About Monteverde & Associates PC NEW YORK, June 21, 2024 (GLOBE NEWSWIRE) -- Monteverde & Associates PC (the "M&A Class Action Firm"), has recovered money for shareholders and is recognized as a Top 50 Firm in the 2018-2022 ISS Securities Class Action Services Report. We are headquartered at the Empire State Building in New York City and is investigating Reneo Pharmaceuticals, Inc. (Nasdaq: RPHM), relating to its proposed merger with OnKure, Inc. Under the terms of the agreement, Reneo stockholders are expe ...

```markdown PART I — FINANCIAL INFORMATION This section presents the unaudited consolidated financial statements and related disclosures for the company [Item 1. Consolidated Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Consolidated%20Financial%20Statements%20(Unaudited)) Net loss reduced due to decreased R&D after mavodelpar suspension, maintaining stable liquidity Consolidated Balance Sheet Highlights (in thousands) | Metric | March 31, 2024 | December 31, 2023 | Change | | :-------------------------------- | :------------- | :---------------- | :----- | | Cash and cash equivalents | $20,375 | $27,632 | $(7,257) | | Short-term investments | $62,460 | $75,331 | $(12,871) | | Total current assets | $83,927 | $106,622 | $(22,695) | | Total assets | $84,639 | $107,436 | $(22,797) | | Total current liabilities | $2,814 | $18,177 | $(15,363) | | Total liabilities | $3,397 | $18,826 | $(15,429) | | Total stockholders' equity | $81,242 | $88,610 | $(7,368) | | Accumulated deficit | $(226,900) | $(218,474) | $(8,426) | Consolidated Statements of Operations and Comprehensive Loss (in thousands, except per share data) | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change | | :------------------------------------------------ | :-------------------------------- | :-------------------------------- | :----- | | Research and development expenses | $4,942 | $10,991 | $(6,049) | | General and administrative expenses | $4,622 | $5,132 | $(510) | | Total operating expenses | $9,564 | $16,123 | $(6,559) | | Loss from operations | $(9,564) | $(16,123) | $6,559 | | Other income | $1,138 | $1,016 | $122 | | Net loss | $(8,426) | $(15,107) | $6,681 | | Comprehensive loss | $(8,446) | $(15,052) | $6,606 | | Net loss per share, basic and diluted | $(0.25) | $(0.60) | $0.35 | | Weighted-average shares outstanding | 33,420,808 | 25,036,410 | 8,384,398 | Consolidated Statements of Cash Flows (in thousands) | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change | | :-------------------------------- | :-------------------------------- | :-------------------------------- | :----- | | Net cash used in operating activities | $(21,014) | $(9,048) | $(11,966) | | Net cash provided by investing activities | $13,757 | $18,507 | $(4,750) | | Net cash provided by financing activities | $0 | $1,009 | $(1,009) | | Net (decrease) increase in cash and cash equivalents | $(7,257) | $10,468 | $(17,725) | | Cash and cash equivalents, end of period | $20,375 | $30,395 | $(10,020) | - The Company has **suspended all development activities** for its only product candidate, mavodelpar, after its pivotal STRIDE study failed to meet primary or secondary efficacy endpoints on December 14, 2023, leading to **workforce reductions** and **approximately $4.1 million in severance and benefit expenses**[24](index=24&type=chunk)[122](index=122&type=chunk) - As of March 31, 2024, the Company had **$82.8 million in cash, cash equivalents, and short-term investments**, which management believes will be **sufficient to fund operations for at least one year**[26](index=26&type=chunk)[91](index=91&type=chunk)[94](index=94&type=chunk) Accrued Expenses (in thousands) | Category | March 31, 2024 | December 31, 2023 | Change | | :-------------------------- | :------------- | :---------------- | :----- | | Accrued clinical and regulatory | $190 | $3,661 | $(3,471) | | Accrued contract manufacturing cost | $1 | $1,100 | $(1,099) | | Accrued compensation | $1,170 | $3,948 | $(2,778) | | Total accrued expenses | $1,807 | $9,129 | $(7,322) | - The Company exercised an **early termination option** for its Sandwich, United Kingdom office lease in January 2024[46](index=46&type=chunk) Stock-Based Compensation Expense (in thousands) | Category | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change | | :-------------------------- | :-------------------------------- | :-------------------------------- | :----- | | Research and development | $253 | $473 | $(220) | | General and administrative | $825 | $684 | $141 | | Total | $1,078 | $1,157 | $(79) | - The Company **repurchased all 576,443 shares** of its common stock previously issued to vTv Therapeutics under the vTv License Agreement for **approximately $4.4 million** in October 2023, and **No milestone payments were achieved or recorded** for the three months ended March 31, 2024 and 2023[68](index=68&type=chunk)[69](index=69&type=chunk) [Consolidated Balance Sheets](index=3&type=section&id=Consolidated%20Balance%20Sheets) This statement provides a snapshot of the company's assets, liabilities, and stockholders' equity at specific points in time [Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This statement details the company's revenues, expenses, and net loss over specific reporting periods [Consolidated Statements of Changes in Stockholders' Equity](index=5&type=section&id=Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) This statement outlines the changes in the company's equity accounts, including common stock and accumulated deficit, over time [Consolidated Statements of Cash Flows](index=6&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) This statement categorizes cash inflows and outflows from operating, investing, and financing activities for specific periods [Notes to Consolidated Financial Statements (Unaudited)](index=7&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements%20(Unaudited)) These notes provide additional detailed information and explanations essential for understanding the company's financial statements [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Strategic shift after mavodelpar failure led to reduced R&D expenses and workforce, with sufficient liquidity for 12 months - Reneo Pharmaceuticals, Inc. has **suspended all development activities** for its only product candidate, mavodelpar, following the **failure of its pivotal STRIDE study** in December 2023[74](index=74&type=chunk) - The Board of Directors initiated a formal process in January 2024 to **evaluate potential strategic alternatives**, including **merger, sale, or other business combinations**, to maximize stockholder value, with **dissolution and liquidation** potentially pursued if no strategic alternative is consummated[75](index=75&type=chunk)[120](index=120&type=chunk) Operating Expenses (in thousands) | Expense Category | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change | | :-------------------------- | :-------------------------------- | :-------------------------------- | :----- | | Research and development | $4,942 | $10,991 | $(6,049) | | General and administrative | $4,622 | $5,132 | $(510) | | Total operating expenses | $9,564 | $16,123 | $(6,559) | - **Research and development expenses decreased by $6.0 million**, primarily due to the **suspension of mavodelpar development** and **workforce reductions**[88](index=88&type=chunk) - **General and administrative expenses decreased by $0.5 million**, mainly due to **workforce reductions**[89](index=89&type=chunk) - **Other income increased by $0.1 million**, driven by higher interest rates in 2024[90](index=90&type=chunk) - As of March 31, 2024, the company had an **accumulated deficit of $226.9 million** and a **net loss of $8.4 million** for the quarter[93](index=93&type=chunk) - The company **terminated its at-the-market equity offering sales agreement** (2023 ATM Facility) with Leerink Partners LLC on April 8, 2024, under which **no shares were sold**[92](index=92&type=chunk) - **Material cash requirements** include future