Abeona Therapeutics Inc.

Good morning and welcome to the Abiona Therapeutics third 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 this conference please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to your host, Greg Ginn, VP of Investor Relations. Greg, the floor is yours.

Thank you, Jenny. Good morning, everyone, and thank you for joining us on our third quarter 2024 conference call. During this call, we'll refer to the press release issued this morning announcing the third quarter results, which is available on our corporate website at www.abionatherapeutics.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 factor sections in our Form 10-K, and periodic reports filed with the SEC. These documents are available on our website at www.abionatherapeutics.com. On the call today with prepared remarks are Dr. Vish Seshadri, Chief Executive Officer, Dr. Mada Vizantavada, Chief Commercial Officer and Head of Business Development, and Joe Vizano, Chief Financial Officer. Also joining us for the Q&A session will be Dr. Brian Keveny, Chief Technical Officer. And with that, I will now turn the call over to Vish Sasadri to lead us off. Vish?

Thank you, Greg. We appreciate everybody joining this call this morning. We have continued to be productive since our last call and have made progress on multiple fronts toward bringing our lead product candidate, Pradamagene Zamycaracil, or PZ Cell, to patients with recessive dystrophic epidermolysis bullosa, or R-DEV. These patients continue to seek durable treatment options for their wounds. I'll start with the regulatory progress first. Since receiving the complete response letter, CRL, in April, we have worked closely with the FDA in preparing the resubmission of our PZ Cell biologics license application and getting it back in the review process. As a reminder, the CRL highlighted the need for additional CNC data pertaining to the validation of certain manufacturing and release testing methods. The CRL 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 Cell. In August, we had a Type A meeting where we aligned with the FDA on the content of the resubmission, including additional information to address all the deficiencies noted in BCRL. I'm pleased to report that we completed the resubmission of our BLA for PZ Cell at the end of October. Just last week, the FDA accepted the resubmission for review and set a PDUFA date of April 29, 2025. Meeting this regulatory milestone in Q4, as per our guidance, was made possible by the tireless efforts and determination of our team, especially technical operations quality, regulatory and clinical, and I thank them for their dedication. The FDA's acceptance of our resubmission indicates that our package includes all the necessary data components, including those items identified in the CRO and observations from the pre-license inspection to support review of the updated dossier. The FDA has previously informed us that they do not intend to host an advisory committee or adcom meeting In addition, pre-licensed inspections for all clinical sites and our manufacturing facility were completed earlier this year. Therefore, we do not anticipate additional site inspections as part of the resubmission review process. We will continue to work with the FDA to facilitate their timely review. We remain confident in our prospects for approval given the unmet medical need in R-DEP to treat large chronic wounds. Our strong clinical data, our comprehensiveness in addressing every CRL item, and PLI observation and our collaborative interactions with and feedback to date from the FDA. So now the focus for the rest of this year and into 2025 is obviously to drive through the regulatory process as we continue to ramp up our commercial readiness activities for a potential launch next year, which Madhav will elaborate on in a moment. But before that, I'm excited to share that we have recently entered into a lease agreement for additional building space in Cleveland, Ohio, adjacent to our existing facility to enable capacity expansion beyond our current manufacturing footprint. I also want to briefly mention the recent issuance of a new U.S. patent for the PV cell. The patent is entitled Gene Therapy for Recessive Dystrophic Epidermolysis Bullosa Using Genetically Corrected Autologous Keratinocytes. and includes claims that cover the use of PZ-cell for treatment of R-dead. The patent has an expiration date of Jan 3rd, 2037, subject to any applicable patent term extension. Another U.S. patent will issue on November 19th, 2024, relating to the packaging and transport system for PZ-cell sheets. Absent any patent term adjustment or extension, that patent would expire in July 2040. The issuance of these patents by the USPTO acknowledges the groundbreaking nature of the technology underlying PZ-Cell. If approved, PZ-Cell will be the first product to use gene-corrected keratinocyte sheets to treat RDEV. Based on PZ-Cell's clinical trial experience, we are optimistic that the underlying technology for making PZ-Cell and using it to treat a human patient that is claimed in this patent, which allows stable insertion of this functional collagen 7 gene into the genome of each patient's own skin cells could uniquely position PC cells to achieve wound healing and pain reduction RdEV wounds following a single administration. I'll now turn the call over to our Chief Commercial Officer, Dr. Madhav Vasanthavada, to highlight our commercial launch preparations. Madhav?

