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Good day and thank you for standing by. Welcome to the DISC Medicine Corporate Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1- 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, John Quizzle. Sir, please go ahead. Thank you. Good morning, and welcome, everyone. This is John Quuzzle speaking, CEO at Disc Medicine, and I'll be joined today by Will Savage, our Chief Medical Officer, and Pamela Stevenson, our chief commercial officer. And we're here to review the top-line results for the Apollo Phase III trial of bitapertin in erythropoietic protoporphyria, or EPP. Before we get started, a few preliminaries. I'd like to remind everyone that we will be making forward-looking statements, and these should be taken in context with respect to materials that we have filed with the SEC and have posted on our website. Additionally, Bidipurton, Silcodibart, and DISC-3405 are investigational agents and are not approved for use as therapies in any jurisdiction worldwide. Okay, well, as indicated in the press release earlier this morning, the top-line Apollo data are very positive achieving all primary and secondary endpoints with remarkably robust p values and we will provide additional data on in this call in a few minutes but first i just want to step back and take a look at the big picture these results mark a significant scientific advancement in epp demonstrating for the first time in the clinic that by targeting the production of the toxic metabolite protoporphyrin 9 or pp9 that causes this debilitating disease it is possible to achieve unprecedented improvements in important metrics of disease status i expect these results will permanently change the focus of drug development in the field moreover this combination of data and the numerous publicly documented patient stories suggests the bit of burden has the potential to fundamentally change the care and life experience of EPP patients. So very exciting results all together. I want to express gratitude to everyone who helped make this possible. The patients deserve the greatest thanks for entrusting us with their health and participating in our trials, but also much gratitude goes to the advocacy groups and the doctors who've worked closely with us and to the academic scientists who described the molecular basis of this disease over decades of research. I also should say that we're grateful to those who stepped up with the capital to support these R&D efforts. We couldn't do this without any of you. And I want to thank the team here at DISC that designed and executed a beautiful series of trials, taking the experiences that we learned in phase two and using those experiences to design a winning phase three trial. There was a lot of anxiety headed into this readout, and fair enough, these endpoints are extremely challenging ones, but our team showed up and delivered both operationally and statistically. This was our first multinational phase three trial as a company, and I believe it won't be our last. We can now progress with great confidence as we begin to design and plan to execute on phase three trials for our pipeline programs in other severe blood disorders. We have a great team of drug developers here at DISC, and the future is exciting. Okay, so now turning to the top-line data, Apollo met both co-primary endpoints and all secondary endpoints. We showed, again, that bitapertin targets the underlying pathophysiology of EPP, reducing whole blood PP9, which is the biochemical driver of light intolerance and other complications of the disease. For the first time, we also showed unequivocally that bitipertin increased the amount of time patients on the trial were able to spend in light without pain, while significantly decreasing the number of phototoxic reactions they experienced. We also saw significant improvements in the time to prodrome and in patient-reported quality of life measures. Bidipurtin has now been studied in over 4,000 clinical trial participants across its development history, and we saw a generally favorable safety and tolerability profile in Apollo that was consistent with prior EPP studies. It is also worth noting that APALO was completed on a remarkably fast timeline, and nearly every patient elected to continue receiving treatment in the open-label extension portion. Collectively, these data provide compelling evidence of the clinical benefit of bitapertin for EPP patients. We look forward to resubmitting an NDA to the FDA by the end of this year, And that would set up a timeline where we would anticipate an FDA decision by mid-2027. Now, we recognize that some of the attendees on today's call may be less familiar with EPP and XLP, so I'll turn it over to Will to provide a brief overview of the disease before he reviews the Apollo trial design and top-line results in greater detail. Thanks, John. I want to take a moment to talk about EPP and why new treatments for this patient population are needed so much. This is a serious, rare, debilitating, lifelong disease that is driven by a genetic mutation which causes the toxic accumulation of the heme metabolic precursor, PP9. X-linked protopropyria is a genetic variant of EPP that similarly results in the accumulation of PP9, the main clinical manifestation is extreme photosensitivity with severe disabling pain attacks called phototoxic reactions when patients are exposed to light. PP9 is a photoreactive molecule, and patients essentially get a chemical burn from the inside out when overexposed to sunlight. The photosensitivity to accumulated PP9 means patients can typically spend about 30 minutes and sometimes as few as a couple minutes in the sun before experiencing symptoms, including excruciating pain swelling and burning all of which can last continuously for days the fear associated with the sun and the psychosocial impact of a lifestyle