Can-Fite BioPharma Ltd.
Q3 2020 Earnings Call Transcript
Published:
- Operator:
- Greetings, and welcome to the Can-Fite BioPharma Third Quarter Results and Business Update Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. And as a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Paul Hoops of investor relations. Thank you, sir. You may begin.
- Paul Hoops:
- Thank you, and good morning, everyone and thanks for joining the Can-Fite third quarter 2020 conference call. Today, the company will provide a financial update for the quarter ended September 30, 2020, as well as the latest developments in Can-Fite's advanced stage clinical pipeline.
- Pnina Fishman:
- Thanks Paul, and thank you all for participating in our call today. During the third quarter, we conducted an interim analysis of our Phase III studies in rheumatoid arthritis and psoriasis. As the analyses has been conducted by two independent data monitoring committees namely the IDMCs. The company was blinded to the data. In early October, we announced the IDMC’s recommendations as follows
- Motti Farbstein:
- Thank you, Pnina. Revenues for the nine months ended September 30, 2020 were $0.61 million compared to $1.84 million for the same period of 2019. The decrease in the revenue was mainly due to the recognition of a lower portion of advance payments received under distribution agreements from Gebro, CKD Pharmaceuticals and Cipher Pharmaceuticals. Research and development expenses for the nine months ended September 30, 2020 were $9.05 million compared with $7.01 million for the same period of 2019. Research and development expenses for the nine months ended September 30, 2020 comprised primarily of expenses associated with the Phase II studies for Namodenoson in the treatment of NASH and liver cancer, as well as expenses for the ongoing Phase III studies of Piclidenoson in the treatment of rheumatoid arthritis and psoriasis. The increase is primarily due to the increased costs associated with the accelerating rate of enrollment of patients for the Phase III studies of Piclidenoson for the treatment of rheumatoid arthritis and psoriasis. General and administrative expenses were $2.14 million for the nine months ended September 30, 2020, compared to $2.22 million for the same period in 2019. The decrease is primarily due to decrease in professional services and travel expenses, which was partially offset by the increase in salaries, and related benefits and insurance expenses. Financial expenses, net for the nine months ended September 30, 2020 was $0.22 million compared to $0.44 million for the same period in 2019. The decrease in financial expenses net is mainly due to the fair value revaluation of the investment in Wize Pharma Inc’s shares which is classified under short-term investment.
- Operator:
- Our first question comes from the line of Peter Levine with Ameriprise. Please proceed with your question.
- Peter Levine:
- Hi. Thank you for the call. I’d like to know when you do feel or when do you think the psoriasis study will be completed? And when will a Phase III trial start for Namodenoson?
- Pnina Fishman:
- Good questions. Thank you, Peter. Basically, regarding the psoriasis, we are doing all the preparatory works to continue enrollment and we assume that enrollment will be done in a couple of months. As we mentioned everything is – most of the expenses have been already paid. So, we are ready to go for it and after we will enroll the last patient, we will rate he will complete at the treatment. So we may assume that it will take like ten months, maximum twelve to complete the psoriasis study and to come up with the data. Regarding the NASH, we are doing now all the thinking work with a couple of key opinion leaders who are really the leaders in the NASH arena and did the same work with a few companies which have been successful and with those which unfortunately failed and we will come up with an announcement when we will complete this preparatory work for the next NASH clinical study. Thank you.
- Peter Levine:
- All right.
- Operator:
- Our next question comes from the line of Ralph Martini , a private investor. Please proceed with your question.
- Unidentified Analyst:
- Yes. Good evening, Dr. Fishman. I just had a few questions here. With regards to the RA study, now I know now that you are terminating that. I’d like to know first, what was the total cost of that study for the RA?
- Pnina Fishman:
- Motti Farbstein:
- Yes. Thank you, Ralph for the question. The costs were between $5 million to $6 million in the interim analysis.
- Unidentified Analyst:
- Thank you very much. And I’d like to know – I know there is a patent that you’ve been approved for Namodenoson in treatment of NASH in Europe. Have you considered filing one in the U.S.? Or what is your approach on this?
- Pnina Fishman:
- Yes, of course, we will include the U.S. when we will make more progress. Of course, will to liaise also with each one of the agencies and absolutely in order to register the drug and as I mentioned couple of times during the company last call, we always work in parallel with the EMA and the FDA and patients from both continents will be included in our Phase III clinical studies before we will register the drug with each one of the agencies.
- Unidentified Analyst:
- Very well. Thank you very much. And lastly, can you maybe elaborate on the fee for service basis on the development of assay for cannabis derived compounds? What do you mean by a fee for service basis?
- Pnina Fishman:
- Okay. Thank you very much for this very good question. Basically, Can-Fite came across very interesting findings that cannabis does not work only through the cannabis receptors, it acts also through our receptors. We have came up with a patent which basically cover all the uses of looking at efficacy of cannabis through our target A3 adenosine receptor. So we can get a sample of cannabis or its ingredients and care the one with the order of the sample if the sample can be efficacious in lots of clinical situations like inflammation, like cancer, like liver diseases, so on, so forth. So, this is what I meant fee for service. We developed a very unique assay which can tell if cannabis or cannabis derivative is clinically efficacious. So this is what I meant when I mentioned fee for service.
- Unidentified Analyst:
- Very well. Thank you for explaining that part. And lastly, I know you have provided many presentations in the last few months for partnerships. How is that going? Maybe you want to share, has there been positive feedback? Is there a plan put forward by your team? Maybe you can shed some light for investors out there?
- Pnina Fishman:
- Sure. First of all, our team is putting lot of efforts in order to create more partnerships. As you know, Can-Fite, we never market its own drug. We are looking for partners that we do it when our drugs, which has very unique profile of both efficacy and very good safety will be launched to the market. I cannot tell you more as a CEO. Of course, I will always be very positive. This is what I can always communicate, but will not dive into any details, but you will hear it in one of our forthcoming PRs. So, I said more than I could say.
- Unidentified Analyst:
- Thank you very much Dr. Fishman and that’s a good sign. I hope the best for you guys and thanks again for the forward update.
- Pnina Fishman:
- Thank you very much. Thank you.
- Operator:
- We have no further questions at this time. I would now like to turn the floor back over to management for closing comments.
- Pnina Fishman:
- Thank you. By the end of this year, we expect to commence patient enrollment in our Phase II COVID-19 study. Looking ahead to 2021, we intend to continue our psoriasis Phase II study. We tend to initiate a pivotal Phase III study in liver cancer and also initiate the next study in NAFLD/NASH. Thank you, everyone for joining us today and have a good day. Bye-bye.
- Operator:
- Ladies and gentlemen, this does conclude today's teleconference. You may disconnect your lines at this time. Thank you for your participation and have a wonderful day.