Capricor Therapeutics Inc
🔔 Watch stock
Assessment
Our Rating
A journalistic assessment by our editorial team at the time of the deep dive — it rates the company, not the entry point. Not investment advice and not a solicitation to buy or sell.
The business works in principle, but one material question is open. As long as it stays open, our findings do not carry a quality verdict.
Why this colour
This rating judges the company, not the stock and not the entry point. Every documented marker for the red level is absent: no going-concern warning, no negative equity, no over-indebtedness, no listing risk for financial reasons. On the contrary, as of March 31, 2026 the company held $278.6 million in cash and marketable securities against $47.6 million of total liabilities, and the quarterly report filed May 13, 2026 calls the funds sufficient for at least twelve months; on the arithmetic, depending on the pace of spending, that is about seven to ten quarters of runway. What is missing for the green level, though, is the essential thing: there is no operating business. Revenue was zero in 2025 and in the first quarter of 2026, and the entire outcome hangs on one single event — the FDA decision on deramiocel, scheduled for August 22, 2026, after the same agency sent a rejection letter in July 2025. On July 27, 2026 it went further in the briefing document for the advisory committee meeting: no statutory evidence of effectiveness, the primary endpoint missed, hypersensitivity reactions at 41.5 against 15.4 percent, an unfavorable benefit-risk profile. The company contradicted this publicly the same day and holds the primary endpoint to have been met under the final version of its analysis plan. Nothing is decided by that — the committee recommendation was still outstanding at the cut-off, the agency ruling all the more so. But a yes is plainly no longer a formality. On top of that sits an open operational question that even a yes from the FDA would not answer: the exclusive U.S. distributor has been the defendant since May 7, 2026, and the company says itself it has no commercialization experience. This is exactly the situation the yellow level exists for — the business can work, but one material operational question is open. On price the rating deliberately says nothing: whether the stock is expensive or cheap is for the scanners to decide. The decision is yours.
What the thesis turns on
Assessment: Opportunities & Risks
Capricor Therapeutics is the countdown trap in its purest form: a date on the calendar — August 22, 2026 — appears to replace the analysis. The balance sheet really is strong ($278.6 million in cash and marketable securities, $47.6 million of liabilities, no going-concern warning), and the Phase 3 data hold up statistically on the company's account. But revenue has been zero since 2025, the FDA already said no to this product in July 2025 and questions both efficacy and safety again in its briefing document of July 27, 2026 — the company publicly disputes that reading — and the exclusive U.S. distributor is now both defendant and major shareholder. Whoever invests here is not buying a metric but three consecutive yeses: from the agency, from the court and from the health care system. Not investment advice.
Balance sheet and funding
Unusually strong for a biotech with no approved product: $278.6 million in cash and marketable securities as of March 31, 2026 against only $47.6 million of total liabilities and $278.7 million of equity — equity consists almost entirely of money. The quarterly report filed May 13, 2026 calls the funds sufficient for at least twelve months; there is no going-concern warning. The only interest-bearing debt as of March 31, 2026 was the $6.3 million CIRM loan; under the repayment agreement documented in April 2026 it fell due no later than June 12, 2026, and no filing submitted so far confirms that it was settled.
Clinical data and regulatory path
On the company's account the Phase 3 HOPE-3 trial delivered statistically significant results in December 2025 (upper-limb function 54 percent slowing, p = 0.029; ejection fraction 91 percent, p = 0.041, across 106 randomized participants), with cardiac scarring data following in March 2026 (p = 0.022). The agency reads the same data differently: after the rejection letter of July 2025 it again holds, in its briefing document of July 27, 2026 for the advisory committee meeting, that the pre-specified primary endpoint was not met and the statutory evidence of effectiveness not established; it also objects to changes made to the statistical analysis plan after unblinding and reports hypersensitivity reactions in 22 of 53 treated participants (41.5 percent) against 8 of 52 on placebo (15.4 percent), plus an unfavorable benefit-risk profile. Capricor contradicted this publicly on July 27, 2026: the governing document, it says, is the final version of the analysis plan (SAP 3.0), finalized before unblinding, under which the primary endpoint PUL 2.0 was met with statistical significance. The target action date of August 22, 2026 is the second attempt, and the agency put its doubts on the record before the meeting.
