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Capricor Therapeutics (CAPR)
NASDAQ:CAPR
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Capricor Therapeutics (CAPR) AI Stock Analysis

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CAPR

Capricor Therapeutics

(NASDAQ:CAPR)

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Neutral 46 (OpenAI - 4o)
Rating:46Neutral
Price Target:
$6.00
▲(1.18% Upside)
Capricor Therapeutics' overall stock score is primarily impacted by its financial struggles, including negative profitability and cash flow issues, compounded by regulatory setbacks and zero revenue. While the company maintains a strong cash position, the bearish technical indicators and negative valuation metrics further weigh down the score.
Positive Factors
Strong Cash Position
A robust cash position ensures Capricor can sustain operations and fund R&D efforts, providing stability and strategic flexibility.
Progress in Exosome Program
Advancements in the exosome program highlight Capricor's innovative capabilities, potentially leading to new revenue streams and partnerships.
Manufacturing and CMC Readiness
FDA validation of manufacturing processes enhances Capricor's credibility and readiness for product commercialization, supporting long-term growth.
Negative Factors
Complete Response Letter from FDA
The FDA's CRL creates regulatory hurdles, delaying product approval and impacting Capricor's ability to generate revenue from Deramiocel.
Increased Operating Expenses
Rising R&D expenses strain financial resources, potentially impacting profitability and necessitating efficient cost management to sustain operations.
Zero Revenue Reported
Zero revenue highlights challenges in product commercialization, affecting financial stability and necessitating successful product launches to improve outlook.

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

Capricor Therapeutics Business Overview & Revenue Model

Company DescriptionCapricor Therapeutics (CAPR) is a biotechnology company focused on developing innovative therapies for the treatment of rare cardiovascular diseases and disorders. The company specializes in regenerative medicine, particularly using its proprietary exosome platform technology derived from cardiac stem cells. Capricor's core products include CAP-1002, an investigational drug aimed at treating Duchenne muscular dystrophy and other related conditions, as well as additional therapeutic candidates targeting various indications in the cardiovascular space.
How the Company Makes MoneyCapricor 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 Earnings Call Summary

Earnings Call Date:Aug 11, 2025
(Q2-2025)
|
% Change Since: |
Next Earnings Date:Nov 10, 2025
Earnings Call Sentiment Negative
The earnings call highlighted Capricor Therapeutics' strong cash position and progress in its exosome program but faced significant challenges with the FDA's complete response letter, increased expenses, and zero revenue, resulting in a net loss. The regulatory delays and lack of clarity on the approval path for Deramiocel contributed to a negative outlook.
Q2-2025 Updates
Positive Updates
Strong Cash Position
Capricor Therapeutics reported a strong cash position with over $120 million in cash, sufficient to support operations into late 2026.
Progress in Exosome Program
Capricor's exosome program, particularly the StealthX vaccine, reached a significant milestone with the clearance of the IND and initiation of the Phase I trial, indicating potential for future business development opportunities.
Manufacturing and CMC Readiness
The FDA accepted all 483 items from Capricor's Pre-License Inspection, validating the company's manufacturing capabilities and commercial readiness.
Negative Updates
Complete Response Letter from FDA
Capricor received a CRL from the FDA for its Biologics License Application for Deramiocel, indicating that the application did not meet the statutory requirements for substantial evidence of effectiveness.
Increased Operating Expenses
Research and development expenses increased significantly to approximately $20.1 million in Q2 2025 from $11.7 million in Q2 2024, impacting the financial performance.
Zero Revenue Reported
The company reported zero revenues for the second quarter and first half of 2025, compared to $4 million and $8.9 million in the respective periods of 2024.
Net Loss Increase
Capricor reported a net loss of approximately $25.9 million for Q2 2025, compared to a net loss of $11 million in Q2 2024.
Regulatory Delays
The FDA's unexpected cancellation of the advisory committee meeting and the lack of clarity on the path forward for Deramiocel has caused delays and uncertainty.
Company Guidance
During the Capricor Therapeutics Second Quarter 2025 Conference Call, significant guidance was provided regarding the company's plans and recent challenges. The call highlighted an unexpected complete response letter (CRL) from the FDA concerning Capricor's Biologics License Application (BLA) for Deramiocel, intended for treating cardiomyopathy in Duchenne muscular dystrophy (DMD) patients. The CRL indicated that the BLA did not meet statutory requirements for substantial evidence of effectiveness, prompting a focus on resolving these issues with the FDA. Despite this setback, Capricor remains steadfast in its commitment to advancing Deramiocel, with the company emphasizing its continued belief in the strength of its submission and the promising data from its HOPE-2 and HOPE-3 trials. The company has scheduled a Type A meeting with the FDA to clarify the path forward, aiming to align on the primary efficacy endpoint for the HOPE-3 trial, which has been amended to focus on left ventricular ejection fraction (LVEF). Financially, Capricor reported a net loss of approximately $25.9 million for Q2 2025, with cash and equivalents totaling around $122.8 million, ensuring operational support into late 2026. The strategic focus remains on securing U.S. approval for Deramiocel, with global expansion plans to be disclosed as they develop.

