Syndax Pharmaceuticals, Inc. ($SNDX)
Earnings Call Transcript · June 8, 2026
Earnings Call Speaker Segments
Corinne Jenkins
AnalystsAll right. Good afternoon, everyone, thanks again for joining us at the Goldman Sachs Global Healthcare Conference. We're thrilled to have Michael Metzger; and Keith Goldan, Chief Executive and Chief Financial Officer for Syndax here with us this afternoon. And maybe we'll just kick it off some high-level questions. First, how do you think about the core competencies of Syndax. And how does that inform kind of your strategic priorities for the business over the near term?
Michael Metzger
ExecutivesFirst of all, thank you, Corrine for inviting us here today, great opportunity to be in front of this audience. So Syndax's in a great position as a company. You mentioned our core competencies. We've been able to bring two drugs all the way through development and get them approved and certainly launched them in the last year plus has been very successful for the company. That kind of informs our core competencies. I would highlight R&D and the ability to translate early science into products of meeting and bringing them all the way through development. So the R&D capabilities of Syndax are quite strong, gotten more robust over time. So that is something we lean on significantly to advance our medicines and really differentiate in the marketplace. And then, of course, the commercialization competency within heme today, we think is differentiating for us as we've advanced both of our medicines and they're both heme medicines to bring them to as many pays as possible. So I think those are core competencies that allow us to advance the business and really drive differentiation over time. So I would highlight those as really important. Maybe more temporarily, we're currently in the middle of a pretty busy clinical data period between ASCO and EHA you speak to the key themes you hope doctors and investors take away from the presentations you have at those two conferences. Absolutely. And it is an exciting time for us as we've been meaningfully represented at all of the conferences most recently at ASCO and then at EHA this coming week, where we have multiple presentations, both oral and poster presentations for both of our medicines. I'd highlight for revenue forge the significant data in combination with standard of care agents that ASA and in COVE, also chemotherapy, 7+3 uses both in relapsed/refractory and in newly diagnosed patients as we're running pivotal trials in newly diagnosed patients, we have a whole slew of data coming in both real world and controlled trials and single-arm trials that help inform and derisk these combinations. I think that's extremely important as we continue to build the business. physicians get comfortable with using the drug both on label and potentially off-label and really solidify our leadership as the median of choice for many years to come. also highlight the maintenance data that has become increasingly important, specifically around the KMT2A population for revenue Forge, where patients are getting in higher -- increasing amounts to transplant, which is a great outcome for patients. And then with [indiscernible] you have the opportunity to go back on the maintenance capacity and that has become an important growth driver for the business. The data that we're seeing in the real world and around many of the centers that we're working with, suggests that patients could do quite well in maintenance. We saw this at ASCO in an oral presentation where a subset of patients, KMT2A NPM1 and now NIP98, which is another important lesion that is able to be treated with Revuforj. We've seen that patients get maintenance and can stay on as a lead market analysis in that trial 2 years of 90%. So that's a sea change versus what you've been able to see before the advent of Revuforj. So I think these are the themes, combination data treating patients earlier, the outcomes there, why it's meaningful to treat them, bring them to transplant and then also give the maintenance. That's what we're hoping to highlight.
Corinne Jenkins
AnalystsAll right. One more temporal question, then we're going to come back to all the clinical and commercial pieces. You recently did this convert -- announced it about a week ago. Maybe talk about that in the context of your overall kind of like financial strategy and funding the business. What does that allow you to do?
Michael Metzger
ExecutivesSure. Maybe I'll start and I'll pass it to Keith. The convert is an opportunistic inbound from fundamental investors, we believe are important to our business going forward. So low cost of capital for us relative to anything we've seen call outline the terms of it. But essentially, it gives us an opportunity to fund beyond our current business. right? And we have a pipeline that's emerging. We'll talk about that at our upcoming R&D Day. We're excited about these assets. We need to invest in them. We want to invest and we want to move them quickly ahead. We have a track record of success, as you mentioned, early bringing assets in, developing them optimally and moving as quickly as we can. I think that is a use of the proceeds as well as for IPF. Beyond this trial that we're running a positive study in IPF will lead to future development and expense and we want to have the resources available to us to exploit that opportunity. So those are sort of the uses, maybe, Keith, you describe...
