Good morning and welcome to RAPT Therapeutics' conference call. At this time, all participants are on a listen-only mode. There'll be a question-and-answer session after the prepared remarks. As a reminder, today's call is being recorded. I would now like to turn the call over to Rodney Young, Chief Financial Officer of RAPT. You may begin. Thank you, Kevin, and good morning. Thanks to all for joining us this morning to discuss our press releases issued this morning, which are available in the investor section of our website at RAPT.com. The slide deck for this call is also available in the investor section of our website. On the call with me today is Dr. Brian Wong, Chief Executive Officer with Prepared Remarks, and we'll have a question-and-answer period at the end. 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'll now turn the call over to Brian. Thank you, Rodney. Good morning, and thank you all for joining the call today regarding RPT904, RAPT's newly in-licensed long-acting anti-IgE antibody for food allergy and other allergic disorders. Slide 2 states our disclaimers. Slide 3 provides a summary of today's presentation. RAPT's mission is to develop transformative therapeutics for high-value inflammatory disorders. Today, we have announced the in-licensing of RPT904, also known as JYB1904, a half-life-extended anti-IgE omalizumab biobetter antibody from Jemincare, a leading Chinese pharmaceutical company with over $6 billion in annual revenue. RAPT's territory will include all territories excluding China, Taiwan, Macau, and Hong Kong, where Jemincare will develop and commercialize JYB1904. Financial terms of the deal include a $35 million upfront payment, approximately $672 million in milestones, the majority of which are sales milestones, and royalty payments to Jemincare in the mid-single digit to low double-digit% range. We are excited to partner with Jemincare to bring this exciting potential new therapy to patients. Omalizumab, marketed as Xolair, is a first-generation anti-IgE antibody approved for food allergy, or FA, Chronic Spontaneous Urticaria, or CSU, asthma, and chronic sinusitis. Jemincare's phase 1 data in healthy volunteers were impressive and demonstrated a best-in-class profile with the potential for less frequent dosing and increased patient compliance. We are planning a phase 2b study in food allergy, with study start expected in the second half of 2025, with top-line data available in the first half of 2027. In parallel, Jemincare is currently running phase 2 studies in China for asthma and Chronic Spontaneous Urticaria, with top-line data expected in the second half of 2025 and the first half of 2026, respectively. Based on the outcome of the phase 2 CSU trials from Jemincare, RAPT will determine how to pursue development in this indication. It is possible we could leverage Jemincare's phase 2 data to potentially initiate a phase 3 trial, assuming regulatory agency agreement. We're also extremely pleased to announce a $150 million financing from top-tier investors, which, along with current cash on hand, will fund the company through our phase 2b food allergy data readout. I'd now like to turn the call over to Rodney Young to speak about the commercial opportunity in FA and CSU. Thank you, Brian. Okay, we're on slide 5. As Brian mentioned, omalizumab is approved for food allergy as it demonstrated robust efficacy in the phase 3 OUtMATCH study, which is summarized here on slide 5. Far more patients were able to achieve the pre-specified food challenge threshold level when treated with omalizumab as compared to placebo. This was observed across a number of common food allergies, including peanut, egg, milk, walnut, hazelnut, and wheat. These data supported the broad label for OMA to cover multiple food allergens. Omalizumab is dosed either once every two weeks or every four weeks, depending on the food allergy dosing table, which takes into account the patient's weight and baseline IgE levels. Turning now to slide 6, omalizumab is off to a highly successful launch and is on a blockbuster trajectory. First off, there are a lot of food allergy patients. According to Roche, there are some 17 million patients in the U.S. with a food allergy, of which approximately 50% have had a severe reaction resulting in approximately 30,000 room visits per year. Omalizumab is the first and only FDA-approved therapy to reduce allergic reactions to multiple foods, and many patients are allergic to more than one food. So the market uptake has been rapid. In the first two quarters after approval, Roche has reported they already had 30,000 patients on treatment, which, if you simplistically annualize, that suggests 60,000 patients on omalizumab in the first year on the market. Moving now to slide 7. So we see a high unmet need and a very large commercial