Conference Transcript - CELC 2026-09-08

Eva Forte, Analyst — Wells Fargo

And yeah, so my name is Eva Forte. I'm one of the Wells biotech analysts. For our next session, we have Ryan Sullivan, CEO and co-founder of CellCuity. Thank you so much for being with us today.

Ryan Sullivan, CEO

My pleasure.

Eva Forte, Analyst — Wells Fargo

Cool. So maybe to start, can you give us just a little bit of the lay of the land and, you know, CellCuity past 12 months, future 12 months?

Ryan Sullivan, CEO

So our lead candidate, the lead drug is now actually an approved drug, RevTorPic. It's a pan-PI3K mTORC1-2 inhibitor. We recently received approval to treat patients who have progressed on their first line of endocrine treatment for metastatic disease, so it's a second-line therapeutic option for patients who have no PIK3CA mutation detected. And we have two regimens that were approved, GETA or REVTORPIC with polycyclob and fulvestrin or REVTORPIC with fulvestrin. And so we're in the midst of preparing for our launch. We expect to ship, have commercially available drug by the end of this quarter. We've also initiated and are enrolling patients in two phase three studies for patients who are treatment naive in the advanced breast cancer setting. There are two different groups of patient population of patients, one that is considered endocrine sensitive, one endocrine resistant. Total number of patients that potentially could be eligible over time would be roughly 90,000 annually. So a very significant patient population. We expect to have data from the endocrine-resistant population sometime late 28, early 29, and for the sensitive population, probably late 29 or 30. We have a phase 1, 2 study underway, ongoing, in prostate cancer, prosecuting a similar underlying biological hypothesis as we've done in breast cancer, which is that it's a hormonally-driven disease, in this case, the endocrine receptor pathway, that involves the PAM pathway, PI3K, AKT, mTOR pathway. And we've reported initial data that, in our view, was favorable. We'll be providing an update with that data later this year at a medical conference. And so there you go. That's an overview.

Eva Forte, Analyst — Wells Fargo

I mean, plenty of stuff there.

Ryan Sullivan, CEO

Oh, and we have another data set. We announced data for patients who have a PIK3C mutation. We presented that data at ASCO. We submitted our supplemental NDA last month. And so we expect things to go the way we hope that that supplement, that SNDA, would be approved sometime the second quarter next year.

Eva Forte, Analyst — Wells Fargo

Got it. So maybe we can start with the approval. Reptropik. I hope I'm pronouncing this right.

Ryan Sullivan, CEO

Reptropik, yeah.

Eva Forte, Analyst — Wells Fargo

So maybe just we can start with, you know, the pushes and pulls of, you know, shifting the launch towards the third quarter. What are the gating factors?

Ryan Sullivan, CEO

Well, we'd always projected third quarter. So essentially, we just provided more detail when we got the approval. As far as the timing of the launch and when the product will be commercially available, Basically, we're waiting to get initial feedback from the FDA on a post-approval supplement for our second manufacturer. The first manufacturer we have has relatively low capacity. And to support the launch, we want to have visibility to confirm that we'll have two manufacturers able to support the volume, you know, what we anticipate the demand. And so this post-approval supplement was provided to the FDA or submitted to the FDA within a week after approval. And so we expect to get some feedback, you know, before the end of this month. The process we have is very robust. You know, the review in the NDA of our first manufacturer was very straightforward. Really no meaningful information requests. So we're very confident about the quality of the data that we submitted, the robustness of the process overall, and the capability of this manufacturer. So it's just a matter of, to be frank, being cautious on my part to minimize the risk of potentially having a drug shortage in the midst of a launch, which obviously would not be a good thing.

Eva Forte, Analyst — Wells Fargo

Got it. And, you know, in this scenario where this second manufacturer would not be able to come online, would you have enough drug supply to actually launch at the end of the quarter?

Ryan Sullivan, CEO

So we just want line of sight on when that manufacturer would be approved. And so we just want to make sure there's no obstacle in that. Again, the process is very robust. Using the same process at the second manufacturer, the data generated in that process. There's probably 50 analytical methods that are used to assess, in effect, to determine adherence to the various specifications, to measure adherence to these specifications. So all those metrics essentially line up. We're very confident. But again, it's the FDA, we're not in charge. And you don't know what you don't know. And so we're just being extra cautious on that front.

Eva Forte, Analyst — Wells Fargo

Got it. So maybe shifting the conversation a little bit to the EAP that you announced. Can you, you know, it's been a few weeks now. Can you just give us some qualitative insights into the EAP?

