Q1 2026 Abeona Therapeutics Inc Earnings Call

May 13, 2026

Operator: Good day, ladies and gentlemen. Welcome to the Abeona Therapeutics Q1 2026 Earnings Conference Call. At this time, all participants are on a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star 0 on your telephone keypad. Please note, this conference is being recorded. I will now turn the conference over to your host, Mr. Joseph Vazzano, Chief Financial Officer at Abeona Therapeutics.

Speaker #2: And a question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press *0 on your telephone keypad.

Speaker #2: And please note, this conference is being recorded. I will now turn the conference over to your host, Mr. Joe Vazzano, Chief Financial Officer at ABEONA Therapeutics.

Operator: Sir, the floor is yours.

Speaker #2: Sir, the floor is yours. Thank you, operator. Good morning and thank you for joining us on our first quarter 2026 results and business update conference call.

Joseph Vazzano: Thank you, operator. Good morning, thank you for joining us on our Q1 2026 Results and Business Update Conference Call. During this call, we will refer to the press release issued this morning announcing the financial results, which is available on our corporate website at www.abeonatherapeutics.com. We anticipate making projections and forward-looking statements during today's call, which are made pursuant to the safe harbor provisions of the federal securities laws. These forward-looking statements are based on current expectations and are subject to change. Actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including but not limited to those outlined in our Form 10-K and periodic reports filed with the Securities and Exchange Commission. These documents are available on our website at www.abeonatherapeutics.com.

Joe Vazzano: Thank you, operator. Good morning, thank you for joining us on our Q1 2026 Results and Business Update Conference Call. During this call, we will refer to the press release issued this morning announcing the financial results, which is available on our corporate website at www.abeonatherapeutics.com. We anticipate making projections and forward-looking statements during today's call, which are made pursuant to the safe harbor provisions of the federal securities laws. These forward-looking statements are based on current expectations and are subject to change. Actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including but not limited to those outlined in our Form 10-K and periodic reports filed with the Securities and Exchange Commission. These documents are available on our website at www.abeonatherapeutics.com.

Speaker #2: During this call, we will refer to the press release issued this morning announcing the financial results which is available on our corporate website at www.abeonatherapeutics.com.

Speaker #2: 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.

Speaker #2: Actual results may defer 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 Securities and Exchange Commission.

Speaker #2: These documents are available on our website at www.abeonatherapeutics.com. Joining me on today's call with PrepareRemarks are Dr. Vishwas Seshadri, Chief Executive Officer and Dr. Madhav Vasanthavada, Chief Commercial Officer.

Joseph Vazzano: Joining me on today's call with prepared remarks are Dr. Vish Seshadri, Chief Executive Officer, and Dr. Madhav Vasanthavada, Chief Commercial Officer. With that, I will now turn the call over to Dr. Seshadri to kick us off. Vish?

Joe Vazzano: Joining me on today's call with prepared remarks are Dr. Vish Seshadri, Chief Executive Officer, and Dr. Madhav Vasanthavada, Chief Commercial Officer. With that, I will now turn the call over to Dr. Seshadri to kick us off. Vish?

Speaker #2: With that, I will now turn the call over to Dr. Seshadri to kick us off. Vish?

Speaker #3: Thank you, Joe, everyone. First, we are excited to share updates on leading indicators of ZivaSkin adoption that signal strong momentum since treating our first commercial patient in December.

Vish Seshadri: Thank you, Joe. Good morning, everyone. First, we're excited to share updates on leading indicators of ZEVASKYN adoption that signal strong momentum since treating our first commercial patient in December. We have now activated 6 qualified treatment centers or QTCs, treated our 5th commercial patient with manufacturing underway for the 6th, and scheduled additional patients throughout the current quarter. The recent acceleration of onboarding efforts of QTCs further underscores their conviction about the role that ZEVASKYN will play in addressing the unmet needs of patients suffering from recessive dystrophic epidermolysis bullosa or RDEB. 3 of the ZEVASKYN treatments reported to date took place in Q1 2026 and translated into net revenue of $8.7 million for that quarter. Second, we're sharing meaningful updates to our R&D pipeline, featuring a potentially game-changing, radically novel engineered T-cell technology for advanced prostate cancer.

Speaker #3: We have now activated six qualified treatment centers, or QTCs, treated our fifth commercial patient, with manufacturing underway for the sixth, and scheduled additional patients throughout the current quarter.

Speaker #3: The recent acceleration of onboarding efforts of QTCs further underscores their conviction about the role that ZivaSkin will play in addressing the unmet needs of patients suffering from recessive dystrophic epididymolysis bullosa or RDEB.

Speaker #3: Three of the ZivaSkin treatments reported to date took place in Q1 2026 and translated into net revenue of $8.7 million for that quarter. Second, we're sharing meaningful updates to our R&D pipeline featuring a potentially game-changing radically novel engineered T-cell technology for advanced prostate cancer.

Speaker #3: By leveraging our proven expertise in advancing complex cell and gene therapies from academia through commercialization, we are well positioned to advance this exciting technology.

Vish Seshadri: By leveraging our proven expertise in advancing complex cell and gene therapies from academia through commercialization, we are well-positioned to advance this exciting technology. Before going there, I'll first turn the call over to Dr. Madhav Vasanthavada to elaborate on the ZEVASKYN launch, which is our foundational and primary focus for Abeona. Madhav?

Speaker #3: But before going there, I'll first turn the call over to Dr. Madhav Vasanthavada to elaborate on the ZivaSkin launch which is our foundational and primary focus for ABEONA.

Speaker #3: Madhav?

Speaker #2: Thank you, Vish. And good morning, everyone. Launch momentum for ZivaSkin and our commercial story continues to build, and we are beginning to see results on multiple fronts.

Madhav Vasanthavada: Thank you, Vish, and good morning, everyone. Launch momentum for ZEVASKYN and our commercial story continues to build. We are beginning to see results on multiple fronts. I'd like to start off by providing you with visibility not only to patients treated so far, but also biopsies expected this quarter. As previously shared, 1 patient, our very first commercial patient, was treated in Q4 2025. 3 patients were treated in Q1 of this year. Additionally, 1 patient has been treated so far this quarter for a total of 5 patients treated to date with ZEVASKYN since launch.

Speaker #2: I'd like to start off by providing you with visibility not only to patients treated so far, but also biopsies expected this quarter. As previously shared, one patient, our very first commercial patient, was treated in the fourth quarter of 2025, and three patients were treated in the first quarter of this year.

Speaker #2: Additionally, one patient has been treated so far this quarter, for a total of five patients treated to date with ZivaSkin since launch. The forward-looking momentum of patients in queue is also picking up with one patient biopsied and manufacturing for that patient currently underway, and six additional patients expected to be biopsied this quarter, three of whom actually just as of this morning, four of whom have scheduled biopsies.

Madhav Vasanthavada: The forward-looking momentum of patients in queue is also picking up with 1 patient biopsied and manufacturing for that patient currently underway, and 6 additional patients expected to be biopsied this quarter, 3 of whom. Actually, just as of this morning, 4 of whom have scheduled biopsies. I'd like to add that all patients treated to date and those scheduled for biopsies are from our first 2 activated QTCs. The other 2 QTCs have identified patients and are not far behind in scheduling for biopsy, which will further add to ZEVASKYN treatments in the coming quarters. While we are pleased to see patients beginning to clear the upstream procurement process and receiving ZEVASKYN treatments, we are equally encouraged by the strong demand reflected in the near-term identified pool of more than 100 patients across our QTCs and the community-based physicians.

Speaker #2: I'd like to add that all patients treated to date and those scheduled for biopsies are from our first two activated QTCs. The other two QTCs have identified patients and are not far behind in scheduling for biopsy which will further add to ZivaSkin treatments in the coming quarters.

Speaker #2: While we are pleased to see patients beginning to clear the upstream procurement process and receiving ZivaSkin treatments, we are equally encouraged by the strong demand reflected in the near-term identified pool of more than 100 patients across our QTCs and the community-based physicians.

Speaker #2: Our field teams are executing well, building deep relationships, expanding awareness, and driving broad reach across dermatology, pediatric dermatology, and subspecialties involved in the care of EB patients.

Madhav Vasanthavada: Our field teams are executing well, building deep relationships, expanding awareness, and driving broad reach across dermatology, pediatric dermatology, and subspecialties involved in the care of EB patients. We continue to engage with referral physician community and have active conversations ongoing with 45 physicians. These are not just one-off touchpoints, but action-oriented back-and-forth interactions which shows real clinical interest and their intent to refer patients for ZEVASKYN. Beyond the numbers, early qualitative launch insights are also encouraging and reinforce our conviction. Importantly, we are hearing positive feedback from QTCs that have treated patients, and their experience with the end-to-end process is getting better with every patient treated.

Speaker #2: We continue to engage with the referral physician community and have active conversations ongoing with 45 physicians. These are not just one-off touch points, but action-oriented, back-and-forth interactions, which shows real clinical interest and their intent to refer patients for ZivaSkin.

Speaker #2: Beyond the numbers, early qualitative launch insights are also encouraging and reinforce our conviction. Importantly, we are hearing positive feedback from QTCs that have treated patients and their experience with the end-to-end process is getting better with every patient treated.

Speaker #2: To elaborate further on the types of initial patients that have been treated and those in the queue, we are happy to note that the initial uptake of ZivaSkin is not confined to a narrowly defined patient or payer type but has spanned across both adults and children with one patient as young as five years of age.

Madhav Vasanthavada: To elaborate further on the types of initial patients that have been treated and those in the queue, we are happy to note that the initial uptake of ZEVASKYN is not confined to a narrowly defined patient or payer type, but has spanned across both adults and children, with one patient as young as 5 years of age. Our payer mix consists of both commercial and Medicaid insurers, indicating the breadth of ZEVASKYN coverage. We are seeing that geographic proximity to QTC has not been a barrier because patients have traveled significant distances, including across state lines, to receive treatment, and our Abeona Assist patient and caregiver support programs have received positive feedback.

