Capricor Therapeutics’ Earnings Call: Progress Amid Challenges

Capricor Therapeutics, Inc. ((CAPR)) has held its Q3 earnings call. Read on for the main highlights of the call.

Capricor Therapeutics’ recent earnings call painted a picture of both progress and challenges. The company is making significant strides in the clinical development of its flagship product, Daramycin, and is gearing up for commercialization. However, the financial landscape is challenging, with zero revenue reported for 2025 and rising operating expenses. Additionally, regulatory hurdles remain a concern following a Complete Response Letter (CRL) from the FDA.

HOPE-3 Phase 3 Clinical Study

The HOPE-3 Phase 3 clinical study of Daramycin is a pivotal moment for Capricor Therapeutics. This large-scale, double-blind, placebo-controlled study, involving 105 participants across 20 centers in the US, aims to treat Duchenne muscular dystrophy. The upcoming top-line readout is eagerly anticipated as it could significantly impact the company’s future.

Strong Safety Profile

Daramycin has shown a robust safety profile, with over 800 infusions administered to approximately 150 boys and young men with Duchenne muscular dystrophy. Importantly, no new or emerging safety signals have been observed, underscoring the drug’s potential as a safe treatment option.

CMC Achievements

Capricor’s San Diego commercial facility is now fully operational, ready for Good Manufacturing Practice (GMP) production. All Chemistry, Manufacturing, and Controls (CMC) issues cited in the CRL have been addressed, ensuring the company’s preparedness for commercialization and long-term product consistency.

Potential Approval and Non-dilutive Capital Opportunities

Should Daramycin receive approval, Capricor stands to gain an $80 million milestone payment from NS Pharma, along with a priority review voucher. These opportunities could provide significant financial support and accelerate the drug’s market entry.

Exosome Platform Development

Capricor’s StealthX program is advancing under Project NextGen, with a Phase 1 clinical trial for a next-generation COVID-19 vaccine underway. Positive results could lead to strategic collaborations and highlight the platform’s potential, broadening the company’s scope beyond Daramycin.

Revenue Decline

The financial report revealed a stark revenue decline, with zero revenue for 2025 compared to $2.3 million in Q3 2024 and $11.1 million in 2024. This drop is attributed to the full recognition of a $40 million US distribution agreement with Nippon Shinyaku.

Increased Operating Expenses

Operating expenses have risen significantly, with research and development costs reaching $18.1 million in Q3 2025, up from $11 million in Q3 2024. General and administrative expenses also increased to $4.1 million from $2.2 million, contributing to a net loss of $24.6 million for 2025.

CRL and Regulatory Challenges

Following a CRL in July, Capricor has had to pivot, using the HOPE-3 study to provide additional evidence of Daramycin’s effectiveness. The FDA’s request for more data and CMC clarifications has posed challenges to the approval timeline, requiring strategic adjustments from the company.

Forward-Looking Guidance

Capricor’s guidance for the future is focused on the HOPE-3 Phase 3 trial, which is crucial for Daramycin’s approval. The trial is designed to assess efficacy in non-ambulant individuals with Duchenne muscular dystrophy, with results expected to address previous FDA concerns. Financially, the company is positioned with $98.6 million in cash, expected to sustain operations into 2026, and is advancing its exosome platform with government support.

In conclusion, Capricor Therapeutics’ earnings call reflects a company at a crossroads, balancing promising clinical developments with significant financial and regulatory challenges. While the path forward is fraught with hurdles, the potential rewards from Daramycin’s approval and the exosome platform’s success could redefine the company’s trajectory.