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1. Company Snapshot

1.a. Company Description

Capricor Therapeutics, Inc., a clinical-stage biotechnology company, focuses on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of spectrum of diseases and disorders.Its lead candidate, CAP-1002, an allogeneic cardiac-derived cell therapy, which has completed phase III clinical trial for the treatment of patients with late-stage Duchenne muscular dystrophy (DMD); and CAP-1002, which is in Phase II clinical trial for the treatment of cytokine storm associated with SARS-CoV-2.The company also develops CAP-2003 that is in pre-clinical development for the treatment of trauma related injuries and conditions; and two vaccine candidates, which are in development stage for the potential prevention of COVID-19.


It collaborates with Lonza Houston, Inc.for the clinical manufacturing of CAP-1002, its cell therapy candidate for the treatment of DMD and other indications.The company was founded in 2005 and is headquartered in San Diego, California.

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1.b. Last Insights on CAPR

Capricor Therapeutics' recent performance has been negatively driven by a lack of significant news flow since the completion of the rolling submission of the BLA for its lead asset, deramiocel, to treat DMD cardiomyopathy in January 2025. While the company received FDA Priority Review for deramiocel on March 4, 2025, and a PDUFA target date of August 31, 2025, this news may not have been enough to drive significant investor interest. Additionally, the absence of recent earnings releases or significant sales or acquisition activity has likely contributed to the stock's lackluster performance.

1.c. Company Highlights

2. Capricor Therapeutics: Awaiting HOPE-3 Results

Capricor Therapeutics reported zero revenue for 2025, compared to $2.3 million in 2024, as the company continues to focus on the development of Daramycin, its investigational cell therapy for Duchenne muscular dystrophy. Research and development expenses increased to $18.1 million in Q3 2025, up from $11 million in Q3 2024, driven by the ongoing HOPE-3 Phase 3 clinical study. The net loss for 2025 was approximately $24.6 million, or -$0.54 per share, in line with analysts' estimates. The company's cash position stands at $98.6 million, expected to cover expenses into 2026.

Publication Date: Nov -23

📋 Highlights
  • HOPE-3 Top-Line Data Imminent: Capricor nears release of Phase 3 results for Daramycin in 105 non-ambulant Duchenne patients, with key endpoints on upper limb and cardiac function.
  • Commercial-Scale Cohort Validation: FDA required Cohort B to assess commercial product efficacy; baseline characteristics and power are consistent across cohorts.
  • Strong Safety Profile: Over 800 infusions administered to ~150 patients show no new safety signals, supporting regulatory submission.
  • Financial Runway Extended: $98.6M cash reserves project to fund operations through 2026, with potential $80M milestone payment from NS Pharma if approved pre-2026.
  • Regulatory Strategy Focused: Type 2 resubmission targets rapid review, leveraging cardiac MRI rigor and pre-specified analyses to address FDA’s CMC concerns.

Financial Performance and Expectations

Analysts expect significant revenue growth in the coming years, with estimates suggesting a 17,175.6% increase in revenue next year. While the current financial performance is largely driven by the company's investment in Daramycin, the potential approval and commercialization of the therapy could lead to a substantial increase in revenue. As Anthony Bergmann stated, the company is "maintaining and watching the burn in every area, building out the team in necessary areas, and investing in areas that will drive value."

Valuation Metrics

The current valuation metrics suggest that the market is pricing in significant expectations for Capricor Therapeutics. The Price-to-Sales Ratio stands at 19.63, indicating a high level of investor confidence in the company's future revenue growth. The Price-to-Book Ratio is 2.5, while the EV/EBITDA ratio is -3.42, reflecting the company's negative earnings. The ROE and ROIC are also negative, at -62.71% and -69.24%, respectively.

Regulatory Progress and Potential Label Expansion

The company is preparing to submit the HOPE-3 results as a formal complete response to the FDA, with the goal of receiving a rapid review and a new PDUFA date. If approved, Daramycin could receive a priority review voucher, which would strengthen the balance sheet and extend the runway. The company is also exploring potential label expansion to include skeletal muscle if the therapy demonstrates statistically significant benefits in this area. As Linda Marbán stated, "if we hit hard on cardiac, we would ask for regulatory flexibility."

Exosome Platform and Partnership Opportunities

Capricor Therapeutics is also developing its exosome platform, with the NIAID funding a study on the COVID vaccine program. The company is waiting for the data from this study and is looking forward to finding the right partner once the data is available. The exosome platform has the potential to provide significant value, with multivalent vaccines, including COVID, flu, and RSV, in planning stages.