Speaker #2: Our payer mix consists of both commercial and Medicaid insurers, indicating the breadth of ZivaSkin coverage. We are seeing that geographic proximity to QTCs has not been a barrier, because patients have traveled significant distances, including across state lines, to receive treatment. Our ABEONA Assist patient and caregiver support programs have received positive feedback.

Speaker #2: Among the patients treated is our very first patient in the commercial setting, who was biopsied in August of 2025, but as you may recall, could not receive ZivaSkin due to a false positive result from a sterility assay.

Madhav Vasanthavada: Among the patients treated is our very first patient in the commercial setting who was biopsied in August 2025, but as you may recall, could not receive ZEVASKYN due to a false positive result from a sterility assay. This patient came back to be re-biopsied early this year, and we are pleased to tell you that this patient was treated successfully. Such determination of patients, families, and physicians to pursue ZEVASKYN speaks volumes about what this therapy means to them. On the market access front, payer coverage continues to strengthen with the percentage of commercially covered lives with published ZEVASKYN policies now reaching 95%. This is a significant accomplishment in the first year post-ZEVASKYN approval. That said, we are navigating a lengthy insurance approval process, which is typical of any high-cost gene therapy at launch, particularly for out-of-state Medicaid patients.

Speaker #2: This patient came back to be rebiopsied early this year, and we are pleased to tell you that this patient was treated successfully. Such determination of patients' families and physicians to pursue ZivaSkin speaks volumes about what this therapy means to them.

Speaker #2: On the market access front, payer coverage continues to strengthen with the percentage of commercially covered lives with published ZivaSkin policies now reaching 95%. This is a significant accomplishment in the first year post-ZivaSkin navigating a lengthy insurance approval process which is typical of any high-cost gene therapy at launch, particularly for out-of-state Medicaid patients.

Speaker #2: Even so, we have seen no patient attrition and no final payer denials to date. Further underscoring the strength of ZivaSkin's value proposition to RDEV patients and their families.

Madhav Vasanthavada: Even so, we have seen no patient attrition and no final payer denials to date, further underscoring the strength of ZEVASKYN's value proposition to RDEB patients and their families. As we continue to follow patients from our phase I, II-A, and phase III trials, we are excited to share that new data will be presented later this week at the Society for Investigative Dermatology, SID, featuring 5-year follow-up of our VIITAL phase III trial as well as a single patient 12 years of follow-up from phase I-IIA study, all of which reinforce durable wound healing and favorable safety profile after a one-time product application. On the patient side, our Strong Together Network continues to be a powerful voice, with patients and caregivers sharing their experiences from clinical trials and helping to generate patient self-referrals.

Speaker #2: As we continue to follow patients from our Phase 1, 2A, and Phase 3 trials, we are excited to share that new data will be presented later this week at the Society for Investigative Dermatology, SID, featuring five-year follow-up of our vital Phase 3 trial as well as a single patient 12 years of follow-up from Phase 1 to A study.

Speaker #2: All of which reinforce durable wound healing and favorable safety profile after a one-time product application. On the patient side, our strong together network continues to be a powerful voice with patients and caregivers sharing their experiences from clinical trials and helping to generate patient self-referrals.

Speaker #2: As our initial ZivaSkin commercial patients share their experiences over time, we expect these stories to become one of the most powerful demand drivers available to us in this rare disease setting.

Madhav Vasanthavada: As our initial ZEVASKYN commercial patients share their experiences over time, we expect these stories to become one of the most powerful demand drivers available to us in this rare disease setting. Lastly, we continue to onboard more ZEVASKYN treatment centers. As announced, we activated NewYork-Presbyterian/Columbia University Irving Medical Center last month. Monday of this week we announced the activation of Children's Hospital of Philadelphia, CHOP, as our sixth QTC. I want to sincerely thank all my team members involved in the onboarding of these centers and to recognize the our QTC physician champions and their team's conviction in ZEVASKYN as they successfully navigated a several-month-long onboarding process. As you can gather from the map, we importantly have QTCs spanning the nation across geographically distinct regions, California, Colorado, Texas and the Gulf Coast, Chicago, and now the East Coast.

Speaker #2: Lastly, we continue to onboard more ZivaSkin treatment centers. As announced, we activated New York Presbyterian Columbia University last month, and Monday of this week, we announced the activation of Children's Hospital of Philadelphia, CHOP, as our sixth QTC.

Speaker #2: I want to sincerely thank all my team members involved in the onboarding of these centers and to recognize our QTC physician champions and their teams' conviction in ZivaSkin as they successfully navigated a several-month-long onboarding process.

Speaker #2: As you can gather from the map, we importantly have QTCs spanning the nation across geographically distinct regions. California, Colorado, Texas, and the Gulf Coast, Chicago, and now the East Coast.

Speaker #2: We continue to have active discussions with additional centers and remain well on track to achieving our goal of having a total of seven QTCs onboarded this year and ensuring even greater access for patients and families across the country.

Madhav Vasanthavada: We continue to have active discussions with additional centers and remain well on track to achieving our goal of having a total of seven QTCs onboarded this year and ensuring even greater access for patients and families across the country. To close, we are progressing through the launch, accruing positive early feedback from treating physicians, a growing referral base, expanding QTC networks, and achieving broad payer acceptance. Every successful biopsy, every treatment, and every positive patient story is reinforcing our conviction in ZEVASKYN. With that, I'll turn the call back to Vish Seshadri for an update on our R&D pipeline. Ganesh?

Speaker #2: To close, we are progressing through the launch accruing positive early feedback from treating physicians, a growing referral base, expanding QTC network, and achieving broad payer acceptance.

Speaker #2: Every successful biopsy, every treatment, and every positive patient story is reinforcing our conviction in ZivaSkin. With that, I'll turn the call back to Dr. Seshadri for an update on our R&D pipeline.

Speaker #2: Vish?

Speaker #3: Thank you, Madhav. Now I'll share some important pipeline updates that highlight our focus on assets that align with our core competencies and what we believe would deliver the greatest long-term value.

Vish Seshadri: Thank you, Madhav. Now I'll share some important pipeline updates that highlight our focus on assets that align with our core competencies and what we believe would deliver the greatest long-term value. As part of this focus effort, we have deprioritized our in-house ophthalmology preclinical programs. Abeona has demonstrated capabilities with ZEVASKYN over the past years in end-to-end development and commercialization of personalized high-value cell therapies with durable clinical benefits for patients with debilitating diseases. Today, we announced the in-licensing of a radically novel cell therapy asset that targets PSMA, or prostate-specific membrane antigen, a validated target for the treatment of advanced prostate cancer, a leading cause of cancer mortality, with more than 30,000 deaths annually in the US. The SIR-T technology was pioneered by Dr. Preet Chaudhary, founder of Angeles Therapeutics and Professor of Medicine at the University of Southern California.

Speaker #3: As part of this focused effort, we have de-prioritized our in-house ophthalmology preclinical programs. ABEONA has demonstrated capabilities with ZivaSkin over the past years in end-to-end development and commercialization of personalized high-value cell therapies with durable clinical benefits for patients with debilitating diseases.

Speaker #3: Today, we announced the in-licensing of a radically novel cell therapy asset that targets PSMA, or prostate-specific membrane antigen, a validated target for the treatment of advanced prostate cancer, a leading cause of cancer mortality with more than 30,000 deaths annually in the US.

Speaker #3: The third key technology was pioneered by Dr. Preet Chaudhari, founder of Angelus Therapeutics and professor of medicine at the University of Southern California. He has more than 200 granted or pending patents worldwide in the field of cell therapy.

Vish Seshadri: He has more than 200 granted or pending patents worldwide in the field of cell therapy. We have included a link to a recent talk by Dr. Chaudhary in today's slides elaborating on the uniqueness and promise of this technology in oncology. PSMA-SIR-T, or ABO-701, is an autologous engineered T-cell therapy that carries a PSMA-directed synthetic immune receptor purposefully structured to overcome the limitations of CARs, or chimeric antigen receptors, and TCRs, which is T-cell receptors. The SIR-T technology is unique in that it can directly recognize and bind a target membrane antigen, like a CAR does, without the need for antigen presentation. However, it retains the physiologic signaling and regulatory features of a native T-cell receptor, which enables more controlled, durable, immune-mediated cell death.

Speaker #3: We have included a link to a recent talk by Dr. Chaudhari in today's slides, elaborating on the uniqueness and promise of this technology in oncology.

Speaker #3: PSMA3T, or ABO701, is an autologous engineered T-cell therapy that carries a PSMA-directed synthetic immune receptor purposefully structured to overcome the limitations of CARs, or chimeric antigen receptors, and TCRs, which is T-cell receptors.

Speaker #3: The third key technology is unique in that it can directly recognize and bind a target membrane antigen like a CAR does, without the need for antigen presentation.

Speaker #3: However, it retains the physiologic signaling and regulatory features of a native T-cell receptor, which enables more controlled durable immune-mediated cell death. In preclinical studies, PSMA3T demonstrated the ability to achieve deep and durable PSMA-specific anti-tumor responses in mouse models and displayed exceptionally modest levels of cytokine release in vitro.

Vish Seshadri: In preclinical studies, PSMA-SIR-T demonstrated the ability to achieve deep and durable PSMA-specific antitumor responses in mouse models and displayed exceptionally modest levels of cytokine release in vitro, a profile that has been elusive for other engineered T-cell therapies in solid tumors. The elimination of tumors in most mice treated with PSMA-SIR-T and its superior performance versus corresponding PSMA CAR T comparator controls suggests a more controlled and durable immune activation in treated mice. We believe these data support a compelling hypothesis that SIR-T technology may overcome key limitations that have historically constrained engineered T-cell therapies in solid tumors. We anticipate IND filing and first-in-human studies to commence in H2 2027.

