NASDAQ:CRIS Curis Q3 2023 Earnings Report $2.41 -0.07 (-2.82%) Closing price 05/2/2025 04:00 PM EasternExtended Trading$2.44 +0.02 (+1.04%) As of 05/2/2025 07:28 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast Curis EPS ResultsActual EPS-$2.13Consensus EPS -$2.32Beat/MissBeat by +$0.19One Year Ago EPSN/ACuris Revenue ResultsActual Revenue$2.83 millionExpected Revenue$2.69 millionBeat/MissBeat by +$140.00 thousandYoY Revenue GrowthN/ACuris Announcement DetailsQuarterQ3 2023Date11/2/2023TimeN/AConference Call DateThursday, November 2, 2023Conference Call Time8:30AM ETUpcoming EarningsCuris' Q1 2025 earnings is scheduled for Tuesday, May 6, 2025, with a conference call scheduled at 8:30 AM ET. Check back for transcripts, audio, and key financial metrics as they become available.Q1 2025 Earnings ReportConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by Curis Q3 2023 Earnings Call TranscriptProvided by QuartrNovember 2, 2023 ShareLink copied to clipboard.There are 5 speakers on the call. Operator00:00:01The conference is now being recorded. Speaker 100:00:21Please 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. Operator00:00:34Thank you, and welcome to Curis' Q3 2023 business update call. Before we begin, I'd like to encourage everyone to go to the Investors section of our website at www.curis.com to find our Q3 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. Operator00:01:11Joining me on today's call are Jim Dentzer, 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. Speaker 200:01:27Thank you, Dantha. Good morning, everyone, and welcome to Curis' 3rd 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 TAKAYAME leukemia and TAKAYAME 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. Speaker 200:02:19In the TAKING leukemia study, We have reopened our clinical sites and are working with them to identify and enroll new patients. As a reminder, The taking 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 twenty twenty four. Lastly, we are working with clinical sites and regulatory authorities on advancing a new triplet study of emavusertib in combination with azacitidine and venetoclax in AML. This study is intended to evaluate safety as well as emilversertib'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. Speaker 200:03:23Our hope is that with the addition of emilucertib 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 4th quarter and see initial data in the second half of next year. In short, we're making great progress in advancing the potential of emabusertib as a monotherapy, as a doublet therapy combining with Ibrutinib and as a triplet therapy in combination with azacitidine and venetoclax, all of which should have data over the coming 4 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. Speaker 200:04:10Diantha? Operator00:04:11Thank you, Jim. For the Q3 of 2023, Curis reported a net loss of $12,200,000 or 2 $300,000 or $2.83 per share for the same period in 2022. Curis reported a net loss of $35,700,000 Or $6.96 per share for the 9 months ended September 30, 2023 as compared to a net loss of 45,300,000 or $9.82 per share for the same period in 2022. Revenues for the 3rd quarters of 20 3 and 2022 were both $2,800,000 Revenues for both periods consist of royalty revenues from Genentech, Genentech and Roche's sales of Erivedge. Revenues for the 9 months ended September 30, 2023, 2022 were both $7,300,000 Research and development expenses were $10,400,000 for the Q3 of 2023 as compared to $10,800,000 for the same period in 2022. Operator00:05:15The decrease in research and development expenses for the quarter is primarily attributable to lower employee related costs due to a reduction in headcount, partially offset by increased clinical costs. Research and development expenses were $29,500,000 for the 9 months ended September 30, 2023, as compared to $34,600,000 for the same period in 2022. General and administrative expenses were 4 $8,000,000 for the Q3 of 2023 as compared to $4,600,000 for the same period in 2022. The increase was primarily attributable to higher professional, legal and consulting services costs. General and administrative expenses were $13,800,000 for the 9 months ended September 30, 2023 as compared to $15,300,000 for the same period in 2022. Operator00:06:06Other income net was $200,000 for the Q3 of 2023 as compared to other expense net of $700,000 for the same period in 2022. Other income and expense net primarily consists of interest income partially offset by non cash expense related sale of future royalties. Other income net was $400,000 for the 9 months ended September 30, 2023 Compared to other expense net of $2,500,000 for the same period in 2022. As of September 30, 