CEO & Founder, Can-Fite BioPharma
Small Molecules for Big Clinical Needs - Can-Fite BioPharma Presents at GCFF June 15
#CanFite is an advanced clinical stage drug development company with a platform oral drug technology designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. Its anti-inflammatory drug candidate, Piclidenoson, was found safe and effective in a Phase 3 trial for #psoriasis . A pivotal Phase 3 psoriasis trial for market approval has been cleared by the European Medicines Agency (EMA) and is now under preparation. Can-Fite’s Namodenoson, for the treatment of cancer and liver diseases, is in a pivotal Phase 3 trial for advanced #livercancer , a...
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 (28 segments)
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Pnina Fishman0:00
And basically the story that I would like to share with you today is very interesting and it goes back a couple of years where we realized that we can target a specific cell surface receptor which can be found only in pathological cells but not in normal cells. I would like to take you through the story and the achievements that we got after we came up with this really amazing story and let me share it with you.
So we are basically an Israeli-based company. We are the management and the discovery labs are based in Israel and we have an excellent group in the United States which is doing the pre-clinical and the clinical development of our drugs. Our drugs are small molecule, orally bioavailable. Patients can take them morning and evening and in a minute you will understand that this drug has robust anti-inflammatory and anti-cancer effect.
During the last couple of years we got into a robust clinical proof of concept. This was very important for us because our drugs are not me-too, they are novel drugs with a very interesting platform technology which I will introduce you with today. And the interesting thing which happened to us was that we could show a robust clinical proof of concept through successful Phase 2 and Phase 3 clinical studies.
We also successfully out-license our drugs. Our strategy is to develop the drugs, to register the drugs, but not to market. So we are continuously putting lots of efforts in order to find partners that will be the ones to market our drugs in the clinic upon registration. And last but not least, we just concluded the first quarter of this year. We have in the bank 12.4 million dollars which will suffice to take us through 2024. And let's start the story.
So the platform technology is very unique as I mentioned already. We have discovered a cell surface receptor, this green structure, which can be found only in pathological states, both inflammatory and cancer cells. And you can see the normal cells do not express the target. All our drugs bind with very high affinity and specificity to the target. So they can bind here, it's like a key and the lock. The target is the lock and the drug is the key. And you can see that the drugs when they get into the body, they will not bind to the normal cells since they do not have the lock. They will bind also here as a result. And after we have treated more than 1,500 patients, we have an excellent safety profile because the normal body cells and normal body tissues are not affected at all by the drugs. At the same time, the drugs have a very good proven therapeutic effect.
And I would like to take you through the different drugs in our pipeline and tell you each one of them where are we. So the first drug candidate is piclidenoson and this is currently positioned for the treatment of psoriasis, a very devastating disease of the skin. I'm sure some of you are familiar. So you can come up and ask me why develop a drug for psoriasis? Well, there are so many drugs out there, biological drugs, which are doing a very good job. But yes, you are right with this question. At the very beginning, these biological drugs are indeed doing a very good job, but after a couple of months or a year, these drugs will stop doing a good job and the patients will deteriorate. Not only that, the drug induces very severe adverse events and the patients need to move to the next biological drug and then again to the next biological drug.
So how is our drug differentiated from the biological ones? So our drug is small molecule, orally bioavailable and patients do not have to go to the outpatient clinic in order to get it via injection or infusion. They can take it at home morning and evening. And our drug does not induce any adverse events. The profile is exactly just a placebo-treated patient with a very nice effect that I will share with you in a minute.
The second drug candidate is namodenoson, currently positioned for the treatment of two very devastating oncological diseases. One is advanced liver cancer, the second one is pancreatic cancer. Everybody knows that till now there is no approved treatment in the clinic. And last but not least, an additional liver disease, it's accumulation of fat in the liver not on an alcoholic basis. And besides these two drugs, we have additional two drugs still in pre-clinical studies. One for the treatment of erectile dysfunction and the other one is targeting cannabinoid receptors and we will get into it down the road of this presentation.
And as I told you, our business development strategy is to out-license. Till today we have already signed seven different out-licensing agreements and got already 20 million dollars out of upfront money with that. Signed agreements in Canada with Cipher, in Eastern Europe with ELP Pharma, in Central Europe with Gebro Pharma. We signed an agreement with a very big Chinese company, CMS Pharmaceuticals, for both drug species. We signed an agreement in Korea, one with CKD and one with Kwangdong. And out of these agreements, and this is only the beginning of partnerships what you see here, and we continuously look for additional partners that will come on board. But out of the seven agreements, we are going to get additional 130 million dollars into the bank which will come out of regulatory milestones. So this is our strategy, it infuses non-dilutive money into the company and we think that we are going on the right avenue regarding the business development activity.
Let me now share with you more data and more facts regarding the drugs and their development. So piclidenoson is our first drug candidate and this is currently developed for the treatment of moderate to severe psoriasis. So you can see here that we have recently concluded a Phase 3 clinical study. We got very good data. You can see here progressive effect all over the study. This is 800 patients, this is PASI 75, the patients, very nice statistically significant value. With this data we have already approached both the EMA in Europe and the FDA in the United States. We have been already approved by the EMA and we are waiting to hear a word from the FDA very, very shortly. You will hear it in the frame of a couple of weeks from now.
In the frame of this Phase 3, we had already compared to Otezla, which is already a drug on the market, okay, which sells like 20 percent of the market. Our safety profile was much better. So we envision that we will be also able to take like 20 percent of the market right after we will register the drug with both the FDA and the EMA.
