Mineralys Therapeutics Files 8-K

TL;DR

Mineralys Therapeutics filed a standard 8-K, no major news.

AI Summary

Mineralys Therapeutics, Inc. filed an 8-K on January 8, 2025, to report on other events and financial statements. The filing does not contain specific financial figures or material events beyond the standard reporting requirements.

Why It Matters

This 8-K filing indicates routine corporate reporting by Mineralys Therapeutics, Inc. without disclosing new material information that would immediately impact investors.

Risk Assessment

Risk Level: low — The filing is a routine 8-K and does not disclose any new material events, risks, or financial changes.

Key Players & Entities

• Mineralys Therapeutics, Inc. (company) — Registrant
• January 8, 2025 (date) — Date of report
• Delaware (jurisdiction) — State of incorporation
• 150 N. Radnor Chester Road, Suite F200, Radnor, Pennsylvania 19087 (address) — Principal executive offices

FAQ

Key Financial Figures

• $0.0001 — ch registered Common Stock, par value $0.0001 per share MLYS The Nasdaq Stock Marke

Filing Documents

• mlys-20250108.htm (8-K) — 32KB
• mlys202501088kex991.htm (EX-99.1) — 18KB
• a1a.jpg (GRAPHIC) — 5KB
• 0001933414-25-000002.txt ( ) — 194KB
• mlys-20250108.xsd (EX-101.SCH) — 2KB
• mlys-20250108_lab.xml (EX-101.LAB) — 23KB
• mlys-20250108_pre.xml (EX-101.PRE) — 13KB
• mlys-20250108_htm.xml (XML) — 3KB

01. Regulation FD Disclosure

Item 7.01. Regulation FD Disclosure. On January 8, 2025, Mineralys Therapeutics, Inc. (the Company) issued a press release announcing that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) Application for a Phase 2 clinical trial to evaluate the effect of lorundrostat in the treatment of subjects with moderate-to-severe obstructive sleep apnea (OSA) and hypertension. A copy of the press release is attached as Exhibit 99.1 and is incorporated herein by reference. In accordance with General Instruction B.2 of Form 8-K, the information in this Item 7.01 of this Current Report on Form 8-K and Exhibit 99.1 hereto shall not be deemed "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 deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing.

01. Other Events

Item 8.01. Other Events. On January 8, 2025, the Company announced that the FDA has cleared the Company's IND Application for a Phase 2 clinical trial to evaluate the effect of lorundrostat in the treatment of subjects with moderate-to-severe OSA and hypertension. The Company anticipates initiating the trial in the first quarter of 2025. The Company believes that its current cash, cash equivalents and investments will be sufficient to fund its planned clinical studies and support its corporate operations through the first quarter of 2026.

01. Financial Statements and Exhibits

Item 9.01. Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Press Release Issued on January 8, 2025 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

Forward Looking Statements

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, statements regarding: the potential therapeutic benefits of lorundrostat; the Company's expectation that aldosterone synthase inhibitors with an SGLT2 inhibitor may provide additive clinical benefits to patients; the Company's expectation that Advance-HTN and Launch-HTN may serve as pivotal trials in any submission of a new drug application (NDA) to the FDA; the Company's ability to evaluate lorundrostat as a potential treatment for chronic kidney disease, uncontrolled hypertension, resistant hypertension, or OSA in patients with hypertension; the planned future clinical development of lorundrostat and the timing thereof; and the expected timing of commencement and enrollment of patients in clinical trials and topline results from clinical trials. 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: 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; later developments with the FDA may be inconsistent with the feedback from the completed end of Phase 2 meeting, including whether the proposed pivotal program will support registration of lorundrostat which is a review issue with the FDA upon submission of an NDA; 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 an

SIGNATURES

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. Dated: January 8, 2025 MINERALYS THERAPEUTICS, INC. By: /s/ Adam Levy Name: Adam Levy Title: Chief Financial Officer and Secretary

View Full Filing

View this 8-K filing on SEC EDGAR