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Capricor Therapeutics (CAPR)
NASDAQ:CAPR
Earnings Data
Report Date
May 08, 2025TBA Not Confirmed
Period Ending
2025 (Q1)Consensus EPS Forecast
-0.32Last Year’s EPS
-0.31Same Quarter Last Year
Strong Buy
Based on 5 Analysts Ratings
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Earnings Call Summary
Earnings Call Date:Mar 19, 2025
|% Change Since: -24.88%
|Next Earnings Date:May 08, 2025
Earnings Call Sentiment|Positive
The earnings call highlights significant progress towards Deramiocel's FDA approval and commercialization, backed by strong safety and efficacy data, a robust manufacturing strategy, and a solid financial position. However, increased operating expenses and a larger net loss present some financial challenges. The pending European agreement also remains a point of uncertainty.Company Guidance
During the Capricor Therapeutics Fourth Quarter 2024 Earnings Call held on March 19, 2025, significant guidance was provided regarding their lead product, deramiocel. The company announced that their Biologics License Application (BLA) for deramiocel to treat Duchenne muscular dystrophy (DMD) cardiomyopathy had been accepted for priority review by the FDA, with a Prescription Drug User Fee Act (PDUFA) date set for August 31, 2025. The application is based on data from the Phase 2 HOPE-2 trial and its open-label extension, with supporting natural history data. The company highlighted deramiocel's strong safety profile, having been administered to over 250 subjects, and its demonstrated clinical efficacy. Capricor is preparing for a potential Advisory Committee (AdCom) meeting and has scheduled a pre-licensing inspection of their manufacturing facility for the second quarter of 2025. They anticipate the commercial launch of deramiocel in the U.S. with approximately 100 patients transitioning from clinical trials, projecting that 50-60% of the U.S. DMD population (around 7,500 individuals) could be eligible for treatment. Their current manufacturing capacity supports 250-500 patients annually, with expansion plans to accommodate up to 3,000 patients by mid-2026. Financially, Capricor reported a cash position of approximately $151.5 million as of December 31, 2024, with a runway extending into 2027. They expect additional non-dilutive cash infusions totaling over $200 million, including an $80 million milestone payment upon FDA approval and potential revenue from deramiocel sales. The company is also advancing their exosome technology platform and exploring European marketing strategies with Nippon Shinyaku.FDA Priority Review for Deramiocel
The Biologics License Application (BLA) for Deramiocel to treat DMD cardiomyopathy was accepted by the FDA for priority review, with a PDUFA date set for August 31, 2025.
Strong Safety and Efficacy Data
Deramiocel has been administered to over 250 human subjects with a strong safety profile, showing clinical and statistically significant efficacy in treating DMD cardiomyopathy.
Robust Manufacturing and Expansion Plans
Capricor's San Diego facility can support 250-500 patients annually, with plans to expand capacity to 2,000-3,000 patients by mid-2026.
Solid Financial Position
Capricor has a cash balance of approximately $151.5 million, with a runway into 2027, and potential non-dilutive cash infusions of over $200 million if FDA approval is received.
Positive Market Access and Reimbursement Outlook
Surveys with top five US payers have shown favorable responses for Deramiocel reimbursement.
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CAPR Earnings History
The table shows recent earnings report dates and whether the forecast was beat or missed. See the change in forecast and EPS from the previous year.
Beat
Missed
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CAPR Earnings-Related Price Changes
Report Date | Price 1 Day Before | Price 1 Day After | Percentage Change |
|---|---|---|---|
| Mar 19, 2025 | $12.22 | $14.36 | +17.51% |
| Nov 13, 2024 | $16.91 | $18.49 | +9.34% |
| Aug 07, 2024 | $3.56 | $3.88 | +8.99% |
| May 13, 2024 | $5.44 | $5.20 | -4.41% |
Earnings announcements can affect a stock’s price. This table shows the stock's price the day before and the day after recent earnings reports, including the percentage change.
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FAQ
When does Capricor Therapeutics (CAPR) report earnings?
Capricor Therapeutics (CAPR) is schdueled to report earning on May 08, 2025, TBA Not Confirmed.
What is Capricor Therapeutics (CAPR) earnings time?
Capricor Therapeutics (CAPR) earnings time is at May 08, 2025, TBA Not Confirmed.
Where can I see when companies are reporting earnings?
You can see which companies are reporting today on our designated earnings calendar.
What companies are reporting earnings today?
You can see a list of the companies which are reporting today on TipRanks earnings calendar.
What is CAPR EPS forecast?
CAPR EPS forecast for the fiscal quarter 2025 (Q1) is -0.32.
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