2023, Curis' cash, cash equivalents and investments totaled $68,500,000 and there were approximately 5,900,000 shares of On the 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. Operator00:07:01With that, I'd like to open the call for questions. Speaker 100:07:22Your first question comes from Yale Jen from Laidlaw and Company. Yale, please go ahead. Speaker 300:07:29Good 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 1. So what's the general context of that? Then I have a follow-up. Speaker 200:07:56Yes. So thank you, Yale. I appreciate that. So we Speaker 100:08:00are going to defer most Speaker 200:08:01of the comments about the ASH abstract until the abstracts go live. However, what I would say is that we have 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. Speaker 200:08:28And 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, 1st, it's an orphan indication within lymphoma. So that means a relatively small number of patients would be needed on the regulatory path. 2nd, there is a very clear unmet need. Speaker 200:09:02There is an Established benchmark for what Ibrutinib looks like in monotherapy in primary CNS lymphoma. Ibrutinib attained a 19% CR rate. And then 3rd, 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 BTK treatment. Can they be resensitized? Speaker 200:09:42That has always been the hypothesis for emavucertib 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. Speaker 300:10:01Okay, great. That's helpful. And the second question here is that you have mentioned earlier that Before that, high risk and MDS development Well, it depends on what you see, what the sort of standard of care potentially could be established. So you will set up the footing for doing that. And what's your current thoughts in terms of that aspect? Speaker 200:10:32No, that's exactly right. So and by standard of care, As you know, the standard of care in AML is the azacitidine venetoclax doublet. Today, as we stand, the standard of Karen MDS is azacitidine monotherapy. The azacitidine venetoclax study is still pending. That's the VIRONA study and those results presumably are imminent. Speaker 200:10:59So we are 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? Speaker 300:11:22Absolutely. That's very, very helpful. And maybe Any timeline you can sort of speculate at this point? Speaker 200:11:33We 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. Speaker 300:11:54Okay, great. That's very helpful. And again, congrats on the progress and look forward to see things at Edge. Speaker 100:12:06Your next question comes from Leigh Whatek from Cantor Fitzgerald. Lee, please go ahead. Speaker 400:12:12Hey, 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? Speaker 200:12:31Yes. 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 spliceosome patients. And MDS as Yale asked about, we are really awaiting news of the VIRONA study to make sure we understand the path forward. In FLT3 And spliceosome, the benchmarks are pretty clear. Speaker 200:13:03FLT3 CR8 with gilteritinib and gilteritinib 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. Speaker 200:13:33The only data in the literature addressing spliceosome patients is that they have the worst of the worst Prognosis. So as you know, in relapsedrefractory AML, the survival is unfortunately quite poor. Median survival in studies ranges from 2 to 4 months. And what we understand From the literature is that the lower end of that range is for the splice of some patients. But as far as we know, nobody has ever demonstrated you can get a response. Speaker 200:14:03So in FLT3, What we're looking to do is can we improve upon FLT3 inhibitors as a class with our FLT3 IRAK4 Targeting molecule, emoVosertib and that would be beating a 12% CR rate or a 22.6% CRH rate. And in spliceosome patients, it would be anything that would be greater than 0 that presumably something north of 10 would be very exciting in that setting. Is that helpful? Speaker 400:14:34Okay. Yes. And I have another question for the triplet. Do you think you need to do more dose work for the combination? And also do you anticipate any drug drug Interaction with the triplet regimen? Speaker 200:14:54Excellent 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 is an overlapping safety profile. That said, of course, that's why you run the studies to see whether or not that stays consistent. Speaker 200:15:16In terms of our expectation, could you remind me where you were headed with that first part of the question In the triplet? Speaker 400:15:25Do you need to do more dose work? Speaker 200:15:28That'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. Speaker 200:15:47We 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 Emma. 