That's good. Okay, good afternoon, everyone. Welcome to Guggenheim Healthcare Innovation Conference. My name is Yatin Suneja, one of the senior biotech analysts here at Guggenheim. It is my pleasure to welcome our next presenting company, RAPT. From the company, we have the Chief Executive Officer, Brian Wong. We also have the Chief Financial Officer, Rodney Young. Gentlemen, thank you so much for your time. Brian, why don't I hand it over to you? Maybe make some opening comments. Tell us about the RAPT story, what you're doing, what are some of the milestones that we need to be focusing on, then I have prepared some Q&A for you. Yeah, sure. First of all, thanks for the invitation. It's a great conference. RAPT Therapeutics is focused on therapeutics development in high-value inflammatory disease indications. Our lead asset is called Ozureprubart, also called RPT904. This is a long-acting anti-IgE omalizumab bio-better antibody that's designed for less frequent dosing than omalizumab, better compliance, but also the ability to treat patients that are currently inaccessible to omalizumab therapy. We can get into those patients, but it's a fairly substantial population. We're very interested in two therapeutic areas. One is food allergy, which is a major market that's just emerging. We've seen Xolair sales now exceed 85,000 in just the first year and a half after launch. We think we can replace omalizumab as a standard of care in food allergy. We're also very excited about Chronic Spontaneous Urticaria or CSU, where omalizumab is a standard of care. Because of the favorable attributes of Ozureprubart, it could replace omalizumab as a standard of care in CSU. Our partner, Jeyou, just reported a 137-patient study in CSU showing 16-week durability with a single dose, which was numerically superior to omalizumab dosed four times during that first 12-week period. Very good durability and very much supports the target product profile across multiple indications. In terms of milestones, we have initiated our phase II-B Prestige study in patients with food allergy that just started. We expect that to take roughly 18 months to topline data. I'm very excited about that because we're also exploring both oma-eligible and ineligible patients in that study. We can talk more about the design. The phase II data in CSU also will enable us, we believe, to go directly to phase III. We're planning to start having interaction with the FDA next year and then start phase III trials before the end of next year. Got it. Very good. Thank you for that context. Simply one high-level question. What is driving interest in this space, in the food allergy space? I mean, you touched a little bit on the Xolair launch, yes, phenomenal launch, 85,000 patients very rapidly. Why do you think Xolair is so successful there? Yeah, so just to put this in perspective, food allergy is about the same size as atopic dermatitis. So it's roughly 17 million patients in the United States diagnosed. And there's very, very little therapeutic options. Prior to Xolair's launch, there was really only immunotherapy, oral immunotherapy, which was inconvenient. It had a lot of AEs and side effects and also required daily maintenance. In addition, it only addressed a single allergen. So you actually had to dose-escalate OIT for every allergen you were allergic to. With Xolair, it's approved for all allergens for patients one and above because of its good safety profile. And because of those attributes, it's just taken off. So over 85,000 patients, sort of that gross run rate of over $3 billion. In the first year and a half, Roche is saying it's one of their fastest-growing franchises, which is not bad for a 22-year-old drug. Yeah, sure. In your assessment, what type of patients are getting Xolair? The severity, the age? Yeah. Yeah. I'll start. Rodney and his team have been doing a lot of research on that with our head of commercial. It was very interesting because it looks like the sweet spot, the most scripts are for adolescents and young adults. You can imagine these are either kids who are going off to school or they're going to college and their parents or they want protection from an accidental exposure to an allergen. That being said, about 40% of scripts are in children. Because there are fewer children than adults, there's only about 4 million children diagnosed with food allergy compared to about 13 million adults. Proportionally, more children are actually getting Xolair. Do you want to add anything to that? No, I think you covered it all. Yeah. Okay. Okay. What are the limitations of Xolair? I think your antibody is unique in a couple of ways. It provides