Good morning and welcome to RAPT's conference call. At this time, all participants are in a listen-only mode. There will be a question-and-answer session after the prepared remarks, and as a reminder, today's call is being recorded. I will now turn the call over to Sylvia Wheeler. You may begin. Thank you, Operator, and good morning. Thank you for joining us to discuss our press release issued this morning, which is available along with accompanying slides in the investor section of the company's website at rapt.com. On the call with me today are Dr. Brian Wong, Chief Executive Officer, and Dr. Will Ho, Chief Medical Officer with prepared remarks, and Rodney Young, Chief Financial Officer, who will join us for the question-and-answer period. In addition, we have a special guest, Dr. Ana María Giménez-Arnau, Professor at the Hospital del Mar Medical Research Institute in Barcelona. As outlined on slide two, we remind you that during this call, we will be making forward-looking statements that are subject to risks and uncertainties. Our actual results may differ materially from those described. We encourage you to review our risk factors in our most recent quarterly report on Form 10-Q, which can be found on our website. While we may elect to update these forward-looking statements in the future, we specifically disclaim any obligation to do so even if our views change. I will now turn the call over to Brian. Thank you, Sylvia. Good morning and thank you for joining us. Today, we are presenting top-line results from a phase II clinical trial evaluating RPT904, also known as JYV1904, in patients with chronic spontaneous urticaria, or CSU. The phase II trial was executed by our partner, JU, formerly known as Gemitier, in China. RAPT owns all ex-China development and commercialization rights to RPT904. This study marks an important step forward in our mission to develop innovative therapies that address the immunologic drivers of inflammation. Starting on slide three, the top-line data from this phase II study are highly encouraging and have exceeded our expectations. This trial was a randomized double-blind trial comparing RPT904 dosed every eight or 12 weeks to Omalizumab dosed every four weeks with a 16-week treatment period. It was not a formal non-inferiority study, and no statistical hypothesis was tested. Results from this study suggest that the efficacy of RPT904 administered either every 8 weeks or every 12 weeks is comparable to Omalizumab, which was administered every 4 weeks. Both RPT904 dosing arms showed numerically superior efficacy to Omalizumab on UAS7, the primary endpoint, as well as a key secondary endpoint called the UAS7=0, or complete response, across all time points, which are weeks 8, 12, and 16. In addition, in the Q12W arm, where only a single dose of RPT904 was administered, numerically superior efficacy was sustained out to 16 weeks, indicating a highly durable therapeutic effect versus Omalizumab. RPT904 was well tolerated across both dosing regimens. There were no drug-related serious adverse events or discontinuations, and no adverse events of special interest, including anaphylaxis. We believe these efficacy and safety data support advancing RPT904 into pivotal phase III studies. We and our partner, JU, plan to engage with regulatory authorities in our respective territories to discuss potential registrational pathways. Additional data, including from the follow-up period and secondary efficacy endpoints, will be presented at a future medical conference. Before we review the data, let me first highlight the mechanism of action and competitive advantages of RPT904. Starting on slide four, immunoglobulin E, or IgE, plays a central role in the pathogenesis of CSU, food allergy, asthma, rhinosinusitis, and other allergic disorders. Upon initial allergen exposure, antigen-presenting cells activate T helper II cells, which stimulate B cells to produce allergen-specific IgE antibodies. IgE binds to the high-affinity FcεRI receptors on mast cells and basophils, which, upon allergen re-challenge, can trigger immediate hypersensitivity reactions, including anaphylaxis. RPT904 acts to interrupt these allergic pathways in two ways: first, by blocking IgE from binding to its receptor, and secondly, by removing IgE from the cell surface of mast cells and basophils. These actions have the additional effect of downregulating the FcεRI receptor, which further desensitizes these cells to further antigenic stimulation. Moving to slide five, Omalizumab is currently the standard of care for CSU patients who are inadequately controlled by high-dose antihistamines. This is due to Omalizumab's high degree of efficacy combined with a well-established tolerability and safety profile. Other agents in development have shown variable efficacy and safety, but none have demonstrated clear advantages to Omalizumab. Despite Omalizumab's position as standard of care, it has limitations in terms of durability and convenience. It requires monthly dosing, which can impact compliance, and roughly 20%-30% of CSU patients require updosing to produce adequate benefit. We believe RPT904 has the potential to address these shortfalls and become the preferred choice therapeutic option in patients inadequately controlled by antihistamines. Slide six highlights RPT904's unique design and potential best-in-class characteristics. RPT904 was engineered to have a longer half-life, driven by the well-validated YTE mutation, a higher affinity for IgE, which should reduce overall dosing burden, and improved drug-like properties, including improved stability and manufacturability, as well as reduced immunogenicity. Importantly, RPT904 targets the same IgE epitope as Omalizumab, and therefore we believe RPT904 carries a high probability of technical success. The molecule has strong intellectual property protection with composition of matter patent applications that, if issued, support exclusivity to at least 2041, excluding patent term extensions. This intelligent engineering was designed to enable less frequent dosing and greater durability. Our modeling suggested that a dose every 8 or 12 weeks instead of every 4 weeks for Omalizumab should be sufficient in patients with CSU, which translates