Curis, Inc.

Good morning and welcome to QRIS's fourth quarter 2024 business update call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing 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 the number one on your touchstone phone. To withdraw your question, please press star, then the number two. Please note this event is being recorded. I would now like to turn the conference over to Deonta Duvall, Curis' Chief Financial Officer. Deonta, please go ahead.

Thank you, and welcome to Curis' fourth 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.curis.com to find our fourth 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 Zone, Chief Development Officer. We will also be available for a question and answers 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 Kyrus' fourth quarter business update call. We made great progress this quarter in both NHL and AML. Let's start with our take-game lymphoma study, which is evaluating M of Usertib in combination with Ibrutinib in PCNSL. Before we discuss the clinical data, I'd like to highlight the encouraging feedback we received from the EMA and FDA on the potential for conditional marketing authorization in Europe and accelerated approval in the U.S. As a reminder, we engaged both agencies about the potential for accelerated filings after the initial early data from PCNSL patients treated with emavucirtib in combination with ibrutinib last year. We met with the agencies in the second half of 2024 and are pleased to announce that both agencies reviewed and provided feedback on our proposed plans for the potential for an accelerated approval pathway based on our ongoing Take Aim lymphoma study. As a reminder, the study is a single-arm, open-label study being conducted in the U.S., EU, and Israel using ORR, as the primary endpoint. Both agencies agreed that patients already enrolled in the trial can be used in the submission as long as they meet the same inclusion-exclusion criteria. They also provided helpful guidance on additional information, such as contribution of effect, to be included as part of the submission. And initial thoughts on the design of our confirmatory study. In short, the discussions were very productive. The development timeline for M of Assertive just got accelerated. Our current Phase 1-2 study is now registrational for both the U.S. and Europe. Obviously, this is the outcome we were hoping for. With over 30 clinical sites now open for enrollment, our goal is to complete enrollment in the next 12 to 18 months. With that, let's turn to the clinical data. As a reminder, We're testing the M of assertive ibrutinib combination in two distinct PCNSL populations, BTKI naive patients and BTKI experienced patients. The thesis for the M of assertive ibrutinib combination supported by both preclinical data and clinical data is that blocking both of the pathways driving disease in NHL Blocking the TLR pathway with emavucirtib and blocking the BCR pathway with ibrutinib maximizes downregulation of NF-kappa-B and can enable patients to achieve an objective response, even if they've been previously treated with a BTK inhibitor and progressed on that treatment. In our press release this morning, we summarized the clinical update for 27 relapsed refractory PCNSL patients in our take-aim lymphoma study, including 20 BTKI-experienced patients and seven BTKI-naive patients. Among the 20 BTKI-experienced patients, change in tumor burden data were available for 13 of them at the cutoff date. Nine of these 13 patients demonstrated a reduction in tumor burden, including six objective responses four CRs and two PRs, with three of the four CRs lasting more than six months. Among the seven BTKI-naive patients, change in tumor burden data were available for six of them at the cutoff date. Five of these six patients demonstrated a reduction in tumor burden, including five objective responses, one CR and four PRs. In summary, we're very encouraged by both the clinical data and the clarity from EMA and FDA on our proposed registrational plans. Over the next 12 to 18 months, we'll be focused on enrolling 30 to 40 additional patients to support a filing for accelerated approval. Finally, to cap off our progress in NHL this quarter, we're pleased to announce that Emma Vucertib has been granted orphan drug designation for primary CNS lymphoma in both the U.S. and in Europe. With that, let's turn to AML. At the ASH conference in December, Dr. Eric Weiner from Dana-Farber presented data for 21 patients with a FLT3 mutation who had received fewer than three lines of prior therapy and were treated with M of assertive as monotherapy at the RP2D of 300 milligrams BID. These data show a 38 percent composite CR rate in the salvage line setting, with 10 objective responses in 19 response-available patients, six full CRs, two CRs with partial or incomplete hematological recovery, and two morphologic leukemia-free state responses. We were especially encouraged to see that these responses were achieved rapidly. with seven of 10 responses reported at the first assessment. To put these data in context, we know that FLT3 patients in the relapsed refractory setting typically receive giltaritinib, a FLT3 inhibitor which was approved with a composite CR rate of 21%. And it's important to remember that this 21% rate was in an ideal population of patients. predominantly naive to FLT3 inhibition. The emavucirtib study, on the other hand, was in salvage line patients. Over 80 percent of the patients on emavucirtib had already been treated with a FLT3 inhibitor and failed. We believe the reason emavucirtib data were so compelling is its novel mechanism of action. It blocks both IRAC4 and FLT3. For several years, it has been suggested in the literature that blocking IRAC4 can enable patients to overcome adaptive resistance to FLT3 inhibition. These clinical data clearly support that thesis. Finally, I'd like to provide an update on our progress with the triplet study in frontline AML. As a reminder, In 2024, we initiated a Phase I study of emavucirtib as an add-on agent to venetoclax and azacitidine in frontline AML. This study is assessing safety and tolerability, where emavucirtib is added to a patient's venasa regimen in 7-, 14-, and 21-day dosing regimens after they have achieved a CR on venasa and while they remain positive for minimal residual disease. We have successfully completed the seven-day cohort, and enrollment of the 14-day cohort is currently ongoing. In short, we had a very productive 2024 and have entered 2025 with positive momentum. We look forward to providing you with additional updates as the year progresses. With that, I'll turn the call over to Diantha for the financial update. Diantha?