Thanks, Vish, and hello, everyone. We are excited about the progress we are making as we continue to prepare for the potential launch of PZ Cell in the U.S. next year. Let me start off with our progress on building the commercialization team and say that we have attracted a strong and passionate group of people with significant launch experience in the cell and gene therapy space and with deep expertise in market access, clinical site onboarding, cell therapy, patient operations, supply chain, patient access, marketing, and medical affairs. At launch, we expect to have approximately 20 members on the PZ Cell commercialization team, and we feel very confident that this team will deliver a successful PZ Cell launch. Before going into other aspects of launch preparations, for those new to the PZ cell story, let me remind you that PZ cell is being developed for the treatment of R-DEB, a recessive form of the genetic condition dystrophic epidermolysis bullosa. R-DEB is a severe debilitating disease in which nearly one-third of the patient's body can be covered in wounds. These wounds can be chronic, they can become chronic, and do not heal by themselves and are at a high risk for several infections, including cancer called squamous cell carcinoma. Patients rarely live beyond 40 years of age. There are no treatments on the market today that can heal Rdap wounds durably with a single treatment application. PZ Cell is approved and we are optimistic of its approval will be the first-in-class autologous gene therapy to have shown game-changing benefits to R-dead patients and their families. In clinical trials, PC-Cell has shown wound healing and pain reduction in large and chronic wounds over multiple years of follow-up after only a single surgical application and with a clean safety profile. We are therefore excited about the impact PZ-Cell will have on our dead patients, and we continue to hear positive feedback about PZ-Cell from physicians, payers, patients, and caregivers we have spoken with. Now, in terms of commercialization strategy, our go-to-market approach is simple. Upon launch, we intend to have onboarded and trained five EV centers that are very well recognized and are geographically dispersed across the U.S. to create the best possible PC cell patient experience. Over time, our focus will be to onboard additional qualified treatment centers, QTCs, while driving patient referrals into the QTCs from other EV treatment centers and community settings. Based on our recently completed claims analysis, we estimate there are about 1,300 dystrophic EB patients being treated in the U.S. Of these patients, we can confirm there are about 750 PZ cell-eligible U.S. RDEP patients. And we have found that nearly 30% of these 750 patients are concentrated at a handful of EB centers, and most of these centers we are targeting at launch. This gives us confidence that we are working with the right treatment centers and are confident in expecting a high demand at launch. We've also learned from claims data that patients travel from far off distances into EV centers of excellence, or COEs. Roughly 40% of patients currently being treated at the COEs come from out of state. Patients travel for specialized care with catchment areas spanning 300 to 400 miles from the COEs and an average referral distance of 250 to 300 miles. These data points continue to strengthen our confidence in PZ cell demand and our commercialization strategy. With regards to progress on treatment site onboarding, we have conducted multiple interdisciplinary meetings between Aviona teams and the potential treatment sites, including executing formal in-person meetings with members of the senior leadership at the hospitals. These meetings are often large group meetings with members from different functions of the hospitals, including contracting, medical, that includes lead EV physicians and surgeons, cell therapy coordinators, pharmacy directors, and revenue cycle managers. These sessions are helping us to align on an execution path towards site onboarding in connection with a potential PC cell approval. The commitment of time and resources by these centers is a testimony to the significant value that PC cell may bring to our dead patients if approved. In the coming months, we will continue with pre-approval onboarding steps and training to ensure the multidisciplinary teams at each center are educated in all aspects of PZ cell treatment and with processes to begin treating patients pending FDA approval. And similar to other cell therapy launches, we would expect sites to be ready to start treating patients in about two to three months post-approval. Now turning to market access, we are focused on ensuring timely and appropriate patient access upon approval. As a reminder on payer mix, we believe approximately 60% of ARDA patients are covered by commercial plans, about 30% by Medicaid, and the remaining 10% by Medicare. Our market access team continues to engage with the key national and regional commercial payers that represent more than 80% of R-debt commercial lives with a goal to remove barriers to access and ensure appropriate reimbursement for PZ-Cell. In the coming months, we will also engage with the state Medicaid programs to support patient access and broaden reimbursement for PZ-Cell. Earlier this August, the Centers for Medicare and Medicaid Services, CMS, granted our request for a product-specific procedure code, ICD-10-PCS, which is now in effect for accurate hospital billing and timely reimbursement for PC cell procedures between healthcare facilities and all types of insurance providers, commercial and governmental. In addition, Medicare has mapped PzCell to a favorable MS-DRG018 assignment, recognizing the breakthrough nature of PzCell's technology for RDAT patients and supporting reimbursement and patient access for the relatively smaller pool of Medicare RDAT patients. MS-DRG018 is among the highest available inpatient hospital reimbursement levels for cell and gene therapy, and we are thrilled by CMS's favorable consideration. Commercial payers are also recognizing the clinical value of a treatment like PZ-Cell as they review the durability of our clinical trials following a one-time treatment application. They also recognize patients may need to come back for additional treatments to cover their previously untreated wound areas. Based in part on our ongoing PZ cell phase 3B study, where six out of seven patients we have treated so far have received PZ cell at least twice, including one patient that has received PZ cell three times. The willingness of returning patients to participate in the PZ cell clinical trials is a testament to the impact on patients from these PZ cell trials. One pediatric patient in the phase 3B study received 12 PZ cell sheets in a single application, providing substantial coverage spanning 480 centimeters square on their back wounds. These data points are all exciting and give us increasing confidence about the role PZ cell could play in treating RDEB wounds upon its potential approval. With that, I would now like to hand the call over to our Chief Financial Officer Joe Azzano to discuss our financial results. Joe?

