Can-Fite to Present its Phase IIb NASH Drug Candidate Namodenoson at Upcoming Conference

Rhea-AI Summary

Can-Fite BioPharma is advancing its Namodenoson liver drug candidate in a Phase IIb NASH study after a successful Phase IIa trial. CEO Dr. Pnina Fishman will present at the H.C. Wainwright 6th Annual NASH Investor Conference on October 17, 2022. NASH represents a significant market opportunity, expected to reach $35-$40 billion by 2025. The ongoing Phase IIb trial will evaluate Namodenoson’s efficacy against placebo in 140 subjects. Namodenoson has shown promise as a treatment for NASH and hepatocellular carcinoma, achieving Orphan Drug and Fast Track Designations.

Currently enrolling Phase IIb NASH study following successful Phase IIa that met all efficacy and safety endpoints

PETACH TIKVA, Israel--(BUSINESS WIRE)-- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, announced today the Company’s CEO Dr. Pnina Fishman will present its liver drug candidate, Namodenoson, at the H.C. Wainwright 6th Annual NASH Investor Conference and conduct one-on-one meetings with investors on October 17, 2022. The virtual conference will feature presentations by private and public companies and a panel discussion by several renowned key opinion leaders in the NASH field.

There is currently no U.S. FDA approved treatment for NASH, an addressable pharmaceutical market estimated to reach $35-$40 billion by 2025 driven by increasing incidence. NASH is the leading cause for liver transplants among women and the second leading cause overall in the U.S. Given the rate of increase, it is expected to become the leading indication for liver transplants in males as well.

Can-Fite is conducting a Phase IIb multicenter, randomized, double-blind, placebo-controlled study in subjects with biopsy-confirmed NASH. The primary objective of the trial is to evaluate the efficacy of Namodenoson as compared to placebo in 140 subjects with NASH, 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.

About Namodenoson
Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated for two indications, as a second line treatment for hepatocellular carcinoma in a pivotal Phase III study, and as a treatment for non-alcoholic steatohepatitis (NASH) in a Phase IIb study. 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: CFBI) 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 24, 2022 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/20221013005106/en/

Can-Fite BioPharma

Motti Farbstein

info@canfite.com

+972-3-9241114

Source: Can-Fite BioPharma Ltd.

FAQ

What is the purpose of Can-Fite's Phase IIb NASH study with CANF?

The Phase IIb NASH study aims to evaluate the efficacy of Namodenoson compared to placebo in subjects with biopsy-confirmed NASH.

When will Can-Fite present at the NASH Investor Conference?

Can-Fite's CEO Dr. Pnina Fishman will present at the H.C. Wainwright 6th Annual NASH Investor Conference on October 17, 2022.

What market potential does NASH have according to Can-Fite's press release?

NASH is projected to reach a pharmaceutical market size of $35-$40 billion by 2025 due to increasing incidence.

How many subjects will be involved in Can-Fite's Phase IIb trial?

The Phase IIb trial will involve 140 subjects randomly assigned to receive either Namodenoson or placebo.

What designations has Namodenoson received from the FDA?

Namodenoson has received Orphan Drug Designation in the U.S. and Europe, and Fast Track Designation as a second-line treatment for hepatocellular carcinoma.