opportunity in food allergy. There are millions of patients, and until the approval of omalizumab, there has not been a convenient, effective treatment for multiple food allergens. The treatment environment has been dominated by inconvenient treatments, including food avoidance, which is the most common treatment approach, which can limit the patient's risk of exposure to the allergen but can be quite burdensome on the patient and the caregiver. Another common approach is allergen desensitization approaches, such as oral immunotherapy, or OIT, which can be effective but, again, are inconvenient and can take a while to work and are generally limited to a single allergen. So to us, the rapid uptake of omalizumab in food allergy underscores that there is a need for a convenient therapeutic option that can address multiple allergens. However, even with OMA's early success, payers and prescribers would welcome a longer-acting treatment to increase compliance with therapy and also expand the pool of patients that would consider taking an injectable therapy. When we tested a target product profile of equivalent efficacy and safety to omalizumab, but with Q8-week dosing as opposed to OMA's Q2 or Q4-week dosing, there was an enthusiastic response from both prescribers and payers. Prescribers would expect to use RPT904 in about 16% of their moderate to severe food allergy patients, compared to the single digits for omalizumab, and payers would support around a 30% premium over an omalizumab biosimilar. Based on the millions of FA patients and assuming OMA biosimilars will be on the market, we estimate peak sales for RPT904 of approximately $4.5 billion in the U.S. alone. Moving to slide 8, we believe CSU is also an exciting commercial opportunity. CSU affects over a million patients in the U.S., of which approximately 400,000 are not well controlled by antihistamines. Omalizumab is the only approved biologic for CSU after an inadequate response to high-dose antihistamines. We believe RPT904 could be positioned as the preferred choice in the front-line setting due to the improved convenience and compliance compared to OMA. Based on our market research, our revenue model suggests approximately $1 billion peak revenue in the US for this indication. I'll turn the call back to Brian now. Thank you, Rodney. On slide 10, I'd like to cover the characteristics of RPT904 and the data supporting this drug candidate as a best-in-class omalizumab biobetter antibody. RPT904 is a half-life-extended anti-IgE monoclonal antibody with improved potency in IgE binding and neutralization. It achieves this half-life improvement by incorporation of the clinically well-validated YTE mutation. Based on the improved half-life and potency, we project the ability to address patients with food allergy and other allergic disorders with Q8-week or Q12-week dosing, which would be highly favorable relative to omalizumab's Q2 or Q4-week dosing. Importantly, RPT904 uses the same clinically validated epitope as omalizumab and therefore uses a proven mechanism of action, which we believe carries a higher probability of success. Furthermore, RPT904 also has the potential to treat patients that are currently excluded from omalizumab treatment due to high weight and/or high IgE levels. Finally, there is a strong patent position with a loss of exclusivity date of 2041 without additional patent term extensions or formulation patents. Slide 11 shows the design of this novel anti-IgE antibody. Jemincare's design principles were to make minimal changes to the omalizumab sequence to retain the same epitope binding as omalizumab while extending half-life and improving drug-like properties. Half-life extension was achieved by incorporating the well-established YTE mutation into the Fc domain. There were no other changes in the Fc region. In the variable domain, affinity maturation was performed by yeast display to improve affinity to IgE by roughly fourfold. In addition, post-translational modification residues were removed to improve manufacturability and stability. An additional humanization was performed in the framework to further reduce potential for immunogenicity. Moving to slide 13, to demonstrate the effects of these improvements, Jemincare performed a phase 1 healthy volunteer study using omalizumab as a comparator. This was a randomized and double-blinded single ascending dose study of five dose strengths of RPT904 from 75 milligrams to 600 milligrams. RPT904 was dosed subcutaneously, and each cohort also contained placebo patients. An omalizumab comparator was also included in the study and dosed at 150 milligrams subcutaneously, so it could be compared head-to-head with the 150 milligram dose of RPT904. The primary endpoint was safety and tolerability, with secondary endpoints including PK, PD, and