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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 49 (OpenAI - 4o)
Rating:49Neutral
Price Target:
$6.50
▲(2.20% Upside)
Capricor Therapeutics' overall stock score is primarily impacted by its financial struggles, including persistent losses and cash flow issues. While technical analysis and earnings call insights provide some positive outlooks, the valuation challenges and regulatory hurdles weigh heavily on the stock's attractiveness.
Positive Factors
Innovative Exosome Technology
The scalable exosome technology enhances Capricor's ability to produce therapeutic products, supporting long-term growth and innovation in regenerative medicine.
Clinical Progress in Duchenne Muscular Dystrophy
Advancements in the HOPE-3 trial position Capricor for potential approval, indicating progress in addressing unmet medical needs and strengthening its market position.
Strong Equity Position
A strong equity position reduces leverage risk, providing financial stability and flexibility to invest in long-term growth initiatives.
Negative Factors
Zero Revenue in 2025
Zero revenue highlights challenges in achieving commercial success, impacting cash flow and financial health, and posing risks to sustainability.
Increased Operating Expenses
Rising operating expenses without corresponding revenue growth strain financial resources, potentially limiting investment in future projects.
Regulatory Challenges
Regulatory hurdles delay product approval and commercialization, affecting timelines and increasing uncertainty in achieving market entry.

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 generates revenue through a combination of research and development funding, grants, and potential future product sales. The company may receive funding through collaborations and partnerships with pharmaceutical companies, which can provide upfront payments, milestone payments based on the achievement of specific development goals, and royalties on future sales of any resulting products. Additionally, Capricor seeks government grants and funding from research institutions to support its clinical trials and research efforts. Their strategic partnerships can also open avenues for co-development or licensing agreements that contribute to their revenue streams.

Capricor Therapeutics Earnings Call Summary

Earnings Call Date:Nov 10, 2025
(Q3-2025)
|
% Change Since: |
Next Earnings Date:Mar 25, 2026
Earnings Call Sentiment Neutral
The earnings call highlighted significant progress in the clinical development of Daramycin and operational readiness for commercialization. However, financial challenges were evident with zero revenue in 2025 and increased operating expenses, alongside the need to address regulatory hurdles following a CRL.
Q3-2025 Updates
Positive Updates
HOPE-3 Phase 3 Clinical Study
The upcoming top-line readout from the HOPE-3 Phase 3 clinical study of Daramycin, aimed at treating Duchenne muscular dystrophy, represents a significant milestone. The trial is one of the largest double-blind, placebo-controlled studies in the Duchenne population, enrolling 105 participants across 20 centers in the US.
Strong Safety Profile
Daramycin has demonstrated a strong and consistent safety profile across more than 800 infusions for approximately 150 boys and young men with Duchenne, with no new or emerging safety signals observed.
CMC Achievements
The San Diego commercial facility is fully operational and preparing for GMP production, with all CMC-related items cited in the CRL addressed. This ensures readiness for commercialization and long-term product consistency.
Potential Approval and Non-dilutive Capital Opportunities
If Daramycin is approved, Capricor is eligible for an $80 million milestone payment from NS Pharma and a priority review voucher.
Exosome Platform Development
The StealthX program under Project NextGen is advancing, with a Phase 1 clinical trial evaluating a next-generation COVID-19 vaccine. Positive results could lead to strategic collaborations and highlight the platform's potential.
Negative Updates
Revenue Decline
Revenue for 2025 was zero compared to approximately $2.3 million for Q3 2024 and $11.1 million for 2024. The previous revenue was from the ratable recognition of a $40 million US distribution agreement with Nippon Shinyaku, which has been fully recognized.
Increased Operating Expenses
Research and development expenses increased to approximately $18.1 million in Q3 2025, compared to $11 million in Q3 2024. General and administrative expenses rose to approximately $4.1 million from $2.2 million in the same period. The net loss for 2025 was $24.6 million, compared to $12.6 million in 2024.
CRL and Regulatory Challenges
Following a CRL in July, Capricor had to shift the role of HOPE-3 to provide additional evidence of effectiveness. The FDA's request for more data and certain CMC clarifications posed challenges to the approval timeline.
Company Guidance
During Capricor Therapeutics' Third Quarter 2025 Conference Call, the company provided guidance on its ongoing and future activities across various metrics. The HOPE-3 Phase 3 clinical trial, which is a pivotal study for its investigational cell therapy Daramycin, enrolled 105 participants to assess efficacy primarily in non-ambulant individuals with Duchenne muscular dystrophy. The trial is statistically powered to detect changes in upper limb and cardiac function, with safety data regularly reported to the FDA. The statistical analysis plan includes evaluations of efficacy across two cohorts, with particular focus on Cohort B, which utilizes commercial-scale manufacturing. The company aims to submit the HOPE-3 results to address issues raised in a Complete Response Letter (CRL) received in July and seeks a new Prescription Drug User Fee Act (PDUFA) date. Financially, Capricor ended the quarter with approximately $98.6 million in cash, expecting it to cover expenses into 2026, with net losses reported at $24.6 million for Q3 2025. The company is also advancing its exosome platform through a US government-funded initiative for developing next-generation vaccines.