Business model and revenue
There is no operating business: revenue was zero in 2025 and in the first quarter of 2026; the $25.2 million of 2023 and $22.3 million of 2024 were upfront and milestone payments from the distribution partner, fully used up by the end of 2024. The net loss climbed to $105.0 million in 2025 and $33.9 million in the first quarter of 2026. The entire value of the company rests on a single product candidate.
Route to market and partner conflict
The exclusive U.S. distributor Nippon Shinyaku/NS Pharma has been the defendant since May 7, 2026: Capricor is asking the Superior Court of New Jersey to rescind the agreement of January 24, 2022 — the same agreement that promises $80.0 million on approval and a 30 to 50 percent revenue share. The partner simultaneously owns more than 10 percent of Capricor stock, and the company concedes in its risk factors that it does not have experience in the commercialization, marketing, sale or distribution of pharmaceutical products on a commercial scale. Since May 25, 2026 there is at least a chief commercial officer (insider filing Form 3 of May 28, 2026); the risk factor in the quarterly report of May 13, 2026 stands unchanged. The binding European term sheet of September 16, 2024 expired on April 1, 2026.
Dilution and legal exposure
Shares outstanding rose from 31,148,320 (December 31, 2023) to 57,911,893 (May 11, 2026), up 86 percent; options and warrants on 17,249,737 more sit against 100 million of authorized capital. Roughly $600 million has been raised since inception against an accumulated deficit of $338.8 million. The 2025 rejection letter produced a securities class action (July 17, 2025) and two derivative actions against the board, with no material reserves as of March 31, 2026.
Worth Noting
Capricor reached our research list through the SEC filing calendar: the current report (8-K) of June 26, 2026 names July 29, 2026 as the date of the FDA advisory committee meeting and August 22, 2026 as the target action date under the Prescription Drug User Fee Act. An advisory committee issues a recommendation; the agency itself makes the decision. It did not arrive through a metric: as of July 28, 2026 Capricor appears in none of our in-house stock scanners, and those lists are recalculated daily.
On price: no daily price serves as a yardstick in this analysis, because around an advisory committee meeting and a target action date it can multiply or collapse within hours — which is exactly what happened on July 27, 2026, when the stock fell 64.5 percent against the July 24, 2026 close (from $19.70 to $6.995) after the FDA briefing document was released. What is quoted is therefore only the dated order of magnitude: market capitalization of roughly $405 million at the July 27, 2026 close (57,911,893 shares at $6.995; the share count and market capitalization in the fundamental-data feed match the quarterly report to the digit). The most recent market price documented in an SEC filing, by contrast, is $30.38 per share, from an insider filing (Form 4) of June 29, 2026 covering a sale on June 25, 2026. What is not reliable is the trailing-twelve-month revenue of roughly $11.1 million shown in the feed: per the financial statements, revenue was zero in 2025 and in the first quarter of 2026. Revenue, earnings and balance-sheet figures are therefore taken from the filings only.
Recency note: the most recent quarterly report (10-Q) is dated May 13, 2026 and has been fully evaluated. Everything filed afterwards has been reviewed — the current reports 8-K of June 8, 2026 (annual meeting; shareholders rejected the proposed officer exculpation amendment, and Rose, Snyder & Jacobs LLP was ratified as auditor) and July 14, 2026 (lease), the initial insider statement (Form 3) of May 28, 2026 recording the appointment of Michael T. Maurer as chief commercial officer effective May 25, 2026, plus insider filings (Form 4) and notices of proposed sale (Form 144) from May and June 2026. There was no new share registration (shelf and prospectus filings S-3 and 424B) and no capital raise after March 31, 2026; there is no deregistration notice (Form 15) and no delisting application (Form 25) — the Nasdaq listing continues. The most recent SEC filing on record is the current report of July 14, 2026. Considered outside the SEC filings: the FDA briefing document for the July 29, 2026 advisory committee meeting, released July 27, 2026 (a primary source, read in full), Capricor's rebuttal in its press release of the same day, and the price reaction of that day. No current report (8-K) covering that rebuttal exists. The outcome of the meeting and the figures for the quarter ended June 30, 2026 were not available at the time of writing.
