Capricor Therapeutics earnings date
Capricor Therapeutics (4LN2) Q3 2026 Earnings Report
DE:4LN2 Q3 2026 EPS Results
- Actual EPS
- -EUR 0.66
- Consensus EPS
- -EUR 0.40
- Beat/Miss
- Missed by -EUR 0.26
- One Year Ago EPS
- -EUR 0.49
DE:4LN2 Q3 2026 Revenue Results
- Actual Revenue
- EUR 0
- Expected Revenue
- EUR 13.82M
- Beat/Miss
- Missed by -EUR 13.82M
- YoY Revenue Growth
- ―
Earnings Announcement Details
- Quarter
- Q3 2026
- Date
- 11/10/2026
- Time
- After Close
- Conference Call
- Tuesday, November 10, 2026
Capricor Therapeutics's next earnings date is estimated for March 11, 2027, based on past reporting schedules.
Q3 2026 Earnings Call Audio
Q3 2026 Earnings Slide Deck
No slide deck is available for this earnings event.
Q3 2026 Earnings Call Summary
The call was predominantly positive, supported by a statistically significant HOPE-3 primary endpoint, favorable two-year extension and integrated-trial data, positive safety experience, cardiac-data recognition, FDA review progress, launch preparation, manufacturing readiness, and a cash runway of at least 12 months. Key negatives were the still-pending FDA decision, the ongoing NS Pharma dispute, no recognized revenue, higher operating expenses, larger net losses, a nonsignificant overall ejection-fraction result, and a 10% workforce reduction. The highlights significantly outweighed the lowlights.
Management said the FDA review remains ongoing with the PDUFA target action date extended to November 22, 2026, after submission of an amendment containing approximately 30,000 pages, and the proposed refined indication is for patients with age greater than 9 years old; commercial readiness is underway across distribution, patient support, market access, medical affairs, and physician education, while the San Diego GMP facility is ready for an initial launch, with the first-floor clean room able to meet the needs of 250 patients per year or around 1000 doses per year and the second floor expected to support 2,000 to 2500 patients or up to 10,000 doses per year operating at full capacity, with validation targeted for the first half of 2020; the company estimates approximately 15,000 people in The US are living with DMD, roughly 2-thirds are ages 9 and older, expects arbitration to commence in mid-2027, reduced its workforce by approximately 10% in the third quarter, reported approximately $198.5 million in cash, cash equivalents, restricted cash and marketable securities as of September 30, 2026, and believes its existing cash, cash equivalents and marketable securities are sufficient to fund operations for at least the next 12 months.
- BLA Advances Through Final FDA ReviewFDA agreed to review additional data and a major amendment to the BLA, extending the PDUFA target action date to November 22, 2026. The August amendment included approximately 30,000 pages of documents, reports, tables, listings, files, and data sets, including 24-month HOPE-3 open-label extension data, sensitivity and robustness analyses, and an integrated summary of efficacy from HOPE-2 and HOPE-3. All requested information has been submitted and the review remains ongoing.
- HOPE-3 Met Its Primary Efficacy EndpointThe full HOPE-3 results published in The Lancet showed a statistically significant slowing of upper-limb disease progression on the Performance of the Upper Limb 2.0, with a p-value of 0.029. The absolute difference between the deramiocel and placebo groups was 1.1 points, which management described as both clinically meaningful and statistically significant.
- Positive Two-Year Open-Label Extension ResultsIn the 24-month HOPE-3 open-label extension, 82 patients received deramiocel for a full year after the randomized phase. Patients who had received placebo lost about 2 points on the Performance of the Upper Limb in Year 1, while their decline slowed to about 0.5 point after starting deramiocel in Year 2. Management described this as a 1.56-point difference and a 76% slowing of disease progression. Patients who started deramiocel in the randomized portion lost less than 1 point in Year 1 and maintained a similarly slow rate of decline in Year 2.
- Results Compared Favorably With Natural HistoryAt month 24, the group treated with deramiocel from the start had declined 3.4 points versus a predicted 5.9 points, while the group that started on placebo had declined 3.8 points versus a predicted 5.4 points based on two natural-history data sets.
- Robustness Analyses Supported the Efficacy SignalMore than 900 reanalyses of the HOPE-3 data addressed questions involving missing data, patient inclusion, and progression definitions. Management stated that the size and direction of the benefit held up across the analyses, with the result at or near statistical significance in the large majority, the estimated benefit centered on about 1 point on PUL 2.0, and every analysis favoring deramiocel rather than placebo.
