What changed in this filing

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Item 1. Financial Statements

2026-05-06 compared with 2025-11-10 · 112 added, 204 removed, 245 unchanged (56% of the section changed)

3 unchanged sentences

(in thousands, except share and per share amounts)

September 30, December 31,

March 31, December 31,

Current assets:

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Common stock, $ 0.0001 par value;

500,000,000 shares authorized as of September 30, 2025 and December 31, 2024;

78,969,459 and 49,821,915 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively

500,000,000 shares authorized as of March 31, 2026 and December 31, 2025;

82,454,950 and 81,536,557 shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively

Additional paid-in capital 1,134,644 1,103,854

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(in thousands, except share and per share data)

Three Months Ended Nine Months Ended

September 30, September 30,

2025 2024 2025 2024

Three Months Ended

Operating expenses:

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Net loss per share attributable to common stockholders, basic and diluted $ ( 0.47 ) $ ( 0.79 )

Weighted-average shares used to compute net loss per share attributable to common stockholders, basic and diluted 70,594,504 49,815,186 63,133,634 48,063,638

Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted 82,834,752 53,163,551

The accompanying notes are an integral part of these condensed financial statements.

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Balance as of December 31, 2024 49,821,915 $ 5 $ 493,770 $ ( 302,518 ) $ 191,257

Issuance of common stock and pre-funded warrants in private placement offering, net of offering costs of $ 3,941

Issuance of common stock in public offering, net of offering costs of $ 12,509

14,907,406 1 188,740 — 188,741

3 unchanged sentences

Balance as of March 31, 2025 64,876,228 $ 6 $ 686,278 $ ( 344,729 ) $ 341,555

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

Issuance of common stock from stock option exercises 45,348 — 40 — 40

Stock-based compensation — — 3,139 — 3,139

Net loss — — — ( 56,342 ) ( 56,342 )

Balance as of September 30, 2024 49,755,946 $ 5 $ 490,499 $ ( 253,572 ) $ 236,932

Mineralys Therapeutics, Inc.

Condensed Statements of Stockholders’ Equity (Continued)

(in thousands, except share data)

Common Stock Additional

Paid-In-Capital Accumulated

Paid-In Capital

Deficit Total

2 unchanged sentences

Balance as of December 31, 2025 81,536,557 $ 8 $ 1,103,854 $ ( 457,169 ) $ 646,693

Issuance of common stock in public offering, net of offering costs of $ 12,509

Issuance of common stock pursuant to ATM Agreement, net of issuance costs and shelf offering costs of $ 82

568,320 — 20,187 — 20,187

3 unchanged sentences

Balance as of March 31, 2026 82,454,950 $ 8 $ 1,134,644 $ ( 496,508 ) $ 638,144

Issuance of common stock pursuant to ATM Agreement, net of issuance costs of $ 46

674,518 — 9,496 — 9,496

Issuance of common stock from stock option exercises 161,059 — 1,079 — 1,079

Issuance of common stock for cash under employee stock purchase plan 13,604 — 142 — 142

Stock-based compensation — — 4,553 — 4,553

Net loss — — — ( 43,274 ) ( 43,274 )

Balance as of June 30, 2025 65,725,409 6 701,548 ( 388,003 ) 313,551

Issuance of common stock in public offering, net of offering costs of $ 17,932

11,274,509 2 269,566 — 269,568

Issuance of common stock pursuant to ATM Agreement, net of issuance costs of $ 88

1,239,522 — 17,775 — 17,775

Issuance of common stock from stock option exercises 730,019 — 6,624 — 6,624

Stock-based compensation — — 5,841 — 5,841

Net loss — — — ( 36,932 ) ( 36,932 )

Balance as of September 30, 2025 78,969,459 $ 8 $ 1,001,354 $ ( 424,935 ) $ 576,427

The accompanying notes are an integral part of these condensed financial statements.

2 unchanged sentences

(in thousands)

Nine Months Ended

September 30,

Three Months Ended

CASH FLOWS FROM OPERATING ACTIVITIES:

1 unchanged sentence

Adjustments to reconcile net loss to net cash used in operating activities:

Accretion of discount on held-to-maturity securities ( 5,671 ) ( 8,068 )

Stock-based compensation 6,548 3,645

Accretion of discount on held-to-maturity securities ( 4,625 ) ( 1,046 )

Depreciation and amortization 6 15

2 unchanged sentences

Prepaid, other current assets, and other assets

( 1,948 ) ( 4,396 )

Accounts payable and accrued liabilities ( 402 ) ( 1,546 )

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Maturities of marketable securities 302,500 35,000

Purchases of property and equipment — ( 96 )

Net cash used in investing activities ( 44,943 ) ( 92,876 )

CASH FLOWS FROM FINANCING ACTIVITIES:

Proceeds from issuance of common stock in September 2025 public offering, net of offering costs 270,200 —

Proceeds from issuance of common stock in March 2025 public offering, net of offering costs 188,880 —

Proceeds from issuance of common stock pursuant to ATM Agreement, net of issuance costs

Proceeds from issuance of common stock pursuant to ATM Agreement, net of ATM issuance costs

Proceeds from stock option exercises 4,055 123

Proceeds from issuance of common stock for cash under employee stock purchase plan 142 138

Payment of shelf offering costs

Proceeds from issuance of common stock and pre-funded warrants in a private placement offering, net of offering costs — 116,059

Proceeds from issuance of common stock in public offering, net of offering costs — 189,166

Net cash provided by financing activities 24,272 189,279

Net increase in cash and cash equivalents 103,506 47,970

Net increase (decrease) in cash and cash equivalents ( 60,142 ) 50,916

Cash and cash equivalents - beginning 172,921 114,091

1 unchanged sentence

$ 112,779 $ 165,007

Supplement Disclosure of Non-Cash Financing Activities:

Offering costs included in accounts payable and accrued liabilities $ 317 $ —

(1) Cash and cash equivalents as of September 30, 2025 exclude investments of $ 376.0 million.

