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Can-Fite Biopharma Ltd
11/30/2020
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. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Paul Kuntz of Investor Relations. Thank you, sir. You may begin.
Thank you. And good morning, everyone, and thanks for joining the CanFight 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 CanFight's advanced stage clinical pipeline. On today's call are CanFight's CEO, Dr. Penina Fishman, and the company's CFO, Monty 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 CanFight'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 forward-looking words such as believe, expect, intend, plan, may, should, or anticipate, or other 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 CanFight's actual results to differ materially from any future results expressed or implied by the forward-looking statements. Now, with that out of the way, I will turn the call over to Dr. Penina Fishman. Please go ahead, Penina.
Thanks, Paul, and thank you all for participating in our call today. During the third quarter, we conducted an interim analysis of our phase 3 studies in the rheumatoid arthritis and psoriasis. The analysis has been conducted by two independent data monitoring committees, namely the IDMC. 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 three study of piclidenazole 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 continues to be blinded to coincide in this rising study, we consider the IDMC's recommendations highly encouraging. Because the optimal dose has now been 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. Piclidenazone is outlicensed for the indication of psoriasis in nine countries through agreements that include milestone payments and royalties on revenues upon regulatory approval. We believe that Piclidenazone 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. All 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 industrial journal. A different IDMC for our acrobat rheumatoid arthritis study recommended that we not continue the rheumatoid arthritis study. Based on this, we unblinded the data and conducted detailed analysis, which showed that although piclidenazole's efficacy was significantly superior to placebo, the study missed the primary endpoint, 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 that have shown promising data, including the psoriasis, NASH, and liver cancer. In further news on piclidenazone, we were pleased to receive both the FDA and the IRB's go-ahead for the phase 2 study of piclidenazone 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 the US NIH Coronavirus Disease 2019 Treatment Guidelines. The randomized double-blind study will evaluate the patients who will receive piclidenazone in addition to standard supportive care as compared to patients who receive standard supportive care with placebo. Piclidenazole's anti-inflammatory properties make it a promising candidate in the fight against this pandemic. We have also had some important developments with namodenozone. Dr. Isat Safadi, who was the principal investigator of our Phase II study of namodenozone in the treatment of nasal dneesh, delivered a late-breaking oral presentation at the American Association for the Study of Liver Diseases, AASOB, conference. Presenting to the world's leading scientists and health care professionals committed to preventing and curing liver diseases, Dr. Safadi concluded in his opinion, and I am citing him, Namodenozone's very impressive study data may be citing a promising drug for the treatment of mesh due to the combination of good efficacy and favorable safety. The AISLD organization is a very prestigious conference and we believe that being selected to present an oral aid breaking presentation indicates that the scientific community see our Namu Denso findings as particularly compelling. This brief was further reinforced when our presentation was selected as the best of believer meeting under the NASH category. At CanFight, we are very encouraged by the level of interest in namodenozone 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 namodenozone in the treatment of NASH. The patent claims include use of the A3 adenosine receptor The target of our platform technology in reducing ectopic fat accumulation, particularly in fatty liver, is manifested in NASH. During this third quarter, we completed 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 Moti Farbstein, our CFO, for a review of the financial results. Moti, please.
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