Curis, Inc.

Good morning, ladies and gentlemen, and welcome to the Curry's first quarter 2024 business update. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Tuesday, May 7, 2024. I would now like to turn the conference over to Dianza Duval. Please go ahead.

Thank you, and welcome to QRIS's first quarter 2024 business update call. Before we begin, I would like to encourage everyone to go to the investor section of our website at www.qris.com to find our first quarter 2024 business update press release and related financial tables. I would also like to remind everyone that during the call, we will be making forward-looking statements, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and actual results may differ materially. For additional details, please see our SEC filings. Joining me today on today's call are Jim Denser, President and Chief Executive Officer, Bob Martel, Chief Scientific Officer, and Jonathan Zung, Chief Development Officer. We will also be available for a question and answer period at the end of the call. I'd now like to turn the call over to Jim.

Thank you, Diantha. Good morning, everyone, and welcome to QRIS's Q1 business update call. This quarter, we made significant progress in advancing emavucirtib in our three key areas of focus. First, as a monotherapy in patients with relapsed refractory AML, with a FLT3 or splicing factor mutation in our Take Aim leukemia study. Second, as a doublet therapy for patients with relapsed refractory primary CNS lymphoma, combining emavucirtib with ibrutinib in our Take Aim lymphoma study. And third, as a triplet therapy in frontline AML for all comers, regardless of mutation status, that combines emavucirtib with azazitidine and venetoclax. Next Tuesday, in connection with the EHA conference's publication of accepted abstracts, we expect to provide a top-line update of clinical data from our Take Aim leukemia study. Previously, we had disclosed data for five patients, three patients with a FLT3 mutation, and three patients with a splicing factor mutation, including one patient with both a FLT3 and a splicing factor mutation who was included in both populations. Our update next week will report data for 25 new patients, bringing the total to 30 relapsed refractory AML patients treated with emavucirtib as a monotherapy. The mutation status for these patients is 12 patients with a FLT3 mutation and 20 patients with a splicing factor mutation, including two patients with both a FLT3 and a splicing factor mutation who are included in both populations. We look forward to discussing the top-line data for these patients on an investor call when the data are released, followed by more detailed presentations at the ASCO and EHA medical conferences that more fully explore amavucirtib's potential to outperform, as a single agent, the benchmarks for existing therapies in genetically targeted AML populations. In the relapsed refractory FLT3 population, the benchmark for FLT3 inhibition is giltaritinib, which, as FDA label demonstrates, can achieve a 21% CR-CRH rate in patients who have failed frontline therapy. With Emovucertib, our goal is to beat that benchmark We think this is possible, even though the majority of patients in our study have failed prior treatment with a FLT3 inhibitor, because unlike existing treatments, emavucertib targets both FLT3 and IRAC4, the escape path for FLT3. This is the central hypothesis of the molecule's design and is demonstrated in the preclinical data. With the 12 patients we'll be showing at ASCO and DEHA, We hope to further support that hypothesis, namely that emavucirtib has the potential to establish a new and best-in-class benchmark for the FLT3 AML population. As we move to the relapsed refractory splicing factor population, we find that the benchmark is, unfortunately for these patients, far lower. There are no drugs approved. Expected survival is only a few months, and existing treatments are ineffective. The only study published for relapsed refractory AML patients with a splicing factor mutation was for patients treated with the AZA-VEN doublet. It was a very small study with only five patients, and the response rate was zero. This is especially notable as ACE of N is standard of care in frontline AML for patients ineligible for intensive induction. We hope M of assertive's novel mechanism can show clear single-agent activity in this very challenging population. Anything that shows M of assertive can beat the 0% benchmark set by ACE of N would be positive. In our expanded data set, we'll be looking for blast count reductions, neutrophil increases, platelet increases, objective responses, and ultimately, of course, extended survival. As we turn to our take-aim lymphoma study, we see significant progress there as well. At the most recent ASH conference, we presented data for five patients with relapsed refractory primary CNS lymphoma who had failed prior treatment with a BTK inhibitor. We expect to provide an update with additional data later this year, most likely at the ASH conference in December. Previously, we have said we expected to report data on 10 to 15 patients. Today, we are pleased to refine that estimate to the high end of the range, as we now expect to report data for approximately 15 relapsed refractory primary CNS lymphoma patients who have failed prior treatment with a BTK inhibitor. We are also pleased to announce the advancement of our triplet study in all comers in frontline AML. We have begun enrollment and expect to have preliminary safety data later this year, again, most likely at the ASH conference in December. The excitement around this frontline study stems from the novel targeting of IRAC4 and builds upon the clear anti-cancer activity we are seeing in our monotherapy studies. We know IRAC4 is an important target in AML, and that neither azazitidine nor venetoclax addresses it. So the logical next step is to explore the EMA-AZA-VEN triplet and its potential to establish a new benchmark for frontline therapy in all comers in AML. In summary, we're encouraged by our progress across the board in leukemia and lymphoma, and we look forward to reporting our updated leukemia data next week. With that, I'll turn the call back over to Diantha to review our financial results for the quarter. Diantha?