Curis, Inc.

Good morning and welcome to QRIS's second quarter 2025 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 be advised this call is being recorded today, Tuesday, August 5th, 2025. 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 second 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.keras.com to find our second 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 expectation 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, Jonathan Zun, 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 our call. I'd now like to turn the call over to Jim.

Thank you, Dantha. Good morning, everyone. and welcome to QRIS's second quarter business update call. We continue to make steady progress in our Take Aim Lymphoma Study, which is evaluating emavucirtib in combination with ibrutinib in patients with PCNSL. 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 directly progressed on PTKI monotherapy. And after collaborative discussions with FDA and EMA, we expect the study to support accelerated submissions in both the US and Europe. Over the next 12 to 18 months, we'll be focused on enrolling 30 to 40 additional patients that we'll need for the NDA and EMA submissions. In June, we attended both the ASCO and EHA conferences and had the opportunity to engage with a number of KOLs who remain excited and supportive about expanding emavucertib into additional indications in CLL and NHL. They were especially interested in exploring emavucertib's potential to fundamentally change the treatment paradigm for CLL and NHL patients currently treated with BTKI monotherapy. BTKI inhibitors became standard of care in CLL and NHL because they deliver a good overall response rate. But these patients on BTKI typically achieve 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 lifelong chronic treatment. And because they never achieve complete remission, many of these patients develop BTKI-resistant mutations and ultimately progress. We're looking to improve current standard of care by adding M of Acertib to a BTK inhibitor, enabling patients to achieve deeper responses and potentially come off treatment, reducing the risk of developing BTKI-resistant mutations and improving a patient's quality of life. The first step in testing this hypothesis is to initiate a proof of concept study in approximately 20 to 30 patients with relapsed refractory CLL who are currently responding to their BTK inhibitor but unable to achieve complete remission or MRD negativity. We have completed the design for this study and are targeting first patient in by year end and initial data in mid-2026. Now let's turn to AML. As you'll recall, at the ASH conference in December, Dr. Eric Weiner from Dana-Farber presented 21 relapsed refractory AML patients with a FLT3 mutation. These data showed a 38% composite CR rate in the salvage line setting with 10 objective responses in 19 patients, and with seven of the 10 responses reported at the first assessment. To put these data into context, giltaritinib, the leading FLT3 inhibitor in relapsed refractory AML, was approved with a composite CR rate of 21% in a patient population where only 13% of the patients had been previously treated with a FLT3 inhibitor. In the emavucirtib study, over 80% of the patients had been previously treated with a FLT3 inhibitor. We believe the reason the emavucirtib data are so compelling is its novel mechanism of action, which blocks both IRAC4 and FLT3. The next step in the development of emavucirtib in AML is to conduct a registrational study comparing emavucirtib versus giltaritinib in the relapsed refractory setting. We're also excited about the potential of emavucirtib in high-risk MDS. In June, it was announced that the Verona study testing the combination of venetoclax and azacitidine missed its primary endpoint. This news generated a lot of discussion at the medical conferences and heightened interest in studying the combination of azacitidine with emavucirtib. We've seen that M of assertive is active as a monotherapy in HRMDS, and we believe the M of assertive azacitidine combination has the potential to address a clear unmet need and offer a compelling new treatment option for patients with MDS. Finally, I'd like to provide an update on our progress with the triplet study in frontline AML. As a reminder, We initiated a phase one study last year of emavucirtib as an add-on agent to venetoclax and azacitidine in frontline AML. We're currently evaluating different dosing regimens of emavucirtib, venetoclax, and azacitidine. To date, we've completed enrollment in the seven-day and 14-day dosing regimens of emavucirtib in a 28-day triplet cycle and are excited to report our progress in this study at the ASH conference in December. As you can see, we had a very exciting and productive quarter, and we look forward to providing additional updates as the year progresses. With that, I'll turn the call back to Diantha for the financial update. Diantha?