Capricor Therapeutics (NASDAQ:CAPR) Posts Quarterly Earnings Results, Misses Estimates By $0.11 EPS

Key Points

• Capricor reported a quarterly EPS loss of $0.70, missing the consensus estimate of a $0.59 loss by $0.11. Operating expenses increased to $42.9 million, resulting in a $40.7 million net loss.
• The FDA advisory committee voted 3–9 against substantial evidence supporting deramiocel for DMD cardiomyopathy. Capricor plans to amend its application with additional 24-month data and analyses focused on upper-limb skeletal function, while the FDA is expected to extend its review timeline.
• Capricor held approximately $238 million in cash and marketable securities at quarter-end, but faces significant regulatory, litigation and commercial uncertainty; analysts have largely downgraded the stock to neutral or negative ratings.

Capricor Therapeutics (NASDAQ:CAPR - Get Free Report) released its earnings results on Thursday. The biotechnology company reported ($0.70) earnings per share (EPS) for the quarter, missing analysts' consensus estimates of ($0.59) by ($0.11), Zacks reports.

Here are the key takeaways from Capricor Therapeutics' conference call:

• The FDA advisory committee voted 3–9 against substantial evidence supporting deramiocel for DMD cardiomyopathy, and the FDA also issued one observation in a Bioresearch Monitoring Inspection.
• Capricor plans to amend its BLA with 24-month open-label data and additional analyses seeking an indication focused on upper-limb skeletal function, the HOPE-3 primary endpoint; the FDA has indicated it will review the amendment and extend the PDUFA date.
• The company disclosed that the reported left-ventricular-ejection-fraction result changed under the prespecified statistical model to a 1.8-point treatment difference with a P=0.09, while the primary upper-limb endpoint remained statistically significant and the cardiomyopathy subgroup result was unchanged.
• Second-quarter operating expenses rose to $42.9 million from $27.7 million a year earlier, producing a $40.7 million net loss; Capricor held $237.9 million in cash and marketable securities and is slowing commercial spending pending regulatory clarity.
• The company withdrew its preliminary-injunction motion against NS Pharma without prejudice and expects arbitration over the U.S. distribution agreement to begin this fall, while broader pipeline work remains on hold and expansion programs are being stage-gated by the U.S. regulatory pathway.

Capricor Therapeutics Stock Performance

NASDAQ CAPR traded up $0.02 during trading on Thursday, reaching $4.21. 13,102,623 shares of the company traded hands, compared to its average volume of 2,008,055. Capricor Therapeutics has a 1-year low of $2.96 and a 1-year high of $40.37. The company has a market cap of $243.80 million, a price-to-earnings ratio of -1.81 and a beta of 0.54. The stock's 50 day moving average price is $19.06 and its two-hundred day moving average price is $25.64.

Capricor Therapeutics News Roundup

Here are the key news stories impacting Capricor Therapeutics this week:

• Positive Sentiment: Capricor said the FDA is actively reviewing its Biologics License Application for deramiocel, a key regulatory catalyst for the company. The company also highlighted published HOPE-3 Phase 3 results showing the trial achieved its primary upper-limb-function endpoint with statistical significance (p=0.029). Capricor Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate Update
• Positive Sentiment: Capricor reported approximately $238 million in cash, cash equivalents and marketable securities as of June 30, 2026, providing substantial funding as it seeks potential approval and commercialization of deramiocel.
• Neutral Sentiment: The company’s quarterly results and corporate update were scheduled for discussion on an afternoon conference call, giving investors an opportunity to obtain additional detail on the FDA review, clinical data and development plans.
• Negative Sentiment: Second-quarter adjusted results were a loss of $0.70 per share, wider than the consensus estimate of a $0.59 loss. The miss reinforces concerns about ongoing cash burn and the lack of near-term product revenue. Capricor Therapeutics Quarterly Earnings Press Release
• Negative Sentiment: Multiple law firms are promoting a securities class action covering investors who bought CAPR between December 17, 2025, and July 26, 2026. The lawsuit alleges Capricor made misleading statements about blinding and protocol procedures in the HOPE-3 trial, after FDA briefing materials and an adverse advisory committee vote triggered a major selloff. The legal claims are allegations, but the litigation adds reputational, financial and regulatory uncertainty; the lead-plaintiff deadline is September 28, 2026. CAPR Deadline Alert Securities Class Action