to just 4-6 injections per year versus 12 injections per year for Omalizumab. This increased dosing convenience should increase patient adherence and therefore better clinical outcomes. In addition, the increased affinity and half-life may also reduce the need for updosing. Primary market research surveying 50 allergists showed these advantages would quickly drive RPT904 to become the preferred treatment option in CSU patients eligible for advanced therapies. With this background information, I will turn the presentation over to our Chief Medical Officer, Will Ho, who will walk through the phase II CSU data in greater detail. Thank you, Brian. I'll start on slide 7 to review the trial design. The phase II study was a randomized double-blind active control trial conducted at sites in China. The study had a 16-week treatment period and then an additional 16-week follow-up period without additional treatment. The data recorded today are from the 16-week treatment period. Planned enrollment was 135 adult patients with CSU who were inadequately controlled by H1 antihistamines. Patients were randomized in equal proportions to receive 300 milligrams of RPT904 every 8 weeks, corresponding to doses at weeks 0 and 8, 300 milligrams of RPT904 every 12 weeks, which was represented by a single dose at week 0 in this trial, or the approved dose of Omalizumab, which is 300 milligrams every 4 weeks, specifically in this trial at weeks 0, 4, 8, and 12. Patients were able to remain on stable dose of background antihistamines throughout the study. The primary endpoint was change from baseline in UAS7 at weeks eight, 12, and 16. Secondary endpoints included complete response defined as UAS7=0, as well as itch severity or ISS7, hive severity or HSS7, angioedema severity or ASS7, and quality of life by DLQI. Results from the complete study, including additional safety and efficacy data from the 16-week follow-up period, will be presented at a later date. Turning to slide eight, which covers patient disposition. Of the 187 patients screened, 137 were randomized. Completion rates were high across all arms, with 94% of patients in the Q8- week group, 98% in the Q12- week group, and 96% in the Omalizumab group completing the 16-week treatment period. Discontinuations were minimal across groups and due to standard reasons, including withdrawal of consent, noncompliance, and insufficient efficacy, but none due to adverse events. Moving to slide nine, baseline demographics and disease characteristics were well balanced between groups. Mean UAS7 scores were approximately 29 across all arms, representing a severe population. Baseline disease severity generally was similar to other reported Omalizumab studies in CSU. Only about 10% of patients had prior exposure to Omalizumab. Note that patients were required to have at least four months washout from prior biologics and could not have had an allergic reaction or poor efficacy to prior Omalizumab to be eligible for the study. Moving on to efficacy on slide 10, this shows the results on the primary endpoint, which was the least squares mean change from baseline on the UAS7 score, seven-day urticaria activity score. On this endpoint, both RPT904 arms showed rapid and at least comparable and even numerically superior efficacy compared to Omalizumab at all time points. At week 12, which is the time point commonly used as the basis of approval, the RPT904 Q8- week arm in gold showed a 22.1 point improvement. The Q12- week arm in orange, which was a single 300 milligram dose of RPT904, showed a 21.7 point improvement, while the Omalizumab Q4 week arm in gray showed an 18.5 point improvement. At week 16, the Q8- week arm showed a 23.2 point improvement. The Q12- week arm showed a 22.2 point improvement, while the Omalizumab arm showed a 19.1 point improvement. The Q12-week arm was particularly notable since after only a single 300 milligram dose at the beginning of the study, RPT904 delivered numerically superior efficacy to four monthly doses of 300 milligrams of Omalizumab out to and including week 16. These data indicate the superior durability of RPT904 compared to Omalizumab. However, no statistical hypothesis was tested in this phase II study. Slide 11 provides results from secondary endpoints for itch and hive severity. Itch as measured by the seven-day itch severity score, or ISS7, and hives as measured by the seven-day hive severity score, or HSS7, are components of the UAS7 score. Similar to the UAS7 score and as expected, both RPT904 arms demonstrated numerical superiority around ISS7 and HSS7 compared to Omalizumab at all time points. Slide 12 depicts the patients with complete responses as assessed by patients who receive a UAS7 score of zero. At week 12, RPT904 showed a numerically greater percentage of patients achieving Complete Response. At this time point, 37% and 39% achieved a UAS7 score of zero in the RPT904 Q8- week and Q12- week arms in gold and orange respectively, versus 24.4% in the Omalizumab group in gray. The percentage of complete responders continued to increase at week 16, where 46% and 44% achieved a Complete Response in the RPT904 Q8- week and Q12- week groups respectively, versus 32% in the Omalizumab group. Therefore, RPT904 can elicit a high degree of Complete Responses at least similar, if not better, to Omalizumab, but a much lower dosing frequency. Let's now move to slide 13, which summarizes top line safety findings. Safety data from the 16-week treatment period were favorable. No treatment-related Serious Adverse Events or Adverse Events of Special Interest were reported. Specifically, there were no reports of anaphylaxis. The incidence of treatment-emergent adverse events were similar across groups, and no patients discontinued due to treatment-related events. Overall, there were no new or unexpected safety signals associated with RPT904. Moving to slide 14, I'd like to now turn the call over to Dr. Giménez-Arnau, a professor at the Hospital del Mar Medical Research Institute and Pompeu Fabra University in Barcelona and a world-renowned expert in CSU. Given Dr. Giménez-Arnau's extensive experience in this space, we've asked her to provide her perspective on these results and how they could influence the