Capricor Reports Q2 2025 Results, FDA Meeting Scheduled for Deramiocel BLA.

• Capricor Therapeutics reports Q2 2025 financial results • Type A meeting with US FDA to discuss Deramiocel BLA • FDA clears IND for StealthX exosome-based vaccine • NIAID initiates Phase 1 clinical trial • Cash balance of $123 million expected to last into Q4 2026 • Capricor seeks to resubmit BLA based on existing dataset • HOPE-3 data (Q4 2025) may serve as supportive and confirmatory evidence • All 483 observations noted in Pre-License Inspection resolved and accepted by FDA

Capricor Therapeutics (NASDAQ: CAPR) is set to release its second quarter 2025 financial results on August 13, 2025, after market close. The biotechnology company will host a conference call and webcast at 4:30 p.m. ET on the same day. The company has made significant strides in its product pipeline, including updates on its lead candidate, Deramiocel, and its exosome-based vaccine.

Deramiocel Update
Deramiocel, an allogeneic cardiac-derived cell therapy for Duchenne Muscular Dystrophy (DMD), has shown promising immunomodulatory effects in clinical trials. Capricor has entered into a commercialization agreement with Nippon Shinyaku Co., Ltd. for Deramiocel in the U.S. and Japan, pending regulatory approval. The company is also seeking to resubmit a Biologics License Application (BLA) based on existing dataset and expects data from the HOPE-3 trial (Q4 2025) to serve as supportive and confirmatory evidence.

StealthX Exosome-Based Vaccine
The FDA has cleared an Investigational New Drug (IND) application for Capricor's StealthX exosome-based vaccine. The company is also initiating a Phase 1 clinical trial in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID). This advancement positions Capricor at the forefront of exosome technology in the development of vaccines and other therapeutic applications.

Financial Outlook
Capricor reports a cash balance of $123 million as of the end of Q2 2025, which is expected to last into Q4 2026. The company's financial health is critical for its ongoing research and development efforts, particularly in light of the regulatory hurdles it faces.

Regulatory Milestones
Capricor has resolved all 483 observations noted in a Pre-License Inspection and has accepted the FDA's resolution. This is a significant milestone for the company, as it indicates progress in addressing regulatory concerns and moving forward with its product candidates.

Analyst Ratings and Price Targets
Wall Street analysts have issued a mix of positive and neutral ratings for Capricor. Six firms have issued buy ratings, while none have issued sell ratings. Analysts have set a median price target of $23.0, with individual targets ranging from $12.0 to $30.0.

Conclusion
Capricor Therapeutics' Q2 2025 financial results and updates on its product pipeline are eagerly anticipated by investors and financial professionals. The company's progress in developing transformative treatments for rare diseases, coupled with its robust financial position, positions it as a key player in the biotechnology sector.

References
[1] https://www.quiverquant.com/news/Capricor+Therapeutics+to+Announce+Second+Quarter+2025+Financial+Results+and+Host+Conference+Call+on+August+13%2C+2025