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11/2/2021
Then welcome to Rigel Pharmaceutical's financial conference call for the third quarter 2021. At this time, all participants are in the 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 third quarter 2021 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 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 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 CEO, Raul Rodriguez,
Thank you, everybody. Thank you, Dolly. And thank you, everyone, for joining our third quarter 2021 conference call. Also with me today are Wolfgang Dummer, our chief medical officer, Dave Santos, our chief commercial officer, and Dean Shorno, our CFO. Now, beginning on slide five, during the third quarter, we made significant progress that sets us up for success in each of our key value drivers now and into 2022. On this call, we'll tell you about growing ITP sales, advancing our clinical program in autoimmune hemolytic anemia, treating hospitalized COVID-19 patients, as well as preparing our earlier stage pipeline programs for mid-stage clinical trials. Today, let me start with our second key value driver, warm autoimmune hemolytic anemia, or warm AIHA. Warm AIHA, in warm AIHA, we achieved an important milestone this quarter. I'm happy to announce that the Pivotal Phase III Forward Trial is now fully enrolled. This brings us closer to delivering robust evidence for TAVALYS as a potentially new first-in-class medicine for the treatment of patients with warm AIHA. Dave will provide an overview of the opportunity in warm AIHA, and Wolfgang will discuss what we expect to see from the Forward Trial and provide insights into why this is an important step forward for patients suffering from this disease. In the past quarter, we completed the expansion of our Hemon commercial organization. We added 16 new sales reps who are now fully trained out in the field and are looking to make an impact starting in this quarter. We have an incredibly capable and experienced organization and now one with even greater reach. Dave will speak about the caliber of this team he's assembled and how this positions us to drive further awareness of Tavalis in ITP and prepares us for a potential opportunity in warm autoimmune hemolytic anemia. In ITP, we continue to see growth in demand this year, but we're also encouraged by some key metrics that mark the potential for future growth, specifically new patient starts, which are the strongest we've seen since 2019 when the pandemic started. Dave and Dean will describe the sale trend in a little bit more detail during this call. On our COVID-19 program, we continue to move forward with 210 patients now enrolled in our phase three study. In early September, results from the phase two study conducted by the NIH were published in the journal Clinical Infectious Disease. This publication provides important clinical data on the use of Fostermatinib in patients hospitalized with COVID-19. Wolfgang will discuss our progress in this program. Regarding our earlier pipeline programs, Our IRAC1-4 program is moving forward with preparations of a Phase 1B-2 study in low-risk MDS. This is an area where there's high unmet need, and we think that our IRAC1N4 molecule, R289, is ideally suited to address this. Our RIP1 inhibitor program partnered with Eli Lilly includes a systemic molecule, R552, which is targeting autoimmune diseases And we are jointly working on starting a phase two trial in 2022. The program also includes a molecule that can penetrate the blood brain barrier for applications in CNS diseases such as Alzheimer's and ALS. We made progress across all our value drivers this quarter and setting the stage for a transformative year for the company in 2022. To tell you more about this, we'll start with Dave's discussion on our commercial progress and expansion. followed by Wolfgang's update on our clinical programs, and then Dean's financial update. Over to you, Dave.
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