treatment landscape. Anna, please go ahead. Thank you so much. You can hear me correctly? Yeah? Yes. Thank you very much for the excellent presentation that you've done regarding this new anti-IgE treatment, which really shows some benefits compared to the therapies that we have now. My first comment is that, first, nowadays, chronic spontaneous urticaria is a prevalent disease worldwide. Still, it is an unmet need to do its early diagnosis, and still, we have many people worldwide who do not obtain as fast as we want an anti-IgE therapy, and they are loose in the magma of different consultations with GPs and pharmacists, et cetera, and they need an early and good treatment for CSU and probably also for the inducible urticarias, chronic spontaneous urticaria inducible. This made one fact, which is important. Still, the anti-IgE therapy, still, Omalizumab, is not completely used by all the potential population that needs to use. This is my first thing that I should transmit. I mean, any anti-IgE therapy has a potential number of people who can really benefit or receive the benefit of its use. The second one is, currently, after the anti-H1, we just have Omalizumab as the potential or the indicated drug. Recently, dupilumab has been approved for CSU, and also Remibrutinib was approved for CSU, but both drugs have different mechanisms of action. Both are really interesting, but Omalizumab has at least 12 years of experience. That means we are using it routinely when the anti-H1 fails. And the question is that Omalizumab has been demonstrated that it is so safe, so effective, it can be used with other comorbidities combined with other drugs, even during pregnancy and even in childhood. That means that not only Omalizumab, but also the anti-IgE therapy in general still will be extremely useful during the next years. Sure. Ligelizumab, you know very well, such people who follow this type of indication for CSU, that it was also a very important anti-IgE therapy, but it stopped the development for different reasons. But the anti-IgE therapy, it addressed to the main key, the principle, the most important key that is capable to activate an autoimmune mechanism, the mast cell and the basophils to degranulate and induce the disease. Then we have still many people to be used, and we are using an anti-IgE therapy who really we have experience, and we are really confident, very confident with this because the risk of anaphylaxis in CSU does not exist. And then we have another big improvement that has been presented now with the RPT904. That really, the data that came from this phase II-B are very clear. And after, we can discuss and we can talk if there are any questions, but the most important question is that it seems it's even more effective than Omalizumab. We will never want to demonstrate to be more effective than Omalizumab, but we want to demonstrate that we are extremely safe for CSU, also for inducible, and we need to increase the compliance of our patients to the treatment, and this new development really offers a pathology which is extremely, extremely interesting because commonly we treat our patients during the first six months with Omalizumab in the department, and each four weeks they should be administered the subcutaneous drug. In this case, we've had even more benefit in the urticaria activity score seven showing double benefit of the minimal important difference. That means a reduction of 20. 20 is twice the minimal important difference in the Urticaria Activity Score 7 demonstrated efficacy reducing itch and hives, then it's really a benefit to not use the drug each month. It's a benefit if we can use just four injections per year. If you ask me how long a patient with CSU will be treated with an anti-IgE therapy for Omalizumab, it was demonstrated that the mean is three years and a half for CSU and for the inducibles four years and a half, then the compliance will be good because if it's subcutaneous, we can control when it's administered, and obviously for the patient, it will be easy to control the disease with less number of injections. Then, I suppose that probably will be some questions, different things that maybe you should ask yourself comparing, for example, with dupilumab with injections each 15 days and the efficacy is very slow, or with the oral treatments that commonly will be two pills per day, et cetera. There are different things which are interesting in all of these drugs that we can go easily accurate or could define because all of them are very interesting. But I must admit that based on the confidence that we have on the anti-IgE therapy in general in all the patients that we treated, the things that were shown today are really very interesting to be followed and to continue on its research. I don't want to say nothing more. If there are any questions from the drug company, do you want to comment something? Please let me know. Okay. Thank you. Thank you, Dr. Giménez-Arnau. Let's move to slide 15. Before I summarize results and next steps, we'd first like to thank and recognize our partners at JU for a well-run and informative study and for their partnership and highly collaborative spirit. The phase II data for RPT904 and chronic spontaneous urticaria demonstrate that the molecule's extended half-life and enhanced pharmacodynamic effects translate into deep and durable clinical benefit. Specifically, dosing every eight or 12 weeks showed comparable efficacy to Omalizumab dosed every four weeks. Durability of RPT904 exceeded expectations, particularly in the Q12- week arm, where a single 300 milligram dose of RPT904 showed numerically superior efficacy to four 300 milligram doses of Omalizumab out to and including week 16. The safety findings of the study also suggested that RPT904 is well tolerated with no significant differences from Omalizumab observed. In totality, these results support the promise of a best-in-class profile across multiple indications, including CSU, food allergy, and other IgE-driven disorders. With respect to CSU, we believe the data justify advancing to phase III trials in CSU, and both RAPT and JU plan to approach regulatory agencies in our respective territories to seek alignment on registrational paths. With respect