Capricor Therapeutics, Inc. (CAPR) Earnings Call Transcripts
Capricor Therapeutics, Inc.'s Latest Earnings Call - June 10, 2026
Capricor Therapeutics, Inc. reported its earnings for Q2 FY2026, highlighting significant regulatory progress and strategic initiatives. The company is focused on the approval of its cardiac-derived cell therapy for Duchenne muscular dystrophy, with a PDUFA date set for August 22, 2026. Revenue and earnings figures were not disclosed, but the company emphasized its strong cash position of $278 million. Management provided updates on their legal action against Ennis Pharma and their commercial launch preparations, including hiring a new Chief Commercial Officer. The guidance remains focused on the upcoming FDA approval and subsequent commercial launch, with no changes to financial guidance reported.
Reported metrics
| Metric | Value |
|---|---|
| Cash Balance | $278 million (inline) |
| PDUFA Date | August 22, 2026 (neutral) |
| HOPE-3 Primary Endpoint | Statistically significant (beat) |
| Manufacturing Capacity | 250 patients annually (positive) |
Guidance from management
Capricor is focused on securing FDA approval for deramiocel with a PDUFA date of August 22, 2026. The company is preparing for a commercial launch and expects to leverage its strong cash position and strategic partnerships.
What management said
No. So they kind of operate on separate arms. So the regulatory pathway, in fact, the FDA maintains a very strong dogma that they don't pay attention to anything that happens out in the marketplace. Their job is to decide if something is safe and efficacious for an indication and then help you decide who that should go to. And so they really don't have any interest in what's going on outside in terms of sales marketi...
Yes. Thanks. Well, obviously, we're thinking and engaging really hard on the payer front right now, speaking with multiple payers, developing our decks needed to get out there. But what we've guided to is that to be at or of the approved exon skipping therapies. I think those are slightly different that they're weight-based, but that's our aim in terms of the current price. This is a chronic therapy, so it will be ...
What analysts pressed on
Analysts expressed concerns about the impact of the legal action against Ennis Pharma on regulatory timing and commercial strategy. There were also questions about pricing strategies and market access in the competitive landscape.
Main topics on the call
- Regulatory Progress — Capricor is actively engaged with the FDA, with a PDUFA date set for August 22, 2026. They have submitted new data from the HOPE-3 trial, which met its primary and secondary endpoints. Management stated, 'We are very muc...
- Legal Action Against Ennis Pharma — Capricor filed a lawsuit against Ennis Pharma due to disagreements over the distribution model. The company plans to launch deramiocel independently. Management noted, 'We filed the litigation... and we look forward to a...
- HOPE-3 Trial Results — The HOPE-3 trial showed statistically significant improvements in upper limb function and cardiac function in Duchenne muscular dystrophy patients. Management highlighted, 'We hit our primary efficacy endpoint... with a ...
- Commercial Launch Preparations — Capricor is preparing for the commercial launch of deramiocel, hiring Mike Moore as Chief Commercial Officer. They are focusing on market access, patient services, and reimbursement strategies. Management stated, 'We exp...
Read the full Capricor Therapeutics, Inc. transcript (June 10, 2026) → Summary generated from the call transcript; every figure above is stated by management on the record.
About Capricor Therapeutics, Inc.
Capricor Therapeutics, Inc. (CAPR) is a publicly listed company in the Biotechnology industry, within the Health Care sector. It trades on NasdaqGS and is based in US. EarningsCalls.dev maintains a free, full-text archive of its earnings call transcripts — 41 calls on record spanning March 18, 2020 to June 10, 2026. Every transcript is split into speaker-by-speaker segments with headline metrics, free to read or available through our REST API.
Earnings Call History
EarningsCalls.dev has 41 Capricor Therapeutics, Inc. earnings call transcripts on record, spanning March 18, 2020 to June 10, 2026. Based on this history, Capricor Therapeutics, Inc. reports quarterly. The most recent call on file is dated June 10, 2026. The full list is below — each row opens the complete, free-to-read transcript.
- Ticker
- CAPR
- Exchange
- NasdaqGS
- Country
- US
- Sector
- Health Care
- Industry
- Biotechnology
- Calls on record
- 41
- First call
- March 18, 2020
- Most recent
- June 10, 2026
- Reporting cadence
- quarterly