Edgewise Therapeutics, Inc. 10-K

Item 9A. Controls and Procedures Evaluation of Disclosure Controls and Procedures We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports filed or submitted under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time period specified in the SEC's rules and forms, and that such information is accumulated and communicated to management including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. As of December 31, 2021, we carried out an evaluation under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934. Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at a reasonable assurance level as of December 31, 2021. Management’s Report on Internal Control Over Financial Reporting This Annual Report on Form 10-K does not include a report of management’s assessment regarding internal control over financial reporting or an attestation report of our registered public accounting firm due to a transition period established by rules of the Securities and Exchange Commission for newly public companies. Changes in Internal Control over Financial Reporting There was no change in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Securities Exchange Act of 1934 that occurred during the quarter ended December 31, 2021 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. Inherent Limitations on Effectiveness of Controls A control system, no matter how well designed and operated, can provide only reasonable and not absolute assurance of achieving the desired control objectives. In reaching a reasonable level of assurance, management necessarily was required to apply its judgment in evaluating the benefits of possible controls and procedures relative to their costs. In addition, the design of any system of controls is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected. ​ Item 9B. Other Information None. Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections None. ​ 165 ​ Table of Contents PART III Item 10. Directors, Executive Officers and Corporate Governance Information required by this item will be contained in our definitive proxy statement to be filed with the SEC on Schedule 14A within 120 days after December 31, 2021, and is incorporated herein by reference. Item 11. Executive Compensation Information required by this item will be contained in our definitive proxy statement to be filed with the SEC on Schedule 14A within 120 days after December 31, 2021, and is incorporated herein by reference. ​ Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters Information required by this item will be contained in our definitive proxy statement to be filed with the SEC on Schedule 14A within 120 days after December 31, 2021, and is incorporated herein by reference. ​ Item 13. Certain Relationships and Related Transactions, and Director Independence Information required by this item will be contained in our definitive proxy statement to be filed with the SEC on Schedule 14A within 120 days after December 31, 2021, and is incorporated herein by reference . ​ Item 14. Principal Accounting Fees and Services Information required by this item will be contained in our definitive proxy statement to be filed with the SEC on Schedule 14A within 120 days after December 31, 2021, and is incorporated herein by reference. ​ PART IV Item 15. Exhibits, Financial Statement Schedules (a) The following documents are filed as part of this report: (1) Financial Statements The financial statements of Edgewise Therapeutics, Inc. are filed as part of this report on Form 10-K under Item 8. Financial Statements and Supplementary Data. (2) Financial Statement Schedules All other schedules have been omitted because they are not required, not inapplicable, or the required information is included in the financial statements or notes thereto. (3) Exhibits The documents listed in the Exhibit Index are incorporated by reference or are filed with this report, in each case as indicated herein (numbered in accordance with Item 601 of Regulation S-K). ​ EXHIBIT INDEX ​ ​ 166 ​ Table of Contents Incorporated by Reference Exhibit Number Exhibit Description Form File No. Exhibit Filing Date 3.1 Amended and Restated Certificate of Incorporation of the Registrant. 8-K 001-40236 3.1 March 30, 2021 3.2 Amended and Restated Bylaws of the Registrant. 