Great. Thanks everyone for coming. My name is Yanan Zhu, and I'm one of the biotech analysts here at Wells Fargo. It's my great pleasure to introduce our next company presenting, enGene. We're fortunate to have the CEO of enGene, Ron Cooper, with us today. Ron will conduct a presentation, and we might have some Q&A afterwards. Ron, please. Great. Thank you very much, Yanan, and first of all, I'd like to express my thanks on behalf of the organization for this kind invitation to the conference. For those of you that are new to enGene, what is enGene? You know, enGene is a company that's focused in non-viral medicines. In fact, in our non-viral delivery, we've kind of cracked the code and actually have a product that's in the clinic, so I'm looking forward to telling you more about that. You know, as you would expect, you know, I'm gonna be making some forward-looking statements, and here's some disclosures there for you. As I said before, enGene is a company that has a wonderful platform, and from that platform, we've created a product called detalimogene voraplasmid, formerly known as EG-70. We believe that this is going to be the most practical therapy for urologists for the management of non-muscle invasive bladder cancer. Why are we excited about this opportunity? Really, three different things. First of all, I think the belief is that the non-muscle invasive bladder cancer market is going to explode. You know, currently, forecasts say it's approximately a $2 billion market, expected to be a $20 billion market on the basis of a number of new agents. We're excited to be part of a growing marketplace. Within that, we believe that our product, detalimogene voraplasmid, is a highly differentiated product candidate, and it has a unique combination of wonderful efficacy, delightful tolerability, and it should be easy to use. The last aspect of that is that detalimogene voraplasmid is in a registrational pivotal study right now. This is a peri-commercial opportunity, and we anticipate filing the BLA in mid twenty twenty-six. As a company, you know, we sit with over $265 million of cash since our, you know, since our last earnings, and we have cash sufficient to get us into twenty twenty-seven, so that should get us past the BLA filing. It is a package of a company with explosive market opportunity, a unique differentiated product, very commercial, and the resources to get there. Now, for those of you that are new to the bladder cancer area, let me orientate you a little bit around the disease, right? First of all, you can see here from this chart that, you know, the majority of patients are in this, what's called non-muscle invasive bladder cancer, which is at the top of the funnel. Over time, these patients, you know, progress into muscle-invasive disease and then eventually into metastatic disease. The majority of the patients, you know, 75%-80% are in this, the larger category, non-muscle invasive bladder cancer, and this is where we were. As you look at the disease itself, what you see is it manifests itself in multiple ways. You know, beginning with, you see CIS, right? You know, which are carcinoma in situ, so these are flat, aggressive, serious tumors, all right? Or you can have papillary, as indicated in this particular visual. Now, when we think of bladder cancer, you know, people say, "Where does this sort of stack up within, within other cancers?" This is a very common cancer. It is a top ten cancer, so a top ten cancer. And it has a pretty heavy burden on society. You can see here that, you know, there's a lot of visits that are associated with it. There's a lot of procedures, and it's estimated that bladder cancer, you know, costs, you know, the U.S. economy, you know, around $7 billion a year. Pretty serious, serious disease. What's different about this disease is it is bladder cancer, but it's not a metastatic disease, right? This is a slow-progressing disease. Bladder cancer, non-muscle invasive bladder cancer, has about a 20% chance of progression over a 10-year time frame. There's time, and if you look right now, about 80% of those NMIBC patients are managed by the urology community. As you can see from this chart here, you know, what happens is these patients are diagnosed, they receive intravesical BCG, which is a, you know, a bacteria, right? They try that again, they may use some other options. What they're trying to do is avoid the patient from becoming muscle invasive, and if they do get to muscle invasive, the next course of treatment is a radical cystectomy, which is effectively, you know, removing the bladder. Now, the nice thing about a radical cystectomy is it is a 100% complete response rate, which is terrific, right? However, in this next slide, you can see that this is a procedure that's associated with a considerable amount of both mortality and morbidity. Remember that these patients, the average age of these patients are in their mid-seventies. If you elect the surgery, you have probably a 10% chance of mortality, but the morbidity associated