Abeona Therapeutics Q1 2025 Earnings Call Transcript

Quartr
Provided by Quartr
May 15, 2025
Skip to Participants
Operator

Good day, and welcome to the Abeona Therapeutics First Quarter twenty twenty five Conference Call. At this time, all participants are in a listen only mode and a question and answer session will follow the formal presentation. Please note this conference is being recorded. I will now turn the conference over to your host, Mr. Greg Chin. Sir, you may begin.

Greg Gin
Greg Gin
Vice President, Investor Relations and Corporate Communications at Abeona Therapeutics

Thank you, Ali, and good morning, and thanks everyone for joining us on our first quarter twenty twenty five results 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.avionatherapeutics.com. We anticipate making projections and forward looking statements during today's call, which 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.

Greg Gin
Greg Gin
Vice President, Investor Relations and Corporate Communications at Abeona Therapeutics

Actual results may differ materially from those expressed or implied in the forward looking statements due to various factors, including, but not limited to, those outlined in our Form 10 ks and periodic reports filed with the SEC. These documents are available on our website at www.abionatherapeutics.com. Joining me today on today's call with prepared remarks are Doctor. Vish Seshadri, Chief Executive Officer Doctor. Mahara Vizantivada, Chief Commercial Officer and Joe Vizana, Chief Financial Officer.

Greg Gin
Greg Gin
Vice President, Investor Relations and Corporate Communications at Abeona Therapeutics

Also, Doctor. Brian Keaveney, Chief Technical Officer will join us for the Q and A session. And with that, I will now turn the call over to Vish Seshadri to lead us off. Vish?

Vishwas Seshadri
Vishwas Seshadri
CEO & Director at Abeona Therapeutics

Thank you, Greg, and good morning. We have had a very exciting and momentous 2025 so far. We are incredibly proud that Avionna is now a commercial stage cell and gene therapy company following the U. S. FDA approval of our first product ZivaSkin just a little over a couple of weeks ago.

Vishwas Seshadri
Vishwas Seshadri
CEO & Director at Abeona Therapeutics

ZivaSkin is the first and only autologous cell based gene therapy for the treatment of adults and pediatric patients with Recessive Dystrophic Epidomyolysis Bullosa or RDEB. This is a persistent unmet need to meaningfully heal RDEB wounds, especially those that are chronic and prone to infection. Through a single application, Ziva Skin can provide the opportunity for significant closure and pain reduction in even the most severe RDEB wounds. The launch is underway and we are quickly building positive momentum. Our marketing, medical affairs, market access, manufacturing and supply teams are all in place and engaging patients, physicians, payers and treatment centers.

Vishwas Seshadri
Vishwas Seshadri
CEO & Director at Abeona Therapeutics

I want to touch upon some highlights on how the launch is going, keeping in mind that we're only about two weeks in. Then Madhav will follow with details on the commercial progress in his remarks. We're pleased to announce that ahead of schedule, we have activated our first Qualified Treatment Center or QTC and that Ziva Skin is now commercially available. Lurie Children's Hospital of Chicago is our first QTC, enabling Lurie to begin identifying patients and our scheduling system is up and running. Lurie Children's is a top ranked hospital and has been a center of excellence for genetic skin diseases for more than thirty years.

Vishwas Seshadri
Vishwas Seshadri
CEO & Director at Abeona Therapeutics

As one of the largest North American centers for Epidomyolysis Bullosa caring for more than 150 affected children and adults, Nuuly Children's has been a member of the ED Clinical Research Consortium since its inception and continues to conduct cutting edge bench and clinical research to better understand the disease and find new treatment options. Doctor. Amy Poller, a world renowned pediatric dermatologist is head of the Epidermolysis Bullosa Research and Care Program at Lurie Children's and Chair of the Department of Dermatology at Northwestern University, Fainberg School of Medicine. And she was also the Chair of the Data Safety Monitoring Board for our pivotal vital study of ZEVASCAN. We look forward to a very collaborative relationship with LURI Children's, which shares our conviction that ZEVASKIN is an important treatment option for people living with RDEB.

Vishwas Seshadri
Vishwas Seshadri
CEO & Director at Abeona Therapeutics

We expect the first patient to be treated at LURI in the third quarter of twenty twenty five. Last week at the Society for Investigative Dermatology Annual Meeting, we presented two late breaking abstracts that further underscore ZevaSkin's efficacy and safety profile. One abstract retails data showing the durable expression of functional Collagen seven anchoring fibrils at ZevaSkin treated site and long term wound closure following a single treatment both of which are hypothesized to be attributable to the presence and persistence of gene modified progenitor cells within the ZevaSkin gene corrected cellular sheath. The second abstract confirmed the absence of squamous cell carcinoma or other cancer at any of the 144 ZEVASKIN treated sites. In seven instances where FCCs were observed in untreated areas testing for pro viral genome and replication competent retrovirus yielded negative results.

