Q1 2025 Abeona Therapeutics Inc Earnings Call
<unk> a question and answer session will follow the formal presentation.
Operator: are in a listen only mode and a question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone key. Please note, this conference is being recorded.
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Speaker Change: I'll now turn the conference over to your host Mr. Greg Jean Sir you may begin.
Greg Chin: I will now turn the conference over to your host, Mr. Greg Chin. Sir, you may begin.
Greg Jean: Thank you Ali.
Speaker Change: Good morning, and thanks, everyone for joining us on our first quarter of 2025 results conference call.
Ali: Thank you, Ali.
Greg Chin: 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.
Speaker Change: During this call we will refer to the press release issued this morning announcing the financial results.
Speaker Change: It is available on our corporate website at Www Dot Avionic therapeutics Dot com.
Speaker Change: We anticipate making projections and forward looking statements during todays call, which are made pursuant to the safe Harbor provisions of the federal Securities laws.
Greg Chin: 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 10-K and periodic reports filed with the SEC. These documents are available on our website at www.abeonatherapeutics.com.
Speaker Change: These forward looking statements are based on current expectations and are subject to change actual results may differ materially.
Speaker Change: 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-K, and periodic reports filed with the SEC.
Speaker Change: These documents are available on our website at www Dot avionic therapeutics Dot com.
Speaker Change: Joining me today on.
Speaker Change: On today's call with prepared remarks are Dr. Vish, Seshadri, Chief Executive Officer, Dr. Manav is on Savada, Chief commercial officer, and Giovanna Chief Financial Officer.
Greg Chin: 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.
Speaker Change: So Dr. Brian Kevin <unk>, Chief Technical Officer will join us for the Q&A session.
Speaker Change: And with that I will now turn the call over to Vish seshadri to lead us off this.
Vish Seshadri: 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 US FDA approval of our first product, ZivaSkin, just a little over a couple of weeks ago. ZivaSkin is the first and only autologous cell-based gene therapy for the treatment of adult and pediatric patients with recessive dystrophic epidermolysis bullosa, or RDEB. This is a persistent, unmet need.
Vish Seshadri: Thank you Greg and good morning, we have had a very exciting and momentous 2025. So far we're incredibly proud that <unk> is now a commercial stage cell and gene therapy company. Following the U S. FDA approval of our first product Veeva skin, just a little over a couple of weeks ago.
Speaker Change: Sure.
Speaker Change: <unk> is the first and only autologous cell based gene therapy for the treatment of adult and pediatric patients with recessive dystrophic epidermolysis <unk> or are dead.
Speaker Change: A persistent unmet need.
Speaker Change: Yeah.
Speaker Change: To meaningfully heal ardeb wounds, especially those that are chronic and prone to infection.
Vish Seshadri: to meaningfully heal other wounds, especially those that are chronic and prone to infection. Through a single application, ZivaSkin 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.
Speaker Change: Through a single application libeskind can provide the opportunity for significant closure in pain reduction and even the most severe or their wounds.
Speaker Change: 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.
Speaker Change: I wanted to touch upon some highlights on how the launch is going keeping in mind that we're only about two weeks and then Margo will follow with details on the commercial progress in his remarks.
Vish Seshadri: 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 are pleased to announce that ahead of schedule, we have activated our first Qualified Treatment Center, or QTC. and that ZivaSkin 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 30 years.
Speaker Change: We're pleased to announce that ahead of schedule, we have activated our first qualified treatment center or <unk>.
Margo: And ziv of skin is now commercially available.
Margo: Lurie Children's hospital of Chicago, with our first Q T SEC, enabling newly to begin identifying patients and our scheduling system is up and running.
Margo: Jewelry children's was the top ranked hospital and has been a center of excellence for genetic skin diseases for more than 30 years as one of the largest north American centers for epidermal licensed bilotta carrying for more than 150 affected children and adults newly children has been a member of the be clinical research.
Vish Seshadri: As one of the largest North American centers for epidermolysis bullosa, caring for more than 150 affected children and adults, Lurie Children's has been a member of the EB 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. Dr. 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 Feinberg School of Medicine. And she was also the chair of the Data Safety Monitoring Board for our pivotal vital study of Ziva's case.
Margo: Insertion since its inception and continues to conduct cutting edge bench and clinical research to better understand the disease and find new treatment options.
Speaker Change: Dr. Amy Poehler.
Speaker Change: World renowned pediatric dermatologists is head of the epidermal licensed Balassa research and care program at Lurie children's and chair of the Department of Dermatology at Northwestern University Sandberg School of Medicine, and she was also the chair of the data safety monitoring board for our pivotal vital study of Zebra scan.
Speaker Change: We look forward to a very collaborative relationship with Lurie children's which shares our conviction that <unk> is an important treatment option for people living with our Deb, we expect the first patient to be treated at Laurie in the third quarter of 2025.
Vish Seshadri: We look forward to a very collaborative relationship with Lurie Children's, which shares our conviction that ZivaSkin is an important treatment option for people living with RDEB. We expect the first patient to be treated at Lurie in the third quarter of 2025.
Speaker Change: Last week at.
Speaker Change: At the society for investigative Dermatology annual meeting.
Vish Seshadri: Last week At the Society for Investigative Dermatology Annual Meeting, we presented two late-breaking abstracts that further underscore ZivaSkin's efficacy and safety profile. One abstract details data showing the durable expression of functional collagen VII anchoring fibrils at ZivaSkin-treated sites 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 ZivaSkin gene-corrected cellular sheet. The second abstract confirmed the absence of squamous cell carcinoma or other cancer at any of the 144 ZivaSkin-treated sites. In seven instances where SCCs were observed in untreated areas, testing for proviral genome and replication-competent retrovirus yielded negative results.