of sunlight avoidance mean many patients experience anxiety and depression the consequences of pp9 accumulation are systemic for example about a third of patients develop hepatobiliary complications which can advance to liver failure and be life-threatening. There is no cure or disease modifying treatment for EPP, so patients typically manage the disease by avoiding light, wearing head-to-toe protective clothing, or sometimes using tanning agents. Our aspiration here is to provide an oral treatment option that targets the cause of the disease and allows patients to be relieved of the debilitating impact of EPP to be relieved from the multifaceted burden of light intolerance, to be free from the need to plan every day around sun exposure, to me free from pain of phototoxic reactions, and to just be able to live their lives. We designed Apollo, our global phase three study, to specifically capture these aspects of the disease. Apollo is a randomized double-blind placebo-controlled trial of 60 milligrams bitopertin versus placebo for six months. Apollo enrolled adults and adolescents age 12 and over with EPP or XLP. Randomization was stratified by baseline light tolerance and geographic region. The study had two co-primary endpoints, average total monthly time in sunlight without pain between 10 a.m. and 6 p.m., during month six, and percent change from baseline in whole-blood metal-free PP9 at six months. Today, we will share the top-line results of Apollo. Here's a look at the baseline characteristics for the 183 Apollo participants. You can see that the treatment arms were generally well-balanced across key demographic and disease characteristics. The study exceeded its original enrollment target of 150 participants, ultimately randomizing 183 participants in just 10 months, reflecting strong patient and physician enthusiasm. Notably, we have meaningful adolescent representation, with 34 of the participants being age 12 to 17, and there is substantial unmet need in this younger group. 7% of participants had XLP. Geographically, we had good global representation, with a roughly even split between patients coming from the U.S. and ex-U.S., we also had even distribution of the season in which patients completed the Apollo study, with half of the patients completing their last month in the spring-summer and the other half completing their last months in the fall-winter months. Overall, these demographic and baseline characteristics are typical of the EPP patient population and are similar to those in our Phase two studies. Before I review the top-line data, I need to remark how compelling these results are. All primary and secondary endpoints were not only met, but met with clinically meaningful magnitude and strong statistical significance. Looking at our co-primary endpoints, Bidipurton met both of them, demonstrating statistically significant reduction in PP9 an increase in total time in light without pain in month six of the trial. Bitipertin-treated participants had a 45.8% reduction in whole-blood metal-free PP9 at month six compared to baseline, and a 41.4% greater reduction in PP9 relative to placebo with a p-value of less than 0.0001. Consistent with the Aurora and Beacon clinical trials, these results continue to support Bidipurin's potential to modify EPP and XLP through reducing production of the disease-causing metabolite in the body. With this PP9 reduction, we observed a statistically significant 12.2-hour improvement in average total time in light without pain during month six of treatment relative to placebo, with a p-value of 0.001. You can see that the y-axis starts at 20, which is intended to roughly indicate an extrapolated baseline monthly light tolerance from the two-week baseline assessment. The average baseline time in light over the 14-day screening period was 11.4 hours for the bitapertin group and 10.7 hours for the placebo group. It's important to note that this endpoint is not a measure of maximum light tolerance. It is a measure of how much time patients were able to choose to spend in light on the study. The secondary endpoints give more insight on the light tolerance improvements with bitapertin. Looking at the first secondary endpoint, bitapartin dramatically decreased the incidence rate of the severe painful phototoxic reactions experienced by patients by 71% relative to placebo with a p-value less than 0.0001. To help put this reduction into perspective, we've also provided on the right the total number of phototoxic reactions observed in each treatment arm over the six-month treatment period, 231 for patients on placebo and 71 for patients on bitapertin. Notably, this marked reduction in phototoxic reactions occurred while patients were spending more time in the sun. Along with the co-primary endpoints, this paints a clear picture of the potential therapeutic profile of bitapretin. This is the first time a potential treatment for EPP has shown robust evidence of whole blood PP9 reduction alongside unequivocal improvement in time and light and substantial reduction in phototoxic reactions, which builds on what we saw in the Phase II Aurora trial. Bidipurin also achieves statistical significance on cumulative total time and light without pain over the entire six-month treatment period relative to placebo. Patients on bidipurinin achieve 58 more hours in sunlight with a p-value less than 0.0001. This is an endpoint precedented by the regulatory approval of alpha-melanotide. Time to prodrome is another way of evaluating light tolerance, and this endpoint captures the weekly sunlight exposure challenges where patients are asked to expose themselves to sunlight until they feel that they cannot tolerate anymore. This analysis was pre-specified for adult patients only as the sunlight challenges were optional for adolescents, which is why the N is a bit lower than the other analyses. At