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Capricor Therapeutics (CAPR)
NASDAQ:CAPR
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Capricor Therapeutics
(NASDAQ:CAPR)
Rating:52Neutral
Price Target:
$11.00
▲( 1.29% Upside)
Positive Factors
FDA Approval and Milestone Payments
Deramiocel’s favorable profile could lead to FDA approval by August 31, 2025, and a concomitant $230M non-dilutive cash infusion.
Strategic Partnerships
Capricor has inked a strategic deal with NS Pharma for U.S. deramiocel commercialization, which includes substantial financial terms and royalties.
Negative Factors
Investor Concerns
Upon announcement of the AdCom, CAPR shares sold off significantly, likely from investor concerns with ongoing changes within the FDA.
Regulatory Risks
Risks include regulatory, commercial, and payor setbacks for deramiocel.
Capricor Therapeutics (CAPR) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$496.39M
Dividend YieldN/A
Average Volume (3M)2.58M
Price to Earnings (P/E)―
Beta (1Y)2.04
Revenue Growth-35.92%
EPS Growth-62.11%
CountryUS
Employees160
SectorHealthcare
Sector Strength43
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.53
Shares Outstanding45,707,820
10 Day Avg. Volume3,861,668
30 Day Avg. Volume2,582,073
Financial Highlights & Ratios
PEG Ratio<0.01
Price to Book (P/B)<0.01
Price to Sales (P/S)0.00
P/FCF Ratio-0.06
Enterprise Value/Market Cap-54.62
Enterprise Value/Revenue-301.22
Enterprise Value/Gross Profit-1.63K
Enterprise Value/Ebitda1.08
Forecast
1Y Price Target
$41.50Price Target Upside282.14% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering7
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 has a strong equity position, but its financials are challenged by negative profitability and cash flow issues. The company operates at a net loss with negative margins and fluctuating cash flows, which are common hurdles in the biotech sector.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.30
Negative
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.65
Positive
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.40
Negative
| Breakdown | |||||
| TTM | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 |
|---|---|---|---|---|---|
| Income Statement | Total Revenue | ||||
| 17.36M | 22.27M | 25.18M | 2.55M | 244.90K | 310.25K | Gross Profit |
| 16.63M | 20.85M | 24.11M | 1.85M | -799.00 | -8.15M | EBIT |
| -25.02B | -42.56M | -24.08M | -29.70M | -20.94M | -13.69M | EBITDA |
| -25.01B | -41.17M | -23.01M | -29.16M | -20.69M | -13.55M | Net Income Common Stockholders |
| -24.42B | -40.47M | -22.29M | ― | -19.41M | -13.48M |
| Balance Sheet | Cash, Cash Equivalents and Short-Term Investments | ||||
| 144.78B | 151.52M | 39.49M | 41.42M | 34.89M | 32.67M | Total Assets |
| 153.77B | 170.48M | 58.73M | 50.09M | 41.33M | 34.62M | Total Debt |
| 1.25B | 1.45M | 2.24M | 2.56M | 2.87M | 318.16K | Net Debt |
| -27.55B | -9.84M | -12.46M | -7.04M | -32.01M | -32.35M | Total Liabilities |
| 3.78B | 25.02M | 36.13M | 38.31M | 9.96M | 6.42M | Stockholders Equity |
| 127.65B | 145.46M | 22.60M | 11.79M | 31.37M | 28.20M |
| Cash Flow | Free Cash Flow | ||||
| -7.37B | -41.53M | -27.64M | 1.56M | -18.01M | -10.60M | Operating Cash Flow |
| -6.47B | -40.00M | -25.60M | 4.92M | -16.81M | -10.05M | Investing Cash Flow |
| 30.97B | -116.18M | 5.11M | -35.07M | -1.20M | 5.44M | Financing Cash Flow |
| 200.84M | 152.77M | 25.58M | 4.87M | 20.23M | 33.38M |
Capricor Therapeutics Technical Analysis
Neutral
10.86
Price Trends
10.72
Positive
12.48
Negative
12.66
Negative
Market Momentum
-0.21
Negative
54.74
Neutral
88.56
Negative
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For CAPR, the sentiment is Neutral. The current price of 10.86 is above the 20-day moving average (MA) of 9.90, above the 50-day MA of 10.72, and below the 200-day MA of 12.66, indicating a neutral trend. The MACD of -0.21 indicates Negative momentum. The RSI at 54.74 is Neutral, neither overbought nor oversold. The STOCH value of 88.56 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral 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 (53)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
53 Neutral | $574.30M | ― | 0.71% | ― | 91657.69% | 97.21% | |
53 Neutral | $5.14B | 3.06 | -43.57% | 2.81% | 16.81% | -0.12% | |
52 Neutral | $496.39M | ― | -75.39% | ― | -35.92% | -62.11% | |
49 Neutral | $766.90M | ― | 91.25% | ― | -17.75% | -19.17% | |
48 Neutral | $472.51M | ― | -31.46% | ― | 6.11% | -37.79% | |
41 Neutral | $530.72M | ― | -27.04% | ― | ― | 6.72% | |
40 Neutral | $574.20M | ― | -37.07% | ― | ― | 26.24% |
* Healthcare Sector Average
Performance Comparison
CAPR
Capricor Therapeutics
10.86
4.79
78.91%
AKBA
Akebia Therapeutics
2.83
1.74
159.63%
TBPH
Theravance Biopharma
9.49
0.94
10.99%
MNMD
Mind Medicine
7.07
-0.88
-11.07%
KROS
Keros Therapeutics
14.16
-35.00
-71.20%
TYRA
Tyra Bioscience
9.59
-7.41
-43.59%
Capricor Therapeutics Earnings Call Summary
Earnings Call Date:May 13, 2025
(Q1-2025)
| % Change Since: 48.77%|
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 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.