So let's move now to the next candidate, namodenoson, which is positioned today for the treatment of advanced liver cancer, pancreatic cancer, and NASH. So let's start from the treatment of advanced liver cancer. And I have to say very proudly that we are not aware of any other company which treats patients in such an advanced stage of the disease. And let's look at the Phase 2 clinical study. And I would like to bring here a test case of a patient which started with a very big tumor in her liver. You can see here the tumor with lots of metastasis all over the body. You can see here how all of the tumor from the liver and also the metastasis from all over the body just disappeared. This was amazing.
Currently we are enrolling patients for a pivotal Phase 3 clinical study approved by both the FDA and the EMA. We have also been granted by both regulatory authorities orphan drug designation and Fast Track. And we are now enrolling patients actively for this study. We are going to have an interim analysis after we will enroll 50 of the patients. And we got the word from both the FDA and the EMA that if the data of the interim analysis will be positive, we will be able to get right away a conditional approval. So we are very happy with what we achieved with the liver cancer, advanced cancer indication, and we are waiting for the interim analysis results.
Regarding the second oncological indication, which is pancreatic cancer, we came up recently with very good pre-clinical studies. Based on it, we developed a Phase 2 clinical study protocol. We will start enrolling patients very, very shortly and will be very happy to share of course the data with the public. We just announced two days ago that we are going to submit an IND to the FDA and hopefully very soon we will be able to come up and tell you that the FDA approved this IND.
Let's move now to the third indication with this drug. NASH is non-alcoholic hepatitis, meaning accumulation of fat in the liver not on an alcoholic basis. Our drug, we took it through a Phase 2b clinical study which showed very good data in reducing liver fat content. It induced anti-inflammatory effect. We selected the dose based on the data of the study. The study also induced a decrease in body weight. We had an excellent safety profile and also reduced fibrosis. Based on the good data, we took the drug through a Phase 2b clinical study where we are now actively enrolling patients in Israel and in Europe. We are also planning to open an IND in the United States. And if the data of this study will be reproducible, it will open the door for us for a Phase 3 clinical study.
As I told you, we have two additional drugs which are still in pre-clinical studies. CF602, based on an anecdotal report, patients told us that they are doing very well with their sexual dysfunction when they are taking Can-Fite drugs. We decided to take a third drug candidate, CF602, and to push it into the clinic based on very good data that we have shown in pre-clinical studies. We have the mechanism of action and during the next year we would like to push this drug into Phase 1 clinical studies.
And last but not least, the cannabinoid program. Also a pre-clinical study program. It happened to be that cannabinoids bind also to the very same target receptor that I mentioned before. So we embarked on this knowledge and we developed an assay which can say on a given cannabinoid if it will be a good candidate later on in the clinic or not.
So if we will now summarize what I have presented you today. So we are developing oral drugs, small molecule drugs with proven safety and very good efficacy in Phase 2 and Phase 3 clinical studies. And we are monetizing our advanced portfolio through corporate partnerships. We have already signed seven different agreements which introduced the company with cash money. We have another therapeutic approach with our unique technology for the treatment of cancer, liver cancer, pancreatic cancer, and inflammatory diseases. We have an intellectual property portfolio which covers and protects all our indications. And financially we are well positioned. Thank you very much for sharing with us the knowledge about our company and I will be very happy to answer questions. Thank you.
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Moderator16:45
Thank you Dr. Fishman. So there's a few questions here from the audience. The first one from Emilio is, this is a tough one, which of your pipeline drugs do you think have the most potential? Obviously everyone has potential, which one do you like the potential most?
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Pnina Fishman17:05
Regarding the drugs, the pipeline, because you have a few. So actually the two first drugs, both piclidenoson and namodenoson, are currently in pivotal Phase 3 studies. Since namodenoson, we think that this will be the first indication to get the approval and hopefully we will be able to come with good news and to share it with you.
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Moderator17:37
Right. And for the next 12 months, how will you advance the pre-clinical products for the next 12 months?
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Pnina Fishman17:48
In the next 12 months, most probably would be also the interim analysis with the liver cancer. And of course we would like to come up with business development milestones that we will be able to sign more agreements and introduce more non-dilutive money into the company.
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Moderator18:12
Great. This question coming from Paul P. said, what role does AI or LLM models now or will play in your pre-clinical phases of product development?
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Pnina Fishman18:25
So regarding the pre-clinical development, we have the CF602 which is currently positioned for the treatment of patients who suffer from sexual dysfunction. And actually the other drugs on the market are drugs which patients who suffer from diabetes or from cardiovascular diseases cannot enjoy. So we are planning to position CF602 for the treatment of patients who suffer from hypertension and from cardiovascular diseases. We bring also to this population of patients a drug to help with their sexual dysfunction.
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Moderator19:06
Great job. That's in time. One last question from Nissan here. He's asking about how's your current partnership, the Chinese partnership, progressing and are you looking to partner with other Asian pharma in the future?
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Pnina Fishman19:20
And yes, the partnership in China is progressing very well. We have a very strong collaboration with CMS Pharmaceuticals and with people who are very professional. We signed also in Asia additional agreements, two agreements in Korea, one with Kwangdong for the psoriasis indication and one with CKD Pharmaceuticals for the namodenoson drug. And we have to sign more agreements in Asia. Do not forget that we are an Israeli company, we are also based in Asia and it's very good to know that we can sign agreements with our neighbors. Thank you for this question.
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Moderator20:03
Great, thank you Pnina for your latest update. Seems like a lot of positive developments are on offer. So, but thank you for your time here sharing with us your story.
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Pnina Fishman20:14
You are very welcome. Thank you very much. Bye bye.