11/9/2022

speaker
Operator
Conference Call Operator

Good afternoon and welcome to QRIS's third quarter 2022 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 touch-tone 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 Kyrus's Vice President of Investor Relations and Corporate Communications, Craig West. Please go ahead.

speaker
Craig West
Vice President of Investor Relations and Corporate Communications

Thank you, and welcome to Kyrus's third quarter 2022 business update call. Before we begin, I would like to encourage everyone to go to the investor section of our website at www.kyrus.com. to find our third 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, Diantha Duvall, Chief Financial 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.

speaker
Jim Denser
President and Chief Executive Officer

Thanks, Craig. Good afternoon, everyone, and welcome to QRIS's third quarter business update call. Every day, we strive to develop the next generation of first-in-class cancer therapies that that meaningfully improve and extend patients' lives. Earlier today, we announced that based on new data we have received in our Take Aim Leukemia study, we've made the decision to focus the company's resources on accelerating the path of bringing M of Assertive to patients. This focus on M of Assertive and the corresponding deprioritization of our other programs will enable a reduction of approximately 30% of the company's workforce and is expected to extend the company's cash runway into 2025. At this time, I'd like to acknowledge that while we are excited about the heightened focus of IMUFUSRTIB, we understand the impact of deprioritizing our other programs has on our valued colleagues and friends who worked on them. We're grateful for all of their hard work, and we wish them well as they pursue new opportunities. Let me turn now to discuss Emma Vucerte and the development activities going on to drive this important asset forward, starting with our recent accomplishments. During the quarter, we were pleased to announce that the FDA has approved the reopening of enrollment in our Take Aim studies in leukemia and lymphoma. Also in the quarter, we sponsored the first annual symposium on IRAC IV. This event brought together academic and industry experts to discuss the latest groundbreaking research in IRAC4. The event was well attended, informative, and frankly, it was a lot of fun to hear about all the great work going on in this important area of cancer biology. We were honored to make the event possible and to host so many of the brilliant pioneers advancing the science of IRAC4. This coming quarter, We'll be releasing new data in our Take Aim Leukemia Study of Emma Vucertib at the 64th Annual Meeting of the American Society of Hematology in New Orleans. These data will include 11 additional patients treated with monotherapy in our targeted populations, those patients whose disease harbors FLT3 or spliceosome mutations. These 11 new patients bring the total number of patients with targeted mutations to 24. As many of you know, there are currently no drugs approved for relapsed refractory AML or MDS patients post-treatment with HMA. The only published data available for the post-HMA setting are for MDS patients treated with chemotherapy, where an 8% ORR was observed. We're very excited to be developing what we hope will be a game-changing therapy for patients who face such a significant unmet need. As a reminder, emavucirtib is currently being evaluated in three separate 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. 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 emavucirtib in patients with lower-risk MDS. The Take Aim leukemia study is open for enrollment in monotherapy at the 200 milligram dose level. We plan to enroll at least nine more patients at this dose and discuss data from those patients with FDA. Provided we receive the agency's agreement in those discussions, we plan to reopen enrollment in the study's expansion arm as well as in a combination arm investigating emavucirtib with azazitidine or venetoclox. Staying with leukemia and MDS for a moment, we believe that the LUCAS study in lower-risk MDS could have a data readout in the first half of 2023. Recall that the LUCAS study is an investigator-sponsored study led by Dr. Uwe Platzbecker, chairman of EHA's scientific working group on MDS. We're excited to see what Emma Hussertib shows in this study. as spliceosome mutations are among the most prominent mutations in lower-risk MDS. In an exciting new and more recent development, we note that Curis will be presenting at CITSE right here in Boston later this week. This presentation will highlight an investigation of the immune modulation that occurs with IRAC4 inhibition in melanoma brain metastases. This is yet another example of the vibrant level of scientific research going on around IRAC4 and demonstrates that emavucirtib's potential quite possibly extends to solid tumors as well as leukemia and lymphoma. In summary, progress this quarter is highlighted by receiving FDA approval to reopen enrollment in both of the TAKE-AIM studies, convening the first IRAC4 symposium, announcing the release of new clinical data at ASH, and announcing the extension of the company's cash runway an additional year into 2025. It has been an eventful quarter, and we look forward to providing important updates on Emma Vucertib at CITSE, ASH, and at other events in the weeks and months ahead. With that, I'll turn the call over to Diantha to review our financial results for the quarter. Diantha?

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

-

-