Keith Goldan
ExecutivesYes. I mean I'd begin by saying that it was opportunistic. The deal came to us. It was unsolicited inbound by a fundamental investor that wanted to anchor in the deal that specifically wanted to participate in the growth of the company through a convert, it was historically low cost of capital for us. It was -- the deal was done at 2.25%, up 35%. And it's a nice addition to our capital structure, which is right now comprised mainly of just equity as well as the synthetic royalty that we sold on Nectimbo to Royalty Pharma. So it's a nice complement to the overall capital structure and use of proceeds like Michael said.
Corinne Jenkins
AnalystsOkay. So maybe digging in on the commercial side, you have Revuforj now approved in relapsed/refractory AML in both the KMT2A and PM1. But if we start with KMT2A. Could you talk about like the patient journey, where they see revenue forge today, kind of what portion of patients are getting that therapy, where they could and where that could kind of go in terms of going to transplant, coming back to maintenance, et cetera.
Michael Metzger
ExecutivesYes, it's a very important advance for patients. I mentioned it earlier. KMT2A patients are generally younger than NPM1 patients, for example. When I say younger, a lot of children, average HNR pivotal trial was about -- so the goal for those patients who hadn't really had a medicine before that was impactful for their disease, certainly not 1 directed at 2. was to get them to remission, which our drug does. About 2/3 of the patients in our pivotal trial got to a complete remission and then get them to transplant. And you treat them for about 2 to 3 months, you bring them to transplant. And then the paradigm is after they've gotten through their engraftment period where their bone marrow repopulates you can put them back on revenue forge to continue treatment and keep them in remission. And right now, what we're seeing, we had about 25% in our clinical trial going to transplant, which is a big difference versus what they've historically had before Revuforj and now in the real world, as we reported in our last quarter, we're at about 50% of patients going to transplant. So about 70% of our patients are treated either second or third line, so that's earlier than they were in the clinical trials drives them to higher response rates and ability to get to more transplantation. And then now what we're seeing patients coming back about 45% of the patients who go to transplant come back for maintenance. We expect that number to grow. We expect it to grow because physicians tell us they want to do it universally. They believe that this is an important impact on patients. We also have seen it in the data, starting to see some real-world data suggesting higher rates of maintenance. And so we will expect that -- we expect that to go to somewhere in the neighborhood of 70% to 80% of the patients going on to maintenance at steady state. So that's the paradigm and that we expect will be a big driver for the business going forward.
Corinne Jenkins
AnalystsWith those kind of in mind, you've said that 6 to 12 months should be like the expected duration of therapy, but that's a pretty big window. What do you need to see that narrow that? And where could it go over time?
Michael Metzger
ExecutivesCertainly, it could go 6 to 12 is a wide window. First year on the market, we saw average duration of therapy in the range to 6-month range that was due to the fact that you had you didn't have the impact of maintenance longer term, right? So you only had 12 months in the market, you didn't have the opportunity for patients to go through their engraftment period and go back on and have the impact of maintenance. Second year, we said somewhere in the 6- to 12-month range. We now know about call it, 50%, 45% of the patients are going on to maintenance. We expect that number to grow meaningfully over time. That will drive the duration of therapy, 6 to 12 months. Could it go longer in the future. Yes. I mean physicians have told us they intend to give in the neighborhood of 12 to 24 months of maintenance on average. And so we need that time to build through the 6 to 12 months in the second year, but we do think it's realistic.
Corinne Jenkins
AnalystsYou think about where you are, like maybe you could mark-to-market from when you launch this product in KMT2AR to today, I guess, how are you tracking in terms of the metrics that you cared about at the time, whether it's like market share or percentage going on to transplant or maintenance, et cetera, versus your expectations?
