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Capricor Therapeutics (CAPR)
NASDAQ:CAPR
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Capricor Therapeutics
(NASDAQ:CAPR)
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Rating:57Neutral
Price Target:
$22.50
▼(-26.23% Downside)
Action:ReiteratedDate:12/09/25
Capricor Therapeutics' overall score is primarily influenced by its financial challenges, including ongoing losses and cash flow issues. However, strong technical indicators and positive clinical trial results provide some optimism. The valuation remains a concern, but the potential for regulatory approval and commercialization could improve the outlook.
Positive Factors
Pivotal HOPE-3 Phase 3 efficacy
A pivotal Phase 3 showing statistically significant skeletal and cardiac benefits materially improves the probability of regulatory approval and payer acceptance. A successful HOPE-3 outcome supports durable commercial demand, partner monetization, and a clearer path to sustainable revenue if approved.
Manufacturing readiness / CMC progress
Having a GMP-ready, commercial-scale facility and resolved CMC issues reduces execution and supply risks at launch. This durable operational capability supports reliable product supply, lowers scale-up uncertainty, and strengthens long-term margins and commercialization credibility with regulators and partners.
Cash runway and non-dilutive milestone potential
A near-term cash runway into 2026 plus a sizable contingent $80M milestone provides durable financial flexibility to complete regulatory steps and initial launch activities without immediate reliance on equity markets, reducing short-term dilution risk and enabling strategic execution of commercialization plans.
Negative Factors
Persistent unprofitability
Sustained negative gross and operating margins reflect structural inability so far to generate product-level profitability. Prolonged losses strain internal capital, increase dependence on external funding, and limit reinvestment capacity, raising execution and dilution risk absent a successful product launch or partner revenue.
Weak cash generation / negative free cash flow
Variable and negative free cash flow indicates the business does not consistently self-fund development and operations. Over the medium term this increases reliance on financing or partnerships, constrains strategic optionality, and can delay or scale back commercialization investments if cash pressures persist.
Regulatory setback requiring additional evidence
A Complete Response Letter that forces HOPE-3 to provide extra evidence raises the probability of delayed approval, added trials or analyses, and higher development costs. This structural regulatory uncertainty lengthens time to revenue and increases execution risk for commercialization plans.
Capricor Therapeutics (CAPR) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$1.66B
Dividend YieldN/A
Average Volume (3M)1.30M
Price to Earnings (P/E)―
Beta (1Y)2.47
Revenue Growth-52.08%
EPS Growth-69.35%
CountryUS
Employees160
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.62
Shares Outstanding54,400,784
10 Day Avg. Volume1,844,241
30 Day Avg. Volume1,303,818
Financial Highlights & Ratios
PEG Ratio-0.31
Price to Book (P/B)3.34
Price to Sales (P/S)21.82
P/FCF Ratio-11.70
Enterprise Value/Market Cap0.84
Enterprise Value/Revenue125.07
Enterprise Value/Gross Profit-21.50
Enterprise Value/Ebitda-16.73
Forecast
1Y Price Target
$54.88Price Target Upside79.93% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering8
EPS Forecast (FY)0.32
Revenue Forecast (FY)$139.23M
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:Mar 12, 2026
(Q4-2025)
| % Change Since: |
Next Earnings Date:May 20, 2026
Earnings Call Sentiment Positive
The call conveyed predominantly positive operational and clinical developments: regulatory momentum with BLA acceptance and a clear PDUFA date, robust Phase 3 HOPE-3 efficacy and safety data (including a 91% slowing of LV ejection fraction decline and supportive functional and imaging endpoints), manufacturing readiness and planned capacity expansion, and recent financings and NASDAQ uplisting to support near-term execution. Counterbalancing these positives are biotech-typical near-term challenges—zero product revenue, materially higher operating expenses and widened net losses in 2025, remaining labeling and regulatory uncertainties, limited neutralization signals in the early StealthX readout, and a manufacturing ramp timeline that may constrain supply until expansions come online. Overall, the strategic and clinical wins (BLA acceptance, pivotal data, manufacturing inspection success, strengthened capital base) outweigh the financial and programmatic risks discussed on the call.Q4-2025 Updates
Positive Updates
BLA Acceptance and PDUFA Date
FDA accepted the company's Class II BLA resubmission for deramycin and assigned a PDUFA target action date of 2026-08-22, marking a major regulatory milestone toward potential approval.
Strong HOPE-3 Phase 3 Efficacy Data
HOPE-3 (n=106) met its primary endpoint (Performance of the Upper Limb) and all Type 1 error‑controlled secondary endpoints; left ventricular ejection fraction showed a 91% slowing of disease progression in all evaluable patients and reached stronger significance in the cardiomyopathy subgroup (p=0.01).
Functional and Imaging Benefits Demonstrated
Statistically significant improvement on a home-based Duchenne Video Assessment (DVA EAT10 BITE) corroborated PUL results (≈50 patients per arm completed DVA); MRI late gadolinium enhancement data showed meaningful reduction in cardiac fibrosis in treated patients versus placebo.
