ABEO

This article first appeared on GuruFocus. Net ZEVASKYN Revenue: $11.4 million in Q2 2026, a 31% increase quarter-over-quarter from $8.7 million in Q1 2026. Patients Treated: 12 patients treated since launch, including five in Q2 2026 and three additional in Q3 2026 to date. Revenue-Recognized Treatments: Revenue recognized for four of five Q2 treatments, as one batch had cell yield below revenue recognition thresholds. Research and Development Expenses: $5 million in Q2 2026, down from $9.6 million in Q1 2026 (which included a one-time $7 million in-licensing cost for ABO-701). Selling, General and Administrative Expenses: $15.8 million in Q2 2026, down from $19.5 million in Q1 2026, reflecting fewer engineering runs and lower manufacturing training costs. Net Loss: $20.2 million, or $0.35 per basic and diluted share, for Q2 2026, compared to a net loss of $17.1 million, or $0.30 per share, in Q1 2026. Cash Position: Cash, cash equivalents, and short-term investments totaled $146.8 million as of June 30, 2026. Warning! GuruFocus has detected 5 Warning Signs with ABEO. Is ABEO fairly valued? Test your thesis with our free DCF calculator. Release Date: August 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Abeona Therapeutics Inc (NASDAQ:ABEO) reported a 31% quarter-over-quarter increase in ZEVASKYN net revenue, reaching $11.4 million in Q2 2026. The company expanded its qualified treatment center (QTC) network to seven activated centers, including major institutions like Cincinnati Children's, CHOP, and New York-Presbyterian, improving patient access. ZEVASKYN received CMS New Technology Add-on Payment (NTAP) status for fiscal year 2027, which provides supplemental reimbursement for hospitals and is expected to facilitate patient access and payer negotiations. Manufacturing yields have improved in commercial settings, averaging nine sheets per lot compared to about five in clinical trials, indicating better production efficiency. The company maintains a strong balance sheet with $146.8 million in cash and short-term investments, supporting its path toward a sustainable cash flow positive business model. Abeona Therapeutics Inc (NASDAQ:ABEO) experienced manufacturing challenges, including a low-yield batch in Q2 and an out-of-specification batch in Q3, leading to no revenue recognition for two treated patients. Patient health deterioration caused two last-minute biopsy cancellations in Q2, disrupting treatment schedules and highlighting the unpredictability of patient flow. The time from patient identification to treatment varies significantly across QTCs, with some sites taking over 12 months to treat their first patient, indicating operational bottlenecks. The company's gross margin was only 63% in Q2, and normalized margins are expected to be 85-90% only at full capacity, which may not be achieved soon. The company has revised its reporting to focus only on completed treatments and revenue, reducing transparency on the patient funnel and leading indicators, which may limit investor visibility. Q: Can you provide details on the manufacturing yield issues that led to no revenue recognition for two patients, and what is the long-term success rate for manufacturing? A: Dr. Vish Seshadri (CEO) clarified that the two non-revenue cases were different: one was a low-yield batch (below the 4-sheet threshold) and the other was an out-of-specification batch related to a new identity test (Pan-CK marker) that was not part of clinical development. Both patients were treated, but no revenue will be recognized. He noted that the average commercial yield is around 9 sheets per lot, which is favorable compared to the ~5 sheets in clinical trials, and views these as rare events. The company is working with the FDA to revisit the specifications for the identity test, which were set based on limited data during BLA review. Q: What is the expected cadence for existing QTCs like Lurie and Stanford to reach one patient per month, and how should we think about the impact of patient cancellations? A: Madhav Vasanthavada (CCO) stated that the one-patient-per-month cadence is still the expectation once centers reach steady state. He noted that while Lurie and Stanford are treating, other centers like UTMB and CHOP are progressing. Regarding cancellations, he explained that two biopsy cancellations in Q2 were due to patient health deterioration, not a lack of willingness. The company is focused on expanding the QTC network and filling the top of the funnel to offset such unpredictable events. Q: Can you elaborate on the significance of the CMS NTAP status for ZEVASKYN and its impact on revenue and margins? A: Madhav Vasanthavada (CCO) explained that NTAP, effective October 1, 2026, provides supplemental reimbursement for Medicare patients (about 10% of the payer mix), which previously had limited access. Dr. Vish Seshadri (CEO) added that NTAP has a "halo effect" on other payers, validating the technology and easing payer negotiations. On margins, Joe Vazzano (CFO) noted that gross margins are heavily dependent on volume due to fixed manufacturing costs, with a normalized steady-state margin expected around 85% to 90%. Q: What is the average number of sheets manufactured per patient in the commercial setting, and how does this compare to clinical trial experience? A: Dr. Vish Seshadri (CEO) reported that the average commercial yield is approximately 9 sheets per lot, which is significantly higher than the ~5 sheets per patient in the Phase 3 VIITAL trial. He emphasized that the low-yield batch was an anomaly, and the company is learning from each batch to improve processes. The threshold for revenue recognition is a minimum of 4 sheets per batch. Q: How large does the QTC network need to be to provide in-state access to the majority of patients, and how important is in-state access? A: Madhav Vasanthavada (CCO) stated that in-state access is important for faster Medicaid reimbursement, but not necessary for all patients, as ~40% of patients at QTCs travel from out of state. He noted that the current network covers ~40% of the addressable market with in-state access, and further expansion will prioritize leading EB centers. He did not provide a specific target number for QTCs but emphasized that the network will continue to grow based on demand. Q: Can you provide more details on the patient funnel and the number of patients identified or in the treatment process? A: Madhav Vasanthavada (CCO) reiterated that over 100 patients have been identified as clinically eligible by community physicians and QTCs. However, he declined to provide specific numbers on the downstream funnel, stating that the rate-limiting step is advancing patients through the treatment process at QTCs. He emphasized that recent patient and physician interactions at conferences have been very positive and are building clinical conviction. Q: How long does it take for a new QTC to begin treating patients, and what are the key variables? A: Dr. Vish Seshadri (CEO) noted that the average time is 4-6 months, but the variance is high. For example, CHOP was activated in May and treated a patient in July, while other sites have taken over 12 months without treating a patient. The variability is driven by payer mixes, state-specific paperwork, and patient scheduling. The company is working with new sites to pre-line up processes before activation to accelerate timelines. Q: What is the financial impact of the two non-revenue treatments, and where do you see normalized gross margins? A: Joe Vazzano (CFO) confirmed that the company absorbs the cost of goods sold for non-revenue treatments, as per agreements. He stated that gross margins are heavily dependent on patient volume due to fixed manufacturing costs, and the company expects normalized gross margins of approximately 85% to 90% at full operating capacity. For Q2 2026, gross margins were around 63%. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

