Rigel Pharmaceuticals, Inc.

Greetings and welcome to the Rigel Pharmaceuticals financial conference call for the fourth quarter and year-end 2021. At this time, all participants are in 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's 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. Please go ahead.

Welcome to our fourth quarter and year end 2021 financial results and business update conference call. The financial press release for the fourth quarter and year end was issued a short while ago and can be viewed along with the company slides for this presentation in the news and events section of our investor relations site on www.reisel.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 31st, 2021, 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.

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 Shorner, our Chief Financial Officer. beginning on slide five. I'd like to discuss the strategic steps we took in 2021 to grow our hematology oncology commercial capabilities and to advance our late stage clinical programs. Importantly, we undertook a Salesforce expansion with the goal of broadening our reach, improving efficiency, and increasing in-person interactions in the field. We also announced plans to focus our resources on our mid and to late stage programs and our overall clinical efforts. We believe this will strengthen our ability to build value for shareholders in 2022 by executing on the near-term value drivers as shown on this slide. First, I want to reiterate the progress we made with our first value driver, growing sales in ITP. In the fourth quarter, we shipped the highest number of bottles of Tobelis to patients and clinic in any quarter since launch. And our new patient starts continue to grow. Dave will provide further details later on in the call. In just a moment, Wolfgang will walk us through a review and timelines of our near-term pivotal phase three readouts for tablis in warm autoimmune hemolytic anemia and COVID-19, as well as advancements of our IRAP1-4 and RIP1 programs. I would like to provide a few highlights. From our second value driver, warm autoimmune hemolytic anemia, the pivotal phase three trial forward trial completed enrollment in the fourth quarter of 2021. We expect to report top-line data from this study in mid-2022. And if the data is positive, we expect to move forward to regulatory filings. An approved indication for warm autoimmune hemolytic anemia would be the first approved therapy of this kind for this patient population. and would be a synergistic tie-in to our Tavolis commercial efforts, giving our sales force another indication to market to this physician segment. Our pivotal phase three COVID-19 trial continues to progress, and we remain on track to complete enrollment and report top-line data in mid-2022. Tavolis is also being evaluated in a phase three trial sponsored by NIH, NHLBI, the ACTIV-4 host tissue study, as a potential treatment for patients hospitalized with COVID-19. We look forward to enhancing our understanding of the clinical profile of tablis in this important setting. Lastly, our advancing pipeline programs. I am pleased that our Phase 1B trial evaluating our IRAC1-4 inhibitor in lower-risk MDS patients is being initiated. R289, our dual IRAC1 and 4 inhibitor, has the potential to provide better suppression of the pro-inflammatory environment that causes low-risk MDS. And we look forward to keeping you updated on this trial as it progresses. A RIP1 inhibitor being developed in collaboration with our partner, Eli Lilly, is also expected to advance into phase two development in psoriasis in the first half of 2022. Now, before I turn the call over to Wolfgang for a deeper dive into our clinical programs, I want to take a moment to provide some further context on the opportunity in warm autoimmune hemolytic anemia and why we're so excited about this. On slide seven, warm autoimmune hemolytic anemia is an indication that shares the same customer base as our current ITP indication, but lacks any approved therapy posteroids. We believe we are uniquely positioned to leverage our knowledge and experience in this market to significantly build the Tavolis franchise. about potential FDA approval and launch in warm autoimmune hemolytic anemia. I will now turn the call over to Wolfgang to discuss warm autoimmune hemolytic anemia from a clinician's perspective and how a targeted therapy like TAVALYS would be an important advancement for patients suffering from this disease. Then later, Dave will provide some perspective on the current treatment landscape and potential market opportunity for TAVALYS in warm autoimmune hemolytic anemia.