an exercise price of $5.00 per ADS, issued by Can-Fite in March 2026, at a reduced exercise price of $2.50 per ADS. The ADSs representing ordinary shares issuable upon exercise of the warrants are registered pursuant to an effective registration statement on Form F-3 (File No. 333-294760). The closing of the offering is expected to occur on or about September 3, 2026, subject to satisfaction of customary closing conditions. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. In consideration for the immediate exercise of the warrants for cash, Can-Fite will issue new unregistered warrants to purchase up to 3,183,476 ADSs. The new warrants will have an exercise price of $2.50 per ADS, will be immediately exercisable until the twenty-four month anniversary of the effective date of the Resale Registration Statement. The gross proceeds to Can-Fite from the exercise of the warrants are expected to be approximately $4.0 million, prior to deducting placement agent fees and offering expenses. The Company intends to use the net proceeds for funding research and development and clinical trials and for other working capital and general corporate purposes. The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "1933 Act"), and, along with the ADSs issuable upon exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. Can-Fite has agreed to file a registration statement with the SEC covering the resale of the shares of ADSs issuable upon exercise of the new warrants (the “Resale Registration Statement”). This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. About Can-Fite BioPharma Ltd. Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company’s lead drug candidate, Piclidenoson recently reported topline results in a Phase 3 trial for psoriasis and commenced a pivotal Phase 3 trial. Can-Fite’s liver drug, Namodenoson, is being evaluated in a Phase III trial for hepatocellular carcinoma (HCC), a Phase 2b trial for the treatment of MASH, and in a Phase 2a study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company’s third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,600 patients in clinical studies to date. For more information please visit: www.canfite.com. Forward-Looking Statements This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, its product development efforts, business, financial condition, results of operations, strategies or prospects. All statements in this communication, other than those relating to historical facts, are “forward looking statements”. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. For example, the Company is using forward-looking statements when it discusses the completion of the offering, the satisfaction of customary closing conditions related to the offering and the intended use of proceeds therefrom. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause Can-Fite’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause actual results, performance or achievements to differ materially from those anticipated in these forward-looking statements include, among other things, our market and other conditions, history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; risks related to not satisfying the continued listing requirements of NYSE American; and statements as to the impact of the political and security situation in Israel on our business. More information on these risks, uncertainties and other factors is included from time to time in the “Risk Factors” section of Can-Fite’s Annual Report on Form 20-F filed with the SEC on March 26, 2026 and other public reports filed with the SEC and in its periodic filings with the TASE. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Can-Fite undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. Contact Can-Fite BioPharmaMotti Farbsteininfo@canfite.com +972-3-9241114