Curis, Inc.

Good afternoon and welcome to QRIS's fourth quarter and year-end 2021 earnings 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 the company's Chief Financial Officer and Chief Administrative Officer, Bill Steinkraus. Please go ahead.

Thank you, and welcome to QRIS's fourth quarter and year-end 2020. Before we begin, I would encourage everyone to go to the investor section of our website, at www.curis.com to find our fourth quarter and year end 2021 earnings 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 Bob Martel, Head of R&D. We will also be available for a question and answer period at the end of the call. I'd now like to turn the call over to Jim. Jim? Thanks, Bill. Good afternoon, everyone.

It's my pleasure to welcome you to QRIS's fourth quarter and year-end earnings call. At QRIS, we're driven by our mission to develop the next generation of transformative cancer therapies that meaningfully improve and extend patients' lives. In the fourth quarter of 2021, we made significant strides towards that goal. To start, we're pleased to announce that our novel IRAC4 inhibitor, CA4948, will be adopting a new generic name, emavucirtib, as well as introducing Take Aim, our brand name for clinical trials moving forward with emavucirtib. The Take Aim branding was selected to highlight the targeted design of emavucirtib as the first in class IRAC4 inhibitor in oncology. As a reminder, emavucirtib is currently being evaluated in nine distinct patient populations across three clinical studies in AML, MDS, and B-cell cancers. The first study, Take Aim Leukemia, is a Phase I-II study with both monotherapy and combination arms for patients with relapsed or refractory acute myeloid leukemia, or AML, and high-risk myelodysplastic syndromes, or MDS. The second study, Take Aim Lymphoma is a Phase I-II combination study with ibrutinib for patients with relapsed or refractory NHL or other hematologic malignancies. The third study is the Phase II Lucas study, evaluating amavucirtib in patients with lower-risk MDS, being led by Dr. Uwe Platzbecker of the University of Leipzig. In early January, we announced positive updated data from the Take Aim Leukemia Study in targeted patients with relapsed refractory AML or MDS whose disease is characterized by a spliceosome or FLT3 mutation. The updated data set supported the findings presented at EHA last year, further demonstrating encouraging anti-cancer activity compared to standard of care therapies in an expanded set of patient data. As of December, we had enrolled 49 patients in monotherapy, 13 of which had genetically defined diseases, either spliceosome mutation or FLT3 mutation, and were evaluable for efficacy. We plan to discuss data from this ongoing study with the FDA in the first half of this year with the goal of clarifying the regulatory path for bringing this novel therapy to patients in critical need. We will provide an update on that discussion later this year. Additionally, enrollment is proceeding well for the combination arm exploring amavucirtib plus azacitidine for patients naive to HMA and amavucirtib plus venetoclax for patients naive to venetoclax. We expect to have initial data from these combinations in the second half of this year. I'd like to briefly touch on the ongoing Phase II Lucas IST for patients with lower-risk MDS being led by Dr. Uwe Platzbecker, the co-chairman of EHA's scientific working group on MDS. Demonstration of safety and efficacy in low-risk MDS could lead to a potential breakthrough in the MDS field. While the current standard of care with EPO-stimulating agents can be effective for patients with lower-risk MDS who have low serum EPO, the effect is often transient. It is not disease-modifying, and it does not prevent the progression of MDS to AML. We believe that emavucirtib, with its direct targeting of IRAC4, could be a transformative disease-modifying alternative, allowing the potential to treat these patients in a much earlier stage of disease. While physicians can give leukemia patients transfusions, and they have drugs that can stimulate blood cell growth, at Curus, we're developing drugs that have potential to stop the cancer. In these early days of clinical testing, our data have demonstrated the potential to do just that, even in patients with spliceosome mutation for whom existing therapies don't work. Now let's move on to our B-cell cancer program and the TAKE-AIM lymphoma study. We initiated the combination study, evaluating emavucirtib with ibrutinib last year, after seeing clear efficacy with this novel monotherapy agent and seeing that the efficacy was durable over such an extended period of time for these extremely sick patients. The dose escalation portion of this study is expected to enroll approximately 18 patients in a 3 plus 3 design with emavucirtib doses starting at 200 and escalating to 300 milligrams BID. Ibrutinib dosing will be whatever is appropriate for the patient's respective NHL subtype. We expect to report initial data from this study in the first half of this year. Moving on to our second asset in the clinic, our first-in-class monoclonal anti-VISTA antibody, CI8993, a novel immune checkpoint inhibitor we're developing in collaboration with Immunext for the treatment of patients with relapsed or refractory solid tumors. We were excited to present clinical data on our phase one dose escalation study of CI8993 in January, demonstrating a promising safety profile and highlighting the potential of CI8993 to activate multiple anti-cancer mechanisms. CI8993 is a monoclonal antibody designed to antagonize VISTA-mediated immune suppression through myeloid and T-cell mechanisms. We believe CI8993 is the most advanced anti-VISTA antibody currently in clinical development and has the potential to be a game-changing cancer therapy. The role of VISTA may go beyond other checkpoint inhibitors, as we believe VISTA inhibition has the potential for broad application in many tumor types, both in monotherapy and in combination with existing checkpoint inhibitors. Because of VISTA's localization on a variety of immune cells, targeting it affects numerous cancer immune mechanisms, many of which are not addressed by targeting PD-1, CTLA-4, or other checkpoints. Our Phase I dose escalation study has shown to date that CI8993 has a safe and well-tolerated safety profile. Initially, we started dosing at 0.15 milligrams per kilogram, which was the highest dose cleared in the Janssen study. We then escalated dosing to 0.3 milligrams per kilogram, and most recently to 0.6 milligrams per kilogram. We're encouraged by our initial safety data as they appear to demonstrate the effectiveness of the procedures we implemented to manage expected CRS effects. The pharmacokinetic profile of CI8993 demonstrates the ability to overcome a PK-SYNC effect and achieve meaningful drug exposure. This fact is exemplified by our observation of clear pharmacodynamic effects in CI8993 with early signs that CI8993 is activating multiple anti-cancer mechanisms in patients tested to date. For these reasons, we believe that therapeutic targeting of VISTA with CI8993 has the potential to be a critical addition to the immune oncology arsenal. We look forward to sharing more data on this in the second half of 2022. In summary, we're pleased with the progress we've made in 2021. And we look forward to further progress in 2022. With that, I'll turn the call over to Bill to review our financial results for the quarter. Bill?