What changed in this filing

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Item 1. Financial Statements

2024-11-12 compared with 2024-08-13 · 62 added, 47 removed, 344 unchanged (24% 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:

15 unchanged sentences

Common stock, $ 0.0001 par value;

500,000,000 shares authorized as of June 30, 2024 and December 31, 2023;

49,710,598 and 41,133,916 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively

500,000,000 shares authorized as of September 30, 2024 and December 31, 2023;

49,755,946 and 41,133,916 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively

Additional paid-in capital 490,499 365,858

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,

2024 2023 2024 2023

5 unchanged sentences

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

Other income 2 1 3 2

Other income (expense) ( 10 ) — ( 7 ) 2

Total other income, net 3,764 3,513 11,772 9,437

22 unchanged sentences

Balance as of June 30, 2023 — — — — 40,856,653 4 362,565 ( 77,559 ) 285,010

Issuance of common stock from stock option exercises — — — — 248,465 — 184 — 184

Stock-based compensation — — — — — — 1,578 — 1,578

Net loss — — — — — — — ( 22,760 ) ( 22,760 )

Balance as of September 30, 2023 — $ — — $ — 41,105,118 $ 4 $ 364,327 $ ( 100,319 ) $ 264,012

Mineralys Therapeutics, Inc.

Condensed Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit) (Continued)

(in thousands, except share data)

Convertible Preferred Stock Series B

16 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

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:

13 unchanged sentences

Purchases of property and equipment ( 96 ) —

Net cash used in investing activities ( 48,216 ) ( 156,390 )

Net cash provided by (used in) investing activities 31,389 ( 152,383 )

CASH FLOWS FROM FINANCING ACTIVITIES:

5 unchanged sentences

Net cash provided by financing activities 116,052 203,174

Net increase in cash and cash equivalents 18,552 13,439

Cash, cash equivalents, and restricted cash - beginning 49,304 87,701

Net increase (decrease) in cash and cash equivalents 47,970 ( 1,401 )

Cash and cash equivalents - beginning 49,304 87,701

Cash and cash equivalents - ending (1)

1 unchanged sentence

Supplement Disclosure of Non-Cash Financing Activities:

Offering costs included in accounts payable and accrued liabilities $ 42 $ —

Conversion of convertible preferred stock to common stock upon closing of initial public offering $ — $ 159,180

(1) Cash and cash equivalents as of June 30, 2024 exclude investments of $ 243.3 million.

Cash, cash equivalents, and investments amounted to $ 311.1 million as of June 30, 2024.

(1) Cash and cash equivalents as of September 30, 2024 exclude investments of $ 166.3 million.

Cash, cash equivalents, and investments amounted to $ 263.6 million as of September 30, 2024.

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

17 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, 2024, the Company had an accumulated deficit of $ 197.2 million and cash, cash equivalents, and investments of $ 311.1 million.

For the six months ended June 30, 2024, the Company had a net loss of $ 72.5 million and net cash used in operating activities of $ 49.3 million.

From inception to June 30, 2024, the Company has funded its operations by raising aggregate gross proceeds of approximately $ 498.8 million from the sale of the Company’s common stock, convertible preferred stock, convertible notes, and pre-funded warrants.

As of September 30, 2024, the Company had an accumulated deficit of $ 253.6 million and cash, cash equivalents, and investments of $ 263.6 million.

For the nine months ended September 30, 2024, the Company had a net loss of $ 128.9 million and net cash used in operating activities of $ 99.5 million.

From inception to September 30, 2024, the Company has funded its operations by raising aggregate gross proceeds of approximately $ 498.8 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 June 30, 2024 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, 2024 will be sufficient to allow the Company to fund operations for at least twelve months from the issuance date of these condensed financial statements.

Mineralys Therapeutics, Inc.

22 unchanged sentences

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

As of June 30, 2024 and December 31, 2023, the Company did not have any restricted cash balances.

The Company’s cash and cash equivalents balances as of June 30, 2024 include cash balances and amounts held primarily in interest-bearing money market accounts.

As of September 30, 2024 and December 31, 2023, the Company did not have any restricted cash balances.

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

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

June 30, December 31,

September 30, December 31,

Cash $ 501 $ 643

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, 2024 and 2023, and no impairment charges were recorded.