with this is pretty, you know, significant. There are complications that are associated with this. There's removal of the prostate. There's, you know, there's shortening of the vagina. You know, so it has an impact on sexual function. You land up with an ostomy bag. You know, so that is a big change in lifestyle for individuals, and it's a six to eight-hour surgery. This is not to be taken, taken lightly. You say, "Well, there's a surgical option. What about the current treatment options, right?" Again, if you look at the current treatment options, there's limitations there as well. The limitations are either on supply or access or, or, or efficacy. You see at the first course is BCG. There's been a global shortage for over a decade of that. You know, we talked to some urologists, they said, "We haven't had BCG in nine years," for instance, right? Where others have had access for a little while, or it's choppy access, so that's not great for patients. You know, and urologists have been trying to come up with solutions. What they do is they use gemcitabine off-label intravesically, and that is a long procedure. It's a bit uncomfortable, so it's not an ideal procedure. There are a couple of other agents that have been approved, but again, these are not agents that are easy to administer, nor are they easily accessible. That's where there's an advent of a bunch of new medicines, right? Where we think that this market has an opportunity to really grow, and that what we're hoping is that we take these patients, and they go from, from one drug to another. They sequence through, and hopefully, we can get them through this period of non-muscle invasive bladder cancer so that they don't die of that cancer, but perhaps they die of other causes, cardiovascular diseases, you know, or the like. If you look at this picture of particular products, that's why we think the profile of detalimogene voraplasmid is really something attractive, really attractive, and we think this could be the most practical therapy for the urologist and for the patient population. Why? First of all, you know, we've already demonstrated clinical activity and, and some pretty good clinical activity from our phase one study. In terms of, of ease of, ease of use, you know, detalimogene voraplasmid is a lyophilized product. It's just a powder. We use water to mix it. There's no handling, no special handling. The chair time for, for patients, it's about, you know, an hour, so very, very straightforward. If you... I'll show you some of our AE data in a bit, but it's a very well-tolerated product. What I'm delighted about is that, you know, we're already at scale from a manufacturing perspective, and we do that in a quite efficient manner, so I think we have a pretty attractive margin with this product. We believe, based on this profile, that detalimogene voraplasmid has the potential to be the first-choice agent, you know, in, in a world where there's multiple drugs being sequenced, you know, one after, after another. Now, how does the product work? This is, you know, a really elegant, non-viral approach to the disease, right? And what we're able to do with detalimogene voraplasmid is both impact the innate and adaptive immunity. How do we do that? How do we do that? First of all, we take a plasmid, and because it's intravesical, we can put a big load of genetic material, and we have an impact on the RIG-I pathway, right? Which draws T cells to the bladder, right? Which is terrific. That is sort of innate activation. At the same time, we also deliver IL-12. Now, many of you might know that IL-12 is probably an effective agent, but given systemically, has too much toxicity. If we deliver it locally, like we're able to do, this actually has a terrific, like, anti-cancer effect, and it's been associated with some memory as well, too. We would call this the, you know, adaptive part. It's a beautiful one-two punch from an efficacy perspective, and you see in the chart on the left there, this is just all delivered nicely locally and that you were able to get with our proprietary technology, the DDX technology, across the lumen of the bladder. The question then becomes, "This sounds elegant. Are you able to make this product?" I think that, again, really elegant manufacturing process, you know, it really is four ingredients. All of these ingredients are readily available. Our manufacturing has been well-characterized. We've already scaled up for our pivotal program. Effectively, what we do is, you know, we take the plasmid, right? We put the genetic material in there. We use our dually derived oligochitosan, which is our proprietary technology, which helps cross the lumen. Put that together. That becomes our drug product, right? We wash that with PEG to help with the charge, and you can see there, that's what allows us to get across the lumen. Because it is four products that are readily available, they're relatively inexpensive to access, they're easily accessed, and at the same time, what we're delighted about is that