Capricor Therapeutics (CAPR) AI Stock Analysis

• Market Cap: $271.56M
• Dividend Yield: N/A
• Average Volume (3M): 1.63M
• Price to Earnings (P/E): ―
• Beta (1Y): 2.54
• Revenue Growth: -50.68%
• EPS Growth: -76.38%
• Country: US
• Employees: 160
• Sector: Healthcare
• Sector Strength: 51
• Industry: Biotechnology
• EPS (TTM): -0.57
• Shares Outstanding: 45,716,976
• 10 Day Avg. Volume: 1,293,274
• 30 Day Avg. Volume: 1,625,199
• PEG Ratio: N/A
• Price to Book (P/B): N/A
• Price to Sales (P/S): N/A
• P/FCF Ratio: N/A
• Enterprise Value/Market Cap: 1.24
• Enterprise Value/Revenue: 25.05
• Enterprise Value/Gross Profit: 27.39
• Enterprise Value/Ebitda: -4.76
• 1Y Price Target: $21.22
• Price Target Upside: 214.84% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 9

• Rating: 43 Neutral
• Price Target: $6.50 ▼(-3.56% Downside)

Capricor Therapeutics faces significant financial and regulatory challenges, with ongoing losses and a negative outlook from the FDA's CRL. The strong cash position and potential in the exosome program are positives, but the bearish technical indicators and unattractive valuation weigh heavily on the overall score.

Positive Factors

Financial Outlook

Capricor ended the quarter financially strong with $122.8 million, providing runway into late 2026 as it navigates the FDA regarding deramiocel's filing.

Regulatory and Manufacturing Clarity

Capricor has outlined a clear path to launch, backed by increasing regulatory and manufacturing clarity, strengthening confidence in deramiocel’s potential approval and commercial readiness.

Therapeutic Durability

Deramiocel offers a first-in-class therapeutic profile with strong clinical and manufacturing support.

Negative Factors

FDA Decision Uncertainty

The FDA continues to evolve under its new leadership, and with it there is likely to be continued volatility.

Regulatory Challenges

The FDA issued a Complete Response Letter (CRL) for deramiocel's Biologics License Application (BLA), which came as a surprise despite detailed conversations with the FDA and completed answers to questions.

Resubmission Risks

The company's desire to resubmit the BLA mostly unchanged poses a risk, despite having answered all FDA questions.

Capricor Therapeutics Business Overview & Revenue Model

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.

How the Company Makes Money

Capricor Therapeutics generates revenue primarily through the development and commercialization of its therapeutic products. The company may engage in various revenue streams, including licensing agreements, collaborations with pharmaceutical companies, and government grants for research and development. Significant partnerships with larger biotech or pharmaceutical firms may provide upfront payments, milestone payments, and royalties on future sales, contributing to Capricor's earnings. Additionally, funding from grants or public offerings may support its operational costs and research initiatives.

Capricor Therapeutics Financial Statement Overview

Summary

Capricor Therapeutics shows significant revenue volatility and operates at a net loss, with negative profit margins. Despite a strong equity position, the company struggles with profitability and cash flow generation, typical of the biotechnology industry.

Income Statement

Capricor Therapeutics has shown significant revenue volatility over the years, with a notable increase in revenue in 2023 compared to previous years, but still operates at a net loss. The gross profit margin is consistently negative, and the EBIT and EBITDA margins are also negative, indicating the company is struggling with profitability. Revenue growth is present but overshadowed by operational inefficiencies and high expenses.

Balance Sheet

The company has a strong equity position with a positive stockholders' equity, and the absence of total debt in the latest year indicates reduced leverage risk. However, the negative total liabilities figure in 2024 raises concerns about data accuracy or financial reporting issues. The equity ratio is favorable given the high equity levels in relation to assets.

Cash Flow

Capricor Therapeutics has experienced fluctuating cash flow from operations, with periods of negative free cash flow, indicating challenges in generating sustainable cash from operations. The free cash flow growth rate is negative, and the operating cash flow to net income ratio is not calculable, highlighting ongoing cash management issues.

