Capricor Therapeutics(CAPR) - 2024 Q3 - Quarterly Results

Deramiocel Development and Commercialization - Capricor initiated a rolling BLA submission for deramiocel in October 2024, with full submission expected by year-end 2024, targeting a potential PDUFA date in the second half of 2025[1][4] - Capricor signed a binding term sheet with Nippon Shinyaku for European expansion and commercialization of deramiocel, with potential milestones totaling approximately $1.5 billion[1][5] - Capricor plans to provide clinical data on skeletal muscle myopathy from the Phase 3 HOPE-3 trial to support potential label expansion for deramiocel[4] Financial Performance and Position - Capricor reported Q3 2024 revenues of approximately $2.3 million, down from $6.2 million in Q3 2023, primarily from ratable recognition of $40 million upfront and milestone payments from Nippon Shinyaku[9] - Revenue for Q3 2024 was $2.26 million, a decrease from $6.19 million in Q3 2023[18] - Total revenue for the nine months ended September 30, 2024, was $11.14 million, down from $13.09 million in the same period in 2023[18] - Capricor's Q3 2024 net loss was approximately $12.6 million, or $0.38 per share, compared to a net loss of $6.4 million, or $0.25 per share, in Q3 2023[11] - Net loss for Q3 2024 was $12.56 million, compared to $6.39 million in Q3 2023[18] - Comprehensive loss for Q3 2024 was $12.62 million, compared to $6.46 million in Q3 2023[18] - Capricor's cash position as of September 30, 2024, was approximately $85.0 million, up from $39.5 million at the end of 2023, supported by recent equity offerings[8] - Cash, cash equivalents, and marketable securities increased to $85.03 million as of September 30, 2024, from $39.49 million as of December 31, 2023[18] - Total assets grew to $92.95 million as of September 30, 2024, from $58.73 million as of December 31, 2023[18] - Total liabilities decreased to $24.69 million as of September 30, 2024, from $36.13 million as of December 31, 2023[18] - Total stockholders' equity increased to $68.26 million as of September 30, 2024, from $22.60 million as of December 31, 2023[18] Clinical Trial Results and Data - Capricor presented positive 3-year safety and efficacy results from the HOPE-2 OLE trial, showing improvements in cardiac function and a statistically significant benefit in PUL v2.0 total score[5] StealthX™ Exosome Platform and Project NextGen - Capricor's StealthX™ exosome platform was selected for Project NextGen, with manufacturing underway and delivery to NIAID planned for Q1 2025, with preliminary data expected in Q2 2025[7] Capital Raising and Cash Runway - Capricor completed a public offering of common stock, raising gross proceeds of approximately $86 million, extending its cash runway into 2027[1][8] Manufacturing and Production Expansion - Capricor is exploring GMP production expansion to meet potential product demand in the U.S. and other regions[4]