All right, good morning, everyone. Thanks for joining us here at the Goldman Sachs Annual Healthcare Conference. Thrilled to be joined today by the team from RAPT Therapeutics. Maybe I'll let you guys introduce yourselves first, and then we can dive into the business. Great. First of all, thanks, Corinne, for the invitation. Really appreciate it. Excited to be here. My name is Brian Wong. I'm the CEO and President of RAPT Therapeutics, and I've been doing R&I work for the last 25 years. I'm Rodney Young. I'm the Chief Financial Officer at RAPT. Perfect. Maybe we can start with the complexion of RAPT, which has changed quite a bit over the past year. Maybe you could provide an overview of the company as it stands today and discuss kind of what you view as the key value drivers over the next 12 months- 24 months. Yeah, great. RAPT has gone through a renaissance. We are focused on INI indications, particularly in allergic diseases. Recently, we acquired a new lead asset called RPT904, which is a next generation extended half-life anti-IgE for a range of allergic disorders, including food allergy and CSU. We acquired this from our Chinese partner called Jemincare, which is a multi-billion dollar pharmaceutical company in China. Very excited about this asset. We're pursuing really important indications, such as food allergy and CSU and others. We are planning to see some data from our partner, Jemincare, in the second half of the year in CSU and in asthma. That'll be an exciting readout. We plan to start a phase 2b study in food allergy in the second half of the year, which would take about 18 months to read out. As Rodney will tell you, we're very well capitalized. Managed to do a good raise at the end of last year and are fully funded through these key data readouts into 2027. Perfect. You mentioned that you acquired RPT904. What attracted you to this particular asset? Could you talk to why you felt RAPT was really well positioned to do the development? Yeah, it's a great question. As you know, the company has been focused on allergic diseases for the past five or six years. We were developing a CCR4 antagonist for a range of allergic disorders, including atopic dermatitis and asthma. We were planning to actually transition to phase III, and unfortunately, we had a clinical setback. Our team and our capabilities are really focused on late-stage development in these indications. RPT904 is particularly interesting because, first of all, we do think it's the best-in-class molecule. When we looked at the emerging field of food allergy and we saw the sales of Xolair, which was just approved last year in February, we saw 30,000 patients in the first two quarters. This is one of the fastest pharmaceutical launches that we've seen in a long time. That really got us very interested in food allergy and other areas. We think 904 is the best-in-class, most advanced asset. Let's dig in on that a little bit more. As an anti-IgE antibody, I guess, how does 904 compare to Xolair? And what do you view as sort of the target product profile for an agent that's going to come up against that kind of product? Yeah, great question. I mean, first of all, Xolair has shown really outstanding efficacy in food allergy with a 60%-70% response rate across all allergens and has shown good activity in CSU. What's exciting about 904 is that it uses the same epitope as omalizumab. From that perspective, it's highly de-risked. It has better half-life through the YTE mutation, which is a commonly used mutation to extend half-life. We've seen it over double the half-life. It's also slightly more potent. The target product profile that you mentioned is that we should be able to dose instead of every two or four weeks, every eight or 12 weeks, and also be able to access patients where Xolair is currently excluded. There are certain patients that are not included in the label. Okay. So you talked about some of the technical modifications that enable this profile, but maybe you can talk about the clinical and preclinical data to date that supports what you're talking about in terms of extended half-life and greater potency. Yeah, it's really important. When we did our deep diligence, this is a molecule that, from the epitope perspective, all the structural studies and biological studies show identical epitope to oma, which is really important in this space. We did see greater affinity and greater half-life. There was a healthy volunteer study that was performed by Jemincare showing a 60-day half-life versus omalizumab is a 24-day half-life. We think that translates into Q12W dosing in most patients. Okay. In terms of the healthy volunteer study, how do you think about the translation of data from China here in the U.S. in this kind of patient population? Yeah, it's really important. I think there's 20-plus years of experience now with approvals of Xolair in multiple regions. I think what's really compelling is that the dosing table, PK/PD, PD efficacy relationships, those are all maintained in all these different regions. I think it's pretty safe to say that, particularly with this epitope, you can translate data from one region to another. Okay. That stole my next question, but I appreciate it. I guess, what have you observed or learned from other extended half-life programs in INI that makes you feel like this is an attractive product profile? I think what's really clear in INI is that compliance and convenience are really important attributes, right? Particularly for diseases like food allergy, where there's so much healthcare resource utilization. If you have patients that are now more patients on the drug and more patients that are compliant to the drug, you reduce healthcare burden. That actually is very attractive to the payers, which Rodney can talk a little bit about. I think from an INI perspective, these half-life extended antibodies are sort of a perfect fit for these indications where convenience and compliance matters. Okay. How do doctors think about, or patients or any of your market research think about the safety component of giving a long half-life agent in some of these settings? When we did our market research, the TPP was similar efficacy to oma, both similar safety and efficacy, so including potentially the black box warning for the anaphylaxis. That did not deter anybody from either the prescriber perspective or the payer perspective. Most prescribers are pretty well attuned to using oma, and it's not been a deterrent to their use. Okay. Yeah, that's very helpful. As you think about then the phase 2B study that you're proposing here in the US, I guess, why did you decide on food allergy? There's a number of different places Xolair is used. Talk to us about that selection. Yeah, again, when we did our research on where the biggest medical needs were for IgE-mediated diseases, food allergy came up number one by far. I mean, there's a lot of patients. oma is a really good drug for food allergy patients, but there's need for a less burdensome version of it. Food allergy came up one. And we did, as Brian mentioned, we noticed the rapid launch, so commercially very attractive. It was pretty much of a no-brainer to go for food allergy first. Okay. You mentioned that Xolair is not available to certain patients. I think it can be kind of difficult from a dosing perspective. Can you talk about the limitations of Xolair for the food allergy population? Yeah, roughly 25% of food allergy patients are off-label. That's because they either have too high IgE and/or high weight. Because of the short half-life and low affinity of oma, it just can't reach those patients, so they're off the label. We think we can actually capture that really high unmet need population. We could talk about it later, but that could actually have implications with respect to pricing as well. Okay. So is that the target population you're going after, or just the population where you feel like this would be well suited that Xolair isn't? I think we can expect a very broad label. Okay. So talk to me about the phase II trial design. What are some of the key parameters that you're looking at as you approach that clinical study? Yeah, I think what we are guided by is the recent Xolair outmatch study, the phase III study that was used as the basis for approval for omalizumab last year. This is what they call a food challenge study, double-blind placebo-controlled food challenge study. Essentially, patients are challenged initially to show that they're sensitive. Then they're enrolled. There is a treatment period. After, in our study, 24 weeks, there's a second challenge to see that threshold, whether that threshold changes. We are essentially following the outmatch protocol, essentially. Using the same thresholds, we're looking at multi-allergen. Beyond peanut, we're looking at milk, egg, and others. We're planning to roll about 100 patients. We're studying two frequencies, Q8W and Q12W versus placebo. We're also planning an extension and a placebo crossover as well at the end of that period. Okay. I mean, you've had the Q8W, you have Q12 W, but you mentioned a 60-day half-life. So how does it work when kind of the drug dips below the half-life and you kind of end up in that last month? Food allergy is the kind of thing where it's very acute. If you have an emergency, it's a really big deal. So how does that work from a PK perspective? Yeah, it's really important to get protection for patients throughout the entire dosing period. When we modeled this, we looked for levels of free IgE, which is the pharmacodynamic target, below a certain threshold that's been very well established. We made sure that every dose at every level of patients that have different IgEs were below that threshold. Okay. So you mentioned the primary endpoint is a food challenge. I guess, what are the target efficacy parameters for that endpoint? What would be a good outcome for a phase II? Yeah. This is great because outmatch shows us the way. Essentially, for peanut, you look for a threshold of 600 milligrams, which is essentially two peanuts. For other allergens in the outmatch study, it was 1,000 milligrams. If patients achieve those thresholds, then they're considered a positive responder. Okay. And so it's percentage of positive responders. Yeah, exactly. Okay. Can you talk about the phase III that would kind of come from that? I assume outmatch again provides you an analog, but can you talk about how that works? Very similar design, larger, of course, to build up the safety database, but would be a double-blind placebo-controlled food challenge study, roughly 24 weeks. We'd have to have a discussion with the FDA about the size, but the outmatch study was approximately 180 patients enrolled. Okay. You've talked a little bit about this already, but in terms of the market opportunity in food allergy, how many patients are there? How should we think about pricing and the nature of this market? Yeah, it's a really big opportunity. I mean, on the order of atopic dermatitis, if not larger. There's roughly 17 million Americans diagnosed with a food allergy, including 6 million children. About a quarter of those, so over 4 million, are severe, so probably the most susceptible to a severe reaction if you have an accidental exposure to the food. That's really the target population that we'd be looking to. Sorry, I forgot the rest of the article. No, maybe I'll dig in a