Good morning, everyone, and thank you for joining the 2024 H.C. Wainwright 26th Annual Global Investment Conference. I'm Dr. Jade Montgomery, an associate biotech research analyst at the firm, and I'd like you to please join me in welcoming to our next presentation, Dr. Brian Kevany, CTO and CSO, and Dr. Madhav Vasanthavada, CCO and Head of Business Development of Abeona Therapeutics, a clinical-stage cell and gene therapy company. Okay, awesome. Thanks. Thanks, everyone, for your patience and for tuning in as we are making progress towards a very important milestone for Abeona and also very important milestones for patients like Giovanna and Noel that you see here on this image, suffering from recessive dystrophic EB condition. As introduced, I also have Brian Kevany, who's our Chief Technical Officer, and Madhav, Chief Commercial Officer, along with some of the management team members. They're all very excited towards this progress, some forward-looking statements. Those who are new to Abeona's story, we are a cell and gene therapy company based in Cleveland. A little over a hundred people, essentially focused on two distinct platforms. One is an ex vivo gene engineering of cell therapy platform, and another one, which is a platform to deliver gene therapies using AAV-based capsids. We also have some out-licensed gene therapies, which with Ultragenyx and with Taysha, but most of our focus right now has been on Pz-cel, which is a late-stage asset, and we are very much on track to resubmit our BLA this year, anticipating approval in the first quarter of next year. So we are obviously very excited for an area of high unmet need, recessive dystrophic EB condition. So that's going to be the most of my focus for this talk here. Pz-cel, many of you may be familiar, it's a horrific disease, and this particular condition is an orphan drug designation that we have gained for Pz-cel. It's a rare pediatric disease designation for dystrophic EB. We have a breakthrough designation, and we also are eligible for a priority review voucher. Dystrophic EB, just with a show of hands in this room, how many of you are familiar with dystrophic EB condition? That's, that's quite a lot of members compared to even a few years ago, where there was not a lot of awareness. And especially with recently approved treatments, the awareness has been growing, and what we are hearing is that there is a need for more than one treatment option in this space, just given the nature of the disease that it is. And given that condition, there's current treatment landscape. If there's one takeaway that we want you to walk out with, it is that Pz-cel is the only investigational therapy that, with a single application, has demonstrated ability to treat large areas of body, chronic wounds, and has shown durable wound healing for multiple years. Single treatment application. And that, in and of itself, is highly meaningful. As we prepare for commercialization, we've been talking to a lot of patients, communities, physicians, as well as payers, and that differentiation and that unique value proposition is meaningful. I won't spend too much time on this slide since many of you are familiar with dystrophic EB, but in a nutshell, what this disease is, it leads to vast areas of the body wounded, and the nature of the wound is that they tend to open, close, reopen, close, and there is a need for treatment options that can provide long-lasting effect. If you don't treat these wounds, they tend to become chronic over time, and the chronic wounds, the chronicity of wounds is correlated with a risk of developing squamous cell carcinoma. Squamous cell carcinoma is highly burdensome on patients, caregivers, and multiple stakeholders. So to say the least, it's, I think everyone in this room will agree, it's got a significant burden, clinical, economic, a humanistic burden, and if we can develop a treatment option that is durable for these patients, it's going to be transformative. In our study with Pz-cel, we have targeted the most difficult-to-treat wounds. This is, w hen we show these images to our patient, to physicians and ask them: "Is this typical of a recessive dystrophic EB patient, moderate or severe?" The answer is yes. This, these are the types of patients that we are talking about, where on average, 1/3 of their body, 30% of their body, is wounded. That's what the natural history shows. And just for reference, 30%, 1% of body surface area is the size of the palm of a recessive DEB patient. 30% you can imagine the magnitude of wounding. The types of wounds that we have picked in our pivotal phase III study, which I'll go a little bit deeper, is that they were open for five years median. Some of these wounds had remained open for 21 years. The inclusion criteria were that they needed to be remained open for at least six months. We don't think that this will be the inclusion criteria for our commercial label, just given the unmet need. We wanted to put a bar that is very high. Existing treatment options, whether they are a gene therapy, gel, or otherwise, are not going to be able to cover these kinds of large areas in one go, and this is, again, resonating that you need multiple treatment options for our DEB patients. In a nutshell, our manufacturing process takes about twenty-five days. We are taking two skin biopsies of the patients. In exchange, we give them a functional version of their own skin that can cover vast areas of their body. So two 8 mm punch biopsies, 25 days later of retroviral transduction into the keratinocyte cells, we are developing skin grafts, functional skin sheets. Up to 12 credit card-sized skin sheets is what we can develop, which gives the modularity or the flexibility to treat either one large area of the body or multiple distinct wounds. This is just a snapshot of how the wounds are