Michael Metzger
ExecutivesWell, we're certainly tracking with expectations, maybe even exceeding expectations. You penetrated about -- it's a 2,000-patient incidents for KMT2A in the U.S. So we penetrated about 50%, approaching 50% in year 1, which sounds very high, and it is very high. There's really nothing indicated for KMT2A and standard of care is not effective, as I mentioned. So that 50%, we believe, could grow to 80% market share. That's about as high as you see in a target for a targeted therapy. So that's essentially where we expect it to go. How long it will take to get there. Probably in the next year to 2 years, we expect to be there.
Corinne Jenkins
AnalystsOkay. The more recent approval for Revuforj was in [indiscernible]. And maybe you could just start by characterizing kind of the competitive position in Revuforj in that patient population where patients have more options.
Michael Metzger
ExecutivesThey do have more options. So NPM1 is a larger patient population, roughly 4,500 patients in the relapsed/refractory setting. They have co-mutation. So NPM1 is a driver mutation. They are often mutated about 85% of the patients have some other mutations. Some are actionable, some are not. I'll mention 2. One is IDH1 or 2 there are medicines approved for those 2 mutations. There's also FLT3, which has some 2 different drugs approved for FLT3. So physicians, when they're thinking about treating NPM1 patients often will reach for standard of care medicine in addition to Revuforj. And so that could impact when they actually give a meta inhibitor, such as revenue forge in the treatment of a patient with -- we do expect to have a dominant share the data that we've put out so far is quite significant, stacks up well against any competition. So efficacy is the most important driver of choice for physicians why they would use our drug over another drug. Our drug has the highest level of efficacy in the category. The drug is very well tolerated. There's a lot of history now. Use of the drug, same physicians are actually treating KMT2A and NPM1. So the expertise and the experience, I should say, treating patients with both now, even preceding the approval in NPM1, we had some utilization off-label for NPM1. So physicians are used to using the drug are comfortable with the profile. The efficacy is strong, as I mentioned. It can be used as monotherapy now in combination. We're seeing about 40% of use in combination with drugs like [indiscernible]. So there's a big body of evidence that the drug is effective. And I would say that the safety is well chronicled. The drug is easily tolerated. Safety is well managed and we understand it well. So physicians are, in turn, kind of feeling very comfortable with the profile compared to what else they have to utilize for these patients.
Corinne Jenkins
AnalystsBetween the two, you've put out like a $2 million or so kind of peak sales opportunity estimate for the drug now that you're on the market, have you learned anything that would shift that expectation?
Michael Metzger
ExecutivesWell, I think the drug is a -- we feel like it's effective, as I said, monotherapy and in combination and the ability to treat patients in combination will drive utilization earlier. When we mentioned the total addressable market, we're talking about treating the absolute most patients you can in the category. So in order to do that, you need to be able to treat them earlier. And I think using the drug in combination will impact that. I think that is 1 potential learning as well as the fact that I would say for NPM1, historically, there have not been a lot of transplants. We don't expect there to be as many transplants as there are in 2 however, that we are seeing patients getting transplanted at or NPM1 specifically on revenue forged so that's sort of an upside that we see. We're excited about that.
Corinne Jenkins
AnalystsAnother kind of source of potential upside is the data you started highlighting with the NUP 98 population. Can you expand on the size of the opportunity and the Revuforj could play there?
Michael Metzger
ExecutivesRight. So it's another lesion. So when we discovered that NPM1 was an area of interest, it was based on the fact that there's an overlapping gene signature with KMT2A, the [indiscernible] signature, upregulation of [indiscernible] is another such lesion where there's upregulation enough [indiscernible] drug has been showing up some of our data sets, and it's exciting to see the impact on that specific lesion. We'll have more data at EHA to highlight that presentation specifically around DIP98,so I would look out for that. It's an important area, and we're learning that as it used to be thought of is it more of a pediatric indication. It's an area where we're seeing adult patients actually show up with 98 as well. And what we've heard from experts is that it could be as large as 5% of AML overall. No overlap with KMT2A or NPM1. So there's no cross co-mutation relative to NPM1. So that's a discrete patient population that could add meaningfully to what we're doing, both in relapsed/refractory disease as well as front line. So again, it's what we would expect as amended inhibitors, we expect to be discovered to be able to be used in other lesions, not just the 3 that we've been talking about, but potentially more in the future as we track that hope signature.
