Reneo Pharmaceuticals, Inc. Files 2023 Annual Report on Form 10-K

Ticker: OKUR · Form: 10-K · Filed: Mar 28, 2024 · CIK: 1637715

Sentiment: neutral

Topics: 10-K, Annual Report, Reneo Pharmaceuticals, Financials, SEC Filing

TL;DR

<b>Reneo Pharmaceuticals, Inc. has filed its 2023 10-K annual report detailing its financial performance and business operations.</b>

AI Summary

Reneo Pharmaceuticals, Inc. (OKUR) filed a Annual Report (10-K) with the SEC on March 28, 2024. Reneo Pharmaceuticals, Inc. filed its annual report on Form 10-K for the fiscal year ended December 31, 2023. The filing includes financial data and disclosures for the period. Key dates mentioned include the fiscal year end of December 31, 2023, and the filing date of March 28, 2024. The company's business address is located at 18575 Jamboree Road, Suite 275-S, Irvine, CA 92612. Reneo Pharmaceuticals operates within the Pharmaceutical Preparations industry (SIC code 2834).

Why It Matters

For investors and stakeholders tracking Reneo Pharmaceuticals, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Reneo Pharmaceuticals' financial health, operational activities, and strategic positioning for the fiscal year 2023, which is crucial for investors to assess the company's performance and future prospects. The detailed disclosures within the 10-K allow stakeholders to understand the company's financial standing, including assets, liabilities, and equity, as well as any significant business developments or risks faced during the reporting period.

Risk Assessment

Risk Level: medium — Reneo Pharmaceuticals, Inc. shows moderate risk based on this filing. The filing is a standard 10-K, which provides a broad overview of the company's financial health and operations, but lacks specific forward-looking financial targets or recent performance metrics that would indicate a higher or lower risk level.

Analyst Insight

Investors should review the detailed financial statements and risk factors within the 10-K to understand Reneo Pharmaceuticals' current financial position and potential challenges.

Key Numbers

Key Players & Entities

FAQ

When did Reneo Pharmaceuticals, Inc. file this 10-K?

Reneo Pharmaceuticals, Inc. filed this Annual Report (10-K) with the SEC on March 28, 2024.

What is a 10-K filing?

A 10-K is a comprehensive annual financial report required by the SEC, covering audited financials, business operations, risk factors, and management discussion. This particular 10-K was filed by Reneo Pharmaceuticals, Inc. (OKUR).

Where can I read the original 10-K filing from Reneo Pharmaceuticals, Inc.?

You can access the original filing directly on the SEC's EDGAR system. The filing is publicly available and includes all exhibits and attachments submitted by Reneo Pharmaceuticals, Inc..

What are the key takeaways from Reneo Pharmaceuticals, Inc.'s 10-K?

Reneo Pharmaceuticals, Inc. filed this 10-K on March 28, 2024. Key takeaways: Reneo Pharmaceuticals, Inc. filed its annual report on Form 10-K for the fiscal year ended December 31, 2023.. The filing includes financial data and disclosures for the period.. Key dates mentioned include the fiscal year end of December 31, 2023, and the filing date of March 28, 2024..

Is Reneo Pharmaceuticals, Inc. a risky investment based on this filing?

Based on this 10-K, Reneo Pharmaceuticals, Inc. presents a moderate-risk profile. The filing is a standard 10-K, which provides a broad overview of the company's financial health and operations, but lacks specific forward-looking financial targets or recent performance metrics that would indicate a higher or lower risk level.

What should investors do after reading Reneo Pharmaceuticals, Inc.'s 10-K?

Investors should review the detailed financial statements and risk factors within the 10-K to understand Reneo Pharmaceuticals' current financial position and potential challenges. The overall sentiment from this filing is neutral.