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 Revenue11.13M22.27M25.18M2.55M244.90K310.25K
Gross Profit-64.75M-27.70M-11.27M-19.27M244.90K310.25K
EBITDA-83.21M-41.14M-23.01M-29.16M-20.69M-13.55M
Net Income-81.99M-40.47M-22.29M-29.02M-20.02M-13.66M
Balance Sheet
Total Assets126.44M170.48M58.73M50.09M41.33M34.62M
Cash, Cash Equivalents and Short-Term Investments98.57M151.52M39.49M41.42M34.89M32.67M
Total Debt14.54M1.45M2.24M2.56M2.87M318.16K
Total Liabilities42.57M25.02M36.13M38.31M9.96M6.42M
Stockholders Equity83.87M145.46M22.60M11.79M31.37M28.20M
Cash Flow
Free Cash Flow-44.68M-41.53M-27.64M1.56M-18.01M-10.60M
Operating Cash Flow-41.35M-40.00M-25.60M4.92M-16.81M-10.05M
Investing Cash Flow-84.94M-116.18M5.11M-35.07M-1.20M5.44M
Financing Cash Flow81.16M152.77M25.58M4.87M20.23M33.38M

Capricor Therapeutics Technical Analysis

Technical Analysis Sentiment
Positive
Last Price6.36
Price Trends
50DMA
6.36
Positive
100DMA
6.68
Negative
200DMA
9.03
Negative
Market Momentum
MACD
-0.15
Negative
RSI
55.24
Neutral
STOCH
70.64
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For CAPR, the sentiment is Positive. The current price of 6.36 is above the 20-day moving average (MA) of 5.74, above the 50-day MA of 6.36, and below the 200-day MA of 9.03, indicating a neutral trend. The MACD of -0.15 indicates Negative momentum. The RSI at 55.24 is Neutral, neither overbought nor oversold. The STOCH value of 70.64 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive 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
53
Neutral
$600.49M-45.38%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
49
Neutral
$304.03M-107.79%-52.08%-69.35%
45
Neutral
$134.26M-121.98%12.26%37.36%
45
Neutral
-100.00%72.45%
42
Neutral
$235.96M82.23%
35
Underperform
$363.22M-8.8118.82%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
CAPR
Capricor Therapeutics
6.36
-6.36
-50.00%
GALT
Galectin Therapeutics
5.46
3.10
131.36%
ALEC
Alector
1.14
-1.05
-47.95%
IMAB
I-MAB
4.00
2.91
266.97%
FDMT
4D Molecular Therapeutics
10.13
2.99
41.88%
HUMA
Humacyte
1.26
-3.17
-71.56%

Capricor Therapeutics Corporate Events

Capricor Therapeutics Reports Q3 2025 Financial Results
Nov 11, 2025

Capricor Therapeutics, Inc. is a biotechnology company focused on developing cell and exosome-based therapeutics for rare diseases, with a prominent focus on Duchenne muscular dystrophy (DMD).

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: Dec 02, 2025