---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-095908"
form_type: "8-K"
ticker: "CAPR"
cik: "0001133869"
company_name: "CAPRICOR THERAPEUTICS, INC."
filed_at: "2026-08-13T20:07:30+00:00"
generated_at: "2026-08-13T20:10:34.225392+00:00"
event_type: "earnings"
sentiment: "negative"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Capricor Q2 net loss $40.7M; FDA panel votes 9-3 against Deramiocel cardiomyopathy

## Summary
- Net loss $40.7M ($0.70/share) vs $25.9M loss in Q2 2025; no revenue; cash $237.9M at June 30.
- FDA advisory committee voted 9-3 against substantial evidence for cardiomyopathy; vote non-binding, BLA still under review.
- HOPE-3 Phase 3 published in Lancet; primary endpoint upper limb function met (p=0.029); LVEF model revised to p=0.09.
- FDA BIMO inspection issued Form 483 with one observation; responses submitted; awaiting feedback.
- Withdrew preliminary injunction vs NS Pharma; arbitration expected this fall; seeks rescission of distribution agreement.

## SEC filing metadata
- accession: 0001104659-26-095908
- form_type: 8-K
- ticker: CAPR
- cik: 0001133869
- company_name: CAPRICOR THERAPEUTICS, INC.
- filed_at: 2026-08-13T20:07:30+00:00
- event_type: earnings
- sentiment: negative
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1133869/000110465926095908/0001104659-26-095908-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1133869/000110465926095908/capr-20260813x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-095908
- JSON: https://secwatch.observer/filing/0001104659-26-095908.json
- Plain text: https://secwatch.observer/filing/0001104659-26-095908.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.