CAPR · Capricor Therapeutics, Inc.
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AI Brief
Q2 FY26 earnings call · Aug 13, 2026TL;DR. Capricor reported Q2 with an adverse FDA Advisory Committee vote (3-9) against its cardiomyopathy indication, but plans a BLA amendment focused on the HOPE-3 upper limb primary endpoint; net loss widened to $40.7M on $42.9M of operating expenses, with $237.9M in cash.
- + Company plans a BLA amendment targeting the HOPE-3 upper limb primary endpoint, with FDA willing to review and extend the PDUFA date
- + HOPE-3 primary endpoint remained statistically significant (PUL 2.0 mean difference 4.55% favoring deramiocel, p=0.029)
- + Full HOPE-3 Phase 3 dataset published in The Lancet following extensive peer review
- + Cash position of approximately $237.9M expected to fund operations for at least the next twelve months
- + In-house San Diego GMP manufacturing facility is operational and positioned to support initial commercial launch if approved
- − FDA Advisory Committee voted 3-9 against deramiocel on the cardiomyopathy effectiveness question
- − Net loss widened to approximately $40.7M ($0.70/share) from approximately $25.9M ($0.57/share) year-over-year
- − Total operating expenses rose to approximately $42.9M from approximately $27.7M year-over-year
- − No revenue recognized for Q2 2026 or 2025, and pipeline programs beyond deramiocel are on hold pending regulatory clarity
- − FDA BIMO inspection resulted in a Form 483 with one observation, with feedback still pending
- − Statistical model revision weakened the LVEF key secondary endpoint to p=0.09 (1.8pp) from the prior reported p=0.04 (2.4pp)
AI-generated from the earnings call and 8-K · may contain errors · not investment advice
Equibles Rating
blended score · not investment adviceBlended from price, momentum, positioning, fundamentals & volatility · daily-close · not investment advice. Market backdrop is context, not part of the score.
Technicals
trend & momentum for long-term holders SellIllustrative technical + ownership context — a signal mix, not investment advice.
Key metrics
Earlier KPI extraction records exist, but do not meet the current evidence-completeness requirements. No current verified series is available. Earlier figures remain withheld until revalidated; this is not evidence that the company reports no KPIs.
Versus peers
Biotechnology — same industry group| Company | Mkt cap | YTD | Rev growth Y/Y | P/E | Short % shares |
|---|---|---|---|---|---|
|
CAPR
this stock
Capricor Therapeutics, Inc.
|
$498.25M | -71.9% | -100.0% | — | 33.9% |
|
VRTX
Vertex Pharmaceuticals Inc / Ma
|
$128.16B | +11.5% | +46.2% | 29.5 | 1.9% |
|
MRNA
Moderna, Inc.
|
$78.44B | +566.3% | +4.3% | — | 8.2% |
|
REGN
Regeneron Pharmaceuticals, Inc.
|
$76.40B | -3.9% | +20.8% | 18.4 | 2.5% |
|
CSLLY
Csl Ltd
|
$61.25B | — | — | — | 0.0% |
Peers by industry group · P/E from as-reported trailing EPS · short % is of shares outstanding
At a glance
key data from every sectionPerformance
| 5D | 20D | 120D | MTD | YTD | |
|---|---|---|---|---|---|
| CAPR | -14.5% | -6.3% | -76.9% | -14.5% | -71.9% |
| SPY | +1.9% | +1.9% | +10.8% | +1.9% | +14.0% |
| vs SPY | -16.4% | -8.2% | -87.7% | -16.4% | -85.9% |