3. NewsRoom

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Caprock Announces Proposed Private Placement

Dec -04

Source: feeds.newsfilecorp.com

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Capricor Therapeutics Announces Proposed Public Offering of Common Stock

Dec -04

Source: globenewswire.com

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Martin Shkreli touts QCLS stock as a long idea after a “bad call” on CAPR

Dec -04

Source: invezz.com

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Capricor Stock Soars, Shkreli Is Short: Here's What Pharma Bro Had To Say

Dec -03

Source: benzinga.com

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Biotech Stock Up Over 400% After Late-Stage Breakthrough

Dec -03

Source: schaeffersresearch.com

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Capricor Therapeutics Duchenne Treatment Shows Strong Heart And Muscle Results In Trial

Dec -03

Source: benzinga.com

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Capricor's muscle disorder cell therapy succeeds in late-stage study

Dec -03

Source: reuters.com

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Capricor Therapeutics Announces Positive Topline Results from Pivotal Phase 3 HOPE-3 Study of Deramiocel in Duchenne Muscular Dystrophy

Dec -03

Source: globenewswire.com

4. Business Breakdown

4.a. Revenues by Country

4.b. Revenues by Segment

5. Expected revenues mid-term growth (12.43%)

6. Segments

Transformative Cell and Exosome-based Therapeutics

Expected Growth: 12.43%

Capricor Therapeutics' transformative cell and exosome-based therapeutics drive 12.43% growth, fueled by increasing demand for novel treatments, advancements in gene editing technologies, and strategic partnerships. The company's lead candidate, CAP-1002, shows promising results in treating Duchenne muscular dystrophy, further boosting growth prospects.

7. Detailed Products

CAP-1002

CAP-1002 is a novel, orally available, small molecule inhibitor of the NLRP3 inflammasome, which is a multi-protein complex that plays a key role in the initiation of inflammation.

CAP-2003

CAP-2003 is a proprietary, orally available, small molecule inhibitor of the NLRP3 inflammasome, designed to treat a range of inflammatory diseases.

CAP-1001

CAP-1001 is a novel, orally available, small molecule inhibitor of the NLRP3 inflammasome, which is a multi-protein complex that plays a key role in the initiation of inflammation.

8. Capricor Therapeutics, Inc.'s Porter Forces

Forces Ranking

Threat Of Substitutes

The threat of substitutes for Capricor Therapeutics, Inc. is medium due to the presence of alternative treatments and therapies for the diseases they are targeting.

Bargaining Power Of Customers

The bargaining power of customers for Capricor Therapeutics, Inc. is low due to the lack of negotiating power of individual patients and the high demand for their products.

Bargaining Power Of Suppliers

The bargaining power of suppliers for Capricor Therapeutics, Inc. is medium due to the presence of multiple suppliers for raw materials and the company's dependence on them.

Threat Of New Entrants

The threat of new entrants for Capricor Therapeutics, Inc. is high due to the growing demand for biotechnology products and the relatively low barriers to entry in the industry.

Intensity Of Rivalry

The intensity of rivalry for Capricor Therapeutics, Inc. is high due to the presence of several established players in the biotechnology industry and the high competition for market share.

9. SWOT Analysis

Strength

Weaknesses

Opportunities

Threats

10. Capital Structure

10.a. Balance Sheet

10.b. Weighted Average Cost of capital

Value
Debt Weight 15.44%
Debt Cost 3.95%
Equity Weight 84.56%
Equity Cost 24.32%
WACC 21.18%
Leverage 18.25%

11. Quality Control: Capricor Therapeutics, Inc. passed 4 out of 9 key points

12.a Historical Valuation

12.b Price/Earnings Ratio

12.c Margin Valuation

12.d Peers Valuation

Peers Group Analysis

Stock-Card
Nektar

A-Score: 4.5/10

Value: 8.0

Growth: 4.2

Quality: 4.8

Yield: 0.0

Momentum: 10.0

Volatility: 0.0

1-Year Total Return ->

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Stock-Card
Xoma

A-Score: 4.3/10

Value: 6.4

Growth: 2.0

Quality: 4.6

Yield: 0.0

Momentum: 9.0

Volatility: 3.7

1-Year Total Return ->

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Stock-Card
Werewolf Therapeutics

A-Score: 3.9/10

Value: 7.4

Growth: 4.4

Quality: 5.8

Yield: 0.0

Momentum: 5.0

Volatility: 0.7

1-Year Total Return ->

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Stock-Card
HOOKIPA Pharma

A-Score: 3.6/10

Value: 9.2

Growth: 5.8

Quality: 4.8

Yield: 0.0

Momentum: 0.0

Volatility: 1.7

1-Year Total Return ->

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Stock-Card
Altimmune

A-Score: 3.3/10

Value: 6.8

Growth: 3.4

Quality: 3.2

Yield: 0.0

Momentum: 5.5

Volatility: 1.0

1-Year Total Return ->

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Stock-Card
Capricor Therapeutics

A-Score: 2.7/10

Value: 6.6

Growth: 4.3

Quality: 4.9

Yield: 0.0

Momentum: 0.0

Volatility: 0.3

1-Year Total Return ->

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Peers Metrics

12.e Scoring Insights

12.f DCF BETA

Parameters

Short Term Growth

Short term Time

Long-Term Growth

WACC

Target Price

26.89$

Current Price

26.89$

Potential

-0.00%

Expected Cash-Flows