📈 Price History

Ratio Health

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📊 Sector Averages

About

Capricor Therapeutics, Inc., a clinical-stage biotechnology company, engages in the development of transformative cell and exosome-based therapeutics for treating duchenne muscular dystrophy (DMD) and other diseases with unmet medical needs in the United States.

Key Ratios Snapshot

📈 Growth Pattern

⚡ Latest Quarter —

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📊 Quick Scorecard

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⭐ Superinvestors Holding CAPR

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Manager	Shares	Value	% of Fund	Period
Steve Cohen Point72 Asset Management	821.2K	$25.0M	0.03%	Mar 2026

SEC Form 13F data. 45-day lag from quarter end.

🔍 Concall Decoded

🎙 Management Tone Tracker Confident Specific → Stable 4 quarters analysed

Q2 2025

Confident Specific

The CEO repeatedly uses phrases like 'we stand behind the strength of our submission', 'we believe we consistently met the agency's expectations', and 'we are proud of our data' despite acknowledging the CRL as unexpected and disappointing. They provide specific details on regulatory interactions, trial design, and financial position.

Q3 2025

Confident Specific

Management uses precise timelines ('weeks away', 'within the next several weeks') and detailed descriptions of statistical analysis plan, manufacturing facility status, and regulatory strategy. Linda Marbán repeatedly emphasizes readiness and data-driven path to approval.

Q4 2025

Confident Specific

Management consistently used strong positive language ('delighted', 'extraordinary', 'very strong', 'no way this would be conditional'), highlighted specific data points (HOPE-3 primary and secondary endpoints met, DVA improvement, fibrosis reduction) and regulatory milestones (BLA accepted, PDUFA set), and directly addressed analyst questions without evasion.

Q1 2026 latest

Confident Specific

Linda Marbán used phrases like 'defining moment', 'compelling data sets', and 'we look forward to labeling discussions', with specific data points and clear plans for commercial launch and litigation.

Guidance Reliability Pending · <3Q data

Investor Lens

The investment thesis is stronger after this call. Management provided clear data from HOPE-3 (statistical significance on primary and secondary endpoints), a concrete PDUFA date, and a credible plan to commercialize independently if the lawsuit succeeds. Key changes: Capricor is no longer reliant on a partner that was underprepared; they now control manufacturing and are actively building a commercial team. Risks remain: the lawsuit outcome is uncertain and could delay launch, and the FDA review always carries risk of a CRL. What to watch next quarter: court decisions on preliminary injunction, labeling discussions with FDA, and PDUFA outcome on August 22, 2026.

AI-generated concall tone analysis · Updated 2026-06-09 · Not investment advice

🎙 Management Tone Confident Specific → Stable 4 quarters Full tone analysis in Intelligence →

📊 MIXED Capricor pursues FDA approval for deramiocel in DMD with PDUFA Aug 22, 2026.

Revenue & Profitability

As of March 31, 2026, Capricor had approximately $279 million in cash equivalents and marketable securities. There was no revenue recognized in Q1 2026 or Q1 2025. Total operating expenses were $36.8 million in Q1 2026, compared to $25 million in Q1 2025. Net loss was $33.9 million ($0.59 per share) vs. $24.4 million ($0.53 per share) in the prior year period.

Outlook

Management emphasized the high unmet need in DMD and the irreversible muscle damage patients face monthly. They believe deramiocel's data supports a compelling case for approval and early treatment initiation. The DMD community is small, defined, and engaged. No broader macro tailwinds or headwinds were discussed.

Growth Drivers

Near-term growth is driven by potential FDA approval of deramiocel in DMD and subsequent commercial launch. Expansion into younger DMD patients, Becker muscular dystrophy (U.S. market ~5,000 patients), and other rare neuromuscular diseases are planned. Lifecycle management includes ex-U.S. approvals (EMA, PMDA) and possibly a priority review voucher (PRV) upon approval.

Balance Sheet & CapEx

Capricor is expanding its San Diego GMP facility to a second floor, targeting full validation and FDA approval in the first half of 2027. Current capacity supports 200–250 patients per year (1,000 doses), with expansion to 2,000–2,500 patients per year (10,000 doses). The company is stockpiling commercial doses once FDA provides labeling guidance. Cash runway is expected into Q4 2027.

Margins

Not discussed in this earnings call.

Key Risks

Key risks include: BLA approval uncertainty (PDUFA date Aug 22, 2026); ongoing litigation with NS Pharma regarding distribution agreement; potential pricing/reimbursement challenges; reliance on FDA labeling discussions; manufacturing scale-up risks; and slower-than-planned exosome pipeline progress. Analysts also flagged the uncertainty of the lawsuit outcome and commercial readiness timing.

Generated by AI · Q1 2026 results · Not investment advice

✓ 📞 Earnings Call Transcripts (5 quarters) submit a missing quarter

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📞 Earnings Call Transcripts (5)

Q1 2026 Q1 2026 2026-05-12

FDA review of deramiocel is progressing with a PDUFA date set for August 2026, while legal action seeks to enable independent commercialization due to a flawed distribution agreement. Financials show strong liquidity and increased investment in launch readiness, with manufacturing and commercial teams being rapidly scaled.

Q4 2025 Q4 2025 2026-03-12

BLA for Deramiocel accepted by FDA with PDUFA date set for August 2026, following strong HOPE-3 trial results showing efficacy in DMD. Cash position is robust at $318M, with manufacturing expansion and commercial launch preparations underway.

Q3 2025 Q3 2025 2025-11-10

Top-line HOPE-3 data for Deramiocel in Duchenne muscular dystrophy is imminent, with FDA review and potential approval targeted for 2026. Cash reserves of $98.6 million support operations into late 2026, and a strong safety profile and commercial readiness position the company for launch if approved.

Q2 2025 Q2 2025 2025-08-11

Q2 2025 saw no revenue and a higher net loss as the company awaits FDA feedback on deramiocel for DMD cardiomyopathy. Cash reserves remain strong, supporting operations into late 2026, while the exosomes platform advances with a Phase I COVID-19 vaccine trial.

Q1 2025 Q1 2025 2025-05-13

Strong progress continues toward deramiocel approval for DMD cardiomyopathy, with robust clinical data, ongoing FDA engagement, and commercial readiness. Cash reserves are solid, with potential for significant non-dilutive funding upon approval. Manufacturing and global expansion plans are advancing.

📊 Analysis Methodology

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