We're here with Dr. Pnina Fishman, the CEO of Can-Fite. Pnina, thanks for being with us today.
Thank you.
Dr. Pnina Fishman, I'd really like to congratulate you on the incredible phase III results that met endpoints on Piclidenoson.
Thank you very much. Yes, we are very happy with the data, and we continue full force. We plan to approach very shortly the FDA in the United States and the EMA in Europe with the pivotal phase III protocol and with the registration plan. We assume that it may take couple of weeks, even couple of month, and afterwards, we will be able to embark on the pivotal phase III study, which will lead towards registration.
You know, one of the things that always struck me, Pnina, was how novel your mechanism of action is with the Piclidenoson, particularly to safety. Maybe you could just share with our audience why this is safer, potentially, based on research in the phase III so far than some of the current standards of care in psoriasis.
Of course. The uniqueness about our mechanism of action, which make our drug unique, is that the drug can bind only to the inflammatory, namely the pathological cells in the skin of patients with psoriasis, but the drug will not bind to the normal skin cells or to any other normal body cells or tissue.
This means that in a disease like psoriasis, where patients need to take the drug for the rest of their time life, so they need to have a safe drug. Our drug is very safe since it spares the normal body cells and tissues. Till today, we have already dosed 2,000 patients with an excellent safety profile.
Based on this safety data and also the efficacy data, we think that this is a breakthrough technology which we will be able to bring to patients that will be able to enjoy it for a very long time.
You recently announced another drug candidate, Namodenoson, which is a phase III trial for liver cancer, received compassionate use approval in Romania. This is the second country to approve compassionate use for Namodenoson for liver cancer. Please tell us more about this exciting program and some of the potential upcoming milestones.
Thank you. Actually it is very good because it can enable us to treat patients which cannot join the clinical study, and we are giving these patients an opportunity to get the treatment. It's very important for the patients, and we are very happy to go for it. Yes, as you said, we do it in Israel and now also in Romania, in Eastern Europe.
Can-Fite has several other programs in development. Please give us a brief overview of the other programs in the pipeline, Dr. Fishman.
Regarding Namodenoson, it's currently developed for liver diseases. The first, as you have just mentioned, is liver cancer, more precisely advanced liver cancer. This patient population does not have any labeled drug.
Can-Fite, to the best of my knowledge, is the only company which develops drug for this advanced stage of the disease. We had some positive data from the former study, and we do hope that with this pivotal study and good data, we will be able to bring this drug into the market and to launch it with both the FDA and the EMA in Europe.
Very exciting. How big are the market opportunities for all these potential drugs that you're pursuing?
Regarding specifically the liver cancer, it's $3 billion. We are also developing the very same drug to patients who suffer from NASH. NASH is a non-alcoholic steatohepatitis, and there is yet no drug in the clinic. There are a couple of companies which have a competition regarding getting into a situation where the FDA or the EMA will grant an approval.
Can-Fite participates in this competition, and we successfully and positively concluded a Phase IIa clinical study, and now we are enrolling patients for a Phase IIb clinical study, which will open for us the gate to the FDA with phase III. This is a huge market of around $25 billion.
We do hope that based on the former positive data, we will come with more, good data and be able to participate in this competition of bringing a drug to these poor patients.
Very, very big addressable markets. I think that's exactly why you've been able to sign licensing agreements, including more than $100 million in milestone payments. Approximately how much of this money's come to the company, and what do you think is the timeline or milestones of potential receipt of additional payments?
Yes. Actually we got already $20 million into the company. This is out of the upfront money. More money, we will get it based upon regulatory milestones. As far as we will progress with the programs which I've just presented to you, we will be able to get more money.
Then when we will launch the drugs into the clinic, we will be able to get royalties and also milestones based on sales. It will take, we think additional like two years till we will be able to get the rest of the money, at least part of it.
Wow, Pnina, 2,000 patients, that sounds like an exceptionally large study. Is that typical?
Yes. At this advanced stage of the development it is typical, and we are very happy with the safety profile.
Very exciting. In summary, what's the essential value proposition, and why should investors take an interest in Can-Fite today?
Yes, thank you. I think that today, Can-Fite has a clinical proof of concept for its technology. We envision that more deals will get into our pipeline, and we will be able to go to additional geographical places in the world and create partnerships. This, of course, will grant our investors a high valuation of the company and a return for their investment.
Well, we've certainly seen a lot of great activity on the shares in the last 24 months, sometimes running many multiples. I'm pretty excited for the future here. Pnina, it's really a great story, and thank you again for being with us today.