mlys-20240630

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, 2024


¨			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 August 2, 2024, there were 49,726,675 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			15
Item 3. Quantitative and Qualitative Disclosures About Market Risk			27
Item 4. Controls and Procedures			28
Part II - Other Information			29
Item 1. Legal Proceedings			29
Item 1A. Risk Factors			29
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds			29
Item 3. Defaults Upon Senior Securities			29
Item 4. Mine Safety Disclosures			29
Item 5. Other Information			29
Item 6. Exhibits			29




	June 30,		December 31,
	2024		2023
	(unaudited)
Assets
Current assets:
Cash and cash equivalents	$	67,856	$	49,304
Investments	243,259		187,263
Prepaid and other current assets	6,886		12,536
Total current assets	318,001		249,103
Investments, noncurrent	—		2,482
Property and equipment, net	42		—
Other assets	449		51
Total assets	$	318,492	$	251,636

Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	1,707	$	601
Accrued liabilities	26,690		9,881

Total current liabilities	28,397		10,482
Commitments and contingencies (Note 4)


Stockholders’ equity:
Common stock, $0.0001 par value; 500,000,000 shares authorized as of June 30, 2024 and December 31, 2023; 49,710,598 and 41,133,916 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively	5		4
Additional paid-in capital	487,320		365,858
Accumulated deficit	(197,230)		(124,708)
Total stockholders’ equity	290,095		241,154
Total liabilities and stockholders’ equity	$	318,492	$	251,636


	Three Months Ended				Six Months Ended
	June 30,				June 30,
	2024		2023		2024		2023
Operating expenses:
Research and development	$	39,273	$	11,884	$	70,027	$	24,177
General and administrative	5,895		3,851		10,503		6,496
Total operating expenses	45,168		15,735		80,530		30,673
Loss from operations	(45,168)		(15,735)		(80,530)		(30,673)

Interest income, net	4,152		3,593		8,005		5,922

Other income	2		1		3		2
Total other income, net	4,154		3,594		8,008		5,924
Net loss	$	(41,014)	$	(12,141)	$	(72,522)	$	(24,749)
Net loss per share attributable to common stockholders, basic and diluted	$	(0.83)	$	(0.31)	$	(1.54)	$	(0.77)
Weighted-average shares used to compute net loss per share attributable to common stockholders, basic and diluted	49,356,287		39,754,981		47,178,288		32,301,136


	Series A Convertible Preferred Stock			Series B Convertible Preferred Stock			Common Stock			Additional Paid-In-Capital		Accumulated Deficit		Total Stockholders’ Equity (Deficit)
	Shares	Amount		Shares	Amount		Shares	Amount
Balance as of December 31, 2022	86,332,216	$	40,987	136,510,868	$	117,657	6,419,238	$	1	$	540	$	(52,810)	$	(52,269)
Conversion of preferred stock to common stock upon closing of initial public offering	(86,332,216)	(40,987)		(136,510,868)	(117,657)		20,637,415	2		158,642		—		158,644
Issuance of common stock in initial public offering, net of issuance costs of $19,441	—	—		—	—		13,800,000	1		201,358		—		201,359

Stock-based compensation	—	—		—	—		—	—		749		—		749
Net loss	—	—		—	—		—	—		—		(12,608)		(12,608)
Balance as of March 31, 2023	—	—		—	—		40,856,653	4		361,289		(65,418)		295,875

Stock-based compensation	—	—		—	—		—	—		1,276		—		1,276
Net loss	—	—		—	—		—	—		—		(12,141)		(12,141)
Balance as of June 30, 2023	—	$	—	—	$	—	40,856,653	$	4	$	362,565	$	(77,559)	$	285,010


		As of December 31, 2023
Balance Sheet Location	Original Maturities	Amortized Cost		Estimated Fair Value

Investments	between 3 and 12 months	$	187,263	$	187,293
Investments, noncurrent	greater than 1 year	2,482		2,486
Total		$	189,745	$	189,779






Common stock options outstanding			4,394,713
Shares available for grant under the 2023 Plan			2,799,930
Shares available for grant under the ESPP			783,718
Pre-funded warrants issued and outstanding			549,755
Total			8,528,116


	Options Outstanding	Unvested RSAs	Shares Available for Grant
2023 Plan	3,525,040	—	2,799,930
2020 Plan	869,673	540,497	—
Total	4,394,713	540,497	2,799,930


	Three Months Ended,
	June 30,
	2024		2023		Change
	(in thousands)


Research and development expenses	$	(39,273)	$	(11,884)	$	(27,389)
General and administrative expenses	(5,895)		(3,851)		(2,044)
Total other income, net	4,154		3,594		560
Net loss	$	(41,014)	$	(12,141)	$	(28,873)


	Six Months Ended,
	June 30,
	2024		2023		Change
	(in thousands)


Research and development expenses	$	(70,027)	$	(24,177)	$	(45,850)
General and administrative expenses	(10,503)		(6,496)		(4,007)
Total other income, net	8,008		5,924		2,084
Net loss	$	(72,522)	$	(24,749)	$	(47,773)


		MINERALYS THERAPEUTICS, INC.


Date:	August 13, 2024	By:	/s/ Jon Congleton
			Jon Congleton
			Chief Executive Officer
			(Principal Executive Officer)

Date:	August 13, 2024	By:	/s/ Adam Levy
			Adam Levy
			Chief Financial Officer and Secretary
			(Principal Financial Officer; Principal Accounting Officer)


	Six Months Ended
	June 30,
	2024		2023		Change
	(in thousands)
Net cash provided by (used in):
Operating activities	$	(49,285)	$	(33,161)	$	(16,124)
Investing activities	(48,216)		(156,390)		108,174
Financing activities	116,053		202,990		(86,937)
Net	$	18,552	$	13,439	$	5,113

SEC Form 10-Q filed by Mineralys Therapeutics Inc.