we've been able to manufacture at scale. We believe that we'll have a cost-efficient therapy that's readily accessible, you know, to urologists around the world. Check mark on unique mechanism action, check mark on our ability to make the product. Does this product work? In our phase I study, our phase I study, where we looked at high-risk, non-responsive BCG patients, you know, with CIS, we looked at different cycles, we looked at different doses, and we looked at both efficacy and tolerability. You can see here both three and six-month efficacy. We were able to demonstrate somewhere between 60-70%. I think, you know, this is an active product. We're very excited about that. On top of this activity, in terms of tolerability, really elegant tolerability as well here. You can see here that most of the AEs are Grade I. You know, there's no Grade IV or V, and we had one Grade III, which is not a trivial drug. You know, what we found when we talked to, you know, physicians and patients, what they anecdotally said to us is most of the AEs are associated with the catheterization. In fact, the product itself, you know, we've heard it described by individuals as saying that, you know, there's really no burning. It's really quite well tolerated by, by the patients. The combination in our phase I study of, you know, good efficacy and good, good tolerability makes us then think about, how do we go to the next step? To go to the next step, we said, "Let's look at what's happening from a precedence perspective, right?" What you see here are the agents that have been approved for NMIBC. What you see there, that the bar is, you know, 19-24% for monotherapy for agents for, for approval. We were also delighted that the FDA very recently issued new draft guidance around what was required for approval, and they reiterated that a single arm open label study is sufficient for approval for us. This, to me, is a great example of the partnership between the regulatory agency and manufacturers like ourselves, where we're working together to come forward with potential solutions for these patients badly in need of new, of new, of new agents. Based on that, we designed our pivotal program, and we're delighted that we have up and going the LEGEND registrational study. In the LEGEND study, again, we, we're looking at what the FDA has asked for BCG unresponsive patients, high risk NMIBC with CIS, right? This is a global study, U.S., Europe, Europe, and Asia, open label study, where we're looking for about 100-100 patients. The way our product is dosed is patient receives 800 micrograms, four times over a 12-week time period. They receive it at weeks one and two, and weeks five and six, rinses, repeat, you know, four times over a year. That's how, that, that's how it's given. What we'll be looking for, the FDA endpoint, is the 12-month complete response. Obviously, we'll look at safety and tolerability. As I said, we're delighted that we're up and going. We have many sites going and, you know, we're enrolling patients, you know, as we speak today. That's the part of it, right? What we've done with detalimogene voraplasmid is put it in a number of other cohorts. What we see at the top here is the pivotal registration cohort. As I said, you know, we've already... we're already up and going with that, and our plan is to share with you a peek at the data. Our plan is to share with you some preliminary data by the end of this, by the end of this month, where we'll share with you approximately twenty-odd patients, six months and three months CIS, and, you know, we'll share with you some of the tolerability as well. We're looking forward to sharing a subset of the patients, around 20% of the pivotal program, and that'll give you a good sense of kind of where we're going. At the same time, we wanted to generate some other interesting evidence for the effect of detalimogene voraplasmid. You see here that we have a number of other cohorts. Cohort two A is a cohort for patients who have not been exposed to BCG, so BCG naive patients. Cohort two B are patients that have had BCG at some time. Sometimes with the restrictions in BCG, a person might get one or two courses and not get the rest of it, or they've had BCG a couple of years ago. Very interesting patient population. I'm pretty excited about the last cohort, cohort three, which are patients with papillary disease, a real unmet need there. Our intent is to generate this data, and it... we hopefully will make that part of our filing package. At a minimum, this is gonna be important information for urologists, probably important information to get into guidelines, and also once you get into guidelines, you often get reimbursement as well. We believe that, in fact, this is going to increase the available patient population for detalimogene voraplasmid, and we're looking forward to generating some important evidence, you know, for the physicians. If you step back, you know, for detalimogene voraplasmid... Why do we think this product is uniquely suited for the urology