immunogenicity. Slide 14 shows key results from the phase 1 trial, which demonstrates improved PK and pharmacodynamics of 904 over omalizumab. The left graph shows that in a head-to-head comparison at 150 milligrams sub Q, the PK profile of 904 was superior to OMA. The half-life of RPT904 was 63 days, while that of omalizumab was 27 days, representing a better than twofold improvement in the half-life. This is consistent with the YTE modification seen in other therapeutic antibodies. In addition, the graph on the right shows that RPT904 shows deeper and more sustained reduction of free IgE compared to OMA at the equivalent 150 milligram dose. Free IgE reduction by OMA is strongly correlated with its efficacy. With respect to other endpoints, RPT904 was safe and well tolerated. All AEs were mild or moderate, with no evidence of clinically significant immunogenicity. Slide 15 shows that simulations of RPT904 on free IgE suppression support Q12-week dosing in most food allergy patients. Using PK parameters from the phase 1 trial and a well-established PK/PD model published by Roche and Novartis, we simulated the dose strength and frequency that would be required for RPT904 to reach therapeutic levels, which for omalizumab is a mean free IgE of 25 nanograms per mL or lower. We also simulated this in subjects with varying weight and IgE levels to project dosing across the food allergy dosing table, which is illustrated on the right. The left graph shows simulated free IgE for a 20-kg patient, which equates roughly to a 6-year-old child, and a baseline IgE of 700 IU per mL, which is the median IgE and age in the phase 3 OUtMATCH study. We first simulated the approved dose of omalizumab, which in this case is 225 mg dosed Q4 weekly, shown with the gray line. Here you can see the free IgE levels fall just below the 25 nanograms per ml threshold. In comparison, modeling dosing of RPT904 at Q12 weeks, shown in the gold line, readily reduced free IgE into the therapeutic range. When we attempted to simulate lengthening omalizumab's dosing to Q8 weeks, shown with the black line, it was no longer able to achieve therapeutic target levels. Therefore, based on these projections, RPT904 may significantly reduce the dosing frequency required for efficacy. When we applied these projections across the food allergy table, as on the right, we demonstrated that most patients can be addressed with Q12-week dosing. Q12-week dosing also included patients in the black shaded region in the lower right part of the dosing table, which are excluded from omalizumab therapy in the label. A small proportion that may not be addressed with Q12-week dosing may be treated with Q8-week dosing. Additional modeling and PK/PD data are expected to help further refine the RPT904 dosing table. Now let's move to ours and Jemincare's phase 2 trial designs on slide 17. This slide shows our proposed phase 2b study for RPT904 as monotherapy in patients with food allergy. This is a randomized double-blinded placebo-controlled food challenge study, initially starting in adolescents and adults and extending to younger children during the course of the study as safety data is collected. All patients are expected to have at least one documented food allergy by laboratory testing and oral food challenge. Assuming successful screening, patients are then randomized and allocated two to two to one on either a Q8-week or Q12-week regimen for the placebo group. We are anticipating a total of 75 patients in this study. After 20 weeks of treatment, patients will be re-challenged with allergen and their thresholds of food measure. We plan to use identical thresholds as those used in the OUtMATCH study for inclusion and for the primary efficacy endpoint. We estimate that this trial could take 18 months from first patient in to top line data. Slide 18 shows our proposed dosing strategy for the phase 2b trial. The OUtMATCH phase 3 trial successfully used the Omalizumab dosing table for patients who were assigned to one of 13 different dosing regimens based on their weight and baseline IgE levels. We plan to use a significantly more simplified dosing table. Patients randomized to either the Q8-week or Q12-week cohorts will be further assigned to either a 150, 300, or 600 milligram dose based on their IgE and weight. We also plan to include patients currently excluded from the Omalizumab label. In addition to data from this phase 2b trial, we are also planning additional PK/PD studies in healthy volunteers and in patients with high IgE levels using the Novartis/Roche free IgE assay to help refine the dosing table for phase 3. Slide 19 shows the two ongoing Jemincare phase 2 and planned phase 3 studies in asthma and CSU. In asthma, Jemincare's phase 2 trial is exploring three dose strengths of RPT904 at 150, 300, and 450 milligrams versus