Cash, cash equivalents, and investments amounted to $ 593.6 million as of September 30, 2025.

Supplemental Disclosure of Non-Cash Financing Activities:

Public offering and shelf offering costs included in accounts payable and accrued liabilities $ 7 $ 289

(1) Cash and cash equivalents as of March 31, 2026 exclude investments of $ 533.3 million.

Cash, cash equivalents, and investments amounted to $ 646.1 million as of March 31, 2026.

The accompanying notes are an integral part of these condensed financial statements.

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Mineralys Therapeutics, Inc.

(the Company) is a clinical-stage biopharmaceutical company focused on developing medicines to target diseases driven by dysregulated aldosterone.

The Company’s clinical-stage product candidate, lorundrostat, is a proprietary, orally administered, aldosterone synthase inhibitor that the Company is developing for the treatment of cardiorenal conditions affected by dysregulated aldosterone, including hypertension and related comorbidities, such as chronic kidney disease and obstructive sleep apnea.

This year, the Company completed two pivotal clinical trials of lorundrostat for the treatment of uncontrolled or resistant hypertension and a Phase 2 trial of lorundrostat in hypertensive participants with Stage 2 to 3b chronic kidney disease.

The Company is also conducting a Phase 2 trial of lorundrostat in hypertensive participants with obstructive sleep apnea.

(the Company) is a biopharmaceutical company focused on developing medicines to target diseases driven by dysregulated aldosterone.

The Company’s product candidate, lorundrostat, is a proprietary, orally administered, aldosterone synthase inhibitor that the Company is developing for the treatment of cardiorenal conditions affected by dysregulated aldosterone, including hypertension and related comorbidities, such as chronic kidney disease and obstructive sleep apnea.

The Company has completed two pivotal clinical trials of lorundrostat for hypertension, one Phase 2 clinical trial in hypertensive participants with chronic kidney disease, and one Phase 2 clinical trial in hypertensive participants with obstructive sleep apnea.

The Company submitted a New Drug Application (NDA) to the U.S.

Food and Drug Administration (FDA) in December 2025 for lorundrostat for the treatment of hypertension in combination with other antihypertensive drugs.

The FDA accepted the NDA submission and provided the Company with a Prescription Drug User Fee Act target date of December 22, 2026 for lorundrostat.

The Company was incorporated as a Delaware corporation in May 2019, and it is headquartered in Radnor, Pennsylvania.

The Company’s operations to date have been limited to business planning, raising capital, in-licensing, conducting preclinical and clinical trials, and other research and development.

The Company’s operations to date have been limited to business planning, raising capital, in-licensing, conducting preclinical and clinical trials, and performing research and development and other activities.

Liquidity and Capital Resources

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The Company’s primary uses of cash to date have been to fund research and development activities, business planning, establishing and maintaining the Company’s intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these operations.

As of September 30, 2025, the Company had an accumulated deficit of $ 424.9 million and cash, cash equivalents, and investments of $ 593.6 million.

For the nine months ended September 30, 2025, the Company had a net loss of $ 122.4 million and net cash used in operating activities of $ 104.5 million.

Since inception, the Company has funded its operations by raising aggregate gross proceeds of approximately $ 1.0 billion from the sale of the Company’s common stock, convertible preferred stock, convertible notes, and pre-funded warrants.

As of March 31, 2026, the Company had an accumulated deficit of $ 496.5 million and cash, cash equivalents, and investments of $ 646.1 million.

For the three months ended March 31, 2026, the Company had a net loss of $ 39.3 million and net cash used in operating activities of $ 39.5 million.

Since inception, the Company has funded its operations by raising aggregate gross proceeds of approximately $ 1.1 billion from the sale of the Company’s common stock, convertible preferred stock, pre-funded warrants, and convertible notes.

The Company has a limited operating history, and the sales and income potential of its business is unproven.

The Company expects to continue to incur substantial losses in the foreseeable future as a result of the Company’s research and development and other activities.

Additional funding will be required in the future to continue with the Company’s planned research and development and other activities.

The Company expects to continue to incur substantial losses for the foreseeable future as a result of the Company’s research and development and other activities.

Additional funding will be required to continue with the Company’s planned research and development and commercial launch activities.

The Company expects to finance its operations through equity offerings, debt financings, and other capital sources, including potential strategic collaborations, licensing, and other similar arrangements.

The Company believes that its cash, cash equivalents, and investments as of September 30, 2025 will be sufficient to allow the Company to fund operations for at least twelve months from the issuance date of these condensed financial statements.

The Company believes that its cash, cash equivalents, and investments as of March 31, 2026 will be sufficient to allow the Company to fund operations for at least twelve months from the issuance date of these condensed financial statements.

Summary of Significant Accounting Policies

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These condensed financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments, which are necessary for a fair presentation of the Company’s financial information.

These unaudited condensed financial statements should be read in conjunction with the audited financial statements and related notes in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.

These unaudited condensed financial statements should be read in

Mineralys Therapeutics, Inc.

Notes to Condensed Financial Statements

conjunction with the audited financial statements and related notes in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025.

Any reference in these notes to applicable guidance is meant to refer to authoritative U.S.

GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Updates of the Financial Accounting Standards Board (FASB).

GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Updates (ASU) of the Financial Accounting Standards Board (FASB).

Segment Information

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Other segment items included in net loss are interest income, net and other income (expense).

These measures of performance, significant expenses, and other items are each reflected in the statements of operations.

These measures of performance, significant expenses, and other items are each reflected in the condensed statements of operations.

The accounting policies of the segment are the same as those described below.

The measure of segment assets is reported on the balance sheets as total assets.

The measure of segment assets is reported on the condensed balance sheets as total assets.

All assets are held in the United States.

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The preparation of financial statements in conformity with U.S.

GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of income and expenses during the reporting period.

GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed financial statements and the reported amounts of income and expenses during the reporting period.

Actual results could differ from those estimates.

3 unchanged sentences

All highly liquid investments that have maturities of 90 days or less at the date of purchase are classified as cash equivalents.

The Company’s cash and cash equivalents balances as of September 30, 2025 and December 31, 2024 include cash balances and amounts held primarily in interest-bearing money market accounts and U.S.

The Company’s cash and cash equivalents balances as of March 31, 2026 and December 31, 2025 include cash balances and amounts held primarily in interest-bearing money market accounts and U.S.

Treasury bills.

As of September 30, 2025 and December 31, 2024, the Company did no t have any restricted cash balances.

As of March 31, 2026 and December 31, 2025, the Company did no t have any restricted cash balances.

The following table provides a reconciliation of cash and cash equivalents as reported in the condensed statements of cash flows to the condensed balance sheets (in thousands):

September 30, December 31,

March 31, December 31,

Cash $ 1,150 $ 1,030

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Financial instruments that potentially subject the Company to concentrations of credit risk primarily consist of cash balances in several accounts with three financial institutions that, from time to time, are in excess of federally insured limits.

Fair Value Measurements

The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values.

ASC Topic 820, Fair Value Measurement, establishes a hierarchy of inputs used in measuring fair value that maximizes the use of

Mineralys Therapeutics, Inc.

Notes to Condensed Financial Statements

observable inputs and minimizes the use of unobservable inputs by requiring that the observable inputs be used when available.

Fair Value Measurements

The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values.

ASC Topic 820, Fair Value Measurement, establishes a hierarchy of inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the observable inputs be used when available.

Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company.

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Such investments are included in cash and cash equivalents and investments in the condensed balance sheets.

The Company determines the appropriate classification of short-term and long-term securities at the time of purchase and re-evaluates such designation as of each balance sheet date.

The Company determines the appropriate classification of securities at the time of purchase and re-evaluates such designation as of each balance sheet date.

Securities are classified as held-to-maturity when the Company has the positive intent and ability to hold the securities to maturity.

Held-to-maturity securities are carried at amortized cost, adjusted for the accretion of discounts using the interest method.

The Company invested in marketable securities during the nine months ended September 30, 2025 and 2024, and no impairment charges were recorded.

The Company invested in marketable securities during the three months ended March 31, 2026 and 2025, and no impairment charges were recorded.

For held-to-maturity investments, the Company periodically reviews each individual security position that has an unrealized loss, or impairment, to determine if that impairment is other-than-temporary.

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Should the equity issuance be abandoned, the deferred offering costs are expensed immediately as a charge to operating expenses in the condensed statements of operations.

Deferred offering costs as of September 30, 2025 and December 31, 2024 were $ 0 and $ 0.4 million, respectively.

Deferred offering costs as of each of March 31, 2026 and December 31, 2025 were $ 0.2 million.

Such costs are classified in other assets on the condensed balance sheets.

3 unchanged sentences

The Company accounts for its stock-based compensation awards in accordance with ASC Topic 718, Compensation – Stock Compensation (ASC 718).

ASC 718 requires all stock-based payments to employees, including grants of employee stock options, to be recognized in the condensed statements of operations based on their fair values.

ASC 718 requires share-based payment arrangements to be recognized in the condensed statements of operations based on their grant date fair values.

The Company’s stock-based awards are subject only to service-based vesting conditions.

The Company measures restricted common stock awards using the difference, if any, between the purchase price per share of the award and the fair value of the Company’s common stock at the date of the grant or modification.

Restricted stock unit awards are measured at the grant date fair value based on the closing price of the Company’s common stock on the date of the grant.

The Company estimates the fair value of its stock option awards using the Black-Scholes option pricing model, which requires the input of assumptions, including (i) the expected stock price volatility, (ii) the calculation of the expected term of the award, (iii) the risk-free interest rate, and (iv) expected dividends.

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Expected Dividends — To date, the Company has not issued any dividends and does not expect to issue dividends over the life of the options and therefore has estimated the dividend yield to be zero.

Subsequent to the closing of the Company’s initial public offering of its common stock in February 2023 (IPO), the Company determines the fair market value of its common stock using the closing price of its common stock as reported on the Nasdaq Global Select Market.

The assumptions underlying these valuations represented management’s best estimate, with the assistance of a third-party valuation specialist, which involved inherent uncertainties and the application of management’s judgment.

As a result, if the Company had used different assumptions or estimates, the fair value of the Company’s common stock and its stock-based compensation expense could have been materially different.

Compensation expense related to awards is recognized on a straight-line basis by recognizing the grant date fair value over the associated service period of the award, which is generally the vesting term.

Subsequent to the closing of the Company’s initial public offering of its common stock in February 2023, the Company determines the fair market value of its common stock using the closing price of its common stock as reported on the Nasdaq Global Select Market.

