Good day, welcome to the Abeona Therapeutics second quarter 2021 conference call. There will be a Q&A session after the presentation, and instructions will follow. As a reminder, today's conference is being recorded. I'll now introduce your host for today's conference, Greg Gin, Vice President of Investor Relations and Corporate Communications at Abeona. Please go ahead. Thank you, Paul. Good morning, everyone. I would like to welcome and thank you for joining us on our second quarter 2021 conference call. The press release announcing the second quarter results and recent operational progress is available on our website at www.abeonatherapeutics.com. On the call today with prepared remarks are Michael Amoroso, Chief Executive Officer of Abeona, and Ed Carr, Chief Accounting Officer. After the prepared remarks, we will host a Q&A session. We are also joined by Dr. Vish Seshadri, Head of Research and Clinical Development, and Dr. Brian Kevany, a lead research scientist working on our preclinical eye programs. Before we start, I will review our safe harbor statement. Remarks made during today's call may contain projections and forward-looking statements regarding future events. Forward-looking statements are made pursuant to the safe harbor provisions of the Federal Securities Laws. These forward-looking statements are based on current expectations and are subject to change, and actual results may differ materially from those expressed or implied in the forward-looking statements. Various factors that could cause actual results to differ include, but are not limited to, those identified under the section entitled "Risk Factors" in the company's annual report on Form 10-K and quarterly reports on Form 10-Q filed by the company with the SEC. These documents are available on our website at www.abeonatherapeutics.com. With that, I will now turn the call over to Michael. Michael? Thank you, Greg. Good morning, everyone, and thanks for joining us. We are excited to be with you today, and I hope this call finds you and your loved ones safe in this still uncertain time. I'd like to begin this morning with a review of our three strategic priorities for this management team in 2021. First, bolstering our relevant operational experience, first and foremost for our management team, but also for our board members. Second, delivering operational excellence, both timely and fiscally disciplined, to make sure we advance our clinical programs with meaningful data toward regulatory milestones. Third, prioritizing, executing, and advancing our preclinical pipeline toward the clinic, starting with a focus that we've discussed on our last call on the eye or our ophthalmic gene therapy programs. Now that it's the midpoint of 2021, let's assess how we're doing. Priority one, accomplished. We have added specific operational experience to our management team and our board of directors. As noted on our Q1 call, we enhanced our board with the appointment of four new members. Most importantly, we strengthened our management team with the appointment of Dr. Vishwas Seshadri, who joined us from a senior-level position at BMS to be our Head of Research and Clinical Development. In addition, we've added even more strength and experience to our clinical development program teams under Vish for EB and MPS. We've added relevant regulatory BLA experience, some of which has been paramount for our successful two Type B meetings over the last six months. We continue to fortify our quality and technical operations teams in Cleveland as we move closer to the BLA readiness skill sets. All of these teams have been strengthened in 2021 thus far, we will continue to be opportunistic about adding the best talent in the marketplace. Priority two, on target. We are delivering and have delivered operational excellence in achieving significant clinical milestones in a fiscally disciplined and timely manner. Let's start with our pivotal program in RDEB, EB-101. I'm excited to tell you about the progress we made in patient enrollment, opening a second site for completing our registration trial, and ultimately all driving towards a BLA in 2022. I'm also excited to tell you about the progress made on our MPS IIIA program, which we had a successful and collaborative Type B meeting with the FDA last month confirming that Transpher A is the pivotal study for ABO-102 in MPS IIIA. Our third clinical program, MPS IIIB, we are at the conclusion of enrollment at the high-dose cohort three level and will be closing the Transpher B study for further accrual. We'll continue to follow these patients to assess long-term safety and efficacy, specifically neurocognitive development over time. Priority three, also on target. We are advancing our preclinical eye programs toward the clinic with great speed and precision. During Q2, we reported the results of two non-human primate studies. We are on track to begin proof of concept studies in the second half of this year, and this will be toxicology study enabling into 2022 in some select ophthalmic indications. Let's