Long-term Complete Response to Can-Fite's Namodenoson in Patient with Advanced Liver Cancer: Article Published in a Leading Scientific Journal

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Can-Fite BioPharma announced the publication of an article in a scientific journal detailing a long-term complete response to namodenoson in a patient with advanced liver cancer. The patient has been treated for over 7 years, showing improved liver function and quality of life. Can-Fite's Phase III clinical study for namodenoson is ongoing, targeting patients with advanced liver disease. The drug has received Orphan Drug status and Fast Track Status for the treatment of hepatocellular carcinoma (HCC). The market for HCC treatments is expected to grow significantly by 2027.

Positive

• Publication of article in scientific journal showcasing long-term complete response to namodenoson in liver cancer patient.
• Patient treated for over 7 years with improved liver function and quality of life.
• Phase III clinical study for namodenoson enrolling CPB7 patients in Israel, Europe, and the US.
• Namodenoson has Orphan Drug and Fast Track Status for HCC treatment.
• Market for HCC treatments estimated to reach $3.8 billion by 2027.

Negative

• None.

Medical Research Analyst

The reported long-term complete response of a patient with advanced liver cancer to Namodenoson under Can-Fite BioPharma's compassionate use program is an encouraging development for treatments targeting hepatocellular carcinoma (HCC). The patient's survival beyond the typical prognosis for such an advanced stage, particularly with Child-Pugh B cirrhosis, suggests a potential for the drug to fulfill an unmet need within this patient demographic.

While individual case reports are valuable, they do not equate to the rigorous, statistical validation provided by larger clinical trials. Nevertheless, the transition of Namodenoson into a pivotal Phase III clinical trial, with its orphan drug and fast track status, indicates that regulatory agencies see promise in the drug's profile. Investors should monitor the progress of the Phase III study, especially the interim analysis by the Independent Data Monitoring Committee, which will provide a more substantiated insight into the drug's efficacy and safety on a larger scale.

Oncology Doctor

The therapeutic landscape for HCC is challenging due to the disease's aggressiveness and the limited efficacy of current treatment options for advanced stages. Namodenoson's reported liver protective effects, paired with its anti-cancer activity, could be significant for patients with limited options. As an oncology specialist, I find that the quality of life improvements mentioned, such as the disappearance of ascites and maintained liver function, are just as important as extending overall survival in such a debilitating condition.

Investors should recognize that such treatments can create value not only through potential market share but also by possibly altering the standard of care if the Phase III trial outcomes are favorable. Given the size of the estimated market for HCC treatments, positive trial results could have a notable impact on Can-Fite's market valuation.

Financial Analyst

Considering the market dynamics, with Delveinsight's projection of the HCC treatment market reaching $3.8 billion by 2027 for the G8 countries, the financial implications for Can-Fite could be substantial if Namodenoson is successful. The orphan drug designation and the fast track status could lead to potential market exclusivities and expedited review, enhancing the market entry process.

An important aspect for investors to consider is the risk associated with the binary outcome of the Phase III trial. While the case study shows potential, the inherent risks of drug development mean that an investment in Can-Fite should be balanced within a well-diversified portfolio. The interim analysis will be a pivotal moment for the company and its investors, as it will provide a clearer signal regarding the potential return on investment.

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 oncological and inflammatory diseases, today announced it published an article in the Experimental and Therapeutic Medicine Journal, titled “Long-term complete response to namodenoson in liver cancer with Child-Pugh B cirrhosis: A case report” (Link). The patient participated in the Phase II Liver Cancer Study and has been treated with namodenoson for >7 years under compassionate use program.

The article describes a patient with advanced liver cancer that was enrolled in the former Can-Fite Phase II study, continues to receive treatment with namodenoson, and has now an overall survival of >7 years, with disappearance of ascites, normal liver function, good quality of life and defined as a long term complete response.

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.

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 in which = Namodenoson is being evaluated as a 2nd or 3rd line treatment for CPB7 patients in whom other approved therapies have not been effective. The study design includes a pre-planned interim analysis by an Independent Data Monitoring Committee (IDMC) upon enrollment of 50% patients.

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.

“There is a market need for a safe and effective treatment of patients with advanced liver disease, defined as CPB7 where we believe Namodenoson has an advantage with its anti-cancer and liver protective effect. The complete response of this patient is a testimony for the potential efficacy of Namodenoson and we are optimistic that more patients in the current Phase III study will respond in a similar way,” 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.

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 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 metabolic dysfunction-associated steatohepatitis (MASH), 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 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/20240425661063/en/

Can-Fite BioPharma

Motti Farbstein

info@canfite.com

+972-3-9241114

Source: Can-Fite BioPharma Ltd.

FAQ

What was the title of the article published by Can-Fite in the Experimental and Therapeutic Medicine Journal?

The title of the article was “Long-term complete response to namodenoson in liver cancer with Child-Pugh B cirrhosis: A case report”.

How long has the patient been treated with namodenoson?

The patient has been treated for over 7 years with namodenoson.

What is the focus of Can-Fite's Phase III clinical study for namodenoson?

The Phase III clinical study is targeting CPB7 patients in Israel, Europe, and the US.

What status has Namodenoson received for the treatment of HCC?

Namodenoson has received Orphan Drug status and Fast Track Status for the treatment of HCC.

What is the estimated market size for HCC treatments by 2027?

The market for HCC treatments is estimated to reach $3.8 billion by 2027 for the G8 countries.