Vishwas Seshadri
Vishwas Seshadri
CEO & Director at Abeona Therapeutics

These clinical results and non clinical results of insertional oncogenesis that were reported at SID further support a favorable benefit risk profile for ZevaSkin. Moving on, I want to briefly remind everyone that earlier this week, we announced that we entered into an agreement to sell for $155,000,000 the Priority Review Voucher or PRV that we received with ZevaSkin approval subject to customary closing conditions including antitrust review under the Hart Scott Rodino Act. PRV proceeds will strengthen our balance sheet to fund our operations as Joe will further elaborate in a bit. These efforts will be critical for both our near term path to profitability and to drive our future growth. I'll now hand the call to our Chief Commercial Officer, Doctor.

Vishwas Seshadri
Vishwas Seshadri
CEO & Director at Abeona Therapeutics

Madhav Basantavada to highlight our commercial launch preparations for ZivaSkin. Madhav?

Madhav Vasanthavada
Madhav Vasanthavada
Senior VP, Chief Commercial Officer & Head of Business Development at Abeona Therapeutics

Thanks, Vish, and hello, everyone. It has been about two weeks since ZivaSkin's approval, and we are off to a very good start. The response from patients, caregivers, and the physician community since gaining ZivaSkin's FDA approval has been incredible. Already in just the last two weeks, our patient hub, Aegina Assist has received phone calls and email inquiries from about 30 patients and families across the country. We recognize that any new product approval comes with interest and excitement, but the volume and nature of these inbound inquiries are very encouraging.

Madhav Vasanthavada
Madhav Vasanthavada
Senior VP, Chief Commercial Officer & Head of Business Development at Abeona Therapeutics

We are hearing from adult patients and parents of children who are all hopeful about the potential impact Zeeva skin can have on them and their loved ones and they want to know how soon they can access this treatment. These calls show the tremendously high unmet need and that patients are urgently seeking reliable and durable treatment options for their RDEB wounds. Many of the callers have told us that they are not satisfied with the currently available treatments either because in their opinion these treatments are not reliably healing their wounds or they are burdened by the continuous and potentially lifelong administration of the current options. LevaSkin is the only treatment proven to reliably close not just small wounds, but large wounded regions of the body with a single treatment application. With Lurie Children's activated as the first ZevaSkin qualified treatment center, Doctor.

Madhav Vasanthavada
Madhav Vasanthavada
Senior VP, Chief Commercial Officer & Head of Business Development at Abeona Therapeutics

Amy Parler and her team at Lohrey can now begin to schedule their identified patients for treatment with ZevaSkin. Our teams will support Lohrey as they identify eligible patients and secure the necessary payer authorizations, which we expect will take several weeks initially. We are currently anticipating the first patient to be biopsied in July 2025 and to receive this treatment in August 2025. In addition to LURI, we are on track to activate other geographically dispersed QTCs by the end of twenty twenty five. Like Lurie's, the other hospitals we are in discussions with are well recognized institutions with cell and gene therapy infrastructure and experience improving providing specialized care for ED patients.

Madhav Vasanthavada
Madhav Vasanthavada
Senior VP, Chief Commercial Officer & Head of Business Development at Abeona Therapeutics

As we've previously mentioned, we expect to see a gradual ramp up at QTCs with centers getting accustomed to ZevaSkin treatment process and the patient journey through treatment of their first one or two patients. With this initial treatment experience, we then expect a greater uptake of ZevaSkin at each QTCs over time. With the already existing number of ZevaSkin eligible patients at these large QTCs and the strong inbound interest we have begun to see through EYLEAN ASSIST, we remain optimistic about our ability to achieve our 2025 goal of treating 10 to 14 patients as we previously guided and look forward to a robust start to 2026. Beyond the positive response from patients, we are equally excited to see the enthusiasm from the ED physician community on the news of ZYNASKIN approval. Last week, we had very successful physician engagements at the Society for Investigative Dermatology Annual Meeting.

Madhav Vasanthavada
Madhav Vasanthavada
Senior VP, Chief Commercial Officer & Head of Business Development at Abeona Therapeutics

Our two late breaking scientific abstracts that Wish mentioned were very well received. Also Doctor. Gene Tang, one of the prominent ED experts and the lead investigator of our VITAL Phase three study gave an oral presentation on ZivaSkin's clinical data to a highly engaged audience and generated interest. We also held an advisory board meeting at the SID meeting with an interdisciplinary group of ED physicians from our potential QTCs. The group was excited about ZevaSkin's approval and was eager to discuss the immediate next steps to putting their identified patients on ZevaSkin treatment and we had a productive discussion.