Thanks, Manav. I would like to remind everyone that you can find additional details on our financial results for the three months ended September 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 $110 million as of September 30, 2024. This compares to $123 million as of June 30, 2024. Based on our current operating plan and assumptions with our existing cash resources, we estimate we have sufficient financial resources to fund operations into 2026. Our cash runway assumptions do not account for any potential revenue from commercial sales of PZ Cell or proceeds from the sale of a Priority Review Voucher, or PRV, if awarded by the FDA. I'll remind you that PZ Cell has been granted rare pediatric disease designation by the FDA. So, upon its potential approval, we believe that we are eligible to receive a PRV. The last two reported PRV sales were each completed at a value of above $150 million, indicating that PRVs could be increasing in value relative to the long-time steady average of about $100 million. Research and development expenses were $8.9 million for the three months ended September 30, 2024, compared to $7.1 million for the three months ended September 30, 2023. Our spend on general and administrative activities was $6.4 million for the three months ended September 30, 2024, compared to $4.2 million for the three months ended September 30, 2023. The increase in general and administrative expenses is primarily due to commercial and launch preparation costs. Net loss was $30.3 million for the third quarter of 2024. It is important to note that the net loss in the third quarter of 2024 included a $15.2 million loss resulting from the quarterly remeasurement of the fair value of warrant and derivative liability. The warrants are required to be classified as a liability and remeasured at a fair market value each reporting period. Net loss in the third quarter of 2023 was $11.8 million, including a $1.1 million loss resulting from the quarterly remeasurement of the fair value warrant liabilities. With that, I will open the call for Q&A. Operator, can you 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 1 on your phone keypad now. A confirmation tone will indicate that your line is in the key. You may press star 2 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 whilst we poll for questions. Thank you. Your first question is coming from Dagon Herr of Stiefel. Dagon, your line is live.

Good morning, guys. Thanks for taking our questions and congrats on all the progress. It's remarkable. Two questions from me. One is for Vish. As we think about the resubmission and the acceptance, given that the CRL was primarily CMC related, I guess which aspect at this point, since it is more of a review issue, which aspect do you think kind of keeps you up at night or do you find to be the most kind of question bearing going forward? And second for Madhav, as we think about the commercial rollout, thanks for the insights on your market research there. How should we think about, or how are you guys thinking about the rollout strategy as we think, you know, Vigevec as well as Phil Suvez, that's already available. Polypharmacy-wise, what's been your respective comment that you've received from payer discussions and how are you kind of strategizing around getting patients back into the centers? Thanks so much.

