Curis, Inc.

Good afternoon, ladies and gentlemen, and welcome to the QRIS third quarter 2025 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, November 6, 2025. I would now like to turn the conference over to Diantha Duvall, Chief Financial Officer. Please go ahead.

Thank you, and welcome to the QRIS third quarter 2025 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 third quarter 2025 business update press release and related financial tables. I'd also like to remind everyone that during the call, we will be making forward-looking statements, which are based on 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, Dr. Jonathan Zung, Chief Development Officer, and Dr. Ahmed Hamdi, Chief Medical Officer. We will also be available for a question and answer period at the end of the call. I'd like to now turn the call over to Jim.

Thank you, DeAntha. Good afternoon, everyone, and welcome to QRIS's third quarter business update call. We continue to make steady progress in our Take Aim Lymphoma study, which is evaluating M of Acertib in combination with Ibrutinib in patients with primary CNS lymphoma, one of the most rare and most difficult to treat of the NHL subtypes. As a reminder, the Take Aim Lymphoma study is a single-arm study with an ORR endpoint that adds emavucirtib to a patient's BTKI regimen after they have progressed on BTKI monotherapy. And after collaborative discussions with the FDA and EMA, we expect the study to support accelerated submissions in both the U.S. and Europe. Over the next 12 to 18 months, we'll be focused on enrolling the additional patients we'll need to support those submissions. If you recall, last quarter we engaged with a number of KOLs who were excited and highly supportive of expanding our M of Usertib studies into additional NHL subtypes. They were especially interested in exploring M of Usertib's potential to fundamentally change the treatment paradigm for CLL patients, where the current standard of care is BTKI monotherapy. BTK inhibitors have become the standard of care in CLL and NHL because of their ability to help patients achieve objective responses. However, these responses are typically partial responses, not complete remission. The unsurprising result is that patients who are treated with a BTK inhibitor end up having to stay on it in chronic treatment for the rest of their lives. Additionally, Since patients never achieve complete remission, many of these patients develop BTKI-resistant mutations, and ultimately, their disease progresses. At QRIS, we're looking to improve upon the current standard of care by adding emavacertib to a patient's BTKI regimen, enabling patients to achieve deeper responses and potentially come off treatment, reducing the risk of developing BTKI-resistant mutations, and improving a patient's overall quality of life. The first step in testing this hypothesis in CLL is to initiate a proof-of-concept study in patients currently on BTKI monotherapy who have achieved a PR but have been unable to achieve complete remission, or UMRD. We have submitted the study protocol to the FDA. We're working to activate clinical sites, and we expect to enroll our first patient in late Q4 or early Q1 with initial data expected at the ASH annual meeting in December 2026.