Hello, we're here with Motti Farbstein, Chief Executive Officer of Can-Fite. Motti, welcome back!
Thank you, Greg. Thank you for having me.
Can-Fite has a robust pipeline with multiple late-stage assets in clinical development. Let's start with a broad overview of your programs.
Okay, we have two drugs in the clinic. The first drug is Namodenoson for liver and oncology. The first indication is advanced liver cancer patients, where we are enrolling patients to a pivotal phase III study. The second one is pancreatic cancer, where we are about to initiate a phase IIa study. And the last indication is MASH, fatty liver. It's an ongoing. We're enrolling patients to a phase IIb study based on a very successful phase IIa. The second drug is Piclidenoson. The first indication is psoriasis, where we are about to initiate the pivotal phase III study. The second one is a rare disease by the name of Lowe syndrome, where we are about to initiate a phase II shortly. And we have also a partner that took the Piclidenoson for dogs' osteoarthritis.
We share the positive Phase II study, and we are hoping to sign a license agreement shortly with this company.
Piclidenoson, Motti, showing significant anti-psoriatic effects in its phase III trials. What have been the key findings in those trials, and what are the next steps towards regulatory approval?
We met our primary and secondary endpoint, which were PASI 75 and PGA, Physician Global Assessment. We have a pivotal phase III ready to go, agreed by the FDA and the EMA, and we will initiate the pivotal study by the fourth quarter of this year.
Now, Can-Fite has secured several out licensing deals with significant upfront and milestone payments, Motti. How much have you received so far, and what could this mean for Can-Fite if you received regulatory approvals for your treatments?
$20 million received in upfront and milestone payments so far. $130 million are potential based on regulatory and sales milestones, and we will get double-digit royalties from the sales.
Motti, as you well know, your drugs are targeting severe unmet medical needs in areas such as liver cancer, psoriasis, and MASH. How big is the overall market opportunity you're aiming to address?
So the liver cancer market is expected to reach $6.3 billion by 2029. The psoriasis drug market is. The focus is to grow up to $32 billion by 2028, and the market of MASH will reach $21.9 billion dollars. As a company, across the indication that we are developing, we aim to reach around 10%-30% of the markets.
Now, let's look ahead. What are some milestones investors should be expecting over the next six to 12 months?
So, in 2024, we will initiate the pancreatic cancer study, the pivotal psoriasis study, and we are hoping to sign the licensing agreement of the osteoarthritis dogs. Next year, we are going to share the interim analysis of the pivotal phase III liver cancer study, and we will initiate the Lowe syndrome rare disease study.
In summary, Motti, what is the essential value proposition? Why should investors take an interest in Can-Fite right now?
Can-Fite has novel therapeutic approach in multi-billion-dollar markets. We have all drugs, very safe. The safety is proven, and the efficacy in two pivotal Phase III studies for liver cancer and psoriasis. We are monetizing the advanced portfolio through corporate partnerships. As I told you before, Greg, we got from this licensing partners till today $20 million undiluted money, and there are $130 million that we should get in the future based on success.
It's a truly fascinating story, Motti. Thank you for sharing it with us today.
Thank you, Greg. Thank you very much.