Ryan Sullivan, CEO

So no, we're very pleased with the response. And there's two components to an EAP. You know, EAP is Expanded Access Protocol. Essentially, think of it as a clinical trial, and we're supplying clinical trial material. So that's why it doesn't interfere with our ability to launch. The challenge for some sites is that their processes to approve a protocol involves conducting their own internal IRB process. Sometimes they'll have scientific committees. And so it can be kind of cumbersome. And given that the launch, the time when the drug will be available, that actually is, this in sense, a number of sites that have these fairly extensive protocol review committees, processes. to use it. So essentially, the doctors that are in best position to take advantage for their patients of the expanded access protocol are ones that rely on or are comfortable accepting a central The protocol is central IRB approval, and they don't have a second step involved, and they can move quickly so that essentially they're not putting patients on EAP, and then a week later, commercial drugs available.

Eva Forte, Analyst — Wells Fargo

Got it. And how long would it take to transition these patients? And also, have you shared any numbers in terms of demand?

Ryan Sullivan, CEO

We haven't. Again, we'll provide updates on our normal quarterly updates for the third quarter would be the time when that would occur. And as far as transitioning patients, I mean, that's part of the protocol is that they will be transitioned. But obviously, we won't do anything that could interrupt their supply. So I think from a practical standpoint, we would imagine that that cutover would occur after they've received day 15 drug. So essentially our drug is administered on days 1, 8, and 15, so roughly a two-week period, and then there's a two-week gap. And so to the extent that there's any process involved in getting the drug to that site and available to that patient, that would make the most sense from a practical standpoint.

Eva Forte, Analyst — Wells Fargo

Got it. And is the EAP only US-based or do you also?

Ryan Sullivan, CEO

It's just US-based, yeah.

Eva Forte, Analyst — Wells Fargo

Okay, got it. So maybe let's talk a little bit about the label and kind of like what feedback have you gotten so far? I mean, for the triplet, we had like 9.4 months PFS versus like two months full restaurant. Like, can you put this into context?

Ryan Sullivan, CEO

So two things, two perspectives to consider when you're trying to compare or to at least assess how our data compares to other data presented. You know, we reported a hazard ratio of 0.24 for our triplet, Geta, Palbo, Fulvestrin, 0.33 for the doublet. If you were to look at historically the trials done in breast cancer, HR-positive breast cancer, you'd see that those results were more favorable than had ever been reported in breast cancer. So very, very historically important sets of data. And then the other way to look at that is to say, OK, most of the drugs evaluated in the second-line setting have been compared to endocrine monotherapy, let's say fulvestrin, which is what we use. So you have a common control. So then you can assess on a relative basis the median PFS of, let's say, the drug regimen versus the controlled fulvestrin. And so our triplet offered four and a half times greater median progression-free survival If you were to look at the historical data for drugs that might be competitive to ours or alternatives that are currently being used, you'd see at best maybe 2x, two times improvement relative to the control. So from a differentiation standpoint, we think Geta, Triplet, and Doublet have established a new benchmark, in our view, and really that warrant them being standard of care for patients who have lack of PIC-3C mutation.

Eva Forte, Analyst — Wells Fargo

Got it. And you also had data for the doublet, which was also meaningfully different.

Ryan Sullivan, CEO

Again, it was very favorable and essentially now with two regimens. So it's unusual when you're launching a drug to give physicians two alternatives. And we think that really will optimize our ability to achieve our target penetration because, as anybody knows, in this cancer setting, there's a wide range of patients. You'll have some 35-year-old woman who are being treated and 75-year-old woman. And then every variation in between, a lot of different clinical characteristics or comorbidities that these patients may have. And so by giving the doctors an opportunity to select one versus the other, again, according to their analysis of the patient's profile, that's great. We think we maximize the likelihood that the doctor will want to use GEDA as a backbone for that second-line setting.

Eva Forte, Analyst — Wells Fargo

Got it. And based on the feedback, what type of patients do you expect would be getting the doublet versus the triplet?

Ryan Sullivan, CEO

So our research indicates in the wild-type setting that we think it'll be roughly an 85 to 15, 80-20 split. Because if you were to look at all the subgroup analyses done in the forest plot analysis for the triplet versus the doublet, you see very consistent greater response levels for the triplet than the doublet. Now, we've heard some doctors say they'll start with the triplet, and they'll monitor the patients. And if they believe the neutropenia that palbocyclib induces is a concern, they can discontinue the palbo and continue with the triplet. but because they know, based on the data, that the doublet offers their patients a good option. And vice versa. Some may start with the doublet, see how the patient does, and add palbocyclic. And so we think, again, that flexibility, giving them that optionality will improve or increase the potential penetration that we can achieve. And they're both good options for patients. Again, depending on the particular clinical profile, So, you know, one might be more appropriate than the other.

