Good morning, everyone, and welcome to the Abeona Therapeutics second quarter 2024 conference call. At this time, all participants are in a listen-only mode, and we will open for questions following the presentation. If anyone should require operator assistance during the conference, please press star zero on your phone keypad. Please note, this conference is being recorded. I will now turn the conference over to your host, Greg Gin, Vice President of Investor Relations and Corporate Communications. Greg, the floor is yours. Thank you, Jenny. Good morning, and thank you for joining us on our second quarter 2024 conference call. During this call, we will refer to the press release issued this morning announcing the second quarter results, which is available on our corporate website at www.abeonatherapeutics.com. I would like to note that remarks made during today's call may contain projections and forward-looking statements. 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 Risk Factors section in our Form 10-K and periodic reports filed with the SEC. These documents are available on our website at www.abeonatherapeutics.com. On the call today with prepared remarks are Dr. Vish Seshadri, Chief Executive Officer, Dr. Madhav Vasanthavada, Chief Commercial Officer and Head of Business Development, and Joe Vazzano, Chief Financial Officer. Also joining us for the Q&A session will be Dr. Brian Kevany, Chief Technical Officer. With that, I will now turn the call over to Vish Seshadri to lead us off. Vish? Thank you, Greg. Good morning, everyone. We appreciate everybody joining this call. We're excited to provide our second quarter update, and I'll start with the status of the BLA resubmission process. As a reminder, the complete response letter highlighted the need for additional CMC information pertaining to, in general, validation requirements for certain manufacturing and release testing methods. The CRL that we received in April did not identify any deficiencies related to the clinical efficacy or clinical safety data in the BLA, and the FDA did not request any new clinical trials or clinical data to support the approval of Pz-cel. Since our last quarterly call, we've continued to make tremendous progress and have now generated the necessary data and reports to address nearly all of the CRL items, with work ongoing for two outstanding items. Specifically, we've completed the work necessary to address deficiencies pertaining to RCR, or replication-competent retrovirus assay, sterile filter validation, container closure integrity testing, whole cell DNA, visual inspection validation, and importantly, data that support the extension of product shelf life. For the two outstanding items, namely our rapid sterility assay and cell-based identity assay, feasibility data that inform the design of our validation protocols have been generated, and we have finalized the validation protocols and have initiated the validation runs. I'm pleased to say we successfully completed a Type A meeting with the FDA last week, wherein we gained preliminary alignment on the acceptability of the data that addressed several of the CMC deficiencies noted in the CRL. In addition, we also gained the FDA input on validation protocols for the rapid sterility and cell-based identity assays, and that has been incorporated into the validation procedures that are now ongoing. Based on the FDA's written responses to our questions in pre-meeting, meeting materials and our minutes from this meeting, we believe we have clarity and alignment with the FDA on the content of our BLA resubmission for Pz-cel. We are therefore on track to resubmit the BLA for Pz-cel this year. If the BLA resubmission is accepted for review, we expect the FDA to set a PDUFA date six months from the date of resubmission. Beyond the progress on Pz-cel, we announced in July a non-exclusive agreement with Beacon Therapeutics, allowing Beacon to evaluate our patented AAV204 capsid for the development and commercialization of potential gene therapies in select ophthalmology indications, with the option to evaluate up to nine targets. We look forward to collaborating with Beacon and believe this agreement underscore AAV204's potential to enable efficient targeting in the eye of novel AAV-based gene therapies for ophthalmic diseases with high unmet need. Finally, I mentioned that we completed a $75 million underwritten offering with institutional investors in May, strengthening our balance sheet and extending our cash runway well beyond anticipated significant regulatory milestones and commercial launch of Pz-cel. I'll now turn the call over to our Chief Commercial Officer, Dr. Madhav Vasanthavada, to provide an update on our commercialization readiness activities. Madhav? Thanks, Vish, and good morning, everyone. We are building a solid foundation to prepare for a successful launch of Pz-cel following its potential approval, and we are very excited by the feedback we've been hearing from multiple stakeholders. I'll start with our support for medical education activities at various conferences, where we have had great conversations with key physicians and