- Integrated HOPE-2 and HOPE-3 Analysis Was PositiveThe integrated summary of efficacy from the two placebo-controlled trials showed that placebo patients lost about 2 points of upper-limb function at 12 months while deramiocel patients lost less than 1 point, producing a combined difference of 1.29 points and a p-value of 0.0087. All 8 sensitivity analyses pointed in the same direction. The integrated ejection-fraction analysis favored deramiocel by about 2.2 percentage points.
- Cardiac Data Received External RecognitionHOPE-3 cardiac data presented at the American Heart Association Scientific Sessions received the American Heart Association Outstanding Research Award in Pediatric Cardiology. Compared with placebo, deramiocel slowed the progression of heart-muscle scarring measured by late gadolinium enhancement on cardiac MRI. In the prespecified subgroup of patients with existing cardiomyopathy, ejection fraction improved by approximately 2.8 percentage points relative to placebo.
- Safety Record Remained FavorableAcross 3 clinical trials, more than 125 patients with DMD received over 1,300 deramiocel infusions. More than 80 patients remain in open-label extension studies, some for more than 5 years, and management stated that deramiocel has been generally well tolerated throughout.
- Broad External Support for the ProgramHOPE-3 results were published in The Lancet, cardiac data received the American Heart Association award, and data were presented at the World Muscle Society and the Advisory Committee meeting. Management also stated that 26 speakers in the open public hearing urged FDA to make deramiocel available and that Dr. Craig McDonald and 27 other Duchenne clinicians and researchers sent FDA a public letter supporting approval based on the strength of the data.
- Defined Target Population and Unmet NeedManagement estimated that approximately 15,000 people in the United States are living with DMD, with roughly two-thirds ages 9 and older, the population addressed by the proposed refined indication. Management stated that no therapy is approved specifically to preserve upper-limb function and that HOPE-3 was designed for this group, including primarily nonambulant patients historically underrepresented in Duchenne clinical trials.
- Commercial Launch Preparation Is UnderwayLaunch planning is underway across distribution, patient support, market access, medical affairs, and physician education. Payer discussions have begun, and the company stated that it is pacing commercial spending to the regulatory timeline.
- Manufacturing Facility Is Operational and ScalableCapricor's San Diego GMP facility is up and running and ready to supply an initial launch if deramiocel is approved. The first-floor clean room is ready to meet the needs of approximately 250 patients per year, or around 1,000 doses per year. The second-floor build-out is progressing, with validation targeted for the first half of 2020 as stated on the call, and is expected to support 2,000 to 2,500 patients or up to 10,000 doses per year at full capacity.
- Prepared for Independent CommercializationBecause the dispute with NS Pharma remains ongoing, Capricor is independently preparing for launch and commercialization without NS Pharma's participation at this point. Management stated that the San Diego facility is operational and that patient support, market access, and medical affairs preparations are progressing.
- Cash Position and RunwayAs of September 30, 2026, cash, cash equivalents, restricted cash, and marketable securities totaled approximately $198.5 million. No shares were sold under the ATM program this year, and management stated that existing cash, cash equivalents, and marketable securities are sufficient to fund operations for at least the next 12 months.
- International and Exosome Pipeline ProgressCapricor initiated regulatory engagement in Europe and Japan. Management stated that it can now manufacture exosomes at clinical and commercial scale, has GMP manufacturing of exosomes, and has targeting and loading opportunities that were not previously available.
DE:4LN2 Earnings History
| Report Date | Fiscal Quarter | Forecast / EPS | Last Year's EPS | EPS YoY Change | Press Release |
|---|---|---|---|---|---|
| Mar 11, 2027 | 2026 (Q4) | -0.33- | -0.56 | ― | ― |
| Nov 10, 2026 | 2026 (Q3) | -0.40-0.66 | -0.49 | -35.19% (-0.17) | |
| Aug 13, 2026 | 2026 (Q2) | -0.53-0.63 | -0.51 | -22.81% (-0.12) | |
| May 12, 2026 | 2026 (Q1) | -0.47-0.53 | -0.48 | -11.32% (-0.05) | |
| Mar 12, 2026 | 2025 (Q4) | -0.46-0.56 | -0.14 | -287.50% (-0.41) | |
| Nov 10, 2025 | 2025 (Q3) | -0.49-0.49 | -0.34 | -42.11% (-0.14) | |
| Aug 11, 2025 | 2025 (Q2) | -0.43-0.51 | -0.32 | -62.86% (-0.20) | |
| May 13, 2025 | 2025 (Q1) | -0.29-0.48 | -0.28 | -70.97% (-0.20) | |
| Mar 19, 2025 | 2024 (Q4) | -0.15-0.14 | -0.02 | -700.00% (-0.13) | |
| Nov 13, 2024 | 2024 (Q3) | -0.32-0.34 | -0.23 | -52.00% (-0.12) |
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.
