Hello, we're here with Pnina Fishman, the Executive Chairperson and Chief Scientific Officer of Can-Fite. Pnina, thanks for being with us today.
Thank you for inviting me.
Can-Fite has an impressive pipeline of late-stage clinical assets. Let's start with a brief overview of your current programs.
Thank you. Our lead drug candidate, Namodenoson, is in pivotal Phase III study for the t reatment of advanced liver cancer. What we are expecting is that if the data will be reproducible, we will be able to get a conditional approval after an interim analysis of this study. The second indication is pancreatic carcinoma, where we are going very shortly to initiate a Phase IIa clinical study. Last but not least, since this drug has a protective effect, we are also treating patients in a Phase IIb with this drug in the MASH indication, which is accumulation of fat in the liver, not on an alcoholic basis. Our second drug candidate is Piclidenoson, currently positioned for the treatment of psoriasis. There are many drugs out there.
However, our drug is a small molecule, orally bioavailable drug, given to patients twice daily, has no adverse events, and can be given for a chronic treatment for a very long time.
Now, Pnina with both the Food and Drug Administration and the European Medicines Agency agreeing on those pivotal Phase III study protocols for your liver cancer program, what are the next steps, and when can we expect results from the interim analysis?
So regarding the advanced liver cancer, we are already enrolling patients, and we are waiting for an interim analysis that will be in about 2 years from now. As I've mentioned, if the data will be positive, we will be able to get a conditional approval for this drug. As of the psoriasis indication, we are going to initiate enrollment for a pivotal Phase III study very shortly. We are going to summarize the data in about 2.5 years from now.
Pnina, Namodenoson has received Orphan Drug and Fast Track designations from the FDA for liver cancer. How do these designations impact the development timeline and market strategy for the drug?
Thank you for this question. Basically, when we have the fast track for Namodenoson, we get an FDA response very quickly after we are submitting data or asking for a specific regulatory status. Regarding the orphan drug, this is very important regarding our intellectual property, and it gets us a... It gets us IP protection for seven years in a couple of countries all over the world. So this regulatory status of the fast track and also the orphan drug are very important for Can-Fite, and we are very proud of it.
Pnina, I'd like you to provide some insights into the unique aspects of Can-Fite's technology platform. I especially want to know how it targets only pathological cells and how that might reduce the side effects compared to traditional treatments.
Indeed, you are right. Our technology knows how to differentiate between pathological cells, between cancer and inflammatory cells and normal body cells. It is based on overexpression of our target, which is an adenosine receptor, only in the pathological cells and not in the normal body cells. So when the drug will get into the body, it will go to its target, which is present only in the pathological cells, and we spare the body normal cells. So this is why today, when we have already dosed more than 2,000 patients with our drug, we know that we have an excellent safety profile based on the platform technology.
I want to turn now to those out- licensing deals that Can-Fite has secured. I want to know, how do these partnerships support your overall business model, and what can investors expect in terms of future deals?
Thank you. Basically, in all our deals, we get upfront money, which is a non-dilutive money, which helps us a lot to keep developing our drugs. At the same time, down the road, when the drugs will start being marketed, we will have more regulatory and sales milestone, which will also get non-dilutive money into the company, and, on top of everything, we will get also double-digit royalties. So and regarding our future plans, of course, we are extensively working on more to sign more out-licensing deal for additional global regions in the world.
How big are the market opportunities that your pipeline is addressing?
So actually, we are looking at huge markets. With the psoriasis, the market is going to be $31 billion in 2028. For the Namodenoson, for the treatment of advanced liver cancer, it's going to be $6.2 billion in 2029, and for the NASH, it's also a huge, huge market. It's going to be more than $20 billion in 2025. So we are addressing, indeed, huge markets with our drugs.
Now in summary, Pnina, I'm an investor, let's say. Tell me, why should I take an interest in Can-Fite right now?
Yes, of course, we are developing small molecule drugs that are given orally to patients with an excellent safety profile and proven efficacy in Phase II and phase three clinical studies. We are in a quite advanced stage of development, and we have couple of out licensing agreements that have been already signed and are a proof of concept for all our efforts to bring the drugs to the clinic. And we think that in quite short time, the company can get a very good valuation based on all these goodies that I have presented you.
It is a truly fascinating story, Pnina. Thank you for sharing it with us today.
Thank you very much.