You guys all set? Okay. Hi, everyone. My name is Maury Raycroft, and I'm one of the biotech analysts here at Jefferies. I'm happy to introduce and welcome Vish Seshadri, CEO, and Madhav Vasanthavada, the Chief Commercial Officer of Abeona Therapeutics. Thanks so much for joining us today. Thank you for having us, Maury. We're going to do fireside chat format. Maybe for those who are new to the story and the company, maybe provide an overview of where you're at with the launch today and talk about the key priorities across the pipeline over the next 12-18 months. Sure. Abeona is a cell and gene therapy company. Our focus is autologous ex vivo engineered cell therapy, and our lead product is ZEVASKYN. This was approved by the FDA for treating patients with wounds and patients with recessive dystrophic EB, and that approval happened in April 2025. We really launched the product more towards the end of the year as we were optimizing some assays while onboarding sites of treatment. We're very encouraged by the momentum that we've built in this launch. To date, we've activated six qualified treatment sites, centers or QTCs in short, and we're seeing a good growth quarter-over-quarter as we had shared in the most recent quarterly call. Starting with quarter four, we treated a patient, and then there's been a steady growth of patient treatments in quarter one. We also gave a little bit of preview to how quarter two is going on in terms of having treated a patient and one patient was in biopsy at that time and four more scheduled and a couple others in the process of getting scheduled. That momentum is building and all this activity happening from the first two activated sites. As we see even more recently activated sites also bringing up patients for treatment, I think this is off to a good place right now. Off to a good start. Can you talk about how the demand is shaping up to date and just based on the 2Q trajectory, how are you thinking about expectations for third quarter and fourth quarter, both in terms of number of patients and pace of ramp? Yeah. The short answer is we expect to see continued growth in third and fourth quarter, but I think I'll let Madhav do the nuances there. Yeah. No, demand is strong. We continue to see patients getting identified not just within the QTCs, but also out in the community setting. As we see patients receiving to get more treatments and some of the recently activated centers as they start putting patients on treatment, then we see more of the layering of the patients into the third and fourth quarter. We have increasing visibility to patients that are in the funnel, and we think that this is going to climb up. Got it. Okay. On the first quarter call, you cited greater than 100 identified patients across QTCs and community physicians. Operationally, what does identified mean? Identified plus eligible versus actively pursuing treatment. I guess, how should we think about that? Identified patients there, these are physicians out in the community and qualified centers who can actively think of patients that they want to prioritize based on the really clinical parameters. These are patients with large chronic wounds that the doctors think are immediate candidates. It's not to say that those are the only patients that they have. There are other patients that are in their practice, but these would be the immediate set of patients. The next step is referring those patients into the qualified centers. So far, we have about roughly 20% of those identified patients that are actively pursuing ZEVASKYN treatments. As these patients clear through the treatment process, we expect more of the patients continue to funnel in into the QTC. Got it. You said 20% or 25? 20. 20%. Got it. From identification to treatment, where's the biggest bottleneck in the funnel today? Is it payer approval versus? How do you think about referrals, QTC intake, and biopsy or surgery scheduling? Right. Since this is not an off-the-shelf product, it's an autologous, so downstream there are steps that need to take place. Upstream, with any other cell and gene therapy, there are a lot of administrative steps that need to take place, right? Especially payer interactions is one of the biggest bottlenecks still, the rate-limiting step, and we expect that to continue even with the new center as they come on board because they'll have to work with insurance, especially if it's an out-of-state patient traveling from a different state. If it's a Medicaid patient, then there are additional steps that take longer lead time. Most of these are usually one-time administrative steps, including physician getting enrolled in a different state program so as to treat their patients. As these patients get treated, then we expect that process also to streamline and get better. Got it. The only thing I'd like to add to that is, the short answer is a QTC is the current bottleneck, but our levers are maximizing the number of QTCs that can be active. We had communicated a goal of five to seven, and that could even go up beyond this year and maybe get to about 10 QTCs early next year. Also, as QTCs are learning the process of moving these patients, the flow rate within a QTC also is improving. Both are levers that are going to cause growth, and we will reach a time where the QTC is no longer a bottleneck. As they clear more patients, more referral can be accommodated at the QTC. That's really how we look at flow right now. Yeah. Just one last thing I'd add is we are seeing, like we mentioned, treatments from Lurie Children's and Stanford, right? In some ways, we are happy to see that. Lurie's and Stanford are treating more patients as opposed to all of