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spk02: Good morning, everybody, and welcome to the Abiona fourth quarter and fiscal year 2022 earnings conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal 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, Mr. Greg Ginn, Vice President of Investor Relations, and Corporate Communications at Abiona. Greg, over to you.
spk06: Thank you, Jenny. Good morning, everyone. I would like to welcome and thank everyone for joining us on our fourth quarter and full year 2022 conference call. The press release announcing the results is available on our website at www.abionatherapeutics.com. On the call today with prepared remarks are Vish Sasadri, Chief Executive Officer of Abiona, and Joe Vizzano, Chief Financial Officer. After the prepared remarks, we will host the Q&A session. For that session, we're also joined by Dr. Brian Keveny, Chief Technical Officer and Head of Research, and Dr. Madhav Vasanthabada, Vice President, Business Development. 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 other periodic reports filed by the company with the SEC. These documents are available on our website at www.abionatherapeutics.com. And with that, I will now turn the call over to our CEO, Vish Seshadri. Vish?
spk05: Thank you, Greg. Good morning, everybody, and thank you all for joining us this morning. We finished 2022 with the biggest clinical milestone achievement in Abiona's history. In November, we successfully completed the pivotal phase three vital study for EB101, our autologous engineered cell therapy, for the treatment of patients with recessive dystrophic epidermolysis bullosa, or RDEP. The trial set a high bar for success, with one of the co-primary endpoints measuring patient-reported pain, which differentiates vital from any other pivotal study in RDEP. A patient's pain perception and scoring for a particular wound can be often influenced by changes in adjacent regions within the same anatomical area and create a halo effect, therefore a signal for pain improvement has to be pronounced enough to cut through the noise and yield a statistically significant result. The VITAL trial met its co-primary endpoints and all other endpoints, demonstrating statistically significant clinically meaningful improvements in wound healing and pain reduction of large chronic RdEV wounds in the EB101 group that exceeded those observed in the control group. In addition, the study also generated positive results and a post-hoc analysis of EB101-treated wounds with severe baseline pain, where we observed even more pronounced pain reduction. No serious treatment-related adverse events were observed, which is consistent with past clinical experience with EB101. The positive vital top-line results, together with compelling long-term Phase I-IIa results demonstrating multiple years of wound healing and pain reduction after an EB101 treatment, show the promise of EB101 as a one-time therapy for a given large chronic R-dev wound. We anticipate that an average of two cycles of treatment per patient will cover their large chronic wound surface area. We're looking forward to the presentation of additional data from VITAL by Dr. Jean Tang, professor of dermatology at Stanford University School of Medicine and principal investigator of the VITAL study during an oral session at the International Societies for Investigative Dermatology, ISID, meeting in May 2023. Since announcing the vital top-line results, we have been focused on preparations for submission of a BLA for EB101 to the FDA. We have had multiple recent collaborative interactions with the FDA through both Type B and informal meetings and communications. We continue to gain alignment with the FDA on various topics, especially those related to CMC, and continue to make progress towards a BLA submission. Toward that goal and as planned, we have started activities for the Process Performance Qualification or PPQ validation campaign for EB101 that is essential for the BLA. The PPQ campaign consists of three consecutive manufacturing runs that need to pass specific tests that attest to critical quality attributes. So that is on track, and we plan to submit the BLA for EB101 in late second quarter or early third quarter of 2023, depending on the scheduling of patient biopsies, which are critical for the PPQ runs. Based on the anticipated timing of BLA submission, we expect potential BLA approval in the late first quarter to early second quarter of 2024. Recall that EB101 has been granted a rare pediatric designation