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8/6/2024
Greetings and welcome to Regil Pharmaceutical's financial conference call for the second quarter 2024. 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, Ray Furey, Rigel's Executive Vice President, General Counsel, and Corporate Secretary. Thank you, Mr. Furey. You may begin.
Welcome to our second quarter 2024 financial results and business update conference call. The financial press release for the second quarter of 2024 was issued a short while ago and can be viewed along with the slides for this presentation in the news and events section of our investor relations site on 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 31st, 2023. report on Form 10Q 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 Chief Executive Officer, Raul Rodriguez.
Thank you, Ray, and thank you everyone for joining today. Also with me today are Dave Santos, our Chief Commercial Officer, Lisa Royker, our Chief Medical Officer, and Dean Chorno, our Chief Financial Officer. Now beginning on slide four. I'm thrilled to introduce you to Gavretto, the latest addition to Rigel's product portfolio. Gavretto is an FDA-approved therapy for the treatment of red fusion positive metastatic non-small cell lung cancer and advanced or metastatic thyroid cancer that we acquired earlier this year. Gavretto has become commercially available from Rigel on June 27th. Our patient services, field teams, and distributors work diligently to ensure a smooth transition, enabling us to provide current, annually prescribed patients and their providers this important treatment option without any interruption. The addition of Gavretto to our growing commercial portfolio now made up of three products supports top-line growth and leverages our existing commercial and medical affairs expertise and capabilities. Moving on to slide five. In the second quarter, we made meaningful progress towards growing the commercial side of our business. We had 33.5 million of net product sales during the quarter, an increase of 40% over 23.9 million in the second quarter of 2023. The continued record performance of Tavalis and ResLidio, coupled with the addition of Gabretto, reflects our successful efforts to expand our hematology and oncology portfolio. We look to continue to grow our existing portfolio and to expand it with new products in the future. On the development side, our IRAC1N4 inhibitor, R289, continues to progress in a Phase 1B trial in lower-risk MDS, with enrollment of the fourth dose group nearing completion. We remain on track to share preliminary data from this study by the end of this year. Our strategic collaborations with MD Anderson Cancer Center and Connect will enable us to explore res lydia in a broad range of IDH1 mutant cancers in a cost and time-efficient manner. These programs continue to progress, and we're excited to share with you today that our first trial with MD Anderson, evaluating res lydia in patients with AML, has opened for enrollment. Lisa will share more details on this shortly. In summary, in the second quarter, we saw record sales of our commercial products. And combined with our cost-effective approach to clinical development, as well as continued financial discipline, we approached net income break-even. This is great progress. Now, with that, I'll turn the call over to Dave to provide a commercial update. Dave?
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