Rigel Pharmaceuticals, Inc.

Greetings and welcome to Roger Pharmaceuticals' financial conference call for the third quarter 2022. 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 our first speaker, Dolly Vance, who is Rigel's senior advisor, legal and corporate affairs. Thank you, Ms. Vance. You may begin.

Welcome to our third quarter 2022 financial results and business update conference call. The financial press release for the third quarter was issued a short while ago and can be viewed along with the accompanying slides for this presentation in the news and events section of our investor relations site on www.rigel.com. As a reminder, during today's call, we may make forward-looking statements regarding our financial outlook and our plans and timing for regulatory and product development. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. A description of these risks can be found in our most recent annual report on Form 10-K for the year ended December 31, 2021 and subsequent filings with the SEC. including our Q3 quarterly report on Form 10-Q on file with the SEC. Any forward-looking statements are made only as of today's date, and we undertake no obligation to update these forward-looking statements to reflect subsequent events or circumstances. At this time, I would like to turn the call over to our President and CEO, Raul Rodriguez. Raul?

Thank you, Dolly, and thank you, everyone, for joining today. Also with me today are Dr. Wolfgang Dummer, our chief medical officer, Dave Santos, our chief commercial officer, and Dean Shorno, our chief financial officer. Now, beginning on slide five. I am pleased to report that we have made significant strides this quarter in growing our commercial and clinical stage hematology oncology business. Starting with our newest product, Olisutinib, we are very excited with the progress we have made since announcing our exclusive worldwide license agreement with Forma Therapeutics. As a reminder, Olisutinib is a potentially market-leading oral therapy for the treatment of relapse or refractory acute myeloid leukemia, or AML. In the near term, olosutinum has the potential to broaden our he-monk portfolio and is highly synergistic with our current commercial and medical affairs infrastructure. As announced earlier today, we are thrilled with the longer-term data from the Phase II registrational study of patients with mutated relapsed refractory AML that were disclosed in an abstract published today for the ASH meeting in December. Wolfgang will discuss this data in greater detail shortly. Dave will also provide further detail on the commercial opportunity for Olisutnib and an update on the launch progress as we work towards the PDUFA date of February 15th of 2023. Our next value driver is growing Tavalise sales in ITP. During the quarter, RIDE will achieve the highest quarterly net product sales for Tavalise in ITP since our launch. This demonstrates the continued momentum we are thriving through our focused commercial activities with Hemonc prescribers. Our global partners are also making great progress. Notably, our partner Kisei has submitted its NDA in Japan for Fostermatinib and ITP, and we look forward to a potential approval in Q1 of 2023. Our third potential product in the Hemonc area is R289, an IRAC1 and IRAC4 dual inhibitor. We believe R289 has the potential to provide effective suppression of the inflammatory cytokines that cause low-risk MDS. Sites are currently opening for our Phase 1B study in low-risk MDS, including a site already open at MD Anderson. As you can see, with these three products, one marketed, tabelis, one nearing approval, olasutinib, and an exciting pipeline opportunity in R289, we are building a very attractive HEMONC portfolio. More to come. We also have a couple programs where we are opportunistically leveraging partnerships to create value. Our FOSTA-MATNA COVID-19 Phase III clinical trial, sponsored by the U.S. Department of Defense, has completed and we disclosed the top-line results on Tuesday of this week. Although we did not meet statistical significance, we are encouraged by the results. Rigel does not plan to commercialize Fostermatinib in COVID-19 on its own, but we are exploring other options with our partner, the Department of Defense, for this product. Wolfgang will follow up later on the call with further details on the results of the FOCUS Phase III clinical trials. Fostermatinib is also being evaluated in a Phase III clinical trial sponsored by the NIH NHLBI as a potential treatment in patients hospitalized with COVID-19. And finally, we are also excited about the potential of our RIP1 inhibitor, R552, being developed in collaboration with our partner, Eli Lilly. The first planned Phase II study is anticipated to start in the first half of 2023 in a large immune indication. Lilly will lead the clinical development and disclose the indication closer to the initiation of that study. Now with that, I'd like to turn the call over to Wolfgang for an overview of the updated or the student updated disclosed today. Wolfgang. Thank you, Raoul.