RAMAT GAN, Israel - Can-Fite BioPharma (NYSE:CANF) Ltd. (NYSE American: CANF) (TASE: CANF), an Israeli biotechnology firm, announced today that its veterinary partner Vetbiolix has reported positive results from a clinical study on canine osteoarthritis, leading to a $325 million licensing agreement. Vetbiolix has completed the study of Piclidenoson, a drug initially developed for human use, and has exercised its option for a full license to commercialize the medication for veterinary use.
The study evaluated the efficacy of Piclidenoson in dogs with osteoarthritis over a 90-day period, using two different dosages. The primary endpoint was based on the Liverpool OsteoArthritis in Dogs (LOAD) questionnaire, which assesses symptom severity and dog mobility. Secondary endpoints included pet parent assessments of pain and veterinarian evaluations of lameness and pain. The results demonstrated a significant improvement in clinical status and a reduction in pain at the higher dosage of the drug.
The licensing deal with Vetbiolix includes an upfront payment, milestone payments, and royalties on sales upon regulatory approval, which could total $325 million over the next ten years for Can-Fite. The canine osteoarthritis market is projected to reach $3 billion by 2028, and current treatments are limited to symptom management with non-steroidal anti-inflammatory drugs (NSAIDs) that have significant side effects, and an injectable drug that targets disease progression.
Piclidenoson, an A3 adenosine receptor agonist, has shown a favorable safety and efficacy profile in human clinical trials for psoriasis. Can-Fite's VP of Business Development, Dr. Sari Fishman, expressed satisfaction with the productive collaboration with Vetbiolix and the potential for Piclidenoson to reach the market quickly, providing a new treatment option for canine osteoarthritis.
Can-Fite BioPharma Ltd. is focused on developing proprietary small molecule drugs for cancer, liver, and inflammatory diseases. Its lead drug candidate, Piclidenoson, has completed a Phase III trial for psoriasis, and the company is also evaluating other drug candidates for various conditions, including liver cancer and erectile dysfunction.
Vetbiolix, a company specializing in veterinary treatments, is responsible for all costs associated with the veterinary clinical development of Piclidenoson. This announcement is based on a press release statement from Can-Fite BioPharma Ltd.
In other recent news, Can-Fite BioPharma reported its financial results and clinical updates for the first half of 2024. The company's revenues were $0.32 million, a decrease from $0.39 million in the same period last year. The net loss improved to $3.95 million, thanks to reduced operating expenses.
In terms of clinical progress, Can-Fite's drug candidate, Namodenoson, is currently in a Phase 3 study for liver cancer and has received Orphan Drug status and Fast Track designation from the U.S. FDA. Another drug, Piclidenoson, showed positive interim results from a canine osteoarthritis study, which could lead to a licensing agreement.
Additionally, Wearable Devices Ltd. announced its upcoming Annual and Special General Meeting of Shareholders, scheduled for late September.
In recent developments, Can-Fite BioPharma was upgraded to a Buy rating by EF Hutton due to the potential of its pipeline drugs, Namodenoson and Piclidenoson. The company also received a Notice of Allowance from the European Patent Office for its erectile dysfunction treatment patent related to the CF602 drug candidate.
InvestingPro Insights
Can-Fite BioPharma's recent licensing agreement for Piclidenoson in the veterinary market aligns with some interesting financial metrics and insights from InvestingPro. The company's stock has shown a significant return over the last week, with InvestingPro data indicating a 9.76% price total return in the past week and an impressive 25.58% return over the last month. This recent performance may reflect investor optimism about the potential $325 million licensing deal.
However, it's important to note that Can-Fite is currently operating at a loss, with an adjusted operating income of -$7.79 million in the last twelve months. This is reflected in an InvestingPro Tip stating that the company is "not profitable over the last twelve months." The licensing agreement could potentially help improve the company's financial position, especially considering another InvestingPro Tip that indicates Can-Fite is "quickly burning through cash."
On a positive note, Can-Fite "holds more cash than debt on its balance sheet," according to an InvestingPro Tip. This financial flexibility could be crucial as the company continues to develop its drug pipeline and pursue commercialization opportunities like the recent veterinary licensing deal.
For investors seeking a more comprehensive analysis, InvestingPro offers 8 additional tips for Can-Fite BioPharma, providing a deeper understanding of the company's financial health and market position.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.