Insider Activity

In related news, CFO Anthony Bergmann sold 24,100 shares of the firm's stock in a transaction that occurred on Thursday, June 25th. The stock was sold at an average price of $30.38, for a total transaction of $732,158.00. Following the completion of the transaction, the chief financial officer owned 11,223 shares in the company, valued at $340,954.74. This trade represents a 68.23% decrease in their position. The transaction was disclosed in a filing with the Securities & Exchange Commission, which is available through the SEC website. Over the last ninety days, insiders sold 25,000 shares of company stock valued at $759,158. Corporate insiders own 9.20% of the company's stock.

Institutional Inflows and Outflows

Several hedge funds have recently bought and sold shares of CAPR. Royal Bank of Canada increased its position in shares of Capricor Therapeutics by 12.4% during the 4th quarter. Royal Bank of Canada now owns 5,040 shares of the biotechnology company's stock worth $146,000 after purchasing an additional 557 shares in the last quarter. Orion Porfolio Solutions LLC bought a new position in Capricor Therapeutics during the 4th quarter valued at about $239,000. New York State Common Retirement Fund boosted its position in Capricor Therapeutics by 124.1% in the fourth quarter. New York State Common Retirement Fund now owns 13,000 shares of the biotechnology company's stock valued at $375,000 after buying an additional 7,200 shares in the last quarter. Voleon Capital Management LP acquired a new position in Capricor Therapeutics in the third quarter valued at about $311,000. Finally, Moneta Group Investment Advisors LLC boosted its position in Capricor Therapeutics by 25.5% in the third quarter. Moneta Group Investment Advisors LLC now owns 34,454 shares of the biotechnology company's stock valued at $248,000 after buying an additional 7,000 shares in the last quarter. 21.68% of the stock is currently owned by institutional investors and hedge funds.

Analysts Set New Price Targets

A number of research analysts have recently commented on CAPR shares. Maxim Group lowered shares of Capricor Therapeutics from a "buy" rating to a "hold" rating in a research report on Thursday, July 30th. Piper Sandler cut Capricor Therapeutics from an "overweight" rating to a "neutral" rating and set a $2.00 price target for the company. in a report on Thursday, July 30th. HC Wainwright reissued a "neutral" rating on shares of Capricor Therapeutics in a report on Monday, July 27th. Wall Street Zen lowered Capricor Therapeutics from a "sell" rating to a "strong sell" rating in a research note on Saturday, August 1st. Finally, Weiss Ratings reaffirmed a "sell (d-)" rating on shares of Capricor Therapeutics in a research report on Monday, June 15th. Ten equities research analysts have rated the stock with a Hold rating and one has issued a Sell rating to the stock. According to MarketBeat.com, the stock currently has an average rating of "Reduce" and an average target price of $29.15.

About Capricor Therapeutics

Capricor Therapeutics, Inc is a clinical-stage biotechnology company focused on the development of cell and exosome-based therapeutics for cardiovascular and rare diseases. Headquartered in Beverly Hills, California, the company leverages proprietary cardiosphere-derived cell (CDC) technology to address conditions characterized by inflammation, fibrosis, and tissue degeneration. Since its founding, Capricor has advanced its lead candidate through multiple clinical trials and has built a pipeline that spans both cell therapy and extracellular vesicle (exosome) platforms.

The company's leading product candidate, CAP-1002, comprises allogeneic CDCs and is being evaluated in indications such as Duchenne muscular dystrophy (DMD) and COVID-19-related heart injury.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to contact@marketbeat.com.

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