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spk09: Good morning and welcome to the QRIS fourth 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, all 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 2. Please note this event is being recorded. I would now like to turn the conference over to Diantha Duvall, QRIS's Chief Financial Officer. Diantha, please go ahead.
spk07: Thank you. And welcome to the QRIS fourth 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.cures.com to find our fourth quarter 2022 business update 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 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 like now to turn the call over to Jim.
spk05: Thank you, Diantha. Good morning, everyone, and welcome to QRIS's fourth quarter business update call. This past quarter, we made important progress with our lead clinical candidate, Emma Vucerted. which is currently being evaluated in two clinical studies. 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. And the Take Aim Lymphoma Study, a Phase I-II combination study with ibrutinib for patients with relapsed or refractory NHL and other hematologic malignancies. We were especially pleased to present an update of clinical data from the Take Game Leukemia Study, in which AML patients with a FLT3 mutation had a CR rate of 29%. AML patients with a spliceosome mutation had a CR-CRH rate of 22%, and MDS patients with a spliceosome mutation had an overall response rate of 45%, with all five responses achieving a marrow-complete remission. This update doubled the size of our earlier data set and reaffirmed emavucirtib's potential to be an important therapeutic alternative for patients with AML or MDS. We've also made important progress in our work to resolve the partial clinical hold on our leukemia study. In last quarter's call, we announced that the FDA had approved the reopening of our clinical sites so that we could enroll nine additional patients at the 200 milligram dose level to facilitate discussions with FDA on the recommended phase 2 dose, or RP2D, and the resolution of the partial clinical hold. We're pleased to announce today that we have completed the reopening of our sites and have also completed the enrollment of the nine additional patients requested by FDA. This is ahead of schedule and we believe reflects the excitement surrounding this novel therapeutic and the critical unmet need in this sorely underserved patient population. We expect to collect data for these patients in Q2 and meet with FDA in Q3 to review those data. We also continue to enroll in our Take Aim lymphoma study, in which we are focusing on primary CNS lymphoma and treating patients with the combination of emavucirtib and ibrutinib. In short, we had a very productive end of 2022. and that momentum is carried forward into 2023. We look forward to working with the FDA in the months ahead to gain alignment on RP2D in our Take Aim leukemia study and resolution of the partial clinical hold. With that, I'll turn the call back over to Diantha to review our financial results for the quarter. Diantha?
spk07: Thank you, Jim. For the fourth quarter of 2022, CURES reported a net loss of $11.3 million, or $0.12 per share, as compared to a net loss of $13.6 million or $0.15 per share for the same period in 2021. CURES reported a net loss of $56.7 million or $0.61 per share for the 12 months ended December 31, 2022 as compared to a net loss of $45.4 million or $0.50 per share for the same period in 2021. Revenues for the fourth quarters of 2022 and 2021 were $2.9 million and $3.1 million respectively. Revenues for the 12 months ended December 31, 2022 and December 31, 2021 were $10.2 million and $10.6 million respectively. Operating expenses for the fourth quarter of 2022 were $13.1 million as compared to $15.7 million for the same period in 2021. Operating expenses for the 12 months ended December 31, 2022 were $63.2 million as compared to $52.7 million for the same period in 2021 and consisted of the following. Royalty revenues, which comprised amounts due to third-party university patent licensors in connection with the Genentech and Roche AeroVeg net sales, were $0.1 million for the fourth quarter of 2022 as compared to $0.2 million for the same period in 2021. Cost of royalty revenues for the 12-month end of December 31, 2022 were $0.3 million as compared to $0.5 million for the same period in 2021. Research and development expenses were $8.7 million for the fourth quarter of 2022 as compared to $10.8 million for the same period in 2021. The decrease in research and development expense for the quarter is primarily attributable to decreased personnel, manufacturing, and clinical development costs, Research and development expenses were $43.3 million for the 12 months ended December 31, 2022, as compared to $34.9 million for the same period in 2021. General and administrative expenses were $4.3 million for the fourth quarter ended December 31, 2022, as compared to $4.8 million for the same period in 2021. The decrease in general and administrative expenses was driven primarily by a decrease in personnel costs. General and administrative expenses were $19.6 million for the 12 months ended December 31, 2022, as compared to $17.3 million for the same period in 21. For the fourth quarters of 22 and 21, total other expense was $1.1 million respectively. Other expense was $3.7 million for the 12 months ended December 31, 2022, as compared to $3.4 million for the same period in 2021. Other expense net for the year ended December 31st, 2022, primarily consisted of expense related to future royalty payments partially offset by interest income. Other expense net for the year ended December 31st, 2021, primarily consisted of imputed interest expense related to future royalty payments partially offset by a gain recognized upon the forgiveness of a PPP loan. As of December 31st, 2022, Curious is cash cash equivalents and investments totaled 85.6 million and there were approximately 96.6 million shares of common stock outstanding. We continue to have a strong cash position and expect our existing cash cash equivalents and investments investments shouldn't it should enable us to maintain our planned operations into 2025. With that, I'd like to. I'd like to open up the call for questions operator.
