ABEONA THERAPEUTICS INC

Previous wording

In addition, on April 16, 2024 we received a Complete Response Letter (a “CRL”) related to our Biologics License Application (BLA) for pz-cel for the treatment of patients with recessive dystrophic epidermolysis bullosa (RDEB). In the CRL, the FDA noted that certain additional information needed to satisfy Chemistry Manufacturing and Controls (“CMC”) requirements must be satisfactorily resolved before the application can be approved. In response, the Company submitted plans to the FDA with the commitment to provide CMC data prior to BLA approval, and full validation reports after approval in mid-2024. There can be no assurance that we will be able to satisfy the requirements of the CRL or the timeline on which we will be able to do so. A delay in receiving approval of the BLA could shorten any periods during which we may have the exclusive right to commercialize our pz-cel or allow our competitors to bring products to market before we do. This may impair our ability to successfully commercialize pz-cel. If any of the foregoing were to occur, our business, financial condition, results of operations, and prospects will be materially harmed.

Current wording

On April 16, 2024 we received a Complete Response Letter (a “CRL”) related to our Biologics License Application (“BLA”) for pz-cel for the treatment of patients with recessive dystrophic epidermolysis bullosa (“RDEB”). In the CRL, the FDA noted that certain additional information needed to satisfy Chemistry Manufacturing and Controls (“CMC”) requirements must be satisfactorily resolved before the application can be approved. On August 8, 2024 we completed a Type A Meeting with the FDA to discuss our forthcoming resubmission of our BLA. We expect to receive the FDA’s meeting minutes within the next few weeks and are on track to resubmit our BLA in the second half of 2024. Upon acceptance of the BLA, we expect the FDA to set a PDUFA date of six months from the date of submission. There can be no assurance that we will be able to satisfy the requirements of the CRL or the timeline on which we will be able to do so. A delay in receiving approval of the BLA could shorten any periods during which we may have the exclusive right to commercialize our pz-cel or allow our competitors to bring products to market before we do. This may impair our ability to successfully commercialize pz-cel. If any of the foregoing were to occur, our business, financial condition, results of operations, and prospects will be materially harmed.