Financial Performance - Reneo Pharmaceuticals reported net losses of $38.4 million and $29.2 million for the nine months ended September 30, 2022, and 2021, respectively, with an accumulated deficit of $123.1 million as of September 30, 2022[92]. - The net loss for the nine months ended September 30, 2022, was $38.4 million, compared to a net loss of $29.2 million for the same period in 2021, indicating a deterioration of $9.2 million[112]. - The company has incurred significant operating losses since inception, with no product candidates approved for sale and no revenue generated from product sales[92]. - The company has not generated any revenue from product sales and does not expect to do so in the foreseeable future[116]. - Net cash used in operating activities for the nine months ended September 30, 2022, was $31.7 million, compared to $28.0 million for the same period in 2021[119]. Cash and Funding - The company has cash, cash equivalents, and short-term investments of $116.1 million, which are expected to fund operations into 2024[96]. - As of September 30, 2022, the company had $116.1 million in cash, cash equivalents, and short-term investments, expected to fund operations into 2024[125]. - Reneo entered into an at-the-market equity offering sales agreement to sell up to $20.0 million in shares of common stock, but has not yet sold any shares under this facility[93]. - The company plans to raise additional capital through various means, including public or private equity offerings, to support ongoing operations and product development[123]. Research and Development - REN001, the lead product candidate, showed an average increase of 104.4 meters in the 12-minute walk test and a 1.7 mL/kg/min increase in weight-adjusted peak oxygen consumption in PMM patients[89]. - The ongoing pivotal Phase 2b study of REN001 in adult PMM patients has achieved over 80% enrollment, with completion expected in Q1 2023 and topline results anticipated in Q4 2023[90]. - The Phase 1b study of REN001 in LC-FAOD patients showed significant improvements, with the LCHAD and CPT2 groups experiencing increases of 73.7 and 51.9 meters in the 12-minute walk test, respectively[91]. - The company anticipates substantial increases in research and development expenses as it advances product candidates through clinical trials and regulatory approvals[102]. - Research and development expenses for Q3 2022 were $9.9 million, an increase of $0.6 million from $9.3 million in Q3 2021, primarily due to a $1.4 million rise in clinical study and manufacturing costs[109]. Operating Expenses - General and administrative expenses for Q3 2022 were $3.9 million, up from $3.4 million in Q3 2021, reflecting increased costs associated with operating as a public company[110]. - Total operating expenses for the nine months ended September 30, 2022, were $39.3 million, compared to $29.2 million for the same period in 2021, representing an increase of $10.1 million[112]. - The company expects to continue incurring net operating losses for at least the next several years as it conducts ongoing and planned clinical trials[94]. Market Need and Designations - There are currently no approved therapies for PMM, with over 66,000 patients in the U.S. and 82,000 in Europe, indicating a high unmet medical need[87]. - Reneo has received orphan drug designation from the FDA for REN001 for PMM and LC-FAOD, as well as Fast Track designation for PMM in the U.S.[88]. Accounting Policies - The preparation of consolidated financial statements requires estimates and judgments affecting reported amounts of assets, liabilities, and expenses[130]. - There were no material changes to critical accounting policies during the nine months ended September 30, 2022, compared to the previous year[132]. - The company bases its estimates on historical experience, known trends, and various other factors deemed reasonable under the circumstances[131]. Other Income - The increase in other income for Q3 2022 was due to higher interest rates earned on short-term investments, rising to $833,000 from $17,000 in Q3 2021[111].

Focused on Improving the Lives of Patients with Rare Genetic Mitochondrial Diseases Nasdaq: RPHM September 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 opportun ...

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, 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 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the ...

Table of Contents 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, 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 ...

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, 2021 RENEO PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 47-2309515 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 18575 Jamboree Road, Suite 275-S, Irvine CA 92612 (Address of princ ...

```markdown [PART I — FINANCIAL INFORMATION](index=3&type=section&id=Part%20I%20%E2%80%94FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) Presents Reneo Pharmaceuticals' unaudited condensed consolidated financial statements and related notes [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20as%20of%20September%2030,%202021%20(Unaudited)%20and%20December%2031,%202020) Total Assets (in thousands) | Date | Amount | | :--- | :--- | | September 30, 2021 | $162,943 | | December 31, 2020 | $55,221 | Cash and Cash Equivalents (in thousands) | Date | Amount | | :--- | :--- | | September 30, 2021 | $126,409 | | December 31, 2020 | $53,613 | Short-term Investments (in thousands) | Date | Amount | | :--- | :--- | | September 30, 2021 | $31,325 | | December 31, 2020 | $0 | Total Stockholders' Equity (Deficit) (in thousands) | Date | Amount | | :--- | :--- | | September 30, 2021 | $156,208 | | December 31, 2020 | $(42,115) | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20for%20the%20three%20and%20nine%20months%20ended%20September%2030,%202021%20and%202020%20(Unaudited)) Net Loss (in thousands) | Period | 2021 | 2020 | Change (YoY) | | :--- | :--- | :--- | :--- | | Three Months Ended Sep 30 | $(12,735) | $(5,094) | $(7,641) | | Nine