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Curis, Inc.
3/13/2023
Good morning and welcome to the QRIS fourth quarter 2022 business update call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After the company's prepared remarks, all participants will have an opportunity to ask questions. To ask a question, you may press star then one on your touch-tone phone. To withdraw your question, please press star then 2. Please note this event is being recorded. I would now like to turn the conference over to Diantha Duvall, QRIS's Chief Financial Officer. Diantha, please go ahead.
Thank you. And welcome to the QRIS fourth quarter 2022 business update call. Before we begin, I would like to encourage everyone to go to the investor section of our website at www.cures.com to find our fourth quarter 2022 business update 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 Bob Martell, Head of R&D. We will also be available for a question and answer period at the end of the call. I'd like now to turn the call over to Jim.
Thank you, Diantha. Good morning, everyone, and welcome to QRIS's fourth quarter business update call. This past quarter, we made important progress with our lead clinical candidate, Emma Vucerted. which is currently being evaluated in two clinical studies. The Take Aim Leukemia Study, a Phase I-II study with both monotherapy and combination arms for patients with relapsed or refractory acute myeloid leukemia, or AML, and high-risk myelodysplastic syndromes, or MDS. And the Take Aim Lymphoma Study, a Phase I-II combination study with ibrutinib for patients with relapsed or refractory NHL and other hematologic malignancies. We were especially pleased to present an update of clinical data from the Take Game Leukemia Study, in which AML patients with a FLT3 mutation had a CR rate of 29%. AML patients with a spliceosome mutation had a CR-CRH rate of 22%, and MDS patients with a spliceosome mutation had an overall response rate of 45%, with all five responses achieving a marrow-complete remission. This update doubled the size of our earlier data set and reaffirmed emavucirtib's potential to be an important therapeutic alternative for patients with AML or MDS. We've also made important progress in our work to resolve the partial clinical hold on our leukemia study. In last quarter's call, we announced that the FDA had approved the reopening of our clinical sites so that we could enroll nine additional patients at the 200 milligram dose level to facilitate discussions with FDA on the recommended phase 2 dose, or RP2D, and the resolution of the partial clinical hold. We're pleased to announce today that we have completed the reopening of our sites and have also completed the enrollment of the nine additional patients requested by FDA. This is ahead of schedule and we believe reflects the excitement surrounding this novel therapeutic and the critical unmet need in this sorely underserved patient population. We expect to collect data for these patients in Q2 and meet with FDA in Q3 to review those data. We also continue to enroll in our Take Aim lymphoma study, in which we are focusing on primary CNS lymphoma and treating patients with the combination of emavucirtib and ibrutinib. In short, we had a very productive end of 2022. and that momentum is carried forward into 2023. We look forward to working with the FDA in the months ahead to gain alignment on RP2D in our Take Aim leukemia study and resolution of the partial clinical hold. With that, I'll turn the call back over to Diantha to review our financial results for the quarter. Diantha?
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