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Good day and welcome to the Abeona Therapeutics First Quarter 2025 Conference Call. At this time all participants are in a listen only mode and a question and answer session will follow the formal presentation. [Operator Instructions]. Please note this conference is being recorded. I will now turn the conference over to your host Mr. Greg Gin. Sir, you may begin.

Thank you Ali and good morning and thanks everyone for joining us on our first quarter 2025 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.abeonatherapeutics.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. 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 10K and periodic reports filed with the SEC. These documents are available on our website at www.abeonatherapeutics.com. Joining me today on today's call with prepared remarks are Dr. Vish Seshadri, Chief Executive Officer, Dr. Madhav Vasanthavada, Chief Commercial Officer and Joe Vazzano, Chief Financial Officer. Also, Dr. Brian Kevany, Chief Technical Officer will join us for the Q&A session. And with that I will now turn the call over to Vish Seshadri to lead us off. Vish.

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

Thanks, Vish, and hello, everyone. It has been about two weeks since

Thanks, Madhav. I would like to remind everyone that you can find additional details on our financial results for the three months ended March 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 $84.5 million as of March 31, 2025, before accounting for the proceeds pending the closing of the PRV sale. This compares to $98.1 million as of December 31, 2024. The proceeds from our PRV sale, once the transaction has closed, will fully fund our operations for over two years, extending our runway through the point of projected

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

Hi. This is Amin [ph] on for Maury. Thank you for taking our questions. Two from us. First, congrats on the activation of the first site. Related to that, what exactly do you mean when you say the site is activated? Does it include the staff and surgeons are all trained at this point? And then the second question is related to, well, you mentioned about the number of patients at the Lurie hospital, but specifically, how many are that patients eligible for P

Thank you, Amin. Go ahead, Madhav.

Thank you. Yes, Amin. So your first question, the definition of activation and whether these sites are trained, yes, they are right now trained and all of the processes within these institutions have been taken care of. They are in a position to have their patients identified for

Very helpful. Thank you.

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

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 Lurie Children's Center, were there any specific factors that led to this being the first one kind of over the line to getting activated? Is there anything special about the projected demand at this center? Any other factors you could say there? And if you can say anything about how Lurie Children's is kind of triaging its identified patients in the early stages of the launch here?

Yes, so I will say that we have been in touch with up to five centers, as we have been discussing, and it's a big credit to Lurie's Children just for the collaboration and the speed with which they have engaged with us just really again testifies the conviction that Lurie's has on

Thank you. And maybe just one quick follow-up, if I may. Thanks for the color on the calls and emails that you said you're receiving from the Abeona Assist reachouts. So is there anything you're getting from these conversations about what the wound profile here is starting to look like? Are these mostly patients with these kind of larger chronic wounds along with a mix of other wounds? Or is this sort of a different kind of distribution than what you kind of saw in the clinical experience? Thank you.

It's hard to comment exactly their wound profile or characteristics, because it's really our Abeona Assist team that is engaging with them. But the context we can provide is these are patients. What we know, they all have large areas of their body. Typically, based on the natural history study, average patient 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, across all of the different regions of the country. So it seems to be people with multiple level of wound burden as well.

And just to add to that also, 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 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.

Okay, understood. Thank you for sharing that.

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

Yes, 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 perspective 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. 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.

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, 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. So we think that the way this would work is they will have the first few patients going in their mind they want to treat patients who have large continuous areas of their body that's wounded. 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. And then they're already thinking about 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 two patients a month, two patients every month per site, because that's going to do with our 10 patients a month capacity and five treatment sites at steady state, that's easily doable for these physicians. They're not like thinking twice about that. Nobody had actually put any resistance to that. Now, this is from their respective QTCs, right? 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, the other institutions have, as their pro forma also 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 the types 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 '26. So we'll see how this goes, but we are optimistic.

Okay. That's a very helpful color. And then maybe just wondering how we should be thinking about the privatization 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,

Thanks for that question, Steve. As we 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 RS1 program. We're all very excited about bringing this to clinic for human studies second half of 2026. And that is still on track, 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 and the second half of 2026 is very much on track. In terms of acceleration, I think things have to happen, like, for example, the animal experiments are going on and that only happens at a certain pace. The follow-up required and all that cannot be really sped up in any way. 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, you know, as we ramp up our

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

Thank you, Steve.

Thank you. Our next question is coming from Ram Selvaraju with H.C. Wainwright. Your line is live. Sorry Ram, I think you might be on mute.

Can you hear me now?

Yes, sir.

Yes. 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 forma cash to be at the end of the second quarter? Thank you.

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

Sure. Yes, so the net proceeds from the PRV sale, once it closes the HSR, will be about $152 million 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 million net proceeds from the PRV. We don't owe anything, any liabilities on that PRV. It's all ours.

Brian, the other question was –

Yes, about the manufacturing question. So, yes, as we've previously communicated, we are at a capacity of roughly 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 to 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 – 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 ten patients a month, we will be converting the vector side of the facility to also be supplying

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

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

And just to give a little bit more context, Ram, what we talked about in terms of expansion is actually beyond the ten patients a month for which additional GMP space is being designed. The design is almost complete now, and we're commissioning the 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 for slots for commercial manufacturing somewhere in the second half of 2027.

And this would also be based in Cleveland, is that correct?

Yes. Cleveland, same building, the same floor.

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 P

Right. We think that at this point in time, the majority will be previously exposed to prior treatments, both the VYJUVEK as well as FILSUVE

Thank you. Our next question is coming from James Molloy with Alliance Global Partners. Your line is live.

Hi, guys. Good morning. Thanks for taking my questions. Congrats on the prior approval as well. Any word on who you guys, the Hartscott, the provision you're waiting for that? 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 second half of 26. Is that EPS profitable or cash profitable?

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

And the last question is, has the acquisition potentially have 220 million or so on the books? Has that increased any inbound calls for potential acquisitions?

Hi, Jim. I think it's premature to address that question, but 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.

Great. Thanks for taking the questions.

Thank you, Jim.

Thank you. [Operator Instructions]. Our next question is coming from David Bautz with

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 timeframe being from when that patient is treated or biopsied to when an Abeona gets payment for that therapy? And is that going to be different for all the different treatment centers, or will that kind of be uniform?

Madhav?

Yes, so thanks, Vish. So, on the topic of payment, I mean, revenue recognition itself will happen right after the patient is treated, David, so that's sort of as far as recognizing the revenue. In terms of the payment and the cash itself, that will really depend. We are still in discussions with the qualified treatment centers on that topic. But it'll 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 therapies. So, you know, I mean, I think from that standpoint, it's looking like it will track 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 the insurance companies. 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 going 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, you know, surgically treated, then that's going to result in revenue recognition and cash incoming.

Okay. Thanks for that.

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 the manufacturing slots 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 train started.

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

Yes, it's more of the latter at this point in time. These are – we just wanted to give sort of the idea of the number of patients who have already called 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. And now that we have announced Lurie, we will certainly let these patients know. The next step would be for these patients then to enroll in our Abeona Assist program so that they can continue to get more information and update and or directly reach out to Dr. Poller and her staff. So that is certainly another option. Plus also other patients who haven't called Abeona Assist also now are aware. So even if they think a fraction of these 30 patients, you know, do sign up and enroll in our program, we've got sufficient, you know, initial inbound interest.

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

Thank you, David.

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

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.