mlys-20240930

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 September 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 November 4, 2024, there were 49,768,669 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			28
Item 4. Controls and Procedures			29
Part II - Other Information			30
Item 1. Legal Proceedings			30
Item 1A. Risk Factors			30
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds			30
Item 3. Defaults Upon Senior Securities			30
Item 4. Mine Safety Disclosures			30
Item 5. Other Information			30
Item 6. Exhibits			30




	September 30,		December 31,
	2024		2023
	(unaudited)
Assets
Current assets:
Cash and cash equivalents	$	97,274	$	49,304
Investments	166,329		187,263
Prepaid and other current assets	4,129		12,536
Total current assets	267,732		249,103
Investments, noncurrent	—		2,482
Property and equipment, net	69		—
Other assets	452		51
Total assets	$	268,253	$	251,636

Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	3,106	$	601
Accrued liabilities	28,215		9,881

Total current liabilities	31,321		10,482
Commitments and contingencies (Note 4)


Stockholders’ equity:
Common stock, $0.0001 par value; 500,000,000 shares authorized as of September 30, 2024 and December 31, 2023; 49,755,946 and 41,133,916 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively	5		4
Additional paid-in capital	490,499		365,858
Accumulated deficit	(253,572)		(124,708)
Total stockholders’ equity	236,932		241,154
Total liabilities and stockholders’ equity	$	268,253	$	251,636


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2024		2023		2024		2023
Operating expenses:
Research and development	$	53,985	$	22,499	$	124,012	$	46,676
General and administrative	6,121		3,774		16,624		10,270
Total operating expenses	60,106		26,273		140,636		56,946
Loss from operations	(60,106)		(26,273)		(140,636)		(56,946)

Interest income, net	3,774		3,513		11,779		9,435

Other income (expense)	(10)		—		(7)		2
Total other income, net	3,764		3,513		11,772		9,437
Net loss	$	(56,342)	$	(22,760)	$	(128,864)	$	(47,509)
Net loss per share attributable to common stockholders, basic and diluted	$	(1.13)	$	(0.57)	$	(2.68)	$	(1.36)
Weighted-average shares used to compute net loss per share attributable to common stockholders, basic and diluted	49,815,186		39,930,748		48,063,638		34,872,287


	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

Issuance of common stock from stock option exercises	—	—		—	—		248,465	—		184		—		184
Stock-based compensation	—	—		—	—		—	—		1,578		—		1,578
Net loss	—	—		—	—		—	—		—		(22,760)		(22,760)
Balance as of September 30, 2023	—	$	—	—	$	—	41,105,118	$	4	$	364,327	$	(100,319)	$	264,012


		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			4,677,742
Shares available for grant under the 2023 Plan			2,450,553
Shares available for grant under the ESPP			783,718
Pre-funded warrants issued and outstanding			549,755
Total			8,461,768


	Options Outstanding	Unvested RSAs	Shares Available for Grant
2023 Plan	3,853,417	—	2,450,553
2020 Plan	824,325	450,478	—
Total	4,677,742	450,478	2,450,553


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


Research and development expenses	$	(53,985)	$	(22,499)	$	(31,486)
General and administrative expenses	(6,121)		(3,774)		(2,347)
Total other income, net	3,764		3,513		251
Net loss	$	(56,342)	$	(22,760)	$	(33,582)


	Nine Months Ended,
	September 30,
	2024		2023		Change
	(in thousands)


Research and development expenses	$	(124,012)	$	(46,676)	$	(77,336)
General and administrative expenses	(16,624)		(10,270)		(6,354)
Total other income, net	11,772		9,437		2,335
Net loss	$	(128,864)	$	(47,509)	$	(81,355)


		MINERALYS THERAPEUTICS, INC.


Date:	November 12, 2024	By:	/s/ Jon Congleton
			Jon Congleton
			Chief Executive Officer
			(Principal Executive Officer)

Date:	November 12, 2024	By:	/s/ Adam Levy
			Adam Levy
			Chief Financial Officer and Secretary
			(Principal Financial Officer; Principal Accounting Officer)


	Nine Months Ended
	September 30,
	2024		2023		Change

Net cash provided by (used in):
Operating activities	$	(99,471)	$	(52,192)	$	(47,279)
Investing activities	31,389		(152,383)		183,772
Financing activities	116,052		203,174		(87,122)
Net	$	47,970	$	(1,401)	$	49,371

SEC Form 10-Q filed by Mineralys Therapeutics Inc.