month six, bit of pertinence significantly increased change from baseline in the average daily sunlight exposure time to prodrome over a two-week interval by 56 minutes relative to placebo, P equals 0.0077. This is a meaningful outcome as delaying the onset of prodromal symptoms extends the period patients can tolerate light exposure before experiencing the earliest signs of a phototoxic reaction. Again, this increase in sunlight exposure is achieved with markedly fewer phototxic reactions. We were also encouraged by the favorable safety profile observed with bitapertin, with no new safety signals identified in Apollo. There were no study discontinuations in the bitapertin group. There were a total of three SAEs occurring in the trial, two in the placebo group, and one in thebitapertrin group, none of which was considered related. Consistent with our phase two studies, dizziness was the most commonly reported treatment emergent adverse event, 50% in the vitapertrine group, 11% in placebo. All events were mild to moderate in severity, generally occurring within a day of treatment initiation, and generally transient. These findings further strengthen the robust and growing body of evidence supporting vitiprtin safety and tolerability profile, which now has been evaluated in over 4,000 clinical trial participants over the course of its development history and studied for up to two and a half years in EPP patients, which we believe demonstrates a favorable long-term safety profile. Taken together, the Apollo top line results highlight why we have confidence in therapeutic potential of bitopertin in EPP and XLP. The data demonstrate a clear impact across multiple dimensions that matter to patients. First and foremost, we have demonstrated consistent, clinically meaningful reductions in the disease-causing metabolite, PP9. This translates into clear evidence that bitopretin treatment increased the amount of total monthly time EPP- and XLT patients were able to spend in light, not only as measured during the course of their day-to-day lives, but also in sunlight challenges testing sunlight tolerance. Importantly, this greater time in light is coupled with a substantial reduction in the incidence rate of severe painful phototoxic reactions. To be able to spend more time in light without incurring pain while reducing risks of phototuxic reactions is a fundamental change to how patients experience their disease. Lastly, we know that these effects are not only measurable, but palpable to patients, as those receiving bitopertin reported clear quality-of-life benefits compared with placebo, including highly statistically significant improvement in patient global impression of change score and patient global impression of severity scores, with more bitopretin-treated patients describing their change in EPP as much better and their severity as not at all severe, respectively, at the end of study, both with p-values of less than 0.0001. Combined with its well-characterized safety and tolerability profile and patient-friendly once-daily oral presentation, we believe Bidipurton has the potential to offer a differentiated and highly attractive therapeutic profile and hope to establish a new standard of care that aligns with the needs and priorities of both patients and physicians. We are excited by these results and what they potentially mean to adolescents and adults with EPP and those who care for them. We are encouraged by the strong interest and enthusiasm we have continued to see from the patient and physician communities in participating in our clinical trials and now our expanded access program. Now I'll hand it off to Pamela to speak more about the EPP market opportunity and launch readiness efforts. Thanks, Will. We wanted to spend a few minutes discussing how we think about the EPP market opportunity and the work we've done to refine our understanding ahead of launch. We generally anchor to three patient population estimates. At the broadest level, estimates of genetic prevalence suggest there was an upper bound of 20,000 people living with EPP in the U.S. Based on our analysis of claims data, we estimate that roughly 14,000 patients aged 12 and older have been diagnosed, and of these, 6,000 are what we would call engaged, meaning they have multiple or recent EPP-related claims. These 6, 000 patients represent what we believe to be the most proximal patient population to activate at launch. In parallel, our field teams, including our key account specialists and our field medical team, have been actively engaging with healthcare providers to better understand current diagnostic and management practices and to support patient validation. This work has helped to validate our market assumptions at the top accounts across the U.S. Over the past six months, we've remained focused on three key priorities, raising awareness, sharpening our understanding of the market, and addressing critical unmet needs for EPP. First, we are actively addressing disease awareness through targeted educational initiatives and the identification of regional opinion leaders who can help organically enhance disease recognition in their communities. At the same time, we continue to deepen our understanding of the EPP landscape through account profiling and patient validation efforts. This work has strengthened our confidence in the opportunity across centers of excellence and high-volume academic institutions, while also helping us to identify and prioritize key community accounts for targeted outreach. Finally, we are excited to announce the upcoming launch of a new PP9 testing program in November of this year. This initiative is designed to provide quick, accurate, and accessible PP9 testing for EPP and XLP, helping to reduce diagnostic barriers. Collectively, these initiatives are building the foundation for a successful launch and will enable us to