NOTE 13 – SUBSEQUENT EVENTS

FDA Approval

On April 28, 2025, the 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, a serious and debilitating genetic skin disease.

Loans Principal Payments

On April 28, 2025, with the FDA approval of ZEVASKYN™ and in accordance with the Loan Agreement, the start date of the loan principal monthly installments was extended from May 1, 2025 to February 1, 2026, which will require reclassification of $5.9 million from current portion of long-term debt to long-term debt as of April 28, 2025.

Sale of Priority Review Voucher

On May 9, 2025 the Company entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher (“PRV”) for gross proceeds of $155 million upon the closing of the transaction. The Company was awarded the PRV following the FDA approval of ZEVASKYN™ (prademagene zamikeracel) on April 28, 2025. The transaction is subject to customary closing conditions, including expiration of the applicable waiting period under the Hart-Scott Rodino (“HSR”) Antitrust Improvements Act.