Thanks, Dagon. Good morning. This is Vish. I'll first address your CMC question, and then I'll have Madhav talk about the . So, in terms of the, as we had previously reported, the Type A meeting, we were quite comprehensive in discussing pretty much all outstanding CMC issues noted in the CRL as well as the PLI. And the only ones we didn't discuss was probably because during the informal meeting leading up to the Type A meeting, we already got those, you know, pre-reviewed, if you may, and kind of got a sense of we were in the right direction there. So in terms of tests or results that the FDA has not yet seen but agreed on, let's say a protocol for validation, the only outstanding ones were identity testing and sterility, right? Those were the two topics. And even there, we had quite deep conversations on exactly what the expectation is. And so for identity testing, we actually had an informal meeting post the type A meeting and shared a little bit of our preliminary data. And we have the confidence based on that discussion that we have what we need to put that package together. I think sterility is the new data that they're going to see, but in terms of what they would expect, the statistical considerations, and, you know, all the types of organisms that we have to demonstrate using our new method. These are all things that we had a pretty good agreement about, which is why I feel, you know, comfortable about how strong our package is. What I'm going to do is Brian Keveny, our chief technical officer, is actually online. So, Brian, if you would like to add any more color on those two aspects, please do so.

Yeah, thanks, Vish, and thanks for the question. Yeah, I think you've covered pretty much everything that we are aligning on internally. I think, you know, sterility was the biggest topic as part of the CRL, so I think, as Vish mentioned, that's one area that we're interested in hearing the additional, having them look at our additional data, especially considering that sterility seems to be like a topic that the agency is paying particularly close attention to. But I can't speak more highly of the data that the team has collected and the package that they've put together for the resubmission. So, I would echo Bish's sentiments around our confidence in the package that we've put into the agency.

Thank you, Brian. Dagon, I hope that addressed your first question. I'll turn it over to Mazov to talk a little bit about how Vajavec's existing treatment options how our therapies will play there.

Yeah, no, thanks, Dagon, for the question. Yeah, so certainly there are existing treatment options, and yes, patients are receiving treatment options in their home setting. When we present the market, based on our market research that we have done, not just with physicians, but also with patients and caregivers, many of the respondents of our market research are on existing treatment options, and they look at the profile of PZ cells, especially the before and after wound images, and the fact that you're able to show how the wounds look like in a finite six-month period of time has been really moving for them, emotionally moving, and they are motivated to consider a treatment like PZ cells just given the extent of wound burden that they have. So when a treatment like PZ-Cell were to get approved and come, you know, to be offered to these patients, we are hearing testimonies that they will consider this treatment option given the effects that at least clinical trials have shown. Now, as we talk about rollout, because we are targeting high-volume EB centers that are not just EB centers but also clinical researchers from these centers, The fact that we are seeing this engagement, we know that there are patients, at least in our preliminary onboarding conversations as we are beginning to have those discussions. And as patients begin to come to these treatment centers and get their treatments, the referral strategy will kick in, as well as other patient-to-patient and, you know, raising awareness through patient advocacy groups and multiple other channels. I think the clinical benefit of this product is going to speak there. So that's how we feel with regards to keeping the demand going. With regards to the payers and the conversations, we have had no pushback with regards to the payer engagement so far about PZ Cell vis-a-vis other treatment options. And again, that goes to, firstly, it's a rare disease part of it, but also goes to the fact that when you can cover large areas of the body with a single, you know, surgical application and multiple years of healing, that data, again, resonates very strongly with them. So we'll certainly keep you all posted, but so far we feel very confident about the uptake.

Sounds good. Look forward to the next progress. Thanks, guys. Thanks, David.

Thank you. Thank you very much. Your next question is coming from Maury Raycroft of Jefferies. Maury, your line is live.

Hi, good morning. Congrats on the progress, and thank you for taking my questions. I was wondering if the favorable Medicare reimbursement designation, how that impacts conversations with payers related to commercial reimbursement plans, and can you talk more about payer conversations and what pricing strategy could look like Maybe remind me if the first treatment will be a flat price and then subsequent treatments would also be a flat price or variable price per number of sheets, or how are you thinking about that?