take a deeper dive into the progress of our clinical programs and preclinical programs. Starting with EB-101, our lead pivotal phase III VITAL study for recessive dystrophic epidermolysis bullosa, or RDEB. We continue to build enrollment momentum in VITAL. There continues to be high and growing level of interest among patients and healthcare professionals. We are very pleased to have recently activated a second clinical trial site at UMass Memorial Medical Center in Worcester, Mass., under principal investigator and world-renowned EB expert, Dr. Karen Wiss. Dr. Wiss is a professor of dermatology and pediatrics at UMass Medical School, and she's the director of pediatric dermatology. We are excited to have the UMass team join Abeona's mission of pursuing a standard of care for large and chronic RDEB wounds. This is a significant and major milestone, and I want to congratulate the team on this timely execution and thank the staff and team at UMass. Now, in addition to our lead trial site at Stanford University Medical Center in Palo Alto, California, we can provide convenient treatment locations for study participants on both the West and East Coast, making travel logistics easier for patients and family. I'll remind our investment community this was one of the major challenges we heard from the community in 2020, and thus far in 2021, it seems to be opening up with our pandemic. This second site is paramount to our success. At the same time, we're expanding necessary physician experience with EB-101 as we plan for potential commercial launch in the U.S. We look forward to collaborating closely with the clinical team at UMass Medical School to screen and enroll subjects in VITAL as soon as possible. They are ready to go. Next, we continue our progress toward completing patient enrollment in the VITAL study. We have successfully administered EB-101 to patient number five. As you may recall from our last call, this is the patient who opted to rebiopsy and make new product. We are extremely happy to report that the rebiopsy and manufacturing of EB-101 product was successful for this patient, and they have received their EB-101 administration. The patient will be followed as per our VITAL protocol. Additional patients continue to be identified and pre-screened at both Stanford and now UMass to determine their eligibility for VITAL. As a reminder, the target for the pivotal trial is the treatment of approximately 35 large chronic wounds across 10 patients-15 patients. Today, I'm excited to report that we have treated more than half of the target number of randomized pairs of wounds thus far. Let's turn our attention to our AAV platform, our second in-clinic program, ABO-102 for Sanfilippo syndrome type A, or MPS IIIA disease. We announced some very exciting news about our Type B meeting with the FDA for the MPS IIIA program. We had a successful collaborative Type B meeting and aligned with the FDA that the current single-arm Transpher A study will serve as the pivotal study for ABO-102 and potentially support a biologic license application, of course, depending on the data set. We have now treated 21 patients in the Transpher A trial. We're excited about the safety and the magnitude of benefit seen with our investigational ABO-102 product in the younger children from the higher dose cohort, as we reported at the WORLDSymposium earlier this year. We remain hopeful that if the more recently dosed children in cohort three display similar treatment effects as those already presented, we could have an evaluable data set in 2022. The patients we serve have tremendous unmet need. We remain fully focused on operational excellence with the intent of now delivering two pivotal data packages in 2022, one for EB-101 and one now for ABO-102. At the Type B meeting, we also aligned with the FDA on the definition of the primary endpoint for Transpher A, which is neurocognitive assessment using the raw score from the Bayley Scales of Infant and Toddler Development and the Kaufman Assessment Battery for Children. These scales will be used in sequence. This is data we're already collecting as secondary endpoints. They will move to primary in Transpher A, Vish will tell you a little bit more about that shortly. We are grateful to the FDA for their guidance, and we look forward to continuing to work closely with the agency toward our goal of bringing potentially life-saving therapy to patients afflicted with MPS IIIA. In the near future, we intend to share the Type B meeting feedback with the EMA, followed by potentially other regulatory authorities around the world to guide our development plans for MAA in ex-U.S. markets. Of course, the United States is our first focus. In addition to the guidance and clarity from the FDA on the regulatory front, we also shared some very encouraging new clinical data from Transpher A that had not before been published this past weekend during an oral presentation at the 16th International Symposium on MPS and Related Diseases. Our new MRI data. The data indicates that ABO-102 increases