spk09: We will now begin the question and answer session. To ask a question, you may press star then 1 on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the key. To withdraw your question, please press star then 2. Once again, that was star then 1 to ask a question. And at this time, we will pause momentarily to assemble the roster. And our first question will come from Ed White of HC Wainwright. Please go ahead.
spk06: Good morning. Thanks for taking my questions. Jim, previously you had said that taking Lofoma, you had expected data in 2023. Now that we're in 2023, can you give us a little bit of guidance as to when we should expect to see that data in this year?
spk05: Thanks, Ed. Thanks for calling in. Yeah, I think our expectation remains the same, that we're hoping to provide an update by year end. If things change between now and then, of course, we'll let you know. But we're very pleased with where we stand on both studies.
spk06: Great, thanks. And you didn't mention the VISTA program at all. I know it's been halted. I just wanted to get your thoughts on that. Is anything changing there? Is there any thoughts being given to restarting this program in 2023, or is that perhaps more out there further?
spk05: Well, yeah, I think it's premature for us to think about restarting it just yet. You remember the reason we paused it had nothing to do with our excitement about the program. It's a terrific target. It's a terrific program. We were making really nice progress, I thought. I think it was more about, given the financial climate, we needed to cut back our cash burn in order to ensure that cash went to 2025. And until we get to a point where we're confident that the market is different or that we've got the ability to access cash that doesn't put any compromising impact onto IRAC 4, we need to go all in on IRAC 4. So as I said, we're really excited for where we are right now. I think we're in a great position to add value to the IRAC4 program this year, and we'll be keeping our eye on the financial markets more broadly as we go through the course of 2023. Okay, thanks, Jim.
spk06: Since you brought up financials, maybe a question for Diantha, just regarding your thoughts on R&D expense throughout the year as the development of NVIC gets back on track. How should we be thinking about the ramp or perhaps just not a ramp or flattening of the R&D expense?
spk07: So, Ed, if you recall, we announced our reprioritization in November, and I think Q4, as we said, the costs are coming down. So I think sort of where we sit in Q4 will likely sort of be the sort of ongoing cost run rate, although I will say it could come down a little bit further just by virtue of the fact we did not avail ourselves of the full quarter post-reprioritization.
spk06: Okay, great. Thanks for taking my questions.
spk09: The next question comes from Sumit Roy of Jones Trading. Please go ahead.
spk02: Good morning, everyone. Congrats on all the progress. The nine patients you mentioned, the additional new patients got enrolled, are these all AML patients? So they are AML and MDS, if you can give us some idea. And also, do you think if you can provide any color on if they are very late-line patients, as you have seen prior to the enrollment hold, you are getting more late-line patients?
spk01: Hey, Suman. This is Bob Martel. Yeah, we're currently, you know, really trying to address the FDA's question around the dosing, and in particular at the lower dose of 200 milligrams. And so we've enrolled these nine patients as part of the regular phase one protocol, which is open to both AML and MDS. You know, we noticed that patients, many of the patients that we've enrolled on the study have had lots of prior lines of therapy. And that's obviously a challenging population to treat. So, you know, while we're not restricting per se, you know, we always seek patients who perhaps a little bit earlier in their lines of therapy. But, you know, for these nine patients, we haven't made specific guidelines.