to food allergy, we are on track to initiate our phase II- B trial before the end of the year, with top line data expected in the first half of 2027. Segueing into food allergy, the design of our phase II- B trial called Prestige is shown on slide 16. Food allergy represents a massive market opportunity, and we believe that RPT904's suggestion for less frequent dosing and broader efficacy in Omalizumab ineligible patients has the potential to position 904 as the preferred therapeutic option in this indication. This phase II-B study is a randomized double-blind placebo-controlled trial of RPT904 monotherapy in 100 patients with food allergies. It is modeled off the recently successful OutMatch trial, which formed the basis of approval for Omalizumab in food allergy. The trial will assess Q8- week and Q12- week dosing of RPT904, identical frequencies to the CSU trial, for a 24-week dosing period. The primary endpoint will be a double-blind placebo-controlled food challenge, and we plan to enroll patients to one or more of the five common food allergens, including the key foods in OutMatch. The study will include approximately 30 clinical sites in the U.S., Canada, and Australia, and we estimate it will take approximately 18 months from study start to top line data. Moving to slide 17, we anticipate several key milestones in the RPT904 development program. Today, you heard the top line results from the phase II CSU trial. JU is planning to approach the Chinese health authorities and could begin a phase III trial as early as the first half of next year. Full data sets from this week 16 treatment period and the completed study, including the 16-week follow-up period, will be presented at future medical conferences. We also plan to present additional PK/PD data, including free IgE measurements from the phase II CSU study. JU is completing a smaller phase II study in moderate to severe asthma, and we expect data readout by the end of the year. That trial is primarily oriented in assessing PK/PD to refine doses for an asthma phase III trial, which, assuming positive data, is anticipated to begin next year by JU. With respect to RAPT development program, as just discussed, we are on track to initiate the phase II-B study for RPT904 in patients with food allergies before the end of the year and expect top line data from that trial in the first half of 2027. These milestones reflect our commitment to advancing RPT904 across multiple allergic and inflammatory conditions. With that, we'd like to open up the call for questions. Thank you. Ladies and gentlemen, we will now begin the question and answer session. As a reminder, in order to ask a question, please press star followed by the number one on your telephone keypad, and if you would like to withdraw your question, simply press star one again. We'll pause for a moment to compile the Q&A roster. Thank you. Your first question comes from the line of Sam Slutsky with LifeSci Capital. Please go ahead. Hey. Good morning, everyone. Thanks for the presentation. Congrats on the data. Just two for me, I guess. First one is just based on the data so far, could you just talk about your confidence level of the Q12- week dosing being basically effective and the right one for food allergy? And then I guess as we think about phase III CSU, could you just kind of review historical timelines, how big of a study you might need given that you can use probably Japan and Korea safety database and just any additional details there? Yeah. Maybe I'll start first with the potential translatability across indications. We do think that, of course, the translatability and the level of confidence is higher now that we've seen that the increased half-life and improved pharmacodynamics will translate clinically. And as just mentioned, we are planning to study the same dosing frequencies in the food allergy study as you've seen in the CSU trial. So I think with the data in hand, we're walking into this phase II-B data with a high degree of confidence. With respect to the CSU safety database and timing, I'll let Will Ho speak to that. Yeah. Thanks. Yeah. The number of patients needed for phase III trials in CSU are probably going to be driven, like you said, more for the safety database than powering to show efficacy given sort of the degree of efficacy that's expected. The safety database is one of the things we'll definitely want to discuss with the FDA and other regulatory agencies. And as you mentioned, JU will be running trials also in parallel, including phase III in CSU and possibly in asthma. Those should count towards the safety database. So we're pretty confident we're not going to need large 1,000-patient studies like some others may be doing. We think it may be a couple of trials that could be just a few hundred patients each, but again, we'll have to do the calculations and discussions. All right. right. Okay. Thanks. Your next question comes from the line of Thomas Smith with Leerink Partners. Please go ahead. Hey, guys. Good morning. Congrats on the stellar data, and thanks for taking our questions. First, on the dosing frequency, given the strong durability you're seeing with the single dose now out to 16 weeks, how are you guys thinking about the optimal dosing interval going forward? Is there potential for you to explore 16 weeks or maybe less frequent dosing in either food allergy or CSU? And then secondly, on safety, I know there weren't any treatment-related discontinuations or FAEs, but could you just elaborate on some of the most frequently observed treatment-related AEs? Was there any pattern there, and did you see any injection site reactions? Thanks so much. Yeah. Thanks for that good question. I think with respect to dosing intervals, I think it's pretty safe to say that the Q12- week is a pretty solid go-forward dose into phase III studies in CSU and certainly backstops confidence in other indications, including food allergy. Of course, the data that shows durability out to week 16 is quite encouraging as well. So we plan to look at the follow-up data as well as additional secondary endpoints, and we'll make that determination of whether additional doses are warranted in the subsequent studies. But right now, moving forward, I think the Q12- week seems to be very, very well supported by the data. And to some extent, it's a little bit of a sweet spot for patients who see their allergist roughly every three months. With respect to safety and whether there's any patterns here, I'll let Will answer that. Yeah. I mean, at a high level, there's definitely no patterns of any safety findings of note, again, across 904 versus Omalizumab treatment arms. Pretty much the same things that you see in other CSU studies. There isn't a signal of anything novel. And not that we could note any specific injection site reactions were commented. There were no AESIs that were of significance. Your next question comes from the line of Yanan Zhu with Wells Fargo Securities. Please go ahead. Oh, great. Thanks for taking our questions, and congrats on the great set of data. I have a question for the KOL on the call. I was wondering, could you talk about the efficacy seems to be better numerically? Do you think this could turn out to be a statistically significant effect in a larger trial? And in your practice, how do you think this 904 could be used? Even with the presence of biosimilar Xolair, dosed more frequently, can you comment on how would you use this new drug? Thanks. This question is for me? Yeah? Yeah. Yeah. Okay. If I understood correctly, how are we using now in the situation that we are now is that during the last week, Omalizumab was immediately substituted by the biosimilar based on the mandatory behavior of the hospital according with health politics, which is the National Health Politics, changing immediately the original product by biosimilar even without asking us our opinion. We can say that the biosimilar from Korea, from Celltrion, has a lot of a good trial, which is a comparison very good with the trial, and it seems the behavior is exactly the same even when people were treated with OMA continuously and they changed to the biosimilar. This is what the trial said, and we will check what happens in the clinical practice, but also, it's not just about how we manage with the biosimilar because we will be very aware about what happened with our patients. I have more than 300 patients with OMA, and 30% of them, they have an increased dose of Omalizumab to 450 or even 600. That means 450 each four weeks because they are not completely controlled. It means three injections each month. Then the potential need to increase the dose, let's see what happened in the real-world practice with the biosimilar and how safe it will be, etc. Let's see because by mandate, we should change, which is not really a thing that I like very much, but we deal with this. Then everything that could improve the actual pathology of Omalizumab and make a difference in the sense that we'll be more comfortable, even more effective, brings a good opportunity for the anti-IgE therapy to be maintained in a high level or standard level because it is a great therapy, at least for CSU and dosable. It is, and it will be, it will continue to be. But really, I mean, as a clinician, these politics on the national health system and how to manage with the biosimilar, etc., is not my objective. I will see what happens with the biosimilar in the clinic during the next year, and I will support the use of our new anti-IgE therapy in spite that we have other drugs that will act through a different mechanism and will be very helpful for CSU because we need also such drugs because not all CSU is the same and not all the phenotypes are the same and not all the triggers are the same. But I think we need to maintain the high standard with the anti-IgE therapy in general. I don't know if I answered your questions regarding safety. It's so safe. Then let's see what happens in the phase III. I don't know if I answered your question. Yeah. That's very helpful. I was wondering, efficacy-wise, do you think this could be a better efficacy drug than Xolair? And if that's the case, whether that could impact in Europe the use versus biosimilar Xolair? And also for the. Yeah. I just wanted to add for the company, last question for the company, can you talk about for the pivotal trial, do you plan or foresee to do a head-to-head comparison with Xolair study or a placebo-controlled study? Thanks, but Doctor, it would be great to hear your thoughts on efficacy, whether it's better than Xolair. Yeah. Yeah. I think that any drug that we develop for CSU needs to make, okay, it's not necessary to position any new drug for CSU in a position that it will be better than Omalizumab. This is a wrong thing. It was not useful for Ligelizumab. It really was a very extremely, extremely good anti-IgE therapy. I think the best thing is to compare to placebo, and going with a head-to-head to OMA, it's not necessary. You can put a branch with OMA, and you can compare how it works, but never position. I will not recommend to position any of the new drugs for CSU as better than Omalizumab. You understand me what I said? The next question comes from the line of Anupam Rama with J.P. Morgan. Hang on. We need to answer the second half of Gannon's question. Just, I think, Gannon, to your question about the design of the phase III trial, obviously, there are details that we'll need to discuss with the regulatory agencies. Traditionally, the FDA has preferred strongly placebo-controlled studies. Obviously, we're focused on U.S. development, although we do think that the European markets are also quite important. It's possible the regulators in Europe may have a view, so we'll have to discuss with them whether a comparator arm would be necessary or not. So to be determined. Great. Thanks. And congrats again on the great data. Thank you. You can introduce a brand to compare, but never decide it as a preconceived. That means position the drug as better than the other, even with remedies, not so. The next question. Yeah. Our Yeah. Our basic assumption is that we're trying to show similarity or relative similarity efficacy to Omalizumab, but much more durable, prolonged efficacy, and much more frequent dosing on top of that. And that's a different improvement than head-to-head efficacy. Thank you. Next question comes from the line of Anupam Rama with JP Morgan. Please go ahead. Hey, guys. Thanks so much for taking the question, and congrats on the data. What do you think is driving sort of this increased complete response signal that you're seeing on UAS7 with longer-term follow-up? And is there a reason to think that the portion of patients achieving a CR may continue to increase with longer-term dosing? And then second question, with the totality of these data, how do you think about unlocking the 904 potential in sort of the Omalizumab ineligible population, particularly in food allergy from a clinical trial perspective? Thanks so much. Yeah. Anna, Tom, thanks for that question. I think with respect to the efficacy, it does look like it's deepening at week 16. I'll just say that we're very pleased with the level of efficacy versus the comparator arm in the study. And obviously, we're already seeing numerical superiority, which is beyond our expectations. We'll have to see how these both arms perform in the 16-week follow-up period. So that data will be presented at a future medical meeting. Right now, our scenario moving ahead is that clearly Q12- week looks interesting and is very solid moving forward. We'll see how other doses play out to see whether it supports less frequent dosing. I think the effect is likely related to the properties of 904, which is the improved half-life and higher affinity, which is probably more effective at reducing local IgE and removing IgE bound to the FcεRI receptor. Maybe I'll let Will talk about assessing the omalizumab-ineligible population in the food allergy study as a way to really differentiate versus Omalizumab. Yeah. I mean, it's interesting. It's trying to translate the CSU data to food allergy, maybe slightly different biology, all driven by IgE. I think we're really excited that this data really is the first set of data in patients with a disease that's driven by IgE has shown such promising efficacy. How that translates into food allergy will be interesting. Again, as what was brought up before, there are different limitations. As opposed to CSU, where it's flat dosing, you're not restricted by high IgE levels or high weights, things like that. In food allergy, based on dosing tables, there are restrictions that patients with extremely high IgEs or high weights aren't currently eligible for Omalizumab. And we've done some modeling with earlier data that suggests 904 should be able to reach more of those patients who are currently excluded from OMA dosing. And we'll be testing that in phase II regimen of including patients not only who are currently eligible for OMA, but for one significant portion of patients that are currently excluded and seeing how that translates. And this data sort of supports the idea that that hopefully will translate either with eight or 12-week dosing in food allergy. Thanks so much for taking the questions. Congrats again. Thanks, Anupam. Your next question comes from the line of Umar Raffat with Evercore ISI. Please go ahead. Hi, guys. Thanks for taking my question. Just wanted to focus on three quick ones, if I may. First, the every 12-week arm, did it actually dose at the 12th week or not? And if it didn't, isn't that an every 16-week arm? I'm just trying to understand that. Number two, could you speak to what the baseline antihistamine levels were and how did that change over time? And number three, as it relates to UAS7 measurement during the course of this trial, was it done in the standard way, twice a day, done over the course of the full week? And I ask because about 13% of the patients in Omalizumab arm were previously on Omalizumab. So I'm just trying to understand how they qualified. Thank you. Yeah. Thanks, Umar. With respect to the first question, the Q12- week arm was a single dose, which was meant to represent a dosing frequency of 12 weeks or less frequent. As you'll recall, the primary endpoint that's typically used as a basis of approval is at 12 weeks. So that single dose is meant to do that. There was no additional dose at week 12. Then with respect to baseline antihistamine use and how the UAS7 scores were run, let me see if we have some information on that. I don't know, Will, if you have that detail. I don't have those details here in the top-line data. Again, the current restrictions on the protocol were they were allowed to be on and need to stay on a stable dose of antihistamine at approved dose. This study didn't include the up to four-fold. And similarly, they could have a rescue medication with another antihistamine at an approved dose. But actual dosages and how they changed over time, that will be analyzed as part of the full data set. He asked you about the way how you assess the Urticaria Activity Score 7. If it was the classical one, twice a day, or just once a day. The classical one, what does it mean? Because which is recommended by the guideline is just one time per day. And the use twice per day is the way how it's used in the Novartis trials. It was your question about this? Yes. Thank you. Yeah. Yeah. I didn't have that. I don't know what you did in this trial, but there are two ways to measure, and it's true that in the Novartis, it's used twice a day, but it has been published a paper where it's the same. It can be compared to use the assessment once a day, then twice a day, which is half of the score. So yeah. So the UAS7 score, which is the sum of the ISS7 and HSS7, it was the sum of the daily ISS and HSS7 scores, which were the average of the morning and the evening scores for each day. Okay. Does that answer your question, Umar? Yep. That's it. Thank you. Okay. The next question comes from the line of Prakhar Agrawal with Cantor Fitzgerald. Please go ahead. Hi. Good morning. And thanks for taking my questions and congrats on the data. So maybe just double-clicking on the efficacy results and why you're seeing better numerical trends compared to Xolair. Have you done any exposure response analysis here? There seems to be some real-world data that Xolair updosing to even 450 mg, 600 mg can lead to slightly better efficacy. So I'm just trying to understand how much of this is due to better exposure for RPT904. Secondly, on the safety side, slightly higher treatment-related adverse events on 904, and given it's long-acting, wanting