Abeona Therapeutics Q4 2024 Earnings Call Transcript

Quartr
Provided by Quartr
March 20, 2025

There are 10 speakers on the call.

Operator

Greetings. Welcome to Aviona Therapeutics Full Year twenty twenty Full Results and Business Update Conference Call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. Please note this conference is being recorded.

Operator

I will now turn the conference over to your host, Greg Jin, VP of Investor Relations and Communications at Abeona. Greg, you may begin.

Speaker 1

Thank you, Paul. Good morning and thank you for joining us on our full year twenty twenty four results and business update conference call. During this call, we will refer to the press release issued this morning announcing the financial results. It's available on our corporate website at www.abionatherapeutics.com. Remarks made during today's call may contain projections and forward looking statements, which are made pursuant to the safe harbor provisions of the federal securities laws.

Speaker 1

These forward looking statements are based on current expectations and are subject to change. 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 Securities and Exchange Commission. These documents are available on our website at www.avionathairapeutics.com. On the call today with prepared remarks are Doctor.

Speaker 1

Vish Seshadri, Chief Executive Officer Doctor. Madhav Visanthavada, Chief Commercial Officer and Head of Business Development Doctor. Brian Kaveny, Chief Technical Officer and Joe Vazano, Chief Financial Officer. And with that, I will now turn the call over to Vish Sesadri to lead us off. Vish?

Speaker 2

Thank you, Greg. We appreciate everybody joining the call this morning. We're less than six weeks away from our PDUFA date of April 29 for Pradimigene zamytereso or pvcell for receptive dystrophic epidermolysis bullosa or RDEP. Since resubmitting our pvcell Biologics License Application in late October and receiving FDA acceptance in early November, we have been working with the FDA on the review process. As a reminder, the FDA has not indicated the need for additional site inspections or an outcome as part of this review.

Speaker 2

On 03/14/2025, we received from the FDA a marked up version of the draft USPI to initiate label discussions. We have also received some post marketing commitments and requirements from the FDA. The potential approval of PD Cell would be a significant moment for the RDEB community, a major milestone for our company and would be the main driver of growth and profitability for Abeona for years to come. In anticipation of the PDUFA date, our launch preparations of PD cells for RDEB are well underway. While five renowned EB treatment centers in The U.

Speaker 2

S. Are undergoing onboarding and activation activities to become VZcell qualified treatment centers or QTCs. We anticipate that sites will be activated and ready to biopsy patients starting in the third quarter of this year, approximately three months after the PDUFA date, similar to past autologous cell therapy launches. In other words, we anticipate launching PD cell in the third quarter of this year pending FDA approval. The RDEB community continues to highlight the unmet medical need for new therapies.

Speaker 2

These patients continue to seek reliable and durable treatment options for their wounds. The strength of our clinical data, manufacturing capabilities, commercial readiness efforts and significant cell and gene therapy launch experience of our commercial team, Abeona is poised to serve The U. S. R DIP community following an approval. We are confident that if approved, PD Cell and its differentiated clinical profile will transform the treatment paradigm for R DIP patients.

Speaker 2

I'll end my remarks with a brief mention of our partnered program with Ultragenyx for San Felipe Syndrome Type A or MPS IIIA. In December, Ultragenyx submitted a BLA to the FDA seeking accelerated approval for UX-one hundred and eleven for patients with MPS IIIA. Last month, Ultragenyx announced that the FDA granted the BLA a priority review with a PDUFA action date of 08/18/2025. So 2025 is shaping up to be a very exciting and momentous year in our company's history with the potential for two FDA approvals of our internal and partnered products. I'll now hand the call to our Chief Commercial Officer, Madhav Vasantavara to highlight our commercial launch preparations for PCCell.

Speaker 2

Madhav?

Speaker 3

Thanks, Vish, and hello, everyone. With less than six weeks until our PDUFA date and label discussions started with the FDA, we are looking ahead to potential PZ cell approval and the prospect of positively impacting the lives of people living with recessive dystrophic EB. Before I share the status of our launch readiness, let me briefly recap how we see the commercial opportunity with PDCELL. In The U. S, based on medical claims data, we estimate there are approximately thirteen hundred dystrophic EB patients.