little. Yeah. Yeah. Oma works really well. We would think that probably about 40% of that target addressable population would be willing to take a shot or a treatment. You're talking about nearly 2 million patients, 1.7 million-2 million patients that we would be looking at. We think we could probably get about 40%-50% of that. Okay. You mentioned pediatrics. Obviously, it's a huge part of this market. How do you think about designing for a pediatric patient population? Are they going to be included in your phase II, or does that come down the road? Yeah, likely we need a discussion with the FDA, but likely will occur in our phase III study. We're looking at children as young as four years old. Okay. What do you need to do from a safety perspective between now and the phase III to enable that? I think the phase II is very much in line with generating that safety data that would be compelling to the agency to allow us to move to younger children. That is exactly how we designed the study. In the pediatric population, you mentioned that one of the reasons people would not be candidates for Xolair is weight. One of the reasons is severity, the other is weight. Are pediatrics better or less well served by Xolair? How should we think about the adults versus pediatric patient groups? Yeah, I think the big challenge with pediatric patients is they tend to be higher IgE, or a lot of them tend to have higher levels of IgE, which requires the more frequent dosing. A lot of them are going to be on the Q2W regimen. For both the kids and the parents, that's pretty burdensome. We think the less frequent dosing, in particular for the pediatric population, is going to be very attractive. Okay. One of the things that people like about Xolair is it works for some asthma, which is often concomitant with food allergy. How do you think about that advantage, and how would you solve for it in terms of your development program? Yeah, I mean, I think this is a pipeline and a product-type opportunity. I think it's very attractive to have a broad label. Patients often have asthma and. Atopic dermatitis, peanut allergy, all of the. Exactly. I think we're starting with food allergy and CSU, but I think our ambition is to have a broad label as possible to make it attractive to that patient. What about delivery? How is Xolair delivered today? Obviously, Q2W is common. Do you have to go to the doctor's office? Is it an auto injector, a subcutaneous? What do you think you would want to show to be competitive from just a delivery mechanism perspective? Yeah, I think it's either a syringe or an auto injector. Right now, the first three times you get the shot, you have to do it in the doctor's office just because they want to observe the patient. I think with less frequent dosing, that would just be a lot easier for patients. We are looking at syringes, auto injectors, etc. Again, we assume at least the first time would probably be in the doctor's office, but after that, it'd be self-injection or the parent, I guess, injecting. Okay. When does the auto injector development or syringe development kind of come into play in your development timelines? Yeah, right now, I think prefilled syringe is where we're going to be focused on, at least for the phase III. And then during that time, we'll be developing devices and our auto injectors as well. Okay. So So that spend is gated on probably a phase II. Yeah, perfect. And then in terms of indication expansion, you talked about CSU, so maybe tell me why that's the right next move beyond food allergy. Yeah, again, when we did our research about where the greatest need was, food allergy was one, CSU was two. Again, oma works really well for CSU patients who are refractory to antihistamine, but there's room for improvements. We think 904 can be that improvement. That's the next one we want to look at. Our partner, Jemincare, is also running a phase II trial in China in CSU. As Brian mentioned, that readout should come later this year. We're obviously anxiously awaiting that to help us determine what our next steps are. Yeah, and they're looking at Q8W and Q12W, which is the same dosing regimen as our food allergy study. It should be informative. Okay. Remind me the scope of the data we'll get from China. I think it's CSU and asthma. Talk to me about what the results we should expect there are. Yeah. For CSU, it's a pretty large study. It's 135 patients studying Q8W and Q12W versus omalizumab as the reference arm. It should be pretty interesting from an efficacy and safety standpoint. We think it will help sort of validate the YTE mutation for these diseases. Are you looking for it to be similar in efficacy to Xolair with more convenient dosing? Exactly. So yeah, our base case scenario is that we see similar efficacy to omalizumab at Q8W with an upside of similar efficacy at Q12W. An upside of better efficacy at 12 weeks? Yeah, similar efficacy to oma, but now at Q12W as opposed to oma's Q4W dosing. Okay. Will that inform your dose selection? Will you continue to do the 12 week regardless of that outcome, or is that going to be a key question? It's a good point. I mean, I think we're probably planning to study Q12W regardless of the CSU data, but I think if we can glean any information, there's probably opportunities to modify the dosing. Is there any reason to think that Q8W, Q12W would work differently in the different populations, or if it's good in CSU, it's good in food allergy and vice versa? I think for omalizumab, where there's a lot of proof and a lot of translation, it should read through pretty well. Okay, understood. In terms of then when you could kick off a CSU study, when does that happen here in the U.S.? Yeah, so if we meet our bar, which is similar efficacy to omalizumab at Q8W, there's a possibility, pending discussion with the regulators, that we could go directly to phase III, which would greatly accelerate our time to approval. Talk to me about that because regulators today, obviously, there's a lot of uncertainty, and particularly on the China translation of clinical data. What do you think? How do you think they'll interpret a Chinese data set as it relates to moving into registrational trial? I think we have the benefit of 20 years of experience with Xolair, and what we've seen is that in terms of PK/PD translatability, dosing tables look similar, patient populations are similar, baseline characteristics are similar. I think there's a high degree of comfort from the agency in translating the data back and forth between China and the U.S. and Europe. Okay. But that would only apply to CSU because they've not done food allergy in China? Food allergy is approved in China. Oh, okay. So then why? Yeah. Why would you do that in CSU, but you're not doing that? Oh, I see. Obviously, we just licensed and built this partnership just late last year, and Jemincare was already in the middle of a CSU study, I think there's something really in the back. Those are ongoing studies in asthma and CSU. We are layering on top of that food allergy. Actually, Jemincare has expressed interest in other indications, including food allergy. I think there's going to be a lot of synchronization between the two companies. Of course, we're waiting to see their CSU data to determine how we're going to proceed in CSU ex-China, outside of China, which could be a phase III trial. Okay. What about asthma? Because that's the other one. Is that something you guys would like to do? Yes. Yeah. Yeah, asthma was third on the list. Right, okay. Where the biggest unmet needs are. Yeah, we definitely are interested in asthma, just although from our perspective, right, it's obviously a lot more challenging development program. I mean, there are longer trials, bigger trials, and all that. For us, we kind of need to titrate where our capital needs are going to be and things like that. Obviously, we want to see the asthma data from Jemincare, and then we'll kind of figure out our path from there. Okay. Sorry, I'm skipping around so much, but on the CSU phase III, if it is a phase III, what does that trial design look like? Yeah, so I think when you look at other phase III trials, they're typically in that 300 patient-400 patient range. Looking at UAS7 as the primary endpoint, typically 12 weeks is the top line data. Okay. 12 weeks for registrational studies. So it seems then if you map that, you could get CSU before you got to food allergy. Potentially, yeah. How do you think about then maybe that sequence of events? If we go to CSU first. If we were to go to CSU, a phase III in CSU, yeah, I think we would likely get to the approval in CSU first before food allergy. That could have some potentially positive implications for the way we think about pricing and things like that. Because again, we would see 904 as being really well positioned in the CSU market. Oma already is the first choice biologic for the antihistamine refractory population. Given, again, if our TPP plays out, we think 904 would be really well positioned to take that place, that first choice place. Help me think about the competitive landscape maybe in CSU, and then we can talk about food allergy. Obviously, there's Xolair. What else is approved or in development, and how are you thinking about kind of competitive positioning beyond just the oma? For CSU? Let's do CSU, and then we'll do food allergy. Yeah. For CSU, obviously, DUPI has just been approved, although oma, at least the clinical trial data, right, shows better efficacy than dupilumab. There are other products in development, the c-K its, some BTKs. The c-K its actually show pretty good efficacy as well, perhaps better than oma, but some question about the side effect profile. Our research suggests that oma and 904, given how effective they are, they would probably be the first choice over the c-K its and the BTK. Our assumption is we would be well positioned to be that first choice in the CSU as the CSU biologic. Okay. And then maybe in food allergy, I think Xolair, obviously. Is there anything else in development that you're monitoring? There are other anti-IgEs potentially coming in food allergy space. We're not aware of any that are as far along as we are, short of 904 is. I think the main competition as we look forward is going to be oma itself as well as the biosimilars. The BTKs have shown efficacy in food allergy and very quick action. I think the question is sort of the long-term safety of those drugs, particularly when you're talking about really young kids as your target population. Chronic dosing. As you think about competing with Xolair, obviously you've got the extended half-life, but are there any other things that you think you can do to sort of gain share in this market, particularly being relatively later and a smaller company? You want to look at? Yeah, I think other than or in addition to the less frequent dosing, which is a really big deal, right? It's much less burdensome to be able if you can dose four times- six times a year as opposed to maybe 13 or 26 times. The other really big differentiation factor is if we can show efficacy in those oma-excluded patients because that's roughly 25% of the food allergy population. That's a big fraction of patients whom we think we could address a good portion of that. Again, for prescribers and payers, that's really important as well. Keep in mind, actually, Xolair is not approved in food allergy in countries