- Q2 net ZEVASKYN® revenue increased 31% quarter-over-quarter to $11.4 million – - Five patients treated with ZEVASKYN in Q2 2026 and three treatments in Q3 2026 to-date; since launch, 12 treatments completed – - Expanding QTC network now includes seven sites nationwide; growing number of QTCs progressing patients through treatment process – - $146.8 million in cash, cash equivalents and short-term investments as of June 30, 2026 – CLEVELAND, Aug. 13, 2026 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today reported financial results for the second quarter of 2026 and provided an update on commercial execution for ZEVASKYN (prademagene zamikeracel). Commercial UpdateSteady launch-year growth for ZEVASKYN. Commercial execution continued to strengthen during the second quarter of 2026 with five patients treated with ZEVASKYN. In the third quarter of 2026 to-date, three patients have completed treatments. Since launch, 12 patient treatments have been completed. Revenue was not recognized for two patients due to low manufacturing yield or not meeting lot release specifications. Expanded qualified treatment center (QTC) network and increased patient onboarding. Abeona continues to expand the ZEVASKYN QTC network, and the number of QTCs that have treated patients with ZEVASKYN has increased. Key recent milestones include: NewYork-Presbyterian/Columbia University Irving Medical Center and Children’s Hospital of Philadelphia (CHOP) were activated as QTCs during the second quarter of 2026. CHOP and University of Texas Medical Branch (UTMB) have commenced collection of patient biopsies, and CHOP has treated its first patient with ZEVASKYN. In the third quarter of 2026, Abeona announced the activation of Cincinnati Children's as the newest ZEVASKYN QTC. Cincinnati Children's is one of the largest epidermolysis bullosa treatment centers in the U.S. Secured CMS New Technology Add-On Payment (NTAP) status for ZEVASKYN. Effective October 1, 2026, ZEVASKYN will have NTAP status under the fiscal year 2027 Hospital Inpatient Prospective Payment System Final Rule from the Centers for Medicare & Medicaid Services (CMS). NTAP provides a pathway for eligible hospitals to receive a supplemental payment from CMS, in addition to the base diagnosis-related group (DRG) payment, when treating Medicare beneficiaries with ZEVASKYN. This designation is expected to support hospital adoption and help facilitate access for Medicare patients, who represent approximately 10 percent of RDEB patients. Continued engagement raising RDEB community awareness. The Company presented 5-year long-term follow-up data after ZEVASKYN application from the VIITAL Phase 3 clinical study and a case report from the longest follow-up of 12 years from the Phase 1/2a study. Presentations were made at key medical congresses, including the Society for Investigative Dermatology (SID) and Society for Pediatric Dermatology (SPD) annual meetings, as well as the debra Care Conference, to drive physician awareness, patient identification, and enable patient referral to the expanding QTC network. “Our confidence in ZEVASKYN’s substantial opportunity is reinforced by our launch progress and experience to date as we engage with a growing number of patients and expand our QTC network," said Vish Seshadri, Ph.D., Chief Executive Officer of Abeona Therapeutics. “As early real-world experience with ZEVASKYN matures across activated sites, we expect to drive broader adoption and long-term growth.” Second Quarter 2026 Financial Results Net ZEVASKYN revenue for the quarter ended June 30, 2026 increased 31% quarter-over-quarter to $11.4 million, compared to $8.7 million in the first quarter of 2026. While five patients were treated with ZEVASKYN during the second quarter of 2026, revenue was recognized for four treatments as one batch yielded fewer than the threshold number of sheets for revenue recognition. Research and development (R&D) expenses were $5.0 million for the second quarter of 2026 compared to $9.6 million in the first quarter of 2026, which included the one-time, up-front cost of $7.0 million for in-licensing ABO-701. Selling, general and administrative expenses were $15.8 million for the second quarter of 2026, compared to $19.5 million for the first quarter of 2026. The decrease primarily reflects fewer engineering runs and less manufacturing training costs in the second quarter of 2026. Net loss was $(20.2) million, or $(0.35) per basic and diluted common share, for the quarter ended June 30, 2026. Net loss for the first quarter of 2026 was $(17.1) million, or $(0.30) per basic and diluted common share. Cash, cash equivalents and short-term investments totaled $146.8 million as of June 30, 2026, compared to $191.4 million as of December 31, 2025. Conference Call DetailsThe Company will host a conference call and webcast on August 13, 2026, at 8:30 a.m. ET to discuss its financial results and corporate progress. To access the call, dial 888-506-0062 (U.S. toll-free) or 973-528-0011 (international) and Entry Code: 245916 five minutes prior to the start of the call. A live, listen-only webcast can be accessed on the Investors & Media section of Abeona's website at https://investors.abeonatherapeutics.com/events. An archived webcast replay will be available for 30 days following the call. About Abeona Therapeutics Abeona Therapeutics Inc. is a commercial-stage biopharmaceutical company developing cell and gene therapies for serious diseases. Abeona’s ZEVASKYN® (prademagene zamikeracel) is the first and only autologous cell-based gene therapy for the treatment of wounds in adults and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). The Company’s fully integrated cell and gene therapy cGMP manufacturing facility in Cleveland, Ohio, serves as the manufacturing site for ZEVASKYN commercial production. The Company’s development portfolio features ABO-701 (PSMA-SIR-T™), a potentially first-in-class engineered T-cell therapy targeting PSMA, engineered to overcome the core failures of cell therapies in solid tumors. For more information, visit www.abeonatherapeutics.com. ZEVASKYN®, Abeona Assist®, Abeona Therapeutics®, and their related logos are trademarks of Abeona Therapeutics Inc. Forward-Looking Statements This press release contains certain statements that are forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and that involve risks and uncertainties. We have attempted to identify forward-looking statements by such terminology as “may,” “will,” “believe,” “anticipate,” “expect,” “intend,” “potential,” and similar words and expressions (as well as other words or expressions referencing future events, conditions or circumstances), which constitute and are intended to identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, numerous risks and uncertainties, including but not limited to our ability to maintain existing and obtain additional regulatory approvals of ZEVASKYN® and any future product candidates; our ability to successfully commercialize and market ZEVASKYN® and any future product candidates, if approved, and the timing of any commercialization and marketing efforts; our ability to manufacture sufficient batches of ZEVASKYN® to meet demand; our ability to manufacture ZEVASKYN® batches that meet certain product release specifications that were required by FDA at the time of BLA approval and implemented based on a limited clinical dataset; the FDA’s willingness to revise such release specifications to reflect real-world manufacturing experience; our ability to manufacture from provided biopsy material a ZEVASKYN® batch for which revenue may ultimately be recognized, which depends on such factors as qualified treatment centers obtaining biopsy samples from ZEVASKYN® patients of sufficient quality to act as starting material for manufacturing ZEVASKYN®, patient-to-patient variability in cell growth during the ZEVASKYN® manufacturing process, patient health deterioration in close proximity to ZEVASKYN® treatment such that treatment is no longer possible, and expiration of ZEVASKYN®’s 84-hour shelf-life before surgical application of ZEVASKYN® can be performed; our ability to activate additional qualified treatment centers to administer ZEVASKYN® on patients; the ability of qualified treatment centers to enroll patients for treatment or administer ZEVASKYN® on patients; our ability submit an investigational new drug application for ABO-701 and enroll patients in new clinical trials; our ability to access additional financial resources and/or our financial flexibility to reduce operating expenses if required; our ability to obtain additional equity funding from current or new stockholders; the potential impact of unpredicted changes in the structure and/or administration of the United States government or its agencies; our ability to out-license technology and/or other assets, deferring and/or eliminating planned expenditures, restructuring operations and/or reducing headcount, and sales of assets; the dilutive effect that raising additional funds by selling additional equity securities would have on the relative equity ownership of our existing investors, including under our existing at-the-market sale agreement; the outcome of any interactions with the FDA or other regulatory agencies relating to any of our products or product candidates; our ability to continue to secure and maintain regulatory designations for our product candidates; our ability to develop manufacturing capabilities compliant with current good manufacturing practices for our product candidates; our ability to manufacture cell and gene therapy products and produce an adequate product supply to support clinical trials and potentially future commercialization; the rate and degree of market acceptance of our product candidates for any indication once approved; our ability to meet our obligations contained in license agreements to which we are party; and macroeconomic uncertainty resulting from changes to U.S. trade policy, including current or future tariffs or other trade restrictions. CONTACT: Contacts: Investor and Media Greg Gin VP, Investor Relations and Corporate Communications Abeona Therapeutics [email protected] Investor Lee M. Stern Meru Advisors [email protected]

