Good afternoon, everyone. My name is Brandon Folkes. I'm one of the equity research analysts here at H.C. Wainwright, and thank you for joining us at our global investment conference. Next up, we have a fireside chat with Eupraxia Pharmaceuticals, and joining me from Eupraxia is the Chief Executive Officer, James Helliwell. Hello, James. Thanks very much for joining me. Brandon, thank you very much for hosting and H.C. Wainwright for having the conference. Fantastic. Well, James, it's been a very exciting, I guess, last 12 months at least, for Eupraxia. Can you just set the scene, though, for investors? What do you think they're still missing the story, and how does Eupraxia look different in 12- 24 months than it does today? I know we have some very exciting data readouts coming. Yeah, I appreciate the opportunity to answer that. First, one of the things is I think a lot of people miss just how big EoE, so eosinophilic esophagitis, is as a disease. Because it was relatively unknown just four years ago. It was an orphan disease. When I went through medical school a little long time ago, it was not a disease. We did not learn about this. And now they're estimating by the time we launch in 2030, there'll be 1 million patients in the U.S. And so there is just one drug right now that is approved for long-term chronic use, and that's only taking about 7%-8% of the market. So that's issue number one. EoE is a lot bigger, I think, than people think it is, and that's going to be coming and growing. Number two is when you look at our approach, it is delivered by the physician. It is guaranteeing compliance. It is looking to be a once-a-year dosing with a drug we already know from off-label use prior works in this disease. There is a lot of the risk that traditionally we think of in drug development that is off the table here. That combined with, as you point out, our data readout in December, which will be an interim look at our phase II-B data, I think that sets us up for being a very different company in 12- 24 months, not just on the back of EoE and ideally data success there launching the phase III, but also where else we can go on the back of that data. In the places we get to go, benign esophageal strictures, fibrosis, stenosis, and Crohn's driven by the physicians in that space and the data that we have been generating. Fantastic. You have generated very good data to date, right? What do you see though as the most important remaining questions that the phase II-B could answer for you? Should we just feel that given the strength of the data to date, just seeing the replication in this larger patient population is going to be very compelling? I think replication is certainly compelling, but I think when we look at the data, there are two sort of pieces to the data here. One of the pieces to the data is looking histologically. When we are taking biopsies, we know that data is real data. That has never been swayed by placebo in other studies. I think people feel very comfortable with that. In our phase II-A study, though, we have not had a placebo arm, and so I think that having that placebo arm in the phase II-B is going to be incredibly important for people to be able to really feel comfortable with the magnitude of improvement that we are seeing in patients, and the number of patients that we are really taking to being fairly symptom-free. Having that against placebo in December will be really important, I think, in reassuring for investors. Fantastic. Just any other color on the details we should expect you to disclose at the interim? Is it going to be pretty detailed what you put out, or how should we think about the level of disclosure on the interim readout? Our intention is to really help answer detailed questions for investors. Even though it is interim, we're basically going to be halfway through the trial at the six-month time point, but we're also going to have other time points. We're going to have about 90 patients or three-quarters of the trial at three months. We're going to have about 45 patients that we're going to have at nine months, and also about 20- 25 patients at a year. It's not just going to be top line. We're going to be talking about the Straumann Dysphagia Index, the SDI, not just in terms of mean numerical shift, but also number of patients or percent of patients that are in clinical remission and really showing people the statistics behind that. Same thing for Dysphagia Symptom Questionnaire, the DSQ, the other PRO in the space. Also showing people the biopsies. So what we're seeing on Eosinophilic Esophagitis Histology Scoring System, changes in inflammation, changes in fibrosis, changes in EREF, so those visual changes that are happening inside the esophagus, and then safety as well. Okay. On histology, should investors expect patient-level remission based on peak eosinophils or primary biopsy site analysis? Yeah, so we've been doing primary biopsy site analyses, and I think what we've found is that really is most useful. So why is that most useful? So eosinophilic esophagitis is a bit of a misnamed disease. It's because we see eosinophils, and that's part of the marker that you have this type 2 inflammatory sensitivity. But we've seen very unfortunately with several products, alirocumab, we've seen it with cendakimab and lirentelimab, that they've done a remarkable job of reducing the eosinophils. What they haven't done is had