operating lease payments, a **special performance award for the CEO (up to $7.5 million)**, and **potential milestone/royalty payments** under the vTv License Agreement, in addition to **costs for evaluating strategic alternatives**[100](index=100&type=chunk)[101](index=101&type=chunk)[102](index=102&type=chunk) [Overview](index=18&type=section&id=Overview) This section provides a high-level introduction to the company's financial condition and operational results, emphasizing recent strategic shifts [History of Mavodelpar Clinical Trials Overview](index=19&type=section&id=History%20of%20Mavodelpar%20Clinical%20Trials%20Overview) This section summarizes the development and clinical trial history of the company's lead product candidate, mavodelpar [License Agreement](index=19&type=section&id=License%20Agreement) This section details the terms and financial implications of the company's licensing agreements, particularly concerning its product candidates [Components of Our Results of Operations](index=20&type=section&id=Components%20of%20Our%20Results%20of%20Operations) This section explains the key revenue and expense categories that constitute the company's financial performance [Results of Operations](index=21&type=section&id=Results%20of%20Operations) This section provides a detailed analysis of the company's financial performance, comparing current and prior period operating results [Liquidity and Capital Resources](index=22&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's ability to meet its short-term and long-term financial obligations and its sources of funding [Cash Flows](index=23&type=section&id=Cash%20Flows) This section analyzes the sources and uses of cash across operating, investing, and financing activities [Material Cash Requirements](index=23&type=section&id=Material%20Cash%20Requirements) This section outlines the company's significant future contractual obligations and other cash commitments [Critical Accounting Policies and Estimates](index=24&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section describes the accounting policies and estimates that require significant judgment and can materially impact financial reporting [Recent Accounting Pronouncements](index=24&type=section&id=Recent%20Accounting%20Pronouncements) This section discusses the impact of recently issued accounting standards on the company's financial statements [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=24&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, Reneo Pharmaceuticals, Inc. is not required to provide market risk disclosures [Item 4. Controls and Procedures](index=24&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were effective as of March 31, 2024, with no material changes in internal control over financial reporting - **Disclosure controls and procedures were effective as of March 31, 2024**[107](index=107&type=chunk) - **No material changes in internal control over financial reporting occurred during the three months ended March 31, 2024**[109](index=109&type=chunk) [Evaluation of Disclosure Controls and Procedures](index=24&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) This section provides an overview of Evaluation of Disclosure Controls and Procedures [Changes in Internal Control over Financial Reporting](index=25&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) This section provides an overview of Changes in Internal Control over Financial Reporting PART II — OTHER INFORMATION This section provides additional information including legal proceedings, risk factors, and equity disclosures [Item 1. Legal Proceedings](index=25&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings, but acknowledges potential future litigation - The company is **not currently a party to any material legal proceedings**[112](index=112&type=chunk) [Item 1A. Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) Significant ongoing net losses, strategic alternative uncertainties, and employee retention challenges pose substantial risks to the company - The company has **incurred significant net losses** since its inception in 2014, with an **accumulated deficit of $226.9 million** as of March 31, 2024, and **expects to continue incurring losses**[117](index=117&type=chunk)[118](index=118&type=chunk) - There is **no assurance** that the evaluation of strategic alternatives will result in a definitive transaction or enhance stockholder value, and a **dissolution and liquidation could lead to a total loss of investment**[119](index=119&type=chunk)[121](index=121&type=chunk) - The company's recent **workforce reductions** (December 2023 and February 2024) may lead to a **loss of key employees**, **impacting the ability to pursue strategic alternatives**[123](index=123&type=chunk) - Future development of any product candidates would require **substantial additional capital**, which may not be available on acceptable terms, potentially forcing **delays or elimination of programs**[124](index=124&type=chunk)[126](index=126&type=chunk) - The regulatory approval process is **lengthy, expensive, and uncertain**, with **no guarantee of success**, and any approved products may face **challenges in market acceptance and reimbursement**[136](index=136&type=chunk)[160](index=160&type=chunk) - The company relies on third parties for clinical trials and manufacturing, and their **failure to meet contractual duties or regulatory requirements could delay or prevent product development**[211](index=211&type=chunk)[218](index=218&type=chunk) - Obtaining and maintaining intellectual property protection is **critical but uncertain**, with **risks of patent invalidation, infringement claims, and challenges in global enforcement**[222](index=222&type=chunk)[233](index=233&type=chunk)[286](index=286&type=chunk) - The company's **common stock price is highly volatile**, influenced by clinical trial results, regulatory decisions, and general market factors, and could **decline due to substantial sales or future dilution**[328](index=328&type=chunk)[344](index=344&type=chunk)[347](index=347&type=chunk) - The company is subject to various U.S. and foreign laws, including anti-corruption, data privacy, and cybersecurity regulations, with non-compliance potentially leading to **significant penalties and business disruptions**[187](index=187&type=chunk)[357](index=357&type=chunk)[359](index=359&type=chunk) [Risks Related to Our Business and Industry](index=26&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Industry) This section details the specific challenges and uncertainties inherent in the company's operations and the pharmaceutical industry [Risks Related to Our Reliance on Third Parties](index=47&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) This section highlights the potential risks arising from the company's dependence on external partners for key functions like manufacturing and clinical trials [Risks Related to Our Intellectual Property](index=50&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) This section addresses the challenges and uncertainties associated with protecting and enforcing the company's intellectual property rights [Risks Related to Ownership of Our Common Stock](index=72&type=section&id=Risks%20Related%20to%20Ownership%20of%20Our%20Common%20Stock) This section outlines the factors that could negatively impact the value and liquidity of the company's common stock for investors [General Risk Factors](index=80&type=section&id=General%20Risk%20Factors) This section covers broad, overarching risks that could affect the company's overall business, financial condition, and future prospects [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=82&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered equity sales occurred; IPO proceeds primarily funded operations, with remaining funds in liquid assets - **No unregistered sales of equity securities occurred during the period**[375](index=375&type=chunk) - The company **completed its IPO in April 2021, generating net proceeds of $84.6 million**. As of March 31, 2024, **approximately $66.6 million of these proceeds have been used to fund operations**, with the remaining invested in **highly liquid money market funds and short-term investments**[376](index=376&type=chunk)[377](index=377&type=chunk) [Unregistered Sales of Equity Securities](index=83&type=section&id=Unregistered%20Sales%20of%20Equity%20Securities) This section discloses any sales of equity securities that were not registered under the Securities Act of 1933 [Use of Proceeds](index=83&type=section&id=Use%20of%20Proceeds) This section details how the net proceeds from the company's public offerings, such as its IPO, have been utilized [Item 3. Defaults Upon Senior Securities](index=82&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) Reneo Pharmaceuticals, Inc. reported no defaults upon senior securities - **There were no defaults upon senior securities**[378](index=378&type=chunk) [Item 4. Mine Safety Disclosures](index=82&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Reneo Pharmaceuticals, Inc. reported no mine safety disclosures - **There were no mine safety disclosures**[378](index=378&type=chunk) [Item 5. Other Information](index=82&type=section&id=Item%205.%20Other%20Information) Reneo Pharmaceuticals, Inc. reported no other information required to be disclosed under this item - **No other information was reported**[379](index=379&type=chunk) [Item 6. Exhibits](index=83&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of the Quarterly Report on Form 10-Q, including certifications and data files - The report includes **certifications from the Principal Executive Officer and Principal Financial Officer (Exhibits 31.1, 31.2, 32.1) and Inline XBRL Instance Document (Exhibit 101.INS)**[382](index=382&type=chunk) [Signatures](index=84&type=section&id=Signatures) The report is duly signed by the President and CEO, and SVP of Finance and Administration, as of May 7, 2024 - The report was **signed by Gregory J. Flesher, President and Chief Executive Officer, and Jennifer P. Lam, Senior Vice President, Finance and Administration, on May 7, 2024**[386](index=386&type=chunk) ```

[1. First Quarter and Recent Highlights](index=1&type=section&id=1.%20First%20Quarter%20and%20Recent%20Highlights) Reneo Pharmaceuticals reported a reduced Q1 2024 net loss of $8.4 million, primarily due to significant R&D and G&A expense reductions following mavodelpar development suspension Q1 2024 Financial Performance Highlights | Metric | Q1 2024 (USD) | Q1 2023 (USD) | Change (YoY) | | :-------------------------------- | :------------ | :------------ | :----------- | | Net Loss | $(8.4) million | $(15.1) million | $(6.7) million | | Net Loss Per Share | $(0.25) | $(0.60) | $(0.35) | | R&D Expenses | $4.9 million | $11.0 million | $(6.1) million | | G&A Expenses | $4.6 million | $5.1 million | $(0.5) million | | Cash, Cash Equivalents, and Short-term Investments (as of March 31, 2024) | $82.8 million | N/A | N/A | - The decrease in **Research and development expenses** was primarily due to the suspension of development activities for **mavodelpar** and cash preservation activities, including **workforce reductions** in December 2023 and February 2024[4](index=4&type=chunk) - The decrease in **General and administrative expenses** was primarily due to **workforce reductions** in December 2023 and February 2024[5](index=5&type=chunk) - The pivotal **STRIDE study** of **mavodelpar** in adult patients with **primary mitochondrial myopathies** **did not meet its primary or secondary efficacy endpoints** in December 2023[7](index=7&type=chunk) - The Company implemented **cost savings initiatives**, including the **suspension of all mavodelpar development activities** and a total **workforce reduction of approximately 90%**[7](index=7&type=chunk) - Reneo retained an **independent financial advisor** to initiate a formal process to **evaluate potential strategic alternatives**[7](index=7&type=chunk) [2. About Reneo Pharmaceuticals](index=1&type=section&id=2.%20About%20Reneo%20Pharmaceuticals) Reneo Pharmaceuticals historically focused on developing therapies for rare genetic mitochondrial diseases - Reneo Pharmaceuticals historically focused on developing and commercializing therapies for patients with **rare genetic mitochondrial diseases**, characterized by the **inability of mitochondria to produce adenosine triphosphate**[6](index=6&type=chunk) [3. Consolidated Financial Statements](index=3&type=section&id=3.%20Consolidated%20Financial%20Statements) This section details Reneo Pharmaceuticals' Q1 2024 financial position, operational performance, and cash flow activities [3.1. Consolidated Balance Sheets](index=3&type=section&id=3.1.%20Consolidated%20Balance%20Sheets) This section presents Reneo Pharmaceuticals' consolidated balance sheet data as of March 31, 2024, detailing assets, liabilities, and equity Consolidated Balance Sheet Data (in thousands) | Metric | March 31, 2024 | December 31, 2023 | | :-------------------------------- | :------------- | :---------------- | | Cash and cash equivalents | $20,375 | $27,632 | | Short-term investments | $62,460 | $75,331 | | Total current assets | $83,927 | $106,622 | | Total assets | $84,639 | $107,436 | | Total current liabilities | $2,814 | $18,177 | | Total liabilities | $3,397 | $18,826 | | Total stockholders' equity | $81,242 | $88,610 | [3.2. Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=3.2.%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section presents Reneo Pharmaceuticals' consolidated statements of operations for Q1 2024 and 2023, detailing operating expenses and net loss Consolidated Statements of Operations (in thousands) | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Research and development | $4,942 | $10,991 | | General and administrative | $4,622 | $5,132 | | Total operating expenses | $9,564 | $16,123 | | Loss from operations | $(9,564) | $(16,123) | | Other income | $1,138 | $1,016 | | Net loss | $(8,426) | $(15,107) | | Net loss per share, basic and diluted | $(0.25) | $(0.60) | | Weighted-average shares used in computing net loss per share, basic and diluted | 33,420,808 | 25,036,410 | [3.3. Consolidated Statements of Cash Flows](index=5&type=section&id=3.3.%20Consolidated%20Statements%20of%20Cash%20Flows) This section outlines Reneo Pharmaceuticals' consolidated statements of cash flows for Q1 2024 and 2023, detailing cash movements Consolidated Statements of Cash Flows (in thousands) | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(21,014) | $(9,048) | | Net cash provided by investing activities | $13,757 | $18,507 | | Net cash provided by financing activities | $0 | $1,009 | | Net (decrease) increase in cash and cash equivalents | $(7,257) | $10,468 | | Cash and cash equivalents, end of period | $20,375 | $30,395 | [4. Forward-Looking Statements](index=2&type=section&id=4.%20Forward-Looking%20Statements) This section contains cautionary language regarding forward-looking statements, noting that future results may differ due to risks and uncertainties - Statements regarding matters that are not historical facts are '**forward-looking statements**' within the meaning of the **Private Securities Litigation Reform Act of 1995**[8](index=8&type=chunk) - Such statements are subject to **risks and uncertainties**, and **actual results may differ materially** from those expressed or implied[8](index=8&type=chunk) - Reneo undertakes **no obligation to update** such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law[8](index=8&type=chunk) [5. Contact Information](index=6&type=section&id=5.%20Contact%20Information) Provides the contact details for investor relations at Reneo Pharmaceuticals, Inc - Investor Relations contact: **Danielle Spangler**, **dspangler@reneopharma.com**[14](index=14&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For The Transition Period From To Commission file number: 001-40315 RENEO PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 47-2309515 (State or other jurisdi ...

