Good afternoon, and welcome to Curis' 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 touchtone 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 Curis' Vice President of Investor Relations and Corporate Communications, Craig West. Please go ahead. Thank you, and welcome to Curis' 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.curis.com to find our third quarter of 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 Dentzer, President and Chief Executive Officer, Diantha Duvall, Chief Financial Officer, and Bob Martell, 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. Thanks, Craig. Good afternoon, everyone, and welcome to Curis' third quarter business update call. Every day, we strive to develop the next generation of first-in-class cancer therapies 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 emavusertib to patients. This focus on emavusertib 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 emavusertib, 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 emavusertib 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 IRAK4. This event brought together academic and industry experts to discuss the latest groundbreaking research in IRAK4. 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 IRAK4. This coming quarter, we'll be releasing new data in our Take Aim Leukemia study of emavusertib 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, emavusertib is currently being evaluated in three separate clinical studies. First, the Take Aim Leukemia study, a phase 1/2 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 1/2 combination study with ibrutinib for patients with relapsed or refractory NHL and other hematologic malignancies. Third, the phase 2 LUCAS study evaluating emavusertib in patients with lower risk MDS. The Take Aim Leukemia study is open for enrollment in monotherapy at the 200 mg 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 emavusertib with azacitidine or venetoclax. 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 emavusertib 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 SITC right here in Boston later this week. This presentation will highlight an investigation of the immune modulation that occurs with IRAK4 inhibition in melanoma brain metastases. This is yet another example of the vibrant level of scientific research going on around IRAK4 and demonstrates that emavusertib'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 IRAK4 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 emavusertib at SITC, 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? Thank you, Jim. Curis today has a strong foundation, both operationally and financially, to allow us to concentrate on emavusertib development. For the third quarter of 2022, Curis reported a net loss of $13.3 million or $0.14 per share, as compared to a net loss of $11.1 million or $0.12 per share for the same period in 2021. Curis reported a net loss of $45.3 million or $0.49 per share for the nine months ended September 30, 2022, as compared to a net loss of $31.8 million or $0.35 per share for the same period in 2021. Revenues for the third quarters of 2022 and 2021 were $2.8 million and $3 million, respectively. Revenues for the nine months ended September 30, 2022 and September 30, 2021 were $7.3 million and $7.5 million, respectively. Operating expenses for the third quarter of 2022 were $15.4 million, as compared to $13.1 million for the same period in 2021. Operating expenses for the nine months ended September 30, 2022 were $50.1 million, as compared to $37 million for the same period in 2021, and consist of the following. Cost of royalty revenues, which is comprised of amounts due to third party university patent licensors in connection with Genentech and Roche's Erivedge net sales were $0.1 million for the third quarter of 2022 as compared to $0.2 million for the same period in 2021. Cost of royalty revenues for the nine months ended September 30, 2022 were $0.2 million, as compared to $0.4 million for the same period in 2021. Research and development expenses were $10.8 million for the third quarter of 2022, as compared to $8.6 million for the same period in 2021. The increase in research and development expenses for the quarter is primarily attributable to increased personnel and consulting costs, partially offset by decreased manufacturing and clinical development costs. Research and development expenses were $34.6 million for the nine months ended September 30, 2022, as compared to $24.1 million for the same period in 2021. General and administrative expenses were $4.6 million for the third quarter ended September thirtieth, 2022, as compared to $4.3 million for the same period in 2021. The increase in general and administrative expenses was driven primarily by the timing of costs. General and administrative expenses were $15.3 million for the nine months ended September thirtieth, 2022, as compared to $12.5 million for the same period in 2021. For the third quarter of 2022 and 2021, total other expense was $0.7 million and $1 million, respectively. Other expense primarily consisted of imputed interest related to the future royalty payments, partially offset by interest income. Other expense was $2.5 million for the nine months ended September thirtieth, 2022, as compared to $2.3 million for the same period in 2021. As of September 30, 2022, Curis' cash equivalents, and investments totaled $98.7 million, and there were approximately 96.4 million shares of common stock outstanding. We are in a strong cash position and expect that our existing 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? We will now begin the question and answer session. To ask a question, you may press star then one on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. Our first question is from Ed White with H.C. Wainwright & Co. Please go ahead. Good afternoon. Thanks for taking my questions. A couple of questions on the headcount reduction. Is