that translate into better clinical effect for patients. So what we know is important to the physicians and to the regulator is that you're taking a hyper-eosinophilic environment and turning it into more normal eosinophilic. So that means you don't need to drive a patient fully under six. It means how much are you changing from baseline? And so we also have the most dense biopsy data of any study to date. And so we use that density to really talk about just how much we're making that change, and we think that's the most important for people to really understand. Fantastic. And just staying on the readouts, I want to just shift to the symptom endpoints. Yeah. How do you think about the hierarchy of symptom endpoints, particularly SDI versus DSQ? Do you think some carry a different weight regulatory versus commercially, just given the unique value profile that your product could bring? We think that both are really important. They actually look at these patients in a slightly different way. DSQ is what we've seen. We often get the question, "DSQ must be what you're looking at because that's what people have been approved on." The answer is, that's what people have brought to the regulatory agency. From the regulatory agency's perspective, you need to show us that you're making a difference to patients. What DSQ does is ask you every day for 14 days how you're feeling in terms of both swallowing symptoms and pain, and then you need to answer eight of 14 times. It's a great measure of how patients are doing. But if you look at the data, it's got a really large standard deviation. That concerns us a little bit. It tells us there's noise in that metric. The other thing it does not do is it doesn't define clinical remission. It doesn't say these patients are essentially living a normal life today. SDI does do that. SDI has also a validated score, has not been used for an approval yet, but defines clinical remission. An improvement of three points or greater says these patients are in clinical remission. We think that's a really important metric from a regulatory perspective. We also think that's a really important commercial metric. What patients are asking is, "I want to feel better." They don't know what their eosinophil count is. They don't know what their Eosinophilic Esophagitis Histology Scoring System is. They just want to feel better. By combining those two things, and the other thing that SDI does differently is it doesn't actually ask about pain on swallowing. We actually just released some pain data, odynophagia data, that demonstrated we were also seeing a very good response there. They're asking similar questions in slightly different ways. We don't think that there's really a hierarchy there. We think they're both equally important, and we're going to ask both as we are in phase II-B and phase III as well. Okay. And you are evaluating two doses, right? We've seen very good data across your doses, even in the much lower doses. That said, we've seen good dose responses as well. How should we think about expectations of the two doses? Similarly, what is the hurdle rate to go with the higher dose? Should they both show very good data? What is the delta, you think, to go with the higher dose? Yeah. When we think about which dose to pick, we want to follow regulatory guidelines, which is find that minimally effective dose. When we think about that, we see very good efficacy in our phase II-A trial from the 6 mg, that 120 dose, and also from the 8 mg, the higher dose. There is a bit of a dose response, but it's a small number of patients. When you actually translate, if you think about what we're giving, we're talking about giving either 120 mg or 160 mg, but over the course of 52 weeks, 365 days. When you break that down into the number of injection sites per day, it's micrograms of difference. We don't think we're necessarily going to see separation between those two across the study in terms of is one more efficacious on a given day. One of the things we know about our DiffuSphere technology is our ability to sort of get duration. As dose goes up, we get duration. Part of the reason we had those two doses wasn't just to see do you get a better SDI or DSQ or Eosinophilic Esophagitis Histology Scoring System, it was to answer the question, how do we make sure we get one-year duration? Because we know that's important commercially for physicians and for patients and payers. When we look at that, I think the primary difference you'll probably see between those two might actually be durability. Given what we've seen to date, the lower dose is, I think, quite convincingly lasting a year in the data. Does that mean that the higher dose, in fact, is a 15 or 18-month product? That's something that we're going to have to see as phase II-B progresses. I think from an investor's perspective, what's important is both of those doses in phase II-A, and we hope this translates into phase II-B, are demonstrating good clinical efficacy, histologic efficacy, and durability. Okay. You talked about even longer duration, right? Duration's a key differentiator for your product, but arguably even six months' duration is clinically and commercially very differentiated, right? How do you view the commercial positioning of the product, depending on what dose it is, but if it was perhaps every six months, nine months, 12 months, or even every 18 months, as you mentioned? We actually