0001558370-21-015674.txt : 20211112 0001558370-21-015674.hdr.sgml : 20211112 20211112090543 ACCESSION NUMBER: 0001558370-21-015674 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 64 CONFORMED PERIOD OF REPORT: 20210930 FILED AS OF DATE: 20211112 DATE AS OF CHANGE: 20211112 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Reneo Pharmaceuticals, Inc. CENTRAL INDEX KEY: 0001637715 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 472309515 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 001-40315 FILM NUMBER: 211400277 BUSINESS ADDRESS: STREET 1: 18575 JAMBOREE ROAD STREET 2: SUITE 275-S CITY: IRVINE STATE: CA ZIP: 92612 BUSINESS PHONE: (858) 283-0280 MAIL ADDRESS: STREET 1: 18575 JAMBOREE ROAD STREET 2: SUITE 275-S CITY: IRVINE STATE: CA ZIP: 92612 10-Q 1 rphm-20210930x10q.htm 10-Q
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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 September 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

Graphic

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

(Address of Principal Executive Offices)

92612

(Zip Code)

(Registrant’s telephone number, including area code): (858) 283-0280

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

  

Trading symbol

  

Name of each exchange on which registered

Common Stock, par value $0.0001 per share

RPHM

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes      No  

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).    Yes      No  

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer

  

  

Accelerated filer

Smaller reporting company

Non-accelerated filer

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes      No  

As of November 9, 2021, there were 24,423,900 shares of the registrant’s common stock, $0.0001 par value per share, outstanding.

TABLE OF CONTENTS

  

Page

Part I

Financial Information

3

Item 1.

Consolidated Financial Statements

3

Condensed Consolidated Balance Sheets as of September 30, 2021 (Unaudited) and December 31, 2020

3

Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and nine months ended September 30, 2021 and 2020 (Unaudited)

4

Condensed Consolidated Statements of Changes in Convertible Preferred Stock and Stockholders’ Equity (Deficit) for the three and nine months ended September 30, 2021 and 2020 (Unaudited)

5

Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2021 and 2020 (Unaudited)

7

Notes to Condensed Consolidated Financial Statements (Unaudited)

8

Item 2.

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

20

Item 3.

Quantitative and Qualitative Disclosures about Market Risk

29

Item 4.

Controls and Procedures

29

Part II

Other Information

30

Item 1.

Legal Proceedings

30

Item 1A.

Risk Factors

30

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

95

Item 3.

Defaults Upon Senior Securities

95

Item 4.

Mine Safety Disclosures

95

Item 5.

Other Information

95

Item 6.

Exhibits

95

Exhibit Index

96

Signatures

98

2

PART I —FINANCIAL INFORMATION

Item 1. Financial Statements

RENEO PHARMACEUTICALS, INC.

Condensed Consolidated Balance Sheets

(In thousands, except share and par value data)

    

SEPTEMBER 30, 

    

DECEMBER 31, 

2021

2020

Assets

(unaudited)

Current assets:

Cash and cash equivalents

$

126,409

$

53,613

Short-term investments

 

31,325

 

Prepaid expenses and other current assets

 

4,931

 

1,412

Total current assets

 

162,665

 

55,025

Property and equipment, net

 

200

 

69

Other non-current assets

 

78

127

Total assets

$

162,943

$

55,221

Liabilities, convertible preferred stock and stockholders’ equity (deficit)

Current liabilities:

 

  

 

  

Accounts payable

$

1,271

$

908

Accrued expenses

 

5,082

 

3,672

Total current liabilities

 

6,353

 

4,580

Deferred rent

 

98

 

36

Performance award (Note 7)

284

Total liabilities

 

6,735

 

4,616

Commitments and contingencies (Note 9)

 

  

 

  

Series A convertible preferred stock, $0.0001 par value; zero and 24,302,472 shares authorized at September 30, 2021 and December 31, 2020, respectively; zero and 24,302,472 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively; liquidation preference of $0 and $49,127 at September 30, 2021 and December 31, 2020, respectively

 

 

45,652

Series B convertible preferred stock, $0.0001 par value; zero and 46,881,028 shares authorized at September 30, 2021 and December 31, 2020, respectively; zero and 23,440,514 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively; liquidation preference of $0 and $47,385 as of September 30, 2021 and December 31, 2020, respectively

 

 

47,068

Stockholders’ equity (deficit):

 

  

 

  

Preferred stock, $0.0001 par value, 10,000,000 and zero shares authorized at September 30, 2021 and December 31, 2020, respectively; zero shares issued and outstanding as of September 30, 2021 and December 31, 2020

Common stock, $0.0001 par value; 200,000,000 and 105,000,000 shares authorized at September 30, 2021 and December 31, 2020, respectively; 24,417,558 and 24,407,722 shares issued and outstanding at September 30, 2021, respectively and 2,053,070 shares issued and outstanding at December 31, 2020

 

3

 

Additional paid-in capital

 

230,309

 

2,843

Accumulated deficit

 

(74,121)

 

(44,958)

Accumulated other comprehensive income

 

17

 

Total stockholders’ equity (deficit)

 

156,208

 

(42,115)

Total liabilities, convertible preferred stock and stockholders’ equity (deficit)

$

162,943

$

55,221

The accompanying notes are an integral part of these condensed consolidated financial statements.