gray matter, corpus callosum, and amygdala volumes in the brain in three young patients with MPS IIIA at 24 months post-treatment compared to an afflicted patient without treatment. Let's talk about this for a moment. Brain volume loss is characteristic in children with MPS IIIA, and it's associated with long-term cognitive and physical disability. Specifically, gray matter is important for cognitive development, corpus callosum for motor function, and amygdala for fear learning as well as social and emotional development. We're excited about the MRI data, as are our clinicians, and it's consistent with previously reported results of preservation of neurocognitive development in the three younger children from cohort three that we have presented from Transpher A earlier this year with the longest follow-up. Moving onward to our last in-clinic program, ABO-101 in the Transpher B study for MPS IIIB. As noted on the last quarterly call, we reported results from Transpher B at the WORLDSymposium in February. The results to date, Transpher B high-dose cohort, like the high-dose cohort from Transpher A, show the drug is safe and well-tolerated, eliciting a dose-dependent, sustained reduction in disease-specific biomarkers, denoting clear biologic effects. As I've reminded you in the past, we absolutely want to see biomarkers moving in the right direction. The gold standard will be the collection of neurocognitive development data, and we need to let that mature into 2022. Previously, we shared the accrual in Transpher B was paused after dosing four patients in the higher cohort because the drug product, again supplied by Nationwide Children's Hospital in Ohio, had reached its two-year shelf life expiry. Some of our additional stability testing results showed specifications were not met for all parameters of Transpher B protocol, specifically physical titer. However, after reviewing the test results based on equivalent potency, infectious titer, as well as the purity profile of the drug, the German Health Regulatory Authority, along with our DSMB, deemed that the benefit of the drug outweighed the risk and endorsed the use of the product for those remaining patients with highest unmet need through the German Named Patient Program. The NPP is a compassionate use program in Germany that allows individuals to be treated at the request of the treating physician and families. We're thankful for the authority and the DSMB acting quickly to get drug to these patients. To date, three patients have been dosed in the German NPP, and a fourth is pre-screened and getting ready for treatment. The total number of patients treated now at the higher dose, 1 x 10^14 vector genomes per kilogram between Transpher B cohort three and now the NPP program, will soon be eight children collectively. In parallel, we're in the process of closing enrollment in the Transpher B study, and patients from both the Transpher B and the Named Patient Program will be monitored with the same rigor for ongoing safety and efficacy of the high-dose ABO-101 product as they would have been within the Transpher B study. While early biomarker data are promising, neurocognitive preservation and development is the gold standard, as we've discussed. We look forward to seeing two-year neurocognitive data beginning in the first half of 2022 for some of the first patients dosed in the higher dose cohort from Transpher B and subsequently will determine next steps for the program once we have some of these important and essential data points. As we await these data, I'll remind you that out of our wholly owned Cleveland non-CDMO-dependent manufacturing facility, ABO-102 for MPS IIIA commercial-grade product is being made. Our experience in AAV production from our fully owned Elisa Linton Center will be highly transferable if and when we decide to manufacture ABO-101 for MPS IIIB program, of course, data dependent in 2022. Finally, I'll give a brief update preclinical and I'll open it up to the group for questions. As previously noted, we conducted preclinical research with novel AAV capsids, including our Abeona invented and partnered capsids in six undisclosed eye indications. These eye indications represent opportunities in the U.S. alone of about 5,000 patients-15,000 patients with the highest unmet need. This continues our Abeona identity as a fully integrated end-to-end gene therapy company focused on high unmet needs. Please hold the line while I dial back out to Michael has rejoined. Go ahead, Michael. Yeah, I'm sorry about that to the community. I'll pick up where I left off with the preclinical programs. In the second quarter, we reported preclinical data from ARVO 2021 and completed non-human primate studies. As a reminder, the NHP results showed that AAV204, one of our in-licensed AAV capsid programs, was superior to AAV8 using a recently developed novel route of ocular administration. Brian will be on the call to tell us about that if you have any questions. In a separate NHP experiment, AAV214 and 214Z5, two wholly owned Abeona capsids, demonstrated