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Mineralys Therapeutics, Inc.

For the period ended Jun 2, 2026. Filed Jun 3, 2026.

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About this filing

A notice of a major event between regular reports, such as results, a deal or a change of executives. It is often the first formal record of the news.

Jun 2, 2026 · Filed Jun 3, 2026

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MLYS$15.33+0.6%Stored close · as of Nov 6, 2026
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Forward Looking Statements

The Company cautions you that statements contained in this report regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on the Company’s current beliefs and expectations and include, but are not limited to, the potential approval by the FDA of the lorundrostat NDA and the Company’s plans to commercially launch lorundrostat, the Company’s expectations with respect to finalizing an agreement with Tanabe to terminate the License Agreement and to have Tanabe’s rights in the licensed intellectual property related to lorundrostat assigned to the Company, and the capital available under the Loan Agreement, including the potential for the Company to draw down additional tranches thereunder. Actual results may differ from those set forth in this report due to the risks and uncertainties inherent in the Company’s business, including, without limitation: any delays in the FDA’s review of the Company’s accepted NDA, including as a result of a government shutdown or reductions in agency funding or personnel; the results of the Company’s clinical trials, including the Advance-HTN and Launch-HTN trials, may not be deemed sufficient by the FDA to serve as the basis for regulatory approval of lorundrostat; later developments with the FDA may be inconsistent with the feedback from prior meetings, including whether the proposed pivotal program will support registration of lorundrostat following the FDA’s review of the Company’s NDA submission; the risk that the funding under the Loan Agreement may not be completed on the timeframe the Company expects, or at all, including as a result of the Company’s failure to meet the conditions required for such funding or failure to comply with the affirmative and negative covenants under the Loan Agreement; the Company may not be able to reach agreement on the proposed Termination Agreement with Tanabe on the Company’s expected timeframe, or at all; the Company’s future performance is dependent entirely on the success of lorundrostat; potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies; the Company’s dependence on third parties in connection with manufacturing, research and clinical and nonclinical testing; unexpected adverse side effects or inadequate efficacy of lorundrostat that may limit its development, regulatory approval and/or commercialization; unfavorable results from clinical trials and nonclinical studies; results of prior clinical trials and studies of lorundrostat are not necessarily predictive of future results; macroeconomic trends and uncertainty with regard to high interest rates, elevated inflation, tariffs and other trade policies, and the potential for a local and/or global economic recession; the Company’s ability to maintain undisrupted business operations due to any pandemic or future public health concerns; regulatory developments in the United States and foreign countries; the Company’s reliance on its exclusive license with Tanabe to provide the Company with intellectual property rights to develop and commercialize lorundrostat; and other risks described in the Company’s filings with the Securities and Exchange Commission (“SEC”), including under the heading “Risk Factors” in the Company’s annual report on Form 10-K, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

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