Curis Inc. (NASDAQ:CRIS) reported a net loss of $11.7 million for the fourth quarter of 2023, which is a slight increase from the $11.3 million loss in the same quarter the previous year. Despite the loss, the company made significant strides in its oncology research, particularly with its drug emavusertib, which is showing promise in treating various forms of cancer. With the partial clinical hold by the FDA now lifted, Curis is moving forward with patient enrollment and expects new data by midyear. The company's financial position, with over $56 million in cash and investments, appears stable enough to fund operations into 2025.
Key Takeaways
- Curis reported a Q4 net loss of $11.7 million, or $2.03 per share, compared to a net loss of $11.3 million, or $2.35 per share, in Q4 2022.
- Revenues for Q4 2023 were $2.7 million, a slight decrease from $2.9 million in the same period last year.
- The FDA's partial clinical hold on the leukemia study was lifted earlier than expected, allowing new patient enrollment and a data update anticipated by midyear.
- Curis is conducting a frontline study of emavusertib in combination with other drugs for AML patients, with preliminary data expected in the second half of the year.
- The company's lymphoma program has seen increased interest, doubling the number of clinical sites.
- An agreement was announced for an investigator-initiated trial of emavusertib in metastatic melanoma patients.
- Curis ended the year with sufficient funds to support planned operations into 2025.
Company Outlook
- Curis is focusing on monotherapy in leukemia and combination therapy in the frontline setting.
- The company is targeting a CR/CRh rate of 20% in salvage-line therapy for leukemia and a CR rate of 20% or higher in lymphoma.
- Curis plans to meet with the FDA once sufficient data is available to discuss the potential of emavusertib.
- Operating expenses are expected to remain consistent year-over-year, with a burn rate of 10-13%.
Bearish Highlights
- The company’s net loss has increased slightly year-over-year.
- Revenue has seen a small decline from the previous year.
Bullish Highlights
- The partial clinical hold by the FDA on the leukemia study has been lifted, allowing for the continuation of research.
- There is promising data in lymphoma, with three out of five patients responding to treatment.
- Curis is exploring the potential of emavusertib in solid tumors, including bladder, gastroesophageal, ovarian, lung, and pancreatic cancers.
- The company has the financial resources to fund research through 2025 without the immediate need for partnerships.
Misses
- No specific misses were highlighted in the provided context.
Q&A Highlights
- Curis discussed the potential efficacy of emavusertib in second-line PCNSL and their plans to discuss with the FDA.
- The company addressed questions about the triplet study in AML, focusing on the importance of safety and efficacy.
- Curis is waiting for the VERONA study readout to determine next steps in high-risk MDS.
Curis Inc. remains focused on advancing its oncology portfolio, with emavusertib at the center of its research efforts. The company's commitment to developing treatments for various cancers, including leukemia, lymphoma, and solid tumors, is evident from its strategic planning and clinical trial advancements. With a clear path forward and solid financial footing, Curis aims to continue its pursuit of innovative cancer therapies that could potentially exceed the current standard of care.
InvestingPro Insights
Curis Inc. (CRIS) has navigated a challenging financial landscape, as reflected in its recent earnings report. In light of this, it's crucial to consider the company's financial health and market performance, which can be further explored with InvestingPro metrics and tips.
The market capitalization of Curis stands at $62.65 million, indicating the company's size in the biotechnology market. Notably, the company's price-to-book ratio over the last twelve months as of Q3 2023 is 1.87, suggesting that the stock may be valued reasonably in relation to its net assets.
One of the InvestingPro Tips highlights that Curis holds more cash than debt on its balance sheet, which is a positive sign for investors concerned about the company's ability to fund its operations and research. However, it's important to note that the company has been quickly burning through cash, which is a critical factor given its significant research and development expenses.
Another tip to consider is that two analysts have revised their earnings upwards for the upcoming period, which may indicate a more optimistic outlook for the company's financial performance. Nonetheless, it's worth mentioning that analysts do not anticipate the company will be profitable this year, which aligns with the reported net losses.
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Full transcript - Curis (CRIS) Q4 2023:
Operator: Good morning, and welcome to Curis' Fourth Quarter 2023 Business Update Call. All participants will be in a listen-only mode. [Operator Instructions] After the company's prepared remarks, all participants will have an opportunity to ask questions. [Operator Instructions] 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.