patients. At the Society for Investigative Dermatology, SID, annual meeting in May, we presented our new long-term safety data of Pz-cel in 18 RDEB patients with the longest follow-up period of 11 years. a key takeaway, in addition to the generally well-tolerated safety profile, no squamous cell carcinoma was reported in any of the 128 Pz-cel treated sites during the follow-up. Squamous cell carcinomas have been reported in non-treated sites unrelated to Pz-cel. In July, at the Society for Pediatric Dermatology SPD Annual Meeting, we presented data illustrating Pz-cel's ability to cover wounds of various sizes, including large areas, and on different anatomical locations. Based on our interactions with healthcare professionals, whether they plan to treat with Pz-cel themselves or refer to qualified treatment centers, they are very enthusiastic about Pz-cel's potential to make a difference in addressing the persistent unmet needs of our patients. We recently attended the DEBRA Care Patient Conference in Atlanta, where we noticed so many of our patients, almost all of them having significant wounds on their bodies, wrapped in bandages. Pz-cel has the potential to heal large body surface areas, including the toughest to treat wounds, while demonstrating meaningful pain and itch reduction based on clinical data from two trials: a phase 1 to 8 study with up to eight years of follow-up, and the intrapatient randomized phase III VITAL study. Pz-cel is the only product in the RDEB space with more than a decade of clinical experience to show not only a clean, long-term safety profile, but also durable wound healing after only a single application. These aspects of Pz-cel make it a highly differentiated and clinically meaningful potential treatment for RDEB patients, caregivers, and physicians. At the DEBRA Care Conference, we also shared a clinical research update and data on wound healing following the Pz-cel treatment process. The interest from patients, caregivers, and providers was palpable when they saw the before and after PD-cell wound healing pictures for several large and chronic wounds. We also heard from patients who have received PD-cell, including a few who had recently completed their second PD-cell treatment. They shared. They reached out to share with us the life-changing impact that PD-cell has had on their lives and the lives of their loved ones. Such testimonials highlight the transformation potential of PD-cell care. Switching our efforts with the payer community, we are excited to announce that our ongoing discussions with major commercial payers are generating positive results. Payers are recognizing the clinical value of PD-cell and its potential to address significant unmet needs in the current treatment landscape, enhancing our optimism for favorable coverage and broad and timely patient access post-approval. Lastly, from a site onboarding standpoint, each interaction with targeted experienced Pz-cel centers is allowing us to deepen relationships and increase our readiness towards site activation. Master service agreement negotiations are ongoing, and we remain on track for potential launch approximately three months after Pz-cel approval. All of these sites remain highly engaged, and we plan to accelerate our onboarding activities soon after BLA resubmission is complete. With that, I will now hand the call over to our Chief Financial Officer, Joe Vazzano, to discuss our financial results. Joe? Thanks, Madhav. I would like to remind everyone that you can find additional details on our financial results for the three and six months ended June 30th, 2024, in our most recent Form 10-Q, which is available on our website. Starting with the financial resources on our balance sheet, we had cash, cash equivalents, short-term investments, and restricted cash of $123 million as of June 30th, 2024. This compares to $62.7 million as of March 31st, 2024. Net cash used in operating activities was $12.7 million for the three months ended June 30th, 2024. Based on our current operating plan and assumptions, with our existing cash resources, also including the credit facility, we estimate we have sufficient financial resources to fund our operations into 2026. Our cash runway assumptions do not account for any potential revenue from commercial sales of Pz-cel or proceeds from the sale of a priority review voucher or PRV, if awarded by the FDA. I'll remind you that Pz-cel has been granted rare pediatric disease designation by the FDA. So upon this potential approval, we believe that we are eligible to receive a PRV. Research and development expenses were $9.2 million for the three months ended June 30th, 2024, compared to $8.5 million for the three months ended June 30th, 2023. Our spend on general and administrative activities was $8.6 million for the three months ended June 30th, 2024, compared to $5 million for the three months ended June 30th, 2023. The increase in general administrative expenses is primarily due to commercial and launch preparation costs. Net income was $7.4 million for the second quarter of 2024. It's important to note that the net income in the second quarter of 