What changed in this filing

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Item 1. Financial Statements

2023-11-07 compared with 2023-08-07 · 54 added, 37 removed, 318 unchanged (22% 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:

12 unchanged sentences

Commitments and contingencies (Note 4)

Series A convertible preferred stock, $ 0.0001 par value, 0 and 86,332,216 shares authorized and 0 and 86,332,216 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively, $ 0 and $ 41,180 aggregate liquidation preference as of June 30, 2023 and December 31, 2022, respectively

Series B convertible preferred stock, $ 0.0001 par value, 0 and 136,510,868 shares authorized and 0 and 136,510,868 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively, $ 0 and $ 118,000 aggregate liquidation preference as of June 30, 2023 and December 31, 2022, respectively

Series A convertible preferred stock, $ 0.0001 par value, 0 and 86,332,216 shares authorized and 0 and 86,332,216 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively, $ 0 and $ 41,180 aggregate liquidation preference as of September 30, 2023 and December 31, 2022, respectively

Series B convertible preferred stock, $ 0.0001 par value, 0 and 136,510,868 shares authorized and 0 and 136,510,868 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively, $ 0 and $ 118,000 aggregate liquidation preference as of September 30, 2023 and December 31, 2022, respectively

Stockholders’ equity (deficit):

Common stock, $ 0.0001 par value, 500,000,000 and 319,000,000 shares authorized and 40,856,653 and 6,419,238 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively

Common stock, $ 0.0001 par value, 500,000,000 and 319,000,000 shares authorized and 41,105,118 and 6,419,238 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively

Additional paid-in capital 364,327 540

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,

2023 2022 2023 2022

32 unchanged sentences

Balance as of June 30, 2022 86,332,216 40,987 136,510,868 117,657 5,614,424 1 130 ( 37,059 ) ( 36,928 )

Issuance of restricted stock awards — — — — 804,814 — — — —

Stock-based compensation — — — — — — 192 — 192

Net loss — — — — — — — ( 6,678 ) ( 6,678 )

Balance as of September 30, 2022 86,332,216 $ 40,987 136,510,868 $ 117,657 6,419,238 $ 1 $ 322 $ ( 43,737 ) $ ( 43,414 )

Mineralys Therapeutics, Inc.

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

(in thousands, except share data)

Convertible Preferred Stock Series B

11 unchanged sentences

Balance as of March 31, 2023 — — — — 40,856,653 4 361,289 ( 65,418 ) 295,875

Issuance of restricted stock awards — — — — — — — — —

Stock-based compensation — — — — — — 1,276 — 1,276

1 unchanged sentence

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

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:

14 unchanged sentences

Issuance of common stock in initial public offering, net of offering costs 202,990 ( 561 )

Proceeds from stock option exercises 184 —

Proceeds from the issuance of Series A convertible preferred stock, net of offering costs — 11,991

7 unchanged sentences

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, 2023 exclude investments of $ 181.6 million.

Cash, cash equivalents, and investments amounted to $ 282.8 million as of June 30, 2023.

Deferred offering costs included in accounts payable and accrued liabilities $ — $ 421

(1) Cash and cash equivalents as of September 30, 2023 exclude investments of $ 179.6 million.

Cash, cash equivalents, and investments amounted to $ 265.9 million as of September 30, 2023.

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 initially developing for the treatment of cardiorenal conditions affected by abnormally elevated aldosterone, including hypertension and chronic kidney disease.

The Company has initiated a pivotal clinical program of lorundrostat for the treatment of uncontrolled or resistant hypertension and has plans to initiate a Phase 2 trial in the second half of 2023 for lorundrostat as a potential therapy to treat patients with Stage 2 to 4 chronic kidney disease.

The Company has initiated a pivotal clinical program of lorundrostat for the treatment of uncontrolled or resistant hypertension and has plans to initiate a Phase 2 trial in the second half of 2023 for lorundrostat in hypertensive patients with Stage 2 to 3b chronic kidney disease.

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

9 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, 2023, the Company had an accumulated deficit of $ 77.6 million and cash, cash equivalents, and investments of $ 282.8 million.

For the six months ended June 30, 2023, the Company had a net loss of $ 24.7 million and net cash used in operating activities of $ 33.2 million.

From inception to June 30, 2023, the Company has funded its operations by raising aggregate gross proceeds of approximately $ 378.8 million from the sale of the Company’s common stock, convertible preferred stock, and convertible notes.

As of September 30, 2023, the Company had an accumulated deficit of $ 100.3 million and cash, cash equivalents, and investments of $ 265.9 million.

