EarningsQ2 2026 Earnings Report
DE:4LN2 Q2 2026 EPS Results
Actual EPS-€0.63
Consensus EPS-€0.53
Beat/MissMissed by -€0.10
One Year Ago EPS-€0.51
DE:4LN2 Q2 2026 Revenue Results
Actual Revenue€0.00
Expected Revenue€0.00
Beat/MissMet expectations
YoY Revenue Growth―
Earnings Announcement Details
QuarterQ2 2026
Date08/13/2026
TimeAfter Close
Conference CallThursday, August 13, 2026
DE:4LN2 Upcoming Earnings
Capricor Therapeutics's next earnings date is estimated for November 17, 2026, based on past reporting schedules.
Q2 2026 Earnings Call Audio
DE:4LN2 Q2 2026 Earnings Call
0:00 / 0:00
Q2 2026 Earnings Slide Deck
No slide deck is available for this earnings event.
Q2 2026 Earnings Call Summary
Earnings Call Sentiment|Neutral
The call balanced meaningful clinical and regulatory progress (Lancet publication, statistically significant primary HOPE‑3 endpoint for upper limb function, established safety exposure, operational in‑house manufacturing and $237.9M cash) against substantial near‑term challenges (AdCom vote against the cardiomyopathy question, mixed secondary endpoint results, no revenue, rising operating expenses and widening losses, a Form 483 observation, paused non‑Daramycin pipeline work, and an ongoing commercial dispute with NS Pharma). Management has a clear path to submit an amendment focused on the primary skeletal muscle indication and the FDA indicated willingness to review it, but regulatory and financial risks remain in the near term.Company Guidance
Regulatory Path Forward and PDUFA Timeline
BLA for Daramycin under FDA review with current PDUFA action date of August 22, 2026; company plans to submit a BLA amendment including 24-month open‑label extension data to pursue a refined upper‑limb skeletal muscle indication and FDA indicated willingness to review the amendment and extend the PDUFA date.
Positive Primary Efficacy Readout (HOPE‑3)
HOPE‑3 primary endpoint (upper limb function, PUL 2.0) statistically significant: 4.5% mean difference in favor of Daramycin, p=0.029, corresponding to a 1.2 absolute change in total PUL 2.0; advisory committee discussion was directionally supportive of this primary endpoint.
Peer‑Reviewed Publication
Full Phase 3 HOPE‑3 data published in The Lancet (first full Phase 3 dataset publication) with supplemental mechanistic and patient‑level data, strengthening public record and credibility of the program.
Safety and Clinical Exposure
Approximately 1,300 intravenous infusions administered across the clinical program to over 200 patients in 3 trials; more than 80 patients in open‑label extensions, some receiving continuous infusions >5 years, and long‑term safety profile described as consistent and well characterized.
Commercial and Manufacturing Readiness
In‑house GMP manufacturing facility in San Diego is operational and positioned to support an initial commercial launch if approved; expansion to second floor underway with target full validation and FDA approval of expanded space estimated in 2027; new CCO hired to build launch organization.
Cash Position and Financial Flexibility
Cash, cash equivalents and marketable securities totaled $237.9 million as of 06/30/2026 and management states they are controlling commercial spend and have flexibility to deploy capital across the remainder of the year.
DE:4LN2 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