Speaker 3

Our research indicates that about seven fifty of those EB patients are RDEB patients with moderate to severe wounds who are potential candidates for PZcell. An average RDEB patient has greater than thirty percent of their body wounded and we estimate two treatment cycles of PZcell would be needed to cover the vast majority of their existing wounds. In other words, with an average of two treatments per patient and about seven fifty patients, we foresee about 1,500 treatment opportunities for PCCell in The U. S. At this time, we are not accounting for potential future RDEB wounds that patients may develop and other factors which could require additional rounds of PD Cell treatment per patient.

Speaker 3

Even with a conservative floor of $1,500,000 per treatment, we believe PD Cell can have a cumulative revenue potential of more than $2,000,000,000 in The U. S. Alone. Our confidence in realizing this opportunity stems from the continued enthusiasm we hear from patients, leading ED physicians and payors. People with RDEB are desperate for therapeutic options that can reliably close multiple stubborn wounds in one treatment application and provide relief from the perpetual burden of chronic wound care.

Speaker 3

EZ Cell has the potential to be a groundbreaking therapy designed to deliver years of wound healing and pain reduction after a single treatment application even in the tough large chronic RDEB wounds. Many of the ED physicians we spoke with at the recent American Association of Dermatologists Annual Conference indicated that they are looking forward to the approval of TZ Cell. That said, TZ Cell treatment like other autologous cell and gene therapies is an involved process that requires extensive treatment planning, travel and care coordination. But despite this, patients are excited about the potential approval of PZcell because of the robust clinical efficacy and durability seen in clinical trials. In a self reported patient survey conducted two years after TZ cell treatment in a Phase onetwoa study, all seven participants reported that they would undergo PD cell treatment again and would recommend the procedure to other patients with our death.

Speaker 3

In fact, in our ongoing Phase 3b trial, the majority of our patients are repeat patients who have elected again to receive PZcell for their previously non treated wound areas. One patient even came back for a third round. We want to make PZcell available and accessible to this patient community as soon as possible following approval. As such, to talk about our launch readiness and expectations, we are in dialogue with five well recognized epidermolysis bullosa EB centers to onboard them for PD cell treatment. These centers are geographically dispersed, each with a large catchment areas of patients and collectively can treat a sizable proportion of our estimated seven fifty PC cell eligible patients.

Speaker 3

We expect the process of site activation to vary from site to site, but based on our experience with the cell and gene therapy launches, site activation could take approximately three months post FDA approval. During these initial months post approval, our teams will work with the centers to discuss eligible patients and secure the necessary payer authorizations. Our goal is to activate our target centers during this launch year that is 2025, so that centers can begin treating patients with PZcell in third quarter of this year as Vrish indicated. We will announce the names of the PCcell qualified treatment centers as they become activated. Once a site is activated, they can begin to schedule patients for biopsy based on available manufacturing slots and treat patients approximately twenty five days from the time of biopsy collection.

Speaker 3

Revenue recognition will occur after the patient is treated with the product. During the early launch phase, we expect to see a gradual ramp up at the QTCs with centers treating one to two patients first as they get accustomed to the PZcell treatment process, patient journey and the reimbursement flow. Then

Speaker 2

as the

Speaker 3

sites become more experienced with PZcell, we expect greater uptake of the product. This gradual ramp up at the sites this year will be happening in parallel with Abeona ramping up our manufacturing capacity to increase launch supply as we have always indicated we would, a topic that Brian will cover later on this call. So, from an overall demand standpoint, we are confident of PDCL's growth and over time with capacity ramped up in 2026, we intend to qualify additional treatment centers while also driving patient referrals into the QTCs from the community practices. Let me now turn to market access where our two main goals are to ensure favorable access policies for the patients and reimbursement for the treatment centers. We remain confident in meeting both these objectives based on our payer interactions so far.

