CAPR — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-13

• Capricor Therapeutics, Inc. is a biotechnology company focused on the development and potential commercialization of cell and exosome-based therapeutics for the treatment of Duchenne muscular dystrophy (“DMD”), a rare genetic disorder characterized by progressive muscle degeneration and premature de…

• Our development efforts for Deramiocel for the treatment of DMD have progressed through multiple clinical studies, and we continue activities to support regulatory review and potential approval in the United States, as well as commercialization preparation, if approved.

• Our core program is focused on the development and commercialization of Deramiocel, a cell therapy product candidate comprised of cardiosphere-derived cells (“CDCs”), a population of cardiac-derived stromal cells isolated from qualified donated human hearts. Deramiocel is designed to slow disease pr…

• Our clinical development program for Deramiocel has focused on adolescents and young adults with DMD, including many patients who are non-ambulatory and experiencing progressive cardiac and skeletal muscle decline. We believe therapies that address inflammatory and fibrotic processes contributing to…

• Extracellular vesicles (“EVs”), including exosomes and microvesicles, are nano-scale membrane-enclosed vesicles secreted by many cell types that contain characteristic lipids, proteins and nucleic acids, including messenger

Text removed vs the prior filing · source: 10-Q · 2025-11-10

• Capricor Therapeutics, Inc. is a clinical-stage biotechnology company focused on the development of transformative cell and exosome-based therapeutics for treating Duchenne muscular dystrophy (DMD), a rare form of muscular dystrophy which results in muscle degeneration and premature death, and other…

• Since our inception, we have devoted substantial resources to developing Deramiocel and our other product candidates including our exosomes platform technology, developing our manufacturing processes, staffing our company and providing general and administrative support for these operations. We do n…

• A summary description of our key product candidates, is as follows:

• Deramiocel for the Treatment of DMD: Regulatory and Clinical Update

• Capricor’s lead clinical program is centered on Deramiocel, an allogeneic cell therapy comprised of cardiosphere-derived cells (“CDCs”), for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy. CDCs are a unique population of cardiac cells derived from healthy donor hearts, a…

Text added vs the prior filing · source: 10-Q · 2026-05-13

• Company holds, we believe that the fair value of our investment portfolio would not be materially impacted by a hypothetical 100 basis point increase or decrease in interest rates.

Text added vs the prior filing · source: 10-Q · 2026-05-13

• During the quarter ended March 31, 2026, the Company completed the implementation of Phase 2 of its enterprise resource planning (ERP) system, which expanded system functionality to encompass manufacturing operations, supply chain management, and materials and inventory tracking. Although the Compan…

• In connection with this implementation, the Company, with the assistance of its third-party system implementer, designed and executed controls throughout the system development life cycle, including change management procedures, user acceptance testing, and data migration validation. The Company als…

• Other than the foregoing, there were no changes in our internal control over financial reporting during the quarter ended March 31, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Text removed vs the prior filing · source: 10-Q · 2025-11-10

• There has been no change in our internal control over financial reporting during the quarter ended September 30, 2025 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Text added vs the prior filing · source: 10-Q · 2026-05-13

• On November 24, 2025, a second derivative action was filed in the Southern District of California naming each of the Directors on the Board of Capricor Therapeutics, Inc. The action alleges, among other things, breaches of fiduciary duties and seeks unspecified damages.

• In April 2026, the Company received certain employment-related claims from former employees. No formal proceedings have been commenced as of the date of this filing. The Company does not believe these matters are material.

• On May 7, 2026, Capricor filed a Complaint for Equitable Relief and Application for Preliminary Injunction in the Superior Court of New Jersey, Chancery Division, Bergen County (the “Lawsuit”). The Lawsuit alleges a fundamental pricing flaw in the Commercialization and Distribution Agreement dated J…

Text added vs the prior filing · source: 10-Q · 2026-05-13

• We may not be successful in our newly filed litigation against NS, and the litigation could result in substantial costs, diversion of resources and harm to our business.

• We have filed a Complaint for Equitable Relief and Application for Preliminary Injunction (the “Complaint”) in the Superior Court of New Jersey, Chancery Division, Bergen County. The Complaint alleges that the defendants named therein, NS, have failed to adequately prepare for the commercial launch …

• judgment that the Company has the right to distribute Deramiocel directly or through distributors other than NS, and other equitable remedies.

• Litigation such as this lawsuit is inherently uncertain, and there can be no assurance that we will prevail in this matter or obtain the remedies we seek. The litigation process may continue for an extended period of time, may be expensive and time-consuming, and may divert the attention and resourc…

• If we are unsuccessful in the litigation, we may be unable to prevent NS from engaging in activities that we believe are harmful to our business. Any unfavorable ruling could adversely affect our competitive position, reduce potential revenues, impair our ability to commercialize our products, or ot…

Text removed vs the prior filing · source: 10-Q · 2025-11-10

• We will incur costs in connection with defending securities class action litigation, the derivative claims and the Section 220 Demand for Inspection recently initiated by certain of our stockholders.

• As noted in our Form 10-K for the year ended December 31, 2024, we may become subject to securities class action litigation or litigation initiated by individual stockholders. This risk is especially relevant due to our dependence on positive clinical trial outcomes and regulatory approvals. As note…

Text added vs the prior filing · source: 10-Q · 2026-05-13

• We inadvertently omitted the disclosure of a Rule 10b5-1 Plan adopted by Karimah Es Sabar, one of our directors, on December 27, 2025, in Item 9B of Part II of our Annual Report on Form 10-K for the year ended December 31, 2025. The details of this plan are set forth below.

Text removed vs the prior filing · source: 10-Q · 2025-11-10

• were intended to meet the affirmative defense conditions of Rule 10b5-1(c) or any other “non-Rule 10b5-1 trading arrangement”.