CAPR 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-14

• 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 RNA and microRNAs. These vesicles facilitate intercellular communication thr…

• Exosomes in particular have attracted increasing interest as potential therapeutic and diagnostic platforms. Their small size, generally low immunogenicity, and ability to deliver biologically active molecules to recipient cells may allow

• them to modulate complex biological pathways. Because exosomes are cell-free vesicles, they may be stored, handled, and administered using approaches similar to those used for certain established biologic therapies.

• HOPE-3 Phase 3 Peer-Review Publication; Update to Statistical Model for LVEF: In July 2026, results from the HOPE-3 trial were published in The Lancet following independent peer review. As part of our dialogue with the FDA regarding the HOPE-3 data, and in connection with the peer review process wit…

• are no longer considered to be controlled for Type I error, and results for those endpoints are reported as nominal. The primary endpoint of HOPE-3 which addresses the skeletal muscle results was unaffected with Deramiocel demonstrating a statistically significant slowing of upper limb disease progr…

相对上期删除的文字 · 来源:10-Q · 2026-05-13

• 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.

• 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

• RNA and microRNAs. These vesicles facilitate intercellular communication through the binding and activation of membrane receptors or through the delivery of molecular cargo into target cells. Through these mechanisms, EVs may influence a variety of biological processes, including cell survival, prol…

• Exosomes in particular have attracted increasing interest as potential therapeutic and diagnostic platforms. Their small size, generally low immunogenicity, and ability to deliver biologically active molecules to recipient cells may allow them to modulate complex biological pathways. Because exosome…

• 2 resubmission, assigning a new PDUFA target action date of August 22, 2026. If approved, Deramiocel has the potential to become the first therapy designed to address both skeletal and cardiac muscle manifestations of DMD.

相对上期删除的文字 · 来源: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.

相对上期新增的文字 · 来源:10-Q · 2026-08-14

• There were no changes in our internal control over financial reporting during the quarter ended June 30, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

相对上期删除的文字 · 来源: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.

相对上期新增的文字 · 来源:10-Q · 2026-08-14

• On October 2, 2025, the Company received a Section 220 Shareholder Demand Letter dated September 30, 2025 to inspect and make copies of certain books and records of the Company. The stockholder's demand is related to, among other things, alleged false and misleading statements purportedly made by of…

• On May 7, 2026, Capricor announced that it had filed a Motion for Preliminary Injunction and Complaint in the Superior Court of New Jersey. The Complaint alleges a fundamental pricing flaw in the U.S. Distribution Agreement and that the defendants named therein, NS, have failed to adequately prepare…

• On May 20, 2026, Capricor received a shareholder litigation demand from Jennifer Godin, a beneficial owner of Capricor common stock, to take action to remedy breaches of fiduciary duties and other violations of law. No settlement amount has been requested yet.

• On July 16, 2026, Mesoblast International Sàrl has filed a patent infringement and declaratory judgment action in the District of Delaware against Capricor, alleging unauthorized manufacture, use, sale, and importation of the cardiosphere-derived cell product Deramiocel for the treatment of DMD. The…

• On July 30, 2026, Darren Ngasseu Nkamga, individually and on behalf of all others similarly situated, filed a class action for securities against Capricor Therapeutics Inc. and certain officers of the Company, alleging that defendants had made materially false and/or misleading statement regarding C…

相对上期删除的文字 · 来源:10-Q · 2026-05-13

• On October 2, 2025, the Company received a Section 220 Shareholder Demand Letter dated September 30, 2025 to inspect and make copies of certain books and records of the Company. The stockholder's demand is related to, among other things, alleged false and misleading statements purportedly made by of…

• 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…

相对上期新增的文字 · 来源:10-Q · 2026-08-14

• The negative vote of the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee is expected to have a significant impact on Deramiocel’s approvability in the U.S. for the treatment of cardiomyopathy in patients with DMD.

• On July 29, 2026, the FDA convened an Advisory Committee to review our BLA for Deramiocel. The single voting question presented to the Advisory Committee asked whether the available evidence supports the effectiveness of Deramiocel for the treatment of cardiomyopathy in patients with DMD. The Adviso…

• It is difficult to predict the outcome of any dispute, and there can be no assurance that we will prevail in this matter or obtain the remedies we seek. The arbitration process may continue for an extended period of time, may be expensive and time-consuming, and may divert the attention and resource…

• If we are unsuccessful in the arbitration, 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 o…

• Regardless of the outcome, arbitration may generate negative publicity, create uncertainty among customers, distributors, suppliers or collaboration partners, and adversely affect our ability to enter into strategic transactions or obtain financing on favorable terms.

相对上期删除的文字 · 来源:10-Q · 2026-05-13

• 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…

• Regardless of the outcome, litigation may generate negative publicity, create uncertainty among customers, distributors, suppliers or collaboration partners, and adversely affect our ability to enter into strategic transactions or obtain financing on favorable terms.

• affect our business, financial condition and results of operations. Even if we are successful in our litigation with NS, we may ultimately partner with one or more distribution partners for the commercialization of Deramiocel in the United States or other territories, and in that event we would depe…

相对上期新增的文字 · 来源:10-Q · 2026-08-14

• The trading arrangements permit transactions in the Company’s common stock in accordance with Rule 10b5-1(c) and applicable company policies regarding insider trading.

相对上期删除的文字 · 来源: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.