did a lot of work here with payers as well as physicians. We went to some of the biggest payers in the U.S. and really tested these questions and said with this TPP, and the TPP on efficacy, just so we are clear, was just we are around where DUPIXENT and Eohilia are. In other words, we are where the market is today in efficacy, no better at all. We are getting this durability solved. At six months, the answer was, this is really compelling for severe patients, for non-compliant patients, but it would not become a first-line therapy at every six months. At nine months, that shifted dramatically. All of a sudden, it was you would go after PPIs, you would probably go after oral steroids, but ahead of biologics. As soon as we hit that one-year mark, that changed, and all of a sudden it was post-PPI, ahead of oral steroids for most of the payers, and clearly ahead of biologics. Part of the reason for that is the compliance issues in this disease. We know that steroids actually work really well in this disease. People take them orally twice a day, and we see approved products elsewhere in the world and sort of off-label here in the United States. When we look at that, what is happening is patients are taking the drug, the drug is working. After about two months, they are feeling a lot better. Then they say, "I do not like taking this twice a day. This is awful. I cannot take it. I want to eat, I want to drink, I want to do the things because I now feel better." So they discontinue, and then they end up back in the emergency room, back for another scope, back through a very expensive cycle. The payer says, "Sure, that drug might be a little bit cheaper, but you know what? My total cost per patient is way up." That is why that durability combined with that similar efficacy really changes the commercial outlook and picture from the payer's perspective, exactly the same thing for the physician. They say, "Look, I am already getting these people in for an endoscopy once a year. What you are saying to me as a physician is you are going to give me something that I can say to my patient, 'Would you like to continue taking this oral drug? Do you want to inject yourself once a week, or do you want me to do something while you are asleep and works the same safety, same efficacy? Which would you prefer?'" Most of their patients are going to say, "Do what you are going to do and do that." That is the response that we have heard from physicians. In addition to the fact, and we did do a webinar on this a little bit, where we went deep into actually the economics of the practice. This actually becomes really compelling from the physician's perspective economically. That is kind of the difference. I think if we get to 18 months, which is not what we are projecting, but were we to get to there, you would solve that durability piece with pricing. Your annualized cost would essentially just be the same from a product perspective, but everybody really remains a winner in that. Okay, fantastic. We touched on durability. If we assume the product is lasting a year, I think the discussion is from an efficacy perspective, you do not need to beat DUPIXENT, right? What is your view on the range of efficacy if the product is dosed annually? We get that durability. What is your work done to show the range of efficacy and response in and around DUPIXENT or relative to DUPIXENT that physicians would prefer that once-a-year program and maybe sort of not focus on that efficacy as much as us investors sort of draw as a line in the sand? Yeah, I think you are right. It certainly is not a line in the sand. It really is ± 10%. If you are in that range, the answer is, again, you are guaranteed compliance with this. The physician is giving it is there, and it is treating the patient. That makes a really big difference because we know that what people do in clinical trials is different than what they do in real life. For a payer, they look at real-life data. In this, we actually get to get some real crossover to real life because once you have given it to the patient, you have got a year of compliance. As we look at that and sort of tested that range, all of our pricing estimates and everything that we got from payers were based on just being in that ± 10% and lasting that kind of 9- 12 month time period. When you test better efficacy, all you do is increase market access and pricing capability. We operate from that baseline, and in phase II-B, that is a real win if we hit sort of in that ballpark. Fantastic. There is a potential to use your product as well as DUPIXENT, right? Obviously, that is not the base case for the majority of patients. But what is the threshold you think for that in terms of insurers sort of having a discussion all flip sided as maybe limiting pricing power, right? Obviously, DUPIXENT is expensive, but you are going to be reducing that pretty significantly, right? Even just using your product in combination. So how do you think about that situation where a physician, even if some patients, the majority are lasting a year, but let us say some are lasting sort of six, nine months, perhaps using DUPIXENT on top of that? Yeah. It has been really interesting. We were expecting, and we tested this question, and we had a third party go out and really do some of this work. When we test these questions, what is really interesting is that physicians are not viewing it as one or the other