Thanks, everyone, for coming. I'm Patrick Colton, Biotech Associate here at Stifel. I'm joined here by RAPT Therapeutics, CEO Brian Wong, and CFO Rodney Young. Thanks, guys, for being here. Thanks for the invitation. Brian, I guess if we could just start off with just a brief overview of the company and maybe a status update. Sure. RAPT Therapeutics is an immunology therapeutics company. We focus on indications where we can really disrupt the standard of care and high-value indications, so multi-billion dollar opportunities. Our lead asset is called ozureprubart (RPT904). This is a long-acting anti-IgE, omalizumab bio-better. I know that's a mouthful. That's been designed for less frequent dosing and better compliance versus Xolair, but also the ability to access patients that are currently off the Xolair label due to restrictions on the label. With those two advantages, we think we can succeed in areas like food allergy, which is a large $40 billion opportunity in the U.S. as well as in chronic spontaneous urticaria, which is also very large, but maybe not as large as food allergy, but still an opportunity to disrupt the standard of care. We recently reported data from a phase II trial showing numerically superior efficacy to omalizumab across all endpoints and all time points, even after a single dose out to week 16. That really speaks to the durability of the drug. Not only will it enable us to move directly to phase III in CSU, but also, I think, translates well to food allergy. We've got multiple milestones upcoming. We're currently phase IIb study for food allergy and plan to start those phase III studies in CSU next year. Great. Thank you. Yeah, I'd love to talk about the design of ozureprubart. Yeah, OZU. OZU. But first, I guess, could you just walk us through the thought process and what went into the acquisition of this asset and maybe what you guys saw? Yeah. Do you want me to start there? Yeah. From the technical side, we really got excited about the food allergy because the launch of Xolair in food allergy has gone phenomenally well. At the time last year, they had 30,000 patients on food allergy in the first two quarters after launch. Now they have 85,000 after six quarters. It has just been a trajectory that's been amazing. We were looking for anti-IgEs that fulfilled certain criteria. One, they had to have extended half-life to improve dosing frequency, better affinity, which would allow us to potentially suppress free IgE better and access patients that were off the Xolair label. Also, really importantly, share the same epitope as omalizumab. We did not want to take any kind of epitope risk. We identified this asset called RPT904. Our partner, Jiangsu Hengrui Pharmaceuticals, calls it JYB1904. Now we're calling it ozureprubart. Rodney can talk a little bit about the terms of the deal. Yeah. I think one of the important things that helped us succeed in licensing the asset was we were able to move quickly. JU was looking for a potential partner who could advance the asset as rapidly as possible. We had a team in place and an infrastructure in place. Our ability to negotiate the license sort of indicated our ability to move. The license terms, it was a $35 million upfront payment. There are about $670 million in milestone payments, of which about $450 million, or more than two-thirds of it, are either approval or beyond approval, so commercial milestones, and about $225 million developmental milestones split across three potential indications. We've talked about us going into food allergy in CSU as the first two indications. The royalties we would owe on sales, they're tiered. The highest tier is low double digits, about as low double digit as you could be. We have all rights globally except for China, Taiwan, Hong Kong, and Macau. Okay. You touched on it a little bit with the overlapping epitope versus omalizumab. I guess, what are some other design differences or similarities versus omalizumab? Maybe with that, how does that read through to some of the other next-gen IgEs that maybe have failed in the clinic? Yeah. As we did research in the space, it became very apparent to us that maintaining the epitope was critical for maintaining the probability of technical success. There were other attempts by Novartis to make a next-generation anti-IgE. A notable one is called ligelizumab, about two logs greater potency than omalizumab, but did not share the same epitope and ultimately failed in asthma and in food allergy to show superiority and actually was worse than omalizumab. That sent up some red flags to us. It, again, made us realize that we really wanted to go after something that shared the identical epitope to OMA. There are other competitors. We can talk about that, which either were less advanced or not as far along, or they did not share the OMA epitope, and we shied away from those assets. I guess talking about food allergy, the competitive landscape, as you kind of alluded to, is growing. I guess, what are your thoughts on positioning here? And then can you talk about positioning versus the generic omalizumab coming to market? Yeah. What's really exciting about food allergy is that it's nearly untapped. There are 17 million patients diagnosed in the U.S. There are 3.4 million people that have visited in