Eva Forte, Analyst — Wells Fargo

Got it. And one of the main pushbacks we've heard has been, you know, the IV dosing versus oral. And maybe can you just, you know, for us and investors, just, you know, can you provide a little bit more color on the feedback you've gotten from KOLs? And also just clarify the dosing and the fact that there's this two week off, you know, time.

Ryan Sullivan, CEO

I think there's a lot of attention paid to the fact to get us infused partially because there's been a lot of work done with oral serves have been five or six drugs that have been evaluated many of the KOLs have participated in that so it's very top of mind and one of the hypotheses or theses for the rationale for for that drug was that it was more convenient alternative than fulvestrin which requires intramuscular shot once a month and that's fine but But in the research that we've done, which essentially weighs, or rather takes into account, or rather assesses community docs as well as docs treating patients in an academic center, we don't find that the infusion is going to be a barrier to take up. We do assessment of the demand that they anticipate using based on response to various potential patients that they might treat. And then we ask what their perspectives are on various characteristics of the drug, whether it's the efficacy or safety profile, or the route of administration. And we ask that question in two different ways. And so what we found amongst, and this is a quantitative survey, we're not interacting, this is done through the internet. And on a blinded basis, they don't know the drug. So we only find the IV is, quote, a negative factor in their consideration of use of the drug by 5% to 8% of the doctors. So for some doctors, it may be a barrier, but I think a very small percentage. For most doctors, roughly 60% or not 60%, about 50%, it's a neutral factor. And in the balance, it's actually favorable because they get to see these patients. These are second-line patients. Their survival projection is a couple years. so they can decline, unfortunately, quickly. And so there's an advantage in that roughly, I think, 30% of these doctors in seeing these patients more frequently. So net-net, we don't view it as a barrier to achieving very significant penetration.

Eva Forte, Analyst — Wells Fargo

Got it. Okay, that's more clear for us. Maybe just talking a little bit of the toxicity profile and kind of, you know, there were these questions on the label. There was a little bit of higher adverse events than what we had seen at the presentation. So maybe can you clarify where is this coming from? And also, particularly for the stomatitis, the prophylactic measures.

Ryan Sullivan, CEO

So there's two ways of assessing adverse events or categorizing them. And what you oftentimes see in publications, which is how we approached it, you'll present treatment-related adverse events. The FDA essentially decides that they want to only look at treatment emergent, which says, regardless of whether there may be a linkage or not, if an event occurred, it's going to be ascribed to the drug. And, okay, that's their right. There wasn't very much variation, to be frank, between treatment-emergent, treatment-related results that we presented. There was one difference in the discontinuation rate for GEDA. And, again, treatment-related was very low, but treatment-emergent was higher. We found that discontinuations of GEDA early on were higher early on, and they were primarily related to one region. And that was a function probably, in our view, of just more caution than was warranted. And so we found in the second study, our mutation study, same sites, but it took longer to enroll, and we had disproportionate number of wild type, that the GEDA discontinuation rate was you know five percent four percent so essentially very very favorable overall so you know we think that um there's always some translation or rather it's very typical to essentially see some you know a couple percent here or there difference between a treatment related characterization of safety data versus a treatment emergent characterization got it makes sense uh maybe just on the launch and kind of like how should we be thinking about the first few weeks or a few months of launch?

Eva Forte, Analyst — Wells Fargo

I mean, we're going to have a temporary J-code. How should we be thinking about reimbursement and friction?