by the FDA, so concurrent with the PLA submission, we plan to submit the application for a Priority Review Voucher, or PRV, which can be used to receive an expedited review process for a subsequent marketing application for a different product and even by a different company. Prior PRVs have been sold to other biopharma companies for approximately $100 million. We have also commenced early commercial planning for EB101. working with Trinity Life Sciences, we initiated discussions in the first quarter of 2023 with stakeholders across the healthcare system, including public and private payers and healthcare providers. Through these engagements, we have shared our clinical data and begun evaluating the market access opportunity and potential pricing for EB-101. We are encouraged by the initial feedback from these stakeholders and feedback that we have received from patient advocates and organizations which collectively support positive coverage decisions and pricing in line with recently approved gene therapies. Based on our initial discussions, payers view R-DEP as a disease with a very high unmet need and believe EB101 has a well-differentiated profile with durable clinical benefits for the treated wounds. Also, given the ultra-rare prevalence of R-DEP, payers view EB101 will have a limited overall budget impact and have indicated a high willingness to cover EB101 with a favorable access policy, giving us confidence in its price potential. Let's turn to our preclinical ophthalmology programs. We are excited by the broad potential for treating serious eye diseases with both our novel AAV capsids and novel gene constructs. We have previously shared that AAV204, a novel AAV capsid, from our in-licensed AIM capsid library showed encouraging tropism and transduction efficiency in the macula and optic nerve in non-human primates with an administration route that is less invasive and safer than subretinal injection. Since then, we evaluated the ability of our gene constructs and capsids to deliver and express the recombinant protein of interest in target eye tissue and rescue mutant phenotypes in mouse disease models. Based on encouraging findings from the animal proof of concept experiments, we are looking forward to reporting new data from these programs at a scientific congress in the second quarter of 2023. Earlier this month, we announced three internally developed investigational preclinical gene therapy product candidates including ABO504 for Stargardt disease, ABO503 for X-linked retinoschisis, and ABO505 for autosomal dominant optic atrophy. We have started to submit pre-IND meeting requests to the FDA for these candidates and anticipate meetings in the second quarter of 2023. Turning to our people, we further strengthened our executive bench over the last year with the addition of three experienced biotechnology industry leaders to our senior management team. Dr. Dmitri Grashev joined us as chief medical officer and Dr. Madhav Vasanthavada as vice president business development. We also promoted Amanda Moore to the role of vice president program leadership and clinical operations. Dr. Grashev has over 20 years of industry experience across multiple therapeutic areas including dermatology, ophthalmology, and oncology, and has multiple global drug approvals while leading clinical development programs at pharmaceutical and biotech organizations. Dr. Vasanth Tavara, who has a Harvard MBA with patents to his name, has over 20 years of experience in the life sciences industry in a variety of R&D and commercial leadership roles at Novartis, Bayer, and Celgene in Bristol-Myers Squibb. He was most recently at Bristol-Myers Squibb, where he led global marketing for the global CAR-T cell therapy franchise. Prior to BMS, he spent nine years at Bayer in a variety of cross-functional leadership roles, including marketing, market access, and sales. Amanda has nearly 20 years of clinical operations and development experience in the biotech and pharmaceutical industry with Biogen, Rekit Benkinsa, Sage Therapeutic, and InterCell. She has a track record of leading innovation in clinical trials pioneering operating committee relationships and oversight of global development programs. The collective experience of these executives, combined with our experienced leaders of manufacturing, quality, and regulatory, position us well as we work towards completing and submitting the BLA for EB101 and preparing for a potential commercial launch. I'll now turn over the call to Joe Vazano to review the financial results.
