All right, we're going to go ahead and get started. I'm Stephen Woolley, one of the senior biotech analysts here at Stifel. I'm glad to have with us for the next session the team from Abeona Therapeutics, Vish Seshadri, who is the CEO, and Madhav Vasanthavada, who is the Chief Commercial Officer. I am getting incrementally better at those names. I think the first time wasn't so great. Anyway, I know a lot happening. We're going to dig into all of that. Maybe before we jump into Q&A, we can or you can just make some introductory comments. Absolutely. First of all, thank you for having us here. Abeona Therapeutics, we are a commercial stage cell and gene therapy company. Commercial stage after the approval of our first asset, which is ZEVASKYN for recessive dystrophic epidermolysis bullosa. It's a connective tissue disorder. This happened in the second quarter. We've made a lot of progress towards our launch of ZEVASKYN in the U.S. since our approval in the last two quarters. We'll, of course, recap. Some of the important things to note here are that the patient demand is shaping up very well for us, the activation of QTCs, which shows the Centers of Excellence want our product. We're getting very good traction with payers, very favorable coverage. These are great indicators for what's to come for 2026. We're very well poised to become a profitable company with the launch of ZEVASKYN in the next year. All right. Let's maybe just start off with some of the updates that you provided yesterday in conjunction with the earnings announcement. I think the most important of which was this temporary pause you placed on the collection of patient biopsies to really, to kind of, I guess, to optimize a sterility test that had lit up a false positive on your first patient-specific manufacturing run. Can you just give us some of the background context here and, I guess, why FDA required this test to be implemented when it hadn't been used before in any clinical trials and after you had already submitted the BLA? Certainly. In the clinical trial setting, just to back up, our sterility package had two tests. One was an in-process. In the middle of the manufacturing process, we would sample and look for bioburden. Bioburden meaning, is there any burden of bacteria in our manufacturing train? When that is clear, we're also going to look at the end product, which is packaged, and that is put to a gold standard test. We call it the USP 71 as per US Pharmacopeia. Those tests take two to three weeks to read out. At the time of release of the product, we do not have the final sterility result from that test. That's an aftermath after a patient has been treated. The FDA, for commercialization, wanted a more robust package where you're actually able to certify that the product leaving your facility is sterile. You need to have sampled it not in the middle of the process, but in the last 72 hours of your manufacturing train, which is why we were asked to develop a rapid sterility assay that can give us that quicker read. That is what we did during the BLA CRL resolution process when we got the approval. Because time was of the essence to get this product to market, we developed this and validated this assay not in the context of an actual patient's manufacturing run, but with all the media and the components that mimic the environment. Unfortunately, what happened in this patient run, this was our very first experience implementing that assay as a lot release assay. This was back in August, correct? This was towards the end of August. What happened in that particular instance is the patient's own manufacturing train has cells, these keratinocytes. Ours is a cell sheet. Some of these keratinocytes come out in the medium. When you're looking for microbial contamination, also human cells can give rise to the same type of signal that a microbe would give you. That is a false positive. Obviously, at the time when it happened, we did not know it was a false positive because we had to investigate and study this problem a lot. Eventually, we got to the answer that the product itself was sterile, but it's the cells that gave rise to the human cells that gave rise to this kind of a signal. We have made the measures to selectively make the human cell-derived signal go away while retaining the ability of the assay to actually detect microbes if they were there. Threading the needle there is important. We have done that. We are impressed with our teams to have turned that around in a quarter's time where not only did you make an assay get rid of that issue, but also retain the same sensitivity for a panel of microbes if you spiked it. OK. So you talked about how you were able to eventually validate the sterility of the drug product, but that the results were only available to you after the expiration date of the product had been reached. Correct. Therefore, you couldn't release it back to the QTC for the purposes of. Treating the patient. Of surgical application. What is the shelf life then of manufactured product? Are you scheduling patients for surgery before you commence an individual manufacturing run? Yes. The first question, how long is the expiry time? It's 84 hours, 84 hours since the harvest and assembly starts, right? So we have to apply the product on the patient in that time window. The second question, a surgery is scheduled the moment a patient takes his slots and provides a biopsy. OK. It's 25 days to manufacture from receiving the biopsy. Approximately 25 days is what they forecast to get an operating room. There's going to be always a window, plus or minus one or two days before and after. That gets solidified when you're closer to the harvest date because then you know with more certainty which exact date is going to be our administration. OK. So when you start to take a patient biopsy, you have clear visibility, plus or minus a day or two, that that product's going to get engrafted back into that patient at time X. Correct. OK. What is your level of confidence now in this new sterility process that you have in