3/19/2026

speaker
Operator
Conference Operator

Good afternoon, ladies and gentlemen, and welcome to the QRIS fourth quarter 2025 Business Update conference call. At this time, all lines are in a 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 today, Thursday, March 19, 2026. I would now like to turn the conference over to Deonta Duval, Curis, Chief Financial Officer, please go ahead.

speaker
Diantha Duval
Chief Financial Officer

Thank you, and welcome to Curis' fourth quarter 2025 business update call. Before we begin, I'd like to encourage everyone to go to the investor section of our website at www.curis.com to find our fourth quarter 2025 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 today 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 it over to Jim.

speaker
Jim Denser
President and Chief Executive Officer

Thank you, Diantha. Good afternoon, everyone, and welcome to QRIS's fourth quarter business update call. We continue to make steady progress in our Take Aim lymphoma study in 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 registrational study with an ORR endpoint that is evaluating emavucirtib in combination with ibrutinib after a patient has progressed on BTKI therapy. And after collaborative discussions with FDA and EMA, we expect the study to support accelerated submissions in both the U.S. and Europe. We continue to make good progress on enrollment in this registrational study and appreciate the ongoing support of our clinical investigators, key opinion leaders, and regulatory authorities. As you recall, last quarter, we engaged with a number of KOLs who were excited and highly supportive about 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. Over the last decade, 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 result is that patients treated with a BTK inhibitor end up having to stay on it in chronic treatment for the rest of their lives. Additionally, Because they never achieve complete remission, many of these patients develop BTKI-resistant mutations, and ultimately, their disease progresses. We are looking to improve upon the current standard of care by adding M of assertive to a patient's BTKI regimen, applying a dual blockade to the two biologic pathways driving CLL. This dual blockade can enable patients whose NHL subtype partially responds to a BTK inhibitor, to achieve deeper responses with the combination, including the ability to achieve complete remission or undetectable disease and the potential for time-limited treatment. If we are successful, adding M of assertive to BTKI could change the treatment paradigm in CLL, reducing the risk of developing a treatment-resistant mutation. and improving a patient's overall quality of life. The first step in testing this hypothesis in CLL is our proof of concept study in patients currently on BTKI monotherapy who have achieved partial remission but have been unable to achieve complete remission or undetectable MRD. We have begun activating clinical sites in the U.S. and Europe and expect to have initial data at the ASH annual meeting in December. With that, let's turn to AML. At the ASH meeting in December, we presented data for our ongoing AML triplet study, which is evaluating the triple combination of M of assertive with azazitidine and venetoclax in AML patients who have achieved complete remission on A's of N but remain MRD positive. These data were for the first two cohorts where patients achieved, excuse me, where patients received M of Acertib for either seven or 14 days in a 28-day cycle, in addition to their azazitidine and venetoclax treatment. In this study, five of eight evaluable patients were able to achieve MRD conversion. That is, they were able to convert from MRD-positive to undetectable disease. We're very encouraged by these initial data and the exciting potential of combining M of Acertib with azazitidine and venetoclax. As you can see, we had a very productive quarter, and then we look forward, of course, to a very exciting 2026 as we're advancing our registrational study in PCNSL and initiating our proof-of-concept study in CLL. With that, I'll turn the call over to Diantha for the financial update.

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