convenience from a dosing standpoint, and I think it's more potent. I think you can also touch on you can also go after the patient population that is not eligible for Xolair. Talk about the limitation and how you will go about those patient populations. Yeah, so omalizumab has been a very successful drug, but of course, it's a 23-year-old drug. It has a relatively short half-life, relatively low affinity. It's a drug that's clearly in need for innovation. Why we're excited about Ozureprubart is that it has enhanced half-life through the YT mutation. It also has been affinity matured in the CDR regions to enhance binding to IgE by roughly fourfold. We've seen that translate through clinically, and we can talk a little bit more about that. I think the other important aspect is that it preserves the same epitope as omalizumab. That's really critical because we know that other attempts to make next-generation IgEs have failed. We believe that's largely because they've changed the epitope. That changes the PD efficacy relationship. Not only do we think we can get to Q12 week dosing relative to omalizumab's Q2 week or Q4 week, and most food allergy patients are treated Q2 week, but we also can access those patients that are off the dosing table for omalizumab due to high weight and high IgE level. All of our modeling suggests that we should be able to get most of those patients on the dosing table with Q12 week, with Q8 week reserved for the highest IgE, highest weight patients. Got it. Got it. Okay, that's very helpful context. Now, the clinical data that you have generated with 904, I still can't pronounce the name yet. Yeah, Ozu. So I'm going to use Ozureprubart. Yeah. Can you review for us how it stacked up versus OMA? What is your comfort level in terms of the dosing frequency that you're going to go after, both in food allergy and also in CSU? Yeah, so obviously, the Healthy Volunteer data showed a 60-day half-life versus omalizumab at 24 days. That was promising. In the CSU study, clearly, we showed outperformance of omalizumab in a head-to-head trial across multiple metrics. This is a 137-patient study, roughly 45 patients per arm, comparing Q8 week dosing of Ozu and also a single dose of Ozu meant to represent a Q12 week arm versus omalizumab dosed every four weeks, everything at 300 mg. What we saw across both of the endpoints, including the UAS7 and also the complete response score, was numerically superior efficacy to omalizumab at both Q8 week and Q12 week arms across all endpoints. This is true actually out to 16 weeks after a single dose of Ozu, which really speaks to the durability of this newly engineered antibody. Okay. Okay. Now the food allergy study, the Prestige study, right, phase II-B, it's already up and running. Walk me through the study design. What type of Xolair ineligible patient are you getting? Are you only focused on the ones that are heavier in weight or just going after higher IgE level as well? Yeah, yeah, that's great. Great point. I think what we learned also from the CSU study is that the Q12 week is a very supported dose to move forward into phase III studies for CSU. It also suggests that in our food allergy study, because the data from the CSU really exceeded our modeling, we think the Q12 week is very, very well supported in the food allergy study. In the food allergy study, it's based off of the omalizumab phase III trial called OUtMATCH. It's a placebo-controlled study. It's a double-blind placebo-controlled food challenge study in 100 patients, roughly. We have a Q8 week arm and a Q12 week arm of Ozu versus placebo. What we're looking for is basically a change in that food challenge sensitivity. We're studying five different foods. Peanut, milk, egg, cashew, and walnut, which are the most common foods that people are allergic to. Essentially, what we're looking for is OMA-like activity at Q8 week as a base case, with Q12 week being upside. I think now we're more confident in the Q12 week arm. We've also included a subpopulation of patients who are high weight and/or high IgE that fall off the OMA dosing table. Seventy-five patients will be OMA-eligible. I see. Twenty-five to up to 40 patients will be OMA-ineligible. The reason why we broke those out is because any activity in that omalizumab-excluded patient population will be, I think, very, very exciting because they have no option. We did not want to dilute out the primary set, which is the OMA-included population. On 75. Yeah. Okay. Now, for these two OMA-ineligible patients, are there different, I would say, efficacy thresholds? Because I think we hear from some investigators that, look, if you have very