spk09: Thank you, Vish. I would like to remind everyone that the Form 10-K is available on our website, which is where you can get additional details on our financial results for the full year ended December 31st, 2022. Starting with the financial resources on our balance sheet, we had cash, cash equivalents, restricted cash, and short-term investments of $52.5 million as of December 31st, 2022, including gross proceeds from the $35 million private placement financing in November of 2022. Net cash used in operating activities was $43.5 million for the full year of 2022, compared to $65.7 million for the full year of 2021. Based on our current operating plan and assumptions, our estimated runway of current financial resources takes us into the third quarter of 2024, which is through the anticipated timing for potential BLA approval for EB101. License and other revenues for the year ended December 31st, 2022, were $1.4 million as compared to $3 million for the same period of 2021. The revenues in 2022 and in 2021 primarily represent clinical milestone payments under two licensing agreements with Keisha Gene Therapies for investigational AAV-based gene therapies for Rett syndrome and CLN1 disease, respectively. Turning over to research and development activities, we had 29.2 of expenses for the year ended December 31st, 2022, compared to $38.7 million for the year ended December 31st, 2021. Our expenses related to general and administrative activities were $17.3 million for the full year ended December 31st, 2022, compared to $21.6 million for the year ended December 31st, 2021. Net loss attributable to common shareholders for the year end of December 31st, 2022 was $43.5 million or $5.53 loss per common share as compared to $84.9 million or $21.57 per loss per common share for the full year of 2021. With that, I'll turn the call back over to the operator for the Q&A session. Thank you very much.
spk02: Thank you very much. The floor is now open for questions. If you have any questions, please press star 1 on your phone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using any speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment whilst we poll for questions. Thank you. Your first question is coming from Maury Raycroft of Jefferies. Maury, your line is live.
spk03: Hi. This is Yao on the line for Maury from Jefferies. Thank you so much for taking my questions. Our first question, I guess, is you previously mentioned there could be an opportunity for a commercial partner on the launch of 101. Can you maybe share your latest thinking on whether this is still something you're considering or you're considering maybe commercializing by yourself? I have a couple of follow-ups. Thank you.
spk05: Sure. Thank you. Good morning, Joe. And thank you for your question. Before I turn it over to our head of business development, I'll just start by saying that at this point in time, we have all the options open, whether we partner or we go it alone. But that's, you know, that's our high level position right now. But there's a lot of progress that's been made. in even learning what are some optimal options for us. So I'm going to turn it over to Dr. Vasanthavada to add more color.
spk04: Thank you. Thank you, Joe, for the question. With regards to partnership, we are pleased with sort of the progress that we are making and the dialogue that we are having with various companies. After we read out the vital top line studies, we found more pharma biotech companies that have come forth and have entered into diligence. So, we are in active discussions with these companies. So, these companies, they have presence in dermatology space, and they have interest in taking EB101 to global markets. So, in terms of timing for a deal, we think an ideal deal timing would be after the BLA submission, because by then we will have largely de-risked EB101 for our partners. So we will be able to likely get the best deal terms and also retain a sizable portion of the asset value. But as we continue to do our own commercial planning and diligence, and as Vish mentioned earlier, based on the recent feedback that we have been hearing from payers, from hospital stakeholders, and from other external parties that we have been speaking with, we are actually very encouraged by the market opportunity and the price potential for EB-101. So while this feedback is going to sort of strengthen our partnership discussions, we've also not ruled out a scenario where we, as an AB owner, could launch EB101 on our own, as the leadership team here has significant experience with prior launches of pathologist cell therapies. So that's really our position right now, which is to keep our options open, see what the deal terms look like, and make a call in the second half. Thanks, Madhav. Joe, did that answer your question?
spk03: Yeah, thank you. And I guess a follow-up to that is, based on your current discussions with payers and other stakeholders in the community, could you maybe share some of your thoughts on what the pricing could look like, what the reimbursement could look like? Any thoughts there?
spk04: Thank you, Joe. So in terms of pricing, we'll say it's a bit early to comment, right, on the specific sort of pricing per se. But in terms of the market research that we have done, we have spoken with various, you know, payers, nearly a dozen payers from national, regional plans, state Medicaid plans, as well as the hospital administrators from potential sites where EB101 could be launched, and we are confident that the EB101 can secure a price point much higher than our initial assumptions, assumptions that we made before the vital data was read out. So that's very encouraging. The recent feedback, what we are hearing from the stakeholders regarding the pricing is based on the vital data, the safety, efficacy, the durability of the data from the Phase I to A. as well as given sort of the ultra-rare nature of the disease and the overall low budget impact. So that's really what is encouraging for us to hear. Nothing different from what we had expected, but to hear this feedback at this point based on the data is a lot more assuring. Also, with regards to reimbursement, it's a similar situation because we've spoken with the hospital administrators at this site. And given the inpatient DRG payment models and the ability to command the pricing reimbursement given the payer mix, which we expect to be slightly over 50% commercially insured patients, we think the dynamics is going to be favorable for the hospitals.