8-K 001-40236 3.2 March 30, 2021 4.1 Amended and Restated Investors’ Rights Agreement by and among the Registrant and certain of its stockholders, dated December 3, 2020. S-1 333-253923 4.1 March 5, 2021 4.2 Specimen common stock certificate of the Registrant. S-1 333-253923 ​ 4.2 ​ March 5, 2021 4.3 Description of Securities. Filed herewith 10.1 ˄ Form of Indemnification Agreement between the Registrant and each of its directors and executive officers. S-1 333-253923 10.1 March 5, 2021 10.2 ˄ 2017 Equity Incentive Plan, as amended, and forms of agreement thereunder. S-1 333-253923 10.2 March 5, 2021 10.3 ˄ 2021 Equity Incentive Plan and forms of agreements thereunder. S-1 333-253923 10.3 March 5, 2021 10.4 ˄ 2021 Employee Stock Purchase Plan and forms of agreements thereunder. S-1 333-253923 10.4 March 5, 2021 10.5 ˄ Offer Letter between the Registrant and Kevin Koch, Ph.D. S-1 333-253923 10.5 March 5, 2021 10.6 ˄ Offer Letter between the Registrant and Alan Russell, Ph.D. S-1 333-253923 10.6 March 5, 2021 10.7 ˄ Offer Letter between the Registrant and R. Michael Carruthers. S-1 333-253923 10.8 March 5, 2021 10.8 ˄ Offer Letter between the Registrant and Behrad Derakhshan, Ph.D. S-1 333-253923 10.9 March 5, 2021 10.9 ˄ Offer Letter between the Registrant and John Moore. S-1 333-253923 10.10 March 5, 2021 10.10 ˄ Offer Letter between the Company and Joanne Donovan, M.D., Ph.D. 10-Q 001-40236 10.1 May 13, 2021 10.11 ˄ Executive Incentive Compensation Plan. S-1 333-253923 10.11 March 5, 2021 10.12 ˄ Executive Change in Control and Severance Plan. S-1 333-253923 10.12 March 5, 2021 10.13 ˄ Outside Director Compensation Policy. S-1 333-253923 10.13 March 5, 2021 10.14 Lease between the Registrant and Regents of the University of Colorado, dated July 21, 2020. S-1 333-253923 10.14 March 5, 2021 167 ​ Table of Contents 23.1 ​ Consent of Independent Registered Public Accounting Firm. ​ Filed herewith ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 24.1 ​ Power of Attorney (reference is made to the signature page hereto). ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 31.1 ​ Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, As Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. ​ Filed herewith ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 31.2 ​ Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 14d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. ​ Filed herewith ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 32.1* ​ Certification of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. ​ Filed herewith ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 101.INS ​ XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document ​ Filed herewith ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 101.SCH ​ Inline XBRL Taxonomy Extension Schema Document ​ Filed herewith ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 101.CAL ​ Inline XBRL Taxonomy Extension Calculation Linkbase Document ​ Filed herewith ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 101.DEF ​ Inline XBRL Taxonomy Extension Definition Linkbase Document ​ Filed herewith ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 101.LAB ​ Inline XBRL Taxonomy Extension Label Linkbase Document ​ Filed herewith ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 101.PRE ​ Inline XBRL Taxonomy Extension Presentation Linkbase Document ​ Filed herewith ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 104 ​ Cover Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101) ​ Filed herewith ​ ​ ​ ​ ​ ​ ​ ​ ​ ˄ Indicates management contract or compensatory plan. ​ * The certifications attached as Exhibit 32.1 that accompany this Annual Report on Form 10-K are deemed furnished and not filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of the Registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Annual Report on Form 10-K, irrespective of any general incorporation language contained in such filing. ​ ​ ​ Item 16. Form 10-K Summary ​ None. 168 ​ Table of Contents ​ SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, duly authorized. Date: February 24, 2022 ​ ​ ​ ​ ​ EDGEWISE THERAPEUTICS, INC. ​ ​ ​ ​ By: /s/ Kevin Koch ​ Name: Kevin Koch ​ Title: President, Chief Executive Officer and Director ​ ​ (Principal Executive Officer) ​ Pursuant to the requirements of the Securities Act of 1934, this report has been signed by the following persons in the capacities and on the dates indicated. ​ Signature ​ ​ Title ​ ​ Date ​ ​ ​ /s/ Kevin Koch Kevin Koch, Ph.D. ​ ​ President, Chief Executive Officer and Director (Principal Executive Officer) ​ ​ February 24, 2022 ​ ​ ​ H /s/ R. Michael Carruthers R. Michael Carruthers ​ ​ Chief Financial Officer (Principal Financial and Accounting Officer) ​ ​ February 24, 2022 ​ ​ ​ /s/ Peter Thompson ​‘s’ Peter Thompson, M.D. ​ ​ Co-Founder, Chairman and Director ​ ​ February 24, 2022 ​ ​ ​ ​ /s/ Alan Russell Alan Russell, Ph.D. ​ ​ Chief Scientific Officer and Director ​ ​ February 24, 2022 ​ ​ ​ ​ /s/ Laura A. Brege Laura A. Brege ​ ​ Director ​ ​ February 24, 2022 ​ ​ ​ ​H /s/ Badreddin Edris Badreddin Edris, Ph.D. ​ ​ Co-Founder and Director ​ ​ February 24, 2022 ​ ​ ​ ​ /s/ Kenneth Harrison Kenneth Harrison, Ph.D. ​ ​ Director ​ ​ February 24, 2022 ​ ​ ​ ​ /s/ Jonathan Root Jonathan Root, M.D. ​ ​ Director ​ ​ February 24, 2022 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 169 ​