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Capricor Therapeutics (CAPR)
NASDAQ:CAPR

Capricor Therapeutics (CAPR) AI Stock Analysis

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Capricor Therapeutics

(NASDAQ:CAPR)

49Neutral
Capricor Therapeutics shows promise with significant progress toward FDA approval and a solid financial runway. However, persistent financial challenges, including profitability and cash flow issues, coupled with weak technical indicators and valuation concerns, weigh heavily on the stock's overall score. The positive sentiment from the earnings call provides some optimism, but operational inefficiencies and increased net losses remain key risks.
Positive Factors
Financial Performance
Capricor announced financial results that exceeded estimates with a lower-than-expected loss, ending the quarter with $151.5 million in cash.
Partnership Expansion
Partnership with Nippon Shinyaku was expanded to include the EU, with combined milestones totaling ~$1.5B, including an $80M milestone for US approval.
Regulatory Progress
The FDA accepted deramiocel's BLA for DMD cardiomyopathy and granted it Priority Review, which is a significant step forward for Capricor.
Negative Factors
Manufacturing Challenges
Capricor is expanding its manufacturing capacity to produce deramiocel for approximately 2,000-3,000 patients, with a new facility expected to be operational by mid-2026.
Regulatory Risks
Capricor plans to file a rolling BLA seeking full approval and a broader label for deramiocel in the treatment of DMD-cardiomyopathy, which may face regulatory hurdles.

Capricor Therapeutics (CAPR) vs. S&P 500 (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 primarily makes money through the development and commercialization of its therapeutic candidates. The company generates revenue through strategic partnerships, licensing agreements, and research collaborations with other biotech and pharmaceutical companies. These partnerships often include upfront payments, milestone payments, and royalties on sales of any successfully developed therapies. Additionally, the company may receive funding through grants and government contracts to support its research and development efforts. Capricor's key revenue streams are closely linked to the progress and commercialization of its clinical-stage products, such as CAP-1002, which targets Duchenne muscular dystrophy and other cardiac-related conditions.

Capricor Therapeutics Financial Statement Overview

Summary
Capricor Therapeutics exhibits significant financial challenges typical in biotech, with high R&D costs and negative profitability indicators. Despite strong equity and no debt, persistent losses and cash flow issues are concerning.
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.
Breakdown
Dec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income StatementTotal Revenue
22.27M25.18M2.55M244.90K310.25K
Gross Profit
-27.70M24.11M1.85M-799.00-8.15M
EBIT
-42.56M-24.08M-29.70M-20.94M-13.69M
EBITDA
-41.17M-23.01M-29.16M-20.69M-13.55M
Net Income Common Stockholders
-40.47M-22.29M-19.41M-13.48M
Balance SheetCash, Cash Equivalents and Short-Term Investments
85.03M39.49M41.42M34.89M32.67M
Total Assets
0.0058.73M50.09M41.33M34.62M
Total Debt
0.002.24M2.56M2.87M318.16K
Net Debt
0.00-12.46M-7.04M-32.01M-32.35M
Total Liabilities
3.99B36.13M38.31M9.96M6.42M
Stockholders Equity
68.26M22.60M11.79M31.37M28.20M
Cash FlowFree Cash Flow
0.00-27.64M1.56M-18.01M-10.60M
Operating Cash Flow
0.00-25.60M4.92M-16.81M-10.05M
Investing Cash Flow
0.005.11M-35.07M-1.20M5.44M
Financing Cash Flow
0.0025.58M4.87M20.23M33.38M

Capricor Therapeutics Technical Analysis

Technical Analysis Sentiment
Negative
Last Price9.40
Price Trends
50DMA
12.71
Negative
100DMA
13.84
Negative
200DMA
11.89
Negative
Market Momentum
MACD
-1.07
Negative
RSI
42.25
Neutral
STOCH
74.12
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 9.4 is below the 20-day moving average (MA) of 10.72, below the 50-day MA of 12.71, and below the 200-day MA of 11.89, indicating a bearish trend. The MACD of -1.07 indicates Negative momentum. The RSI at 42.25 is Neutral, neither overbought nor oversold. The STOCH value of 74.12 is Neutral, 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 (48)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
49
Neutral
$429.36M-48.16%-11.55%-37.48%
49
Neutral
$478.05M91.25%-17.75%-19.17%
48
Neutral
$6.46B1.17-48.25%2.67%19.50%0.61%
46
Neutral
$516.76M-41.46%2250.99%3.52%
42
Neutral
$447.55M-31.60%6.72%
41
Neutral
$431.88M-29.04%12.12%-19.00%
27
Underperform
$418.29M-68.01%26.24%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
CAPR
Capricor Therapeutics
9.82
3.89
65.60%
AKBA
Akebia Therapeutics
1.89
0.49
35.00%
TBPH
Theravance Biopharma
8.63
-1.06
-10.94%
MNMD
Mind Medicine
5.60
-4.28
-43.32%
KROS
Keros Therapeutics
13.09
-44.91
-77.43%
TYRA
Tyra Bioscience
8.43
-6.23
-42.50%

