Abeona Therapeutics at Jefferies Conference: ZivaSkin’s Promising Launch

On Wednesday, 04 June 2025, Abeona Therapeutics (NASDAQ:ABEO) presented at the Jefferies Global Healthcare Conference 2025, unveiling strategic plans centered around the promising launch of ZivaSkin, a new therapy for Recessive Dystrophic Epidermolysis Bullosa. While the company reported positive initial feedback and financial stability, challenges remain in scaling manufacturing and expanding treatment centers.

Key Takeaways

• Abeona has secured $155 million from a PRV sale, supporting operations for two years.
• ZivaSkin’s pricing strategy is set at $3.1 million, justified by its long-term efficacy.
• The company aims to achieve profitability in early 2026, driven by ZivaSkin sales.
• Plans are underway to expand the network of Qualified Treatment Centers (QTCs) to five by the end of 2025.
• Abeona is exploring regulatory pathways for ZivaSkin in Western Europe and Japan.

Financial Results

• Cash Position: With $155 million from the PRV sale and $85 million in cash at the end of Q1, Abeona’s funds exceed $200 million, covering two years of operating expenses.
• Profitability: The company anticipates profitability by early 2026, targeting cash flow positivity with the treatment of 36 patients, potentially reaching 50.
• Gross to Net Adjustments: Expected to stabilize in the mid-to-upper teens percentage range, considering discounts and rebates.

Operational Updates

• ZivaSkin Launch: Positive feedback marks the launch, with Lurie Children’s Hospital as the first activated QTC. The goal is to treat 10-14 patients in 2025.
• Qualified Treatment Centers: Five centers are targeted for activation by the end of 2025, with an upper double-digit number of eligible patients expected.
• Manufacturing: Current capacity is four slots per month, with plans to increase to six by the end of 2025 and 10 by mid-2026. A manufacturing shutdown in December is anticipated to have minimal impact.

Future Outlook

• Capacity Expansion: Additional space is being secured to increase capacity beyond 10 slots per month, expected online by late 2027.
• Ex-US Expansion: Abeona is assessing regulatory and reimbursement pathways in major markets like Western Europe and Japan.
• Market Penetration: The focus is on reaching a 750-patient market in the U.S., with 30% concentrated in seven centers of excellence.

Q&A Highlights

• Early Patient Response: ZivaSkin has been well-received, with all approached patients expressing interest.
• Payer Engagement: Positive engagement with insurers, including coverage agreements for over 100 million lives.
• Channel Strategy: Offering both buy-and-bill and CVS specialty pharmacy models to treatment centers.

In conclusion, Abeona Therapeutics’ strategic plans for ZivaSkin and its financial outlook were detailed at the Jefferies Global Healthcare Conference 2025. For a complete understanding, readers are encouraged to refer to the full transcript below.

Full transcript - Jefferies Global Healthcare Conference 2025:

Unidentified speaker: Good. You

Madhav Visanavada, Chief Commercial Officer, Abiona: guys all set? Yeah.

Unidentified speaker: We’re all set, if you can hear

Madhav Visanavada, Chief Commercial Officer, Abiona: us. Hi,

Maury Raycroft, Biotech Analyst, Jefferies: everyone. My name is Maury Raycroft, and I’m one of the biotech analysts at Jefferies. It’s with great pleasure that I’d like to welcome the team from Abiona. We’ve got the CEO, Vish Sahadri, and Madhav Visanavada, the Chief Commercial Officer, and then Joe Visanno, CFO. Thanks so much for joining us today.

Unidentified speaker: Thank you for having us.

Maury Raycroft, Biotech Analyst, Jefferies: And we’re going do fireside chat format. So for those who are new to the story, maybe give a one minute intro to Abiona and your recently approved transformational therapy for RDEB.

Unidentified speaker: Sure. And even if you’re not new to the story, we have a new story, which is we are a commercial stage cell and gene therapy company with the approval of Ziva Skin just over a month ago. And this is for patients with recessive dystrophic epidermolysis bullosa and treating their wounds. And with the approval, we also got a PRV grant. And we announced that we are in a sale agreement for $155,000,000 with those proceeds.

We’re funded for eight quarters of our operations without even accounting for the revenue generation. And so we do anticipate being a profitable company early half of twenty twenty six. And our partner programs with Ultragenyx and Tasia are also doing very well. Ultragenyx asset UX one hundred eleven has a PDUFA date that is coming up in August as well. So with all that, I can just say that we’re a grossly undervalued company at a market cap of about $300,000,000 Great opportunity.