3

RENEO PHARMACEUTICALS, INC.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share data)

(Unaudited)

THREE MONTHS ENDED SEPTEMBER 30, 

NINE MONTHS ENDED SEPTEMBER 30, 

    

2021

    

2020

    

2021

    

2020

    

Operating expenses:

Research and development

$

9,318

$

4,431

$

21,069

$

10,826

General and administrative

 

3,434

 

668

 

8,125

 

2,475

Total operating expenses

 

12,752

 

5,099

 

29,194

 

13,301

Loss from operations

 

(12,752)

 

(5,099)

 

(29,194)

 

(13,301)

Other income

 

17

5

 

31

 

89

Net loss

 

(12,735)

 

(5,094)

 

(29,163)

 

(13,212)

Unrealized gain (loss) on short-term investments

 

12

 

(4)

 

17

 

Comprehensive loss

$

(12,723)

$

(5,098)

$

(29,146)

$

(13,212)

Net loss per share attributable to common stockholders, basic and diluted

$

(0.52)

$

(2.48)

$

(1.82)

$

(6.54)

Weighted-average shares used in computing net loss per share, basic and diluted

 

24,396,798

 

2,052,838

 

16,025,813

 

2,021,031

The accompanying notes are an integral part of these condensed consolidated financial statements.

4

RENEO PHARMACEUTICALS, INC.

Condensed Consolidated Statements of Changes in Convertible Preferred Stock and Stockholders’ Equity (Deficit)

(In thousands, except share data)

(Unaudited)

CONVERTIBLE

ACCUMULATED

PREFERRED STOCK

ADDITIONAL

OTHER

TOTAL

Series A

Series B

Common Stock

PAID-IN

COMPREHENSIVE

ACCUMULATED

STOCKHOLDERS'

    

SHARES

    

AMOUNT

    

SHARES

    

AMOUNT

SHARES

    

AMOUNT

    

CAPITAL

    

INCOME

    

DEFICIT

    

EQUITY (DEFICIT)

Balances, December 31, 2020

24,302,472

$

45,652

23,440,514

$

47,068

2,053,070

$

$

2,843

$

$

(44,958)

$

(42,115)

Issuance of series B convertible preferred stock, net of issuance costs of $29

 

23,440,514

47,356

Stock based compensation

 

471

471

Stock option exercise

 

70,663

139

139

Net loss

(7,212)

(7,212)

Balances, March, 31, 2021

 

24,302,472

$

45,652

46,881,028

$

94,424

2,123,733

$

$

3,453

$

$

(52,170)

$

(48,717)

Conversion of convertible preferred stock into common stock upon initial public offering

(24,302,472)

(45,652)

(46,881,028)

(94,424)

15,907,629

2

140,076

140,078

Issuance of common stock in public offering, net of offering costs

6,250,000

1

84,532

84,533

Vesting of early exercised options

7,337

14

14

Stock-based compensation

854

854

Change in unrealized holding gains and losses on short-term investments

 

5

5

Net loss

(9,216)

(9,216)

Balances, June 30, 2021

24,288,699

3

228,929

5

(61,386)

167,551

Vesting of early exercised options

7,337

15

15

Stock option exercises

111,736

220

220

Stock-based compensation

1,145

1,145

Change in unrealized holding gains and losses on short-term investments

 

12

12

Net loss

(12,735)

(12,735)

Balances, September 30, 2021

 

$

$

24,407,772

$

3

$

230,309

$

17

$

(74,121)

$

156,208

5

CONVERTIBLE

ACCUMULATED

PREFERRED STOCK

ADDITIONAL

OTHER

TOTAL

Series A

Series B

Common Stock

PAID-IN

COMPREHENSIVE

ACCUMULATED

STOCKHOLDERS'

    

SHARES

    

AMOUNT

    

  SHARES  

    

AMOUNT

    

SHARES

    

AMOUNT

    

CAPITAL

    

INCOME

    

DEFICIT

    

EQUITY (DEFICIT)

Balances, December 31, 2019

24,302,472

$

45,652

$

2,008,905

$

$

2,363

$

3

$

(25,493)

$

(23,127)

Stock based compensation

 

92

92

Stock option exercise

 

13,269

26

26

Change in unrealized holding gains and losses on short-term investments

7

7

Net loss

(4,431)

(4,431)

Balances, March, 31, 2020

 

24,302,472

$

45,652

$

2,022,174

$

$

2,481

$

10

$

(29,924)

$

(27,433)

Stock based compensation

88

88

Change in unrealized holding gains and losses on short-term investments

(6)

(6)

Net loss

(3,687)

(3,687)

Balances, June 30, 2020

24,302,472

$

45,652

$

2,022,174

$

$

2,569

$

4

$

(33,611)

$

(31,038)

Stock based compensation

 

84

84

Stock option exercise

 

26,093

51

51

Change in unrealized holding gains and losses on short-term investments

(4)

(4)

Net loss

(5,094)

(5,094)

Balances, September 30, 2020

 

24,302,472

$

45,652

$

2,048,267

$

$

2,704

$

$

(38,705)

$

(36,001)

The accompanying notes are an integral part of these condensed consolidated financial statements.