Speaker #3: A profile that has been elusive for other engineered cell therapies in solid tumors. The elimination of tumors in most mice treated with PSMA3T and its superior performance versus corresponding PSMACAR-T comparator controls suggests a more controlled and durable immune activation in treated mice.

Speaker #3: We believe these data support a compelling hypothesis that 3T technology may overcome key limitations that have historically constrained engineered T-cell therapies in solid tumors.

Speaker #3: We anticipate IND filing and first-in-human studies to commence in the second half of 2027. In the near term, we will gain regulatory alignment beginning with a pre-IND meeting with the FDA on June 3rd, 2026, and engage a CDMO for supply readiness while our internal teams maintain operational focus on ZivaSkin commercialization.

Vish Seshadri: In the near term, we will gain regulatory alignment, beginning with a pre-IND meeting with the FDA on 3 June 2026, and engage a CDMO for supply readiness while our internal teams maintain operational focus on ZEVASKYN commercialization. With that, I now pass the call to our Chief Financial Officer, Joseph Vazzano, to discuss our Q1 financial results. Joe?

Speaker #3: With that, I'll now pass the call to our Chief Financial Officer, Joe Vazzano, to discuss our first-quarter financial results. Joe?

Speaker #4: Thank you, Vish. I would like to remind everyone that you could find additional details on our financial results for the first quarter ending March 31st, 2026, in our most recent 10-Q.

Joseph Vazzano: Thank you, Vish. I would like to remind everyone that you could find additional details on our financial results for Q1 ending 31 March 2026 in our most recent Form 10-Q. We reported total net product revenue of $8.7 million for Q1 2026. All 3 patients treated in the quarter were commercially insured patients. This reflects a strong quarter-over-quarter increase of $6.3 million compared to $2.4 million in Q4 2025. The growth was driven by early commercial traction following the launch of ZEVASKYN. Cost of sales for the quarter was $2.7 million compared to $1 million in the prior quarter. The increase was primarily driven by the scaling of commercial ZEVASKYN, with 3 patient treatments in Q1 versus 1 treatment in Q4. Turning to operating expenses.

Joe Vazzano: Thank you, Vish. I would like to remind everyone that you could find additional details on our financial results for Q1 ending 31 March 2026 in our most recent Form 10-Q. We reported total net product revenue of $8.7 million for Q1 2026. All 3 patients treated in the quarter were commercially insured patients. This reflects a strong quarter-over-quarter increase of $6.3 million compared to $2.4 million in Q4 2025. The growth was driven by early commercial traction following the launch of ZEVASKYN. Cost of sales for the quarter was $2.7 million compared to $1 million in the prior quarter. The increase was primarily driven by the scaling of commercial ZEVASKYN, with 3 patient treatments in Q1 versus 1 treatment in Q4. Turning to operating expenses.

Speaker #4: We reported total net product revenue of $8.7 million, for the first quarter of 2026. All three patients treated in the quarter were commercially insured patients.

Speaker #4: This reflects a strong quarter-over-quarter increase of 6.3 million dollars compared to 2.4 million dollars in the fourth quarter of 2025. The growth was driven by early commercial traction following the launch of ZivaSkin.

Speaker #4: Cost of sales for the quarter was $2.7 million. Compared to $1 million in the prior quarter. The increase was primarily driven by the scaling of commercial ZivaSkin, with three patient treatments in Q1 versus one treatment in Q4.

Speaker #4: Turning to operating expenses. R&D expenses were $9.6 million. Compared to $9.9 million. In the first quarter of 2025. Notably, Q1 2026 includes a $7 million upfront payment related to the in-licensing of our PSMA3T asset.

Joseph Vazzano: R&D expenses were $9.6 million compared to $9.9 million in Q1 2025. Notably, Q1 2026 includes a $7 million upfront payment related to the in-licensing of our PSMA-SIR-T asset. Excluding this transaction, R&D expenses declined meaningfully, reflecting the transition of certain manufacturing costs capitalized to inventory and engineering runs that are no longer considered R&D following the FDA approval of ZEVASKYN. Selling, general, and administrative expenses were $19.5 million, representing an increase of $9.7 million year-over-year Q1. This increase was expected and reflects our continued investment in commercial infrastructure post-approval. Key drivers include $5.4 million in personnel and stock-based compensation, $1.9 million of costs related to engineering runs, with the remainder due to other commercialization costs.

Joe Vazzano: R&D expenses were $9.6 million compared to $9.9 million in Q1 2025. Notably, Q1 2026 includes a $7 million upfront payment related to the in-licensing of our PSMA-SIR-T asset. Excluding this transaction, R&D expenses declined meaningfully, reflecting the transition of certain manufacturing costs capitalized to inventory and engineering runs that are no longer considered R&D following the FDA approval of ZEVASKYN. Selling, general, and administrative expenses were $19.5 million, representing an increase of $9.7 million year-over-year Q1. This increase was expected and reflects our continued investment in commercial infrastructure post-approval. Key drivers include $5.4 million in personnel and stock-based compensation, $1.9 million of costs related to engineering runs, with the remainder due to other commercialization costs.

Speaker #4: Excluding this transaction, R&D expenses declined meaningfully, reflecting the transition of certain manufacturing costs, capitalized to inventory, and engineering runs that are no longer considered R&D following the FDA approval of ZivaSkin.

Speaker #4: Selling, general, and administrative expenses were $19.5 million, representing an increase of $9.7 million year over year for the first quarter. This increase was expected and reflects our continued investment in commercial infrastructure post-approval.

Speaker #4: Key drivers include $5.4 million in personnel and stock-based compensation, $1.9 million of costs related to engineering runs, with the remainder due to other commercialization costs.

Speaker #4: Net loss for the quarter was $17.1 million. Or 30 cents per basic and diluted common share. Compared to a net loss of $12 million or 24 cents per basic and diluted common share, in the first quarter of 2025.

Joseph Vazzano: Net loss for the quarter was $17.1 million, or $0.30 per basic and diluted common share, compared to a net loss of $12 million or $0.24 per basic and diluted common share in Q1 2025. The year-over-year change primarily reflects increased commercial investment and the PSMA-SIR-T licensing transaction. We ended the quarter with $168.3 million in cash equivalents, and short-term investments compared to $191.4 million at the end of 2025. Our balance sheet remains strong and positions us well to support continued commercial execution and pipeline advancement. We anticipate minimal R&D expenditures for the PSMA program, limited to low single-digit million dollars for the remainder of this year. Overall, we are encouraged by the early commercial progress of ZEVASKYN and remain disciplined in our capital allocation as we scale the business.

Joe Vazzano: Net loss for the quarter was $17.1 million, or $0.30 per basic and diluted common share, compared to a net loss of $12 million or $0.24 per basic and diluted common share in Q1 2025. The year-over-year change primarily reflects increased commercial investment and the PSMA-SIR-T licensing transaction. We ended the quarter with $168.3 million in cash equivalents, and short-term investments compared to $191.4 million at the end of 2025. Our balance sheet remains strong and positions us well to support continued commercial execution and pipeline advancement. We anticipate minimal R&D expenditures for the PSMA program, limited to low single-digit million dollars for the remainder of this year. Overall, we are encouraged by the early commercial progress of ZEVASKYN and remain disciplined in our capital allocation as we scale the business.

Speaker #4: The year-over-year change primarily reflects increased commercial investment and the PSMA3T licensing transaction. We ended the quarter with $168.3 million in cash, cash equivalents, and short-term investments, compared to $191.4 million at the end of 2025.

Speaker #4: Our balance sheet remains strong and positions us well to support continued commercial execution and pipeline advancement. We anticipate minimal R&D expenditures for the PSMA program, limited to low single-digit million dollars, for the remainder of this year.

Speaker #4: Overall, we are encouraged by the early commercial progress of ZivaSkin and remain disciplined in our capital allocation as we scale the business. With that, I'll pass the call back to Vish for closing remarks before opening the call for Q&A.

Joseph Vazzano: With that, I'll pass the call back to Vish for closing remarks before opening the call for Q&A. Vish?

Joe Vazzano: With that, I'll pass the call back to Vish for closing remarks before opening the call for Q&A. Vish?

Speaker #4: Vish?

Speaker #3: To summarize, we are encouraged by favorable trends in leading indicators of ZivaSkin launch performance, that is, the foundation on which we have taken a bold step in advancing PSMA3T development.

Vish Seshadri: To summarize, we are encouraged by favorable trends in leading indicators of ZEVASKYN launch performance. That is the foundation on which we have taken a bold step in advancing PSMA-SIR-T development. Every milestone we've discussed ultimately connects back to patients with serious diseases who are waiting for better, more innovative medicines. Our mission is not just a statement, but a commitment that guides how we allocate capital, how we prioritize our pipeline, and how we measure success. With that, I request the operator to open the floor for questions.

Speaker #3: Every milestone we've discussed ultimately connects back to patients with serious diseases, who are waiting for better, more innovative medicines. Our mission is not just a statement, but a commitment that guides how we allocate capital, how we prioritize our pipeline, and how we measure success.

Speaker #3: With that, I request the operator to open the floor for questions.

Speaker #1: Thank you. Ladies and gentlemen, 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.

Operator: Thank you. Ladies and gentlemen, 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. A confirmation tone will indicate your line is in the question queue, and 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 star keys. One moment please while we poll for questions. Thank you. Our first question today is coming from Kristen Kluska with Cantor Fitzgerald. Your line is live.

Speaker #1: A confirmation tone will indicate your line is in the question queue. And you may press star 2 if you would like to remove your question from the queue.

Speaker #1: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we pull for questions.

Speaker #1: Thank you. Our first question today is coming from Kristin Kluska with Canter Fitzgerald. Your line is live.

Speaker #5: Hi. Good morning, everybody, and congrats on all the progress here around ZivaSkin. So now that you have five patients treated and quite a few in the biopsy pipeline, can you give us a sense of what the typical patient profile has looked like across treatment?