necessarily. So they often talk about they would want to step through us, and then they would get to DUPIXENT. But what we heard a lot was, "Well, you know, what I might try and do is use DUPIXENT at half the dose and still use you." Cost to the payer the same, and the patient now gets this multimodal therapy that in their view, and there is no evidence for this, we have not tested this and no one else has, but does that make a difference? The other sort of question that we tested is, what about people who have atopic dermatitis, for example, and EoE, and are already on a biologic once a week? What do you do with them? The answer there was a lot of people said, "Well, our assumption was that the immediate answer would be, well, I will just double the dose and use the same drug." In fact, that was not really the answer. A lot of the times the answer came back as actually we would add you to the regimen they were already on, and we think that we would get sort of a better benefit. Clearly, those are all things that need to be tested as we go through. But like so many diseases where multimodal therapy becomes the standard, we think if we look eight years down the road, multimodal therapy is likely in EoE for a patient group going to be the answer. Fantastic. Safety has been very, very good so far as well, right? I think the local delivery has really sort of validated the thesis. As we go into bigger trials, though, if we were to see some steroid-related adverse events, probably not critical, right? Not sort of thesis breaking. I think we have got past that. How do you think about sort of the AE profile going forward and the acceptable level of steroid-related events, should we see any going forward? Yeah. First we need to compare there to what people are getting today. The sort of most on-label prescribed drug is Jorveza, so an oral dissolving tablet of budesonide around the world. According to their product monograph, it is a 25% oropharyngeal candidiasis rate. That is acceptable by the community. Our view is, that means if you were 2%- 3%, it would be entirely acceptable in view of our product, and clearly well ahead of that level of complication that has already been deemed acceptable. The reality is, to date, in our phase II-A trial, it has been 0%. Very rarely do things remain zero, but the answer is we would like to see it as close to zero as we can get it there. The other comment that I will make on safety, not just steroid-related side effects, is because we just have not seen any cortisol suppression. We also do corticotropin stimulation test. We actually test that the HPA axis is actually intact. Nobody has failed that. Also, and sometimes we get this question, people say, "You are doing a lot of injections in the esophagus. How do we know that is safe?" Well, the answer to that is we now, we are about 95% recruited in this trial. That is a complication that is going to occur in the first 24- 48 hours because it is procedure related. We have done more than 3,000 individual injections, and it has been absolutely safe and well-tolerated. When we look at both sides of this, both the short term and the long term, you are right, this product has demonstrated what we think to date has been really good safety, and we look forward to continuing to prove that out and show that to the regulators as we go forward. Fantastic. I am going to sneak in one more if I may. Absolutely. Just because Eupraxia is more than just the EoE program, right. You touched on some of the other indications you are going or potentially could go after, but can you just talk how those other indications fit commercially with EoE and especially pricing and reimbursement, right? Yeah. That is always the key. Absolutely. What is interesting is when we look at benign esophageal strictures, this is 1 million patients in the United States, 500,000 of whom are actually going for balloon endoscopies every year. There is no on-label therapeutic and nothing in development for these people. It is devastating. Some people are going for weekly balloon endoscopies. Some people it is monthly. It is really difficult. The standard of care is a submucosal injection of immediate release triamcinolone. The standard of care is to use a steroid submucosally, which is exactly what we do. They are coming to us and saying, "We want to use your drug instead of this drug that is only lasting a day or two." That creates a great commercial opportunity. It is the exact same doctors. It is the same call point. It would be the same dose of drug, so same pricing and very much aligned. Large number of patients, very little competitive environment. The physicians, the lower GI physicians have come to us also and really suggested that in fibrostenosing Crohn's, this could be a really compelling sort of opportunity for them to try and stop those stenotic lesions developing. They do annual colonoscopies, they see those lesions years before they become a problem, and they just watch them get worse. By giving an injection and hopefully holding that fibrosis from progressing, really giving them optionality. That is something we look forward to starting proof of concept trials in both of those in 2027 on the back of the final learnings from the data that we will get from the phase II-B in early December. Fantastic. James, you are out of time. Thanks very much. Thank you very much. Thank you, everybody. Appreciate it. Thank you.