The Company invested in marketable securities during the nine months ended September 30, 2024 and 2023, 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.

6 unchanged sentences

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

Deferred offering costs as of June 30, 2024 and December 31, 2023 were $ 0.4 million and $ 0 , respectively.

Deferred offering costs as of September 30, 2024 and December 31, 2023 were $ 0.4 million and $ 0 , respectively.

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

26 unchanged sentences

The following table sets forth the potential common shares excluded from the calculation of net loss per common share because their inclusion would be anti-dilutive:

Six Months Ended

Nine Months Ended

September 30,

Outstanding options 4,677,742 2,568,503

4 unchanged sentences

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 (ASU 2023-07), which requires all public entities, including public entities with a single reportable segment, to provide in interim and annual periods one or more measures of segment profit or loss used by the chief operating decision maker to allocate resources and assess performance.

Additionally, the standard requires disclosures of significant segment expenses and other segment items as well as incremental qualitative disclosures.

The guidance in this update is effective for the Company’s fiscal year 2024 annual reporting period.

The Company is currently in the process of evaluating the effects of this pronouncement on its related disclosures.

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, 2024 and December 31, 2023 (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, 2024 and December 31, 2023 (in thousands):

September 30, December 31,

Cash equivalents

3 unchanged sentences

Money Market Funds —The carrying amounts of money market funds reported as cash and cash equivalents in the condensed balance sheets approximate their fair values due to their short-term nature.

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, 2024 and December 31, 2023, the Company had short- and long-term U.S.

Treasury bills.

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 .

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, 2024 and December 31, 2023, the Company had short- and long-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 .

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 June 30, 2024

As of September 30, 2024

Balance Sheet Location Original Maturities Amortized

17 unchanged sentences

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 Mitsubishi Tanabe’s prior consent.

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

Mineralys Therapeutics, Inc.

Notes to Condensed Financial Statements

sublicensees initiate a challenge to the patent rights licensed to the Company by Mitsubishi Tanabe.

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

The Company incurred $ 0 and $ 4.0 million of research and development expenses pursuant to the Mitsubishi License during the six months ended June 30, 2024 and 2023, respectively, that related to the Company’s initiation of its pivotal clinical program of lorundrostat.

As of June 30, 2024, the Company has paid an aggregate of $ 9.0 million in development milestone payments and has no remaining development milestone obligations under the Mitsubishi License.

The Company incurred $ 0 and $ 4.0 million of research and development expenses pursuant to the Mitsubishi License during the nine months ended September 30, 2024 and 2023, respectively, that related to the Company’s initiation of its pivotal clinical program of lorundrostat.

As of September 30, 2024, the Company has paid an aggregate of $ 9.0 million in development milestone payments and has no remaining development milestone obligations under the Mitsubishi License.

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 six months ended June 30, 2024 and 2023, and no material legal proceedings are currently pending or threatened.

The Company was not subject to any material legal proceedings during the nine months ended September 30, 2024 and 2023, 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 June 30, 2024 and December 31, 2023.

Accrued Liabilities

Accrued liabilities consisted of the following (in thousands):

June 30, December 31,

September 30, December 31,

Research and development expenses $ 24,080 $ 7,122

5 unchanged sentences

Capital Stock

As of June 30, 2024, the Company had reserved authorized shares of common stock for future issuance as follows:

As of September 30, 2024, the Company had reserved authorized shares of common stock for future issuance as follows:

Common stock options outstanding 4,677,742

14 unchanged sentences

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 Warrants (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.

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

17 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.

The Company has not yet sold any ATM Shares as of June 30, 2024.

The Company has not yet sold any ATM Shares as of September 30, 2024.

Stock-Based Compensation

14 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, 2024, the Company had the following balances by plan:

As of September 30, 2024, the Company had the following balances by plan:

Outstanding Unvested

9 unchanged sentences

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 June 30, 2024, the Company had 783,718 shares available for issuance and 27,621 cumulative shares had been issued under the ESPP.

As of September 30, 2024, the Company had 783,718 shares available for issuance and 27,621 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.

2 unchanged sentences

Total stock-based compensation expense reported in the 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,

2024 2023 2024 2023

3 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