The earnings call highlighted Capricor Therapeutics' strong cash position and progress in its exosome program but faced significant challenges with the FDA's complete response letter, increased expenses, and zero revenue, resulting in a net loss. The regulatory delays and lack of clarity on the approval path for Deramiocel contributed to a negative outlook.

Company Guidance

During the Capricor Therapeutics Second Quarter 2025 Conference Call, significant guidance was provided regarding the company's plans and recent challenges. The call highlighted an unexpected complete response letter (CRL) from the FDA concerning Capricor's Biologics License Application (BLA) for Deramiocel, intended for treating cardiomyopathy in Duchenne muscular dystrophy (DMD) patients. The CRL indicated that the BLA did not meet statutory requirements for substantial evidence of effectiveness, prompting a focus on resolving these issues with the FDA. Despite this setback, Capricor remains steadfast in its commitment to advancing Deramiocel, with the company emphasizing its continued belief in the strength of its submission and the promising data from its HOPE-2 and HOPE-3 trials. The company has scheduled a Type A meeting with the FDA to clarify the path forward, aiming to align on the primary efficacy endpoint for the HOPE-3 trial, which has been amended to focus on left ventricular ejection fraction (LVEF). Financially, Capricor reported a net loss of approximately $25.9 million for Q2 2025, with cash and equivalents totaling around $122.8 million, ensuring operational support into late 2026. The strategic focus remains on securing U.S. approval for Deramiocel, with global expansion plans to be disclosed as they develop.

Strong Cash Position

Capricor Therapeutics reported a strong cash position with over $120 million in cash, sufficient to support operations into late 2026.

Progress in Exosome Program

Capricor's exosome program, particularly the StealthX vaccine, reached a significant milestone with the clearance of the IND and initiation of the Phase I trial, indicating potential for future business development opportunities.

Manufacturing and CMC Readiness

The FDA accepted all 483 items from Capricor's Pre-License Inspection, validating the company's manufacturing capabilities and commercial readiness.

Capricor Therapeutics (CAPR) Earnings, Revenues Date & History

The upcoming earnings date is based on a company’s previous reporting, and may be updated when the actual date is announced

Daily Earnings Calendar >

CAPR Earnings History

Report Date	Fiscal Quarter	Forecast / EPS	Last Year's EPS	EPS YoY Change	Slides	Play Transcript
Nov 12, 2025	2025 (Q3)	-0.54 / -	-0.38	―	―	―
Aug 11, 2025	2025 (Q2)	-0.48 / -0.57	-0.35	-62.86% (-0.22)	―
May 13, 2025	2025 (Q1)	-0.32 / -0.53	-0.31	-70.97% (-0.22)	―
Mar 19, 2025	2024 (Q4)	-0.17 / -0.16	-0.02	-700.00% (-0.14)	―
Nov 13, 2024	2024 (Q3)	-0.36 / -0.38	-0.25	-52.00% (-0.13)	―
Aug 07, 2024	2024 (Q2)	-0.36 / -0.35	-0.29	-20.69% (-0.06)	―
May 13, 2024	2024 (Q1)	-0.11 / -0.31	-0.31	0.00% (0.00)	―
Feb 29, 2024	2023 (Q4)	-0.09 / -0.02	-0.31	93.55% (+0.29)	―
Nov 14, 2023	2023 (Q3)	-0.30 / -0.25	-0.26	3.85% (+0.01)	―
Aug 07, 2023	2023 (Q2)	-0.35 / -0.29	-0.29	0.00% (0.00)	―

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

CAPR Earnings-Related Price Changes

Report Date	Price 1 Day Before	Price 1 Day After	Percentage Change
Aug 11, 2025	$7.82	$8.04	+2.81%
May 13, 2025	$7.30	$7.67	+5.07%
Mar 19, 2025	$12.22	$14.36	+17.51%
Nov 13, 2024	$16.91	$18.49	+9.34%

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.

FAQ

When does Capricor Therapeutics (CAPR) report earnings?

Capricor Therapeutics (CAPR) is schdueled to report earning on Nov 12, 2025, After Close (Confirmed).

What is Capricor Therapeutics (CAPR) earnings time?

Capricor Therapeutics (CAPR) earnings time is at Nov 12, 2025, After Close (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 (Q3) is -0.54.

Become an Expert with TipRanks Premium

What am I Missing?

Make informed decisions based on Top Analysts' activity

Know what industry insiders are buying

Get actionable alerts from top Wall Street Analysts

Find out before anyone else which stock is going to shoot up

Get powerful stock screeners & detailed portfolio analysis

Subscribe Now See Plans & Pricing