nearly identical levels of transduction compared with AAV8 of photoreceptor and retinal pigment epithelium cells, which are the cell types most frequently affected in inherited retinal diseases. These data are believed to be very important findings, as we'll remind you, the gold standard today in ophthalmic subretinal drug delivery is AAV8. We're enthusiastic about the findings. We're moving, as we speak, to proof of concept studies in the second half of this year. This will enable toxicology studies in 2022. With that, I'm going to turn over to Ed, our Chief Accounting Officer, to review our financial results. Please, Ed. Thank you. Thank you, Michael. I would like to remind everyone that the Form 10-Q is available on our website, which is where you can get additional details on our financial results for the three and six months ended June 30, 2021. While pursuing the key strategic priorities outlined by Michael, we have thoughtfully and carefully managed our spending decisions. Across each function within the organization, there is a balanced approach to not only focusing on moving forward towards our key milestones, but also using our cash resources prudently and on time to deliver results. Looking at research and development activities in the second quarter of 2021, we spent $7.4 million, which is consistent with the $7.2 million spent in the first quarter of 2021. Research and development spend includes the cost of the clinical development of the EB-101 and MPS programs, the manufacturing of the drug products for EB-101 and ABO-102, and our preclinical ophthalmic research activities. Our spend on general and administrative activities was $5.5 million in the second quarter of 2021, down significantly from the $6.6 million spent in the first quarter of 2021. General administrative spend includes the cost of personnel not working directly on clinical and pre-clinical activities, as well as professional fees, insurance, rent, and office expenses. The decrease in general administrative spend in the second quarter of 2021 results primarily from lower professional fees. Turning to the financial resources on our balance sheet, we had cash equivalents, and short-term investments of $77.6 million as of June 30, 2021, as compared to $86.8 million as of March 31, 2021. The change in cash resulted primarily from $11.5 million of cash used in operating activities, partially offset by $2.3 million of cash from financing activities. Based on our existing cash equivalents, and short-term investments, our ability to access additional financial resources, and our financial flexibility to reduce operating expenses if required, we believe that we have sufficient resources to fund operations through at least the next 12 months. With that, I'll turn the call back over to Michael. Michael? Thank you very much, Ed. We're committed to delivering operational excellence and bringing the gene therapies to patients with no approved treatments. We continue to advance our clinical programs with great operational know-how, many of our preexisting team and new hire talent, and with fiscal discipline. We've activated a second clinical trial site at UMass. We are moving toward completing enrollment for EB-101 phase III vital study in RDEB. In MPS IIIA, we've aligned with the FDA on Transpher A as the pivotal trial and the primary endpoint, giving us great guidance and clarity on the potential regulatory path for ABO-102. We are focusing our resources on completing these registration-enabling studies and preparing for the potential of two BLA filings. The second quarter was a highly effective and productive quarter for Abeona, and I want to thank our patients, their families, and our team, including our investors, who make this incredible drug development possible. With that, I turn it over to the operator to open up questions and answers. Thank you. Thank you. Ladies and gentlemen, the floor is now open for questions. If you have any questions or comments, please press star one on your phone at this time. We ask that while posing your question, you please pick up your handset if listening on speakerphone to provide optimum sound quality. Please hold while we poll for questions. The first question is coming from Kristen Kluska from Cantor Fitzgerald. Kristen, your line is live. Hi, good morning, everyone. Congrats on the Type B meeting outcome, thanks for taking the questions. The first one I have is, could you remind us about the latest efforts and the current database for natural history in MPS IIIB? Given that for MPS IIIA, you've achieved the best results when treating early in the high-dose cohort, how should we also be thinking about perhaps the long-term data in cohort two, given that these patients are actually receiving a higher dose than MPS IIIA? Thanks, Kristen. Good to hear your voice. Juan Ruiz is actually with us on the phone, my lead clinician and MD from the IIIB program. I think we're asking about the natural history registries that exist, or repositories, if you will, that exist for IIIB. Kristen, I'll