8/4/2022

speaker
Jamie
Conference Call Operator/Moderator

Good afternoon, everyone, and welcome to QRIS's second quarter 2022 earnings conference call. All participants will be in a listen-only mode. Should you need assistance, please see 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 using a touchtone telephone. For all 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 conference over to QRIS's Vice President of Investor Relations and Corporate Communications, Craig West. Sir, please go ahead.

speaker
Craig West
Vice President of Investor Relations and Corporate Communications

Thank you, Jamie, and welcome to QRIS's second quarter 2022 earnings call. Before we begin, I would like to encourage everyone to go to the QRIS investor section of our website at www.curus.com to find our second 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. I'd now like to turn the call over to Jim. Jim.

speaker
Jim Denser
President and Chief Executive Officer

Thank you, Craig. Good afternoon, everyone, and welcome to QRIS's second quarter earnings call. Every day at QRIS, we strive to develop the next generation of first-in-class cancer therapies that meaningfully improve and extend patients' lives. We have several updates for you this quarter. First, as we've noted previously, the path of drug development is seldom a straight line, and the second quarter began with FDA placing a partial clinical hold on our take-game studies in leukemia and lymphoma in April. We're having productive discussions with the agency to bring these discussions to a resolution as quickly as possible. Second, we're delighted to announce that we have appointed a new CFO, which I'll talk about more in a minute. Third, the second quarter also saw several positive presentations on emavucirtib at ASCO and EHA, both by our internal team at QRIS and by several of our partners in academia with whom we are expanding the frontiers of IRAC4 research. These presentations included the first data from the combination arm of the Take Aim lymphoma study, as well as additional data in solid tumors and novel discoveries that are deepening our understanding of IRAC4 biology. In short, we're encouraged that in M of assertive, we have a drug that works. as a single agent in exactly the places our research predicted. To start our update tonight, I'd like to welcome Diantha Duvall, who is joining the QRIS team as our new CFO. Diantha began her career with PricewaterhouseCoopers, and over the last 20 years has built an impressive track record of financial leadership at Merck, Biogen, BioVerative, and Genosha. We're delighted to have such a well-respected industry veteran join the team. I'd also like to take this opportunity to thank Bill Steinkraus. He has been a key leader on the executive team at QRIS, and we wish him all the best in his future endeavors. Turning now to our pipeline and our lead asset, Emma Vucertib, our first-in-class program specifically designed to target IRAC4 and FLT3. Emma Vucertib is currently being evaluated in three clinical studies. First, the Take Aim Leukemia Study, 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. Second, the Take Aim lymphoma study, a Phase I-II combination study with ibrutinib for patients with relapsed or refractory NHL or other hematologic malignancies. And third, the Phase II Lucas Study, evaluating M of assertive in patients with lower-risk MDS. Starting with the Take Aim Leukemia Study, we continue to work with FDA on resolving the partial clinical hold. We've had productive interactions with the agency and hope to provide an update soon. At ASCO and EHA, we presented positive clinical data showing early and compelling response rates in AML or MDS patients with spliceosome or FLT3 mutations. These results demonstrate both a well-tolerated regimen and improved anti-cancer activity compared with the current standard of care. As the leader in IRAC4, we are pleased to be hosting an IRAC4 symposium on October 7th. In this symposium, we'll be bringing together experts from academia, clinicians, and other corporates in panel discussions To be clear, this will not be a forum for a curious data update. The aim of the symposium is to address and advance topics of key interest to everyone in the IRAC4 community. We'll be releasing more details on this event soon. Now let's turn to our study of M of assertive in B-cell cancers and the take-aim lymphoma study of patients with NHL and CLL. Our first look at initial data presented at ASCO and EHA, showed the results from nine evaluable patients. Eight of the nine patients experienced tumor burden reduction, including two CRs and two PRs. We share the excitement of our investigators that one of the observed CRs was in a patient who had received prior treatment with ibrutinib, suggesting that the combination may be able to overcome resistance to ibrutinib. Also at ASCO and EHA this year, we presented work by curious scientists describing the novel observation that IRAC4 localizes to the nucleus in cancer cells. When nuclear IRAC4 is found with two NF-kappa B proteins, P50 and P65, this triple presence in the nucleus is associated with better patient responses to MF-USERTA. This new finding deepens our understanding of IRAC4 biology and its role in cancer and marks an important next step in the development of biomarkers for identifying patients who could benefit from treatment with emavucirtib. The ASCO and EHA conferences also saw presentations by our partners in academia showing emavucirtib's potential in several other tumor types, including solid tumors such as gastric cancer, melanoma brain metastases, and primary CNS lymphoma. In short, the second quarter was an exciting time for IRAC4 research and expanding the potential of emavucirta. Now let's move to our second asset, CI8993, the first in class monoclonal anti-VISTA antibody we're 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. By blocking VISTA, a checkpoint associated with T cell suppression, we hope to increase T cell-mediated immune function. In preclinical models, addressing VISTA demonstrates exciting anti-cancer potential, both in monotherapy and in combination with CTLA-4 and PD-1. We believe CI8993 is the most advanced anti-VISTA antibody currently in clinical development, and we're pleased to announce that we have cleared the 0.6 milligram per kilogram dose level in our dose escalation study and are currently enrolling at the dose level of 1 mg per kg. We are hosting the second annual VISTA symposium this year on September 23rd. As with the Iraq for symposium. This will not be a forum for a curious data update the aim of the symposium is to address and advance topics of key interest to everyone in the Vista community. We look forward to providing a curious data update later this year. In summary, we're pleased with the progress we've made this quarter. We're excited to have Diantha on board, and we look forward to providing important updates on both Emma Vucertib and CIED 993 in the weeks and months ahead. With that, I'll turn the call over to Bill to review our financial results for the quarter.

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