SEC Form 8-K filed by MannKind Corporation
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SECURITIES AND EXCHANGE COMMISSION
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| Item 8.01 | Other Events. |
On November 10, 2025, MannKind Corporation (the “Company”) announced that it is discontinuing its Phase 3 clinical trial evaluating nebulized inhalation suspension of clofazimine (“MNKD-101”) for the treatment of refractory nontuberculous mycobacterial (“NTM”) lung disease (the “ICoN-1 Study”). The decision to discontinue the trial follows an analysis of sputum culture conversion data, conducted as part of routine study monitoring and in accordance with the trial protocol, for the first 46 participants who had completed the double-blind treatment phase of the study. None of these 46 participants showed evidence of sputum culture conversion, raising concerns regarding the likelihood of achieving the study’s key primary endpoint. Following an ad hoc meeting of the data safety monitoring board (“DSMB”) for the ICoN-1 Study on November 8, 2025, the DSMB reviewed the data and agreed with the decision to discontinue the trial due to futility. In this meeting and in all past DSMB meetings, no safety issues were found.
The Company intends to investigate the reasons for this outcome and use the findings to help guide the ongoing development of MNKD-102, the dry powder formulation of clofazimine, which is in the process of advancing from pre-clinical development towards Phase 1.
Forward-Looking Statements
Statements in this report that are not statements of historical fact are forward-looking statements. Words such as “plans,” “expects,” “intend,” “will,” “anticipate,” “potential” and similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements regarding the future development of MNKD-102. These forward-looking statements are based upon the Company’s current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include risks and uncertainties regarding pipeline development and capital resource considerations. Additional risks are detailed in the Company’s filings with the Securities and Exchange Commission (“SEC”), including under the heading “Risk Factors” in MannKind’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, filed with the SEC on November 5, 2025. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this report. All forward-looking statements are qualified in their entirety by this cautionary statement, and the Company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this report.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| MannKind Corporation | ||||||
| Date: November 10, 2025 | By: | /s/ David Thomson | ||||
| David Thomson, Ph.D., J.D. | ||||||
| Executive Vice President, General Counsel and Secretary | ||||||