On May 15, 2025 Abeona Therapeutics Inc. (Nasdaq: ABEO) reported financial results and business highlights for the first quarter of 2025 and shared recent operational progress (Press release, Abeona Therapeutics, MAY 15, 2025, View Source [SID1234653156]).

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"ZEVASKYN’s approval just a few weeks ago is a landmark achievement for recessive dystrophic epidermolysis bullosa patients and signifies Abeona’s transition to a commercial-stage cell and gene therapy company," said Vish Seshadri, Chief Executive Officer of Abeona. "We are rapidly advancing the launch of ZEVASKYN and building positive momentum. Patients can now start their treatment journey with Lurie Children’s activated as our initial treatment center ready to identify patients and our scheduling system is operational. In addition, we are collecting patient registrations through our patient support program, Abeona Assist, and have entered into agreements with commercial payer groups ensuring broad access to ZEVASKYN."

Recent Developments

ZEVASKYN FDA approval, commercial launch progress and new data

● FDA approval of first-in-class RDEB therapy: On April 28, 2025, the U.S. FDA approved ZEVASKYN (prademagene zamikeracel) gene-modified cellular sheets, also known as pz-cel, as the first and only autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with RDEB. There is no cure for RDEB and ZEVASKYN is the only FDA-approved product to treat RDEB wounds with a single application.
● Activation of first ZEVASKYN Qualified Treatment Center (QTC): Following approval, ZEVASKYN is now commercially available in the U.S. after the activation of Ann & Robert H. Lurie Children’s Hospital of Chicago, a top-ranked hospital, as the first of five QTCs for ZEVASKYN. The first patient is expected to be treated in the third quarter of 2025. Abeona expects to activate all five QTCs by the end of 2025.
● High interest from patients and caregivers: Since approval, approximately 30 patients and caregivers have started registering in the Abeona Assist patient services program.
● Increasing enthusiasm from healthcare professionals: New data from two posters were presented at the 2025 Society for Investigative Dermatology (SID) Annual Meeting. One poster presentation details the potential progenitor cell populations within ZEVASKYN that may contribute to long-term wound closure and persistent COL7A1 expression observed after a single treatment. A second poster presentation details the absence of insertional oncogenesis and replication competent retrovirus in clinical and pre-clinical experience with ZEVASKYN.

● Securing broad patient access: Abeona has executed value-based agreements with several commercial payer groups representing dozens of downstream plans and approximately 100 million commercially-insured lives. In addition, Abeona is in active discussions with multiple commercial and government payers to further expand ZEVASKYN access to eligible patients in the U.S.

Key corporate updates

● Secured non-dilutive capital: Abeona entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease PRV for gross proceeds of $155 million upon the closing of the transaction. Abeona was awarded the PRV following the FDA approval of ZEVASKYN.

"The proceeds from our PRV sale fully fund our operations for over two years, extending our runway through our projected ZEVASKYN-driven profitability in early 2026," said Joe Vazzano, Chief Financial Officer of Abeona. "This robust financial footing, achieved even before ZEVASKYN revenues, eliminates the need for additional capital to reach this crucial commercial milestone."

Financial Results

Cash, cash equivalents, restricted cash and short-term investments totaled $84.5 million as of March 31, 2025, before accounting for the proceeds pending the close of the PRV sale. As of December 31, 2024, cash, cash equivalents, restricted cash and short-term investments totaled $98.1 million.

Research and development spending for the three months ended March 31, 2025 was $9.9 million, compared to $7.2 million for the same period of 2024. The increase was primarily due to increased headcount related to scale-up of manufacturing capacity in preparation for the planned ZEVASKYN commercial launch and pre-clinical development work. General and administrative expenses were $9.8 million for the three months ended March 31, 2025, compared to $7.1 million for the same period of 2024. The increase was primarily due to increased headcount associated with the planned launch of ZEVASKYN.

Net loss was $12.0 million for the first quarter of 2025, or $0.24 loss per common share. Net loss in the first quarter of 2024 was $31.6 million, or $1.16 loss per common share.

Conference Call Details

The Company will host a conference call and webcast on Thursday, May 15, 2025, at 8:30 a.m. ET, to discuss the financial results and corporate progress. To access the call, dial 877-545-0523 (U.S. toll-free) or 973-528-0016 (international) and Entry Code: 292299 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.