What changed in this filing

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Item 1. Financial Statements

2025-08-12 compared with 2025-05-12 · 75 added, 51 removed, 347 unchanged (27% of the section changed)

3 unchanged sentences

(in thousands, except share and per share amounts)

March 31, December 31,

June 30, December 31,

Current assets:

14 unchanged sentences

Common stock, $ 0.0001 par value;

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

64,876,228 and 49,821,915 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively

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

Additional paid-in capital 701,548 493,770

6 unchanged sentences

(in thousands, except share and per share data)

Three Months Ended

Three Months Ended Six Months Ended

June 30, June 30,

2025 2024 2025 2024

Operating expenses:

25 unchanged sentences

Balance as of March 31, 2024 49,632,989 5 484,256 ( 156,216 ) 328,045

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

Mineralys Therapeutics, Inc.

Condensed Statements of Stockholders’ Equity (Continued)

(in thousands, except share data)

Common Stock Additional

10 unchanged sentences

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

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

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

2 unchanged sentences

(in thousands)

Three Months Ended

Six Months Ended

CASH FLOWS FROM OPERATING ACTIVITIES:

17 unchanged sentences

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

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

Proceeds from stock option exercises 1,202 203

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

Payment of shelf offering costs ( 57 ) ( 347 )

1 unchanged sentence

Net cash provided by financing activities 199,110 116,053

Net increase in cash and cash equivalents 50,916 41,114

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

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

2 unchanged sentences

Supplement Disclosure of Non-Cash Financing Activities:

Public offering and shelf offering costs included in accounts payable and accrued liabilities $ 289 $ 321

(1) Cash and cash equivalents as of March 31, 2025 exclude investments of $ 178.0 million.

Cash, cash equivalents, and investments amounted to $ 343.0 million as of March 31, 2025.

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 $ 13 $ 42

(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.

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

4 unchanged sentences

(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, 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.

The Company is also conducting a Phase 2 trial of lorundrostat in hypertensive patients with Stage 2 to 3b chronic kidney disease and a Phase 2 trial of lorundrostat in hypertensive patients with obstructive sleep apnea.

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.

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

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

3 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 March 31, 2025, the Company had an accumulated deficit of $ 344.7 million and cash, cash equivalents, and investments of $ 343.0 million.

For the three months ended March 31, 2025, the Company had a net loss of $ 42.2 million and net cash used in operating activities of $ 45.5 million.

From inception to March 31, 2025, the Company has funded its operations by raising aggregate gross proceeds of approximately $ 700.0 million from the sale of the Company’s common stock, convertible preferred stock, convertible notes, and pre-funded warrants.

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.

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 March 31, 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 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.

Summary of Significant Accounting Policies

9 unchanged sentences

Notes to Condensed Financial Statements

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

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).

4 unchanged sentences

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

The measure 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 statements of operations.

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

9 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 March 31, 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 June 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 March 31, 2025 and December 31, 2024, the Company did not have any restricted cash balances.

As of June 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):

March 31, December 31,

June 30, December 31,

Cash $ 1,009 $ 664

3 unchanged sentences

The Company has no significant off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts, or other hedging arrangements.

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

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

20 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 three months ended March 31, 2025 and 2024, and no impairment charges were recorded.

The Company invested in marketable securities during the six months ended June 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 March 31, 2025 and December 31, 2024 were $ 0.3 million and $ 0.4 million, respectively.

Deferred offering costs as of June 30, 2025 and December 31, 2024 were $ 0.3 million and $ 0.4 million, respectively.

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

6 unchanged sentences

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.

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 expected term of the award, (iii) the risk-free interest rate, and (iv) expected dividends.

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.

Volatility — Due to the Company’s limited operating history and a lack of company-specific historical and implied volatility data, the Company has based its estimate of expected volatility on the historical volatility of a group of similar publicly-traded companies.

18 unchanged sentences

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

Six Months Ended

Outstanding options 6,993,414 4,394,713

21 unchanged sentences

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 March 31, 2025 and December 31, 2024 (in thousands):

March 31, December 31,

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,

Cash equivalents

6 unchanged sentences

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

Treasury Bills—As of June 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 March 31, 2025

As of June 30, 2025

Balance Sheet Location Original Maturities Amortized

18 unchanged sentences

Notes to Condensed Financial Statements

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 months ended March 31, 2025 and 2024.

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 months ended March 31, 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 six months ended June 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 liabilities related to such obligations in its condensed financial statements as of March 31, 2025 and December 31, 2024.

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.

2 unchanged sentences

Accrued liabilities consisted of the following (in thousands):

March 31, December 31,

June 30, December 31,

Research and development expenses $ 14,656 $ 8,614

3 unchanged sentences

Capital Stock

As of March 31, 2025, the Company had reserved authorized shares of common stock for future issuance as follows:

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

Common stock options outstanding 6,993,414

7 unchanged sentences

Public Offering

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

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

and Goldman Sachs & Co.

7 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 $ 100,000,000 (the ATM Shares).

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

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

4 unchanged sentences

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.

As of March 31, 2025, the Company had not yet sold any ATM Shares.

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.

Private Placement Offering

8 unchanged sentences

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 (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 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 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

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.

Mineralys Therapeutics, Inc.

Notes to Condensed Financial Statements

smaller number of shares as determined by the Company’s board of directors.

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.

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.

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

As of August 12, 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 March 31, 2025, the Company had the following balances by plan:

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

Outstanding Unvested

6 unchanged sentences

2023 Employee Stock Purchase Plan

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

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.

1 unchanged sentence

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 March 31, 2025, the Company had 1,273,941 shares available for issuance and 35,617 cumulative shares had been issued under the ESPP.

ESPP purchases of common stock occur at a price equal to 85 % of the

Mineralys Therapeutics, Inc.

Notes to Condensed Financial Statements

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.

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

Three Months Ended Six Months Ended

June 30, June 30,

2025 2024 2025 2024

Research and development $ 1,943 $ 1,281 $ 3,571 $ 2,246

2 unchanged sentences

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