Mineralys Therapeutics, Inc.
For the period ended Sep 30, 2026. Filed Nov 4, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 4, 2026
What changed in Risk Factors?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-11.
0001933414-26-000114
Item 1A. Risk FactorsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-04.
0001933414-26-000144
Item 1A. Risk FactorsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 15 previous paragraphs and 20 current paragraphs.
13 unchanged; 2 reworded; 5 added; 0 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 0 previous and 0 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (5)
Current report
The following risk factor is modified since our Annual Report on Form 10-K for the year ended December 31, 2025:
Current report
Changes in trade policy and inflation could adversely affect our business and results of operations.
Current report
The U.S. government has adopted new approaches to trade policy, and in some cases has renegotiated or terminated certain existing bilateral or multilateral trade agreements. The U.S. government has also imposed significant tariffs on many foreign goods. In particular, tariffs are likely to make importing pharmaceuticals from certain countries more expensive or require companies to incur significant costs to transition to alternative suppliers within the United States. Based on currently available information, our importation of lorundrostat drug product may be subject to tariffs as high as 100% of the imported value. If imposed, these tariffs would directly increase our costs, adversely affect our cash flows, and result in higher expenses associated with the manufacture of lorundrostat. Future tariff increases or other changes in U.S. trade policy could exacerbate these challenges. For instance, in response to these tariffs, other countries have threatened, announced, or implemented retaliatory tariffs on U.S. goods, which could potentially lead the U.S. government to further increase tariffs on foreign goods.
Current report
While inflation in the United States has been relatively low in recent years, the economy in the United States has encountered a material level of inflation since 2021. Although inflation has eased somewhat in 2024 and 2025, it has raised our costs for commodities, labor, materials, services, and other costs required to grow and operate our business, and failure to secure these on reasonable terms may adversely impact our financial condition.
Current report
Elevated inflation, along with public health concerns, domestic and international elections and other political developments, and domestic and global supply chain disruptions, have caused, and may in the future cause, global economic uncertainty and uncertainty about the interest rate environment, which may make it more difficult, costly, or dilutive for us to secure additional financing. In addition, political tensions and uncertainty as a result of trade policies could reduce trade volume, investment, technological exchange, and other economic activities between major international economies, resulting in a material adverse effect on global economic conditions and the stability of global financial markets. A failure to adequately respond to these risks could have a material adverse impact on our financial position.
Reworded paragraphs (2)
Previous wording
Our business, financial condition, and operating results may be affected by a number of factors, whether currently known or unknown, including, but not limited to, those described in Part I, Item 1A, “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2025. Any one or more of such factors could directly or indirectly cause our actual results of operations and financial condition to vary materially from past or anticipated future results of operations and financial condition. Any of these factors, in whole or in part, alone or combined with any of the other factors, could materially and adversely affect our business, financial condition, results of operations, and stock price. Except as set forth below, there have been no material changes to our risk factors since our Annual Report on Form 10-K for the year ended December 31, 2025.
Current wording
Our business, financial condition, and operating results may be affected by a number of factors, whether currently known or unknown, including, but not limited to, those described below and in Part I, Item 1A, “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2025. Any one or more of such factors could directly or indirectly cause our actual results of operations and financial condition to vary materially from past or anticipated future results of operations and financial condition. Any of these factors, in whole or in part, alone or combined with any of the other factors, could materially and adversely affect our business, financial condition, results of operations, and stock price. Except as set forth below, there have been no material changes to our risk factors since our Annual Report on Form 10-K for the year ended December 31, 2025.
Previous wording
The following risk factors are new as a result of entering into the Loan Agreement in June 2026:
Current wording
The following risk factors are new since our Annual Report on Form 10-K for the year ended December 31, 2025 and arose as a result of entering into the Loan Agreement in June 2026: