Recent Updates
Recently added Catalysts
CANF Positive Sentiment Score: 85/100

Can-Fite Broadens its Strong Intellectual Property (IP) for NASH: Received Patent Allowance in Canada Patent has already been issued in other major markets including the U.S., EU, Japan and China

Key Takeaway: Can-Fite BioPharma has announced the receipt of a Notice of Allowance from the Canadian Intellectual Property Office for a patent application related to the treatment of non-alcoholic steatohepatitis (NASH) using Namodenoson. The company has reported positive results from earlier Phase IIa trials and is currently preparing to begin a Phase IIb study involving 140 patients. The growing market for NASH treatments is expected to create significant opportunities for Can-Fite as it advances its drug development efforts.

Market Sentiment Analysis

POSITIVE FACTORS

  • Can-Fite has received a patent allowance in Canada for its treatment of NASH, enhancing its intellectual property portfolio.
  • The Phase IIa study of Namodenoson indicated significant reductions in liver fat and liver enzymes, showcasing its effectiveness.
  • The NASH market is projected to grow significantly, reaching $24 billion by 2028, indicating potential revenue streams for Can-Fite.

Full Press Release Details

Can-Fite Broadens its Strong Intellectual
Property (IP) for NASH: Received Patent Allowance in Canada
Patent has already been issued in
other major markets including the U.S., EU, Japan and China
PETACH TIKVA, Israel, February 28, 2024 -- 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.
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.
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 addresses multi-billion dollar markets
in the treatment of cancer, liver, and inflammatory disease. One of the two Company's lead drug candidates, Piclidenoson recently reported
positive topline results in a Phase III trial for psoriasis. A pivotal Phase III for this drug is expected to commence soon. Can-Fite's
other lead drug for treating cancer and liver diseases, 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 for its HCC indication 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. Piclidenoson and Namodenoson 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

Frequently Asked Questions

What patent was recently allowed for Can-Fite in Canada?

Can-Fite received a patent allowance for using Namodenoson to treat ectopic fat accumulation.

What are the benefits of Namodenoson in clinical studies?

Namodenoson reduced liver fat, decreased liver enzymes, and lowered body weight in NASH patients.

What is the primary endpoint of the Phase IIb study for Namodenoson?

The Phase IIb study's primary endpoint is liver pathology in 140 enrolled patients.

What therapeutic areas does Can-Fite focus on?

Can-Fite develops drugs for oncological and inflammatory diseases, including liver issues.

What market potential does the NASH treatment hold?

The NASH market is projected to reach $24 billion by 2028.

Last updated: Feb 28, 2024