the other centers treating one or two patients and kind of taking a pause. That just tells us that the end-to-end experience within these centers is getting better and better, and they are already treating and identifying more patients, which is a positive sign there. Yeah. Vish, when would you get to that point to where you feel like there's not that much friction there, the bottleneck is gone with the QTCs? I think it's a little bit of a TBD because the QTCs are themselves learning. These are doctors that have not put patients through an autologous therapy in their practice in the past, right? They're working with multiple stakeholders within their own organizations. There is a P&T committee. There are people that determine the payer pathways and how paperwork moves and things like that. They're learning. We believe that some sites where you've seen a gap of being active but not yet produced a patient, it's really the initial starting trouble. Once they get that process going and they know how it moves, we believe that's going to be setting the ball in motion. We feel strongly we're very well positioned by start of 2027 that our first activated QTCs should be firing at cruise control rate. Got it. Makes sense. You mentioned prior that you're in active dialogue with about 45 physicians. What's the mix there? Maybe talk about the EB centers versus community dermatology, pediatric derms, and what are the top one to two objections that you hear before a referral happens? These physicians are mainly out in the community setting, and we have a field team in place that are actively engaging in dialogue with these physicians, and the level of interest from community physicians is very strong. When the dialogue is happening between the physician and patients, we are not seeing patients saying, "No, I'm not interested in ZEVASKYN. This is not a therapy for me." That's a pretty strong indicator of the interest and the level of interest out in the patients. Actually, some of those physicians out in the community want to become a center to treat. We know that there is some infrastructure that is required, so we have to essentially say that no referral, and they are open to referring the patients, because oftentimes in this setting, patients are traveling hundreds of miles to go to a specialty center for other procedures. That referral mechanics is going to get better. In fact, some of the patients that we have treated, and actually they are in the funnel, are already referred in into the QTCs. As their referred patients get treated, then referring physicians also want to funnel more patients into the QTC. Got it. Interesting. You mentioned the travel distance, you said that that hasn't really been a barrier. I guess in the real world, what's the practical limiter for travel cases? Is it logistics, timing, payer, caregiver burden? How do you expect the patient mix to evolve between the local QTC patients versus out-of-state travelers over time? The mix will always remain that way. You will have a lot of out-of-state patients coming in because just sheer number of QTCs we have and the number of states. We expect to have about seven maybe this year, and then hope to get around to about 10 number. That mix will always remain. There are logistical aspects with travel and such, but again, like I said, these patients are used to traveling out of state. They trust EB centers. They would rather fly hundreds of miles to go to a doctor and the institution that they trust for other procedures versus anywhere else. We have great support programs in place. Our Abeona Assist program has been well-received, and we have patients who have gone through our clinical trials, especially long-distance travel, Strong Together Network, also really helping future patients explain what the process is like. Got it. For launch parameters, there's multiple launch parameters that you're closely watching at this point. What's the single most important leading indicator you track that best reflects true demand right now? Right now, since we are in this initial sort of stages of launch since December we launched, there is a short term, then there is a midterm, and a long term, kind of a way I would look at it. Short term is what we are communicating. Number of treatments, number of biopsies in that particular quarter. We'll continue to give that kind of an outlook in every quarter for maybe a couple of quarters, and then we'll look to retire those kinds of KPIs. We've said 100-plus patients that have been identified that are out in the community. That is a pretty strong indication of the level of interest, and our work is sort of cut out for 2026 and 2027 to convert those patients into treatments. In the long term, we know that there are about 750 patients based on our claims data that are recessive patients phenotypically which have got large and chronic wounds. Coming again with other treatments such as VYJUVEK and Filsuvez that are already in the market that have been identifying patients, many of these patients we believe will also be candidates for ZEVASKYN. Coming in as a second to market gene therapy offers a lot of advantages, and just being able to target, and we know the types of physicians who actually have their patients. It's a way that we can actively engage with those physicians to convert those patients onto treatments. When you say one true parameter that best predicts or something like that, it's really what Madhav was saying is that it's a viewpoint. Are you looking at it myopically versus are you looking at it strategically? Myopically, of course, how many biopsies are already scheduled? That's probably the best indicator of what's coming in