identify, reach, and support patients more effectively from day one. Now I'll hand it back to John to provide some closing remarks thanks Pamela the positive Apollo top-line results represent an important milestone for the program and based on these results we plan to resubmit an NDA to the FDA by the end of the year with an FDA decision then anticipated by mid 2027 we look forward to engaging with the agency with the goal of bringing an important innovative medicine to the EPP and XLP community as efficiently as possible. We also plan to present more detailed data with additional insights from Apollo during a future medical conference. In the meantime, we remain committed to supporting eligible patients through both our ongoing open label extension study Helios and our expanded access program, which is active in the U.S. and other select countries. In parallel, we are continuing to advance our commercial readiness efforts as Pamela discussed so we are one step closer in our mission to deliver meaningful new medicines to patients with serious hematologic diseases and significant unmet needs Apollo marks our first phase three win as a company and we look forward to bringing that same level of rigor across our rapidly advancing portfolio of new medicines, each with significant commercial potential. CELCO-Divart, an investigational antibody designed to suppress hepcidin, is being evaluated in anemia of myelofibrosis. DISC-3405, an investigation antibody designed to induce hepciden, is being evaluated polycythemia vera and sickle cell disease. Both of these programs have shown positive Phase II readouts earlier this year, and both assets are on track. and expected to begin phase three studies in 2027. And we expect to present additional data for both of these programs by the end of this year, 2026. So a lot of exciting things to come. And before we open it up to Q&A, I wanna just reiterate that none of this work would be possible without the patients and families, investigators and advocates who have continued to support the advancement of the Bidafurton program. We are deeply grateful for their partnership and trust. And with that, thank you for joining and I'll hand it back to the operator for Q&A. Thank you. As a reminder to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press Star one one again. We ask that you please limit yourselves to one question, one follow up. One moment as we compile our Q&a roster. Our first question is going to come from the line of Roger Sung with Jefferies. Your line is open. Please go ahead. Roger Sung, Jefferies, Great team, congrats for this impressive result. And thanks for taking our question. Two from us. One is, would those two co-primary endpoints clearly support the regulatory approval? The secondary endpoint seems to be very clinically meaningful. Can you just comment on the magnitude of the benefit do physicians, patients want to see to potentially drive the real-world adoption, particularly for the phototoxic reaction reduction and the time to prodromal with the sunlight challenge? And then regarding the safety, the only thing stick out is the dizziness, but understand this amount and the transient. And then I just want to confirm, do those events occur if Biddle restarts after temporary pause upon the AE? And how do you believe Bidtle will be used in the real world with this business profile? Thank you. Thanks, Roger. Will, I'll pass that to you. Sure. So I think that the profile that we see with reduction in the disease-causing protoporphyrin 9 coupled with large reductions in phototoxic reactions and meaningful improvements in light tolerance is a profile that is going to be extremely appealing to physicians and patients. I think that regarding the dizziness, it does tend to occur very early on in the study or early on upon initiation of treatment and is short-lived. We don't have data on stopping and restarting drug at this time. I will say that this dizzines has not led to any discontinuations. And so, you know, I think a potential real-world use case in the future is, you know, not going to have a meaningful impact on the way people live their lives. Got it. Thanks. Congrats again. Thank you. And one moment for our next question. Our next question comes from the line of Thomas Smith with Lear Inc. Partners. Your line is open. Please go ahead. Hey, guys. Good morning. Congrats on these truly stellar data and this really huge milestone for the company. Thanks for taking our questions. Now that you have the results in hand, just wondering if you can expand on the plans for NDA resubmission, what are the gating factors, and what are your expectations for the label now that you're pursuing full approval rather than accelerated approval. And then as a follow-up, I was wondering if you could provide an update on the long-term extension and expanded access programs for Benapurton, specifically wondering how many patients are in these respective programs that could become eligible for commercial drug if approved. Are there any plans to further expand the EAP, maybe adding some additional centers now that we have these definitive and, frankly, compelling results? thanks so much yeah thanks for the question Tom right we are obviously excited to to go and engage with the regulators as quickly as we can with this kind of data set and and to that point you know we're on track with our prior guidance to move towards the NDA resubmission by the end of the year which obviously feels long to all of us but really is as fast as you can manage this kind of thing. So we're moving with all urgency on that front. Yeah, and then meanwhile, these ongoing, the Helios trial and as well as EAP, we feel like these are really important to allow continuity in therapy for patients who've been in our study as well, as an opportunity for those who have need but were not able to get into our study. So in