All right, we're coming up on quarter after four. This is the Can-Fite BioPharma webinar. We're going to be getting started. Pnina and, Moti, with your permission, at a quarter after four, we will push record. I will read out the safe harbor, and we will get started. How does that sound?
Perfect.
Very good.
Recording in progress.
Hello, this is Craig with RedChip Companies. Thank you for joining today's event with Can-Fite BioPharma, which trades on the NYSE American under the ticker CANF. 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, Moti Farbstein. We will begin with a brief presentation in a moment, and afterward, Pnina and Moti 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 facts should also be considered forward-looking statements. Of course, forward-looking statements involve risks and uncertainties. With that said, I now turn this call over to the Can-Fite team. Please go ahead.
Oh, thank you, Craig. Pnina, can you move to the first slide?
Yes, sure.
Oh, thank you for the opportunity to present, and good evening, to all of you. Good night from Israel. Can-Fite develops safe drug for the treatment of oncological and inflammatory diseases. We are in advanced clinical stage, shortly to pivotal phase III studies. We have short regulatory approval pathway. We are working both with the FDA and EMA. The business model is to license out, and as of today, we have six successful partners. Regarding the financial summary, we are duly listed at Tel Aviv and New York Stock Exchange using ADR as the tool. Last financials, by the end of the year, we had around $9 million.
So the money that we have in the bank and the money that we should get as a short-term milestone from our current partners should support the company for at least a year. For the platform technology, Pnina, the scientific officer.
Yes, sure.
Founder of the company. Please.
Sure. So, as many of you know, Can-Fite has platform technology, where we are targeting a specific receptor that can be found on pathological cells, meaning cancer and inflammatory cells, but it is very hard to find this target on normal body cells. This is very interesting because when the drugs will get into the body, they will be able to bind here, but not bind to the normal cells, and as a result, the safety profile that we have seen during our clinical studies with both lead drug candidates, Piclidenoson and Namodenoson, is excellent. All our pipeline drugs are small molecules, orally bioavailable, and patients are taking them morning and evening. We have some proven therapeutic effect through phase II and even phase III clinical studies that have been conducted. And as I mentioned, the safety profile is excellent.
While looking at the pipeline, you can see here our two most advanced drugs are Piclidenoson and Namodenoson. The first drug candidate, Piclidenoson, is currently in a pivotal phase III clinical study for the treatment of psoriasis. We have an agreement with both the FDA and the EMA in Europe on the protocol, and it is very interesting because we are talking here on a very safe drug, small molecule, taken by the patients, as I mentioned, morning and evening. No injections, no nothing else like the other biological drugs, and we will discuss it a bit later. Additional indication with the very same molecule is a very rare genetic disease by the name of Lowe Syndrome.
This hasn't been found by the Can-Fite team, but by a third party in a university in Italy, and Can-Fite has licensed this use, and we plan to conduct a clinical study to initiate it quite shortly. You may know that for rare genetic syndrome, you can get an approval very shortly after concluding the data from very few patients. Last but not least, as a point, we decided that if the drug has a robust anti-inflammatory effect, it can work also in animals and indeed, Vetbiolix, which is a vet company, veterinarian company, has licensed the very same drug for the use in pets, and just recently, they came up with very good data, and they are going now to in-license our drug.
The second drug candidate, namodenoson, is also a small molecule orally bioavailable drug, and the first indication is advanced liver cancer, where we are enrolling currently patients for a pivotal phase III clinical study, also in agreement with the FDA and with the EMA, and we will have an interim analysis in this study. Additional indication is pancreatic cancer. We came across very good preclinical data showing that the drug is efficacious also in animals and in vitro studies in pancreatic cancer, and very shortly, we are going to initiate patient enrollment for a phase IIa study, which will be a type of a proof of concept study. Last but not least, the very same drug has a liver protective effect, and this is why we are using it for the treatment of NASH. Recently, the name has been changed to MASH.
It's non-alcoholic steatohepatitis, and we are enrolling patients for a phase II B clinical study. Last but not least, we have a drug in preclinical study, which is positioned for the treatment of erectile dysfunction. We will brief you about it very shortly. Moti, maybe you would like to summarize corporate data.