Speaker Change: <unk> two late breaking abstracts that further underscores the efficacy.
Speaker Change: That's a good safety profile.
Speaker Change: One abstract detailed data showing the durable expression of functional collagen seven anchoring fibrils at <unk> can treat at site and long term wound closure. Following a single treatment both of which are hypothesized to be attributable to the presents and persistence of gene modified progenitor cells within the <unk> gene corrected cellular.
Speaker Change: Our sheets.
Speaker Change: Second abstract confirm the absence of squamous cell carcinoma or other cancer at any of the 144 zero skin treated sites.
Speaker Change: Seven instances, where FCC's were observed in untreated areas testing for pro viral genome and replication competent retrovirus yielded negative results. These clinical results and non clinical results of insertion of oncogenesis that were reported at <unk> further supports a favorable benefit risk.
Vish Seshadri: These clinical results and non-clinical results of insertional oncogenesis that were reported at SID further support a favorable benefit-risk profile for ZivaSkin. Moving on, I want to briefly remind everyone that earlier this week we announced that we entered into an agreement to sell for $155 million the Priority Review Voucher, or PRV, that we received with ZivaSkin 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.
Speaker Change: Profile towards Derisking.
Speaker Change: Moving on I want to briefly remind everyone that earlier. This week, we announced that we entered into an agreement to sell $4 hunting $55 million. The priority review voucher or P. R. V that we received with zebra skin approval subject to customary closing conditions, including antitrust.
Speaker Change: To review under the Hart, Scott Rodino Act.
Speaker Change: The proceeds will strengthen our balance sheet to fund our operations as Joe will further elaborate in a bit.
Speaker Change: These efforts will be critical for both our near term path to profitability and to drive our future growth.
Speaker Change: I'll now hand, the call to our Chief commercial officer, Dr model doesn't have order to highlight our commercial launch preparations for <unk>.
Madhav Vasanthavada: I'll now hand the call to our Chief Commercial Officer, Dr. Madhav Vasanthavada, to highlight our commercial launch preparations for ZivaSkin. Madhav. 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, Abeona 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.
Speaker Change: <unk>.
Speaker Change: Thanks, Rich and Hello, everyone.
Speaker Change: It has been about two weeks since the <unk> approval.
Speaker Change: And we are off to a very good start.
Speaker Change: The response from patients caregivers and the physician community since gaining zama skins FDA approval has been incredible.
Speaker Change: Already in just the last two weeks our patient hub.
Speaker Change: <unk> and.
Speaker Change: As you see phone calls and E mail inquiries.
About penalty patients and families across the country.
Speaker Change: We recognize that any new product approval comes with interest and excitement, but the volume and nature of these inbound inquiries are very encouraging.
Speaker Change: I'm hearing from adult patients and parents of children.
Madhav Vasanthavada: We are hearing from adult patients and parents of children. who are all hopeful about the potential impact ZivaSkin 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 RDEV 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 option.
Speaker Change: We're all hopeful about the potential impact zero skin can have on them and their loved ones and they want to know how soon they can access to treatment.
Speaker Change: These calls so the tremendously high unmet need and that patients are urgently seeking reliable and durable treatment options for their <unk>.
Speaker Change: 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 heating their homes.
Speaker Change: They are burdened by the continuous and potentially lifelong administration after current options.
Speaker Change: <unk> is the only treatment proven to reliably close not just smartphones, but large wounded regions of the body with a single treatment application.
Madhav Vasanthavada: ZivaSkin 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 ZivaSkin qualified treatment center, Dr. Amy Paller and her team at Lurie can now begin to schedule their identified patients for treatment with ZivaSkin. Our teams will support LORI 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.
Speaker Change: With Lori children's activated as the first zero skin qualified treatment center, Dr. Amy Poehler and her team at Lori can now begin to schedule that identified patients for treatment with <unk>.
Speaker Change: Our teams will support Laurie as they identify eligible patients and secure the necessary payer authorizations, which we expect will take several weeks initially.
Speaker Change: We are currently anticipating the first patient to be Biopsied in July 2025, and to receive this treatment in August 2025.
Speaker Change: In addition to Laurie.
Speaker Change: We are on track to activate other geographically dispersed <unk> by the end of 2025.
Madhav Vasanthavada: In addition to Lurie, we are on track to activate other geographically dispersed QTCs by the end of 2025. Like Lurie's, the other hospitals we are in discussions with are well-recognized institutions with cell and gene therapy infrastructure and experienced in providing specialized care for EBP. As you've previously mentioned, we expect to see a gradual ramp up at QTC. with centers getting accustomed to ZivaSkin 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 ZivaSkin at each QTCs over time. with the already existing number of ZivaSkin-eligible patients at these large QTCs.
Speaker Change: Like you raised the other hospitals, we are in discussions with our well recognized institutions with cell and gene therapy infrastructure and experienced improving providing specialized care for <unk> patients.
Speaker Change: As we've previously mentioned, we expect to see a gradual ramp up at <unk>.
Speaker Change: With centers getting accustomed to zebra skin treatment process and the patient journey through treatment of their first one or two patients with.
Speaker Change: With this initial treatment experience. We then expect a greater uptake of derisking at each <unk> overtime.
Speaker Change: With the already existing number of zebra skin eligible patients at these large <unk>.
Speaker Change: And the strong inbound interest we have begun to see through <unk> assist.
Madhav Vasanthavada: and the strong inbound interest we have begun to see through Abeona 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 ZivaSkin approval. Last week, we had very successful physician engagements at the Society for Investigative Dermatology annual meeting. Our two late-breaking scientific abstracts that Vish mentioned were very well received. Also, Dr. Gene Tang, one of the prominent ED experts and the lead investigator of our vital phase 3 study, gave an oral presentation on ZivaSkin's clinical data to a highly engaged audience and generated interest.