omalizumab dosed using the approved dosing table in patients with moderate to severe disease. There are 60 patients in total, and the primary objective is to establish the optimal phase 3 dosing regimen using the PK/PD data generated from this study. Lung function, including FEV1 and exacerbation rates, will also be measured as secondary endpoints. If successful, Jemincare is planning a single large phase three study designed to assess non-inferiority versus omalizumab. The phase two trial in CSU is geared towards exploring efficacy, comparing the flat dose of 300 milligrams 904 at Q8-week or Q12-week versus Xolair's approved dose of 300 milligrams Q4-week. A total of 135 patients are expected to enroll in this study. If successful, Jemincare is planning a phase three trial in 200-400 patients assessing non-inferiority versus Xolair as the basis for approval. BLA submissions for CSU and asthma are anticipated in 2028 and 2029, respectively. Slide 20 highlights the anticipated milestones for the RPT904 program. We anticipate IND filing for the food allergy study followed by the start of the phase 2b trial in the second half of 2025, with top-line data expected in the first half of 2027. In parallel to the food allergy phase 2b study, we are planning to conduct additional PK/PD studies in healthy volunteers and in patients with high IgE levels to help refine the dosing table for phase 3 clinical trials. Jemincare's asthma study is expected to read out in the second half of 2025, and their CSU trial data is expected in the first half of 2026. Assuming success in the phase 2 CSU trial, RAPT is considering initiating a phase 3 trial in CSU pending regulatory agreement in the second half of 2026. In summary, we are very excited by RPT904's potential to address high unmet needs in food allergy and other allergic disorders. The announced financing should provide sufficient capital to achieve key data milestones, including the phase 2b trial in FA. We are looking forward to working with Jemincare and the current and new investors as we pave a bright new path for the company. Thank you for your time and attention. I'd now like to open up the call for questions. Thank you, ladies and gentlemen. If you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered or you wish to move yourself from the queue, please press star 11 again. We'll pause for a moment while we compile our Q&A roster. Our first question comes from Anupam Rama with J.P. Morgan. Your line is open. Hey, guys. Thanks so much for taking the question and congrats on the deal. Quick question. A couple of clarification questions, actually. So how confident are you that FDA is going to be comfortable with sort of a healthy volunteer study that's been conducted in China versus having to conduct one here? And then also just wondering why maybe not pursue CSU more aggressively, given you're considering that if you get positive top-line data from your versus the food allergy. Thanks so much. Yeah. Hi, Anupam. I'll take your questions here. So with respect to using the healthy volunteer data, this is something we're very comfortable with. The FDA guidance is for the use of trials outside of an IND are very clear of what's accepted and what's not. And our regulatory consultants and our regulatory group are comfortable that we should be able to move directly to phase 2b. The worst-case scenario is that we might need to perform a run-in as part of the phase 2b protocol, but we're fairly comfortable that we can move forward directly into that study. With respect to moving more aggressively to CSU, as you'll recall, Jemincare is performing a phase 2 study right now in 135 patients with CSU. And we think we could potentially leverage that data to go directly to a phase 3 trial, pending, of course, discussions with regulatory agencies, which would indeed accelerate the program and would provide information which would allow us to further refine dosing for that phase 3 trial. So that's how we're thinking about it. Awesome. Thank you, guys, so much for taking the question and congrats again. Thank you. Thanks, Anupam. One moment for our next question. Our next question comes from Thomas Smith with Leerink Partners. Your line is open. Hey, guys. Good morning. Thanks for taking the questions and congrats on the in-licensing deal here. Two questions on our end. First, can you walk us through the outstanding steps and the gating factors to starting the phase 2b study in the second half of next year? Is there any ongoing TOX work or CMC manufacturing work that needs to happen before you can start that study? And then secondly, can you just elaborate on your expectations for biosimilar omalizumab competition? I know in your market research, you assumed sort of equal safety and efficacy versus OMA with the less frequent dosing, but I'm