Safety and Long-Term Exposure
Deramycin safety profile reinforced by >800 intravenous infusions across studies, evidence of long-term safety in open-label extension studies with some patients receiving continuous infusions up to five years and >100 patients in OLE collectively.
Manufacturing and Commercial Readiness
In-house GMP facility in San Diego completed FDA pre-license inspection; all Form 483 observations addressed. Current capacity supports ~250 patients/year with expansion (adding ~6 clean rooms) planned to support ~2,500 patients/year (~10,000 doses annually) with full capacity expected online in late 2027.
Strengthened Balance Sheet and Capital Raise
Management stated cash position strengthened by late-December financings. CFO disclosed incremental financing events in Dec 2025: public offering net proceeds $162M and ATM draw of $75M; company believes cash is sufficient to fund operations into 2027 (management cited ~$318M cash; CFO provided detailed financing amounts).
Strategic and Visibility Wins
Company was approved for uplisting to the NASDAQ Global Select Market; management highlighted potential eligibility for a transferable Priority Review Voucher upon approval and submission of full HOPE-3 dataset for peer-reviewed publication.
Exosome Platform Progress
Phase 1 StealthX COVID vaccine (Project NextGen, NIAID) shown to be well tolerated; preclinical data and platform learnings support further engineering of exosomes for muscle targeting and multiple payloads with IND-enabling programs targeting IND filing in 2027.
Negative Updates
Revenue Decline to Zero
Revenue for 2025 was $0 (versus $11.1M in 2024); full-year revenue 2025 was $0 compared to $22.3M in 2024 (a 100% year-over-year decline) as prior milestone/upfront payments were fully recognized in 2024.
Significantly Higher Operating Expense and Wider Losses
Full-year operating expenses rose to $108.1M in 2025 from $64.8M in 2024 (+≈66.9%), driven by clinical, regulatory, manufacturing and infrastructure investments. Net loss widened to ~$105.0M in 2025 from ~$40.5M in 2024 (increase of ~159.3%).
Regulatory and Labeling Uncertainty Remains
Although BLA resubmission accepted, final label scope (cardiomyopathy-only vs broader DMD indication and potential age/function limits) has not been negotiated with FDA; the company noted FDA has not identified review issues but labeling discussions remain unresolved.
StealthX Early Immunogenicity Limitations
Phase 1 StealthX vaccine showed favorable safety but limited neutralization at tested dose levels; NIAID requested exploring higher doses and adjuvants, introducing additional development choices and uncertainty for that program.
Near-Term Manufacturing Capacity Constraints
Current facility can support only ~250 patients/year before expansion; expansion to ~2,500 patients/year is planned but not available until late 2027, which could constrain supply if demand or rapid transition of trial patients occurs sooner.
Ambiguity in Reported Cash Figures
Transcript contains inconsistent cash statements (management cited approximately $318,000,000 as of 12/31/2025 while CFO remarks include financing details that—if mis-typed—create ambiguity in the reported cash total); clear cash runway messaging depends on reconciling these figures.
Uncertainty on PRV Value and Timing
Potential to receive a Priority Review Voucher (PRV) upon approval was noted, but market value is uncertain (analyst cited a recent PRV sale at $205M and a PRV sunset date of 2029-09-30), creating variability in potential monetization expectations.
Company Guidance
Management said the resubmitted BLA was accepted and assigned a PDUFA target action date of August 22, 2026, supported by the pivotal HOPE‑3 trial (106 patients) which met its primary PUL endpoint and all Type‑1‑error‑controlled secondary endpoints, with left ventricular ejection fraction showing a 91% slowing of disease progression (statistically significant overall and p=0.01 in the cardiomyopathy subgroup); the program has >800 IV infusions across studies, >100 OLE patients (some on continuous infusions up to five years), and manufacturing passed the FDA pre‑license inspection with all Form‑483s addressed and current capacity to support ~250 patients/year (with stockpiling plans) and an expansion (≈6 additional clean rooms) expected to support ~2,500 patients/year or ~10,000 doses annually coming online in late‑2027; financially the company reported cash of approximately $318,000,000 as of 12/31/2025 (the CFO also reported cash, cash & marketable securities of ~$3.181 billion), received $162,000,000 net proceeds from a December offering and drew $75,000,000 under an ATM, had 2025 revenue of $0 (vs ~$22.3M FY‑2024), FY‑2025 operating expenses of ~$108.1M (vs $64.8M FY‑2024) and a FY‑2025 net loss of ~$105.0M (vs $40.5M FY‑2024), believes current capital funds operations into 2027, and noted eligibility for a transferable priority review voucher (sunset 09/30/2029) upon approval.Capricor Therapeutics Financial Statement Overview
Summary
