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Can-Fite Partner Vetbiolix Accelerate Piclidenoson Development with Advanced Clinical Trial for Canine Osteoarthritis in a $3.8 Billion Market

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Can-Fite BioPharma (NYSE: CANF) announced that its partner Vetbiolix is launching an advanced clinical study for Piclidenoson in dogs with osteoarthritis, following a successful two-month clinical trial. The companion animal arthritis market, valued at $3.8 billion in 2023, is projected to reach $6.3 billion by 2030.

Piclidenoson is expected to capture up to 6% market share, with potential peak worldwide sales of $445 million by 2034. Can-Fite will receive a 15% royalty on worldwide sales, projecting aggregate revenues of $325 million over the next decade with an anticipated 2029 launch.

The drug offers advantages over current treatments, including oral NSAIDs with harmful side effects and injectable DMOADs. Piclidenoson presents a potentially safer and more effective oral treatment option, supported by favorable safety profiles in both human and animal studies.

Can-Fite BioPharma (NYSE: CANF) ha annunciato che il suo partner Vetbiolix sta avviando uno studio clinico avanzato per Piclidenoson nei cani affetti da osteoartrite, dopo un trial clinico di successo durato due mesi. Il mercato dell'artrite negli animali da compagnia, valutato 3,8 miliardi di dollari nel 2023, è previsto raggiungere i 6,3 miliardi di dollari entro il 2030.

Si prevede che Piclidenoson catturerà fino al 6% della quota di mercato, con potenziali vendite mondiali massime di 445 milioni di dollari entro il 2034. Can-Fite riceverà una royalty del 15% sulle vendite mondiali, prevedendo ricavi aggregati di 325 milioni di dollari nel prossimo decennio con un lancio previsto nel 2029.

Il farmaco offre vantaggi rispetto ai trattamenti attuali, inclusi gli NSAID orali con effetti collaterali dannosi e i DMOAD iniettabili. Piclidenoson presenta un'opzione di trattamento orale potenzialmente più sicura ed efficace, supportata da profili di sicurezza favorevoli in studi sia umani che animali.

Can-Fite BioPharma (NYSE: CANF) anunció que su socio Vetbiolix está lanzando un estudio clínico avanzado para Piclidenoson en perros con osteoartritis, tras un exitoso ensayo clínico de dos meses. El mercado de la artritis en animales de compañía, valorado en 3.8 mil millones de dólares en 2023, se proyecta que alcanzará los 6.3 mil millones de dólares para 2030.

Se espera que Piclidenoson capture hasta el 6% de la cuota de mercado, con ventas mundiales máximas potenciales de 445 millones de dólares para 2034. Can-Fite recibirá un 15% de regalías sobre las ventas mundiales, proyectando ingresos agregados de 325 millones de dólares durante la próxima década, con un lanzamiento anticipado en 2029.

El fármaco ofrece ventajas sobre los tratamientos actuales, incluidos los AINE orales con efectos secundarios dañinos y los DMOAD inyectables. Piclidenoson presenta una opción de tratamiento oral potencialmente más segura y efectiva, respaldada por perfiles de seguridad favorables en estudios tanto humanos como animales.

Can-Fite BioPharma (NYSE: CANF)는 파트너인 Vetbiolix가 성공적인 2개월 임상 시험을 거쳐 Piclidenoson에 대한 개의 골관절염을 위한 고급 임상 연구를 시작한다고 발표했습니다. 반려동물 관절염 시장은 2023년 38억 달러로 평가되며, 2030년까지 63억 달러에 이를 것으로 예상됩니다.

Piclidenoson은 최대 6%의 시장 점유율을 차지할 것으로 예상되며, 2034년까지 전 세계 판매 최대 4억 4천 5백만 달러의 잠재력을 가지고 있습니다. Can-Fite는 전 세계 판매에 대해 15%의 로열티를 받을 예정이며, 2029년 출시를 예상하여 향후 10년 동안 3억 2천 5백만 달러의 총 수익을 전망하고 있습니다.

이 약물은 현재의 치료법보다 장점이 있으며, 해로운 부작용이 있는 경구 NSAID 및 주사형 DMOAD를 포함합니다. Piclidenoson은 인간 및 동물 연구에서 긍정적인 안전성을 바탕으로 잠재적으로 더 안전하고 효과적인 경구 치료 옵션을 제공합니다.

Can-Fite BioPharma (NYSE: CANF) a annoncé que son partenaire Vetbiolix lançait une étude clinique avancée pour Piclidenoson chez les chiens atteints d'arthrose, suite à un essai clinique réussi de deux mois. Le marché de l'arthrite chez les animaux de compagnie, évalué à 3,8 milliards de dollars en 2023, devrait atteindre 6,3 milliards de dollars d'ici 2030.

Piclidenoson devrait capturer jusqu'à 6% de part de marché, avec des ventes mondiales maximales potentielles de 445 millions de dollars d'ici 2034. Can-Fite recevra des redevances de 15% sur les ventes mondiales, prévoyant des revenus globaux de 325 millions de dollars au cours de la prochaine décennie avec un lancement anticipé en 2029.

Le médicament présente des avantages par rapport aux traitements actuels, y compris les AINS oraux avec des effets secondaires nocifs et les DMOAD injectables. Piclidenoson propose une option de traitement oral potentiellement plus sûre et plus efficace, soutenue par des profils de sécurité favorables dans des études tant humaines qu'animales.

Can-Fite BioPharma (NYSE: CANF) gab bekannt, dass sein Partner Vetbiolix eine fortgeschrittene klinische Studie zu Piclidenoson bei Hunden mit Osteoarthritis startet, nachdem eine erfolgreiche zweimonatige klinische Prüfung durchgeführt wurde. Der Markt für Arthritis bei Haustieren, der 2023 auf 3,8 Milliarden Dollar geschätzt wird, soll bis 2030 auf 6,3 Milliarden Dollar anwachsen.

