Can Fite BioPharma Ltd (CANF) Quote

Can-Fite: Scientific Article Published by KOL Presents Namodenoson as a Promising Drug Candidate to Treat Advanced Liver Cancer and MASH

https://finance.yahoo.com/news/fite-scientific-article-published-kol-110000491.html

A pivotal Phase III trial for advanced liver cancer, approved by FDA & EMA and a MASH Phase IIb are enrolling patients

PETACH TIKVA, Israel, April 15, 2024--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced that Biomedicines published an article titled "Namodenoson at the Crossroad of Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Hepatocellular Carcinoma (HCC)". Biomedicines is a highly reputable journal that publishes articles on clinical and basic science topics in medicine. https://www.mdpi.com/2227-9059/12/4/848.

The article’s first author, Dr. Ohad Etzion, is a renowned key opinion leader (KOL) in the Hepatology field and is the engine for some of the novel drugs under development for the treatment of MASH and additional liver diseases. Dr. Etzion is the Head, Department of Gastroenterology and Liver Diseases, at Soroka University Medical Center, Beer Sheva, Israel.

The Biomedicines article presents the pre-clinical and clinical activity of Namodenoson and the mechanism of action through which the drug induces the anti-cancer activity and at the same time the liver protective effects. This dual activity enables the drug to have positive effects in both liver cancer and MASH.

Currently, Namodenoson is being evaluated in LiverationTM, a pivotal Phase III study for advanced liver cancer that has been approved by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and also in a Phase IIb study in patients with MASH.

"We are very much encouraged by the clinical data from the Phase II study in HCC and the Phase IIa study in MASH. The drug mechanism of action which is presented in the manuscript and entails inflammatory cytokine inhibition together with the stimulation of positive cytokines, position Namodenoson as a promising safe drug," stated Dr. Etzion.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

Can-Fite: Submits FDA with an IND Application to Conduct Phase IIb Clinical Trial of Namodenoson in MASH Patients

https://finance.yahoo.com/news/fite-submits-fda-ind-application-110000607.html


Namodenoson demonstrated anti-fibrosis, anti-steatosis and anti-inflammatory effects in former Phase IIa study

Patient enrolment for Phase IIb study is ongoing in Europe and Israel

RAMAT GAN, Israel, April 03, 2024--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), also known as non-alcoholic steatohepatitis (NASH), for the Company’s ongoing Phase IIb clinical study.

Can-Fite’s drug candidate, Namodenoson, has been shown to reduce hepatic steatosis, inflammation, and fibrosis, as well as body weight reduction, in a Phase IIa clinical study where data have been already published in a peer scientific journal (Link to Manuscript). Currently Can-Fite is enrolling patients for a Phase IIb clinical study in Europe and in Israel and is seeking IND approval in order to include US patients in the ongoing study.

The Phase IIb trial is a multicenter, randomized, double-blind, placebo-controlled study in subjects with biopsy-confirmed MASH. The primary efficacy objective of the trial is to evaluate the efficacy of Namodenoson as compared to placebo in 140 subjects with MASH, as determined by a histological endpoint. Eligible subjects are randomly assigned in a 2:1 ratio to oral doses of Namodenoson 25 mg every 12 hours or a matching placebo for 36 weeks.

"We are eager to look at the therapeutic effect of Namodenoson in patients with MASH," said Motti Farbstein, chief executive officer of Can-Fite. "Prior human data showed that treatment with Namodenoson leads to significant anti-MASH effects. Namodenoson’s novel liver-protective mechanism of action provides a unique opportunity to potentially improve inflammation and reduce hepatic steatosis and fibrosis which may provide important therapeutic benefits for patients."

Rates of MASH are increasing in the United States in concert with increasing rates of obesity and diabetes and is estimated to affect 2-5% of adult Americans. By 2028, Vantage Market Research estimates the addressable pharmaceutical market for MASH will reach $21.9 billion in size. In March 2024, Madrigal Pharmaceuticals announced FDA approval of Rezdiffra (resmetirom) for the treatment of MASH with moderate to advanced liver fibrosis, potentially paving the way for more drugs that target this huge market.

Can-Fite BioPharma, Ltd. to Present at the LD Micro Invitational XIV

https://finance.yahoo.com/news/fite-biopharma-ltd-present-ld-110000897.html

Ramat Gan, Israel--(Newsfile Corp. - April 1, 2024) - Can-Fite BioPharma, Ltd. (NYSE American: CANF) announced today that it will be presenting at The 14th Annual LD Micro Invitational at the Sofitel New York on April 8th-9th, 2024. The event is expected to feature 80 companies presenting in half-hour increments, as well as private 1:1 meetings.

Can-Fite BioPharma, Ltd. is scheduled to present on April 9th at 4:30 PM ET. Motti Farbstein, CEO, will be leading the presentation.

We invite interested parties to register to watch the presentation virtually here.

CANF under $3

Can-Fite Reports 2023 Financial Results and Clinical Update

https://finance.yahoo.com/news/fite-reports-2023-financial-results-110000839.html

Ewopharma acquired marketing rights for namodenoson in the treatment of pancreatic carcinoma

RAMAT GAN, Israel, March 28, 2024--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced financial results and clinical updates for the twelve months ended December 31, 2023.

Recent Clinical & Development Milestones Achieved

Namodenoson Drug Candidate:

Ewopharma recently acquired marketing rights for Namodenoson in the treatment of pancreatic carcinoma
This adds up to an out licensing agreement that Can-Fite signed with Switzerland-based Ewopharma in 2021, for exclusive distribution of both Piclidenoson and Namodenoson in Central Eastern European (CEE) countries (Piclidenoson for the treatment of psoriasis and Namodenoson for the treatment of liver cancer and NASH). Under the terms of the distribution agreement, Ewopharma AG paid Can-Fite an upfront payment of US$2.25 million with up to an additional US$40.45 million, payable upon the achievement of regulatory and sales milestones, plus 17.5% royalties on net sales. Recently, Ewopharma AG exercised its right to expand the distribution agreement to include the indication of pancreatic cancer and the transaction terms of the distribution agreement are applicable to such indication.
Can-Fite Broadens its Strong Intellectual Property (IP) for NASH (MASH): Received Patent Allowance in Canada
Can-Fite received a Notice of Allowance from the Canadian Intellectual Property Office for its patent application titled "An A3 Adenosine Receptor Ligand For Use In Treating Ectopic Fat Accumulation". This invention addresses the use of Namodenoson for the reduction of liver fat in patients with NASH a clinical indication that is being developed by Can-Fite. In a successfully concluded Phase IIa study, Namodenoson, one of the Company’s two drugs in advanced clinical development, reduced liver fat content, showed anti-inflammatory effects manifested by a significant decrease in the liver enzymes ALT & AST, and decreased body weight in patients with NASH. A Company-sponsored study for Namodenoson for this indication is currently enrolling patients for a Phase IIb study which will include 140 patients, in whom liver pathology is the primary endpoint. Patent has already been issued in other major markets including the U.S., EU, Japan and China.
Piclidenoson Drug Candidate:

Positive Data from the COMFORT-1 Phase III Psoriasis Study Published in a Top Scientific Journal
The Journal of the European Academy of Dermatology and Venereology (EADV) published an article titled "Efficacy and safety of piclidenoson in plaque psoriasis: Results from a randomized phase 3 clinical trial (COMFORT-1)". EADV is a top ranked peer reviewed journal (impact factor 9.2) that publishes articles on clinical and basic science topics in dermatology. The article’s first author, Dr. K.A Papp, is an internationally renowned key opinion leader in the psoriasis field and was the engine for some registered drugs on the market for this devastating skin disease. The EADV article presents the safety and efficacy of Piclidenoson in the randomized, placebo- and active-controlled, double-blind Phase III COMFORT-1 trial. As previously reported, the study met its primary endpoint which was the proportion of patients achieving ≥75% improvement in Psoriasis Area and Severity Index (PASI) from baseline (PASI-75) at Week 16 (3 mg BID dose: PASI 75 rate of 9.7% vs. 2.6% for Piclidenoson vs. placebo, p=0.037). Piclidenoson’s efficacy continued to increase throughout the study period in a linear manner with an excellent safety and tolerability profile. Currently, Piclidenoson is being evaluated in COMFORT-2 a pivotal Phase III study that has been approved by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

"Our advanced-stage pipeline continues to achieve milestones, with Piclidenoson and Namodenoson both positioned as potentially safe and effective treatments for the oncological diseases liver cancer & pancreatic carcinoma and the inflammatory and metabolic diseases psoriasis and NASH. We anticipate additional clinical progress and new out licensing deals in this year," stated Can-Fite CEO Motti Farbstein.

Financial Results

Revenues for the year ended December 31, 2023 were $0.74 million, a decrease of $0.07 million, or 8.6%, compared to $0.81 million for the year ended December 31, 2022. The decrease in revenues was mainly due to the recognition a lower portion of advance payments received under the Ewopharma distribution agreement entered in 2021 and a lower portion of advance payments received under distribution agreements from Gebro, Chong Kun Dung Pharmaceuticals, and Cipher Pharmaceuticals.

Research and development expenses for the year ended December 31, 2023 were $5.98 million, a decrease of $1.78 million, or 22.9%, compared to $7.76 million for the year ended December 31, 2022. Research and development expenses for the year ended December 31, 2023 comprised primarily of expenses associated with the completion 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 NASH. The decrease is primarily due to a decrease in expenses associated with Piclidenosnon.

General and administrative expenses were $2.95 million for the year ended December 31, 2023 a decrease of $0.19 million, or 6.05%, compared to $3.14 million for the year ended December 31, 2022. The decrease is primarily due to the decrease in directors and officer’s insurance policy premium. We expect that general and administrative expenses will remain at the same level through 2024.

Financial income (expense), net for the year ended December 31, 2023 aggregated $0.56 million compared to financial expense, net of $(0.07) for the year ended December 31, 2022. The decrease in financial expense, net was mainly due to increase interest from deposits and reduction in expenses related to the revaluation of our short-term investment.

Net loss for the year ended December 31, 2023 was $7.63 million compared with a net loss of $10.17 million for the same period in 2022. The decrease in net loss for the year ended December 31, 2023 was primarily attributable to the decrease in research and development expenses and in general and administrative expenses.

As of December 31, 2023, Can-Fite had cash and cash equivalents and short term deposits of $8.90 million as compared to $7.98 million at December 31, 2022. The decrease in cash during the year ended December 31, 2023 is due to the ongoing operations of the Company which was offset by the Company’s financing during January 2023 and exercise of certain warrants during November 2023.

The Company's consolidated financial results for the year ended December 31, 2023 are presented in accordance with US GAAP Reporting Standards.

More detailed information can be found in the Company’s Annual Report on Form 20-F for the fiscal year ended December 31, 2023, a copy of which has been filed with the Securities and Exchange Commission (SEC). The Annual Report, which contains the Company’s audited consolidated financial statements, can be accessed on the SEC’s website at http://www.sec.gov/ as well as via the Company’s investor relations website at https://ir.canfite.com. The Company will deliver a hard copy of its Annual Report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request to Can-Fite Investor Relations at 26 Ben Gurion Street, Ramat Gan, 5257346, Israel or by phone at +972-3-9241114.

CONSOLIDATED BALANCE SHEETS
U.S dollars in thousands (except for share and per share data)





December 31,







2023





2022

















ASSETS



























CURRENT ASSETS:



























Cash and cash equivalents



$

4,278





$

2,978



Short term deposits





4,625







5,001



Prepaid expenses and other current assets





986







1,170



Short-term investment





19







8





















Total current assets





9,908







9,157





















NON-CURRENT ASSETS:



































Operating lease right of use assets

52



84

Property, plant and equipment, net





29







42





















Total non-current assets





81







126





















Total assets



$

9,989





$

9,283



CONSOLIDATED BALANCE SHEETS
U.S dollars in thousands (except for share and per share data)





December 31,







2023





2022

















LIABILITIES AND SHAREHOLDERS’ EQUITY



























CURRENT LIABILITIES:



























Trade payables



$

427





$

896



Current maturity of operating lease liability

27



48

Deferred revenues





622







783



Other accounts payable





944







775





















Total current liabilities





2,020







2,502





















NON-CURRENT LIABILITIES:































Long - term operating lease liability

13



14

Deferred revenues





1,713







2,295





















Total long-term liabilities





1,726







2,309





CONTINGENT LIABILITIES AND COMMITMENTS





















SHAREHOLDERS’ EQUITY:



































Ordinary shares of no-par value - Authorized: 5,000,000,000 shares at December 31, 2023 and December 31, 2022; Issued and outstanding: 1,359,837,393 and 815,746,293 shares as of December 31, 2023 and December 31, 2022





-







-



Additional paid-in capital





163,597







154,192



Accumulated other comprehensive income





1,127







1,127



Accumulated deficit





(158,481

)





(150,847

)















Total shareholders’ equity





6,243







4,472

















Total liabilities and shareholders’ equity



$

9,989





$

9,283



CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
U.S dollars in thousands (except for share and per share data)





Year ended December 31,







2023





2022

















Revenues



$

743



$

810















Research and development expenses





(5,983

)





(7,763

)

General and administrative expenses





(2,955

)





(3,143

)













Operating loss





(8,195

)





(10,096

)















Total financial income (expense), net





561





(77)













Net loss





(7,634

)





(10,173

)



















Basic and diluted net loss per share





(0.01

)





(0.01

)



Weighted average number of ordinary shares used in computing basic and diluted net loss per share

1,278,333,912

815,746,293

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 profile with experience in over 1,600 patients in clinical studies to date. For more information please visit: www.can-fite.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. 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 any resurgence of the COVID-19 pandemic and the war between Israel and Hamas; 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 28, 2024 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240328586605/en/

Contacts

Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114


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Namodenoson Treatment for Pancreatic and Liver Cancer: Data will be Discussed in Out-licensing and Distribution Partnering Meetings at Bio Europe Conference

https://finance.yahoo.com/news/namodenoson-treatment-pancreatic-liver-cancer-110000148.html

PETACH TIKVA, Israel, March 11, 2024--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncology and inflammatory diseases, today announced its VP of Business Development, Dr. Sari Fishman, will present data from the pancreatic and liver cancer programs during numerous partnering meetings at the BIO-Europe Spring 2024 in Barcelona, Spain, on Mar 18-27, 2024 (https://informaconnect.com/bioeurope-spring/).

