Can-Fite Biopharma | Benzinga Healthcare Small Cap Conference

🎥 Mar 31, 2022 📺 Benzinga Events ⏱ 15m 👁 95 views

Pnina Fishman - CEO, Can-Fite Biopharma The Benzinga Global Small Cap Conference bridges the gap between Small Cap companies, investors, and traders. Learn about small cap investing with clearly defined Educational Modules, take a look at a curated group of Small Cap investment opportunities, and connect with the global Small Cap audience in an intimate, virtual setting. Register for FREE ➡️https://www.benzinga.com/events/small... Missed something? Get lifetime access to the video recordings here: https://events.benzinga.com/small-cap... Discovering new investment opportunities doesn't end...

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About Pnina Fishman

Pnina Fishman, CEO and founder of Can-Fite Biopharma, has presented company updates in multiple investor webinars and conferences between 2022 and 2025. She stated that the company has signed seven out-licensing agreements, receiving $20 million in upfront non-dilutive payments, with an additional $130 million expected from regulatory and sales milestones. Fishman noted that as of early 2025, the company had approximately $8 million in cash, which she said should support operations for 16 to 18 months. She described ongoing enrollment in a Phase III trial for Namodenoson in advanced liver cancer and a Phase IIb trial in NASH, and said the company is planning a Phase IIa study in pancreatic cancer. Fishman also reported that a Phase III trial for Piclidenoson in psoriasis had completed enrollment and that topline results were expected. Fishman has characterized Can-Fite’s drugs as orally bioavailable small molecules that target the A3 adenosine receptor, which she said is present only in pathological cells. She cited a published comparison suggesting Piclidenoson showed sustained efficacy beyond 12 weeks compared to Otezla, and described a liver cancer patient who, she said, had been treated for over seven years and was considered cured. Fishman stated that the company’s strategy is to develop and register drugs but not to market them, relying on partnerships for commercialization. She acknowledged that the share price did not reflect the pipeline in her view, and expressed confidence that positive clinical data would be reflected in the stock price.

Source: AI-verified profile updated from Pnina Fishman's recent appearances. Browse all interviews →

Transcript (21 segments)

Host0:04

Here right now, and there she is, CEO of Can-Fite, Pnina. How's it going?

Pnina Fishman0:11

Hi, good, good. Now to share my stream...

Host0:12

Hi, that's okay. We have your slides right here. There they are. And I'm going to step off here and I'm going to let you roll with it. I will say, just tell us when you want us to turn the slides, and we'll... we're the ones that are going to do it. So you would wait for your verbal cue. You just tell us what number slide you want to go on, and we'll be on this slide. So guys, let's go ahead and start turning. Okay, great. So shall we start? The floor is yours.

Pnina Fishman0:52

Okay, thank you very much. Welcome to the Can-Fite presentation. I'm very happy to be here today and to update you regarding our progress. Here is a forward-looking statement. Next slide, please.

And I would like to share with you the company profile. We are an advanced clinical stage drug development company where we develop small molecular oral drugs for the treatment of inflammatory and cancer indications. We have a robust clinical proof of concept which we came up with in the last couple of months, and I will be very happy to share it with you. Our technology is covered by 15 patent families, and we have successfully signed licensed deals that we have already signed recently. And we are putting lots of effort into signing more deals. As you know, we are dually listed on the New York Stock Exchange and the Tel Aviv Stock Exchange. We are trading with ADRs, and we are covered by four analysts from H.C. Wainwright, Alliance Global Partners, Roth Capital, and A.G.P. Next slide, please.

So it is very important for me to share with you our unique platform technology. Basically, we are targeting a specific cell surface receptor, the green structure, which is upregulated in pathological cells, but normally the body cells do not bear the target. So the drugs bind here to the target, and when they will get into people who suffer from one of the diseases that we are targeting, the drug will go here and will induce apoptosis, say death of the pathological cells, whereas the normal body cells will be reflected away since they do not express the target. Till today, we have treated more than 1,500 patients with an excellent safety profile. Next slide, please.

So what do we have on our pipeline? The first drug candidate, piclidenoson, is currently developed for psoriasis. We just completed patient enrollment for a Phase 3 clinical study which will entail more than 407 patients. With the very same drug, which has a robust anti-inflammatory effect, we are treating also COVID-19 patients under an open IND with the FDA, and the enrollment now is ongoing. The second drug candidate, namodenoson, which is a very stable drug, is positioned for the treatment of liver indications since the drug is not degraded by the liver. And we are treating patients with advanced liver cancer and also with NASH. In each of these indications, we successfully concluded a Phase 2 study. And with the advanced liver cancer, we are now initiating a pivotal Phase 3 study which is approved both by the FDA and by the EMA. And with the NASH, after we concluded positively the Phase 2a, we are continuing and we are already approved by IRBs for the Phase 2b clinical study. We have two programs in three clinical studies. The CF602 is positioned for erectile dysfunction and also targets the A3 adenosine receptor. It seems that CBD binds with high affinity to the very same target that I presented to you before, and we have the tool to identify and to predict which CBD will perform very well in the clinic. Let's move on now. Next slide, please.

