Capricor Therapeutics, Inc.

Item 8.01. Other Events. Phase 3 Peer-Review Publication; Update to Statistical Model for LVEF On July 29, 2026, Capricor Therapeutics, Inc. ("Capricor" or the "Company") issued a press release announcing the publication in The Lancet of the final one-year results from its HOPE-3, Phase 3 clinical trial evaluating Deramiocel, its investigational cell therapy for the treatment of Duchenne muscular dystrophy ("DMD"). The manuscript underwent independent peer review, providing external validation of the trial's statistical methodology and findings. The results, which have now been published, are based on the Company’s prespecified Statistical Analysis Plan version 3.0 ("SAP 3.0"). As part of its ongoing dialogue with the FDA regarding the HOPE-3 data, and in connection with the peer review process with The Lancet, the Company identified an update to the statistical model used in its analysis of left ventricular ejection fraction ("LVEF"), the key secondary endpoint of the study. Under the revised model, LVEF yields a p=0.09 (1.8 percentage point treatment difference), compared to p=0.04 previously reported (2.4 percentage point treatment difference). In the pre-specified cardiomyopathy subgroup, the result is nominally significant at p=0.02 (2.8 percentage point treatment difference). The other additional type-1 error-controlled endpoints will be characterized as nominally significant under applicable hierarchical testing procedures. The primary efficacy endpoint result and all other trial data remain unchanged. A copy of the press release has been filed as Exhibit 99.1 hereto and is incorporated herein by reference. Bioresearch Monitoring (BIMO) Inspection On July 4, 2026, the Company was notified by the FDA of a Bioresearch Monitoring (BIMO) inspection of the Company’s clinical operations related to its Biologics License Application for Deramiocel for the treatment of DMD. The inspection commenced on July 6, 2026 and concluded on July 20, 2026. At the conclusion of the inspection, the FDA issued a Form FDA 483, Notice of Inspectional Observations, citing one observation relating primarily to the Company's standard operating procedures, documentation practices, vendor oversight, and audit report timeliness in connection with the conduct of the HOPE-3 clinical trial. The Company does not believe the observation affects the integrity or reliability of the HOPE-3 data. The Company is preparing its formal response and intends to respond completely in a timely manner.