Can-Fite’s pipeline of indications includes Namodenoson for the treatment of advanced liver cancer and pancreatic cancer; both indications have been licensed to the Swiss company Ewopharma for Eastern Europe. The liver cancer indication has been licensed as well to CMS in China and CKD in South Korea. Piclidenoson has been out-licensed to Cipher in Canada; Gebro Pharma for Swiss, Spain, Austria; CMS for China; and Kyongboo for South Korea. Each of the deals include upfront and milestone payments. The Company’s growing slate of indications and advanced pipeline are attracting increased interest from additional potential partners. Focusing on its core expertise in clinical development, Can-Fite pursues a strategy of partnering with companies in specific geographic markets that specialize in pharmaceutical distribution and regional regulatory approval.

"Advanced liver cancer and pancreatic cancer are Can-Fite’s clinical-stage indications for Namodenoson and am delighted with the interest that Namodenoson is raising with companies that will participate in the Bio Europe Conference and are experts in drug development and distribution in the oncology arena. The conference provides us with the opportunity to present our other developments to lead pharmaceutical companies," stated Dr. Sari Fishman, VP Business Development at Can-Fite.

Can-Fite Broadens its Strong Intellectual Property (IP) for NASH: Received Patent Allowance in Canada

https://finance.yahoo.com/news/fite-broadens-strong-intellectual-property-120000915.html

Patent has already been issued in other major markets including the U.S., EU, Japan and China

PETACH TIKVA, Israel, February 28, 2024--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced it received a Notice of Allowance from the Canadian Intellectual Property Office for its patent application titled "An A3 Adenosine Receptor Ligand For Use In Treating Ectopic Fat Accumulation". This invention addresses the use of Namodenoson for the reduction of liver fat in patients with NASH a clinical indication that is being developed by Can-Fite. In a successfully concluded Phase IIa study, Namodenoson, one of the Company’s two drugs in advanced clinical development, reduced liver fat content, showed anti-inflammatory effects manifested by a significant decrease in the liver enzymes ALT & AST, and decreased body weight in patients with NASH. A Company-sponsored study for Namodenoson for this indication is currently enrolling patients for a Phase IIb study which will include 140 patients, in whom liver pathology is the primary endpoint.

Can-Fite’s Namodenoson, is currently out-licensed for the treatment of NASH to the Swiss company Ewopharma for territories in Eastern Europe, to CMS China for the territories of China, HK and Macau, and to the South Korean company CKD for the territory of South Korea. The Company also has a distribution agreement in Canada for its anti-inflammatory drug, Piclidenoson, for the treatment of psoriasis.

"This additional patent in Canada for fatty liver disease adds to our growing IP estate for this high-value indication of the Namodenoson drug candidate. Our strong and broad IP, together with the positive data from the Phase IIa and the drug safety, position it as a promising candidate for the treatment of this liver disease," stated Dr. Ilan Cohn, Can-Fite founder, a recognized business development expert in the medical arena, and also a leading Israeli patent attorney and Partner & co-Founder of Cohn, de Vries, Stadler & Co, Patent and Trademark Attorneys.

The NASH market is expected to reach $24 billion by 2028. According to the American Liver Foundation, between 30-40% of adults in the U.S. have non-alcoholic fatty liver disease, one of the most common causes of liver disease in the U.S. Non-alcoholic steatohepatitis affects up to 5% of Americans, or up to 16 million people and is expected to be most frequent reason for liver transplants in the U.S. by 2030.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is currently being evaluated in a pivotal Phase III trial for advanced liver cancer, a Phase IIb trial for the treatment of steatotic liver disease (SLD), and the Company is planning a Phase IIa study in pancreatic cancer. A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential expression may be one of the important factors that accounts for the excellent safety profile of the drug.

Can-Fite Expands the Out-Licensing Deal with Ewopharma to Include the Pancreatic Cancer Indication

https://finance.yahoo.com/news/fite-expands-licensing-deal-ewopharma-120000467.html

PETACH TIKVA, Israel, January 30, 2024--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced that it has expanded its out licensing transaction with Ewopharma AG. to include the pancreatic cancer indication of Can-Fite.

During 2021, Can-Fite entered into an exclusive distribution agreement for Piclidenoson with Switzerland-based Ewopharma AG for the treatment of psoriasis and Namodenoson for the treatment of hepatocellular carcinoma (HCC) and nonalcoholic steatohepatitis (NASH). Under the terms of the distribution agreement, Ewopharma AG paid Can-Fite an upfront payment of US$2.25 million with up to an additional US$40.45 million, payable upon the achievement of regulatory and sales milestones, plus 17.5% royalties on net sales. In exchange, Ewopharma AG received the exclusive right to market and sell Piclidenoson in Central Eastern European (CEE) countries and Namodenoson in CEE countries and Switzerland.

Ewopharma AG exercised its right to expand the distribution agreement to include the indication of pancreatic cancer and the transaction terms of the distribution agreement are applicable to such indication.

Ewopharma is a pharmaceutical sales and marketing firm that helps pharma companies access markets in CEE and Switzerland. In addition to Can-Fite, Ewopharma AG has distribution agreements with many leading healthcare companies including Eisai and Biogen.

"We are very pleased to expand the distribution agreement with Ewopharma, a leader in pharmaceutical distribution in Central Eastern Europe and Switzerland and include the pancreatic cancer indication. We consider this to be an important transaction for Can-Fite that will enable penetration into Ewopharma’s territory right after approval of the drug for this indication, where there are no other efficacious drugs," stated Can-Fite VP Business Development Dr. Sari Fishman.

Can-Fite: Top Scientific Journal Published Positive Data from the COMFORT-1 Phase III Psoriasis Study

https://finance.yahoo.com/news/fite-top-scientific-journal-published-120000010.html

Piclidenoson is a small molecule safe oral drug suitable for the chronic treatment of patients who suffer from moderate to severe plaque psoriasis.

PETACH TIKVA, Israel, January 29, 2024--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced that the Journal of the European Academy of Dermatology and Venereology (EADV) published an article titled "Efficacy and safety of piclidenoson in plaque psoriasis: Results from a randomized phase 3 clinical trial (COMFORT-1)". EADV is a top ranked peer reviewed journal (impact factor 9.2) that publishes articles on clinical and basic science topics in dermatology. Article Link.

The article’s first author, Dr. K.A Papp, is an internationally renowned key opinion leader in the psoriasis field and was the engine for some registered drugs on the market for this devastating skin disease.

The EADV article presents the safety and efficacy of Piclidenoson in the randomized, placebo- and active-controlled, double-blind Phase III COMFORT-1 trial. As previously reported, the study met its primary endpoint which was the proportion of patients achieving =75% improvement in Psoriasis Area and Severity Index (PASI) from baseline (PASI-75) at Week 16 (3 mg BID dose: PASI 75 rate of 9.7% vs. 2.6% for Piclidenoson vs. placebo, p=0.037). Piclidenoson’s efficacy continued to increase throughout the study period in a linear manner with an excellent safety and tolerability profile.

Currently, Piclidenoson is being evaluated in COMFORT-2 a pivotal Phase III study that has been approved by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

"We are very much encouraged by the excellent data in the first Phase III study demonstrating the significant effect of Piclidenoson in psoriasis," stated Dr. Fishman, Can-Fite’s Chief Scientific Officer and Executive Chairman. "We plan to start treating patients in our pivotal trial very shortly and hope that Piclidenoson, with its safety and efficacy profile, given orally to psoriasis patients will become a drug of choice."

About Piclidenoson

Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with an excellent safety profile demonstrating evidence of efficacy in Phase II and III psoriasis studies. The drug’s mechanism of action entails inhibition of the inflammatory cytokines interleukin 17 and 23 (IL-17 and IL-23) and the induction of apoptosis of patients’ skin cell keratinocytes involved with disease pathogenicity. Based on preclinical efficacy data, Piclidenoson is also being co-developed for the treatment of Lowe Syndrome, a rare genetic disease.

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 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. 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 COVID-19 pandemic and the Russian invasion of Ukraine; 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 30, 2023 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240129306975/en/

Contacts

Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114

The Anti-Obesity Effect of Can-Fite’s Namodenoson: Molecular Mechanism of Action in Pre-clinical and Human Studies

https://finance.yahoo.com/news/anti-obesity-effect-fite-namodenoson-120000346.html

Robust support for Namodenoson’s potential development as an anti-obesity drug, a projected $100 billion market by 2030

PETACH TIKVA, Israel, December 20, 2023--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today reported new data on Namodenoson’s anti-obesity mechanism of action.

New data demonstrate that treatment of fat cells (3T3-L1 adipocytes) with Namodenoson leads to modulation of proteins that increase adiponectin level. Adiponectin is a regulator of fat production in the cells, resulting in the inhibition of fat levels. Furthermore, Namodenoson reduced body weight in an experimental animal model of obesity induced by a high fat diet. In a Phase IIa NASH study, in patients treated with Namodenoson, a 2.1% weight loss was observed after 3 months of treatment (Safadi at Al) and a significant decrease in serum adiponectin levels was found.

"These new preclinical data, together with the excellent safety profile of Namodenoson in humans demonstrated to date, serve as robust support for its potential development as an anti-obesity drug," said Pnina Fishman, Ph.D., CSO & Executive Chairman of Can-Fite BioPharma.

The global obesity treatment market is lucrative due to the awareness of a link between chronic diseases and obesity. The World Health Organization reports that obesity has nearly tripled since 1975 and at least 2.8 million people are dying as a results of obesity each year. According to Goldman Sachs Research, the anti-obesity medications market is estimated reached $6 billion on an annualized basis in 2023 and is expected to grow to $100 billion by 2030.

Can-Fite Received FDA Positive Response to Psoriasis Pediatric Plan

https://finance.yahoo.com/news/fite-received-fda-positive-response-120000414.html


FDA encouraged the Company to accelerate enrollment of adolescent patients due to Piclidenoson’s good safety profile

There is an unmet need for safe, convenient, and effective drugs to treat chronic plaque psoriasis in children

PETACH TIKVA, Israel, December 18, 2023--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced that it received a positive response from the U.S. Food and Drug Administration (FDA) on the Pediatric Study Plan for the treatment of children suffering from psoriasis with Piclidenoson.

The plan has been submitted to allow enrollment of children with psoriasis to Can-Fite’s upcoming Phase 3 pivotal clinical psoriasis studies, aiming at registration of Piclidenoson with both the FDA and the European Medicines Agency (EMA) for the treatment of plaque psoriasis.

There is a high market need for a safe and efficacious drug for the treatment of children who suffer from psoriasis. There are a couple of small molecule or biological drugs on the market, however all have safety issues and are not satisfactory regarding efficacy. Therefore, there is a high market need which will enable Can-Fite to position Piclidenoson with its favorable safety and good efficacy as a treatment for this chronic and devastating disease.

Can-Fite believes the inclusion of children in one or both of the Phase 3 studies significantly broadens any future market launch potential of the drug. Psoriasis affects millions of people worldwide, including a significant number of children who endure the physical and emotional burden of this challenging disease.

"We believe Piclidenoson’s oral formulation with its excellent safety profile, combined with its progressive effectiveness over time make it ideally suited for the chronic treatment of psoriasis in adults and children alike," stated Can-Fite VP Drug Development, Dr. William Kerns.

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 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. 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 COVID-19 pandemic and the Russian invasion of Ukraine; 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 30, 2023 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20231218865060/en/

Contacts

Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114

Can-Fite’s Namodenoson for the Treatment of Pancreatic Cancer Patients: Progress in Clinical Development

https://finance.yahoo.com/news/fite-namodenoson-treatment-pancreatic-cancer-120000962.html

Study will aim to enroll about 20 patients to establish safety and clinical activity

PETACH TIKVA, Israel, December 04, 2023--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced that it completed the design of a Phase IIa study protocol for the treatment of patients with pancreatic cancer and plans to submit the protocol shortly to ethical committees for approval.

Can-Fite completed the protocol design of the CF102-222PC clinical study entitled: "A Phase II Open-Label Study of the Safety and Activity of Namodenoson in the Treatment of Advanced Pancreatic Adenocarcinoma".

This is a multicenter open-label trial in patients with advanced pancreatic adenocarcinoma whose disease has progressed on at least 1st-line therapy or who refuse standard treatment. The trial will evaluate the safety, clinical activity, and pharmacokinetics (PK) of Namodenoson in this population. All patients will receive oral Namodenoson 25 mg administered twice daily for consecutive 28-day cycles. Patients will be evaluated regularly for safety. Approximately 20 evaluable patients will be enrolled. The primary objective of this trial is to characterize the safety profile of Namodenoson and the secondary objective is to evaluate the clinical activity as determined by the Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DoR), and Overall Survival (OS).

The study will be conducted by Dr. Salomon Stemmer, a leading key opinion leader, at the Institute of Oncology, Rabin Medical Center, Israel.

