Can-Fite Biopharma, Ltd. (NYSE American: CANF) Investor Webinar - Oct. 29, 2024

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, 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 cell 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 2 and some of our Phase 3 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. The first drug candidate is Piclidenoson, currently developed in a Phase 3 study for the treatment of psoriasis, a devastating skin disease. And let's take into consideration that we are developing here a 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 Niemann-Pick disease. It's a genetic rare disease where 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 in a Phase 3 clinical study, for pancreatic cancer at a Phase 2a clinical study, which very shortly we are going to embark on, and also last but not least, for MASH, till recently has been called NASH, and it's 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 a Phase 2b clinical study, and we are expecting positive data which will open for us the way to go to a Phase 3 study under FDA approval. And last but not least, we have CF102, which is a drug for 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 via the FDA and also via the EMA, as Motti mentioned, but we will not be the ones to market them. So under this model, we have already out-licensed a couple of deals: two in Europe, one in China, two in Korea, one in Canada, and one with Vetbiolics, a French company which got the license for the animal, for pets who suffer from osteoarthritis. Overall, we got already $20 million of front money and more $130 million based on milestones that need to be introduced to the company upon reaching of some milestones. And last but not least, we also get royalties. It's something that we are working very hard on, and hopefully, very shortly, we will be able to come with more partnerships which infuse non-dilutive money into the company. So let's go very rapidly through the drugs. 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's a small molecule drug and it is taken by the patients twice daily since its half-life is 8 to 10 hours. And the first indication and the most advanced one is severe psoriasis. And as I mentioned, we have already shown in Phase 2 and Phase 3 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. And 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 3 clinical study that we have concluded recently. And 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. So you can see that we are working in parallel through the two agencies. And now we are conducting the Phase 3 clinical study. We will start patient enrollment very shortly. The protocol is straightforward, 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 Vetbiolics, 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 to Can-Fite, which is $325 million during the next decade. And we are looking forward for this indication. Looking at Namodenoson, which is our second drug candidate, again a small molecule that has a half-life of 12 hours, given to the patients morning and evening. The first indication is advanced liver cancer, now in a pivotal Phase 3 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. 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's 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 drug 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 a 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 of apoptosis of 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 2 clinical study, and what we are doing currently is a Phase 2b clinical study. And as I mentioned, we hope that it will open for us the way to conduct a Phase 3 clinical study and to register this drug with the FDA and also with the EMA. I will skip the CF102 because it's only preclinical, and Motti will conclude.

This is a very good question. And actually, the drug will work linearly, and the patient will improve along the time that he's taking the drug. And we need to keep in mind that this is a chronic disease, and the response will start after two months, and we go higher and higher. And patients can take it for a very long time, chronically, and enjoy the drug 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.

Yes, the response of the patient was very good. You may know that these patients are waiting for 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 a very broad effect, and we are trying through compassionate use and other ways to see which additional liver indications will be suitable for us to treat patients.

The drugs 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. And the drugs are also very stable and are not degraded, for example, by the liver, and this is the reason that they can work in the liver. So we are not looking for modifications in the current drugs. They have modified the original backbone. Adenosine has been modified by, I have to mention it, the head of the American Society of Chemistry, and he's a guy who is based at the NIH, Dr. Jacobson. And we licensed 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.

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 a 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 the reason that we can use our drug in advanced liver cancer patients. So this is the distinction between our drugs and the ones which are under development or already prescribed on the market.

You're welcome. Thank you. Bye-bye.