Do not confuse: SEC identifier 0001133869 previously carried the names Nile Therapeutics and SMI Products; Capricor went public in 2013 through a merger with a Nile subsidiary. Deramiocel was called CAP-1002 in older trials and releases — it is the same product. Analyses are evergreen; daily prices are not a buy argument.
Stock Watch
This analysis is as of August 26, 2026. Stock Watch will tell you what's changed at CAPR since then.
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Price history
Chart
Interactive price chart (TradingView).
52-week range: 3.90 $ to 35.30 $ · Last price: 9.40 $ (As of: September 17, 2026)
Key figures
Key figures at a glance
Every figure we hold for this stock, grouped by topic. The question mark next to a label explains what the number means.
Basics
Performance
Technical Indicators
Calculated from the price history · as of 09/18/2026
Valuation
Profitability
Balance Sheet & Safety
Growth
Dividend
This stock currently pays no dividend.
Quality & Screener
Highlighted are things our editorial team noticed: green = stands out as strong, red = deserves a closer look. No single metric is a verdict on its own — always read it in context.
Comparison
Industry comparison
The stock alongside the largest companies in the same group. The median row is the middle value of the companies shown above — not of the whole industry.
Industry: Biotechnology
| Company | Market cap ($B) | P/E | EV/EBITDA | Gross Margin % | EBIT Margin % | Sales Growth (Year) % | Perf. 1Y % |
|---|---|---|---|---|---|---|---|
| Capricor Therapeutics Inc CAPR | 2.3 | – | -2.7 | -896.1 | 0.0 | -100.0 | 54.9 |
| Vertex Pharmaceuticals Inc VRTX | 130.6 | 31.3 | 24.5 | 55.0 | 38.1 | 9.6 | 33.4 |
| Regeneron Pharmaceuticals Inc REGN | 82.0 | 19.9 | 13.1 | 44.5 | 20.7 | 1.0 | 35.5 |
| Moderna Inc MRNA | 62.7 | – | 4.6 | -66.0 | -131.1 | -39.2 | 532.3 |
| argenx NV ARGX | 61.9 | 38.1 | 34.2 | 59.1 | 32.0 | 89.6 | 30.9 |
| Revolution Medicines Inc RVMD | 40.9 | – | -9.7 | -174,708.6 | 0.0 | -100.0 | 338.3 |
| BeiGene, Ltd. ONC | 40.0 | 63.1 | 34.1 | 88.9 | 19.1 | 40.2 | 6.4 |
| Alnylam Pharmaceuticals Inc ALNY | 32.6 | 61.8 | 28.4 | 79.7 | 23.0 | 65.2 | -48.1 |
| Royalty Pharma Plc RPRX | 32.5 | 31.8 | 19.6 | 95.8 | 100.3 | 5.1 | 68.6 |
| Median of companies shown | 40.9 | 34.9 | 19.6 | 55.0 | 20.7 | 5.1 | 35.5 |
Based on the most recently reported figures. Only stocks from the same trading venue are lined up, so the market caps are counted in one currency. Compare in a chart →
Fiscal years
Annual Figures
Fiscal years from the audited annual reports, oldest first. EBIT is the operating profit before interest and taxes; total assets are everything the company owns.
