secwatch.observer — SEC 8-K summary
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Issuer:     CAPRICOR THERAPEUTICS, INC. (CAPR)
CIK:        0001133869
Form:       8-K
Filed at:   2025-05-13T23:59:59+00:00
Accession:  0001558370-25-007574
Event type: earnings
Sentiment:  negative
Materiality: 0.65
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Capricor Q1 net loss $24.4M; deramiocel BLA PDUFA Aug 31, 2025
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- Net loss of $24.4M ($0.53/sh) vs $9.8M loss ($0.31/sh) in Q1 2024; revenue $0 vs $4.9M.
- Cash and equivalents $144.8M as of Mar 31, 2025; expected to fund operations into 2027.
- FDA accepted BLA for deramiocel in DMD-cardiomyopathy with priority review; PDUFA date Aug 31, 2025.
- Mid-cycle review with FDA completed; no significant deficiencies identified; advisory committee planned.
- Appointed Dr. Michael Binks as CMO; NIAID plans to initiate StealthX vaccine Phase 1 trial in Q3 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1133869/000155837025007574/0001558370-25-007574-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1133869/000155837025007574/capr-20250513x8k.htm
  HTML page:      https://secwatch.observer/filing/0001558370-25-007574

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer