Welcome back, everyone. Next up, we have Can-Fite BioPharma. It trades on the NYSE American under the symbol CANF, and is an advanced clinical stage drug development company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. Please welcome its COO and CFO, Motti Farbstein. Nice to see you, Motti. Nice to see you again.
Thank you. Thank you, Anna. Thank you for the opportunity presented to your conference. That's the forward-looking statement, and I will jump to the presentation. Can-Fite is an advanced clinical stage company. We have small molecule drugs that to treat inflammatory and cancer indication. We have a robust clinical proof of concept following a phase II and phase III studies, and the technology is covered by 15 patent families. The business model is to license out, and as of today, we have successful out-licensing deals that infused more than $20 million to the company, and additional $130 million we will get based on development milestone, regulatory approvals, and by the end, we will get double-digit royalties from the net sales.
We are duly traded at the NYSE American and Tel Aviv , using ADR as a tool. Last financials, we had $12.4 million in our bank. We started actually the technology back at university from basic research of our chairman, Professor Pnina Fishman. We are targeting a unique target. It's the adenosine receptor. It's actually the A3 adenosine receptor. It's the green spiral that you can find on the top on the right, and you can see that you can find it only on the pathological cells and not on the normal cells. We are global leader on this target. All our pipeline drugs are bind only to the pathological cells, but not the normal cells, as they do not have the target.
Our drugs are small molecules, orally bioavailable , available drugs. It's proven therapeutic effect, high efficacy, and good safety, with anti-inflammatory and anti-cancer effect demonstrated in our studies. We have an excellent, safety profile demonstrated in, more than 1,500 patients. We have two, drugs in the clinic. The first one is Piclidenoson for psoriasis. Following a phase III studies, we are now heading into a phase III studies that recently, cleared by the FDA and the EMA. The second drug is Namodenoson. We have liver cancer, for, patients who do not have any other alternative, and there is an open, ongoing phase III studies in the U.S. and Europe. We are now in the preparatory work for a phase IIa in pancreatic cancer.
I will talk about it later. We have program also for NASH, where there's an ongoing phase IIb study in Europe and Israel. We are going to file an IND and continue and add some sites in the U.S. On top of it, we have two preclinical programs. The first one is CF602 for erectile dysfunction. We have cannabinoids. I will talk about it later, if there will be time in my presentation. The business model is to license out. We see ourselves as a company who knows how to bring an idea from the bench to the clinic. As of today, we have six territorial partners. As you can see in the map, we have a company in Canada that took psoriasis.
We have two companies that took our drugs to some countries in Europe, mainly Eastern Europe. We have a partner, CMS, which took our drugs to China and the territories. We have also two partners in South Korea. As I mentioned before, we got undiluted $20 million from these deals. We should get $130 million. It's potentially based on regulatory and sales milestones, and on top of it, there will be two double-digit royalties from the net sales. We'll go briefly now on the drugs in the pipeline, and I will start with Piclidenoson for the psoriasis. We share the Phase III positive data by the end of last year.
We compare our drug, as you can see in the slide, to two dose group of Piclidenoson, and compare it to Otezla, apremilast and placebo. The study name is COMFORT. In COMFORT, phase III studies made the primary endpoint, which was the superiority versus placebo on week 16. As you can see in the graph, we looked at the PASI 75. The phase III shows all of the patients see improving, progressive response over time. Demonstrated excellent safety profile, and the safety profile of our treated patient is, was overlapped with the one of the placebo-treated group. We had better safety profile than the Otezla. As of today, we received the go-ahead from the FDA and the EMA.
for our registration plan of Piclidenoson for psoriasis, which will include two phase III studies that we will conduct in parallel. The second drug in the clinic is Namodenoson for liver cancer, pancreatic, and NASH. I want to share with you, one patient from our, former phase II study. This patient, was enrolled to the study, and as of today, till today, it's actually 6.5 years. This patient is continued, treated with Namodenoson under an open-label expansion program in Europe. This patient, had a complete response, complete cleared of all the lesion, all the cancer lesions.
Over the course of 6.5 years, the clinical benefits included disappearance of ascites, return to normal liver function, and disappearance of peritoneal carcinomatosis. Based off the phase II data, there is now an phase III studies, pivotal one. The name of the study is LIVERATION, and the FDA and the EMA agreed on the study protocol. There will be an interim analysis by Independent Data Monitoring Committee after 50% of the planned 450 patients that we are planning to enroll to the study. The Namodenoson will be given as a second or third-line treatment for advanced liver cancer patients. Patient who there's no other therapies or the third therapy that they took before is no longer effective. The primary endpoint is overall survival.
We have Orphan Drug status from the FDA and the EMA, and a Fast Track status that was granted by the FDA. In addition, there is a compassionate use programs in two countries, both in Israel and Romania. The second indication is pancreatic cancer, and due to the good data of the liver cancer patients, we did some preclinical studies, and we showed that we reached 90% inhibition in pancreatic cancer growth. We have the molecular mechanism of action, which is the regulation of the WNT and inhibition of NF-κB signaling pathways. We are now planning and preparing a phase IIa study. We are going to do a second-line therapy, an open label, using the same dose, 25 mg, as the liver cancer patients.
The efficacy endpoint will include objective response, progression- free survival, duration of response, overall survival, and of course, the safety. In addition, we are now in the process of submitting an IND to the FDA, and we will open also sites in the U.S. On top of it, we have a program with NASH. It's a Nonalcoholic Steatohepatitis, or Nonalcoholic Fatty Liver. It's accumulation of fat in the liver and not due to alcohol consumption. There's unmet need, and there's no FDA approved treatment as of today. We concluded the phase IIa study successfully. We showed that we reduced the liver fat content in the liver, anti-inflammatory effect. We chose the dose, decreased the body weight of the patient who took Namodenoson, and we had an excellent safety.
Following the phase IIa, there is now an open phase IIb study. It's a multicenter, randomized, double-blind, placebo-controlled study in 140 subjects with biopsy-confirmed NASH. The patients will be randomized in 2 to 1 toward the Namodenoson versus the placebo. We will follow the patients till 36 weeks, and the primary efficacy endpoint will be determined by the liver biopsy at week 36. The CF602 for erectile dysfunction, and you can ask me Anna why we are developing it, but we find it as a serendipity. We have an anecdotals reports from patients and physicians that was treated with our drug, both women and men, testifying that the drug reversed the sexual dysfunction.
We have another molecule, it's called CF602, that we took into some preclinical study and showed that the activity of CF602 is a significant full recovery from erectile dysfunction in diabetic rat model. We can use it as a topically or a systemic agent. It's dose-dependent with a linear effect, and the response in the model was after single dose of six CF602. We have the mechanism of action and, as of today, I can tell you that we are not developing more resources to develop it, but looking and talking to potential partners for the erectile dysfunction indication. The last indication that we have is cannabinoids.
The rationale was that we found out the cannabinoids are known to bind also to our target, the A3 adenosine receptor, and mediate the clinical effects through the receptors. As of today, we have an assay to identify clinically active cannabinoids, where we can select the best active cannabinoids that will be good for liver cancer and liver fibrosis. We have the intellectual property, the market is huge, and the same with the erectile dysfunction. We are talking and looking for a partner in the cannabinoids area. To summarize, we have an oral drug with proven safety and efficacy in phase II and 3. The assets in phase III are for psoriasis and liver cancer.
We also have a strong efficacy in NASH, we are going to start phase II in pancreatic cancer. We monetize advanced portfolio through corporate partnerships. I talked about it. We are looking to find more partners. It is a novel therapeutic approach. It's a unique technology for the treatment of cancer, liver, and inflammatory disease, addressing multi-billion dollar markets. The intellectual property portfolio consists of 15 families, protects in different layers, the indications and the drugs. As of today, the money that we have and the money that we should get from the partners, we think that we are financially well-positioned. We have enough money for at least 18 months from today. Thank you.
Well, that happens to all of us. Sorry, Motti. You mentioned partners. Would you like to explain a little bit more details what type of partners you're looking for?
Yes. The partner that we are looking for, a partner that will take the drugs, and we will give them the sales rights or the license for a specific territory and specific indication. As I showed, we had some small deals in Canada, a few countries in Europe, China, South Korea, but the U.S. and the majority of Europe is open for deals, the same as South America. That's for the Piclidenoson and Namodenoson. As I mentioned before, we are looking also for partners to partner the preclinical technologies, the erectile dysfunction and the cannabinoids.