Kristen Kluska: Hi. Good morning, everybody, and congrats on all the progress here around ZEVASKYN. Now that you have 5 patients treated and quite a few in the biopsy pipeline, can you give us a sense of what the typical patient profile has looked like across treatment? Are these more severe patients? Are any that have come back from the clinical trial to get another cycle? For those that have undergone the procedure already, have they commented on whether they would be interested in potentially coming back in the future for another cycle?

Speaker #5: Are these more severe patients? Are any of these any that have come back from the clinical trial to get another cycle? And for those that have undergone the procedure already, have they commented on whether they would be interested in potentially coming back in the future for another cycle?

Speaker #3: Hi, Kristin. Good morning, and thanks for that question. Yes. So with regard to your first question about the patient profile, what we hear from physicians are these are severe patients, as we had expected.

Madhav Vasanthavada: Hi, Kristen. Good morning, and thanks for that question. Yes, with regard to your first question about the patient profile, what we hear from physicians are these are severe patients as we had expected. Many of those patients treated would require more than 12 sheets of ZEVASKYN. There is still an unmet need even in these treated patients. Of course, it's early to say how many of these patients will come back and at what point in time will they come back for a second treatment. There is definitely a clinical need from that standpoint. The second part, clinical trial patients, they are interested. We know that patient consults are happening.

Speaker #3: And many of those patients treated would require more than 12 sheets of ZivaSkin. So there is still an unmet need, even in these treated patients.

Speaker #3: Of course, it's early to say how many of these patients will come back and at what point in time will they come back for a second treatment.

Speaker #3: But there is definitely a clinical need from that standpoint. The second part, clinical trial are interested and we know that patient consults are happening.

Speaker #3: It's just a matter of, for those patients, when would be the right time for them to come in for a retreatment with ZivaSkin. And so we'll keep you updated if we have that kind of information.

Madhav Vasanthavada: It's just a matter of, for those patients, when would be the right time for them to come in for a retreatment with ZEVASKYN. We'll, you know, keep you updated if we have that kind of information. From the patients who have received, you know, ZEVASKYN already, Yeah, I think I already addressed that part, which is, you know, we don't know exactly when they'll come in, but there is certainly a need for that.

Speaker #3: And from the patients who have received ZivaSkin, already, yeah, I think I already addressed that part, which is we don't know exactly when they'll come in, but there is certainly a need for that.

Speaker #5: Okay. Thank you for that. And then just as we think about how to model this out for Q2, we know one patient has officially been treated.

Kristen Kluska: Okay. Thank you for that. Just as we think about how to model this out for Q2, we know 1 patient has officially been treated, you know, all this color is really helpful around the biopsy schedule. Just kind of, you know, what can you tell us about your sense of how many patients you ultimately believe will have the procedure, meaning you get paid for it in Q2, versus how we should be thinking about maybe some of these trickling into next quarter?

Speaker #5: And all this color is really helpful around the biopsy schedule. But just kind of, what can you tell us about your sense of how many patients you ultimately believe will have the procedure, meaning you get paid for it in Q2, versus how we should be thinking about maybe some of these trickling into next quarter?

Speaker #3: Thanks for that question, Kristin. It's hard to precisely place how many of the I think we gave visibility to at least eight patients today in the call.

Madhav Vasanthavada: Thanks for that question, Kristen. It's hard to precisely place how many of the I think we gave visibility to at least eight patients today in the call, one treated, one in manufacturing process, and six that are in the biopsy scheduling process, right? We could anticipate that maybe one or two of those patients who may be biopsied in June, anything after the first week of June, would fall into July treatment. Is it one? Is it two? Is it three? It's very hard to predict because some may be in the borderline, and the manufacturing turnaround time is not a very precise number, even though we have it approximately 23 or 24 days. That is something that we'll have to see.

Speaker #3: One treated, one in manufacturing process, and six that are in the biopsy scheduling process, right? So we could anticipate that maybe one or two of those patients who may receive who may be biopsied and June, anything after the first week of June would fall into July treatment.

Speaker #3: Is it one? Is it two? Is it three? It's very hard to predict because some may be in the borderline and the manufacturing turnaround time is not a very precise number, even though we have it approximately 23 or 24 days.

Speaker #3: That is something that we'll have to see. But a good chunk of the patients that we have described today should fall under quarter two treatments.

Madhav Vasanthavada: A good chunk of the patients that we have described today should fall under Q2 treatments.

Speaker #5: Thank you.

Kristen Kluska: Thank you.

Speaker #3: Thank you, Kristin.

Madhav Vasanthavada: Thank you, Kristen.

Speaker #1: Thank you. Our next question is coming from Mauri Raycroft with Jefferies. Your line is live.

Operator: Thank you. Our next question is coming from Maury Raycroft with Jefferies. Your line is live.

Speaker #6: Hi. Good morning. Congrats on the progress. And thanks for taking my questions. Maybe as a follow-up to Kristin's last question, for the patients treated so far from my understanding, they've been treated at Laurie's in Stanford.

Maury Raycroft: Hi. Good morning. Congrats on the progress, and thanks for taking my questions. Maybe as a follow-up to Kristen's last question, for the patients treated so far, from my understanding, they've been treated at Lurie's in Stanford. Can you clarify what other QTCs are fully activated? It may be too early for this, but can you provide some bookending for what patient volume could look like per QTC or across the QTCs for 2026, and maybe what steady state could look like eventually as well?

Speaker #6: Can you clarify what other QTCs are fully activated? And it may be too early for this, but can you provide some bookending for what patient volume could look like per QTC or across the QTCs for 2026?

Speaker #6: And maybe what steady state could look like eventually as well?

Speaker #3: Yeah, Mauri. So in addition to Laurie Children's and Stanford Children's, we have Colorado, Children's Hospital that's active, and UTMB, University of Texas in Galveston.

Madhav Vasanthavada: Maury. In addition to Lurie Children's and Stanford Children's, we have Children's Hospital Colorado that's active and UTMB, University of Texas in Galveston, which is also active. Of course, the most recent ones were Columbia and CHOP. We do know that Colorado and UTMB have patients actively identified, and they are working through the administrative process to put them on, and we expect that we should receive biopsy schedule requests for their patients imminently. In terms of the volume, these are centers. Colorado is actually a very well-known institution for EB care. You know, in terms of the cadence, what we have been hearing from QTC is treating 1 patient a month at a steady state is quite doable.

Speaker #3: Which is also active. And of course, the most recent ones were Columbia, and CHOP. We do know that Colorado and UTMB have patients actively identified and they are working through the administrative process to put them on and we expect that we should receive biopsy schedule requests for their patients imminently.

Speaker #3: And in terms of the volume, these are centers. Colorado is actually a very well-known institution for EB care. And in terms of the cadence, what we have been hearing from QTCs is treating one patient a month at a steady state is quite doable.

Speaker #3: So we it's just a matter of getting these patients initiated with biopsy and the treatment cadence.

Madhav Vasanthavada: It's just a matter of getting these patients, initiated with biopsy and the treatment cadence.

Speaker #6: Got it. That's helpful. And based on the comments in the prepared remarks around the length of the insurance approval process, it seems like ultimately this is not limiting usage, but is this something that you have line of sight on that you can improve?

Maury Raycroft: Got it. That's helpful. Based on the comments in the prepared remarks around the length of the insurance approval process, it seems like ultimately this is not limiting usage, but is this something that you have line of sight on that you can improve? How can improving this factor into your ability to fine-tune projections? Do you anticipate there could be greater pushback or friction when it comes to re-treating patients?

Speaker #6: And how can improving this factor into your ability to fine-tune projections? And then do you anticipate there could be greater pushback or friction when it comes to retreating patients?

Speaker #3: Yeah. Definitely the process will improve. Oftentimes with gene therapy, especially high-cost gene therapy, the initial process of payer clearance, especially if a patient is traveling from out of state, there is additional layers that of paperwork that need to be secured.

Vish Seshadri: Definitely the process will improve. Oftentimes with gene therapy, especially high-cost gene therapy, the initial process of payer clearance, especially if a patient is traveling from out of state, there is additional layers of paperwork that need to be secured. Starting with, you know, physicians also need to be enrolled. It's a one-time enrollment. Like, for example, if a patient is traveling from a different state to get, receive treatment in one of these QTC states, then the physician from the qualified center, whether it's a surgeon, anesthesiologist, or the EB physician, need to be enrolled in sort of the out-of-state, you know, patient state. That is a one-time process, as well as, you know, just providing a fee schedule.

Speaker #3: Starting with physicians also need to be enrolled it's a one-time enrollment. So for example, if a patient is coming from traveling from a different state to get received treatment in one of these QTC states, then the physician from the qualified center, whether it's a surgeon, anesthesiologist, or the EB physician, need to be enrolled in sort of the out-of-state patient.

Speaker #3: So that is a one-time process. As well as just providing a fee schedule. Sometimes when you have an established product, there is a fee schedule that's already in place.

Vish Seshadri: Sometimes when you have an established product, there is a fee schedule that's already in place, so you don't need additional letters of agreement or a single case agreement for those patients. Because we are navigating these initial, you know, payer processes, it takes a little additional time. Once that is secured, then it gets better over time. That's been our experience, and that's how it's panning out.

Speaker #3: So you don't need additional letters of agreement or a single-case agreement for those patients. So because we are navigating these initial payer processes, it takes a little additional time.

Speaker #3: But once that is secured, then it gets better over time. So that's been our experience and that's how it's panning out.

Speaker #6: Got it. Okay. That's helpful. Thanks for taking my

Maury Raycroft: Got it. Okay, that's helpful. Thanks for taking my questions.

Speaker #3: Thank you, Mauri.

Vish Seshadri: Thank you, Maury.

Speaker #1: Thank you. Our next question is coming from Stephen Willie with Stifel. Your line is live.

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

Speaker #7: Yeah. Good morning. Thanks for taking the questions. Maybe just a little bit of a follow-up. What is the average scheduling lead time for biopsies right now?

Stephen Willey: Yeah, good morning. Thanks for taking the questions. Maybe just a little bit of a follow-up. What is the average scheduling lead time for biopsies right now? Just curious how far out these procedures are being scheduled.

Speaker #7: Just curious, how far out these procedures are being scheduled.

Speaker #3: Yeah. Thank you, Steve. If you look at the time that a patient is identified as a XevoSkin patient, and then the time that it takes for them to actually get biopsied, right?

Vish Seshadri: Thank you, Steve. If you look at the time that a patient is identified as a ZEVASKYN patient and then the time that it takes for them to actually get biopsied, right? That is the kind of time that you're talking about. It's very variable. I think the factors that determine that are the type of payer, how recent a QTC is to the process. For example, now Lurie, as you all know, have treated some patients and maybe they've gotten into a rhythm, and there's a lot of precedents that's been set, whereas the other sites that are just about starting, this is the first time, right? It's very hard to generalize an average time because we have examples of patients where when we, when we activated Lurie's, I think the first patient was biopsied in August.

Speaker #3: That is the kind of time that you're talking about. It's very variable. I think the factors that determine that are the type of payer, how recent QTC is to the process.

Speaker #3: For example, now Lou Rees, as you all know, has treated some patients and maybe they've gotten into a rhythm and there's a lot of precedence that's been set.

Speaker #3: Whereas the other sites that are just about starting, this is the first time, right? So it's very hard to generalize an average time because we have examples of patients where when we activated Lou Rees, I think the first patient was It was two months or something ever since activation.

Vish Seshadri: This is pretty early. It was 2 months or something since activation. Whereas we have seen certain sites that have been active for, you know, 6 or 7 months, and they're just coming up for their first patient biopsy, you know, preparing that, for that. It's a very variable thing, and with n of 5, 6 sites, it's very hard to say this is a trend. I think, you know, a good estimate is 4 to 5 months is what it's taking for any site that gets active to get their first patient on a biopsy schedule there. I hope that answered your question.

Speaker #3: Whereas we have seen certain sites that have been active for six or seven months, and they're just coming up for their first patient biopsy, preparing for that.

Speaker #3: So it's a very variable thing. And with end of five, six sites, it's very hard to say this is a trend, but I think a good estimate is four to five months is what it's taking for any site that gets active to get their first patient on a biopsy schedule there.

Speaker #3: I hope that answered your question.

Speaker #7: No, it did. Thank you. And then I guess the PSMA CERT looks conceptually pretty interesting. I think you spoke to the $7 million licensing fee.

Stephen Willey: No, it did. Thank you. The PSMA-SIR-T looks conceptually pretty interesting. I think you spoke to the $7 million licensing fee. Can you speak to any additional economics that might be owed on the progression of that product? I know you're in the process of tech transfer now, but what are the implications for manufacturing in terms of the need to build out additional suites to potentially accommodate the clinical development of this product? Thanks.

Speaker #7: Can you speak to any additional economics that might be owed on the progression of that product? And then I know you're in the process of tech transfer now, but what are the implications for manufacturing?

Speaker #7: In terms of the need to build out additional suites to potentially accommodate the clinical development of this product? Thanks.

Speaker #3: Sure. In terms of deal economics, right? It's the upfront payment that we shared of 7 million. And ABONA is going to develop this asset until the end of phase one.

Vish Seshadri: Sure. In terms of deal economics, right? It's the upfront payment that we shared of $7 million. Abeona is gonna develop this asset until end of phase I. There's gonna be dose escalation and dose expansion, and those first-in-human studies do not start until second half of 2027, as I mentioned. There is just about $1 million of milestone payments up to that time point through the end of phase I. That happens with the first patient dose and the last patient, maybe. If you look at that, it's not, you know, the upfront payment is really the main substantial payment that's done right now.

Speaker #3: So there's going to be dose escalation and those expansion. And those first-in-human studies do not start until second half of 2027, as I mentioned.

Speaker #3: There is just about a dollar million of milestone payments up to that time point through the end of phase one. That happens with the first patient dosed and the last patient, maybe.

Speaker #3: So if you look at that, it's not the upfront payment that's really the main substantial payment that's done right now. In terms of deal structure, at the end of Phase 1 data, we have two potential paths.

Vish Seshadri: In terms of deal structure, at the end of phase I data, we have two potential paths. One could be a 50-50 development with Angeles, so we share the cost and we share the proceeds later. Or it could be an outright licensing deal where we'll have some biobucks and royalties that Abeona will fully own the program but provide to Angeles. Which of these paths is going to actually prevail? It's gonna be a long journey to even discovering that because the data will determine those. It's early to comment on that. In terms of cost implications, I wanted to make sure this is very well understood, right?

Speaker #3: And one could be a 50/50 development with Angeles. So we share the cost and we share the proceeds later. Or it could be an outright licensing deal where we'll have some BioBox and royalties that ABONA will fully own the program but provide to Angeles.

Speaker #3: So which of these paths is going to actually prevail? It's going to be a long journey to even discovering that because the data will determine those.

Speaker #3: So it's early to comment on that. But in terms of cost implications, I wanted to make sure this is very well understood, right? So until first-in-human studies begin, there's not a big cost load on ABONA because once the upfront payment has been done, it's low single-digit millions of a CDMO developing the process.

Vish Seshadri: Until first-in-human study is big and there's not a big cost load on Abeona because once the upfront payment has been done, it's low single-digit millions of a CDMO developing the process. As you know, engineered T-cells, it's not as complex as ZEVASKYN, fortunately. You know, it's going to be mostly a cut and paste kind of process. We already have GMP-grade vector that has been produced and it's a matter of locking down process and these processes are fairly standard, so it's gonna be done by an external CDMO, and we're not going to disturb our internal teams in Cleveland. We're laser focused on the ZEVASKYN commercialization.

Speaker #3: And as you know, engineer T cells it's not as complex as XevoSkin, fortunately. But it's going to be mostly a cut-and-paste kind of process.

Speaker #3: We already have GMP-grade vector that has been produced. And it's a matter of locking down process. And these processes are fairly standard. So it's going to be done by an external CDMO and we're not going to disturb our internal teams in Cleveland.

Speaker #3: We're laser-focused on the XevoSkin commercialization. So there's a very small team that's just going to drive the project. Out of a CDMO and when the time comes for and the regulatory team is also involved in getting clarity and alignment with the regulatory agencies on what our trial design looks like and how we go about that.

Vish Seshadri: There's a very small team that's just gonna drive the project out of a CDMO when the time comes for the regulatory team is also involved in, you know, getting clarity and alignment with the regulatory agencies on what our trial design looks like and how we go about that. Other than that, from a personnel standpoint, Abeona is laser-focused on ZEVASKYN commercialization, and any significant costs will not hit us until we get into human clinical studies, which happens in the second half of 2027. I hope that gives a little bit of some color on what we are undertaking for the near term with PSEN 130.

Speaker #3: So other than that, from a personnel standpoint, ABONA is laser-focused on XevoSkin commercialization. And any significant costs will not hit us until we get into human clinical studies which happens in the second half of 2027.

Speaker #3: I hope that gives a little bit of some color on what we are undertaking for the near term with PSMA CERT.

Speaker #7: Yeah. No, that's helpful. The external CDMO kind of addresses the question on the manufacturing front. Can you just say whether or not the 50/50 copromotum I'm presuming that decision is made by Angeles, based upon a review of phase one data?

Stephen Willey: Yeah, no, that's helpful. The external CDMO kind of addresses the question on the manufacturing front. Can you just say whether or not the 50/50 co-promote, I'm presuming that decision is made by Angeles Therapeutics based upon a review of phase I data?

Speaker #3: Correct. Actually, the option for us to pursue the program is after Phase One. Angeles has the option to either do the 50/50 co-development or a license agreement, with what Fish had mentioned, with predefined financial terms for an agreement that'll be agreed upon later.

Vish Seshadri: Correct.

Madhav Vasanthavada: Yeah, actually, the option for us to pursue the program is after the phase I. Angeles Therapeutics has the option to either do the 50/50 co-development or a license agreement with what Vish Seshadri had mentioned with predefined financial terms for an agreement that'll be agreed upon later.

Speaker #7: Understood. Very helpful. Thank you.

Stephen Willey: Understood. Very helpful. Thank you.

Speaker #1: Thank you. Our next question is coming from Raghuram Salvaraju with HC Wainwright. Your line is live.

Operator: Thank you. Our next question is coming from Raghuram Selvaraju with H.C. Wainwright. Your line is live.

Speaker #8: Hello. Congrats on the quarter and on activating the new QTCs. This is a met on for ROM. I just had a few questions. One was, what have been the key challenges associated with setting up additional qualified treatment centers, and how do you think those will play out in the future?

Ahmed: Hello. Congrats on the quarter and on activating the new QTCs. This is Ahmed on for Ram. I just had a few questions. One was, what have been the key challenges associated with setting up additional Qualified Treatment Centers, and how do you think those will play out in the future? My second question was on the patients receiving ZEVASKYN. How often does cell harvesting from RDEB patients fail due to insufficiency?

[Analyst] (H.C. Wainwright): Hello. Congrats on the quarter and on activating the new QTCs. This is Ahmed on for Ram. I just had a few questions. One was, what have been the key challenges associated with setting up additional Qualified Treatment Centers, and how do you think those will play out in the future? My second question was on the patients receiving ZEVASKYN. How often does cell harvesting from RDEB patients fail due to insufficiency?

Speaker #8: And my second question was on the patients receiving XevoSkin. How does how often does cell harvesting from ARDA patients fail due to insufficiency?

Speaker #3: Thank you. So the first question you asked was the key challenges with activating QTC centers. I think more than challenges, I'll just say, what are all the various milestones in the journey that have to check a box, right?

