Q3 2025 Capricor Therapeutics Inc Earnings Call Transcript

Nov 10, 2025 / 09:30 PM GMT

Transcript 10-Q8-K

Key Points

Positve

Capricor Therapeutics Inc (CAPR) is nearing a major milestone with the upcoming top-line readout from their HOPE 3, phase 3 clinical study of Daremiah cell for Duchenne muscular dystrophy.
The HOPE 3 trial is one of the largest double-blind placebo-controlled studies in the Duchenne population, enrolling 105 participants across 20 centers in the U.S.
No new or emerging safety signals have been observed in the trial, maintaining a strong safety profile for Daremiah cell.
Capricor Therapeutics Inc (CAPR) has a solid cash position of approximately $98.6 million, expected to cover expenses into the fourth quarter of 2026.
The company is eligible for an $80 million milestone payment and a priority review voucher if Daremiah cell is approved, providing significant non-dilutive capital opportunities.

Negative

Revenue for the third quarter of 2025 was zero, compared to approximately $2.3 million for the same period in 2024.
Operating expenses have increased significantly, with research and development expenses rising to approximately $18.1 million in Q3 2025 from $11 million in Q3 2024.
The company reported a net loss of approximately $24.6 million for the third quarter of 2025, compared to a net loss of $12.6 million for the same period in 2024.
Capricor Therapeutics Inc (CAPR) received a Complete Response Letter (CRL) from the FDA, citing the need for additional evidence of effectiveness and certain CMC clarifications.
The FDA has classified the resubmission as type 2, which means the review period can be up to 6 months, potentially delaying the approval process.

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

CAPR.OQ - Capricor Therapeutics Inc
Q3 2025 Capricor Therapeutics Inc Earnings Call
Nov 10, 2025 / 09:30PM 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 3rd quarter 2025 conference call.

At this time, all participants are in a listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press 0 for the operator.

This call is being recorded on Monday, November 10, 2025.

I would now like to turn the conference over to our CFO AJ Bergman for the forward-looking statement. Please go ahead.

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Unidentified_2 [2]
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