Capricor Therapeutics(CAPR) - 2023 Q4 - Annual Results

Financial Performance - Capricor reported total revenue of approximately $12.1 million for Q4 2023, a significant increase from approximately$1.0 million in Q4 2022, representing a growth of over 1,100%[10] - The company’s total operating expenses for Q4 2023 were approximately $13.2 million, compared to approximately$9.0 million in Q4 2022, reflecting a year-over-year increase of about 46%[14] - Capricor's net loss for Q4 2023 was approximately $0.8 million, or$0.02 per share, a substantial improvement from a net loss of approximately $7.7 million, or$0.31 per share, in Q4 2022[15] - For the full year 2023, Capricor reported a net loss of approximately $22.3 million, or$0.83 per share, compared to a net loss of approximately $29.0 million, or$1.18 per share, for the full year 2022[15] Cash and Milestone Payments - The company’s cash, cash equivalents, and marketable securities totaled approximately $39.5 million as of December 31, 2023, down from approximately$41.4 million on December 31, 2022[13] - Capricor received its first milestone payment of $10.0 million under its U.S. Distribution and Commercialization Agreement with Nippon Shinyaku in January 2024[13] - Positive outcome from interim futility analysis triggered a$10 million milestone payment under the U.S. Distribution and Commercialization Agreement with Nippon Shinyaku[32] - Potential for $90 million in additional milestone payments prior to approval and$605 million post-approval based on sales targets[32] Clinical Trials and FDA Meetings - The company plans to have a Type-B meeting with the FDA in Q1 2024 to discuss commercial manufacturing planning for CAP-1002[1] - Capricor plans to report topline data from the HOPE-3 (Cohort A) study in Q4 2024[1] - Enrollment completed in Cohort A of Phase 3 HOPE-3 trial with 61 subjects randomized in a 1:1 ratio[32] - Cohort B enrollment underway, aiming for approximately 44 subjects, expected to complete by Q2 2024[32] - FDA Type-B meeting in Q1 2024 to discuss expedited BLA pathway for CAP-1002[26] Partnerships and Collaborations - The company is exploring additional partnerships outside of the U.S. and Japan to support the commercialization of CAP-1002 for DMD[1] - Collaboration with NIAID for a Phase 1 clinical trial of an exosome-based multivalent vaccine for SARS-CoV-2[26] Product Development - Capricor's proprietary StealthX™ exosome-based vaccine for SARS-CoV-2 is part of Project NextGen, with a Phase 1 clinical trial to be conducted by NIAID[23] - New San Diego manufacturing facility established to scale up CAP-1002 production for commercial use[32] - Capricor's proprietary StealthX™ platform technology is being developed for targeted delivery of therapeutics[33] Trial Outcomes - Positive data from HOPE-2 OLE trial showing a delta change of 4.9 points (p=0.021) after 24 months of treatment[32] - Anticipated top-line data from Cohort A to be reported in Q4 2024[32]