tiprankstipranks
Trending News
More News >
Capricor Therapeutics, Inc. (CAPR)
:CAPR
Advertisement

Capricor Therapeutics (CAPR) AI Stock Analysis

Compare
1,057 Followers

Top Page

CAPR

Capricor Therapeutics

(NASDAQ:CAPR)

Rating:46Neutral
Price Target:
$6.00
▼(-7.41%Downside)
Capricor Therapeutics' overall stock score is primarily affected by financial struggles and technical weaknesses. While strategic and operational initiatives in the earnings call and corporate events show potential, significant risks remain due to regulatory challenges and financial instability.
Positive Factors
Clinical Trial Evidence
Positive 4-year OLE data was presented at the Parent Project Muscular Dystrophy conference, showing that Deramiocel continues to preserve cardiac function and maintain a favorable long-term safety profile.
Financial Stability
Capricor is well-capitalized with $145M in cash, providing runway into 2027.
Regulatory Environment
FDA has signaled willingness to work with sponsors on areas of high unmet need, suggesting a more favorable approval pathway for rare diseases.
Negative Factors
Approval Probability
The probability of approval for deramiocel has been reduced to 45% from 65%.
Clinical Data Requirements
The CRL cited a lack of substantial evidence of effectiveness and the need for more clinical data.
Regulatory Challenges
Capricor announced Deramiocel cell therapy for Duchenne muscular dystrophy cardiomyopathy received a CRL, sending CAPR shares down 33%.

Capricor Therapeutics (CAPR) vs. SPDR S&P 500 ETF (SPY)

Capricor Therapeutics Business Overview & Revenue Model

Company DescriptionCapricor 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 MoneyCapricor Therapeutics makes money primarily through the development and commercialization of its therapeutic candidates. The company's revenue model is centered around securing funding through collaborations, grants, and potential licensing agreements. Key revenue streams include partnerships with larger pharmaceutical companies, government grants, and research collaborations that provide financial support for its research and development activities. Additionally, Capricor aims to generate revenue through the eventual commercialization of its therapies, either independently or through strategic partnerships, once they receive regulatory approval. The company's progress in clinical trials and the successful development of its product pipeline are significant factors contributing to its earnings potential.

Capricor Therapeutics Earnings Call Summary

Earnings Call Date:May 13, 2025
(Q1-2025)
|
% Change Since: -11.23%|
Next Earnings Date:Aug 07, 2025
Earnings Call Sentiment Neutral
The earnings call highlighted positive advancements in the approval process for deramiocel, strong safety and efficacy data, strategic partnerships, and a solid financial position. However, the decline in revenue, increased expenses, and significant net loss cast some concerns on the financial performance. Despite these financial challenges, the strategic and clinical advancements suggest a cautiously optimistic outlook.
Q1-2025 Updates
Positive Updates
Advancements Toward Deramiocel Approval
Capricor Therapeutics is on track with their BLA for deramiocel to treat DMD cardiomyopathy, with a smooth FDA path and an upcoming advisory committee meeting seen as a positive step.
Strong Safety and Efficacy Data
Deramiocel has demonstrated a strong safety record with over 700 infusions across 250 patients and significant efficacy in slowing cardiac decline, supported by multiple clinical trials and extensions.
Strategic Appointments and Partnerships
Appointment of Dr. Michael Binks as Chief Medical Officer and active collaboration with NS Pharma for U.S. launch readiness strengthens Capricor's commercial prospects.
Robust Financial Position
Capricor has a cash balance of approximately $145 million, with a runway into 2027 and potential non-dilutive cash infusions totaling over $200 million upon FDA approval.
International Expansion Plans
Capricor is actively negotiating for European distribution with Nippon Shinyaku and planning for international expansion of their HOPE-3 trial.
Negative Updates
Revenue Decline
Capricor reported zero revenue for Q1 2025, a decrease from $4.9 million in Q1 2024, due to the full recognition of the $40 million U.S. distribution agreement with Nippon Shinyaku by December 2024.
Increased Operating Expenses
Research and development expenses increased to $16.2 million in Q1 2025 from $10.1 million in Q1 2024, and general and administrative expenses rose to $3.1 million from $1.8 million.
Significant Net Loss
Capricor reported a net loss of $24.4 million for Q1 2025, compared to a net loss of $9.8 million in Q1 2024, reflecting increased operational costs and no revenue.
Company Guidance
During the Capricor Therapeutics First Quarter 2025 Earnings Call, the company provided guidance on several key metrics. The CFO, A.J. Bergmann, outlined forward-looking statements regarding various aspects of the company's future, including R&D plans, regulatory filings, and financial estimates. CEO Linda Marban discussed the progress of the Biologics License Application (BLA) for deramiocel, emphasizing its potential as a first-in-class therapy for Duchenne muscular dystrophy cardiomyopathy, with a strong safety record demonstrated in over 700 infusions and 250 patients. The company highlighted the ongoing HOPE-3 Phase 3 trial, fully enrolled in the U.S., and plans for international expansion. Capricor reported a cash balance of approximately $145 million as of March 31, 2025, with a financial runway into 2027. Potential infusions of over $200 million could be achieved through milestone payments and the sale of a Priority Review Voucher. The company also detailed its commercial manufacturing preparations, European partnering opportunities, and exosome platform development. Financially, Capricor reported zero revenue for Q1 2025, with operating expenses of approximately $16.2 million for R&D and $3.1 million for general and administrative costs, resulting in a net loss of $24.4 million for the quarter.