6

RENEO PHARMACEUTICALS, INC.

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

NINE MONTHS ENDED

SEPTEMBER 30, 

2021

    

2020

Cash flows from operating activities

  

 

  

Net loss

$

(29,163)

$

(13,212)

Adjustments to reconcile net loss to net cash used in operating activities:

 

  

 

  

Depreciation and amortization

 

33

27

Amortization/accretion on short-term investments

 

113

(17)

Changes in the fair value of performance award (Note 7)

 

284

Stock-based compensation

 

2,470

264

Changes in operating assets and liabilities:

 

Accounts payable, accrued expenses and other

 

1,816

20

Prepaid expenses and other assets

 

(3,577)

(203)

Deferred rent

 

62

(4)

Net cash used in operating activities

 

(27,962)

 

(13,125)

Cash flows from investing activities

Purchases of property and equipment

 

(108)

(8)

Purchase of available-for-sale short-term investments

 

(31,421)

Proceeds from maturities of available-for-sale short-term investments

 

7,400

Net cash (used in) provided by investing activities

 

(31,529)

 

7,392

Cash flows from financing activities

Proceeds from issuance of Series B convertible preferred stock, net of issuance costs

 

47,239

Proceeds from initial public offering, net of offering costs

 

84,641

Proceeds from exercise of stock options

407

77

Net cash provided by financing activities

 

132,287

 

77

Net increase (decrease) in cash and cash equivalents

 

72,796

 

(5,656)

Cash and cash equivalents, beginning of period

 

53,613

17,501

Cash and cash equivalents, end of period

$

126,409

$

11,845

Supplemental cash flow information:

 

  

 

  

Vesting of unvested exercised options

$

19

$

Property and equipment in accounts payable

$

56

$

The accompanying notes are an integral part of these condensed consolidated financial statements.

7

RENEO PHARMACEUTICALS, INC.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

1. Organization and Business

Organization

Reneo Pharmaceuticals, Inc. (Reneo or the Company) was incorporated in the state of Delaware on September 22, 2014 (Inception). The Company is a clinical-stage pharmaceutical company focused on the development of therapies for patients with rare genetic mitochondrial diseases. In December 2017, the Company in-licensed REN001, a novel oral peroxisome proliferator-activated receptor (PPAR) agonist.

Reverse Stock Split

On April 5, 2021, the Company effected a 1-for-4.4748 reverse stock split of its common stock. The par value and the authorized number of shares of the common stock were not adjusted as a result of the reverse stock split. The reverse stock split resulted in an adjustment to the Series A and Series B convertible preferred stock conversion prices to reflect a proportional decrease in the number of shares of common stock to be issued upon conversion. The accompanying condensed consolidated financial statements and notes to the condensed consolidated financial statements give retroactive effect to the reverse stock split for all periods presented.

Initial Public Offering

On April 13, 2021, the Company completed an initial public offering (IPO) of its common stock. In connection with its IPO, the Company issued and sold 6,250,000 shares of its common stock at a price to the public of $15.00 per share. The gross proceeds from the IPO were approximately $93.8 million before deducting underwriting discounts and commissions of $6.6 million and offering expenses of approximately $2.6 million payable by the Company.

At the closing of the IPO, 71,183,500 shares of outstanding convertible preferred stock were automatically converted into 15,907,629 shares of common stock. Following the IPO, there were no shares of preferred stock outstanding.

Liquidity

The Company has incurred significant losses and negative cash flows from operations. From Inception through September 30, 2021, the Company has raised net cash proceeds of approximately $230.6 million primarily through equity financings, including the net proceeds from the IPO, to support its drug development efforts. As of September 30, 2021, the Company had cash, cash equivalents and short-term investments of $157.7 million and an accumulated deficit of $74.1 million. The Company had a net loss of $29.2 million and used cash of $28.0 million for operating activities for the nine months ended September 30, 2021. In accordance with Accounting Standards Codification (ASC) Topic 205-40, Presentation of Financial Statements - Going Concern, management is required to perform a two-step analysis over the Company’s ability to continue as a going concern. Management must first evaluate whether there are conditions and events that raise substantial doubt about the Company’s ability to continue as a going concern for a period of 12 months from the date the condensed consolidated financial statements are issued. If management concludes that substantial doubt is raised, management is also required to consider whether its plans alleviate that doubt.