Maury Raycroft, Biotech Analyst, Jefferies: Yeah. Great overview for Abiona. And I want to talk about the launch for RDEB. And so you’ve mentioned Lurie Children’s Hospital now activated as the first qualified treatment center. What specific metrics are you tracking at this site, such as patient throughput and referral volume from other centers of excellence?

Madhav Visanavada, Chief Commercial Officer, Abiona: Yeah. I’ll start off by saying that just about a month into launch, as Vish mentioned, and the feedback that we are hearing from multiple stakeholders has been very positive. I mean, the standard of therapy that exists right now for recessive Deb is just not bending the trajectory of this disease and the progression. And with ZivaSkin, what we are able to bring is with a single treatment application, ability to cover large areas of the body, regions of the body with long lasting efficacy and outcome. And because it’s autologous, we are working with treatment centers to get them activated.

And LURI’s was one of our first treatment center that has activated. And now with that, we are able to track the number of patients. We are learning more about the patients that are getting referred into LURIs from adjacent areas. And as we learn more, we’ll be able to communicate the actual numbers because there are steps that have to happen between identifying a patient and eventually placing them on therapy. But overall, the launch is off to a good start.

Maury Raycroft, Biotech Analyst, Jefferies: Got it. Okay. And can you give an update on the latest number of QTCs that are online or expected to come online soon? And when should we expect the next site activation? And what’s your timeline to fully activate all five centers?

Madhav Visanavada, Chief Commercial Officer, Abiona: Timeline to fully activate all five is by the end of this year. And we are actively working with these various other centers. And every center is working at a different pace. So we’ll keep them activated I mean, everyone informed. It’s hard to tell as to what’s going to be the next center.

But the site activation also maps up to our supply ramp capacity. As we get more centers onboarded, that also matches up with how many supply slots we have. So that’s a good cadence there.

Maury Raycroft, Biotech Analyst, Jefferies: Got it. And for these five centers, maybe just talk about how many total eligible patients are currently being treated at these centers? And how many do you expect will ultimately get the therapy?

Madhav Visanavada, Chief Commercial Officer, Abiona: So across the five centers, we believe there’s about upper double digit number of patients that are PC cell eligible. And as we have more active centers, then yes, then begin to start placing them on therapies. But if you look at these double digit number of patients, even if a fraction of them get on treatment, they’ve got enough demand to take us through this year and into the first quarters of next year before even triggering any referral activities from other centers into these QTCs. So there’s sufficient bolus of patients.

Unidentified speaker: And just to be clear, the numbers that Madhav was stating is those that are organically de novo patients being treated for other things in these centers already, right? So not specifically for referring it to a ZivaSkin site or anything. So that should even ramp up the numbers a little bit.

Maury Raycroft, Biotech Analyst, Jefferies: Got it. And just from the early experience at Lurie’s specifically, how have patients responded when the new therapy is proposed? And roughly what percentage of eligible patients are open to getting ZivaSkin?

Madhav Visanavada, Chief Commercial Officer, Abiona: The reaction has been very positive. In speaking with some of the physicians, none of the patients that were approached for Ziva Skin said they are not interested. So it’s overwhelmingly positive. Patients have reached out to physicians to asking more about this treatment and the process to getting this treatment. So far, it’s been exactly as we had thought that it will play out.

Maury Raycroft, Biotech Analyst, Jefferies: Got it. Okay. And last time we spoke, you talked about the Avionna Assist and that you’ve had 30 patient inquiries through that. Do have an update on just the call volume and interest for Xenoscan?

Madhav Visanavada, Chief Commercial Officer, Abiona: Yeah. First, I’ll say that the call volume, the 30 patients that we talked about, is just a sliver. There are other channels, right? And it’s not the universe of patients that have called in. There are many other ways, which is the qualified treatment centers themselves and these physicians who are seeing those patients.

So we don’t have the full visibility into that pool of patients yet. But even if you were to just look at the 30 patients, the initial interest, and you convert a fraction of those patients into treatment, again, going to our supply capacity and the ramp, which we have said about 10 to 14 patients this year, we will have treated and met our goals for this year and leading into next year.

