Hello. Thank you for joining today's event with Can-Fite BioPharma, which trades on the New York Stock Exchange American, under the ticker CANF. My name is Craig, and I'm with Red Chip. With us today, we have Pnina Fishman, who is Can-Fite's Executive Chairman and Chief Scientific Officer, and Can-Fite's CEO and CFO, Motti Farbstein. We will begin with a brief presentation in a moment, and afterward, Pnina and Motti will answer your questions. Users may ask a question at any time by using the Q&A tool at the bottom of the Zoom window. Because we have a great many participants today, we will take questions in written form only. Before we begin, please allow me to read the Safe Harbor Statement. This call may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
All statements pertaining to future financial and/or operating results, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management, constitute forward-looking statements. Any statements that are not historical fact should also be considered forward-looking statements. Of course, forward-looking statements involve risks and uncertainties. With that said, I now turn the call over to Can-Fite. Please go ahead.
Thank you, Craig. Thank you. I will start with the company overview and let Pnina continue with the development. In Can-Fite, we have safe drugs for the treatment of oncological and inflammatory diseases. We are in advanced clinical stage pipeline with a short regulatory approval pathway, working in parallel with the FDA and the EMA. We already have successful out-licensing deals. We are dually traded at the New York Stock Exchange and Tel Aviv Stock Exchange. Last financial, we had $4.7 million. Since then, we raised $5 million. So the money that we have in the bank and the short-term milestone that we should get from our current partners should support the company for the next 16-18 months. Thank you. Pnina?
Okay. Thank you, Motti. So just in a very concise way, we have a very unique platform technology where we are targeting a specific cell surface receptor. It's a green color here, which is present only in pathological cells, including inflammatory and cancer cells. When you look at normal cells, they do not express the receptor, which is the target. So when the drugs will get into the body of the patient, they will bind only here to the pathological cells and will induce apoptosis, meaning cell death, whereas the normal body cells will be refractory to the drugs. What does it mean? It means after we have treated today thousands of patients, it means that we have, first of all, an excellent safety profile. We have also showed efficacy in some of our phase two and some of our phase three clinical studies.
We will dive into it a bit down the road. And all our pipeline drugs are small molecule, orally bioavailable drugs, which will bind with high affinity and selectivity to the target, which is the A3 adenosine receptor. Let's look at the pipeline together. And the first drug candidate is Piclidenoson, currently developed phase III study for the treatment of psoriasis, a devastating skin disease. And let's take into consideration that we are developing here small molecule, orally bioavailable drug, very safe, in distinction from the biological drugs on the market, which are given by infusion or injection and have lots of adverse events, and patients are moving from one drug to the other. We are coming here with a very interesting drug candidate. The second indication is Lowe syndrome.
It's a genetic rare disease where a third party showed, a third party in Italy showed a very high efficacy of the drug in experimental animal models, and we are now developing a protocol for this study, which will be a very small one, not more than four patients, and if it will be successful, we will be able to register it right afterwards with the FDA and start marketing it. Last but not least, we are developing also the very same drug for osteoarthritis in pets, and actually, this is very interesting because we are embarking on this indication in a totally different population. Regarding the second drug candidate, Namodenoson, it is currently developed for advanced liver cancer, phase three clinical study, for pancreatic cancer, a phase two A clinical study, which very shortly we are going to embark on.
Also, last but not least, for MASH, till recently it has been called NASH, and it's an accumulation of fat in the liver of the patients. Only one drug has been registered till today, and it's a huge, huge market. We are currently in phase IIb clinical study, and we are expecting positive data, which will open for us the way to go to a phase III study under FDA approval. Last but not least, we have CF602, which is a drug for dysfunction, erectile dysfunction, and it's still in preclinical studies. Okay. So till today, we have out-licensed our drugs through a couple of agreements. Basically, the idea is that we will be the ones to develop the drugs, to register the drugs vis-à-vis the FDA, and also vis-à-vis the EMA, as Motti mentioned, but we will not be the ones to marketing.