ask you to clarify, are we also asking about the expectation of the higher dose cohort from IIIB, and if we're expecting similarities to IIIA? I just want to clarify the second part of that question before I have Juan answer, please. Sure. Also, the focus was on cohort two for MPS IIIB, just given that the protocol for the MPS IIIB trial includes higher doses relative to what you're studying for MPS IIIA. Got you. Okay. There's two doses in MPS IIIB, cohort two and three, that are higher than the highest dose in MPS IIIA. Obviously, a different drug. I think we also believe the data we showed in February was from cohort three, also from MPS IIIB, the highest dose, 1 x 10^14. I'll let Juan address both of those. Juan, let me open it up to you to please address what natural history data exists for MPS IIIB and what we should be looking for from MPS IIIB, which arm, which we discussed as far as expecting neurocognitive results in 2022. Please, Juan. Yes. Thank you, Michael, and thank you, Kristen, for the question. Regarding MPS IIIB, Nationwide Children's Hospital conducted a natural history study for IIIA and IIIB They use the information to inform their clinical trials. There is already data gathered from Nationwide on IIIB patients. In addition, Chester Whitley at the University of Minnesota conducted a natural history study on IIIB patients that has been published. We have access to this information that we are using to compare the children in our trials. Also BioMarin has released some data on a significant natural history study on IIIB patients for their own programs. This information has been collected and is being used, and we are using it in a similar way to the information collected for IIIA for our Transpher A programs. We are confident that there will be a amount of information that is needed in order to make the comparisons between the evolution of the children in Transpher B with natural history data. Regarding doses in Transpher B versus Transpher A, I would like to remind first that the product that we are using in both trials, although based on AAV9, both of them, have some differences. The Transpher A, I mean the product for the MPS IIIA program, is a self-complementary AAV9 versus the single-stranded AAV9 vector for the Transpher B. This has implications regarding the speed of the gene transduction and also the amount of gene expression. Although the doses are different and 3 x 10^13 in Transpher A versus 1 x 10^14 in Transpher B, this is somehow compensated with the higher expression derived for self-complementary AAVs. In that regard, yes, the cohort two that is using 5 x 10^13 in the Transpher B program would be kind of similar to the higher dose in cohort three in Transpher A, but it's difficult to compare because of this explanation. We are continually collecting data from these children, and we will have data along the year, and they will complete two years follow-up before the end of the year, and we'll be ready for beginning of 2022. Thank you, Juan. Thanks for the excellent explanation. Yes. Thank you very much. Moving on to ABO-102, is there a specific time length of follow-up that you're looking to collect for the more recently treated patients in cohort three as it relates to your comments about having a potential pivotal package next year? Kristen. Great question. I'll take that one. I think the timeline that you guys have heard me talk about on post-treatment, not that it's a perfect science, but I'll just remind you, is that two-year time point. Knowing that neurocognition and development and those comparisons versus the scale of Bayley and ultimately, hopefully Kaufman, and Vish will speak about that, I'm sure, coming up in another question, as Bayley turns to Kaufman, as a child gains a certain level of acceptable cognitive age, which is obviously a good news if you're turning to that survey. The bottom line here is two years, Kristen. two years is that time point we've talked about. Again, what does that relate to? Basically, our youngest patients are around 12 months. Where you really start to see the separation versus the historical controls out there, the natural history, is that three-year timeframe we've talked about, Kristen. We want to make sure we've got at least two years post follow-up of a treated patient. Again, that was based on the youngest patient at the time being treated at about 12 months. It could be lesser data. For example, if you're treating a patient at baseline who's two years old, now at two years, they're going to be four. You should see a real clear delineation. We think two years is a minimum follow-up that's really important. Kristen, by the fall of next year, with the majority of all the cohort three, the 3 x 10^13 for ABO-102 from Transpher A, we'll have almost all patients will be past two years by the fall, and we'll have some patients up to about five years. That's where we say, based on the magnitude of effect still being determined in the SAP with the FDA, we talked a little bit about it'll be a review decision, which