2024 included a $24.9 million gain resulting from the quarterly remeasurement of the fair value of warrant liability. These warrants are required to be classified as a liability and remeasured at fair market value each reporting period. ...Net loss in the second quarter of 2023 was $16.7 million, including an $8.6 million loss resulting from the quarterly remeasurement of the fair value of warrant liabilities. And with that, I'll hand the call back over to Vish for brief closing remarks before opening the call for Q&A. Thanks, Joe. In closing, we have made significant progress in less than four months since receiving the Complete Response Letter. We are in a much better position than we could have hoped for, and we are on track for the BLA resubmission in the second half of 2024. We remain committed to bringing Pz-cel to patients with RDEB as quickly as possible. I firmly believe we will get there. Operator, please open the Q&A session. Thank you very much. At this time, we'll be conducting our question-and-answer session. If you would like to ask a question, please press star one on your phone keypad now. A confirmation tone will indicate that your line is in the question queue. You may press star two if you would like to remove your question from the queue. For any participants using speaker equipment, it may be necessary to pick up your handset before you press the keys. Please wait a moment while we poll for questions. Thank you. Your first question is coming from Maury Raycroft of Jefferies. Maury, your line is live. Hi, good morning. This is Farzin from Maury. For the two remaining outstanding items related to sterility assays and identity assays, can you say more about what the FDA feedback was? Like, I mean, are they asking for you to replicate something for a new iteration, or are they asking for a new experiment? Good morning, and thank you for that question. So let me take the first outstanding item, which is the rapid sterility test. As a reminder, this is a method that was suggested by the FDA themselves because of prior experience with this approach. The suggestions were primarily to the statistical approach that we're using to establish the comparability between the current gold standard USP 71 method of looking at sterility and what we have developed. And it is not a development of a new experimental method per se. So I just wanted to clarify what that input was to the validation procedure. We don't see this as even a major amendment to how we were validating. This was out of abundance of caution. We wanted the FDA to take a look at our validation protocol and approach and suggest if they had a preference for one statistical method versus other. So that's really what we had, and that's why we wanted to hold off in starting the validation experiment until we got that feedback. So that's regarding the sterility assay. Regarding the identity assay, we've actually started the validation work, and we have pretty good alignment from the FDA on our approach in how we look at the cell composition of our sheet. The discussion was more around what kind of characterization data to be included and how we put justifications in place that the way we've developed these identity assays. So I hope that addresses the two questions. Happy to talk further about it if you are interested. Got it. And then, did the FDA provide feedback on the retroviral replication assay? Is that one good to go, or there's no more feedback from the FDA? Yes, that one is good to go. Even before we had the Type A meeting, we had written back and forth with the FDA and shared the data that we've generated and wanted the confirmation that this really addresses the need for the RCR assay, and we have that behind us now. Got it. And then one quick one is that, will you need to have another formal meeting with the FDA, or is there any more granularity on the, when in second half can you submit it? So we do not plan to have any more formal meetings with the FDA, like a Type A or Type B meeting, per se. But we are not guiding exactly when the second half of this year we're planning the resubmission, purely because the validation runs are ongoing as we speak. And you know, it's just a matter of when they get completed. So it's tricky to predict when exactly these types of experiments will be completed, the reports generated, all the I's dotted and Ts crossed. So we will guide as previously we had done. We remain on track for a second half of the year submission. Thank you so much. Thank you very much. Your next question is coming from Dae Gon Ha of Stifel. Dae Gon Ha, your line is live. Hey, good morning, guys. Thanks for taking our question a little bit more. Was there any direct feedback on additional data or additional assay? I mean, it seems like, the last time we spoke, everything was on track to be sort of, you know, at the end of the Type A Meeting, that seemed almost like the rate-limiting step before you resubmit. So I'm just wondering if there was anything additional that you need to run or anything additional that needs to be completed to kind of fulfill the dotting of the Ts and the, you know, I guess, dotting