CEO & Founder, Can-Fite BioPharma
Can-Fite Biopharma, Ltd. (NYSE American: CANF) Investor Webinar - Feb. 25, 2025
Can-Fite BioPharma is an advanced clinical stage drug development company with a platform of oral drugs designed to address multi-billion-dollar markets in the treatment of oncology and inflammatory diseases. The Company’s lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis. Can-Fite’s liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of NASH a Phase III trial for hepatocellular carcinoma (HCC), and the Company is planning a Phase IIa study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designat...
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.
Transcript (34 segments)
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Craig Bellford0:01
Hello, this is Craig Bellford with Red Chip Companies. Thank you for joining today's event with Can-Fite BioPharma, which trades on the New York Stock Exchange American under the ticker CNF. With us today we have Pnina Fishman, who is Can-Fite's Executive Chairman and Chief Scientific Officer, and Can-Fite's CEO and CFO, Motti Farbstein. We will begin with a brief presentation in a moment, and afterward Pnina and Motti will answer your questions. Users may ask a question at any time by using the Q&A tool at the bottom of the Zoom window. Because we have a great many participants today, we will take questions in written form only. Before we begin, please allow me to read the Safe Harbor statement. 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, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management, constitute forward-looking statements. Any statements that are not historical fact should also be considered forward-looking statements. Of course, forward-looking statements involve risks and uncertainties. With that said, I now turn this webinar over to Can-Fite. Please go ahead.
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Pnina Fishman1:18
Thank you, Craig. Bri, can you move to the first slide? No, I thought you will start, but I can do it. Yes, sure. So we are developing safe drugs for the treatment of pathological inflammatory diseases. We have an advanced clinical-stage pipeline with short regulatory approval pathways, both to the FDA and the EMA. Successful out-licensing deals. We are dually traded at the New York and Tel Aviv stock exchanges with around 10 million ADRs outstanding. Last financial, or by the end of 2024, we had around $8 million in the bank. So the money that we have and the short-term milestones that we should get from our current partners should support the company for the next 16 to 18 months.
Okay, so as part of you may already know, we have a very unique platform technology. We have a target which is a specific cell surface receptor, the A3 adenosine receptor, where our drugs will bind to the target, which are the inflammatory or cancer cells. And you can see here that normal cells are very low or no, they are nude and do not bear the target. And this is the reason that when the drug will get into the body, it will bind only here and will not bind to the normal cells and will not harm them. After we have already treated a couple of thousands of patients, we know that this is the reason why our drugs are so safe. We have proven therapeutic effect from Phase 2 and even Phase 3 clinical studies and an excellent safety profile.
While looking at the pipeline, so we have the Piclidenoson drug, which is our anti-inflammatory drug, and we currently use to treat psoriasis patients. We are conducting a pivotal Phase 3 clinical study. The second indication with this drug is a rare genetic disease, Fabry syndrome. Actually, we are not the ones who came up with this indication. It came from Naples University in Italy, and they used our research drug and found that they can cure preclinical experimental models of Fabry syndrome. As I mentioned, a rare genetic disease which actually affects the kidney and the brain. With Piclidenoson, we are doing now all the preparatory work for a Phase 2 clinical study. Last but not least, we decided that since the drug has a robust anti-inflammatory effect, we can out-license it also for the treatment of dog osteoarthritis. And in the frame of the presentation, you will see this as well.
The second drug candidate is Namodenoson. This is our oncological drug where today we are developing it towards advanced liver cancer. We have an ongoing pivotal Phase 3 clinical study in patients who suffer from this disease, and we also treat patients with pancreatic carcinoma in the frame of a Phase 2A clinical study. And then we have the CF602, which is still in early development stages for the treatment of erectile dysfunction. These are our corporate partnerships. We have already signed seven of them. To a company which is based in Central Europe, actually two companies, and one for Eastern Europe, one for Central Europe, not all the countries, only three countries. We have licensed it for China, also for Korea, for Cipher Pharmaceuticals in Canada, and for Vetbiolix, who is the company who licensed the utilization of pets for osteoarthritis. In the frame of these studies, we got an upfront money of $20 million, and more $130 million will come down the road.