Diantha Duvall: Thank you, and welcome to Curis' fourth quarter 2023 business update call. Before we begin, I would like to encourage everyone to go to our Investors section of our website at www.curis.com to find our fourth quarter 2023 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 Dentzer, President and Chief Executive Officer; and Jonathan Zung, Chief Development Officer. We will also be available for a question-and-answer period at the end of our call. I'd like to -- I'd now like to turn the call over to Jim. Jim?
Jim Dentzer: Thank you. Thank you, Diantha. Good morning, everyone, and welcome to Curis' fourth quarter business update call. I'd like to start today's call with a look back over the past 12 months. Entering 2023, the whole biotech industry was struggling in the headwinds of a green financial market. Curis faced all of that and the daunting challenge of seeing our leukemia study stalled on partial clinical hold with the FDA. In the face of that adversity, the Curis team rose to the challenge. We worked tirelessly in answering questions posed by the FDA. This included enrolling additional patients at 200 milligrams BID and performing additional analyses. As a result, we were able to confirm the safety profile of emavusertib, gain alignment on the optimal dosing regimen for monotherapy and secure the removal of the partial clinical hold, a full quarter earlier than expected. We then redirected our energy to reopening clinical sites and enrolling new patients. In our monotherapy study, we are targeting a genetically-defined population of relapsed/refractory AML patients with a FLT3 or spliceosome mutation. Enrollment is going quite well and we expect to have a data update by midyear. While that study advances, we have initiated a frontline study of emavusertib in combination with azacitidine and venetoclax for all AML patients regardless of their mutation status. This study is being conducted at sites in Spain, Germany and Italy, and we expect preliminary data from this study in the second half of this year. All in all, a terrific year of progress in leukemia. Now let's turn into our lymphoma program, which is generating an equally high level of interest. After reviewing initial data collected across multiple NHL subtypes, we focused our efforts on the ultra-orphan indication of primary CNS lymphoma, or PCNSL, where we are evaluating emavusertib in combination with ibrutinib. We identified key sites, initiated enrollment. And in December, we released new clinical data in relapsed refractory PCNSL at the ASH conference in San Diego. The meetings we had with physicians at ASH were terrific, and we were especially pleased to have Dr. Greg Nowakowski, and Dr. Han Tun from the Mayo Clinic present the data. As a reminder, frontline treatment in PCNSL is high-dose methotrexate and chemo. When that no longer works, there is no approved second-line treatment. In our study, three of five patients were able to achieve complete remission of their disease. It is admittedly a small number of patients. However, the response and interest from the clinical community was very encouraging. In the eight weeks since ASH, our team has been fielding calls from clinical sites across the US and Europe wanting to participate in our trials. In fact, by the end of Q1, we expect to have doubled the number of clinical sites versus where we were a year ago. Obviously, this is a reflection of the excitement about emavusertib, but it is also a reflection of the indefatigable efforts of the Curis team. I couldn't be more proud of them. Finally, in December, we announced that we entered into an agreement for an investigator-initiated trial to study the combination of emavusertib and pembrolizumab in patients with metastatic melanoma. We're excited that this study presents an opportunity to expand upon the research done at academic centers and the NCI to explore the potential of emavusertib in solid tumors. In short, we had an incredibly productive 2023, and we look forward to continuing that momentum in 2024. With that, I'll turn the call back over to Diantha to review our financial results for the quarter. Diantha?
Diantha Duvall: Thank you, Jim. For the fourth quarter of 2023, Curis reported a net loss of $11.7 million or $2.03 per share as compared to a net loss of $11.3 million or $2.35 per share for the same period in 2022. Curis reported a net loss of $47.4 million or $8.96 per share for the 12 months ended December 31, 2023 as compared to a net loss of $56.7 million or $12.14 per share for the same period in 2022. Revenues net for the fourth quarter of 2023 were $2.7 million compared to $2.9 million for the same period in 2022. Revenues net for the 12 months ended December 31, 2023, were $10 million compared to $10.2 million in 2022. Research and development expenses were $10 million for the fourth quarter of 2023 compared to $8.7 million in 2022. The increase in R&D was driven by higher clinical development costs. R&D was $39.5 million for the 12 months ended December 31, 2023, compared to $43 million in 2022. General and administrative expenses were $4.9 million for the fourth quarter of 2023 compared to $4.3 million in 2022. The increase in G&A was driven primarily by higher professional, legal and consulting services. G&A was $18.6 million for the 12 months ended December 31, 2023 compared to $19.6 million in 2022. Other income net was $0.5 million for the fourth quarter of 2023 compared to other expense net of $1.1 million in 2022. Other income net was $0.9 million for the 12 months ended December 31, 2023 compared to other expense net of $3.7 million in 2022. Other income expense net consists of interest income and non-cash expense related to the sale of future royalties. As of December 31, 2023, Curis' cash, cash equivalents and investments totaled $56.3 million, and there were approximately 5.9 million shares of common stock outstanding. We continue to be in a solid cash position and expect that our existing cash, cash equivalents and investments will enable our planned operations into 2025. With that, I'd like to open the call for questions. Operator?
Operator: We will now begin the question-and-answer session. [Operator Instructions] And our first question will come from Ed White of H.C. Wainwright. Please go ahead.
Ed White: Good morning. Thanks for taking my questions. Jim, you mentioned that in the primary CNS lymphoma trial, you have doubled the clinical sites open versus this time last year. I'm just wondering if you can let us know how many sites that is and how many sites you plan to open.
Jim Dentzer: We try to get out of the details of the number of sites that we have in any given time because, of course, we're always increasing them. But I think the reason why we mentioned that this call is because it's a reflection of the kind of conference we had. Obviously, we were very encouraged by the data ourselves. And if you were at ASH, you saw that our booth was incredibly busy. But that's been followed up by being able to get these new sites up and running and online. And we've got, as I said, not the expectation to double by the end of Q1, but enthusiasm more broadly across the world, not just in the U.S. So it's really exciting from our perspective, and I'm hopeful that we can keep that momentum going forward.
Ed White: Thanks. Can you give us your thoughts on the size of that primary CNS lymphoma market?
Jim Dentzer: Sure. It's an ultra-orphan market. It's one of the reasons why we selected it. So if you think across the landscape of non-Hodgkin's lymphoma, and everywhere where BTK gets used, of course, we have been targeting broadly. Anytime you use BTK, you're down regulating in a kappa-B from one pathway. There are a lot of BTK inhibitors targeting that path. We're the only one that targets the other path. When we look across the landscape of non-Hodgkin's lymphoma, we focused in on primary CNS first because it's so small, incidence of 5 per million. That yields a lot of very attractive benefits from a development perspective, especially in conversations with regulatory authorities. But also within primary CNS lymphoma, it's a fairly aggressive lymphoma where we can -- we believe we can address the disease quickly. As you saw in the data, the three or five complete responses, we got a few of that in the first three months on treatment. So that's very helpful. And of course, there are no effective treatments. There are no approved drugs for relapsed/refractory PCNSL. So if we can go after a disease that ultra-orphan, where there are no approved treatments, and we can see this kind of response from the drug, it's really encouraging.
Ed White: Okay, thanks, Jim. And now perhaps if I could just ask a big-picture question. I wanted to get your thoughts on the potential in solid tumors. You had mentioned the IST beginning in combination with KEYTRUDA and metastatic melanoma. I just wanted to get your thoughts on that market in solid tumors overall.
Jim Dentzer: Yes. So solid tumors is really exciting. We have been of course from the very beginning in identifying this target one of the things that was so exciting was that the role of IRAK4 in oncology more broadly was something that Curis had discovered and no one else knew about. So when we were designing the molecule originally, we had the Pharmacyclics template in mind of how do you go after a blockbuster indication or an indication with multibillion dollar revenue potential, what no one else knows about yet. And we designed that molecule, so that it would be effective in lymphoma, but also would confer some competitive advantage in leukemia and in solid tumors. As you know we -- our first studies started in lymphoma and that's of course where our most recent data are as well and that's really compelling. The data in lymphoma in the targeted population that we would expect to hit in the IRAK4 or spliceosome population and the FLT3 population those data look really compelling. We've just started the frontline study. And then to your point in melanoma, this is the first time we've gone into solid tumors. Now there's been a lot of work done by the NCI and by academic centers in studying emavusertib in various types of solid tumors. So we know there's a lot of interesting work going on for example in bladder cancer, in gastroesophageal cancer, in ovarian, in lung, in pancreatic. There are a number of different solid tumors, where it looks like IRAK4 plays a significant role and where our drug might be able to confer benefit. This is the first time we're going into that. I think it's a little premature to talk about how large all of those markets are. But the idea that we have a drug that looks as though it could provide incremental benefit that no other drug does in these very targeted markets individually and of course at the high level across the world of human solid tumors is really quite exciting.
Ed White: Thank you, Jim. And the last question if I could. Just wanted to get your thoughts on partnering the product in solid tumors, is that something that you'd be looking at, or is this something as you expand into solid tumors that you think you could fund on your own going down the road?
Jim Dentzer: Sure. So, I mean, take the melanoma study as the case in point. Obviously, that's a study we would rather not pay for. There are a lot of trials maybe 1,000. There are a lot of clinical trials going on right now of a company's drug in combination with pembro, Merck's PD-1, which is most people consider it deleting PD-1. But the way most of those work is, they beg Merck to give them free drug and then they run the study. We have the opposite. We're going to get data from this study and we're the one providing free drug. Merck's the one picking up the tab for the study. So, obviously, what most companies would hope for is just getting free drug. Ideally, if we're going to expand the number of clinical studies that we can run, whether it's in lymphoma or in leukemia or now in solid tumors, at the minimum, we'd like to get a 50-50 study. I think it's overly optimistic that we're going to be able to find all of our future studies are 100% funded by the partner without giving up any rights. But at this point in time, obviously, we're really excited that we're going to have the opportunity to get data across lymphoma, leukemia and now solid tumors and we can afford to do it. So as long as we can afford to keep our rights and generate the data that show that this drug has such significant potential, I think that's our plan.
Ed White: Okay. Great. Thanks for taking my questions.
Jim Dentzer: You bet.
Operator: The next question comes from Soumit Roy of JonesTrading. Please go ahead.
Soumit Roy: Good morning, everyone, and congratulations on all the progress on multiple fronts. One question on the frontline, the triple combo with emavusertib, azacitidine [ph] and venetoclax. You're starting -- you mentioned three different countries including Europe. Are you planning on initiating some US trial sites also? The second was …
Jim Dentzer: Go ahead.
Soumit Roy: Keeping this trials, is that in combination of ibrutinib, or still you are planning to do monotherapy emavusertib patients?
Jim Dentzer: Okay. So the first one first. So the initial study for the triplet, we're really targeting some sites where we think we can get data relatively quickly. Because we want to -- in these early stages the most important thing is to generate the data as quickly as we can and prove that the triplet works. We've got a lot of preclinical data that suggests that IRAK4 is the primary driver of disease in half of all AML patients. There's a published article as you know the Smith Choudhary article that was published in Nature in 2019 pointed that out. Half of all patients this is the number one driver of disease. In the other half of patients, it's not the number one driver of disease, but it's a secondary or tertiary driver. So really this should provide incremental benefit from a new mechanism that no other drug does. So the long-term to capture as many patients as we can is to, of course, go frontline in combination with standard of care. That's azacitidine and venetoclax. So our hope would be that we can recapitulate in humans what we found in the lab and that is whether you add emavusertib to aza or to ven or the aza-ven combo. This significantly increases the efficacy of that standard of care treatment. So that's what we found in the lab. And again that's what we want to try and identify very quickly, if possible in the clinic. And of course, we always want to check for safety. Aza and ven, as you know, are a pretty tough regimen to tolerate. They're effective but they're pretty tough to tolerate. Anecdotally half of all patients that go on that aza-ven doublet, have to discontinue treatment. So what we're going to be doing in the early days is putting patients on and confirming that there is no safety overlap as we expect. And then second, of course, we're going to be looking for that efficacy signal. And if you want to do that kind of exploration quickly, it really helps to identify the sites that you can focus on in a very concentrated way and those are the sites we've chosen to initiate that study. Your second question could you remind me?
Soumit Roy: Yes, I fully understand. So, on the PCNSL trial, so are you expecting to get frontline patients? If you want to get to that you want to combine with emavusertib or ibrutinib? What's the plan here?
James Dentzer: No, thank you thank you for that. So right now the combination is emavusertib and ibrutinib and it's in relapsed refractory patients and that's the initial starting point, and again the rationale for first the combination of ema and ibrutinib that one's clear. In the case of lymphoma, the problem driving disease for patients with NHL is NF-kappaB overactivity. So when NF-kappaB is overactive what happens is it disrupts, the apoptotic process of the malignant cells. So if you're on a BTK inhibitor today, the reason you're on that BTK inhibitor is that it blocks the BCR pathway, which is one of two pathways, driving NF-kappaB overactivity. We now know that that's effective and you get a pretty high response rate on BTK inhibitors. And in fact as you know it's a $10 billion to $15 billion market today ibrutinib, itself is $10 billion of that the AbbVie (NYSE:ABBV), J&J drug. What we're looking to do in lymphoma is hit NF-kappaB as hard as we can. There are now five big pharma companies that are chasing after BTK inhibitors of various flavors covalent or non-covalent, all of them working effectively the same way, all of them blocking that, BCR pathway driving NF-kappaB. The second pathway, the toll-like receptor pathway is currently unaddressed. Curis is the only company that has a drug that blocks that path, that's emavusertib. It binds to MYD88 Myddosome and without that binding in the absence of IRAK4 Myddosome and the toll-like receptor path more broadly shut down. So it stands to reason when you step back, if you have lymphoma that's effectively treated by BTK, you'll always want to block the NF-kappaB or down regulate NF-kappaB as strongly as you can. So hit the BCR path with BTK, hit the toll-like receptor path with IRAK4. The combination not monotherapy, the combination should always be better than either one alone. And that's what we found in the lab. And, of course, that's what we're finding so far in the clinic. So that's the logic for the combination with emavusertib. In terms of going to front-line eventually, of course, we would like to suggest that the long-term possibility that we're going to explore is, is this an opportunity to have a companion front-line standard of care with BTK across non-Hodgkin's lymphoma? Now it's a little premature for that. We've chosen primary CNS lymphoma as our proof-of-concept indication to prove it out. And we've been able to show that we can generate data pretty quickly. But long-term, I think of course we're going to want to go frontline in combination with BTK inhibitors. For now having an ultra-orphan indication where we can go into the relapsed/refractory setting where there are no drugs approved that should offer a pretty compelling regulatory opportunity. So that's why we're going down that path. I hope it was helpful.
Soumit Roy: No we got it. And speaking of companion, since you're moving into the solid tumor, I'm curious if you're going to push forward the companion diagnostic for IRAK4 mutation assay, and if that would be helpful in carving the market both for -- inside the solid tumor space and also eventually in the leukemia setting?
James Dentzer: Yeah. So the short answer is yes. The long answer is it's a little more complicated. So in the short answer, are we pursuing the identification and the regulatory path for a companion diagnostic for IRAK4 expression? The answer is yes, absolutely. The more complicated answer is we don't want that to slow down our path to development and making this drug available for patients. So the way we're ensuring that fastest path is in monotherapy in the leukemia side where we're looking to go into patients that have either a FLT3 mutation or an IRAK4 overexpression. We're going to focus the IRAK4 population using spliceosome mutations. Now spliceosome mutations are a subset of patients that over-express IRAK4. The reason why you'd go after spliceosome mutations, is those mutations are already identified in existing gene panels. So a companion diagnostic is much easier. We don't need to have a new assay identifying IRAK4. We can just lean into the existing panels, the Illumina (NASDAQ:ILMN) panel, the FoundationOne panel, places like MD Anderson that have a proprietary gene panels. These panels are already run on their existing patients. And we can lean into that and say if you have one of these specific mutations by definition, you have IRAK-4 expression and use that as our mechanism. But longer term, of course, we're going to want a diagnostic. It's the logic for going frontline in combination. We're going to go all comers where we won't need a companion diagnostic.
Soumit Roy: Thank you again, for taking all the questions and congrats on the progress.
Jim Dentzer: Sure. Thank you.
Operator: The next question comes from Li Watsek of Cantor Fitzgerald. Please go ahead.
Li Watsek: Hey. Good morning. Thanks for taking my questions. Jim, I guess, for the data that you're going to present from the Leukemia study around midyear, maybe just set the expectations for us a little bit with data set that we are going to see, what the bar is for the three as well as for spliceosome mutations? And then for the combo data that's going to come second half of this year, maybe tell us a little bit about, the bar here. Because is [indiscernible], as we know, the bar is fairly high, pretty effective. And also, as you alluded to earlier about toxicities and do you expect any overlapping talks with this regimen?
Jim Dentzer: Yeah. Thank you, Li. I appreciate you dialing in. So on those questions, first, in terms of the number of patients, we've consistently said what we'd like to have is a data set of 10 to 20 patients. We now have a data set of three patients, in spliceosome, three patients in FLT3 at our target dose and five patients, of course, in primary CNS. We'd like to increase that data set to -- equals 20 to 50, somewhere in that range. I hope that we're going to be in a position, where we've got data collected. Of course, you enroll the patients, treat them, follow them for a period of time and then assess the responses. My hope is that we would be in a position to have that level of and that level of data in Leukemia, Spliceosome and FLT3 by midyear and in Lymphoma by year-end. In terms of the benchmark, what we think we need to do to be effective in the monotherapy side is, we're targeting a CR/CRh rate of 20%, lower bound in the low-teens, 12%, 13% kind of lower bound. But a 20% CR/CRh rate in salvage-line therapy, for either FLT3 or spliceosome in leukemia, we think is very compelling. Of course, our first three patients look better than that. But let's not get ahead of ourselves. It's only three patients. As we get to 10 to 20 patients, what we'd really hope is that we can clear that CR/CRh rate of 20% and be [indiscernible]. On the Lymphoma side, because there are no existing treatments, that bar is probably lower. What we do know is that the largest data set available for BTK as a monotherapy in primary CNS lymphoma was a study of 52 patients, the CR rate was 19. So you'd expect one out of five patients or again, roughly a 20% CR rate in that population. And that's in BTKi-naïve patients. Once they've failed BTK, you'd expect that re-challenging them with BTK yet again, probably wouldn't work at all. You might expect zero out of 5. That we're getting three out of five so far is obviously highly encouraging. I don't think we need to maintain quite that rate. But if we can maintain in BTK experience patients, a 20% or higher CR rate in lymphoma, I think that we've got a very compelling data set to have a discussion with FDA. So 10 to 15 -- I'm sorry, 10 to 20 patients in all indications, is what we're hoping for. We look to be in a position to have data in that range for leukemia by midyear and for lymphoma by year-end. Was that helpful?
Li Watsek: And overlapping toxicities with antiretroviral.
Jim Dentzer: Yes. Yeah. Yeah. So that's the number one thing to look for in the triplet. Of course, it makes sense that -- if you looked at our preclinical data and we've got a really nice outline of the preclinical data in our corporate deck, it's very clear that from an efficacy perspective, in the lab we were able to add efficacy to aza to aza-ven. And it looks like if the consistency that we saw from mechanism to lab to clinic works the same way in the leukemia triplet, that it's worked everywhere else we've tested we would expect to see that. The part that I'd say really merit some exploration is making sure knowing that the toxis is high in aza-ven, that we don't add to it. We don't have any reason to believe that it would be – that adding emavusertib would make it less tolerable based on what we know. There is no overlapping safety profile. However, as we said, half of all patients that go on to aza-ven have difficulty tolerating it. We – first thing we're going to look for as we add our drugs to aza-ven is to make sure we're not exacerbating those toxicities. I think with efficacy you always look for but first things first, let's make sure that we've got a drug that's tolerable in combination.
Li Watsek: And what are your thoughts on the maintenance setting in AML? Are you collecting any data points that could potentially maybe support off-label use?
Jim Dentzer: Well, obviously, off-label use is something that happens but companies don't target that. What we do look for is do we have a drug that first and foremost is safe. Second has a compelling and unique efficacy profile, so that we can provide a measure of efficacy that you can't get from other drugs. And then third to your point, you want to make sure you've got a drug that can be taken chronically for long periods of time. Some of the indications we're going after like AML are fairly aggressive but others like Waldenstrom’s are quite indolent. We have a patient that's been on drug for I believe over four years now. So we've got a great track record. These are still early days of drug development for emavusertib but I think so far we've been able to check all three boxes. The drug looks in almost 200 patients tested to have a really good safety profile. It looks as though it does provide in humans the same kind of clinical efficacy that we were seeing in the lab. And it looks as though you can take this drug over a long period of time in a maintenance setting. And that's of course, that's the trifecta that you hope for as a drug developer.
Li Watsek: Thank you.
Jim Dentzer: Yes.
Operator: Next question comes from Yale Jen of Laidlaw & Company. Please go ahead.
Yale Jen: Good morning and thanks for taking the question. Jim you have talked about that you will be interested to move to MDS, high-risk MDS, the second line but your waiting for the VERONA study readout. Just to your best knowledge, when do you think that might happen and what – and if that takes place sometime in the future? And what's your plan at this point?
Jim Dentzer: Yes. Thank you, Yale. Appreciate the question. So you're exactly right, the opportunity in MDS looks terrific. The clinical data that we've put out so far looks as though in MDS just as it did in AML and just as it has in lymphoma, it appears as though this drug has a single agent is active. It provides unique and compelling anticancer activity. We would really like to do in MDS what we're doing in leukemia, which is go frontline in combination with standard of care and see whether or not we can provide benefit. Can this really add to the effectiveness of standard of care? Well in AML we know what the standard of care is. It's aza-ven. I think MDS development has just gone a little slower with aza-ven. A lot of people were expecting it might have read out this past to ASH. Now people are looking for ASCO to be frank. We don't know any more than you do of when those are going to read out, but we do expect it's imminent. And the answer is standard of care in MDS is going to be either aza or the aza-ven doublet. If VERONA reads out positively it's aza-ven; if it reads out negatively its aza. And what we want to know is which of those two wins, if you like, so that we can then initiate a combo, whether it's a doublet or a triplet to see whether we can add benefit to that population in the frontline setting. So we're eagerly anticipating it as you are. And as soon as we have those results, we'll be looking to initiate a frontline study in combination in MDS as well.
Q – Yale Jen: Okay. Great. That's very helpful. And my second question here is that earlier we thought -- we were sort of expecting that you guys may conduct a meeting with the FDA to talk about the next stage of development after the AML data. Do you anticipate this meeting could happen later -- much later this year or you anticipate this potentially be a 2025 event?
Jim Dentzer: So I really can't speak on behalf of the FDA, how quickly we're going to have that meeting. We are, of course, very interested in having it as soon as possible. I think we have the kind of drug that the FDA should likely be as interested in as all of our investigators are. And that is, we've got a drug that has a great safety profile, that really seems to add efficacy wherever we're testing it and may be able to provide benefit in areas like second-line PCNSL where there are no drugs approved. The FDA ought to be receptive to that. So as soon as we can get a sufficient number of patients together, and it's probably in that 10 to 20 range, depending upon what kind of results we're getting, if the results are consistent moving forward to what we've seen in the past, we'd be looking to have a meeting with FDA as soon as we can. And then, of course, as you know, the FDA has got a lot of guidelines about when you apply and how quickly they have those meetings. But we'd be somewhat subject to the FDA's scheduling on their end. But we look really forward to being able to tell you when we've got that call on the docket, so that we can push forward these drugs as quickly as possible.
Q – Yale Jen: Okay. Great. Maybe just tackle one last housekeeping question. I know you guys do not typically give guidance in terms of the operating expenses. But could you give more directionally -- directional sort of suggestion in terms of the operating expenses this year 2024 comparing to 2023. Thanks.
Jim Dentzer: Yes. Why don't I ask Diantha to chime in on that.
Diantha Duvall: Thanks, Jim. So yes, I mean, we believe that our operating expenses are going to remain relatively consistent. As we've guided, the $56 million of cash gets us into 2025. So that gives us a burn rate in kind of 10% to 12%, may peak up to 13% depending on timing of some manufacturing and other things that tend to be a little bit more chunky. But I think you should expect it to be fairly consistent year-over-year.
Q – Yale Jen: Okay. Great. Thanks a lot. Congrats all of the development and look forward to the data readout
Jim Dentzer:
,:
Operator: The next question comes from Bill Jahangiri [ph] of Truist Securities. Please go ahead.
Q – Unidentified Analyst: Congratulations. Thanks for taking the questions. We were wondering if there were any -- if you could tell us anything about strategic or partnership interest at JPM from your end. And then also for the triplet study in AML for the patients you're enrolling, could you just remind us what the bars would be for that one? Thank you.
Jim Dentzer: Sure. Thanks Bill. So as you can imagine the interest that we've seen on the partnering side kind of mirrors the interest that we've got in the investigator side participating in our trials. And we of course, are always having conversations, with potential partners. And at some point, I think many people would like to imagine that if we can go broadly, with this drug everywhere where we think it could work. So that's across lymphoma in areas wherever BTK gets used in leukemia, AML and MDS in a frontline setting and now in solid tumors. We just started in melanoma. But as I mentioned, there are a number of other solid tumor indications that have been studied with our drug by NCI and academic centers. And Curis just can't afford -- we're too small, we can't afford to run studies in all those areas. At some point, it's going to make sense to turbocharge those clinical efforts with the help of a partner both with bank book and manpower. Going forward, I think it's unlikely that we're going to strike a deal as we did in melanoma where we don't have to give up any rights, and we get -- just providing drug, we get data. But I think at some point that will make sense. And I would say, we're not giving guidance on timing for that, but I'd say stay tuned. This looks to be a really compelling drug, and Curis is not the only company that's recognized that. And could you remind me, Bill, the second part of your question?
Unidentified Analyst: Yes, for the triplet. So I'm not really sure what the patients look like and the eligibility criteria. So I was wondering if you could just tell us like what the bar would be for success there. And just overall benchmarks.
Jim Dentzer: Right. Thank you. Yes, I think as I mentioned to Li Watsek at Cantor, I think the bar really is -- it's a safety bar in the early days. We are cognizant that the doublet of Aza/Ven is difficult for patients to tolerate. When we look at the drugs we're combining with, whether it's Aza/Ven or ibrutinib for that matter, these are all drugs that they're effective, but their safety profiles are tough. And so the first order of business, if we're going to combine with those, we want to make sure that we don't take a difficult regimen to tolerate and may get worse. So first things first. There's no reason to believe we have an overlap of safety profile, but we need to test that out in patients and make sure that, that's so. It's easily the thing we're looking for first. Now of course, whenever you're looking for safety, once you pass that hurdle, you're going to be looking for signs of efficacy. And we're going to want to be able to see that we can replicate in the clinic with the triplet what we've been able to do in all of our other studies to-date, and that is recapitulate the preclinical experience and show that adding emavusertib, that addressing this novel driver of cancer in IRAK4, that addressing that target does yield incremental efficacy above and beyond current standard of care. And if we can do that, I think that's the home run. So first things first, safety, but of course, we're going to look for efficacy as well. Hopefully…
Q – Unidentified Analyst: That's wonderful.
Jim Dentzer: Yes.
Q – Unidentified Analyst: Yes. And I guess, one last one. I just want to verify, make sure I'm not thinking about this incorrectly. It seems like you're already hitting the duration bar in CNS lymphoma, right? We just need that data set to grow?
Jim Dentzer: Yes. I think we -- it's exactly right. I think the data set was fantastic. In fact, it was quite a bit better than we would need. But it's early days, stand up 5. So as we go to 10 and then to 20 patients, as I said, I think what we need to be able to show, if you had 20 patients with primary CNS lymphoma, that you were treating that had failed high-dose methotrexate and chemo. Today, they're going to go on BTK. They're going to go on ibrutinib. You'd expect four of those 20 patients to get a response based on the largest study that's been done on ibrutinib monotherapy, CR rate of 19. So let's round up a little bit, call it, 20 you'd need four CRs out of 20 patients. In our case, we're three of five. We need to add 15 more patients and get one more CR just to match the earlier line. Because remember, all of our patients have failed ibrutinib. You'd expect zero out of 20, if you rechallenge them with ibrutinib. So in our case, if we can match that prior line of get four out of 20 or one more CR out of the next 15 patients, I think we've got a really compelling discussion to have with FDA. And I think, frankly, our odds are pretty good at that.
Q – Unidentified Analyst: Thank you.
Jim Dentzer: You bet.
Operator: 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, Jim Dentzer for any closing remarks.
Jim Dentzer: Thank you, Andrea. And thank you, everyone, for joining today's call, and 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 and the NCI for their ongoing help and support. We look forward to updating you again soon. Operator?
Operator: The conference has now concluded. Thank you for attending today's presentation and you may now disconnect.
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