Abeona's first-quarter 2026 call showed the ZEVASKYN launch inflecting. Net product revenue jumped to $8.7 million from $2.4 million in Q4 2025 on three commercially insured treatments, which carried a far more favorable gross-to-net than the Q4 Medicaid patient; five patients had been treated since launch, a sixth was in manufacturing, and at least six more were scheduled for biopsy. The QTC network expanded to six activated centers - adding NewYork-Presbyterian/Columbia and Children's Hospital of Philadelphia for national coverage - against a goal of seven by year-end, and coverage reached 95% of commercially insured lives with still no attrition or final payer denials. Abeona also broadened its pipeline, in-licensing the novel PSMA-directed engineered T-cell therapy ABO-701 for advanced prostate cancer from Angeles Therapeutics for a $7 million upfront, while deprioritizing in-house ophthalmology; a pre-IND FDA meeting was set for June 3, 2026 and first-in-human studies for the second half of 2027. The negatives were a wider net loss of $17.1 million (-$0.30 per share), partly from the $7 million upfront and commercial investment, cash declining to $168.3 million, SG&A rising to $19.5 million, a still-lengthy and variable four-to-five-month insurance-and-treatment cycle (especially for out-of-state Medicaid), and treatments still concentrated at the first two QTCs. Management maintained that monthly profitability could begin as soon as June 2026, with manufacturing ramping from six to about ten runs per month by year-end and gross-to-net expected to settle in the mid-to-upper teens as volume scales.
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 website at www.abeonatherapeutics.com. We anticipate making projections and forward-looking statements during today's call, which are made pursuant to the safe harbor provisions of the federal securities laws. These forward-looking statements are based on current expectations and are subject to change. Actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including but not limited to those outlined in our Form 10-K and periodic reports filed with the Securities and Exchange Commission. These documents are available on our website at www.abeonatherapeutics.com.
Joining me on today's call with prepared remarks are Dr. Vishwas Seshadri, Chief Executive Officer, and Dr. Madhav Vasanthavada, Chief Commercial Officer. With that, I will now turn the call over to Dr. Seshadri to kick us off. Vish?
Thank you, Joe, and good morning, everyone. First, we're excited to share updates on leading indicators of ZEVASKYN 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 scheduled additional patients throughout the current quarter. The recent acceleration of onboarding efforts of QTCs further underscores their conviction about the role that ZEVASKYN will play in addressing the unmet needs of patients suffering from recessive dystrophic epidermolysis bullosa or RDEB. Three of the ZEVASKYN treatments reported to date took place in Q1 2026 and translated into net revenue of $8.7 million for that quarter. Second, we're sharing meaningful updates to our R&D pipeline, featuring a potentially game-changing, radically novel engineered T-cell technology for advanced prostate cancer.
By leveraging our proven expertise in advancing complex cell and gene therapies from academia through commercialization, we are well-positioned to advance this exciting technology. Before going there, I'll first turn the call over to Dr. Madhav Vasanthavada to elaborate on the ZEVASKYN launch, which is our foundational and primary focus for Abeona. Madhav.
Thank you, Vish, and good morning, everyone. Launch momentum for ZEVASKYN 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 ZEVASKYN 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 6 additional patients expected to be biopsied this quarter, 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 ZEVASKYN treatments in the coming quarters. While we are pleased to see patients beginning to clear the upstream procurement process and receiving ZEVASKYN treatments, we are equally encouraged by the strong demand reflected in the near-term identified pool of more than 100 patients across our QTCs and the community-based physicians.
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 ZEVASKYN. Beyond the numbers, early qualitative launch insights are also encouraging and reinforce our conviction. Importantly, we are hearing positive feedback from QTCs that have treated patients, and their experience with the end-to-end process is getting better with every patient treated.
To elaborate further on the types of initial patients that have been treated and those in the queue, we are happy to note that the initial uptake of ZEVASKYN is not confined to a narrowly defined patient or payer type, but has spanned across both adults and children, with one patient as young as five years of age. Our payer mix consists of both commercial and Medicaid insurers, indicating the breadth of ZEVASKYN coverage. We are seeing that geographic proximity to QTC has not been a barrier because patients have traveled significant distances, including across state lines, to receive treatment, and our Abeona Assist patient and caregiver support programs have received positive feedback.
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 ZEVASKYN due to a false positive result from a sterility assay. This patient came back to be rebiopsied early this year, and we are pleased to tell you that this patient was treated successfully. Such determination of patients, families, and physicians to pursue ZEVASKYN speaks volumes about what this therapy means to them. On the market access front, payer coverage continues to strengthen with the percentage of commercially covered lives with published ZEVASKYN policies now reaching 95%. This is a significant accomplishment in the first year post ZEVASKYN approval. That said, we are navigating a lengthy insurance approval process, which is typical of any high-cost gene therapy at launch, particularly for out-of-state Medicaid patients.