Due to the Company’s continuing research and development activities, the Company expects to continue to incur net losses into the foreseeable future and may never become profitable. As a result, the Company will need to raise capital through public or private equity or debt financings, government or other third-party funding, collaborations, strategic alliances and licensing arrangements or a combination of these.

There can be no assurance that the Company will be successful in obtaining additional funding, that the Company’s projections of its future working capital needs will prove accurate, or that any additional funding would be sufficient to continue operations in future years. If the Company is not able to secure adequate additional funding, the Company may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, and/or

8

suspend or curtail planned programs. Any of these actions could materially harm the Company’s business, results of operations, and future prospects. The Company’s ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and disruptions to, and volatility in, financial markets in the United States and worldwide resulting from the ongoing COVID-19 pandemic. The Company may not be able to secure additional financing in a timely manner or on favorable terms, if at all. In addition, successful transition to attaining profitable operations is dependent upon achieving a level of revenues adequate to support the Company’s cost structure.

As of September 30, 2021, the Company had $157.7 million in cash, cash equivalents and short-term investments, which management believes will be sufficient to fund operations for at least one year from date on which this Quarterly Report on Form 10-Q is issued.

2. Summary of Significant Accounting Policies

Basis of Presentation and Consolidation

The accompanying unaudited condensed consolidated financial statements as of September 30, 2021 and for the three and nine months ended September 30, 2021 and 2020 have been prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) for interim financial information. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for annual financial statements. The condensed consolidated balance sheet at December 31, 2020 has been derived from the audited financial statements at December 31, 2020, but does not include all of the information and footnotes required by U.S. GAAP for complete financial statements.  In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the financial position and results of operations of the Company have been included.  Operating results for the three and nine months ended September 30, 2021 are not necessarily indicative of the results that may be expected for the year ending December 31, 2021. These condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto for the year ended December 31, 2020, which are included in the Company’s prospectus, dated April 8, 2021, that forms a part of the Company’s Registration Statement on Form S-1 (File. No. 333-254534) as filed with the Securities and Exchange Commission (SEC) pursuant to Rule 424(b) under the Securities Act of 1933, as amended (the Securities Act), on April 9, 2021.

The condensed consolidated financial statements include the accounts of Reneo Pharmaceuticals, Inc. and its wholly owned subsidiary, Reneo Pharma Ltd located in the United Kingdom (UK). All intercompany balances and transactions among the consolidated entities have been eliminated in consolidation.

Use of Estimates

The preparation of the Company’s condensed consolidated financial statements requires management to make estimates and assumptions that impact the reported amounts of assets, liabilities and expenses and the disclosure in the Company’s condensed consolidated financial statements and accompanying notes. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances. By their nature, estimates are subject to an inherent degree of uncertainty and, as such, actual results may differ from management’s estimates.

Risks and Uncertainties

Any product candidates developed by the Company will require approvals from the U.S. Food and Drug Administration (FDA) or foreign regulatory agencies prior to commercial sales. There can be no assurance that the Company’s current product candidates will meet desired efficacy and safety requirements to obtain the necessary approvals. If approval is denied or delayed, it may have a material adverse impact on the Company’s business and its financial statements.

The Company is subject to a number of risks similar to other clinical-stage pharmaceutical companies including, but not limited to, dependency on the clinical and commercial success of the Company’s product candidate, REN001, ability to obtain regulatory approval of REN001, the need for substantial additional financing to achieve its goals, uncertainty of

9

broad adoption of its approved products, if any, by physicians, consumers and third-party payors, significant competition and untested manufacturing capabilities, and dependence on key individuals and sole source suppliers.

The Company’s business has been and could continue to be adversely affected by the evolving COVID-19 pandemic. For example, the COVID-19 pandemic has resulted in and could result in delays to the Company’s clinical trials for numerous reasons, including additional delays or difficulties in enrolling patients, diversion of healthcare resources away from the conduct of clinical trials, interruption or delays in the operations of the FDA or other regulatory authorities, and delays in clinical sites receiving the supplies and materials to conduct the Company’s clinical trials. At this time, the extent to which the COVID-19 pandemic impacts the Company’s business will depend on future developments, which are highly uncertain and cannot be predicted.

Segment Reporting

The Company operates and manages its business as one operating segment, which is the business of developing novel therapies for rare genetic mitochondrial diseases. The Company’s chief executive officer, who is the chief operating decision maker, reviews financial information on an aggregate basis for allocating and evaluating financial performance.

Cash and Cash Equivalents

The Company considers all highly liquid investments with original maturities of three months or less, when purchased, to be cash equivalents. As of September 30, 2021 and December 31, 2020, the Company had cash balances deposited at a major financial institution. Cash balances are subject to minimal credit risk as the balances are with high credit quality financial institutions. Cash equivalents, which consist of money market accounts and commercial paper, are stated at fair value.

Short-term Investments

The Company accounts for short-term investments in accordance with ASC Topic 320, Investments – Debt and Equity Securities. Management determines the appropriate classification of its investments at the time of purchase and reevaluates such determinations at each balance sheet date.