Madhav Vasanthavada
Madhav Vasanthavada
Senior VP, Chief Commercial Officer & Head of Business Development at Abeona Therapeutics

Over the past two weeks, we have also made significant strides in ensuring that the value of ZivaSkin is recognized by payers and that patients have timely and broad access to this therapy. We are actively progressing discussions around outcomes based agreements, reinforcing our confidence in Zevoskin's real world impact and supporting favorable access for patients. We're especially excited to announce that we have now executed outcomes based agreements with two payer contracting organizations. The first with Anton Rx, a leading pharmacy solutions provider representing several regional commercial and managed Medicaid payers and the second with one of the largest medical connectives serving approximately 100,000,000 commercially insured lives. These two agreements represent a significant milestone in our efforts to ensure ZivaSkin reaches the patients who need it most.

Madhav Vasanthavada
Madhav Vasanthavada
Senior VP, Chief Commercial Officer & Head of Business Development at Abeona Therapeutics

Additionally, we are continuing to actively engage with several well recognized commercial payers and all state Medicaid programs to further expand ZivaSkin access to eligible patients across the country and we'll keep you updated on our progress. With that, I would like to hand the call over to our Chief Financial Officer, Joe Vazano to discuss our financial results. Joe?

Joseph Vazzano
Joseph Vazzano
Chief Financial Officer at Abeona Therapeutics

Thanks, Manav. I would like to remind everyone that you can find additional details on our financial results for the three months ended 03/31/2025 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 $84,500,000 as of 03/31/2025, before accounting for the proceeds pending the closing of the PRV sale. This compares to $98,100,000 as of 12/31/2024. The proceeds from our PRV sale once the transaction is closed will fully fund our operations for over two years, extending our runway through the point of projected ZivaSkin driven profitability in early twenty twenty six.

Joseph Vazzano
Joseph Vazzano
Chief Financial Officer at Abeona Therapeutics

This robust financial footing achieved even before ZevaSkin revenues have begun eliminates the need to raise additional capital to reach this crucial commercial milestone. Research and development expenses were $9,900,000 for the quarter ended 03/31/2025 compared to $7,200,000 for the quarter ended 03/31/2024. The increase was primarily due to increased headcount related to scale up of manufacturing capacity in preparation for the planned ZivaSkin commercial launch and preclinical development work. Our spend on general and administrative activities was $9,800,000 for the quarter ended 03/31/2025 compared to $7,100,000 for the quarter ended 03/31/2024. The increase was primarily due to increased headcount associated with the planned launch of VIVUSKIN.

Joseph Vazzano
Joseph Vazzano
Chief Financial Officer at Abeona Therapeutics

Net loss was $12,000,000 for the first quarter of twenty twenty five or $0.24 loss per common share as compared to $31,600,000 or $1.16 loss per common share for the first quarter of twenty twenty four. In terms of upcoming Investor Relations activities, we will be participating in the Jefferies Global Healthcare Conference in early June. And with that, I will open the call for Q and A. Operator, please open the Q and A session.

Operator

Thank you. At this time, we'll be conducting our question and answer session. Our first question is coming from Raycroft with Jefferies. Your line is live.

Amin Makarem
Amin Makarem
Vice President, Biotech Equity Research at Jefferies

Hi. This is Amin on for Maury. Thank you for taking our questions. Two from us. First, congrats on the activation of the first site.

Amin Makarem
Amin Makarem
Vice President, Biotech Equity Research at Jefferies

Related to that, what exactly do you mean when you say the site is activated? Does it include that the staff and surgeons are all trained at this point? And then the second question is related to well, mentioned about the number of RDEF patients at Laurier Hospital, but specifically how many RDEF patients are eligible for PZ cell at this treatment center? And in general, how about the other treatment centers? How many RDEF patients do you think they are eligible at these centers as well for PZ cell?

Vishwas Seshadri
Vishwas Seshadri
CEO & Director at Abeona Therapeutics

You. Mean go ahead, Madhu.

Madhav Vasanthavada
Madhav Vasanthavada
Senior VP, Chief Commercial Officer & Head of Business Development at Abeona Therapeutics

Thank you. Yes. So, I mean to your first question, the definition of activation and whether these sites are trained, yes, they are right now trained and every all of the processes within these institutions have been taken care of. They are in a position to have their patients identified for ZivaSkin and begin the process to get payer authorizations. And once we have the payer approval for these patients, they can already start to slot their patients for a manufacturing schedule.