Capricor Therapeutics Financial Statement Overview

Summary
Capricor Therapeutics faces significant financial challenges typical of the biotechnology sector, with negative profitability and cash flow issues despite a strong equity position. Revenue growth is present but overshadowed by operational inefficiencies and persistent losses.
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.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue13.39M22.27M25.18M2.55M244.90K310.25K
Gross Profit11.76M20.84M24.11M1.86M-798.00310.25K
EBITDA-69.99M-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 Assets133.57M170.48M58.73M50.09M41.33M34.62M
Cash, Cash Equivalents and Short-Term Investments122.80M151.52M39.49M41.42M34.89M32.67M
Total Debt1.04M1.45M2.24M2.56M2.87M318.16K
Total Liabilities28.59M25.02M36.13M38.31M9.96M6.42M
Stockholders Equity104.98M145.46M22.60M11.79M31.37M28.20M
Cash Flow
Free Cash Flow-56.38M-41.53M-27.64M1.56M-18.01M-10.60M
Operating Cash Flow-52.99M-40.00M-25.60M4.92M-16.81M-10.05M
Investing Cash Flow-82.94M-116.18M5.11M-35.07M-1.20M5.44M
Financing Cash Flow148.48M152.77M25.58M4.87M20.23M33.38M

Capricor Therapeutics Technical Analysis

Technical Analysis Sentiment
Negative
Last Price5.93
Price Trends
50DMA
6.57
Negative
100DMA
7.37
Negative
200DMA
9.75
Negative
Market Momentum
MACD
-0.19
Positive
RSI
41.78
Neutral
STOCH
16.28
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 5.93 is below the 20-day moving average (MA) of 6.32, below the 50-day MA of 6.57, and below the 200-day MA of 9.75, indicating a bearish trend. The MACD of -0.19 indicates Positive momentum. The RSI at 41.78 is Neutral, neither overbought nor oversold. The STOCH value of 16.28 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 (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
58
Neutral
$509.99M-38.87%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
46
Neutral
$287.10M-120.15%-50.68%-76.38%
45
Neutral
$131.58M-121.98%12.26%37.36%
45
Neutral
-100.00%72.45%
42
Neutral
$249.07M63.92%
35
Underperform
$363.22M-8.8117.80%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
CAPR
Capricor Therapeutics
5.93
-13.61
-69.65%
GALT
Galectin Therapeutics
5.20
2.31
79.93%
ALEC
Alector
1.28
-4.78
-78.88%
IMAB
I-MAB
4.00
2.90
263.64%
FDMT
4D Molecular Therapeutics
10.50
2.43
30.11%
HUMA
Humacyte
1.33
-4.19
-75.91%

Capricor Therapeutics Corporate Events

Capricor Therapeutics Faces Challenges Despite Strong Cash Position
Sep 1, 2025

Capricor Therapeutics’ recent earnings call presented a mixed sentiment, highlighting both strengths and challenges. The company showcased its robust cash position and progress in its exosome program, yet faced hurdles with the FDA’s complete response letter, rising expenses, and zero revenue, culminating in a net loss. Regulatory delays and uncertainty surrounding Deramiocel’s approval path further contributed to a negative outlook.

Capricor Therapeutics: Q2 2025 Financial and Strategic Update
Aug 12, 2025

Capricor Therapeutics, Inc. is a biotechnology company focused on developing innovative cell and exosome-based therapies for rare diseases, with a leading candidate aimed at treating Duchenne Muscular Dystrophy (DMD).

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: Oct 31, 2025