Mineralys Therapeutics, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Mineralys Therapeutics, Inc. has filed its 2023 annual report (10-K) detailing its fiscal year operations and financial standing.</b>

AI Summary

Mineralys Therapeutics, Inc. (MLYS) filed a Annual Report (10-K) with the SEC on March 21, 2024. Mineralys Therapeutics, Inc. filed its 2023 Form 10-K on March 21, 2024. The company's fiscal year ends on December 31st. The filing covers the period from January 1, 2023, to December 31, 2023. Mineralys Therapeutics, Inc. is incorporated in Delaware. The company's business address is in Radnor, PA.

Why It Matters

For investors and stakeholders tracking Mineralys Therapeutics, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Mineralys Therapeutics' financial performance, operational activities, and strategic direction for the fiscal year 2023. Investors and stakeholders can use this report to assess the company's financial health, understand its business model, and evaluate potential risks and opportunities.

Risk Assessment

Risk Level: low — Mineralys Therapeutics, Inc. shows low risk based on this filing. The filing is a standard 10-K for a company that appears to be in its early stages, with no specific financial performance data or significant events detailed in the provided header information, suggesting a focus on foundational reporting.

Analyst Insight

Review the full 10-K filing for detailed financial statements, risk factors, and management discussion to understand Mineralys Therapeutics' current operational status and future outlook.

Key Numbers

• 2023-12-31 — Fiscal Year End (Conformed Period of Report)
• 2024-03-21 — Filing Date (As of Date)
• 2023-02-14 — IPO Date (Initial Public Offering Date)

Key Players & Entities

• Mineralys Therapeutics, Inc. (company) — Filer name
• 0001933414 (company) — Central Index Key
• 2834 (company) — Standard Industrial Classification (Pharmaceutical Preparations)
• DE (company) — State of Incorporation
• Radnor, PA (company) — Business Address City, State
• Mitsubishi Tanabe (company) — Collaborative Arrangement Transaction Party

FAQ

Industry Context

Mineralys Therapeutics operates in the Pharmaceutical Preparations industry, focusing on the development and commercialization of therapeutics.

Regulatory Implications

The filing is made under the Securities Exchange Act of 1934, requiring public companies to disclose material information about their business, financial condition, and operations.

What Investors Should Do

1. Analyze the full 10-K for detailed financial statements and footnotes.
2. Examine the 'Risk Factors' section for potential business and financial risks.
3. Review the 'Management's Discussion and Analysis of Financial Condition and Results of Operations' for insights into performance drivers.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K.
• 2024-03-21: Filing Date — Date the 10-K was officially submitted to the SEC.
• 2023-02-14: Initial Public Offering (IPO) — Date of the company's IPO.

Year-Over-Year Comparison

This is the first 10-K filing for Mineralys Therapeutics, Inc. as a public company, covering the fiscal year ending December 31, 2023.

Key Financial Figures

• $130 billion — nd resulting in an estimated average of $130 billion annual economic burden in the United St

Filing Documents

• mlys-20231231.htm (10-K) — 1410KB
• mlys-fy2310kex44.htm (EX-4.4) — 21KB
• mlys-fy2310kex231.htm (EX-23.1) — 2KB
• mlys-fy2310kex311.htm (EX-31.1) — 10KB
• mlys-fy2310kex312.htm (EX-31.2) — 10KB
• mlys-fy2310kex321.htm (EX-32.1) — 5KB
• mlys-fy2310kex322.htm (EX-32.2) — 5KB
• mlys-fy2310kex971.htm (EX-97.1) — 26KB
• mlys-20231231_g1.jpg (GRAPHIC) — 220KB
• mlys-20231231_g10.jpg (GRAPHIC) — 540KB
• mlys-20231231_g11.jpg (GRAPHIC) — 33KB
• mlys-20231231_g2.jpg (GRAPHIC) — 525KB
• mlys-20231231_g3.jpg (GRAPHIC) — 655KB
• mlys-20231231_g4.jpg (GRAPHIC) — 377KB
• mlys-20231231_g5.jpg (GRAPHIC) — 1599KB
• mlys-20231231_g6.jpg (GRAPHIC) — 145KB
• mlys-20231231_g7.jpg (GRAPHIC) — 1416KB
• mlys-20231231_g8.jpg (GRAPHIC) — 384KB
• mlys-20231231_g9.jpg (GRAPHIC) — 616KB
• 0001628280-24-012358.txt (&nbsp;) — 21317KB
• mlys-20231231.xsd (EX-101.SCH) — 34KB
• mlys-20231231_cal.xml (EX-101.CAL) — 41KB
• mlys-20231231_def.xml (EX-101.DEF) — 195KB
• mlys-20231231_lab.xml (EX-101.LAB) — 496KB
• mlys-20231231_pre.xml (EX-101.PRE) — 363KB
• mlys-20231231_htm.xml (XML) — 523KB

Risk Factors

Item 1A. Risk Factors 31

Unresolved Staff Comments

Item 1B. Unresolved Staff Comments 90

Cybersecurity

Item 1C. Cybersecurity 90

Properties

Item 2. Properties 91

Legal Proceedings

Item 3. Legal Proceedings 91

Mine Safety Disclosures

Item 4. Mine Safety Disclosures 91 Part II 92

Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 92

[Reserved]