Corinne Jenkins
AnalystsAnd in terms of the development strategy to make sure physicians understand they can use it there and that they do what kind of like investment you're talking about and making sure that, that gets educated, et cetera?
Michael Metzger
ExecutivesWell, we have some investigator-initiated work. We also have some real-world data that we're putting together. So we'll continue to put that data out at conferences and potentially have a strategy to get it into guidelines, which would be impactful for physicians.
Corinne Jenkins
AnalystsOkay. Beyond the relapsed/refractory patient populations we've just been talking about. You also have clinical efforts in the frontline setting. Maybe as you look at the front line, how do you think about the pockets of unmet need and how revenue for kind of might be able to satisfy those.
Michael Metzger
ExecutivesYes, certainly. The unmet need is probably the highest in the unfit population. So there's unfit and fit within AML. Fit is generally patients who can withstand high-dose chemotherapy and unfit are generally older patients who do not take the same regimen of chemotherapy. They generally get [indiscernible]. Then ASA is approved and is now actually very impactful for patients. And it's thought that maybe even patients who are fit for chemotherapy might be better off with taking [indiscernible]. That's an emerging thesis, some data at ASH this year that suggests that, that could be the case, a lower impact regimen from a chemo perspective. So the area of highest unmet need in the front line is certainly the unfit patient population. And so our data so far is the most robust in combination with [indiscernible]. We've been able to show impact on CR rate well beyond the doublet in Phase I/II trial called BD AML trial. We continue to update that data. And we have overall survival as an important readout in that trial towards the end of this year. So that's an important supportive data set. We are running a pivotal trial in the frontline to get the drug to as many patients as possible as quickly as possible. And that's -- it's called the EVOLVE trial.
Corinne Jenkins
AnalystsMaybe you could double-click on that a little bit in terms of what we expect to see from a clinical data generation perspective over the next 12 to 24 months in the frontline setting.
Michael Metzger
ExecutivesRight? So we're enrolling this 400 to 500 patient trial called EVOLVE. It's a randomized trial on top of standard of care, Veneza. CR-it's dual primary end point, independently powered so you can win on either CR is the accelerated approval endpoint. OS is the confirmatory endpoint. And that trial is up and running with the global registration trial. So it's up and running now. We expect to open several hundred sites around the world and enroll the patients over the next year. So that's the time line. We have given guidance on when we expect to finish that enrollment exactly. But it's something where we started first. We expect to be first to frontline, and I think this is the trial that will likely get there beyond before others. The second trial is the REVEAL trial in the FIT patient population, similarly sized with an accelerated approval endpoint as well as event-free survival as the other endpoint confirmatory endpoint. But both of these trials up and running enrolling patients globally and on plan to get there first.
Corinne Jenkins
AnalystsYou mentioned Beat AML, and I think you anticipate having some update that program as well this year. How should we think about benchmarks from BAML and how they might translate into our confidence in the frontline strategy?
Michael Metzger
ExecutivesSo the [indiscernible] is the -- was the approval trial for [indiscernible] alone. And that is, I think, widely accepted as the benchmark with a CR rate in the 30% range, 30% to 40% range as well as overall survival in the high 14 around 14.5 months in that range. what we're looking to do is improve upon both. And so far, BAML has shown us on a CR rate, we're at close to 70%, so almost double we're seeing with Veneza alone. And overall survival on a very immature look at 7 months, we were out to about 15 months already pacing a little have where Venezia alone. We do expect to do a mature look at the data at the end of the year, which will be many more months of follow-up, bigger data set. So that's of interest to us as well. We think we'll add meaningfully to the overall survival piece of the puzzle here, which should portend well for derisking the EVOLVE trial.