Compensation expense related to time-based awards, including restricted stock units, is recognized on a straight-line basis by recognizing the grant date fair value over the requisite service period, which is generally the vesting term.

Management evaluates its award grants and modifications and will adjust the fair value if any are determined to be spring-loaded.

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The diluted net loss per share attributable to common stockholders is computed by giving effect to all potential common stock equivalents outstanding for the period, determined using the treasury stock method.

For purposes of this calculation, unvested restricted stock awards and stock options to purchase common stock are considered to be common stock equivalents but have been excluded from the calculation of diluted net loss per share attributable to common stockholders as their effect is anti-dilutive.

For purposes of this calculation, unvested restricted stock awards, restricted stock units, and stock options to purchase common stock are considered to be common stock equivalents but have been excluded from the calculation of diluted net loss per share attributable to common stockholders as their effect is anti-dilutive.

The weighted-average number of common shares used in the basic and diluted net loss per share attributable to common stockholders calculations includes the weighted-average pre-funded warrants outstanding during the period, as they are exercisable at any time for nominal cash consideration.

The following table sets forth the potential

The following table sets forth the

Mineralys Therapeutics, Inc.

Notes to Condensed Financial Statements

common shares excluded from the calculation of net loss per share attributable to common stockholders because their inclusion would be anti-dilutive:

Nine Months Ended

September 30,

potential common shares excluded from the calculation of net loss per share attributable to common stockholders because their inclusion would be anti-dilutive:

Three Months Ended

Outstanding options 7,420,692 6,778,317

Unvested restricted stock units 702,948 —

Unvested restricted stock awards 64,714 309,028

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Unless otherwise discussed, the Company believes the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption.

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280):

Improvements to Reportable Segment Disclosures, which expands annual and interim disclosure requirements for reportable segments, including public entities with a single reportable segment, primarily through enhanced disclosures about significant segment expenses.

The Company adopted this standard for the Company’s fiscal year 2024 annual reporting period, and it is applicable to interim periods thereafter.

In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40):

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Early adoption is permitted.

The Company is evaluating the impact of ASU 2024-03 on its financial statements and related disclosures.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740) - Improvements to Income Tax Disclosures.

The new standard requires a company to expand its existing income tax disclosures, specifically related to the rate reconciliation and income taxes paid.

The standard is effective for the Company beginning in fiscal year 2025.

The Company does not expect to early adopt this new accounting standard.

The new standard is expected to be applied prospectively, but retrospective application is permitted.

The Company is currently evaluating the impact of ASU 2023-09 on its financial statements and related disclosures.

The Company is evaluating the impact of ASU 2024-03 on its disclosures.

While the Company expects that additional disaggregated disclosures will be required upon adoption, the guidance will not affect the recognition or measurement of expenses.

Fair Value of Financial Instruments

The following table presents financial instruments measured at fair value on a recurring basis based on the fair value hierarchy as of September 30, 2025 and December 31, 2024 (in thousands):

September 30, December 31,

The following table presents financial instruments measured at fair value on a recurring basis based on the fair value hierarchy as of March 31, 2026 and December 31, 2025 (in thousands):

March 31, December 31,

Cash equivalents

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There were no transfers within the fair value hierarchy during the periods presented.

Mineralys Therapeutics, Inc.

Notes to Condensed Financial Statements

The following methods and assumptions were used by the Company in estimating the fair values of each class of financial instrument disclosed herein:

1 unchanged sentence

The fair values of money market funds are determined by Level 1 inputs utilizing quoted prices (unadjusted) in active markets for identical assets.

Treasury Bills—As of September 30, 2025 and December 31, 2024, the Company had short-term U.S.

Treasury Bills — As of March 31, 2026 and December 31, 2025, the Company had short-term U.S.

Treasury bills.

Fair values of these securities are determined by Level 2 inputs utilizing quoted prices (unadjusted) in active markets for similar assets.

Fair values of these securities are determined by Level 2 inputs utilizing quoted prices

Mineralys Therapeutics, Inc.

Notes to Condensed Financial Statements

(unadjusted) in active markets for similar assets.

The following table presents information about the Company’s investments in held-to-maturity U.S.

Treasury bills as of each reported date (in thousands):

As of September 30, 2025

As of March 31, 2026

Balance Sheet Location Original Maturities Amortized

Cost Estimated

Cash and cash equivalents less than 3 months $ 104,448 $ 104,445

Investments between 3 and 12 months $ 533,281 $ 533,211

Total $ 480,479 $ 480,508

As of December 31, 2025

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Commitments and Contingencies

License Agreement with Mitsubishi Tanabe

In July 2020, the Company entered into a license agreement (the Mitsubishi License) with Mitsubishi Tanabe Pharmaceutical Company (Mitsubishi Tanabe), pursuant to which Mitsubishi Tanabe granted the Company an exclusive, worldwide, royalty-bearing, sublicensable license under Mitsubishi Tanabe’s patent and other intellectual property rights to exploit products incorporating lorundrostat (formerly MT-4129) (Lorundrostat Products) for the prevention, treatment, diagnosis, detection, monitoring, or predisposition testing with respect to indications, diseases, and conditions in humans.

Pursuant to the Mitsubishi License, the Company paid Mitsubishi Tanabe a $ 1.0 million upfront fee and development milestone payments of $ 9.0 million in the aggregate.

The Company has remaining obligations to pay Mitsubishi Tanabe commercial milestone payments of up to $ 155.0 million in the aggregate upon first commercial sale and upon meeting certain annual sales targets, as well as additional commercial milestone payments of up to $ 10.0 million for a second indication.