Speaker 3

Avionna will give QTCs the flexibility to procure PZcell either as a buy and bill product or to a specialty pharmacy and sites like this flexibility to be able to choose. Because access and reimbursement are critical success factors for any high cost gene therapy, we have been laser focused on educating the payer community and have had over 40 pre approval information exchanges communicating our clinical trial results. To remind you in terms of the payer mix, our data shows us that sixty percent to sixty five percent of our dead lives are covered by commercial plans, about thirty percent to thirty five percent by Medicaid and the remaining less than ten percent by Medicare. Payers recognize the persistent unmet need in the RDEB treatment landscape and the tremendous clinical value of PZcell as they review PZcell's ability to cover large areas of the body and clinical data showing multiple years of wound healing and pain reduction after a single treatment application. Just last week, we were an emerging biotech sponsor at the PCMA Annual Meeting, one of the industry's most important payer conferences and we were pleased with the positive reactions we have received on the clinical and economic value of PD Cell during multiple private in person engagements with the largest national payers in the country, covering the majority of RDEB commercial lives.

Speaker 3

At approval, we plan to file for the Medicaid Drug Regate Application or NDRA and apply for a PCCELL specific J code so that state Medicaid programs will have an opportunity to carve out PCCELL from the bundle payment methodology with the goal of speeding up access and reimbursement. Finally, I want to mention Adeona Assist, our integrated support program designed to help eligible patients navigate their entire PC cell treatment journey, including travel and logistics. With that, I would like to hand the call over to Doctor. Brian Kevany, our Chief Technical Officer, to discuss commercial manufacturing for PZcell. Brian?

Speaker 3

Thanks,

Speaker 4

Madhav. We continue to prepare our Curtin Good Manufacturing Practices facility in Cleveland, Ohio for manufacturing commercial grade PZcell drug products. As a reminder, our Cleveland site is a completely non CDMO dependent facility for the production of PZcell as well as our retroviral vector. As Vish mentioned, we anticipate launching PZcell in the third quarter of this year pending FDA approval and we are on track from a manufacturing perspective prepared to begin receiving biopsy samples from qualified treatment centers and initiating the manufacturing process to support the plant's launch. Our facility is led by a team of highly skilled production, process and assay development and quality control scientists with expertise in cell and gene therapy, particularly in cell culture, analytical testing and wet lab techniques.

Speaker 4

The maximum capacity at our cGMP facility supports PZ cell manufacturing for up to ten patients or manufacturing runs per month. We have previously communicated that PZcell will be a supply measured launch and there will be a ramp up period to get to maximum capacity. We currently estimate our initial manufacturing capacity during the early launch phase to be about four treatments per month and we plan to gradually ramp that monthly capacity to six treatments starting roughly at the end of twenty twenty five to early twenty twenty six toward achieving a maximum capacity of 10 monthly treatments in the first half of twenty twenty six. We believe the planned manufacturing capacity ramp up will sync up well with the ramp for Q2Cs treating our first patients during the early launch phase this year. It is important to note that we have a planned annual manufacturing shutdown for maintenance of equipment in the facility, which is standard for cell therapy facilities.

Speaker 4

This planned shutdown is crucial to maintain operational integrity, regulatory compliance and product safety and we schedule it during the December, January holiday timeframe to minimize any temporary impact on our production capacity. We have already taken steps to enable capacity expansion beyond our current manufacturing footprint. During the fourth quarter of twenty twenty four, we leased additional building space in Cleveland adjacent to our existing facility, which will allow us to create additional manufacturing space to increase production capacity for PZ cell. In the coming months, we will be assessing design plans and we'll share more on our increased manufacturing capacity on a future call. Our long term plan is to build manufacturing capacity to support 200 plus annual PZ cell treatment by the second half of twenty twenty seven.

Speaker 4

I'd like to hand the call over to our Chief Financial Officer, Joe Guzzano to discuss our financial results.

Speaker 5

Thank you, Brian. I would like to remind everyone that you can find additional details on our financial results for the full year ended 12/31/2024, in our most recent Form 10 ks, 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 $98,100,000 as of 12/31/2024. This compares to $52,600,000 as of 12/31/2023. 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.

Speaker 5

Our cash runway assumptions do not account for any potential revenue from commercial sales of pzcell or proceeds from the sale of a Priority Review Voucher or PRV if awarded by the FDA. I'll remind you that PZcell 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. Research and development expenses was $34,400,000 for the full year ended 12/31/2024, compared to $31,100,000 for the full year ended 12/31/2023. Our spend on general and administrative activities was $29,900,000 for the full year ended 12/31/2024, compared to $19,000,000 for the full year ended 12/31/2023.