Months Ended Sep 30 | $(29,163) | $(13,212) | $(15,951) | Research and Development Expenses (in thousands) | Period | 2021 | 2020 | Change (YoY) | | :--- | :--- | :--- | :--- | | Three Months Ended Sep 30 | $9,318 | $4,431 | $4,887 | | Nine Months Ended Sep 30 | $21,069 | $10,826 | $10,243 | General and Administrative Expenses (in thousands) | Period | 2021 | 2020 | Change (YoY) | | :--- | :--- | :--- | :--- | | Three Months Ended Sep 30 | $3,434 | $668 | $2,766 | | Nine Months Ended Sep 30 | $8,125 | $2,475 | $5,650 | Net Loss per Share (Basic and Diluted) | Period | 2021 | 2020 | | :--- | :--- | | Three Months Ended Sep 30 | $(0.52) | $(2.48) | | Nine Months Ended Sep 30 | $(1.82) | $(6.54) | [Condensed Consolidated Statements of Changes in Convertible Preferred Stock and Stockholders' Equity (Deficit)](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Convertible%20Preferred%20Stock%20and%20Stockholders'%20Equity%20(Deficit)%20for%20the%20three%20and%20nine%20months%20ended%20September%2030,%202021%20and%202020%20(Unaudited)) - All Series A and Series B convertible preferred stock were converted into **15,907,629 shares** of common stock upon the IPO in April 2021[18](index=18&type=chunk) - Issuance of **6,250,000 shares** of common stock in the public offering resulted in **$84,532 thousand** in additional paid-in capital, net of offering costs[18](index=18&type=chunk) Total Stockholders' Equity (Deficit) (in thousands) | Date | Amount | | :--- | :--- | | September 30, 2021 | $156,208 | | December 31, 2020 | $(42,115) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20nine%20months%20ended%20September%2030,%202021%20and%202020%20(Unaudited)) Net Cash Used in Operating Activities (in thousands) | Period | 2021 | 2020 | | :--- | :--- | :--- | | Nine Months Ended Sep 30 | $(27,962) | $(13,125) | Net Cash (Used in) Provided by Investing Activities (in thousands) | Period | 2021 | 2020 | | :--- | :--- | :--- | | Nine Months Ended Sep 30 | $(31,529) | $7,392 | Net Cash Provided by Financing Activities (in thousands) | Period | 2021 | 2020 | | :--- | :--- | :--- | | Nine Months Ended Sep 30 | $132,287 | $77 | Net Increase (Decrease) in Cash and Cash Equivalents (in thousands) | Period | 2021 | 2020 | | :--- | :--- | :--- | | Nine Months Ended Sep 30 | $72,796 | $(5,656) | Cash and Cash Equivalents, End of Period (in thousands) | Date | Amount | | :--- | :--- | | September 30, 2021 | $126,409 | | September 30, 2020 | $11,845 | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) [1. Organization and Business](index=8&type=section&id=1.%20Organization%20and%20Business) - Reneo Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company focused on developing therapies for rare genetic mitochondrial diseases, with **REN001** as its lead product candidate[26](index=26&type=chunk) - The company effected a **1-for-4.4748 reverse stock split** of its common stock on April 5, 2021[27](index=27&type=chunk) - An Initial Public Offering (IPO) was completed on **April 13, 2021**, issuing **6,250,000 shares** at **$15.00 per share** for gross proceeds of approximately **$93.8 million**. All outstanding convertible preferred stock converted into **15,907,629 shares** of common stock at the IPO closing[28](index=28&type=chunk)[29](index=29&type=chunk) - As of **September 30, 2021**, the company had **$157.7 million** in cash, cash equivalents, and short-term investments, and an accumulated deficit of **$74.1 million**. Management believes these funds are sufficient to fund operations for at least **one year**[30](index=30&type=chunk)[35](index=35&type=chunk) [2. Summary of Significant Accounting Policies](index=9&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) - Unaudited condensed consolidated financial statements are prepared in accordance with U.S. GAAP for interim information and include Reneo Pharmaceuticals, Inc. and its UK subsidiary[36](index=36&type=chunk)[37](index=37&type=chunk) - Short-term investments are classified as available-for-sale securities and carried at fair value, with unrealized gains and losses reported in accumulated other comprehensive income[46](index=46&type=chunk) - Research and development costs are expensed as incurred, including manufacturing, preclinical/clinical trials, license fees, and salaries[53](index=53&type=chunk) - All convertible preferred stock was converted to common stock in connection with the IPO in April 2021[52](index=52&type=chunk) - The company is evaluating the impact of new accounting pronouncements: ASU 2019-12 (Income Taxes) effective **Jan 1, 2022**; ASU 2016-13 (Credit Losses) effective **Jan 1, 2023** (no material impact expected); and ASU 2016-02 (Leases) effective **Jan 1, 2022** (expects recording of right-of-use asset and lease liability)[63](index=63&type=chunk)[64](index=64&type=chunk)[66](index=66&type=chunk) [3. Fair Value Measurements](index=13&type=section&id=3.%20Fair%20Value%20Measurements) - The company uses a three-tier fair value hierarchy: **Level 1** for money market investments, **Level 2** for commercial paper, and **Level 3** for the CEO's performance award[68](index=68&type=chunk)[69](index=69&type=chunk)[71](index=71&type=chunk)[72](index=72&type=chunk) Assets Measured at Fair Value (September 30, 2021, in thousands) | Asset | Level 1 | Level 2 | Level 3 | Total | | :--- | :--- | :--- | :--- | :--- | | Money market investments | $124,010 | $— | $— | $124,010 | | Commercial paper | $— | $31,325 | $— | $31,325 | | **Total Assets** | **$124,010** | **$31,325** | **$—** | **$155,335** | Liabilities Measured at Fair Value (September 30, 2021, in thousands) | Liability | Level 1 | Level 2 | Level 3 | Total | | :--- | :--- | :--- | :--- | :--- | | Performance award | $— | $— | $284 | $284 | | **Total Liabilities** | **$—** | **$—** | **$284** | **$284** | Performance Award Fair Value Change (in thousands) | Item | Amount | | :--- | :--- | | Balance as of January 1, 2021 | $— | | Expense recorded upon consummation of the IPO | $590 | | Change in fair value | $(306) | | Balance as of September 30, 2021 | $284 | [4. Property and Equipment, Net](index=14&type=section&id=4.