On June 3, 2026, Abeona Therapeutics Inc. (the "Company") reported to have participated in a pre-Investigational New Drug application ("Pre-IND") meeting with the U.S. Food and Drug Administration ("FDA") regarding ABO-701, a recently licensed radically novel engineered T-cell therapy, targeting Prostate-Specific Membrane Antigen to treat prostate cancer. While official minutes of the meeting have not yet been received, we believe the meeting was constructive and continues to target submission of an IND application for ABO-701 in 2027, consistent with our previously stated timeline.

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We can provide no assurance that the FDA will not require additional studies, data, or information before accepting an IND submission for ABO-701, or that any IND submission, if submitted, will be accepted by the FDA or result in authorization to commence clinical trials. Our development plans remain subject to ongoing evaluation and may be revised based on, among other things, feedback received from the FDA, results of preclinical studies, manufacturing considerations, and other factors.

(Press release, Abeona Therapeutics, JUN 3, 2026, View Source [SID1234666436])