the last year. Very, very high unmet need and a high economic burden to the health care system as well. We've seen this incredible launch with Xolair with 85,000 patients now in the first six quarters after launch, which makes it one of Roche's fastest-growing franchises, which is not bad for a 23-year-old drug. That speaks to the very, very high unmet need in food allergy without a lot of competition. We think that based on, and we'll get into this, the differentiated features of our molecule, which we touched on, this should allow us preferred positioning as well as driving the ability for premium pricing as well. It will allow us to displace omalizumab as the standard of care. The only other mechanism that we're aware of is the BTK inhibitors, which Novartis is moving into phase III development for food allergy. Their position in that is a fast-acting drug. I think it may be limited in terms of treating young children with a BTK inhibitor. I think the safety of an omalizumab-like molecule has been so well established that it probably will become the, we think we're going to compete very favorably to Remibrutinib. I guess, do you need to be better than omalizumab or the generic? Maybe if not, how is your profile differentiated where you don't have to be? Yeah. Yeah. So we've done a lot of primary market research talking to payers, prescribers, and patients. The TPP we've gone out with is OMA-like safety and efficacy, but with less frequent dosing. The two differentiating factors that have really come to the fore, right, the less frequent dosing, most food allergy patients are on Q2 week dosing. If we can dose Q8 week or Q12 week, that's a really big differentiation, particularly for kids. Patients would like that. Prescribers would like that. The payers recognize that because of that factor, the convenience factor, that's likely to increase the compliance. If you can keep the patients on the drug, you should have better patient outcomes. That should lead to fewer visits, less health care utilization. The payers like that as well and would be willing to reimburse OZU at a premium relative to Xolair. The other really key differentiating factor, Brian alluded to it, if we can show efficacy in that fraction of patients who are ineligible for omalizumab per the label, right, these are the high IgE and/or high weight patients, those patients cannot take OMA. We would literally be addressing an unmet need. Again, there we should have some pricing leverage, which again, the payers would recognize. When we talk to them, the payers suggest they'd be willing to reimburse at about, call it 15%-20% premium relative to Xolair. Yeah, relative to the branded. Let's talk about that a little bit. First, I guess, if we just an overview of the phase IIb food allergy study design progress and maybe bar for success, and then a little bit about enrolling the OMA eligible versus ineligible and what makes you able to do that. Yeah. We're very excited that the FDA cleared our IND recently. We just started last month the study. It's very much modeled off of the OUtMATCH study, which was the phase III study that was basis of approval for Xolair. This is a double-blind placebo-controlled food challenge study. It's exactly as you kind of imagine it. Patients with a certain level of set sensitivity to five different foods, peanut, egg, milk, walnut, or cashew, are enrolled into the study. There's a 24-week dosing period of OZU at either Q8 week or Q12 week. There's an exit challenge to look to see if they achieve a certain threshold of sensitivity. Those are considered responders. In the omalizumab study, they saw a roughly 60%-70% response rate across most of the food allergens. The study is powered to detect OMA-like activity in the OMA eligible patient population. There's a subpopulation that we're enrolling, which is the OMA ineligible patient population, where we're looking for any trends of activity because obviously the bar is a lot lower there. We don't need to see the same level of efficacy in the OMA eligible patient population. That's roughly 25%-40% patients. So 75% OMA eligible, 25%-40% OMA ineligible patients. One part is power. The other is exploratory. The goal of this is to understand how to include the entire population in the phase III trials so that we can get a broad label for all patients irrespective of their IgE or body weight. Okay. Makes sense. You talked about the food challenge. Is this a difficult trial to enroll given that setup and maybe with Xolair being on the market right now and maybe any indication of how enrollment is going and timing? Yeah. We just started at the end of October. It's a little bit too early to say, but there's a lot of enthusiasm. We're basically on track for all of the site activations and enrollment so far, but still early to say. I think there's certainly a lot of patients out there. Just as another really important point, OMA is not approved for food allergy outside of the U.S. We're opening sites not only in the U.S., but also in Canada and Australia to capture that patient flow. That being said, patients in this study need to be exposed to food that they've been told all their life they need to avoid. It really does limit the patient pool that's willing to participate in the study. Again, we think