Vish Seshadri: Thank you. The first question you asked was the key challenges with activating QTC centers. I think more than challenges, I'll just say, what are all the various milestones in the journey that have to check a box, right? I mean, this is a huge undertaking by a QTC. An AB physician has to gather, you know, a multidisciplinary team first, and they need to have anesthesiologists and plastic surgeons who are familiar with the RDEB patients and what types of care they need. Once such a team forms and they feel that feasibility from a center's perspective and the ability to deliver this exists, they have to make a business case for their management.

Speaker #3: I mean, this is a huge undertaking by a QTC. And AB physician has to gather a multidisciplinary team first. And they need to have anesthesiologists and plastic surgeons who are familiar with the ARDA patients.

Speaker #3: And what types of care they need. And once such a team forms and they feel that feasibility from a center's perspective and the ability to deliver this, exists, they have to make a business case for their management.

Speaker #3: And there's that itself is a few months' journey because every buy-and-bill that they have to put some financial risk on there, P&L, is going to be scrutinized carefully.

Vish Seshadri: There's that itself is a few months journey because every buy and build that they have to, you know, put some financial risk on their P&L is going to be scrutinized carefully. All that is in itself a month process, and then we have the onboarding. Once that has been checked off and everybody has agreed in that QTC that they're gonna go with this journey, then you're gonna have onboarding, medical onboarding as well as, you know, clinical training and quality training and all those types of events. Then there's numerous legal policies, the trade policies, the master service agreements. Those are all, again, legal steps that take several months.

Speaker #3: So all that is in itself a month's process. And then we have the onboarding. Once that has been checked off and everybody is agreed in that QTC that they're going to go with this journey, then you're going to have onboarding, medical onboarding, as well as clinical training and quality training and all those types of events.

Speaker #3: And so and then there's numerous legal policies, the trade policies, the master service agreements. Those are all, again, legal steps that take several months.

Vish Seshadri: That's the reason why the journey of actually the first handshake with a QTC to when they're ready to treat a patient has been several months, sometimes even more than a year long. We started that process with our first set of QTCs very early. You know, it's kind of what you alluded to is there a unlimited number of QTCs that we can activate? The answer is no, because the multidisciplinary team is the key for which QTCs can actually activate, and that's something that we always carefully weigh in because, you know, that's important from a patient experience and patient care and outcome perspective.

Speaker #3: So that's the reason why the journey of actually the first handshake with a QTC to when they're ready to treat a patient has been several months, sometimes even more than a year long.

Speaker #3: And we started that process with our first set of QTCs. Very early. And it's kind of what you alluded to is, is there an unlimited number of QTCs that we can activate?

Speaker #3: And the answer is no because the multidisciplinary team is the key for which QTCs can actually activate. And that's something that we always carefully weigh in because that's important from a patient experience and patient care and outcome perspective.

Vish Seshadri: You know, of the 23 centers where there are EB patients cared for today, a good, you know, 5 to 10 centers already have these multidisciplinary teams in place, and those are our focus areas. As we had stated earlier, our goal was to have about 7 centers active, because when 7 centers are active and produce at least 1 biopsy a month, we're gonna be up to our manufacturing capacity of 7 to 10 or whatever that number happens to be, because some centers will do more than a biopsy a month. We want to ramp up as we ramp up our capacity as well. Those are all factors that kind of speak to the overall QTC numbers. Anything else, Madhav?

Speaker #3: And off the 23 centers where there are EB patients cared for today, a good 5 to 10 centers already have these multidisciplinary teams in place.

Speaker #3: And those are our focus areas. And as we had stated earlier, our goal was to have about 7 centers active because when 7 centers are active and produce at least one biopsy a month, we're going to be up to our manufacturing capacity of 7 to 10 or whatever that number happens to be because some centers will do more than a biopsy a month.

Speaker #3: So we want to ramp up as we ramp up our capacity as well. So those are all factors that kind of speak to the overall QTC numbers.

Speaker #3: Anything else, Madhav?

Madhav Vasanthavada: Yeah, I'll just add that you summed it up well, Vish. I mean, just in terms of challenges, right, every QTC has a different risk tolerance. We observed that some institutions started even before, you know, right after ZEVASKYN approval. There were other institutions that wanted to wait for the actual FDA approval to happen last year before they began to invest their time and energy. Yet there were some other institutions that wanted to see reimbursement pathway established. Now we are beginning to see greater engagement with the tail of these other centers, EB centers, and the traction is picking up. I mean, with the recent announcements and additional centers, as Vish said, we are well on track. We believe we'll be able to get another QTC also activated.

Speaker #9: Yeah. I'll just add that you summed it up well, Vish. I mean, just in terms of challenges, right, every QTC has a different risk tolerance.

Speaker #9: We observed that some institutions started even before—right after XevoSkin approval—there were other institutions that wanted to wait for the actual FDA approval to happen last year before they began to invest their time and energy.

Speaker #9: Yet there were some other institutions that wanted to see reimbursement pathway established. So now we are beginning to see greater engagement with the tail of these other centers, EB centers, and the traction is picking up.

Speaker #9: I mean, with the recent announcements and additional centers as Vish said, we are well on track. We believe we'll be able to get another QTC also activated.

Vish Seshadri: The second question that you asked about patients getting the harvest, can you please elaborate on your question? Is this the biopsy to delivering the sheets manufacturing process success rate, or was it something else that you were referring to here?

Speaker #3: And the second question that you asked about patients getting the harvest. Can you please elaborate on your question? Is this the biopsy to delivering the sheets manufacturing process success rate or was it something else that you were referring to here?

Speaker #8: Yes, exactly. Just the basically after the biopsy, how long is there kind of failure rate between the biopsy and the patient receiving the treatment?

Ahmed: Yes, exactly. Just the, basically after the biopsy, how long is there kind of a failure rate between the biopsy and the patient receiving the treatment?

[Analyst] (H.C. Wainwright): Yes, exactly. Just the, basically after the biopsy, how long is there kind of a failure rate between the biopsy and the patient receiving the treatment?

Speaker #3: Yeah. Our experience so far in the commercial setting is that every time that we have received a valid biopsy, we have been able to produce sheets the numbers could be variable, but in the majority of cases, we are actually producing double-digit number of sheets.

Vish Seshadri: Our experience so far in the commercial setting is that every time that we have received a valid biopsy, we have been able to produce a sheet. The numbers could be variable, but in majority of cases, we are actually producing the double-digit number of sheets. We're happy with what we're seeing in terms of success rate. Beyond that, I think the timing of how long it takes from skin to skin, as you know, is a variable time. It can be anywhere as early as 23 days in some cases, and it can be as lengthy as 26 days. I think that's still a very tight window, but that's kind of our range of turnaround time we've seen so far.

Speaker #3: So we're happy with what we're seeing in terms of success rate. But beyond that, I think the timing of how long it takes from skin to skin as you know is a variable time.

Speaker #3: It can be anywhere as early as 23 days in some cases, and it can be as lengthy as 26 days. So I think that's still a very tight window.

Speaker #3: But that's kind of our range of turnaround time we've seen so far.

Ahmed: Got it. Thanks so much. If I may just have one quick follow-up is, I guess, what is the Abeona's plan to optimize ZEVASKYN value outside of the US?

[Analyst] (H.C. Wainwright): Got it. Thanks so much. If I may just have one quick follow-up is, I guess, what is the Abeona's plan to optimize ZEVASKYN value outside of the US?

Speaker #8: Got it. Thanks so much. If I may just have one quick follow-up is, I guess, what is the ABEONA's plan to optimize XevoSkin value outside of the US?

Speaker #3: Yeah. That's something that's been on top of our mind. We're already looking at what are the markets that we can first supply from our Cleveland site because that is the lowest hanging fruit in terms of timing.

Vish Seshadri: Yeah, that's something that's been on top of our mind. We're already looking at what are the markets that we can first supply from our Cleveland site, because that is the, you know, lowest hanging fruit in terms of timing. It is probably if you're looking at markets like Europe and Japan, the logistical challenges in delivering from Cleveland, more than product delivery could be related to bringing the biopsies of the patients and cold chain and things like that. That's something that we're working out, but you should have such updates in the following quarterly calls. Right now, it's, you know, our teams are so spread already thin in making sure that every aspect of the US launch is maximized.

Speaker #3: It is probably, if you're looking at markets like Europe and Japan, the logistical challenges in delivering from Cleveland more than product delivery, it could be related to bringing the biopsies of the patients and cold chain and things like that.

Speaker #3: And that's something that we're working out. But we should have such updates in the following quarterly calls. Right now, our teams are already so spread thin making sure that every aspect of the US launch is maximized.

Vish Seshadri: We are, we're definitely, you know, there's a subteam that is looking at these external opportunities. Hopefully, in later quarterly calls, we give some better color to what that path looks like.

Speaker #3: We are definitely there's a sub-team that is looking at these external opportunities. So hopefully, in later quarterly calls, we'll give some better color to what that path looks like.

Ahmed: Got it. Thank you so much.

[Analyst] (H.C. Wainwright): Got it. Thank you so much.

Speaker #8: Got it. Thank you so much.

Operator: Thank you. Our next question is coming from Jeff Jones with Oppenheimer. Your line is live.

Speaker #10: Thank you. Our next question is coming from Jeff Jones with Oppenheimer. Your line is live.

Jeff Jones: Good morning, guys, thanks for taking the question. Again, congrats on a great quarter. Maybe following up on QTC activation, with 6 on board and a target of 7 by end of year seems a pretty low bar for you to get 1 more in by year-end. Just how are you thinking about building out additional QTCs as we look ahead into additional quarters and into next year? How, as you mentioned, how that aligns with capacity. Maybe on pipeline, you deprioritized the ophthalmology programs, and you brought on board an oncology program. How are you thinking about pipeline moving forward? Are you thinking about oncology specifically or maybe outline for us, sort of how you're thinking about that strategically?

