mlys-20250331

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 March 31, 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 and posted on its corporate web site, if any, every Interactive Data File required to be submitted and posted 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 and post 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 Act). Yes o No x

As of May 8, 2025, there were 65,175,287 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			16
Item 3. Quantitative and Qualitative Disclosures About Market Risk			29
Item 4. Controls and Procedures			29
Part II - Other Information			31
Item 1. Legal Proceedings			31
Item 1A. Risk Factors			31
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds			31
Item 3. Defaults Upon Senior Securities			32
Item 4. Mine Safety Disclosures			32
Item 5. Other Information			32
Item 6. Exhibits			32




	March 31,		December 31,
	2025		2024
	(unaudited)
Assets
Current assets:
Cash and cash equivalents	$	165,007	$	114,091
Investments	178,019		84,096
Prepaid and other current assets	11,480		7,164
Total current assets	354,506		205,351

Property and equipment, net	38		53
Other assets	397		499
Total assets	$	354,941	$	205,903

Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	373	$	479
Accrued liabilities	13,013		14,167

Total current liabilities	13,386		14,646
Commitments and contingencies (Note 4)


Stockholders’ equity:
Common stock, $0.0001 par value; 500,000,000 shares authorized as of March 31, 2025 and December 31, 2024; 64,876,228 and 49,821,915 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively	6		5
Additional paid-in capital	686,278		493,770
Accumulated deficit	(344,729)		(302,518)
Total stockholders’ equity	341,555		191,257
Total liabilities and stockholders’ equity	$	354,941	$	205,903


	Three Months Ended
	March 31,
		2025		2024
Operating expenses:
Research and development		$	37,879	$	30,754
General and administrative		6,568		4,608
Total operating expenses		44,447		35,362
Loss from operations		(44,447)		(35,362)

Interest income, net		2,239		3,853

Other income (expense)		(3)		1
Total other income, net		2,236		3,854
Net loss		$	(42,211)	$	(31,508)
Net loss per share attributable to common stockholders, basic and diluted		$	(0.79)	$	(0.70)
Weighted-average shares used to compute net loss per share attributable to common stockholders, basic and diluted		53,163,551		44,900,755



	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


		As of March 31, 2025
Balance Sheet Location	Original Maturities	Amortized Cost		Estimated Fair Value
Cash and cash equivalents	less than 3 months	$	39,750	$	39,748
Investments	between 3 and 12 months	178,019		177,999

Total		$	217,769	$	217,747


		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			6,778,317
Shares available for grant under the 2023 Plan			2,137,973
Shares available for grant under the ESPP			1,273,941
Shares available for grant under the 2025 Inducement Plan			1,000,000
Pre-funded warrants issued and outstanding			549,755
Total			11,739,986


	Options Outstanding	Unvested RSAs	Shares Available for Grant
2023 Plan	6,158,872	—	2,137,973
2020 Plan	619,445	309,028	—
2025 Inducement Plan	—	—	1,000,000
Total	6,778,317	309,028	3,137,973


	Three Months Ended,
	March 31,
	2025		2024		Change
	(in thousands)


Research and development expenses	$	(37,879)	$	(30,754)	$	(7,125)
General and administrative expenses	(6,568)		(4,608)		(1,960)
Total other income, net	2,236		3,854		(1,618)
Net loss	$	(42,211)	$	(31,508)	$	(10,703)


		MINERALYS THERAPEUTICS, INC.


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

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


	Three Months Ended
	March 31,
	2025		2024		Change

Net cash provided by (used in):
Operating activities	$	(45,487)	$	(19,139)	$	(26,348)
Investing activities	(92,876)		(55,952)		(36,924)
Financing activities	189,279		116,205		73,074
Net	$	50,916	$	41,114	$	9,802

SEC Form 10-Q filed by Mineralys Therapeutics Inc.