Can-Fite BioPharma Ltd. (CANF) Q3 2020 Earnings Report, Transcript and Summary

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. [Operator Instructions] 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.

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. On today’s call are Can-Fite's CEO, Dr. Pnina Fishman; and the company's CFO, Motti Farbstein. At the end of the call, we will have a question-and-answer session. We will start with a brief Safe Harbor statement. This conference call may contain forward-looking statements about Can-Fite's expectations, beliefs or intentions regarding, among other things, market risks and uncertainties, its product development efforts, business, financial condition, results of operations, strategies or prospects. Forward-looking statements can be identified by the use of the forward-looking words such as believe, expect, intend, plan, may, should or anticipate or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause Can-Fite's actual results to differ materially from any future results expressed or implied by the forward-looking statements. Now, with that overlay, I will turn the call over to Dr. Pnina Fishman. Please go ahead Pnina.

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: we were very pleased to have a positive result in our psoriasis Comfort trial. The IDMC recommended that we proceed with this Phase III study of Piclidenoson in the treatment of moderate-to-severe plaque psoriasis. The IDMC further recommended that we continue with the original sample size and drop one dose group based on the positive data. While the interim data continue to be blinded to Can-Fite, in this psoriasis study, we consider the IDMC’s recommendations highly encouraging because the optimum dose is now being identified, we believe the study can be concluded earlier than originally planned. The majority of costs associated with this Phase III Comfort study have been previously paid. Piclidenoson is out-licensed for the indication of psoriasis in nine countries through agreements that include milestone payments and royalties on revenues upon regulatory approval. We believe that Piclidenoson has a clear value proposition in the psoriasis market, based on its demonstrated safety and efficacy to date, and the benefit of being an oral drug among a growing number of injectable biologics. Oral drugs are cost effective and more convenient for the patient. Both of these factors are preferred by psoriasis patients based on a 2018 study published in an industry journal. A different IDMC for our Acrobat Rheumatoid Arthritis study recommended that we not continue the Rheumatoid Arthritis study. Based on this, we unblended the data and conducted the detailed analysis which showed that although Piclidenoson’s efficacy was significantly superior to placebo, the study missed the primary endpoints which was non-inferiority versus the comparator methotrexate. A graph summarizing the data is presented in today’s press release that we have published earlier. Moving forward, we are putting more focus on our clinical programs with a strong promising data including the psoriasis, NASH and liver cancer. And further news on Piclidenoson, we were pleased to receive both the FDA and the IRB’s go-ahead for the Phase II study of Piclidenoson in the treatment of COVID-19. We expect to enroll our first patient before the end of the year. The 28-day study will enroll 40 patients hospitalized with moderate COVID-19 per thee U.S. NIH Coronavirus Disease 2019 Treatment Guidelines. The randomized, double blind study will evaluate the patients who will receive Piclidenoson in addition to standard supportive care, as compared to patients who receive standard supportive care with placebo. Piclidenoson’s anti-inflammatory properties make it a promising candidate in the fight against this pandemic. We had also made some important developments with Namodenoson. Dr. Rifaat Safadi, who was the Principal Investigator of our Phase II study of Namodenoson in the treatment of NAFLD/NASH delivered a late-breaking oral presentation at the American Association for the Study of Liver Diseases, AASLD conference, presenting to the world’s leading scientists and healthcare professionals committed to presenting and curing liver diseases, Dr. Safadi concluded in his opinion and hindsight Namodenoson’s very impressive study data may result in a promising drug for the treatment of NASH due to the combination of good efficacy and favorable safety. The AASLD organization is a very prestigious conference and we believe that being selected for presenting oral late-breaking presentation indicates that the scientific community sees our Namodenoson findings as particularly compelling. This brief was further reinforced when our presentation was selected as ‘Best of The Liver Meeting’ under the NASH category. At Can-Fite we are very encouraged by the level of interest in Namodenoson in the treatment of NASH from both the scientific and business communities. Further strengthening our IP portfolio, intellectual property portfolio, the European Patent Office issued a patent for Namodenoson in the treatment of NASH. The patent’s claims include use of the A3 adenosine receptor, the target of our platform technology, in reducing ectopic fat accumulation, particularly in fatty liver as manifested in NASH. During this third quarter, we completed the development also of a cell-based assay to identify clinically active cannabis derived compounds that bind to and activate our target the A3 Adenosine Receptor. In addition to using this assay in the development of our own cannabis derived compound-based therapeutics, we also plan to market the assay on a ‘fee for service’ basis to researchers and other cannabis companies worldwide. I will now turn the call over to Motti Farbstein, our CFO for a review of the financial results. Motti, please.

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. Can-Fite's net loss for the nine months ended September 30, 2020 was $10.81 million, compared with a net loss of $7.84 million for the same period in 2019. As of September 30, 2020, Can-Fite had cash and cash equivalents of $10.22 million, as compared to $2.69 million at December 31, 2019. The increase in cash during the nine months ended September 30, 2020 is due to an aggregate of $17.68 million net proceeds received through a warrant exercise transaction in January 2020, a public offering in February 2020, partial exercises in March, April and May 2020 of warrants issued in the February 2020 public offering, and a registered direct offering in June and July 2020 which was offset by net cash used in operating activities of $10.16 million. I will now turn the call over to Paul for our Q&A session.

[Operator Instructions] Our first question comes from the line of Peter Levine with Ameriprise. Please proceed with your question.

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?

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.

All right.

[Operator Instructions] Our next question comes from the line of Ralph Martini [Ph], a private investor. Please proceed with your question.

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?

I will refer this question to Motti Farbstein our CFO.

Yes. Thank you, Ralph for the question. The costs were between $5 million to $6 million in the interim analysis.

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?

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.

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?

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.

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?

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.

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.

Thank you very much. Thank you.

We have no further questions at this time. I would now like to turn the floor back over to management for closing comments.

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.

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.