Interested in Abeona Therapeutics Inc.? Here are five stocks we like better. ZEVASKYN revenue rose 31% sequentially to $11.4 million in the second quarter, with five patients treated but revenue recognized for only four because of a low-yield manufacturing batch. Abeona has treated 12 patients since launch and expanded its qualified treatment-center network to seven locations. Patient scheduling disruptions and manufacturing issues affected commercialization, including two biopsy cancellations and a subsequent out-of-specification batch. The company will focus future updates on patients treated and revenue recognized rather than earlier pipeline indicators. CMS granted ZEVASKYN New Technology Add-on Payment status for fiscal 2027, potentially improving hospital reimbursement and access for Medicare and dual-eligible patients. Despite higher revenue, Abeona’s quarterly net loss widened to $20.2 million, while cash and short-term investments totaled $146.8 million. Abeona Therapeutics (NASDAQ:ABEO) reported second-quarter revenue growth from its ZEVASKYN cell therapy launch while outlining operational challenges involving patient scheduling and manufacturing that affected revenue recognition. The company recorded net ZEVASKYN revenue of $11.4 million for the quarter ended June 30, up 31% from $8.7 million in the first quarter. Abeona treated five patients during the second quarter but recognized revenue for four treatments because one batch had cell yield below the threshold for billing. The company said it has treated 12 patients since ZEVASKYN’s launch, including three additional patients treated in the third quarter to date. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be Chief Executive Officer Vish Seshadri said Abeona expanded its qualified treatment center, or QTC, network during the quarter. Following the addition of Cincinnati Children’s Hospital, the company has activated seven QTCs nationwide, meeting its stated goal for the year. NewYork-Presbyterian/Columbia University Irving Medical Center and Children’s Hospital of Philadelphia, or CHOP, were activated during the second quarter. CHOP completed its first ZEVASKYN treatment in July after being activated in May, while the University of Texas Medical Branch recently completed its first patient biopsy. → Nebius’ Q2 Beat Shows the AI Bottleneck Is Capacity, Not Demand According to Chief Commercial Officer Madhav Vasanthavada, about 40% of Abeona’s addressable market has in-state access to a QTC based on claims analysis. He said QTCs also serve patients traveling from other states, and the company is receiving requests from additional epidermolysis bullosa treatment centers to offer ZEVASKYN. Abeona said the treatment’s logistics require coordination among dermatologists, surgeons, anesthesiologists, hospital staff, payers and patients. ZEVASKYN has an 84-hour shelf life, making scheduling particularly important for biopsies, manufacturing and treatment procedures. → On Holding's Price Stumble May Be an Opening for a Company Built to Run Management said the launch has produced operational lessons, including delays from patient health changes and limitations in manufacturing yields. During the second quarter, two scheduled biopsies were canceled at the last minute because of patient health deterioration. Vasanthavada said those cancellations reflected the need to reschedule rather than patients deciding against treatment. The company also reported one low-yield manufacturing batch in the second quarter and one out-of-specification batch in the third quarter. No revenue was recognized for either treatment, although both patients received the available product and were treated. Seshadri said the low-yield issue was the first such event observed across the company’s clinical and commercial experience. A batch producing fewer than four sheets is considered low yield for revenue-recognition purposes, he said. The company’s commercial manufacturing runs have averaged about nine sheets per lot, compared with about five sheets per patient in its Phase 3 VIITAL trial, where six sheets was the maximum allowed. The out-of-specification batch involved an identity test related to Pan-CK marker expression on keratinocytes, according to Seshadri. He said the issue did not concern product safety or potency. Abeona has discussed the matter with the FDA and is gathering manufacturing data that it believes could support a revision to the specification. The company expects to provide an update in a subsequent quarterly report. Abeona said it will no longer emphasize leading indicators such as scheduled biopsies or biopsies in manufacturing in its quarterly disclosures, citing external variables that can disrupt the path to revenue-generating treatment. Instead, future reports will focus on patients treated during the quarter and net revenue recognized. Abeona also highlighted that the Centers for Medicare & Medicaid Services granted New Technology Add-on Payment, or NTAP, status for ZEVASKYN, effective Oct. 1, 2026, for fiscal 2027. Vasanthavada said NTAP provides supplemental reimbursement to hospitals for eligible high-cost therapies administered during inpatient stays. Of 15 applications submitted through the traditional pathway for fiscal 2027, ZEVASKYN was one of three that received NTAP status, he said. Management said Medicare represents roughly 10% of the payer mix for recessive dystrophic epidermolysis bullosa, or RDEB. The company said the designation could improve access for Medicare and dual-eligible patients by helping treatment centers cover costs beyond standard hospital payments. Executives also said they expect the designation to support discussions with other payers, though they did not quantify its expected revenue impact. Abeona reported research and development expense of $5 million for the second quarter, down from $9.6 million in the first quarter. The prior quarter included a $7 million one-time upfront cost related to the in-licensing of ABO-701. Selling, general and administrative expense declined to $15.8 million from $19.5 million in the first quarter, primarily due to fewer engineering runs and lower manufacturing training costs. Net loss was $20.2 million, or $0.35 per basic and diluted share, compared with a net loss of $17.1 million, or $0.30 per share, in the first quarter. As of June 30, Abeona had $146.8 million in cash equivalents and short-term investments. Chief Financial Officer Joseph Vazzano said gross margins depend heavily on the number of patients treated in a quarter because many manufacturing costs are fixed. He said Abeona believes gross margins could reach roughly 85% to 90% at full operating capacity. Management said its near-term focus is increasing the number of patients entering the treatment process, expanding QTC access and improving treatment-center readiness as it works toward a more consistent cadence of patient treatments. Abeona Therapeutics is a clinical‐stage biopharmaceutical company focused on the development and commercialization of gene and cell therapies for severe, life‐threatening rare diseases and oncology indications. Founded in 2014 and headquartered in Cleveland, Ohio, Abeona leverages proprietary viral and non‐viral delivery platforms to correct or compensate for underlying genetic deficiencies. The company's research efforts target pediatric neurodegenerative disorders as well as debilitating dermatologic conditions with high unmet medical need. The company's lead clinical programs include separate AAV‐based gene therapies for CLN1 and CLN3 forms of neuronal ceroid lipofuscinosis, alongside an ex vivo autologous cell therapy for recessive dystrophic epidermolysis bullosa. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Abeona Therapeutics Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management reported treating 12 patients since launch, including 5 in Q2 2026, though revenue was recognized for only 4 treatments due to manufacturing variability. The company achieved its goal of activating 7 qualified treatment centers (QTCs) by year-end, including high-volume sites like Cincinnati Children's and CHOP. Operational complexity is driven by ZEVASKYN's 84-hour shelf life, requiring precise real-time coordination between dermatologists, surgeons, and anesthesiologists. Patient health volatility led to two last-minute biopsy cancellations in Q2, which could not be backfilled due to the extensive pre-scheduling required for surgical slots. Manufacturing yields are averaging 9 sheets per lot, which is higher than clinical trial averages, though one low-yield batch fell below the 4-sheet revenue recognition threshold. Management is shifting reporting metrics to focus on completed treatments and recognized revenue rather than leading indicators like scheduled biopsies, which have proven unpredictable. The company expects a steady-state cadence of approximately 1 patient per month per QTC once centers move past the initial learning curve. CMS granted New Technology Add-on Payment (NTAP) status effective October 1, 2026, which management believes will facilitate access for the 10% Medicare patient mix. Abeona is working with the FDA to revise specifications for the Pan-CK identity test after a batch failed a threshold set during BLA review based on limited data. Management believes clinical conviction will reach a 'tipping point' as early treaters share positive real-world outcomes through peer-to-peer dialogue. The financial strategy targets a sustainable cash-flow-positive model by maintaining a consistent cadence of patient treatments and leveraging a largely fixed manufacturing cost base. One batch was designated 'out of specification' due to a new identity test not used in clinical trials; the patient was treated, but no revenue was recognized. Q2 gross margins were 63%, but management anticipates normalized margins of 85% to 90% as volumes increase and fixed costs are better absorbed. R&D expenses decreased significantly quarter-over-quarter following a one-time $7 million in-licensing cost for ABO-701 in Q1 2026. The company maintains a cash position of $146.8 million as of June 30, 2026, to support the ongoing commercial rollout. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management explained that the failed identity test (Pan-CK marker) was based on specifications set during BLA review using only 6 samples, which may not reflect true GMP manufacturing variability. The company is gathering data to justify a lower specification to the FDA, noting the failure did not impact product safety or potency. Vish Seshadri clarified that any batch producing fewer than 4 sheets is considered low-yield and will not result in recognized revenue, even if the patient is treated. Despite the one low-yield event, commercial batches are currently averaging 9 sheets, well above the 5-sheet average seen in Phase III trials. While Medicare is only 10% of the payer mix, NTAP provides a critical mechanism for hospitals to avoid P&L losses on high-cost innovative therapies. Management expects a 'halo effect' where NTAP validation assists in negotiations with private payers and state Medicaid programs. Timelines vary significantly; CHOP treated a patient within two months of activation, while other sites have exceeded 12 months without a treatment. Management attributed delays to state-specific Medicaid paperwork and the time required for pharmacy and therapeutics (P&T) committee reviews.

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This article first appeared on GuruFocus. Release Date: May 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Abeona Therapeutics Inc (NASDAQ:ABEO) reported strong revenue growth with $8.7 million in net revenue for Q1 2026, driven by the commercial launch of ZevaSkin. The company successfully activated six qualified treatment centers (QTCs) and treated five commercial patients, with additional patients scheduled for treatment. Positive feedback from QTCs and patients indicates strong demand and successful treatment experiences with ZevaSkin. Abeona Therapeutics Inc (NASDAQ:ABEO) has secured 95% commercial coverage for ZevaSkin, indicating broad payer acceptance. The company announced the in-licensing of a novel cell therapy asset targeting advanced prostate cancer, expanding its R&D pipeline. The insurance approval process for ZevaSkin is lengthy, particularly for out-of-state Medicaid patients, which could delay treatments. Operating expenses increased significantly, with selling, general, and administrative expenses rising to $19.5 million, reflecting continued investment in commercial infrastructure. The company reported a net loss of $17.1 million for the quarter, primarily due to increased commercial investment and licensing transactions. There is uncertainty regarding the exact number of patients that will be treated in the upcoming quarters, making it difficult to predict revenue accurately. The transition of certain manufacturing costs to inventory and engineering runs is no longer considered R&D, which may impact future financial reporting. Warning! GuruFocus has detected 6 Warning Signs with ABEO. Is ABEO fairly valued? Test your thesis with our free DCF calculator. Q: Can you give us a sense of what the typical patient profile has looked like across treatment with ZivaSkin? Are these more severe patients, and are any of them returning from clinical trials for another cycle? A: (Dr. Madhav Visantabhata, Chief Commercial Officer) The patients treated so far are indeed severe cases, as expected. Many require more than 12 sheets of ZivaSkin, indicating an unmet need even after treatment. While it's early to determine how many will return for another cycle, there is a clinical need for retreatment. Clinical trial patients are interested, and consultations are ongoing to determine the right time for retreatment. Q: How many patients do you anticipate will undergo the ZivaSkin procedure in Q2, and how should we think about these numbers trickling into the next quarter? A: (Dr. Vish Seshadhari, CEO) We have visibility on at least eight patients, with one treated, one in manufacturing, and six in the biopsy scheduling process. It's challenging to predict precisely, but a good chunk of these patients should fall under Q2 treatments. Some may spill over into July, depending on biopsy timing and manufacturing turnaround. Q: Can you clarify which Qualified Treatment Centers (QTCs) are fully activated and provide some insight into patient volume expectations per QTC for 2026? A: (Dr. Madhav Visantabhata, Chief Commercial Officer) In addition to Lurie Children's and Stanford Children's, Colorado Children's Hospital and UTMB in Galveston are active. Columbia and CHOP were recently activated. Colorado and UTMB have identified patients and are working through the administrative process. Treating one patient per month at a steady state is feasible for these centers. Q: How do you plan to optimize ZivaSkin's value outside of the U.S.? A: (Dr. Vish Seshadhari, CEO) We are exploring markets where we can supply from our Cleveland site, such as Europe and Japan. Logistical challenges, like biopsy delivery and cold chain management, are being addressed. Updates on international expansion will be provided in future quarterly calls. Q: What gives you confidence in the PSMA CIR-T technology for treating advanced prostate cancer, given past struggles with solid tumor CAR-T programs? A: (Dr. Vish Seshadhari, CEO) The PSMA CIR-T technology is fundamentally different from CAR-T. It combines the best features of CARs and TCRs, allowing for direct recognition and binding to target antigens without the need for antigen presentation. Preclinical data shows promising results, with deep and durable anti-tumor responses and low cytokine release. This novel approach has generated excitement among KOLs and offers new hope for solid tumor treatment. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

- Three patients treated with ZEVASKYN® in Q1 2026 - - QTC network expands to six sites, with two new additions on the East Coast - - In-licensed radically novel engineered T-cell technology with game changing potential in the field of solid tumors; ophthalmology programs deprioritized - - $168.3M in cash, cash equivalents and short-term investments as of March 31, 2026 - - Webcast today at 8:30am ET - CLEVELAND, May 13, 2026 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today reported financial results for the first quarter of 2026, highlighting commercial momentum for ZEVASKYN. Steady increase in ZEVASKYN adoption with three patients completing treatment in the first quarter of 2026, one treatment to date in the second quarter, one biopsy currently in manufacturing process, and six additional patients expected to be biopsied in the second quarter, three of whom have biopsies scheduled. Qualified treatment center (QTC) network expands to six sites with the activation of New York-Presbyterian / Columbia University Irving Medical Center in New York, NY and Children’s Hospital of Philadelphia (CHOP). Patient access to ZEVASKYN continues to grow with published coverage policies now in place for 95% of commercially insured U.S. lives. Data presentation at SID2026 on sustained wound healing and long-term safety after one-time pz-cel application: 12-year case report and 5-year Phase 3 data “We are excited that an increasing number of patients at our QTCs are getting scheduled for ZEVASKYN slots this quarter,” said Vish Seshadri, PhD, President and CEO of Abeona Therapeutics. “We’re encouraged by the recent acceleration of onboarding efforts of QTCs to activate, so they can begin to treat patients with ZEVASKYN.” Pipeline Update Building on its proven end-to-end competency in engineered cell therapy, Abeona will focus its