the U.S., across the Heliost trial, you know, it's roughly 150 patients present in the Helios trial. And then in the EAP, we haven't disclosed specific numbers yet, but I can say the demand has been very high. We are enrolling patients there as quickly as we can. And to your point, we actually are bringing on new sites also as quickly als we can, and I think the rate of living step has simply been operational to allow people to get access here through that EAP mechanism. So, yeah, really excited to see that kind of group of patients with access to therapy continue growing as we move through the regulatory process, and hopefully that will all come to a resolution by the middle of next year. Great. Thanks, John. Congrats again on the data. Thanks so much. Thank you. And one moment for our next question. Our next question will come from the line of Christian Kleska with Cantor Fitzgerald. Your line is open. Please go ahead. Good morning. Let me also add my congratulations on these unprecedented data. So two questions for me. The first is just on the prevalence of patients. It seems like there's more than double that are diagnosed that are not engaged in the system. How much of this do you believe is attributed to the fact that these patients either aren't interested or haven't been able to tolerate or are effective on standard of care and thus might reenter the system if there are new options out there for them, including bitopertin. And then just on the efficacy, recognizing that you are just seeing the top line now, can you give us a sense of any trends you see over time for, as I know, for example, the drug takes a couple weeks for those PP9 reductions to get in the Goldilocks zone. So, do you start to see even more benefits as patients progress further on therapy? Thanks again. Yeah, thanks, Kristen. You know, maybe I'll just hit your second question first. I think we can expect to see the same kind of trend in the Apollo data that we've seen in phase two, where patients tend to experience or take advantage of the opportunity to spend more time in light over time. We've seen that just be kind of a continuous increase as you move from the Aurora main trial into the phase two trial, into the long-term extension. So we don't have the formal analysis from phase three yet, but I imagine those trends will be the same. And, you know, while it does take about six weeks to reach a maximum reduction in PP9, we often, you know, have seen and heard patients with improvements in their symptoms or reporting improvements, you know, as early as the first week or so of therapy. So I think a pretty exciting package there. Meanwhile, to your first part of your question, we have had, you know, we were able to retain a significant portion of our sales force as well as our MSL team. Those folks have been out working to engage with the physician community, discuss disease state education and awareness. And we've learned a tremendous amount from that group. But maybe for more detail, I'll hand it over to Pamela. Sure. Thanks, John. Hi, Kristen. The question that you raised about the patients who are sort of outside of the engaged patients, your hypothesis is right on in terms of those patients. They are just not being currently managed by EPP specialists. And I do believe, based on what we've learned out in the field, that a fair number of them will come back into the system once there is a product that's available to them. And also, once you know there is more awareness of the you know EPP and new products at the community level so you know we've learned this through you know our disease state education efforts as John mentioned we're out there in the field talking to both the academic centers and identifying the community specialists who are you know sort of knowledgeable and willing to to treat EPP so we do anticipate those will be more patients coming back into the system once there are options for them thank you in one moment for our next question our next question comes from the line of Shawn lawman with Morgan Stanley your line is open please go ahead good morning John and congrats again um you know given that the EPP treatment could potentially be lifelong what have Apollo and plus Helios taught you about longer-term persistence and tolerability that might not be obvious from the six-month pivotal data set? Yeah, thanks, Sean. Great question. And, you know, just to reiterate, what we did see in six months is that, you know, zero study discontinuations from the treatment arm. I think that speaks volumes already to the need and demand here for bit of burden. and the long-term extension has shown similar levels of persistence. Will, do you have any additional comments? Sure. I think what the data from our Helios long- term extension study has shown us that the PP9 reductions, as would be predicted, persist for years, and time and light actually continues to improve as patients continue on bit of hurt in the past six months. Wonderful. Thank you. Thanks. Thank you, and one moment for our next question. Our next question is going to come from the line of Tara Bancroft with TD Callen. Your line is open. Please go ahead. Hi. Good morning, and I also want to offer a very sincere congratulations. These data are absolutely beautiful. So I want to ask a little bit more, you know, it was helpful to hear all the thoughts on on how you'll reach all the different segments that make up the TAM, Pamela. So thanks for that. But I was wondering if you could also maybe talk about your thoughts on how you actually envision like peak potential estimates of BITO. Like what level of use do you think you'll get in the highly engaged patients, you know, in terms of penetration of that population? And then how do you envision use to grow in the other segment, the larger segment, especially, you Know, with all the efforts that you're implementing, like, the