Can-fite Biopharma | Investor Presentation | Benzinga Global Small Cap Conference

Good morning, good afternoon. We are doing very well.

Okay, thank you very much. So I'm Pnina Fishman and I'm the CEO of Can-Fite BioPharma. And let me take you... Okay, can you move to the next slide, please? No, the next one. Okay, so looking at our company profile, we are an Israeli-based biopharmaceutical company where the discovery labs and the company management are based in Israel. And in the United States, we have a team who is on top of the pre-clinical, clinical, and regulatory affairs. We are developing small molecular bioavailable drugs for the treatment of inflammatory, cancer, and metabolic indications. We have a robust clinical proof of concept for our platform technology, which is very unique. I will share it with you in a minute. And the proof of concept is based on phase two and phase three clinical studies. Our strategy is to out-license our drug. We will be the one to develop, to register, but not to market. And we have already been successful to sign a couple of deals which granted the company overall 20 million dollars as upfront non-dilutive money, and more 130 million dollars will come a bit down the road from regulatory and sales milestones. The company is dually listed on the TASE and on the New York Stock Exchange. And let's move to the next slide, please.

So our platform technology is very unique since our drugs target only the pathological cells in the body, cells like inflammatory and cancer cells. You can see the receptor, the A3 adenosine receptor, which is painted green here in comparison to normal body cells in the bottom cartoon on the right side. So normally the body cells do not express or bear the targets. So when our drugs will get into the body, they will bind and destroy, will induce cell death only of the pathological cells and will spare the normal body cells. As a result, we have an excellent safety profile after we have dosed today more than 1,500 patients. Let's move to the next slide, please.

And you can see the drug development pipeline. So on the left upper side, our first drug candidate, piclidenoson, is currently positioned for psoriasis. We are in phase three clinical studies. We have an ongoing phase three which we are going to complete patient enrollment quite shortly and come up with the data towards end of this year. The second indication is COVID-19. We are enrolling patients for a phase two COVID-19 under an open IND with the FDA. We are going also to conclude this study towards end of year. The second drug candidate is namodenoson, and we develop it for advanced liver cancer. We are doing now all the preparatory work for a pivotal phase two clinical study. And the second indication with namodenoson is non-alcoholic steatohepatitis, a disease which many companies are now competing but no one was successful to register a drug with the FDA. We successfully concluded a phase twoa clinical study and are heading for a phase twob clinical study. Last but not least, we have two additional pre-clinical programs. The one is our third drug candidate, CF602, currently positioned for erectile dysfunction, not for healthy subjects like the Viagra, Cialis, or Levitra which are on the market, but for patients who suffer from diabetes and from cardiovascular diseases and cannot enjoy the other drugs on the market. And the cannabinoids, we happen to realize that cannabis-derived compounds bind to the very same target which I presented earlier, and we are embarking on this finding and can pinpoint cannabinoids which will be the best to perform in the clinic. And we are embarking on it and looking at these compounds, pushing them into the clinic. If we look at the next slide, please.

So you can see that till today we have a very robust clinical proof of concept which came out of the interim analysis that we conducted back on October 2020 after we have enrolled 50 percent of the patients to the phase three clinical study in psoriasis. We had an IDMC committee which was on top of the data and very strongly recommended to continue patient enrollment based on both efficacy and safety. The company was blinded to the data. Regarding the NASH, we concluded very positively a phase twoa clinical study. You can see on the top of the slide the decrease of the fat in the liver after we have treated patients with our drug for only three months. And last but not least, the advanced liver cancer phase two study. We identified a subpopulation of very advanced liver cancer who are defined as Child-Pugh B7 patients, and you can see here the prolongation, the extension of the overall survival of this patient population, which was the basis for the forthcoming pivotal phase three study that we are going to initiate towards end of this year.

In the next slide, what we can see is our business development strategy. We will be the ones to register the drugs vis-à-vis the FDA and the EMA, but not the ones to market the drugs. So we are continuously and actively looking for partnerships. We have already signed seven different partnerships with different companies all over the world, and each one of the deals entails upfront money upon signing, regulatory milestone payments, royalties, double-digit royalties, and it goes from 10 to 23 percent of royalties, and sales milestone payments that will be paid down the road. As I mentioned, till today we have already received 20 million dollars out of the upfront money, and 130 million dollars will come a bit down the road. Next slide, please.

I would like now to share with you a couple of facts regarding our lead drug candidate, piclidenoson, currently developed for psoriasis and for COVID-19. Next slide, please. So the phase three psoriasis clinical study entails four arms. As I mentioned, we successfully got a positive interim analysis data and were very highly recommended to continue patient enrollment. We have just come two weeks ago with an announcement that we have already enrolled 75 percent of the patients from this study, and top-line results are expected end of this year. Next slide, please. Here we see the COVID-19. Next slide. The COVID-19 study, we have an open IND with the FDA since the very same drug, piclidenoson, has a robust anti-inflammatory effect and it can inhibit the main manifestation of COVID-19, which is cytokine release syndrome, and this is a reason for the inflammation in the lung and for the death of these patients. So we are trying to develop our drug and to position it in moderate to severe hospitalized patients which have been affected by the disease. We are expecting top-line results towards end of this year. Next slide, please.

I would like now to share with you the namodenoson, a drug which is positioned for liver diseases, the advanced liver cancer and the NASH. And in the next slide, please, we can see the liver cancer indication which is now under preparatory work for a pivotal phase three clinical study. We have been granted by the FDA and EMA orphan drug status and by the FDA fast track status. This helps us a lot with the development of the drug. We have in Israel an ongoing compassionate use program, and towards end of year we are going to initiate the pivotal phase three clinical study. Let's move now to the next slide which summarizes the NASH indication. NASH is non-alcoholic steatohepatitis, meaning accumulation of fat in the liver not on an alcoholic basis. We concluded, as I mentioned, positively a phase twoa clinical study. We reduced liver fat content, inhibited fibrosis, introduced an anti-inflammatory effect, and the drug showed excellent safety profile. We are expecting to initiate this study on Q4 this year. And in the next slide, you can see the two pre-clinical programs that we have. This one regarding erectile dysfunction is with our drug CF-602, which is an allosteric modulator at the receptor. And interestingly, in pre-clinical studies we could see both systemic effect of the drug and also the same topical effect of the drug. We are now looking to partner regarding this molecule and to have a partner that will help us and support pushing this drug into clinical studies. And last but not least, next slide, this is the cannabinoid program. We know that cannabinoids bind to the very same target. We have already identified one cannabinoid which has a robust effect in liver diseases and has an anti-cancer and anti-fibrotic effect. We are working in order to push compounds into the clinic.

And just to summarize, the next slide, please. What I presented you today is a novel therapeutic approach where we are targeting a specific cell surface receptor which is present only in pathological cells but not in normal body cells. And this is the reason why our drugs have such a good safety profile and also very good efficacy. We have a quite broad intellectual property portfolio. We have signed till today a couple of partnerships which already granted the company 20 million dollars in non-dilutive money and will grant more money down the road. And now we are financially well positioned, and we think that it's a very good time to join us between now and Q4, where we will come up with a couple of clinical milestones regarding both data and also initiation of clinical studies. In the meantime, as I mentioned, we are working in order to sign more partnerships. I would like to thank you for listening to our presentation, and we'll be very happy to answer questions. Thank you.

I hope I got that right. Not yet, but it is on our agenda. Thank you.

Thank you very much. Bye bye.