spk02: Totally understandable. That's really helpful. And one last question is, you previously had four patients on hemobusative and venetoclax combination with 50% response rate. Can you confirm if these patients are still being treated?
spk01: Yeah, we haven't really given any updates on the, you know, since the ASH presentation. You know, we're not prepared on this call to provide any further detail other than, you know, the fact that, you know, the data that we saw was quite impressive where we had, you know, deep responses in, you know, in the patients' AML, MDS responses. you know, three out of the four patients who had assessments available had pretty dramatic reductions in their blast count. And as you mentioned, two of them with, you know, getting their blast count back to normal. So as you know, just to talk a little bit to the mechanism, you know, venetoclax hits BCL2. Well, the other major anti-apoptotic factor in these patients that's preventing the cancer from undergoing apoptosis is MCL1, and in fact, hitting IRAC4 reduces MCL1. So, you know, we think this is a great potential combination from a mechanistic standpoint, and we're really excited, ultimately, to get more data on that combination.
spk02: Thank you for taking the questions, and congrats on all the progress.
spk00: Thanks, Shuman.
spk09: The next question comes from Yeojin of Laidlaw & Co. Please go ahead.
spk04: Good morning, and thanks for taking the question. Just for the nine patients you recently completed, do they have any sort of difference compared to the prior patients, or they are very much similar to the one you have enrolled before?
spk01: Yeah, Yeojin, I would say, you know, They're basically similar for all intents and purposes to the prior patients that are phase one. You know, in general, we're enrolling patients essentially last line, patients who've had all available therapies. And so, again, these patients are in a very difficult situation. And like we've said before, the fact that we've been seeing efficacy, such striking efficacy in the earlier patients is pretty amazing, honestly. So we're just continuing to enroll that same population. Eventually, you know, once we identify a recommended phase two dose, we'll be, as we've mentioned, selecting targeted patients who are, you know, much more likely to respond. So patients with the two splicing factor mutations, SF3B1 and U2AF1, we'll be selecting only those patients going forward once we get to our recommended dose. Similarly, the FLT3 mutation as well, that's another selected patient population that we'll be investigating in the future as soon as we get our recommended dose.
spk04: Okay, great. And maybe just elaborate a little bit more in terms of the previous question, which is the What do you anticipate? What should we see any read through from the hash meetings? The data is presented not too long ago. And thanks.
spk01: Well, I think the biggest read through from my perspective was the fact that, as you remember, back in 2022, we had had pretty striking data early in the year and towards the ash of the year prior. One of the exciting things about ASH this last year was that we essentially doubled the patient population and continued to see, you know, continued to see very dramatic activity including multiple new responses. You know, oftentimes you can get a, you know, a signal in the first couple of patients and then it never pans out in the end. Well, in this case, it's continuing as we expand our database. And, you know, also, you know, the fact that these patients are having really durable responses when they get a response, you know, over six months. And almost all of the patients had had prior HMA, which is, as you know, a very difficult patient population to treat. You know, the median survival, as we've said before, in AML for these patients is about two and a half months. So, We've been really excited to see the data that we've gotten so far, and that was really the big read-through is that we continue to get it as we're essentially doubling the patient population.
spk03: Okay, great. That's very helpful, and best of luck for this move forward, and thanks. Thank you.
spk09: Once again, if you would like to ask a question, please press star, then 1. And our next question will come from Lee Watson of Cancer Fitzgerald. Please go ahead.
spk08: Hi there. This is Rosemary on for Lee. Thank you so much for taking our questions. So regarding the nine patients and your discussion with the FDA, would you be able to tell us potentially what types of data you would be collecting and talking about with them? And when do you anticipate you might communicate the feedback with the street after the 3Q meeting?