For the nine months ended September 30, 2023, the Company had a net loss of $ 47.5 million and net cash used in operating activities of $ 52.2 million.

From inception to September 30, 2023, the Company has funded its operations by raising aggregate gross proceeds of approximately $ 378.8 million from the sale of the Company’s common stock, convertible preferred stock, and convertible notes.

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, 2023 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, 2023 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, 2023 and December 31, 2022, the Company did not have any restricted cash balances.

As of September 30, 2023 and December 31, 2022, the Company did not have any restricted cash balances.

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

June 30, December 31,

September 30, December 31,

Cash $ 1,352 $ 2,872

1 unchanged sentence

Total cash and cash equivalents $ 86,300 $ 87,701

The Company’s cash and cash equivalents balances as of June 30, 2023 include cash balances, bank deposits, and amounts held primarily in interest-bearing money market accounts.

The Company’s cash and cash equivalents balances as of September 30, 2023 include cash balances, time deposits, and amounts held primarily in interest-bearing money market accounts.

As of December 31, 2021, the Company had $ 50 thousand classified as restricted cash, which is reported in the 2022 opening cash, cash equivalents, and restricted cash balance reported in the condensed statements of cash flows.

23 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, 2023 and 2022, and no impairment charges were recorded.

The Company invested in marketable securities during the nine months ended September 30, 2023 and 2022, 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.

If the Company believes an impairment of a security position is other than temporary, based on available quantitative and qualitative information as of the report date, the loss will be recognized as other income, net in the Company’s condensed statements of operations and a new cost basis in the investment is established.

If the Company believes an impairment of a security position is other than temporary, based on available quantitative and qualitative information as of the report date, the loss will be recognized within other income, net in the Company’s condensed statements of operations and a new cost basis in the investment is established.

Mineralys Therapeutics, Inc.

4 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, 2023 and December 31, 2022 were $ 0 and $ 1.6 million, respectively.

Deferred offering costs as of September 30, 2023 and December 31, 2022 were $ 0 and $ 1.6 million, respectively.

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

23 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 2,568,503 1,320,932

6 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 June 30, 2023 and December 31, 2022 (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, 2023 and December 31, 2022 (in thousands):

September 30, December 31,

Cash equivalents

Bank deposits $ 50,877 $ —

Money market funds $ 45,356 $ 84,829

Time deposits 39,592 —

Total cash equivalents $ 84,948 $ 84,829

1 unchanged sentence

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

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

Money Market Funds and Time Deposits—The carrying amounts of money market funds and time deposits 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.

1 unchanged sentence

Notes to Condensed Financial Statements

Treasury Bills—As of June 30, 2023 and December 31, 2022, the Company had short- and/or long-term U.S.

Treasury Bills—As of September 30, 2023 and December 31, 2022, the Company had short- and/or long-term U.S.

Treasury bills.

1 unchanged sentence

The following table presents held-to-maturity U.S.

Treasury bills information as of each reported date:

As of June 30, 2023

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

As of September 30, 2023

Balance Sheet Location Original Maturities Amortized Cost Estimated Fair Value

8 unchanged sentences

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 the Company is obligated to pay Mitsubishi Tanabe development milestone payments of up to $ 9.0 million in the aggregate and 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.

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

10 unchanged sentences

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 $ 4.0 million and $ 0 of research and development expenses related to the Mitsubishi License during the six months ended June 30, 2023 and 2022, respectively.

The Company incurred $ 4.0 million and $ 0 of research and development expenses related to the Mitsubishi License during the nine months ended September 30, 2023 and 2022, respectively.

A development milestone was achieved in March 2023 related to the Company’s planned initiation of its pivotal clinical program of lorundrostat.

1 unchanged sentence

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, 2023 and 2022, 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, 2023 and 2022, 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, 2023 and December 31, 2022.

Accrued Liabilities

Accrued liabilities consisted of the following (in thousands):

June 30, December 31,

September 30, December 31,

Research and development expenses $ 5,853 $ 4,846

5 unchanged sentences

Capital Stock

As of June 30, 2023, the Company had reserved authorized shares of common stock for future issuance as follows:

Common stock options outstanding 2,657,113

As of September 30, 2023, the Company had reserved authorized shares of common stock for future issuance as follows:

September 30,

Shares available for grant under the 2023 Plan 3,198,474

Common stock options outstanding 2,568,503

Shares available for grant under the ESPP 400,000

40 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,

2023 2022 2023 2022

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