Sure. As I said at the beginning, that, the business model is to license out. We started with the, territorial deals. As you can see, we have six territorial deals in Eastern Europe, three countries in, Western Europe, Spain, Switzerland, and Austria, China, and the territories, South Korea, Canada. We received till today, undiluted $20 million as, upfront and milestone payment, and we should get more, based on success, $130 million. This deals, structure is, getting upfront money, regulatory milestone, and then we will get the, double-digit royalties, from these deals. In addition, of the six clinical deals, as Pnina mentioned, we have also a veterinarian partner by the name of Vetbiolix, that took the rights to develop, Piclidenoson for osteoarthritis.
Okay, so the first drug candidate, as I mentioned, is Piclidenoson. It's a small molecule, orally bioavailable drug, and it is positioned today for the treatment of inflammatory indication. The first is moderate to severe psoriasis, and there is a very definitive rationale and a definitive mechanism of action why we are taking this drug for the treatment of psoriasis. And you may know that on the market, we have drugs which are monoclonal antibodies against interleukin-17 , interleukin-23 , and our drug is doing the very same job. And this was the rationale, together with the very robust antiproliferative effect. I will not get now into the whole molecular mechanism of action, but it is very interesting that the drug is capable to induce apoptosis of inflammatory cells.
All of us know that the cells on the skin of the patients are inflammatory cells, and when they are going through an apoptotic pathway, it supplies us with a very interesting mechanism of action. And in the phase III study that we have already concluded recently and published, you can see that we reached the primary endpoint, which was PASI 75, and also the secondary endpoint. And also, we compared our drug to Apremilast, which is also an oral drug already on the market. The data brought us to conduct the pivotal phase III clinical study. Very shortly, we will initiate patient enrollment for this study, and hopefully, the patients will be able to enjoy this drug. They can take it at home.
As I mentioned, the drug safety profile is excellent, and when we compare it to the biological drugs on the market, we know the patient enjoy for the very first month, a very good response, but the response may deteriorate, severe adverse events and adverse event starts coming up, and the patients switch to the next drug and then to the next drug. We are coming here with small molecule drug, which will be very good for patients who need to take the drug for the rest of their lifetime. As we mentioned before, we decided to take this drug also for veterinary uses in pets. Many pets suffer from osteoarthritis. The company that we are going for a partnership is Vetbiolix.
They have conducted a study in pets, which was very successful, and we hope that this drug will be able to be launched to the market quite shortly, and we will be able to get profits from this drug. This is a huge, huge market. Going to the second drug candidate, namodenoson, which is also a small molecule, orally bioavailable drug, taking as well, morning and evening. We have positioned it for the treatment of oncological diseases and also for the treatment of NASH, based on the liver protective effect of the drug. You can ask, how come that a drug can act as an anticancer and at the same time as a liver protective effect.
So just recently, we came across very interesting mechanism of action, showing also both in animals and in humans, that our drug pushes actually the production of a positive cytokine by the name of adiponectin, which induces both the anticancer and also the liver protective effect. There are more mechanistic pathways for the anticancer effect, which you can see here. Again, we see apoptosis of the liver cancer cells, specific apoptosis. While at the same time we are protecting the normal liver cells, and this is really in distinction from all the other drugs on the market, which are positioned for the treatment of liver cancer, and they are unfortunately inducing liver hepatotoxicity. So this is an example of a patient which has been treated with our drug in the phase II study.
I would like to mention that in this study we had 78 patients. Part of them received placebo, part received the active drug. Some patients responded with partial response, and we had one patient who responded with a complete response. I would like to pay your attention here. This is a tumor lesion in the liver. Look how it looks after couple of months, and this is after more months, just disappeared. Not only that, but this is a patient which is fully cured today. All the metastasis were from the... All the body have been disappeared. She's fully cured and yet still getting our drug chronically for the last 7 years. So this is a very, very interesting. Regarding the pivotal phase III study, by the way, the name of the study is Liveration.
