mlys-20231221

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): December 21, 2023

MINERALYS THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)


Delaware	001-41614	84-1966887
(State or other jurisdiction of incorporation or organization)	(Commission File Number)	(I.R.S. Employer Identification No.)

150 N. Radnor Chester Road, Suite F200 Radnor, Pennsylvania 19087
(Address of principal executive offices) (Zip Code)
	(888) 378-6240
(Registrant’s telephone number, include area code)
N/A
(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.0001 per share	MLYS	The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01. Regulation FD Disclosure.

On December 21, 2023, Mineralys Therapeutics, Inc. (the “Company”) issued a press release announcing that the first subject has been dosed in the Launch-HTN pivotal trial. 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 Current Report on Form 8-K, including Exhibit 99.1, 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.

Item 8.01. Other Events.

On December 21, 2023, the Company announced that the first subject has been dosed in the Launch-HTN (NCT06153693) pivotal trial to evaluate the safety and efficacy of lorundrostat for the treatment of uncontrolled hypertension or resistant hypertension, when used as an add-on therapy to prescribed background treatment.

Launch-HTN is the second of two clinical trials under the planned pivotal program to evaluate the safety and efficacy of lorundrostat when added to subjects’ existing background hypertension treatment. This trial is designed to model real world treatment of uncontrolled hypertension and resistant hypertension in the primary care setting. Launch-HTN is a global, randomized, double-blinded, placebo-controlled Phase 3 trial that is designed to enroll up to approximately 1,000 eligible adult participants who are failing to achieve their blood pressure goal on two to five background antihypertensive medications. Eligible subjects will be randomized to one of three arms: placebo, lorundrostat 50 mg once daily (QD), and lorundrostat 50 mg QD and then titrated to 100 mg QD, as needed, at week six. The primary endpoint of the trial is change from baseline in systolic blood pressure versus placebo after 12 weeks of treatment, as measured by automated office blood pressure monitoring.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits


Exhibit No.						Description

99.1						Press Release Issued on December 21, 2023

104						Cover Page Interactive Date File (embedded within the Inline XBRL document)

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: December 22, 2023	MINERALYS THERAPEUTICS, INC.


	By:	/s/ Adam Levy

	Name:	Adam Levy

	Title:	Chief Financial Officer, Chief Business Officer and Secretary