place going forward? We've done a lot of experimentation with a new test versus the old test in its ability to generate a false positive and pressure the system with created environments like that. We've reduced the risk significantly from maybe 35% risk of false positive down to less than 1%. We can never certify 0% because that's just not achieved in biological processes, right? We're happy with where we are at this point in time. This kind of issue should be extremely rare if it ever happens. OK. Is there a—this may be kind of a similar question, but asked a different way. Is there a specific timeline in which you need to initiate the manufacturing process after you've collected the biopsy? Does the biopsy itself kind of have an expiration date that's associated with it? Absolutely. The biopsy arrives at our site within 24 hours. As soon as it arrives, we put that into the process. We have some hold time data, but we do know that biopsy is a cold chain reception, so we have to process it immediately. There is no opportunity to freeze it down in that state. OK. So you said that you resumed patient biopsy collection earlier this month, right? I think that was stated yesterday. Correct. We had to wait until the 30 days passed after submitting this package to the FDA. So yeah. OK. What does this now—I know you didn't give any firm guidance yesterday. What does this now imply about the number of patients that you might be able to treat before the end of this year? I guess, how is that number influenced by either logistical variables kind of happening at the QTC level? How is it influenced by the annual manufacturing shutdown, which you need to do for QC purposes sometime next month? Yeah, that's a great question. Just in terms of dates, right, August 6 is when we could go to the sites and say we're past the 30 days and we can take biopsies. And here are the dates. We're giving you a two-week window because if you imagine December, mid-December shutdown, the latest we could take is the second or third week of November. We're giving a very short window, which is immediate. Can patient logistics line up within that? You can see how challenging it is for a site to be able to work out with patients and say, hey, you have two weeks. Do you want to take this? That means December, you've got to come for your application of ZEVASKYN. I don't have a definitive answer at this point in time as to where that would land, whether we are able to match and marry our slots with patient logistics. The challenge is that it's a very short window. That's why we're not guiding anything for what we can expect in 2025. OK. Maybe still a little bit of near-term uncertainty just in terms of what that number looks like by the end of the year. I think what was encouraging from yesterday's update were some of the metrics that you provided on the demand front. Right. It sounds like you already have 12 ZEVASKYN Product Order Forms from patients that have been identified within the first two QTCs. Can you maybe talk about what that Product Order Form represents? Is that just kind of a formal consent on the part of the patient? What subsequently needs to happen between securing that initial Product Order Form and eventually treating that patient? Yeah. I can take that, Steve. Yeah, definitely encouraging, right? The ZPOF, as we call it, the ZEVASKYN Product Order Form. Before I go into the steps of what happens, just putting this in the context of what happened in that we could not provide this product to the patient, obviously, that's a disappointment for this patient who has given the biopsy. And it's a disappointment for the physician who has taken it, which is this one, in this case, it was Lurie Children's. Despite that, we have seen this conversion of identified patients into a Product Order Form. And that is really encouraging, right? What needs to happen from a time a patient has been identified, which is basically based on clinical criteria, they've got large wound areas, and they are candidates to ZEVASKYN Product Order Form is an initial consult and a treatment decision and the patient and families willing to move forward with it. We have secured those of the more than a dozen patients that we said we got 12 ZPOFs, which is a pretty good conversion. Now, prior authorization, so clinical prior auth needs to happen as a general step, and financial clearance need to be in place before these patients can be scheduled for biopsies. We have already secured clinical prior auth for several of these 12 ZPOFs. For additional patients, we've already gotten financial clearance in place. Patients are ready to be scheduled for biopsies, some slots already for 2026 that have been taken. Because this is a November, it is always a holiday period. You have got patient preferences. They do not want to be hospitalized right around Christmas time. For those reasons, you are already looking into 2026. As we navigate this process, the remaining of these 12 ZPOFs, we will be getting clearance from financial clearances as well. While we do all these, also the demand, as we mentioned on the call, has grown. The 12 has now become close to 30, which is really what excites and encourages and coming from both centers, Stanford as well as Lurie. OK. I guess of the 12 ZPOFs that you were able to secure, how many of those came from patients that were actively being treated within the QTC that you activated? What proportion of those were referrals from other centers of excellence into the QTC? Can you give that level of granularity? Yeah. We have visibility into that. Vast majority are organic to the two centers. Two patients, two of the 12 ZPOFs, are referred in in this initial 12 ZPOFs. OK. It sounds like there's a little bit of, I don't want to say uncertainty, but just variability around kind of what that lead time might look like in between securing the ZPOF and then scheduling and executing on the biopsy. Do you have any sense maybe once you get a better idea as to the clinical authorization and the financial authorization as to what that