Capricor Therapeutics(US:CAPR)2025-11-10 21:01Financial Performance - Revenues for Q3 2025 were $0, a decrease from approximately $2.3 million in Q3 2024; revenues for the first nine months of 2025 were also $0, down from approximately $11.1 million in the same period of 2024[10]. - Total operating expenses for Q3 2025 were approximately $26.3 million, compared to approximately $15.3 million for Q3 2024; total operating expenses for the first nine months of 2025 were approximately $79.0 million, up from approximately $46.0 million in the same period of 2024[11]. - The net loss for Q3 2025 was approximately $24.6 million, or $0.54 per share, compared to a net loss of approximately $12.6 million, or $0.38 per share, for Q3 2024[12]. - Total revenue for Q3 2025 was $0, compared to $2,261,642 in Q3 2024, representing a decrease of 100% year-over-year[26]. - The net loss for Q3 2025 was $24,570,647, compared to a net loss of $12,556,728 in Q3 2024, indicating a 96% increase in losses[26]. - The net loss per share for Q3 2025 was $0.54, compared to $0.38 in Q3 2024, reflecting a 42% increase in loss per share[26]. - Comprehensive loss for Q3 2025 was $25,114,099, compared to $12,615,494 in Q3 2024, indicating a 99% increase in comprehensive losses[26]. Cash and Assets - Cash, cash equivalents, and marketable securities totaled approximately $98.6 million as of September 30, 2025, down from approximately $151.5 million as of December 31, 2024[9]. - Cash, cash equivalents, and marketable securities decreased to $98,565,971 as of September 30, 2025, down from $151,515,877 at the end of 2024, a decline of 35%[28]. - Total assets decreased to $126,438,207 as of September 30, 2025, from $170,481,086 at the end of 2024, a reduction of 26%[28]. - Total liabilities increased to $42,570,952 as of September 30, 2025, compared to $25,018,750 at the end of 2024, an increase of 70%[28]. Research and Development - A Phase 1 clinical trial for the StealthX™ exosome-based vaccine is ongoing, with initial topline data expected in Q1 2026[5]. - Topline results from the pivotal HOPE-3 Phase 3 study (n=105) of Deramiocel for Duchenne muscular dystrophy are expected in Q4 2025[5]. - Research and development expenses increased to $20,359,098 in Q3 2025, up from $11,807,867 in Q3 2024, reflecting a 72% increase[26]. Regulatory and Operational Updates - Capricor plans to resubmit its Biologics License Application (BLA) pending the results of the HOPE-3 study, with a review period anticipated to be up to six months[6]. - The company has completed its FDA Pre-License Inspection for its GMP facility, which is now operational and ready for initial commercial launch upon approval[6]. - Deramiocel has received Orphan Drug Designation from both the U.S. FDA and the European Medicines Agency for the treatment of Duchenne muscular dystrophy[18]. Shareholder Information - The weighted average number of shares outstanding increased to 45,716,151 in Q3 2025 from 33,090,063 in Q3 2024[26]. - Capricor's available cash is expected to cover anticipated expenses into Q4 2026, excluding any additional potential milestone payments[13].