"This Phase IIa study is designed as an open-label one, enabling us to assess the safety and potential efficacy of Namodenoson in pancreatic cancer patients whose disease has progressed despite first-line treatment. Our positive Namodenoson data in pancreatic carcinoma experimental models together with the positive data in the Phase II advanced liver cancer study, with a patient showing overall survival of 7 years, encouraged us to initiate the current Phase IIa study," stated Can-Fite’s Medical Director Dr. Michael Silverman.

Namodenoson recently received peer-reviewed recognition for its efficacy findings in pancreatic cancer including from the American Association of Cancer Research (AACR) which accepted Can-Fite’s study titled "Namodenoson Inhibits the Growth of Pancreatic Carcinoma via De-regulation of the Wnt/ß-catenin Signaling Pathway" for a poster presentation at the AACR Special Conference on Pancreatic Cancer, and from Biomolecules, a scientific journal focused on the function and mechanism of bioactive molecules, which published an article titled "Namodenoson Inhibits the Growth of Pancreatic Carcinoma via Deregulation of the Wnt/ß-catenin, NF-?B, and RAS Signaling Pathways".

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

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. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of steatotic liver disease (SLD), a Phase III 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 profile with experience in over 1,600 patients in clinical studies to date. For more information please visit: www.can-fite.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. 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 COVID-19 pandemic and the Russian invasion of Ukraine; 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 30, 2023 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20231204860062/en/

Contacts

Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114

Can-Fite Reports Third Quarter 2023 Financial Results and Clinical Update

https://finance.yahoo.com/news/fite-reports-third-quarter-2023-120000702.html

Advanced liver cancer patient in prior Phase II study remains cancer-free 6.9 years after starting treatment with Namodenoson

PETACH TIKVA, Israel, November 30, 2023--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced financial results for the nine months ended September 30, 2023.

Clinical & Development Milestones Achieved

Namodenoson Drug Candidate:

Complete Response and 6.9 Year Survival Reported in Patient with Advanced Liver Cancer Treated with Namodenoson

A patient who had participated in Can-Fite’s prior Phase II liver cancer study who continues to receive treatment with Namodenoson under a compassionate use program now has overall survival of 6.9 years with the disappearance of ascites, normal liver function, and good quality of life, defined as a complete response. Enrollment is ongoing in Can-Fite’s pivotal Phase III study of Namodenoson in the treatment of advanced liver cancer. During the third quarter, the American Society of Clinical Oncology (ASCO) selected Can-Fite for the prestigious Breakthrough Abstract Award from Conquer Cancer® for its abstract titled "A novel approach for the treatment of advanced hepatocellular carcinoma (HCC)".

Pancreatic Carcinoma Phase IIa Study with Namodenoson is Underway

Namodenoson inhibited the growth of pancreatic carcinoma in a pre-clinical study through a mechanism that entails the Ras pathway. The Company continues to receive awards and recognition from leading cancer associations, and articles summarizing Namodenoson’s robust anti-cancer effect in pancreatic carcinoma have been published. The American Association of Cancer Research (AACR) accepted Can-Fite’s study titled "Namodenoson Inhibits the Growth of Pancreatic Carcinoma via De-regulation of the Wnt/ß-catenin Signaling Pathway" for a poster presentation at the AACR Special Conference on Pancreatic Cancer. Biomolecules, a peer-reviewed scientific journal focused on the function and mechanism of bioactive molecules, published an article titled "Namodenoson Inhibits the Growth of Pancreatic Carcinoma via Deregulation of the Wnt/ß-catenin, NF-?B, and RAS Signaling Pathways".

Piclidenoson Drug Candidate:

Entered Rare Genetic Disease Market with Treatment for Lowe Syndrome

In preclinical studies, Piclidenoson has been found to be effective in Lowe Syndrome, a rare genetic disease with no treatment available, and an estimated $100 million treatment market in the U.S. alone. Lowe Syndrome usually develops in the first year of life, causing brain abnormalities associated with intellectual disabilities and a life span shortened to less than 40 years. The discovery of Piclidenoson’s efficacy in Lowe Syndrome was made by researchers at the University of Naples Federico II and The Telethon Institute of Genetics and Medicine in Italy after testing thousands of compounds in search of a treatment. Can-Fite and Fondazione Telethon signed an agreement outlining their collaboration for the development of Piclidenoson for the treatment of Lowe Syndrome. As a rare genetic disease in dire need of a treatment, Lowe Syndrome may qualify for an accelerated approval path, and Can-Fite plans to move into an advanced stage clinical study in this indication.

Harnessing Artificial Intelligence (AI) to Identify and Accelerate New Oncology Programs:

Through an agreement with Collaborations Pharmaceuticals, Can-Fite is utilizing AI and machine learning (ML) to develop and bring to market next-generation A3 adenosine receptor (A3AR) oncology drugs at a significantly reduced development time and cost. New molecules will be designed with high affinity and selectivity to A3AR, the target of Can-Fite’s platform technology.

"In addition to the several major value-driving milestones achieved during the third quarter, we continue to enroll and treat patients in our pivotal Phase III liver cancer study and Phase IIb study for NASH. Our pivotal Phase III study in psoriasis is expected to commence soon while we also prepare for a Phase IIa study in pancreatic cancer," stated Motti Farbstein, Can-Fite’s CEO and CFO. "We believe our advanced stage pipeline with multiple indications positions Can-Fite well for partnerships and for achieving regulatory and market success based on our robust portfolio."

Financial Results

Revenues for the nine months ended September 30, 2023 were $0.59 million compared to revenues of $0.61 million for the same period in 2022. Revenues for the nine months ended September 30, 2023 and September 30, 2022 comprised of recognition of a portion of advance payments received under distribution agreements with Gebro, CKD, Cipher and Ewopharma.

Research and development expenses for the nine months ended September 30, 2023 were $4.71 million compared with $5.30 million for the same period in 2022. Research and development expenses for the nine months ended September 30, 2023 comprised primarily of expenses associated with the completion of the Phase III study of Piclidenoson for the treatment of psoriasis and two ongoing studies for Namodenoson, a Phase III study in the treatment of advanced liver cancer and a Phase IIb study for NASH.

General and administrative expenses were $2.23 million for the nine months ended September 30, 2023 compared to $2.31 million for the same period in 2022. The decrease is primarily due to the decrease in directors and officer’s insurance policy premium. We expect that general and administrative expenses will remain at the same level through 2023.

Financial income, net for the nine months ended September 30, 2023 was $0.38 million compared to financial expense, net of $0.14 million for the same period in 2022. The decrease in financial expense, net was mainly due to revaluation of our short-term investment and increase in interest income from deposits in 2023.

Net loss for the nine months ended September 30, 2023 was $5.98 million compared with a net loss of $7.15 million for the same period in 2022. The decrease in net loss for the nine months ended September 30, 2023 was primarily attributable to the decrease in research and development expenses and in general and administrative expenses.

As of September 30, 2023, Can-Fite had cash and cash equivalents and short term deposits of $7.94 million as compared to $7.98 million at December 31, 2022. The decrease in cash during the nine months ended nine 30, 2023 is due to the ongoing operations of the Company which was offset by the Company’s fundraise during January 2023. During November 2023, Can-Fite raised approximately $3 million from the exercise of certain warrants.

The Company's consolidated financial results for the nine months ended September 30, 2023 are presented in accordance with US GAAP Reporting Standards.

CONSOLIDATED BALANCE SHEETS

U.S dollars in thousands (except for share and per share data)

September 30,

December 31,

2023

2022

ASSETS

CURRENT ASSETS:

Cash and cash equivalents

$

3,383

$

2,978

Short term deposits

4,556

5,001

Prepaid expenses and other current assets

1,122

1,170

Short-term investment

3

8

Total current assets

9,064

9,157

NON-CURRENT ASSETS:

Operating lease right of use assets

72

84

Property, plant and equipment, net

33

42

Total non-current assets

105

126

Total assets

$

9,169

$

9,283

CONSOLIDATED BALANCE SHEETS

U.S dollars in thousands (except for share and per share data)

September 30,

December 31,

2023

2022

LIABILITIES AND SHAREHOLDERS’ EQUITY

CURRENT LIABILITIES:

Trade payables

$

647

$

896

Current maturity of operating lease liability

34

48

Deferred revenues

783

783

Other accounts payable

746

775

Total current liabilities

2,210

2,502

NON-CURRENT LIABILITIES:

Long - term operating lease liability

17

14

Deferred revenues

1,707

2,295

Total long-term liabilities

1,724

2,309

CONTIGENT LIABILITIES AND COMMITMENTS

SHAREHOLDERS’ EQUITY:

Ordinary shares of no-par value - Authorized: 5,000,000,000 shares at September 30, 2023
and December 31, 2022; Issued and outstanding: 1,224,837,393 and 815,746,293 shares as
of September 30, 2023 and December 31, 2022

-

-

Additional paid-in capital

160,937

154,192

Accumulated other comprehensive income

1,127

1,127

Accumulated deficit

(156,829

)

(150,847

)

Total shareholders’ equity

5,235

4,472

Total liabilities and shareholders’ equity

$

9,169

$

9,283

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

U.S dollars in thousands (except for share and per share data)

Nine months ended

September 30,

2023

2022

Revenues

$

588

$

613

Research and development expenses

(4,716

)

(5,309

)

General and administrative expenses

(2,233

)

(2,317

)

Operating loss

(6,361

)

(7,013

)

Total financial income (expense), net

379

(141)

Net loss

(5,982

)

(7,154

)

Basic and diluted net loss per share

(0.00

)

(0.01

)

Weighted average number of ordinary shares used in computing basic and diluted net loss per share

1,209,797,279

815,746,293

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 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. 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 COVID-19 pandemic and the Russian invasion of Ukraine; 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 30, 2023 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20231130873648/en/

Contacts

Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114

Can-Fite Announces Exercise of Warrants for Approximately $3.0 Million in Gross Proceeds

https://finance.yahoo.com/news/fite-announces-exercise-warrants-approximately-185300215.html

PETACH TIKVA, Israel, Nov. 21, 2023 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced the entry into a definitive agreement for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 1,963,637 American Depositary Shares (ADSs), having exercise prices ranging from $6.00 to $5.50 per ADS, issued by Can-Fite in December 2021 and January 2023, at a reduced exercise price of $1.53 per share. The ADSs representing ordinary shares issuable upon exercise of the warrants are registered pursuant to effective registration statements on Form F-3 (File No. 333-262055) and Form F-1 (File No. 333-269485). The closing of the offering is expected to occur on or about November 24, 2023, 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 3,927,274 ADSs. The new warrants will have an exercise price of $1.75 per ADS, will be immediately exercisable and have a term of exercise equal to five years from the date of issuance. In addition, Can-Fite has agreed to reduce the exercise price of series B warrants to purchase 1,363,637 ADSs held by the warrant holder from $5.50 per ADS to $1.75 per ADS and extend the term of such series B warrants to twenty months from the closing date.

The gross proceeds to Can-Fite from the exercise of the warrants are expected to be approximately $3.0 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.

Can-Fite: Complete Response and 6.9 Years Overall Survival in a Patient with Advanced Liver Cancer Treated with Namodenoson

https://finance.yahoo.com/news/fite-complete-response-6-9-120000052.html


PETACH TIKVA, Israel, November 21, 2023--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced that a patient who participated in the Phase II Liver Cancer Study and was treated with namodenoson has a complete response and overall survival of 6.9 years (82.8 months).

Liver Cancer designated as hepatocellular carcinoma (HCC), is a major global health problem due to its incidence, associated mortality, and lack of effective treatment modalities, particularly for patients with advanced hepatic dysfunction known as disease stage Child Pugh B.

A patient with advanced HCC that was enrolled in the former Can-Fite Phase II study continues to receive treatment with namodenoson and has now an overall survival of 6.9 years with the disappearance of ascites, normal liver function, and good quality of life and defined as a complete response.

Can-Fite has received agreement from both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) on a pivotal Phase III clinical study which is now enrolling patients in Israel, Europe and the US. Namodenoson has Orphan Drug status with both the FDA and EMA, as well as Fast Track Status with the FDA for the treatment of HCC. A compassionate use program has been ongoing in Israel and Romania.

The double blind, placebo-controlled trial will enroll 450 patients diagnosed with HCC and underlying Child Pugh B7 (CPB7) through clinical sites worldwide. Patients will be randomized to oral treatment with either 25 mg Namodenoson or matching placebo given twice daily. The primary efficacy endpoint of the trial is overall survival. Other oncology trial efficacy outcomes, such as tumor radiographic response rates and median progression-free survival, as well as standard safety parameters, will be assessed.

An interim analysis will be conducted by an Independent Data Monitoring Committee (IDMC) after 50% of enrolled patients are treated. Namodenoson will be evaluated as a 2nd or 3rd line treatment for CPB7 patients in whom other approved therapies have not been or are no longer effective.

"We are currently enrolling patients for the pivotal Phase III clinical study and hope that if the interim analysis data will be positive, we will be able to get a conditional approval, and that patients who suffer from this devastating disease will enjoy our drug," stated Can-Fite CEO Motti Farbstein.

According to the American Cancer Society, liver cancer accounts for more than 700,000 deaths globally each year. HCC is commonly aggressive with poor survival rates. As new drugs that effectively and safely treat HCC are developed and approved, the market for HCC treatments is estimated by Delveinsight to reach $3.8 billion by 2027 for the G8 countries.

Can-Fite Issues Business Update: All Clinical Programs and Business Development Activities Remain Solidly on Track

https://finance.yahoo.com/news/fite-issues-business-clinical-programs-110000836.html

Company management updates about ongoing activities and progress

PETACH TIKVA, Israel, November 01, 2023--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today confirmed that all of the Company’s clinical and business development activities are ongoing and proceeding by both its Israeli and US based staff.