The Company’s investments are classified as available-for-sale securities. Available-for-sale securities are carried at fair value, with the unrealized gains and losses reported in accumulated other comprehensive income (loss) in stockholders’ equity (deficit). Realized gains and losses on sales of investments are included in interest income and are derived using the specific identification method for determining the cost of securities.

The Company recognizes an impairment charge when a decline in the fair value of its investments in debt securities below the amortized cost basis of such securities is judged to be other-than-temporarily impaired. Factors considered in making such a determination include the duration and severity of the impairment, the reason for the decline in value, the potential recovery period and if the entity has the intent to sell the security, or if it is more likely than not that it will be required to sell the security before recovery of its amortized cost basis. The Company did not recognize any other-than-temporary impairment charges on its short-term investments during the three and nine months ended September 30, 2021 and 2020.

Money market account balances are included as cash and cash equivalents on the condensed consolidated balance sheets, which are also disclosed in Note 3, Fair Value Measurements.

Impairment of Long-Lived Assets

Long-lived assets consist primarily of property and equipment. Long-lived assets are tested for impairment when events and circumstances indicate the assets might be impaired by first comparing the estimated future undiscounted cash flows of the asset or asset group to the carrying value. If the carrying value exceeds the estimated future undiscounted cash flows, an impairment loss is recognized based on the amount that the carrying value exceeds the fair value of the asset or

10

asset group. The Company did not recognize impairment losses during the nine months ended September 30, 2021 and 2020.

Convertible Preferred Stock

The Company records convertible preferred stock at fair value on the dates of issuance, net of issuance costs. Prior to the IPO, upon the occurrence of certain potential events that would have been outside the Company’s control, including a “deemed liquidation event” such as a merger, acquisition and sale of all or substantially all of the Company’s assets, holders of the convertible preferred stock could cause redemption for cash. Therefore, convertible preferred stock was classified as temporary equity (mezzanine) on the condensed consolidated balance sheets as events triggering the liquidation preferences are not solely within the Company’s control. All convertible preferred stock was converted to common stock in connection with the IPO in April 2021.

Research and Development Costs and Accruals

All research and development costs are expensed as incurred. Research and development costs consist primarily of costs associated with manufacturing drug substance and drug product, costs associated with preclinical studies and clinical trials (including amounts paid to clinical research organizations and other professional services), license fees, salaries and employee benefits.

The Company records accruals for estimated research and development costs, comprising payments for work performed by third party contractors, laboratories, participating clinical trial sites and others. Some of these contractors bill monthly based on actual services performed, while others bill periodically based upon achieving certain contractual milestones. Payments made in advance of or after the performance are reflected in the condensed consolidated balance sheets as prepaid expenses or accrued liabilities, respectively. Up-front costs, such as costs associated with setting up clinical trial sites for participation in the trials, are expensed immediately once the set-up has occurred as research and development expenses. The Company accrues the costs incurred under agreements with these third parties based on estimates of actual work completed in accordance with the respective agreements. If the actual timing of the performance of services or the level of effort varies from the estimate, the Company adjusts accrued expenses or prepaid expenses accordingly, which impact research and development expenses.

License Fees

The Company expenses amounts paid to acquire licenses associated with products under development when the ultimate recoverability of the amounts paid is uncertain, and the technology has no alternative future use when acquired. Acquisitions of technology licenses are charged to expense or capitalized based upon management’s assessment regarding the ultimate recoverability of the amounts paid and the potential for alternative future use. The Company has determined that technological feasibility for its product candidate would be reached when the requisite regulatory approvals are obtained to make the product available for sale. Contingent milestone payments are recognized when the related contingency is resolved, and the amounts are paid or become payable. These amounts are expensed to research and development if there is no alternative future use associated with the license or capitalized as an intangible asset if alternative future use of the license exists.

Patent Costs

Costs related to filing and pursuing patent applications are expensed as incurred, as the recoverability of such expenditures is uncertain. These costs are included in general and administrative expenses.

Stock-Based Compensation

Compensation expense related to stock options granted to employees and non-employees is measured at the grant date based on the estimated fair value of the award and is recognized on a straight-line basis over the requisite service period. Forfeitures are recognized as a reduction of stock-based compensation expense as they occur. The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model.

11

Foreign Currency Transactions

The functional currency of Reneo Pharma Ltd is the U.S. dollar. All foreign exchange transactional and remeasurement gains and losses are recognized in the condensed consolidated statements of operations and comprehensive loss. For the nine months ended September 30, 2021 and 2020, total foreign currency gains and losses were not material.

Comprehensive Income or Loss

Comprehensive income or loss is defined as a change in equity during a period from transactions and other events and circumstances from non-owner sources.