Revenue, operating income and net income per fiscal year $M
Revenue Operating income Net income
| Fiscal Year | Revenue ($M) | EBIT ($M) | Net Income ($M) | EPS ($) | Operating Cash Flow ($M) | Equity ($M) | Total Assets ($M) |
|---|---|---|---|---|---|---|---|
| 2016 | 3 | -17 | -19 | -10.14 | -16 | -4 | 19 |
| 2017 | 1 | -13 | 2 | 0.91 | -14 | 11 | 16 |
| 2018 | 2 | -15 | -15 | -5.17 | -14 | 5 | 9 |
| 2019 | 1 | -8 | -8 | -2.06 | -7 | 7 | 11 |
| 2020 | 0 | -14 | -14 | -0.88 | -10 | 28 | 35 |
| 2021 | 0 | -21 | -20 | -0.87 | -17 | 31 | 41 |
| 2022 | 3 | -30 | -29 | -1.18 | 5 | 12 | 50 |
| 2023 | 25 | -24 | -22 | -0.83 | -26 | 23 | 59 |
| 2024 | 22 | -43 | -40 | -1.15 | -40 | 145 | 170 |
| 2025 | 0 | -108 | -105 | -2.26 | -70 | 306 | 356 |
Quarters
Quarterly Figures
Each bar is one quarter, the last one is the most recent. Use the switch to step through the individual figures.
Revenue & Profit
Cash Flow
Balance Sheet
Margins
Per Share
Click the chart or tab into it, then use ← and → to step through the periods.
None of the selected stocks reports this metric. Pick another metric or switch between annual and quarterly.
· Total · per year
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The figures could not be loaded right now.
Source: fundamental data
| Quarter | EPS (Earnings Per Share) | EPS YoY (%) | Sales ($M) | Sales YoY (%) | Net Margin (%) | OCF ($M) | FCF ($M) |
|---|---|---|---|---|---|---|---|
| 2024: Q4 | -0.20 | – | 11 | -7.90 | -63.90 | -15 | -16 |
| 2025: Q1 | -0.53 | – | 0 | -100.00 | – | -6 | -8 |
| 2025: Q2 | -0.57 | – | 0 | -100.00 | – | -20 | -22 |
| 2025: Q3 | -0.54 | – | 0 | -100.00 | – | -20 | -24 |
| 2025: Q4 | -0.62 | – | 0 | -100.00 | – | -24 | -29 |
| 2026: Q1 | -0.59 | – | 0 | – | – | -29 | -40 |
| 2026: Q2 | -0.70 | -22.80 | – | – | – | -32 | -36 |
What Do These Terms Mean?
- EPS (Earnings Per Share):
- Quarterly profit divided by the total share count — how much of the profit works out to a single share.
- YoY (Year over Year):
- Change versus the same quarter a year ago — this is how you compare without seasonal distortion (e.g. the holiday shopping season).
- Sales:
- All revenue for the quarter, before any costs are deducted — the top line of the income statement.
- Net Margin:
- What percentage of sales is left over as profit in the end. Negative means the company is posting a loss.
- OCF (Operating Cash Flow):
- The cash that actually flows into the till from the core business during the quarter — harder to dress up than book profit.
- FCF (Free Cash Flow):
- Operating cash flow minus capital expenditures — the money that's genuinely free to use, say for paying down debt, buybacks, or dividends.
Screening
Appears in These Scanners
This stock currently matches 13 of our scanner strategies — each hit links to the scanner.
Quality & Balance Sheet
Breakout & Setup
Momentum & Trend
- 21-EMA Trend
- Gary Antonacci: Dual Momentum (Stock Adaptation)
- Kathy Donnelly: Liquid Movers Up
- Power Trend
- RS Leader (≥90)
- Stan Weinstein: Stage 2
Research
Only genuine hits from verified scanners count; pure ranking metrics (P/E, P/S, and similar, which just sort the whole universe) don't count as a hit. View all scanners
Outlook
Analysts & Price Target
Combined picture of the price targets and recommendations of every analyst covering the stock. Price targets are expectations for the next 12 months, not promises — and they often follow the price rather than predict it.