We got the blessing of the FDA and the EMA. We introduced an interim analysis into this, into the protocol design, and we have the word of the agencies that if the interim analysis will be positive, we will be able to register this drug. So Namodenoson will be evaluated as a second and third line. Primary endpoint will be overall survival. We have also an orphan drug status and the first fast track status and compassionate use program in both Israel and Romania. And last but not least, we are treating also, as I mentioned, pancreatic cancer. A phase IIa clinical study will be initiated very shortly, and we start enrolling patients.
And you can see here the mechanism of action is very, very important, and we see it as a monotherapy standalone drug, and we have lots of expectation towards this drug in this patient population, which are not responders to many drugs. And you can see here again that we are inducing apoptosis of the pancreatic cancer cells. So, regarding the third indication, which is MASH, as I mentioned to you, the rationale was that we see liver protection. In the first study that we have conducted, it was a phase IIa study. We saw very good data, statistically significant data, showing that the drug act as a robust anti-inflammatory drug and reduce the liver enzymes, ALT and AST.
We had an antifibrotic effect and also anti-steatotic effect, and currently, we are conducting a phase IIb clinical study with this drug. Now we are taking also biopsies from the patient, and we hope that if the data will be reproducible, it will open for us the gate to go for phase III clinical study. We just recently submitted, also opened an IND in the United States, and we initiate also patient enrollment in the United States on top of the enrollment in Israel and in five countries in Europe. I will just mention this drug, which is a very interesting drug, by the way.
We have seen in the frame of our other clinical studies that those patients, for example, psoriasis patients who suffered from psoriasis and also from erectile dysfunction, approached the investigators claiming that they do not suffer anymore from erectile dysfunction. This prompted us to initiate the development of CF602 for the treatment of this indication. We are still in preclinical studies. Moti, maybe you would like to come up with the closing highlights. Thank you.
Thank you, Pnina. So, in Can-Fite, we are developing all drugs with proven safety, which is today close to 2,000 patients, and efficacy. We have two pivotal phase III studies. We are already successful in monetizing the advanced portfolio through corporate partnership. We received $20 million till today, and they're up to $113 million more based on success. We are talking to more companies, so hopefully we'll be able to share with the- with you more partners deals in the future. We have a novel therapeutic approach. As Pnina told you, we started to develop it. Actually, Pnina started to develop it at the university, and we are very proud that from the academy we are now at the last steps and very close to registration.
We have a very broad intellectual property portfolio consists of 15 patents family, and we have enough cash to support the company for the next 12 months. Thank you very much.
Thank you very much, Can-Fite. We are opening up this call to your questions. Again, please type in your question using the Q&A button down at the bottom of your Zoom window. I will then read it aloud, and the Can-Fite team will answer it aloud. We already have some questions submitted here. A key question to consider, often in post-hoc analysis, it's discovered that a subgroup was significant. Mechanistically, what is it about Child-Pugh B that suggests this group is more likely to be responders? By understanding this, we can reason that the current trial has a higher probability of success.
Yes. Actually, I haven't brought it up during this short presentation, but, thanks to the one who is bringing it up and coming up with this question. In the former study, we have realized that the patients who responded, all of them were, belonged to a specific, stage of the disease, namely Child-Pugh B 7. We decided to go ahead and develop the drug for this specific, stage, since till today there is no drug for this patient population. It is a more, advanced stage, of the disease. So we do think that if we could show that this subpopulation, could respond to the drug in the former study, they will be also the responders in the current study, which enroll only this, patient population.
Actually, I have to share with you that we tried to look for an answer why this specific population was a better responder. It was very hard to find it. Thank you.
Is it possible, this person writes in follow-up, that Child-Pugh B is a higher expressor of A3AR?
This is a very good question. Yes. What we see in general is that as far as the patient is more sick, there is more expression of the target. Our target is named A3AR. So yes, this is certainly may be the reason. Thank you for raising it up. .
Thank you. Another question: Given the benign profile, if results are good in Child-Pugh seven, does it suggest that namodenoson is likely to be used in other HCCs?
In other stages of HCC? Can you repeat only the last part of the question? I can't-
Absolutely. Let me just read it all over again. Given the benign profile, if results are good in Child-Pugh 7, does it suggest that Namodenoson is likely to be used in other HCCs?
Uh-
Other stages of AE, this person adds, since AE profile is benign. Again, other stages of HCC since the AE profile is benign, this person is adding.