Net Loss Per Share

The Company computes basic loss per share by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share assumes the conversion, exercise or issuance of all potential common stock equivalents, unless the effect of inclusion would be anti-dilutive. For purposes of this calculation, common stock equivalents include the Company’s stock options and convertible preferred stock, which are convertible into shares of the Company’s common stock. No shares related to the convertible preferred stock were included in the diluted net loss per share calculation for the three or nine months ended September 30, 2021 and 2020 because the inclusion of such shares would have had an anti-dilutive effect. The shares to be issued upon exercise of all outstanding stock options were also excluded from the diluted net loss per share calculation for the three and nine months ended September 30, 2021 and 2020 because such shares are anti-dilutive.

Historical outstanding anti-dilutive securities not included in the diluted net loss per share calculation include the following:

    

September 30, 2021

    

September 30, 2020

    

Convertible preferred stock (as converted)

 

5,430,957

Common stock options

3,215,904

 

941,621

Total

3,215,904

 

6,372,578

New Accounting Pronouncements

Recent Accounting Pronouncements Not Yet Adopted

In December 2019, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2019-12, Simplifying the Accounting for Income Taxes. The standard simplifies the accounting for income taxes, eliminates certain exceptions within ASC 740, Income Taxes, and clarifies certain aspects of the current guidance to promote consistency among reporting entities. The new guidance will be effective for the Company as of January 1, 2022. Most amendments within the standard are required to be applied on a prospective basis, while certain amendments must be applied on a retrospective or modified retrospective basis. The Company is in the process of evaluating the impact of the application of this ASU on its condensed consolidated financial statements.

In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments. The standard amends the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses for most financial assets and certain other instruments that aren’t measured at fair value through net income. For available-for-sale debt securities, entities will be required to recognize an allowance for credit losses rather than a reduction in the carrying value of the asset. Entities will no longer be permitted to consider the length of time that fair value has been less than amortized cost when evaluating when credit losses should be recognized. This new guidance is effective for the Company as of January 1, 2023. The Company is currently evaluating the impact of this ASU and does not expect that adoption of this standard will have a material impact on its condensed consolidated financial statements and related disclosures.

12

In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) in order to increase transparency and comparability among organizations by recognizing lease assets and lease liabilities on the balance sheets for those leases classified as operating leases under previous GAAP. ASU 2016-02 requires a lessee to recognize a liability for lease payments (the lease liability) and a right-of-use asset (representing its right to use the underlying asset for the lease term) on the balance sheet. In July 2018, the FASB issued ASU 2018-11, Leases (Topic 842): Targeted Improvements, which provides entities an optional transition method to apply the new guidance as of the adoption date, rather than as of the earliest period presented. In transition, entities may also elect a package of practical expedients that must be applied in its entirety to all leases commencing before the effective date, unless the lease was modified, to not reassess (a) whether a contract is or contains a lease, (b) lease classification or (c) determination of initial direct costs, which effectively allows entities to carryforward accounting conclusions under previous U.S. GAAP. This ASU is effective for annual reporting periods beginning after December 15, 2021, and interim periods within fiscal years beginning after December 15, 2022, with early adoption permitted. The Company plans to adopt the ASU on January 1, 2022 and is currently in the process of evaluating the impact of the application of this ASU and expects the recording of a right-of-use asset and lease liability on its condensed consolidated financial statements and related disclosures.

3. Fair Value Measurements

ASC Topic 820, Fair Value Measurement, establishes a fair value hierarchy for instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company’s own assumptions (unobservable inputs). Observable inputs are inputs that market participants would use in pricing an asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances.

ASC 820 identifies fair value as the exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a three-tier fair value hierarchy that distinguishes between the following:

Level 1 – Observable inputs such as quoted prices in active markets for identical assets or liabilities.

Level 2 – Inputs, other than quoted prices in active markets, that are observable for the asset or liability, either directly or indirectly.

Level 3 – Unobservable inputs in which there is little or no market data, which requires the Company to develop its own assumptions.

Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability. The Company’s financial assets are subject to fair value measurements on a recurring basis.

The Company classifies its money market funds as Level 1 using the quoted prices in active markets.

In November 2020, the Company hired a new chief executive officer under which the chief executive officer is entitled to receive a special performance bonus in the amount of $7.5 million (Performance Award), payable in cash, common stock or a combination of cash and common stock, at the election of the Company, based on achievement of certain conditions as described in more detail in Note 7. The Company estimated the fair value of the Performance Award using a Monte Carlo simulation, which utilizes level 3 inputs such as volatility, probabilities of success, and other inputs that are not observable in active markets. The Performance Award is required to be measured at fair value on a recurring basis each reporting period, with changes in the fair value recognized in general and administrative expense in the condensed consolidated statements of operations and comprehensive loss over the derived service period of the award.

13

No assets or liabilities were transferred into or out of their classifications during the nine months ended September 30, 2021 and 2020.