Maury Raycroft, Biotech Analyst, Jefferies: Got it. And how do you triage the leads that come in, maybe through Avionna Assist or from elsewhere? And just how are you kind of setting up for these patients to get treated, given the limited treatment window and manufacturing capacity?

Madhav Visanavada, Chief Commercial Officer, Abiona: So triaging the patients, it really depends on patient’s preference. I mean, patients that are closer to Lurie’s of these patients who have called in are more inclined towards going to Lurie’s children right now. There are some patients who want to see as to what other treatment centers are coming up online. But the fact of the matter is that even though these are 30 initial inbounds, the level of engagement remains. These are not callers who have called us once and then hung up their phone.

There’s active dialogue back and forth that’s going on with the patients who have called in already.

Maury Raycroft, Biotech Analyst, Jefferies: Got it. Makes sense. And then your treatment window appears to run from August when you expect to enroll the first and treat the first patient through November before the December shutdown, what operational metrics are in place to ensure that you meet your 10 to 14 patient treatment goal for 2025?

Unidentified speaker: The first and foremost is the number of slots, manufacturing slots, that we have prepared for this year. It’s more than sufficient to meet that 10 to 14. Initially, we’re going to be operating at a ratio of many slots that we have released will be engineering runs. And a couple maybe in the first month, a couple commercial runs, and then maybe four slots or so, maybe engineering runs. And then as we go closer to November, we’ll phase out the engineering and ramp up more commercial slots.

This is routine practice because we’ve trained a lot of new people. You don’t want to put them all on a commercial run. But if you really add up from a slots perspective, we feel that we have enough of a buffer above the 10 to 14 to be able to supply this year.

Maury Raycroft, Biotech Analyst, Jefferies: Got it. So could go beyond 14 if need be, or if it works out that way? Correct. Okay. And how will the planned December manufacturing shutdown impact ability to meet first quarter ’twenty six treatment goals?

And what mitigation strategies are in place to minimize disruption of patient care and revenue?

Unidentified speaker: From a timing perspective, if you look at when the facility shutdown is planned, it’s from about the December. And the facility will be back in process for January. So it’s very early in January that the site is actually up and running. So we’re ready to take any biopsies at that time. And this is the natural holiday period where patients would also prefer to they have their activities planned and everything.

So it’s very minimal disruption for the patients themselves. It’s just that you wouldn’t take a biopsy in the December trying to treat them in the December or something like that. So that’s minimally disruptive. That’s why we choose the December month, because that’s when patients even have probably other things planned in.

Maury Raycroft, Biotech Analyst, Jefferies: Got it. Makes sense. And you plan to scale from four to six manufacturing slots per month by the end of this year to 10 per month in the first half of twenty twenty six. What do you have to do and able to do that? And maybe just talk about the amount of support from staffing that you would need for that as well.

Unidentified speaker: So to operate six a month, we already have the staff hired. And they’re already under training, right? So by the time August comes, we are going to have them fully trained. It’s more to do with to ramp up from six to ten, we’re going to be hiring more personnel that will be coming on board in the quarter two, quarter ’3 kind of time frame. And so when you’re looking at first half of next year, they should also be trained.

So from an FTE perspective, we’re well ahead in our plan. And this year, six a month, the facility is already up and running. And we should be operating at six a month technically, although a proportion of those are going to be engineering runs, even by August, September kind of time frame.

Maury Raycroft, Biotech Analyst, Jefferies: Got it. Okay. So basically, you’ve got enough in house already to meet those goals Correct. Okay. And in your earnings call, you mentioned leveraging the RVV manufacturing site to expand ZivaSkin capacity.

What technical or regulatory considerations are involved with repurposing that space?

Unidentified speaker: So that is the space within our GMP space, the compartment that has about four slots added to the six. That’ll take us to 10 by first half of next year. Right now, we use that space for RVV manufacturing. Once we have done three, four batches of RVV manufacturing, we have enough supply to take us to three years even. And so that area is going to be changed manufacturing.

This is what is going to add the four slots, right? And we’ve had the discussion during the inspection with the FDA that this is our intent. There’s no roadblock per se, but we have to submit the change control protocol to the FDA. And that should be done by quarter three of this year. So that gives us sufficient lead time to have that even approved.

So by first quarter of next year, we should anticipate that those regulatory processes should all be in place.