Madhav Vasanthavada
Madhav Vasanthavada
Senior VP, Chief Commercial Officer & Head of Business Development at Abeona Therapeutics

So they have the ability to go ahead with patient identification and scheduling manufacturing. With regards to the patients with Amy Parler with Doctor. Amy Parler and her institution, there are we don't know the exact number of eligible patients. But from our prior discussions, are at least a couple of dozen of patients that Doctor. Amy Poller and her institutions treat within their own institutions.

Madhav Vasanthavada
Madhav Vasanthavada
Senior VP, Chief Commercial Officer & Head of Business Development at Abeona Therapeutics

But then also there are other physicians from the local community that we are hearing are in touch with her and referring their patients over to Lutz children. So we do think that over time these patients' count is going to build and there are going to be more patients identified from this center. Thank you.

Operator

Thank you. Our next question is coming from Kristen Kluska with Cantor Fitzgerald. Your line is live.

Richard Miller
VP - Biotech Equity Research at Cantor Fitzgerald

Hello. This is Rick Miller on for Kristen. Thanks for taking our questions. We'll start with one and then maybe a follow-up. So for the Lohrey Children's Center, were there any specific factors that led

Madhav Vasanthavada
Madhav Vasanthavada
Senior VP, Chief Commercial Officer & Head of Business Development at Abeona Therapeutics

beyond just the clinical manifestation of these patients also the insurance and the type of insurance that these patients have? We think that commercially insured patients would have faster access just because of the way that the insurance companies work relative to the Medicaid plans, which may take a few more extra months to open up the access. And so based on that factor and as well as the patient preference and how soon they can come for treatment, we'll be able to smart these patients in manufacturing schedules. But that also all works out fine in our particular case just because given our manufacturing and the supply ramp that we had described in the past where it gave us a chance with July as the first potential treatment slot, we have sufficient headroom to be able to smart these patients depending on how their access also works out.

Richard Miller
VP - Biotech Equity Research at Cantor Fitzgerald

Thank you. And maybe just one quick follow-up if I may. Thanks for the color on the calls and e mails that you said you're receiving from the Abeona assist reach outs. So is there anything you're getting from these conversations about what the wound profile here Are these mostly patients with these kind of larger chronic wounds along with a mix of other wounds?

Richard Miller
VP - Biotech Equity Research at Cantor Fitzgerald

Or is this sort of a different kind of distribution than what you kind of saw in the clinical experience? Thank you.

Madhav Vasanthavada
Madhav Vasanthavada
Senior VP, Chief Commercial Officer & Head of Business Development at Abeona Therapeutics

It's hard to comment exactly their wound profile or characteristics because it's really our ABONAI assist team that is engaging with them. But the context we can provide is these are patients what we know they are they all have large areas of their body typically based on the natural history study average patients has at least a third of their body that is wounded. And some of the patients have said they have waited their entire life for having reliable treatment options as well as we are seeing patients across all age ranges from both across pediatric patients as well as adult patients. We've got children of adult patients who are calling in to see how soon they can access as well as caregivers of younger patients. So it seems to be across all of the age spectrum and across all of the age range I mean across all of the different regions of the country. It seems to be people with multiple level of wound burden as well.

Vishwas Seshadri
Vishwas Seshadri
CEO & Director at Abeona Therapeutics

Just to add to that also

Vishwas Seshadri
Vishwas Seshadri
CEO & Director at Abeona Therapeutics

Rick, it's also somewhat challenging for us to know on a patient by patient basis because what we get is a consolidated view or kind of an update because this is managed by a separate team. And so we don't have patient by patient health information, but we just get kind of an insights on what is the overarching patient types that are generally calling in. So that's why it's hard to place too much detail on the wound type, chronicity, location, those types of details yet.

Richard Miller
VP - Biotech Equity Research at Cantor Fitzgerald

Okay. Understood. Thank you for sharing that.

Operator

Thank you. Our next question is coming from Stephen Willey with Stifel. Your line is live.

Stephen Willey
Managing Director at Stifel Institutional

Yeah. Good morning. Thanks for taking the question and congrats on the progress. I was just wondering if you could maybe provide some color around what the prospective QTCs that you're looking at now have intimated about patient throughput? I guess both in terms of what patient volumes might look like at launch and maybe where that metric might go once logistics are optimized?

Stephen Willey
Managing Director at Stifel Institutional

And do you expect to see much variance in this throughput capacity across the QTCs that you intend to bring online? And then I just have a quick follow-up.

Madhav Vasanthavada
Madhav Vasanthavada
Senior VP, Chief Commercial Officer & Head of Business Development at Abeona Therapeutics

Yes, Steven. Thanks for that question. In terms of the patient throughput early on at the time of launch, we do think that there are patients. As I mentioned also at the ad board that we did last week, where we had physicians from basically all of our target qualified treatment centers around the table. And they were discussing about their identified patients in their mind they already have queued up.

