Item 9A. Controls and Procedures
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
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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, 2025, 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, 2025.
Management’s Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act). Under the supervision of and with the participation of our principal executive officer and principal financial officer, our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2025, based on the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in “Internal Control-Integrated Framework” (2013). Based on this assessment, management concluded that our internal control over financial reporting was effective as of December 31, 2025.
Attestation Report of the Registered Public Accounting Firm
The effectiveness of our internal control over financial reporting has been audited by KPMG LLP, an independent registered public accounting firm, as stated in their attestation regarding internal controls over financial reporting included in the report of independent registered public accounting firm included in Item 8 of this Annual Report.
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, 2025 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
Director and Officer Trading Arrangements
During the last fiscal quarter, the following directors and “officers,” as defined in Rule 16a-1(f) of the Exchange Act, adopted a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” each as defined in Item 408 of Regulation S-K:
On December 26, 2025 , Joanne Donovan , Chief Medical Officer , adopted a Rule 10b5-1 trading arrangement providing for the sale from time to time of up to 125,361 shares of our common stock. The trading arrangement is intended to satisfy the affirmative defense in Rule 10b5-1(c). The duration of the trading arrangement is until December 28, 2026 , or earlier if all transactions under the trading arrangement are completed.
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No other directors or “officers,” as defined in Rule 16a-1(f) of the Exchange Act, adopted or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” each as defined in Item 408 of Regulation S-K, during the last fiscal quarter.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
None.
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, 2025, 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, 2025, 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, 2025, 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, 2025, 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, 2025, and is incorporated herein by reference.
PART IV
Item 15. Exhibit and 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, are 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).
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EXHIBIT INDEX
Incorporated by Reference
Exhibit
Number
Exhibit Description
Form
File No.
Exhibit
Filing Date
3.1
Amended and Restated Certificate of Incorporation of the Registrant.
10-Q
001-40236
3.1
August 8, 2024
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.
10-K
001-40236
4.3
February 24, 2022
4.4
Form of Indenture
S-3ASR
333-279299
4.4
May 10, 2024
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 ˄
2021 Employee Stock Purchase Plan, as amended, and forms of agreement thereunder.
10-K
001-40236
10.5
February 23, 2023
10.6 ˄
2024 Inducement Equity Incentive Plan and related forms of stock option and restricted stock unit agreements.
8-K
001-40236
10.1
August 12, 2024
10.7 ˄
Offer Letter between the Registrant and Kevin Koch, Ph.D.
S-1
333-253923
10.5
March 5, 2021
10.8 ˄
Offer Letter between the Registrant and Alan Russell, Ph.D.
S-1
333-253923
10.6
March 5, 2021
10.9 ˄
Offer Letter between the Registrant and R. Michael Carruthers.
S-1
333-253923
10.8
March 5, 2021
10.10 ˄
Offer Letter between the Registrant and Behrad Derakhshan, Ph.D.
S-1
333-253923
10.9
March 5, 2021
10.11 ˄
Offer Letter between the Registrant and John Moore.
S-1
333-253923
10.10
March 5, 2021
10.12 ˄
Offer Letter between the Registrant and Joanne Donovan, M.D., Ph.D.
10-Q
001-40236
10.1
May 13, 2021
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10.13 ˄
Offer Letter between the Registrant and Robert Blaustein, M.D., Ph.D.
10-K
001-40236
10.20
March 3, 2025
10.14 ˄
Offer Letter between the Registrant and Michael Nofi.
8-K
001-40236
10.1
November 10, 2025
10.15 ˄
Executive Incentive Compensation Plan.
S-1
333-253923
10.11
March 5, 2021
10.16 ˄
Executive Change in Control and Severance Plan.
S-1
333-253923
10.12
March 5, 2021
10.17 Ù
Amended and Restated Outside Director Compensation Policy.
10-Q
001-40236
10.1
May 8, 2025
10.18 Ù
Form of Restricted Stock Unit Agreement .
10-Q
001-40236
10.2
May 11, 2023
10.19 ˄+
Stock Option Agreement between the Registrant and Dr. Alan Russell, dated as of September 19, 2017.
S-8
333-283051
10.2
November 7, 2024
10.20
Sales Agreement, dated May 10, 2024, by and between the Registrant and Leerink Partner LLC.
S-3
333-279299
1.2
May 10, 2024
10.21
Letter Agreement between the Registrant and R. Michael Carruthers.
Filed herewith
19.1
Insider Trading Policy
10-K
001-40236
19.1
March 3, 2025
23.1
Consent of Independent Registered Public Accounting Firm.
Filed herewith
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 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
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
97.1
Compensation Recovery Policy
10-K
001-40236
97.1
February 22, 2024
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
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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
Ù
Indicates management contract or compensatory plan.
+
Portions of this exhibit have been redacted in compliance with Regulation S-K Item 601(a)(6).
*
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.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Date: February 26, 2026
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 Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Signature
Title
Date
/s/ Kevin Koch
President, Chief Executive Officer and Director
February 26, 2026
Kevin Koch, Ph.D.
(Principal Executive Officer)
/s/ Michael Nofi
Chief Financial Officer
February 26, 2026
Michael Nofi
(Principal Financial and Accounting Officer)
/s/ Peter Thompson
Co-Founder, Chairman and Director
February 26, 2026
Peter Thompson, M.D.
/s/ Alan Russell
Chief Scientific Officer and Director
February 26, 2026
Alan Russell, Ph.D.
/s/ Laura A. Brege
Director
February 26, 2026
Laura A. Brege
/s/ Badreddin Edris
Co-Founder and Director
February 26, 2026
Badreddin Edris, Ph.D.
/s/ Jonathan Fox
Director
February 26, 2026
Jonathan Fox, M.D., Ph.D., FACC
/s/ Christopher Martin
Director
February 26, 2026
Christopher Martin
/s/ Arlene Morris
Director
February 26, 2026
Arlene Morris
/s/ Jonathan Root
Director
February 26, 2026
Jonathan Root, M.D.
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