Interview with Pnina Fishman, CEO of Can-Fite BioPharma

🎥 Mar 30, 2023 📺 Benzinga Partner Studio ⏱ 8m 👁 74 views

Can·Fite BioPharma is an Israeli biopharmaceutical abd biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases. The Company has fully integrated pharmaceutical discovery and clinical development capabilities. The Company has an advanced pipeline of proprietary drug candidates in Phase II and Phase III clinical development which address inflammatory, liver and metabolic diseases. Can-Fite's platform technology utilizes the Gi protein associated A3 adenosine receptor (A3AR) as a therapeutic target. A3AR is highly expr...

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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 (16 segments)

Interviewer0:03

Welcome. Today I'm here with Dr. Pnina Fishman from Can-Fite BioPharma. Dr. Fishman, thank you for joining us. How are you doing?

Pnina Fishman0:08

Thank you.

Interviewer0:11

It's great to have you here. It's an absolute pleasure to be speaking with you. Can you start off, just tell us about the phase three psoriasis study? What do you hope piclidenoson will achieve?

Pnina Fishman0:19

Piclidenoson is an orally bioavailable drug. The drug binds specifically only to the inflammatory cells in the patient's skin, and the drug is taken orally, so it is very convenient for the patients. Till today, we have already looked at more than 2,000 patients, tested the drug in more than 2,000 patients with an excellent safety profile and very good efficacy. We are now waiting for the data from a phase three clinical study, which will, at the end of the day, entail 400 patients. One year ago, we had an interim analysis from this study, which included 200 patients, and the data, both safety and efficacy, were very good. The company was blinded to the data, but there was a committee on top of the data which came up, and they recommended to the company very strongly to go ahead, since the data from the study and the safety were both very good.

Interviewer1:32

That's terrific news. And then, of course, if the study achieves its primary endpoint at 16 weeks against that placebo, what's the next step for piclidenoson?

Pnina Fishman1:40

We are including four different arms, four groups. Two groups are piclidenoson in two different dosages, and then we compare it to Otezla. This is a Celgene drug which is currently marketed by Amgen, and everything is, of course, compared to a placebo group. So we have two groups. The patients are treated for 16 weeks as of the primary endpoint, and then each patient which is happy can stay on the study for 32 weeks. So actually, very shortly, we will come up with the top-line results, which will include the primary endpoint on week 16. The primary endpoint is PASI 75, meaning 75% improvement on the drug for each one of the patients. We also look at 90% improvement and also 100% improvement. So in a nutshell, this is the design of the study, and we are very positive based on the interim analysis, and of course, looking forward to the data which are going to be released very shortly during Q1 this year.

Interviewer3:05

That's fantastic. And then for some further context, how does piclidenoson compare with Otezla so far? Is there published data showing that piclidenoson may be better at sustaining that efficacy longer term than Otezla beyond that 24-week period?

Pnina Fishman3:20

Actually, we have published a scientific article in a peer-reviewed journal comparing the performance of our drug to Otezla. Interestingly, Otezla will start to plateau after 12 weeks. Otezla had a very low PASI 90 in the patients and no PASI 100. When we compare it to our drug, 30% of the patients had PASI 90, meaning 90% improvement, and 10% had PASI 100, meaning total clearance. Now, our drug did not plateau; it kept doing a very good job in a very linear way. We hope, again, that this data, which we have already published based on the phase 2/3 data, will be reproducible, and we will be able to show both good safety—we know already that the safety is very good—but also very good efficacy.

Interviewer4:28

That's terrific. And then on a larger note, to kind of expand off of that prior point, how does piclidenoson compare to the biologics that dominate the psoriasis market currently?

Pnina Fishman4:37

Thank you for bringing up this question. Actually, biological drugs are doing a very good job at the very beginning. However, the adverse events are quite severe. Two percent of the patients, unfortunately, will develop lymphoma, and then other adverse events will develop as well as long as time goes by and the patient is taking the drug. When we compare it to the safety profile of piclidenoson, we have an excellent safety profile. Also, biological drugs are usually given via injection. Our drug is a tablet given morning and evening at the patient's home, so it is much, much more convenient for the patient to use. Hopefully, our drug will show good data in this phase three clinical study when we compare it to the biological drugs which are currently on the market.

Interviewer5:44

Fantastic. And then diving into the details just a little bit more as we start to close out, can you tell us how piclidenoson works? Why it might be more safe and more effective than other psoriasis treatments that are on the market today?

Pnina Fishman5:54

So basically, we studied a lot the mechanism of action of piclidenoson, and what we learned was that piclidenoson actually inhibits a couple of cytokines which are very prominent and important for the development and also for the maintenance of the disease itself. Also, just recently, we came up and announced that piclidenoson has a capability just to kill, to induce apoptosis, to induce death of pathological cells in the skin. These pathological cells are proliferating and growing in the skin and remediating the disease. So the capability of our drug to bind specifically only to the pathological cells, and the normal body cells are refractory to the effect of the drug, make it a very specific one. And with its very good safety profile, we hope that we will come up with positive data and be able to bring this drug into patients.

Interviewer7:01

That's wonderful. And then last question from our end, looking into the near future here, when do you expect to announce those phase three results?

Pnina Fishman7:07

Actually, the primary endpoint, as I mentioned, is PASI 75, and our hope, of course, is that our drug will perform better than the placebo in a statistically significant way. And as for Otezla, good data will show that our drug is not inferior to Otezla, but we hope very much that we will show also superiority.

Interviewer7:33

Amazing. Dr. Pnina Fishman of Can-Fite BioPharma, it's been a wonderful conversation. A lot to look forward here, and we certainly look forward to talking again with you soon. Thank you so much for being here.

Pnina Fishman7:42

Thank you very much.