Breakdown	TTM	Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement
Total Revenue	13.39M	22.27M	25.18M	2.55M	244.90K	310.25K
Gross Profit	12.25M	20.84M	24.11M	1.86M	-798.00	310.25K
EBITDA	-70.47M	-41.14M	-23.01M	-29.16M	-20.69M	-13.55M
Net Income	-69.98M	-40.47M	-22.29M	-29.02M	-20.02M	-13.66M
Balance Sheet
Total Assets	133.57M	170.48M	58.73M	50.09M	41.33M	34.62M
Cash, Cash Equivalents and Short-Term Investments	122.80M	151.52M	39.49M	41.42M	34.89M	32.67M
Total Debt	4.42M	1.45M	2.24M	2.56M	2.87M	318.16K
Total Liabilities	28.59M	25.02M	36.13M	38.31M	9.96M	6.42M
Stockholders Equity	104.98M	145.46M	22.60M	11.79M	31.37M	28.20M
Cash Flow
Free Cash Flow	-34.81M	-41.53M	-27.64M	1.56M	-18.01M	-10.60M
Operating Cash Flow	-32.87M	-40.00M	-25.60M	4.92M	-16.81M	-10.05M
Investing Cash Flow	-97.49M	-116.18M	5.11M	-35.07M	-1.20M	5.44M
Financing Cash Flow	148.46M	152.77M	25.58M	4.87M	20.23M	33.38M

Capricor Therapeutics Technical Analysis

• Technical Analysis Sentiment: Negative
• Last Price: 6.74
• 50DMA: Negative
• 100DMA: Negative
• 200DMA: Negative
• MACD: Positive
• RSI: Neutral
• STOCH: Neutral

Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For CAPR, the sentiment is Negative. The current price of 6.74 is below the 20-day moving average (MA) of 7.14, below the 50-day MA of 7.85, and below the 200-day MA of 11.68, indicating a bearish trend. The MACD of -0.49 indicates Positive momentum. The RSI at 45.28 is Neutral, neither overbought nor oversold. The STOCH value of 33.48 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for CAPR.

Capricor Therapeutics Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
TBPH	66 Neutral	$707.58M	59.64	6.23%	―	24.49%	―
KROS	66 Neutral	$631.57M	49.63	3.33%	―	85820.30%	―
Sector *	51 Neutral	$7.92B	-0.43	-41.67%	2.21%	22.29%	-1.85%
AKBA	49 Neutral	$800.74M	―	91.25%	―	16.75%	14.72%
CAPR	43 Neutral	$271.56M	―	-120.15%	―	-50.68%	-76.38%
TYRA	41 Neutral	$647.03M	―	-31.21%	―	―	-5.63%
MNMD	40 Neutral	$702.29M	―	-59.11%	―	―	39.66%

Capricor Therapeutics Corporate Events

Capricor Receives FDA CRL for Deramiocel BLA

On July 11, 2025, Capricor Therapeutics announced it received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) for Deramiocel, a cell therapy for cardiomyopathy associated with Duchenne muscular dystrophy. The FDA cited the need for additional clinical data and outstanding items in the Chemistry, Manufacturing, and Controls section. Capricor plans to resubmit its BLA with data from the ongoing Phase 3 HOPE-3 trial in Q3 2025 and intends to engage with the FDA to discuss the path forward. The company remains committed to advancing Deramiocel through the approval process despite the unexpected FDA decision.

Capricor Therapeutics Approves 2025 Equity Incentive Plan

Capricor Therapeutics, Inc. announced that its stockholders approved the 2025 Equity Incentive Plan during the 2025 Annual Meeting of Stockholders. This plan, previously approved by the Board of Directors, reserves 3,500,000 shares of common stock for equity-based awards to employees, non-employee directors, and consultants, with an automatic annual increase in shares authorized for issuance starting January 1, 2026, through January 1, 2035. This development is expected to enhance the company’s ability to attract and retain talent, thereby potentially impacting its operational capabilities and market positioning.