Exhibit 99.1 Reneo Pharmaceuticals Reports Fourth Quarter And Full Year 2023 Financial Results And Business Update IRVINE, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- Reneo Pharmaceuticals, Inc. (Nasdaq: RPHM), a pharmaceutical company historically focused on the development and commercialization of therapies for patients with rare genetic mitochondrial diseases, today reported financial results for the fourth quarter and year ended December 31, 2023 and provided a business update. Fourth Quarter and Recent ...

Part I — Financial Information [Item 1. Consolidated Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Consolidated%20Financial%20Statements%20(Unaudited)) The unaudited consolidated financial statements detail the company's financial position, operations, and cash flows [Consolidated Balance Sheets](index=3&type=section&id=Consolidated%20Balance%20Sheets) Assets and Liabilities (in thousands) | Assets and Liabilities | Sep 30, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | **Assets:** | | | | Cash and cash equivalents | $11,737 | $19,927 | | Short-term investments | $113,877 | $81,246 | | Prepaid expenses and other current assets | $3,158 | $5,180 | | Total current assets | $128,772 | $106,353 | | Property and equipment, net | $529 | $453 | | Right-of-use assets | $1,006 | $1,292 | | Other non-current assets | $81 | $84 | | **Total assets** | **$130,388** | **$108,182** | | **Liabilities:** | | | | Accounts payable | $2,473 | $1,893 | | Accrued expenses | $10,765 | $4,827 | | Operating lease liabilities, current portion | $325 | $404 | | Total current liabilities | $13,563 | $7,124 | | Operating lease liabilities, less current portion | $812 | $1,059 | | Performance award | $1,069 | $29 | | **Total liabilities** | **$15,444** | **$8,212** | | **Stockholders' equity:** | | | | Common stock | $3 | $3 | | Additional paid-in capital | $305,479 | $236,693 | | Accumulated deficit | $(190,517) | $(136,683) | | Accumulated other comprehensive loss | $(21) | $(43) | | **Total stockholders' equity** | **$114,944** | **$99,970** | | **Total liabilities and stockholders' equity** | **$130,388** | **$108,182** | [Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Operating Expenses and Loss (in thousands, except per share data) | Operating Expenses and Loss | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $13,622 | $9,938 | $39,009 | $27,348 | | General and administrative | $7,266 | $3,902 | $19,038 | $11,938 | | Total operating expenses | $20,888 | $13,840 | $58,047 | $39,286 | | Loss from operations | $(20,888) | $(13,840) | $(58,047) | $(39,286) | | Other income | $1,692 | $833 | $4,213 | $931 | | Net loss | $(19,196) | $(13,007) | $(53,834) | $(38,355) | | Unrealized gain (loss) on short-term investments | $10 | $(194) | $22 | $(60) | | Comprehensive loss | $(19,186) | $(13,201) | $(53,812) | $(38,415) | | Net loss per share, basic and diluted | $(0.57) | $(0.53) | $(1.81) | $(1.57) | | Weighted-average shares used in computing net loss per share, basic and diluted | 33,807,945 | 24,496,313 | 29,718,689 | 24,472,974 | [Consolidated Statements of Changes in Stockholders' Equity](index=5&type=section&id=Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) Stockholders' Equity (in thousands, except share data) | Stockholders' Equity | Dec 31, 2022 | Mar 31, 2023 | Jun 30, 2023 | Sep 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | Common Stock (Shares) | 24,699,553 | 25,107,430 | 33,800,788 | 33,872,166 | | Common Stock (Amount) | $3 | $3 | $3 | $3 | | Additional Paid-In Capital | $236,693 | $238,859 | $303,877 | $305,479 | | Accumulated Other Comprehensive Income (Loss) | $(43) | $12 | $(31) | $(21) | | Accumulated Deficit | $(136,683) | $(151,790) | $(171,321) | $(190,517) | | Total Stockholders' Equity | $99,970 | $87,084 | $132,528 | $114,944 | - Issuance of common stock in public offering, net of offering costs: **$58,862 thousand (7,906,250 shares)** in Q2 2023[17](index=17&type=chunk)[48](index=48&type=chunk) - Issuance of common stock in private placement, net of offering costs: **$4,667 thousand (625,000 shares)** in Q2 2023[17](index=17&type=chunk)[49](index=49&type=chunk) [Consolidated Statements of Cash Flows](index=7&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Cash Flows (in thousands) | Cash Flows | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(43,929) | $(31,749) | | Net cash used in investing activities | $(29,254) | $(30,925) | | Net cash provided by financing activities | $64,993 | $146 | | Net decrease in cash and cash equivalents | $(8,190) | $(62,528) | | Cash and cash equivalents, beginning of period | $19,927 | $124,660 | | Cash and cash equivalents, end of period | $11,737 | $62,132 | [Notes to Consolidated Financial Statements (Unaudited)](index=8&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements%20(Unaudited)) [1. Organization and Business](index=8&type=section&id=1.%20Organization%20and%20Business) The company is a clinical-stage pharmaceutical firm facing substantial doubt about its ability to continue as a going concern - Reneo Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company focused on developing therapies for rare genetic mitochondrial diseases, with **mavodelpar (REN001)** as its lead product candidate[25](index=25&type=chunk) - The company incurred a **net loss of $53.8 million** for the nine months ended September 30, 2023, with an **accumulated deficit of $190.5 million**[26](index=26&type=chunk) - Management has concluded that **substantial doubt exists about the company's ability to continue as a going concern** for more than one year from the filing date[28](index=28&type=chunk) - Plans to alleviate going concern risk include **raising additional capital** through equity or debt financings and the ability to defer certain commercial development activities[28](index=28&type=chunk) [2. Summary of Significant Accounting Policies](index=9&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) The financial statements are prepared under GAAP, consistent with prior annual reports, with recent accounting standard updates noted - The unaudited consolidated financial statements are prepared in accordance with GAAP and include accounts of the Company and its wholly-owned subsidiaries[30](index=30&type=chunk)[32](index=32&type=chunk) - The Company adopted ASU 2016-13 (Financial Instruments - Credit Losses) as of January 1, 2023, with **no material impact** on its financial statements[34](index=34&type=chunk) - The Company is currently evaluating the impact of ASU 2022-03 (Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions)[35](index=35&type=chunk) [3. Net Loss Per Share](index=10&type=section&id=3.