Yeah, thanks, Maury. I think the Medicare question on the reimbursement. So the reimbursement, the MS-DRG-018 is going to be applied only to the Medicare pool of patients. So the actual nature of reimbursement is not going to spill into the commercial side because the commercially insured patients we expect will have a single, you know, or a case rate arrangement often between the provider side and the payer side. But the fact that we have a DRG018 is going to, is reflected positively by commercial payers because they recognize that this is a sophisticated technology and not a, not any other burn, you know, procedure kind of a graft-related cost. So the value of the technology, the genetic nature of it has been established with this assignment. So that is one. The ICD-10 PCS code is what is really positive because that procedure code, which is product-specific procedure code, will make it, the hospital billing, even for the commercially insured patients, seamless because now, you know, they don't have to rely on a multiple miscellaneous code. So I think that ICD-10 PCS code is going to help even with commercially insured patients. With regards to the pricing strategy or pricing, the way we are thinking about it is a flat price per treatment for the patients. And we expect for the NDC that we have all available PC cell sheets. will be supplied and that'll all have one flat price per kit. So up to 12 sheets, one flat price. If the patient were to come back, let's say later down the line in their lifetime, that will be a separate, its own standalone price point, flat price. We are still discussing with payers with regards to, you know, with regards to any, there won't be any, VAC price changes between the first and the second treatment cycles. And we also have not had any pushback with regards to any subsequent treatment cycles from the payers. Does that answer, Maury, or any follow-up?

Yeah. Yeah, that's really helpful. And maybe one other question. Just wondering if you have line of sight into How many patients you could treat commercially potentially by the end of 2025, assuming approval and then the two to three months launching after the approval? And then can you talk more about what needs to be done to make the new facility operational that you're leasing and when that could happen as well?

Yeah, in terms of how many patients we can expect to treat, I think that is something certainly we will continue to monitor and probably guide as we get closer. What our strategy is, you know, is to have a centralized, you know, location to be able to funnel in all of the patients and get them queued up from a payer coverage and insurance benefit standpoint, because that's going to be a process that we will start soon after we get approval from alongside which we will get the centers of excellence, qualified treatment centers, activated and make them patient ready. So part of it is going to depend on how quickly we can bring the qualified treatment centers and make them patient ready to treat after we get the approval. So that is one. And then the second is, of course, on the manufacturing side, we are going to ramp up that capacity. We have said and we continue to believe that the demand at the time of launch is going to exceed the supply, and that is certainly our focus as Vish alluded on the call. We have already started thinking about expanding our manufacturing footprint in the building where we are and how to go about that. So, Vish, if you have anything else to add on that.

Yeah, thanks, Madhav, and thanks for that question, Maury. I think it's probably a good idea to remind people people that at launch, we're going to have manufacturing capacity. The current manufacturing footprint can take us up to about 10 patient runs or 10 manufacturing runs in a month. But even that will have a certain ramp up speed, not because of the space per se, but because of hiring and training personnel. We're already doing some of that pre-approval to train more manufacturing people. However, I think the ramp up will continue post approval as well, just to kind of balance out where we focus our efforts leading up to the launch, right? So the timing by which we will be operating at that full 10 a month kind of capacity is a little bit in flux, but we think that by end of 2025, we should be achieving at least close to that kind of capacity. And the additional space that we talked about, it's a bit early. We have leased the space. We are engaging with design engineers who have experience in designing for such types of manufacturing GMP spaces for these types of autologous processing suites. And we're trying to see how best to optimize that. I think there are multiple scenarios we are considering right now. So as we get closer and closer to the approval time, we'll give you more color as to how that ramp up will look like, how quickly we can because there are multiple factors we are optimizing for. One is the speed at which we can add more additional suites, and the other is how can we do that without disturbing existing manufacturing space because you can't compromise on that. I think balancing these two as well as how much space do we really need to bring into additional GMP manufacturing, I think these are all parts of the equation that will get clearer and clearer as we do our homework a little bit. So hopefully by the next call, Maury, we should have a little bit more clarity on that. I hope at least conceptually it gives you an idea of how we're looking at capacity because as Madhav mentioned, clearly the demand is going to be a lot more than our supply at the time of approval.