practice? Stepping back again, as I illustrated to you before, this is cancer, but it's slow progressing. This is not oncology, this is urology, and this is not all urology. Most of the patients are in busy community practices. When they're making decisions, what are they looking for? First of all, they're looking for some efficacy, and I think I've shown, I've shown you that we've demonstrated some interesting efficacy, you know, with, with detalimogene. They're also looking for a favorable AE profile. I think I displayed that most of our AEs are attributed to the catheterization. It's a very well-tolerated product, but the ease of administration for both the physician and the patients in these busy practices is a really important, you know, choice factor. We believe that given our attractive cost of goods and our ability to scale, we'll be able to supply the market, so there'll be ample detalimogene available. Because there are no special handling requirements, it's mixed with water, it literally can sit in a refrigerator in the physician's office. The physician can reach for it, and their practice can mix it with water, and the patient can have it, you know, can have it right away, and an hour later, they're out. That really fits well with how the current practice is being done and really nicely for the patients as well. We believe that detalimogene really becomes practical therapy, and it is our intent that when physicians go to look for a medicine, you know, they will reach for that first. You know, and then if you think about some of the other choices that they're going to have, we just believe that based on what's available now and what's going to be in the future, and in our dialogue with urologists, the profile of detalimogene is really attractive. As I said, good clinical activity, well tolerated, and easy. If you compare this to some of the other agents that are being developed, I think it's really exciting to have these new agents. I think, you know, as I displayed, as I talked before, you know, this is a slow-progressing disease. These products will all be sequenced, right? They're gonna be important, important medicines. You know, some of these medicines require multiple pre-washes and longer, longer dwell time. Other of these products require insertion of a device and the feeling of having something, you know, within the bladder. Some of these other products require very long thaw times. These are complications that make life more difficult for those community urologists. They're trying to be efficient, they're trying to move patients through, they're trying to maximize, you know, the space in their, in their clinics. We believe that it really is a profile that lends itself to first choice use for the urologist. At the same time, though, we also want this to be good for patients, right? And, and detalimogene was designed with patients in mind. It's only one hour of administration, and there's nothing that you need to do afterwards. There's no bleaching of urine, there's no, there's no restrictions on how these individuals interact with family members. There's no pre-washes that are associated as well. It's just very easy with the patient, for the patient. And we also believe that, you know, if these patients are sitting in, you know, rural America, not close to, to a major, major city, they can go to their local urologist to get this, this treatment. And, and for them, the convenience factor of doing this compared to some of the other agents, I think is, is a real, real advantage. That being said, right, what I am really excited about for this market and for, and, for patients is that there are multiple new approaches that are now are on the horizon in NMIBC. This market is actually going to grow and, and transform. You can see here, you know, from, from the, from this slide that, you know, you have non-viral gene therapy, won't be the only one with detalimogene. There are viral gene therapies, recombinant, you know, immunotherapy and checkpoint inhibitors, drug devices, and bacterial ones, right? Having these different tools is really going to transform the way that urologists will be able to manage, you know, this, this disease. As I said before, we expect patients to cycle or sequence through these different treatment regimens. You can see from this slide here that there are some limitations to these new technologies in how they're delivered. What we believe is there's gonna be a nice dialogue between the urologist and the patient to say, "Look, you've been diagnosed with NMIBC. There are multiple options here. Here are the pros and cons for you. Our belief is because detalimogene should be readily available, sitting in the doctor's fridge, it's gonna be easy for the doctor to administer, easy for the patient to take on with only an hour of dwell time, it makes it the ideal first-choice medicine. As this paradigm shifts in NMIBC to becoming more of a chronic disease, in fact, detalimogene will be an important medicine for that. Now, the question is, you