Madhav Vasanthavada
Madhav Vasanthavada
Senior VP, Chief Commercial Officer & Head of Business Development at Abeona Therapeutics

So we think that the way this would work is they will have first few patients going in their mind they want to treat patients who have large contiguous areas of their body that's wounded first. And of course with every production you're getting up to 12 sheets that can be manufactured right? So it's not just one or two wounds. You can pretty much cover large areas of the body. So these physicians are thinking about that to tackle those patients first.

Madhav Vasanthavada
Madhav Vasanthavada
Senior VP, Chief Commercial Officer & Head of Business Development at Abeona Therapeutics

And then they're already thinking about their then the next sort of tier of patients will be those who have discrete wounds in various anatomical regions. So in terms of throughput to put some numbers, even if when we post to them at two patients a month, two patients every month per site, because that's going to with our 10 patients a month capacity and five treatment sites at steady state that's easily doable for these physicians. They are not like thinking twice about that. Nobody had actually put any resistance to that. Now this is from their respective QTCs, right?

Madhav Vasanthavada
Madhav Vasanthavada
Senior VP, Chief Commercial Officer & Head of Business Development at Abeona Therapeutics

We will over time begin to also talk to other centers of excellence and have those patients referred in into these QTCs. So at these kinds of throughput two patients a month per treatment center is doable. As part of our onboarding process, as we speak with certain QTCs, other institutions have as their pro form a also have indicated that they would like to go to four patients a month, just because they have enough throughput capacity at their centers and sufficient bed capacity and things of that nature. So we are the type of numbers that we are talking about here is very much doable. It's really going to be the first couple of patients that they will put through the treatment and then ramp it up in 2026.

Madhav Vasanthavada
Madhav Vasanthavada
Senior VP, Chief Commercial Officer & Head of Business Development at Abeona Therapeutics

So, we'll see how this goes, but we are optimistic.

Stephen Willey
Managing Director at Stifel Institutional

Okay. That's very helpful color. And then maybe just wondering how we should be thinking about the prioritization of the earlier stage pipeline now that you have improved visibility into the balance sheet. I mean, you obviously have a lot on your plate right now, the Seamusken right now. But just curious if the sense of urgency at all around the pipeline has kind of changed at all following the PRV sale? Thanks.

Vishwas Seshadri
Vishwas Seshadri
CEO & Director at Abeona Therapeutics

Thanks for that question, Steve. As we've communicated earlier, we have two assets ARVO, which is the big ophthalmology scientific congress that happened recently. We had some very interesting data from our RX1 program. We're all very excited about bringing this to clinic for human studies second half of twenty twenty six. And that is still on track.

Vishwas Seshadri
Vishwas Seshadri
CEO & Director at Abeona Therapeutics

Even though we haven't talked much about it in the background that work has been happening. We have clear instructions from our pre IND meeting from the FDA on what's required to take these assets to clinical trials. So that at least one asset from our ophthalmology pipeline going into clinic in the second half of twenty twenty six is very much on track. In terms of acceleration, I think there is things have to happen like for example the animal experiments are going on and that only happens at a certain pace. You have to do the follow-up required and all that is cannot be really sped up in any way.

Vishwas Seshadri
Vishwas Seshadri
CEO & Director at Abeona Therapeutics

But this is a good natural cadence for our pipeline going into clinic because by then we would have established our run rate for commercial performance as well. So it fits very nicely with our as we ramp up our XevaSkin commercial progress here. And of course the other preclinical programs will follow on the heels of the first one which is RS1. And what is very encouraging about these programs is with ophthalmology gene therapy we're not the manufacturing in CMC is not as intense as it is for an autologous product. So this can and this is all managed through CDMOs.

Vishwas Seshadri
Vishwas Seshadri
CEO & Director at Abeona Therapeutics

So it's not putting additional burden on our company per se and at manageable pace of spending. So that's really how we are looking at it. But from a developing data perspective, you're going to hear more and more in the upcoming scientific congresses as we generate these animal data. And what we see so far is very encouraging.

Stephen Willey
Managing Director at Stifel Institutional

All right. Very good. Thanks for taking the questions.

Vishwas Seshadri
Vishwas Seshadri
CEO & Director at Abeona Therapeutics

Thank you, Steve.

Madhav Vasanthavada
Madhav Vasanthavada
Senior VP, Chief Commercial Officer & Head of Business Development at Abeona Therapeutics

Thank you.

Operator

Thank you. Our next question is coming from Ram Selvaraju with H. C. Wainwright.

Operator

Your line is live. So Rob, I think you might be on mute.

Raghuram Selvaraju
Managing Director, Healthcare Equity Research at H.C. Wainwright & Co., LLC

Can you hear me now?

Operator

Yes, sir.

