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Projected Income of $325M to Can-Fite Over the Next 10 Years After Vetbiolix Exercised its Option and Licensed Piclidenoson for Veterinary Osteoarthritis The agreement has been signed upon successful conclusion of a clin

Key Takeaway: Can-Fite BioPharma Ltd. has announced a development and commercialization agreement with Vetbiolix for its drug Piclidenoson, aimed at treating osteoarthritis in companion animals. Vetbiolix's option to license Piclidenoson followed a successful clinical study in dogs, indicating promising efficacy and safety. The estimated income of $325 million over the next decade reflects Can-Fite's potential royalty earnings upon regulatory approval. The veterinary market for osteoarthritis therapies is expected to grow significantly in the coming years.

Market Sentiment Analysis

POSITIVE FACTORS

  • Projected income of $325M indicates strong financial potential.
  • Successful clinical study in dogs with osteoarthritis supporting drug efficacy.
  • Market for canine osteoarthritis treatments is projected to grow significantly.

CONCERNS & RISKS

  • Dependency on regulatory approvals for market launch.
  • Market competition with existing treatments that have significant side effects.

Full Press Release Details

Projected Income of $325M to Can-Fite
Over the Next 10 Years After
Vetbiolix Exercised its Option and
Licensed Piclidenoson for Veterinary
The agreement has been signed upon
successful conclusion of a clinical study in dogs with osteoarthritis
RAMAT GAN, Israel, Sept. 24, 2024 (GLOBE
NEWSWIRE) -- 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, today announced that its veterinary partner Vetbiolix
exercised its option and signed a development and commercialization agreement with Can-Fite for the development of Piclidenoson for
the treatment of osteoarthritis in companion animals including dogs and cats.
Vetbiolix concluded successfully a clinical study
in dogs with osteoarthritis who were treated orally with piclidenoson for a couple of months period. The arthritis market for companion
animals is estimated by Coherent Market Insights to be $3.8 Billion in 2023 and is expected to grow to $6.3 Billion by 2030. Can-Fite
and Vetbiolix model that Piclidenoson has the potential to capture up to 6% of this opportunity, with peak worldwide sales of $445 Million
by 2034. Under the agreement, Can-Fite is entitled to receive a 15% royalty on worldwide sales in this indication. This means that Can-Fite's
upfront and royalties on sales upon regulatory approval for veterinary use, is projected to be $325 million in the aggregate over the
next decade assuming a 2027 launch.
Current treatments for canine osteoarthritis include
oral non-steroidal anti-inflammatory drugs (NSAIDs) which only treat symptoms and carry significant harmful side effects, and an injectable
disease modifying osteoarthritis drug (DMOAD) that targets the progression of the disease. Piclidenoson, an oral drug that has a favorable
safety profile in humans and in animal studies, offers a potentially safe and effective oral treatment for canine osteoarthritis.
"The veterinary market is a significant
opportunity where our drugs may have an impact. Both the size of the market and the shorter timelines to regulatory approval have the
potential to result in milestone and royalty revenues for Can-Fite. We believe Piclidenoson's safety and efficacy data in dogs indicate
it may offer relief to the growing number of companion animals with osteoarthritis," stated Can-Fite VP Business Development Dr.
Matthieu Roquette, President at Vetbiolix commented,
"The quality of preclinical and clinical data generated by us on Piclidenoson, and its pharmacological profile make this highly
selective A3 Adenosine Receptor Agonist a drug candidate likely to meet the unmet veterinary medical need to date in the management of
osteoarthritis pathology in dogs and cats."
On top of the U.S. Can-Fite patent #10,265,337
Vetbiolix applied for additional new patent applications based on the new data from the dog clinical study that has been concluded recently.
Vetbiolix develops innovative products for treatment
and prevention of diseases affecting pets. As pharmaceutical and biotech companies research novel molecules and compounds for human medicine,
tests in different species often reveal exciting possibilities for pets. Vetbiolix has developed a unique approach focused on turning
this potential into innovative prescription medicines and care products for pets. To date, veterinarians have still few therapeutics and
real preventive care products at their disposal that have been specifically developed and approved for pets. Along with a virtual VetBiotech
organization, Vetbiolix exclusively focuses on clinical developments of prescription medicines, diagnostics, nutraceuticals and care products
for pets, thanks to its qualified external R&D partners in Europe & the US. Vetbiolix is supported by the Eurasant Bio-Incubator,
the northern France health cluster ranked among the top 20 best European incubators fostering pharm/biotech start-up development (Labiotech.eu
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 NASH 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,
revenue projections, 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.

Frequently Asked Questions

What is Piclidenoson used for in veterinary medicine?

Piclidenoson is developed for treating osteoarthritis in dogs and cats.

How much revenue is projected for Can-Fite from Piclidenoson?

Can-Fite projects $325 million in income from Piclidenoson over ten years.

What is the current market size for osteoarthritis treatment in pets?

The osteoarthritis treatment market for pets is estimated at $3.8 billion in 2023.

What advantage does Piclidenoson offer over existing treatments?

Piclidenoson offers a safer oral treatment option with a favorable safety profile.

Who is Can-Fite's veterinary partner for Piclidenoson?

Can-Fite's veterinary partner is Vetbiolix, responsible for its development.

Last updated: Sep 24, 2024