development efforts on ABO-701, a recently licensed radically novel engineered T-cell therapy targeting Prostate-Specific Membrane Antigen (PSMA). PSMA is a validated target for advanced prostate cancer, which is a leading cause of cancer mortality, with more than 30,000 deaths annually in the U.S. despite multiple approved therapies and recent advances in the field. ABO-701 is an autologous engineered T-cell therapy that carries a Synthetic Immune Receptor (SIR-T™) designed to overcome the limitations of CAR and TCR approaches. The SIR-T™ platform underlying ABO-701 was developed by Preet M. Chaudhary, M.D., Ph.D., Professor of Medicine and Chief of Jane Ann Nohl Division of Hematology and Center for the Study of Blood Diseases at University of Southern California (USC) Keck School of Medicine and Director of USC Blood and Marrow Transplant and Cell Therapy Program. The patents covering the SIR-T™ platform are owned by Angeles Therapeutics, Inc. In pre-clinical studies, ABO-701 has demonstrated durable tumor control in mouse models and modest levels of cytokine release – a profile that has been elusive to other engineered cell therapies in the solid tumors. Abeona expects to file an Investigational New Drug (IND) application and commence first-in-human studies with ABO-701 in the second half of 2027 while engaging a contract development and manufacturing organization for supply readiness in the meantime. This development plan and timing allow the Company to maintain its focus on commercializing ZEVASKYN. As part of the Company’s portfolio optimization, Abeona has deprioritized its in-house ophthalmology programs. First Quarter 2026 Financial Results Abeona reported net product revenue of $8.7 million in the first quarter ending March 31, 2026. This represents a quarter-over-quarter increase in net product revenue of $6.3 million compared to $2.4 million in the fourth quarter of 2025. Cost of sales for the first quarter of 2026 was $2.7 million, primarily driven by scaling of commercial ZEVASKYN. This represents a quarter-over-quarter increase in cost of sales of $1.7 million compared to $1.0 million in the fourth quarter of 2025, reflecting three patient treatments in the first quarter of 2026 versus one patient treatment in the prior quarter. Total research and development (R&D) expenses were $9.6 million for the first quarter of 2026 compared to $9.9 million in the first quarter of 2025. The first quarter of 2026 includes a single up-front payment of $7.0 million for in-licensing of the PSMA-SIR-T™ asset, now ABO-701. Excluding this transaction, R&D spending decreased by $7.4 million. The reduction in expenses was primarily due to costs capitalized into inventory and engineering runs and other production costs that are no longer considered research and development due to FDA approval of ZEVASKYN in April of 2025. Selling, general and administrative (SG&A) expenses for the first quarter of 2026 were $19.5 million, a $9.7 million increase over the first quarter of 2025. This increase primarily reflects Abeona’s commercial transition following the April 2025 FDA approval of ZEVASKYN, including $5.4 million in personnel and stock-based compensation, $1.9 million of certain engineering and training expenses previously classified as R&D that were transitioned to SG&A post-approval, and the remainder due to other commercial costs related to ZEVASKYN. Net loss was $(17.1) million for the quarter ending March 31, 2026, or $(0.30) per basic and diluted common share. Net loss for the first quarter of 2025 was $(12.0) million, or $(0.24) per basic and diluted common share. Cash, cash equivalents and short-term investments totaled $168.3 million as of March 31, 2026, compared to $191.4 million as of December 31, 2025. Conference Call Details The Company will host a conference call and webcast on Wednesday, May 13, 2026, at 8:30 a.m. ET to discuss its financial results and corporate progress. To access the call, dial 888-506-0062 (U.S. toll-free or, 973-528-0011 (international) and Entry Code: 305519 five minutes prior to the start of the call. A live, listen-only webcast with slides can be accessed on the Investors & Media section of Abeona’s website at https://investors.abeonatherapeutics.com/events. An archived webcast replay will be available for 30 days following the call. About Abeona Therapeutics Abeona Therapeutics Inc. is a commercial-stage biopharmaceutical company developing cell and gene therapies for serious diseases. Abeona’s ZEVASKYN® (prademagene zamikeracel) is the first and only autologous cell-based gene therapy for the treatment of wounds in adults and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). The Company’s fully integrated cell and gene therapy cGMP manufacturing facility in Cleveland, Ohio serves as the manufacturing site for ZEVASKYN commercial production. The Company’s development portfolio features ABO-701 (PSMA-SIR-T™), a potentially first-in-class engineered T-cell therapy targeting PSMA, engineered to overcome the core failures of cell therapies in solid tumors. For more information, visit www.abeonatherapeutics.com. ZEVASKYN®, Abeona Assist™, Abeona Therapeutics®, and their related logos are trademarks of Abeona Therapeutics Inc. About Prostate Cancer Prostate cancer is the most frequently diagnosed malignancy in men in the United States and remains a leading cause of cancer-related mortality. Most prostate cancer-related deaths are due to advanced disease, and high-grade localized disease almost inevitably progresses to advanced prostate cancer. Despite advances in androgen receptor pathway inhibitors, chemotherapy, and radioligand therapies, patients with advanced prostate cancer survive for a median of less than 2 years from starting therapy in the metastatic setting, underscoring the need for novel therapeutic strategies. About Angeles Therapeutics Angeles Therapeutics was founded by Preet M. Chaudhary, M.D., Ph.D. For inquiries regarding the SIR-T™ platform, please contact Angeles Therapeutics at [email protected] or visit www.angelestherapeutics.com. Forward-Looking Statements This press release contains certain statements that are forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and that involve risks and uncertainties. We have attempted to identify forward-looking statements by such terminology as “may,” “will,” “believe,” “anticipate,” “expect,” “intend,” “potential,” and similar words and expressions (as well as other words or expressions referencing future events, conditions or circumstances), which constitute and are intended to identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, numerous risks and uncertainties, including but not limited to, our ability to successfully commercialize and market ZEVASKYN, including manufacturing sufficient batches of ZEVASKYN to meet demand; the therapeutic potential of ZEVASKYN; whether the unmet need and market opportunity for ZEVASKYN are consistent with the Company’s expectations; continued interest in our portfolio; our ability to submit an investigational new drug application for ABO-701 and enroll patients in clinical trials; the outcome of future meetings with and inspections by the FDA or other regulatory agencies, including those relating to preclinical programs and to the cGMP manufacturing of ZEVASKYN; the ability to achieve or obtain necessary regulatory approvals for our pre-clinical programs; our ability to execute on our key business priorities; the impact of any changes in the financial markets and global economic conditions, including those resulting from changes to U.S. or other countries’ trade policy, such as current or future tariffs; risks associated with data analysis and reporting; and other risks disclosed in the Company’s most recent Annual Report on Form 10-K and subsequent periodic reports filed with the Securities and Exchange Commission. The Company undertakes no obligation to revise these forward-looking statements or to update them to reflect events or circumstances occurring after the date of this press release, whether as a result of new information, future developments or otherwise, except as required by the federal securities laws. Contacts: Investor and Media Abeona Therapeutics [email protected] Investor Lee M. Stern Meru Advisors [email protected]