Speaker Change: We remain optimistic about our ability to achieve our 2025 board of trading 10% to 14 patients as we previously guided and look forward to a robust start to 2026.
Speaker Change: Beyond the positive response from patients we are equally excited to see the enthusiasm from the physician community on the news of Zebra skin approval.
Speaker Change: Last week, we had very successful physician engagement at the society for investigative dermatology annual meeting.
Speaker Change: Our two late breaking scientific abstracts that rich mentioned were very well received.
Speaker Change: Also Dr. Jian Tang one of the prominent <unk> experts and the lead investigator of our vital phase III study gave an oral presentation on zero skins clinical data to a highly engaged audience and generated interest.
Speaker Change: We also held an advisory board meeting at the <unk> meeting.
Madhav Vasanthavada: 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 ZivaSkin's approval and was eager to discuss the immediate next steps to putting their identified patients on ZivaSkin treatment, and we had a productive discussion. 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. We are actively progressing discussions around outcomes-based agreements, reinforcing our confidence in ZivaSkin's real-world impact, and supporting favorable access for patients.
Speaker Change: With an interdisciplinary group of physicians from our potential <unk>.
Speaker Change: The group was excited about zero skins approval and was eager to discuss the immediate next steps to putting that identified patients on <unk> treatment and we had a productive discussion.
Speaker Change: Over the past two weeks, we have also made significant strides in ensuring that the value of their skin is as recognized by payers.
Speaker Change: And that patients have timely and broad access to this therapy.
Speaker Change: We are actively progressing discussions around outcomes based agreements.
Speaker Change: Enforcing our confidence in vivo skins, real world impact and supporting favorable access for patients.
Speaker Change: Yes, especially excited to announce that we have now executed outcomes based agreements with two payer contracting organizations.
Madhav Vasanthavada: We're especially excited to announce that we have now executed outcomes-based agreements with two-payer contracting organizations. The first with Anton Arex, a leading pharmacy solutions provider representing several regional commercial and managed Medicaid payers. and the second with one of the largest medical collectives serving approximately 100 million commercially insured lives. These two agreements represent a significant milestone in our efforts to ensure ZivaSkin reaches the patients who need it most. Additionally, we are continuing to actively engage with several well-recognized commercial payers and all state Medicaid programs to further expand ZivaScan access to eligible patients across the country, and we'll keep you updated on our progress.
Speaker Change: First with antibiotics.
Speaker Change: Leading pharmacy solutions provider, representing several regional commercial and managed Medicaid payers.
Speaker Change: The second with one of the largest medical collectives.
Speaker Change: Approximately $100 million commercially insured lives.
Speaker Change: These two agreements represent a significant milestone in our efforts to ensure leave us getting reaches the patients who need it most.
Speaker Change: Additionally, we are continuing to actively engage with several well recognized commercial payers and all state Medicaid programs to further expand zero gain access to eligible patients across the country and we'll keep you updated on our progress.
Speaker Change: With that I would like to hand, the call over to our Chief Financial Officer, Joe <unk> to discuss our financial results Joe.
Joe Vazzano: With that, I would like to hand the call over to our Chief Financial Officer, Joe Vazzano, to discuss our financial results. 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 PRVC. This compares to $98.1 million as of December 31st, 2024.
Speaker Change: Joe.
Speaker Change: Thanks model.
Speaker Change: I would like to remind everyone that you can find additional details on our financial results from the three months ended March 31 2025.
Speaker Change: 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.
Speaker Change: 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 <unk> sale.
Speaker Change: This compares to $98 $1 million as of December 31, 2024.
Speaker Change: The proceeds from our <unk> once the transaction is closed will fully fund our operations for over two years, extending our runway through the point of projected levered skin driven profitability in early 2026.
Joe Vazzano: 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 2026. This robust financial footing, achieved even before ZivaSkin revenues have begun, eliminates the need to raise additional capital to reach this crucial commercial mile. Research and development expenses were $9.9 million for the quarter ended March 31st, 2025, compared to $7.2 million for the quarter ended March 31st, 2025. 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.
Speaker Change: This robust financial footing achieved even before it was even three and revenues have begun eliminates the need to raise additional capital to reach this crucial commercial milestone.
Speaker Change: Research and development expenses were $9 $9 million for the quarter ended March 31, 2025, compared to $7 $2 million for the quarter ended March 31 2024.
Speaker Change: The increase was primarily due to increased head count related to scale up of manufacturing capacity in preparation for the planned <unk> commercial launch and preclinical development work.
Speaker Change: Our spend on general and administrative activities with $9 $8 million for the quarter ended March 31, 2025, compared to $7 $1 million for the quarter ended March 31 2024.
Joe Vazzano: Our spend on general and administrative activities was $9.8 million for the quarter ended March 31st, 2025 compared to $7.1 million for the quarter ended March 31st, 2024. The increase was primarily due to increased headcount associated with the planned launch of Ziva.
Speaker Change: The increase was primarily due to increased head count associated with the planned launch of <unk>.
Speaker Change: Net loss was $12 million for the first quarter of 2025 or 24.
Joe Vazzano: Net loss was $12 million for the first quarter of 2025, or $0.24 loss per common share, as compared to $31.6 million, or $1.16 loss per common share for the first quarter of 2024.
Speaker Change: Loss per common share.
Speaker Change: As compared to $31 6 million or $1 16 loss per common share for the first quarter of 2024.
Speaker Change: In terms of upcoming Investor relation activities, we will be participating in the Jefferies Global Healthcare conference in early June.
Joe Vazzano: In terms of upcoming investor relation activities, we will be participating in the Jeffries Global Health Care Conference in early.
Speaker Change: And with that I will open the call for Q&A operator, please open the Q&A session.