%20Net%20Loss%20Per%20Share) Basic loss per share is presented, while diluted loss per share excludes anti-dilutive common stock equivalents - Basic loss per share is calculated by dividing net loss by the weighted average number of common shares outstanding[37](index=37&type=chunk) - Diluted net loss per share **excludes common stock equivalents** (stock options and restricted stock units) because their inclusion would be anti-dilutive[37](index=37&type=chunk) Anti-Dilutive Securities | Anti-Dilutive Securities | As of September 30, 2023 | As of September 30, 2022 | | :--- | :--- | :--- | | Common stock options outstanding | 6,095,807 | 4,470,120 | | Unvested restricted stock units | 441,500 | 309,500 | | Total | 6,537,307 | 4,779,620 | [4. Fair Value Measurements](index=10&type=section&id=4.%20Fair%20Value%20Measurements) Financial instruments are classified using a three-tier hierarchy, with a significant Level 3 liability for a performance award - The company categorizes its money market funds as **Level 1** and commercial paper and U.S. treasury securities as **Level 2**[41](index=41&type=chunk) - The CEO's special performance award is a **Level 3 liability**, measured at fair value using a Monte Carlo simulation[42](index=42&type=chunk) Fair Value Measurements (in thousands) | Fair Value Measurements | Level 1 (Sep 30, 2023) | Level 2 (Sep 30, 2023) | Level 3 (Sep 30, 2023) | Total (Sep 30, 2023) | | :--- | :--- | :--- | :--- | :--- | | **Assets:** | | | | | | Money market investments | $4,946 | — | — | $4,946 | | U.S. treasury securities | — | $113,877 | — | $113,877 | | **Total Assets** | **$4,946** | **$113,877** | **—** | **$118,823** | | **Liabilities:** | | | | | | Performance award | — | — | $1,069 | $1,069 | | **Total Liabilities** | **—** | **—** | **$1,069** | **$1,069** | | Fair Value Measurements | Level 1 (Dec 31, 2022) | Level 2 (Dec 31, 2022) | Level 3 (Dec 31, 2022) | Total (Dec 31, 2022) | | :--- | :--- | :--- | :--- | :--- | | **Assets:** | | | | | | Money market investments | $9,365 | — | — | $9,365 | | Commercial paper | — | $4,978 | — | $4,978 | | U.S. treasury securities | — | $76,253 | — | $76,253 | | Commercial paper | — | $4,993 | — | $4,993 | | **Total Assets** | **$9,365** | **$86,224** | **—** | **$95,589** | | **Liabilities:** | | | | | | Performance award | — | — | $29 | $29 | | **Total Liabilities** | **—** | **—** | **$29** | **$29** | Performance Award (in thousands) | Performance Award | Amount | | :--- | :--- | | Balance as of January 1, 2023 | $29 | | Change in fair value | $1,040 | | Balance as of September 30, 2023 | $1,069 | [5. Marketable Debt Securities](index=12&type=section&id=5.%20Marketable%20Debt%20Securities) The company's available-for-sale debt securities, primarily U.S. treasuries, are carried at fair value with minor unrealized losses - Investments in debt securities are classified as **current assets available-for-sale** and are carried at fair value[45](index=45&type=chunk) Available-for-sale securities (in thousands) | Available-for-sale securities | Amortized Cost (Sep 30, 2023) | Gross Unrealized Gains (Sep 30, 2023) | Gross Unrealized Losses (Sep 30, 2023) | Fair Market Value (Sep 30, 2023) | | :--- | :--- | :--- | :--- | :--- | | U.S. treasury securities | $113,898 | $1 | $(22) | $113,877 | | Total | $113,898 | $1 | $(22) | $113,877 | | Available-for-sale securities | Amortized Cost (Dec 31, 2022) | Gross Unrealized Gains (Dec 31, 2022) | Gross Unrealized Losses (Dec 31, 2022) | Fair Market Value (Dec 31, 2022) | | :--- | :--- | :--- | :--- | :--- | | U.S. treasury securities | $76,297 | $2 | $(46) | $76,253 | | Commercial paper | $4,993 | — | — | $4,993 | | Total | $81,290 | $2 | $(46) | $81,246 | [6. Accrued Expenses](index=12&type=section&id=6.%20Accrued%20Expenses) Accrued expenses more than doubled, driven by increased clinical, regulatory, and compensation-related costs Accrued Expenses (in thousands) | Accrued Expenses | As of Sep 30, 2023 | As of Dec 31, 2022 | | :--- | :--- | :--- | | Accrued clinical and regulatory | $5,176 | $1,872 | | Accrued contract manufacturing cost | $1,005 | $1,583 | | Accrued compensation | $3,830 | $807 | | Accrued other | $754 | $565 | | Total accrued expenses | $10,765 | $4,827 | [7. Leases](index=13&type=section&id=7.%20Leases) The company holds operating leases for office space in the U.S. and U.K. with a weighted-average remaining term of 3.4 years - The Company leases office space in Irvine, California (through November 30, 2026) and Sandwich, United Kingdom (through October 23, 2027)[47](index=47&type=chunk) Lease Information | Lease Information | As of Sep 30, 2023 | As of Sep 30, 2022 | | :--- | :--- | :--- | | Weighted incremental borrowing rate | 5% | 5% | | Weighted average remaining lease term (in years) | 3.4 | 3.8 | | Cash paid for amounts included in the measurement of lease liabilities (in thousands) | $430 | $397 | | Lease expense (in thousands) | $354 | $338 | Maturities of Lease Liabilities (in thousands) | Maturities of Lease Liabilities | As of Sep 30, 2023 | | :--- | :--- | | 2023 (remaining three months) | $94 | | 2024 | $381 | | 2025 | $381 | | 2026 | $343 | | 2027 | $34 | | Total lease payments | $1,233 | | Less: Imputed interest | $(96) | | Present value of lease liabilities | $1,137 | [8. Stockholders' Equity](index=13&type=section&id=8.%20Stockholders'%20Equity) The company raised approximately $63.6 million in net proceeds through a public offering and a concurrent private placement in May 2023 - On May 8, 2023, the Company completed a public offering, selling 7,906,250 shares of common stock at $8.00 per share, generating approximately **$58.9 million in net proceeds**[48](index=48&type=chunk) - On May 9, 2023, the Company completed a concurrent private placement, selling 625,000 shares of common stock to Abingworth Bioventures 8 L.P. at $8.00 per share, generating approximately **$4.7 million in net proceeds**[49](index=49&type=chunk) [9. Stock-Based Compensation](index=14&type=section&id=9.