Speaker 5

The increase in general and administrative expenses is primarily due to commercial launch preparation costs, which included the hiring of a well experienced commercial team to support the potential launch. Net loss was $63,700,000 for the full year ended 12/31/2024, or $1.55 loss per common share as compared to $54,200,000 or $2.53 loss per common share for the full year of 2023. Lastly, we have received a question from investors about when we will start recognizing revenue after PD Cell is commercially launched. As we stated earlier on this call, we are planning for commercial launch in the third quarter of this year if PZcell is approved. Revenue recognition occurs upon PZcell administration, that is the surgical procedure.

Speaker 5

So that would give you a sense of the time it would take from a patient being biopsied through the twenty five day PD cell manufacturing process to when we recognize revenues. And with that, I will open the call for Q and A. Operator, can you please open the Q and A session of this call?

Operator

Certainly. At this time, we will be conducting a question and answer session. And the first question today is coming from Kristin Kluska from Cantor. Kristin, your line is live.

Speaker 6

Hi, good morning, everyone. Thanks for taking the questions. And just want to say very much appreciate how transparent you've been with us during this review process, including last year. So considering where you are in discussions right now with the agency, do you feel that the FDA is satisfied with the work you've done on the CMC side that resulted in the CRL last year? Have you fielded more questions specific on that?

Speaker 6

Do you have a sense of any work that you'll need to do on that side?

Speaker 2

Good morning, Kristen. Thank you for the question. I would say this, we have addressed all the asks of the FDA from our side that came out from the CRO. We did not negotiate any of those points. I mean, those 12 items that we had articulated last year.

Speaker 2

And so we took the approach of comprehensively addressing each and every one of those and we believe we've done that. And the reason we believe we've done that is because how many touch points we've had like five or six informal meetings with them in the time between the CRL and the resubmission and also a formal Type A meeting where we got a lot of our questions answered. So we feel like we have addressed all of those. And then of course through the current review process after the resubmission, the types of questions we IRs that we had received and how we addressed them, even the amount of time that has gone past our resubmission, we just put two and two together. And if you look at the holistic picture, we feel like we're in a good place, of course.

Speaker 2

Technically, we cannot say the FDA has said you've satisfied all these items because review is still ongoing. But from our end we have really checked those boxes. I hope that addresses your question.

Speaker 6

Yes, it does. Thank you. And then of the five centers that you referenced, have you had conversations with them specifically just to get an early sense of maybe the percent of their patients that may be eligible for this therapy over time?

Speaker 2

Great. And for that question, I'll actually turn over to Madhav to address it as the person that is directly in dialogue here.

Speaker 3

Yes. Kristen, thanks for that question. These centers that we are talking to, they are large as we have discussed in the past, large academic institutions with patients. We will get more closer soon after approval in terms of how many actual number of patients, but we continue to hear from them that there are patients who they see PZcell as a really good option for their moderate severe ARDA patients, primarily complementary to the existing treatment options. So from that standpoint, they have patients that they are thinking about, but as soon as we have approval, we'll begin to start clearing all of the access related topics that we discussed.

Speaker 3

In terms of the numbers of patients, about thirty percent of the seven fifty patients are primarily based on the claims analysis are in seven centers of excellence. Five of these seven centers, we are already in discussions with. So

Speaker 7

we

Speaker 3

are looking at least a triple digit number of patients that are currently housed within these institutions and a pretty sizable number of those triple digit number of patients would be at least at the early phase

Speaker 2

of

Speaker 3

launch candidates and then they will come on the product over time.

Speaker 6

Okay, thanks. And last question for me, I've seen a lot of new investor faces on the story over the last few weeks and months in particular. So can you just remind us what's really going to be the top reason for a patient wanting to seek this therapy? Is it just the wound profile itself and having to deal with the bandages? Is it in particular because these wounds make patients more susceptible to things like squamous cell carcinoma and infections, which are leading causes of mortality here?

Speaker 6

Just what is like really drilling down the key reason? Thank you so much again.