Item 6. [Reserved] 92

Management's Discussion and Analysis of Financial Condition and Results of Operations

Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations 92

Quantitative and Qualitative Disclosures About Market Risk

Item 7A. Quantitative and Qualitative Disclosures About Market Risk 104

Financial Statements and Supplementary Data

Item 8. Financial Statements and Supplementary Data F- 1

Changes in and Disagreements With Accountants on Accounting and Financial Disclosure

Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 106

Controls and Procedures

Item 9A. Controls and Procedures 106

Other Information

Item 9B. Other Information 107

Disclosure Regarding Foreign Jurisdiction that Prevent Inspections

Item 9C. Disclosure Regarding Foreign Jurisdiction that Prevent Inspections 107 Part III 108

Directors, Executive Officers and Corporate Governance

Item 10. Directors, Executive Officers and Corporate Governance 108

Executive Compensation

Item 11. Executive Compensation 108

Security Ownership of Certain Beneficial Owner and Management and Related Stockholder Matters

Item 12. Security Ownership of Certain Beneficial Owner and Management and Related Stockholder Matters 108

Certain Relationships and Related Transactions, and Director Independence

Item 13. Certain Relationships and Related Transactions, and Director Independence 108

Principal Accountant Fees and Services

Item 14. Principal Accountant Fees and Services 108 Part IV 109

Exhibit and Financial Statement Schedules

Item 15. Exhibit and Financial Statement Schedules 109

Form 10-K Summary

Item 16. Form 10-K Summary 109

Signatures

Signatures 111 RISK FACTORS SUMMARY Our business, results of operations, financial condition, and growth prospects may be affected by a number of factors, whether currently known or unknown. 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, let alone combined with any of the others, could materially and adversely affect our business, financial condition, results of operations, and stock price. We have provided a summary of some of these risks below, with a more detailed explanation of those and other risks applicable to the Company in Part I, Item 1A. " Risk Factors " in this Annual Report. Summary of Risks Related to Our Business The principal risks and uncertainties affecting our business include the following: We have a limited operating history and none of lorundrostat or any future product candidates have been approved for commercial sale. We have a history of significant net losses since our inception and expect to continue to incur significant losses for the foreseeable future. We may never generate any revenue or become profitable or, if we achieve profitability, we may not be able to sustain it. We will need substantial additional funds to pursue our business objectives, which may not be available on acceptable terms, or at all. Failure to obtain this necessary capital when needed on acceptable terms, or at all, may force us to delay, limit, reduce, or terminate our product development programs, commercialization efforts, or other operations. Our future performance at this time is entirely dependent on the success of our only product candidate, lorundrostat, which is currently in clinical development and has not completed a pivotal trial. If we are unable to advance lorundrostat in clinical development, obtain regulatory approval, and ul

FORWARD-LOOKING STATEMENTS AND MARKET DATA

FORWARD-LOOKING STATEMENTS AND MARKET DATA This Annual Report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act). All statements other than statements of historical facts contained in this Annual Report, including statements regarding our future results of operations and financial position, business strategy, research and development plans, the anticipated timing, costs, design, and conduct of our ongoing and planned preclinical studies and planned clinical trials for lorundrostat and any future product candidates, the timing and likelihood of regulatory filings and approvals for lorundrostat and any future product candidates, our ability to commercialize our product candidates, if approved, the potential to develop future product candidates, the potential benefits of strategic collaborations and our intent to enter into any strategic arrangements, the timing and likelihood of success, and plans and objectives of management for future operations and future results of anticipated product development efforts, are forward-looking statements. These statements involve known and unknown risks, uncertainties, and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. This Annual Report also contains estimates and other statistical data made by independent parties and by us relating to market size and growth and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions, and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high de

Business

Item 1. Business Business Overview We are a clinical-stage biopharmaceutical company focused on developing medicines to target diseases driven by abnormally elevated aldosterone. Our clinical-stage product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor (ASI) that we are initially developing for the treatment of cardiorenal conditions affected by abnormally elevated aldosterone, including hypertension and chronic kidney disease (CKD). In the United States, there are over 115 million patients who have sustained elevated blood pressure (BP), or hypertension, and more than half of this population fails to achieve their BP goals, defined as BP of below 130/80 mmHg, with currently available medications. There are over 30 million treated patients who do not achieve their BP goal, of whom approximately 20 million have systolic BP levels greater than 140 mmHg. Patients with hypertension that persists despite taking two or more medications have 1.8 and 2.5 times greater mortality risk due to either cardiovascular disease or stroke, respectively. In a Phase 2 proof-of-concept clinical trial evaluating 200 subjects (Target-HTN) with uncontrolled hypertension (uHTN), defined as individuals who are unable to achieve BP of below 130/80 mmHg despite taking two or more lines of antihypertensive medication, or resistant hypertension (rHTN), defined as individuals who are unable to achieve BP of below 130/80 mmHg despite taking three or more antihypertensive medications typically including a diuretic, lorundrostat demonstrated a clinically meaningful and statistically significant reduction in BP with once-daily dosing and was well tolerated. Abnormally elevated aldosterone levels are a key factor in driving hypertension in approximately 25% of hypertensive patients. In addition to hypertension, we intend to investigate the benefits of lorundrostat in subjects with hypertension and CKD. We believe that our product candi

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View this 10-K filing on SEC EDGAR