outside the U.S. I think there's a very high imminent need in Europe and other countries as well. What about on pricing? Obviously, I think Xolair is priced for the breadth of indications. How would you think about pricing given you also aspire to a broad set of indications? Yeah, I think so by the time we get on the market, obviously biosimilars will have been approved and very likely will have driven down the pricing of branded Xolair. Again, the differentiating factors that we aspire to have, right, the less frequent dosing and the treating of the oma-excluded patients, that should give a real clinical difference relative to oma and the biosimilars, which we think should be rewarded with better pricing. In our market research, payers have said, yeah, if you can show that that's really important, that's really valuable, they'd be willing to reimburse at a premium, potentially at a premium to the branded oma. Okay. And then on the commercial infrastructure side, when we had spent time discussing atopic derm in the past, you'd always talked about being comfortable with the clinical development capabilities, but when you got to commercialization and a larger market opportunity, wanting to think about a partner, how should we think about this for, again, large indications and INI? I think our thinking is similar. It's a portfolio in a product, basically, right? You'd have multiple therapeutic categories that you potentially would be marketing to. There, it's a little harder for a smaller company to address all of that. Obviously, a partner could make sense, but the devil's always in the details. Okay. At what point in time would that make more sense to you in terms of looking for a partner? Can you get through phase III and all of these indications, or does it make sense to look past the proof of concept data? That's a good question. I mean, I think normally once you have the 2b data and you're starting to go into the phase III, that's probably the sweet spot to start talking about potential partnerships. Okay. You, I think, have said that you have cash run rate into the first half of 2027. What activities specifically are embedded in that guidance? Primarily, we made sure we would get to the end of that phase 2b trial in food allergy. The wild card is the CSU program because, again, we're waiting to see the Jemincare data. As we said, it's possible we could go into a phase III trial there. If that is the case, we didn't project that in that runway calculation, so we likely need to raise additional capital for that. Okay. You would still want to preserve cash beyond the food allergy, so you'd need additional capital. You wouldn't pull forward the runway guidance? Yes. Yeah. Okay. You, I think, have disclosed that you're working again on a next-generation CCR4 antagonist. So I guess where do you get confidence in that mechanism given the clinical challenges you ran into last year? Yeah, no, we still remain excited about CCR4 as a target. Even though our phase II trials were terminated early, and obviously because of that, not as clean as we'd like, I think we've seen enough information from there to be really excited about that pathway. We still think there's a high imminent need for an oral drug for a range of TH2-driven disorders like asthma, like atopic dermatitis and others. Okay. How is this next generation drug differentiating versus your prior 193? Higher selectivity, higher potency, and larger safety margins. Do we understand now, having spent some time with the data, what led to the safety issues that you had? You know, there was only one event. We talk about one event, right? It's hard to draw, make correlations or anything like that. I think in theory, we know enough where I think we know exactly kind of how to improve a molecule and reduce that risk dramatically even further. I think the next generation molecule, which we're planning to, we're still very, very close to making that declaration, should have all those attributes. Okay. So in terms of timeline for that program? You know, assuming that everything's on track, we should be in the clinic next year. Okay. I guess in terms of development priorities, previously it was atopic dermatitis. Is that what we should expect first again? We haven't disclosed the data yet. I think our perspective is that the target is still very promising for a range of TH2-driven disorders. Okay. How would it fit relative to the priorities in terms of capital allocation? We just talked about runway. Where does this asset in any clinical development fit? Yeah. I mean, I think 904 food allergy is very clearly the top priority, and that's the one we're going to make sure we get to the finish line on. Beyond that, we'll have to see. I mean, obviously, if we're going to a phase III in CSU, that's going to be pretty high priority too. As Brian said, you know, we're pretty excited about the opportunity for an oral CCR4. If we have a chance to take that into the clinic for a range of TH2 disorders, we'll have to figure out a way to do that. Right. Anything else you want investors to understand about the business today and kind of the path forward from here? I think you were very thorough, Corinne. No, I think, yeah, I mean, just the bottom line is that there's now over 50,000 patients in food allergy alone for Xolair in the first four quarters. I think that just tells you how high the unmet need is. We are extremely excited about having a better molecule. Yeah. Obviously, there's data this year, which we're excited about, and then 18 months later, data in food allergy. Great. I appreciate the time this morning. I think we got through a lot, so I appreciate it. Yeah, you're very thorough. Thank you. Thanks again.