Operator: And with that, I will open the call for Q&A. Operator, please open the Q&A. Thank you. At this time, we'll be conducting our question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. The confirmation tone will indicate your line is in the question. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start button. One moment, please, while we poll for questions. Thank you.
Speaker Change: Banking.
Speaker Change: At this time, we'll be conducting our question and answer session.
Speaker Change: To ask a question. Please press star one on your telephone keypad.
Information tone will indicate your line is in the question queue.
Speaker Change: You May press star two if he would like to remove your question from the queue.
Speaker Change: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star Keith.
Speaker Change: One moment, please while we poll for questions.
Speaker Change: Thank you.
Speaker Change: Our first question is coming from Maury Raycroft with Jefferies. Your line is life.
Amin: Our first question is coming from Maury Raycroft with Jeffreys. Your line is live. Hi, this is Amin on for Morrie. Thank you for taking our questions. Two from us.
Speaker Change: Hi, This is on for Maury. Thank you for taking our questions two from US first congrats on the activation of the first sites.
Madhav Vasanthavada: 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 ARDEP patients at Lurie Hospital, but specifically, how many ARDEP patients are eligible for PZ Cell at this treatment center? And in general, how about the other treatment centers? How many ARDEP patients do you think they are eligible at these centers as well for PZ Cell? Thank you.
Related to that what exactly do you mean, when you say decided to activate it does it include.
Speaker Change: Staff and surgeons are all trained at this point.
Speaker Change: And then the.
Speaker Change: The second question is related to well you mentioned about the number of Arda patients Laurie hospital, but specifically how many are that patients are eligible for PZ cell at this treatment center and in general how about the other treatment centers. How many patients do you think they are eligible.
Speaker Change: At these centers as well for PC sell.
Thank you.
Speaker Change: Go ahead and model.
Madhav Vasanthavada: I mean, go ahead, Madhav. Thank you. Yes, Amin, to 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 ZivaScan 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. So they have the ability to go ahead with patient identification and scheduling manufacturing. With regards to the patients, with Dr. Amy Poller and her institution, we don't know the exact number of eligible patients, but from our prior discussions, there are at least a couple of dozen of patients that Dr. Amy Poller and her institution treat within their own institutions.
Speaker Change: Thank you.
Speaker Change: Yeah. So I mean to your first question the definition of activation and whether these sites are trained yes. They are right now trained and.
Speaker Change: All of the processes, but ended institutions have been been taken care off they are in a position to.
Speaker Change: Have their patients identified for zebra skin and begin the process to get payer authorizations and once we have the payer approval for these patients they can already start.
Speaker Change: Struck their patients for our manufacturing schedules.
Speaker Change: So they have they have the ability to go head with pace.
Speaker Change: Patient identification and scheduling manufacturing.
Speaker Change: With regards to the patients.
Speaker Change: With Amy partnered with Dr. Amy Pilar and her institution that are we don't know the exact number of eligible patients but from our prior discussions that are at least a couple of dozen of patients that Dr. Amy Poehler and hooded institutions treat within their own institutions.
Speaker Change: Then also there are other.
Speaker Change: Other physicians from the local community that we are hearing.
Madhav Vasanthavada: 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 low-risk children. So we do think that over time, these patient counts are going to build, and there are going to be more patients identified from this. We have.
Speaker Change: In fact to retire and referring their patients over to Louise children.
Speaker Change: So we do think that over time, these patients comps going to build and they're going to be more patients identified from this center.
Speaker Change: Very helpful. Thank you.
Madhav Vasanthavada: Thank you.
Speaker Change: Thank you.
Speaker Change: Our next question is coming from Kristen <unk> with Cantor Fitzgerald Your line is life.
Rick Miller: Our next question is coming from Kristen Kluska with Cantor Fitzgerald. Your line is live.
Speaker Change: Hello. This is Rick Miller on for Christy and thanks for taking our questions. We'll start with one and then maybe a follow up so for the lorry children Center, where 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 or any other factors you could say, there and and if you can say anything about how.
Rick Miller: Hello, this is Rick Miller on for Kristen. Thanks for taking our questions. We'll start with one and then maybe a follow up.
Madhav Vasanthavada: 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?
Speaker Change: Now Laurie children's is kind of Triaging. It's identified patients you know in the early stages of the launch here.
Madhav Vasanthavada: And if you can say anything about how Lurie Children's is kind of triaging its identified patients, you know, in the early stages of the launch here. Yeah, so I will say that we have been in touch with, you know, 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 ZivaSkin and expediting the processes and then internal administrative processes. Um, obviously it's a, it's a pretty large center and that also goes to show that Dr. Pollard and her team have this desire to begin, start treating their patients.
Speaker Change: Yes, so I will say that we have been in touch with.
Speaker Change: Up to five centers as we have been discussing and it's a big credit to Lewis children, just for the collaboration and the speed with which they have engaged with us.
Speaker Change: Just really again justifies the conviction that <unk> has on veeva skin in expediting the processes and then internal administrative processes.
Speaker Change: Obviously, it's a pretty large center and that also goes to show that.
Speaker Change: <unk> and her team.
Speaker Change: Have this.
Speaker Change: Our desire to begin start treating their patients.
Speaker Change: So I think it just every site is working at a different speed.
Madhav Vasanthavada: So, I think it just, you know, every site is working at a different speed and we'll continue to, of course, work with the same speed with other centers as well. And hopefully, in the very near future, be able to announce additional treatment centers.
Speaker Change: And we will continue to.
Speaker Change: Course work with the same speed with other centers as well and hopefully in the very near future be able to.
Speaker Change: Announce additional treatment centers.
Speaker Change: With regards to patient Triaging.