of the I's and crossing the Ts, if you will. And then one question for Madhav. In your prepared remarks, you were talking about on track for launching about three months after Pz-cel approval. Did I hear that correct? If so, just wondering what additional work needs to get done to get the sites on board. It seems like six months is quite a bit of time, but now you're estimating about, you know, three more months beyond that. So, any update on that would be great. Thanks so much. ... Great. Thank you, Dae Gon Ha. Let me address your first question regarding any additional data. We have generated a lot of feasibility data for those two outstanding topics that I spoke about. And if you really look at the laundry list of the number of things that we had to do, you're looking at the tip of the iceberg here, right? I mean, these are just the two aspects, but they are also the more, relatively more complex assays. And before conducting validation, we have generated the feasibility data that inform the design. And having done that, we wanted to make sure that we put the protocols in front of the FDA and make sure that, you know, they're, you know, aligned with how we've approached it, right? So it's really input on that. It is not additional work that they've suggested. It's essentially statistical approaches to how you establish comparability. In fact, I'm only talking about what is that little piece within the complex question of sterility that we needed to tweak based on the FDA's feedback, but there are many, many different aspects of it that we've already aligned on. So, we're good to go on that. So even having just that piece in the validation protocol that they advised to follow a slightly different approach, is a pretty big win for us because it could have gone multiple different ways. And having known this clarity, we feel pretty confident based on all the data we've generated using the system in-house. As a reminder, both these assays are done in-house. We're not getting this done through a vendor. So, that's something that's assuring it's in our control, so it's just a matter of generating that data. And I know that previously we had not guided exactly when in the second half, and we leave it at that because it's, you know, all the pins fall in place exactly the way we want it, maybe end of September, early October. We don't want to go into the guessing, speculating game right now. Is it quarter three or is it quarter four? But we do feel quite confident that it will get done this year. And to your other question on what kind of site onboarding activities would be, you know, completed by the time we get approval and what has to be triggered after, I'll let Madhav address that. Yeah. Thanks, Dae Gon Ha, for that question. So we are very much engaged with the sites in training them, but there are certain aspects that can only be done after a product insert or prescribing information is given, which is beyond past approval. So training the sites on the actual product information once we have the price point, we have to load that as part of the charge master in the hospital institutions, you know, the P&T committee and the agenda item that is placed on there in certain institutions. So things of that nature, that can only be done after we have the label, very similar to all of the CAR T-cell therapies as a model. And having launched those therapies, we typically guide 2-3 months is usually the timeframe that's needed for post-approval activations. We'll, of course, be working as soon as we can in getting the centers ready so that, you know, first patient can be treated, because that's really our intent there. Hopefully, that gives some context there. Yeah, no, that's, that's very helpful. I guess on, on that point, on the pricing and reimbursement, you also talked about some payer discussions being fruitful. Yeah. I was wondering if you could comment on sort of the poly, I guess, combo therapy type of discussions. Have you had that? What are the sort of feedback on payer side about funding both Filsuvez as well as PG cells? Generally, when I look at the Pz-cel profile, it's resonating extremely well. I think payers understand Vyjuvek is on the market, Filsuvez is on the market, and the profile for Pz-cel is distinct and differentiated in that for large and chronic wounds, especially where there's a very heavy bacterial burden. We haven't heard any major, you know, direct objections of blocking one versus the other because the modalities are distinct. So, so far so good, and we are, of course, also working with payers to making sure that the access policies that we eventually come out with are favorable because these patients require multiple treatment options. The fact that Pz-cel is a one, you know, single application for durable years of wound coverage versus the Filsuvez, where, you know, there is an option, you know, you can pause, continue, and that kind of thing. It also works favorably, you know, from that perspective. Great. Thanks for taking our questions. Yeah. Thank you very much. Your next question is coming from Ram Selvaraju of H.C. Wainwright. Ram, your line is