Capricor Therapeutics reports Q4 EPS (2c), consensus (9c)

Reports Q4 revenue $12.1M compared with approximately $1.0M for the fourth quarter of 2022, consensus $10.6M…”2023 was a pivotal year for Capricor marked by major advances in our CAP-1002 cell therapy program for the treatment of Duchenne muscular dystrophy DMD ,” said Linda Marban, Ph.D., Capricor’s chief executive officer. “Over the course of the year, we completed enrollment in Cohort A of our Phase 3, HOPE-3 pivotal trial, reported the positive outcome of our interim futility analysis, aligned with the U.S. Food and Drug Administration FDA on key deliverables necessary for the filing of a Biologics License Application BLA , completed construction on our new San Diego manufacturing facility and began clinical dosing of Cohort B of the HOPE-3 trial from our San Diego facility. Each of these achievements are major milestones on our path towards potential approval of CAP-1002 for the treatment of DMD. While there are limited treatment options currently available for patients with DMD, we believe in the potential of CAP-1002’s ability to significantly slow down disease progression. Observed robust and consistent efficacy combined with a favorable safety/tolerability profile, positions CAP-1002 as a potential anchor therapy for patients. In 2024, we plan to meet with FDA to continue to discuss options for potential expedited approval pathways and Capricor is well-positioned to execute on several important milestones including reporting top-line data from our pivotal trial in the fourth quarter of 2024.”