On Wednesday, Abeona Therapeutics (NASDAQ:ABEO) discussed first-quarter financial results during its earnings call. The full transcript is provided below. Benzinga APIs provide real-time access to earnings call transcripts and financial data. Visit https://www.benzinga.com/apis/ to learn more. Access the full call at https://www.webcaster5.com/Webcast/Page/1818/53958 Abeona Therapeutics Inc reported Q1 2026 net revenue of $8.7 million, driven by the launch of ZEVA skin, with a notable increase from Q4 2025. The company has activated six qualified treatment centers (QTCs) for ZEVA skin, with plans to onboard a seventh by year-end, aiming for one patient treatment per center per month. Abeona is advancing a novel engineered T-cell therapy for prostate cancer, with an IND filing planned for 2027, while deprioritizing its ophthalmology programs. Management highlighted strong initial demand for ZEVA skin, with a current pool of over 100 identified patients and positive feedback from treatment centers. The company maintains a strong balance sheet with $168.3 million in cash and anticipates minimal R&D expenditure for the new PSMA program this year. OPERATOR Good day ladies and gentlemen and welcome to The Abeona Therapeutics first quarter 2026 earnings conference call. At this time all participants are on a listen only mode and a question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press Star0 on your telephone keypad and please note this conference is being recorded. I will now turn the conference over to your host, Mr. Joe Vizzano, Chief Financial Officer at Abeona Therapeutics. Sir, the floor is yours. Joe Vizzano (Chief Financial Officer) Thank you Operator. Good morning and thank you for joining us on our first quarter 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 [email protected]. 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, expressed or implied in the forward looking statements due to various factors including but not limited to those outlined in our Form 10K and periodic reports filed with the securities and Exchange Commission. These documents are available on our website at www.abeonatherapeutics.com. joining me on today's call with prepared remarks are Dr. Vish Seshadri, Chief Executive Officer and Dr. Madhav Vasantavada, Chief Commercial Officer. With that, I will now turn the call over to Dr. Shashaudhary to kick us off Vish. Vish Seshadri Thank you Joe and good morning everyone. First, we're excited to share updates on leading indicators of ZEVA skin adoption that signaled strong momentum. Since treating our first commercial patient in December, we have now activated six qualified treatment centers or QTCs, treated our fifth commercial patient with manufacturing underway for the sixth, and schedule additional patients throughout the current quarter. The recent acceleration of onboarding efforts of QTCs further underscores their conviction about the role that ZEVA skin will play in addressing the unmet needs of patients suffering from recessive dystrophic epidermolysis bullosa or RDEB. Three of the ZEVA skin 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 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. But before going there, I'll first turn the call over to Dr. Madhav Vasantavada to elaborate on the Ziva Skin launch, which is our foundational and primary focus for Abeona Madhav. Madhav Vasantavada (Chief Commercial Officer) Thank you Vish and good morning everyone. Launch momentum for Ziva Skin and our commercial story continues to build and 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, 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. Additionally, one patient has been treated so far this quarter for a total of five patients treated to date with Ziva Skin 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. 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 QTCs have identified patients and are not far behind in scheduling for biopsy which will further add to ZEVA skin treatments in the coming quarters. While we are pleased to see patients beginning to clear the upstream procurement process and receiving Zeva skin 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. 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 touch points but action oriented back and forth interactions which shows real clinical interest and their intent to refer patients for ZEVA skin. Beyond the numbers, early qualitative launch insights are also encouraging and reinforce our conviction. Importantly, we are hearing positive feedback from QTC's that have treated patients and their experience with the end to end process is getting better with every patient treated. 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 Zeva skin 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. Our payer mix consists of both commercial and Medicaid insurers indicating the breadth of ZEVA skin coverage and 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 Abiona Assist patient and caregiver support programs have received positive feedback. 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 ZEVA skin 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 Ziva skin 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 ZEVA skin policies now reaching 95%. This is a significant accomplishment in the first year post Zevaskin 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. Even so, we have seen no patient attrition and no final payer denials to date, further underscoring the strength of Zevaskin's value proposition to RDEV patients and their families 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 featuring 5 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 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. As our initial ZEVA skin 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 ZEVA skin 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. 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 team's conviction in zebra skin and 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. We continue to have active discussions with additional centers and remain well on track to achieving our goal of having a total of 7 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 broadcast payer acceptance. Every successful biopsy, every treatment and every positive patient story is reinforcing our conviction in Ziva skin. With that, I'll turn the call back to Dr. Seshadri for an update on our R and D pipeline. Vish Seshadri Dinesh 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 focused effort we have deprioritized our in house ophthalmology preclinical programs. Ebiona has demonstrated capabilities with Zeva skin 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 DIS 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 U.S. the CIRT technology was pioneered by Dr. Preet Chaudhary, 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. We have included a link to a recent talk by Dr. Chowdhury in today's slides elaborating on the uniqueness and promise of this technology in oncology. PSMA CIRT or AB0701 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 third 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. In preclinical studies, people PSMA CIRT 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 cell therapies in solid tumors. The elimination of tumors in most mice treated with PSMA CIRT 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 CIR 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 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 3, 2026 and engage a CDMO for supply readiness while our internal teams maintain operational focus on Ziva skin commercialization. With that, I now pass the call to our Chief Financial Officer Joe Ozzano to discuss our first quarter financial results. Joe Vizzano (Chief Financial Officer) Joe 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 31, 2026. In our most recent 10Q, we reported total net product revenue of $8.7 million for the first quarter of 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 the fourth quarter of 2025. The growth was driven by early commercial traction following the launch of Zevaskin. 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 Zevaskin with three patient treatments in Q1 versus one treatment in Q4. 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 PSMA certification. Excluding this transaction, R and D expenses declined meaningfully, reflecting the transition of certain manufacturing costs capitalized to inventory and engineering runs that are no longer considered R and D. Following the FDA approval of Zevaskin. Selling general and Administrative expenses were $19.5 million, representing an increase of $9.7 million year over year first quarter 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. Net loss for the quarter was $17.1 million or $0.3 per basic and diluted common share compared to a net loss of $12 million or $0.24 per basic and diluted common share in the first quarter of 2025. The year over year change primarily reflects increased commercial investment and the PSMA certi 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. Our balance sheet remains strong and positions us well to support continued commercial execution and pipeline advancement. We anticipate minimal R and 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 Ziviskin 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 and A Vish Vish Seshadri to summarize, we are encouraged by favorable trends in leading indicators of Ziva Skin launch performance. That is the foundation on which we have taken a bold step in advancing PSMA CRT development. Every milestone we 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. 