Capricor Therapeutics, Inc.
- Open
- 10.07
- Day high
- 10.65
- Day low
- 9.60
- Prev close
- 10.01
- Volume
- 5.1M
- Mkt cap
- $575M
- P/E (TTM)
- —
- EPS (TTM)
- —
- P/B
- 2.3
- P/S
- —
- Yield
- —
- Per share
- —
- ▼Insiders net selling -$1.5M over the last 3 months (0 open-market buys, 4 sales)
- 🏛Institutions reducing (13F)
Capricor Therapeutics, Inc. (CAPR) is a Healthcare company listed on NASDAQ. The stock is up 61% over the past year. Over the trailing 3 months, insiders filed 0 open-market buys and 4 sales (SEC Form 4).
Capricor Therapeutics, Inc. (CAPR) financials & analyst ratings
Fundamentals (TTM)
Analyst consensus · 5 analysts
Source: exchange market data + company filings. Figures are trailing-twelve-month or as most recently reported. For informational purposes only — not investment advice.
CAPR earnings date, history & EPS estimates
| Report date | EPS est | EPS actual | Surprise | Revenue | Rev. surprise |
|---|---|---|---|---|---|
| Aug 13, 2026 | $-0.59 | $-0.70 | -18.9% | — | — |
| May 12, 2026 | $-0.55 | $-0.59 | -7.3% | — | — |
| Mar 12, 2026 | $-0.51 | $-0.62 | -21.8% | — | — |
| Mar 19, 2025 | $-0.31 | $-0.16 | +48.4% | $11M | +102.4% |
| Feb 29, 2024 | $-0.09 | $-0.02 | +77.8% | $12M | +14.0% |
| Nov 14, 2023 | $-0.29 | $-0.25 | +13.8% | $6M | -43.2% |
| May 11, 2023 | $-0.32 | $-0.31 | +3.1% | $3M | +497.3% |
| Mar 15, 2023 | $-0.33 | $-0.31 | +6.1% | — | — |
| Nov 10, 2022 | $-0.29 | $-0.26 | +10.3% | $2M | +278.9% |
| Aug 10, 2022 | $-0.25 | $-0.29 | -16.0% | — | — |
| Mar 10, 2022 | $-0.19 | $-0.26 | -36.8% | $-244653 | — |
| Aug 12, 2021 | $-0.23 | $-0.21 | +8.7% | $204082 | -8.0% |
CAPR insider trading activity (SEC Form 4)
| Date | Insider | Type | Shares | Price |
|---|---|---|---|---|
| Jun 29, 2026 | Bergmann Anthonyofficer: CHIEF FINANCIAL OFFICER | Sell | 24,100 | $30.38 |
| Jun 29, 2026 | Krasney Karenofficer: EVP, GENERAL COUNSEL | Sell | 24,100 | $30.38 |
| Jun 29, 2026 | Bergmann Anthonyofficer: CHIEF FINANCIAL OFFICER | Option | 24,100 | $3.18 |
| Jun 29, 2026 | Krasney Karenofficer: EVP, GENERAL COUNSEL | Option | 24,100 | $3.18 |
| Jun 24, 2026 | Bergmann Anthonyofficer: CHIEF FINANCIAL OFFICER | Option | 400 | $3.18 |
| Jun 24, 2026 | Bergmann Anthonyofficer: CHIEF FINANCIAL OFFICER | Sell | 400 | $30.00 |
| Jun 24, 2026 | Bergmann Anthonyofficer: CHIEF FINANCIAL OFFICER | Option | 500 | $3.18 |
| Jun 24, 2026 | Krasney Karenofficer: EVP, GENERAL COUNSEL | Option | 500 | $3.18 |
| Jun 24, 2026 | Krasney Karenofficer: EVP, GENERAL COUNSEL | Option | 400 | $3.18 |
| Jun 24, 2026 | Krasney Karenofficer: EVP, GENERAL COUNSEL | Sell | 400 | $30.00 |
| May 28, 2026 | Maurer Michael Tofficer: CHIEF COMMERCIAL OFFICER | Grant | 80,000 | $29.36 |
| May 19, 2026 | Bergmann Anthonyofficer: CHIEF FINANCIAL OFFICER | Option | 3,000 | $1.39 |
| May 14, 2026 | Litvack Frankdirector | Option | 3,937 | $1.39 |
| May 4, 2026 | Krasney Karenofficer: EVP, GENERAL COUNSEL | Option | 25,000 | $3.18 |
| May 4, 2026 | Krasney Karenofficer: EVP, GENERAL COUNSEL | Sell | 25,000 | $31.70 |
Source: CAPR SEC Form 4 filings, latest Jun 29, 2026. For informational purposes only — not investment advice.
