Curis, Inc.

Good afternoon, everyone, and welcome to QRIS's first quarter 2022 earnings conference call. All participants will be in a listen-only mode. Should you need assistance, please say no to 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 and then one on a touchtone telephone. To withdraw your questions, you may press star and two. Please also note today's event is being recorded. At this time, I'd like to turn the commerce call over to Kyrus's Vice President of Investor Relations and Corporate Communications, Craig West. Sir, please go ahead.

Thank you, and welcome to Kyrus's first quarter 2022 earnings call. Before we begin, I would encourage everyone to go to the investor section of our website at www.kyrus.com. to find our first quarter 2022 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, Bill Steinkraus, Chief Financial Officer and Chief Administrative 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, and I'd now like to turn the call over to Jim. Jim.

Thanks, Craig. Good afternoon, everyone, and welcome to QRIS's first quarter 2022 earnings call. For those of you who haven't yet had the pleasure of meeting Craig, he recently joined the company as our Vice President of Investor Relations and Corporate Communications, and we're delighted to have him on the team. Every day at Curus, we strive to develop the next generation of first-in-class cancer therapies that meaningfully improve and extend patients' lives. The first quarter of 2022 has been a reminder that the path in clinical development is not always a straight line and that we need to collaborate with many different stakeholders along the way. We are encouraged by the knowledge that we have a drug that works as a single agent in exactly the places we expect it to. Further, the company is well positioned to manage through the dynamics of drug development, and we remain confident in our pipeline, our strategy, and our team. Let's start our update tonight with our lead asset, Emovucirtib, formerly known as CA4948, our first-in-class program specifically designed to target IRAC4 and FLT3. Emovucirtib is currently being evaluated in three clinical studies. First, the Take Aim Leukemia Study, a Phase I-II study with monotherapy and combination arms for patients with relapsed or refractory acute myeloid leukemia, or AML, and high-risk myelodysplastic syndromes, or MDS. Second, the Take Aim Lymphoma Study, a Phase I-II combination study with ibrutinib for patients with relapsed or refractory NHL and other hematologic malignancies. And third, the Phase II Lucas Study, evaluating M of assertive in patients with lower risk MDS. In January, we announced positive updated clinical data from the Take Aim Leukemia Study, showing early but compelling response rates in patients with spliceosome or FLT3 mutations. These results demonstrated both a manageable safety profile and improved anti-cancer activity compared with the current standard of care. Patients enrolling in this study are often in rough shape. They tend to be heavily pretreated and have an expected median survival of less than six months. Given that baseline, we've been very encouraged by the study results to date. We'll be presenting the data highlighted in January at the ASCO and EHA medical conferences in June. Beyond that, we expect to report updated data from the monotherapy and combination portions of the study later this year. In April, the FDA asked us to pause the enrollment of new patients, placing partial clinical holds on both the take-aim leukemia and take-aim lymphoma trials, following Curis' report to the FDA of the death of a relapsed refractory AML patient who after being on study drug for nine cycles, experienced among several other conditions, rhabdomyolysis. Patient safety is always our top priority. We're working with the FDA to provide additional data related to rhabdomyolysis and also our recommendation of 300 milligrams BID as the recommended phase two dose. And we hope to resolve the partial holds as quickly as possible. We expect to provide updated guidance on the timing for discussions with FDA on a potential rapid registrational path for emavucirtib after the partial clinical hold has been resolved and any potential impact on the study can be determined. Now let's turn to our study of emavucirtib in B-cell cancers, the take-aim lymphoma study. We expect to report initial data from this study at both ASCO and EHA in June, the same data at both meetings, to address both the American and European audiences. This update will include new data on approximately a dozen patients who have received emavucirtib in combination with ibrutinib in several types of NHL. As a reminder, Part A1 of the study, which is completed, Examined Dose Escalation in Monotherapy. Part A2 in process now is exploring the combination of emavucirtib and ibrutinib. This combination 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 and ibrutinib dosing will be whatever is appropriate for the patient's respective NHL subtype. In this initial data set, we'll be looking to confirm that the combination of emavucirtib and ibrutinib can be dosed safely without overlapping toxicities. And of course, we also hope to see signs of anti-cancer activity. Especially for patients relapsed or refractory to BTK inhibitors, signs of anti-cancer activity would be an early and encouraging proof of concept for the scientific literature which suggests that targeting both the BCR and TLR pathways may prove more effective than targeting either pathway alone. I'd also like to comment briefly on our collaboration studying emavucirtib in patients with low-risk MDS. This study is being led by Dr. Uwe Platzbecker, the co-chairman of the European Hematology Association's scientific working group on MDS. We hope to report data on this study later in 2022. Being able to demonstrate safety and efficacy in these patients could represent a potential breakthrough in the MDS field. In March, a new potential opportunity for IRAC4 inhibition was identified with the publication of preclinical data in the peer-reviewed journal Gastroenterology, authored by our collaborators at the Washington University School of Medicine in St. Louis. This manuscript examines the role of IRAC4 and the preclinical efficacy of emavucirtib in combination with checkpoint immunotherapy in pancreatic ductal adenocarcinoma, a disease type with a very poor prognosis and in need of new therapeutic options. As we look ahead, we hope to build upon these results, working with the NCI and our other collaborators to identify additional new cancer targets where emavucirtib could address areas of high unmet need. Moving to our second asset, CI8993, this is the first-in-class monoclonal anti-VISTA antibody, which we are developing in collaboration with Immunext. for the treatment of patients with relapsed or refractory solid tumors. CI8993 is designed to antagonize the VISTA signaling pathway, thereby increasing T-cell-mediated immune function. 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, affecting numerous cancer-related immune mechanisms, many of which are not addressed by targeting PD-1, CTLA-4, or other immune checkpoints. In January, we presented updated clinical data highlighting an encouraging safety profile and early signs of CI8993's potential to activate multiple anti-cancer immune mechanisms. We were additionally pleased with the PK profile, which exhibits saturation kinetics, suggesting the potential to overcome the anticipated sync effect. Dose escalation has proceeded to the 0.6 milligrams per kilogram dose level and will continue until the recommended phase two dose has been determined. We look forward to reporting expanded safety and tolerability data along with initial PK, PD, and anti-cancer data from the trial in the second half of 2022. In summary, we're pleased with the clinical results observed to date, and we expect to provide several updates later this year, including new clinical data in both IRAC4 and VISTA programs. In the meantime, we'll work with the FDA to resolve partial clinical holds as quickly as possible. As we have said to many of you in calls over the last few weeks, clinical development is never a straight road. We're fortunate to be working with a molecule with the unique and compelling profile of M of Usurtib. With that, I'll turn the call over to Bill to review our financial results for the quarter. Bill?