%20Stock-Based%20Compensation) Stock-based compensation expense increased, driven by awards under the 2021 Equity Incentive Plan and a CEO performance award Shares Reserved for Future Issuance (as of Sep 30, 2023) | Shares Reserved for Future Issuance | Shares | | :--- | :--- | | Common stock options outstanding | 6,095,807 | | Unvested restricted stock units | 441,500 | | Available for future grants under the 2021 Equity Incentive Plan | 1,300,869 | | Available for future grants under the 2021 Employee Stock Purchase Plan | 546,341 | | Total shares of common stock reserved | 8,384,517 | Stock Option Activity (nine months ended Sep 30, 2023) | Stock Option Activity | Options Outstanding | Weighted Average Exercise Price | | :--- | :--- | :--- | | Outstanding at December 31, 2022 | 5,877,745 | $4.47 | | Granted | 548,915 | $6.88 | | Exercised | (149,190) | $2.15 | | Forfeited/Expired | (181,663) | $5.60 | | Outstanding at September 30, 2023 | 6,095,807 | $4.71 | | Vested at September 30, 2023 | 2,946,079 | $4.94 | | Exercisable at September 30, 2023 | 3,416,089 | $4.52 | - Unrecognized stock-based compensation expense at September 30, 2023, was **$9.5 million**, expected to be recognized over a weighted-average vesting term of 2.4 years[56](index=56&type=chunk) - The CEO's **$7.5 million Performance Award** resulted in **$1.0 million in compensation expense** for the nine months ended September 30, 2023, recognized in general and administrative expense[64](index=64&type=chunk)[65](index=65&type=chunk) Stock-Based Compensation Expense (in thousands) | Stock-Based Compensation Expense | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $537 | $411 | $1,504 | $1,184 | | General and administrative | $892 | $579 | $2,289 | $1,919 | | Total | $1,429 | $990 | $3,793 | $3,103 | [10. License Agreement](index=17&type=section&id=10.%20License%20Agreement) The company holds an exclusive worldwide license for mavodelpar from vTv Therapeutics, involving milestone and royalty payment obligations - In December 2017, the Company in-licensed mavodelpar (REN001) from vTv Therapeutics LLC, obtaining an **exclusive, worldwide license** for PPARδ agonists[25](index=25&type=chunk)[69](index=69&type=chunk) - The license agreement included an initial upfront fee of **$3.0 million** and the issuance of **576,443 shares** of common stock to vTv Therapeutics[69](index=69&type=chunk) - The Company is obligated to pay up to **$64.5 million in development and regulatory milestones** and up to **$30.0 million in sales-based milestones**, plus tiered royalty payments[70](index=70&type=chunk) [11. Subsequent Events](index=17&type=section&id=11.%20Subsequent%20Events) Post-quarter end, the company repurchased shares from vTv Therapeutics and established a new $100.0 million ATM equity offering facility - On October 30, 2023, the Company **repurchased 576,443 shares** of its common stock from vTv Therapeutics for approximately **$4.4 million** and subsequently retired them[71](index=71&type=chunk) - On November 13, 2023, the Company entered into a new At-The-Market (ATM) equity offering sales agreement to sell up to **$100.0 million** in common stock[72](index=72&type=chunk) - Concurrently, the 2022 ATM Facility with Leerink, under which **$1.2 million** in shares had been sold, was terminated[72](index=72&type=chunk)[73](index=73&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial results, highlighting increased net losses driven by higher R&D and G&A expenses, and addresses liquidity risks [Overview](index=19&type=section&id=Overview) - Reneo Pharmaceuticals is a clinical-stage company developing mavodelpar, a PPARδ agonist, for rare genetic mitochondrial diseases[77](index=77&type=chunk)[80](index=80&type=chunk) - Mavodelpar has received **orphan drug and Fast Track designations** in the U.S. and Europe for various indications[82](index=82&type=chunk) - The pivotal Phase 2b STRIDE study for PMM completed enrollment in March 2023, with **topline data expected in December 2023**[84](index=84&type=chunk)[87](index=87&type=chunk) [Components of Our Results of Operations](index=21&type=section&id=Components%20of%20Our%20Results%20of%20Operations) - **Research and development expenses are expected to increase substantially** due to advancing product candidates through clinical trials and regulatory processes[98](index=98&type=chunk) - **General and administrative expenses are expected to increase** to support corporate infrastructure growth and commercial development activities[102](index=102&type=chunk) Research and Development Expenses (in thousands) | Research and Development Expenses | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Clinical and regulatory | $7,373 | $5,555 | $20,408 | $14,143 | | Contract manufacturing cost | $2,609 | $2,469 | $7,761 | $6,802 | | Nonclinical | $632 | $577 | $3,719 | $3,060 | | Medical affairs | $2,217 | $193 | $4,883 | $409 | | Research and development-other expense | $791 | $1,144 | $2,238 | $2,934 | | Total | $13,622 | $9,938 | $39,009 | $27,348 | [Results of Operations](index=23&type=section&id=Results%20of%20Operations) Comparison of Three Months Ended September 30, 2023 and 2022 | (in thousands) | Sep 30, 2023 | Sep 30, 2022 | Change | | :--- | :--- | :--- | :--- | | Research and development | $13,622 | $9,938 | $3,684 | | General and administrative | $7,266 | $3,902 | $3,364 | | Total operating expenses | $20,888 | $13,840 | $7,048 | | Loss from operations | $(20,888) | $(13,840) | $(7,048) | | Other income | $1,692 | $833 | $859 | | Net loss | $(19,196) | $(13,007) | $(6,189) | - **Research and development expenses increased by $3.7 million** for the three months ended September 30, 2023, due to increased clinical development and medical affairs costs[105](index=105&type=chunk) - **General and administrative expenses increased by $3.4 million** for the three months ended September 30, 2023, due to commercial development and personnel costs[107](index=107&type=chunk) Comparison of Nine Months Ended September 30, 2023 and 2022 | (in thousands) | Sep 30, 2023 | Sep 30, 2022 | Change | | :--- | :--- | :--- | :--- | | Research and development | $39,009 | $27,348 | $11,661 | | General and administrative | $19,038 | $11,938 | $7,100 | | Total operating expenses | $58,047 | $39,286 | $18,761 | | Loss from operations | $(58,047) | $(39,286) | $(18,761) | | Other income | $4,213 | $931 | $3,282 | | Net loss | $(53,834) | $(38,355) | $(15,479) | - **Research and development expenses increased by $11.7 million** for the