Capricor Therapeutics, Inc. (CAPR) Earnings
Capricor Therapeutics, Inc. is expected to report next earnings on November 9, 2026 (in NaN days), with a consensus EPS estimate of $-0.14. CAPR has beaten EPS estimates in 7 of its last 12 reported quarters (average surprise +0.1% over the last four).
| Report date | EPS est | EPS actual | Surprise | Revenue | Rev. surprise |
|---|---|---|---|---|---|
| Aug 13, 2026 | $-0.59 | $-0.70 | -18.9% | — | — |
| May 12, 2026 | $-0.55 | $-0.59 | -7.3% | — | — |
| Mar 12, 2026 | $-0.51 | $-0.62 | -21.8% | — | — |
| Mar 19, 2025 | $-0.31 | $-0.16 | +48.4% | $11M | +102.4% |
| Feb 29, 2024 | $-0.09 | $-0.02 | +77.8% | $12M | +14.0% |
| Nov 14, 2023 | $-0.29 | $-0.25 | +13.8% | $6M | -43.2% |
| May 11, 2023 | $-0.32 | $-0.31 | +3.1% | $3M | +497.3% |
| Mar 15, 2023 | $-0.33 | $-0.31 | +6.1% | — | — |
| Nov 10, 2022 | $-0.29 | $-0.26 | +10.3% | $2M | +278.9% |
| Aug 10, 2022 | $-0.25 | $-0.29 | -16.0% | — | — |
| Mar 10, 2022 | $-0.19 | $-0.26 | -36.8% | $-244653 | — |
| Aug 12, 2021 | $-0.23 | $-0.21 | +8.7% | $204082 | -8.0% |
Source: company filings + earnings calendar. For informational purposes only — not investment advice.
Earnings call summary
Q2 FY2026 · August 13, 2026
AI summary of management’s prepared remarks and analyst Q&A. For informational purposes only — not investment advice.
Management highlights
- Regulatory Update for Daromyosal (DERM-ISL) • The Biologics License Application (BLA) for Daromyosal for DMD remains under FDA review with an original PDUFA date of August 22, 2026. In July 2026, the FDA Advisory Committee voted 3 in favor, 9 against on whether existing data provided substantial evidence of effectiveness for the requested cardiomyopathy indication. • The committee only voted on the cardiomyopathy indication, which used a key secondary endpoint from the HOPE III study (not the study's powered primary endpoint). The committee received directional supportive feedback for the HOPE III primary endpoint of upper limb function improvement. • Capricor will submit a BLA amendment to refocus Daromyosal on the upper limb skeletal muscle indication, supported by 24-month open-label extension data and additional existing data analyses. The FDA has agreed to review the amendment and extend the PDUFA date upon receipt. • The full HOPE III Phase III dataset was published in *The Lancet* after peer review. A pre-planned statistical model adjustment changed the overall population left ventricular ejection fraction result from 2.4pp difference (p=0.04) to 1.8pp difference (p=0.09), but the pre-specified cardiomyopathy subgroup result (2.8pp difference, p=0.02) and the statistically significant primary upper limb endpoint (4.55% treatment difference, p=0.029) remain unchanged. No other study data was altered. • The FDA completed a BIMO inspection and issued one observation on a Form 483; Capricor has submitted its response and is awaiting feedback. - Commercial and Manufacturing Readiness • Commercial readiness activities are proceeding at a slower pace pending further regulatory clarity, with spending controlled to preserve cash. Capricor's in-house GMP manufacturing facility in San Diego is operational and ready to support an initial launch if approved. Expansion of the facility is ongoing, with full validation and approval targeted for 2027. • A new chief commercial officer with direct DMD and rare disease experience has joined the company, and the launch organization and market access team are being built out. - Legal Dispute with NS Pharma • Capricor withdrew its motion for a preliminary injunction (originally scheduled for August 10, 2026) without prejudice to resolve the contractual dispute via arbitration after the FDA issues its decision, when a full regulatory record will be available. • The company's underlying position remains unchanged: it continues to believe the U.S. pricing structure agreed with NS Pharma is flawed and would impede patient access, and it still seeks rescission of the agreement. Arbitration is expected to begin in fall 2026. - Pipeline • All pipeline work unrelated to DERM-ISL is currently paused pending regulatory clarity for the lead program. • Regulatory engagement for DERM-ISL has been initiated in Europe and Japan. Planned expansions into younger DMD patients and Becker muscular dystrophy remain strategic priorities, with clinical trial initiation timelines dependent on the U.S. regulatory pathway outcome.
Guidance
- Management did not issue traditional financial guidance for future periods, as the company's near-term operations are entirely contingent on the FDA's outcome for the BLA amendment. - The expanded GMP manufacturing facility in San Diego is still targeted for full validation and FDA approval in 2027, maintaining prior guidance. - Capital expenditures and commercial spending are being paced to align with regulatory developments, and the company retains flexibility to adjust capital deployment through the remainder of 2026 based on regulatory outcomes.
Segment performance
Capricor Therapeutics recognized no revenue in Q2 2026 or Q2 2025. Total operating expenses for Q2 2026 were $42.9 million, up from $27.7 million in Q2 2025. The increase in operating expenses was driven by investments in clinical, regulatory, manufacturing, and commercial infrastructure for the company's lead Duchenne muscular dystrophy (DMD) program. Net loss for Q2 2026 was approximately $40.7 million (70 cents per share), compared to a net loss of $25.9 million (57 cents per share) in Q2 2025. For the six months ended June 30, 2026, net loss was $74.7 million, up from $50.3 million for the same period in 2025. As of June 30, 2026, Capricor held $237.9 million in cash, cash equivalents, and marketable securities, with an accumulated deficit of $379.6 million.
Risks & headwinds
- There is significant uncertainty around the FDA's eventual review outcome for the amended BLA for Daromyosal; the negative advisory committee vote for the original indication creates regulatory risk for the program. - The FDA issued a Form 483 observation following the BIMO inspection; regulatory feedback on Capricor's response is still pending, which could introduce additional delays or requirements for the BLA approval. - The ongoing contractual dispute with NS Pharma creates uncertainty around U.S. pricing and commercial launch logistics if Daromyosal is approved. - The company has a substantial accumulated deficit and ongoing net operating losses, with cash runway dependent on regulatory progress and future capital raising activities.