Capricor Therapeutics(CAPR) - 2025 Q1 - Quarterly Results

Financial Performance - Revenues for Q1 2025 were $0, a decrease from $4.9 million in Q1 2024, primarily due to the recognition of previous milestone payments[10] - Total operating expenses for Q1 2025 were approximately $25 million, compared to $15.2 million in Q1 2024, reflecting an increase in R&D and administrative costs[11] - The net loss for Q1 2025 was approximately $24.4 million, or $0.53 per share, compared to a net loss of $9.8 million, or $0.31 per share, in Q1 2024[11] - Cash, cash equivalents, and marketable securities decreased to $144.78 million from $151.52 million, a decline of approximately 4.8%[27] - Total assets decreased to $153.77 million from $170.48 million, representing a decrease of about 9.8%[27] - Total liabilities increased to $26.12 million from $25.02 million, an increase of approximately 4.4%[27] - Total stockholders' equity remained relatively stable at $45.68 million compared to $45.58 million, showing a slight increase of about 0.2%[27] - The number of common shares issued and outstanding decreased to 127.65 million from 145.46 million, a reduction of approximately 12.2%[27] Regulatory and Clinical Developments - The FDA has set a PDUFA target action date for the BLA of deramiocel for Duchenne muscular dystrophy on August 31, 2025[5] - Capricor's StealthX™ vaccine program is on track for a Phase 1 clinical trial initiation in Q3 2025, pending regulatory clearance from NIAID[3] - The company completed a mid-cycle review meeting with the FDA with no significant deficiencies identified, and a late cycle meeting is scheduled for June 2025[5] - Capricor's BLA for deramiocel is supported by data from the Phase 2 HOPE-2 trial, demonstrating significant improvements in cardiac function[6] Management and Operational Updates - Capricor ended Q1 2025 with a cash position of approximately $145 million, expected to support operations into 2027[3] - Capricor appointed Dr. Michael Binks as Chief Medical Officer, bringing over 25 years of experience in clinical development[8] - The company has expanded its internal manufacturing capacity to support increased commercial manufacturing[6]