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 one on your telephone keypad. A confirmation tone will indicate your line is in the question key and you may press Star two 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 Kristin Kluska with Kantor Fitzgerald. Your line is live. Kristin Kluska (Equity Analyst) Hi, good morning everybody and congrats on all the progress here around Zeva Skin. 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. 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? Madhav Vasantavada (Chief Commercial Officer) 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, and many of those patients treated would require more than 12 sheets of zeva skin. So 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. But there is definitely a clinical need from that standpoint. The second part, clinical trial patients, they are interested and we know that patient consults are happening. It's just a matter of for those patients, when would be the right time for them to come in for a retreatment with Ziva skin? And so we'll keep you updated if we have that kind of information. And from the patients who have received Zeva skin 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. Kristin Kluska (Equity Analyst) Okay, thank you for that. And then just as we think about how to model this out for 2Q, we know one patient has officially been treated 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 in two view versus how we should be thinking about maybe some of these trickling into next quarter. Madhav Vasantavada (Chief Commercial Officer) 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, one treated, one in manufacturing process, and six assessments 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 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 the sum 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. But a good chunk of the patients that we have described today should fall under Quarter, two treatments. Thank you, Kristin. OPERATOR Thank you. Our next question is coming from Maury Raycroft with Jefferies. Your line is live. Maury Raycroft (Equity Analyst) 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 Lorrey's in Stanford. 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 and maybe what steady state could look like eventually as well? Madhav Vasantavada (Chief Commercial Officer) Yeah, Maurice. So in addition to Lurie Children's and Stanford Children's, we have Colorado Children's Hospital, that's active and utmb, University of Texas in Galveston, 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. 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 QTC is treating one patient a month at a steady state is quite doable. So it's just a matter of getting these patients initiated with biopsy and the treatment cadence. Maury Raycroft (Equity Analyst) 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? 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? Madhav Vasantavada (Chief Commercial Officer) 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 of paperwork that need to be secured. 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 the out of state patient state. 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. 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, 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. Okay, that's helpful. Thanks for taking my questions. OPERATOR Thank you, Maury. Steven Willey (Equity Analyst) Thank you. Our next question is coming from Steven Willey with Stifel. Your line is live. Madhav Vasantavada (Chief Commercial Officer) 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 are being scheduled. Yeah. Thank you, Steve. If you look at the time that a patient is identified as a Zeva skin 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 QTC is to the process. For example, now, Lou Rees, as you all know, have treated some patients and maybe they've gotten into a rhythm and there's a lot of precedence that's been set. 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 Lurie's, I think the first patient was biopsied in August. This is pretty early, it was two months or something since activation. 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. So it's a very variable thing. And with n of 5 to 6 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. I hope that answered your question. Steven Willey (Equity Analyst) No, it did. Thank you. And then I guess the PSMA certi looks conceptually pretty interesting. I think you spoke to the $7 million licensing fee. Can you speak to any additional economics that might be owed on the progression of that product? And then I know you're in the process of tech transfer now, but what are the implications for manufacturing in terms of the need to build out additional suites to potentially accommodate the clinical development of this product. Thanks. Sure. Vish Seshadri In terms of deal economics, right, it's the upfront payment that we shared of 7 million and Abeona is going to develop this asset until end of phase one. So there's going to be dose escalation and dose expansion and those first in human studies do not start until second half of 2027. As I mentioned, there is just about a$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. So if you look at that, it's not, you know, the upfront payment is really the main substantial payment that's done right now. In terms of deal structure at the end of phase one data, we have two potential paths and one could be a 5050 development with Angelus. So we share the cost and we share the proceeds later. Or it could be an outright licensing deal where we'll have some bio bucks and royalties that Aviona will fully own the program but provide to Angelus. 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. So it's early to comment on that. But in terms of cost implications, I wanted to make sure this is very well understood until first in human studies begin. There's not a big cost load on Abeona because once the upfront payment has been done, it's low single digit, millions of CDMO developing the process and as you know, engineered T cells. It's not as complex as Diva skin fortunately, but 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 going to be done by an external CDMO and we're not going to disturb our internal teams. In Cleveland, we're laser focused on the Zebraskin 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 regulatory agencies on what our trial design looks like and how we go about that. So other than that, from a personnel standpoint, Ab Earn is laser focused on Zeva skin 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 PSMA 30. Steven Willey (Equity Analyst) Yeah, I know, that's helpful. The external CDMO kind of addresses the question on the manufacturing front. Can you just say whether or not the 5050 co promoter. I'm presuming that decision is made by Angelus based upon a review of phase one data. Vish Seshadri Actually the option for us to pursue the program is after the phase one Angelus has the option to either do the 5050 co development or a license agreement with what Fish had mentioned with predefined financial terms for an agreement that'll be agreed upon later. Steven Willey (Equity Analyst) Understood, very helpful. Thank you. OPERATOR Thank you. Our next question is coming from Raghuram Salvaraju with HC Wainwright. Your line is live. Ahmed Congrats on the quarter and on activating the new QTCs. This is Ahmed on Foram. 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? And my second question was on the patients receiving Zeva skin. How often does cell harvesting from RDEP patients fail due to insufficiency? Vish Seshadri 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? I mean this is a huge undertaking by a qtc. An AB physician has to gather a multidisciplinary team first and they need to have anesthesiologists and plastic surgeons who are familiar with the RDEV patients 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. And that itself is few months journey because every buy and bill that they have to, you know, put some financial risk on their P and L is going to be scrutinized carefully. So 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 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. And then there's numerous legal policies, the trade policies, the master service agreements, those are all again legal steps that take several months. 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. And we started that process with our first set of QTCs very early. And you know, it's kind of what you alluded to is is there an unlimited number of QTCs that we can activate? 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, you know, that's important from a patient experience and patient care and outcome perspective. And of the 23 centers where there are EB patients cared for today, a good 5 to 10 centers already have these multidisciplinary teams in place. And those are our focus areas. And as we had stated earlier, our goal was to have about seven centers active. Because when seven 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. 