Q2 2026 Capricor Therapeutics, Inc. Earnings Call Transcript
Key Points
- Capricor Therapeutics Inc (CAPR) is actively working with the FDA to amend its BLA for deramiocel, focusing on the upper limb skeletal muscle indication, which was the primary endpoint of the HOPE-3 study and showed statistically significant results.
- The HOPE-3 trial results were published in The Lancet, a prestigious peer-reviewed journal, providing strong external validation of the efficacy data.
- The company has a robust safety database, with over 1,300 infusions administered to more than 200 DMD patients, including some treated for over five years, demonstrating a well-characterized long-term safety profile.
- Capricor Therapeutics Inc (CAPR) maintains a strong cash position of approximately $237.9 million, providing financial flexibility to support ongoing regulatory and manufacturing activities.
- The company's in-house GMP manufacturing facility is operational and positioned to support an initial commercial launch, with expansion plans on track for 2027.
- The FDA has shown flexibility and willingness to review the proposed BLA amendment, indicating a collaborative approach to finding a path forward for deramiocel.
- The FDA's Advisory Committee voted 9 to 3 against the effectiveness of deramiocel for treating cardiomyopathy in DMD patients, a significant setback for the original indication.
- The statistical model for the key secondary endpoint (left ventricular ejection fraction) was revised, resulting in a less favorable p-value (0.09 vs. 0.04), which may raise concerns about data robustness.
- The company's dispute with NS Pharma over the US pricing agreement remains unresolved, with arbitration not expected to begin until fall, creating ongoing legal and commercial uncertainty.
- All pipeline programs not directly related to deramiocel are on hold, limiting diversification and future growth opportunities until regulatory clarity is achieved.
- The company reported a net loss of $40.7 million for Q2 2026, an increase from $25.9 million in the prior year, reflecting rising operating expenses and no revenue.
- The BLA review process has been extended due to the amendment, delaying the potential approval and commercial launch of deramiocel.
Good afternoon ladies and gentlemen and welcome to the Capricor Therapeutics second quarter 2026 Conference Call. (Operator Instructions) The call is being recorded on Thursday, August 13, 2026.
And I would now like to turn the conference over to CFO, AJ Bergmann, for the forward-looking statement. Please go ahead.
Thank you very much. Before we begin, I'd like to remind you that any statements made during today's call that are not historical are considered to be forward-looking statements. Actual results may differ materially from those indicated by these statements as a result of various important factors, including those discussed in the risk factors section of our company's most recent annual report on Form 10-K and our most recent quarterly reports on Form 10-Q, as well as other reports filed with the SEC. Any forward-looking statements may represent our views as of today, August 13, 2026. An audio replay of the call will be available on our website following its completion.
| Access to All Earning Calls and Stock Analysis | |
| 30-Year Financial on one screen | |
| All-in-one Stock Screener with unlimited filters | |
| Customizable Stock Dashboard | |
| Real Time Insider Trading Transactions | |
| 8,000+ Institutional investors’ 13F holdings | |
| Powerful Excel Add-in and Google sheets Add-on | |
| All data downloadable | |
| Quick customer support | |
| And much more... |
Trustpilot
We'd love to learn more about your experiences on GuruFocus.com and how we can improve!
Take Survey