Under this model, we have already out-licensed a couple of out-licensed deals, two in Europe, one in China, two in Korea, one in Canada, and one with Vetbiolix, a French company, which got the license for the animal for pets who suffer from osteoarthritis. Overall, we got already $20 million upfront money, and more $130 million based on milestones needs to be introduced to the company upon reaching of some milestones. Last but not least, we also get royalties, and it's something that we are working very hard on, and hopefully, and very shortly, we will be able to come with more partnership, which infuses non-dilutive money into the company. Let's go very rapidly through the drug. Piclidenoson, our lead drug candidate, is an adenosine derivative. I will not get into the chemical formula.
However, the take-home message here is that it is a small molecule drug, and it is taken by the patients twice daily since its half-life time is eight-to-nine hours. And the first indication, the most advanced one, is severe psoriasis. And as I mentioned, we have already shown in phase two and phase three clinical studies the efficacy and the safety of the drug. We have a very distinctive molecular mechanism of action for this drug. And what the biological drugs are doing and what is used today in the clinic are monoclonal antibodies against some cytokines like Interleukin-17 and Interleukin-23. Our drug, Piclidenoson, is doing the job as a small molecule drug.
Just to give you a glimpse on the data that we have already seen, so we reached the primary endpoint and also the secondary endpoints in a phase three clinical study that we have concluded recently. Based on it, we are doing now the pivotal clinical study, which has been approved by both the FDA in the States and the EMA in Europe. You can see that we are working in parallel through the two agencies. Now we are conducting the phase three clinical study. We will start patient enrollment very shortly. The protocol is straightforward, one, very similar to the former one, and hopefully, we will be able to achieve the endpoints that you can see here. Piclidenoson is also developed for osteoarthritis in pets.
We have a partnership with Vetbiolix, a veterinarian company based in France, and they are going to develop the drug to complete the preclinical studies and to launch the drug into the clinic. And just recently, they concluded very nicely a clinical study in Beagles, which gave very good results, statistically significant results. You can see it here, a fantastic improvement of the osteoarthritis in the pets. So this is a huge, huge market of $3 billion, and the deal has been evaluated as a $300 million deal, which will introduce Can-Fite with $325 million during the next decade, and we are looking forward to this indication. Looking at Namodenoson, which is our second drug candidate, again, a small molecule that has a half-life time of 12 hours, giving to the patients morning and evening.
The first indication is advanced liver cancer, now in phase three, pivotal phase three clinical study, and the rationale is based on the fact that this is a very unique drug. Advanced liver cancer is not affected by any type of chemotherapy, and our drug is capable to induce cell death, meaning to kill the liver cancer cells to prolong the overall survival, and additional very interesting data that we have seen. One patient, you can see here, she started with a huge tumor in the liver, which decreased during a couple of months. She is now treated for more than seven years on the drug, and she is now defined as cured, so we hope very much in the current clinical study that we are conducting, the name of the study is Liberation, that we will be able to show also very good results.
Just to mention, the drug has an orphan drug status, fast track status, and also compassionate use in both Israel and Romania. We have also the pancreatic cancer, which is a very, very interesting indication. We got fantastic 90% inhibition of pancreatic cell growth in vitro and in vivo, meaning in the lab and in animal studies. We have submitted the protocol to the FDA, which approved the protocol. And currently, we are initiating patient enrollment in Israel, and the United States will follow. And we have a very definitive molecular mechanism of action, again, apoptosis of pancreatic cancer cells in the pancreas. So that's the design of the clinical study that we hope very much that the first patients will come on board very shortly.
