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SAN DIEGO - Capricor Therapeutics (NASDAQ:CAPR), currently valued at $364 million and showing signs of being undervalued according to InvestingPro Fair Value metrics, announced Monday that the first subjects have been dosed in a Phase 1 clinical trial of its StealthX exosome-based vaccine, marking the first human testing of the platform.
The trial is being conducted and funded by the National Institute of Allergy and Infectious Diseases (NIAID) under the U.S. Department of Health and Human Services’ Project NextGen, following FDA clearance of the Investigational New Drug application. The company maintains a strong balance sheet with more cash than debt, which is crucial for supporting its clinical development programs.
The study includes four dosing arms and initially focuses on the SARS-CoV-2 spike protein, with plans to add an arm testing a multivalent version incorporating the nucleocapsid protein pending separate FDA clearance.
"The initiation of this study marks an important milestone in vaccine development as StealthX potentially offers an alternative to mRNA vaccines," said Linda Marbán, Chief Executive Officer of Capricor, according to the company’s press release.
The StealthX platform uses engineered exosomes, nano-sized particles that play a role in cell-to-cell communication, to display viral proteins on their surface. The company states the technology contains no adjuvants and uses a more natural delivery system with native proteins.
While initially targeting SARS-CoV-2, Capricor aims to position StealthX as a versatile platform with potential applications across various therapeutic areas, including rare diseases.
Project NextGen is a federal initiative aimed at accelerating the development of next-generation vaccine platforms against respiratory viruses and other infectious threats. Initial data from the study is expected in the first quarter of 2026.
Separately, Capricor reported holding a Type A meeting with the FDA regarding its Deramiocel program for Duchenne Muscular Dystrophy and plans to provide updates when written feedback becomes available. While the stock has experienced a significant 47% decline over the past six months, analysts maintain optimistic price targets, with InvestingPro data showing targets ranging from $12 to $29 per share. Get access to 8 more exclusive ProTips and comprehensive analysis through InvestingPro’s detailed research reports, available for over 1,400 US stocks.
In other recent news, Capricor Therapeutics reported a significant loss in its Q2 2025 earnings. The company posted an earnings per share (EPS) of -$0.57, which was below the anticipated -$0.48. Additionally, Capricor’s revenue was reported at $0, a steep decline from $4 million in the same quarter the previous year. These financial results have raised concerns among investors regarding the company’s performance and future outlook. The earnings report reflects ongoing challenges for Capricor Therapeutics in maintaining revenue streams. The company’s recent developments highlight the importance of monitoring future earnings reports for potential improvements or further declines. Investors will be keen to see how Capricor addresses these financial hurdles in the coming quarters.
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