%20Property%20and%20Equipment,%20Net) Total Property and Equipment, Net (in thousands) | Date | Amount | | :--- | :--- | | September 30, 2021 | $200 | | December 31, 2020 | $69 | Depreciation and Amortization Expense (in thousands) | Period | 2021 | 2020 | | :--- | :--- | :--- | | Three Months Ended Sep 30 | $13 | $9 | | Nine Months Ended Sep 30 | $33 | $27 | [5. Accrued Expenses](index=15&type=section&id=5.%20Accrued%20Expenses) Total Accrued Expenses (in thousands) | Date | Amount | | :--- | :--- | | September 30, 2021 | $5,082 | | December 31, 2020 | $3,672 | Breakdown of Accrued Expenses (in thousands) | Category | Sep 30, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | Accrued contract manufacturing expenses | $1,563 | $1,389 | | Accrued clinical expenses | $1,467 | $1,019 | | Accrued compensation | $1,366 | $888 | | Other accrued expenses | $686 | $376 | [6. Convertible Preferred Stock and Stockholders' Equity (Deficit)](index=15&type=section&id=6.%20Convertible%20Preferred%20Stock%20and%20Stockholders'%20Equity%20(Deficit)) - All **24,302,472 shares** of Series A convertible preferred stock were converted into **5,430,957 shares** of common stock upon the IPO in April 2021[77](index=77&type=chunk) - Series B convertible preferred stock: **23,440,514 shares** issued in December 2020 for **$47.4 million** gross proceeds, and another **23,440,514 shares** issued in March 2021 for **$47.4 million** net proceeds. All outstanding shares converted into **10,476,672 shares** of common stock upon the IPO[78](index=78&type=chunk)[79](index=79&type=chunk)[80](index=80&type=chunk) Shares Reserved for Future Issuance (September 30, 2021) | Item | Shares Reserved | | :--- | :--- | | Common stock options outstanding | 3,215,904 | | Available for future grants under the 2021 Equity Incentive Plan | 2,061,163 | | Available for future grants under the 2021 Employee Stock Purchase Plan | 243,058 | | **Total shares of common stock reserved** | **5,520,125** | [7. Stock-Based Compensation](index=16&type=section&id=7.%20Stock-Based%20Compensation) - The company adopted the 2021 Equity Incentive Plan and 2021 Employee Stock Purchase Plan in March 2021, effective prior to the IPO, reserving shares for future grants[85](index=85&type=chunk)[86](index=86&type=chunk) Stock Option Activity (Nine Months Ended September 30, 2021) | Item | Options Outstanding | Weighted-Average Exercise Price | | :--- | :--- | :--- | | Outstanding at December 31, 2020 | 935,478 | $2.56 | | Granted | 2,487,285 | $5.59 | | Exercised | (206,859) | $1.97 | | Outstanding at September 30, 2021 | 3,215,904 | $4.95 | Non-cash Stock-Based Compensation Expense (in thousands) | Period | 2021 | 2020 | | :--- | :--- | :--- | | Three Months Ended Sep 30 | $1,145 | $84 | | Nine Months Ended Sep 30 | $2,470 | $264 | - A **$7.5 million Performance Award** for the CEO, classified as a liability, resulted in a **$0.3 million expense** for the nine months ended September 30, 2021[94](index=94&type=chunk) [8. License Agreement](index=19&type=section&id=8.%20License%20Agreement) - In **December 2017**, Reneo entered into an exclusive, worldwide license agreement with vTv Therapeutics for PPARδ agonists, including **REN001**[97](index=97&type=chunk) - The agreement included an upfront payment of **$3.0 million cash** and **309,576 shares** of common stock, expensed as research and development costs[97](index=97&type=chunk) - Potential milestone payments total up to **$64.5 million** for development/regulatory achievements and **$30.0 million** for sales-based milestones, plus tiered royalties[98](index=98&type=chunk) - A **$2.0 million milestone payment** was made and expensed in July 2021[99](index=99&type=chunk) [9. Commitments and Contingencies](index=19&type=section&id=9.%20Commitments%20and%20Contingencies) - The company has non-cancelable operating leases for office space in San Diego (through **July 2023**) and Irvine, California (through **November 2026**), with total minimum lease payments of **$1.6 million** for the Irvine lease[100](index=100&type=chunk)[101](index=101&type=chunk)[159](index=159&type=chunk) Rent Expense (in thousands) | Period | U.S. 2021 | U.S. 2020 | UK 2021 | UK 2020 | | :--- | :--- | :--- | :--- | :--- | | Three Months Ended Sep 30 | $117 | $46 | $6 | $7 | | Nine Months Ended Sep 30 | $233 | $138 | $20 | $19 | - The company is not currently a party to any **material legal proceedings**[105](index=105&type=chunk)[171](index=171&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Reneo Pharmaceuticals' financial condition, operational results, clinical trials, IPO impact, and capital needs [Forward-Looking Statements](index=20&type=section&id=Forward-Looking%20Statements) - This discussion contains forward-looking statements based on current expectations, which involve risks and uncertainties[107](index=107&type=chunk) - Actual results could differ materially from anticipated outcomes due to various factors, including those detailed in the 'Risk Factors' section[107](index=107&type=chunk) - Investors are cautioned not to unduly rely on these statements due to their inherent uncertainty[108](index=108&type=chunk) [Overview](index=20&type=section&id=Overview) - Reneo Pharmaceuticals is a clinical-stage company developing **REN001**, a PPARδ agonist, for rare genetic mitochondrial diseases such as primary mitochondrial myopathies (PMM), long-chain fatty acid oxidation disorders (LC-FAOD), and McArdle disease[109](index=109&type=chunk)[113](index=113&type=chunk) - The company initiated the STRIDE study, a global Phase 2b clinical trial of **REN001** in PMM patients, with topline results expected in **2023**. Enrollment for exploratory Phase 1b trials in McArdle disease and LC-FAOD has been completed, with results expected in **Q1** and **Q2 2022**, respectively[115](index=115&type=chunk)[116](index=116&type=chunk) - As of **September 30, 2021**, the company had **$157.7 million** in cash, cash equivalents, and short-term investments, and an accumulated deficit of **$74.1 million**. Management