Mineralys Therapeutics Files 8-K

TL;DR

MLYS filed an 8-K on 6/10/24, standard reporting.

AI Summary

Mineralys Therapeutics, Inc. filed an 8-K on June 10, 2024, reporting other events and financial statements. The company, incorporated in Delaware with its principal executive offices in Radnor, Pennsylvania, operates in the pharmaceutical preparations sector.

Why It Matters

This filing indicates routine corporate reporting, including financial statements and other events, which is standard for publicly traded companies.

Risk Assessment

Risk Level: low — This is a routine 8-K filing for corporate reporting and does not contain significant new information that would immediately impact the company's risk profile.

Key Numbers

• 001-41614 — SEC File Number (Identifies the company's filing with the SEC.)
• 84-1966887 — IRS Employer Identification No. (Company's tax identification number.)

Key Players & Entities

• Mineralys Therapeutics, Inc. (company) — Registrant
• June 10, 2024 (date) — Date of report
• Delaware (jurisdiction) — State of incorporation
• Radnor, Pennsylvania (location) — Principal executive offices
• 2834 (sic_code) — Standard Industrial Classification for Pharmaceutical Preparations

FAQ

Key Financial Figures

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

Filing Documents

• mlys-20240610.htm (8-K) — 30KB
• 0001933414-24-000025.txt ( ) — 160KB
• mlys-20240610.xsd (EX-101.SCH) — 2KB
• mlys-20240610_lab.xml (EX-101.LAB) — 23KB
• mlys-20240610_pre.xml (EX-101.PRE) — 13KB
• mlys-20240610_htm.xml (XML) — 3KB

01. Other Events

Item 8.01. Other Events. As previously disclosed, in April 2023, Mineralys Therapeutics, Inc. (the Company) initiated its first pivotal trial, Advance-HTN, a randomized, double-blind, placebo-controlled Phase 2 clinical trial to evaluate the efficacy and safety of lorundrostat for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), when used as an add-on therapy to a standardized background treatment of two or three antihypertensive medications in 261 adult subjects. Subjects who meet screening criteria will have their existing hypertension medications discontinued and start on a standard regimen of an ARB and a diuretic, if previously on two medications, or a standard regimen of ARB, diuretic and calcium channel blocker if previously on three to five medications. Subjects who remain hypertensive despite the standardized regimen are then randomized into three cohorts and treated for twelve weeks: lorundrostat 50 mg QD, lorundrostat 50 mg QD, and an option to titrate to 100 mg QD at week four based on defined criteria or placebo. The initial primary endpoint of the trial was change in 24-hour ambulatory systolic blood pressure (BP) at week twelve from baseline for active cohorts versus placebo. Topline data from this trial is anticipated in the fourth quarter of 2024. In December 2023, the Company initiated its second pivotal trial, Launch-HTN, a randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate the efficacy and safety of lorundrostat for the treatment of uHTN or rHTN, when used as an add-on therapy to their existing, prescribed background treatment of two to five antihypertensive medications in up to approximately 1,000 adult subjects. Subjects are then randomized into three cohorts and treated for twelve weeks: lorundrostat 50 mg QD, lorundrostat 50 mg QD and an option to titrate to 100 mg QD at week six based on defined criteria or placebo. The initial primary endpoint of the trial was change in offic

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 Company's plan to revise the primary endpoint for the Advance-HTN trial; 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 or uncontrolled 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 FDA may not support the Company's proposed revision to the primary endpoint for the Advance-HTN trial; 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 lorundrost

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: June 10, 2024 MINERALYS THERAPEUTICS, INC. By: /s/ Jon Congleton Name: Jon Congleton Title: Chief Executive Officer

View Full Filing

View this 8-K filing on SEC EDGAR