Capricor Therapeutics (NASDAQ: CAPR) reported Q2 2025 financial results and provided key updates on its lead candidate Deramiocel. The company has scheduled a Type A meeting with the FDA to discuss the Deramiocel BLA resubmission path, following a Complete Response Letter. All 483 observations from the Pre-License Inspection have been resolved.
Financial highlights include a cash position of $122.8 million, expected to fund operations into Q4 2026. Q2 2025 resulted in a net loss of $25.9 million ($0.57 per share), compared to $11.0 million in Q2 2024. Operating expenses increased to $27.7 million from $15.6 million year-over-year.
The company's HOPE-3 Phase 3 trial completed its 12-month treatment period with topline data expected in Q4 2025. Additionally, the FDA cleared the IND for StealthX™ exosome-based vaccine, with NIAID initiating the Phase 1 clinical trial.
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