nine months ended September 30, 2023, driven by clinical development and medical affairs costs[110](index=110&type=chunk) - **General and administrative expenses increased by $7.1 million** for the nine months ended September 30, 2023, due to commercial development and personnel costs[111](index=111&type=chunk) - **Other income increased** for both periods due to higher interest rates and increased short-term investment balances[108](index=108&type=chunk)[112](index=112&type=chunk) [Liquidity and Capital Resources](index=25&type=section&id=Liquidity%20and%20Capital%20Resources) - As of September 30, 2023, the company had **$125.6 million in cash, cash equivalents, and short-term investments**[113](index=113&type=chunk) - Current funds are not sufficient for more than one year, raising **substantial doubt about its ability to continue as a going concern**[121](index=121&type=chunk)[122](index=122&type=chunk) - Financing activities provided **$65.0 million in cash** for the nine months ended September 30, 2023, primarily from a public offering and private placement[128](index=128&type=chunk) Cash Flows (in thousands) | Cash Flows | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(43,929) | $(31,749) | | Net cash used in investing activities | $(29,254) | $(30,925) | | Net cash provided by financing activities | $64,993 | $146 | | Net decrease in cash and cash equivalents | $(8,190) | $(62,528) | [Critical Accounting Policies and Estimates](index=27&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) - The company's critical accounting policies and estimates remain **consistent with those in its 2022 Annual Report**, with no material changes[134](index=134&type=chunk) [Recent Accounting Pronouncements](index=28&type=section&id=Recent%20Accounting%20Pronouncements) - Refer to Note 2 of the Notes to Consolidated Financial Statements for a description of recent accounting pronouncements[135](index=135&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section is not required for smaller reporting companies, and thus no disclosures about market risk are provided - Quantitative and Qualitative Disclosures about Market Risk are **not required for smaller reporting companies**[136](index=136&type=chunk) [Item 4. Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of September 30, 2023 [Evaluation of Disclosure Controls and Procedures](index=28&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) - Management concluded that **disclosure controls and procedures were effective** as of September 30, 2023[137](index=137&type=chunk) [Changes in Internal Control over Financial Reporting](index=28&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) - There were **no material changes** in internal control over financial reporting during the quarter ended September 30, 2023[138](index=138&type=chunk) Part II — Other Information [Item 1. Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings - The Company is **not currently a party to any material legal proceedings**[140](index=140&type=chunk) [Item 1A. Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) The company faces numerous risks including ongoing losses, going concern doubt, and dependence on its sole product candidate, mavodelpar [Risks Related to Our Business and Industry](index=29&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Industry) - The company has incurred **significant net losses** since inception and anticipates continued losses, raising **substantial doubt about its ability to continue as a going concern**[150](index=150&type=chunk)[151](index=151&type=chunk)[153](index=153&type=chunk) - **Substantial additional capital is required** to develop and commercialize mavodelpar; failure to secure financing may force delays[154](index=154&type=chunk)[157](index=157&type=chunk)[163](index=163&type=chunk) - The company is **entirely dependent on the success of mavodelpar**, its only product candidate[164](index=164&type=chunk)[166](index=166&type=chunk)[167](index=167&type=chunk) - **Clinical trials may fail** to adequately demonstrate mavodelpar's safety and efficacy, potentially preventing or delaying regulatory approval[168](index=168&type=chunk)[171](index=171&type=chunk)[172](index=172&type=chunk) - The **regulatory approval process is lengthy, expensive, and uncertain**, and denial or delay would adversely impact revenue generation[188](index=188&type=chunk)[190](index=190&type=chunk)[193](index=193&type=chunk) - The **COVID-19 pandemic** has adversely affected and could continue to affect operations and clinical trials[195](index=195&type=chunk)[197](index=197&type=chunk)[198](index=198&type=chunk) - Mavodelpar **may not gain market acceptance** among physicians, patients, and healthcare payors, even if approved[222](index=222&type=chunk)[225](index=225&type=chunk) - The company faces **significant competition** from other biotechnology and pharmaceutical companies with greater resources[248](index=248&type=chunk)[250](index=250&type=chunk)[253](index=253&type=chunk) [Risks Related to Our Reliance on Third Parties](index=62&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) - The company's business is **dependent on the vTv License Agreement**; its termination would result in the loss of significant rights[305](index=305&type=chunk)[307](index=307&type=chunk) - **Reliance on third-party Contract Research Organizations (CROs)** for clinical trials poses risks if they fail to meet contractual duties[308](index=308&type=chunk)[309](index=309&type=chunk)[310](index=310&type=chunk) - **Complete reliance on third parties for manufacturing** carries risks of failure to obtain regulatory approval for facilities or insufficient quantities[313](index=313&type=chunk)[314](index=314&type=chunk)[315](index=315&type=chunk)[316](index=316&type=chunk) [Risks Related to Our Intellectual Property](index=65&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) - Commercial success depends on **obtaining and maintaining sufficient intellectual property protection** for mavodelpar[319](index=319&type=chunk)[320](index=320&type=chunk)[321](index=321&type=chunk)[322](index=322&type=chunk) - **Patent applications may not result in issued patents**, and existing patents may be challenged, invalidated, or rendered unenforceable[324](index=324&type=chunk)[325](index=325&type=chunk)[326](index=326&type=chunk) - **Patent terms may be inadequate** to protect product