Got it. Yeah, all really helpful context. Thanks for taking my questions.

Thank you very much. Your next question is coming from James Malloy of Alliance Global Partners. James, your line is live.

Hey, guys. Thank you very much for taking the questions. And actually, a little more on the question from before or the answer from before. You said that 10 patient runs per month. What does that translate into sort of per year? About 225 patients in the target that you walk through, the 30% of the 750 that are eligible upon should you get approval. How should we on the outside looking in be thinking about when you guys could be able to potentially supply that 225 or potentially even expand that going forward? Thank you.

Yeah, thanks, Jim. So yeah, the 10 patients a month translates to about 120 a year. Our goal is to go beyond that, right? So that's why we are looking at additional space and lease agreements and things like that. How quickly will that come to effect? I think it's a little premature to speak about it because there are multiple components in that and there is also regulatory review involved because once the additional space is created and we start to do engineering runs, we have to submit those designs and there's going to be a need for, you know, regulatory review as well. I think approximately the lead time is going to be anywhere between 18 to 24 months. That is just based on analogs we've seen in the past from these types of therapies. So can it be sooner or even later? I think that is something that we will have more clarity as these designs for new building space get crystallized a little bit and our dialogue with the FDA will end through that step. we'll get more clarity, but I think a good ballpark is, you know, a year and a half to two years after we've made a clear design print on the paper. So, that's kind of a very high-level estimation.

Excellent. Thank you, Brian. The best you can do at this point, of course. You know, given sort of the demand versus supply you guys will be facing, and you guys are very good at giving ideas on pricing. You obviously see by Chuvex pricing. What do you guys think on pricing power to raise pricing going forward as, you know, as you're expanding capacity?

You mean pricing for PT cell treatment, Jim?

Yes. Yes, of course.

Yeah, I mean, I think price for PC cell treatment, yeah, definitely there is value here that we are bringing to the patients and the community, and we will want to capture that value through pricing. Given the durability, et cetera, we have talked about it as comparable to one-time, you know, gene therapy price, you know, that PC cells can secure, and that is really what our going in assumption is we haven't guided in terms of the numbers. I think in our last call, we've said a floor of 1.5 million per PV treatment. We are continuing to explore the upper bounds of this because we, our main goal is not to limit patient access, right? We want to make sure payers are comfortable And we are exploring our options in terms of especially when you have a product like PG Cell with its efficacy and, you know, the outcomes that we have, what options are there on the table. So we are being creative and want to, of course, make sure that we recognize the value that we are bringing and are able to capture it through pricing is certainly one lever. And as I mentioned, patients, you know, we do expect them to come back for a repeat, you know, treatment for the previously untreated areas, which will be its own, you know, billing cycle and its own price there, right? So that's how we are thinking about it. And the fact that we are in-house, we are not relying on a third party to produce our vector. You know, it's all done by Abiona. That in and of itself gives us a lot of control, autonomy, as well as, you know, a profitable model to be able to exercise that, right? So it is helping us from both sides that we have the ability to control the speed and also manage the cost while we think about the manufacturing scale.

Great. Thank you very much. That certainly seems a pretty straightforward calculation to show the value. of a treatment you're helping these patients avoid. Did I hear correctly, $1.5 million a year, annual cost of therapy, roughly?

It's not a year. It's per treatment, which is a flat price.

Right. Okay. Great. Thank you.

Thank you very much. Just a reminder, if anyone has any remaining questions, you can press star 1 on your keypad to join the key. Thank you. Your next question is coming from Kristen Kluska of Cantor Fitzgerald. Kristen, your line is live.

Hi, good morning, everybody. Thanks for taking the questions and congrats on the resubmission and appreciate all the transparency you've shared with us over the last few months. Very helpful. So as you think about potential conversations with surgeons and doctors, if you are approved, I mean, I think the data and the durability really speak for themselves, but can you share with us how you're going to talk to them about the actual surgical procedure, including how the patients in the trial experience in the past have responded from it? Do you see this as a potential barrier? Thank you.