wondering if you see any potential to differentiate on efficacy or safety. And then if you could just expand on your assumptions here in terms of the number of biosimilar competitors and your pricing assumptions, how should we think about that 30% premium to biosimilar OMA? Thanks. Tom, I'm going to answer your second question first about biosimilars. So we understand, even Roche has said they expect biosimilar competition beginning in 2026. So we do expect there will be a handful of biosimilars on the market, say three to four at least. I mean, I think I'll let Brian speak to the potential for increased efficacy, but when we tested our target product profile in our primary market research, we assumed equivalent efficacy but less frequent dosing. And we actually only tested Q8-week or tested Q8 and 12, but even at Q8-week dosing, it was a very enthusiastic response from payers and providers. So we do kind of see that differentiating versus the biosimilars. And that was pretty much what the payers were looking to support, why they would be willing to pay a premium versus the biosimilar OMA. And I'll just add, when you look at the OUtMATCH data, clearly there's robust efficacy with a high effect size over placebo, not only over peanut allergy, but also across a range of allergens that were studied in that phase 3 trial. And so from our perspective, maintaining that efficacy and providing more convenience for patients, but also greater adherence to the drug, and also potentially opening up the pool of patients that would be willing to take an injectable because now you're at Q12-week or Q8-week, is the base case value proposition. It is possible because of the improved potency and the enhanced recycling due to the YTE mutation that we might be able to drive deeper free IgE reductions. And certainly, that's true in patients that are currently excluded from Xolair therapy based on the label. But that would certainly be an upside case. Again, Xolair is already highly efficacious based on that food challenge study. Got it. That's helpful. And then, yeah, I was wondering if you could just kind of walk us through the gating factors here to getting the phase 2b food allergy study off the ground? Yeah. I mean, I think there are no limitations once the requisite toxicology is completed. Obviously, we need to start working with Jemincare to have material ready for the phase 2 trial. And in parallel, we'll be in the process of doing tech transfer as well so that we have multiple redundant pathways for manufacture. But there really is nothing standing in our way at this point starting that phase 2b trial. Got it. That makes sense. All right, guys. Thanks for taking the questions. Yeah. Thanks. One moment for our next question. Our next question comes from Prakhar Agrawal with Cantor Fitzgerald. Your line is open. Hi. Thank you so much for taking my questions and congrats on the deal. So maybe first question, Brian, the epitope is similar, but the IgE reduction is turning out to be a little bit better for Jemincare's asset. So maybe just talk us through the rationale on why you believe that's happening. And secondly, more on the commercial side because the clinical risk should be low here, but commercial, given Xolair biosimilars, the commercial risk should be there. So maybe just talk about what came up during your peer discussions on the pricing, where the biosimilars will land up, and what exactly are payers saying that will let them cover a more convenient Xolair. Thank you. Yeah, Prakhar, thanks for the question. As you recall from the phase 1 data on slide 14, when you compared 150 milligram of 904 versus the 150 milligram omalizumab in a head-to-head comparison, 904 showed both deeper and more sustained reduction in free IgE compared to omalizumab. And so we think this will greatly translate into the need for less frequent dosing across most of that food allergy dosing table. One caveat, of course, that, as I mentioned, Jemincare is using non-standard free IgE assay. This is an assay format that has not been used by Novartis and Roche. And therefore, making comparisons of absolute free IgE levels to other trials is not possible with these data. But the relative differences are clear and can be interpreted as such. There's a significantly better pharmacodynamic effect with 904 versus OMA. Yeah, and Prakhar, just with respect to the commercial side, we did obviously, we do expect biosimilar omalizumab competition by the time we are on the market. So one of the key questions we explored was where we see that pricing going. And when we talked to the payers, we asked them basically how much price erosion would they be expecting for the biosimilar versus the branded. And you get back a range anywhere from 35%-40% price erosion. So in our modeling, we had assumed 40% price erosion