lead time might look like? Is there a duration that you want to bring that down to? Yeah. Early the second quarter call, we mentioned around 3 months-4 months time that it takes for any new therapy, any new cell and gene therapy because you don't have payer policies in place. People are trying to figure out the mechanics. We expect that time should come down. We'll keep a track of how much we can bring it better. With new payer policies and better handle of the administrative process, it should come down to maybe like a two to three-month kind of a window. OK. Yeah, for future patients. You mentioned kind of the 12-30, right, that 2.5-fold increase in demand. And these are patients who have, I guess, intimated that they want to be treated, right? Is that the correct way to think about it, or? For the 12, for sure, because we've got ZPOF and they're all signed up. For the 30, the total 30, many of them have. Of course, we are waiting for a signature on the dotted line, right, as a firm commitment. These are identified patients, meaning intent to treat. The physicians believe they will be great candidates. Now it's the process of getting them through the consult process and getting the ZPOF so that they can start with the next steps. OK. That's probably, again, like some combination of organic patients within that QTC as well as patients who have been. Referred in. Sourced from. Correct. From other Centers of Excellence. Right there also, the vast majority are QTC patients. We have started seeing referrals coming in from the non-QTC. On our second quarter call, not yesterday, but the previous one, we had mentioned the total number of QTC plus non-QTC were about 50 patients we had, right? And that 50 has also grown. We did not announce it yesterday, but it is growing north of 50 now. OK. We are really focused on what's in front of us, which is the 12 ZPOF. We want to clear the rest. We want to start treating these patients. While we do so, the remaining, the 30 that there are, we want to begin to get them through the process, right, and clear those. If you look at those 30, five of those are referred in. Twenty-five are organic pool of patients. In speaking with the QTCs, the three QTCs that we have in hand, there are about 100+ patients that are recessive dystrophic patients at these three QTCs. If you're looking at it, it's really about a quarter of the visible patients at these QTCs that are currently being considered for ZEVASKYN. You should expect that to kind of scale in tranches and more patients coming in. OK. You activated your third QTC, which was Colorado Children's. Right. How should we think about the pace of new QTC activation over the course of maybe, say, the next like 3 months-6 months? And then where do you think that number needs to go over the longer term? Our goal is to get 5 centers-7 centers activated. We are in the next 2026, we are very much on track to getting them activated in the three to six-month horizon that you're saying. I think that should be doable. There's a lot of interest coming in, actually, from hospitals after we got FDA approval of ZEVASKYN stepping forward, saying they want to be ZEVASKYN treatment centers. We are already in active discussions with them. We're just being strategic about the geographic footprint because we want to span out across. Obviously, getting some on the eastern seaboard would be great. In the south, southern part would be really helpful for these patients. We're just being strategic. In the long run, seven, maybe even max to 10 would be a good sort of footprint. It's not that we need those QTCs in order to hit our goals. Even from the three that we have, we've got enough demand already in place. We know these patients tend to travel long distances anyway. We just want to be spreading it out across. What are some of the other variables you consider just beyond geographical location? I would imagine the ability of one of these centers to throughput patients and having surgical resources. Exactly. Access to anesthesiologists who are comfortable doing this in an RDEB patient. Right. We are in talks, really, with the Centers of Excellence that have multidisciplinary teams that have this kind of infrastructure for other procedures, whether it is hand surgeries or GI dilatation or squamous cell carcinoma excision. Those who know how to handle EB patients and have worked well. Obviously, there is training going on. Capacity in these hospitals is certainly a consideration, right? I mean, you have some big institutions that already have said, we have a capacity. We can treat four patients a month. That is in our pro forma. That is how we have built the business case to get the buy-in from our leadership. We want to start treating one or two patients a month. We want to do that. We are going to scale it up. In getting a site onboarded is obviously a pretty big endeavor, getting signatures from the topmost leadership where they are checking out what is my reimbursement going to look like, what's my economic model going to look like, what kind of resources do I need to deploy. These hospitals also are equally motivated to identify these patients and put them on because they have resources that they have in place and they want to produce. OK. I believe Colorado Children's is a participating trial site in this other phase III product that's currently in development, this Castle Creek product. Does this at all, because I know we've been asked this question, does this at all become a potential headwind at this individual QTC, right, whereby if I'm an RDEB patient, my option is either to participate in a clinical trial or to kind of go through all of the steps that are necessary to procure therapy with ZEVASKYN? Yeah. Go ahead. I was just going to say that ZEVASKYN is a proven product, approved product that is commercially available in this country. If anything, I would consider headwinds for an investigational product because when you have an approved product and an investigational product, the unmet need is so high, you're going to get the