Corinne Jenkins
AnalystsOkay. And how should we think about the market opportunity in the frontline setting relative to the other -- you know.
Michael Metzger
ExecutivesRelapse [indiscernible]. Yes, so the newly diagnosed setting, about 9,000 patients between the fit and unfit patient population. It's about 55-45 split between patients who are fit for chemotherapy versus patients who are not fit for chemotherapy. And so that opportunity, if you think about it as, call it, we like to think about it as a $5 billion plus setting in the sense that you have 9,000 patients at roughly 40,000 to 50,000 a month for the drug, WAC pricing and patients staying on for likely 12 to 24 months is what we expect in the frontline setting. That's the calculation you get to that kind of total addressable market of about $5 billion.
Corinne Jenkins
AnalystsAnd maybe just last week some before we talk about Nick tempo, but how do you think about the competitive landscape in frontline versus the competitive landscape that you like are currently situated in?
Michael Metzger
ExecutivesWell, we were the first to get the drug approved in KMT2A and NPM1 and I expect that we'll be first to front line as well. We started first. We have the most data there. Physicians are extremely enthusiastic. We're working with the best groups in the world to get those trials up and running and enrolled. So I think we have a very good setup to be first. And I think the profile that we've shown to date with the combination has really shown us up to be as pretty much as good as you can get. And so -- we feel very encouraged by the data. We feel encouraged by our position and we'll have a dominant share once we get there. But I think it's important to be there first, and that's what we're set up to do.
Corinne Jenkins
AnalystsOkay. Nick Timo was approved in August '24, and it's a partner product with Insight. Maybe you could just talk about kind of again mark-to-market eye in the launch to date and compare for your expectations in chronic graft versus disease.
Michael Metzger
Executives[indiscernible] was approved in third line plus chronic GVHD. As you all know, it launched in February of 25 in the first 11 months on the market, did $152 million in sales. close competitors, the product called [indiscernible], which was also approved in third-line GVHD a couple of years prior, and we outpaced what they were able to do in their first 12 months by a nice margin in terms of sales, in terms of patients treated. So that's usually not how it goes. Usually, order of entry, you have some step down off of the prior drug that has been approved, and that was not the case with us. So I would say it surpassed our expectations in the first year. The product is very well accepted by physicians at this point. So it's very broadly covered not only by payers, but physicians are writing the product. And that's because the efficacy is probably the best they've seen in the category for heavily pretreated patients to see that kind of level of efficacy and tolerability is really encouraging. So physicians are warming to the product, we've seen about 50% penetration in fourth line, about 1/3 of patients in third line, so growing meaningfully. And so that has been a nice start for [indiscernible] we do expect it to grow meaningfully from here as we continue to penetrate [indiscernible] and waiting on combination trials. We have an important combination reading out in the fourth quarter of this year. That could drop utilization really open up Nictembo frontline opportunity for additional growth.
Corinne Jenkins
AnalystsOkay. Since you just mentioned that, I guess, could you talk about the broader development strategy for Netia in the context of GVHD, including the subcutaneous product that's in development.
Michael Metzger
ExecutivesSure. So we -- you mentioned subcu, subcu right now, the product is an IV dose every 2 weeks or potentially once a month as well. Physicians have the opportunity to do that. The product, we believe, will grow meaningfully once we have combination data in -- with frontline or I should say, other agents that are approved standard of care. So ruxolitinib, Jakafi is approved in second line. steroids are approved in first line. So we have trials combining with both -- at the end of this year, in fourth quarter, we'll have data on a very interesting Phase II trial where we combined with ruxolitinib. We also have a rux arm in that trial and a steroid arm in that trial. Seeing the components will be pretty revealing in terms of what we can do, can we improve upon the standard of care, ruxolone or steroid alone. In that population, again, newly diagnosed patients. So I think that's a very important trial in the fourth quarter. We're also running a pivotal trial, in combination with steroids. Steroids are effective, but you tend not to want to use them too long. They have some difficult side effects, tolerability gets a little challenging as well. So you want to be able to use steroids early on in the treatment course but turn them on them off and the ability to combine with axatilimab or Nictimbo and really keep efficacy at a high rate. While safety and tolerability keeps pace. I think that's the name of the game, eliminate steroids from that regimen over time. that pivotal trial will read out in early 2028. So these are the key trials that we're launching in order to -- or carrying on in order to really solidify our position and build our position in chronic GVHD. And you mentioned subcu. Subcu is a nice add-on potentially for GVHD and even for other indications such as IPF, we are running an important trial in the ability to give the drug perhaps once a month as the subcu could open up some opportunities for us within that paradigm.