spk03: Yeah, that makes sense. Maybe one more for me. Just thinking ahead of the commercial launch, we can imagine there might be a bolus of patients waiting for the therapy that could transform their lives, but also maybe after the initial bolus, then maybe there will be only sort of the incidence rate patients. So how do you think about the distribution of the incoming patients, and do you have any sort of predictions here?
spk04: Yeah, clearly, as you know, Joe, very well, that we need on average two cycles of treatments to cover the patient's large chronic wounds. There is a significant prevalent pool of patients already out there, which will, given the autologous cell therapy nature, will take us several years to be able to treat the prevalent pool of patients. And if you look at the incidence rate which is coming through based on the epi numbers which are out there, we think it's sufficient to be able to carry on even to create these incidence patient pool for our dead which will express large and chronic wounds given the mutation rates. So we do think that this is going to be healthy in terms of the patient pool plus As more therapies come here in this space and the awareness that is raised and the genetic testing that conducts for RDEB, that there's going to be a patient that will sustain the stream.
spk05: Yeah, and just to add to that, right, so you brought up the point about the pent-up demand or a prevalent pool that exists today. Even to address that unmet need, it's going to take us a few years to get to a steady-state incidence-based model. So, I mean, we would have done good service to patients if we have reached that point, but there's a lot of work that needs to happen even before we get to that point. So hopefully that gives a little bit of an idea for how we think about the forecasting of demand here.
spk03: Thank you so much for taking our questions. Thank you, Joe.
spk02: Thank you very much. Your next question is coming from Kristin Kluska of Cantor Fitzgerald. Kristin, your line is live.
spk01: Hi, good morning everybody. Thanks for taking my questions. Maybe the first one on EB101, could you remind us what endpoints you intend on sharing data from Vital at ISID in a few weeks? And given this is the inaugural conference, what is your expectation on the attendance in terms of thought leaders, physicians, et cetera, that you think will help to put the therapy on more radars given, one, it's an international conference, but then also it's your first presentation post the top line at a scientific conference a few months ago?
spk05: Thanks, Kristen, and always great to hear from you. So your first question around the attendance at the international SID, as you all probably know, this year it's taking place in Japan. What we are hearing is that even though it's an international conference, there is a significant attendance from specialty dermatologists, even from the U.S., as well as other regions in the world that will be planning to attend this conference. Given how concentrated EB patient care is, as we know in the U.S., we anticipate many of these KOLs to be present in that Congress. In terms of endpoints, you asked endpoints. Very importantly, both the co-primary endpoints, which is, you know, investigator-assessed wound healing, as well as patient-reported pain outcome, are important when we consider the overall efficacy and value of this product will be presented. In addition to There's something that we have not discussed yet is this is not only the ISID. Timed around that same timeframe will also be our publication of the pivotal trial results in a peer-reviewed journal, which will have a lot more reach in terms of getting to the specialty dermatologists who treat diseases such as R-DEP. So that's going to be around, positioned around the same time. And you should be, in addition to looking at the endpoints, which are measured at the 24-week time point, over these scientific congresses, as well as the publication, we will also be communicating what is the, you know, longitudinal progression of wounds after we've treated them, how quickly these wounds are closing. Even at the 12-week time point, that's a secondary or exploratory outcome measure. You're going to hear more about those types of endpoints. Never to forget, what is the durability of treatment? So these are things that are going to add to what we will hear in the first instance at ISID. And of course, not to forget that the safety profile of the product is also very important to keep in mind, which is very consistent and favorable compared to what we've seen in the Phase I-IIa study. So it's the holistic data and how the therapy is likely to be received is what you can expect to gain from both the ISID as well as the publication of pivotal results.