Speaker 3

I think the key reason from what we are hearing is the need to have durable or a longer term closure of the wounds. Really these patients have multiple wounds on their bodies and if there is a treatment option that can minimize chances of infections, minimize reduction in the bandage and the wound dressing changes, these are really the quality of life impact that they would have. Squamous cell carcinoma is certainly a significant factor that is riding not just for patients and caregivers also from physicians' standpoint. So and we know that there is a high relation between squamous cell carcinoma occurrence as the wounds get more and more chronic. So they're always watching out for that.

Speaker 3

And therefore, especially for chronic wounds, if you're able to treat and heal these wounds, then that's a significant impact for them. So that's really the primary driver. And over time, I think there will be many more quality of life impacts as patients get treated.

Speaker 6

Thanks again and wishing you all the best in the next six weeks.

Speaker 2

Thank you, Chris.

Operator

Thank you. The next question will be from Maury Raycroft from Jefferies. Maury, your line is live.

Speaker 7

Hi. This is Amin on for Maury. Thank you for taking our questions. Two from us. First on the label draft that you mentioned, is the draft that you received from the FDA in line with your vision for PZ cell?

Speaker 7

Or do you anticipate further modifications and discussions with the FDA? And the second question is probably for Madhub. On upon the approval, do you expect a patient backlog until you reach maximum manufacturing capacity? Or do you think patient interest and manufacturing capacity will increase gradually without creating that backlog?

Speaker 2

Thank you for the question. I'll take the first one and then pass it on to Madhav. So your question was whether the draft label is aligned or consistent with our expectations. The short answer is yes. As you can imagine, there are a lot of different details where it will get refined over back and forth between the FDA and the sponsor.

Speaker 2

So that's very routine process. But in terms of the big ticket items of how we look at the label, there are no big surprises here.

Speaker 3

Madhu? Yes. And I would add with regards to the patient backlog, we do anticipate that happening. And I know we had mentioned that early on and we continue to feel that this particular launch early on for sure is supply gated for the several months coming up at the very least as we are ramping up to 10 patients a month. To Kristen's earlier question as well, we have received interest, right, from these physicians who are identifying patients that we will work with them to clear the to begin to have the patients get on manufacturing slots.

Speaker 3

So early on at the time of launch for the several months, as we release the manufacturing slots, we want to make sure that these slots are occupied for the foreseeable months and we will continue to keep you updated in terms of how that is shaping up. But yes, we are very much expecting there will be a few of patients.

Speaker 7

Thank you very much.

Operator

Thank you. And the next question is coming from Francois Brisebois from Oppenheimer. Your line is live.

Speaker 8

Hi. Thanks for taking the question and thanks for the updates on the developments here. I was just wondering, you mentioned you were at conferences recently. Can you help us understand maybe the physician education that's necessary? The trials have been going on for a while.

Speaker 8

So I'm just wondering if this is a situation where the doctors are just waiting for it? Or is there still, based on the fact that it's not approved yet, is there still a lot of physician education and training that's necessary at launch? Then I'll

Operator

have a follow-up. Thank you.

Speaker 3

So physician education is yes, physician education is certainly needed. I mean, in terms of the focus areas for us, we are really discussing in greater detail with the qualified or the centers that they're looking to onboard and qualify. But for the rest of the physician out in the community, as we understand there are about 23 centers of excellence that have a coordinated practice for EB clinics and we are really targeting at the time of launch a subset of those. So for the rest of the centers, as well as for the community physicians, we have not gone out and discussed really PZ cell with them because we are still waiting for the approval to happen. So as we begin to raise our promotional measures and efforts as well as engage with other patients who have gone through clinical trials in the past and share their experiences, that is definitely going to get more of the word and attention out there.

Speaker 3

So did that answer your question or in terms of the training aspect and awareness?

Speaker 8

Yes. No, no, absolutely. And I think the competitor having a product out there has probably helped as well for awareness. But I guess so on the physician side and then on the patient angle, is this an RDEB community? This is so severe that I was just wondering how tightly knit is the patient community and I'm not talking a full blown DTC, but is there an angle on the digital side?

Speaker 8

Is there an online community that makes these patients very aware quickly of the opportunity or how do you market to them? Thank you.