to better understand the duration of these adverse events relative to Xolair. And then third question, the relationship between baseline IgE and efficacy is maybe not that relevant in CSU as it is for food allergy. But in your view, are there any truths to food allergy, especially for high IgE patients and very high IgE patients included in this trial? Thank you so much. Yeah. With respect to PKPD assessments, those data will be forthcoming so we can look to see. I mean, we do. I I think it's logical to assume that based on the modeling as well as the healthy volunteer data, that there should be better reduction in free IgE, and that likely will translate into potentially more robust efficacy. As you pointed out, and Dr. Giménez-Arnau pointed out, approximately 20%-30% of CSU patients do updose Omalizumab in the real-world setting and suggest that there is perhaps some underdosing in that population because roughly 70%-80% of those patients do respond to updosing. So that's what we might be seeing here play out. But again, I just want to reiterate that our baseline TPP is comparable efficacy to Omalizumab at less frequent dosing. So I think we're very pleased with the results from the study so far. With respect to the safety findings, maybe I'll turn it over to Will about those and whether there were any patterns or duration there. Yeah. No. Of course, the full data set will be part of a later disclosure. But as far as we could tell, there was nothing notable as far as difference of duration of adverse events or difference of signal. And really, there was no, didn't feel there was anything significantly different between the OMA arms and the 904 arms as far as either treatment-related or unrelated AEs. They're all seen pretty consistent with what you see in CSU studies. And then as IgE levels. Yeah. The baseline IgE levels have not yet been reported. And obviously, we don't have yet the patient-level data. But once we get that, we can see if there's any correlations there. Just in general, with CSU, we wouldn't expect patients with very high IgE levels that would translate necessarily to food allergy. Thank you. Your next question comes from the line of Kaveri Pohlman with Clear Street. Please go ahead. Hi. Yeah. Good morning. Congrats on the results, and thanks for taking my questions. Can you provide any additional details on your plans to discuss the data with the FDA? When do you expect to have that discussion? Can the process be started immediately, or do you have to wait for additional data to take the package to the FDA? And the current timeline of the second half, 2026, for trial initiation, does that assume phase II, or you could initiate big phase III trials also in that timeframe if the FDA agrees? And I also want to understand how much read-through this data provides to the food allergy program because you still have plans to test both Q8 and Q12 dosing in the phase II- B trial. Does that change any of your current plans for that study and just focus on Q12 dosing? Thank you. Yeah. I think with respect to the timing of our interactions with the FDA and the start of the trial, I think that's to be determined. And as we look at this data or continue to look at this data, we'll make that determination of the timing for that. With respect to the food allergy dosing, just recall that most food allergy patients are treated with Q2 week dosing. So Q8- week dosing would be still a very significant step change for those patients. And all of our market research suggests that would be essentially a home run. Obviously, with the CSU data in hand, I think that builds confidence that Q12- week would also be sufficient. But I think we believe that Q8- week and Q12- week would still both be wins in the food allergy setting. So no plans to change dosing at this time. Thanks, Kaveri. The next question comes from the line of Yatin Suneja with Guggenheim. Please go ahead. Hey, guys. Thank you for taking my question. Maybe just a quick one for me on the food allergy side. What do you need to do in order for you to go into a younger patient population? I think right now you are going up to 16 or 12. Could you remind us what work is needed? And anything on your market access research suggests? Because at some point, Xolair biosimilars. I'm just curious to understand how the pricing and the access is going to work out. Thanks. Yeah. Maybe I can get started on the patient age. What's interesting about the script-level data for Omalizumab is that it does appear that adolescents and too young adults appear to be the sweet spot. Roughly 60% of the scripts are there. About 40% are children younger than 12. So this study that we're planning is starting in adolescents 12 years and above. But we think that with a longer-acting, less frequent dosing regimen, that there would broaden the market and expand the market, particularly in children as well. So we're really excited to get to younger patients. And of course, I'll let Will opine about this or talk about this. But assuming that the safety looked good in this phase II-B study, we would be going and looking to expand the age group to younger groups in the phase III trials. Yeah. I think the key thing from the phase II is first to obtain the age 12 and up safety and efficacy data of food allergy patients. And then based on those results, hopefully be able to support the idea of going into lower patient populations, eventually targeting the ages one and up similar to what OMA has for their approval. But exactly the staging of that will depend on the data and discussions with the agency. The second question was regarding the pricing, or. I mean. yeah. Assuming we get the label of one and above, as with OMA, I don't think we would have any difference in pricing based on age. It's pretty much just based on dosage, so we would assume we would be doing similarly. The next question comes from the line of Emily Bodnar with H.C. Wainwright. Please go ahead. Hi. Good morning. This is Joey on for Emily. Congratulations on the data, and thanks for taking our question. So regarding a phase III program initiation, do you not believe that there's a need for U.S.