the next month or something. Whereas, if you're looking at next year and the year after, I think, our conviction in the number of RDEB patients that have severe to moderate disease, we believe that is our TAM. The 750 patients, on average, they're going to need two treatments per patient, and so there's a Close to more than 1,000 treatment opportunities right there. I think clearing that is going to be a question of when these sites will attain their best flow rates. Yeah. I mean, that's- Yeah. That makes sense. The next question I was going to ask just on prior comments from you guys where you said approximately one patient per month per QTC is achievable at steady state. What assumptions drive that, and are those assumptions informed by the two sites currently treating patients? Yeah. I think this is what the physicians at the hospitals, at the QTCs have told us, that treating one patient a month is doable within their facilities. There are some centers that can certainly treat more. They have the bed capacity, they have the patient volume, while others may not be as active because some of them are not EB centers, they're relying on inbound referrals. On average, one patient per QTC per month is quite doable and realistic. Yeah. Got it. Getting to the point where all cylinders are firing, is that early 2027? Is that where, like you mentioned earlier, where the QTCs are fully functioning, would that be the point where you're at the one patient per month rate? I think the activated QTCs that we have today, right? Yeah. If you even take the last activated QTC that we announced, that's a good timeframe for them to have achieved their cadence, regular cadence. Of course, those that get activated subsequently will have varying degrees of lead time to get to that. That's a pretty good assumption. Okay. For new sites, you framed approximately four to five months from activation to first biopsy. What are you doing to compress the ramp with training, process standardization and scheduling? Yeah. We are actively engaging with these centers now, even as they are signing the master service agreement and activation to identify their patients, possibly start patient identification, prior authorization process, if they can even initiate that. These are some of the things that we are actively looking to do. Every institution is different in terms of the subsequent steps that they have to take. There is oftentimes a P&T review committee that takes place after a site is activated. There is a high-cost drug committee that's looking at it. These are all institutional one-time steps, which we think is actually a good thing because that just means even at the leadership level, there is visibility that, okay, once we have onboarded this therapy, then we want to actually see patients getting treated at these centers. Yeah. Makes sense. For sites active for months, but still slow to first biopsy, what is typically the gating factor for those sites? This particular one is, like I said, with any cell and gene therapy, it depends on the payer mix is where we are seeing is the deciding factor. There are certain institutions that just seem to have certain patients that are more Medicaid and more out of state, and that has been taking a little longer. On the flip side, you've got centers that are producing, and they are actively identifying patients and are treating. I think it's a net-net, and that's why, as we have now identified these four additional centers that are yet to treat, we know that they have patients and initiated that process. We expect to see patients coming through from those centers as well. Got it. Yeah, over the next 2 to 3 quarters, how should we think about the volume contribution from the first two centers versus newly activated QTCs? We should expect to see more patients coming in from the newly activated centers picking up. Yeah In the subsequent quarters. Yeah. By the end of the year While at the same time, Stanford and Lurie Children's are also identifying patients. Got it. By the end of the year, could it be like a 75%/25% split or a 90/10, or? I would say about, yeah, still majority would come from Stanford and the early activated centers. Depending on how quickly they can clear up their process for the first few patients, then you will see first half of 2027 is where you should expect more patients coming in from the recently activated centers. The other part of that equation with the question you asked, what the split between the first two centers versus the others. One of the reasons it is harder to predict is because even for the seventh site, we said five to seven is the goal this year. Even that seventh site, we have a few different sites that are working actively. We do not know which one may be that particular seventh site. Depending on how many patients they have, how aggressive they are with identifying patients. Some of them may be identifying patients even before activation is completed and try to cut that time. If they come in with a lot of patients, that equation can change easily. Yeah. We're dealing with small numbers right now today. It's hard to predict, but I think Stanford and Lurie are going to be significant contributors. Yeah. That makes sense. Okay. Maybe let's shift gears and, well, actually for getting that third QTC treating patients, what needs to happen there? Do you have an idea of what site that's going to be? I think the good news is it's not going to take until the year-end to see that happening. I think they're all at the edge. Different things need to happen at different sites. Which one is going to beat the other one? We'll have to just wait and see. We are seeing some signs that