is great. That's okay. I think people are very confident in the results we see thus far. We think we get past that two-year mark and around the fall of next year for almost all of the patients, and we think we can have a valuable package that early. We'll have between two and five years on those patients. Thanks. Appreciate that. The last question on the same program. In regards to the brain MRI data you recently shared, were there any other measurements conducted at time points besides 24 months? Just looking across these three patients in good detail now that you have some neurocognitive findings, biomarkers, and this data as well, could you talk about how all of these endpoints are correlating with each other? Yeah, sure. I'm going to turn that back over to Juan because he can do a better justice to that than I can. Juan, do you want to take that one, please? Thanks. Yes. Thank you, Kristen. This is a very important question. Yes, indeed, we see a very good correlation between the biomarker data showing a sustained decrease two years after the treatment in CSF heparan sulfate. Brain MRI data, where we see that compared to the brain atrophy that is progressing in children without treatment, the three children for which we have two years follow-up have shown this increase in gray matter volume, amygdala volume, and also corpus callosum volume. To mention just three areas of the brain. There are other data showing the same direction. We are deviating from the brain atrophy and loss of tissue in the trial, and this correlates with the cognitive evolution of these children that has shown over two years, and in fact, 30 months and 36 months in them, because we have two years and a half and three years data, have shown continuous gain in cognitive skills, going beyond the ceiling of certain natural history, and deviating clearly from what is expected according to natural history data. Thank you, Juan. Thanks, Kristen. Thanks. Thank you. The next question is coming from Maury Raycroft from Jefferies. Maury, your line is live. Hi. Good morning, everyone. Congrats on the progress, and thanks for taking my questions. I'll start off sticking with the MPS IIIA program. For the neurocog time point, you mentioned both Bayley and Kaufman are used sequentially, and it sounds like Kaufman is used after Bayley. I'm just wondering if you could talk more about this and the timing. Separately, can you provide specifics on how the two endpoints will be weighted in FDA's review? I guess, will a patient have to improve on both measures or one or the other in order to succeed? Hey, Maury, how you doing? Good questions. I'm going to turn it over to Vish and have him answer. The short answer on the second is no, they're not co-primary endpoints. They're used in tandem. Vish, maybe you can walk the group through how Bayley and Kaufman work together, when the handoff occurs, and it will be really one seamless test and not co-primary in any way. Please go ahead, Vish. Sure. Thanks, Michael, and thanks, Maury, for the question. Just to clarify, Bayley and Kaufman are used sequentially, as you pointed out correctly, and not in combination. Bayley is used in children until they reach the upper limit of the scale at about 42 months of the development age. After that upper limit is reached for Bayley, Kaufman will replace Bayley to continue the evaluation of children. In the natural history studies in MPS IIIA to date, it's important to note that Kaufman was not implemented mainly because the children never achieved a cognitive age close to that 42 months of development age, and that upper limit observed was about 30-31 months. In Transpher A, however, we are already collecting data with Kaufman, as children are reaching that 42-month cognitive age time point, which is something that's very interesting, and we will continue to follow. The short answer is they are not going to be combined. They will be measured sequentially. I hope that clarifies, Maury, your question. Yes. Yeah, it's really helpful. It sounds like any data that you get on Kaufman, there's probably not much natural history data to compare to. Any data you get on Kaufman will be important and kind of like a bonus for FDA's review. Is that the right way to think of it? That's correct. There's not very much natural history data for Kaufman. It'll be descriptive for us. Got it. Okay. Thank you. The other question was on EB-101, and you said you dosed more than half of the target, 35 wounds in five patients. Just wondering if there's anything you can say about the types of wounds you're seeing, how they compare to the phase I/II experience. At this point, can you put any more, I guess, finer points or clarity on timelines? Maury, thank you. I'll take that. It's Michael. First and foremost, past the halfway point on wounds. Large and chronic wounds. Remember, guys, different types of EB out there. Just a quick reminder, RDEB is the worst, unfortunately, the worst prognosis of all EB right now, morbidity and mortality. The two different types of wounds that occur