Corinne Jenkins
AnalystsOkay. Maybe in the interest of time, I want to shift to the IPF trial, so thank you for the segue. In terms of the data updates that we're going to get later this year, I guess, could you remind us of the trial design in terms of patient inclusion, exclusion criteria? And you're just confident that this Phase II will be representative and derisking a registrational program.
Michael Metzger
ExecutivesThat's exactly the setup. The setup this is a randomized trial, 2:1 on top of standard of care. So patients can receive pirfenidone or nictetinib as background therapy, we will stratify for those patient segments. It's a 26-week endpoint. A good test of the medicine over a period of time, which we think translates well into a 52-week potential extrapolation of that data. the trial is -- as I said, it's 135 patients. So it's, again, randomized. 135 patients. We actually overenrolled it a bit. So it's about 145 patients well powered to show at least a mildifference in decline between the placebo arm and the active arm. And this is a -- so this is the endpoint is -- can it's the you want to be able to kind of extrapolate to that Phase III. So we believe that this will be a good test. It's well powered to show a meaningful effect on FEC. We'll look at a variety of secondary measures as well. DLCO and quality of life measures. So this has the opportunity if the drug works well in this category to be a fantastic add-on as a therapy that doesn't have drug-drug interactions it's an antibody. So it could combine very nicely with other standard of care agents and we'll be testing on top of standard of care. So for us, we feel like this is a very precise and well-conducted Phase II proof of positive trial.
Corinne Jenkins
AnalystsOne of the questions we get is what the level of confidence is that 6 months is enough time to see separation between patients that are on the treatment arm versus patients who are not -- what is your kind of level of confidence that you will? And that you've enrolled the right patients to kind of see that separation?
Michael Metzger
ExecutivesWell, 26 weeks, if you look at the trials that have done -- that have been positive in those products that have gone on to prove themselves on the 52-week endpoint in larger pivotal trials. You look at the curves at 26 weeks, and they separate and they stay separate. So I think based on what we've observed from other trials, should be able to have a good result and have a durable result by the 26-week time point. So we feel quite confident in that. And it's not true of trials that were run on the 12-week end points. So that's what kind of drove us to power it up use a dose that we feel very comfortable with, which is the 0.3 milligram dose and stick to the 26-week end point. we're including patients, as I said, they are stable on background therapy. So they have to have some respiratory -- meaningful respiratory function, but have frank disease. So we're looking at adding to what standard of care is and obviously staying on therapy is going to be important. So you want to have enough fitness where you can test the disease -- test the medicine in those patients, but not lose patients because of -- they're too sick to participate.
Corinne Jenkins
Analysts[indiscernible] like a very busy clinical indication right now in terms of competitive agents. How do you think about the fit of this drug and mechanism of action relative to some of the other ones in the category right now?
Michael Metzger
ExecutivesSo the mechanism is its CSF1R inhibitor. So CSF1, as we know, in GVHD is upregulated and affects the disease causing macrophage. So similar in IPF where you see upregulation of CSF1 and actually having high rate high levels of CSF1 is a negative prognostic factor for disease and progression in IPF. So I think there's a -- we feel a commonality of if you can impact the disease-causing macrophages by down-regulating CSF1, you have an opportunity to impact both fibrosis and inflammation. And so that is a new mechanism, different cell type than anybody else is kind of targeting within IPF. And so if we have the opportunity to show this in this trial where we impact the disease, it will be the first time CSF1 has been able to show those types of effects excuse me. And as I mentioned, have a potential combination with other standard of care agents that impact other cells.