Additionally, the Company is obligated to pay Mitsubishi Tanabe tiered royalties at percentages ranging from the mid-single-digits to ten percent ( 10 %) of aggregate net sales of each Lorundrostat Product on a Lorundrostat Product-by-Lorundrostat Product and country-by-country basis, until the later of (i) the expiration of the last-to-expire valid Mitsubishi Tanabe patent claim covering a Lorundrostat Product, (ii) ten years from the first commercial sale of a Lorundrostat Product, or (iii) the expiration of regulatory exclusivity in such country.

Tanabe License Agreement

In July 2020, the Company entered into an exclusive license agreement (the Tanabe License) with Tanabe Pharma Corporation (Tanabe) (formerly Mitsubishi Tanabe Pharma Corporation), pursuant to which Tanabe granted the Company an exclusive, worldwide, royalty-bearing, sublicensable license under Tanabe’s patent and other intellectual property rights to exploit products incorporating lorundrostat (formerly MT-4129) (Lorundrostat Product) for the prevention, treatment, diagnosis, detection, monitoring, or predisposition testing with respect to indications, diseases, and conditions in humans.

Pursuant to the Tanabe License, the Company paid Tanabe a $ 1.0 million upfront fee and development milestone payments of $ 9.0 million in the aggregate.

The Company has remaining obligations to pay Tanabe commercial milestone payments of up to $ 155.0 million in the aggregate upon first commercial sale and upon meeting certain annual sales targets, as well as additional commercial milestone payments of up to $ 10.0 million for a second indication.

Additionally, the Company is obligated to pay Tanabe tiered royalties at percentages ranging from the mid-single digits to ten percent ( 10 %) of aggregate net sales of each Lorundrostat Product on a Lorundrostat Product-by-Lorundrostat Product and country-by-country basis, until the later of (i) the expiration of the last-to-expire valid Tanabe patent claim covering a Lorundrostat Product, (ii) ten years from the first commercial sale of a Lorundrostat Product, or (iii) the expiration of regulatory exclusivity in such country.

Such royalties are subject to reduction under specified conditions, including lack of patent coverage and generic competition.

The Company has no remaining development milestone obligations under the Mitsubishi License and did not incur any development or commercial expenses pursuant to the Mitsubishi License during the three or nine months ended September 30, 2025 and 2024.

The Company has no remaining development milestone obligations under the Tanabe License and did not incur any development or commercial expenses pursuant to the Tanabe License during the three months ended March 31, 2026 and 2025.

The Company is obligated to use commercially reasonable efforts to conduct and complete the development activities and to file for regulatory approval for at least one Lorundrostat Product in a major market country and consider in good faith developing at least one Lorundrostat Product in a non-major market country.

If the Company elects to sublicense its rights under the Tanabe License to a third party with respect to exploitation of lorundrostat or any Lorundrostat Product in certain countries in Asia, the Company has agreed to negotiate such a sublicense first, for a specified period of time, with Tanabe, if Tanabe notifies the Company that it would like to obtain such a sublicense.

The Company also agreed not to commercialize any competing product prior to three years following the first commercial sale of the first Lorundrostat Product in any country without Tanabe’s prior consent.

Unless terminated earlier, the Tanabe License will continue until the expiration of all of the Company’s royalty obligations to Tanabe.

The Company may terminate the Tanabe License for any or no reason upon 90 or 180 days’ prior written notice to Tanabe, depending on whether the Lorundrostat Product has received

Mineralys Therapeutics, Inc.

Notes to Condensed Financial Statements

If the Company elects to sublicense its rights under the Mitsubishi License to a third party with respect to exploitation of lorundrostat or any Lorundrostat Product in certain countries in Asia, the Company has agreed to negotiate such a sublicense first, for a specified period of time, with Mitsubishi Tanabe, if Mitsubishi Tanabe notifies the Company that it would like to obtain such a sublicense.

Unless terminated earlier, the Mitsubishi License will continue until the expiration of all of the Company’s royalty obligations to Mitsubishi Tanabe.

The Company may terminate the Mitsubishi License for any or no reason upon 90 or 180 days’ prior written notice to Mitsubishi Tanabe depending on whether the Lorundrostat Product has received regulatory approval.

Mitsubishi Tanabe may terminate the Mitsubishi License if the Company has not initiated regulatory consultation for the first global clinical trials of lorundrostat in at least one major market country within a specified amount of time or if the Company or its affiliates or sublicensees initiate a challenge to the patent rights licensed to the Company by Mitsubishi Tanabe.

In addition, either party may terminate the Mitsubishi License in the event of an uncured material breach by or bankruptcy of the other party, subject to certain notice and cure periods, or upon the other party’s bankruptcy or insolvency.

regulatory approval.

Tanabe may terminate the Tanabe License if the Company or its affiliates or sublicensees initiate a challenge to the patent rights licensed to the Company by Tanabe.

In addition, either party may terminate the Tanabe License in the event of an uncured material breach by or bankruptcy of the other party, subject to certain notice and cure periods, or upon the other party’s bankruptcy or insolvency.

Liabilities for loss contingencies arising from claims, assessments, litigation, fines, penalties, and other sources are recorded when it is probable that a liability has been incurred and the amount can be reasonably estimated.

From time to time, the Company may become involved in legal proceedings arising in the ordinary course of business.

The Company was not subject to any material legal proceedings during the three or nine months ended September 30, 2025 and 2024, and no material legal proceedings are currently pending or threatened.

The Company was not subject to any material legal proceedings during the three months ended March 31, 2026 and 2025, and no material legal proceedings are currently pending or threatened.