approved product that you get preferentially utilized. For that purpose, we're not worried that this is going to be a headwind. In terms of, I mean, we don't have a restriction on what clinical trials you participate in and whether you would also be a candidate for ZEVASKYN. Neither would it be a problem for the payer because that doesn't reach into the payer's pocket either. I think from our perspective, this is a good thing that patients have multiple different options. If anything, that site becomes very attractive, that if I want to participate in that trial, this is a site that I want to go to. That relationship exists. There is also this therapy available, right? I look at it more positively. There may be other insights. We do not have a lot of data that we have been able to comb through with what is the expectation or product profile for the product you are talking about. That should be, as and when we learn more, we can assess. Yeah. Yeah, for what it's worth, I think some of the KOL feedback we've received on that product has been a bit mixed, right? Like these are patients who have obviously large, significant, painful wounds. And this is like a frequent series of injections around the perimeter of these wounds. Yeah, up to 50 cm square, right? I mean, I think there is a wound size classification there, which you have to treat. Plus also, I don't think they have an exclusion that if you get ZEVASKYN or other products that you exclude, it would be smart on their part not to put such kind of exclusively commercially available options. You're talking about, yeah, non-compete kind of a situation. OK. Can you talk about some of the incremental progress you've made on the reimbursement front? I guess, do you expect the issuance of the permanent J Code, which becomes active January 1, to further streamline the reimbursement process for you, or is that just a nice thing to have? I mean, we are very happy to have received a permanent J Code. We are happy because our stakeholders, hospitals, have said they are thrilled to see a J Code in place. I mean, on the surface, you would not think a J Code is an extremely important thing for an inpatient hospital-administered product that goes through negotiated rates. With other therapies, hospitals have got burnt in the past where there has either been an underpayment or a long time to account receivable in the absence of a permanent code. With the miscellaneous code, there is a lot of paperwork and unpredictable reimbursement. Getting a permanent code is really a step in the right direction. Overall, to your first question around coverage, I mean, the payer mix, vast majority, 60% are commercially insured. We are seeing strong cadence of policies, as I mentioned on our call. That is very encouraging. On the Medicaid side, we now have baseline coverage for all 50 states. That is great because we participated in this national drug rebate agreement with CMS. As of October 1, 2025, we have baseline coverage. This J Code is going to help further with the reimbursement at the hospitals, which is also promising. Reimbursement-wise, we are looking good. The policies are looking good. It is just a matter of now reducing the time to access and trying to get the patients on treatment. OK. To your prior point about needing to get the signatures from the people at the top of those institutions, I'm sure having that J Code in place maybe. Correct. It's going to be helpful because if you're treating one or two patients, then yeah, you can afford to have longer receivables, account receivables. If you have got a queue of patients, you want to start seeing, right, the reimbursement come in at a faster cadence. Otherwise, you're not going to be like, guys, let's put a pause on that. I think just from that standpoint, it's a step in the right direction. OK. Can you talk about what payers are requiring right now to pre-authorize for treatment? I know you have some value-based arrangements in place as well. Can you maybe talk about how those are structured? Yeah. So the payer, the policies, they varies. Most of them are policy coverage to label, which is the broadest type you could have, which is any patient, whether it's adult or pediatric, regardless of age, regardless of wound size, is going to get ZEVASKYN. That's your straightforward. Then you've got restrictive policies in some cases where they manage to the inclusion-exclusion criteria, however the phase three was designed. Those are the type. Even in those cases, for example, if you have our inclusion five years and above was the criteria for us. We do know there is a case where there is a younger patient with a physician writing a letter of medical necessity. We have been able to overturn such cases. Policies are there, but we have been able to overturn some of those denials, like the physicians have been able to overturn. Sorry. Value-based. Value-based agreement. Yeah. The value-based agreement, the way it is structured is if you're a patient who gets a treatment, for the value-based to trigger, you should have come again a second time to receive the product. Only then the value-based agreement kicks in. When you come the second time, it's a wholesale acquisition cost, less whatever the discount we're talking about. You're paying the second time. If you are retreating a previously treated area, then there is a modest discount that is applied. OK. OK. I want to ask you about retreatment as well in a minute. From a manufacturing perspective, right, I think you have or you were getting to having, I think, four slots- six slots online before the end of this year. Yes. I think that number is supposed to grow to the 10 range sometime next year. Yep. I know you have additional capacity that's available to you if needed. Can you just kind of talk us through what the next wave of expansion looks like on the manufacturing front in terms of just timing, costs, and how many slots do you feel like you need to get to? Yeah. I can talk about that. When we are done with the shutdown in January, when we come back up online, we're going to be operating at six a month cadence. Going from 6- 10 will probably take the first half of the year because from a capacity perspective, we already have the GMP space that was currently being used for making the vector. We have to change that over to drug product manufacturing because we've made sufficient vector that takes us two, three years forward. That requires regulatory filing, which we'll do early next year. We're on track by mid-year to have that additional four slots per month also opened up. We should be by mid-year 2026, we should be operational capacity at 10 a month. Now, the question you asked is beyond the 10 a month kind of expansion. We've done our homework. We've done the designs. We've looked at the space that's available in the same fourth floor of our building and earmarked the area that's going to add additional slots beyond the 10. We have the ability to go up to another approximately 10 slots. While we have all the designs ready, even the RFP process and everything for the construction, the triggers are going to happen by end of Q1 or in the Q2 time frame because we want to be judicious on when we commit capital to that kind of a project because, I mean, it's a two and a half year project or one and a half to two year project, rather. Around late 2027 is when you can anticipate those suites becoming available commercially operating. Now, regarding how much more do we want? Do we want to make the 10 into 20, or is it just 15? I think those are a little bit of a TBD. We're studying the market. Not only that, we're also studying XUS markets at the same time because we're looking at models where you supply XUS from our Cleveland site. Is that logistically possible? As answers to all those questions show up, we should have a better picture of what is the degree of expansion we should put that additional space to and how much dollars that's going to entail. OK. I guess as you're thinking about the possibility of a second manufacturing expansion, how does this notion of patient retreatment inform that, right? It does. How are you thinking about the potential for patients to receive two, maybe more, ZEVASKYN treatments over the course of their care? Right. Our assumption is that if you look at 750 patients as our TAM so far, which is even kind of bottom up from the 23 Centers of Excellence with claims analysis, which is moderate to severe RDEB, we do believe that the average patient will require two treatments. If you take our VIITAL study, the pivotal study, 11 patients were treated in VIITAL. Of those 11, six have already come back in the phase three B study for their second treatment. One of those six patients came for a third treatment. We already have evidence within our small clinical trial experience that they're coming back for more treatments. We also know some of the patients who've been through our studies are waiting for commercial ZEVASKYN also for the second time already. Given that, we do have to look at the TAM as average two patients per those 750 patients, which is 1,500 treatment opportunities. If you take 1,500 treatment opportunities, we're still log orders below that in how much we can supply in a given year, right? We do have to see at what stage are sites unlocking the capacity because there is no point rebuilding all the capacity and sites can only do two a month and there are five or seven sites. We all have to ramp up in a synchronous way. That's something that will give a clearer picture as we get through the first stages, which is let's get to our four and then let's get to the 10, right? OK. Maybe just to wrap up quickly, you do have a gene therapy platform. It's AAV-based. You have some polio and preclinical assets in the ophthalmology space. Can you talk about this ABO 503 drug? I know you just got selected for participation in this rare disease endpoint advancement pilot program FDA has. What kind of benefits does that confer? Yeah, very prestigious program. Only three assets are chosen in a given year max. To have made it to that list of the FDA, it's great. Basically, what this means is that they recognize that high unmet need, rare disease, plus the complexity of clinical endpoints in that disease and the potential promise of your therapy for those patients. Those are the ingredients that go into choosing a certain asset for that. What it gives us in terms of benefit is a continuous dialogue with the agency as we generate clinical data, even without treating, if we just use certain types of metrics to see what is the function that we're trying to improve, can this be an endpoint? It gives us an ability to have that continuous dialogue without going through a lot of the traditional structured ways. That cuts time. I think you just appointed a new head of clinical development who actually has some background in ophthalmology. Should we take that as a signal that you're going to commit some internal resources towards advancing this? Yes, that was the impetus to bring on Dr. James Gow, not only an ophthalmologist, but also a gene therapy expert. That is in our wheelhouse, right? We are excited that he is going to be able to guide. It is himself, plus also his network of contacts that are retinal surgeons and ophthalmologists around the country that are going to be very important in driving these programs to clinic. Our goal is for end of 2026 to have one of them at least start dosing patients. OK. And then just lastly, what does the balance sheet look like right now? What does that allow you to execute on? We reported $207.5 million that gives us two years of operating runway without accounting for any revenues that we're going to generate very soon. That's exciting because it not only gives us the time and cushion, but also advance our pipeline. In the backdrop of that, what is exciting is 2026, we're going to be a profit-generating company in the first half. This is unlocking great potential for us. OK. If there are no additional questions, Vish, Madhav, really appreciate it. Thank you. Thank you very much. Thanks everyone.