Speaker 3

Absolutely. We do have it's a very tight, as you said, very tight knit patient community. We have advocacy groups that have been great partners with us even through the approval process. So we will have a digital presence. We are in discussions with these and that's patients who will be able to share sort of their stories, as well as, of course, our website presence and social media.

Speaker 3

We will be there to raise this awareness. And as you mentioned, there is a lot of coming in second to market in this particular space as a gene therapy has its own advantages, not only in terms of some of the early patients and patient identification, but also from other aspects of payers and access clearances. So in terms of our digital presence, we will be there to do all of the right things there. But also in terms of physical presence and field personnel, we'll have members of our team who will be out in the community to raise awareness and begin to start help with the referral of these patients into the qualified treatment centers. So that's really going to be our two pronged approach, but given our supply capacity, we are also trying to titrate as to how much of rigor we want to put on these different measures, because we do know that the unmet need exists.

Speaker 3

And from what we are hearing from physicians, it's really a complementary aspect to existing treatment. So it's really going to be over a period of time how we gate our marketing resources.

Speaker 8

Thank you.

Operator

Thank you. The next question is coming from Ram Selvaraju from H. C. Wainwright. Ram, your line is live.

Operator

Hi. Thanks for taking

Speaker 5

my questions. Firstly, on the PRV, I was just wondering if you could enumerate any potential factors that might preclude the PRV from being granted or if at this juncture you fully expect it to be awarded? And also if you could comment on the recent environment for PRV resales?

Speaker 2

Good morning, Ram. Thank you for the question. We do not anticipate any potential factors that may preclude a PRV for us. In general, the big requirement items for PRV eligibility are you should have a rare pediatric designation, which we do. The second is we should have a priority review in the current review process, which we do.

Speaker 2

And finally, this has to be a new drug. It's the Pradamajine, Zamiqirastil is a first time launch, right? So if you looked at past examples, it's the same drug is rebranded, but it's the same vector or whatever process you had, then there was an example where PRV was not granted. We don't believe that applies to us because it's a first time launch for us. So those were the three big topics on checking off our wheel gearing up for PRV here.

Speaker 2

But to flip back that question, if there are anything else that we have not discussed as eligibility factors that you've heard, we'd definitely like to hear, but we have not we don't have any such things right now. And your second part of the question was the recent trend in PRV sales, right? We have seen that after the program has been put on hold or we don't know the future of the PRV program, where it's headed and that uncertainty may have created a different pricing trend for the last four PRVs, I think, which are sold for north of $150,000,000 Our goal is to optimize the pricing. We're not really in a rush that the PRP has to sell the day we get granted. If we get granted, we have the time now since we have our cash runway to optimize for pricing over speed.

Speaker 2

So that's where I would leave it. But if you have any follow-up questions on this topic, happy to address it.

Speaker 5

And also just to add into that, one of those four PRVs was sold within a week of actually getting approval at the full $150,000,000 price tag. Okay, very helpful. And then the only other follow-up was with respect to potential positioning and deployment of PV cell in markets outside of The U. S. In particular, wanted to see if you had any other comments regarding logistical potential deployment of this for treatment of European RDEB patients and what other high priority markets you potentially see as being viable for PC cell ex U.

Speaker 5

S? Thank you.

Speaker 2

Sure. I will start with Madhu. Feel free to add your thoughts. We do have a lot of interest from Europe and also some Asian markets for PDcell. Just from a bandwidth perspective, we haven't been able to entertain those discussions in much depth.

Speaker 2

We have those inquiries in a warm relationship right now, because we wanted to get through the PD cell approval in The U. S. First and then we will be able to have more meaningful dialogues. But the interest, the markets, they exist as we understand. We need to do a little bit more homework on the timing of when we will be able to supply there and also whether there are creatives, I mean our default assumption is that we will need to set up manufacturing shop in a European location.