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 Dosing regimen for emulsertib in that setting. Any other questions, Leigh? Speaker 400:16:24No, that's great. Thank you. Speaker 200:16:26Excellent. Thank you. Speaker 100:16:28Your next question comes from Dane Leone from Speaker 200:16:35Raymond Speaker 300:16:38James. Speaker 100:16:44He disconnected from the line. Your next question comes from A. J. Rashid from Columbia Eagle. A. Speaker 100:16:52J, please go ahead. Speaker 200:16:58On the Overland dispute? That last one broke up. I'm sorry about that. Are there any other questions in the queue? Speaker 100:17:13Okay. 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 Fenzer, for any closing remarks. Speaker 200:17:31Thank 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 Curis for their tireless commitment and to our partners at Aurigene and the NCI for their ongoing help and support. We look forward to updating you again soon. Colin? Speaker 100:17:54Thank you. Ladies and gentlemen, this concludes your conferenceRead morePowered by Conference Call Audio Live Call not available Earnings Conference CallCuris Q3 202300:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) Curis Earnings HeadlinesCuris (CRIS) Expected to Announce Earnings on TuesdayMay 5 at 3:06 AM | americanbankingnews.comFY2025 EPS Estimates for Curis Boosted by Cantor FitzgeraldMay 4 at 3:15 AM | americanbankingnews.comHere’s How to Claim Your Stake in Elon’s Private Company, xAIEven though xAI is a private company, tech legend and angel investor Jeff Brown found a way for everyday folks like you… To partner with Elon on what he believes will be the biggest AI project of the century… Starting with as little as $500.May 5, 2025 | Brownstone Research (Ad)Curis (NASDAQ:CRIS) Earns Hold Rating from Analysts at StockNews.comMay 3 at 1:49 AM | americanbankingnews.comFinancial Analysis: Curis (NASDAQ:CRIS) vs. Gene Biotherapeutics (OTCMKTS:CRXM)May 1, 2025 | americanbankingnews.comCuris to Report First Quarter 2025 Financial and Operating Results and Host Conference Call and Webcast on May 6, 2025April 29, 2025 | prnewswire.comSee More Curis Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Curis? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Curis and other key companies, straight to your email. Email Address About CurisCuris (NASDAQ:CRIS), a biotechnology company, engages in the discovery and development of drug candidates for the treatment of human cancers in the United States. Its clinical stage drug candidates include Emavusertib, an oral small molecule IRAK4 kinase inhibitor, which is in a Phase 1/2 open-label, single arm expansion trial in patients with relapsed or refractory, or R/R, AML and high-risk myelodysplastic syndromes. The company's pipeline also includes Fimepinostat, an oral dual inhibitor of HDAC and PI3K enzymes for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma; CA-170, an oral, small molecule antagonist designated as CA-170 that selectively targets PD-L1 and VISTA; and CA-327, an oral, small molecule, TIM3/PD-L1, which is a molecule antagonist of PD-L1 and TIM3. It has collaboration agreement with Genentech Inc., or Genentech and F. Hoffmann-La Roche Ltd, or Roche, for the commercialization of Erivedge, an orally-administered small molecule hedgehog signaling pathway antagonist for the treatment of advanced basal cell carcinoma, or BCC; Aurigene Discovery Technologies Limited for the discovery, development, and commercialization of small molecule compounds in the areas of immuno-oncology and precision oncology; and also licensed four programs under the Aurigene collaboration, including emavusertib. Curis, Inc. was incorporated in 2000 and is headquartered in Lexington, Massachusetts.View Curis ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Amazon Earnings: 2 Reasons to Love It, 1 Reason to Be CautiousMeta Takes A Bow With Q1 Earnings - Watch For Tariff Impact in Q2Palantir Earnings: 1 Bullish Signal and 1 Area of ConcernVisa Q2 Earnings Top Forecasts, Adds $30B Buyback PlanMicrosoft Crushes Earnings, What’s Next for MSFT Stock?Qualcomm's Earnings: 2 Reasons to Buy, 1 to Stay AwayAMD Stock Signals Strong Buy Ahead of Earnings Upcoming Earnings Advanced Micro Devices (5/6/2025)American Electric Power (5/6/2025)Constellation Energy (5/6/2025)Marriott International (5/6/2025)Energy Transfer (5/6/2025)Mplx (5/6/2025)Brookfield Asset Management (5/6/2025)Arista Networks (5/6/2025)Duke Energy (5/6/2025)Zoetis (5/6/2025) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. 