Madhav Vasanthavada: Um, with regards to patient triaging, um, I think the way this would work is various factors will come into play, um, beyond just the clinical manifestation of these patients. Also, the insurance and the type of insurance that these patients have, um, we think that, you know, commercially insured patients, um, 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. Um, and so based on that factor, um, and as well as the patient preference, um, and how soon they can come up for treatment, we'll be able to slot these patients in manufacturing schedule.
Speaker Change: I think the way this would work as various factors will come into play.
Speaker Change: Beyond just the clinical manifestation of these patients also the insurance and the type of insurance that these patients have.
Speaker Change: We think that commercially insured patients.
Speaker Change: 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.
Speaker Change: And so based on that factor and as well as the patient preference and how soon they can come for treatment will be able to slot. These patients in manufacturing schedule.
Speaker Change: But that also all works out fine in our particular case, just because given our own manufacturing and the supply ramp that we had described in the past.
Madhav Vasanthavada: 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'll give us a chance, you know, with July as the 1st, uh, in a potential treatment slot, we are give we have sufficient, you know, headroom to be able to slot these patients, depending on how their access also works. Thank you.
Speaker Change: When you gave us a chance with July is the first.
Speaker Change: And a potential treatment slot, where we have sufficient.
Speaker Change: Headroom to be able to slot these patients depending on how did Axa is also works out.
Speaker Change: 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 are receiving from the a b on SaaS reach out. So is there anything youre getting from these conversations about what the wound profile here is starting to look like are these mostly patients with these kind of larger.
Madhav Vasanthavada: 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 reach outs. 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.
Speaker Change: Chronic wounds.
Speaker Change: With a mix of other wounds.
Speaker Change: Or is this sort of a different kind of distribution than what you kind of saw in the clinical experience. Thank you.
Speaker Change: It's hard to comment exactly there wound profile characteristics, because it's really our <unk> team that is engaging with them, but the context. We can provide is is these are patients with what we know they are they are all have large areas of their barney.
Madhav Vasanthavada: It's hard to comment exactly their wound profile or characteristics, because it's really our abionicist 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 3rd 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.
Speaker Change: Typically.
Speaker Change: Based on the natural history study average patients has at least a third of their body that is.
Speaker Change: <unk>.
Speaker Change: And some of the patients who have said they have wasted their entire life for <unk>.
Having reliable treatment options.
Speaker Change: As well as we are seeing patients.
Ross all age ranges from both across pediatric patients as well as adult patients.
Speaker Change: Patients got children.
Speaker Change: Children or adults patients who are calling in to see how soon they can access.
Madhav Vasanthavada: You know, patients, you'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's, it seems to be people with multiple level of burden as well.
Speaker Change: As well as you know.
Speaker Change: Rivers of younger patients so it.
Speaker Change: It seems to be across all of the age spectrum and across all of the age range.
Speaker Change: Across all of the different.
The regions of the country.
Speaker Change: So.
Speaker Change: It seems to be people with multiple level of wound burden as well.
Speaker Change: And that also right.
Speaker Change: 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 yet.
Madhav Vasanthavada: 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.
Speaker Change: Kind of any insights on what is the overarching.
Speaker Change: Patient types that are generally calling in so that's why it's hard to place too much detail on the wound type chronic city location those types of details yet.
Speaker Change: Okay understood. Thank you for sharing that.
Madhav Vasanthavada: Thank you for sharing that. Thank you.
Speaker Change: Thank you.
Stephen Willey: Our next question is coming from Stephen Willey with Stifel. Your line is life.
Stephen Willey: Our next question is coming from Stephen Willey with Stiefel. Your line is... 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, you know, 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?
Stephen Willey: Yes. Good morning, Thanks for taking my question and congrats on the progress.
Stephen Willey: Was just wondering if you could maybe provide some color around what the perspective Q T sees that.
Stephen Willey: Youre looking at now have intimated about patient throughput.
Stephen Willey: I guess, both in terms of patient volumes might look like a launch in may.
Stephen Willey: Maybe where that metric might go once once logistics are optimized and do you expect to see much variance in this throughput capacity across the car T cells that you intend to bring online.
Stephen Willey: A quick call.
Madhav Vasanthavada: And then I just have a quick follow-up. Yes, thanks for that question in terms of the patient, you know, throughput early on at the time of launch, we do think that there are patients as you know, 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 first few patients going in their mind.
Stephen Willey: Yes Stephen.
Stephen Willey: Thanks for that question.
Stephen Willey: In terms of the patient throughput early on at the time of launch.
Stephen Willey: We do think that there are patients.
Speaker Change: As I mentioned also the onboard that we did last week.
Speaker Change: Where we had physicians from basically all of our target quantified treatment centers around the table.
Speaker Change: And they were discussing about been identified patients in their mind, they already have queued up.
Speaker Change: So we think that the way. This will work is they will have for the few patients going in their mind, they want to treat patients who have large contiguous areas of the body that's wounded.
Madhav Vasanthavada: They want to treat patients who have large continuous areas of their body that's wounded. Plus, of course, you know, 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 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.
Speaker Change: Plus of course with every production youre getting up to 12 sheets that can be manufactured right. So it's not just one or two months you can pretty much cover large areas of the body.
Speaker Change: So the physicians are thinking about that.
Speaker Change: To tackle those patients first.
Speaker Change: And then they are already thinking about there then the next sort of tier of patients will be those will have discrete wounds and various entercom nickel regions.
Speaker Change: So in terms of throughput to put some numbers, even if when we posed to them.
Speaker Change: Two patients a month.
Speaker Change: Two patients every month per site.
Speaker Change: That's going to with our 10 patients a month capacity.
Speaker Change: And five treatment sites at steady state.
Speaker Change: Easily doable for these physicians.
Speaker Change: They're not like thinking twice about that nobody had actually put any resistance to that.