high IgE level, your disease severity tends to be a little bit higher. So can you actually have a low, can you afford lower efficacy in that patient population? In the high IgE? High IgE. Yeah. Yeah, I think because OMA is not, so first of all, omalizumab performed very well in the, of course, the OMA-included set. I think the bar is lower in the high IgE, high weight patients. Now, there's going to be a limit to the level of protection that you're going to be willing to tolerate. I think given that OMA showed a 60%-70% response rate, I don't think you need that level in the OMA-ineligible patient population. Irrespective of their high IgE level. Exactly. You're saying there is no difference between. Shouldn't be. High IgE or the weight? That's right. Okay. Okay. Okay. You have said that it's going to take the data is going to come in the first half of 2027. When we do the checks, we talk to physicians, they're like, "Look, there is so much demand." Roche put 25,000 patients on the drug in one quarter. Why will it take that long? Yeah. Yeah. A couple of things. One is because of that ramp-up, right, that rapid ramp-up, which is, I think, very, very exciting for us because it tells you there's a high in that need. There are probably a smaller pool of patients that are available for trial. Also, the bar for a trial requires food challenge. I think one of the things that patients really do not like to do is to expose themselves to the food that they are allergic to. We require two of those challenges. Logistically, yes, there are a lot of patients, but the trial itself is quite rigorous, which is good for the trial, but may slow down enrollment. That said, just to be actually, it is really important. Oma is not approved in food allergy outside the United States. We are opening sites in Canada and Australia where there is no option. We think that the actual patient flow there should be quite robust as well. These OMA-ineligible, they should be lining up, right? Because they do not have an option. That's right. right. It's roughly 25% of food allergy patients. Yeah, of the food allergy patients, 20%-30, yeah, 25%. Okay. Any other consideration for patient enrollment other than the food challenge, any particular feature that we need to keep? Yeah, so it's rigorous. We require positivity based on lab testing, allergen-specific IgE and skin prick, as well as food challenge. There's a 24-week dosing period, and there's a second food challenge as well. Yeah, we'll get to learn. I think really importantly, we're actually testing the second challenge at drug trough. We really should be able to prove the durability of clinical activity there as well. The endpoint is, yeah, endpoint is at what time frame? 24 weeks. Twenty-four weeks. We'll get the twenty-four-week by in the first half. Okay. Okay. All right. I think I'm good on the food allergy side. Now, what about CSU? It seems like you are going into the pivotal study. Just trying to get a sense of the size, scope, and what is the differentiation there. Yeah, so we're very excited about the phase II CSU data. We think it's very enabling. We think that the 300 mg Q12 week dose is well supported by that study. That's our go-forward dose into phase III. It will require a discussion with the FDA, but given the familiarity with omalizumab and the mechanism of action, we don't think we're going to need 1,000 patient phase III studies. We're thinking sort of several hundred patients per trial. These would be two independent placebo-controlled studies with a 12-week endpoint. How long will it take you to do these things? Yeah, we haven't given sort of a time frame, but again, these are not large studies. I think we'll probably come back with some estimates there. They're not large 1,000 patients. You still have to meet with the FDA to figure it out. Okay. On the asthma side, is that also a consideration once we see the data from your partners? Yeah. So just as a reminder, Jeyou is running a small asthma study, roughly 60 patients, and the primary endpoint is PKPD. So they're looking at free IgE reduction really as a basis to confirm a dose to move to their phase III trials. RAPT is not planning, given the competitive landscape in the U.S. and in Europe, not planning asthma development. What we would like to see in this output, which should come before the end of the year, is a deeper and more sustained reduction in free IgE head-to-head versus omalizumab. I see. Okay. That's helpful. Rodney, maybe I wanted to pick your brain on the market dynamic, specifically in food allergy. The one question we get from investors on the biosimilar dynamic, right, at some point, Xolair, or