The recurring fair value measurement of the Company’s assets measured at fair value at September 30, 2021 consisted of the following (in thousands):

Quoted Prices in

Significant

Active Markets

Significant Other

Unobservable

  

For Identical Items

Observable Inputs

Inputs

    

(Level 1)

    

(Level 2)

    

(Level 3)

    

Total

Assets

 

  

  

 

  

 

  

Cash and cash equivalents:

Money market investments

$

124,010

$

$

$

124,010

Investments:

Commercial paper

31,325

31,325

Total

$

124,010

$

31,325

$

$

155,335

Liabilities

Performance award

$

$

$

284

$

284

Total

$

$

$

284

$

284

The following table summarizes changes in fair value measurements of the Performance Award during the nine months ended September 30, 2021 (in thousands):

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

The recurring fair value measurement of the Company’s assets measured at fair value at December 31, 2020 consisted of the following (in thousands):

Quoted Prices in

Significant

Active Markets

Significant Other

Unobservable

  

For Identical Items

Observable Inputs

Inputs

    

(Level 1)

    

(Level 2)

    

(Level 3)

    

Total

Assets:

 

  

  

 

  

 

  

Money market investments

$

49,632

$

$

$

49,632

Total

$

49,632

$

$

$

49,632

4. Property and Equipment, Net

Property and equipment, net, consisted of the following (in thousands):

    

September 30, 2021

    

December 31, 2020

Computer, software and office equipment

$

286

$

122

Leasehold improvements

30

 

30

Total property and equipment, gross

 

316

 

152

Less: accumulated depreciation and amortization

 

(116)

 

(83)

Total property and equipment, net

$

200

$

69

Depreciation and amortization expense related to property and equipment was $13,000 and $9,000 for the three months ended September 30, 2021 and 2020, respectively, and $33,000 and $27,000 for the nine months ended September 30, 2021 and 2020, respectively.

14

5. Accrued Expenses

Accrued expenses consisted of the following (in thousands):

    

September 30, 2021

    

December 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

Total other accrued expenses

$

5,082

$

3,672

6. Convertible Preferred Stock and Stockholders’ Equity (Deficit)

Series A Convertible Preferred Stock

In December 2017, January 2018, and May 2019, the Company issued a total of 24,302,472 shares of Series A convertible preferred stock to certain investors at $2.16 per share.

In connection with the IPO (Note 1) in April 2021, all outstanding shares of Series A convertible preferred stock were converted into 5,430,957 shares of common stock.

Series B Convertible Preferred Stock

In December 2020, the Company and certain investors entered into a Series B preferred stock purchase agreement, whereby the Company issued 23,440,514 shares of Series B convertible preferred stock at $2.0215 per share for total gross proceeds of approximately $47.4 million before deducting offering costs of $0.3 million, which constituted the closing of the first tranche of the Series B convertible preferred stock. In connection with the closing of the first tranche of Series B convertible preferred stock in December 2020, the Company issued rights to the purchasers for the purchase of an additional 23,440,514 shares of Series B convertible preferred stock under the same terms and conditions upon the board of directors’ determination of either (i) that the cash balance of the Company is below $10 million, or (ii) approving the Company’s initial public offering of shares of its common stock pursuant to a registration statement under the Securities Act (Series B Tranche Right).

The Company evaluated the Series B Tranche Right and concluded that it was not a free-standing instrument that met the definition of a derivative that required separate accounting.

In March 2021, the Company completed the Series B Tranche Right at $2.0215 per share. A total of 23,440,514 shares of Series B convertible preferred stock were issued for aggregate net proceeds of approximately $47.4 million.

In connection with the IPO in April 2021, all outstanding shares of Series B convertible preferred stock were converted into 10,476,672 shares of common stock.

Shares Reserved for Future Issuance

As of September 30, 2021, the Company had reserved shares of its common stock for future issuance as follows:

    

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

15

7. Stock-Based Compensation

In 2014, the Company adopted the 2014 Equity Incentive Plan (the 2014 Plan). The 2014 Plan provides for the issuance of incentive stock options to employees of the Company and non-statutory stock options, restricted stock awards, restricted stock unit awards, stock appreciation rights and other stock awards to directors, employees and consultants of the Company. In March 2021, the Company’s board of directors increased the option pool by 234,158 shares of common stock.

Under the 2014 Plan, certain employees may be granted the ability to early exercise their options. The shares of common stock issued pursuant to the early exercise of unvested stock options are restricted and continue to vest over the requisite service period after issuance. The Company has the option to repurchase any unvested shares at the original purchase price upon any voluntary or involuntary termination. The shares purchased by the employees and non-employees pursuant to the early exercise of stock options are not deemed, for accounting purposes, to be outstanding until those shares vest. As of September 30, 2021, stock options to purchase 9,785 shares of common stock have been early exercised and were subject to vesting. Cash received in exchange for early exercises of stock options has been recorded as a liability for the early exercise of stock options and will be transferred into common stock and additional paid-in capital as the shares vest. As of September 30, 2021, such liability for early exercises of stock options was immaterial.