See the full CAPR insider & 13F page →Capricor Therapeutics, Inc. company profile
Overview
Capricor Therapeutics, Inc. (NASDAQ:CAPR) is a clinical-stage biotechnology company founded in 2005 and headquartered in San Diego, California. The company went public in 2007 and focuses on developing transformative cell and exosome-based therapeutics for treating various diseases and disorders. Capricor is primarily known for its lead candidate deramiocel (formerly CAP-1002), an allogeneic cardiac-derived cell therapy that has completed Phase III clinical trials for treating late-stage Duchenne muscular dystrophy (DMD). The company has submitted a Biologics License Application (BLA) to the FDA for deramiocel, with a priority review PDUFA date of August 31, 2025.
Business
Capricor operates in the biotechnology sector, specifically developing advanced cellular and exosome-based therapeutics. The company's primary focus areas include rare disease treatments and vaccine development. Deramiocel (CAP-1002) represents the company's flagship product - an allogeneic cardiac-derived cell therapy designed to treat cardiomyopathy associated with Duchenne muscular dystrophy. DMD is a rare genetic disorder affecting approximately 15,000-20,000 boys and young men in the United States, characterized by progressive muscle degeneration. The cardiac complications of DMD are particularly severe, as patients often develop dilated cardiomyopathy that can lead to heart failure and death. Deramiocel works by delivering cardiac-derived cells that may help preserve heart function and slow disease progression. The therapy targets approximately 50-60% of the DMD population, roughly 7,500-8,000 patients who develop cardiac complications. Exosome Platform Technology (StealthX) represents the company's second major area of development. Exosomes are naturally occurring nanovesicles that cells use to communicate with each other. Capricor's StealthX platform aims to engineer these exosomes to deliver therapeutic payloads precisely to target tissues. The company is developing this technology for both vaccine applications and therapeutic delivery systems. Under the U.S. government's Project NextGen program, Capricor is developing a COVID-19 vaccine candidate using this exosome platform. Revenue is primarily generated through partnership agreements and milestone payments, with the most significant being the distribution partnership with Nippon Shinyaku covering U.S. and Japanese markets. This partnership has provided upfront payments and offers potential milestone payments exceeding $1.5 billion upon achieving various regulatory and commercial milestones.
Revenue model
Capricor operates a partnership-driven business model typical of clinical-stage biotechnology companies. The company generates revenue through strategic partnerships, milestone payments, and licensing agreements rather than direct product sales, as its lead therapy is still awaiting FDA approval. The primary revenue source comes from the partnership with Nippon Shinyaku, a Japanese pharmaceutical company that has exclusive distribution rights for deramiocel in the United States and Japan. This partnership has already provided significant upfront payments, including a $40 million distribution agreement that is being recognized ratably over time. Upon FDA approval of deramiocel, Capricor expects to receive an $80 million milestone payment, followed by additional milestone payments based on commercial milestones that could total over $1.5 billion. The company's revenue model faces several key factors that could impact profitability. Regulatory approval risk represents the most significant factor - FDA approval of deramiocel would unlock substantial milestone payments and ongoing royalties from Nippon Shinyaku's commercialization efforts. Market penetration rates will directly affect revenue, as the therapy targets a specific subset of DMD patients with cardiac complications. Pricing and reimbursement dynamics will be crucial, though initial payer feedback has been positive given the lack of existing therapies specifically targeting DMD cardiomyopathy. Manufacturing scale represents both a cost factor and revenue enabler. The company's San Diego facility currently supports 250-500 patients annually, with expansion planned to serve 2,000-3,000 patients by mid-2026. Manufacturing costs per patient will likely decrease with scale, improving margins. Competition from other DMD therapies could impact market share, though deramiocel's unique focus on cardiac complications provides differentiation from existing skeletal muscle-focused treatments. The exosome platform offers additional revenue diversification through potential partnerships and licensing deals, though this remains in earlier development stages compared to the DMD program.