Maury Raycroft, Biotech Analyst, Jefferies: Got it. Okay. And maybe for pricing, we thought it was a positive that you ended up with a $3,100,000 price for this therapy. And we think it’s reasonable as well based on the improvement patients are getting. Just how do you anticipate any payer pushback or carve outs in case a graft fails?

How do you think about that?

Madhav Visanavada, Chief Commercial Officer, Abiona: Yeah, we have not had any pushbacks from the payers. I mean, the reaction has been exactly as expected. And also the pricing as we launched, right? It wasn’t just coming out of the blue and putting a price number out there. There’s a lot of research that went behind the pricing.

Because if you look at the standard of care, the wound bandage itself on a monthly basis can be $169,000 a month for recessive DEP patients. And you just mount that and accumulate that. That’s exorbitant amount. Some of the recently launched gene therapies are going into tens of millions of dollars in lifelong managing. And it’s just not cutting it in terms of efficacy and durable healing.

So we’ve had dialogue with payers before coming into the marketplace with this kind of a price range. So right now, where we are in the process, we’re obviously discussing with the payers around agreements. And we are standing behind the efficacy of our product, which is the outcomes agreement, right? So it’s been received very well. And of course, this is the commercial segment.

And we are now also started discussing with the Medicaid channel to open up the access for these patients.

Maury Raycroft, Biotech Analyst, Jefferies: Got it. And maybe just talk about your latest discussions with payers and what percentage of insured lives are now eligible for Ziva Skin. And what do insurance companies need to see in order to pre authorize this treatment for a patient?

Madhav Visanavada, Chief Commercial Officer, Abiona: Percent of lives covered, as we announced, we entered into agreement with a large conglomerate. So that’s 100,000,000 plus lives, commercially insured lives that’s already covered. And these are the agreements that we are having with commercial plans. But you don’t need to have an outcomes agreement for a payer to cover a patient. In terms of any prior authorization, a prescription really from the physician, and then clinical criterias and the discussions that happen.

So it’s a process that as you have patients coming through the system, there’s a letter of medical necessity in the absence of a policy. Payers will have a commercial policy placed in a few months. That’s our goal.

Maury Raycroft, Biotech Analyst, Jefferies: Got it. And with both buy and bill and CVS specialty pharmacy models available, how are you guiding treatment centers and hospitals on choosing the optimal channel? And what are the operational or reimbursement trade offs between the two?

Madhav Visanavada, Chief Commercial Officer, Abiona: Yeah. So we have two channels, as you said, for a hospital to procure the product, one either through the buy and bill, and the other is through the CVS specialty pharmacy. We cannot guide a hospital one way or the other. It’s really what the hospital will look into their mechanics. A lot of the hospitals have said they are leaning they will go with the buy and bill model because they are very comfortable with it.

They have treated many other patients with other cell and gene therapies and understand the mechanics of it. But there is an option for CVS specialty as well if they want to offload any of their reimbursement risk, for example. Got it.

Maury Raycroft, Biotech Analyst, Jefferies: Okay. And maybe comment on what you expect for gross to net ratio and walk through some of

Madhav Visanavada, Chief Commercial Officer, Abiona: the assumptions behind that, including the expected payer mix and Medicaid onboarding timelines. The gross to net overall at a steady state, we assume around mid to upper teens. That’s when we get to in the next part of the year. Early on, we expect that to be on the lower side because most of the gross to net is adjusted based on the discounts that are rebates that are given to the payers. And majority of our payer lives are commercially insured lives, where these are negotiated agreements.

And then as we have Medicaid that opens up, then you have the government 23.1% rebate that goes to the Medicaid channel. So net net, at a steady state, we’ll have around mid to upper teens. Got it.

Maury Raycroft, Biotech Analyst, Jefferies: Okay. And for financial outlook, you’ve guided to cash flow positivity in 2026 with just thirty six patients treated. How confident are you in achieving this target? And do you still expect manufacturing to be a bottleneck in 2026?

Unidentified speaker: So we’re confident not only in achieving that 36, I think we’re confident also in exceeding that expectation because, as I mentioned, by end of twenty twenty five, we should be operating at six patients a month capacity. And by first half of twenty twenty six, we should ramp that up to 10. So you can already see why 36 is pretty kind of a low bar in terms of our supply capacity. It’s just the point of neutrality. Anything north of the 30 six is you’re looking at a profitable company, right?