In March 2021, the Company’s board of directors adopted the Company’s 2021 Equity Incentive Plan (the 2021 Plan), and the Company’s stockholders approved the 2021 Plan in April 2021. The 2021 Plan became effective immediately prior to the execution of the underwriting agreement in connection with the IPO. Under the 2021 Plan, the Company may grant stock options, stock appreciation rights, restricted stock, restricted stock units, and other awards to individuals who are then employees, officers, directors or consultants of the Company, and employees and consultants of the Company’s affiliates. A total of 2,187,524 new shares of common stock were approved to be initially reserved for issuance under the 2021 Plan. In addition, the number of shares of common stock reserved for issuance under the 2021 Plan includes 117,639 shares (as adjusted for reverse stock split) reserved and available for issuance pursuant to the grant of new awards under the 2014 Plan as of the effectiveness of the 2021 Plan and will include any shares subject to stock awards granted under the 2014 Plan that, after the date the 2021 Plan became effective, are forfeited or otherwise become available under the 2014 Plan. The number of shares of common stock reserved for issuance under the 2021 Plan will also automatically increase on January 1 of each calendar year, beginning on January 1, 2022 and continuing through and including January 1, 2031, by 5% of the total number of shares of common stock outstanding on December 31 of the immediately preceding calendar year; provided, however, that the Company’s board of directors may act prior to January 1st of a given year to provide that the increase for such year will be a lesser number of shares of common stock. As of September 30, 2021, there were 2,061,163 shares available for future grant under the 2021 Plan.

In March 2021, the Company’s board of directors adopted the Company’s 2021 Employee Stock Purchase Plan (ESPP), and the Company’s stockholders approved the ESPP in April 2021. The ESPP became effective immediately prior to the execution of the underwriting agreement in connection with the Company’s IPO. A total of 243,058 shares of common stock were approved to be initially reserved for issuance under the ESPP. No shares have been issued under the ESPP through September 30, 2021.

16

A summary of the Company’s stock option activity and related information during the nine months ended September 30, 2021 is as follows:

    

    

Weighted-

    

Weighted- Average

 

Options

Average Exercise

Remaining

 

Aggregate

Outstanding

Price

Contractual Term

 

Intrinsic Value

Outstanding at December 31, 2020

935,478

$

2.56

7.7

Granted

2,487,285

$

5.59

Exercised

(206,859)

$

1.97

Outstanding at September 30, 2021

 

3,215,904

 

$

4.95

 

8.6

$

8,868,000

Vested at September 30, 2021

 

687,583

 

$

2.67

 

7.3

$

3,015,000

Exercisable at September 30, 2021

 

3,215,904

 

$

4.95

 

8.6

$

8,868,000

Options exercisable at September 30, 2021 include vested options and options eligible for early exercise. All outstanding options as of September 30, 2021 are expected to vest.

The weighted-average assumptions used in the Black-Scholes option pricing model to determine the fair value of the employee stock option grants were as follows:

    

Nine Months Ended

 

September 30, 

 

    

2021

    

2020

 

Risk-free interest rate

 

0.69

%  

1.07

%

Expected volatility

 

72.9

%  

71.7

%

Expected term (in years)

 

5.9

 

5.9

Expected dividend yield

 

%  

%

The weighted average grant date fair value of options granted during the three months ended September 30, 2021 was $6.58. No options were granted during the three months ended September 30, 2020. The weighted average grante date fair value of options granted during the nine months ended September 30, 2021 and 2020 was $3.59 and $2.48, respectively.

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Fair value of common stock. For periods prior to the IPO, the fair value of the shares of common stock underlying the stock options has been determined by the Company’s board of directors, with input from management. Historically, since there has been no public market for the Company’s common stock, the Company’s board of directors determined the fair value of the Company’s common stock on each grant date by considering a number of objective and subjective factors, including the most recent independent third-party valuations of the Company’s common stock, sales of the Company’s convertible preferred stock to unrelated third-parties, operating and financial performance of the Company, the lack of liquidity of capital stock and general and industry-specific economic outlook, and the Company’s board of directors’ assessment of additional objective and subjective factors that it believed were relevant. 

Risk-free interest rate. The Company bases the risk-free interest rate assumption on the U.S. Treasury’s rates for U.S. Treasury zero-coupon bonds with maturities similar to those of the expected term of the award being valued.

Expected volatility. The expected volatility assumption is based on the volatilities of a peer group of similar companies whose share prices are publicly available. The peer group was developed based on companies in the biotechnology industry.

Expected term. The expected term represents the period of time that options are expected to be outstanding. Because the Company does not have historical exercise behavior, it determines the expected life assumption using the simplified method, which is an average of the contractual term of the option and its vesting period.

Expected dividend yield. The Company bases the expected dividend yield assumption on the fact that it has never paid cash dividends and has no present intention to pay cash dividends.

Unrecognized compensation expense at September 30, 2021 for both employee and non-employee stock-based compensation expense was $7.1 million, which is expected to be recognized over a weighted-average vesting term of 2.79 years.

Non-cash stock-based compensation expense recorded in the condensed consolidated statements of operations and comprehensive loss is as follows (in thousands):

Three Months Ended

Nine Months Ended

September 30, 

September 30, 

    

2021

    

2020