Capricor Therapeutics Financial Statement Overview

Summary
Capricor Therapeutics has a strong equity position but struggles with profitability and cash flow, typical of the biotech industry. Despite revenue growth, operational inefficiencies and consistent losses are significant risks.
Income Statement
30
Negative
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
65
Positive
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
40
Negative
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.
BreakdownDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue22.27M25.18M2.55M244.90K310.25K
Gross Profit20.84M24.11M1.86M-798.00310.25K
EBITDA-41.14M-23.01M-29.16M-20.69M-13.55M
Net Income-40.47M-22.29M-29.02M-20.02M-13.66M
Balance Sheet
Total Assets170.48M58.73M50.09M41.33M34.62M
Cash, Cash Equivalents and Short-Term Investments151.52M39.49M41.42M34.89M32.67M
Total Debt1.45M2.24M2.56M2.87M318.16K
Total Liabilities25.02M36.13M38.31M9.96M6.42M
Stockholders Equity145.46M22.60M11.79M31.37M28.20M
Cash Flow
Free Cash Flow-41.53M-27.64M1.56M-18.01M-10.60M
Operating Cash Flow-40.00M-25.60M4.92M-16.81M-10.05M
Investing Cash Flow-116.18M5.11M-35.07M-1.20M5.44M
Financing Cash Flow152.77M25.58M4.87M20.23M33.38M

Capricor Therapeutics Technical Analysis

Technical Analysis Sentiment
Negative
Last Price6.48
Price Trends
50DMA
10.03
Negative
100DMA
10.64
Negative
200DMA
13.52
Negative
Market Momentum
MACD
-1.14
Positive
RSI
35.81
Neutral
STOCH
17.93
Positive
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 6.48 is below the 20-day moving average (MA) of 8.68, below the 50-day MA of 10.03, and below the 200-day MA of 13.52, indicating a bearish trend. The MACD of -1.14 indicates Positive momentum. The RSI at 35.81 is Neutral, neither overbought nor oversold. The STOCH value of 17.93 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for CAPR.

Capricor Therapeutics Risk Analysis

Capricor Therapeutics disclosed 75 risk factors in its most recent earnings report. Capricor Therapeutics reported the most risks in the "Finance & Corporate" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Capricor Therapeutics Peers Comparison

Overall Rating
UnderperformOutperform
Sector (52)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
57
Neutral
$556.51M-31.46%6.11%-37.79%
52
Neutral
$7.61B0.10-63.03%2.08%16.34%0.32%
51
Neutral
$584.05M0.71%91657.69%97.21%
49
Neutral
$1.05B91.25%-17.75%-19.17%
46
Neutral
$296.19M-75.39%-35.92%-62.11%
41
Neutral
$573.26M-27.04%6.72%
40
Neutral
$748.73M-37.07%26.24%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
CAPR
Capricor Therapeutics
6.48
2.05
46.28%
AKBA
Akebia Therapeutics
3.84
2.36
159.46%
TBPH
Theravance Biopharma
11.13
0.92
9.01%
MNMD
Mind Medicine
9.72
0.30
3.18%
KROS
Keros Therapeutics
14.38
-35.91
-71.41%
TYRA
Tyra Bioscience
10.78
-9.57
-47.03%

Capricor Therapeutics Corporate Events

Product-Related AnnouncementsRegulatory Filings and Compliance
Capricor Receives FDA CRL for Deramiocel BLA
Negative
Jul 11, 2025

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.

The most recent analyst rating on (CAPR) stock is a Buy with a $77.00 price target. To see the full list of analyst forecasts on Capricor Therapeutics stock, see the CAPR Stock Forecast page.

Shareholder MeetingsBusiness Operations and Strategy
Capricor Therapeutics Approves 2025 Equity Incentive Plan
Positive
May 27, 2025

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.

The most recent analyst rating on (CAPR) stock is a Buy with a $77.00 price target. To see the full list of analyst forecasts on Capricor Therapeutics stock, see the CAPR Stock Forecast page.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: Jul 22, 2025