very reasonably we can complete the study in 18 months. There might be some ways to accelerate that. We're obviously exploring ways to increase the number of sites and so forth. We have about 30 sites planned. Right now we're planning for a readout early 2027. Okay. Just going back to the omalizumab launch today, what have you learned from it? What is really driving the success here? Omalizumab? Yeah. Yeah. I think prior to the launch of omalizumab, patients really only had Palforzia, which is the peanut oral immunotherapy or homebrew immunotherapy. That requires very complicated up-titration. Often patients do have an anaphylactic reaction or allergic reaction to that therapy. And it's not a cure. It requires maintenance doses that are daily maintenance doses. It's very inconvenient for the patient. A lot of patients drop out due to AEs. In a head-to-head study of Xolair versus OIT, Xolair was numerically more effective and had many, many fewer dropouts and discontinuations versus OIT. That is why it's becoming the standard of care now very rapidly. The other thing to point out is Xolair can treat multiple food allergens. OIT typically allergen by allergen. You can take one. Xolair can address. About 40%-50% of patients have more than one food allergy. That is a really important advantage as well. Okay. You mentioned enrolling outside of the U.S. omalizumab or Xolair is not approved outside the U.S. in food allergy. What proportion of sites or patients do you expect to be outside of the U.S. in any sort of indication of? Majority of sites are still going to be in the U.S. There are some very well-trained high-volume sites that we've identified in Canada and Australia that we think will really contribute to the patient flow. Of course, the OMA ineligible population should be relatively easy to enroll in all countries. Right. Makes sense. Great. Let's talk about the phase II CSU data that you guys just read out. Maybe just walk us through that data to start. Yeah. Obviously it met our best case scenario. This was a 135-patient planned study comparing Q8 week and Q12 week at 300 mg of OZU versus the approved dose of omalizumab at 300 mg Q4 week in patients that are refractory to their antihistamines. The Q8 week was two doses at week zero and week eight. The Q12 week dose was really a single dose because of the typical endpoints at week 12. They measured this out to week 16. On the two endpoints that were measured, which is the UAS7, and that is the typical endpoint used as the basis for approval, and the UAS7=0, which is essentially complete response, no disease activity, we saw numerically superior efficacy at all time points, week eight, 12, and 16 versus omalizumab on both doses, even the single dose. Very exciting. It really supports the durability and the potential for limiting up-dosing, which roughly 20%-30% of Xolair patients are required to do. We think that also sets us up for a clear dose for moving forward to phase III, which is the Q12 week dose. Yeah. I guess it's a very convenient profile versus Xolair. You mentioned durability. I guess how should we think about durability here out past 12 weeks and 16 weeks? We have seen some Xolair data, some real-world data where efficacy kind of falls off after about a year. Is there potential to be differentiated there? Yeah, I think so. In fact, next year at a medical meeting, we'll be presenting data from the 16-week extension. We'll see the performance of that single dose over a 32-week period. We'll really get to understand the full kinetics and the durability throughout that 32-week period, which could be pretty interesting, right? I think the way that we're viewing this, the TPP that we've presented to prescribers and payers is basically similar efficacy, but less frequent dosing. Q8 was acceptable. Q12 week was considered very attractive. Now we're seeing efficacy that's numerically superior to omalizumab. I think the question is, how will that manifest? I think one of the really exciting features is that, as I mentioned, a lot of Xolair patients require up-dosing to 450 or 600 mg or more frequent dosing. If we can tell a patient, "We don't need to adjust your dose. You can be on this every 12 weeks and control your urticaria," I think that's going to be a very attractive profile. Yeah. Yeah. I guess looking forward, what does the development path look like in the U.S. for CSU? Yeah. We hope to start phase III studies with a prefilled syringe at the end of next year. Obviously, that's predicated on discussions with the FDA as part of an end-of-phase II meeting. We're gearing up for that. The trials themselves, given the fact that our partner will be running studies in China and contributing to the safety database, we are contemplating two phase III trials of roughly 300 patients per trial. That, in addition to the safety database from our partner, we think should be sufficient for the FDA. We'll have to have those conversations. Those numbers are all safety-driven. I guess just thinking about the barzolvolimab trials, those are like two 900-patient trials. Those are massive trials to run. You guys could run a 300-patient trial. That's all based on safety, or is it because Xolair has been approved? Yeah. I I think there's a lot of tailwinds here. The first tailwind