Indemnification Agreements

In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners, and other parties with respect to certain matters including, but not limited to, losses arising from breach of such agreements or intellectual property infringement claims made by third parties.

In addition, the Company has entered into indemnification agreements with officers of the Company and members of its board of directors that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors.

The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited.

To date, the Company has not incurred any material costs as a result of such indemnifications.

The Company is not aware of any claims under indemnification arrangements, and it has not accrued any material liabilities related to such obligations in its condensed financial statements as of September 30, 2025 and December 31, 2024.

Accrued Liabilities

Accrued liabilities consisted of the following (in thousands):

September 30, December 31,

March 31, December 31,

Research and development expenses $ 4,587 $ 3,460

2 unchanged sentences

Total $ 13,602 $ 13,096

Mineralys Therapeutics, Inc.

Notes to Condensed Financial Statements

Capital Stock

As of September 30, 2025, the Company had reserved authorized shares of common stock for future issuance as follows:

As of March 31, 2026, the Company had reserved authorized shares of common stock for future issuance as follows:

Common stock options outstanding 7,420,692

1 unchanged sentence

Shares available for grant under the ESPP 2,067,084

Shares available for grant under the 2025 Inducement Plan 1,000,000

Restricted stock units outstanding

Pre-funded warrants issued and outstanding 549,755

Shares available for grant under the 2025 Inducement Plan 539,748

Total 14,147,149

In connection with the closing of the IPO in February 2023, the Company’s board of directors approved an amendment to the Company’s amended and restated certificate of incorporation (the Restated Certificate).

The Restated Certificate amended and restated the Company’s amended and restated certificate of incorporation, in its entirety to, among other things, increase the authorized number of shares of common stock to 500,000,000 shares and authorize 50,000,000 shares of undesignated preferred stock that may be issued from time to time by the Company’s board of directors in one or more series.

Public Offerings

On September 2, 2025, the Company entered into an underwriting agreement (the September 2025 Underwriting Agreement) with BofA Securities, Inc., Evercore Group L.L.C.

and Goldman Sachs & Co.

LLC as representatives of the several underwriters named therein (collectively, the Underwriters), relating to the issuance and sale of 11,274,509 shares of the Company’s common stock at a price of $ 25.50 per share for net proceeds of approximately $ 269.6 million after deducting an underwriting discount of 6 % and other offering expenses.

The offering was made pursuant to the Company’s registration statements on Form S-3 and Form S-3MEF (Registration Statement Nos.

333-278122 and 333-289998, respectively) previously filed with and declared effective by the SEC, and a prospectus supplement and accompanying prospectus filed with the SEC.

The Company is using the net proceeds from this offering to fund clinical development of lorundrostat, including research and development and manufacturing, and pre-commercialization activities, as well as for working capital and general corporate purposes.

On March 11, 2025, the Company entered into an underwriting agreement (the March 2025 Underwriting Agreement) with the Underwriters, relating to the issuance and sale of 14,907,406 shares of the Company’s common stock at a price of $ 13.50 per share for net proceeds of approximately $ 188.7 million after deducting an underwriting discount of 6 % and other offering expenses.

The offering was made pursuant to the Company’s shelf registration statement on Form S-3 (Registration Statement No.

333-278122) previously filed with and declared effective by the SEC (the Registration Statement), and a prospectus supplement and accompanying prospectus filed with the SEC.

The Company is using the net proceeds from this offering to fund the clinical development of lorundrostat, including research and development, manufacturing, and pre-commercialization activities, as well as for working capital and general corporate purposes.

At Market Equity Offering Sales Agreement

On March 21, 2024, the Company entered into an ATM Equity Offering Sales Agreement (the ATM Agreement) with BofA Securities, Inc.

and Evercore Group L.L.C.

as the Company’s sales agents (the Agents) and/or principals.

Pursuant to the terms of the ATM Agreement, the Company was permitted to sell from time to time through the Agents shares of the Company’s common stock having an aggregate offering price of up to $ 100.0 million (the ATM Shares).

However, on September 2, 2025, the Company delivered written notice to the Agents that it was suspending its use of and terminating the prospectus supplement, dated April 11, 2024, related to the ATM Shares previously issuable pursuant to the terms of the ATM Agreement (the ATM

Mineralys Therapeutics, Inc.

Notes to Condensed Financial Statements

Prospectus Supplement).

On November 6, 2025, the Company delivered a written notice to the Agents to exercise its right to terminate the ATM Agreement, effective November 9, 2025.

Prior to the termination of the ATM Agreement and the ATM Prospectus Supplement, the ATM Shares were issuable pursuant to the Registration Statement.

Sales of the ATM Shares were made by means of ordinary brokers’ transactions on the Nasdaq Global Select Market or as otherwise agreed by the Company and the Agents.

Under the terms of the ATM Agreement, the Company was permitted to sell the ATM Shares from time to time to an Agent as principal for its own account at a price to be agreed upon at the time of sale.

Any sale of the ATM Shares to an Agent as principal would have been pursuant to the terms of a separate terms agreement between the Company and such Agent.

Beginning in April 2025 and through September 30, 2025, the Company sold an aggregate of 1,914,040 ATM Shares at a weighted-average price of $ 14.32 per share for aggregate net proceeds of approximately $ 27.3 million after deducting commissions to the Agents and other offering expenses.

During the three months ended September 30, 2025, the Company sold an aggregate of 1,239,522 ATM Shares at a weighted-average price of $ 14.41 per share for aggregate net proceeds of approximately $ 17.8 million after deducting commissions to the Agents and other offering expenses.

