Curis, Inc.

Good morning, ladies and gentlemen, and welcome to the QRIS Provide Second Quarter 2024 Business Update Conference Call. 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 Thursday, August 1, 2024. I would now like to turn the conference over to DeAntha Duvall. Please go ahead.

Thank you, and welcome to QRIS's second 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 second 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 on today's call are Jim Denser, President and Chief Executive 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, Dantha. Good morning, everyone, and welcome to QRIS's second quarter business update call. Let's start with our take-aim lymphoma study, which is evaluating emavucirtib in combination with ibrutinib in relapsed refractory PCNSL patients that have failed after treatment with a BTK inhibitor. These patients have generally seen methotrexate, chemo, and radiation in the frontline setting, followed by ibrutinib in the second line. As patients progress on ibrutinib, they're eligible to enroll into our study where we add emavucirtib to their ibrutinib regimen. The scientific thesis for this combination is that blocking both of the pathways driving NHL, the TLR pathway with emavucirtib and the BCR pathway with ibrutinib, can enable patients to achieve an objective response even after they have progressed on ibrutinib in monotherapy. We presented data for the first five patients in this study at the ASH conference last December, where we reported an objective response rate over 50%. These data were early, but very encouraging, especially given the high unmet need in this population. We have continued to enroll patients in this study, and as we noted in our press release this morning, have recently initiated discussions with regulatory authorities to gain alignment on the registrational path for emavucirtib. in combination with ibrutinib in primary CNSL. It goes without saying that defining the registrational path is a critical next step in M of Assertive's development, and I'm pleased with our most recent engagement with FDA. I look forward to communicating the outcome of these discussions at the appropriate time. Discussions are also progressing in Europe, where we're pleased to report that M of Assertive has been granted orphan drug designation for primary CNS lymphoma by the European Commission. This designation provides several benefits, including 10 years of market exclusivity, reduced fees for protocol and scientific assistance, as well as marketing authorization applications, and a central application process for marketing authorization with the European Medicines Agency. While these regulatory discussions are ongoing, we continue to make excellent progress on the operational front as well and expect to reach our target number of 30 clinical sites in the U.S. and Europe and have initial data for 15 to 20 patients by year end. Now let's move to our take-game leukemia study, which is evaluating emavucirtib in monotherapy in patients with relapsed refractory AML. At ASCO and EHA earlier this year, We provided updated data for two patient populations in this study, patients with a splicing factor mutation and patients with a FLT3 mutation. In the splicing factor mutation, four of 18 evaluable patients achieved an objective response, including one complete remission, or CR, two CRs with partial hematologic recovery, or CRH, and one morphologic leukemia-free state, or MLFS. In the FLT3 population, six of 11 evaluable patients achieved an objective response, including three CRs, one CRH, and two MLFSs. Also of note, three of the patients were naive to treatment with a FLT3 inhibitor. All three of these patients achieved objective responses. And three of the remaining eight patients those who had failed prior treatment with a FLT3 inhibitor were able to achieve an objective response with emavucirtib. We believe these data support emavucirtib's novel mechanism and its potential as a treatment for patients with relapsed refractory AML. In the frontline setting, you may remember that preclinical data demonstrate a synergistic effect when M of assertive is combined with azacitidine and venetoclax, the standard of care in frontline AML. We recently initiated a study of this triple combination, that is, M of assertive in combination with azacitidine and venetoclax in frontline AML. We expect to have initial safety data from this study later this year. Overall, I'm very pleased with the progress in both our take-aim leukemia and take-aim lymphoma studies, and I look forward to providing additional updates as the year progresses. With that, I'll turn the call over to Diantha for the financial update.