"Can-Fite remains focused and stronger than ever in our purpose to bring medications to market that improve and save lives. We are working closely with our US based executives, Dr. Bill Kerns and Dr. Michael Silverman, with all our consultants and our collaboration partners in Canada, Europe, the US, China and South Korea. All the investigators participating in the conductance of the clinical studies are working full force and continue patient enrolment for the ongoing advanced clinical studies," stated Dr. Pnina Fishman, Can-Fite’s Chief Scientific Officer and Executive Chairman. "Our business development activities are robust and we are receiving a high level of interest, in both Namodenoson and Piclidenoson, which we believe may lead to new pharma partnerships in the near-term."

The Company’s advanced-stage clinical pipeline includes two pivotal Phase III studies: an ongoing trial in advanced liver cancer and a psoriasis study that has been cleared by the U.S. Food and Drug Administration as well as the European Medicines Agency and is expected to commence enrollment shortly. Phase II trials include an ongoing study for steatotic liver disease (SLD), formerly known as NASH, and preparatory work is underway for a Phase IIa trial in pancreatic cancer.

Can-Fite’s latest value-driving developments include its entry into the rare genetic diseases market with Piclidenoson which was found to be effective in pre-clinical studies for the treatment of Lowe Syndrome, an estimated $100 million treatment market in the U.S. alone in which there is no therapeutic treatment option available. Through a partnership with Collaborations Pharmaceuticals, Can-Fite will now utilize artificial intelligence (AI) and machine learning (ML) techniques to identify next-generation A3 adenosine receptor drug agonists and significantly reduce development time and costs of bringing such drugs to market.

Can Fite: Namodenoson Inhibits Pancreatic Carcinoma Published in Leading Scientific Journal; Robust anti-Cancer Effect & Molecular Mechanism of Action

https://finance.yahoo.com/news/fite-namodenoson-inhibits-pancreatic-carcinoma-110000122.html

These data support namodenoson as a leading drug candidate to treat patients in an exploratory Phase II clinical study

PETACH TIKVA, Israel, October 30, 2023--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncology, inflammatory and liver diseases, today announced that Biomolecules, a peer-reviewed scientific journal focused on function and mechanism of bioactive molecules, published an article titled "Namodenoson Inhibits the Growth of Pancreatic Carcinoma via Deregulation of the Wnt/ß-catenin, NF-?B, and RAS Signaling Pathways", authored by Can-Fite’s CSO Dr. Pnina Fishman and others.

The article includes a summary on the robust inhibition of pancreatic carcinoma growth, both in vitro and in vivo and a definitive description of the molecular mechanism of action. The latter includes de-regulation of three signal transduction pathways known to play a pivotal role in the etiology and pathology of the disease, including the Wnt, NF-kB and the RAS signalling pathway. As a result, death of pancreatic carcinoma cells takes place via apoptosis. This mechanism is highly important since pancreatic carcinoma cells are resistant to the chemotherapy.

The Company is developing an exploratory Phase II study protocol that is designed to allow treatment of patients with pancreatic carcinoma who failed first line therapy. The study objectives will include safety and efficacy of the Namodenoson drug.

Currently, Namodenoson is being evaluated in a pivotal Phase III study that has been approved by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

"We are very much encouraged by the excellent data in the pre-clinical studies demonstrating the impressive anti-cancer effect of Namodenoson against pancreatic carcinoma," stated Dr. Fishman, Can-Fite’s Chief Scientific Officer and Executive Chairman. "We plan to start treating patients very shortly and hope that Namodenoson, with its positive safety and efficacy profile, will prolong life for pancreatic cancer patients."

Can-Fite to Harness Artificial Intelligence to Develop Novel Anti-Cancer Drugs


Can-Fite signed an agreement with Collaborations Pharmaceuticals, a leading expert in Artificial Intelligence and Machine Learning

PETACH TIKVA, Israel, October 26, 2023--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncology and inflammatory diseases, today announced that it entered into an agreement with Collaborations Pharmaceuticals, Inc. (CPI) to develop anti-cancer drugs utilizing artificial intelligence (AI) and machine learning (ML) techniques. This project will aim to develop a next-generation A3 adenosine receptor drug agonists that significantly reduce the development time and cost of bringing such drugs to market.

CPI will utilize, apply and use AI and ML tools, including their MegaSyn generative AI method, to design new molecules with high affinity and selectivity to the A3AR Can-Fite target. CPI will also perform the chemical synthesis of the newly designed molecules with the ultimate goal of developing novel and robust anti-cancer drug candidates. Can-Fite will perform the testing of the biological anti-cancer effects and validate the molecular mechanism of the novel, chemically synthesized drug candidates.

"Our vision is to deliver in silico small molecule drug candidates in a better and faster way to patients via a collaboration with Collaborations Pharmaceuticals. Our accumulated experience of bringing anti-cancer drugs which target the A3AR from lab to patients will be implemented into this AI drug development project," stated Prof. Pnina Fishman, Executive Chairman and CSO at Can-Fite.

"We are delighted that Can-Fite chose our team of experts for this AI-led drug discovery collaboration and look forward to demonstrating what our technology can do," said Sean Ekins, PhD, DSc., CEO and Founder of Collaborations Pharmaceuticals, Inc. We also look forward to complementing their outstanding scientific approach with our integrated technology platform and ability to generate novel and selective molecules."

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 profile with experience in over 1,600 patients in clinical studies to date. For more information please visit: www.can-fite.com.

About Collaborations Pharmaceuticals:
Collaborations Pharmaceuticals, Inc. developed MegaSyn for generative drug design. In addition they have developed Assay Central® software for data curation and machine learning as well as curated model collections such as MegaTox®, MegaTrans® and MegaPredict®. Collaborations Pharmaceuticals, Inc. performs research and development on innovative therapeutics for multiple rare and neglected diseases and consults for pharmaceutical and consumer product companies. For more information, http://www.collaborationspharma.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. 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 COVID-19 pandemic and the Russian invasion of Ukraine; 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 30, 2023 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20231026204622/en/

Contacts

Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114

Collaborations Pharmaceuticals, Inc.
Sean Ekins, PhD., D.Sc.
CEO and President
sean@collaborationsPharmaceuticals.com


Business Wire

Can-Fite to Share its Rare Genetic Disease Lowe Syndrome Novel Treatment with Orphan Drug Japanese Companies

https://finance.yahoo.com/news/fite-share-rare-genetic-disease-110000359.html

PETACH TIKVA, Israel, October 09, 2023--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncology, inflammatory and liver diseases, today announced that the Company’s Director of Business Development Dr. Sari Fishman will conduct virtually one-on-one meetings with Japanese companies specializing in the development of Orphan Drugs, at the BioJapan Conference held from October 11-13, 2023, in Yokohama, Japan https://jcd-expo.jp/en/.

Can-Fite signed recently an agreement with Fondazione Telethon for the co-development of Piclidenoson for the treatment of Lowe syndrome based on breakthrough findings of Dr. Antonella De Matteis that the Can-Fite drug Piclidenoson is efficacious in pre-clincial studies in treating Lowe Syndrome. FDA & EMA approvals for rare genetic diseases are faster and require clinical studies with smaller number of patients.

Additional meetings with Japanese companies who are interested in the Oncology and Dermatology Can-Fite’s indications will take place as well.

"The Lowe Syndrome is Can-Fite’s first rare genetic disease indication and I am happy that it raises high interest of Japanese companies who are experts in the orphan drug arena. The conference provides us with the opportunity to present our other developments to lead Japanese pharmaceutical companies," stated Dr. Sari Fishman, Director of Business Development at Can-Fite.

Can-Fite Novel Approach for the Treatment of Pancreatic Carcinoma with Namodenoson Receives Appreciation of the American Association of Cancer Research (AACR)

https://finance.yahoo.com/news/fite-novel-approach-treatment-pancreatic-110000987.html

Namodenoson robustly inhibits pancreatic carcinoma growth in pre-clinical studies, via inhibition of KRAS and Wnt pathways

Poster summarizing the inhibitory effect of Namodenoson in pancreatic carcinoma is presented today at the AACR conference

Exploratory Phase II pancreatic cancer study protocol has been developed and is to be submitted to ethical committees in Israel and the U.S.

PETACH TIKVA, Israel, September 27, 2023--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncology, inflammatory and liver diseases, today announced that its study titled "Namodenoson Inhibits the Growth of Pancreatic Carcinoma via De-regulation of the Wnt/ß-catenin Signaling Pathway" has been accepted for a poster presentation at the AACR Special Conference on Pancreatic Cancer, held from September 27-30, 2023, in Boston, Massachusetts.

The pre-clinical studies presented in the poster used advanced pancreatic carcinoma patient cells that were treated with Namodenoson both in tissue cultures and in in vivo studies. Namodenoson treatment resulted in a significant growth inhibition and de-regulation of two signal transduction pathways, the Wnt and the KRAS, both of which are responsible for the etiology and pathology of this devastating disease.

Can-Fite completed the development of an exploratory Phase II protocol in patients with pancreatic carcinoma who have failed first line treatment and plans to shortly submit it for approval to medical sites in Israel and the U.S. Safety and efficacy endpoints including objective response, progression-free survival, duration of response, disease control, and overall survival will be monitored.

"The robust inhibition of pancreatic carcinoma growth both in vitro and in vivo, together with the definitive mechanism of action is a strong basis for evaluating Namodenoson in patients with pancreatic carcinoma where chemotherapeutic drugs have a very limited effect. We are very happy that the AACR granted us the opportunity to present these encouraging data and to discuss the very important results with the leading global experts in this field," stated Prof. Pnina Fishman, CSO & Executive Chairman of Can-Fite.

About Pancreatic Cancer

The highest incidence rates for pancreatic cancer are in Asia, Europe, and North America. According to the American Society of Clinical Oncology (ASCO), in 2020, an estimated 496,000 people were diagnosed with pancreatic cancer globally and an estimated 466,000 died from the disease. The 5-year survival rate for people with pancreatic cancer in the U.S. is 11%. Acumen Research estimates the global pancreatic cancer therapeutics market was valued at approximately $3.6 billion in 2021 and is projected to grow to approximately $6.6 billion by 2030.

About Namodenoson

Namodenoson was evaluated in Phase 2 trials for two indications, as a second line treatment for hepatocellular carcinoma (HCC), and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). It is currently in a Phase 2b trial for steatotic liver disease and a pivotal Phase 3 for HCC. Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

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 profile with experience in over 1,600 patients in clinical studies to date. For more information please visit: www.can-fite.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. 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 COVID-19 pandemic and the Russian invasion of Ukraine; 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 30, 2023 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230927971749/en/

Contacts

Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114

Can-Fite to Share with Investors Latest Oncology and Rare Genetic Disease Developments at the H.C. Wainwright 25th Annual Conference

https://finance.yahoo.com/news/fite-share-investors-latest-oncology-110000778.html

Thu, September 7, 2023 at 2:00 PM GMT+3

PETACH TIKVA, Israel, September 07, 2023--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncology, inflammatory and liver diseases, today announced that the Company’s CEO Motti Farbstein will present at the H.C. Wainwright 25th Annual Conference. In addition to the presentation, he will conduct one-on-one meetings with investors at the conference.
Motti Farbstein will highlight Can-Fite’s advanced stage pipeline including the pancreatic carcinoma and the rare genetic disease Lowe Syndrome latest developments on September 11th. An updated company presentation has been uploaded to the company website.

The information in this preliminary prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and we are not soliciting an offer to buy these securities in any state or jurisdiction where the offer or sale is not permitted.

SUBJECT TO COMPLETION, DATED SEPTEMBER 1, 2023

$100,000,000 Ordinary Shares

American Depositary Shares representing Ordinary Shares

Warrants

Subscription Rights

Units

We may offer, issue and sell from time to time up to US$100,000,000, or its equivalent in any other currency, currency units, or composite currency or currencies, of our ordinary shares, including in the form of American Depositary Shares, or ADSs, warrants to purchase ordinary shares, including in the form of ADSs, subscription rights and a combination of such securities, separately or as units, in one or more offerings. Each ADS represents 300 ordinary shares. This prospectus provides a general description of offerings of these securities that we may undertake.

We refer to our ordinary shares, ADSs, warrants, subscription rights, and units, collectively as “securities” in this prospectus.



Each time we sell our securities pursuant to this prospectus, we will provide the specific terms of such offering in a supplement to this prospectus. The prospectus supplement may also add, update, or change information contained in this prospectus. You should read this prospectus, the accompanying prospectus supplement, together with the additional information described under the heading “Where You Can More Find Information About Us,” before you make your investment decision.



We may, from time to time, offer to sell the securities, through public or private transactions, directly or through underwriters, agents or dealers, on or off the NYSE American or Tel Aviv Stock Exchange Ltd., or the TASE, as applicable, at prevailing market prices or at privately negotiated prices. If any underwriters, agents or dealers are involved in the sale of any of these securities, the applicable prospectus supplement will set forth the names of the underwriter, agent or dealer and any applicable fees, commissions or discounts.



Our ADSs are listed on the NYSE American under the symbol “CANF”. On August 31, 2023, the closing price of our ADSs on the NYSE American was US2.94 per ADS. Our ordinary shares also trade on the Tel Aviv Stock Exchange, or TASE, under the symbol “CANF”. On August 31, 2023, the last reported sale price of our ordinary shares on the TASE was NIS 0.035 or $0.009 per share (based on the exchange rate reported by the Bank of Israel on the same day).




https://fintel.io/doc/sec-can-fite-biopharma-ltd-1536196-f3-2023-september-01-19601-217

Can-Fite Reports Second Quarter 2023 Financial Results & Progress in Two Pivotal Phase III Clinical Studies

https://finance.yahoo.com/news/fite-reports-second-quarter-2023-110000587.html

PETACH TIKVA, Israel, August 31, 2023--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncology, inflammatory and liver diseases, today announced financial results for the six months ended June 30, 2023.