Capricor Therapeutics faces financial challenges typical of the biotechnology sector, with high R&D costs and irregular revenue streams. Despite a strong equity position, the company struggles with profitability and cash flow generation. Revenue growth potential exists, but operational inefficiencies and persistent losses pose significant risks.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 | 11.13M | 22.27M | 25.18M | 2.55M | 244.90K | 310.25K |
| Gross Profit | -64.75M | -27.70M | -11.27M | -19.27M | 244.90K | 310.25K |
| 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 Assets | 126.44M | 170.48M | 58.73M | 50.09M | 41.33M | 34.62M |
| Cash, Cash Equivalents and Short-Term Investments | 98.57M | 151.52M | 39.49M | 41.42M | 34.89M | 32.67M |
| Total Debt | 14.54M | 1.45M | 2.24M | 2.56M | 2.87M | 318.16K |
| Total Liabilities | 42.57M | 25.02M | 36.13M | 38.31M | 9.96M | 6.42M |
| Stockholders Equity | 83.87M | 145.46M | 22.60M | 11.79M | 31.37M | 28.20M |
Cash Flow | ||||||
| Free Cash Flow | -68.38M | -41.53M | -27.64M | 1.56M | -18.01M | -10.60M |
| Operating Cash Flow | -61.04M | -40.00M | -25.60M | 4.92M | -16.81M | -10.05M |
| Investing Cash Flow | -68.99M | -116.18M | 5.11M | -35.07M | -1.20M | 5.44M |
| Financing Cash Flow | 81.16M | 152.77M | 25.58M | 4.87M | 20.23M | 33.38M |
Capricor Therapeutics Technical Analysis
Positive
30.50
Price Trends
25.91
Positive
20.09
Positive
14.17
Positive
Market Momentum
1.86
Negative
58.74
Neutral
65.01
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 30.5 is above the 20-day moving average (MA) of 28.10, above the 50-day MA of 25.91, and above the 200-day MA of 14.17, indicating a bullish trend. The MACD of 1.86 indicates Negative momentum. The RSI at 58.74 is Neutral, neither overbought nor oversold. The STOCH value of 65.01 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
UnderperformOutperform
Sector (51)
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
57 Neutral | $1.66B | -11.68 | -90.96% | ― | -52.08% | -69.35% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
47 Neutral | $424.90M | -2.14 | -47.27% | ― | ― | ― | |
46 Neutral | $199.24M | -8.32 | ― | ― | ― | 18.82% | |
46 Neutral | $242.80M | -1.08 | -224.96% | ― | 12.26% | 37.36% | |
45 Neutral | $223.88M | -3.93 | 853.54% | ― | ― | 82.23% |
* Healthcare Sector Average
CAPR
Capricor Therapeutics
30.50
17.62
136.80%
GALT
Galectin Therapeutics
3.09
1.48
91.93%
ALEC
Alector
2.20
0.82
59.42%
FDMT
4D Molecular Therapeutics
8.33
4.15
99.28%
HUMA
Humacyte
1.16
-1.85
-61.46%
Capricor Therapeutics Corporate Events
Private Placements and Financing
Capricor Therapeutics Announces $150 Million Public Offering
Neutral
Dec 5, 2025
On December 5, 2025, Capricor Therapeutics announced the pricing of a public offering of 6,000,000 shares of common stock at $25.00 per share, expected to generate gross proceeds of $150 million. The proceeds will support the development and manufacturing of product candidates, working capital, and general corporate purposes, with the offering anticipated to close on December 8, 2025, subject to customary conditions.
The most recent analyst rating on (CAPR) stock is a Hold with a $26.00 price target. To see the full list of analyst forecasts on Capricor Therapeutics stock, see the CAPR Stock Forecast page.
Business Operations and StrategyProduct-Related Announcements
Capricor Therapeutics Reports Positive HOPE-3 Trial Results
Positive
Dec 3, 2025
On December 3, 2025, Capricor Therapeutics provided an update on the top-line results from its HOPE-3 Phase 3 trial during a conference call. The trial, which involved 106 patients, focused on the efficacy and safety of Deramiocel for treating Duchenne muscular dystrophy. The results indicated significant improvements in skeletal muscle function and cardiac endpoints, confirming the findings of previous trials. The trial met its primary and key secondary endpoints, demonstrating a favorable long-term safety profile and sustained efficacy over four years. This development could potentially enhance Capricor’s position in the biotechnology industry and provide new treatment options for patients with high unmet needs.
The most recent analyst rating on (CAPR) stock is a Hold with a $6.50 price target. To see the full list of analyst forecasts on Capricor Therapeutics stock, see the CAPR Stock Forecast page.
Business Operations and StrategyProduct-Related Announcements
Capricor Therapeutics Announces Positive Phase 3 Trial Results
Positive
Dec 3, 2025
On December 3, 2025, Capricor Therapeutics announced positive topline results from its pivotal Phase 3 HOPE-3 clinical trial evaluating Deramiocel in boys and young men with Duchenne muscular dystrophy. The trial demonstrated statistically significant improvements in both skeletal and cardiac function, meeting its primary and key secondary endpoints. These results highlight Deramiocel’s potential as a first-in-class therapy for Duchenne cardiomyopathy, a leading cause of mortality in DMD. The company, in collaboration with its commercial partner Nippon Shinyaku, is advancing launch readiness activities to support patient access, pending regulatory approval.
The most recent analyst rating on (CAPR) stock is a Hold with a $6.50 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.