And I would like to share with you the robust clinical proof of concept that we have today. With this psoriasis Phase 3 study, we have conducted an interim analysis on October 2020. The interim analysis was positive, showing both safety and efficacy with 200 patients, and we were highly recommended by the committee which was on top of the data to continue patient enrollment. As I mentioned earlier, we already completed patient enrollment, and we will come up with the data early 2022. Regarding the NASH Phase 2a study, we could show anti-fibrotic and anti-inflammatory effects. This is the basis to continue to the next stage, the Phase 2b study. And with the advanced liver cancer, which could show that the patient population, which are type B7 patients, constituted 70% of the patients with advanced liver cancer, we could show prolongation of overall survival. And based on this data, the FDA approved the pivotal Phase 3 study that we are going to initiate during Q4 this year. Next slide, please.

I would like to take you through our business development strategy. We are developing the drugs, we will register the drugs, but we will not be able and we do not mean to market the drugs. So we are extensively working on signing deals with partners which will be the ones to market our drugs globally. So till today, we signed a deal in China, in South Korea and Canada, in Spain, Austria and Switzerland, Europe, and also in Eastern Europe for each of these indications. Out of this deal, we got already $20 million as upfront money, which is non-dilutive money, and more $130 million will come based on regulatory and sales milestone payments. And this is beside the royalties that we are going to get from each of the deals. We are extensively continuing to look for partners, and we hope that more deals will come down the road and we will be able to share it. Next slide, please.

I would like to brief you now, next slide, regarding the first drug candidate, piclidenoson, where we have a specific mechanism of action, molecular mechanism of action. As I mentioned, we came up with positive interim analysis data back on October 2020, and we hope very much that the data will be reproducible and we are going to come up with top-line results on Q1, early Q1 2022. Next slide, please.

With the very same drug, we also treat COVID-19, and this is based on the robust effect and on the fact that before the pandemic, we came up with a publication showing that this drug has robust cytokine release syndrome inhibitory effect. You may know that the reason of the death of the COVID-19 patients is because of the cytokine release syndrome and the inflammation in the lungs. So we are currently enrolling patients in Israel and in Europe for a COVID-19 Phase 2 study open under an IND with the FDA, and we hope to come up with the data on Q2 2022. Next slide, please.

I would like to share with you now our second drug candidate, namodenoson, currently positioned for the treatment of liver diseases, advanced liver cancer, and also NASH. Next slide, please.

So as of the advanced liver cancer, we are going to initiate the pivotal Phase 3 study which is under the agreement of both FDA and also EMA. With both agencies, we have a status of an orphan drug designation, and with the FDA also a fast track status. In Israel, we have an ongoing compassionate use, and during Q4 we are going to initiate the pivotal Phase 3 study. Being successfully concluded, we will be able to register this drug both with the FDA and also with the EMA. Next slide, please.

I would like to share with you the second indication with namodenoson, which is NASH. As I mentioned, we successfully concluded a Phase 2a study. We could show reduced liver fat content, inhibition of fibrosis, anti-inflammatory effect, and decrease in body weight. We also selected the dose, and as I mentioned, we are currently approved by IRBs for a Phase 2b clinical study. Enrollment is expected to commence every day, and in this study we are going to include liver biopsies which will allow us to initiate the Phase 3 vis-à-vis the FDA. Next slide, please.

I would like to share with you our drug which is positioned for erectile dysfunction, CF602. This is also a small molecule drug. Based on anecdotal records from patients which participated in our clinical studies, they came up and stated that they are doing very well with their erectile dysfunction. So this prompted us to take this drug, CF602, and to test it in three clinical models. And what we could show is that we have a significant full recovery from erectile dysfunction in diabetic rat models, both when we are treating topically and when we are treating orally. We are now putting lots of efforts to push this molecule into the clinic. Next slide, please.

Last but not least, and as I mentioned, we realized that cannabinoids, actually more precisely CBD, are targeting the very same receptors. And with very minor, small dosages of CBD, I mean nanomolar and picomolar concentrations, we are successful to go into pure liver diseases like liver fibrosis and liver cancer. We are going to present data from our studies during the American Association for the Study of Liver Diseases very shortly. This is a very interesting project based on our platform technology. Next slide, please.

And just to conclude, what I presented to you today is a novel therapeutic approach. Can-Fite develops a couple of drugs based on a unique technology of a receptor which is present only on pathological cells. All three drugs that we are developing are all drugs with proven safety and efficacy. We have a very broad intellectual property portfolio, we have already signed corporate partnerships, and we are now financially well positioned. Thank you very much, and I thank you for participating in our presentation.

Host14:12

Thank you very much. We got a couple of questions from the chat, Pnina, before we hop off. I will ask this one from Ralph: Do you believe that your pipeline reflects your share price, and if not, why? Do you have any theories as to why your shares are or would be undervalued in that sense?

Pnina Fishman14:34

Yeah, of course, the CEO will never be happy with the share price, and we think that based on the pipeline, the share price needs to go up. We believe that as we see more and more clinical proof of concept, it will be reflected in the share price. We are now looking forward to the psoriasis data and the COVID-19 data, and we are sure that for successful conclusion, it will be reflected in the share price.

Host15:12

Pnina Fishman is the CEO of Can-Fite BioPharma. There's the URL and the ticker on the screen. Pnina, thank you so much. Oh, you know, actually, let's see one more from Ralph because, you know, kind of gotta show love to the chat. Um, I ain't just talking about the website, that's not even a question, never mind. Pnina, thank you, thank you so much for the time and have a good rest of your day.

Pnina Fishman15:38

Thank you very much.