Hello, everyone, and welcome. This is Paul Kuntz with RedChip Companies. I want to thank you all for joining today's event with Can-Fite BioPharma. Can-Fite trades on the Nasdaq under the ticker symbol, on the NYSE American under the ticker symbol CANF. With us today, we have Can-Fite CEO Motti Farbstein, and Executive Chairperson and Chief Scientific Officer, Pnina Fishman. We will begin with a brief presentation in a moment, and then we'll be opening up the event for questions thereafter. Attendees may submit questions at any time by simply clicking the Q&A button at the bottom of the screen, and we'll get to those when we open up the Q&A session. Now, before we begin, I do need to read through the Safe Harbor statement real quick.
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, among 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, and of course, forward-looking statements involve risks and uncertainties. With that said, I will now turn the webinar over to the Can-Fite team. Please go ahead.
Well, thank you, Paul. So, I will give a short introduction and move it to pass the presentation to Pnina. So, in Can-Fite, we have safe drugs for the treatment of oncological and inflammatory diseases. We are in advanced clinical stage pipeline. We have short regulatory approval pathway. We are talking both to both agencies, the FDA and the EMA. The business model is to license out, and as of today, we have successful seven out- licensing deals. We are dually traded at the Tel Aviv and New York Stock Exchange using ADR as a tool, and last financials, we had around $9 million at the bank, and the money that we have in the short term that we should get from our partners should support the company for the next 15 months. Pnina?
Hi, everybody, and welcome to our presentation. We will try very hard to do it in a very concise way, and we'll wait to your questions. So, our company is based on a very interesting technology, where our drug bind to pathological cells. Since they bind to a specific cell surface receptor that can be found only on pathological cells, whereas normal body cells, you can see that in this cartoon, it looks like a nude cell, will not be able to bind the drug. It means that when the drugs, our drugs will get into the body, they will bind exclusively only to the disease cells, cancer or inflammatory cells, but will not bind to the normal body cells.
It means that we have an excellent safety profile, and we know it today after we have dosed more than 1,600 patients. The drugs are very unique, and upon binding to the target, they induce apoptosis, meaning cell death of both inflammatory and cancer cells. We have proven therapeutic effect to our drugs, which has been shown in phase II and phase III clinical studies, and we will try to take you through some of the data during the presentation. Next slide, please. What we can see here is our pipeline. The first drug candidate that you see on the screen is Piclidenoson, currently positioned for the treatment of psoriasis, which is an inflammatory disease. We are in phase III clinical study. The protocol is in agreement with the FDA and the EMA.
The second drug candidate, Namodenoson, is currently positioned for the treatment of two oncological diseases. One is advanced liver cancer, the second is pancreatic carcinoma. With the first liver cancer, we are in a pivotal phase III clinical study, enrolling patients, and with the pancreatic cancer, we are very close to initiate the phase IIa clinical study after we have seen excellent preclinical data. Last but not least, the very same drug induces protective effect to the liver, and this is the reason that we are treating also MASH patients. MASH before is designated as NASH. It's accumulation effect in the liver, and we are currently conducting a phase IIb clinical study. Last but not least, we have a drug, CF602, which is still in preclinical studies for the treatment of erectile dysfunction in patients who cannot enjoy the drugs on the market.
Patients like diabetic patients or those who suffer from high blood pressure, and this drug is still in preclinical studies, but has a very, very good proof of concept. Next slide, please. So, we are investing lots of efforts in finding partners that will be able to market the products upon registration. Till today, we've signed seven deals. One in Canada, one in Central Europe, one in Eastern Europe, one in China, one in Korea, and one even with a French company for the utilization of our first drug candidate, Piclidenoson, in pets who suffer from osteoarthritis. So out of this deal, we have already got into the bank $20 million cash money, and then additionally, $130 million is going to get into the company upon reaching some milestones.
All of them, of course, depend on the successful of the clinical studies and then, depend on sales milestones. And on top of it, we have two royalties in each one, of our deals. Next slide, please. So our first drug candidate is Piclidenoson. It is small molecule, orally bioavailable. As I mentioned before, it targets inflammatory cells only and not normal body cells. Next slide, please. So the rationale to go and to treat patients who suffer from psoriasis came out of the fact that this drug has a very robust anti-inflammatory effect. It is very similar to the drugs, to the biological drugs, which are on the market today, and target two very important cytokines, interleukin- 17 and interleukin- 23.
We have learned that our drug has a robust anti-inflammatory effect in psoriasis patients, and this was the reason that we took the drug to treat this disease. Next slide, please. We went through a phase II and phase II, three clinical studies, and you can see on the left side of the slide, the effect of our drug versus which we treated the patients in two dosages versus the placebo, which is the lower line, and there is a very good statistically significant difference both in the primary endpoint, which is defined as PASI 75. This is the endpoint which is used in all the clinical studies and actually define 75% of body surface which is improved after treatment with the drug. And also we met the secondary endpoint of this study.
Based on the data, we approached both the FDA and the EMA, and they gave us a go-ahead to go to a pivotal study. Next slide, please. To a pivotal study, which will be conducted globally, and we are going to start this study very shortly. Our second drug candidate is Namodenoson, also a small molecule drug with a half-life time of 12 hours, meaning and also for the Piclidenoson drug, the patients are taking the drug morning and evening at home. Of course, it's a tablet, very easy to take. Next slide, please. So with the Namodenoson, our first indication is advanced liver cancer.
This has a very interesting history since you may know that in liver cancer, there is no response to any type of chemotherapy, and our drug is capable to induce apoptosis, meaning cell death of the liver cancer cells. And this was the rationale to take this drug, which is very stable and is not degraded by the liver, through clinical studies in advanced liver cancer. Next slide, please. So we conducted a phase II study. We had patients which responded with a partial response, and one patient responded in a fantastic way in a full, complete response. She has a very long-term complete response. Actually, she's cured by now. She's still treated with the drug for the last seven years, even more, seven years.
And this data are very interesting and based on the data of the phase II study, we have been prompted to initiate a pivotal phase III study. Next slide, which also has been approved by both the FDA and the EMA. We designated this study as Liveration, and study endpoint, of course, is overall survival. We have received an orphan drug designation by both the FDA and EMA, and a Fast Track by the FDA, and we have compassionate use programs both in Israel and in Romania. This study is already enrolling patients. We will have an interim analysis, and in case the interim analysis will be positive, we will be able to get a conditional approval from the regulatory authorities. Next slide, please.
With the very same drug, we are also planning, and it's very shortly it's coming, treat patient with pancreatic carcinoma. This is based on very good published preclinical studies showing the robust effect of our drug on pancreatic carcinoma cells, also inducing apoptosis of the pancreatic carcinoma cells through a very definitive mechanism of pathway, which actually is the mechanism through which the cells are proliferating and are not, again, responding to chemotherapy. So next slide. We have designed a phase IIa clinical study. It will include around 20 patients, maybe more. It will be conducted in Israel and in the United States. We plan to initiate it very shortly. Secondary endpoint will be safety . Sorry, primary endpoint and secondary endpoint will be, of course, objective response, progression-free survival, and of course, overall survival.
Next slide, please. So as I mentioned earlier, since this drug has a robust protective effect on the liver at a point and based on very good, actually excellent, preclinical studies and also very good data from a phase II-A clinical study, we are currently enrolling patients for a phase IIb clinical study. These patients, we are using biopsies. This is the regulation of the FDA in this indication. And, basically, we are conducting this study in order to open the door for a phase III study if the data will be reproducible. We have heard lately about two companies. One company which came up with the first drug in MASH, and the second one is Viking, which came this week during the EASL.
This is the conference in Europe for hepatologists. They presented also positive data. I am mentioning it because it is very important to know that there are now two companies who made it and who reached the primary and secondary endpoint in MASH, and we hope very much that we will be the next one online. As I said, currently, we are enrolling patients for a phase IIb clinical study. Next slide, please. Last but not least, 602, as I told you, and it's nice to complete this presentation with this drug, which is a very interesting one. This drug, we decided to develop it since it. During our clinical studies, patients reported that their sexual dysfunction situation is improved after they are taking the Can-Fite drugs.
We decided to select additional drug candidate, and to develop it into this very important indications in patients with diabetic or with high blood pressure. These patients cannot enjoy the other drugs on the market due to the safety issues, and this drug is a very safe one. Thank you very much. Motti, maybe you would like to conclude and to do the summary.
You, you're on mute there, Motti.
Motti, you are on mute. Motti, you are on-
Sorry, sorry. Can you hear me? Yes. Okay. So, thank you, Pnina. As you could understand from this great presentation, that we have all drugs with proven safety and efficacy. We're about to have two pivotal phase III study, one for psoriasis and one in advanced liver cancer. We are monetizing the advanced portfolio through corporate partnerships. As of today, we have 6 territorial partners, one with the pet. Hopefully, we will have more partners down the road this year. We have a novel therapeutic approach, a very broad intellectual property portfolio, and, regarding our finance, we have enough cash for the next 15 months to go and to continue our development. So thank you very much.