Ryan Sullivan, CEO

So, you know, temporary J-code, one of the biggest or potential obstacle when you're launching, I should step back, anytime you're launching a drug first time, there's a variety of friction points, right? Systems have to put in place order sets, essentially, which is information related to your drug and to their electronic health records. Well, that can take, depending on the account, a few weeks can take a couple months. And that greatly facilitates prescription of the drug. And so, okay, that's one friction point. Another friction point is reimbursement and time to reimbursement. And so our drug is a buy and bill drug. So essentially these accounts will take ownership of the drug when we ship it, and they will be obligated to pay us at the time they do. Well, with temporary J-code, the reimbursement process, the time when they get paid by the insurance company, can be very extended, because it's not a streamlined process without a J-code in place. And so they're reluctant to potentially become cash flow And so the way to ameliorate that or mitigate that is to offer extended payment terms to those accounts. And so, for instance, if it normally take 60 days for them to get paid by an insurance company, but with a temporary J-quot, it could be 120 days, as an example, will offer extended terms to them. So they're not, in effect, cash flow negative, out of pocket by buying our drug. And that's been found to be a good way to address concerns by these accounts. But any launch will typically, it doesn't go to 0 to 60 in a week. There's a lot of work that's needed to be done. You know, for instance, with strategic accounts, getting pathways characterized, with obviously insurers getting them to put you on the formulary and hopefully, you know, assign you a preferred status along the way. Those steps take time. Our team has been meeting with, you know, this is a market access-related dynamics. The team has been meeting with these accounts for the past 18 months. You know, since we've had our data, we could present our data. And they can do that. But they're not treaters, so you can safe harbor to talk to them about the data. You can't really get formal committee reviews until you have your label. So we submitted the dossiers and other materials that are required for them to do an assessment of the drug more formally immediately after the approval. And so that process is underway, and we're very, very satisfied with how that process is going at, you know, the national accounts and strategic accounts.

Eva Forte, Analyst — Wells Fargo

Got it. So revenue might not be the best metric at the beginning to really assess how the launch is going. What other metrics are you going to provide to investors?

Ryan Sullivan, CEO

Well, you know, we'll provide some color. So one drawback of having a buy-in bill drug is that unlike, let's say, drugs that are shipped through a pharmacy, we won't have visibility into which doctor prescribed it or whether it's a new patient. And so the revenue will be the most important metric overall for assessing the launch. But then there will be what you might call softer metrics, but they're activity metrics related to status with different insurers or status with strategic accounts. So we'll provide color on that. The data that's more granular that, let's say, oral drugs have, because they're mostly prescribed through pharmacies directly, directly, is something we'll be able to get on a lagging basis, essentially two to three month lagging basis, for accounts that represent roughly 40% of patients. So it'll be helpful data internally. We'll be sorting through the best way to present it because, again, it'll be lagging and we want to make sure the data is consistently available. It won't really be helpful to provide one-off data sets. And any data that we present, we'll want to make sure we can present consistently, and the reliability of it will be consistent as well.

Eva Forte, Analyst — Wells Fargo

Very helpful. And maybe can you just provide some color on your pricing strategy, and how should we be thinking about Growth to Net?

Ryan Sullivan, CEO

So we submitted our pricing to the various pricing compendium. Those are the organizations that payers' strategic accounts use to access the price for their systems. That will vary depending on their system and where they fall. in the universe of public, private, et cetera. So our price is $30,000 per cycle or $32,500 per month. There's 13 cycles. It's a 20-day cycle, so 13 cycles in a year. Each vial is $10,000. We've reported that the average duration of treatment that we found in our Victoria 1 study for the wild type was around 10 months. So each patient, you know, we think generate or rather utilize 10 months or rather utilize a drug for 10 cycles at that price. The gross to net we estimate will be about 80%, so 20% off the wholesale acquisition cost. So you think it's favorable, and there's fewer hands that the drug goes through when it's a buy-in bill than if it's an oral drug, you know, going through PBMs and a bunch of other potential intermediaries. And so it's a more efficient distribution, which results in, we think, net-net, rather, you know, higher gross to net than you might otherwise get.

Eva Forte, Analyst — Wells Fargo

Got it. And this number of cycles, is this for the triplet, for the doublet, or for, you know, both?

Ryan Sullivan, CEO

They're somewhat comparable. And so from our perspective, you know, our goal is that physicians use this drug because we think it offers their patients the best opportunity to be progression as free as long as possible. If they use the doublet, fine, great. If they use the triplet, fine. You know, essentially what we think the impact for us will be is that they're using our drug. Duration of treatment will be comparable, you know, plus or minus a month or so. But it's more important, in our view, that by giving doctors an option, We think we've increased the number of patients, the percentage of patients that they'll be willing to treat with our regimen.

Eva Forte, Analyst — Wells Fargo

Got it. And in terms of the launch, do you have any proxies that you can share with us, the way we think about GEDA's launch?