spk01: Thank you. And given that you've had a heavy dialogue with stakeholders across the healthcare system, curious how much the questions or topics have focused specifically around the wound profiles themselves that have been evaluated. And anything surprising that came out of these conversations to you? Anything that perhaps you're thinking about a little bit differently now?
spk05: Thank you. In terms of the wound profiles, There is a lot of education that needs to still happen. As you can imagine, over the last 12 months, a lot of payers as well as other stakeholders are learning about R-DEP for the first time because there haven't been any approved therapies. And as you know, we've heard that this is the worst disease that you never heard of. That's what R-DEP is. So there is a lot of education that happens in these dialogues that we have with the payers. Certainly, you know, resonating. So the fact that we have large and chronic wounds. These are very specific types of wounds that we included in our study and the debilitating nature of those wounds because they have a lesser tendency to self heal is being well recognized And it's definitely evidence-driven. It's not knowledge that is coming out of, you know, ideas. It's evidence-driven when you look at the healing rates of the types of wounds that we've treated in Vital. They're very low compared to some of the smaller and recurrent wounds. So that is happening as we speak to the payers, and these messages are resonating quite well. I will also ask Madhav to add a little bit of color to what I just shared because he has been in these calls with the payers himself. And Madhav, go ahead.
spk04: Thanks, Kristen, for the question. Speaking of payers, there are payers who know about eB-Space and there were others who actually didn't have much of an idea. But in looking through the stimuli, They clearly see this as one of the diseases with very high burden, which we expected, but it was reassuring to hear from them. In terms of the cost, they realize that patients right now are spending an exorbitant amount of monies out of pocket, and that in looking at specifically when we showed them sort of the vital data, the types of wounds, they see that this will clearly, you know, is addressing the unmet need, especially the one-time application for the R-DEP, you know, sort of the large wounds and the durability of wound healing that is associated is really transformational from their perspective. So because of that, they have not raised any indication about, you know, coverage. This is clearly, you know, going to have favorable access and prior authorization to the trial criteria and willingness to cover the pricing.
spk05: Does that answer your question, Kristen?
spk01: Yes, it does. Thank you. And if I may ask one more on the optimality portfolio. So we got a little bit of initial thoughts and data, but I'll stay tuned in the next couple months for some more detailed presentation. But just looking at the targets you chose, how do you think that, you know, one, they fit into the blueprint of some of the success, some of the understandings that this field, broadly speaking, has learned about gene therapy and ophthalmology disorders. But then, you know, to kind of take that question a step forward, what do you think about some of your preclinical data and your approach that, you know, potentially allows for you to go after these targets versus in the past, you know, perhaps others couldn't address these indications?
spk05: Thank you for that question, Kristen. A lot of dialogue has been happening. not just as an afterthought, but even before we undertook these specific diseases as, um, um, uh, as you would, one would recognize, we have chosen, these are still rare diseases, probably not ultra rare, like some of the other indications like our debt that we have had in the past, uh, prevalence in the U S around 5,000 to 15,000 kind of, uh, um, us prevalence numbers alone. Of course, there are certain geographies where these diseases are even more pronounced because of the genetic background. And the unmet need exists because a lot of approaches. So talking in general about gene therapies, ophthalmology is one of the top priority areas where gene therapy can add a lot of value. And this is coming out of the understanding that a local application in an immunologically, relatively immunologically privileged site in the body, which is the eye, lends itself as a very ideal target for where we can use gene intervention to produce a lot of value for patients here. And that led us to think about ophthalmology in the first place. And then, Abiona also has other strengths in this space where we have manufacturing capability we've manufactured for MPS 3A in the past. So the AAV manufacturing capability exists within the organization and talent like Dr. Brian Keveny who has worked on the eye space even prior to Abiona brings a lot of value for us here. But thinking about the eye indications where you have monogenetic diseases where a single gene replacement can rescue the kind of phenotype that is causing the disease basically requires very small quantities of gene compared to some of the other systemic diseases, like where you have to have IV use of, let's say, three times 10 to the 13, or E to the 14 kind of quantities of vector genomes. We are looking at log orders lesser. So we can easily, scaling up is not a problem. And AAV204 that we've shared in the past, our proprietary capsule that came out of the AIM library, has very favorable properties, both in terms of tropism for targeting specific eye diseases and also the ability to be injected in favorable routes of administration, like para-retinal that we've shared data in the past from non-human primates. So these are all our strengths. I'm going to ask Dr. Brian Keveny himself to even add color to where our differentiation is, that why we think we can crack the code when some have not been yet. And Brian, please feel free to add color to what I just said.
