Want to see CAPR full AI Analyst Report?
Top Page
Capricor Therapeutics
(NASDAQ:CAPR)
Select Model
Select Model
Rating:46Neutral
Price Target:
$4.00
▼(-79.70% Downside)
Action:Reiterated
Date:08/01/26
The score is held down primarily by weak financial performance (ongoing losses and escalating cash burn) and very poor technical positioning (shares far below major moving averages). Valuation support is limited due to negative earnings, while the earnings call and corporate updates provide some upside from clinical/regulatory progress but are tempered by advisory-committee and litigation/commercialization risks.
Positive Factors
Pivotal Phase 3 efficacy
A statistically significant Phase 3 result provides durable clinical proof-of-concept for deramiocel in DMD, strengthening regulatory credibility, payer conversations, and the company’s ability to defend labeling and use cases over the next several quarters regardless of short-term market moves.
Negative Factors
Persistent cash burn and no product revenue
Zero product revenue and sustained negative operating and free cash flow mean the company remains dependent on financing to fund operations and commercialization. Persistent cash burn undermines self-funding, increases dilution or debt risk, and constrains strategic optionality long-term.
Read all positive and negative factors
Positive Factors
Negative Factors
Pivotal Phase 3 efficacy
A statistically significant Phase 3 result provides durable clinical proof-of-concept for deramiocel in DMD, strengthening regulatory credibility, payer conversations, and the company’s ability to defend labeling and use cases over the next several quarters regardless of short-term market moves.
Read all positive factors
Capricor Therapeutics (CAPR) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$242.65M
Dividend YieldN/A
Average Volume (3M)1.65M
Price to Earnings (P/E)―
Beta (1Y)2.17
Revenue Growth-100.00%
EPS Growth-62.96%
CountryUS
Employees231
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-2.32
Shares Outstanding57,911,892
10 Day Avg. Volume1,657,460
30 Day Avg. Volume1,646,431
Financial Highlights & Ratios
PEG Ratio-0.13
Price to Book (P/B)4.39
Price to Sales (P/S)0.00
P/FCF Ratio-18.45
Enterprise Value/Market Cap<0.01
Enterprise Value/RevenueN/A
Enterprise Value/Gross Profit>-0.01
Enterprise Value/Ebitda<0.01
Forecast
1Y Price Target
$4.90Price Target Upside-75.13% Downside
Rating ConsensusHold
Number of Analyst Covering10
EPS Forecast (FY)-0.55
Revenue Forecast (FY)$113.42M
Capricor Therapeutics Business Overview & Revenue Model
Company Description
Capricor Therapeutics, Inc. (CAPR) is a biotechnology company focused on developing cell- and exosome-based therapeutics for rare diseases, with its lead clinical program centered on Duchenne muscular dystrophy (DMD). The company’s development eff...
How the Company Makes Money
null...
Capricor Therapeutics Earnings Call Summary
Earnings Call Date:May 12, 2026
(Q1-2026)
| % Change Since: |
Next Earnings Date:Aug 12, 2026
Earnings Call Sentiment Positive
The call conveyed strong clinical and regulatory progress for deramiocel — statistically significant phase 3 efficacy (primary and cardiac secondary endpoints), robust long-term safety exposure, active BLA review with a clear PDUFA date, in-house manufacturing capabilities and a solid cash runway. Management also articulated a concrete commercialization plan and eligibility for a monetizable Priority Review Voucher. Offsetting these positives are notable near-term risks: an active lawsuit with NS Pharma that creates distribution uncertainty (and potential need to repay $50M), rising operating expenses and no current product revenue, manufacturing labeling constraints for an ultra-cold-chain therapy, and unresolved ASP/AMP payer complexities that could affect access. On balance, the material clinical/regulatory achievements and internal control of manufacturing and cash resources outweigh the legal and commercial execution risks, but the litigation and payer/pricing issues remain important near-term uncertainties.Positive Updates
Pivotal Phase 3 Efficacy — HOPE-3 Met Primary Endpoint
HOPE-3 (n=106) met its primary endpoint (PUL v2.0) with ~54% reduction in disease severity at 12 months (p=0.029). All type-1-error controlled secondary endpoints were also significant, supporting clinical benefit in Duchenne muscular dystrophy (DMD).
Negative Updates
Litigation with NS Pharma / Nippon Shinyaku
Capricor filed suit (May 7, 2026) seeking rescission of the U.S. distribution agreement and a preliminary injunction to permit Capricor to distribute deramiocel. Litigation introduces material uncertainty around commercial distribution and timing; outcome depends on court rulings.
Read all updates
Q1-2026 Updates
Positive
Negative
Pivotal Phase 3 Efficacy — HOPE-3 Met Primary Endpoint
HOPE-3 (n=106) met its primary endpoint (PUL v2.0) with ~54% reduction in disease severity at 12 months (p=0.029). All type-1-error controlled secondary endpoints were also significant, supporting clinical benefit in Duchenne muscular dystrophy (DMD).