Clinical Progress

Pivotal Phase III Advanced Liver Cancer Study—Can-Fite’s pivotal Phase III liver cancer study, Liveration, which continues enrollment is designed to assess Namodenoson in the treatment of patients with advanced hepatocellular carcinoma (HCC) and underlying Child Pugh B7 (CPB7) who have not responded to one or two other lines of therapy. The primary endpoint is overall survival. An interim analysis will be conducted by an Independent Data Monitoring Committee (IDMC) after 50% of the planned 450 patients are enrolled and treated.

Breakthrough Abstract Award–Can-Fite was recently granted a prestigious Breakthrough Abstract Award by the American Society of Clinical Oncology (ASCO) Conquer Cancer Foundation for the development of a novel approach to treat advanced liver cancer with the A3 adenosine receptor agonist, Namodenoson.

Exploratory Phase II Pancreatic Cancer Study—Can-Fite is preparing an open-label Phase II exploratory trial to assess the safety and efficacy of Namodenoson in the treatment of patients with pancreatic cancer who have received at least one previous systemic therapy. In pre-clinical studies, Namodenoson demonstrated a robust anti-growth effect against pancreatic carcinoma, reaching 90% growth inhibition. The mechanism of action entails de-regulation of the Wnt signal transduction pathway, a key modulator of pancreatic carcinoma cell growth.

ASCO Recognition—Can-Fite’s pancreatic cancer program received recognition from ASCO when its study titled "Effects of Namodenoson on Pancreatic Carcinoma: Preclinical Evidence" was published in the Journal of Clinical Oncology supplement of the 2023 ASCO Annual Meeting Proceedings.

Preparatory Work for Pivotal Phase III Psoriasis Study; Can Fite Received Green Light from FDA and EMA— Following positive responses from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for its registration plan and pivotal Phase III study protocol for Piclidenoson in the treatment of moderate to severe psoriasis, the Company is preparing for study initiation. The FDA requested two Phase III studies and also encouraged the Company to enroll adolescent patients due to Piclidenoson’s strong safety profile demonstrated over its development history and prior clinical studies. Can-Fite has submitted to the FDA a pediatric plan to allow the registration of Piclidenoson for the treatment of adolescents. Inclusion of adolescents for the psoriasis Indication is expected to broaden the market.

Development for Treatment of Lowe Syndrome, a Rare Genetic Disease—Researchers at the University of Naples Federico II and The Telethon Institute of Genetics and Medicine (TIGEM) in Italy found Piclidenoson to be effective in pre-clinical studies for the treatment of Lowe Syndrome. Can-Fite and Fondazione Telethon signed an agreement outlining their collaboration for the development of Piclidenoson for the treatment Lowe Syndrome, a rare genetic disease with no treatment available, and an estimated $100 million treatment market in the U.S. alone.

"With two ongoing studies and two more about to commence in large treatment markets with unmet needs, we continue to advance our late-stage development pipeline to bring our potentially game-changing drugs to market," stated Can-Fite CEO & CFO Motti Farbstein.

Dr. Pnina Fishman, Can-Fite’s CSO and Executive Chairman added, "We are particularly excited about our entry into the rare genetic disease field with the discovery of Piclidenoson’s efficacy in Lowe Syndrome in pre-clinical studies. Given Piclidenoson’s very favorable safety profile, we believe it will be a good candidate for directly entering advanced stage trials in children and adolescents living with Lowe Syndrome. Rare genetic diseases can have a more direct rapid path to regulatory approval with smaller trial sizes due to the pressing need in a small, unserved patient population. "

Financial Results

Revenues for the six months ended June 30, 2023 were $0.39 million compared to revenues of $0.41 million during the six months ended June 30, 2022. Revenues for the six months ended June 30, 2023 and June 30, 2022 comprised of recognition of a portion of advance payments received under distribution agreements with Gebro, CKD, Cipher and Ewopharma.

Research and development expenses for the six months ended June 30, 2023 were $3.41 million compared with $3.27 million for the same period in 2022. Research and development expenses for the first half of 2023 comprised primarily of expenses associated with the completion 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 SLD. The increase is primarily due to an increase in expenses associated with Namodenoson.

General and administrative expenses were $1.47 million for the six months ended June 30, 2023 compared to $1.57 million for the same period in 2022. The decrease is primarily due to the decrease in public and investor relations expenses and in directors and officer’s insurance policy premium. We expect that general and administrative expenses will remain at the same level through 2023.

Financial income, net for the six months ended June 30, 2023 was $0.27 million compared to financial expense, net of $0.18 million for the same period in 2022. The decrease in financial expense, net was mainly due to revaluation of our short-term investment and increase in interest income from deposits in 2023.

Net loss for the six months ended June 30, 2023 was $4.22 million compared with a net loss of $4.62 million for the six months ended June 30, 2022. The decrease in net loss for the six months ended June 30, 2023 was primarily attributable to the increase in finance income, net.

As of June 30, 2023, Can-Fite had cash and cash equivalents and short term deposits of $9.60 million as compared to $7.98 million at December 31, 2022. The decrease in cash during the six months ended June 30, 2023 is due to the ongoing operations of the Company.

The Company's consolidated financial results for the six months ended June 30, 2023 are presented in accordance with US GAAP Reporting Standards.

CONSOLIDATED BALANCE SHEETS
U.S dollars in thousands (except for share and per share data)

June 30,

December 31,

2023

2022

Unaudited

ASSETS

CURRENT ASSETS:

Cash and cash equivalents

$

3,458

$

2,978

Short term deposits

6,147

5,001

Prepaid expenses and other current assets

1,293

1,170

Short-term investment

11

8

Total current assets

10,909

9,157

NON-CURRENT ASSETS:

Operating lease right of use assets

87

84

Property, plant and equipment, net

36

42

Total non-current assets

123

126

Total assets

$

11,032

$

9,283

CONSOLIDATED BALANCE SHEETS
U.S dollars in thousands (except for share and per share data)

June 30,

December 31,

2023

2022

Unaudited

LIABILITIES AND SHAREHOLDERS’ EQUITY

CURRENT LIABILITIES:

Trade payables

$

810

$

896

Current maturity of operating lease liability

44

48

Deferred revenues

783

783

Other accounts payable

596

775

Total current liabilities

2,233

2,502

NON-CURRENT LIABILITIES:

Long-term operating lease liability

22

14

Deferred revenues

1,903

2,295

Total long-term liabilities

1,925

2,309

CONTIGENT LIABILITIES AND COMMITMENTS

SHAREHOLDERS’ EQUITY:

Ordinary shares of no-par value - Authorized: 5,000,000,000 shares at June 30, 2023 and December 31, 2022; Issued and outstanding: 1,224,837,393 and 815,746,293 shares as of June 30, 2023 and December 31, 2022

-

-

Additional paid-in capital

160,814

154,192

Accumulated other comprehensive income

1,127

1,127

Accumulated deficit

(155,067

)

(150,847

)

Total equity

6,874

4,472

Total liabilities and shareholders’ equity

$

11,032

$

9,283

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
U.S dollars in thousands (except for share and per share data)

Six months ended

June 30,

2023

2022

Unaudited

Revenues

$

392

$

409

Research and development expenses

(3,417

)

(3,273

)

General and administrative expenses

(1,471

)

(1,576

)

Operating loss

(4,496

)

(4,440

)

Total financial income (expense), net

276

(185)

Net loss

(4,220

)

(4,625

)

Basic and diluted net loss per share

(0.00

)

(0.00

)

Weighted average number of ordinary shares used in computing basic and diluted net loss per share

1,202,110,110

815,746,293

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 profile with experience in over 1,600 patients in clinical studies to date. For more information please visit: www.can-fite.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. 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 COVID-19 pandemic and the Russian invasion of Ukraine; 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 30, 2023 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230831472440/en/

Contacts

Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114

Can-Fite Enters Rare Genetic Disease Field Based on impactful findings of a Fondazione Telethon and Naples University Researcher showing Piclidenoson is efficacious in Treating Lowe Syndrome

https://finance.yahoo.com/news/fite-enters-rare-genetic-disease-111000088.html

Can-Fite Signed agreement with Fondazione Telethon for co-development of Piclidenoson for the treatment of Lowe syndrome an estimated $100 M market in the U.S. only with no drug available

FDA & EMA approvals for rare genetic diseases are fast and require clinical studies with small number of patients

Dr. Antonella De Matteis, Professor of Biology, Department of Molecular Medicine and Medical Biotechnology at the University of Naples Federico II, and Program Coordinator of the Cell Biology and Disease Mechanisms at The Telethon Institute of Genetics and Medicine (TIGEM) in Italy

PETACH TIKVA, Israel, August 24, 2023--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, announced today it plans to develop its lead drug candidate, Piclidenoson, for the treatment of Lowe Syndrome based on recent efficacy findings by Dr. Antonella De Matteis, Professor of Biology, Department of Molecular Medicine and Medical Biotechnology at the University of Naples Federico II, and Program Coordinator of the Cell Biology and Disease Mechanisms at The Telethon Institute of Genetics and Medicine (TIGEM) in Italy. Can-Fite and Fondazione Telethon have signed an agreement outlining their collaboration for the development of Piclidenoson for the treatment of Lowe Syndrome, a high medical need with no drug available. Fondazione Telethon is an Italian nonprofit organization whose mission is to advance biomedical research toward the diagnosis, cure, and prevention of genetic diseases, and it established TIGEM in 1994.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230824833299/en/


Lowe Syndrome, also known as oculo-cerebro-renal syndrome (OCRL), an X-linked genetic condition occurring almost exclusively in males, is a multisystem disorder characterized by vision problems including clouding of the lenses of the eyes (cataracts) that are present at birth, kidney problems that usually develop in the first year of life, and brain abnormalities associated with intellectual disabilities, and a life span that rarely exceeds 40 years. Lowe Syndrome prevalence is estimated at approximately 1 in 500,000. (Graphic: Business Wire)

Lowe Syndrome, also known as oculo-cerebro-renal syndrome (OCRL), an X-linked genetic condition occurring almost exclusively in males, is a multisystem disorder characterized by vision problems including clouding of the lenses of the eyes (cataracts) that are present at birth, kidney problems (consisting in urinary loss of proteins and solutes) that usually develop in the first year of life, and brain abnormalities associated with intellectual disabilities, and a life span that rarely exceeds 40 years. Lowe Syndrome prevalence is estimated at approximately 1 in 500,000.

"Having tested thousands of compounds in search of a treatment for Lowe Syndrome, Piclidenoson is the only compound we’ve found to date that has shown to be effective in pre-clinical studies. Importantly, we observed that Piclidenoson treatment in mouse models of Lowe syndrome leads to a significant decrease of the urinary loss of proteins in diseased animals," Dr. De Matteis stated. "We chose to investigate Piclidenoson based on the availability of extensive scientific data showing its excellent safety, coupled with efficacy in this disease which involves renal, cerebral, and ocular manifestations."

Can-Fite Chairman Dr. Pnina Fishman commented, "We are hopeful that Piclidenoson can offer a much needed treatment for infants, children, and young people living with Lowe Syndrome. Based on Piclidenoson’s proven safety profile in clinical trials to date, and because Lowe is a rare disease in dire need of treatment, we plan to move into an advanced stage clinical study which may open a path to approval. Dr. De Matteis and her team have made an impactful discovery with Piclidenoson and we look forward to working with her and Fondazione Telethon."

Can-Fite estimates the total addressable market for the treatment of Lowe Syndrome at approximately $100 million in the U.S. alone, based on incidence and cost of treatment for other rare genetic pediatric syndromes. The Company is not aware of any drug candidates currently in development for the systemic treatment of Lowe Syndrome.

As a rare genetic pediatric disorder, Lowe Syndrome may qualify for Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), granting special development status to accelerate development at a reduced cost. The FDA’s Orphan Drug designation grants 7 years of market exclusivity, tax credits, waiver of the Prescription Drug User Fee Amendments fee (currently $3.1 million in 2022), and access to additional grants and support from the FDA. Piclidenoson for the treatment of Lowe Syndrome may also qualify for the FDA’s Rare Pediatric Disease Priority Review Voucher, granting an accelerated review process for marketing approval.

About Fondazione Telethon

Fondazione Telethon ETS is one of the main Italian biomedical charities, founded in 1990 on the initiative of a group of patients suffering from muscular dystrophy. Its mission is to achieve the cure of rare genetic diseases through scientific research of excellence, selected according to the best practices shared internationally. Through a unique method in the Italian panorama, it follows the entire "research chain" dealing with fundraising, selection and funding of projects and the research activity itself carried out in the centers and laboratories of the Foundation. Telethon also develops collaborations with public health institutions and pharmaceutical industries to translate the results of research into therapies accessible to patients. Since its foundation, Telethon has invested more than 660 million euros in research, has funded 2,960 projects with 1,720 researchers involved and 630 diseases studied. To date, thanks to Fondazione Telethon, the first gene therapy with stem cells in the world has been made available, thanks to the collaboration with the pharmaceutical industry. This therapy is intended for the treatment of ADA-SCID, a severe immunodeficiency that compromises the body's defenses from birth. In 2023, Fondazione Telethon became responsible for the production and distribution of the drug to eligible patients in the European Union

Another gene therapy resulting from Telethon research made available is the one for a serious neurodegenerative disease, metachromatic leukodystrophy. This therapeutic approach is in an advanced stage of development for another immunodeficiency, Wiskott-Aldrich syndrome. Other diseases on which the gene therapy developed by Telethon researchers has been evaluated in patients are beta thalassemia and two metabolic diseases of childhood, mucopolysaccharidosis type 6 and type 1. In addition, within the Telethon institutes a targeted therapeutic strategy is being studied or developed for other genetic diseases, such as hemophilia or various hereditary vision defects. In parallel, the study of basic mechanisms and potential therapeutic approaches for diseases still unanswered continues in all laboratories funded by Telethon.

