Indicate by check mark whether the registrant
files or will file annual reports under cover Form 20-F or Form 40-F.
On November 2, 2026, Can-Fite BioPharma Ltd. issued
a press release entitled “Can-Fite Announces Eurasian Patent Allowance Supporting Piclidenoson Development and Commercialization
in Lowe Syndrome”. A copy of this press release is furnished herewith as Exhibit 99.1.
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
Exhibit 99.1
Can-Fite Announces Eurasian Patent Allowance
Supporting Piclidenoson Development and Commercialization in Lowe Syndrome
Allowed claims cover Lowe syndrome and
Dent disease 2; Can-Fite holds development, commercialization,
and out-licensing rights for these indications under its agreement with
Fondazione Telethon
Ramat Gan, Israel, Nov. 02, 2026 (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 that the Eurasian Patent Office (EAPO) has issued a notification of readiness
to grant a patent covering the use of Piclidenoson for the treatment of diseases associated with OCRL deficiency, including Lowe syndrome
and Dent disease 2.
Lowe syndrome is a rare X-linked multisystem
genetic disorder caused by mutations in the OCRL gene, resulting in severe renal, neurological, and ocular manifestations. The renal disease
is characterized by progressive proximal tubular dysfunction leading to Fanconi syndrome, chronic kidney disease, and eventual kidney
failure. Current management is supportive, and no approved therapy addresses the underlying disease mechanism.
The patent application is owned by Fondazione
Telethon, Can-Fite’s research partner. Under its agreement with Fondazione Telethon, Can-Fite holds the rights to develop, commercialize,
and out-license Piclidenoson for the treatment of Lowe syndrome. The allowance strengthens the intellectual property foundation supporting
Can-Fite’s development program and future partnering opportunities in this indication. The grant remains subject to completion of
the required formalities.
Piclidenoson was selected for clinical evaluation
based on compelling preclinical studies demonstrating restoration of OCRL-dependent cellular function conducted 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 a collaboration agreement for the clinical development of Piclidenoson for the treatment of Lowe Syndrome,
a high medical need with no drug available.
The Phase 2 study is an open-label, single-center
clinical trial designed to evaluate the efficacy and safety of oral Piclidenoson administered twice daily for six months in 5 adult patients
with genetically confirmed Lowe syndrome. The primary endpoint is improvement in renal uptake of 99mTc-DMSA as a measure of proximal tubular
reabsorption capacity, with secondary endpoints evaluating urinary biomarkers of tubular function, Fanconi syndrome parameters, and safety.
“This patent allowance strengthens
the intellectual property foundation of our Lowe syndrome program and supports its long-term commercial potential,” said Motti Farbstein,
CEO of Can-Fite BioPharma. “Together with our development, commercialization, and out-licensing rights, this milestone supports
our strategy to advance Piclidenoson as a potential treatment for patients with this rare genetic disease and pursue future partnering
opportunities.”
About Piclidenoson
Piclidenoson is a robust anti-inflammatory
agent, currently being evaluated in a pivotal Phase 3 psoriasis clinical study under approval of both the U.S. Food and Drug Administration
(FDA) and the European Medicines Agency (EMA).
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.
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 Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American:
CANF) (TASE: CANF) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion
dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company’s lead drug candidate, Piclidenoson recently
reported topline results in a Phase 3 trial for psoriasis and commenced a pivotal Phase 3 trial. Can-Fite’s liver drug, Namodenoson,
is being evaluated in a Phase III trial for hepatocellular carcinoma (HCC), a Phase 2b trial for the treatment of MASH, and in a Phase
2a study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation
as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially
treat other cancers including colon, prostate, and melanoma. CF602, the Company’s third drug candidate, has shown efficacy in the
treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,600 patients in clinical studies
to date. For more information please visit: www.canfite.com.
Forward-Looking Statements
This press release may contain forward-looking
statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, the expected grant of the patent
described herein, the scope and potential benefits of intellectual property protection, Can-Fite’s development of Piclidenoson for
Lowe syndrome, and potential commercialization and partnering opportunities. 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 market and other conditions, history of losses
and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all;
uncertainties of cash flows and inability to meet working capital needs; the initiation, timing, progress and results of our preclinical
studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical
trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates,
and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product
candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our
business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain
for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual
property rights of others; competitive companies, technologies and our industry; risks related to not satisfying the continued listing
requirements of NYSE American; and statements as to the impact of the political and security situation in Israel on our business. More
information on these risks, uncertainties and other factors is included from time to time in the “Risk Factors” section of
Can-Fite’s Annual Report on Form 20-F filed with the SEC on March 26, 2026 and other public reports filed with the SEC and in its
periodic filings with the TASE. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof. Can-Fite undertakes no obligation to publicly update or review any forward-looking
statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities
laws.
Contact
Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114
