mlys-20250630

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549




			Form 10-Q

(Mark One)


x			QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2025


¨			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ______ to ______

Commission file number 001-41614




MINERALYS THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)


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

150 N. Radnor Chester Rd, Suite F200, Radnor, PA 19087
(Address, including zip code, of principal executive offices)

888-378-6240
(Registrant's telephone number, including area code)

(Former name, former address and former fiscal year, if changed since last report): NA

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, $0.0001 par value per share	MLYS	The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports); and (2) has been subject to such filing requirements for the past 90 days. Yes x No o

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes x No o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

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. o

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No x

As of August 7, 2025, there were 66,295,184 shares of the registrant’s common stock outstanding.

Mineralys Therapeutics, Inc.

Table of Contents


			Page
Part I - Financial Information			1
Item 1. Financial Statements			1
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations			17
Item 3. Quantitative and Qualitative Disclosures About Market Risk			32
Item 4. Controls and Procedures			32
Part II - Other Information			34
Item 1. Legal Proceedings			34
Item 1A. Risk Factors			34
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds			34
Item 3. Defaults Upon Senior Securities			35
Item 4. Mine Safety Disclosures			35
Item 5. Other Information			35
Item 6. Exhibits			35




	June 30,		December 31,
	2025		2024
	(unaudited)
Assets
Current assets:
Cash and cash equivalents	$	101,788	$	114,091
Investments	223,128		84,096
Prepaid and other current assets	10,353		7,164
Total current assets	335,269		205,351

Property and equipment, net	22		53
Other assets	433		499
Total assets	$	335,724	$	205,903

Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	3,164	$	479
Accrued liabilities	19,009		14,167

Total current liabilities	22,173		14,646
Commitments and contingencies (Note 4)


Stockholders’ equity:
Common stock, $0.0001 par value; 500,000,000 shares authorized as of June 30, 2025 and December 31, 2024; 65,725,409 and 49,821,915 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively	6		5
Additional paid-in capital	701,548		493,770
Accumulated deficit	(388,003)		(302,518)
Total stockholders’ equity	313,551		191,257
Total liabilities and stockholders’ equity	$	335,724	$	205,903


	Three Months Ended				Six Months Ended
	June 30,				June 30,
	2025		2024		2025		2024
Operating expenses:
Research and development	$	38,278	$	39,273	$	76,157	$	70,027
General and administrative	8,468		5,895		15,036		10,503
Total operating expenses	46,746		45,168		91,193		80,530
Loss from operations	(46,746)		(45,168)		(91,193)		(80,530)

Interest income, net	3,474		4,152		5,713		8,005

Other income (expense)	(2)		2		(5)		3
Total other income, net	3,472		4,154		5,708		8,008
Net loss	$	(43,274)	$	(41,014)	$	(85,485)	$	(72,522)
Net loss per share attributable to common stockholders, basic and diluted	$	(0.66)	$	(0.83)	$	(1.44)	$	(1.54)
Weighted-average shares used to compute net loss per share attributable to common stockholders, basic and diluted	65,451,297		49,356,287		59,341,368		47,178,288



	Common Stock	Additional Paid-In-Capital	Accumulated Deficit		Total Stockholders’ Equity
							Shares			Amount
Balance as of December 31, 2023		41,133,916	$	4	$	365,858		$	(124,708)		$	241,154
Issuance of common stock and pre-funded warrants in private placement offering, net of offering costs of $3,941		8,339,169	1		116,058			—			116,059

Issuance of common stock from stock option exercises		159,904	—		149			—			149

Stock-based compensation		—	—		2,191			—			2,191
Net loss		—	—		—			(31,508)			(31,508)
Balance as of March 31, 2024		49,632,989	5		484,256			(156,216)			328,045


Issuance of common stock from stock option exercises		58,717	—		54			—			54
Issuance of common stock for cash under employee stock purchase plan		18,892	—		138			—			138
Stock-based compensation		—	—		2,872			—			2,872
Net loss		—	—		—			(41,014)			(41,014)
Balance as of June 30, 2024		49,710,598	$	5	$	487,320		$	(197,230)		$	290,095


		As of June 30, 2025
Balance Sheet Location	Original Maturities	Amortized Cost		Estimated Fair Value
Cash and cash equivalents	less than 3 months	$	4,961	$	4,961
Investments	between 3 and 12 months	223,128		223,085

Total		$	228,089	$	228,046


		As of December 31, 2024
Balance Sheet Location	Original Maturities	Amortized Cost		Estimated Fair Value
Cash and cash equivalents	less than 3 months	$	29,825	$	29,829
Investments	between 3 and 12 months	84,096		84,123

Total		$	113,921	$	113,952






Common stock options outstanding			6,993,414
Shares available for grant under the 2023 Plan			1,761,818
Shares available for grant under the ESPP			1,260,337
Shares available for grant under the 2025 Inducement Plan			1,000,000
Pre-funded warrants issued and outstanding			549,755
Total			11,565,324


	Options Outstanding	Unvested RSAs	Shares Available for Grant
2023 Plan	6,416,912	—	1,761,818
2020 Plan	576,502	247,951	—
2025 Inducement Plan	—	—	1,000,000
Total	6,993,414	247,951	2,761,818


	Placebo	Lorundrostat 25 mg	Placebo-Adjusted
Change in systolic BP (mmHg)*	-1.76	-9.25	-7.5 (p=0.0024)
Change in spot UACR (mg/g)	-6.60%	-30.51%	-25.60% (p=0.0015)
Change in eGFR** (mL/min/1.73m2)	-2.20%	-6.78%	-4.58% (p=0.0362)
Treatment Emergent Adverse Events (TEAEs) leading to discontinuation of study drug	1/57 (2%)	2/58 (3%)
Confirmed hyperkalemia*** (K + >6.0 mmol/L)	0/59 (0%)	3/58 (5%)


	Three Months Ended,
	June 30,
	2025		2024		Change
	(in thousands)


Research and development expenses	$	(38,278)	$	(39,273)	$	995
General and administrative expenses	(8,468)		(5,895)		(2,573)
Total other income, net	3,472		4,154		(682)
Net loss	$	(43,274)	$	(41,014)	$	(2,260)


	Six Months Ended,
	June 30,
	2025		2024		Change
	(in thousands)


Research and development expenses	$	(76,157)	$	(70,027)	$	(6,130)
General and administrative expenses	(15,036)		(10,503)		(4,533)
Total other income, net	5,708		8,008		(2,300)
Net loss	$	(85,485)	$	(72,522)	$	(12,963)


	Six Months Ended
	June 30,
	2025		2024		Change

Net cash provided by (used in):
Operating activities	$	(75,656)	$	(49,285)	$	(26,371)
Investing activities	(135,757)		(48,216)		(87,541)
Financing activities	199,110		116,053		83,057
Net	$	(12,303)	$	18,552	$	(30,855)


		MINERALYS THERAPEUTICS, INC.


Date:	August 12, 2025	By:	/s/ Jon Congleton
			Jon Congleton
			President and Chief Executive Officer
			(Principal Executive Officer)

Date:	August 12, 2025	By:	/s/ Adam Levy
			Adam Levy
			Chief Financial Officer and Secretary
			(Principal Financial Officer; Principal Accounting Officer)

SEC Form 10-Q filed by Mineralys Therapeutics Inc.