So let's go over the drugs in our pipeline in a very concise way. So you can see here the molecule of Piclidenoson, which is a small molecule drug. This is a chemical profile of the drug. The interesting thing and the take-home message is that the drug can be taken orally twice daily. And as I mentioned, we are developing it currently for moderate to severe psoriasis. So why this drug can be positioned for the treatment of psoriasis? So first of all, the target itself, the A3 adenosine receptor, is overexpressed on the cell surface of the skin cells. And also, our drug can push the inhibition of two very important cytokines, interleukin 17 and interleukin 23, which are by antibodies to these cytokines positioned today as biological drugs to treat psoriasis. So since our small molecule drug Piclidenoson can do a very similar job, we think that we can position it very nicely in the world of biological drugs with all the adverse events and severe adverse events that we see. So you can realize that this drug has a robust anti-psoriatic effect. We have here all the molecular mechanism of action that I will not get into it right now, but this was rational to take this drug into this indication.
And you can see here a glimpse of the data that we got in the first Phase 3 study. Basically, we hit both the primary endpoint, which was PASI 75, and also the secondary endpoint, which was PGA 2. And in this study, we also had the ACR. So this actually opened for us the door for the current Phase 3 clinical study. In a minute, I will get into it. Just before it, I would like to show you that the drug can be active also topically. And here in a preclinical model, we see how Piclidenoson very nicely cleans the skin of the animals that were infected with psoriasis.
So where are we today? Today, very shortly, we are going to start initiating the Phase 3 clinical study, enrolling patients in agreement with both the FDA and the EMA on the study protocol. We will treat patients with Piclidenoson, a twice-daily drug. It's a tablet, so it's very convenient for the patients to take it. And the primary objectives of this study will be the two primary and secondary that I presented you before, which is PASI 75 and PGA 2. And of course, we look at the safety of the drug in the patients. So I would like also to share with you very shortly some data regarding the veterinary effect of Piclidenoson in pets who suffer from osteoarthritis. So you can see here, in a very robust and statistically significant way, the effect of our drug Piclidenoson. In this specific study, we used not we, but the partner used dogs. And this is a very good basis for the partner to keep developing this drug, and hopefully, it will be registered quite shortly for treatment of pets. And this will bring Can-Fite a very good and non-dilutive income.
Regarding Namodenoson, which is our oncology drug, so the chemical formula is very similar but different from Piclidenoson. And this drug also is a small molecule drug which can be taken orally twice daily by the patient. So the first indication is advanced liver cancer, and of course, the rationale is the robust anti-cancer effect that we have found in preclinical studies. Again, I will not get into the molecular mechanism of action, but it is very well defined. It's extensively published by Can-Fite and by others. And I would like to give you here an example of a patient which responded in a fantastic way in the frame of the Phase 2 clinical study. You can see here with the round red circle the lesion that this patient had in the liver, and you can see that along the study period, the lesion now is much smaller and it just disappeared. Not only the liver lesion, but also all the metastasis has disappeared. This is a patient which was treated more than eight years on our drug. Now it's under compassionate use, but before it was under the Phase 2 clinical study.
So this brings us to the current study that we are enrolling patients. Just before, to give you the regulatory status of this drug: it's an orphan drug. We got a breakthrough designation both by the FDA and by the EMA, a fast track by the FDA, and we are heading towards an interim analysis. And if the drug will become, with positive data, we will be able to have a conditional approval and to start marketing the drug after 50% of the patients will be enrolled. Last but not least, we have the pancreatic cancer that we are treating in the frame of our oncological indications. And the rationale again is a very robust anti-cancer effect. 90% of the pancreatic cells have been just destroyed upon treatment with our drug. We have the molecular mechanism of action where we induce apoptosis, meaning a programmed cell death of the pancreatic cancer cells. And this study is an ongoing study. This is basically the description of the study: it's an open-label, oral dose Namodenoson 25 mg twice daily. Primary endpoint: safety. And secondary endpoint is objective response, progression-free survival, duration of response, so on and so forth.
