Q4 2025 Capricor Therapeutics Inc Earnings Call Transcript

Mar 12, 2026 / 08:30 PM GMT

Transcript 10-K8-K

Key Points

Positve

Capricor Therapeutics Inc (CAPR) received FDA acceptance for their Biologics License Application (BLA) for Jeremiasel, with a target action date set for August 22, 2026.
The HOPE 3 trial showed significant results, meeting primary and secondary endpoints, indicating Jeremiasel's potential to stabilize both skeletal and cardiac muscle function in Duchenne muscular dystrophy patients.
The company has a strong financial position with approximately $318 million in cash and marketable securities, sufficient to fund operations into the fourth quarter of 2027.
Capricor Therapeutics Inc (CAPR) successfully completed an FDA pre-license inspection of their manufacturing facility, positioning them well for potential commercial launch.
The company is expanding its manufacturing capabilities to support increased demand, with plans to treat up to 2,500 patients per year by late 2027.

Negative

Revenue for the fourth quarter of 2025 was zero, compared to $11.1 million in the same period of 2024, indicating a significant drop in revenue.
Total operating expenses increased significantly to $29.2 million in Q4 2025 from $18.8 million in Q4 2024, reflecting higher costs associated with clinical, regulatory, and manufacturing activities.
Net loss for the fourth quarter of 2025 was approximately $30.2 million, a substantial increase from a net loss of $7.1 million in the same quarter of 2024.
The company faces potential challenges in scaling manufacturing to meet future demand, requiring further investment and regulatory approvals.
There is uncertainty regarding the final labeling discussions with the FDA, which could impact the scope of Jeremiasel's approval and market potential.

Refinitiv StreetEvents Event Transcript
E D I T E D V E R S I O N

CAPR.OQ - Capricor Therapeutics Inc
Q4 2025 Capricor Therapeutics Inc Earnings Call
Mar 12, 2026 / 08:30PM GMT

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Presentation
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Unidentified_1 [1]
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Good afternoon ladies and gentlemen, and welcome to the Capricorn Therapeutics 4th quarter and full year 2025 conference call.

At this time, all participants are not listen-only mode.

Following the presentation, we will conduct a question-and-answer session.

If at any time during this call, he required immediate assistance, please press 0 for the operator.

This calls may be regarded today.

Thursday, March 12, 2026.

I would not like to turn the conference over to CFO AJ Bergmann for the forward-looking statement.

Please go ahead, sir

Thank you and good afternoon, everyone.

Before we start, I would like to state that we will be making

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