believes these funds are sufficient to fund operations for at least **one year**[118](index=118&type=chunk) - The company expects to continue incurring net operating losses and increasing expenses for research and development, general and administrative activities, and capital expenditures, necessitating additional capital raises[120](index=120&type=chunk)[121](index=121&type=chunk) [COVID-19](index=22&type=section&id=COVID-19) - The COVID-19 pandemic has adversely affected and could continue to affect the company's business, operations, and clinical development timelines, including early closure of a Phase 1b trial and temporary pauses in enrollment for other trials[123](index=123&type=chunk)[226](index=226&type=chunk) - Potential future impacts include delays in patient enrollment, clinical site operations, regulatory reviews, and supply chain disruptions[123](index=123&type=chunk)[223](index=223&type=chunk)[226](index=226&type=chunk)[228](index=228&type=chunk)[230](index=230&type=chunk) - The ultimate economic impact and duration of the pandemic remain uncertain, potentially affecting the company's ability to access capital[232](index=232&type=chunk)[233](index=233&type=chunk) [License Agreement](index=22&type=section&id=License%20Agreement) - Reneo entered into an exclusive, worldwide license agreement with vTv Therapeutics in **December 2017** for PPARδ agonists, including **REN001**[124](index=124&type=chunk)[126](index=126&type=chunk) - The agreement includes an upfront payment of **$3.0 million cash** and common stock, potential development and regulatory milestone payments up to **$64.5 million**, sales-based milestones up to **$30.0 million**, and tiered royalty payments[126](index=126&type=chunk) - A **$2.0 million milestone payment** was made to vTv Therapeutics in July 2021[126](index=126&type=chunk) [Components of Our Results of Operations](index=23&type=section&id=Components%20of%20Our%20Results%20of%20Operations) [Research and Development Expenses](index=23&type=section&id=Research%20and%20Development%20Expenses) - Research and development expenses are recognized as incurred and include personnel, contract research organizations (CROs), manufacturing, preclinical/clinical trials, regulatory activities, and license fees[127](index=127&type=chunk)[128](index=128&type=chunk) - R&D expenses are expected to increase substantially due to advancing product candidates through clinical trials, preclinical studies, and regulatory approval[129](index=129&type=chunk) - Factors influencing R&D costs include the scope, progress, results, and costs of clinical trials, per patient trial costs, number of trials/sites/patients, patient enrollment uncertainties (including COVID-19 impact), safety monitoring, manufacturing costs, strategic collaborations, and intellectual property costs[133](index=133&type=chunk) [General and Administrative Expenses](index=24&type=section&id=General%20and%20Administrative%20Expenses) - General and administrative expenses primarily consist of personnel costs (salaries, benefits, stock-based compensation) for executive, finance, accounting, compliance, and human resource functions[130](index=130&type=chunk) - These expenses also include corporate facility costs, legal fees, insurance costs, and fees for accounting and consulting services[130](index=130&type=chunk) - General and administrative expenses are expected to increase significantly to support continued research and development activities and public company operations[131](index=131&type=chunk) [Other Income](index=24&type=section&id=Other%20Income) - Other income consists of interest income on the company's cash, cash equivalents, and short-term investments[132](index=132&type=chunk) [Results of Operations](index=25&type=section&id=Results%20of%20Operations) [Comparison of Three and Nine Months Ended September 30, 2021 and 2020](index=25&type=section&id=Comparison%20of%20Three%20and%20Nine%20Months%20Ended%20September%2030,%202021%20and%202020) Total Operating Expenses (in thousands) | Period | 2021 | 2020 | Change | | :--- | :--- | :--- | :--- | | Three Months Ended Sep 30 | $12,752 | $5,099 | $7,653 | | Nine Months Ended Sep 30 | $29,194 | $13,301 | $15,893 | Net Loss (in thousands) | Period | 2021 | 2020 | Change | | :--- | :--- | :--- | :--- | | Three Months Ended Sep 30 | $(12,735) | $(5,094) | $(7,641) | | Nine Months Ended Sep 30 | $(29,163) | $(13,212) | $(15,951) | [Research and Development Expenses](index=25&type=section&id=Research%20and%20Development%20Expenses_2) - Research and development expenses increased by **$4.9 million** to **$9.3 million** for the three months ended September 30, 2021, and by **$10.3 million** to **$21.1 million** for the nine months ended September 30, 2021, compared to the same periods in 2020[135](index=135&type=chunk)[136](index=136&type=chunk) - The increase was primarily due to higher clinical trial and manufacturing costs for the STRIDE and FORWARD studies, restart of Phase 1b clinical trials, increased licensing costs (**$2.0 million**), and higher employee-related costs[135](index=135&type=chunk)[136](index=136&type=chunk) - A **$1.5 million tax rebate** from the UK government in 2020 contributed to the year-over-year difference for the nine-month period[136](index=136&type=chunk) [General and Administrative Expenses](index=25&type=section&id=General%20and%20Administrative%20Expenses_2) - General and administrative expenses increased by **$2.7 million** to **$3.4 million** for the three months ended September 30, 2021, and by **$5.6 million** to **$8.1 million** for the nine months ended September 30, 2021, compared to the same periods in 2020[137](index=137&type=chunk)[138](index=138&type=chunk) - This increase was mainly driven by higher employee and personnel-related expenses (including stock-based compensation), increased directors and officers insurance premiums post-IPO, and higher outside professional services[137](index=137&type=chunk)[138](index=138&type=chunk) [Other Income](index=26&type=section&id=Other%20Income_2) - Other income for the three