Vishwas Seshadri
Vishwas Seshadri
CEO & Director at Abeona Therapeutics

Yes.

Raghuram Selvaraju
Managing Director, Healthcare Equity Research at H.C. Wainwright & Co., LLC

So I just wanted to see if you could provide us with some additional granularity regarding how you expect to scale up commercial supply as and when demand progresses to that point and the degree to which you have sufficient commercial bandwidth now to meet the demand of x number of patients? Also this question is for Joe. Can you just clarify for us what you expect the net proceeds to Abeona to be from the sale of the PRV? And if you can give us a sense of what you anticipate pro form a cash to be at the end of the second quarter? Thank you.

Vishwas Seshadri
Vishwas Seshadri
CEO & Director at Abeona Therapeutics

Thank you, Ram. Maybe Joe you can take that question first and then we'll move to Brian for the manufacturing scale up.

Joseph Vazzano
Joseph Vazzano
Chief Financial Officer at Abeona Therapeutics

Sure. Yes. So the net proceeds from the PRV sale once it closes the HSR will be about $152,000,000 or so. And so I mean it's tough to project ending cash as of June. Not sure if it will clear that time period by then, but we can expect about $152,000,000 net proceeds from the PRB.

Joseph Vazzano
Joseph Vazzano
Chief Financial Officer at Abeona Therapeutics

We don't owe anything, any liabilities on that PRB. It's all of ours.

Vishwas Seshadri
Vishwas Seshadri
CEO & Director at Abeona Therapeutics

Brian, the other question was yes, ahead.

Operator

Yes, how about the manufacturing question?

Brian Kevany
Brian Kevany
Senior VP, CTO & CSO at Abeona Therapeutics

Yes.

Brian Kevany
Brian Kevany
Senior VP, CTO & CSO at Abeona Therapeutics

So, yeah, as we've previously communicated, we are at a capacity of roughly or four patients per month at launch, which is where we are right now. As the year continues and we onboard additional QTCs, we will be ramping six patients per month, with an anticipation of being at eight and ten patients per month, by early next year. For a little bit of context, we have and within our overall facility, we have two independent facilities that supply both. One supplies the drug product, the other supplies the vector that's used within the drug product manufacturing. As we ramp to 10 patients a month, we will be converting the vector side of the facility to also be supplying ZivaSkin for commercial manufacturing to allow us to get to that 10 patients per month.

Brian Kevany
Brian Kevany
Senior VP, CTO & CSO at Abeona Therapeutics

But we believe that that will scale well with the onboarding of the QTCs and the anticipated ramp in patient availability.

Raghuram Selvaraju
Managing Director, Healthcare Equity Research at H.C. Wainwright & Co., LLC

And just to clarify with sorry, just wanted to clarify. The 10 patients per month run rate can readily be addressed with your existing facility's bandwidth. You would not need to expand the facility footprint in order to meet 10 patients per month demand level. Is that correct?

Madhav Vasanthavada
Madhav Vasanthavada
Senior VP, Chief Commercial Officer & Head of Business Development at Abeona Therapeutics

Correct. Correct. Yes. The current facility will support that 10 patients per month.

Vishwas Seshadri
Vishwas Seshadri
CEO & Director at Abeona Therapeutics

And just to give a little bit more context Ram, what we talked about in terms of expansion is actually beyond the 10 patients a month for which additional GMP space is being designed. The design is almost complete now and we're commissioning starting of building out that GMP space which can add roughly about the same number of slots per month. The exact number of slots we just need to finalize and we'll communicate soon. But that part of the facility will be ready to for slots for commercial manufacturing somewhere in the second half of twenty twenty seven.

Raghuram Selvaraju
Managing Director, Healthcare Equity Research at H.C. Wainwright & Co., LLC

And this would also be based in Cleveland. Is that correct?

Vishwas Seshadri
Vishwas Seshadri
CEO & Director at Abeona Therapeutics

Yes. Cleveland same building the same floor.

Raghuram Selvaraju
Managing Director, Healthcare Equity Research at H.C. Wainwright & Co., LLC

Okay. And then just very quickly for Madhav. I was wondering if at this point you have some sense of the prior treatment history of certain RDEB patients who might be considered candidates for PZ cells. And if you are seeing at this juncture specific possibilities of treating patients with PZ cells who previously had been treated with VYJUVEC or even with Filsuvez? And how that situation seems to be shaping up?

Raghuram Selvaraju
Managing Director, Healthcare Equity Research at H.C. Wainwright & Co., LLC

And how you expect it to evolve going forward just in terms of prior treatment history with other approved RDEB products? Thank you.