Capricor Therapeutics Earnings Call Summary

Earnings Call Date: Mar 19, 2025 | % Change Since: -23.08% | Next Earnings Date: May 8, 2025
Earnings Call Sentiment Positive
The earnings call highlights significant progress towards Deramiocel's FDA approval and commercialization, backed by strong safety and efficacy data, a robust manufacturing strategy, and a solid financial position. However, increased operating expenses and a larger net loss present some financial challenges. The pending European agreement also remains a point of uncertainty.
Highlights
FDA Priority Review for Deramiocel
The Biologics License Application (BLA) for Deramiocel to treat DMD cardiomyopathy was accepted by the FDA for priority review, with a PDUFA date set for August 31, 2025.
Strong Safety and Efficacy Data
Deramiocel has been administered to over 250 human subjects with a strong safety profile, showing clinical and statistically significant efficacy in treating DMD cardiomyopathy.
Robust Manufacturing and Expansion Plans
Capricor's San Diego facility can support 250-500 patients annually, with plans to expand capacity to 2,000-3,000 patients by mid-2026.
Solid Financial Position
Capricor has a cash balance of approximately $151.5 million, with a runway into 2027, and potential non-dilutive cash infusions of over $200 million if FDA approval is received.
Positive Market Access and Reimbursement Outlook
Surveys with top five US payers have shown favorable responses for Deramiocel reimbursement.
Lowlights
Increased Operating Expenses
Research and development expenses increased from $9.4 million in Q4 2023 to $13.6 million in Q4 2024, and G&A expenses increased from $2.1 million to $3 million in the same period.
Net Loss Increase
Net loss for the fourth quarter of 2024 was approximately $7.1 million, up from a net loss of $800,000 in the same quarter of 2023.
Pending Finalization of European Agreement
Negotiations with Nippon Shinyaku for European distribution have not yet resulted in a final definitive agreement.
Company Guidance
During the Capricor Therapeutics Fourth Quarter 2024 Earnings Call held on March 19, 2025, significant guidance was provided regarding their lead product, deramiocel. The company announced that their Biologics License Application (BLA) for deramiocel to treat Duchenne muscular dystrophy (DMD) cardiomyopathy had been accepted for priority review by the FDA, with a Prescription Drug User Fee Act (PDUFA) date set for August 31, 2025. The application is based on data from the Phase 2 HOPE-2 trial and its open-label extension, with supporting natural history data. The company highlighted deramiocel's strong safety profile, having been administered to over 250 subjects, and its demonstrated clinical efficacy. Capricor is preparing for a potential Advisory Committee (AdCom) meeting and has scheduled a pre-licensing inspection of their manufacturing facility for the second quarter of 2025. They anticipate the commercial launch of deramiocel in the U.S. with approximately 100 patients transitioning from clinical trials, projecting that 50-60% of the U.S. DMD population (around 7,500 individuals) could be eligible for treatment. Their current manufacturing capacity supports 250-500 patients annually, with expansion plans to accommodate up to 3,000 patients by mid-2026. Financially, Capricor reported a cash position of approximately $151.5 million as of December 31, 2024, with a runway extending into 2027. They expect additional non-dilutive cash infusions totaling over $200 million, including an $80 million milestone payment upon FDA approval and potential revenue from deramiocel sales. The company is also advancing their exosome technology platform and exploring European marketing strategies with Nippon Shinyaku.

Capricor Therapeutics Corporate Events

Product-Related AnnouncementsRegulatory Filings and Compliance
Capricor Therapeutics’ Deramiocel Receives FDA Priority Review
Positive
Mar 4, 2025

On March 4, 2025, Capricor Therapeutics announced that the FDA has accepted its Biologics License Application for deramiocel, an investigational cell therapy for Duchenne muscular dystrophy cardiomyopathy, and granted it Priority Review with a target action date of August 31, 2025. If approved, deramiocel would be the first therapy for this condition, potentially offering a new treatment landscape for patients and stakeholders in the DMD community.

Glossary
OutperformA stock rated as "Outperform" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock is likely to deliver higher returns compared to the average returns of other stocks in the same sector or market index. Investors might consider this stock a good buying opportunity.
NeutralA stock rated as "Neutral" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly attractive nor unattractive for investment. Investors may consider holding onto the stock, as it is not expected to either significantly outperform or underperform the market.
UnderperformA stock rated as "Underperform" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock may deliver lower returns compared to the average returns of other stocks in the same sector or market index. Investors might consider selling the stock or avoiding it as an investment.

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.