candidates for a sufficient time, leading to earlier competition from generic products[331](index=331&type=chunk)[333](index=333&type=chunk)[335](index=335&type=chunk) - **Protecting intellectual property rights globally is challenging** due to differing laws and enforcement[363](index=363&type=chunk)[364](index=364&type=chunk)[365](index=365&type=chunk)[366](index=366&type=chunk) - **Third-party claims alleging intellectual property infringement** could prevent or delay drug development and incur substantial damages[396](index=396&type=chunk)[397](index=397&type=chunk)[399](index=399&type=chunk)[401](index=401&type=chunk)[410](index=410&type=chunk)[412](index=412&type=chunk) - **Inability to protect the confidentiality of trade secrets** would harm the business and competitive position[425](index=425&type=chunk)[427](index=427&type=chunk)[428](index=428&type=chunk) [Risks Related to Ownership of Our Common Stock](index=89&type=section&id=Risks%20Related%20to%20Ownership%20of%20Our%20Common%20Stock) - The **trading price of the common stock is likely to be highly volatile**, and investors could lose all or part of their investment[439](index=439&type=chunk)[441](index=441&type=chunk) - **Principal stockholders and management own a significant percentage** of the stock, enabling them to exert substantial control[444](index=444&type=chunk) - **Future sales and issuances of common stock** could result in additional dilution for existing stockholders and cause the stock price to fall[445](index=445&type=chunk)[459](index=459&type=chunk)[460](index=460&type=chunk) - As an emerging growth company, **reduced reporting requirements may make the common stock less attractive** to investors[446](index=446&type=chunk)[449](index=449&type=chunk) [General Risk Factors](index=96&type=section&id=General%20Risk%20Factors) - The company is subject to U.S. and foreign **export/import controls, sanctions, and anti-corruption laws**[470](index=470&type=chunk)[471](index=471&type=chunk) - **Business disruptions** from natural disasters, epidemics, or man-made events could seriously harm future revenues[472](index=472&type=chunk)[473](index=473&type=chunk) - **Compromised information technology systems** due to cyberattacks could lead to regulatory actions, litigation, and reputational harm[474](index=474&type=chunk)[476](index=476&type=chunk)[477](index=477&type=chunk)[478](index=478&type=chunk)[481](index=481&type=chunk)[482](index=482&type=chunk)[486](index=486&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=99&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company repurchased shares from vTv Therapeutics and details the use of proceeds from its 2021 IPO [Unregistered Sales of Equity Securities](index=99&type=section&id=Unregistered%20Sales%20of%20Equity%20Securities) - There were **no unregistered sales of equity securities** during the period[491](index=491&type=chunk) [Issuer Purchases of Equity Securities](index=99&type=section&id=Issuer%20Purchases%20of%20Equity%20Securities) - On October 30, 2023, the Company **repurchased 576,443 shares** of its common stock from vTv Therapeutics for approximately **$4.4 million**[492](index=492&type=chunk) [Use of Proceeds](index=99&type=section&id=Use%20of%20Proceeds) - The company received **net proceeds of $84.6 million** from its April 2021 IPO[493](index=493&type=chunk) - As of September 30, 2023, approximately **$23.8 million of the IPO net proceeds have been used**[494](index=494&type=chunk) - Remaining IPO proceeds are allocated to fund **continued research and development of mavodelpar** and for general purposes[495](index=495&type=chunk) [Item 3. Defaults Upon Senior Securities](index=100&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities during the period - There were **no defaults upon senior securities**[496](index=496&type=chunk) [Item 4. Mine Safety Disclosures](index=100&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) The company reported no mine safety disclosures - There were **no mine safety disclosures**[497](index=497&type=chunk) [Item 5. Other Information](index=100&type=section&id=Item%205.%20Other%20Information) The company established a new $100.0 million At-The-Market equity offering facility and terminated a prior agreement [Entry into New Sales Agreement](index=100&type=section&id=Entry%20into%20New%20Sales%20Agreement) - On November 13, 2023, the Company entered into a new At-The-Market (ATM) equity offering sales agreement, allowing it to sell up to **$100.0 million** in common stock[498](index=498&type=chunk) [Termination of Prior Sales Agreement](index=100&type=section&id=Termination%20of%20Prior%20Sales%20Agreement) - On November 13, 2023, the prior 2022 ATM Facility, under which **$1.2 million** in shares had been sold, was terminated[500](index=500&type=chunk) [Item 6. Exhibits](index=101&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of the Quarterly Report on Form 10-Q - The exhibit index includes corporate documents, legal opinions, sales agreements, and **Sarbanes-Oxley Act certifications**[502](index=502&type=chunk) [Signatures](index=102&type=section&id=Signatures) The report is duly signed by the principal executive and financial officers on November 13, 2023 - The report is signed by Gregory J. Flesher, President and Chief Executive Officer, and Jennifer P. Lam, Senior Vice President, Finance and Administration[506](index=506&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40315 Reneo Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 47-2309515 (State or other jur ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40315 Reneo Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 47-2309515 (State or other ju ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For The Transition Period From To Commission file number: 001-40315 RENEO PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 47-2309515 (Stat ...

Focused on Improving the Lives of Patients with Rare Genetic Mitochondrial Diseases Nasdaq: RPHM November 2022 Forward-Looking Statements 2 This presentation contains "forward-looking" statements that are based on our management's beliefs and assumptions and on information currently available to management. Forward-looking statements include all statements other than statements of historical fact contained in this presentation, including information concerning our business strategy, objectives and opportuni ...