Madhav Vasanthavada
Madhav Vasanthavada
Senior VP, Chief Commercial Officer & Head of Business Development at Abeona Therapeutics

Right. We think that at this point in time majority will be previously exposed to prior treatments both VYZUVEC as well as PRUZUVEC. And that's what we hear also not just from patients, but also from the physicians. And they're all pretty comfortable with that discussion also. In fact, that was also a point of our conversation.

Madhav Vasanthavada
Madhav Vasanthavada
Senior VP, Chief Commercial Officer & Head of Business Development at Abeona Therapeutics

So over time, we with that said, there are patients that we hear who have not gotten any of the previous treatment, right? But that's relatively we don't know what percent, but it's minority is what we would think. Let's say over time, we do expect we expect that pretty much to be the case because these patients will require as many treatment options that they can get just because of their wound modalities and such. So, we'll continue to track that as we get into real treatments.

Operator

Thanks, Yi. Our next question is coming from James Malloy with Alliance Global Partners. Your line is live.

James Molloy
Managing Director, Equity Research, Biotechnology & Specialty Pharmaceuticals at Alliance Global Partners

Hey, guys. Good morning. Thanks for taking my questions. Congrats on the prior approval as well. Any word on who you guys the Hudson's got the provisions you're waiting for that?

James Molloy
Managing Director, Equity Research, Biotechnology & Specialty Pharmaceuticals at Alliance Global Partners

Any word on who you sold it to? Is that something you won't be able to release? And then Joe had mentioned on the PRV that profitable by picking up 26%. Is that EPS profitable or cash profitable?

Joseph Vazzano
Joseph Vazzano
Chief Financial Officer at Abeona Therapeutics

Yes. So in regards to the buyer of the PRB that's undisclosed. And yes, for 2026, yes, I'm anticipating positive EPS.

James Molloy
Managing Director, Equity Research, Biotechnology & Specialty Pharmaceuticals at Alliance Global Partners

Okay. And then last question is, has the acquisition and potentially having $220,000,000 or so on the books, does that increase any inbound calls for potential acquisitions?

Vishwas Seshadri
Vishwas Seshadri
CEO & Director at Abeona Therapeutics

Hi, Jim. I think it's premature to address that question. But we when we have any updates, we will definitely bring that out to share. But at this time, we don't have any updates on that front.

James Molloy
Managing Director, Equity Research, Biotechnology & Specialty Pharmaceuticals at Alliance Global Partners

Okay. Thanks for taking the questions.

Vishwas Seshadri
Vishwas Seshadri
CEO & Director at Abeona Therapeutics

Thank you, Jim.

Operator

Thank you. Our next question is coming from David Boutes with Zacks SmallCap Research. Your line is live.

David Bautz
Senior Analyst at Zacks Small Cap Research

Hey, good morning everyone. Thanks for taking the question and congrats on the progress. I was wondering if you could just kind of remind us of how billing and reimbursement is going to work. For example, you've got a patient who's expected to be biopsied in July and treated in August. I'm just curious how long do you anticipate the time frame being from when that patient is treated or biopsied to when Abeona gets payment for that therapy?

David Bautz
Senior Analyst at Zacks Small Cap Research

And is that going to be different for all the different treatment centers? Or will that kind of be uniform?

Madhav Vasanthavada
Madhav Vasanthavada
Senior VP, Chief Commercial Officer & Head of Business Development at Abeona Therapeutics

Yes. So thanks, Vish. So on the topic of payment, I mean revenue recognition itself will happen right after the patient is treated David. And so that's sort of as far as recognizing the revenue. In terms of the payment and the cash itself that will really depend.

Madhav Vasanthavada
Madhav Vasanthavada
Senior VP, Chief Commercial Officer & Head of Business Development at Abeona Therapeutics

We are still in discussions with the qualified treatment centers on that topic. But it will be on par with any other cell and gene therapy in terms of the payables. But these are large institutions who have experience doing other cell and gene therapy. I mean, think from that standpoint, it's looking like it will crack along the same lines. But before any patient is placed on treatment, at least from the provider standpoint or the hospital standpoint, there will be pre negotiated or there will be discussions already with insurance companies.

Madhav Vasanthavada
Madhav Vasanthavada
Senior VP, Chief Commercial Officer & Head of Business Development at Abeona Therapeutics

So it's not like they're up for a surprise that they have treated the patient and they don't know whether they're to get reimbursed or not on the back end. So we do anticipate a very high level of certainty that if a patient is treated and surgically treated then that's going to result in revenue recognition and cash incoming.

David Bautz
Senior Analyst at Zacks Small Cap Research

Okay. Thanks for that.