About Piclidenoson

Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with an excellent safety profile demonstrating evidence of efficacy in Phase II and Phase III clinical studies. The drug’s mechanism of action entails inhibition of the inflammatory cytokines interleukin 17 and 23 (IL-17 and IL-23) and the induction of apoptosis of patients’ skin cell keratinocytes involved with the disease pathogenicity.

Can-Fite Submitted to FDA a Pediatric Plan to Allow Registration of Piclidenoson for the Treatment of Adolescents with Psoriasis

https://finance.yahoo.com/news/fite-submitted-fda-pediatric-plan-110000850.html

FDA encouraged the Company to enroll adolescent patients due to Piclidenoson’s good safety profile

There is an unmet need for safe, convenient, and effective drugs to treat chronic plaque psoriasis in the adolescents

PETACH TIKVA, Israel, August 18, 2023--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncology, inflammatory, and liver diseases, today announced that it submitted a pediatric study plan to the U.S. Food and Drug Administration (FDA) for the treatment of adolescents suffering from psoriasis with Piclidenoson.

The plan has been submitted to allow enrollment of adolescents with psoriasis to Can-Fite’s upcoming two Phase 3 pivotal clinical psoriasis studies, aiming at registration of Piclidenoson with both the FDA and the European Medicines Agency (EMA) for the treatment of plaque psoriasis.

There is a high market need for a safe and efficacious drug for the treatment of adolescents who suffer from psoriasis. There are a couple of small molecule or biological drugs on the market in use for adolescents with psoriasis, all have safety issues and are not satisfactory regarding the efficacy. Therefore, there is a high market need which will enable Can-Fite to position Piclidenoson with its favorable safety and good efficacy as a treatment for this chronic and devastating disease.

Can-Fite believes the inclusion of adolescent patients in one or both of the Phase 3 studies significantly broadens any future market launch potential of the drug. Psoriasis affects millions of people worldwide, including a significant number of adolescents who endure the physical and emotional burden of this challenging disease.

"Based on the FDA’s recommendation to enroll adolescents into the upcoming Phase 3 psoriasis trials, we believe Piclidenoson’s oral formulation with an excellent safety record, combined with its progressive effectiveness over time, make it ideally suited for the chronic treatment of psoriasis in adults and adolescents alike," stated Can-Fite CEO & CFO Motti Farbstein.

Presenting on the Emerging Growth Conference on August 9 & 10 Register Now

https://finance.yahoo.com/news/presenting-emerging-growth-conference-august-110000739.html

MIAMI, Aug. 08, 2023 (GLOBE NEWSWIRE) -- EmergingGrowth.com a leading independent small cap media portal announces the schedule of the 60th Emerging Growth Conference on August 9, 10, 2023.

The Emerging Growth Conference identifies companies in a wide range of growth sectors, with strong management teams, innovative products & services, focused strategy, execution, and the overall potential for long-term growth.

Register for the conference here.

Submit Questions for any of the presenting companies to:
Questions@EmergingGrowth.com

For updates, follow us on Twitter

Day 1
August 9, 2023

10:00
Virtual Lobby opens.
Register for the Conference. If you already registered, go back to the registration link and click “Already registered” and enter your email.

10:10
Introduction

10:15 – 10:45
Longeveron (NASDAQ: LGVN)
Mohamed Wa’el Ahmed Hashad, CEO & Director

10:50 – 11:20
ASP Isotopes, Inc. (NASDAQ: ASPI)
Paul Elliot Mann, CEO & Chairman

11:25 – 11:55
Alpha Tau Medical, Ltd. (NASDAQ: DRTS, DRTSW)
Raphi Levy, CFO

12:00 – 12:30
Kintara Therapeutics, Inc. (NASDAQ: KTRA)
Robert Hoffman CEO

12:35 – 1:05
Sigyn Therapeutics, Inc. (OTCQB: SIGY)
James Allen Joyce, CEO

2:40 – 2:50
dynaCERT Inc. (OTCQB: DYFSF) (TSX: DYA)
James Payne President / CEO & Director

2:55 – 3:05
Willow Biosciences, Inc. (OTCQB: CANSF) (TSX: WLLW)
Dr. Chris Savile, President / CEO

3:10 – 3:20
Intellabridge Technology Corporation (OTCQB: KASHF) (CSE: KASH) (FSE: KASH)
John Eagleton, CEO

Day 2
August 10, 2023

10:00
Virtual Lobby opens.
Register for the Conference. If you already registered, go back to the registration link and click “Already registered” and enter your email.

10:10
Introduction

10:15 – 10:45
22nd Century Group, Inc. (NASDAQ: XXII)
Jim Mish, CEO

10:50 – 11:20
Jaguar Health, Inc. (NASDAQ: JAGX)
Lisa A. Conte, Founder / CEO / President & Director

11:25 – 11:55
Regen BioPharma Inc. (OTC Pink: RGBP)
David Koos, President / CEO & Harry M. Lander, Ph.D. Senior Scientific Consultant

Postponed
Odyssey Health Inc. (OTC Pink: ODYY)
Erik Emerson, CCO

1:10 – 1:40
Big Screen (OTC Pink: BSEG)
Kimberely Kates, CEO

1:45 – 2:15
Renforth Resources, Inc. (OTCQB: RFHRF) (CSE: RFR)
Nicole Brewster, President & CEO

2:40 – 2:50
ClearOne (NASDAQ: CLRO)
Derek Graham, CEO & Narsi Narayanan, CFO

2:55 – 3:05
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF)
Motti Farbstein, COO & CFO

On July 31, 2023, Can-Fite BioPharma Ltd. (the “Company”) convened the Annual General Meeting of Shareholders (the “Annual General Meeting”), however, the Annual General Meeting was adjourned for one week to the same day, time and place due to lack of quorum. Accordingly, the Company’s Annual General Meeting will be reconvened on Monday, August 7, 2023 at 3:00p.m., Israel time at the Company’s offices located at 10 Bareket Street, Petach Tikva, Israel.

Can-Fite: Granted Breakthrough Abstract Award for Namodenoson in Treatment of Advanced Liver Cancer by ASCO Conquer Cancer Foundation

https://finance.yahoo.com/news/fite-granted-breakthrough-abstract-award-110000477.html

Can-Fite’s novel approach for the treatment of advanced liver cancer will be presented at the American Society of Clinical Oncology (ASCO) Breakthrough Meeting in Japan on August 4th 2023

Namodenoson is in pivotal Phase 3 study for the treatment of advanced hepatocellular carcinoma (HCC)

A patient from the prior Phase 2b study is cancer-free >6 years following initial treatment with Namodenoson

PETACH TIKVA, Israel, July 17, 2023--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncology, inflammatory and liver diseases, today announced its abstract titled "A novel approach for the treatment of advanced hepatocellular carcinoma (HCC)" is one of the highest scoring abstracts and has won the prestigious Breakthrough Abstract Award from Conquer Cancer®, the ASCO Foundation, and the 2023 ASCO Breakthrough Program Committee.

Can-Fite’s Chief Scientific Officer, Founder, and Executive Chairman, Dr. Pnina Fishman, will present the poster at the ASCO Breakthrough Meeting which will take place August 3 – 5, 2023 in Yokohama, Japan.

Namodenoson has received significant acknowledgment in the scientific and medical community, as evidenced by the numerous peer-reviewed publications and conferences in which it has been published and presented. Currently being evaluated in a pivotal Phase 3 multinational registration trial for the treatment of HCC and underlying Child Pugh B7, Namodenoson has also completely cleared cancer in an HCC patient who was enrolled in Can-Fite’s Phase 2b HCC trial. The patient continues to be treated through a compassionate use program in Romania, where she remains cancer-free more than six years following her first dose of Namodenoson.

"We are honored to receive this prestigious award from Conquer Cancer and ASCO," Dr. Fishman stated. "Our Phase 3 registration trial is designed to treat patients who have tried, yet not benefitted from the few other FDA-approved HCC treatments on the market today. We are hopeful that Namodenoson, with its liver-protective properties, can safely prolong life for advanced liver cancer patients."

Can-Fite to Present at the Emerging Growth Conference on July 13, 2023

https://finance.yahoo.com/news/fite-present-emerging-growth-conference-110000578.html

Can-Fite invites individual and institutional investors as well as analysts to attend its real-time, interactive presentation at the Emerging Growth Conference

PETACH TIKVA, Israel, July 07, 2023--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncology, inflammatory, and liver diseases, today announced it has been invited to present at the Emerging Growth Conference on Thursday, July 13, 2023 at 11:25 AM ET.

This live, interactive online event will give existing shareholders and the investment community the opportunity to interact with Can-Fite’s CEO, Motti Farbstein, in real time.

Mr. Farbstein will present and subsequently open the floor for questions. Please submit your questions in advance to Questions@EmergingGrowth.com or ask your questions during the event and Mr. Farbstein will do his best to get through as many of them as possible.

Please register here LINK to ensure you are able to attend the conference and receive any updates that are released.

If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available on EmergingGrowth.com and on the Emerging Growth YouTube Channel, http://www.YouTube.com/EmergingGrowthConference. We will release a link to that after the event.

Can-Fite Receives U.S. FDA’s Go Ahead for Piclidenoson Psoriasis Registration Plan

FDA encouraged the Company to enroll adolescent patients due to the strong safety profile of the drug demonstrated over the development history and prior clinical studies

https://www.businesswire.com/news/home/20230629172102/en/Can-Fite-Receives-U.S.-FDA%E2%80%99s-Go-Ahead-for-Piclidenoson-Psoriasis-Registration-Plan/

June 29, 2023 07:00 AM Eastern Daylight Time

PETACH TIKVA, Israel--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncology, inflammatory, and liver diseases, today announced that it received feedback and advice from the U.S. Food and Drug Administration (FDA) with respect to non-clinical and clinical development and registration plans for Piclidenoson for the treatment of patients with moderate to severe plaque psoriasis.
The FDA had a positive view of the non-clinical studies conducted by the Company and the accumulated safety data that the Company submitted to the agency as part of the registration plan.

The FDA provided advice on the randomized, double-blind, placebo-controlled Phase 3 clinical trial protocol with Piclidenoson that is aimed at demonstrating clinical safety and efficacy for the treatment of patients with moderate to severe plaque psoriasis. The FDA requested two Phase 3 safety and efficacy studies and also encouraged the Company to enroll adolescent patients due to the strong safety profile of the drug demonstrated over the development history and prior clinical studies. To harmonize the requests of the European Medicines Agency (EMA) and the FDA, Can-Fite plans to conduct two Phase 3 studies in parallel, including adolescent patients.

Can-Fite believes the inclusion of adolescent patients in one or both of the Phase 3 studies significantly broadens the market launch potential of the drug. Psoriasis affects millions of people worldwide, including a significant number of adolescents who endure the physical and emotional burden of this challenging disease. There are limited treatment options available for adolescent patients in the U.S. Otezla is not approved for use in adolescents, and existing oral options include steroids and off-label use of retinoids (acitretin) and methotrexate, both of which carry significant safety and tolerability issues for teenagers. The Company believes that Piclidenoson represents a promising oral option for this underserved population.

Upon positive conclusion of the Phase 3 program, the Company plans to submit a New Drug Application (NDA) to the U.S. FDA and Marketing Authorization Plan (MAA) to the EMA.

“We are delighted to share the positive feedback that we received from the U.S. FDA and we believe that Piclidenoson’s oral dosage and excellent safety record, combined with its progressive effectiveness over time, make it ideally suited for the chronic treatment of psoriasis,” stated Can-Fite CEO Dr. Pnina Fishman.

Can-Fite up 6% premarket on planned IND for pancreatic cancer candidate

Jun. 13, 2023 8:01 AM ETCan-Fite BioPharma Ltd. (CANF)

By: Jonathan Block, SA News Editor

Can-Fite BioPharma (NYSE:CANF) said it is preparing to submit an Investigational New Drug (IND) application to the US FDA for its pancreatic cancer candidate namodenoson.

The Israeli biotech's stock is up 6% in premarket trading.

With the submission, the company will begin an open-label phase 2 trial of namodenoson in pancreatic cancer patients who have been on at least one prior therapy.

Can-Fite (CANF) is also enrolling patients in a phase 3 trial of namodenoson for hepatocellular carcinoma.

Seeking Alpha's Quant Rating views the company as a strong sell.

Can-Fite to Submit IND for the Treatment of Pancreatic Cancer Patients with Namodenoson

https://finance.yahoo.com/news/fite-submit-ind-treatment-pancreatic-110000402.html

Namodenoson’s robust effect reached 90% inhibition of pancreatic cancer growth in pre-clinical studies

PETACH TIKVA, Israel, June 13, 2023--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncology, inflammatory, and liver diseases, today announced that it is doing all the preparatory work for an FDA Investigational New Drug (IND) submission for the treatment of pancreatic carcinoma with Namodenoson.

Pre-clinical studies demonstrate a robust dose dependent anti-proliferative effect of Namodenoson on pancreatic carcinoma cells originating from both male and female patients, reaching 90% growth inhibition.