Madhav Vasanthavada: 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, other institutions have, as their pro forma 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.
Speaker Change: This is from their respective Qvc's right.
Speaker Change: We will over time.
Speaker Change: I'll begin to also talk to other centers of excellence and have those patients referred in into these <unk>.
Speaker Change: And these kinds of throughput to patients.
Speaker Change: Month or treatment center is doable.
Speaker Change: As part of our Onboarding process as we speak with certain <unk> other institutions have as their pro forma also have indicated that they would like to go to four patients a month, just because they have enough throughput capacity in data centers.
Speaker Change: And sufficient bed capacity and things of that nature.
Speaker Change: So.
Speaker Change: We are the types of numbers that we're talking about here is very much doable.
Madhav Vasanthavada: 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.
Speaker Change: It's really going to be the first couple of patients that they will go through their treatment and then ramp it up in <unk> and 'twenty six so we'll see how this goes but we are optimistic.
Speaker Change: Okay, that's very helpful color.
Stephen Willey: Okay, that's very helpful color.
Speaker Change: 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 and see what's going on right now but.
Madhav Vasanthavada: 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, see the skin right now, but I'm just curious if the sense of urgency at all around the pipeline has kind of changed at all following the PRB sale. Thanks.
Speaker Change: Just curious if the sense of urgency at all around the pipeline has kind of changed at all following the Peel yourself.
Speaker Change: Thanks for the question, Steve as we've communicated earlier, we have two assets ARVO, which is the big Ophthalmology science.
Madhav Vasanthavada: 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 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, at least one asset from our ophthalmology pipeline going into clinic in the second half of 2026 is very much on track.
Speaker Change: Scientific Congress that happened recently, we had some very interesting data from our RSV program.
Speaker Change: We're all very excited about bringing this to clinic for.
Speaker Change: Human studies.
Speaker Change: 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 <unk>.
Speaker Change: <unk> from our pre IMD meeting from the FDA on what's required to take these assets too.
Speaker Change:
Speaker Change: Clinical trials, so that at least one asset from our ophthalmology pipeline going into clinic in the second half of 2026 is very much on track.
Speaker Change: Turns of acceleration I think.
Madhav Vasanthavada: In terms of acceleration, I think things have to happen. 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, as we ramp up our ZivaScan commercial progress here. And, of course, the other preclinical programs will follow on the heels of the first one, which is RS1.
Speaker Change: There is things have to happen.
Speaker Change: Like for example, the animal experiments are going on and that only happens at a certain pace you have the follow up required in all of that is 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 <unk>.
Speaker Change: <unk> performance.
Speaker Change: Performance as well so it hits very nicely with our.
Speaker Change: As we ramp up our.
Speaker Change: Zero skin commercial progress here.
Speaker Change: And of course, the other preclinical programs a follow on the heels of.
Speaker Change: The first one which is our S. One and what is very encouraging about these programs is with ophthalmology gene therapy, we're not.
Madhav Vasanthavada: And what is very encouraging about these programs is with ophthalmology gene therapy, we're not, the manufacturing and CMC is not as intense as it is for an autologous product. So, this can, and this is all managed through CDMOs, so it's not putting additional burden on our company per se, and at manageable pace of spending. So, that's really how we're looking at it, but from a developing data perspective, you're gonna hear more and more in the upcoming scientific congresses as we generate these animal data.
Speaker Change: The manufacturing in CMC is not as intense as it is for an autologous product. So this can and this is all managed.
Speaker Change: Through <unk>, so its not putting additional burden on our company per se and at a manageable pace of spending. So that's that's really how we're looking at it but from a.
Speaker Change: Developing data perspective, youre 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.
Madhav Vasanthavada: And what we see so far is very encouraging. Alright, very good.
Speaker Change: Alright, very good thanks for taking the questions.
Madhav Vasanthavada: Thanks for taking the question. Thank you. Stay fine. Thank you.
Steve: In Q, Steve Thank you.
Speaker Change: Thank you. Our next question is coming from Ron So variety with H C. Wainwright Your line is life.
Raghuram Selvaraju: Our next question is coming from Raghuram Selvaraju with HC Wainwright.
Raghuram Selvaraju: Your line is Sorry, Rob, I think you might be on mute. Can you hear me now? Yes, sir. Yes.
Speaker Change: So Rob I think you might be on mute.
Ron So: Can you hear me now.
Speaker Change: Yes, yes.
Speaker Change: Yes.
Speaker Change: So just wanted to see if you could provide us with some additional granularity regarding how you expect to scale up our commercial supply as and when demand progresses to that point and the degree to which you have sufficient commercial bandwidth now to meet.
Raghuram Selvaraju: 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, you know, demand progresses to that point and the degree to which you have sufficient commercial bandwidth now to meet the demand of, you know, X number of patients.
Speaker Change: The demand of X number of patients on <unk>.
Speaker Change: Also this question is for Joe can you just clarify for US what you expect the net proceeds to abbe owner to be from the sale of the PR V and if you can give us a sense of what do you anticipate pro forma cash to be at the end of the second quarter. Thank you.
Joe Vazzano: 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.
Rob: Thank you Rob maybe Joe you can take that.
Joe Vazzano: Thank you, Ram.
Speaker Change: <unk> first and then we'll move to Brian for the manufacturing scale up.
Brian Kevany: Maybe, Joe, you can take that question first, and then we'll move to Brian for the manufacturing scale-up. Sure, yeah, so the net proceeds from the PRV sale, you know, once it closes the HSR, will be about $152 million. And so, I mean, it's tough to project. Ending cash as of June, not sure if it will... We'll 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.
Joe: Sure, Yes, so the net proceeds from the <unk> sale once it closes.
Joe: HSR will be about $152 million or so.
Joe: And so I mean, it's tough to project.
