Capricor Therapeutics Files 8-K

TL;DR

Capricor filed an 8-K with updated financials and exhibits. Nothing major disclosed yet.

AI Summary

On December 3, 2025, Capricor Therapeutics, Inc. filed an 8-K report. The filing primarily concerns financial statements and exhibits, along with other events and a Regulation FD disclosure. No specific financial figures or new material events were detailed in the provided excerpt.

Why It Matters

This 8-K filing indicates Capricor Therapeutics is providing updated financial statements and exhibits, which is standard procedure for public companies to maintain transparency with investors.

Risk Assessment

Risk Level: low — The filing is a routine 8-K for financial statements and exhibits, not indicating any immediate material adverse events.

Key Players & Entities

• CAPRICOR THERAPEUTICS, INC. (company) — Registrant
• December 3, 2025 (date) — Date of Report
• Delaware (jurisdiction) — State of Incorporation
• 001-34058 (file_number) — SEC File Number

FAQ

Key Financial Figures

• $0.001 — h Registered Common Stock, par value $0.001 per share CAPR The Nasdaq Capital M

Filing Documents

• capr-20251203x8k.htm (8-K) — 50KB
• capr-20251203xex99d1.htm (EX-99.1) — 31KB
• capr-20251203xex99d1001.jpg (GRAPHIC) — 5KB
• 0001104659-25-117947.txt ( ) — 206KB
• capr-20251203.xsd (EX-101.SCH) — 3KB
• capr-20251203_lab.xml (EX-101.LAB) — 15KB
• capr-20251203_pre.xml (EX-101.PRE) — 9KB
• capr-20251203x8k_htm.xml (XML) — 5KB

01

Item 7.01 Regulation FD Disclosure. On December 3, 2025, Capricor Therapeutics, Inc. (the "Company") announced positive topline results from its pivotal Phase 3 HOPE-3 clinical trial. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated by reference into this Item 7.01 of this Current Report on Form 8-K. The information under Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be incorporated by reference into any of the Company's filings under the Exchange Act, unless expressly set forth as being incorporated by reference into such filing.

01

Item 8.01 Other Events. As disclosed above, the Company announced positive topline results from its pivotal Phase 3 HOPE-3 clinical trial. HOPE-3 is a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating Deramiocel in boys and young men with Duchenne muscular dystrophy. The study randomized 106 participants across 20 leading U.S. clinical sites. Participants received intravenous Deramiocel at 150 million cells per infusion or placebo every three months for a 12-month period. The average age of participants was approximately 15 years and all were on a stable corticosteroid regimen throughout the study. Baseline demographics were well balanced between treatment arms, approximately 90 percent were receiving cardiac medications at baseline, and over 75 percent had diagnosed cardiomyopathy. Deramiocel maintained a favorable safety and tolerability profile consistent with prior clinical experience. Topline Efficacy Results Endpoint % Slowing of Progression 3 (Deramiocel vs. Placebo) p-value Performance of Upper Limb (PUL v2.0) Total Score 1 (Primary, n=105) 54% p=0.029 Left Ventricular Ejection Fraction (LVEF %) 2 (Key Secondary, n=83) 91% p=0.041 n reflects the number of patients in the ITT population with evaluable PUL v2.0 assessments at 12 months. 2 n reflects the number of patients in the ITT population with centrally reviewed and evaluable cardiac MRI LVEF assessments at 12 months. 3 Percent slowing is calculated as the treatment difference divided by the placebo change from baseline. The Company expects that detailed HOPE-3 results will be submitted for presentation at a future scientific meeting and for publication in a peer-reviewed journal. Concurrently, the Company and its commercial partner, Nippon Shinyaku (U.S. subsidiary, NS Pharma, Inc.) are advancing launch readiness activities aimed to support timely patient access to Deramiocel, pending potential regulatory approval.

Forward-Looking Statements

Forward-Looking Statements 2 2025, and in the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, as filed with the Securities and Exchange Commission on November 10, 2025. All forward-looking statements in this press release a

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits 99.1 Press Release, titled "Capricor Therapeutics Announces Positive Topline Results from Pivotal Phase 3 HOPE-3 Study of Deramiocel in Duchenne Muscular Dystrophy", dated December 3, 2025. 104 Cover Page Interactive Data File (formatted as inline XBRL). 3

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized. CAPRICOR THERAPEUTICS, INC. Date: December 3, 2025 By: /s/ Linda Marbn, Ph.D. Linda Marbn, Ph.D. Chief Executive Officer 4

View Full Filing

View this 8-K filing on SEC EDGAR