spk08: Yeah, thanks, Vish, and thanks, Kristen, for the question. Yeah, I think the priority here around picking several of these indications was, as Vish mentioned, you know, high unmet needs, a patient population that would support a commercial product, as well as a way for us to develop a novel differentiating therapy prospect to avoid some of the issues that have been seen with other therapies and to take advantage of some of the core competencies that we have at Abiona. You know, for Stargardt disease, we presented two years ago at Arvo a method utilizing the CRE-LOC system, which is a recombination-based system, to express ABCA4, which is a protein that exceeds the carrying capacity of a standard AAV genome. We utilize a dual AAV system here that allows us to get a full-length ABCA4 protein. We showed this in tissue culture at Arvo two years ago and we've now translated that into animals and shown expression of full-length ABCA4 in the correct cells after a subretinal injection using our technology. and hope that this will be sort of one of the next programs that we push forward into a pre-IND meeting and into IND enabling studies this year. As it relates to the other two programs that we're looking at, the main issue with a lot of gene therapies in the eye these days is around an immunological response when the virus is directly injected into the vitreous. So there have been a number of issues in clinical trials with high levels of inflammation after these injections. The advantage for AV204, we believe, and how we differentiate it from some of these other capsids is this vector shows very high tropism to the macula and optic nerve with a pararetinal injection, which is a modified intravitreal injection that positions the vector directly next to the target tissues, literally on top of the retina as opposed into the sort of mid vitreous. And what we found is we can avoid all of these immunological responses because we can lower the dose by sometimes more than a log. And so what we saw was very high expression of the gene in those areas with no immune response in the non-human primates. So I think this is one of the ones that we're really excited about in terms of how we differentiate ourselves from some of the other players in this field is that we, we are able to avoid those issues and hopefully, allow for somewhat of a more potentially safer route of injection.
spk05: Thanks, Brian. Kristen, I hope that answered your question.
spk01: Yes, thank you. Looking forward to seeing all these data presentations in the next quarter.
spk05: Thank you.
spk02: Thank you very much. Just as a reminder, if you do still have a question, please press star 1 on your phone keypad now. Our next question is coming from James Malloy of Alliance Global Partners. James, your line is live.
spk07: Hey, guys. Thanks for taking my question. I wanted to touch on one of the comments that was made earlier about discussions with payers and the price coming in much higher than previously thought. I think previously consensus had been $300,000 to $500,000 per treatment per patient. Could you talk to, are payers thinking double that, triple that, one and a half times that? Can you talk to where you think payers may be coming in, given the rarity of this disease and the absolute inability to treat it otherwise? And then can you talk to, as well, you said about two treatments per patient, how many sites per patient? Would it just be two, do you think, over the lifetime of a patient? Or what do you think is the actual number of sites per patient you might be able to treat? Thank you.