is that we'll have more safety from our partner. Second is there's a lot of familiarity with the mechanism. Particularly, we share the same epitope as omalizumab. I think there's a lot of comfort. One example is that the agency let us move directly to a phase IIb study based off of Chinese healthy volunteer data. Again, they have cited clearly that omalizumab, the safety and the PKPD and efficacy is very similar across different ethnicities. A lot of comfort there. Would you guys consider running a head-to-head versus omalizumab? Is that in the cards? Yeah. The question comes up a lot. I think from an approval standpoint, that's not necessary. I think you might consider maybe some post-approval studies where you're looking at switching, for example, or you're looking at a head-to-head study. Those are trials we're contemplating, but not necessarily part of the core trials that are required for approval. Should we think about positioning here versus omalizumab any different than food allergy, or is it similar? Very similar. OMA is a standard of care now in both indications. The feedback we've been getting, particularly after this data, is that over 90% of patients will switch from omalizumab to OZU. If you present this option to patients, we hear that over 90% of new scripts will be OZU. So far, the feedback has been very, very positive. Okay. Awesome. Across both trials and just with this program in general on safety, anaphylaxis, obviously the black box on Xolair, from what all of our KOL conversations, it's extremely rare. Some of them have never seen it throughout their entire career. You are testing a more potent molecule. I guess how do you think about that? Is this just a class warning? Part of it is I think early on, this was one of the first approved drugs. The anti-TNF were maybe first. The agencies at the time really felt like antibodies did not belong in indications outside of oncology. I think there was a lot of conservatism at the FDA at the time. Over the years, you can see the FDA becoming much more relaxed and much more, I think, familiar with the efficacy and the safety profile of OMA to the point where an investigator-sponsored study in food allergy led to this very broad label for all food allergens in patients one year and above. Now, does that mean we will be able to avoid the class? Depends on the data. I think we can make strong arguments. Allergens are very familiar with Xolair. I think what we are probably the black box warning really affects are the derms that treat CSU, which is a minority of the prescribers. Right. Okay. Great. Other indications of interest? I guess your partner is running an asthma trial. I guess could you talk about that and maybe other broader indications you could take this into? Yeah. I think so anti-IgEs have been approved in asthma and chronic rhinosinusitis and have shown activity in allergic rhinitis as well, another massive opportunity. I mean, just imagine being able to treat severe allergic rhinitis with one shot every quarter. That can be very attractive. I think we're focused right now on the areas of highest eminent need, which is food allergy and CSU. OMA is not the standard of care in asthma. We are aware that as we launch the drug, the broader label will help lift the entire brand because these diseases are so coincident in the same patient. It is something that we're considering as part of a life cycle strategy in the future. Okay. What's the timing of taking forward other indications? I think we're going to wait to see how the food allergy study looks. Obviously, that is really the biggest untapped market. We're assuming success there. Then we can plan out next steps from that, line extensions and so forth. Definitely. Okay. I do want to ask one question on the next-gen CCR4 antagonist. I guess what does the path forward look like there? Does some of the preliminary data that you got from 193 give you confidence in that target still? Yeah, any color there? Yeah. The results from our early terminated studies were still very supportive of the target across a range of TH2-driven disorders like asthma, atopic dermatitis. We still believe that an oral drug, a once-daily oral drug, would be commercially a massive success in those indications, very similar indications to dupilumab. We selected a second-generation molecule in the second quarter. They are undergoing IND enabling studies. We do not have an official date of when we are going to be back in the clinic, but it should be by next year. We will be able to file the IND. Awesome. Yeah. So we're excited about that. Of course, it's earlier. And so really, the OZU is taking the center stage for now. Yeah. I always like that mechanism. You guys had a recent raise. Rodney, I guess if you could just give a rundown on cash runway and the embedded assumptions there. Yeah. So with the raise, our pro forma cash balance at the end of Q3 is $392 million. Feels good to say that. That runway we project will carry us into mid-2028, by which time we've said we expect the food allergy phase IIb readout first half of 2027. We should have that. We should be well into our phase III CSU program. We potentially should start the phase III food allergy trial. Great. Any questions? Thank you, guys. Appreciate it. Appreciate it. Thank you.