Ryan Sullivan, CEO

Well, so we have 90 folks, 90 oncology sales representatives in the field today. Then they're managed by 10 in 10 regions. We have a team of MSLs that are also calling on doctors, coordinating with the regions and how they're going after those accounts. Our strategic accounts team, essentially a separate group of individuals, works kind of from the top down. And so they're the folks that are coordinating with, let's say, the Dana-Farber's of the world, U.S. oncology's of the world, UPMC's of the world, to get incorporated into their pathways. Those accounts are particularly relevant, UPMC and Dana-Farber as an example, because not only are they making pathway decisions for their own system, but they also make those pathways available to other systems. And so let's say UPMC will actually, their pathway document, ClinPath, will be something that up to 15, systems that treat roughly 15% of all patients would be utilizing to guide their treatment guidelines. And so a lot of work on our teams around getting those pathway determinations finalized, hopefully incorporating GETA as a regimen. So we'll provide updates on, as appropriate, any activity there that we think will be helpful for people to understand the status of the launch.

Eva Forte, Analyst — Wells Fargo

Got it. And in terms of, you know, PIC3 mutant patients, you showed the data, you submitted the SMDA, you mentioned second quarter for a potential approval. Can you maybe just put the data into context? This is a more competitive space than the wild-type patients. and also how should we be thinking about incorporation of this data on label?

Ryan Sullivan, CEO

So the data that we reported at ASCO showed that they got a doublet and triplet offered two times the median PFS benefit. Hazard ratio was 0.5. So essentially it showed head-to-head the benefit of a multi-target PAM inhibitor versus a single-target PAM inhibitor, a single-component PAM inhibitor. Our research indicates there'll be significant preference for this regimen. And it's not often that you get a 2x delta relative to an active control, as this was. And as far as, you know, competition, I think there's potential competition or additional options coming out. We think the data was very convincing, very convincingly demonstrated the importance of multi-target inhibition of this pathway. You know, there's the two drugs that hit in the second-line setting that are approved that address this pathway. One's a PA3K-alpha inhibitor, alpalypsid, picray. The other's an AKT inhibitor, TruCat, capovacitor. If you look into the data, you'll see that they offer very, very comparable efficacy, you know, compared to endocrine therapy. And that's not surprising to us. We think there's limited biological potential when you're only inhibiting a single component. And so to the extent that there are other drugs coming down the pike that are hitting a single component, biologically we think that that approach is obsolete. We think, ultimately, if you can comprehensively inhibit this pathway, as our drug does, as RevTropic does, that that will induce a more favorable treatment effect. We've published a lot of non-clinical data in a variety of tumor cell lines, whether it's breast cancer, prostate, endometrial, ovarian, et cetera. And very consistently shown that Geta is, in his breast cancer in particular, 300 times more potent than a single-target inhibitor, whether it's an Everolimus hitting M4Q1 or Kapovacitor hitting AKT or Alpalipsib hitting PI3K alpha. And that just relates to the nature of this pathway. Very complex, multiple components, inhibiting one component induces activity down the others and essentially cross-activates the others that are uninhibited. And if you are able to shut this pathway down by hitting all these components, you don't need very much drug, 12 nanomolar versus 6,000 nanomolar, for instance, to induce a half-maximal effect. So it's very relevant. It's orders of magnitude better to comprehensively inhibit that. So we'll see what comes of these other drugs. but we think the underlying mechanism of action of GETA is very, very relevant. And we think ultimately that's going to maintain as a standard of care for these patients.

Eva Forte, Analyst — Wells Fargo

Very helpful. And maybe can you share with us how you're thinking about duration of treatment for this PIK3 mutant patients compared to the wild type and also commercial opportunity versus the wild type?

Ryan Sullivan, CEO

So 60% of patients don't have a PIC3C mutation detected. That's the wild-type group that we have approval for. 40% have a PIC3C mutation. The data that we presented for duration of treatment for the mutant is much more immature than the data we presented for the wild-type. And so the mutant population with fairly short follow-up average duration was in the 11-month to 12-month range. So it'll be greater than the wild-type. As that data matures, essentially, when you're doing an average, what can really greatly impact or help your average duration is just that a lot of these patients are on drug for years. And so that obviously will boost up the overall average. So, you know, we think net-net, the mutant population will represent, you know, 45% of the total market, 40% plus a little bit more on top because of the somewhat longer average duration of treatment.

Eva Forte, Analyst — Wells Fargo

Got it. And maybe just on the survival benefit, I mean, we haven't seen maybe an overall survival for neither the wild type or the mutant patients so far, but when should we be expecting this and how important do you think it is for, you know, doctors?