hopefully by quarter three, you'll see third sites. Okay Contributing patients. It's not a question of if, it's just a question of when. Yeah. We know that these centers have patients because we are working with them. We should expect treatments coming out. Yeah. Maybe by the second quarter earnings update, you could have some sort of an update on that then? Absolutely. Possibly. Possible. Yep. Okay. Shifting gears, you said no final payer denials and no attrition so far. Can you walk through just the Medicaid versus commercial pathways and which tends to be faster to authorization or reimbursement? Yeah. That's a really good sign. We are seeing no final payer denials. We've got more than 95% of coverage policies published from commercial insurance. That's really a good sign. Medicaid, we have established baseline coverage across all 50 states. From a coverage standpoint, we are in good shape. It's usually the time that takes between financial agreement, payment rate negotiation between the institution, the QTC, and the payer that oftentimes dictate how quickly or how late it might take. Sometimes if you have already a payment rate established, not just for the product. The product part, the gene therapy, that's relatively straightforward because medical policy is in place. It's usually the procedure, the anesthesia, the surgery, and those aspects, which for the first time, those are the rates that takes time to negotiate. Once you have treated a patient, then subsequent patients, it gets better because you already have a pre-agreed contract in the prior. It really depends on what pathway. It appears like in-state Medicaid is quick. Fastest. The next is commercial, and the slowest would be an out-of-state Medicaid. Just from our slim experience we've had in the last few months. Yeah This looks like what's happening there. How do those buckets break out again or? Most patients, 60% of our patients are commercial. Commercial insurance. About 30%-35% may be Medicaid. Because we have such few sites compared to the number of states, you will just by sheer numbers. Right. There's going to be out-of-state Medicaids out there. That makes sense. On retreatment, do you expect payers to view it as a routine continuation or a new high-friction approval each time? What evidence data will make retreatment smoother over time? Yeah. We are not expecting any friction during a retreatment because again, the payer has covered it for the first time, and there are payment rates, everything established. We expect the second time around to go smoother. Got it. Okay. What proportion of patients do you think are going to seek retreatment? I think you said on average, all the patients will get two. We believe a majority. Almost every patient is going to look for a second treatment for the previously untreated wounds. It's not just a matter of how much area we can cover in a treatment, it's also the location of these wounds, because in immobilizing the patient after application, you're not going to be able to do a front and back wounds in the same surgery. You're going to see patients come back more the rule than the exception that they will seek a second- Yeah Treatment. For patients who become more active or who are more active, if they disrupt a wound, I guess, how does that work? How do you anticipate that in your projections? Yeah. I don't know if that particular example itself changes our assumptions because retreatment is any way something that's going to be driven by wounds that exist. Yeah That were not treated all at once. In that process, when they come for second treatment for newer wounds, if a particular sheet had to be applied to a previously treated wound, so be it, right? Because the batch was created because you have other open wounded areas. I don't think from a label perspective, that's not restricted or anything. Yeah Doctors will prioritize which wounds they should treat with the number of sheets that are available. Got it. Makes sense. Wanted to talk about manufacturing too. Roughly what share of end-to-end cycle time is manufacturing versus payer administration and scheduling today? Which is the most fixable in the near term? Yeah. The turnaround time for manufacturing is relatively small compared to the patient journey once they enter the funnel but get to a biopsy, right? That's probably the most variable as well as longer path. The turnaround time itself is about 25 days, right? Versus we just discussed, it can take anywhere between 3 to 4 months or five months for those patients to get to that point of biopsy. In terms of optimization of turnaround time itself, I think that's relatively fixed because how the product process is developed. Our optimization focus is all on how can we get the upstream journey of the patient up to the point of biopsy further streamlined and optimized. I think that's a matter of practice and experience that site by site, you're going to see that improve with more treatments. Got it. You've discussed ramping internal capacity to approximately 10 by year-end and designing additional suites as well. Where are you on the manufacturing ramp and timing to start complete additional suite build-out? Yeah, the current manufacturing is six a month, right? The number of slots we have, and we have already started making the amendment protocols. We're working with the agency in converting the RVV manufacturing suite into ZEVASKYN drug product manufacturing, and that is still going on track, to reach this 10 a month by fourth quarter of this year. We have designs for additional GMP space, beyond the 10 a month. We've already started some long lead activities, like, the right pipes and the carbon dioxide supplies