Corinne Jenkins
AnalystsOkay. And then just remind us because this is a partnered asset, how did the economics and decision-making work between you and your partner in Insight?
Michael Metzger
ExecutivesYes. Do you want to talk about that?
Keith Goldan
ExecutivesSure. So we have the asset is partnered with Insight for all indications. So for research and development purposes, for any indication in the U.S. Insight pays 55%. We pay 45%. So we get advantaged economics there. But then commercially, for any indication, it's a 50-50 profit split defined as net product revenue, which insight books, less cost of sales, less advertising and promotion gets you to a net product contribution. And that split 50-50, we pick up the 50% on our P&L as collaboration revenue.
Corinne Jenkins
AnalystsAnd in terms of the decision-making around the IPF program, what does that look like pending positive data later this year?
Michael Metzger
ExecutivesWell, both parties will have a decision to make. We do these things together, but we also have independent decisions. And if one party wants to go forward, they can without the other. But most likely, with a positive result we expect both parties to participate together in funding the trials and finishing development.
Corinne Jenkins
AnalystsAnd what does the registrational study look like in IPF? And kind of could you give us a sense for time lines there as well?
Michael Metzger
ExecutivesWell, we haven't guided on time lines is a little premature. Trial design will have something to do with the result that we see in Phase II. And I mean specifically around the number of patients that we're going to need to include in the trial. It will likely be on trial. We'll use this trial as a supporting trial for the package for approval. And it will be the standard end points, 52 weeks, FVC, secondary endpoints as well. So it will look a lot like what others have done. I don't think we're looking to blaze a new trail on a pivotal trial really kind of carry through what we learned and recapitulate a lot of that in -- from the Phase II into Phase III.
Corinne Jenkins
AnalystsOkay. You highlighted the R&D Day earlier, I guess what should we be focused on as we head into that event?
Michael Metzger
ExecutivesLook, I think the R&D Day is our first opportunity to do this. We had announced through the R&D announcement that we have an early pipeline now that we are excited to talk about. It's getting to that stage, and it will require some investment. We talked about the converter earlier, and that's one of the uses of proceeds to beyond '26 to really accelerate the early pipeline, new science, on strategy, precision medicine within oncology. Those are the themes. And we're very excited about these opportunities. We'll also talk about IP and GVHD and some of our ongoing work with rev Forge as well talk about frontline. And so it's an opportunity for us to really put in perspective all of the R&D work with some emphasis on some of the new projects that we're working on.
Corinne Jenkins
AnalystsSo obviously, all of that is kind of internal, at least already internal. How do you think about kind of the broader business development opportunity and capital allocation as you have a little bit more cash on the balance sheet, shifting to profitability over the intermediate term?
Michael Metzger
ExecutivesLook, profitability is something we can do with the existing cash that we have on the balance sheet. None of our expense guidance has changed. We feel like we are driving the profitability to both products really contribute to that. significantly, and we'll get there reasonably soon. I think the new cash is a really important piece of the puzzle from a standpoint of growth right? So new products in the pipeline as well as some of these adjacent opportunities, IPF being one of them, where we need to be able to invest in those opportunities alone. I think BD fits in from the standpoint of we're always interested in looking at new opportunities, but we're very disciplined, keep a very high bar. We have some additional flexibility, but I wouldn't conclude that we're going to go spend a lot of money on new business development. I think we feel very confident in what we're working on today and what we're bringing through, and we'll talk a little bit more about that at the R&D Day.
Corinne Jenkins
AnalystsYou [indiscernible] follow with that, I guess we'll see you guys in July. And thank you so much for joining us for those of us who joined this year and online.
Michael Metzger
ExecutivesGreat. Thanks, Corrine.
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