testing and everything. That would be really helpful. Thank you. Yeah, thanks, Tara. Yeah, we're certainly excited about the potential here that this kind of clear data set, I think, will, as Pamela mentioned in the last question, kind of make it easier to engage with physicians around this. But, Pamela, do you want to talk about some these attributes? Sure. So, you know, absolutely in this engaged patient population, you know, what we see is, you know, a lot of patients and families who are, you know, really ready and wanting to, you know, engage and are looking for an option. So I think there, you know, with this sort of concentration of these patients in the top centers, I think it, you that speaks to a relatively quick adoption. In the broader community, it's more of a question of ensuring that the patients are aware of where they can go seek care with knowledgeable providers and that they're getting the appropriate PP9 testing, which is one of the, you know, the reasons that we're launching this new PP9 Testing Program and that their able to gain access to the product. So I think there, as we always see, it may take a little bit longer for these patients to get into the system, but once they're in the system I think they'll be ready to go. Great. Thanks so much. Thank you. And one moment for our next question. Our next question is going to come from the line of Evan Ziegerman with BMO Capital Markets. Your line is open. please go ahead i'll thank you so much for taking my questions three for me first off um in terms of the nda resubmission aside from this data set what else do you need to put together for the agency um number two i know you know you previously submitted under the commissioner's priority review program but would you be eligible for a pediatric rare disease priority review voucher upon approval and three for eugene um i know that you had folks on board that were you know going to be there to commercialize. How quickly can you re-engage the prior commercial folks to make sure that you're set up for success? Thank you so much. Yeah. Thanks, Evan. So, in terms of the NDA resubmission, I think everyone saw the CRL, the GAP, or the requested evidence from the FDA was really pointing at these Apollo trial data. And given how clean the data are, we think that's really the the substance of the resubmission there's always you know you're supposed to kind of integrate your safety database and your your efficacy information across the multiple trials um but that's about it you know non-clinical cmc these these modules are all uh previously aligned to the process we've already been to so we don't we don' anticipate any additional uh submission data on on those fronts um so really focused on on the apollo data uh uh yeah we were delighted to have a shot at this through the cnpv um uh that that that program is now kind of utilized for us and we're just going through a regular uh resubmission process under under the standard phase three traditional approval pathway um uh we did include a substantial number of adolescents now in this trial. We don't yet have a specific subgroup analysis of that group, although broadly speaking, we expect all subgroups here to show the same trends given the p-values that we're seeing. So we feel optimistic that that group's going to show nice results, as they did in phase two, but in much smaller numbers. So, we will be seeking a label that covers both adolescents and adults, and we do have a rare pediatric disease designation, so if we're successful, it would make us eligible for a PRV, so that's something we're keeping an eye on. Lastly, the question of how we rebuild and ramp up to commercialize, and yes, our CFO And Franchi is here as well, and Pamela. So, Jean, you want to just comment quickly on that? Hi, Evan. Thank you. Yes, and keep in mind, remember baseline here. We do have half of our sales team in place already, and as Pamela already highlighted, they have been incredibly active in the field along with our medical affairs team. On top of that, remember we were in a race to get to market under the voucher prior, so we were able to ramp within two months so I'm quite confident with this data being incredibly attractive Pamela and the team will be able to wrap back up very quickly because we've kept all our activities ongoing so we're in a very good place for a traditional approval thank you one moment for our Our next question comes from the line of Derek Archilla with Wells Fargo. Your line is open. Please go ahead. Hey. Good morning, and let me add my congrats on the data this morning. So maybe first off, can you just discuss the prior CNES versus NADI split in the trial? What was kind of the enrollment mix, and did efficacy really differ between those two groups? And then just in terms of the label, obviously the co-primary is getting on the label. Would you specifically look to include those phototoxic reaction reductions and time to prodrum data on the label? Thanks. Yeah, thanks, Derek. For sure. I mean, with all of our secondaries, we think are quite meaningful, and we will look to get them onto the label. I think that would be extremely helpful as we look to launch the product. But in terms of CNES, I guess baseline characteristics, I'm not sure I can really speak to that. But, Will, do you have anything to say? Sure. I think we enrolled a general EPP population that had inclusion-exclusion criteria that really didn't limit to a meaningful degree who could enter. And that's in EPP clinical trials, that's a similar case across the board. Got it. Thank you. All right. Thanks. Thank you, and one moment for our next question. Our next question will come from the line of Douglas Tao with C.H. Wainwright. Your line is open. Please go ahead. Hi. Good morning. Thank You for taking the questions, and congrats on the data. You know, John, you just talked about the data