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spk03: Good morning and welcome to QRIS's third quarter 2023 business update call. All participants will be in a 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 marks. All participants will have an opportunity to ask questions. To ask a question, you may press star followed by one on your touchtone phone. To withdraw your question, simply press star followed by two. Please note that this event is being recorded. I would now like to turn the conference over to Diantha Duvall, Curis' Chief Financial Officer. Diantha, please go ahead.
spk00: Thank you, and welcome to Curis' third quarter 2023 business update call. Before we begin, I'd like to encourage everyone to go to the investor section of our website at www.cures.com to find our third quarter 2023 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 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 Jonathan Zung, our Chief Development 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.
spk02: Thank you, Dantha. Good morning, everyone, and welcome to QRIS's third quarter business update call. This quarter marked a key inflection point for the company. and for patients as we were able to return our focus to clinical enrollment in our Take Aim Leukemia and Take Aim Lymphoma studies with the removal of the partial clinical hold. Later this morning, abstracts for the 65th ASH annual meeting will be unveiled, and we are pleased to have several abstracts under consideration. At ASH, we expect to provide an update from our Take Aim Lymphoma study including our first look at proof of concept data for patients with primary CNS lymphoma, a rare form of extranodal non-Hodgkin lymphoma for which there are limited treatment options. In the Take Aim Leukemia study, we have reopened our clinical sites and are working with them to identify and enroll new patients. As a reminder, the Take Aim Leukemia study is a monotherapy study targeting patients with relapsed or refractory AML with either a FLT3 or spliceosome mutation. Enrollment of new patients has begun, and we expect to have our first look at data from these patients in the first half of 2024. Lastly, we are working with clinical sites and regulatory authorities on advancing a new triplet study of emavucirtib in combination with azacitidine and venetoclax in AML. This study is intended to evaluate safety as well as emavucirtib's ability to enhance the effectiveness of azacitidine and venetoclax by studying AML patients who are responding to azacitidine and venetoclax treatment but still have minimal residual disease or MRD. Our hope is that with the addition of emavucirtib to their treatment regimen, we can help these patients convert from MRD positive status to MRD negative. We expect to initiate this study in the fourth quarter and see initial data in the second half of next year. In short, we're making great progress in advancing the potential of emavucirtib as a monotherapy, as a doublet therapy combining with ibrutinib, and as a triplet therapy in combination with azazitidine and venetoclax, all of which should have data over the coming four quarters. We look forward to providing those updates. With that, I'll turn the call back over to Diantha to review our financial results for the quarter. Diantha?
spk00: Thank you, Jim. For the third quarter of 2023, QRIS reported a net loss of $12.2 million, or $2.13 per share, as compared to a net loss of $13.3 million, or $2.83 per share, for the same period in 2022. QRIS reported a net loss of $35.7 million, or $6.96 per share for the nine months ended September 30, 2023, as compared to a net loss of $45.3 million, or $9.82 per share, for the same period in 2022. Revenues for the third quarters of 2023 and 2022 were both $2.8 million. Revenues for both periods consist of royalty revenues from Genentech and Roche's sales of Aravage. Revenues for the nine months ended September 30, 2023 and 2022 were both $7.3 million. Research and development expenses were $10.4 million for the third quarter of 2023, as compared to $10.8 million for the same period in 2022. The decrease in research and development expenses for the quarter is primarily attributable to lower employee-related costs due to reduction in headcount, partially offset by increased clinical costs. Research and development expenses were $29.5 million for the nine months ended September 30, 2023, as compared to $34.6 million for the same period in 2022. General and administrative expenses were $4.8 million for the third quarter of 2023, as compared to $4.6 million for the same period in 2022. The increase was primarily attributable to higher professional, legal, and consulting services costs, General administrative expenses were $13.8 million for the nine months ended September 30, 2023, as compared to $15.3 million for the same period in 2022. Other income net was $0.2 million for the third quarter of 2023, as compared to other expense net of $0.7 million for the same period in 2022. Other income and expense net primarily consists of interest income partially offset by non-cash expense related to the sale of future royalties. Other income net was $0.4 million for the nine months ended September 30, 2023, compared to other expense net of $2.5 million for the same period in 2022. As of September 30, 2023, QRIS's cash, cash equivalents, and investments totaled $68.5 million, and there were approximately 5.9 million shares of common stock outstanding. We continue to be in a strong cash position and expect that our existing cash, cash equivalents, and investments should enable us to maintain our planned operations into 2025. With that, I'd like to open the call for questions. Operator?
spk03: Thank you. Ladies and gentlemen, we'll now begin the question and answer session. Should you wish to ask a question, please press star followed by one on your touchtone phone. Should you wish to withdraw your question, please press star followed by two. Your first question comes from Yale Jen from Laidlaw and Company. Yale, please go ahead.
spk06: Good morning and thanks for taking the questions and congrats on the progress. Two questions here. The first question is that in terms of the ASH abstract you intend to present, could you give us a little bit color? You mentioned there's more than one, so what's the general context of that? Then I have a follow-up.
spk02: Thank you, Yael. I appreciate that. So we're going to defer most of the comments about the ASH abstract until the abstracts go live. However, what I would say is that we've got leukemia and lymphoma ongoing. The leukemia study really got started or restarted in July with the enrollment of new patients. So those data are really a 2024 story, not an ASH story. Lymphoma is really going to be the new data that are coming at ASH. And as we've talked about before, we have in the past looked at monotherapy and combination therapy. We've established our dose, and we've targeted the indication of primary CNS lymphoma as the ideal place for us to go. The reason we selected primary CNS was, as you recall, first, it's an orphan indication within lymphoma. So that means a relatively small number of patients would be needed on the regulatory path. Second, there's a very clear unmet need. There is an established benchmark for what ibrutinib looks like in monotherapy in primary CNS lymphoma. Ibrutinib attained a 19% CR rate. And then third, it really is going to establish what I hope to be A nice opportunity for us to demonstrate first whether we can be an additive benefit. Can we increase the CR rate by adding our drug to ibrutinib? But also, can we get CRs in patients who have progressed on VTK treatment? Can they be resensitized? That has always been the hypothesis for emavucirtib and IRAC4 inhibition. This will be the first time we can see data to see whether or not that's possible. So that would be my expectation for reviewing the data at ASH. Leukemia is a 2024 story. The ASH story is going to be lymphoma.