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. Anything else, Madhav? Madhav Vasantavada (Chief Commercial Officer) 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, right after Ziva Skin 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. So 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, additional centers, as Vish said, we are well on track. Vish Seshadri We believe we'll be able to get another QTC also activated. 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 sheet manufacturing process success rate or was it something else that you were referring to here? Ahmed 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? Vish Seshadri 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 you know, in majority of cases we are actually producing the double digit number of sheets. 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. 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, but that's kind of our range of turnaround time we've seen so far. Got it. Ahmed Thanks so much. If I may just have one quick follow up is I guess what is the Aviona's plan to optimize Sivaskin value Vish Seshadri outside of the U.S. 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. 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. That's something that we're working out. But we should have such updates in the following quarterly calls. Right now our teams are so spread already thin in making sure that every aspect of the US launch is maximized. We are definitely there's a sub team that is looking at these external opportunities. So hopefully in later quarterly calls we give some better color to what that path looks like. OPERATOR Thank you so much. Thank you. Our next question is coming from Jeff Jones with Oppenheimer. Your line is live. Jeff Jones (Equity Analyst) Good morning guys and 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 one 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 and how, as you mentioned, how that aligns with capacity. 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? Are you thinking about oncology specifically or maybe outline for us sort of how you're thinking about that strategically. Vish Seshadri So first I'll ask Madhav to respond Madhav Vasantavada (Chief Commercial Officer) to the QTC question. Vish Seshadri 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. 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, nine or ten centers, we are in a pretty good shape 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. 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 Madhav Vasantavada (Chief Commercial Officer) these other centers also active. Vish Seshadri 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, six this year and we're already in ramp up mode to bring it up to 10 by end of the year. So 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 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 has already happened and we're raring to go. Right. So it's the right trigger and that's not very far away. We can again speak about that in the upcoming quarterly updates. But rest assured, we are not going to artificially restrict ourselves to seven sites. As Madhav mentioned, if there's more sites that show that multidisciplinary teams are pulled together and they have EV 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. And your second question was about our move from ophthalmology to oncology. I just wanted to reiterate one thing. I think where our strengths are and where we have done well learning from the zebraskin 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, but where our strengths can actually, if you look at 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. 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 were all from the CAR T world. We've done launching of Brianzi Abecma and in fact, Dr. Preet Chowdhury, 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. 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. So you see that the strength in the oncology field really is not something that we have to start from ground zero here. So every little angle that you're looking from, we have that, 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 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. 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. 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 license 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. And 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, why not? And we were waiting for the right moment, which was Ziva Skin is in a good place with its launch. 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. And so this was the right kind of time. So that's really where we've shifted. This doesn't mean to say we're not putting a stake in the ground, say we're going to be an oncology company. 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 that is, you know, 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 is huge long term value in that. So that's how this asset really fit. Checked all the boxes that we're describing here. Jeff Jones (Equity Analyst) Thank you guys very much. OPERATOR Thank you. Jim Malloy (Equity Analyst) Thank you. Our next question is coming from Jim Malloy with Alliance Global Partners. Your line is live. Hi, good morning. Thank you very much for taking my questions. Just a couple quick questions on pricing. And so the 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? And then I guess a follow up would be on the OPEX, you know, ex the, the 7 million one timer. These are the RMD and GNA numbers we should expect sort of going forward through the rest of 26. Thank you. Thanks, Jim. So regarding the gross to net for Q1, all the all three patients treated in the quarter were commercial compared to Q4 where it was the Medicaid patient. So on the commercial patient 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 net will be in the mid to upper teens when we have more patients treated. And then for your second question, so if you exclude the $7 million upfront payment for R&D and SGA, the total spend will be pretty much the same for the rest of the year. Again as we treat more patients and get more volume in there, some of the costs will come out of sga, the engineering run and they will go to cost of goods sold. So but the overall run rate, again throw out the $7 million expense is reflective of the rest of the year. Okay, great. A quick follow up if I could please. Any guidance on the six or seven people potentially in the shoot for second quarter what that mix looks like on commercial versus Medicare Medicaid, of mix that we have. 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% or something like that is Medicaid. So that is the split we're looking at. Got it. Thank you. And have you guys thought, have you guys put out any guidance when you anticipate being profitable? I know last year you put some guidance out and obviously things have changed since then. We haven't. You know, we maintain the assumption that we had 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. So next month. Excellent. Thank you very much for taking the questions. OPERATOR Thank you. Our final question today is coming from David Boutts with Zach's Small Caps Small Capital Research. Your line is live. David Boutts (Equity Analyst) 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? Vish Seshadri 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. So a lot of the innovation in the CAR T field has been about better signaling domains or the zeta domains. And they're built on an existing CAR structure, 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 various population based constraints. What the third T 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 sir. 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? That's what we are encouraged with. And these experiments have been repeated many, many times with variations in manufacturing process and everything. So we're excited, 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. 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 and that has a lot of technical details. If you're interested. I encourage anyone to go and listen to that. So hope I answer your question. Yeah, sounds great. David Boutts (Equity Analyst) Appreciate it. OPERATOR Thank you. Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company's SEC filings and official press releases. Corporate participants' and analysts' statements reflect their views as of the date of this call and are subject to change without notice. Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga: ABEONA THERAPEUTICS (ABEO): Free Stock Analysis Report This article Abeona Therapeutics Q1 2026 Earnings Call: Complete Transcript originally appeared on Benzinga.com ﾩ 2026 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.