Es wird erwartet, dass Piclidenoson bis zu 6% Marktanteil erobern wird, mit potenziellen Höchstverkäufen weltweit von 445 Millionen Dollar bis 2034. Can-Fite wird eine Lizenzgebühr von 15% auf den weltweiten Verkaufszahlen erhalten, mit einer Projektion von Gesamteinnahmen in Höhe von 325 Millionen Dollar im nächsten Jahrzehnt und einem erwarteten Markteintritt im Jahr 2029.

Das Medikament bietet Vorteile gegenüber den aktuellen Behandlungen, einschließlich oraler NSAIDs mit schädlichen Nebenwirkungen und injizierbaren DMOADs. Piclidenoson stellt eine potenziell sicherere und effektivere orale Behandlungsoption dar, unterstützt durch günstige Sicherheitsprofile in sowohl menschlichen als auch tierischen Studien.

Positive
  • Successful completion of initial two-month clinical trial in dogs
  • Large market opportunity: $3.8B market size with projected growth to $6.3B by 2030
  • Projected peak sales of $445M by 2034 with 6% market share
  • Expected $325M in aggregate revenues over next decade
  • Patent protection with additional new patent applications filed
Negative
  • Launch not expected until 2029, indicating long time to market
  • Market share projection of 6% suggests penetration
  • Faces competition from established treatments including NSAIDs and DMOADs

Insights

Can-Fite's veterinary partnership with Vetbiolix represents a strategic expansion into the $3.8 billion companion animal arthritis market, with Piclidenoson now advancing to an advanced clinical study following successful initial results. The move leverages their existing A3 Adenosine Receptor technology platform into veterinary medicine, where development timelines and approval processes are typically accelerated compared to human therapeutics.

The canine osteoarthritis treatment landscape currently offers options - either symptom-focused NSAIDs with concerning side effect profiles or injectable disease-modifying treatments that are less convenient for pet owners. Piclidenoson's potential as an oral DMOAD with a favorable safety profile could address a significant unmet need, particularly as pet ownership and willingness to invest in companion animal health continue to rise.

The patent strategy appears robust, combining Can-Fite's existing US patent protection with Vetbiolix's new applications based on clinical data. This creates a potential competitive moat that could protect market position through the projected 2034 peak sales period. While the 6% projected market penetration seems ambitious, specialty veterinary medications with clear advantages can achieve such targets, particularly with proper distribution and veterinarian education.

This partnership represents a potentially significant revenue stream for Can-Fite, a microcap biotech with a current market capitalization of just $9.9 million. The projected $325 million in aggregate upfront payments and royalties over the next decade (assuming 2029 launch) would provide substantial value relative to the company's current size.

The economics of the deal - a 15% royalty on worldwide sales - aligns with industry standards for out-licensed technology with established proof-of-concept data. Based on the projections, Vetbiolix is forecasting peak sales of $445 million by 2034, implying annual royalty revenue of approximately $66.75 million at peak for Can-Fite.

The veterinary market offers several advantages for small biotechs: faster time-to-market, lower development costs, and reduced regulatory hurdles compared to human therapeutics. This creates a potential near-term revenue opportunity while Can-Fite continues development in human indications. However, investors should recognize that these projections assume successful clinical development, regulatory approval, and market adoption - all carrying execution risk. The compressed timeline to projected 2029 launch suggests Vetbiolix expects a streamlined development path, though specific regulatory milestones weren't detailed in the announcement.

Can-Fite’s upfront and royalties on sales upon regulatory approval of Piclidenoson for veterinary use, is projected to be $325 million in the aggregate over the next decade assuming a 2029 launch

Ramat Gan, Israel, March 20, 2025 (GLOBE NEWSWIRE) --  Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, today announced that its veterinary partner Vetbiolix is initiating an advanced clinical study in dogs with osteoarthritis, utilizing oral daily treatment with Piclidenoson.

As previously reported, Vetbiolix concluded successfully a clinical study in dogs with osteoarthritis who were treated orally with Piclidenoson for a two 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 2029 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. Sari Fishman.

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.

About Vetbiolix

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 Eurasanté Bio-Incubator, the northern France health cluster ranked among the top 20 best European incubators fostering pharm/biotech start-up development (Labiotech.eu 2019).

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 liver drug, Namodenoson, is being evaluated in a Phase III trial for hepatocellular carcinoma (HCC), a Phase IIb trial for the treatment of MASH, and in 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: https://www.canfite.com/.

Forward-Looking Statements

This press release contains 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, including statements regarding projected revenue. 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.

Contact

Can-Fite BioPharma

Motti Farbstein

info@canfite.com

+972-3-9241114


FAQ

What is the projected market share and revenue for CANF's Piclidenoson in the veterinary market?

Piclidenoson is expected to capture 6% market share with peak sales of $445M by 2034, generating $325M in aggregate revenues for CANF through 2029-2034.

How large is the companion animal arthritis market that CANF is targeting?

The companion animal arthritis market is valued at $3.8B in 2023 and is projected to grow to $6.3B by 2030.

What advantages does CANF's Piclidenoson offer over existing canine osteoarthritis treatments?

Piclidenoson offers a safer oral treatment alternative to NSAIDs, which have significant side effects, and injectable DMOADs, with favorable safety profiles in both humans and animals.

When is CANF's Piclidenoson expected to launch for veterinary use?

Piclidenoson is anticipated to launch in 2029 for veterinary use.

What royalty percentage will CANF receive from Vetbiolix for Piclidenoson sales?

Can-Fite will receive a 15% royalty on worldwide sales of Piclidenoson for veterinary use.
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