months ended September 30, 2021, was **$17 thousand**, up from **$5 thousand** in 2020[140](index=140&type=chunk) - For the nine months ended September 30, 2021, other income decreased by **$57 thousand** to **$31 thousand**, from **$88 thousand** in 2020, primarily due to lower interest income from declining federal funds rates despite increased cash balances[141](index=141&type=chunk) [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) [Overview](index=26&type=section&id=Overview_2) - The company has incurred operating losses and negative cash flows, with an accumulated deficit of **$74.1 million** as of **September 30, 2021**[142](index=142&type=chunk) - Net proceeds from the April 2021 IPO were **$84.6 million**, contributing to **$157.7 million** in cash, cash equivalents, and short-term investments as of **September 30, 2021**[145](index=145&type=chunk)[146](index=146&type=chunk) - Management believes current funds are sufficient to fund operations through planned near-term clinical milestones, but anticipates continued net losses and the need for additional capital[143](index=143&type=chunk)[146](index=146&type=chunk) [Cash Flows](index=26&type=section&id=Cash%20Flows) Cash Flow Summary (Nine Months Ended September 30, in thousands) | Activity | 2021 | 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(27,962) | $(13,125) | | Net cash (used in) provided by investing activities | $(31,529) | $7,392 | | Net cash provided by financing activities | $132,287 | $77 | | Net increase (decrease) in cash and cash equivalents | $72,796 | $(5,656) | - Net cash used in operating activities increased due to higher net loss. Investing activities shifted to a net use due to purchases of available-for-sale short-term investments[147](index=147&type=chunk)[148](index=148&type=chunk)[150](index=150&type=chunk) - Net cash provided by financing activities significantly increased due to proceeds from the IPO (**$84.6 million net**) and issuance of Series B convertible preferred stock (**$47.2 million**)[151](index=151&type=chunk) [Funding Requirements](index=27&type=section&id=Funding%20Requirements) - The company will require **significant additional capital** for **REN001** development, regulatory approval, and commercialization, as it currently generates no product sales revenue[153](index=153&type=chunk) - Future capital requirements depend on factors such as clinical trial progress, manufacturing costs, regulatory outcomes, milestone payments, intellectual property costs, and market acceptance[155](index=155&type=chunk) - Funding may be sought through equity or debt financings, collaborations, or licensing arrangements, which could lead to dilution for stockholders or restrictive covenants[154](index=154&type=chunk)[157](index=157&type=chunk)[158](index=158&type=chunk) [Contractual Obligations & Commitments](index=28&type=section&id=Contractual%20Obligations%20%26%20Commitments) - No material changes to contractual obligations were reported during the nine months ended September 30, 2021, except for a new operating lease for U.S. headquarters in Irvine, California[159](index=159&type=chunk) - The Irvine lease has terms through **November 2026**, with total minimum lease payments of **$1.6 million**[159](index=159&type=chunk) [Off-Balance Sheet Arrangements](index=28&type=section&id=Off-Balance%20Sheet%20Arrangements) - The company did not have any off-balance sheet arrangements during the periods presented[160](index=160&type=chunk) [Critical Accounting Policies and Estimates](index=28&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) - The company's financial statements are based on estimates and judgments that affect reported amounts of assets, liabilities, and expenses[162](index=162&type=chunk) - No material changes to critical accounting policies were reported during the three months ended September 30, 2021, from those discussed in the Prospectus[163](index=163&type=chunk) [Recent Accounting Pronouncements](index=29&type=section&id=Recent%20Accounting%20Pronouncements) - Refer to Note 2 of the condensed consolidated financial statements for a description of recent accounting pronouncements applicable to the company[164](index=164&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This item is not required for smaller reporting companies, and therefore, no quantitative or qualitative disclosures about market risk are provided - This item is not required for smaller reporting companies[165](index=165&type=chunk) [Item 4. Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the principal executive and financial officers, evaluated the company's disclosure controls and procedures and concluded they were effective as of September 30, 2021. The company acknowledges the inherent limitations of control systems, providing reasonable rather than absolute assurance. No material changes to internal control over financial reporting occurred during the quarter [Evaluation of Disclosure Controls and Procedures](index=29&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) - The principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective as of **September 30, 2021**[166](index=166&type=chunk) [Limitations on the Effectiveness of Controls](index=29&type=section&id=Limitations%20on%20the%20Effectiveness%20of%20Controls) - A control system, regardless of design, can provide only reasonable, not absolute, assurance that its objectives are met[167](index=167&type=chunk) - The company's disclosure controls and procedures are designed to provide reasonable assurance that their objectives are met[167](index=167&type=chunk) [Changes in Internal Control over Financial Reporting](index=29&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) - No changes to internal control over financial reporting occurred during the quarter ended September 30, 2021, that materially affected, or are reasonably likely to materially affect, internal control over financial reporting[168](index=168&type=chunk) [PART II — OTHER INFORMATION](index=30&type=section&id=Part%20II%20%E2%80%94%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) Reneo Pharmaceuticals is not currently involved in any material legal proceedings and is unaware of any threatened or pending litigation. However, the company acknowledges that disputes may arise in the ordinary course of business, which could potentially have an adverse impact on its consolidated results of operations or financial position - The company is not currently a party to any **material legal proceedings**[171](index=171&type=chunk) - The company is unaware of any threatened or pending litigation[105](index=105&type=chunk) - Future disputes could arise from normal business operations, potentially having a **material adverse effect** on consolidated results or financial position[105](index=105&type=chunk)[171](index=171&type=chunk) [Item 1A. Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) Outlines significant risks to Reneo's business, financial condition, and growth, covering operational, third-party, IP, and stock ownership factors [RISK FACTORS SUMMARY](index=30&type=section&id=RISK%20FACTORS%20SUMMARY) - The company has incurred significant net losses since inception and anticipates continued losses, requiring **substantial additional financing**[173](index=173&type=chunk) - Business success is entirely dependent on **REN001**, its only product candidate; failure to advance or commercialize would be **materially harmful**[173](index=173&type=chunk) - Clinical trials are lengthy, expensive, and uncertain, with results of earlier studies not necessarily predictive of future outcomes, and potential for delays or failure to demonstrate safety and efficacy[173](index=173&type=chunk) - The COVID-19 pandemic has adversely affected and could continue to affect operations and clinical development timelines[173](index=173&type=chunk) - Significant competition and potentially smaller market opportunities for **REN001** could adversely affect future revenue[173](index=173&type=chunk) - Reliance on a license agreement with vTv Therapeutics and third parties for clinical trials and manufacturing poses risks, including potential termination of the license or failure of third parties to meet obligations[180](index=180&type=chunk) - Intellectual property protection may be insufficient, and principal stockholders and management exert significant control over corporate matters[180](index=180&type=chunk) [RISK FACTORS](index=31&type=section&id=RISK%20FACTORS) [Risks Related to Our Business and Industry](index=31&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Industry) - The company has incurred significant net losses since inception (**$29.2 million** for nine months ended **Sep 30, 2021**, and **$74.1 million** accumulated deficit) and anticipates continued losses, requiring **substantial additional financing**[178](index=178&type=chunk)[181](index=181&type=chunk)[182](index=182&type=chunk) - Success is entirely dependent on **REN001**, its only product candidate; failure to develop, obtain regulatory approval, or commercialize **REN001** would **materially harm** the business[188](index=188&type=chunk) - Clinical trials are lengthy, expensive, and uncertain; they may fail to demonstrate safety and efficacy, leading to delays or denial of regulatory approval, and earlier results may not be predictive of future outcomes[191](index=191&type=chunk)[194](index=194&type=chunk)[195](index=195&type=chunk) - Difficulties in patient enrollment, especially for rare diseases, or delays in clinical trial commencement/completion due to regulatory issues, CRO performance, manufacturing problems, or the COVID-19 pandemic, could **increase costs** and **delay revenue**[197](index=197&type=chunk)[198](index=198&type=chunk)[203](index=203&type=chunk)[205](index=205&type=chunk) - REN001 or future product candidates could be associated with side effects or adverse events, potentially delaying or preventing regulatory approval, or leading to restrictive labeling or market withdrawal post-approval[210](index=210&type=chunk)[211](index=211&type=chunk) - The regulatory approval process is lengthy, expensive, and uncertain; approval is not guaranteed and may be for limited indications or require costly post-marketing studies[213](index=213&type=chunk)[214](index=214&type=chunk)[220](index=220&type=chunk) - The COVID-19 pandemic has caused and could continue to cause disruptions to clinical trials, regulatory operations, and supply chains, **negatively impacting business and financial condition**[221](index=221&type=chunk)[226](index=226&type=chunk)[228](index=228&type=chunk)[230](index=230&type=chunk) - If market opportunities for **REN001** are smaller than anticipated or the company faces substantial competition, future revenue may be **adversely affected**. Orphan drug designation does not guarantee market exclusivity or faster approval[237](index=237&type=chunk)[238](index=238&type=chunk)[281](index=281&type=chunk)[285](index=285&type=chunk)[287](index=287&type=chunk) - The company currently lacks a marketing and sales organization; building one or relying on third parties will be **expensive** and may not be successful, hindering product commercialization and revenue generation[246](index=246&type=chunk)[247](index=247&type=chunk) - Changes in healthcare laws and regulations, including cost-containment measures and drug pricing scrutiny, could **increase costs**, **limit coverage and reimbursement**, and **affect profitability**[268](index=268&type=chunk)[273](index=273&type=chunk)[274](index=274&type=chunk)[275](index=275&type=chunk) - The company is highly dependent on key personnel; inability to attract and retain qualified staff could **harm business strategy and development efforts**[293](index=293&type=chunk)[296](index=296&type=chunk) - The company is subject to stringent and changing privacy laws (e.g., HIPAA, CCPA, GDPR); actual or perceived failure to comply could lead to enforcement actions, litigation, reputational damage, and operational disruption[307](index=307&type=chunk)[315](index=315&type=chunk)[317](index=317&type=chunk)[318](index=318&type=chunk)[319](index=319&type=chunk)[323](index=323&type=chunk) - The