Ryan Sullivan, CEO

So there hasn't been a survival advantage shown for any drug in the second-line setting. And I think this is the various confounding factors that make that challenging. In the wild type setting, we've presented interim OS analysis for both the wild type of a mutant and showed favorable trends. In the wild type, we think the survival data will be confounded because we allowed crossover. Patients who were treated in the control arm with fulvestrant were allowed to cross over. Roughly 60% or so crossed over. So essentially, we're competing against ourselves in that OS analysis. Whereas in the wild type, or rather in the mutant population, there was no crossover. So it's head to head. Again, promising but preliminary, immature data in the mutant segment. And so if that analysis we think will have the best potential opportunity to show a possible survival benefit. But again, it's a high hurdle to meet, and it hasn't been met to date in the second-line setting in breast cancer.

Eva Forte, Analyst — Wells Fargo

Got it. Very helpful. Maybe just, you know, with the last few minutes, just wanted to touch upon the first-line study. You included the endocrine-sensitive patient population earlier this year? How are you thinking about the strategy there and what gets you confident that you can succeed?

Ryan Sullivan, CEO

So there are 90,000 women each year who are diagnosed with metastatic disease that is untreated, treatment-naive patients. 60,000 of them are endocrine-sensitive. They get about 25 months of benefit from their current treatments, It's medium progression-free survival. In a Phase I-B study that enrolled 41 patients, we reported 48 months meeting PFS. So obviously, it compares very favorably to the reported data for the current standard of care. So we were optimistic about that study. Certainly, the fact we had two positive readouts in wild-type and mutant that showed very significant activity of GETA gives us additional confidence. But that's a longer study. We're enrolling, I think, 760 patients or so, or 780. And so we don't expect that data probably until late 29, 30 sometime. Endocrine-resistant population, worst prognosis. These are women who didn't get much benefit from their adjuvant endocrine therapy, their letrozole or tamoxifen. They're only getting about seven to eight months of immediate progression-free survival from their standard of care therapy. So it's a lower bar to beat. In some ways, you can think of it as almost a second-line study in the context of the data that we need to show. And we think the data we've shown to date, if we repeat what we did in the second-line setting, in that setting, we'd have a positive readout, we think. So we're optimistic about both studies. And we think having the quality and differentiation of the data that we showed in the second-line setting It just augurs very well in the first-line setting. And importantly, this pathway, the PAM pathway, one thing that distinguishes it from, let's say, the estrogen receptor pathway, which can be affected by prior treatment and induce ESR1 mutations, PIC3CA status is stable, and it's intrinsic. So that mutational status doesn't change over time. First-line patients with PIK3CA mutant is very similar to the second-line patients. So there's no transition. And our data from the first-line population was 80% wild-type, i.e. it showed really that the extended progression-free survival we reported occur even though most of these patients lacked a mutation. So we think that provides demonstration of the important role this pathway plays intrinsically in this disease. It's not a function of what patients receive for prior treatment.

Eva Forte, Analyst — Wells Fargo

Got it. And you also mentioned earlier this year you were working on a sub-Q formulation. Maybe can you just give us the latest there?

Ryan Sullivan, CEO

So sub-Q formulation we think is going to be most important for patients who are endocrine sensitive, right? Patients who could be on this drug for several years. For obvious reasons, it would be more convenient for them to have the ability to have a shot, potentially take, you know, self-inject. We don't think it's going to be as impactful or really very impactful on the second line or setting or the endocrine resistant population. It'll help, but it's not determinative. And so we've begun that work. We began that work, you know, a while ago. We're advancing several candidates formulations and there's a variety of criteria that we're using to evaluate those. And so we're moving those through the pipe. And the goal is to have an approved sub-Q formulation in time or to coincide with approval, we hope, of our regimen for the endocrine-sensitive population. And that, you know, 2030 timeline.

Eva Forte, Analyst — Wells Fargo

Got it. Very helpful. Maybe just, are there any questions in the room? No? Okay. I'll ask one last on prostate. We have data coming up in the fourth quarter of this year? Maybe can you just give us a sense of what should we expect?

Ryan Sullivan, CEO

Sure. We presented data probably last year. In our view, it was favorable. It showed, compared to historical data, a meaningful increase in percentage of patients that were regression-free at six months. So this update will have data from an additional dose. We'll also also provide some additional subgroup analyses that we think will be informative. And then we'll also update on our next step towards the development of the drug in that Got it.

Eva Forte, Analyst — Wells Fargo

Well, we're out of time. Thanks so much for joining us today. This was very helpful.