What changed in this filing

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Item 1. Financial Statements

2025-11-10 compared with 2025-08-12 · 88 added, 61 removed, 361 unchanged (29% of the section changed)

3 unchanged sentences

(in thousands, except share and per share amounts)

June 30, December 31,

September 30, December 31,

Current assets:

14 unchanged sentences

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

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

Additional paid-in capital 1,001,354 493,770

6 unchanged sentences

(in thousands, except share and per share data)

Three Months Ended Six Months Ended

June 30, June 30,

Three Months Ended Nine Months Ended

September 30, September 30,

2025 2024 2025 2024

31 unchanged sentences

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.

20 unchanged sentences

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)

Six Months Ended

Nine Months Ended

September 30,

CASH FLOWS FROM OPERATING ACTIVITIES:

7 unchanged sentences

Prepaid, other current assets, and other assets

( 2,658 ) 5,337

Accounts payable and accrued liabilities 8,558 20,837

6 unchanged sentences

CASH FLOWS FROM FINANCING ACTIVITIES:

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

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

4 unchanged sentences

Net cash provided by financing activities 494,298 116,052

Net increase (decrease) in cash and cash equivalents ( 12,303 ) 18,552

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

Cash and cash equivalents - beginning 114,091 49,304

2 unchanged sentences

Supplement Disclosure of Non-Cash Financing Activities:

Funds receivable from the sale of common stock pursuant to ATM Agreement, net of issuance costs $ 574 $ —

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

(1) Cash and cash equivalents as of June 30, 2025 exclude investments of $ 223.1 million.

Cash, cash equivalents, and investments amounted to $ 324.9 million as of June 30, 2025.

(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.

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

5 unchanged sentences

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.

The Company has 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.

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.

4 unchanged sentences

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 June 30, 2025, the Company had an accumulated deficit of $ 388.0 million and cash, cash equivalents, and investments of $ 324.9 million.

For the six months ended June 30, 2025, the Company had a net loss of $ 85.5 million and net cash used in operating activities of $ 75.7 million.

Since inception, the Company has funded its operations by raising aggregate gross proceeds of approximately $ 717.4 million from the sale of the Company’s common stock, convertible preferred stock, convertible notes, and pre-funded warrants.

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.

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

2 unchanged sentences

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 June 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 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.

Summary of Significant Accounting Policies

28 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 June 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 September 30, 2025 and December 31, 2024 include cash balances and amounts held primarily in interest-bearing money market accounts and U.S.

Treasury bills.

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

As of September 30, 2025 and December 31, 2024, 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):

June 30, December 31,

September 30, December 31,

Cash $ 1,213 $ 664

26 unchanged sentences

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 six months ended June 30, 2025 and 2024, and no impairment charges were recorded.

The Company invested in marketable securities during the nine months ended September 30, 2025 and 2024, 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.

4 unchanged sentences

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 June 30, 2025 and December 31, 2024 were $ 0.3 million and $ 0.4 million, respectively.

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

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

27 unchanged sentences

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

Six Months Ended

Nine Months Ended

September 30,

Outstanding options 6,612,340 4,677,742

16 unchanged sentences

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, with early adoption permitted.

The Company does not expect to early adopt the new standard.

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.

1 unchanged sentence

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 June 30, 2025 and December 31, 2024 (in thousands):

June 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 September 30, 2025 and December 31, 2024 (in thousands):

September 30, December 31,

Cash equivalents

Money market funds $ 111,936 $ 83,602

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

Mineralys Therapeutics, Inc.

Notes to Condensed Financial Statements

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

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 June 30, 2025 and December 31, 2024, the Company had short-term U.S.

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

Treasury bills.

2 unchanged sentences

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

As of June 30, 2025

As of September 30, 2025

Balance Sheet Location Original Maturities Amortized

16 unchanged sentences

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.

Mineralys Therapeutics, Inc.

Notes to Condensed Financial Statements

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.

7 unchanged sentences

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 six months ended June 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 or nine months ended September 30, 2025 and 2024, and no material legal proceedings are currently pending or threatened.

Indemnification Agreements

3 unchanged sentences

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 June 30, 2025 and December 31, 2024.

Mineralys Therapeutics, Inc.

Notes to Condensed Financial Statements

Accrued Liabilities

Accrued liabilities consisted of the following (in thousands):

June 30, December 31,

September 30, December 31,

Research and development expenses $ 14,638 $ 8,614

2 unchanged sentences

Total $ 22,399 $ 14,167

Mineralys Therapeutics, Inc.

Notes to Condensed Financial Statements

Capital Stock

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

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

Common stock options outstanding 6,612,340

6 unchanged sentences

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 Offering

On March 11, 2025, the Company entered into an underwriting agreement (the Underwriting Agreement) with BofA Securities, Inc., Evercore Group L.L.C.

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

2 unchanged sentences

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

Pursuant to the terms of the ATM Agreement, the Company may 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).

The ATM Shares will be issued pursuant to the Registration Statement.

Sales of the ATM Shares will be made by means of ordinary brokers’ transactions on the Nasdaq Global Select

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

Market or as otherwise agreed by the Company and the Agents.

Under the terms of the ATM Agreement, the Company may also 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 be pursuant to the terms of a separate terms agreement between the Company and such Agent.

Beginning in April 2025 and through June 30, 2025, the Company sold an aggregate of 674,518 ATM Shares at a weighted-average price of $ 14.15 per share for aggregate net proceeds of approximately $ 9.5 million after deducting commissions to the Agents and other related costs.

As of June 30, 2025, the Company had approximately $ 90.5 million of ATM Shares remaining available for sale pursuant to the ATM Agreement.

Subsequent to June 30, 2025 and through August 12, 2025, the Company sold an additional 563,426 ATM Shares at a weighted-average price of $ 14.03 per share for aggregate net proceeds of approximately $ 7.9 million after deducting commissions to the Agents.

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.

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.

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.

Under the terms of the Pre-Funded Warrants, the Company may not effect the exercise of any portion of any Pre-Funded Warrant, and a holder will not have the right to exercise any portion of any Pre-Funded Warrant, which, upon giving effect to such exercise, would cause a holder (together with its affiliates) to own more than a specified beneficial ownership limitation of either 4.99 %, 9.99 %, or 19.99 % (as selected by such holder prior to the issuance of the Pre-Funded Warrant) of the number of shares of common stock outstanding immediately after giving effect to such exercise, as such percentage ownership is determined in accordance with the terms of the Pre-Funded Warrants.

However, any holder may increase or decrease such percentage to any other percentage not in excess of 19.99 %, provided that any increase in such percentage shall not be effective until 61 days after such notice is delivered to the Company.

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.

3 unchanged sentences

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

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.

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.

5 unchanged sentences

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 August 12, 2025, no shares had been issued under the 2025 Inducement Plan.

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

2020 Equity Incentive Plan

4 unchanged sentences

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 June 30, 2025, the Company had the following balances by plan:

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

Outstanding Unvested

10 unchanged sentences

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

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

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

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 Six Months Ended

June 30, June 30,

Three Months Ended Nine Months Ended

September 30, September 30,

2025 2024 2025 2024

2 unchanged sentences

$ 5,841 $ 3,139 $ 14,039 $ 8,202

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