Distribution of Recommendations
Estimates by Fiscal Year
| Fiscal Year | EPS Estimate ($) | EPS Range ($) | Revenue Estimate ($M) | Expected Growth | Analysts |
|---|---|---|---|---|---|
| 12/31/2026 | -1.45 | -2.75 – 1.70 | 56 | 35.7% | 9 |
| 12/31/2027 | -1.48 | -2.84 – 0.62 | 57 | -1.8% | 9 |
Average of the analyst estimates for the coming fiscal years. The range shows how far the most optimistic and the most cautious estimate sit apart — the wider it is, the less certain the expectation.
Valuation
What is priced in?
Free cash flow over the past twelve months is negative, which rules out a serious reverse calculation. Any growth rate only makes a negative cash flow more negative; no present value comes out of it. What the price reflects here is therefore not a stream of cash flows, but the expectation that there will be one at all.
A simplified model calculation — not a forecast and not a recommendation.
AI classification
AI Rating
Geprüft am 28.07.2026 gegen den Geschäftsbericht (10-K) für 2025 (eingereicht 17.03.2026), den Geschäftsbericht (10-K) für 2024 (eingereicht 26.03.2025) sowie die vier jüngsten Quartalsberichte (10-Q) bis zum 31.03.2026 (eingereicht 13.05.2026): In den sechs ausgewerteten SEC-Filings von Capricor Therapeutics gibt es keinen wesentlichen KI-Bezug. Über alle sechs Dokumente hinweg fällt der Begriff „artificial intelligence“ kein einziges Mal, „machine learning“ kein einziges Mal; die einzige Erwähnung überhaupt ist ein einzelnes „AI“ in den Risikofaktoren des 10-K für 2025, und zwar über das Verhalten der US-Arzneimittelbehörde, nicht über das eigene Geschäft: „The administration and agencies have also made abrupt announcements about new or changed regulatory policies, such as policies related to use of AI to review product applications.“ (deutsch: „Die Regierung und die Behörden haben zudem abrupt neue oder geänderte regulatorische Vorgaben angekündigt, etwa Vorgaben zum Einsatz von KI bei der Prüfung von Zulassungsanträgen.“) Das ist eine Aussage über regulatorische Unwägbarkeiten im Umfeld — weder eine KI-Umsatzquelle noch ein belegter operativer KI-Einsatz noch ein konkretes KI-Geschäftsrisiko für das eigene Modell, wie es der Kriterienkatalog für „bedroht“ verlangt. Capricor ist ein Zelltherapie-Entwickler ohne Produktumsatz; die Wertschöpfung liegt in Herstellung und klinischer Prüfung von Deramiocel (CAP-1002), nicht in Software. Damit bleibt es nach der Vorrang-Regel bei „neutral“ (Negativ-Befund, geprüfte Filings vollständig gelistet).
View the full file — quotes, sources, reviewed filings
Filings Reviewed: 10-Q 2026-05-13 · 10-Q 2025-11-10 · 10-Q 2025-08-11 · 10-Q 2025-05-14 · 10-K 2026-03-17 · 10-K 2025-03-26
Rated on July 28, 2026 · How the Rating Is Built
Growth
Growth Score
Ten checks against the annual reports — each one passed counts a point.
- Revenue grows by more than 15% a year over three years -100.0%
- More than 10% revenue growth is expected for the coming year -1.2%
- Share count grows by less than 3% a year 23.7%
- Revenue growth plus cash-flow margin add up to at least 40 ("Rule of 40") no data
- Gross margin at 40% or higher and without meaningful erosion no data
- Goodwill from acquisitions does not grow faster than revenue 0.0%
- Net debt below twice EBITDA 300 m net cash
- Operating cash flow covers the profits of the last three years 32 m
- Return on capital at 15% or higher, or up versus two years ago -33.8%
- Insiders hold at least 10% or are net buyers 9.5%
A criterion without figures counts neither as passed nor as failed; a score is only produced from 7 judgeable criteria upwards. Source: fundamental data. All ten criteria in detail
Quality check
AAQS
1/10The AAQS (AlleAktien Quality Score) checks 10 quality criteria on growth, profitability, and balance-sheet strength — per the methodology developed and published by AlleAktien, calculated by us from our own fundamental data. A stock counts as a quality stock from 9 out of 10 points. Where a company has a shorter listing history, we calculate over the fiscal years available (at least five).