An open-label Phase 2 exploratory trial to assess the safety and efficacy of Namodenoson in the treatment of patients with pancreatic cancer who have received at least one previous systemic therapy will be initiated. The study will enroll patients in Israel at the Rabin Medical Center and will be conducted by Dr. Salomon Stemmer, an oncology key opinion leader and Professor at the Institute of Oncology, Rabin Medical Center, Israel. Patients will receive Namodenoson at a dose of 25 mg orally, twice daily. Study endpoints will include safety, objective response, progression-free survival, duration of response, disease control (defined as an objective response or stable disease), and overall survival.

The IND submission will cross reference all the data previously shared with the FDA related to the development of Namodenoson for the treatment of advanced liver cancer. Can-Fite is currently enrolling patients in a pivotal Phase 3 study in hepatocellular carcinoma, in agreement with both the FDA and the European Medicines Agency (EMA).

"We are making progress towards Namodenoson’s first clinical trial in pancreatic carcinoma. Once this study is underway, Can-Fite’s pipeline will include two oncology indications with Namodenoson in clinical trials. We hope our oral anti-cancer drug, with its good safety and robust anticancer effect, will help and support patients with this devastating disease," stated Can-Fite CEO Dr. Pnina Fishman.

The highest incidence rates for pancreatic cancer are in Asia, Europe, and North America. According to the American Society of Clinical Oncology (ASCO), in 2020, an estimated 496,000 people were diagnosed with pancreatic cancer globally and an estimated 466,000 died from the disease. The 5-year survival rate for people with pancreatic cancer in the U.S. is 11%. Acumen Research estimates the global pancreatic cancer therapeutics market was valued at approximately $3.6 billion in 2021 and is projected to grow to approximately $6.6 billion by 2030.

About Namodenoson

Namodenoson was evaluated in Phase 2 trials for two indications, as a second line treatment for hepatocellular carcinoma (HCC), and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). It is currently in a Phase 2b trial for NASH, a pivotal Phase 3 for HCC, and is headed into a Phase 2a for pancreatic cancer. Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

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 anti-inflammatory drug, Piclidenoson reported topline results in a Phase 3 trial for psoriasis and is expected to commence a pivotal Phase 3. Can-Fite's cancer and liver drug, Namodenoson, is being evaluated in a Phase 2b trial for the treatment of non-alcoholic steatohepatitis (NASH), a Phase 3 trial for hepatocellular carcinoma (HCC) is enrolling patients, and the Company is planning 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 1,500 patients in clinical studies to date. For more information please visit: www.can-fite.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. 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 COVID-19 pandemic and the Russian invasion of Ukraine; 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 30, 2023 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230613143878/en/

Contacts

Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114

Seems nobody is interested in partnering with CANF.
No surprise though!

Can-Fite to Participate in Out-licensing and Distribution Partnering Meetings at Bio International Convention in Boston

https://finance.yahoo.com/news/fite-participate-licensing-distribution-partnering-110000323.html

PETACH TIKVA, Israel, June 02, 2023--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncology, inflammatory and liver diseases, today announced its VP of Business Development, Dr. Sari Fishman, will participate in numerous partnering meetings at the Bio International Convention in Boston, Massachusetts on June 5-8, 2023.

Can-Fite currently has out-licensing and distribution deals with six pharma companies across North America, Europe, and Asia, which include upfront and milestone payments. The Company’s growing slate of indications and advanced pipeline are attracting increased interest from additional potential partners. Focusing on its core expertise in clinical development, Can-Fite pursues a strategy of partnering with companies in specific geographic markets that specialize in pharmaceutical distribution and regional regulatory approval.

Can-Fite’s pipeline of indications includes:

Psoriasis

Headed into pivotal Phase 3 market registration trial

Liver Cancer

Pivotal Phase 3 market registration trial

NASH

Phase 2b

Pancreatic Cancer

Headed into Phase 2a

Erectile Dysfunction

Preclinical

Cannabinoids

Preclinical

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 anti-inflammatory drug Piclidenoson reported topline results in a Phase 3 trial for psoriasis and is expected to commence a pivotal Phase 3. Can-Fite's cancer and liver drug, Namodenoson, is being evaluated in a Phase 2b trial for the treatment of non-alcoholic steatohepatitis (NASH), enrollment is expected to commence in a Phase 3 trial for hepatocellular carcinoma (HCC), and the Company is planning 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 1,500 patients in clinical studies to date. For more information please visit: www.can-fite.com.

Can-Fite Reports First Quarter 2023 Financial Results & Provides Clinical Update

https://finance.yahoo.com/news/fite-reports-first-quarter-2023-110000043.html

PETACH TIKVA, Israel, June 01, 2023--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncology, inflammatory and liver diseases, today announced financial results for the three months ended March 31, 2023.

Clinical and Corporate Development Highlights Include:

NAMODENOSON

Oncology

Pivotal Phase 3 Liver Cancer Study—Can-Fite’s ongoing pivotal Phase 3 liver cancer study is designed to assess Namodenoson in the treatment of patients with advanced hepatocellular carcinoma (HCC) and underlying Child Pugh B7 (CPB7) who have not responded to 1 or 2 other lines of therapy. The primary endpoint is overall survival. An interim analysis will be performed.

During the first quarter, a study titled "Targeting the A3 adenosine receptor to treat hepatocellular carcinoma: anti-cancer and hepatoprotective effects" was published in the peer-reviewed journal Purinergic Signalling.

Phase 2a Pancreatic Cancer Study—Can-Fite is preparing for an open-label Phase 2 exploratory trial to assess the safety and efficacy of Namodenoson in the treatment of patients with pancreatic cancer who have received at least one previous systemic therapy. Safety and efficacy endpoints including objective response, progression-free survival, duration of response, disease control, and overall survival will be monitored. The study will be conducted by Dr. Salomon Stemmer, an oncology key opinion leader and Professor at the Institute of Oncology, Rabin Medical Center, Israel. In pre-clinical studies, Namodenoson had a significant anti-cancer effect in pancreatic carcinoma as a monotherapy and an additive effect when combined with gemcitabine, the standard-of-care chemotherapy for pancreatic cancer. The mechanism of action entails de-regulation of the Wnt signal transduction pathway, a key modulator of pancreatic carcinoma cell growth.

Can-Fite filed a patent application that covers the use of Namodenoson for the treatment of pancreatic cancer. Moreover, Can-Fite’s pancreatic cancer program received recognition from ASCO when its study titled "Effects of Namodenoson on Pancreatic Carcinoma: Preclinical Evidence" was published in the Journal of Clinical Oncology supplement of the 2023 ASCO Annual Meeting Proceedings.

Pancreatic cancer is an unmet medical need. According to the American Society of Clinical Oncology (ASCO), in 2020, an estimated 496,000 people were diagnosed with pancreatic cancer globally and an estimated 466,000 died from the disease. The 5-year survival rate for people with pancreatic cancer in the U.S. is 11%. Acumen Research estimates the global pancreatic cancer therapeutics market was valued at approximately $3.6 billion in 2021 and is projected to grow to approximately $6.6 billion by 2030.

Liver Diseases

Phase 2b NASH Study—A Phase 2b NASH study is currently ongoing to evaluate Namodenoson’s efficacy as compared to placebo, determined by a histological endpoint. Namodenoson met its primary endpoint of reducing liver fat, inhibiting fibrosis, and demonstrating an anti-inflammatory effect in a prior Phase 2a NASH study.

Compassionate Use in Patients with Decompensated Liver Cirrhosis—Based on data showing that Namodenoson has liver protective effects, Namodenoson is now given to patients with decompensated cirrhosis, an advanced form of cirrhosis associated with liver failure for which there are no therapeutic options other than liver transplantation. Patients will be treated with Namodenoson at the Soroka Medical Center in Israel under compassionate use.

Decompensated cirrhosis is an acute deterioration in liver function in patients with cirrhosis, characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome, or variceal hemorrhage. This is an unmet medical need and there is no therapeutic approach that has shown efficacy in slowing disease progression. An estimated 10.6 million people globally had decompensated cirrhosis in 2017, with few treatment options available aside from liver transplants if the decompensated cirrhosis has reached an advanced stage. The treatment of liver cirrhosis in the U.S. is estimated to become an approximately $15 billion market by 2030.

PICLIDENOSON

Green Light from EMA for a Pivotal Phase 3 Psoriasis Study—The European Medicines Agency (EMA) gave Can-Fite a positive opinion on its registration plan for a pivotal Phase 3 clinical trial for Piclidenoson in the treatment of moderate to severe psoriasis. The pivotal study and the safety of the 3 mg twice daily dose of Piclidenoson are accepted by the agency.

Can-Fite has submitted a comparable data package to the U.S. Food and Drug Administration (FDA) and expects a similar response.

Corporate Developments

New Management Structure as Advanced Stage Pipeline Moves Toward Commercialization—Effective June 30, 2023, executive changes go into effect to support the Company’s continued success. Motti Farbstein will lead Can-Fite as Chief Executive Officer and continue to serve as its Chief Financial Officer. Dr. Pnina Fishman, Can-Fite’s Scientific Founder, will move from her position as CEO to become Executive Chairman of the Board as well as continuing to serve as Chief Scientific Officer.

Raised $7.5 Million—In January 2023, Can-Fite raised $7.5 million through a concurrent registered direct offering and private placement. The Company’s cash and equivalents on March 31, 2023 was $12.4 million and is expected to cover all clinical development programs and general and administrative expenses for more than a year from the date of this press release.

"During 2023 we plan to increase our efforts towards establishing additional distribution deals and partnerships. We continue to make progress with our two main indications, liver cancer and psoriasis, as we open additional avenues with niche indications based on evidence of the efficacy and safety of our drugs," stated Can-Fite CEO Dr. Pnina Fishman.

Financial Results

Revenues for the three months ended March 31, 2023 were $0.19 million, a decrease of $0.01 million, or 4.40%, compared to $0.20 million for the three months ended March 31, 2022. The decrease in revenues is considered to be immaterial.

Research and development expenses for the three months ended March 31, 2023 were $2.06 million, an increase of $0.24 million, or 13.17%, compared to $1.82 million for the three months ended March 31, 2022. Research and development expenses for the first quarter of 2023 comprised primarily of expenses associated with the completion 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 NASH. The increase is primarily due to an increase in expenses associated with Namodenoson.

General and administrative expenses for the three months ended March 31, 2023 were $0.84 million an increase of $0.09 million, or 12.33%, compared to $0.75 million for the three months ended March 31, 2022. The increase is primarily due to the increase in travel expenses and increase in accrued bonuses to the Company’s employees. We expect that general and administrative expenses will remain at the same level through 2023.

Financial income, net for the three months ended March 31, 2023 was $0.16 million compared to finance expense, net of $0.06 million for the three months ended March 31, 2022. The increase in financial income, net was mainly due to exchange rate differences which in 2023 was recorded as income and in 2022 was recorded as expense and revaluation of our short-term investment which in 2023 was recorded as income and in 2022 was recorded as expense.

Net loss for the three months ended March 31, 2023 was $2.55 million compared with a net loss of $2.43 million for the three months ended March 31, 2022. The increase in net loss for the three months ended March 31, 2023 was primarily attributable to an increase in research and development expenses which was partly offset by an increase in finance income, net.

As of March 31, 2023, Can-Fite had cash and cash equivalents and short term deposits of $12.4 million as compared to $7.98 million at December 31, 2022. The increase in cash during the three months ended March 31, 2023 is due to the issuance of share capital and warrants which was offset by ongoing operations of the Company.

The Company's consolidated financial results for the three months ended March 31, 2023 are presented in accordance with US GAAP Reporting Standards.

Can-Fite: Namodenoson’s Inhibition of Pancreatic Carcinoma Receives Recognition from the American Society of Clinical Oncology (ASCO)

https://finance.yahoo.com/news/fite-namodenoson-inhibition-pancreatic-carcinoma-110000370.html

Abstract published online in the Journal of Clinical Oncology supplement of the 2023 ASCO Annual Meeting Proceedings

Can-Fite to initiate Phase 2a pancreatic cancer study

Namodenoson significantly inhibits growth of pancreatic carcinoma as a stand-alone treatment and in combination with gemcitabine

PETACH TIKVA, Israel, May 30, 2023--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncology, inflammatory and liver diseases, today announced that its study titled "Effects of Namodenoson on Pancreatic Carcinoma: Preclinical Evidence" is published online in the Journal of Clinical Oncology supplement of the 2023 ASCO Annual Meeting Proceedings. The abstract can be read here: LINK

The pre-clinical study used advanced pancreatic carcinoma patient cells that were treated with Namodenoson as a stand-alone and in combination with gemcitabine, the leading chemotherapy used to treat pancreatic cancer.

A significant dose-dependent inhibition of pancreatic cancer cell growth was found when the cells were exposed to Namodenoson. The combined treatment with Namodenoson plus gemcitabine had an additive inhibitory effect. The molecular mechanism of action, downregulation of the Wnt signaling pathway, is known to be active in pancreatic cancer and also reflects the well-established mechanism of action of Can-Fite’s small molecule drug platform.

Can-Fite plans to initiate an open-label Phase 2a exploratory trial to assess the efficacy and safety of Namodenoson in the treatment of patients with pancreatic cancer who have received at least one previous systemic therapy. Safety and efficacy endpoints including objective response, progression-free survival, duration of response, disease control, and overall survival will be monitored. The study will be conducted by Dr. Salomon Stemmer, an oncology key opinion leader and Professor at the Institute of Oncology, Rabin Medical Center, Israel.