We have a question from Nicolas Thompson. Wants to know about your licensing deals. How many do you have, and how are they structured?
Okay, I'll jump to the slide, which will be easier for me. I'm back to the slide of our partners. You can see there's a typical deal structure. It's on the middle down of the study, which consists of upfront money upon the signing of the distribution deal or licensing deal, there are regulatory milestones patients, along with this, the development of the drug labelization. There are royalties, double digits, as of today, between 10% and 23% from the net sales. There are sales milestone payments when we reach certain amounts of sales per year. You can see that we have on the map, in America, we have only Canada, a few countries in Europe, China, South Korea.
That's the type of deal that we are looking. We think now that we are entering into two pivotal studies, both in psoriasis and liver cancer, that now it's a good time for us, and we are doing it. Talking to potential partners and find them, and bringing in them on board to help us develop and sell the drugs.
Question from Francisco Vilar: What is the timeline for the Namodenoson liver cancer clearing phase III?
We started to enroll patients recently. We think that it will take us between 18- 24 months to get into the interim analysis. Interim analysis can be a good point for the company either to get a conditional approval or to continue the study and get a good feedback from the study. That's about the timelines. We might be earlier, but I don't want to be too optimistic timelines.
Dagan Levi asks: How far will your cash in the bank take you before you need to raise funds?
As of today, we have enough cash for the next 18 months. We do hope that the next cash that we will get will be undiluted money from a new deal that we will get and not from the market.
Avery Kelley wants to know: When finding new partners, are they for technology, funding, or both? Can you explain how a deal would be structured?
The current partners in the bank, we are looking, biopharmaceutical companies, pharma companies, they have the ability to sell the drugs. We know how to develop drugs. We are looking for partners who will be able to sell the drugs all over the world.
TR wants to know an update on the Piclidenoson treatment for pet osteoarthritis trial.
I skipped this one, that's on the same slide that we presented with the company by the name of Vetbiolix, the French company, that took the rights to develop Piclidenoson for dogs for osteoarthritis, which is a major problem for dogs. They are doing now the animal study. We are looking and waiting for the data, and once we will have it, we will share it with the public. I think within the next few months, but it's up to the company, and I have to mention that they are doing it on their own resources, and we are going to benefit from it if it will be positive.
Cope wants to know: How is your funding typically structured?
As of today, mainly was, we tap the market using our shelf, registered direct . That's what the structure of our recent is.
Seth Bonilla asks: What is your most proprietary technology that would make you an attractive takeover candidate?
I think both the. With the liver cancer, we are treating patients who have no other alternative. It's there in a phase where either there is no drug approved for them, or the drug that they are using it no longer benefit. They cannot benefit from it, mainly due to liver toxicity, and due to our safety, we are treating patients who have no other alternative. That's the liver cancer patients, which is in a pivotal stage. I can add also that the psoriasis one, there are many drugs on the market. The psoriasis patients are getting the disease in our, their twenties, thirties, forties, and they need to take drug all over their life, and they are looking for a safe, orally bioavailable drug with an efficacy. We think that there is a room in the market for a drug like Piclidenoson for psoriasis patients.
Kyle Paul asks: Are the rising interest rates affecting business or funding at all?
Not as of today, as we have enough money. I cannot predict what will be in the future.
No one can.
Yeah.
Well, this was great technology, great products. Do you want to give us some closing remarks for our viewers?
I can only say that, you know, we are a small company. The market cap is very small. We have two assets in phase III. We have partners. We need a success, one success to be in the market cap that we think that we should be, not where we are today. I'm sure that every company is saying the same, but I gave the presentation and look at the data, the assets, the market cap, and if you have more questions, I'll be very happy to answer. If not, thank you, Anna.
Yes. One last question for you.
Sure.
Do you release guidance?
What type of guidance?
Well, guidance on the stock.
We have, we share our press releases a lot. We are, traded at the New York Stock Exchange, so we're filing all our 10-Qs and everything that we need. If not, there's a. You always can approach the company and ask me whatever you want.
Perfect. Well, thank you so much for joining us, and we certainly hope you come back on the conference in the future with some updates.