Speaker #11: Good morning, guys, and thanks for taking the question again. Congrats on a great quarter. Maybe following up on QTC activation, with six on board and a target of seven by end of year, it seems a pretty low bar for you to get one more in by year-end.

Speaker #11: Just how are you thinking about building out additional QTCs as we look ahead into additional quarters and into next year and how, as you mentioned, how that aligns with capacity?

Speaker #11: And then maybe on pipeline, you've deprioritized the ophthalmology programs, and you've brought on board an oncology program. How are you thinking about pipeline moving forward?

Speaker #11: Are you thinking about oncology specifically, or maybe outline for us sort of how you're thinking about that strategically?

Vish Seshadri: Great. First, I'll ask Madhav to respond to the QTC question.

Speaker #3: Great. So first, I'll ask Madhav to respond to the QTC question.

Madhav Vasanthavada: Yeah. Jeff, yes. I mean, we continue to work with a few more centers, based on the knowledge we have. A total of 10 EB centers have this kind of infrastructure that Vish alluded to earlier, cross-functional discipline of, you know, multidisciplinary team, as well as EB patients that frequent those centers. We are working with these institutions and at our various stages of onboarding. I think if we get to that kind of a number, 9 or 10 centers, we are in a pretty good shape because we continue to hear from centers about 1 patient a month is a good cadence to that we can expect for these centers to treat. If we maintain that would be really our steady state.

Speaker #9: So Jeff, yes. I mean, we continue to work with a few more centers based on the knowledge we have. A total of 10 EB centers have this kind of infrastructure that Vish alluded to earlier, cross-functional discipline of multidisciplinary team, as well as EB patients that frequent those centers.

Speaker #9: So we are working with these institutions, and at our various stages of onboarding, I think if we get to that kind of a number, 9 or 10 centers, we are in pretty good shape.

Speaker #9: Because we continue to hear from centers about one patient a month is a good cadence that we can expect for these centers to treat.

Speaker #9: And if we maintain that, that would be really our steady state. So let's see. This year, next year, would be we should be able to get all these other centers also active.

Madhav Vasanthavada: Let's see, this year, next year we should be able to get all these other centers also active.

Speaker #3: Yeah. And also, you asked this question, how are we building our internal capacity, right? We're very diligent in building up, and we had announced six at launch and six this year.

Vish Seshadri: Yeah. Also, you asked this question, how are we building our internal capacity, right? We're very diligent in building up, and we had announced 6 at launch and 6 this year, and we're already in ramp-up mode to bring it up to 10 by end of the year. The numbers that Madhav shared in terms of QTC numbers goes hand-in-hand with how we are building our internal capacity, so we'll be able to, you know, match the demand. From a longer-term perspective, definitely, we have work that has progressed on getting additional suites designed. We haven't started construction yet, but a lot of the design work has already happened, and we're raring to go, right?

Speaker #3: And we're already in ramp-up mode to bring it up to 10 by the end of the year. So the numbers that Madhav shared in terms of QTC numbers go hand in hand with how we are building our internal capacity.

Speaker #3: So we'll be able to match the demand. And from a longer-term perspective, definitely we have work that has progressed on getting additional suites designed and starting to we haven't started construction yet, but a lot of the design work is already happened, and we're ready to rearing to go, right?

Vish Seshadri: It's the right trigger, and that's not very far away. We can, you know, again, speak about that in the upcoming quarterly updates. Rest assured, we're not going to artificially restrict ourselves to 7 sites. As Madhav mentioned, if there's more sites that show that multidisciplinary teams are pulled together and they have, you know, RDEB experience, that's an added advantage as well. We are well on our way to get a healthy number of QTCs activated even just in 2026. Your second question was about our move from ophthalmology to oncology. I just wanted to reiterate one thing, right?

Speaker #3: So is the right trigger and that's not very far away. We can again speak about that in the upcoming quarterly updates. But rest assured with we are not going to artificially restrict ourselves to seven sites as Madhav mentioned.

Speaker #3: If there's more sites that show that multidisciplinary teams are pulled together and they have EB experience, that's an added advantage as well. So we are well on our way to get a healthy number of QTCs activated even just in 2026.

Speaker #3: And your second question was about our move from ophthalmology to oncology. I just wanted to reiterate one thing, right? I think where our strengths are and where we have done well learning from the XevoSkin experience is really how do we develop complex biologics that have the types of profiles of long-term durable clinical meaningful clinical benefit for patients with serious diseases?

Vish Seshadri: I think, where our strengths are and where we have done well learning from the ZEVASKYN experience is really how do we develop complex biologics that have the types of profiles of long-term, durable, clinical, meaningful clinical benefit for patients with serious diseases. We're not defining ourselves as a rare disease or an ophthalmology or an oncology company. Where our strength can actually, if you, if you look at, you know, the CMC aspect of it, you will see a perfect fit. I mean, in fact, some of these engineered T-cell therapies are a little bit even more advanced and defined than the types of autologous cells we are working with. It feels a little easier, even a little bit of a breath of fresh air in that sense.

Speaker #3: We're not defining ourselves as a rare disease or an ophthalmology or an oncology company, but where our strengths can actually if you look at the CMC aspect of it, you will see a perfect fit.

Speaker #3: I mean, in fact, some of these engineered T-cell therapies are a little bit even more advanced and defined than the types of autologous cells we are working with.

Speaker #3: And it feels a little easier even a little bit of a breath of fresh air in that sense. But if you look at our commercial teams, we're all from the CAR-T world.

Vish Seshadri: If you look at our commercial teams, we're all from the CAR T world. We've done launching of Breyanzi, Abecma, and in fact, Dr. Preet Chaudhary, with whom we have done this deal, was one of our customers when we were in the hematology CAR T launching expedition at that time. We've continued to discuss what are these unmet needs and how do we really get breakthrough there. As an innovator, we've held that dialogue from those days, right? You see that the strength in the oncology field really is not something that we have to start from ground zero here. Every little angle that you're looking from, we have that. Of course, clinical development, we will build it over the clinical trial experience.

Speaker #3: We've done launching of BRIANCI, Abecma, and in fact, Dr. Preet Choudhury, with whom we have done this deal, was one of our customers when we were in the hematology CAR-T launching expedition at that time.

Speaker #3: And we've continued to discuss what are these unmet needs and how do we really get breakthrough there? And as an innovator, we've held that dialogue from those days, right?

Speaker #3: So you see that the strength in the oncology field really is not something that we have to start from ground zero here. And so every little angle that you're looking from, we have that.

Speaker #3: Of course, clinical development—we will build it over the clinical trial experience. But the move from ophthalmology to oncology was really, I would call it, semi-opportunistic, but there are a lot of synergies with the CMC path that we've learned and how to work with the FDA and what they expect in this kind of a technology.

Vish Seshadri: But the move from ophthalmology to oncology was really, you know, I would call it semi-opportunistic, but a lot of synergies with the CMC paths that we've learned and how to work with the FDA and what they expect in this kind of a technology and also knowing what are the unmet needs in the solid tumor space, generally. Prostate specifically, of course, some of us have launched products in the prostate space in our past lives, so that's also bringing us the relationships.

Speaker #3: And also knowing what are the unmet needs in the solid tumor space, generally. And prostate specifically, of course—some of us have launched products in the prostate space in our past lives.

Speaker #3: So that's also bringing us the relationship. And also the KOLs that have the KOLs that we have interacted with in ad boards, even before we licensed this asset, have taken a look at a lot of the data and these are the top international six or eight KOLs who opine and they're very eager and interested in participating in these trials, even putting their patients on this type of technology.

Vish Seshadri: Also the KOLs that we have interacted with in ad boards even before we licensed this asset, have taken a look at a lot of the data, and these are the top international, six or eight KOLs who opine, and they are very eager and interested in participating in these trials, even putting their patients on this type of technology. You know, when you have everything from a capability standpoint lining up to take us to a disease where, of course, the market potential is a log order bigger from where we are in the rare disease space, you know, why not? I mean, we were waiting for the right moment, which was ZEVASKYN is in a good place with its launch.

Speaker #3: And when you have everything from a capability standpoint lining up to take us to a disease where, of course, the market potential is a log order bigger from where we are in the rare disease space, why not?

Speaker #3: I mean, and we were waiting for the right moment which was XevoSkin is in a good place with its launch. We're already seeing early indicators that this is taking off.

Vish Seshadri: We're already seeing early indicators that this is taking off, and that's what we had kept this. I mean, this has been a diligence that we've been doing for quite a while. This was the right kind of time. That's really where we've shifted. This doesn't mean to say we're not putting a stake in the ground saying we're gonna be an oncology company. If our technologies, for example, CD19 as a CAR T field found great application beyond the hematology where we started, and now everybody that has a CD19 asset is in the autoimmune space. That is, you know, I mean, still leveraging their strengths in a completely different disease area, right?

Speaker #3: And that's what we had kept this. I mean, this has been a diligence that we've been doing for quite a while. And so this was the right kind of time.

Speaker #3: So that's really where we've shifted. This doesn't mean to say are we we're not putting a stake in the ground and say we're going to be an oncology company.

Speaker #3: If our technologies for example, CD19 as a CAR-T field, found great application beyond hematology where we started and now everybody that has a CD19 asset is in the autoimmune space.

Speaker #3: That is I mean, still leveraging their strengths in a completely different disease area, right? We're going to follow such paths where we have good science that takes us to solving big problems and there's huge long-term value in that.

Vish Seshadri: We're gonna follow such paths where we have good science that takes us to solving big problems, and there is huge long-term value in that. That's how this asset really fit, checked all the boxes that we're describing here.

Speaker #3: So that's how this asset really fit checked all the boxes that we're describing here.

Speaker #1: Great. Thank you guys very much.

Joseph Vazzano: Great. Thank you guys very much.

Joe Vazzano: Great. Thank you guys very much.

Speaker #3: Thank you.