And the interesting thing is that we are treating also patients which have accumulation of fat in the liver, patients who are defined as MASH patients, metabolic associated steatohepatitis. And why? How can we say that we have an anti-cancer effect together with this effect? So it happened to be that on top of the anti-cancer effect, we have a liver protective effect. We also see anti-steatotic effect and anti-fibrotic effect in the patients. We concluded very successfully a phase two clinical study, and what we are doing currently is a phase two B clinical study. And as I mentioned, we hope that it will open for us the way to conduct a phase three clinical study and to register this drug with the FDA and also with the EMA. I will skip the CF602 because it's only preclinical, and Motti, maybe you will conclude. Oh, thank you, Pnina.
So we have all drugs with proven safety and efficacy in pivotal phase three studies, as Pnina mentioned. We succeeded to monetize the advanced portfolio through a corporate partnership that infused the company more than $20 million, and we should get $130 million more down the road based on success from these deals. We also, as Pnina mentioned, are talking to other potential partners, and hopefully, we will be able to share another deal or two till the end of this year. We have a novel therapeutic approach, intellectual property portfolio that consists of 15 patent families, and we have enough money for the next 18 months. Thank you very much. And if you have any questions, this is the time.
Thank you very much. If you wish to reach the team here at Can-Fite, use the, yeah, the Q&A button, sorry.
Click it and then type in your question in the text box, as people have already done. Once patients start taking your medication, how rapidly does the psoriatic patient achieve efficacy? He writes, "If the drug is discontinued, for how long does the patient continue to have efficacy?"
This is a very good question. And actually, the drug will work linearly, and the patient will improve along the time that he is taking the drug. And we need to keep in mind that this is a chronic disease. The response will start after two months and will go higher and higher, and patients can take it for a very long time chronically and enjoy the drug. And due to the excellent safety profile and the efficacy, which will increase as far as the patient is taking the drug.
Thank you very much.
When do you think money should start coming in for the pet osteoarthritis drug? You said you have enough money to get us through 16-18 months. So does that mean we won't be doing any more offerings in the next 12 months?
Okay. So we should get some money from the pets, from the Vetbiolix company shortly. As we mentioned, we hope to sign a new partnership deal shortly. We cannot commit, but we are working very hard to do it. We cannot commit that we will not do any more offering for the next 12 months, but we will try to do anything to not hamper the share price.
Is the war affecting your progress in any way? Oh, no, the war is not affecting.
The whole development team is in the U.S., and our clinical studies are all around the world in the U.S. and Europe, minimal sites in Israel. So the war is not affecting us. We do not have any assets in Israel. The drugs are manufactured outside of Israel and stored outside of Israel. So really, there is no effect of the war. Can you give us some insights into the insider ownership at Can-Fite, please? Yes, the insider ownership is around 2%. We are trying to buy when we can, when we are not exposed to insider information, and when we are doing something that it's open to the whole public, not only using registered direct, where only accredited funds can join.
If you wish to reach the team here with your question, click on the Q&A button and type in your question in the text box.
We will then read it aloud for the team. What are some potential catalysts that your various trials could create that investors can look for in the coming months and into 2025?
So we are going to initiate shortly the pivotal phase III study in psoriasis. As Pnina mentioned, we are going to start the enrollment of the pancreatic cancer study. Next year, we will have the data of the cancer, liver cancer interim analysis, and the MASH. And hopefully, there will be also business milestones like signing more deals with more partners.
Thank you very much. Again, to reach the team, click the Q&A button and then type in your question using the text box. We will read it aloud. Have you had any big pharmaceutical companies approach possibly buy you out? If not, what price would you accept?
We cannot discuss.
We are talking to many companies, but we cannot discuss these kinds of questions at this point.
Can you tell us any more about the patient with liver decompensated cirrhosis who was treated with Namodenoson under compassionate use at the Soroka Medical Center in Israel and what this treatment showed?
Yes. The response of the patient was very good. You may know that these patients are waiting for transplantation, kidney transplantation, or liver transplantation, and they will be able to get it only if their liver functions will improve, and we have approached this result with the patient that has been treated, so as we mentioned, our drug has a liver protective effect with very broad effects, and we are trying through compassionate use and other ways to see which additional liver indications will be suitable for us to treat patients with. All right.