and the sort of hope to get approval in adolescents. We know that a fairly significant part of the opportunity here is with children under 12. You'd always sort of talked about sort of eventually getting to that. And, you know, I know it's still early, but given the sort of compelling nature of this data, I'm just curious if you have some additional thoughts on how quickly you would be able to initiate a study to go into younger patients. And if you have any thoughts, I mean, because obviously, you know, you noted there is a difference in terms of how you looked at the adolescent patients in terms, in terms of time to prodrome. Would this be a study sort of largely replicating Apollo, or would there be some other considerations needed looking at younger patients? Thank you. Yeah, it's a great question. I mean, I think the youngest patients of EPP is definitely a group that we want to try to help out here. And as usual, you approach it carefully, walking through adults and adolescents first and then moving on to the youngest pediatric population. So that is certainly part of our plans. We have a PIP that's been largely aligned with European regulators, and we plan to go down that path. The other thing we're going to be focusing a lot, as Pamela already alluded to, is trying to improve the diagnostic journey here. You know, the number of patients under 12 diagnosed with the disease is actually quite small today. And part of that is because it takes so long to get diagnosed. And one of our missions is to really try to help the physician and patient community reach a diagnosis much faster so we can deliver appropriate care much sooner and hopefully help people you know adjust to the disease and get better care as quickly as possible so I think the focus on the pediatric population is important to us it's a small group patients right now but what we're looking to you know kind of approval awareness and access and as I mentioned we'll be progressing with I think you know typically in this situation a pretty small study is all that's required. That's something we'll talk more about in the future. Great. Thank you. That is very helpful. I am just curious, maybe Pamela can talk about this. You have obviously been in the field doing work. I'm just curious what the most striking learning you've had over the last six months now that you've engaged on the ground talking to clinicians. Thank you. I think one of the most striking insights is how this disease, when you're really out in the community and you go into a physician's office that may not be aware of EPP, consistently what we see is they are interested and eager to learn more. There's a real human interest element to this, where people, providers in the communities, they want to help identify and diagnose and manage and help these patients. So I think that's been a really nice thing to see. You don't always see that. So that would be number one. And then, you know, the other thing I would just say is, you know, among the top centers, just a real high, on the other hand, like a very high awareness and readiness, you know, obviously based on the clinical trials, the EAP, there's a lot of awareness now there in the top accounts. And they're just – everyone is really eager to have this product approved. Okay, great. Thank you so much, and congrats on the data. Yeah, thanks, Doug. Thank you. And our next question is going to come from the line of Rami Katkouda with LifeSci Capital. Your line is open. Please go ahead. Hi, guys. Wanted to pass along my congrats from the data as well, and thanks for taking my questions. I guess the reduction in phototoxic reactions is particularly compelling. Can you provide any additional color on whether BIDO reduced the severity and duration of these reactions as well, and whether the benefit was driven by fewer patients experiencing reactions or a lower frequency of events per patient? And then, I guess more broadly, could the treatment effect with BID0 be even larger when accounting for the increased time outdoors for many patients? Yeah. Thanks for those questions. We certainly agree that those reductions in phototoxic reactions is an important endpoint here, an important indicator of benefit to patients. The specifics of your question, we may not have it in our top line, but Will, I'll pass it to you. Suffice it to say, there are going to be a lot of exciting and interesting analyses that come from this data set that we don't have right now as part of top line data. But to your first question, that is something that we will be able to look to. Regarding the second question, I guess, I mean, we have the data that we have in our trial. I think an individual patient experience can be, the data might not capture every individual's experience. You know, it might be a lot more time in life for a number of individuals on bit of pertinence. But, you know, at the end of the day, right now, we're talking about the trial output and what we see when we look at the population enrolled. Makes sense, and congrats again. Thank you. Thank you, and one moment for our next question. Our next question comes from the line of David near Garten with Woodbush Securities. Your line is open. Please go ahead. Hey, thanks for taking the question. I just had a quick one. Most of mine have been asked. And in the market research, just how many of the patients are paying patients versus Medicare, Medicaid in your research? Thanks. Hey, David, I can answer that. So for EPP, what we see is about 60% of patients are covered through commercial insurance, 25% Medicare, and 15% through Medicaid. So really, really strong. Great. Thank you. One moment for our next question. Our next question is going to come from the line of Martin Oster with Raymond James. Your line is open. Please go ahead. Thanks for taking the question. Congrats to the team on a really well-executed trial. So