And we’re both from a demand perspective as well as a supply perspective, we

Maury Raycroft, Biotech Analyst, Jefferies: think that’s quite a low hanging fruit for 2026. Are you saying what the upside could be beyond ’36 on what that could look like?

Unidentified speaker: Well, I think we have bookends. We have scenarios. I think the middle of the range could be anywhere around 50 patients because if you’re operating at six a month, even even not counting the 10 a month, which kicks in some point during the year, let’s say six is what you assume you should be well able to achieve that 50 patients treated. So I’m giving you like a 14 patient x’s here as a scenario case, which is not out of the realm of achievability.

Maury Raycroft, Biotech Analyst, Jefferies: Got it. Okay. That’s helpful. And once cash flow turns positive, how are you thinking about the capital allocation? Will you prioritize pipeline expansion, commercial infrastructure, or strengthening the balance sheet?

And this is

Unidentified speaker: not an eitheror between the three, but there’s a little bit of a prioritization. The prioritization is maximizing The US opportunity for Zevoskin is our top priority. And when we take care of that, it’s going to fund us adequately to pursue both, the other two things, which is pipeline expansion. And we’ll do the pipeline expansion in a very thoughtful way and cadence that there is no distress on the strength of the balance sheet per se.

Maury Raycroft, Biotech Analyst, Jefferies: Got it. Okay. And you mentioned the PRV that you sold for 155,000,000 How does that factor into investment plans through 2026? And what’s the expected cost of the new facility you’re planning to build for Avion?

Joe Visanno, CFO, Abiona: Yes. So the $155,000,000 plus our cash at the end of Q1 of $85,000,000 puts us north of $200,000,000 And like Vish had mentioned earlier, that’s sufficient to cover two years’ worth of operating expenses before accounting for any ZivaSkin revenues. So with that, we’re able to fund the capacity expansion, which we think it will be about 25,000,000 to $30,000,000 spread over about a twenty four month period.

Unidentified speaker: Got it. And just to be clear, the capacity expansion we’re talking about here is beyond the 10,000,000 a month that we’re already securing by first half of twenty twenty six. So to add even more Right. On of that. Right.

Madhav Visanavada, Chief Commercial Officer, Abiona: Okay.

Maury Raycroft, Biotech Analyst, Jefferies: Is there more about that, just the additional capacity that you’re adding that you want to mention?

Unidentified speaker: It’s basically not a completely greenfield new building or anything. It’s in the same floor where we currently have our 10 a month. We’re just taking additional space in the same floor. So it’s a very limited spend. We have already gotten the designs done.

And we’re also getting contract bids. So we feel good about the later half of twenty twenty seven is about the time we would have that go online.

Maury Raycroft, Biotech Analyst, Jefferies: Got it. Okay. And for ZevaSkin, wondering if there’s plans to pursue regulatory submissions outside The United States. And could this lead to new partnerships with potential upfronts? And also just wondering if you think that patients from ex US could come to The United States to get treated and what your thoughts are on that type of approach.

Unidentified speaker: So to understand the opportunity outside of The United States, we’ve just kicked off a project as we speak to do a scour of at least the major markets, let’s say Western Europe and Japan, on what the regulatory requirements would be, as well as what the reimbursement scenario looks like for those markets to inform our go to market strategies. We do know from preliminary research there are some centers of excellence, like Austria, which is a big EB clinic. And countries in the vicinity actually get patients there to get treated. So there could be some interesting models. We want to have this we should have more of an update closer to late quarter three on this project.

And that’ll inform, if we do it ourselves, what the parameters should be. Or if we are willing to partner, what can we accept, right? So that we should have more updates on that.

Maury Raycroft, Biotech Analyst, Jefferies: Got it. And maybe talk about the long term view on market penetration in RDEB and how you see the addressable patient pool evolving as awareness of this approach increases.

Madhav Visanavada, Chief Commercial Officer, Abiona: I mean, long term view wise, right now we have identified the seven fifty patients that are in The US. And about thirty percent of those seven fifty patients are in these seven centers of excellence that we are looking to target and bring them on board. We also see that some of the patients who are calling us are not genotyped. They have large wounds. They’re adult patients, but they’re not genotyped.

