Rigel Pharmaceuticals, Inc.

Greetings, and welcome to Rigel Pharmaceuticals' financial conference call for the second quarter 2021. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. When required, 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 2021 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 page on our website, 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, 2020, 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 CEO, Raul Rodriguez.

Thank you, Dolly, and thank you, everyone, for joining us on our second quarter 2021 conference call. Also joining me today are Wolfgang Dummer, our chief medical officer, Dave Santos, our chief commercial officer, and Dean Shornow, our CFO. Now beginning on slide five. During the second quarter, RIGEL continued to make good progress across all of our key value drivers, as you see on this page. While some of the headwinds of the COVID pandemic began to subside, the opportunity to address the pandemic remained very real and very near-term. We'll discuss this during our call. In ITP, we had very good growth relative to last year, as well as a substantial improvement over Q1. with a 38% increase in net sales. Dave and Dean will describe our net sales trend in more detail. Dave will also describe how we're increasing the size of our sales force to better address our heme and heme-on customers in ITP and to prepare for the potential opportunity in warm autoimmune hemolytic anemia, or AIHA. We made important progress in warm AIHA. We have now enrolled 80% of our targeted 90 patients in this trial. We added eight patients in the last three months. This enrollment progress puts us closer to our goal to be the first approved product for the treatment of warm AIHA, with the potential to capture a substantial share of this significant market opportunity. We have also made excellent progress in our COVID program with Fostermatinib, which has the potential to provide a still much needed therapy for hospitalized COVID patients. In Q2, we reported positive top line results from our phase two clinical trial conducted in collaboration with NIH and ANOVA. Wolfgang will provide a brief overview of these exciting and potentially impactful results with an update on our other COVID clinical trials. In late May, we filed the EUA with the US FDA and are awaiting their decision. Our own phase three trial in hospitalized COVID patients has enrolled very quickly. reaching over 150 patients, nearly half the targeted 308 patients, and with 90 patients enrolling in just the last two months. We are delighted to be included in the NIH-sponsored ACTIV-4 host tissue study in hospitalized patients with COVID-19 and see that the first patient has already enrolled. On our earlier programs, with our IRAC-1-4 program, We have received FDA feedback on our low-risk MDS study and have incorporated it into our Phase 1-2 study protocol. We look forward to starting this with our R289, which is a prodrug of our R835 molecule. With our RIP1 inhibitor program, we have two efforts moving forward with our partner, Lilly. We are working on entering a Phase 2 clinical study with R552, a systemic molecule, And we're also advancing our CNS penetrant molecule, which is in preclinical studies and has potential in indications such as Alzheimer's and ALS. In all, we had a very good quarter across all of our key value drivers. While we're still navigating through some of the COVID headwinds in some areas, we hope these will subside during the second half of the year. The opportunity to address what is a substantial need in COVID remains and we are committed to the patients who are suffering and the clinicians who are treating them as well. Today we'll start with Dave's discussion on our commercial progress and expansion, then followed by Wolfgang's update on our clinical programs, and then Dean's financial update. Dave, to you.