Even so, we have seen no patient attrition and no final payer denials to date, further underscoring the strength of ZEVASKYN's value proposition to RDEB patients and their families. As we continue to follow patients from our phase 1/2a, and phase III trials, we are excited to share that new data will be presented later this week at the Society for Investigative Dermatology, SID, featuring five years follow-up of our VIITAL phase III trial as well as a single patient 12 years of follow-up from phase 1/2a 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 ZEVASKYN commercial patients share their experiences over time, we expect these stories to become one of the most powerful demand drivers available to us in this rare disease setting. Lastly, we continue to onboard more ZEVASKYN treatment centers. As announced, we activated NewYork-Presbyterian/Columbia University 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 ZEVASKYN as they successfully navigated a several-month-long onboarding process. As you can gather from the map, we importantly have QTCs spanning the nation across geographically distinct regions, California, Colorado, Texas and the Gulf Coast, Chicago, and now the East Coast.
We continue to have active discussions with additional centers and remain well on track to achieving our goal of having a total of seven QTCs onboarded this year and ensuring even greater access for patients and families across the country. To close, we are progressing through the launch, accruing positive early feedback from treating physicians, a growing referral base, expanding QTC networks, and achieving broad payer acceptance. Every successful biopsy, every treatment, and every positive patient story is reinforcing our conviction in ZEVASKYN. With that, I'll turn the call back to Dr. Seshadri for an update on our R&D pipeline. Vish?
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. Abeona has demonstrated capabilities with ZEVASKYN over the past years in end-to-end development and commercialization of personalized high-value cell therapies with durable clinical benefits for patients with debilitating diseases. Today, we announced the in-licensing of a radically novel cell therapy asset that targets PSMA or prostate-specific membrane antigen, a validated target for the treatment of advanced prostate cancer, a leading cause of cancer mortality with more than 30,000 deaths annually in the U.S. The CAR-T technology was pioneered by Dr. Preet Chaudhary, founder of Angeles 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. Chaudhary in today's slides, elaborating on the uniqueness and promise of this technology in oncology. PSMA CAR-T or ABO-701 is an autologous engineered T-cell therapy that carries a PSMA-directed synthetic immune receptor purposefully structured to overcome the limitations of CARs, or chimeric antigen receptors, and TCRs, which is T-cell receptors. The CAR-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. 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, PSMA CAR-T demonstrated the ability to achieve deep and durable PSMA-specific antitumor responses in mouse models and displayed exceptionally modest levels of cytokine release in vitro, a profile that has been elusive for other engineered cell therapies in solid tumors. The elimination of tumors in most mice treated with PSMA CAR-T and its superior performance versus corresponding PSMA CAR-T comparator controls suggests a more controlled and durable immune activation in treated mice. We believe these data support a compelling hypothesis that CAR-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 3rd, 2026, and engage a CDMO for supply readiness while our internal teams maintain operational focus on ZEVASKYN commercialization. With that, I now pass the call to our Chief Financial Officer, Joe Vazzano, to discuss our first quarter financial results. 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 31st, 2026, in our most recent Form 10-Q. 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 ZEVASKYN. Cost of sales for the quarter was $2.7 million compared to $1 million in the prior quarter. The increase was primarily driven by the scaling of commercial ZEVASKYN, with 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 CAR-T asset. Excluding this transaction, R&D expenses declined meaningfully, reflecting the transition of certain manufacturing costs capitalized to inventory and engineering runs that are no longer considered R&D following the FDA approval of ZEVASKYN. Selling general and administrative expenses were $19.5 million, representing an increase of $9.7 million year-over-year 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 $0.30 per basic and diluted common share, compared to a net loss of $12 million or $0.24 per basic and diluted common share in the first quarter of 2025. The year-over-year change primarily reflects increased commercial investment and the PSMA CAR-T licensing transaction. We ended the quarter with $168.3 million in cash equivalents, and short-term investments, compared to $191.4 million at the end of 2025. Our balance sheet remains strong and positions us well to support continued commercial execution and pipeline advancement. We anticipate minimal R&D expenditures for the PSMA program, limited to low single-digit million dollars for the remainder of this year.
Overall, we are encouraged by the early commercial progress of ZEVASKYN and remain disciplined in our capital allocation as we scale the business. With that, I'll pass the call back to Vish for closing remarks before opening the call for Q&A. Vish?