I am currently not seeing any questions in the queue. However, we'll give everyone another few seconds for any final thoughts they would like to offer to the Can-Fite team. Are there any chemistry possibilities that might improve the efficacy of your drugs? I noticed that many of your drugs are insoluble.
The drugs are insoluble, but yet they are insoluble in water, but yet they dissolve very easily in fatty solvents. We do not have any issues with the bioavailability of the drug the other way around. The drugs are also very stable and are not degraded, for example, by the liver, and this is a reason that they can work in the liver. So we are not looking for modifications in the current drugs. They have been modified.
The original backbone adenosine has been modified by, I have to mention it, the head of the American Chemical Society. And he's based, a guy who is based in the NIH, Dr. Jacobson. And we license the drugs from this guy. And we think that the drugs are very good regarding their chemistry and hope to bring them into patients and into the market very shortly.
Any recruitment updates for liberation? Are we approaching an interim analysis?
The interim analysis should be somewhere the second half of next year. As it's a survival study, it's very hard to pinpoint exactly when we will reach the interim analysis, but the expected days should be somewhere the second half of next year. And when we will be close to this date, we will release an update.
Where would you say you stand with regard to competing companies in liver disease?
What was the word? Can you repeat again your question?
Of course. Where would you say that Can-Fite stands in regard to competing companies in liver disease?
Okay. So again, the drugs which are on the market today are biological drugs. They are giving most of them, 95%, only at the first-line treatment. We are treating patients who failed first-line, and we can be used as second-line and third-line. Why? Because all the drugs on the market induce hepatotoxicity, liver toxicity. Our drug has a protective effect on the liver. So this is a reason that we can use our drug in advanced liver cancer patients. So this is a distinction between our drugs and the one which are under development or already prescribed on the market.
How do you register for the pancreatic cancer study in the United States?
The U.S. site is not open yet.
As Pnina mentioned, we are opening a site in Israel, but anyone who wants to can write to either RedChip or to Can-Fite Info inbox, and we will send you the contact details of the one who is in charge in the US of our clinical studies.
Could you produce a slide with expected trial completion dates and FDA filing dates?
No, we have submitted the protocol to the FDA. We are working on opening a site in the United States. So we are working in the States regarding the pancreatic cancer, and it will be conducted in parallel in Israel and in the US.
One more time, we will open this floor to any more final thoughts for the Can-Fite team. All right. Pnina and Motti, could you leave us with some final thoughts? Perhaps you'd like to give us the essential value proposition.
Why should investors take an interest in Can-Fite BioPharma right now?
First of all, thank you, Craig and RedChip, for letting us present the company. We can tell you that we are very proud that we took a basic idea, actually, it was Pnina's idea at the university, and pushed it forward, and now we are on the verge of registering one or two of our clinical studies with the two pivotal phase three studies. So we do think that with the success that we had and the prospect of the company, we are a very good company to look at and, I don't know what to say, invest in, but take an interest and looking and following and looking at the advantage, and hopefully, we will be able to bring drugs to the market, will help the patients, and help the investors. Thank you, Craig. Thank you very much.
For more information on Can-Fite, reach RedChip at 1-800-REDCHIP. That's 1-800-733-2447. You may also use RedChip's information page for Can-Fite. It's canfiteinfo.com. There you can view and download the investor presentation and fact sheet and sign up for news alerts on Can-Fite. Please be sure to watch Small Stocks, Big Money, RedChip's program featuring exciting small-cap companies every Saturday at 7:00 P.M. Eastern on Bloomberg USA. Join RedChip's forthcoming webinars. OS Therapies tomorrow, Wednesday, October 30th. Inspira Technologies on Monday, November 4th, and Nexalin Technology on Tuesday, November 5th. All webinars start at 4:15 P.M. U.S. Eastern. Register for those events and for all RedChip webinars at redchip.com/events, where you can also view an archived version of today's webinar. Thanks again to our many participants today, and thank you, Pnina and Matti.