live. Thank you so much for taking my questions, and congratulations on all the progress. I just wanted to ask one quick clarificatory point regarding the process via which the FDA will consider the resubmission. What is the statutory timing with which the FDA would need to respond to the BLA resubmission once it is filed and assign a PDUFA date? Can you just remind us what that timeframe is, please? Yeah. To our understanding, Ram, great to hear from you. Thank you for the question. Our understanding is that, upon resubmission, in a 2-week timeframe, the FDA indicates their acceptance of the resubmission and determines also at that point in time, whether it's a type one or a type two variation of the resubmission. We anticipate this may be a type two kind of variation, but that's to be determined. In terms of timing, if it is a type two, then it is six months from the time of resubmission that the FDA would likely set a PDUFA date. I hope that answers the question. Yes, very much so. So, and just for a quick other follow-up. If we just, for a moment, think about the hypothetical scenario in which you receive a PRV and elect to monetize it. In such a context, can you give us a sense of whether strategically you would look to broaden your product offerings, specifically in the dermatology space, or if you would think strategically about potentially broadening your reach into other rare diseases as you think about the optimal commercial strategy for the company? Great question, Ram. So you're talking about pipeline and other assets here, not just the Pz-cel lifecycle management. So Pz-cel lifecycle management itself is one avenue we haven't really discussed very much, whether it's ex-U.S. expansion or whether we're talking about other types of applications, because we're hearing from a lot of patients that they want Pz-cel to be applied for hand surgeries and things like that, which we haven't evaluated clinically, right? So that's one aspect of it. The other aspect of it is we have core competencies in engineered cell therapy with the Pz-cel experience. So that is very applicable, as you can see, in multiple engineered cell therapy avenues in a disease-agnostic way. And when I say disease-agnostic way, the entire commercial infrastructure that we set up for autologous cell therapy itself is. It can have a translational effect in multiple other therapeutic areas, just by the nature of how, you know, it's whether it's a skin-to-skin or a vein-to-vein process and the patient experience that is involved here, right? So... And do not forget, we also have our ophthalmology platform, where we have, you know, AAV, novel AAV capsids with with you know tropism and transduction efficiencies in select eye compartments, and we haven't forgotten those. In the background, there's work that is going on, with especially our retinal RS1 program. And so in what all different directions, I think it's going to be sowing the seeds in a few different multiple avenues and then letting you know those saplings grow and see where we can actually best marry both the R&D and commercial infrastructure we're building with the Pz-cel launch, and which where the areas of promise are showing up. So I think it's really going to be a discovery process. We'll talk more and more about it as we get closer to Pz-cel launch, but just to avoid being schizophrenic right now, we're so focused on the Pz-cel launch itself, because that is really the most critical deliverable for the company. Thank you so much for that thoughtful response, and congrats again on all the progress. Thank you, Ram. Thank you very much. Just a reminder to everyone, if you would still like to ask a question, you can press star one on your phone keypad now to join the queue. Thank you. Your next question is coming from Kristen Kluska of Cantor Fitzgerald. Kristen, your line is live. Hi, this is Rick Miller on for Kristen. Thanks for taking our question. On the fast approach the FDA suggested, are you able to characterize whether this is a more stringent approach, or what was the motivation, do you think, for suggesting this specific approach? Yeah. Thank you, Rick. Can you repeat that question? I just wanna make sure I understand it correctly before I respond. Yeah. So, I believe you mentioned, statistics, a statistical approach that the FDA suggested, related to one of the two remaining outstanding items. So just kind of if you're able to characterize whether this approach is a more stringent approach, or, or what do you think the motivation there was for, suggesting this specific approach? Yeah, the motivation is purely precedence, right? The FDA has preference for a certain type of approach. Guidances do not always exactly specify how to interpret when it comes to actual experimentation. For the given context of how we conduct the experiment, we have a very sensitive, rapid detection assay that we've developed for sterility, which is actually not the first time. I think there's this bioluminescence methods exist for other companies and therapeutic products. And historically, we've used USP 71 approaches to how we look at sterility. And I think when we show