So that’s also another opportunity to see, Okay, how does the market improve? We have said that an average recessive dep patient has significant areas of their body wounded, that they’ll require a repeat treatment with ZivaSkin, which every time they come for a repeat treatment, that’s a billing unit. So there could be more treatment needs that will happen there. So we are looking at recessive DEB certainly right now with ZeevaSkin, but also lifecycle. In addition to what Vish mentioned on ex US opportunity, there’s also lifecycle opportunity that we are evaluating.

Because these patients have their fingers and digits that get fused. So there is an opportunity when you do debride and you open up, deglove these patients with applying a gene modified skin sheet. That can significantly impact their quality of life and trajectory. So there’s a lot of opportunity with ZivaSkin. We are taking one step at a time.

But the underlying feedback that we continue to hear is very positive.

Maury Raycroft, Biotech Analyst, Jefferies: Got it. And why don’t you ask just on the competitive landscape, how you view that, and how ZivaSkin differentiates versus the others?

Madhav Visanavada, Chief Commercial Officer, Abiona: Yeah, as we’ve said, I mean, there is a constant burden of treatment, constant burden of wound care that these patients undergo. What ZivaSkin does is a single application that covers not just small recurring wounds, but large regions of the body, but single application and keeps it long lasting. We have followed these patients and published data for up to eight years. So that is profound, not just wound healing, but also pain and itch reduction. Itch is a huge burden on these patients.

And also, the risk of squamous cell carcinoma is so real. By mid to upper teens, there is a very high risk of developing squamous cell. And we are not saying that by applying ZivaScan you can avoid squamous cell because that was not our study endpoint. But when we look retrospectively over the eleven years of follow-up across all the treated wound sites, none of the wound sites have shown squamous cell carcinoma, even though squamous cell was seen in other non treated areas of the body. So the opportunity to be able to close these wounds and improve their quality of life is profound.

Maury Raycroft, Biotech Analyst, Jefferies: Got it. And Vish, earlier you mentioned Autogenics with their MPS IIIA drug getting approved soon. It’s an Abiona homegrown drug. And you guys would be eligible for royalty there. And there’s also Atacea one hundred two for Rett syndrome, which is a few years behind this MPS IIIA program, which is with a different company, Atacea.

Maybe talk about both of those partnered programs and what Abiono would be eligible from those programs.

Unidentified speaker: Absolutely. Joe, I think you have this answer.

Joe Visanno, CFO, Abiona: Sure, thanks. So for the Tacea program, we’re eligible for clinical, regulatory and commercial milestones in addition to an upper single digit royalty on net sales. And then for the Ultragenyx program, which has a PDUFA date coming up in August, we are eligible for tiered royalties up to 10% in addition to some commercial milestones as well.

Maury Raycroft, Biotech Analyst, Jefferies: Got it. Okay. And these are not factored into your projections or guidance at all?

Joe Visanno, CFO, Abiona: No. All upside.

Maury Raycroft, Biotech Analyst, Jefferies: Vish, you also mentioned just how you’re focused on ZevaSkin first, but then next, you may be able to develop the pipeline. You’ve talked about preclinical programs in the past and have disclosed some interesting proof of concept data there. Are there any immediate plans to ramp up investment and to focus on one of those programs?

Unidentified speaker: Yeah, the RS1 program, we even presented data at ASGCT. We think this is going to be a uniquely differentiated asset. These patients it affects boys, basically. And retinaschis is an inherited monogenic disease. And we are seeing some very interesting properties of the proprietary capsid that we have in targeting certain compartments of the eye.

And we believe this is going to be differentiated. There are not very many options for these patients. And even if you look at the current clinical trial landscape, there’s probably one drug that is being tested. And even there, it’s a very small sliver of patients that we need to choose because if you do a subretinal injection, there’s this risk of retinal detachment. So we have a novel route of administration as well, where we’re able to transduce these cells, photoreceptors.

So this is very exciting. We want to take this program to the clinic later half of twenty twenty six. And we’re on track for that. The investments that are required now, given where we are with our funding and everything, the kind of investment that we need to take this program into clinic, it’s a very small spend at a low rate. So this is not going to pressure us financially.

And we will still be able to sow seeds to see if there is any catalysts that come up in the next two to three year time frame from clinical data.

Maury Raycroft, Biotech Analyst, Jefferies: Got it. And Manav, earlier you mentioned just with some of the information that’s coming in from the different centers and from the call volume as well that you guys are quantifying that. Could you provide more specifics on that in the second quarter conference or your earnings update and just what you’re seeing with the launch initially?