spk01: Well, let me start with the data, and then maybe Jim can talk about the communication. So, the FDA is, you may be familiar with Project Optimist. So, let me start from there. This is an effort that the FDA has undertaken in the last year or so to try to participate much more in the determination of the recommended phase two dose for essentially all oncology drugs that are going through phase one. they've kind of set some guidelines around this, and one of which is, you know, exploring multiple doses where there is some efficacy and safety. So, you know, in the example of emavucirtib, we've had actually three doses that met our safety criteria, meaning that we felt that they were safe, they didn't have, you know, a high rate of dose-limiting toxicities, but all three doses also had some efficacy. We had explored the 300 and the 400 dose twice daily and felt that the 300 offered comparable efficacy to the 400 when we evaluated that. Well, we had originally only evaluated three patients at the 200. So the FDA just wanted us to explore that a little bit more. And that's the goal for the nine patients is to get that total up to 12 patients so that since we did have some efficacy at that dose level, they wanted to better understand that as well. And ultimately, that's the driving force around why they've asked us for this. You know, and we don't think this is unique to Curious or Emma Vucertib. I think that they're really doing this for, you know, all companies who are in their early phase one development.
spk05: Yeah, let me add to that, Lee. So first, when we talk about the different dose levels. As Bob said, we know Project Optimus is about trying to find the lowest dose that can lead to that optimal efficacy level. I think one of the things that gets us so excited is that all of the doses at 200, 300, and 400 that we tested have efficacy. That's the good news. It's also the good news if you're interested in Project Optimus because, of course, it means you want to make sure you fully explore those. The question about data that we would have by the end of the year. You know, we're still anticipating that we're going to have data in both leukemia and lymphoma by the end of the year. My hope is that we're going to have some output from FDA as well to talk about. Whether or not we end up at 200 or 300 remains to be seen, of course. Right now, we're just doing everything that the FDA has asked, and we are thrilled that we were able to get the sites open and patients enrolled ahead of schedule. And I think, as I said in my comments, both the dire situation that these patients are in, the critical unmet need, and the excitement among our investigators to get this new therapy and treating patients.
spk01: And Leah, and just to give a little bit more detail on the specific data, one thing that the FDA really likes is what they call an efficacy response analysis. And so, I'm sorry, exposure response analysis. So what they look at closely is the actual exposure of emavucirtib in each patient. So as you know, we're doing detailed pharmacokinetic analyses on all of these patients. So they'll look at that, they'll compare that to safety, they'll compare it to efficacy, and that will help give them and us a very granular understanding of the optimal dose. And so that's really the fundamental aspect of what we're going to be looking for.
spk08: Got it. Thank you. I'm sorry, maybe just one quick follow-up. If you potentially have your hold lifted in 3Q or 4Q, how quickly do you think you could restart?
spk01: Well, we're already, you know, the studies are actually already open and going. So it would essentially be, you know, once we have that agreement, the studies are already open and we continue with that dose level. So I don't anticipate any significant delay once that happens.
spk05: Yeah, Rosemary, let me add to that. So that was when I said it kind of quickly in the comments, but Of course, when we went on hold, you have to effectively shut your sites down. The big change that we had at the end of last year was they allowed us to resume enrollment. So we went through the process already in Q4 of getting all our sites open and then recruiting new patients. So to Bob's point, as far as the FDA is concerned, we are open. We needed to recruit those nine patients, but that's now done. We're now in the process of wait for the data, give it to the FDA, and see which dose they prefer. Do they prefer 200 or 300? Either way, our sites are open and we're off to the races.
spk08: As soon as you get the dose, you can go.
spk01: We can continue enrollment at that dose, which ultimately, you know, we feel like we can accumulate data there. We're interested in you know, let's step back and think about our overall potential registrational plan. So we've mentioned that there's a couple of opportunities for very rapid registration, and that would be single-arm studies in FLT3-mutated patients with FLT3-mutated AML, and secondly, in patients with, you know, splicing factor-mutated AML. And so those are single-arm studies that As soon as we have our dose, we can start expanding that and really, at that point, having much greater clarity on what our registrational plan will be.
spk08: Got it. Thank you so much for answering my questions.
spk03: Thank you, Rosemary.
spk09: 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 Denser, for any closing remarks.
spk05: Thank you, Operator. And thank you, everyone, for joining today's call. And as always, a thank you to the patients and the families participating in our clinical trials, to our team at Curis for their hard work and commitment, and to our partners at Origine, Immunext, and the NCI for their ongoing help and support. We look forward to updating you again soon. Operator? Operator?
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