Ending cash as of June.
Joe: I'm not sure if it will.
Joe: Clear that time period by that but we can expect about 152 million net proceeds from the purely we don't owe anything.
Joe: Any liabilities on that P. R V. It's all ours.
Joe: Brian.
Joe: The other question was yeah got it about the manufacturing question yeah. So.
Brian Kevany: Brian, the other question was, yeah, got it. Yeah, about the manufacturing question? Yeah. So yeah, 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.
Joe: As we've previously communicated we are.
Joe: The capacity of roughly <unk> <unk>.
Joe: More patients per month at launch, which is where we are right now.
Joe: As the year continues and we onboard additional acute disease, we will be ramping six patients per month.
Speaker Change: With an anticipation of being the eight and 10 patients per month.
Joe: By early next year.
Speaker Change: For a little bit of context, we have.
Speaker Change: Within our overall facility, we have two independent facilities that supply both one.
Speaker Change: Drug product.
Speaker Change: Our supplies the vector that's used within the drug product manufacturing.
Speaker Change: As we ramp up to 10 patients a month, we will be converting the vector side of the facility to also be supplying the skin for commercial manufacturing to allow us to get to that 10 patients per month, but we believe that that will scale with the onboarding of the Q T season.
Brian Kevany: 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. But we believe that that will scale well with the onboarding of the facility.
Speaker Change: Anticipated ramp in patient availability.
Brian Kevany: Anticipated Rampant Patient of the And just to clarify, which... Sorry, I just wanted to clarify, the 10 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 10 patients per month demand level. Is that correct? Right, correct. Yeah, the current facility will support that 10 patients. 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.
Speaker Change: And just to clarify.
Speaker Change: Okay.
Speaker Change: Alright.
Speaker Change: Just wanted to clarify.
Speaker Change: The 10 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 10 patients per month demand level is that correct.
Speaker Change: Correct correct, yes, the current facility will support that 10 patients per month.
Speaker Change: And just give a little bit more context from what we've talked about in terms of expansion is actually beyond the 10 patients a month.
Speaker Change: For which additional GMP space is being designed.
Speaker Change: Design the design is almost complete now and where.
Speaker Change: <unk> starting of building up that GMP space, which can add roughly about the same number of slots per month.
Speaker Change: The exact number of slots, we just need to finalize and communicate soon but that part of the facility will be.
Brian Kevany: We just need to finalize and we'll communicate soon, but that part of the facility will be ready to, you know, for slots for commercial manufacturing somewhere in the second half of 2027. And this would also be based in Cleveland, is that correct? Yep, Cleveland, same building, the same floor.
Speaker Change: Ready to.
Speaker Change: Four slots for commercial manufacturing somewhere in the second half of 2027.
Speaker Change: Yeah.
Speaker Change: And this would also be based in Cleveland is that correct.
Speaker Change: Cleveland same building the same floor.
Okay, and then just very quickly for Manav.
Speaker Change: I was wondering if at this point you have some sense of the prior treatment history of certain ardeb patients who might be considered candidates for PV cells and if you are seeing at this juncture.
Madhav Vasanthavada: 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 RDEV 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 Vyjuvik or even with and, you know, how that situation seems to be shaping up and how you expect it to evolve going forward, just in terms of prior treatment history with other approved RDEV products. Thank you. Right, we think that at this point in time, majority will be previously exposed to prior treatments, both Y-Juvec as well as Fils-Au-Vec, and that's what we hear also, not just from patients, but also from the physicians.
Speaker Change: The specific possibilities of treating patients with PV cell, who previously had been treated with <unk> or even with <unk> and how that situation seems to be shaping up and how you expect it to evolve going forward just in terms of prior treatment history with other approved ardeb products. Thank you.
Speaker Change: Right.
Speaker Change: We think that at this point in time majority will be previously exposed to.
Speaker Change: Our treatments, both my jewelry as well as food Suez.
Speaker Change: And that's.
Speaker Change: Next one for you here and also nausea from patients, but also from the physicians and their own pretty.
Speaker Change: Comparable with that discussion also.
Madhav Vasanthavada: And they're all pretty comfortable with that discussion also. In fact, that was also a point of our conversation. So, over time, 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. It's 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, you know, 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 treatment.
Speaker Change: In fact that was also a point of honor.
Speaker Change: Conversation.
Speaker Change: So over time, we would that said there are patients that we here who have not gotten any of the previous treatment.
Speaker Change: Relatively we don't know what percent budgets minority is what we would think.
Speaker Change: Let's say over time.
Speaker Change: We do expect.
Speaker Change: 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.
Speaker Change: We will continue to track that as we get into real treatments.
Speaker Change: Thanks.
Speaker Change: Our next question is coming from James Molloy with Alliance Global Partners. Your line is life.
Madhav Vasanthavada: Thank you.
James Malloy: Our next question is coming from James Malloy with Alliance Global Partners. Your line is live. Hey, guys. Good morning. Thanks for taking my questions. Congrats on the prior approval as well. Any word on who you guys are? The Hart-Scott 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 2nd of 26. Is that EPS profitable or cash profitable? Yeah, so in regards to the buyer of the PRB, that's undisclosed. And yeah, for 2026, yes, I'm anticipating positive EPS.
James Molloy: Hey, guys. Good morning, Thanks for taking my questions. Congrats on the on the prior approval as well.
Speaker Change: Any word on who you guys are the Hart Scott.
Speaker Change: The provision you're waiting for that any word on who are you sold the two is that something that you will be able to release and then Joe had mentioned the on the well.
Speaker Change: P. R V. The profitable second half 'twenty six.
Speaker Change: EPS profitable cash possible.
Speaker Change: Yes, so in regards to the buyer of the pier B that's undisclosed.