Thank you both. We are, as everyone knows, we're gonna be opening up the call for the Q&A portion of the event. If you do have a question, you can click the Q&A button at the bottom of the screen and just simply type your question in, and we will get to those as they come in. We have had a few questions already. One of the first questions was: What are the next key milestones that we should be looking out for, for with the phase III trials in psoriasis and liver cancer?
Very good question. As I have mentioned, in the liver cancer, and it will be also implemented in the psoriasis, we are looking forward to interim analysis data. Since these are pivotal phase III studies, we decided to introduce interim analysis, and for the liver cancer, it will be very critical since we will be able to get conditional approval if the data will be reproducible. Thank you.
Thank you. Our next question: How do you intend to position Piclidenoson against existing psoriasis treatments?
Okay. So, I like to be asked this question since there are many biological drugs out there and why Can-Fite is develop a drug. So the answer is very simple. Our drug is a small molecule, orally bioavailable one, given to the patients morning and evening via a tablet. All the other drugs are given, either by infusion, injection, whatsoever, but this is not the main issue. Main issue is that at the very beginning, these drugs are very efficacious, but as far as time long by, they start to lose the efficacy, and this is also not the main issue. Main issue is the patients start to develop, adverse events, even severe adverse events. And this is a reason that we think that a small molecule drug can be excellent to treat patients which suffer from a chronic disease for a lifetime.
So that's the answer, and I hope it's okay.
Very good. Thank you. We had another, I guess, follow-up question to the earlier one. When do you anticipate an interim analysis to occur?
This is something that we keep for the company info to come up with the PR. It's confidential information, which we cannot share with you right now, but we are enrolling patients, and it goes well.
Very good, thank you. Our next question: Given the breadth of your clinical trials and ongoing operational costs, what are your plans for ensuring that Can-Fite remains well-funded to continue advancing the clinical programs?
So as I say, we have enough cash for the next 15 months, and we are working very hard to find new partners and to bring more undiluted money to the company. So hopefully that the next money that will come to the company, we always, we have an open shelf, and we can raise money, but we think that in this share price, it's too low to raise money now. So that's my answer. I don't want to commit myself, but we are working very hard to secure undiluted money to the company.
Excellent. Very good, thank you. And, just to remind our viewers, if you do have a question, you can click the Q&A button at the bottom of the screen, and we will get to those as they come in. We had another question: your research into cannabinoid-based treatments targeting A3AR is intriguing. Could you provide more insight into the current stage of this research and potential applications?
Yes. This is still in a preclinical studies. We came up with a couple of publications, and so, and participation in scientific meetings. The data are really very interesting, but it is still an early project.
Thank you. And one more question that we have here. Can you share more about the nature and potential impact of your current out-licensing deals, and how do these partnerships enhance your development and commercialization efforts?
Motti, would you like to take it?
I think that we can talk about it in two aspects. One, they serve as a third-party validation. We go through very thorough due diligence from these partners, and they are bringing money now to develop the drugs. There will be development milestones, and then there will be sales milestone and royalties. So that's our way to finance the clinical studies.
Very good. Thank you. It looks like we do not have any further questions at this point. A great presentation, very thorough, but are there any final comments that you would like to leave with our audience before we do wrap things up?
Thank you very much for listening to the presentation. We think that we are very proud that we took an idea from the university, and we have now two pivotal phase III studies. The market cap is low, so it might be an opportunity. So, and, thank you very much. We are very open to answer any follow-up question, and we can do it through RedChip.
Excellent. Thank you very much. And, as I just noted, if you do have any questions after we wrap up today, please reach out to us here at RedChip. You can call us at 1-800-RedChip. That's 1-800-733-2447 or you can email us at canf@redchip.com. That's simply the ticker symbol, canf@redchip.com. We also have a page on our website at redchip.com, where you can get the latest investor presentation, fact sheet, and get news. You can also sign up for news alerts about Can-Fite there, and that's simply redchip.com/stocks/CANF. And with that, I want to thank everyone for joining us today. And thank you, Pnina. Thank you, Motti, for sharing the story. We definitely look forward to having you back to share more of the success as you continue.
Thank you very much. Bye-bye.
Bye.