know, can we execute on this? Let me close by saying, before I turn it over to questions, that I think we have a qualified team that is well-poised to execute on this ambitious plan. I think what's nice about our team is we have a combination of folks that have worked both in big pharma and biotech, but also in academic medicine. Our Chief Medical Officer, Dr. Pruthi, who's here with us, you know, has been a urologist for multiple decades, has treated many of these patients, has done, you know, over 1,700 cystectomies, so has a good knowledge of what's, of what's going on. Our CFO, Ryan, who's here as well, has worked in multiple companies in banking as well, and that team is committed to making sure we execute on our plan. Let me close where we were, where we were at the beginning, and I'm happy to take some questions. You know, we are very excited about this opportunity because I think we're at the forefront of a real revolution in the management of NMIBC, the very beginning of this, right? I- we, we believe that this market is going to absolutely explode. The profile of detalimogene voraplasmid, and you see a picture of it here, it's just a very simple, you know, product where you just mix with, with water. It just- the profile just fits so nicely for both physicians and patients in a combination of just terrific efficacy, tolerability, and ease of use. As an investment thesis, we believe we have a product candidate. It's a near-term commercial opportunity as we're in a pivotal program, and we expect to, you know, we expect to file the BLA in mid-2026. I really thank you all for your interest and attention, and I'll open the floor up for any questions. Great. Thanks, Ron. While Raj also is joining you on the stage, let me start with the question. You recently joined the company in July. You had a great career. People might remember, some of the investors will remember you led Albireo into its acquisition, and you previously had decades of experience at BMS. The question is, what made you make the decision to come out of retirement and join enGene? Thanks. Thank you for that question. You know, really, I think it was three things, some of those themes I talked about, I talked today. I think the first thing is, you know, the treatment of NMIBC is really poor, right? And I really believe that our team here at enGene can make a real impact on those patients. At the same time, I'm delighted at the FDA's partnership with the industry, you know, to lower the bar a little bit, and you see innovation occurring. This market, as I said, approximately $2 billion now, and projected to be $20 billion. To be at the forefront of a market that's gonna change that, that to me is pretty exciting. The second thing is... Look, I've launched dozens of products all over the world of different types and different shapes, and I love detalimogene voraplasmid because this is a highly differentiated product, very different. Non-viral gene therapy, you know, we've been able to sort of crack the code on that, and having a product that, you know, it's easy for the doctor, easy for the patient, it's just a logical product. From a risk perspective, look, having presided over a lot of phase III studies, and you have a binary event, and you're waiting years for that, we're an open-label study. We have a sense of where we're going, and I believe that, you know, we have a product candidate, you know, that has a high chance of approvability, you know, because of the guidance of the FDA. I think the third thing to think about is, I believe it's an underappreciated company. I think the way that we became public was, you know, was non-traditional, so a lot of individuals haven't really been exposed to, to enGene. A lot of individuals haven't really understood that this is a urology product, right? Which is well within the abilities of a company like ourselves. A lot of individuals don't understand that, in fact, the company has a very strong platform, but really good manufacturing capabilities as well. You know, having a reasonable cost of goods and a good margin gives us a lot of flexibility. The combination of explosive market opportunity, differentiated product, and a very capable and underappreciated team has made it a terrific journey for me thus far. Those insights. The company, I think, is ready to provide some interim look into the ongoing pivotal study. Could you share what could we expect in terms of patient number, follow-up, and how do we interpret the data and timing? Yeah. As I alluded to in the presentation, I think I'd like to characterize this data as sort of preliminary data. You know, it's an open-label study, so there's no huge statistical analysis. You should expect around twenty-ish patients, in that order, six-month CRs, three-month CRs, complete response rate, and we'll share with you where we are from a tolerability standpoint. This is approximately 20% of the overall study. However, it's a similar data set in size for our phase I data. I think you should walk away with that understanding