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

Speaker #4: Thank you. Our next question is coming from Jim Malloy with Alliance Global Partners. Your line is live.

Speaker #5: Hi. Good morning. Thank you very much for taking my questions. Just a couple of quick questions on pricing and sort of gross to net.

James Molloy: Hi. Good morning. Thank you very much for taking my questions. Just a couple quick questions on pricing and sort of gross to net. Mechanistically, looking at the revenue number you guys printed in the quarter at $3.1 million per, looks like a much more favorable gross to net discount for you guys on the quarter. Can you talk a little bit to how you're seeing the payer mix come through on that and the pricing holding there? Then I guess a follow-up would be on the OpEx. You know, ex the $7 million one-timer, these are the R&D and SG&A numbers we should expect sort of going forward through the rest of 2026. Thank you.

Speaker #5: Mechanistically looking at the revenue number you guys printed in the quarter at $3.1 million per, looks like a much more favorable gross to net discount for you guys on the quarter.

Speaker #5: Can you talk a little bit to how you're seeing the payer mix come through on that and is the pricing holding there? And then I guess a follow-up would be on the OPEX.

Speaker #5: X the $7 million one-timer, are these the R&D and GNA numbers we should expect sort of going forward through the rest of '26? Thank you.

Speaker #3: Thanks, Jim. Yeah. So regarding the gross to net for Q1, all three patients treated in the quarter were commercial compared to Q4 where it was the Medicaid patient.

Joseph Vazzano: Thanks, Jim. Regarding the gross to net for Q1, all three patients treated in the quarter were commercial, compared to Q4, where it was the Medicaid patient. On the commercial patient, there's far less, you know, rebates and discounts than the government 23.1% rebate that was for the Medicaid patient. Going forward, again, you know, when things normalize with more patients, we think the gross to net will be in the, you know, mid to upper teens when we have more patients treated. Then, you know, for your second question, you know, if you exclude the $7 million upfront payment for R&D and, you know, SG&A, the total spend will be pretty much the same for the rest of the year.

Joe Vazzano: Thanks, Jim. Regarding the gross to net for Q1, all three patients treated in the quarter were commercial, compared to Q4, where it was the Medicaid patient. On the commercial patient, there's far less, you know, rebates and discounts than the government 23.1% rebate that was for the Medicaid patient. Going forward, again, you know, when things normalize with more patients, we think the gross to net will be in the, you know, mid to upper teens when we have more patients treated. Then, you know, for your second question, you know, if you exclude the $7 million upfront payment for R&D and, you know, SG&A, the total spend will be pretty much the same for the rest of the year.

Speaker #3: So on the commercial patients, there's far less rebates and discounts than the government 23.1% rebate that was for the Medicaid patient. So going forward, again, when things normalize with more patients, we think the gross to net will be in the mid to upper teens.

Speaker #3: When we have more patients treated. And then for your second question, yeah. So if you exclude the $7 million upfront payment for R&D and SG&A, the total spend will be pretty much the same for the rest of the year.

Speaker #3: Again, as we treat more patients and get more volume in there, some of the costs will come out of SGNA, the engineering runs, and they will go to cost of goods sold.

Joseph Vazzano: Again, as we treat more patients and get more volume in there, some of the costs will come out of SG&A, the engineering runs, and they will go to cost of goods sold. But the overall run rate, again, throw out the, you know, $7 million expense, is reflective of the rest of the year.

Joe Vazzano: Again, as we treat more patients and get more volume in there, some of the costs will come out of SG&A, the engineering runs, and they will go to cost of goods sold. But the overall run rate, again, throw out the, you know, $7 million expense, is reflective of the rest of the year.

Speaker #3: So but the overall run rate again, throw out the $7 million expense is reflective of the rest of the year.

Speaker #1: Okay, great. Maybe a quick follow-up, if I could, please. Any guidance on the six or seven people potentially in the shoot for second quarter?

James Molloy: Okay, great. A quick follow-up if I could please. Any guidance on the six or seven people potentially in the shoot for Q2? What that mix looks like on commercial versus Medicare, Medicaid?

Speaker #1: What that mix looks like on commercial versus Medicare? Medicaid?

Speaker #3: Just similar kind of mix that we have.

Vish Seshadri: The similar, kind of, you know, mix that we have. Yeah. Overall, we can expect based on our claims data and what we've understood of the market, about 60% commercial, about 30% to 33% or something like that, is Medicaid. That is the split we're looking at.

Speaker #4: Yeah. And overall, we can expect based on our claims data and what we've understood of the market, about 60% commercial, about 30 to 33 percent or something like that is Medicaid.

Speaker #4: So that is the split we're looking at.

Speaker #1: Got it. Thank you. And have you guys thought have you guys put any guidance on when you anticipate being profitable? I know last year you put some guidance out and obviously things have changed since then.

James Molloy: Got it. Thank you. Have you guys put any guidance on when you anticipate being profitable? I know last year you put some guidance out, and obviously things have changed since then.

Speaker #3: We haven't we maintain the assumption that we had in the last call that we believe depending on how these biopsies come out that Vish and Madhav had spoken about earlier, we believe we can achieve monthly profitability starting potentially in June.

Joseph Vazzano: We haven't, you know, we maintain the assumption that we had that in the last call that we believe, you know, depending on how these biopsies come out, that Vish and Madhav had spoken about earlier, we believe we can, you know, achieve monthly profitability starting potentially in June. Next month.

Joe Vazzano: We haven't, you know, we maintain the assumption that we had that in the last call that we believe, you know, depending on how these biopsies come out, that Vish and Madhav had spoken about earlier, we believe we can, you know, achieve monthly profitability starting potentially in June. Next month.

Speaker #3: So next month.

Speaker #1: Excellent. Thank you very much for taking the questions.

James Molloy: Excellent. Thank you very much for taking the questions.

Speaker #4: Thank you. Our final question today is coming from David Bouts with Zach's Small Caps or Small Capital Research. Your line is live.

Operator: Thank you. Our final question today is coming from David Bautz with Zacks Small-Cap or Small-Cap Research. Your line is live.

Speaker #5: Hey, good morning, everyone. Appreciate the update today. Given the fact that most solid tumor CAR-T programs have struggled in the past, I'm just curious—what was it specifically about 701 that gives you confidence that it could be successful?

David Bautz: Hey, good morning, everyone. Appreciate the update today. Given the fact that most solid tumor CAR T programs have struggled in the past, I'm just curious, what was it specifically about seven zero one that gives you confidence that it could be successful?

Speaker #3: Yeah. Thanks, David, for that question. First of all, we have to underscore that this is not a CAR-T. The synthetic immune receptors are fundamentally differently structured.

Vish Seshadri: Yeah. Thanks, David, for that question. First of all, we have to, you know, underscore that this is not a CAR T. The synthetic immune receptors are fundamentally differently structured. You know, a lot of the innovation in the CAR T field has been about, you know, better signaling domains or, you know, the zeta domains, and they're built on an existing CAR structure, right? I mean, it's physiologically very different from the natural TCRs that you have. Of course, the TCR technologies themselves have failed due to other reasons, which are, you know, to do with MHC restriction and, you know, the various, you know, population-based constraints. What the SIR-T technology does is actually take the best of both worlds.

Speaker #3: So a lot of the innovation in the CAR-T field has been about better signaling domains or the zeta domains. And the built-on and existing CAR structure, right?

Speaker #3: I mean, it's physiologically very different from the natural TCRs that you have. And then, of course, the TCR technologies themselves have failed due to other reasons, which are to do with MHC restriction and the various population-based constraints.

Speaker #3: What the CERT technology does is actually take the best of both worlds. It will probably take me two days to describe all the components of the technology that make us believe that it's different, but if you look at the money slide, the pipeline, the preclinical data that we shared, we've used a CAR control with the same kind of binding domain, which is the receptor, which recognizes and binds to PSMA, but the rest of the structure is all like a CAR versus the SER.

Vish Seshadri: It would probably take me 2 days to describe all the components of the technology that make us believe that it's different. If you look at the money slide, the preclinical data that we shared, we've used a CAR control with the same kind of binding domain, which is the receptor, which recognizes and binds to PSMA, but the rest of the structure is all like a CAR versus the SIR. You can see that in a preclinical model in mice, you already see that difference. How can you generate persistent serial killer T cells that go after a tumor-specific membrane antigen, right? That's what we're encouraged with. These experiments have been repeated many times and with variations in manufacturing process and everything. We're excited.

Speaker #3: And you can see that in a preclinical model, in mice, you already see that difference. How can you generate persistent serial killer T cells that go after a tumor-specific membrane antigen, right?

Speaker #3: That's what we are encouraged with. And these experiments have been repeated many, many times with variations and manufacturing process and everything. So we're excited.

Speaker #3: Our KOL community is excited that this is a new hope. So we're not doing exactly the same thing that has been done in the past.

Vish Seshadri: Our KOL community is excited that this is a new hope. We're not doing exactly the same thing that has been done in the past. There is true novelty structurally as well as functionally in this approach. That's what really gives us. We have included a link that takes you to a talk by the inventor himself, and that has a lot of technical details. If you're interested, I would encourage anyone to go and listen to that. Hope I answered your question.

Speaker #3: There is true novelty structurally as well as functionally in this approach. So that's what really gives us and we have included a link that takes you to a talk by the inventor himself.

Speaker #3: And that has a lot of technical details if you're interested. I would encourage anyone to go and listen to that. So I hope I answered your question.

Speaker #5: Yeah. Sounds great. Appreciate it.

David Bautz: Yeah. Sounds great. Appreciate it.

Speaker #1: Thank you.

Vish Seshadri: Thank you.

Speaker #4: Thank you. Ladies and gentlemen, this does conclude today's Q&A session. And also today's call. You may disconnect your lines at this time. And we thank you for your participation.

Operator: Thank you. Ladies and gentlemen, this does conclude today's Q&A session and also today's call. You may disconnect your lines at this time, and we thank you for your participation.