spk05: Thank you for the question and great to hear from you, Jim. So, your first question was around specifics around pricing and how payers are reacting or sensitivity to elasticity to the price, if you may. And, yes, we had communicated a range for illustrative purpose in the past of 300 to 500K. And the reason why we're saying that we're relooking at those numbers post-vital is, first of all, to recognize the fact that the vital study results were a lot more encouraging than the base case scenario that we would have hoped for, right? So that's there. And which is what is resonating with a lot of these payers in thinking about the disease. the value that the therapy as a one-time administration for a given set of wounds can give years of benefit. And also part of the thinking is also evolving as we have potentially other therapies that will be entering the market prior to us. And so they're going to also be setting precedents for how payers cover for transformational outcomes in this kind of disease. Now to your specific question of are we thinking about double, triple, triple, That range, it's very premature to say where we would put a price point, but we have tested a range that straddles all that you mentioned, and we've seen that it's really, you know, there is lesser of elasticity to the pricing and more of focus on how a patient could actually benefit, especially if you have pain control for years. how that translates into benefit for the patient. That's where a lot of the stakeholders are focused, given that this is not a very high prevalence disease. It's an ultra rare disease. They want to, they're more interested in what gives the best benefit for the patient. So I don't want to state a particular price point, but when we do such research, we are testing scenarios that straddle various levels of pricing. So I leave it at that for the pricing question with the payers. But your other question was, how many sites in the patient are we looking to cover, and how is that distribution in the patient's body and things like that? We've seen that our dead patients, right from the very early stages of their life, sometimes even babies are born with large wounds, an entire heel missing, skin, things like that have been seen. So the wounding actually happens across all multiple different positions in the body. For a therapy like EB101, we believe that large areas of wounding, sometimes an entire back, an entire thigh, where the wound size even exceeds the size of graft, we've been able to apply grafts in a quilt-like fashion and actually cover larger areas that go beyond the 40 centimeters squared which is the size of each EB101 graft itself. So having said that, our calculation based on these are all based on published data on the disease characteristics and how much body surface area on average a R-DEP patient has with these large chronic wounds, it's approximately 1,000, give or take, 960 centimeters squared of such area. And given how much we manufacture in one run, Our estimation is for an average patient, you're going to have two cycles of therapy. So, of course, an average means there's a distribution around the mean, which means some patients can have pretty much entire coverage in one sitting. Some patients may need more than two. So, it's a variable value proposition, but we believe that, you know, patients will get multiple rounds of therapy. And that will definitely, you know, non-incrementally add to the clinical benefit that they get because for a given wound that is treated, what is important is there's years of benefit after the one-time application. And that's what is going to be driving the value proposition for the product. I hope that answers your question, but happy to have further discussion.
spk07: Thank you very much. I did like to follow up, if I could please. Obviously, you know, competitor out there, but Jubek expected to come into the market. Do you have any anecdotal discussions with payers on comparing and contrasting the two products and, you know, perhaps treating different segments of the market?
spk05: Great. I'm going to ask Madhav to address this question because he's in the thick of payer discussion.
spk04: No, thanks for that question. Yes, we did. This is a blinded study, right? And so we did show the profile of competing products that are currently expected to launch in this space. And the way we did it, we first showed the profile of product X, which is EB101, and what kind of pricing that would come. And then based on the pricing that was put on, when you show the reaction of competing products, that didn't really change what their assumptions would be with regards to pricing, largely because the types of wounds that they view that these two products will treat are very different, which independently corroborates with our assumptions. And there wasn't any restrictions that they said that they would come in for one product versus the other or step edits or any kind of, you know, stringent management, which is all very encouraging overall.
spk05: Thank you, Jim.
spk02: Okay. We appear to have no further questions in the queue. I'm now going to hand back over to Vish for any closing remarks.
spk05: Thank you, Jenny. In closing, we're excited about the potential of EB101 and our other gene therapy programs to improve the lives of patients with serious diseases. I want to thank the Abiona team for their continued dedication and efforts toward improving care for patients. I also want to thank our shareholders and other stakeholders who've listened to this call, and we'll talk to you on the next quarterly call. Thank you.
spk02: Thank you, everyone. This does conclude today's conference. You may disconnect your phone lines at this time and have a wonderful day. Thank you for your participation.
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