Speaker Change: Yes for 2026, yes, I'm anticipating.
Speaker Change: Positive EPS.
Speaker Change: And our last question is has the acquisition and potentially you have 220 million or so on the books is that the increase in the inbound calls for central acquisitions.
Vish Seshadri: And the last question is, has, you know, with the acquisition and potentially having, you know, 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 we when we have any updates, we will definitely bring that out to, you know, share. But at this time, we don't have any updates on that front. All right, great. Thank you for taking the question. Thank you, Jim. Thank you.
Jim: Hi, Jim.
Speaker Change: I think it's premature too.
Jim: Address that question, but.
Jim: When we have any updates we will definitely bring that out to you know share.
Jim: Sure, but at this time, we don't have any update on that front.
Jim: Great. Thanks for taking questions.
Jim: Thank you Jim.
Speaker Change: Thank you once again as a reminder, if you have any questions. Please press star one on your telephone keypad.
David Bouts: Once again, as a reminder, if you have any questions, please press star 1 on your telephone keypad. Our next question is coming from David Bouts with SACS Small Cap Research. Your line is open. 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 biopsy to when 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?
Speaker Change: Our next question is coming from David boats with Zacks small cap research. Your line is now.
David Boats: Hey, good morning, everyone. Thanks for taking the question and congrats on the progress.
David Boats: I was wondering if you could just kind of remind us of how billing and reimbursement is going to work for example, where you've got a patient who is expected to be biopsied in July and treated in August I'm, just curious how long do you anticipate the.
David Boats: Timeframe being from when that patient is treated or biopsy to win a b yamana gets a payment for that therapy and is that going to be different for all the different treatment centers or will that kind of be uniform.
David Boats: So thanks.
Speaker Change: Fish, so on the topic of payment I mean revenue recognition itself will happen right. After the patient is treated.
Joe Vazzano: Yeah, so thanks, Vish. So on the topic of payment, I mean, revenue recognition itself will happen right after the patient is treated. 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, you know, the payable. But these are large institutions who have experience doing other cell and gene therapy. So, you know, I mean, I think from that standpoint, it's, it's looking like it will track along the same lines.
Speaker Change: David and so thats sort of recognizing the revenue in terms of the payment and the cash itself Nike really depend we are still in discussions with the quantified treatment centers on that topic.
Speaker Change: But it'll be on par with any other cell and gene therapy in terms of the payables.
Speaker Change: These are large institutions, who have experience doing other cell and gene therapies. So.
Speaker Change: I mean, I think from that standpoint.
Speaker Change: It's looking like a deep track along the same lines.
Speaker Change: But any 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 its not like theyre up for a surprise that they have treated a patient and they don't know whether theyre going to get reimbursed or not on the backend.
Vish Seshadri: But before any patient is placed on treatment, at least from the provider's standpoint or the hospital's 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 income. 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 up front before they take up a manufacturing slot because they don't want that risk on them, right?
Speaker Change: So we do anticipate a very high level off.
Speaker Change: So to entity that if a patient is treated and.
Speaker Change: So it should be accretive than that.
Speaker Change: Thats going to result in revenue recognition and cash in coming.
Speaker Change: Okay. Thanks for that David.
Speaker Change: 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.
Speaker Change: And while the policies that are being put in place by the various commercial insurers in the Meanwhile.
Speaker Change: <unk>.
Speaker Change: <unk> 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 slots because they don't want that work on them right. So that explains why there was a little bit of a lead time, even to get the train started.
Vish Seshadri: So that explains why there is 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 Chicago? Are they just trying to get their name in the queue? What are they interested in doing there? Yeah, 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 in the last, you know, 2 weeks.
Speaker Change: Right. Okay understood. So for the you know approximately 30 patients that you indicated you've received inbound interest on our all these patients looking to go to children's hospital in Chicago or are they just trying to get their name in the queue Oh, what are they interested in doing there.
Speaker Change: 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 in the last two weeks.
Speaker Change: And at that point, we Didnt have a quantified, peaking center announced so it's more about the queuing up of these patients and now that we have announced Louise.
Vish Seshadri: 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's, we will certainly let these patients know the next step would be that for these patients, and then to enroll in our, you know, as this program so that they can continue to get more information and update and or directly reach out to the parlor and her staff. So, that is certainly another options plus also other patients who haven't called also now are aware. So, even if we think a fraction of these 30 patients, you know, do sign up and enroll in our program, we've got sufficient initial inbound interest.
Speaker Change: We'll certainly let these patients now the next step would be for these patients and to enroll in our in our <unk> program. So that they can continue to get more information and update and or directly reach out to the preponderant or SaaS.
Speaker Change: So that is certainly another options.
Speaker Change: POS also other patients who haven't called <unk>, but it's also an hour away.
Speaker Change: So even if we think a fraction of these 30 patients.
Speaker Change: Do sign up and Rolling our program there.
Speaker Change: Is that sufficient.
Speaker Change: Initial inbound interest.
Yeah, absolutely alright, thanks for taking the questions.
Vish Seshadri: Yeah, absolutely. All right. Thanks for taking the questions. Thank you, David. Thank you.
David Boats: Thank you David.
Speaker Change: Thank you Alex we have no further questions on the lines I'd like to hand, it back to Mr. Bush soldering for any closing remarks.
Vish Seshadri: 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, Ellie, 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.
Speaker Change: Thank you Ellie.
Speaker Change: And thank you everyone for joining us.
Speaker Change: For todays 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.
Speaker Change: Updates on the commercial launch progress very soon so have a wonderful day and we'll talk soon.
Vish Seshadri: So, have a wonderful day, and we'll talk soon. Thank you.
Speaker Change: 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.
Operator: Ladies and gentlemen, this does conclude today's call. You may disconnect your lines at this time and we thank you for your participation.