the impact going to be felt more on the G&A or the R&D expense line? Should we be seeing the impact starting in the fourth quarter, or is this gonna be really a 2023 event for the impact on expenses? Yeah. Thanks, Ed. First, thanks for taking the question. The impact is really, it's across the company, and it is both G&A and R&D. Obviously, it starts with everything that's not directly related to emavusertib. We are absolutely concentrating all of our resources towards emavusertib, and therefore, anything that wasn't directly related was something that we could live without. If we could live without, and that extended our cash runway without having to do anything else, I mean, this is the luxury of starting with such a strong balance sheet that we have this flexibility. With these data in, it becomes increasingly clear that this is a drug, and this needs to get to NDA submission with haste. We're gonna dedicate and redouble all of our efforts to make that happen and insulate ourselves from the need to raise money in the meantime. Yeah, broad-based across G&A and R&D. There will be some impact in Q4, but it's really as you look out over the full two-year period that follows that you'll see that that cash runway impact. Okay. Thanks, Jim. I'm just curious with the VISTA program. Will we be seeing more data from CI-8993? What's going to happen to patients that are currently enrolled, if there are any? And are you looking at this as just halting the program for now, or is this something that you might want to partner or out-license for someone else to bring forward? Yeah. I think of this as more of a pause or suspension of activity. We're not enrolling new patients in that study. As you know, we love the VISTA target. I think it's fantastic. In a world where you've got two programs in the clinic, and one of them has really not just proven data that it shows it works consistently from theory to lab to clinic, but you now have a new batch of clinical data that shows you've got an eye to NDA, and then the other program is still in dose escalation. If you can't afford to do both, boy, the decision's clear. You go with the one that's got the proven data. I love VISTA as a target, but we need to take the effort and the money and the people that are dedicated to that program right now and be laser-focused on emavusertib. Okay, that makes sense. Thanks for taking my questions. Sure. Thank you. The next question is from Sumit Roy with Jones Research. Please go ahead. Hi, everyone. Congrats on all the progress. A quick one on the expected ASH data from the monotherapy and the combo arm. Could you give us any color on what kind of duration of drug these patients will be? Is it just 28 days or a little longer than that since you just started enrolling? Yeah. It's a little longer than that, and it includes data for some patients. As you may remember, we were put on clinical hold last spring, so we had some patients that had just started the study before the FDA halted enrollment of new patients. We've got the data is related to those patients incrementally. I do think, obviously, it's a significant add to the data set. It's almost doubling the number of patients we've got with a target mutation, so I think it's a very meaningful update. Really looking forward to talking about the results of how those patients are doing when we get to ASH. The venetoclax combo arm, that started recently right there. That started, again, before the FDA hold. Any patients that were started, if you dosed drug, for sake of argument, 24 hours before the hold came in, you stayed on drug. The FDA didn't ask us to take people off drug. They just said, "Don't put more on." We had already started putting patients on combination therapy. As you can imagine, investigators are really excited about combo therapy and monotherapy with this program. Anybody that started the study shortly before the FDA told us to stop adding new ones was able to stay on study, and we've got five of those patients that we're gonna talk about at ASH. Great. This is really helpful. One last question. If you can provide any color, like what are you seeing these new patients are being more spliceosome mutant patient, or are you seeing more FLT3 mutant patient getting enrolled? Yeah. I wanna be a little cautious about saying too much about the data before we get to ASH. I'd just say that, look, you know, we are really excited about this program. This is the first new target identified in AML and MDS in years. Not only is it the newest target, but coincidentally, it's the largest target. It looks like every patient or virtually every patient across the spectrum of AML and MDS overexpresses that long isoform of IRAK4, and at least half the population has a very heavy overexpression of that kinase. We expect that the excitement's gonna continue as long as the data stay consistent, theory to lab to clinic, that if you have lots of IRAK4 long, monotherapy should be sufficient to knock it down and knock it down hard. If you have a little bit of IRAK4-L, it's still a driver of disease, it's simply not the only driver of disease. Those will be the patients that benefit from combo therapy. We're gonna see that as we moved from theory to the lab, the data were really consistent and attractive. Now that we've doubled the data set in our targeted population, have we been able to maintain that level of consistency in the data? Should the you know excitement be building not just at the company and among investors, but frankly among physicians and patients? That's what we're eager to talk about when we get to ASH. Great. Thank you so much for taking the questions. Yeah. Again, if you have a question, please press Star then one. The next question is from Li Watsek with Cantor Fitzgerald. Please go ahead. Hi. Thank you for taking my question. Quick one on ASH. For the 11 additional enrolled patients, by the time of the presentation, could you give us a sense of how