As of September 30, 2025, the Company had approximately $ 72.6 million of ATM Shares remaining available for sale pursuant to the ATM Agreement.

However, following the termination of the ATM Prospectus Supplement and the ATM Agreement, the Company may not make any sales of ATM Shares pursuant to the ATM Agreement.

Private Placement Offering

On February 7, 2024, the Company entered into a securities purchase agreement (the Purchase Agreement) with the purchasers named therein (the Purchasers), for the private placement (the Private Placement) of (i) 8,339,169 shares (the Shares) of the Company’s common stock at a price of $ 13.50 per Share, and (ii) with respect to certain Purchasers, pre-funded warrants to purchase an aggregate of 549,755 shares of common stock (the Pre-Funded Warrants) in lieu of shares of common stock, at a purchase price of $ 13.499 per Pre-Funded Warrant (the shares of common stock issuable upon exercise of the Pre-Funded Warrants, the Warrant Shares) for aggregate net proceeds of approximately $ 116.1 million.

Each Pre-Funded Warrant has an exercise price of $ 0.001 per share of common stock, is immediately exercisable on the date of issuance, and will not expire.

The Company is using the net proceeds from the Private Placement to fund the research and development of lorundrostat and for working capital and general corporate purposes.

The Company registered the resale of the Shares and the Warrant Shares on the Registration Statement.

Pursuant to the Purchase Agreement, the Company agreed to use its reasonable best efforts to keep the Registration Statement effective until the earliest of (i) the time as all of the Shares and Warrant Shares purchased by the Purchasers pursuant to the terms of the Purchase Agreement have been sold pursuant to the Registration Statement, or (ii) such time as the Shares and Warrant Shares become eligible for resale by non-affiliates without any volume limitations or other restrictions pursuant to Rule 144 under the Securities Act of 1933, as amended, or any other rule of similar effect.

At-the-Market Equity Offering Sales Agreements

On November 10, 2025, the Company entered into an ATM Equity Offering Sales Agreement (the ATM Agreement) with BofA Securities, Inc., Evercore Group L.L.C., and Goldman Sachs & Co.

LLC, pursuant to which the Company may sell shares of its common stock having an aggregate offering price of up to $ 300.0 million from time to time.

During the three months ended March 31, 2026, the Company sold pursuant to the ATM Agreement an aggregate of 568,320 shares of common stock at a weighted-average price of $ 35.66 per share for aggregate net proceeds of approximately $ 20.2 million after deducting commissions and offering expenses.

There were no sales of common stock pursuant to the ATM Agreement during the three months ended March 31, 2025.

From inception of the ATM Agreement and through March 31, 2026, the Company sold an aggregate of 2,720,508 shares of common stock at a weighted-average price of $ 41.45 per share for aggregate net proceeds of approximately $ 112.4 million after deducting commissions and offering expenses.

As of March 31, 2026, approximately $ 187.2 million of shares remained available for sale pursuant to the ATM Agreement.

On March 21, 2024, the Company entered into an ATM Equity Offering Sales Agreement (the Prior ATM Agreement) with BofA Securities, Inc.

and Evercore Group L.L.C.

Effective November 9, 2025, the Prior ATM Agreement was terminated in connection with the execution of the ATM Agreement.

There were no sales of common stock pursuant to the Prior ATM Agreement during each of the three months ended March 31, 2026 and March 31, 2025.

From inception of the Prior ATM Agreement and through its termination effective November 9, 2025, the Company sold an aggregate of 1,914,040 shares of common stock at a weighted-average price of $ 14.32 per share for aggregate net proceeds of approximately $ 27.3 million after deducting commissions and offering expenses.

Stock-Based Compensation

2023 Incentive Award Plan

In February 2023, the Company’s board of directors adopted and stockholders approved the 2023 Incentive Award Plan that became effective upon the closing of the IPO (the 2023 Plan), under which the Company may grant stock options, restricted stock awards (RSAs), dividend equivalents, restricted stock units, stock appreciation rights, and other stock or cash-based awards to its employees, consultants, and directors.

The number of shares of the Company’s common stock initially available for issuance under awards granted pursuant to the 2023 Plan was the sum of (i) 4,650,000 shares of the Company’s common stock, plus (ii) any shares subject to outstanding awards under the 2020 Plan described and defined below as of the effective date of the 2023 Plan that become available for issuance under the 2023 Plan thereafter in accordance with its terms.

Mineralys Therapeutics, Inc.

Notes to Condensed Financial Statements

The number of shares initially available for issuance will be increased on January 1 of each calendar year beginning in 2024 and ending in and including 2033, by an amount equal to the lesser of (i) 4 % of the shares of the Company’s common stock outstanding on the final day of the immediately preceding calendar year and (ii) such smaller number of shares as determined by the Company’s board of directors.

No more than 100,000,000 shares of the Company’s common stock may be issued upon the exercise of incentive stock options under the 2023 Plan.

Shares issued under the 2023 Plan may be authorized but unissued shares, shares purchased on the open market, or treasury shares.

The Company grants equity awards under the 2023 Incentive Award Plan (the 2023 Plan).

During the three months ended March 31, 2026, the Company began granting restricted stock units under the 2023 Plan.

2025 Employment Inducement Incentive Award Plan

On February 10, 2025, the Company’s board of directors adopted and approved the 2025 Employment Inducement Incentive Award Plan (the 2025 Inducement Plan), which became effective on February 10, 2025.