within RDEB are kind of, if you will, earlier in the chronology of the disease, small clustering, recurrent wounds. Think about a patch of blisters that opens, close, open and close. Some of the other life sciences companies are concentrating on such wounds. We think that's great. We think that'll be super complementary, and we're rooting very hard for patients and our partner companies out there. Where EB-101 kicks in, Abeona's work's been focused more, if you will, on kind of that last line of defense. The other half of the RDEB wounds, which is when those wounds are no longer recurrent, small, open-close cluster, they just become one continuous chronic wound. Definition of large in the trial, 20 cm or greater. I'll remind everybody, we have entire legs, thighs, entire backs, hundreds of centimeters of wounds at times. Chronic, this is an important term. Chronic means the wound has now been open for six months or longer and can no longer close itself. That's where you need the regeneration of skin that we're obviously doing with the keratinocytes for EB-101 and the surgical transplantation. Those are the wounds that we are focusing on in VITAL in the RDEB trial. I think, Maury, what I could tell you, obviously, it's an ongoing pivotal, so we're not looking at data along the way. I could tell you that feedback's been positive. I think what we're trying to replicate, and I think the consistency you'll be looking for here is what we see from the phase I/II. I'll remind everybody, we just showed you durability data of almost six years. This is really important, right? We know it's not a topical gel. We know you got to take some biopsies from patients. You got to make these grafts, and you got to put them on. The reality for this drug product is it's got to be worth it. We believe the key here is in the worst of the worst wounds that lead to ultimate morbidity and mortality, the durability will be super important. Maury, that's what we're looking for. Can't talk to you too much about results, safety, and efficacy because we are in pivotal. The second part of that, Maury, for EB was I'm sorry, remind me the second part of that question. Just based on if you have more clarity on timing at this point. Timing, yep. You've already got greater than half in that five patients. Yeah. Thanks, Maury. So far we're not changing. I always said we said the terms wasn't guidance, but a bold goal we were putting for the team. Frankly, I joke because the patients really need us. We're not changing our push to try to hit accrual by the end of this year. We're still on that. It is a bold goal. We truly don't know what the run rate will be monthly now that UMass is on board, Maury, right? Really important. We treated patient five. We've got some candidates in the queue here. I won't say anything about the next patient just yet. It's a little premature, but now we've got two sites on the east and west coast. We've got to see how that plays out. We can treat up to two patients a month in our facility right now, while we're still in clin dev stage, before we turn on commercial manufacturing size. That's really important to know. Right now, we're still holding to our bold goal of end of the year. Later this year, probably on our next call, Maury, I can give you a better idea if it might spill into Q1 at all to get to our accrual, because it is tough to predict when patients come in the queue for the trial. We're very, very pleased with what we're seeing. We think we're getting past the halfway point is very important. Now we've got two sites. If you just think about if that could expedite and we could double the amount of volume, I think we could be getting toward the end really close. Just a reminder to the group, once we accrue, why that's so important is from the last patient plus six months, that'll be when we have top-line data to say if it's a positive pivotal phase III at that point in time. If we accrue at the end of this year, we're looking for positive top-line results mid next year, Maury. Great. That's really helpful. Thanks for taking my questions. Thank you. Thank you. The next question is coming from Mani Foroohar from SVB Leerink. Mani, your line is live. Hey, guys. Thanks for taking the question. I'm going to go a little more of a practical commercial one. We talk a lot about capacity and manufacturing as if it's number of patients, I want to narrow in on more of a volume, I guess, an area question. When you're talking about large wounds, that sometimes can scale, as you said, to entire backs, large parts of the chest, a very high percentage of body surface area. Can you help scale for us the absolute area of graft you could manufacture on an annualized basis? How to think about that, as some of these patients may require tremendous volumes of grafts with implications for per patient cost, per patient required manufacturing volume, et cetera. Mani, good question and thanks. Good to hear your voice. I'll take that one. It's a great question. The fact that we're having practical conversations is good news, right? As