Key Dates

Filing Stats: 4,454 words · 18 min read · ~15 pages · Grade level 17.6 · Accepted 2024-03-28 16:01:38

Key Financial Figures

Filing Documents

Business

Item 1. Business 6

Risk Factors

Item 1A. Risk Factors 27

Unresolved Staff Comments

Item 1B. Unresolved Staff Comments 83

Cybersecurity

Item 1C. Cybersecurity 83

Properties

Item 2. Properties 84

Legal Proceedings

Item 3. Legal Proceedings 85

Mine Safety Disclosures

Item 4. Mine Safety Disclosures 85 PART II

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 86

[Reserved]

Item 6. [Reserved] 87

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 88

Quantitative and Qualitative Disclosures About Market Risk

Item 7A. Quantitative and Qualitative Disclosures About Market Risk 95

Financial Statements and Supplementary Data

Item 8. Financial Statements and Supplementary Data 95

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 118

Controls and Procedures

Item 9A. Controls and Procedures 118

Other Information

Item 9B. Other Information 118

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 119 PART III

Directors, Executive Officers and Corporate Governance

Item 10. Directors, Executive Officers and Corporate Governance 120

Executive Compensation

Item 11. Executive Compensation 120

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

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 120

Certain Relationships and Related Transactions, and Director Independence

Item 13. Certain Relationships and Related Transactions, and Director Independence 120

Principal Accountant Fees and Services

Item 14. Principal Accountant Fees and Services 120 PART IV

Exhibit and Financial Statement Schedules

Item 15. Exhibit and Financial Statement Schedules 121

Form 10-K Summary

Item 16. Form 10-K Summary 124 2 CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K (the Annual Report) may contain "forward-looking statements" within the meaning of the federal securities laws made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth under Part I, Item 1A, "Risk Factors" in this Annual Report. Except as required by law, we assume no obligation to update these forward-looking statements, whether as a result of new information, future events or otherwise. These statements, which represent our current expectations or beliefs concerning various future events, may contain words such as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "design," "due," "estimate," "expect," "goal," "intend," "may," "objective," "plan," "predict," "project," "positioned," "potential," "seek," "should," "target," "will," "would" or the negative or plural of those terms, and similar expressions intended to identify statements about the future, although not all forward-looking statements contain these words. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these statements. Such statements may include, but are not limited to, statements concerning the following: our plans to evaluate and explore a variety of potential strategic alternatives focused on maximizing stockholder value, including, but not limited to, a merger, sale, other business combination, a strategic partnership with one or more parties, or the licensing, sale or divestiture of our assets; our or any third party's ability to obtain and

Business

Item 1. Business Overview Reneo is a pharmaceutical company historically focused on the development and commercialization of therapies for patients with rare genetic mitochondrial diseases, which are often associated with the inability of mitochondria to produce adenosine triphosphate (ATP). Our only product candidate, mavodelpar, is a potent and selective agonist of the peroxisome proliferator-activated receptor delta (PPAR). Mavodelpar has been shown to increase transcription of genes involved in mitochondrial function and increase fatty acid oxidation (FAO), and may increase production of new mitochondria. On December 14, 2023, we announced that our pivotal STRIDE study, a global, randomized, double-blind, placebo-controlled Phase 2b trial of mavodelpar in adult patients with primary mitochondria myopathy (PMM) due to mitochondrial DNA (mtDNA) defects, did not meet its primary or secondary efficacy endpoints. As a result, we suspended the development activities for mavodelpar and implemented cash preservation activities, including a substantial workforce reduction. We implemented a reduction in workforce in December 2023 and February 2024, and currently have eight full-time employees remaining. In January 2024, our Board of Directors retained an independent financial advisor to initiate a formal process to evaluate potential strategic alternatives focused on maximizing stockholder value, including, but not limited to, a merger, sale, other business combination, a strategic partnership with one or more parties, or the licensing, sale or divestiture of our assets. Our Board of Directors, in consultation with our independent financial and legal advisors, is evaluating a number of indications of interest we have received. If we do not successfully consummate a strategic alternative, our Board of Directors may decide to pursue a dissolution and liquidation of our company. We are no longer pursuing further clinical development of mavodelpar at this time. The di

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