Rigel Pharmaceuticals, Inc.

Greetings and welcome to the Rigel Pharmaceuticals Financial Conference Call for the second 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 Executive Vice President, Corporate Affairs and General Counsel. Thank you, Ms. Vance. You may begin.

Welcome to our second quarter 2022 financial results and business update conference call. The financial press release for the second 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. They 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 Q2 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 Dave Santos, our chief commercial officer, Dr. Wolfgang Dummer, our chief medical officer, and Dean Shornow, our chief financial officer. On slide five, We are also very pleased to have Dr. Jorge Cortes joining us today to provide a clinical perspective on our recently acquired pipeline addition, olasutinib. Dr. Cortes is an internationally recognized expert in leukemia and has led the development of numerous leukemia treatments, including for basulib, synribil, and inclusive, who were used for the treatment of chronic myeloid leukemia, or CML. and Teresimo, who's a treatment for older patients with acute myeloid leukemia, or AML. Dr. Cortez is currently the director of the Georgia Cancer Center, which he joined in 2019 after spending 23 years at the University of Texas MD Anderson Cancer Center, where he held many roles in the Department of Leukemia Division of Cancer Medicine, including Deputy Department Chair and the Chair of the AML and CML Sections. In addition, he was the deputy division head for the Cancer Network and chair of the executive IRB. Importantly for us today, he is a clinical trial investigator on the Olisutinib trial. Beginning on slide six, I am pleased to report that we have made significant strides this quarter in growing our commercial hematology oncology business. I'll start with our first value driver on this slide, growing ITP sales. During the second quarter, Rigel achieved the highest quarterly net product sales for Tavalise in ITP since launch. This demonstrates the continued momentum we are driving through our commercial activities with Hemonc prescribers. As you may recall, last year, we undertook a Salesforce expansion to broaden our reach, improve efficiency, and increase in-person interactions. These initiatives are yielding results, and we believe that we have all the components in place to drive continued growth in ITP sales. Additionally, in May, we entered into a collaboration agreement with Knight Therapeutics to commercialize Fosamatinib in Latin America, including Mexico, Central and South America, and the Caribbean. It will be great to be able to provide access to Fosamatinib for patients suffering from ITP in these countries as well. In addition to our collaboration partner, Kisei, in April, we announced that Kisei had submitted its NDA in Japan for Fostermatinib and ITP. We look forward to a potential approval in Q1 of 2023. A new value driver for Rigel is Olisutinib. We are very pleased to announce that we have entered into an exclusive worldwide licensing agreement with Forma Therapeutics for Olisutinib. Wellacitinib is a potential market-leading oral therapy for the treatment of relapse or refractory acute myeloid leukemia. This collaboration will broaden our near-term HEMONC portfolio and is highly synergistic with our current commercial infrastructure. I will talk more about this program right after I review the balance of the pipeline, and Dave will also provide detail on the commercial opportunities. In June, we reported top line data for our pivotal phase three forward trial in WARM AIHA. The trial missed the primary input in the overall patient population. However, in a post hoc analysis, response rates in Western countries favored Fostermatinib over placebo. We are continuing to evaluate this data and plan to share our findings with the FDA to determine the best path forward for WARM AIHA. With no currently approved therapies in this indication, we continue to believe that there is an opportunity for TAVALYs to improve the outcomes for patients with this disease. We have also advanced our Fostermandib COVID-19 program. We have completed enrollment of our pivotal phase three trial in July with 280 patients, which we believe sufficiently powers the study, and we expect to report top-line data in Q4. Fostermatinib is also being evaluated in a Phase III trial sponsored by NIH, NHLBI, as a potential treatment in high-risk patients hospitalized with COVID-19. These trials have the potential to show the benefit of Fostermatinib as a treatment in patients with severe COVID-19. Wolfgang will discuss this program later in the call. Lastly, turning to our earlier pipeline programs, IRAC-1-4 and RIP-1, Due to everything we want to cover today, I will just give a short overview on the status of these programs. As we had shared with you before, we are evaluating R289, IRAC1 and 4 dual inhibitor in low-risk MDS. We believe R289 has the potential to provide effective suppression of the inflammatory environment that causes low-risk MDS. Study startup activities are currently ongoing, and we are targeting the third quarter of this year for study initiation. We are also excited about the advancement of our RIP1 inhibitor, R552, being developed in collaboration with our partner, Eli Lilly, into phase 2 development. We see a mechanistic, clinical, and scientific rationale for R552 in several large immune indications, such as psoriasis, RA, and IBD. The initial phase 2 study is anticipated to start in Q2 of 2023. Lily will disclose the indication closer to the initiation of that study. Additionally, we are completing our work on a RIP1 inhibitor that can cross the blood-brain barrier for the treatment of CNS diseases. Lily will then lead the development of these RIP inhibitors. Moving on to slides. I would like to discuss our new collaboration with Forma Therapeutics for olosutinib, Rigel's newest value driver. I would like to provide a brief overview of the transaction, and Dave will provide our commercial and strategic rationale and why we feel that olosutinib has the potential to be a meaningful therapeutic option for patients with AML. Under the terms of the agreement, Rigel receives an exclusive worldwide licensing rights to Olasutinib in all indications. With an initial focus on relapse or refractory, IDH positive AML patients. This includes the right to grant sub-licenses in ex-U.S. territories. In exchange, Rigel will pay FORMA a $2 million upfront payment. In addition, FORMA will be eligible to receive an additional $17.5 million upon the achievement of certain near-term milestones. The deal also includes potential future development and commercial milestone payments, as well as tiered royalties on net sales of Olicitinib. FORMA has submitted the new drug application to the U.S. FDA following positive results from a Phase II registrational trial, with a PDUFA action date of February 2023. less than seven months from now. The mid-cycle review with FDA has been completed. Based on that meeting, we were told that there is currently no plans for an advisory committee meeting, no major safety issues have been identified, and currently no REMS program is likely to be required. If approved, Olasutinib will expand our Hemonc product portfolio and enable Rigel to detail two important therapies to our Hemonc physicians. Rigel will leverage our Hemonc capabilities to maximize the commercial potential of Olasutinib, which we believe can become an important and differentiated product in this space, particularly given that AML is an aggressive and very difficult-to-treat disease. Results from the Phase II registrational study of olosutinib as a monotherapy demonstrated promising efficacy, including a 13.8-month median duration of response and a favorable tolerability profile. Rigel plans to initially focus on the commercialization of olosutinib as a monotherapy in mutant IDH1-positive relapse or refractory AML setting. There's also the potential to explore olisutinib in the first-line IDH-positive AML setting, as well as in combination, both of which were explored in the Phase II study. Beyond AML, olisutinib has been explored as a monotherapy in glioma and in cholangiocarcinoma. We look forward to advancing olisutinib through the regulatory process and potentially bringing this important therapy to patients in need. With that, I will turn the call over to Dave for a commercial and therapeutic area overview. Dave.