So beside the oncological indications, we have also an indication with NASH, which is a disease where fat accumulates in the liver, not on an alcoholic basis. And based on the very good protective effect that our drug has in the liver, we decided to go ahead and to test this drug in patients through Phase 2A, which was very successful. And then we decided to move to Phase 2B. In distinction from the Phase 2A, the Phase 2B includes also biopsies from the patients. And we hope that the data will be reproducible, and this data will be able to take us and to open the door for a Phase 3 clinical study in this very interesting indication where only one drug is registered on the market. This is CF602. As I told you, it's a very early drug, and we saw that in the frame of the clinical studies that our drug improved erectile dysfunction. And we decided to take the third molecule and to develop it into this indication. And Motti, would you like to summarize?
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Motti Farbstein15:35
Thank you, Pnina. So we have oral drugs with proven safety and efficacy in pivotal Phase 3 studies. Piclidenoson and Namodenoson are our Phase 3 assets in psoriasis and liver cancer. We were able to monetize the advanced portfolio through corporate partnerships. We already received more than $20 million till today, and there are potentially up to $130 million from these deals. We have a novel therapeutic approach, as Pnina described, broad intellectual property portfolio, and we have enough cash in the bank and short milestones from the partners to support the company for the next 16 to 18 months. Thank you. So if there are questions, Craig, are we ready for them in writing?
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Craig Bellford16:20
Yes, yes, yes. Thank you very much. Okay, thank you for that presentation, Pnina and Motti. To reach the team here at Can-Fite, please type in your question using the Q&A button at the bottom of your Zoom window. You'll see it there, Q&A, in the middle of your screen. And then once your question is in, I will read it aloud and the Can-Fite team will answer. And we've already had some questions submitted. Number one: Your Namodenoson drug shows potential to stabilize advanced liver cirrhosis, as we were talking, offering new hope amid limited treatment options. Is there anything else you can tell us now that you did not say during the presentation?
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Pnina Fishman17:18
Actually, yes. We are treating under compassionate use patients with decompensated liver cirrhosis. And we came up with a PR reporting that we have a patient which responded in a fantastic way, and we shared it. And we hope that we will have more patients responding this way. And this is part of the story that this drug, on one hand, induces the anti-cancer effect, and on the other hand, has a protective effect towards the liver. And this is the reason that it enables us to treat also patients with NASH. Thank you.
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Craig Bellford18:03
What is the timeline for your Phase 3 trials to end?
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Motti Farbstein18:06
So the liver cancer, the pivotal Phase 3 study, we should have the data of the interim analysis during the second half of 2026. And as Pnina mentioned, if it will be positive, we might get immediately a conditional approval from the agencies. With the psoriasis, we are in submission. We are doing the submission as we are speaking now, and we will share the details about the study shortly with the public.
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Craig Bellford18:36
And as a follow-up, when do you project to get results from your Phase 3 trials?
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Motti Farbstein18:41
Basically, it's the same question. The liver cancer interim analysis by the second half of 2026.
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Craig Bellford18:48
The Namodenoson oral drug is also well positioned in the field of anti-obesity owing to its activity and favorable safety profile. The US Patent Office granted a patent for use as an anti-obesity drug. Could you please give us some details?
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Pnina Fishman19:07
Yes, we can share with you some details. The most robust evidence that we have is from our former Phase 2 clinical, Phase 2A in patients with NASH, where we saw that patients lost weight. And now in the current ongoing study, we are... the former study was only for three months, and we have already saw it in the current study, which will take eight months. We also hope to see the very same data. We have lots of data from preclinical studies and also mechanism of action, and we hope very much we will be able to show it in the ongoing clinical study that we are now conducting.