placed. The procedure is done under general anesthesia. Patient stays inpatient for up to seven days in our clinical study, and then the patients are discharged. So all of the clinical data that we have shown, including here, which is an example from a phase I to II-A study, is with a single treatment application. That single treatment episode of care, when this lady is back for five years, curable wound healing. When we show these kinds of images, it's definitely meaningful for the patients, what they can experience potentially. We have tracked these patients for up to eight years, and we have published this data. Some of you may recall wound healing of greater than 50% and greater than 75% wound healing, as well as associated pain reduction from these wounds. Why do we think that kind of durability is being seen? That's because we believe it's our mechanism of action, where we are using a retrovirus vector, and once we do the punch biopsy, we are picking certain cells that have markers similar to progenitor stem cells in our punch biopsy samples. The gene is getting stably integrated into the chromosome. So when the sheets are applied onto the body, as a cell goes through a cell division process, we believe that there are carbon copies of the gene that are being made through the cell division, which leads to sustained production of collagen. We have seen, by using a microbiopsy that we've taken on the treated areas, for up to 24 months, we have seen the collagen production at the anchoring fibers level. We didn't continue the study because it's very difficult for patients to give a portion of their treated area for analysis. Based on the strength of the phase I to II-A study, we went on with a phase III pivotal study design, which is a randomized intra-patient controlled study that was done at Stanford and UMass Memorial. In a nutshell, what we did is we had certain wounds on the patient's body that were treated with Pz-cel, and we had certain matching control wounds, and we looked at co-primary endpoints of at least 50% wound healing, which in and of itself is pretty, you know, given the large areas of the body to be treated. FDA wanted us to demonstrate a 50%, at least 50% wound healing and pain reduction in the treated areas. It's just to show that the treated and the control arm were balanced in our study. Here is the overall clinical trial outcome, where we have seen that across all the different time points studied, as early as six weeks, we've been able to demonstrate significant wound healing across multiple levels of wound healing, whether it's greater than 50%, greater than 75%, or complete wound healing. The green bars were significantly greater than the blue bars. The green ones are the treated arms, and the blue are the control. I know these are just the numbers, but if you look at images, this is an example of the thigh wound, which is significant area. This required three grafts in the thigh area, and you can see that this particular wound healed. When we projected this to patients and asked them, they've felt this was a completely healed wound. But in fact, this wound was not scored as completely healed. It was scored as a greater than 75% because of some of the crusting that you see at the bottom right, and since it was difficult to assess if underneath the crust, it's completely healed or not. But this is a meaningful outcome if we were to ask patients and caregivers. And the fact that they are able to see a before and after image and imagine as to what their wounds could look like in six months out, in a wound that had taken a long time is certainly important. This is yet another example of two wounds, B4 and E9. E9 is an example of a completely healed wound, and B4 was scored as a 75%. Even though it looks completely healed, it was scored as 75% just because of the speck that you see at the bottom right here, which at that snapshot, wasn't fully healed. Similar to wound healing, we have shown significant reduction in pain in the treated areas. Pain were assessed for each wound site within two hours of dressing change, and that's the time zone where wounds are most painful. As you appreciate here, there's a significant reduction. Also, what we are not showing here is significant reduction in itch, and itching is a big burden on these patients because the more they itch, that there is a chance that the wounds can open up again. So there was also significant itch reduction that was demonstrated. Favorable safety profile, no serious treatment-emergent adverse effects that were reported. These are pooled data from across our phase I to II-A and VIITAL reports. There's no instance of replicating competent retrovirus that was observed, and no squamous cell carcinoma was reported at the treatment site. Earlier this year, in summer, we reported new long-term clinical data on safety with 11 years of follow-up. And again, no squamous cell carcinoma was reported in any of the 128 sites that were treated with Pz-cel during the follow-up, even though SCC has been reported in non-treated areas. Yet again, goes to show that the strength of clinical data, 'cause it's been 11 years since the time we dosed our first patient, we treated our first patient, and it's comforting to know that the safety profile is very clean for these patients who are highly fragile otherwise. On the right side, we also presented a poster at the Society of Pediatric Dermatology to showcase all the locations, because physicians were asking: "Where can I treat a patient? You know, if I have a patient who has a wound in the shoulder area or on the thigh area or on the shin area, is Pz-cel appropriate?" So we showed data from our VIITAL study, a body map of all the anatomical areas, the anterior, the posterior, the extremities, and the core, where Pz-cel was successfully applied, and you've got