In accordance with Rule 5635(c)(4) of the Nasdaq Stock Market listing rules, equity awards under the 2025 Inducement Plan may only be made to an employee if he or she is granted such awards in connection with the commencement of his or her employment with the Company and such grant is a material inducement to his or her entering into employment with the Company.

The Company has reserved 1,000,000 shares of common stock for issuance pursuant to non-qualified stock options and restricted stock units under the 2025 Inducement Plan.

As of November 10, 2025, no shares had been issued under the 2025 Inducement Plan.

The Company maintains the 2025 Employment Inducement Incentive Award Plan (the 2025 Inducement Plan), under which non‑qualified stock options and restricted stock units may be granted in connection with the commencement of employment.

During the three months ended March 31, 2026, the Company began granting restricted stock units under the 2025 Inducement Plan.

2020 Equity Incentive Plan

On July 7, 2020, the board of directors adopted, and the Company’s stockholders approved, the 2020 Equity Incentive Plan.

The 2020 Equity Incentive Plan, as amended and restated (the 2020 Plan), provided for the grant of incentive stock options to employees of the Company, and for the grant of non-statutory stock options, RSAs, restricted stock unit awards, and other forms of stock awards to employees, directors, and consultants of the Company.

Subsequent to the closing of the IPO, no additional awards will be granted under the 2020 Plan.

However, the 2020 Plan will continue to govern the terms and conditions of the outstanding awards granted under it.

Shares of the Company’s common stock subject to awards granted under the 2020 Plan that expire, lapse, or are terminated, exchanged for cash, surrendered, repurchased, or forfeited following the effective date of the 2020 Plan will be available for issuance under the 2023 Plan in accordance with its terms.

As of September 30, 2025, the Company had the following balances by plan:

The 2020 Equity Incentive Plan (the 2020 Plan) continues to govern the terms of outstanding awards, although no new awards are granted under the plan.

As of March 31, 2026, the Company had the following balances by plan:

Outstanding Unvested

RSAs Shares Available

2023 Plan 6,264,374 — 1,412,873

Restricted Stock Awards Unvested

Restricted Stock Units Shares Available

2023 Plan 6,841,701 — 568,040 2,866,922

1 unchanged sentence

325,344 — 134,908 539,748

2020 Plan 253,647 64,714 — —

Total 7,420,692 64,714 702,948 3,406,670

2023 Employee Stock Purchase Plan

In February 2023, the Company’s board of directors and stockholders approved the 2023 Employee Stock Purchase Plan (the ESPP), which became effective in February 2023.

The ESPP permits eligible employees who elect to participate in an offering under the ESPP to have up to a specified percentage of their eligible compensation withheld, subject to certain limitations, to purchase shares of common stock pursuant to the ESPP.

A total of 400,000 shares of the Company’s common stock was initially reserved for issuance under the ESPP.

The first ESPP offering period commenced on July 1, 2023, with each new six-month offering period beginning each January 1 and July 1.

ESPP purchases of common stock occur at a price equal to 85 % of the lower of (i) the closing price on the first trading day of the offering period or (ii) the closing price on the last trading day of the offering period.

As of September 30, 2025, the Company had 1,260,337 shares available for issuance, and 49,221 cumulative shares had been issued under the ESPP.

Mineralys Therapeutics, Inc.

Notes to Condensed Financial Statements

In addition, the number of shares available for issuance under the ESPP will be annually increased on January 1 of each calendar year beginning in 2024 and ending in and including 2033, by an amount equal to the lesser of (i) 1 % of the shares outstanding on the final day of the immediately preceding calendar year and (ii) such smaller number of shares as is determined by the Company’s board of directors, provided that no more than 15,000,000 shares of the Company’s common stock may be issued under the ESPP.

Total stock-based compensation expense reported in the condensed statements of operations was allocated as follows (in thousands):

Three Months Ended Nine Months Ended

September 30, September 30,

2025 2024 2025 2024

2023 Employee Stock Purchase Plan

The Company maintains the 2023 Employee Stock Purchase Plan (the ESPP) under which eligible employees may purchase shares of common stock through payroll deductions.

As of March 31, 2026, the Company had 2,067,084 shares available for issuance, and 57,839 cumulative shares had been issued under the ESPP.

Total stock-based compensation expense recognized was allocated as follows (in thousands):

Three Months Ended

Research and development $ 2,476 $ 1,628

1 unchanged sentence

$ 6,548 $ 3,645

The Company is subject to taxation in the United States and various states.

The Company computes its quarterly income tax provision by using a forecasted annual effective tax rate and adjusts for any discrete items arising during the quarter.

The primary difference between the effective tax rate and the federal statutory rate is due to federal and state income tax expense offset by valuation allowance on the Company’s deferred tax assets.

The Company recorded no income tax expense for the nine months ended September 30, 2025 and 2024.

No tax benefit was provided for losses incurred in the United States because those losses are offset by a full valuation allowance.

On July 4, 2025, the One Big Beautiful Bill Act (OBBBA) was signed into law, which enacts significant changes to U.S.

tax and related laws.

Some of the provisions of the new tax law affecting corporations include but are not limited to current deduction of domestic research expenses, increasing the limit of the deduction of interest expense deduction to thirty percent of EBITDA, and one hundred percent bonus depreciation on eligible property acquired after January 19, 2025.

The Company has evaluated the impact of the new tax law on its financial condition and results of operations.

OBBBA will have no impact on the Company's effective income tax rate, its net deferred federal income tax liability, or current taxes payable.

The impact of the tax law changes from the OBBBA is included in the Company’s financial statements beginning in the three months ended September 30, 2025.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Financial Statements