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Craig Bellford20:00
Your veterinary partner, Vetbiolix, reported positive final results from the clinical study of Piclidenoson in dog patients with osteoarthritis. What can you tell us about this achievement?
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Pnina Fishman20:12
A very good question. Actually, we haven't yet tried it in human beings. And when we look a couple of years from now, we would like, or less, we would like to include it in the basket of indications. Because we knew from preclinical studies, again I'm saying it, that the drug has a fantastic effect in osteoarthritis. And this was the basis to our license it to Vetbiolix. And we were very happy when Vetbiolix repeated our data. And yes, it's a good question, and we are also thinking about it, transferring it into humans.
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Craig Bellford21:04
Thank you very much. We have a submitted question about how to reach the company. Easy, [email protected]. The ticker symbol [email protected]. We will forward any and all information, questions, etc., sent to that address to the Can-Fite team. Can you tell us about the projected income over the next 10 years after Vetbiolix exercised its option and licensed Piclidenoson for veterinary osteoarthritis?
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Pnina Fishman21:47
Yes, the projected income for the next 10 years is around $325 million, assuming or taking into consideration that we will take 6% of the market in 2030, that should be 6.3 billion.
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Craig Bellford22:11
The FDA granted your pancreatic cancer drug with an orphan designation. What is the next step now for this trial now that you have this designation?
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Pnina Fishman22:22
Oh, Motti, please. Okay. Actually, the orphan designation helps us a lot with the FDA because we have like priority that they will look at the data in a very fast way. And more so, we are very happy that we got this designation, and we have already embarked on it when we had to get the approval for the current pivotal Phase 3 study. And hopefully, we will use it when we will have the interim analysis data.
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Craig Bellford22:59
How many patients are currently enrolled in your pancreatic cancer Phase 2B study?
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Pnina Fishman23:04
It's not public information, and probably we will share it with our 20-F shortly. It's a small study, an open one with 20 patients. And I can tell you, Craig, that we have no problems to enroll patients to the study.
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Craig Bellford23:23
Will you be presenting at any upcoming biotechnology or scientific conferences?
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Pnina Fishman23:28
Yes, we will in a couple of them. Every year, we participate at least in one or two big meetings like the ASCO. And now we are going to participate in the GI, as you mentioned, and then in the next coming EASL, which relates to the liver. So we are very active regarding participation in conferences, publications, scientific publications, and of course, interactions with the medical community.
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Craig Bellford24:17
To reach the team, click the Q&A button, type in your question, we will read it aloud, and Can-Fite will answer. We have one question here so far: What are some potential catalysts for your various trials that investors could be looking forward to in the coming months in 2025?
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Motti Farbstein24:39
We will initiate the pivotal study for the psoriasis, going to be shortly. We will release some data about the enrollment of the studies. There will be no data readout till the end of 2025, but a lot of readouts due in 2026.
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Craig Bellford25:05
Thank you very much, Motti and Pnina. We will wrap up now, but let's conclude with a few remarks here. For more information on Can-Fite, you can reach us again at [email protected]. You may also call us in the United States at 1-800-RED-CHIP. Please visit also the information page created by Red Chip for Can-Fite. It's CNFinfo.com. There you can view and download the investor presentation seen today and fact sheet for Can-Fite, and sign up for news alerts on Can-Fite. Red Chip is excited to announce the launch of Red Chat, our advanced AI assistant designed to empower investors with instant, in-depth insights on 4,000 small-cap and micro-cap stocks, including of course Can-Fite. Try it now on cinfo.com/redchat. Watch Small Stocks, Big Money, Red Chip's program featuring exciting small-cap companies every Saturday night at 7:00 p.m. Eastern on Bloomberg USA. And finally, join Red Chip's next webinar with Green Power Motor Company tomorrow at 4:15 p.m. US Eastern. Register for all Red Chip webinars at redchip.com/events, where you can also view an archived version of today's webinar. Thanks again to our participants today, and thank you, Pnina and Motti.
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Pnina Fishman26:40
Thank you.