On August 14, 2025 Abeona Therapeutics Inc. (Nasdaq: ABEO) reported financial results and business highlights for the second quarter of 2025 and shared recent operational progress (Press release, Abeona Therapeutics, AUG 14, 2025, View Source [SID1234655279]).
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"ZEVASKYN’s launch is demonstrating positive early momentum," said Vish Seshadri, Chief Executive Officer of Abeona. "The first ZEVASKYN patient treatment is on track for the third quarter of 2025 with multiple additional patients identified and advancing through the process to initiate treatment. The enthusiasm from the RDEB community and clinicians, alongside our substantial progress with payer coverage, affirms ZEVASKYN’s crucial role in transforming patient care."
Recent Developments
FDA approval and commercial launch of ZEVASKYN
● FDA approval of first-in-class RDEB therapy: In April 2025, the U.S. FDA approved ZEVASKYN (prademagene zamikeracel) for the treatment of wounds in adult and pediatric patients with RDEB.
● ZEVASKYN now available at Qualified Treatment Centers (QTCs): RDEB patients can access ZEVASKYN at both Ann & Robert H. Lurie Children’s Hospital of Chicago and Lucile Packard Children’s Hospital Stanford. The Company is on track and expects to activate additional sites in 2025.
● Strong demand for ZEVASKYN with several patients identified and treatment process initiated: The first ZEVASKYN patient has been biopsied and treatment is expected in 3Q 2025. Demand for ZEVASKYN continues to grow with more than a dozen patients identified within the two QTCs and several advancing through the administrative process. In addition, more than three dozen patients have already been identified as candidates for ZEVASKYN at referring sites (non-QTCs).
● Secured broad patient access: So far, 100% of submitted prior authorization requests have been approved. Among commercial insurers that cover approximately 60% of RDEB lives, positive coverage for ZEVASKYN has been established with multiple large national and regional payers. United Healthcare, the nation’s largest payer covering more than 43 million lives or approximately 16% of the U.S. insured population, published a favorable coverage policy for ZEVASKYN consistent with the FDA-approved label without imposing any additional restrictions. Abeona has entered into the National Drug Rebate Agreement (NDRA) with the U.S. Centers for Medicare and Medicaid Services (CMS) to facilitate expedited coverage and reimbursement for ZEVASKYN across all 51 state Medicaid programs and Puerto Rico. Some states have already implemented favorable coverage criteria for ZEVASKYN.
● Ramping up supply of ZEVASKYN: Abeona remains on-track to scale-up supply capacity for up to 10 patients per month in mid-2026.
● Broadening ZEVASKYN medical awareness: In June, The Lancet, a respected global medical journal, published results from the pivotal Phase 3 VIITAL study (NCT04227106) evaluating the efficacy and safety of ZEVASKYN for the treatment of RDEB wounds.
Other corporate updates
● Licensing agreement for novel AAV204 capsid for ophthalmology gene therapy: Beacon Therapeutics exercised its option to license from Abeona the AAV204 capsid for use in potential gene therapies for a range of prevalent and rare retinal diseases.
● Secured non-dilutive capital: Abeona closed the sale of its Rare Pediatric Disease priority review voucher (PRV) for gross proceeds of $155 million. Abeona was awarded the PRV upon FDA approval of ZEVASKYN.
Financial Results
Cash, cash equivalents, restricted cash and short-term investments totaled $225.9 million as of June 30, 2025, including net proceeds from the PRV sale. The current cash position, without accounting for anticipated revenue from ZEVASKYN, is expected to be sufficient to fund current and planned operations for over two years.
As Abeona transitions into a commercial organization, its second quarter financial results show the reclassification of certain manufacturing and development costs from research and development (R&D) expense to inventory or selling, general, and administrative (SG&A) expenses.
R&D spending for the three months ended June 30, 2025 was $5.9 million, compared to $9.2 million for the same period of 2024. The reduction in R&D expense was primarily due to costs capitalized into inventory and select costs, such as engineering runs and other production costs, reclassified as SG&A following FDA approval of ZEVASKYN. SG&A expenses were $17.1 million for the three months ended June 30, 2025, compared to $8.6 million for the same period of 2024. In addition to the reclassification of select R&D expense to SG&A, the increase in SG&A reflects increased headcount and professional costs associated with the commercial launch of ZEVASKYN.
Net income was $108.8 million for the second quarter of 2025, or $2.07 per basic and $1.71 per diluted common share, including the gain from the sale of the PRV. Net income in the second quarter of 2024 was $7.4 million, or $0.19 per basic and a net loss of $(0.26) per diluted common share.
Conference Call Details
The Company will host a conference call and webcast on Thursday, August 14, 2025, at 8:30 a.m. ET, to discuss the financial results and corporate progress. To access the call, dial 877-545-0320 (U.S. toll-free) or 973-528-0002 (international) and Entry Code: 829076 five minutes prior to the start of the call. A live, listen-only webcast and archived replay of the call can be accessed on the Investors & Media section of Abeona’s website at View Source The archived webcast replay will be available for 30 days following the call.