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There are 5 speakers on the call. Operator00:00:01The conference is now being recorded. Speaker 100:00:21Please 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. Operator00:00:34Thank you, and welcome to Curis' Q3 2023 business update call. Before we begin, I'd like to encourage everyone to go to the Investors section of our website at www.curis.com to find our Q3 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. Operator00:01:11Joining me on today's call are Jim Dentzer, 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. Speaker 200:01:27Thank you, Dantha. Good morning, everyone, and welcome to Curis' 3rd 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 TAKAYAME leukemia and TAKAYAME 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. Speaker 200:02:19In the TAKING leukemia study, We have reopened our clinical sites and are working with them to identify and enroll new patients. As a reminder, The taking 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 twenty twenty four. Lastly, we are working with clinical sites and regulatory authorities on advancing a new triplet study of emavusertib in combination with azacitidine and venetoclax in AML. This study is intended to evaluate safety as well as emilversertib'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. Speaker 200:03:23Our hope is that with the addition of emilucertib 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 4th quarter and see initial data in the second half of next year. In short, we're making great progress in advancing the potential of emabusertib as a monotherapy, as a doublet therapy combining with Ibrutinib and as a triplet therapy in combination with azacitidine and venetoclax, all of which should have data over the coming 4 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. Speaker 200:04:10Diantha? Operator00:04:11Thank you, Jim. For the Q3 of 2023, Curis reported a net loss of $12,200,000 or 2 $300,000 or $2.83 per share for the same period in 2022. Curis reported a net loss of $35,700,000 Or $6.96 per share for the 9 months ended September 30, 2023 as compared to a net loss of 45,300,000 or $9.82 per share for the same period in 2022. Revenues for the 3rd quarters of 20 3 and 2022 were both $2,800,000 Revenues for both periods consist of royalty revenues from Genentech, Genentech and Roche's sales of Erivedge. Revenues for the 9 months ended September 30, 2023, 2022 were both $7,300,000 Research and development expenses were $10,400,000 for the Q3 of 2023 as compared to $10,800,000 for the same period in 2022. Operator00:05:15The decrease in research and development expenses for the quarter is primarily attributable to lower employee related costs due to a reduction in headcount, partially offset by increased clinical costs. Research and development expenses were $29,500,000 for the 9 months ended September 30, 2023, as compared to $34,600,000 for the same period in 2022. General and administrative expenses were 4 $8,000,000 for the Q3 of 2023 as compared to $4,600,000 for the same period in 2022. The increase was primarily attributable to higher professional, legal and consulting services costs. General and administrative expenses were $13,800,000 for the 9 months ended September 30, 2023 as compared to $15,300,000 for the same period in 2022. Operator00:06:06Other income net was $200,000 for the Q3 of 2023 as compared to other expense net of $700,000 for the same period in 2022. Other income and expense net primarily consists of interest income partially offset by non cash expense related sale of future royalties. Other income net was $400,000 for the 9 months ended September 30, 2023 Compared to other expense net of $2,500,000 for the same period in 2022. As of September 30, 2023, Curis' cash, cash equivalents and investments totaled $68,500,000 and there were approximately 5,900,000 shares of On the 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. Operator00:07:01With that, I'd like to open the call for questions. Speaker 100:07:22Your first question comes from Yale Jen from Laidlaw and Company. Yale, please go ahead. Speaker 300:07:29Good 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 1. So what's the general context of that? Then I have a follow-up. Speaker 200:07:56Yes. So thank you, Yale. I appreciate that. So we Speaker 100:08:00are going to defer most Speaker 200:08:01of the comments about the ASH abstract until the abstracts go live. However, what I would say is that we have 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. Speaker 200:08:28And 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, 1st, it's an orphan indication within lymphoma. So that means a relatively small number of patients would be needed on the regulatory path. 2nd, there is a very clear unmet need. Speaker 200:09:02There is an