CAPRICOR THERAPEUTICS, INC.

Capricor Therapeutics, Inc. reported its third-quarter financial results for 2026, showing a widening net loss of $42.66 million compared to $24.57 million in the prior year's quarter. For the nine-month period, the net loss also increased to $117.33 million from $74.87 million. Operating expenses rose significantly, driven by increased research and development costs. The company's cash position saw a substantial decrease, while its marketable securities portfolio grew.

Capricor Therapeutics announced its third quarter 2026 financial results, reporting a net loss of $42.7 million, or $0.73 per share, compared to a net loss of $24.6 million, or $0.54 per share, in the third quarter of 2025. Operating expenses increased significantly due to pre-commercial activities and manufacturing scale-up, leading to a workforce reduction of approximately 10%. The company's cash position decreased to $198.5 million. Key corporate updates include the ongoing FDA review of the Deramiocel BLA for Duchenne muscular dystrophy, with a PDUFA date set for November 22, 2026. Positive clinical data from the HOPE-3 trial, including a 76% slowing in upper limb decline and an award for cardiac results, were highlighted.

Capricor Therapeutics reported a net loss of $40.7 million for the second quarter of 2026, an increase from $25.9 million in the same period last year, with total operating expenses rising to $42.9 million. The company maintained a strong cash position of $237.9 million as of June 30, 2026, sufficient to fund operations for at least the next twelve months. The Biologics License Application (BLA) for Deramiocel remains under active FDA review, despite a negative Advisory Committee vote (3 in favor, 9 against) regarding its use for cardiomyopathy in Duchenne Muscular Dystrophy, though feedback on upper limb function was supportive. The full HOPE-3 Phase 3 dataset, demonstrating statistically significant slowing of upper limb disease progression, was published in The Lancet.

Capricor Therapeutics announced that the FDA's Cellular, Tissue and Gene Therapies Advisory Committee voted against the effectiveness of Deramiocel for cardiomyopathy in Duchenne muscular dystrophy patients (3 for, 9 against). While the recommendation is non-binding, the FDA will consider it in its ongoing review of the Biologics License Application (BLA). The PDUFA target action date remains August 22, 2026, and Capricor remains committed to the therapy.

Capricor Therapeutics announced that the FDA's Cellular, Tissue and Gene Therapies Advisory Committee voted against the effectiveness of Deramiocel for treating cardiomyopathy in Duchenne muscular dystrophy (DMD) patients, with a vote of 3 for, 9 against, and 0 abstain. While the vote is non-binding and addressed a narrower indication, the committee's feedback on upper limb function was directionally supportive. Capricor remains committed to Deramiocel, expressing confidence in its HOPE-3 data, and continues to work with the FDA towards a potential approval by the August 22, 2026 PDUFA target action date.

Capricor Therapeutics announced the publication of final one-year results from its HOPE-3 Phase 3 clinical trial for Deramiocel in Duchenne muscular dystrophy (DMD) in The Lancet. The trial met its primary endpoint, showing Deramiocel slowed upper limb function decline by 54% (p=0.03). An update to the statistical model for the key secondary endpoint, LVEF, resulted in a p=0.09 (1.8 percentage point difference), compared to p=0.04 previously reported. Additionally, the company received a Form FDA 483 with one observation following a Bioresearch Monitoring (BIMO) inspection related to its Biologics License Application (BLA) for Deramiocel, which remains under active FDA review with a PDUFA target action date of August 22, 2026.

Capricor Therapeutics announced that The Lancet has published positive results from its pivotal Phase 3 HOPE-3 clinical trial evaluating Deramiocel for Duchenne muscular dystrophy (DMD). The trial met its primary endpoint, demonstrating a 54% slowing of upper limb function decline and showing clinically meaningful cardiac benefits. This independent peer-reviewed publication validates the trial's design and findings, reinforcing the company's Biologics License Application (BLA) which is currently under active FDA review with a PDUFA target action date of August 22, 2026.

Capricor Therapeutics, Inc. has entered into a lease agreement for a new 171,000 square foot headquarters in San Diego, California. The facility will include expanded manufacturing cleanrooms, research and development laboratories, and administrative offices. The lease, with an initial monthly base rent of approximately $958,000, includes significant rent abatements and a contingency for FDA approval of Deramiocel by December 31, 2026.

Capricor Therapeutics announced that the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee will convene on July 29, 2026, to discuss the company's Biologics License Application (BLA) for Deramiocel. The BLA, seeking approval for the treatment of Duchenne muscular dystrophy (DMD), remains on track for its PDUFA target action date of August 22, 2026. The application is supported by positive data from the Phase 2 HOPE-2 and HOPE-2-OLE trials, as well as the Phase 3 HOPE-3 trial, which met its primary and key secondary endpoints.

Capricor Therapeutics announced positive five-year data from its ongoing HOPE-2 Open-Label Extension (OLE) study of Deramiocel for Duchenne Muscular Dystrophy (DMD). The data showed durable skeletal and cardiac muscle benefit, with attenuated disease progression and stable cardiac function, maintaining a favorable safety profile. These findings will be presented alongside previously reported positive results from the HOPE-3 Phase 3 trial, which met its primary and key secondary endpoints. The company's Biologics License Application (BLA) for Deramiocel is currently under FDA review, with a PDUFA target action date of August 22, 2026.