"These encouraging results in pancreatic cancer are very much in line with our findings for Namodenoson in advanced liver cancer clinical trials," stated Can-Fite CEO Dr. Pnina Fishman. "We are pleased to have these data shared through ASCO’s annual meeting, where we expect it will get high visibility with leading oncologists focused on pancreatic cancer as well as potential research and development partners as we head into our exploratory Phase 2a study."

About Pancreatic Cancer

The highest incidence rates for pancreatic cancer are in Asia, Europe, and North America. According to the American Society of Clinical Oncology (ASCO), in 2020, an estimated 496,000 people were diagnosed with pancreatic cancer globally and an estimated 466,000 died from the disease. The 5-year survival rate for people with pancreatic cancer in the U.S. is 11%. Acumen Research estimates the global pancreatic cancer therapeutics market was valued at approximately $3.6 billion in 2021 and is projected to grow to approximately $6.6 billion by 2030.

About Namodenoson

Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma (HCC), and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). It is currently in a Phase IIb trial for NASH and a pivotal Phase III for HCC. Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

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. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of non-alcoholic steatohepatitis (NASH), and enrollment is expected to commence in a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver 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 1,500 patients in clinical studies to date. For more information please visit: www.can-fite.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. 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 COVID-19 pandemic and the Russian invasion of Ukraine; 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 30, 2023 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230530005167/en/

Contacts

Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114

Can-Fite: Presenting Namodenoson’s New Pancreatic Cancer Indication to Potential Partners at BioEquity Europe 2023

https://finance.yahoo.com/news/fite-presenting-namodenoson-pancreatic-cancer-110000482.html

PETACH TIKVA, Israel, May 15, 2023--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer, and liver diseases, today announced its VP of Business Development, Dr. Sari Fishman, will participate in BioEquity Europe which takes place on May 14th – 16th, 2023 in Dublin, Ireland.

Dr. Fishman will conduct one-on-one meetings with potential strategic partners for Can-Fite’s advanced stage pipeline including pharma companies focused on oncology, dermatology, and liver diseases. To date, Can-Fite has monetized its portfolio through out-licensing and distribution deals in select territories.

"We believe Namodenoson’s new indication for the treatment of pancreatic cancer is generating interest from companies that are looking to augment their portfolio with novel solutions for this devastating disease. We look forward to productive meetings at BioEquity," stated Dr. Sari Fishman.

Can-Fite recently announced plans to initiate an open-label Phase 2 exploratory trial to assess the efficacy and safety of Namodenoson in the treatment of patients with pancreatic cancer who have received at least one previous systemic therapy. Pre-clinical studies conducted on advanced pancreatic carcinoma patient cells showed Namodenoson had a significant anti-cancer effect.

Acumen Research estimates the global pancreatic cancer therapeutics market was valued at approximately $3.6 billion in 2021 and is projected to grow to approximately $6.6 billion by 2030.

All You Need to Know About Can-Fite Biopharma Ltd (CANF) Rating Upgrade to Buy
[FWIW]
https://finance.yahoo.com/news/know-fite-biopharma-ltd-canf-160004443.html

Can-Fite Biopharma Ltd (CANF) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #2 (Buy).
An upward trend in earnings estimates -- one of the most powerful forces impacting stock prices -- has triggered this rating change.

BioLine RX (BLRX)

https://finance.yahoo.com/news/7-high-potential-penny-stocks-175605720.html

BioLine RX (NASDAQ:BLRX) just announced the FDA acceptance of its APHEXDA (motixafortide) new drug application (NDA). This is for stem cell mobilization for autologous transplantation in multiple myeloma patients. There’s a PDUFA target date of Sept. 9.

Even better, BLRX just announced the publication of data from its GENESIS Phase 3 clinical trial in the Nature Medicine journal, which “evaluated the safety and efficacy of the company’s lead investigational candidate motixafortide plus granulocyte colony-stimulating factor (G-CSF) versus placebo plus G-CSF for the mobilization of hematopoietic stem cells in patients with multiple myeloma prior to autologous stem cell transplantation (ASCT).”

These data highlighted the potential of motixafortide plus G-CSF, if approved, to enhance the treatment options for clinicians and patients with multiple myeloma undergoing ASCT.

Thanks Midas.

Will do.

At first glance, BLRX has almost a billion share OS as well, so only marginally better from a share structure standpoint.

Will do some more DD, though. Looking for a good candidate in the next few months after GMDA gets taken out for hopefully $7-8 per share !

Murocman

CANF has had a rs a couple of months ago, and will probably have it yet again within 6 months.
Imo you'd better look into BLRX and skip CANF.

Thanks. I wonder if they will reverse split at some point? Hard to move the share price and market cap up very much with so much liquidity.

Murocman

Find your answer here:

https://www.tase.co.il/en/market_data/company/1272/securities/listed?securityId=1094473

1 United States Dollar equals
3.66 Israeli New Shekel

Was just looking at the share data here. ETrade list a market cap of $8.09 million, but there are 1.22 Billion shares outstanding!

Is that correct?

Murocman

Can-Fite to Initiate Exploratory Phase 2 Trial with Namodenoson in Pancreatic Cancer Patients

https://finance.yahoo.com/news/fite-initiate-exploratory-phase-2-110000221.html%

Exploratory, small, open-label study aims to assess potential efficacy of Namodenoson following strong preclinical results in pancreatic cancer

Namodenoson, now in a pivotal Phase 3 liver cancer study, has completely cleared liver cancer in a patient who remains cancer-free 6 years after starting treatment

PETACH TIKVA, Israel, May 09, 2023--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced that it will initiate an open-label Phase 2 exploratory trial to assess the efficacy and safety of Namodenoson in the treatment of patients with pancreatic cancer who have received at least one previous systemic therapy.

Patients will receive Namodenoson at a dose of 25 mg orally, twice daily. Efficacy endpoints will include objective response, progression-free survival, duration of response, disease control (defined as an objective response or stable disease), and overall survival. Safety will be assessed as well. The study will be conducted by Dr. Salomon Stemmer, an oncology key opinion leader and Professor at the Institute of Oncology, Rabin Medical Center, Israel.

Namodenoson is currently under a pivotal Phase 3 study for the treatment of advanced liver cancer and has completely cleared cancer in an advanced liver cancer patient who remains cancer-free 6 years after starting treatment.

"This relatively small exploratory trial is designed as an open-label study, enabling us to assess the potential efficacy of Namodenoson in pancreatic cancer. We’ve seen Namodenoson’s potent anti-cancer effects in treating people with liver cancer and believe that based on recent pre-clinical results, our drug may be equally effective in pancreatic cancer, an indication in need of more effective treatments," stated Can-Fite CEO Dr. Pnina Fishman.

The highest incidence rates for pancreatic cancer are in Asia, Europe, and North America. According to the American Society of Clinical Oncology (ASCO), in 2020, an estimated 496,000 people were diagnosed with pancreatic cancer globally and an estimated 466,000 died from the disease. The 5-year survival rate for people with pancreatic cancer in the U.S. is 11%. Acumen Research estimates the global pancreatic cancer therapeutics market was valued at approximately $3.6 billion in 2021 and is projected to grow to approximately $6.6 billion by 2030.

About Namodenoson
Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

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. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of non-alcoholic steatohepatitis (NASH), and enrollment is expected to commence in a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver 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 1,500 patients in clinical studies to date. For more information please visit: www.can-fite.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. 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 COVID-19 pandemic and the Russian invasion of Ukraine; 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 30, 2023 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.

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Contacts

Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114

Inhibition of Pancreatic Cancer by Namodenoson: Molecular Mechanism of Action Discovered by Can-Fite Scientists

https://finance.yahoo.com/news/inhibition-pancreatic-cancer-namodenoson-molecular-110000959.html

The anti-cancer effect in pancreatic carcinoma is mediated via a key signal transduction pathway

According to the American Society of Clinical Oncology (ASCO) in 2020 an estimated 496,000 people were diagnosed with pancreatic cancer globally

PETACH TIKVA, Israel, May 02, 2023--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced that it discovered the mechanism of action (MOA) involved with the significant anti-cancer effect of Namodenoson in pancreatic carcinoma. Namodenoson de-regulates the Wnt signal transduction pathway, a key modulator of pancreatic carcinoma cell growth.

The discovery was made when analyzing results from pre-clinical studies conducted on advanced pancreatic carcinoma patient cells exposed to Namodenoson, which had a significant anti-cancer effect. This is the same MOA at work for Namodenoson in liver cancer.

Namodenoson is currently under a pivotal Phase III study for the treatment of advanced liver cancer and has completely cleared cancer in an advanced liver cancer patient who remains cancer-free 6 years after starting treatment.

"Knowing Namodenoson’s mechanism of action in pancreatic cancer is an important step in moving this indication toward potential partnerships. Our findings inform potential dosage and study design and increase the probability of success in human trials," stated Can-Fite CEO Dr. Pnina Fishman.

The highest incidence rates for pancreatic cancer are in Asia, Europe, and North America. According to the American Society of Clinical Oncology (ASCO), in 2020, an estimated 496,000 people were diagnosed with pancreatic cancer globally and an estimated 466,000 died from the disease. The 5-year survival rate for people with pancreatic cancer in the U.S. is 11%. Acumen Research estimates the global pancreatic cancer therapeutics market was valued at approximately $3.6 billion in 2021 and is projected to grow to approximately $6.6 billion by 2030.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

A complete and total fluff
PR if i ever saw one!

Can-Fite Announces New Management Structure as Advanced Stage Pipeline Moves Toward Commercialization

https://finance.yahoo.com/news/fite-announces-management-structure-advanced-110000293.html

Dr. Pnina Fishman appointed Executive Chairman of the Board

Motti Farbstein appointed Chief Executive Officer in addition to continuing as Chief Financial Officer

PETACH TIKVA, Israel, April 24, 2023--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced executive changes to support the Company’s continued success in advancing its pipeline toward commercialization through two pivotal Phase III trials in psoriasis and liver cancer.

Dr. Pnina Fishman, the Company’s Scientific Founder, was appointed Executive Chairman of the Board to guide the Company’s strategic direction. She will continue to serve as Chief Scientific Officer (CSO) overseeing the Company’s scientific programs and clinical development pipeline. Motti Farbstein will lead the Company as its new Chief Executive Officer (CEO) while continuing to serve as the Company’s Chief Financial Officer (CFO), a position he has held since 2005. Dr. Ilan Cohn, the Company’s Co-Founder and former Chairman, remains on the Board and will continue to guide the Company’s intellectual property strategy and portfolio. Dr. Cohn is a patent attorney and a Co-Founder and Senior Partner of the IP firm Cohn, De Vries, Stadler & Co. These executive changes go into effect on June 30, 2023.

"Having developed Can-Fite’s platform technology and guided our pipeline into pivotal studies, I am pleased to turn the CEO role over to Motti who has the financial and clinical expertise to lead Can-Fite into the registration stage," Dr. Fishman stated. "I will continue to guide our clinical programs as CSO while also taking part in setting the Company’s strategic direction as Executive Chairman of the Board. I have full confidence in Motti’s ability to execute on substantial opportunities for our late-stage clinical pipeline. I am also thankful to Ilan, my Co-Founder, for his dedication serving as Chairman for the past ten years and look forward to his continued support on the board, particularly with IP matters."

"I’m honored and excited to lead Can-Fite as CEO. Having served the Company for 20 years, I’m dedicated to bringing our oral drugs to market to serve patients in need, especially in our most advanced indications in psoriasis and liver cancer," stated Motti Farbstein. "Pnina, Ilan, and I will continue to work closely along with the rest of our team in a seamless transition. As we advance through two pivotal studies, we anticipate the potential for additional distribution transactions and other commercial opportunities."

Can-Fite: EMA Gives Green Light for Piclidenoson Pivotal Phase III Clinical Trial for Psoriasis Treatment

https://finance.yahoo.com/news/fite-ema-gives-green-light-110000952.html

The Pivotal Study is Aimed to Support a Marketing Authorization Application

PETACH TIKVA, Israel,, April 10, 2023--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced that it received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) with respect to the submission of a registration plan for a pivotal Phase III clinical trial for the treatment of moderate to severe psoriasis. The pivotal Phase III study and the safety of the 3 mg twice daily dose of Piclidenoson are accepted by the agency.

The Company intends to initiate a prospective double-blind, placebo-controlled and randomized clinical trial with its lead product Piclidenoson aimed at demonstrating clinical safety and efficacy for the treatment of moderate to severe psoriasis sufficient to support a marketing authorization application.

The agency also commented on the registration plan submitted by the Company relating to the chemistry, manufacturing, and controls (CMC), nonclinical data, and clinical pharmacology data. Can-Fite is currently submitting a comparable data package to the US Food and Drug Administration.

Can-Fite recently reported topline results from its Phase III COMFORT™ study which met its primary endpoint with statistically significant improvement over placebo in psoriasis patients and an excellent safety profile for Piclidenoson.

"Piclidenoson’s oral dosage and excellent safety record combined with its progressive effectiveness over time make it ideally suited for the treatment of psoriasis, a chronic disease. Should this market registration study produce positive results similar to our COMFORT study, we believe Piclidenoson will be well positioned in a very large market which needs more safe and effective oral drug options," stated Can-Fite CEO Dr. Pnina Fishman.

Dr. Sari Fishman, the Company’s Vice President of Business Development, will participate in the BIO-Europe Spring® partnering conference in Basel, Switzerland from March 20 to 22, 2023. Dr. Fishman will conduct one-on-one meetings with a substantial number of potential partners interested in licensing and distribution arrangements for Can-Fite’s advanced-stage drug candidates Piclidenoson and Namodenoson.

I can safefly assume no potential partners were interested, otherwise
we should have been duly informed!