already. Where the willingness to pay a premium comes from, we think, and again, based on the primary market research we did with the prescribers and the payers, is, first of all, OMA is a good product for this segment, right? There's no really convenient treatment that can treat multiple food allergies. A lot of patients have more than one food allergy. That's already good compared to the alternatives. What the payers really were enthusiastic about was less frequent dosing because that's going to enhance compliance, which should enhance the efficacy. For them, better compliance, better efficacy is likely to lead to less visits because of less accidental exposures to the allergens. That's very valuable to the payers or meaningful to the payers. That's really what's driving, we think, a lot of the willingness of the payers to pay a premium for an extended half-life OMA. Yeah. And given the size of the market, potential for premium pricing, even in the backdrop of OMA biosimilars and assumed gross-to-net discounts, etc., this is still quite a large product. As Rodney said earlier, $4.5 billion in estimated sales with those assumptions. Just one quick question, Rodney, with the pro forma cash, where does this take you in terms of the runway? Yeah. So with the $150 million PIPE and our Q3 cash balance was about $98 million. So when we modeled out the runway, including accounting for the upfront, etc., we get well into mid-2027, well past the time we expect to have the phase 2b food allergy readout. Thank you so much. One moment for our next question. Our next question comes from Andy Chen with Wolfe Research. Your line is open. Hey, thank you for taking the question. Congrats on the deal. And I'm looking at your slide seven, your market research again. So the 16% of prescribers that want to use your product, can you talk about what is the other 84%? Is a large fraction of that driven by untreated patients or patients that are untreated by biologics, or is it mostly driven by Xolair or maybe other off-label biologics? And also a quick follow-up on the payer question. So obviously, the pricing of OMA biosimilar hasn't stabilized yet. It hasn't even really happened yet. But can you talk about how you asked that question that led to your answer of 30% premium? Thank you. Yeah. Great questions, Andy. So address the first one, the 16%. So you generally ask the prescribers, "How are you treating your patients now?" And you kind of offer them the current menu of options. And then you put, quote, "Product X into the mix," and you ask the question again. In the current mix, probably two-thirds or so of the answer is going to be, "We tell them to avoid the foods they're allergic to." So that leaves you kind of with 30-ish% left. And a lot of that, OMA is about 10-ish%. And then there's all the desensitization approaches, OIT, oral immunotherapies, and the like. And then combinations of OIT and omalizumab. So then when you ask that's the current menu. Then you ask them the future menu, which includes Product X, which is 904. The prescribers jump to 16%, they would treat their food allergy patients. And that compares to when you give them the full menu, including Xolair, that 16% compares to omalizumab dropping to kind of high single digits. So already on a head-to-head basis, at least theoretically, when you ask them or give them the choice, 904 is preferred versus omalizumab or an OMA biosimilar. Similarly, again, when you query payers about pricing and things like that, you tell them, and they will tell you, "They know a biosimilar OMA is coming." So the question is, "Where do you see that price erosion going?" So you first get that, and they kind of use that as their reference price, and then think about how much of a premium over that they would be willing to pay for a target product profile that is an omalizumab equivalent efficacy, but Q8-week dosing or better. And again, it's that dosing less frequently, that differentiation, they believe, will lead to the increased compliance that I think is what they consider as valuable and willing to pay a premium for. Thank you. I'm not showing any further questions at this time. I'd like to turn the call back over to Brian for any closing remarks. I'd like to thank the entire RAPT team, the BD teams, and the diligence teams at RAPT. And thank you for your attention. Look forward to interacting with you in the future. Ladies and gentlemen, so this concludes today's presentation. You may now disconnect and have a wonderful day. And pardon me, are you guys still there? Yes. We did have. Actually, they just left the queue. We did have someone else queue, but they left the queue, so I'll go ahead and end the call. Okay. Can you tell me who it was? It was Yanan. Oh, okay. We'll follow up with him. All right. Thank you. Thanks. Bye. Thank you.