spk06: Okay, great. That's helpful. And the second question here is that you have mentioned earlier that before that high-risk MDS development will depend on what you see the but the sort of standard of care potentially could be established so you would set up the footing for doing that. And what's your current thoughts in terms of that aspect?
spk02: No, that's exactly right. And by standard of care, as you know, the standard of care in AML is the azazididine venetoclax doublet. Today, as we stand, the standard of care in MDS is azazididine monotherapy. The azacitidine venetoclax study is still pending. That's the Verona study. And those results presumably are imminent. So we're waiting to see, of course, if that study is positive or negative. If that study is positive and the doublet is also the standard of care in MDS, we'll want to proceed with a triplet. If, on the other hand, it's negative and azacitidine remains as monotherapy, the standard of care, then we would look to proceed with a doublet. Is that helpful?
spk06: Oh, absolutely. That's very, very helpful. And maybe a timeline you can sort of speculate at this point?
spk02: We don't run that study, so unfortunately, no. I mean, I think what the broader world is expecting is that it's sometime over the next few months, whether that's ASH or sometime in early 2024. Of course, we don't know any more than you do. But we are eagerly awaiting the outcome of those data.
spk06: Okay, great. That's very helpful. And again, congrats on the progress. I look forward to, you know, see things advance.
spk02: Thank you very much, Hale.
spk03: Your next question comes from Lee Waddock from Cantor Fitzgerald. Lee, please go ahead.
spk01: Hey, good morning. Thanks for taking our questions. Jim, maybe... Can you just frame the expectations for us a little bit for the data update in first half of next year, particularly in AML and MDS, what the bar will be?
spk02: Yeah. So in AML and MDS, it's going to be separate, right? So we are proceeding with monotherapy in patients in the relapsed refractory setting for FLT3 and and spliceosome patients. And MDS, as Yale asked about, we're really awaiting news of the Verona study to make sure we understand the path forward. In FLT3 and spliceosome, the benchmarks are pretty clear. FLT3 CR8 with giltaritinib, and giltaritinib, as you know, is the market leader for FLT3 inhibitors, is 12%. So, of course, we would look to want to improve on that. Their CRH rate was 22.6%. And, of course, we would want to improve on that. In spliceosome patients, it's not clear that there are any treatments capable of getting a CR rate. As far as I know, there's never been anything published. The only data in the literature addressing spliceosome patients is that they have the worst of the worst prognosis. So as you know, in relapsed refractory AML, the survival is unfortunately quite poor. Median survival in studies ranges from two to four months. And what we understand from the literature is that the lower end of that range is for the spliceosome patients. But as far as we know, nobody's ever demonstrated you can get a response. So in FLT3, what we're looking to do is can we improve upon FLT3 inhibitors as a class? with our FLT3-IRAC4-targeted molecule, M of assertive, and that would be beating a 12% CR rate or a 22.6% CR-CRH rate. And in spliceosome patients, it would be anything that would be greater than zero, presumably something north of 10 would be very exciting in that setting. Is that helpful? Okay.
spk01: Yes. And I have another question for the triplet patient. Do you think you need to do more dose work for the combination? And also, do you anticipate any drug-drug interaction with a triplet regimen?
spk02: Excellent question. So the answer to the second one of do we expect any DDI drug-drug interaction, I'd say we don't expect it. based on the work we've done in the lab and the clinical work we've done to date. We don't see that there's an overlapping safety profile. That said, of course, that's why you run the studies, to see whether or not that stays consistent. In terms of our expectation, could you remind me where you were headed with that first part of the question in the triplet?
spk01: Do you need to do more dose work?
spk02: Oh, that's right. So the answer to that is yes. I mean, our first foray into the triplet study, we're going to be evaluating both safety and efficacy. So we think we know the right dose. We certainly know the right dose for monotherapy. We think we have the right dose in combination with ibrutinib and venetoclax. But this will be the first time we've studied the triplet in the clinic of AZA and VEN and EMA. So I think based on the results of those, one of the things we're going to want to see is can we determine the appropriate dose and regimen for emosertib in that setting.
spk05: Any other questions, Lee?
spk01: No, that's great. Thank you. Excellent.
spk05: Thank you.
spk04: Your next question comes from Dane Leone from Raymond James. Dane, please go ahead.
spk03: He disconnected from the line. Your next question comes from AJ Rashid from Columbia Eagle.
spk04: AJ, please go ahead.
spk05: on the Oberlin dispute? That last one broke up.
spk02: Sorry about that. Are there any other questions in the queue?
spk03: Okay. It appears there are no further questions. So... This concludes our question and answer session. I'd like to turn the conference back over to the company's president and chief executive officer, James Dentzer, for any closing remarks.
spk02: Thank you, Colin, and thank you, everyone, for joining today's call. As always, thank you to the patients and families participating in our clinical trials, to our team at Curus for their tireless commitment and to our partners at Origin and the NCI for their ongoing help and support. We look forward to updating you again soon.
spk05: Colin?
spk04: Thank you. Ladies and gentlemen, this concludes your conference call for today.
spk03: We thank you for participating and ask that you please disconnect your lines.
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