Vishwas Seshadri
Vishwas Seshadri
CEO & Director at Abeona Therapeutics

David, just to add to that right? This explains why there is a little bit of a lead time even between approval and treating our first patient because even though we have a site activated now and while the policies are being put in place by the various commercial insurers in the meanwhile these sites will be working on a case by case basis to make sure that reimbursement is kind of dealt with upfront before they take up a manufacturing slot because they don't want that risk on them, right? So that explains why there's a little bit of a lead time even to get the trains started.

David Bautz
Senior Analyst at Zacks Small Cap Research

Right. Okay. Understood. So for the approximately 30 patients that you indicated you've received inbound interest on, are all these patients looking to go to Children's Hospital Chicago? Or are they just trying to get their name in the queue? Like what are they interested in doing there?

Madhav Vasanthavada
Madhav Vasanthavada
Senior VP, Chief Commercial Officer & Head of Business Development at Abeona Therapeutics

Yeah. It's more of the latter at this point in time. These are we just wanted to get sort of the idea of the number of patients who have already called in, in the last two weeks. And at that point, we didn't have a qualified treatment center announced. So it's more about the queuing up of these patients.

Madhav Vasanthavada
Madhav Vasanthavada
Senior VP, Chief Commercial Officer & Head of Business Development at Abeona Therapeutics

And now that we have announced LURIs, we will certainly let these patients know. The next step would be for these patients then to enroll in our ADUNA ESS program, so that they can continue to get more information and updates and or directly reach out to Doctor. Parler and her staff. So that is certainly another option. Plus also other patients who haven't called avioni assist also now are aware.

Madhav Vasanthavada
Madhav Vasanthavada
Senior VP, Chief Commercial Officer & Head of Business Development at Abeona Therapeutics

So even if we think a fraction of these 30 patients do sign up and enroll in our program, we've got sufficient initial inbound interest.

David Bautz
Senior Analyst at Zacks Small Cap Research

Yes, absolutely. All right. Thanks for taking the questions.

Vishwas Seshadri
Vishwas Seshadri
CEO & Director at Abeona Therapeutics

Thank you, David.

Operator

Thank you. As we have no further questions on the line, I'd like to hand it back to Mr. Vish Sisadri for any closing remarks.

Vishwas Seshadri
Vishwas Seshadri
CEO & Director at Abeona Therapeutics

Thank you, Ali, and thank you everyone for joining us for today's business update. As you can see a lot of progress has been made very quickly this year in 2025 and we look forward to bringing you more updates on the commercial launch progress very soon. So have a wonderful day and we'll talk soon. Bye bye.

Operator

Thank you. Ladies and gentlemen, this does conclude today's call. You may disconnect your lines at this time and we thank you for your participation.

Executives
    • Greg Gin
      Greg Gin
      Vice President, Investor Relations and Corporate Communications
    • Vishwas Seshadri
      Vishwas Seshadri
      CEO & Director
    • Madhav Vasanthavada
      Madhav Vasanthavada
      Senior VP, Chief Commercial Officer & Head of Business Development
    • Joseph Vazzano
      Joseph Vazzano
      Chief Financial Officer
    • Brian Kevany
      Brian Kevany
      Senior VP, CTO & CSO
Analysts
    • Amin Makarem
      Vice President, Biotech Equity Research at Jefferies
    • Richard Miller
      VP - Biotech Equity Research at Cantor Fitzgerald
    • Stephen Willey
      Managing Director at Stifel Institutional
    • Raghuram Selvaraju
      Managing Director, Healthcare Equity Research at H.C. Wainwright & Co., LLC
    • James Molloy
      Managing Director, Equity Research, Biotechnology & Specialty Pharmaceuticals at Alliance Global Partners
    • David Bautz
      Senior Analyst at Zacks Small Cap Research
Powered by Quartr

Key Takeaways

  • Abeona is now a commercial‐stage cell and gene therapy company after FDA approval of ZevaSkin, the first autologous cell‐based gene therapy for RDEB offering significant wound closure and pain reduction in a single application.
  • The first Qualified Treatment Center was activated ahead of schedule at Lurie Children’s Hospital, with patient identification and scheduling underway and the first treatment expected in Q3 2025.
  • Late‐breaking data at the Society for Investigative Dermatology meeting demonstrated durable collagen VII expression, sustained wound closure, and no treatment‐related cancers, reinforcing ZevaSkin’s favorable benefit–risk profile.
  • Abeona entered an agreement to sell its Priority Review Voucher for $155 million, and combined with existing cash reserves, will fund operations into early 2026, supporting a path to profitability without additional capital raises.
  • The company has secured outcomes‐based contracts with two major payer organizations covering nearly 100 million lives and plans to scale manufacturing to treat up to ten patients per month using its existing facilities.
AI Generated. May Contain Errors.
Earnings Conference Call
Abeona Therapeutics Q1 2025
00:00 / 00:00

Transcript Sections