Established benchmark for what Ibrutinib looks like in monotherapy in primary CNS lymphoma. Ibrutinib attained a 19% CR rate. And then 3rd, 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 BTK treatment. Can they be resensitized? Speaker 200:09:42That has always been the hypothesis for emavucertib 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. Speaker 300:10:01Okay, great. That's helpful. And the second question here is that you have mentioned earlier that Before that, high risk and MDS development Well, it depends on what you see, what the sort of standard of care potentially could be established. So you will set up the footing for doing that. And what's your current thoughts in terms of that aspect? Speaker 200:10:32No, that's exactly right. So and by standard of care, As you know, the standard of care in AML is the azacitidine venetoclax doublet. Today, as we stand, the standard of Karen MDS is azacitidine monotherapy. The azacitidine venetoclax study is still pending. That's the VIRONA study and those results presumably are imminent. Speaker 200:10:59So we are 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? Speaker 300:11:22Absolutely. That's very, very helpful. And maybe Any timeline you can sort of speculate at this point? Speaker 200:11:33We 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. Speaker 300:11:54Okay, great. That's very helpful. And again, congrats on the progress and look forward to see things at Edge. Speaker 100:12:06Your next question comes from Leigh Whatek from Cantor Fitzgerald. Lee, please go ahead. Speaker 400:12:12Hey, 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? Speaker 200:12:31Yes. 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 spliceosome patients. And MDS as Yale asked about, we are really awaiting news of the VIRONA study to make sure we understand the path forward. In FLT3 And spliceosome, the benchmarks are pretty clear. Speaker 200:13:03FLT3 CR8 with gilteritinib and gilteritinib 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. Speaker 200:13:33The only data in the literature addressing spliceosome patients is that they have the worst of the worst Prognosis. So as you know, in relapsedrefractory AML, the survival is unfortunately quite poor. Median survival in studies ranges from 2 to 4 months. And what we understand From the literature is that the lower end of that range is for the splice of some patients. But as far as we know, nobody has ever demonstrated you can get a response. Speaker 200:14:03So in FLT3, What we're looking to do is can we improve upon FLT3 inhibitors as a class with our FLT3 IRAK4 Targeting molecule, emoVosertib and that would be beating a 12% CR rate or a 22.6% CRH rate. And in spliceosome patients, it would be anything that would be greater than 0 that presumably something north of 10 would be very exciting in that setting. Is that helpful? Speaker 400:14:34Okay. Yes. And I have another question for the triplet. Do you think you need to do more dose work for the combination? And also do you anticipate any drug drug Interaction with the triplet regimen? Speaker 200:14:54Excellent 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 is an overlapping safety profile. That said, of course, that's why you run the studies to see whether or not that stays consistent. Speaker 200:15:16In terms of our expectation, could you remind me where you were headed with that first part of the question In the triplet? Speaker 400:15:25Do you need to do more dose work? Speaker 200:15:28That'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. Speaker 200:15:47We 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 Emma. 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 Dosing regimen for emulsertib in that setting. Any other questions, Leigh? Speaker 400:16:24No, that's great. Thank you. Speaker 200:16:26Excellent. Thank you. Speaker 100:16:28Your next question comes from Dane Leone from Speaker 200:16:35Raymond Speaker 300:16:38James. Speaker 100:16:44He disconnected from the line. Your next question comes from A. J. Rashid from Columbia Eagle. A. Speaker 100:16:52J, please go ahead. Speaker 200:16:58On the Overland dispute? That last one broke up. I'm sorry about that. Are there any other questions in the queue? Speaker 100:17:13Okay. 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 Fenzer, for any closing remarks. Speaker 200:17:31Thank 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 Curis for their tireless commitment and to our partners at Aurigene and the NCI for their ongoing help and support. We look forward to updating you again soon. Colin? Speaker 100:17:54Thank you. Ladies and gentlemen, this concludes your conferenceRead morePowered by