withdrawal of the UK from the EU (Brexit) may **adversely impact regulatory approvals**, impose trade restrictions, and **increase expenses** for developing, manufacturing, and commercializing products in the EU or UK[325](index=325&type=chunk)[327](index=327&type=chunk) - Product liability lawsuits from clinical testing or commercialization could result in **substantial liabilities**, limit commercialization, or exceed insurance coverage[328](index=328&type=chunk)[330](index=330&type=chunk) - The ability to utilize net operating loss (NOL) carryforwards and other tax attributes may be limited by ownership changes or state tax laws, potentially **increasing future tax liabilities**[331](index=331&type=chunk)[332](index=332&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 depends on a license agreement with vTv Therapeutics for **REN001**; termination of this license would result in the **loss of significant rights** and **harm the business**[335](index=335&type=chunk) - The company relies on third-party Contract Research Organizations (CROs) to conduct, supervise, and monitor its clinical trials. Failure of CROs to perform contractual duties, meet regulatory requirements (GCPs), or adhere to deadlines could **delay or terminate clinical trials** and hinder regulatory approval or commercialization[337](index=337&type=chunk)[339](index=339&type=chunk)[340](index=340&type=chunk) - The company relies completely on third parties to manufacture preclinical and clinical drug supplies, and intends to rely on them for commercial supplies. These manufacturers may fail to obtain/maintain regulatory approval for facilities (cGMP), provide sufficient quantities, or meet quality standards or prices, leading to **delays or inability to commercialize**[343](index=343&type=chunk)[344](index=344&type=chunk)[346](index=346&type=chunk) - The use of hazardous substances by third-party manufacturers could lead to **liability for damages** from contamination or injury, for which the company does not have insurance[348](index=348&type=chunk) [Risks Related to Our Intellectual Property](index=65&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) - The company's success depends on obtaining and maintaining **sufficient intellectual property protection** (patents, trade secrets, confidentiality agreements) for **REN001** and other proprietary technologies[350](index=350&type=chunk) - Patent issuance, scope, validity, and enforceability are uncertain; patents may be challenged, invalidated, or circumvented by third parties, and patent terms may be inadequate to protect competitive position before or shortly after commercialization[352](index=352&type=chunk)[353](index=353&type=chunk)[354](index=354&type=chunk)[356](index=356&type=chunk)[359](index=359&type=chunk)[362](index=362&type=chunk)[365](index=365&type=chunk) - Patent prosecution is **expensive**, **time-consuming**, and **complex**; non-compliance with procedural requirements can lead to abandonment or lapse of patent rights[358](index=358&type=chunk)[373](index=373&type=chunk) - Changes in U.S. or foreign patent laws (e.g., America Invents Act) could **diminish the value of patents**, increasing uncertainties and costs for prosecution and enforcement[382](index=382&type=chunk)[386](index=386&type=chunk)[388](index=388&type=chunk)[389](index=389&type=chunk) - Protecting intellectual property rights globally is challenging due to varying laws and costs, potentially allowing competitors to practice inventions in countries without protection[390](index=390&type=chunk)[394](index=394&type=chunk) - The company may face claims challenging inventorship or ownership of its patents and other intellectual property, leading to **costly litigation** or **loss of valuable rights**[396](index=396&type=chunk)[397](index=397&type=chunk)[398](index=398&type=chunk) - Obtaining necessary licenses for product components and processes from third parties may be **difficult** or available only on **commercially unreasonable terms**, potentially hindering development or commercialization[400](index=400&type=chunk)[406](index=406&type=chunk)[419](index=419&type=chunk) - Failure to comply with obligations under license agreements (e.g., with vTv Therapeutics) could result in **termination of licenses** and **loss of rights essential to the business**[413](index=413&type=chunk)[415](index=415&type=chunk) - Third-party claims alleging intellectual property infringement could prevent or delay drug development, lead to **costly litigation**, **substantial damages**, or require obtaining licenses[420](index=420&type=chunk)[423](index=423&type=chunk)[428](index=428&type=chunk) - The company relies on trade secrets for proprietary know-how; inability to protect confidentiality due to disclosure, misappropriation, or independent discovery by competitors could **harm its competitive position**[450](index=450&type=chunk)[451](index=451&type=chunk)[453](index=453&type=chunk)[455](index=455&type=chunk)[456](index=456&type=chunk) - Inadequate protection of trademarks and trade names could **hinder name recognition** and **adversely affect the business**[460](index=460&type=chunk)[461](index=461&type=chunk) [Risks Related to Ownership of Our Common Stock](index=86&type=section&id=Risks%20Related%20to%20Ownership%20of%20Our%20Common%20Stock) - The trading price of the company's common stock is likely to be **highly volatile** due to factors such as clinical trial results, regulatory decisions, market acceptance, competition, and general economic conditions[464](index=464&type=chunk)[465](index=465&type=chunk)[467](index=467&type=chunk) - The company is subject to securities class action litigation, which could result in **substantial costs** and **diversion of management's attention**[468](index=468&type=chunk) - Principal stockholders and management own a **significant percentage** of the company's stock, allowing them to exert **significant control** over matters requiring stockholder approval[469](index=469&type=chunk) - Future sales and issuances of common stock or rights to purchase common stock, including under equity incentive plans, could result in **additional dilution** of existing stockholders' ownership and cause the stock price to fall[485](index=485&type=chunk)[486](index=486&type=chunk)[487](index=487&type=chunk) - As an emerging growth company and smaller reporting company, the company benefits from reduced reporting requirements, which may make its common stock **less attractive to some investors**[471](index=471&type=chunk)[474](index=474&type=chunk) - Anti-takeover provisions in charter documents and Delaware law could **delay or prevent a change of control**, potentially limiting the market price of common stock and frustrating attempts to replace management[489](index=489&type=chunk)[490](index=490&type=chunk) - Exclusive forum provisions in the company's charter documents may **limit stockholders' ability to obtain a favorable judicial forum** for disputes with the company or its directors, officers, or employees[492](index=492&type=chunk)[493](index=493&type=chunk) [General Risk Factors](index=93&type=section&id=General%20Risk%20Factors) - The company is subject to U.S. and foreign export/import controls, sanctions, anti-corruption laws (e.g., FCPA), and anti-money laundering laws; violations can lead to **criminal liability** and other **serious consequences**[495](index=495&type=chunk)[496](index=496&type=chunk) - Business disruptions from natural disasters (e.g., earthquakes, fires), medical epidemics (e.g., COVID-19), or man-made events could **seriously harm future revenues and financial condition** and **increase costs**[497](index=497&type=chunk) - Internal computer systems and those of third-party collaborators are vulnerable to security breaches, cyberattacks, and other disruptive incidents, risking **unauthorized access**, **data loss**, **significant liabilities**, and **reputational damage**, with insurance potentially being inadequate[498](index=498&type=chunk)[500](index=500&type=chunk)[501](index=501&type=chunk)[504](index=504&type=chunk) - If securities or industry analysts publish inaccurate or unfavorable research about the company, its stock price and trading volume could **decline**[505](index=505&type=chunk)[507](index=507&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=95&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section details the company's Initial Public Offering (IPO) completed on April 13, 2021, where it sold 6,250,000 shares of common stock at $15.00 per share, generating $84.6 million in net proceeds after deducting underwriting discounts and offering expenses. As of September 30, 2021, these net proceeds had not been used and were invested in short-term, interest-bearing obligations, with management retaining broad discretion over their future application [Unregistered Sales of Equity Securities](index=95&type=section&id=Unregistered%20Sales%20of%20Equity%20Securities) - No specific unregistered sales of equity securities were reported under this sub-heading[508](index=508&type=chunk) [Use of Proceeds](index=95&type=section&id=Use%20of%20Proceeds) - The company completed its IPO on **April 13, 2021**, selling **6,250,000 shares** of common stock at **$15.00 per share**, resulting in **$84.6 million** in net proceeds after **$9.2 million** in fees[508](index=508&type=chunk)[509](index=509&type=chunk) - As of **September 30, 2021**, none of the net proceeds from the IPO had been used; funds are invested in short-term, interest-bearing obligations[510](index=510&type=chunk) - Management retains **broad discretion** over the future application of the net proceeds[510](index=510&type=chunk) [Item 3. Defaults Upon Senior Securities](index=95&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities during the period - No defaults upon senior securities were reported[511](index=511&type=chunk) [Item 4. Mine Safety Disclosures](index=95&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) The company reported no mine safety disclosures - No mine safety disclosures were reported[512](index=512&type=chunk) [Item 5. Other Information](index=95&type=section&id=Item%205.%20Other%20Information) No other information was reported under this item - No other information was reported under this item[513](index=513&type=chunk) [Item 6. Exhibits](index=95&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including organizational documents, various agreements, equity incentive plans, and certifications required by the Sarbanes-Oxley Act. It also includes Inline XBRL documents for financial data [Exhibit Index](index=96&type=section&id=Exhibit%20Index) - The exhibit index includes organizational documents (Amended and Restated Certificate of Incorporation, Bylaws), various agreements (Investors' Rights Agreement, Employment Agreement), equity incentive plans (2021 Employee Stock Purchase Plan, 2021 Equity Incentive Plan forms), and certifications (Section 302 and 906 of Sarbanes-Oxley Act)[517](index=517&type=chunk) - Inline XBRL documents (Instance, Taxonomy Extension Schema, Calculation, Definition, Label, Presentation Linkbase Documents, and Cover Page Interactive Data File) are also included[517](index=517&type=chunk) ```

Focused on Improving the Lives of Patients with Rare Genetic Mitochondrial Diseases Nasdaq: RPHM September 2021 Forward-Looking Statements 2 This presentation may not be reproduced, retransmitted or further distributed to any other person or published, in whole or in part, for any other purpose. This presentation regarding Reneo Pharmaceuticals, Inc. (the "Company") is for you to familiarize yourself with the Company. This presentation is for information and education purposes only. No reliance may be place ...

Table of Contents 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, 2021 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 ( ...

For the transition period from to Table of Contents 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, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-40315 Reneo Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 47-2309515 ...