that we have a well-tolerated product that is active, and I think we believe we have a product candidate that, you know, will meet the threshold to be an approvable product. And the timing of that data and the forum, from which the data will be presented? Yeah. We've committed that, you know, that data will be available by the end of September, and I think our intent would be to have an event to share the data with you and explain it as well. Got it. Got it. There are, as you have mentioned, CG Oncology's product, J&J's product are being developed, and you have shared your earlier phase one data as well. How do we think about the response rate endpoint? Of course, you have highlighted a lot of differentiations on the ease of use, and so, you know, it doesn't feel like, in terms of the efficacy, this product could win, even if it's not the same in terms of CR rate as other products. How should we think about what can the ease of use help the product, and how do we think of the implication on efficacy? Yes, let me start, and then I'll turn it over to Dr. Pruthi to talk about, you know, what really happens when a patient comes into the clinic and how they make decisions. You know, I think, you know, look, we always prefer head-to-head studies, right? Homogenous patient population, homogenous patient designs. You know, I understand in the absence of head-to-head studies, that people are gonna make comparisons across studies. That being said, the reality is these are very different studies, different patient populations. You know, when you talk to community urologists, while they're focused on having drugs that are efficacious, you know, the difference between one CR rate and another, it's really quite marginal. You know, the choice is really around, you know, is there a product that's approved? Can I get it? Can I get reimbursement? Is it easy to get at, right? I think we feel pretty comfortable that we have a good level of efficacy, a great tolerability. We can manufacture the product. Maybe, Raj, you can talk a little bit about, you know, from a urology perspective, you know, what happens when that patient comes in. Yeah. Thank you, Ron, and thanks, everyone. I think there are two things. One is having, again, taken care of these patients, sat across from them for twenty-five years. I'm thrilled that it was just fifteen years ago that the treatment for these patients was BCG, more BCG, radical cystectomy, and that was it. Now we're talking about three, four, five different agents in this space, and this is music to my ears. It's a better thing for patients. It's better for providers to give them another option. As far as what your question, Ron, it's a great one, it's much more nuanced, that conversation that happens in that clinic room between the patient and the doctor. One of the things that it starts with is asking the patient: What are your goals of care? Is it cure? If it is, I have something with a near 100% cure rate of a radical cystectomy. Now, these are the trade-offs with that, too. Is goals of care, "Hey, I can't come in here every three weeks. I can't get a ride. I have to get my daughter, she has to take time off of work." Is it, afraid of a virus? "I don't want to go to an academic center." What are the things that are important to that patient? I think, I think to, to Ron, your point is, I think patients are willing to kind of make that decision out of the isolated context of what is only the CR, right? Because we know that we have that. I think I want efficacy. I want something that's approvable, that my doctor can get ahold of. I'd like to stay in my community, and I'd like to balance some of those side effects and toxicities with it. Got it. That's a very individualized decision. Got it. Maybe last question on the treatment, on the landscape, what will happen to the non-muscle invasive bladder cancer space? Some have articulated that they see sequential treatment in order to buy more and more time before a patient has to let go of their bladder. Do you share the same sense? Please give us a sense of how the treatment landscape will look. I think, I think that's a great question. I think that's exactly what will happen. The rate of progression to muscle-invasive disease is 20% at 10 years. To me, what that speaks to is that is an opportunity to, like you said, sequence agents in order to avoid cystectomy. In fact, cystectomy-free rates is an important FDA endpoint as well. How long can you put in these, again, our older patients may be infirm, so I think delaying cystectomy is a adequate endpoint. I think you'll absolutely see sequencing. What order we do them in or not probably relates to, again, ease, what's easy, maybe mechanism of action and so forth, but I think that absolutely will happen. Great. I couldn't see the time. I think we were- I think we're at time. We're, we're... Yeah, yeah, I think we're right about time. With that, I think I want to thank the company for providing an insightful session to investors, and thanks everyone for coming.