Yeah, thanks for that question, Kristen. We don't see this as a barrier, but I can give you a high-level answer. So, the surgeons don't consider this as anything especially new beyond what plastic surgery procedure would entail. We don't see the surgery aspects of applying PZ cell itself as a barrier. As you know, two of the five centers potentially could be our clinical sites, and our clinical sites have had a lot of that experience through our trials. And we've seen through the experience of onboarding the UMass site that was onboarded around the later half of our vital study that the surgical aspects were actually pretty smooth in the communications between the doctors that were at Stanford and you know, at UMass. And we see the site onboarding path to be seamless that way because we've been through that kind of an experience once. It's just replicating best practices that we need to achieve. I think from a patient perspective, having these additional sites should only be more helpful because our goal is to minimize their travel time and some of the logistic burden that comes with that. Madhav, let me ask you to add more color based on our recent interactions with potential sites that we're already working with in terms of the multidisciplinary aspects of how PZ cell application can be cross-pollinated for best practices across these centers.

Right. Yeah, no, absolutely. Everything what Vish mentioned, that's really the sentiment we are seeing from the other sites also, Kristen, that we are interacting with. Surgically, they are so comfortable because this is being technologically dispersed for them from the rational procedures standpoint, you know. In fact, even dermatological surgeons have applied PV cell. It's just that, you know, we say surgeons or plastic surgeons because they tend to have, you know, privileges to the OR. But these surgeons are part of the conversations we are having, and they are seeing the technology, and for them, this is not at all a difficult thing. We are also working with the cell therapy coordinators at these centers. I think that's the beauty because these centers are, have onboarded multiple cell therapies in their institutions. And from that standpoint, there is an infrastructure, there is a process flow. Yes, of course, there are nuances for PD cell because PD cell, when approved, will be the first ex vivo autologous non-systemic therapy, right, period. I mean, across all of the technologies out there. So because of that, there are certain nuances of, okay, areas to be treated and mapping that out for the patient. And the fact that, you know, the clinical trial experience we have gained now with our phase 3B study is also just helping build that experience curve for us. So no real, you know, issues that we are seeing from a procedural standpoint. And as Vish mentioned, yes, the patients, they are coming back for un-treated areas that in and of itself is a pretty positive thing that they see the benefit.

Thank you so much for that. And then when you resubmitted the BLA and the resubmission was accepted for review, did you get any sense from the agency whether the focus during the time from now to the BITUFA is solely going to be on those redline items that were new essentially from the first time, or are they going to be looking at everything holistically? Thank you again.

Thank you, Kristen. The short answer is no, we don't have a sense yet. We just had the two-week period. They're going to just look at all the components of data that have been requested and is our application complete in many ways, right? So we do not have any sense to whether everything that has been previously reviewed is going to be opened up again versus, you know, focus on the delta, right? But our assumption is that, you know, majority of the review will focus on those additional items just based on our conversations leading up to the resubmission and also the nature of what a CRL really is. By process, a CRL is supposed to be a comprehensive list of things that having reviewed the entirety of the package, these are the things that you know, you need to deliver for an approval. So, in that spirit, our assumption is that, yes, the focus is going to be on those additional items, but very soon we're going to have that dialogue pick up because it's just been about that two-week period since we made the resubmission. So, we'll definitely, as we've been transparent all these months, we will continue to do that, Christian.

Thank you. Thank you very much. Well, we appear to have reached the end of our question and answer session, so I will now hand back over to Vish for his closing remarks.

Thank you so much. And before I give you the closing remarks, I just wanted to clarify one of the Q&A questions was about a pricing floor. We have not really disclosed any or even finalized pricing for PZCell at this point in time. Jim, the question that you had asked was about The 1.5 million was just the floor that we had communicated. We do see from a lot of our dialogues so far that there could be an upside. So we're still investigating that. So just wanted to clarify that so people don't think that we have priced PZCell at any given price point yet. So with that, I think, you know, in closing, we're one step closer to a potential approval for PZCell. And we believe that we're well positioned for this significant opportunity ahead at Ebiona, and we look forward to finishing this year strong and to a potentially transformative 2025 for the company. And I know we did not talk much about our pipeline, which we will do in our future calls. We just wanted to focus today's time on the upcoming preparations for PGCell. So thank you, everyone, for joining us today for the business update, and we'll talk to you again soon.

thank you very much 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