congrats to everyone there. Couple questions, I guess. One would be on your ex-US regulatory strategy. Curious if there's any kind of updates about your thought there, and then maybe just really high-level comments about sort of what does that commercial opportunity look like relative to the US opportunity in your mind at this time? Thanks. Yeah, thanks, great question. we are vigorously pursuing approval in European countries as well. And our guidance is that we will get a submission. We expect to get a subscription into the EMA in 2027. So that's the kind of timeline we're on there. I think it is a meaningful commercial opportunity. There are actually quite a lot of patients in Europe, probably roughly the same frequency of occurrence demographically in European countries as in the U.S. Of course, it takes some time to kind of access all the different countries there. There's more territorial complexity. But we think it's quite meaningful. And obviously, we're super appreciative that European sites participated in this trial for the first time. And we saw really vigorous enrollment there. So we think there's a high degree of patient unmet need that we want to try to meet in European countries thanks on thank you one moment for our next question our next question is going to come from the line of Steven Willie with steeples your line is open please go ahead yeah good morning and congratulations on the data really well run study um most my questions have been asked but you know we've received a few questions this morning just regarding comparison of Apollo data to the Dersimalligan-inspired data. And I know the endpoints are nuanced in a way that don't provide a direct apples-to-apples comparison, and Dersmalligan obviously isn't addressing the underlying pathology of the disease. But just curious if you could kind of speak to how you're thinking about any high-level comparisons here relative to the inspire data? Thanks. Yeah, thanks. It's a great question. I think one of the features of our data that has been the most exciting to us is the consistency that we've seen in the reduction in pain in these patients, the phototoxic reactions. If you recall in the Aurora study, you know, underpowered or really not powered for this endpoint, but nonetheless, anomalies, stat sig, you know, pre-specified endpoint stat sig showing about a 75% reduction in the rate of phototoxic reactions. And there, you knows, was definitely a diminishment in the number of people who were having reactions. That was very clear in that Phase II data set. And what we're seeing now in a properly powered Phase III trial is, you now, p-value less than 0.0001 on that reduction and pain reactions. We've shown you here, it's based on the number, well, we've seen, we shared with you the number of reactions across the study, and it's a 71% reduction, right? So, incredibly consistent data across these two trials. I think that's striking and distinctive about this product, and I think it probably is, in a sense, capturing what happens when you get to the root cause of this disease and, you know, reduce the whole blood PP9 and the production of PP9 that we think is driving the disease state. All right, thank you. Thanks. Thank you. And one moment for our next question. Our next question comes from the line of Danielle Brill with Truist Securities. Your line is open. Please go ahead. Hi, guys. Good morning. I'll extend my congrats as well on the data. Excellent outcome here. So one on the robustness of the result, I recognize that we're not going to see detailed subgroup analyses until you present them at a meeting as they're being worked through, but I was wondering if you could provide any qualitative color on whether the treatment effect was consistent across geographies. And then a commercial question, of the roughly 6,000 engaged patients that you view for the proximal launch opportunity, how much of that population have you actually validated at the account level versus remaining a claim-derived estimate? Thank you. Yeah, great question. Thank you. Will, why don't you speak to the clinical side, and then Pamela, you can touch on the commercial side. Sure. Regarding the subgroup, I think with the magnitude and the statistical significance that we're seeing there's not going to be meaningful differences across subgroups that are important so while we you know it's something that we may look at in the future I don't think it's going to change any of the conclusions of this study and then on your commercial question as I mentioned we really have spent you know the last six months digging into validating patients in the sort of the top 100 and 120 accounts across the U.S., and I would say everything that we've seen to date has been consistent with what we've seen in the claims data. We've been able to validate a significant number of patients and, you know, are very confident in the, you know, the claims-data analysis that we already shared for these top-level accounts. One clarification. I'm sorry. So, of those 6,000, would you, like, are you saying the majority of them, you would assume, are concentrated across those top 120 accounts? I would say that, well, you know, we have, I wouldn't, what I would Say for this is that we have identified a fair number of them in these top accounts. I think what we will see as we go out and the product becomes available is that more patients will funnel into those accounts. Understood. Thank you so much for the question. Sure. Thanks. Thank you. And I'm showing no further questions at this time. And I would like to hand the conference back over to John Quizzle for closing remarks. okay yeah so obviously we're delighted with the data and the progress we've made and thank you all for your attention today this concludes today's conference call thank you for participating and you may now disconnect everyone have a great day