and things like that. I think, in terms of actually initiating construction work, we have to do it a little thoughtfully so it doesn't disrupt the current ramp-up that we've done in the current half of the facility. I think to get to a pretty good cadence of treating patients, by end of this year, I think we want to get that undisrupted, then we can talk. There are personnel that will be involved in the expansion part also, and we don't want that to be a burden when we're trying to ramp up commercial treatment. We just have to do it thoughtfully, but we have long lead items already taken care of. Got it. The plans are definitely in place, but just the timing of when you actually want to do it, you want to optimize that. Correct. Yeah. Okay. Makes sense. For ex-U.S. strategy, you said Europe and Japan are interesting, but logistics are tricky. What's the most likely first ex-U.S. route? Is it shipping from Cleveland, a regional manufacturing partner, or an ex-U.S. commercial partner? Yeah, the soonest or earliest ex-U.S. opportunity is definitely the markets that we can supply from Cleveland. We do have some work exploring which those markets could be. I know we discussed Europe, Japan. The challenges in that is also the cold chain biopsy that we have to bring from the patient to our site. It has to be within 24 hours. Our drug product, while it has 84-hour shelf life, it requires QP clearance once we even ship it out of here. Typically, if you look at CAR T products, the additional time that they will put for turnaround time when you go from a U.S. to an ex-U.S. location from a U.S. supply, standard is one week. We've always had that model, right? It's somewhat challenging, but, as you said, the nearest opportunities would be Cleveland supply. For those markets like Europe and Japan, we're under exploration for other models that would be a little bit more mid to long-term, but like establishing maybe manufacturing outside if there is a partner that could do that. We're happy to engage with technology transfer and things like that. We're working that out, but near term, we'll look at Cleveland-based supply. Got it. Now that you've got ZEVASKYN on the market for a while, are you getting people from ex-U.S. reaching out about the therapy and, could they potentially come to the U.S.? It'd be very expensive. Every day there is some email or something from an ex-U.S. country saying, "We'd like to get ZEVASKYN in our country, and we'd like to work with you." I think that interest is definitely there. We're selective in how we go about it. Of course, there's a lot of noise. We have to do the right strategy. Yeah, there is a lot of interest. Got it. Okay. Let's shift gears and talk about ABO-701, your recently in-licensed asset. Maybe you provide an intro to that and talk about the mechanism and how it differs from other CAR T approaches. Yeah, I think the first thing is this is not a CAR T, right? CAR Ts typically have not produced a lot of success in solid tumors because of issues like tonic signaling and exhaustion of the T cells and things like that. If you don't have persistence, you won't be able to find the target and clear tumors effectively. This technology really overcomes that by using more like a physiological signaling structure that a TCR, native TCR, which is nature-made. At the same time, it retains the binding ability like a CAR T to directly bind to the antigen without the need for an MHC kind of antigen presentation. That's really what SIR-T technology is, and we've been looking at this asset for two to three years now. The first time I've ever seen that someone in a preclinical study has actually demonstrated the same counterpart control structure, which is a CAR T with the same binder, compared head-to-head with a SIR-T with that binder, and showing that physiologically as well as clinically in mice, you can see that difference, right? I think that's really exciting. This is going to be taking some time. The second half of next year is when we plan to go to clinic. In the meanwhile, we're having dialogue with the FDA and getting to learn what the regulatory path looks like, and we're still on track for that second half of next year to first in human. Got it. For PSMA, the perception's that there's a lot of competition for that target. Where do you differentiate? Right. I know if you take CARVYKTI many years ago, multiple myeloma would have looked like a crowded market, but it's a $2 billion drug, and the reason is because one-time therapy that gives you months to years of remission. That is the same kind of play that we're looking for in prostate cancer with RLTs and bispecifics and all those other technologies out there. It's still an unmet need because you have to get meaningful durable remission, deep and durable remissions, and this is what the Target Product Profile for our PSMA target is. PLUVICTO, if you've followed that launch trajectory, that sets the path, and we can definitely offer this kind of a Target Product Profile. Got it. I think we're out of time. Maybe, just to close out, you've reiterated potential monthly profitability starting in June. What needs to happen operationally for that to be sustainable? Maybe just highlight the key events ahead investors should be focused on. That is purely volume driven, right? If you have more than three patients treated in a given month, it's a cash flow positive month, right? That's as simple as that. Sustaining that is basically, I think, again, volume driven and with more sites and better flow rate per site. I think this is just an inevitable phenomena. Yeah. Okay. Vish, Madhav, thanks so much for joining us today. Thank you, Maury. Appreciate it.