that method A and method B are equivalent, there are multiple different approaches of showing that. Here, what the FDA has given clear instructions to us is that, when you're looking at either a non-inferiority or a comparability in terms of how you quantitate any microorganisms, you spike in our, you know, matrices and show that you're able to detect with equal level of sensitivity, that requires a certain way of statistical handling. So that's really what the feedback was about. So, hope that gives a little bit more color. Yeah, that helps a lot. Thank you. That's all for us. Thanks. Thank you very much. Your next question is coming from James Molloy of Alliance Global Partners. James, your line is live. Hey, guys. Good morning. Thank you very much for taking my questions. Had a quick question on in the PRV market. I know that Biogen recently reported they sold their last one for $89 million, down a little from $100 million, that sort of had been going. Have you guys seen any softening in the PRV market or anything, or are there anything going on there that you guys are noting, assuming, again, you get the approval and get a PRV and look to monetize it? Thank you for that question, Jim. I'll let Joe address the question here. Yeah, thanks for that, Jim. Yeah, other than that example that you mentioned, I have not seen any softening. I've still seen deals north of $100 million.... 103 or so. I think the going rate is normally about $100 million, still. Yeah. [crosstalk] Excellent. Thank you. It's usually an optimization between speed and pricing, right? And in our case, the advantage of being funded so well beyond the approval time frame allows us to optimize for pricing rather than for speed. I think that's what is important. But overall, if you look at the last several months or years even, the price of a PRV has been rather steady at around that $100 million mark. So I would leave it at that, but we're confident that we're not doing a fire sale here. Excellent. Absolutely not, no. And then maybe given the, you know, competitive Vyjuvek selling pretty well, getting off to a nice jump, has that impacted or has there any change to potential looking at a potential partnership rather than a self-launch or combination or some sort of combination thereof, on your end, should, again, should you get approval? Oh, Jim, we are very much committed for self-launch, actually, even more so now that Vyjuvek's performance... I mean, I think Vyjuvek's performance, the first, gene therapy, what it clearly shows is, the willingness for patients and the community to try gene therapies for a genetic disorder like this, right? So that, I think, is as a class, this is a good sign. And the fact that, Pz-cel, all things that you are aware of in terms of clinical differentiation and everything, what we communicated, is, is a very strong value proposition. These patients, for their large surface areas, require a solution which Pz-cel can offer, and the willingness to pay from payer communities is so high for an ultra-rare disease. So it's, it's, it's a profitable business model from that perspective. So I think this is the right step for Abeona at this time, launching it ourselves and with a very finite, you know, centers of excellence model. We have a great team in place. All the people here from our commercial team with prior cell therapy and launch and experience, and even from market access, having launched Orgovyx and gene therapy experience. So I think we have put together a really good team focused on the launch, and then, of course, we can scale it to other opportunities, as Ram was asking earlier. Okay, then maybe last question here. Any, any updates on sort of the earlier stage, early stage pipeline? Obviously, you guys are... have your hands full, getting this, getting this through, but, any, any thoughts on the earlier stage and, and sort of the next key catalyst we should keep an eye on for? Yeah. Thanks, Jim. Earlier stage assets, the AAV-based ophthalmology assets that we have, we've continued to, you know, generate further numbers in our preclinical data, which are encouraging, especially with our RS1 program, and hopefully in a future scientific conference, we will be probably able to provide an R&D update with more data there. But in terms of any committed development into clinical trials, it's something that's TBD. We'll communicate more about these programs as we get closer to the Pz-cel launch, and as I mentioned, just so our organization, which is thin and lean, is very focused on a successful Pz-cel launch. That's really the reason why we haven't spoken so much about our ophthalmology program. Great. Thank you for taking the questions. Thank you, Jim. Thank you very much. Well, that appears to be the end of our question and answer session. I will now turn the call back over to Vish for closing remarks. Thank you, Jenny. Thank you, everyone, for joining us, for today's business update. With that, we'll talk to you again soon. Thank you very much. This does conclude today's conference call. You may now disconnect your phone lines and have a wonderful day. Thank you for your participation.