robustness of the data there. In addition to the clinical progress, we have made significant progress towards our BLA resubmission, and we are on track, as I said earlier. For some of you who may not be familiar, we did receive a CMC-related complete response letter in April of this year, for certain activities and validation requirements that needed to be done, and admittedly, that probably put some pressure on our valuation. The good news, there was no questions that were asked with regards to clinical efficacy or clinical safety, so all of the data that we have shown so far have been shown and shared with the FDA as part of our BLA submission, and there has been no questions. FDA has not asked us to do any new clinical studies. What we needed to really show is certain CMC-related experiments, which now we have completed a Type A meeting with the FDA in August of this year, and we have gained alignment with the FDA in terms of the path forward for BLA resubmission. So with that, you know, marching towards BLA resubmission, in parallel, we're also making a lot of progress towards commercial readiness, trying to understand this marketplace. And if you think about Pz-cel and the opportunity, we can be more happier in many ways to come second to market, so to speak, with this gene therapy. We estimate more than 1,500 treatment opportunities with Pz-cel, and the way we define a treatment opportunity is, on average, patient requiring two treatment cycles. We think that there are, of the 1,200 or so patients with dystrophic EB, we believe there are about 750 patients that should be Pz-cel-eligible. 750, two treatment cycles, and pricing, we expect to put it for each treatment cycle. You have a patient, treatment cycle, that's a price point. Months or years down the line, patient comes back for a second episode of care, its own distinct billing unit. In talking to payers, we have been in active, you know, conversations through a few different forums. Payers' willingness to cover remains because they see the types of images and the clinical impact that we are bringing for an ultra-rare patient population. There is a willingness to cover Pz-cel, and so based on that, we project more than $550 million peak annual revenue for Pz-cel, and this projection is founded on the enthusiasm that we are seeing from advisory boards, through market research, with patients, with caregivers, with payers. And it's important that the durability, which is really resonating, we are hearing that there is need for multiple treatment options. We are seeing interest, at least from some of the patients that we have talked as to they want to know the process, what happens before and after Pz-cel procedure. And on the payer side, they definitely appreciate what Pz-cel could bring with multiple years of outcome. In terms of our strategy, it's going to be to focus on the high-volume EB centers. These are the centers where the patients have built the trust with centers of excellence, so we want to capitalize on that, engage with five to seven centers where the patients tend to go, either for their hand surgeries or for dilatation, for squamous cell carcinomas. There are multiple reasons why patients do visit these centers of excellence for their care. So it's not a foreign concept for them to go to centers of excellence. So we are targeting five to seven, onboarding them, and if we can identify one or two patients per center per month following the ramp up, that would be a really good, really good spot for us and towards that effect, we are actively working with these sites. These sites are qualified treatment centers, are geographically dispersed, and we are building a really highly nimble infrastructure and team, both on the manufacturing side, ramping up our teams, and also on the commercial side, bringing in people who have significant experience launching cell and gene therapies. Speaking of the payers, this is an important, obviously, chapter for us as we focus, because a little over 50% are commercially insured patients, 30% or so are Medicaid, and about 10% Medicare. One good news for us, are very positive, is we were able to secure an ICD-10 procedure code for Pz-cel. Because if you appreciate, Pz-cel is a gene therapy, but also requires a procedure to apply it, an inpatient hospital procedure. So for the procedure part, that code is applicable for Medicaid and for commercial insurance also. So if we would have received a procedure code that talks about it, a burn, you know, graft, we would have been in a tough spot. But the fact that we got a procedure code that recognizes the genetic nature of this treatment puts us really well for future discussion with commercial payers. And the commercial payer discussions are ongoing, and we'll continue to keep you updated as we learn more from a coverage and reimbursement. So I just want to summarize in the interest of time here, we have five seconds left, is we are in a very good spot as a company compared to where we were. Pz-cel is a highly differentiated product in an area of unmet need, in an area where you need multiple treatment options for these patients. We've been able to demonstrate instantaneous closure of large wound areas while demonstrating significant pain reduction with multiple years of wound healing, with a single treatment application while improving quality of life. We continue to hear good, positive feedback from payers from our pricing and reimbursement potential, and we will continue to work with sites to get them onboarded. And this is really our focus area. Keeping our heads down, getting BLA resubmitted this year, continue to prepare for launch while we assess what are the lifecycle management opportunities and identify future programs for development. So I thank you for your time. If you have questions, I know that we can take on-