Read all positive updates
Company Guidance
Management said the deramiocel BLA resubmission (classified as a Class 2, accepted as complete) is under active FDA review with a PDUFA target action date of August 22, 2026 and near‑term labeling discussions expected; they highlighted HOPE‑3 Phase 3 results from 106 patients (1:1 randomization) showing ~54% reduction in disease severity on PUL v2.0 at 12 months (p=0.029), LVEF slowing of ~91% in all evaluable patients and ~120% in the cardiomyopathy subset (p=0.01), noted >800 IV infusions completed and ~90 open‑label extension patients with up to 5 years of dosing supporting safety, and said FDA information requests have been primarily CMC/clinical clarifications; commercial and manufacturing guidance included an in‑house PLI‑inspected facility able to support ~200–250 patients/year (≈1,000 doses/year at 4 doses/patient), a planned expansion to ~2,000–2,500 patients/year (~10,000 doses/year) with full validation targeted in 2027, plans to stockpile commercial doses once labeling is set (including an interim label solution for the ultracold product), upcoming EMA/PMDA engagements, potential receipt/monetization of a Priority Review Voucher upon approval, and financials of ~$279M cash (3/31/2026) with Q1 2026 operating expenses of ~$36.8M (vs ~$25M in Q1 2025) and a Q1 2026 net loss of ~$33.9M ($0.59/share), which management believes provides runway into 2027.Capricor Therapeutics Financial Statement Overview
Summary
Income Statement
18
Very Negative
Balance Sheet
62
Positive
Cash Flow
21
Negative
| Breakdown | TTM | Dec 2025 | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 0.00 | 0.00 | 22.27M | 25.18M | 2.55M | 244.90K |
| Gross Profit | -42.41M | 0.00 | -27.70M | -11.27M | -19.27M | 244.90K |
| EBITDA | 893.33M | -100.11M | -39.04M | -21.22M | -28.49M | -19.78M |
| Net Income | -114.59M | -105.04M | -40.47M | -22.29M | -29.02M | -20.02M |
Balance Sheet | ||||||
| Total Assets | 326.28M | 355.95M | 170.48M | 58.73M | 50.09M | 41.33M |
| Cash, Cash Equivalents and Short-Term Investments | 278.61M | 318.13M | 151.52M | 39.49M | 41.42M | 34.89M |
| Total Debt | 21.12M | 17.94M | 4.83M | 5.61M | 5.94M | 6.25M |
| Total Liabilities | 47.58M | 50.16M | 25.02M | 36.13M | 38.31M | 9.96M |
| Stockholders Equity | 278.70M | 305.79M | 145.46M | 22.60M | 11.79M | 31.37M |
Cash Flow | ||||||
| Free Cash Flow | -113.96M | -72.72M | -41.53M | -27.64M | 1.56M | -18.01M |
| Operating Cash Flow | -92.63M | -69.81M | -40.00M | -25.60M | 4.92M | -16.81M |
| Investing Cash Flow | -81.05M | 97.48M | -116.18M | 5.11M | -35.07M | -1.20M |
| Financing Cash Flow | 250.31M | 248.89M | 152.77M | 25.58M | 4.87M | 20.23M |
Capricor Therapeutics Risk Analysis
Capricor Therapeutics disclosed 30 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 |
|---|---|---|---|---|---|---|---|
54 Neutral | $526.42M | -3.83 | -36.83% | ― | 383560.87% | 20.87% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
46 Neutral | $242.65M | -1.66 | -59.27% | ― | -100.00% | -62.96% | |
46 Neutral | $181.09M | -1.11 | -2781.56% | ― | 289.94% | 16.60% | |
44 Neutral | $212.72M | -7.30 | 21.05% | ― | ― | 43.38% | |
43 Neutral | $179.86M | -1.27 | -295.17% | ― | -79.15% | 5.68% |
* Healthcare Sector Average
CAPR
Capricor Therapeutics
3.85
-4.05
-51.27%
GALT
Galectin Therapeutics
2.97
-0.68
-18.63%
ALEC
Alector
1.51
0.06
4.14%
FDMT
4D Molecular Therapeutics
10.18
3.76
58.57%
HUMA
Humacyte
0.65
-1.63
-71.36%
Capricor Therapeutics Corporate Events
Business Operations and StrategyRegulatory Filings and Compliance
Capricor Faces FDA Panel Setback on Deramiocel Therapy
Negative
Jul 30, 2026
On July 29, 2026, the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee concluded that current evidence does not support the effectiveness of Capricor Therapeutics‘ Deramiocel for treating cardiomyopathy in Duchenne muscular...
Business Operations and StrategyProduct-Related AnnouncementsRegulatory Filings and Compliance
Lancet Validates Capricor’s HOPE-3 Duchenne Trial Results
Positive
Jul 29, 2026
On July 29, 2026, Capricor reported that The Lancet published the final one-year results from its Phase 3 HOPE-3 trial of Deramiocel in Duchenne muscular dystrophy, confirming the study met its primary endpoint with a 54% slowing of upper limb fun...
Business Operations and Strategy
Capricor Therapeutics Signs Strategic Headquarters Lease Agreement
Positive
Jul 15, 2026
On July 9, 2026, Capricor Therapeutics signed a lease for approximately 171,000 rentable square feet at 9625 Towne Centre Drive in San Diego to serve as its new headquarters with expanded manufacturing, RD labs and corporate offices. The lease ter...
Business Operations and StrategyProduct-Related AnnouncementsRegulatory Filings and Compliance
Capricor Faces FDA Advisory Review for DMD Therapy
Positive
Jun 26, 2026
On June 26, 2026, Capricor Therapeutics announced that the U.S. Food and Drug Administration’s Cellular, Tissue, and Gene Therapies Advisory Committee will meet on July 29, 2026, to review its Biologics License Application for Deramiocel, an...
Business Operations and StrategyLegal Proceedings
Capricor Sues NS Pharma Over Deramiocel U.S. Rights
Negative
May 7, 2026
On May 7, 2026, Capricor Therapeutics filed a lawsuit in the Superior Court of New Jersey against Nippon Shinyaku and its U.S. unit NS Pharma over their U.S. distribution agreement for Deramiocel, its investigational Duchenne muscular dystrophy th...
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.