Speaker 2

But we're also now more recently hearing there are ways depending on the shelf life of a product, even for a transplant like product that has very limited shelf life, there are ways in which you could supply from a U. S. Location to European countries, but we will explore that optionality after launch. Madhav, sorry, please do add any other

Speaker 3

Yes, you've addressed most. And I would just say even within Europe, right, Ram, we'll look to see what's really the market where the reimbursement landscape also in the market access looks positive. We know that for instance, Austria and Germany maybe are a couple of markets where there may be a greater appetite and we understand that especially for these kinds of surgeries, Austria is a big center where patients already travel to the EB center. So from a logistics standpoint, it's not like we have to go into multiple markets, but rather already take advantage of the infrastructure and the patient pathway that exists in these kinds of markets. And if we are able to just deploy one or maybe two centers over time, that can really be a huge benefit from cost and speed to market kind of standpoint.

Speaker 3

And then other markets, of course, we will continue we need to do more of the homework on this as Vish said, but we also understand Japan could be a potential or Asia Pacific, but these are more over time as we have the U. S. FDA approval. Once we have it, then that's our next chapter we want to get there.

Speaker 5

Thank

Operator

you. Thank you. The next question is coming from David Bautz from Zacks Small Cap Research. Research.

Speaker 9

You had mentioned that you want to get five treatment centers online with launch or when you launch, but what is the ultimate goal for the total number of treatment centers you'd like to see one day? Is it to get it up to ten, fifteen? What do you see in terms of that?

Speaker 3

I think total number not at this point in time, we don't anticipate going more than 10. And yes, so five this year and building it up slowly. Part of the reason is because we see that patients already in the status quo are used to traveling to centers that have specialty to be able to do multiple procedures, right, either for infections or surgical procedures, syndactyly and for various reasons. They are comfortable traveling not for periodic application, but for these kinds of one time important procedures. Now this is a therapeutic options we see and we have heard from patients that there is a very high willingness to travel to these centers as far as 200, two 50 miles radius.

Speaker 3

So we want to keep the number of centers tight and build the experience curve for these centers, so that as they do more patients and more applications, they just get better and better at it. So that's really our goal. And that also matches up with our supply, right? Because one of the things having launched CAR T cell therapies in the past is we got ran into issues with our supply and keeping up the expectations. So we we're careful in terms of keeping that experience going given where we are with regards to our supply situation as well.

Speaker 3

And as we ramp our supply, then yes, certainly we will explore ways to have more centers onboarded.

Speaker 9

Okay, great. Thanks for that. And in terms of treatment, you mentioned that most patients are probably going to require two treatments. And I'm just curious, what is the maximum surface area that a patient can be treated with at one time? And then what kind of dictates that number?

Speaker 3

So the maximum surface area that can be treated is we can supply up to 12 sheets, collagen producing keratinocyte sheets and 40 centimeters square is the size for each of the sheets. So 12 times 40 is up to four eighty centimeters square. From the natural history studies, we've seen that patients have on average 30, actually some patients have even up to eighty percent of their bodies wounded for recessive deb. So if we go with thirty percent and we come back of the envelope body surface area analysis, we estimate around 1,000 centimeters square of body is covered in large chronic wounds and non flexion parts of the body. So with that calculation, we are estimating around two rounds because two times four eighty.

Speaker 3

But then there is we cannot guarantee that there's going to be 12 sheets for each and every patient, right, because it's a cellular engineered cell therapy. And so for that reason, there is a chance that we may not, we probably eight or 10. So that just those are the factors that we will have to see over time how many treatment cycles will be required and also patients coming back to get their additional parts of their body treated. So that's sort of the math behind how we estimate about two treatments for a patient.

Speaker 9

Okay, great. Appreciate the information there. Thanks for taking the questions.

Operator

Thank you. There were no other questions in queue at this time. I would now like to hand the call back to Vish Sesadri for closing remarks. Thank you, Paul.

Speaker 2

Our top priorities continue to be to secure FDA approval for and launching PD cells in The U. S. As a new treatment for ARTA patients. We believe we are well positioned for the significant opportunity ahead of Abeona and we look forward to a potentially transformative 2025 for the company. Thank you everyone for joining us for today's business update.

Speaker 2

We'll talk to you again soon.

Operator

Thank you. This does conclude today's conference. You may disconnect your lines at this time. Thank you for your

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Earnings Conference Call
Abeona Therapeutics Q4 2024
00:00 / 00:00
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