many you'd be able to get a potential efficacy read on? I know it's a little early. Thank you, Lee, first for the question. We're gonna be talking about efficacy for all 11 patients. We're gonna be looking at an efficacy pool of 24 patients with a targeted mutation. Obviously we consider this a significant and meaningful update. And as I said, we're really excited about doing it. Stay tuned. Great. Thank you. Just one follow-up. When do you think you'd potentially be able to go back to the FDA with these new patient data and then discuss the next steps for emavusertib? Yeah, it's a great question. You know, let's step back in time just as a reminder. When the FDA put us on hold in the spring, they had three fundamental questions. The first one was, there was a patient who died, and they wanted to make sure that that wasn't an issue with the drug or the study in any way. Second, they knew that we had an early signal. It was rare, but a signal in CPK elevation in rhabdo. They wanted to make sure that wasn't a problem in the index patient, in the patient death or in any other patient. Make sure that they didn't need to change our protocol in any way. Are we identifying and managing CPK elevation in rhabdo appropriately? Third, they asked us about dose, Project Optimus. Mm-hmm. Which dose is the right dose to take into recommended phase 2. We were able over the course of the summer, and we said this in the beginning, and I'm glad, of course, to be able to say now that it worked out that way. The FDA was gonna get comfortable as we were, as they learned more about the patient death, that this is a patient with a relapsed refractory AML, who had a life expectancy of 2.3 months in the literature. That patient died in month 9. Our view would be that patient. The question shouldn't be why did the patient die? The question should be how did that patient get to month 9? The answer is, of course, the drug. The patient eventually did progress, and the FDA, of course, got comfortable with that as they reviewed more data. The second question was on CPK elevation in rhabdo. We do know it is rare to see it in our study, but we do see it. We do know that our drug can exacerbate a CPK elevation in some patients. We do know that there are confounding factors, and we were able to identify them in the data with FDA. If you're on a statin, if you're on a fibrate, if you're a heavy exerciser, you will see CPK elevation. But we know exactly what to look for. The protocol has really good language for identifying it, training the patients, doing blood draws to see if there is a CPK elevation, and the procedures are in the protocol for managing effectively. We didn't have any patients have a renal complication, which was obviously terrific. The FDA reviewed all of our procedures and all of our data and of course got comfortable with that as well. It was the last question on dose, and this is really getting to answer your question directly, that the FDA was able to focus on the most and would involve most of the discussion. In the context of Project Optimus, where the FDA wants to know and be involved in which dose moves forward in drug studies, emavusertib represents an ideal drug for that purpose. We studied and cleared, for safety purposes, 200 milligrams, 300 milligrams, and 400 milligrams, and all three dose levels got responses. That's the perfect place for FDA to want to sink their teeth in. Now, we came back suggesting that between 300 and 400, there was no efficacy increase, but there was a risk that there might be some off-target effect. We were saturating the target at 300, so it didn't make sense to go to 400. 300 was better between those two. Between 200 and 300, we feel as though when we run our exposure analyses, there's a higher probability of getting a response at 300 milligrams, and therefore 300 is better than 200. The FDA said, "Okay, we appreciate the logic. That makes sense. We'd just like to see a few more patients at that lowest dose level to make sure we agree. The negotiation with FDA was all about how many more patients do you need to be able to see to help us decide, is 200 or 300 the appropriate recommended phase 2 dose? We agreed on the number 9. We're gonna spend the next, you know, this quarter of course, now that we're open for enrollment. The blocking and tackling is in process of getting all of our sites open. Then of course we're gonna quickly move into enrolling those 9 additional patients. My hope would be that, you know, sometime early to mid next year, we've got those patients on study, we can run the analyses on them, build the briefing book and have that discussion with FDA. One of two outcomes is going to happen. Either the data's gonna come back exactly the way we thought and the way the early data suggested, and 300's our dose and FDA will agree, or frankly, we're wrong, and when we put 9 more patients on at 200 milligrams, we get a bunch of CRs at 200 milligrams, in which case, you know what? The FDA turned out to be right, or at least the question turned out to be valid. We will then move forward with 200 milligrams as our dose. We should know that sometime by mid-next year would be my guess. Right. Great. Great. It was a really long answer, but I wanted to make sure to address it thoroughly. Did that help? No. Thank you. Yes. Appreciate that very much. Thank you. Good. Okay. Thank you. This concludes our question and answer session. I would like to turn the conference back over to the company's President and Chief Executive Officer, James Dentzer, for any closing remarks. Excellent. Thank you, operator. Thank you everyone for today 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 hard work and commitment, and to our partners at Aurigene, ImmuNext, and the NCI for their ongoing help and support. We look forward to updating you again soon. Thanks, Gary. Thank you. The conference is now concluded. Thank you again for your participation. You may now disconnect.