Madhav Visanavada, Chief Commercial Officer, Abiona: Yeah. We should be able to have a better handle on how many what patients identified patient looks like. We are hoping by then we will already have prior authorization and insurance discussions ongoing. Second quarter, maybe biopsy. We have guided third quarter, right, for treating patients.

So we should have a lot more clarity by then. But in terms of the demand and the expectation is very much like on track, which we have said that there is already patients that are being identified, and we’ll be able to convey more in terms of how many actually there are.

Unidentified speaker: And because there are many steps in the funnel, right now, it’s hard to predict what’s that one good leading indicator for the next quarter sales or something like that. I think that’s going to take some experience because patients have to go to prior auth and the slot has to be taken and the biopsy is done. So there’s numerous steps that get to a patient from the first step to the treatment, right? So as we learn this by end of the year, should have a pretty good idea of what’s a good leading indicator for the forecast.

Maury Raycroft, Biotech Analyst, Jefferies: Got it. Yeah. So all this information you’re collecting, that’ll help you provide investors more clarity on which metrics are going be important for tracking Okay. So maybe to wrap up, if you can just recap key milestones ahead over the next six to twelve months that investors should be focused on. I think the biggest milestone is the launch

Unidentified speaker: of Zeeva Skin and performance with 10 to 14 patients as our target and getting the QTCs up and running and initiated. I think these are the catalysts that are important for our launch of Ziva Skin. And of course, on top of that, we have other PDUFA action dates for our partnered programs and everything. So there’s a lot of news flow coming up even just within 2025.

Maury Raycroft, Biotech Analyst, Jefferies: Got it. Well, congrats again. And thanks Hi, everyone. My name is Maury and then Joe Vizano, CFO. Thanks so much for joining us today.

Unidentified speaker: Thank you for having us.

Maury Raycroft, Biotech Analyst, Jefferies: And we’re going to do fireside chat format. So for those who are new to the story, maybe give a one minute intro to Abiona and your recently approved transformational therapy for RDEB.

Unidentified speaker: Sure. And even if you’re not new to the story, we have a new story, which is we are a commercial stage cell and gene therapy company with the approval of Ziva Skin just over a month ago. And this is for patients with recessive dystrophic epidermolysis bullosa and treating their wounds. And with the approval, we also got a PRV grant. And we announced that we are in a sale agreement for $155,000,000 with those proceeds.

We’re funded for eight quarters of our operations without even accounting for the revenue generation. And so we do anticipate being a profitable company early half of twenty twenty six. And our partner programs with Ultragenyx and Teixa are also doing very well. Ultragenyx asset UX one hundred eleven has a PDUFA date that is coming up in August as well. So with all that, I can just say that we’re a grossly undervalued company at a market cap of about $300,000,000 Great opportunity.

Maury Raycroft, Biotech Analyst, Jefferies: Yeah, great overview for Abiona. And I want to talk about the launch for RDEB. And so you’ve mentioned Lurie Children’s Hospital now activated as the first qualified treatment center. What specific metrics are you tracking at this site, such as patient throughput and referral volume from other centers of excellence?

Madhav Visanavada, Chief Commercial Officer, Abiona: Yeah. I’ll start off by saying that just about a month into launch, as Vish mentioned, and the feedback that we are hearing from multiple stakeholders has been very positive. I mean, the standard of therapy that exists right now for recessive deb is just not bending the trajectory of this disease and the progression. And with ZivaSkin, what we are able to bring is with a single treatment application, ability to cover large areas of the body, regions of the body with long lasting efficacy and outcome. And because it’s autologous, we are working with treatment centers to get them activated.

And Lourie’s was one of our first treatment center that has activated. And now with that, we are able to track the number of patients. We are learning more about the patients that are getting referred into LURI’s from adjacent areas. And as we learn more, we’ll be able to communicate the actual numbers because there are steps that have to happen between identifying a patient and eventually placing them on therapy. But overall, the launch is off to a good start.

Got it. Okay. And can you give an update on the latest number of QTCs that are online or expected to come online soon? And when should we expect the next site activation? And what’s your timeline to fully activate all five centers?

Timeline to fully activate all five is by the end of this year. And we are actively working with these various other centers. And every center is working at a different pace. So we’ll keep them activated I mean, everyone informed. It’s hard to tell

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