- Sales growth 10Y > 5% -100.0%
- Exp. sales growth 3Y > 5% –
- EBIT growth 10Y > 5% –
- Exp. EBIT growth 3Y > 5% –
- Net debt < 4x EBIT –
- EBIT positive, 10Y straight 0
- Max. EBIT decline < 50% –
- Return on equity > 15% -34.4%
- ROCE > 15% -33.8%
- Expected return > 10% –
View stocks with the full AAQS score · Read the methodology at AlleAktien
Source: fundamental data
The company
About the Company
Capricor Therapeutics, Inc., ein Biotechnologieunternehmen in der klinischen Phase, beschäftigt sich mit der Entwicklung transformativer zell- und exosombasierter Therapeutika zur Behandlung der Duchenne-Muskeldystrophie (DMD) und anderer Krankheiten mit ungedecktem medizinischem Bedarf in den USA.
- Employees
- 231
- Headquarters
- San Diego, CA
- Address
- 10865 Road to the Cure, 92121 San Diego, United States
- Phone
- 858 727 1755
- Website
- capricor.com
- IPO Date
- 02/13/2007
- ISIN
- US14070B3096
- Stock Split
- 1:10 on 06/05/2019
- Stock Split
- 1:50 on 11/21/2013
Management
| Name | Title | Birth Year |
|---|---|---|
| Frank Isaac Litvack FACC, M.D. | Executive Chairman of the Board | 1956 |
| Linda Marbán Ph.D. | Co-Founder, President, CEO & Director | 1963 |
| Anthony J. Bergmann M.B.A. | CFO & Corporate Treasurer | 1986 |
| Karen G. Krasney Esq., J.D. | Executive VP, General Counsel & Secretary | 1953 |
| Kristi A. H. Elliott Ph.D. | Chief Operating & Science Officer | – |
| Minghao Sun Ph.D. | Senior Vice President of Quality Control, Research & Product Development | – |
| Mark Awadalla | Chief Development Officer | – |
| Micheal Binks M.D. | Chief Medical Officer | – |
| Michael Maurer | Chief Commercial Officer | – |
| Nathaniel Hogan Ph.D. | Director of Biostatistics of Capricor Therapeutics | – |
Executives per the latest required filings; titles kept in their original language. Source: fundamental data.
Filings
Company Filings (8-K)
An 8-K is the filing a US company must use to disclose material events immediately — takeovers, changes at the top, major contracts or payment troubles, for instance. The links open the original document at the US Securities and Exchange Commission (SEC).
- 08/24/2026 CAPRICOR THERAPEUTICS, INC. (CAPR): Other Events; Financial Statements and Exhibits SEC ↗
- 08/13/2026 CAPRICOR THERAPEUTICS, INC. (CAPR): Results of Operations and Financial Condition; Financial Statements and Exhibits SEC ↗
- 07/30/2026 CAPRICOR THERAPEUTICS, INC. (CAPR): Other Events; Financial Statements and Exhibits SEC ↗
- 07/29/2026 CAPRICOR THERAPEUTICS, INC. (CAPR): Other Events; Financial Statements and Exhibits SEC ↗
- 07/14/2026 CAPRICOR THERAPEUTICS, INC. (CAPR): Entry into a Material Definitive Agreement; Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant SEC ↗
Data as of: September 17, 2026 · Source: fundamental data & SEC filings (annual and quarterly reports, 10-K/10-Q)
Note: pure fact-based analysis, not investment advice and not a solicitation to buy or sell. All figures without guarantee.