it's already out there, right? How does the biosimilar, what would be the impact of biosimilar when it comes? How do you think about that? Even if we assume biosimilar-type pricing, I think the market is still big, but I want you to sort of contextualize for us. Yeah. So the patent for Xolair is going to expire this year. They expect the first biosimilar to hit the market late next year. They're coming. We would assume biosimilar pricing would erode the Xolair pricing. We've taken that into account as we think about how our pricing strategy, how we would approach our pricing strategy. The key for us is how is Ozu going to be clinically differentiated from both Xolair and the biosimilars? We think there's two important ways, right? One is the less frequent dosing, which should lead to the patients will obviously prefer that. They'll like that, not having to take it every two weeks, having the chance to take it every 12 weeks. That should decrease the dosing burden, but increase compliance. Better compliance should lead to better patient outcomes, which payers recognize should reduce, for example, the use of healthcare resource. The other really important differentiating factor is, as Brian mentioned, if we can treat the OMA-ineligible population, those patients really have no alternative. There, we would clearly be meeting an unmet need, literally be meeting an unmet need. Those two things, we think, give us clear differentiation from Xolair as well as the biosimilars. In our research, when we talk to payers, they'd be willing to reimburse Ozu relative to Xolair at about 15%-20% premium. Got it. That's for overall? Yes. Okay. For Xolair ineligible, what are the risks? Why can't you treat them with your drug? The OMA failures? Ineligible. Oh, it doesn't. OMA- ineligible. Why can't we treat them? Yeah. I mean, the data, I mean, it's much more important. I don't think you have the weight restrictions or what are the risks there? Yeah. No, based on our modeling and based on the data that we've seen today, we think we can access most of those patients with Q12 week dosing. Maybe Q8 week dosing reserved for the very highest IgE. Sometimes the IgE can get up to as high as 5,000. We've modeled that. We can access those with Q8 week dosing. Okay. Okay. What will be the pivotal path here in food allergy, one study, two studies? One advantage of moving first with CSU directly to phase III is that we're building that safety database. For a food allergy, which probably will come as a supplemental PLA, we'd only need a single phase III. That's what Xolair did, just like a one. They didn't even run the study. No, it was. National. Yeah. It was interesting. NIAID. NIAID. So far, study. Yeah. Ran the study. Okay. I think I'm good here. Maybe quickly on anything on the competitive landscape that you're keeping a close eye on. There is a bunch of stuff happening on the competitive side. Yeah. I think for CSU, we look at dupilumab and remibrutinib's approval in CSU. Oma will still maintain its dominance as standard of care despite those launches. And CKIT, we also think, will be second line in Xolair failures primarily. What we expect to happen is that Ozu, because of its differentiation, will take that front line preferred option in patients who fail their antihistamines and take them. In fact, in our early research, 90% of patients will switch from oma to Ozu. Most of the new scripts will actually be Ozu based on the data that we've generated to date. With food allergy, remi is being tested in phase III next year for food allergy, but that's really the only option. I do not think remi is going to be used broadly, particularly in young patients. Safety issues. Yeah. Okay. Maybe, Rodney, final question for you. How's the cash position, the bond rate, all of that stuff? Yeah. We reported about $157 million in cash at the end of Q3. With the raise we just did a couple of weeks ago, we have a pro forma cash balance of about $392 million. We project that runway to last us through mid-2028. By that point, we expect to have the food allergy phase II-B readout in the first half of 2027. We will have hopefully started our phase III program in CSU and potentially started the phase III in food allergy. Got it. Maybe one question. How many sites are there for the Prestige study? Over 30 sites. Over 30. That's global? Global. Yeah, exactly. Most in the United States, then supplemented in sites in Canada and Australia. Not Europe? Not yet. No. The study, by the time we got Europe on, we'd hopefully be done with the study. Thank you so much. I think that's all I had for you. Thank you, gentlemen. Appreciate it. Thank you. Thank you.