So today, there are already a couple of drugs on the market with for the stage, which is called Child-Pugh A. So we are really focused on the Child-Pugh B. If the drug will be successful, we will go to the 8 and to the 9, meaning to more advanced patients. Currently, we are focused on the 7, so this will be the way that we will make progress with this drug. Thank you.
EF Hutton has initiated research coverage on Can-Fite. This happened a few weeks ago with a buy rating and a $10 target. Who else is covering the company?
Actually, two of our analysts I saw today on the list participating. It's Jason Kolbert from EF Hutton and Jim Molloy from AGP. In addition, we have also an analyst from H.C. Wainwright that's covering us.
In early July, the company submitted an application to the FDA for that orphan drug designation for your drug candidate, Namodenosone, in the treatment of pancreatic carcinoma. When might you expect to hear back from the FDA on this?
Usually it takes 60 days. It means the FDA can come back in 60 days. We are also looking forward to hear good news regarding this regulatory status. Of course, we will come up and announce it.
This person wants to know about Child-Pugh B. What is the market size in that segment in Child-Pugh B?
Actually, Child-Pugh B is like 70% of the patient population. Unfortunately, we need to take into consideration that patients who are Child-Pugh A will come quite shortly and will be Child-Pugh B. So, as I said, it's 70% of the whole patient population of patients with advanced liver cancer.
Can you tell us more about the patient with liver decompensated cirrhosis, who was treated with namodenosone under compassionate use at the Soroka Medical Center in Israel, and what this treatment showed?
Actually, this is very interesting, and we decided to go to this patient population who suffer from what you have just said, liver decompensation. These patients, many of them, are waiting for liver transplantation, and they are waiting for the status of the liver that will be improved in order to get into the list of patients who are waiting for the liver transplant. So what we think is that we can turn these patients and make them get into the list while improving their liver function, liver status, liver enzymes. And the patients which we have informed on, she also has a PBC, primary biliary cirrhosis, and we improved her situation. And that's the patient that we came up with.
In the meantime, more patients have been enrolled into this small study, and we will come up with news very shortly. Sorry.
Yes. Can you touch on the Namodenoson patent update from last week?
On the namodenoson update on what?
Mm-hmm. On the patent.
Patent, patent. Yes. Let me, let me just repeat the question.
You-
This person wants to know, can you touch upon the Namodenoson patent update from last week?
Of course. So basically, we do not have, and I'm saying it in a very open way, composition of matter patent, because we have licensed both piclidenoson and namodenoson from the NIH in Bethesda, and it took time after we licensed and we developed it. But we have very good use patents regarding the different clinical indications. We have the way of synthesis patents. For each indication, we submitted and have approved patents for each one of the indications. And also, of course, the orphan drug status grant us with couple of good years after the drug will be registered, and we need to take into consideration that it is a new chemical entity. So taken together, we have a very good profile for the namodenoson patents that we have today.
Again, if you wish to submit a question, please use that Q&A button at the bottom of your Zoom window. Give everyone a moment or two to think of any more questions for Pnina and Modi. All right. I'm not seeing any more questions. Pnina and Modi, would you like to wrap up with a few words, perhaps with the essential value proposition? Why should an investor take an interest in Can-Fite right now?
First of all, thank you for participating in the interest in Can-Fite. We are company with good clinical data with efficacy and safety. We are addressing multibillion dollars market in few indications. We have few shots on goal. The market cap is around $20 million as of today, so it might be an opportunity. We will keep developing. We can see in the future the drugs registered and ready to help the patient population.
Thank you very much. Participants, for more information on Can-Fite, you can reach RedChip at 1-800-REDCHIP. That's 1-800-733-2447. You may also use RedChip's landing page for Can-Fite. It's canfinfo.com, canfinfo.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, including occasionally Can-Fite, every Saturday at 7 P.M. Eastern on Bloomberg USA. Join RedChip's forthcoming webinars. Mobilicom on Tuesday, August 13, Nexalin Technology on Wednesday, August 14, and Genetic Technologies on Thursday, August 15. All webinars start, like today's, 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.
Thank you, Pnina and Modi.
You're welcome.
You're welcome.
Thank you.
Thank you very much. Bye-bye.