Competitive moat
Capricor's competitive moat is moderately strong but faces several limitations typical of biotechnology companies. The company's primary moat stems from regulatory exclusivity and specialized manufacturing capabilities rather than traditional competitive advantages. Regulatory barriers provide the strongest protection. If approved, deramiocel would be the first and only FDA-approved therapy specifically targeting DMD cardiomyopathy, providing significant first-mover advantage and regulatory exclusivity. The complex nature of cell therapy manufacturing creates additional barriers to entry, as competitors would need to develop their own manufacturing processes, conduct extensive clinical trials, and navigate regulatory approval processes that typically take 5-10 years. Manufacturing expertise represents another defensive element. Capricor has developed specialized capabilities in cardiac-derived cell therapy production, including a dedicated GMP facility in San Diego. The company's manufacturing processes and quality systems have been developed over years of clinical trials and regulatory interactions, creating institutional knowledge that would be difficult for competitors to replicate quickly. However, the moat has notable weaknesses. Patent protection appears limited based on available information, and the underlying science of cell therapy is not proprietary to Capricor. Large pharmaceutical companies with greater resources could potentially develop competing therapies, particularly as the DMD market attracts increasing attention from major players like Sarepta Therapeutics and PTC Therapeutics. Platform risk also exists - while deramiocel targets cardiac complications, other companies are developing gene therapies and other approaches that might address DMD more comprehensively. The company's exosome platform provides some diversification but remains in early development stages. The partnership with Nippon Shinyaku provides commercial strength but also creates dependency risk, as Capricor relies heavily on its partner's commercial execution capabilities and market access.
Risks & safety
Capricor presents a moderate margin of safety profile typical of late-stage biotechnology companies approaching commercialization. **Overall Assessment**: Adequate near-term safety with regulatory execution risk **Cash and Liquidity Position**: - Cash and short-term investments: $28.8 million (Q1 2025) - Total current assets: $146.3 million vs. current liabilities: $22.3 million - Current ratio: 6.55x indicating strong liquidity position - Cash runway extends into 2027 based on current burn rate - Quarterly cash burn: approximately $7.6 million (Q1 2025) **Debt and Solvency**: - Minimal debt with debt-to-equity ratio: 0.01 - Strong balance sheet with total assets of $153.8 million vs. total liabilities of $26.1 million - No significant solvency concerns in near-term **Valuation Considerations**: - Trading at 3.4x price-to-book ratio - Negative earnings due to pre-revenue development stage - Enterprise value reflects regulatory approval risk and commercial potential - Potential $80 million milestone payment upon FDA approval provides significant value catalyst **Other Risk Factors**: - Binary regulatory risk with PDUFA date of August 31, 2025 - Revenue concentration risk through Nippon Shinyaku partnership - Limited diversification beyond DMD indication currently
Recent development
Over the past few years, Capricor has executed a focused strategy centered on advancing deramiocel toward FDA approval while building commercial infrastructure and expanding its technology platform. The most significant development has been the progression of deramiocel through regulatory approval. The company completed its Phase III HOPE-3 pivotal trial and submitted a BLA to the FDA, which was accepted for priority review with a PDUFA date of August 31, 2025. This represents the culmination of years of clinical development, including positive data from the HOPE-2 open-label extension study showing statistically significant benefits with 50% delay in disease progression and improvements in cardiac function measures. Manufacturing scale-up has been a major strategic focus. The company's San Diego GMP manufacturing facility became fully operational and has been expanded to support commercial production. Current capacity supports 250-500 patients annually, with planned expansion to serve 2,000-3,000 patients by mid-2026. This manufacturing infrastructure positions the company for commercial launch while maintaining control over production quality and costs. The Nippon Shinyaku partnership has been strategically expanded and strengthened. Beyond the initial U.S. distribution agreement, the partnership now includes potential milestone payments exceeding $1.5 billion and covers both U.S. and Japanese markets. Nippon Shinyaku has dedicated a 125-person team to prepare for potential commercial launch, leveraging their existing experience in the DMD market. Platform diversification through the StealthX exosome technology represents a significant strategic expansion. The company was selected for the U.S. government's Project NextGen COVID-19 vaccine program, with NIAID conducting a fully funded Phase 1 clinical trial starting in Q3 2025. This provides validation of the platform technology and government funding for development. The company has also strengthened its financial position through strategic fundraising, including an $86 million public offering in 2024 that extended the cash runway into 2027 and provided resources for commercial preparation and platform expansion.
CAPR company profile · for informational purposes only — not investment advice.
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