we get closer to patients, that's a really important point. Let's talk about that a little bit. Let me remind you what one product of EB-101 is. They are six sheets. One product is six 40 cm sq, a little bit bigger than maybe the largest business card you've seen. 40 cm sq sheets times six for 240 cm will be what one product delivery is, one product transplantation. I'll remind you how we got there. True empiricism, guys. That was how it was done at Stanford. When we spoke to the FDA before starting the trial, of course, this is an investigational therapy, so it's not something that the FDA felt comfortable going even beyond that of go head to toe or double the size of the grafts. We truly follow the empiricism of what started at Stanford. There's no perfect science for that. Of course, our process development teams are looking at what's the next product follow on, how do we enhance that? What I will tell you is if you look at the EB-101 typical patient, as we've thought about our forecasting and the capacities we're going to need. About 50% of their wounds, so think about 2,000 patients- 2,500 patients a year with RDEB in the U.S. specifically. It's not a concentrated disease. You'd see similar, for example, you could expect similar in the EU5 and so on. It's diffuse across the world. If you just think about 2,000, 2,500 patients with RDEB, about 50% of their wound burden at any given time is large chronic wounds. The other 50% are small recurrent. Now again, do we think that small recurrent could be addressed? That's some phase IV work we'll do with EB-101. First things first, we want it to be the line of defense for the most problematic and troublesome wounds. That's the positioning of the EB-101 product durability in the worst of the worst wounds. If you look at the RDEB wound distribution of about 50% in these patients at any given time, there's also a range of different afflicted wound surface area, Mani, on these patients. The best published literature shows about 30% of the body surface area afflicted with wounds at any given time. Think about half of that being large and chronic. If you do the math on that, at 240 cm sq, this will be a repeat treatment. Very important to understand. This will be a therapy that you're looking at probably a median of four over a lifetime to treat the entire wound surface area of large chronic wounds on the median EB-101 RDEB patient. Okay. I walked you through some numbers there. You're thinking about three to four, a little more than three, about four administrations over the lifetime. You could imagine maybe there's one or two procedures a year. Let's say two years in, you've had your three or four procedures, and you've now covered that full body surface area. We think that's super important because we're approving this drug on improvement in quality of life when you really think about pain and the ability to close wounds. Mortality is something that we'll have to look at long-term as we follow these patients in a long-term follow-up, how much body surface area do you need to close for how long? Our goal here is to get to all of the large chronic wounds, and in some of our phase IV work, follow-on work, we'll focus on maybe the small recurrent wounds. Okay? Mani, hope that gives you a little bit of a depiction. Thanks. That's really helpful. Thank you. There are no more questions in the queue. I will hand the call back to the management team for any closing remarks. Well, Paul, operator, I thank you for your help today. I thank our investment community. Without your interest, without you guys writing the analyses, without your investments, we would not be able to bring these potentially and hopefully life-saving therapies to these patients. I want to thank the patients and families. As always, I want to thank my team. I think the Abeona team has really shown a lot of progress over the last nine plus months that I've been with them, and I'm very privileged to be part of this group. I think we're doing a lot with a small, mighty group of people. We're continuing to bring talent in. We'll continue to talk to you about our three management team priorities, talent, operational excellence, and then, of course, first and foremost in our in-clinic programs, two of which now we're in pivotal and we're looking intended to bring to registration. We could have valuable packages as early as next year for both. Patients really need that. We'll keep you up to date on that. Again, super progress that's been made in Brian's domain and Lunis' domain in research under Vish, of bringing really prioritizing first our core pre-clin programs, the eye, and moving them closer to the clinic. I thank the teams and the patients for all the work. I thank the investment community for their interest. I know I'll speak to some of you in follow-up. Again, thank you. Please be safe, everybody. Thank you, ladies and gentlemen. This does conclude today's conference call. You may disconnect your phone lines at this time, and have a wonderful day. Thank you for your participation.