Curis, Inc.

Good morning and welcome to Curious' fourth quarter 2023 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, call participants will have an opportunity to ask questions. To ask a question, you may press star then one on your touchtone phone. To withdraw your question, please press star then two. 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 QRIS's fourth quarter 2023 business update call. Before we begin, I would like to encourage everyone to go to our investor section of our websites, at www.cures.com to find our fourth quarter 2023 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 file-in. 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 our call. I'd now like to turn the call over to Jim. Jim?

Thank you. Thank you, Dantha. Good morning, everyone, and welcome to QRIS's fourth quarter business update call. I'd like to start today's call with a look back over the past 12 months. Entering 2023, the whole biotech industry was struggling in the headwinds of a grim financial market. Curis faced all of that and the daunting challenge of seeing our leukemia study stalled on partial clinical hold with the FDA. In the face of that adversity, the Curis team rose to the challenge. We worked tirelessly in answering questions posed by the FDA, This included enrolling additional patients at 200 milligrams BID and performing additional analyses. As a result, we were able to confirm the safety profile of MF-inserted, gain alignment on the optimal dosing regimen for monotherapy, and secure the removal of the partial clinical hold a full quarter earlier than expected. We then redirected our energy to reopening clinical sites and enrolling new patients. In our monotherapy study, we are targeting a genetically defined population of relapsed refractory AML patients with a FLT3 or spliceosome mutation. Enrollment is going quite well, and we expect to have a data update by mid-year. While that study advances, we have initiated a frontline study of emavucirtib in combination with azazitidine and venetoclax for all AML patients regardless of their mutation status. This study is being conducted at sites in Spain, Germany, and Italy, and we expect preliminary data from this study in the second half of this year. All in all, a terrific year of progress in leukemia. Now let's turn to our lymphoma program, which is generating an equally high level of interest. After reviewing initial data collected across multiple NHL subtypes, We focused our efforts on the ultra-orphan indication of primary CNS lymphoma, or PCNSL, where we are evaluating M of assertive in combination with ibrutinib. We identified key sites, initiated enrollment, and in December, we released new clinical data in relapsed refractory PCNSL at the ASH conference in San Diego. The meetings we had with physicians at ASH were terrific, and we were especially pleased to have Dr. Greg Nowakowski and Dr. Han Tun from the Mayo Clinic present the data. As a reminder, frontline treatment in PCNSL is high-dose methotrexate and chemo. When that no longer works, there is no approved second-line treatment. In our study, three of five patients were able to achieve complete remission of their disease. It is admittedly a small number of patients. However, the response and interest from the clinical community was very encouraging. In the eight weeks since ASH, our team has been fielding calls from clinical sites across the U.S. and Europe wanting to participate in our trials. In fact, by the end of Q1, we expect to have doubled the number of clinical sites versus where we were a year ago. Obviously, this is a reflection of the excitement about emavucirtib, but it is also a reflection of the indefatigable efforts of the KERAS team. I couldn't be more proud of them. Finally, in December, we announced that we entered into an agreement for an investigator-initiated trial to study the combination of emavucirtib and pembrolizumab in patients with metastatic melanoma. We're excited that this study presents an opportunity to expand upon the research done at academic centers and the NCI to explore the potential of MFHS tumors. In short, we had an incredibly productive 2023, and we look forward to continuing that momentum in 2024. With that, I'll turn the call back over to Diantha to review our financial results for the quarter. Diantha?