-based phase II data from a regulatory perspective? And if these data are increasing the FDA development priority in the U.S., what next steps are getting taken or aiming for advancement in 2026? And also. Yeah. Oh, sorry. Sorry. I'll follow up. Yeah. I think that's a good question. I think we're confident we could initiate a phase III study based on these data. Obviously, we'll need to have a discussion with the regulatory authorities to align on that plan. There's very good translatability between Asian patients and countries and Western countries. The labeling is nearly identical. Dosing is very similar. PKPD is similar, and the safety profile is very similar as well. And just recall that the FDA recently provided us a safe-to-proceed letter to start a phase II-B study in the U.S. based off of Chinese healthy volunteer data. So I think the FDA does recognize and is comfortable with the mechanism of action, particularly the Omalizumab and epitope. So nothing is guaranteed here, but I think there are a lot of reasons to expect that there will be a path forward to registrational studies there. Got it. That makes sense. And in the trial itself, do you have any reasons why you think that in the week 12 group for the Omalizumab arm, why did the urticaria-free rate decline? Oh, you mean the UAS7? Yeah. I mean, just the. Yeah. These are small cohort arms, and there's variability week to week. There are small numbers of missing data. There's some imputation done there, but very little data is missing. So it's all within the range of just the one or two patients that might be different between arms. And as far as we can tell, nothing of significance. But of course, we need to continue to follow this and have larger patient cohorts. That makes sense. Thank you for taking our questions. And the last question for today comes from the line of Etzer Darout with Barclays. Please go ahead. Thanks for taking the question. I have one question for you and one for Dr. Ana, if you could. The first question, just wondered if based on these results and understanding these are CSU and food allergy are different indications, but is there an opportunity to maybe tweak the food allergy study sort of ahead of starting it? Or is it the data really in CSU today just more confirming of the plans that you already have in place for that study? And then for Dr. Ana, just wanted to get your sense of how you could see sort of this once-every-12-week profile fitting into the treatment paradigm here for CSU when we kind of look at maybe some of the other competitors entering the space like Remibrutinib, which was recently approved. Just your thoughts around that dynamics and the. Thank you. Yeah. I think I'll start with the first question here. I think that the data very much are consistent with our modeling and our projections that, well, Q12- week would cover sufficiently the level of free IgE reduction that would be required for efficacy. So it really is confirmatory, I think, for that hypothesis and supports the modeling that we've done. And I'll let, of course, Anna respond to the competitive landscape. For me. Yeah. Go ahead, Anna. Yeah. Yeah. We have anti-H1. We have OMA. And we already have now approved by the FDA Dupilumab, and Remibrutinib. You know very well Remibrutinib is a very selective anti-BTK treatment who goes inside the mast cells and modulates the expression of the high-affinity IgE receptor independently of its stimulation, independently of the stimulation with an IgG or an IgE or an IgG against an IgE, etc., because there are different endotypes. It's oral. It's two pills per day. During how long the episode will continue and how long it will be necessary. And it will depend on the patient. But the question is that it's very fast and is an oral drug. And it's effective, and it's demonstrated to be safe. Dupilumab is also safe. It's slow. And it's administered each 15 days in a subcutaneous way. And we have OMA monthly, very safe. But we have 30% of the patients that we need to increase the dosage and 13% for which does not work because it's a very low proportion of CSU where the anti-IgE therapy does not work. And there is probably a place for the anti-BTK, etc. The question is, we do not can substitute the anti-IgE therapy by these other new treatments. We cannot do it. Those treatments, all of them are necessary. And all of them will have a position. And maybe some of them could even be put in the future before the use of the anti-H1 because we are now using everything when the anti-H1 fails. At licensed dose or when we increase the doses. But the anti-IgE therapy will always be there. And then it will always be there. Now, the new guidelines will put after when the anti-H1 fails, it will put at the same level anti-IgE, Dupi, and the anti-BTK in order to give a sense of freedom to the doctors to choose the best treatment, talking with the patient according to their preferences. Because there will be someone that will be using Dupi when there are atopic comorbidities and Remy when you want to go fast, but also we don't have 100% of benefits, and probably in many patients, we could even combine them, but my message here is that the anti-IgE therapy will be maintained because it's so effective and safe, and then the other one will not substitute this one. I think so. This is my feeling. The question is that after OMA, we just have cyclosporine or corticosteroid or nothing, and we need these other potential treatments. All of them, we are requiring all of them, and we need to improve the use of the anti-IgE therapy. This is my message. Thank you. Thank you, and congrats on the data. That is all the time we have for the question-and-answer session. I would now like to turn the call back over to Brian Wong for closing remarks. Thank you, Operator. In closing, armed with these data, we look forward to an expeditious development plan for 904 and food allergy at CSU. We look forward to keeping you apprised of our progress, and we appreciate your support. I'd also like to thank the amazing team here at RAPT, our partners and collaborators, and the patients participating in our clinical trials. With that, Operator, we can close the call. Thank you. Ladies and gentlemen, that concludes today's conference call. You may now disconnect your lines. Thank you and have a good.