ARS Pharmaceuticals, Inc. 10-K

Item 9A. Controls and Procedures. Evaluation of Disclosure Controls and Procedures As required by Rules 13a-15(b) and 15d-15(b) of the Exchange Act, our management with the participation of our Chief Executive Officer and our Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2021. The term “disclosure controls and procedures” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of December 31, 2021, our Chief Executive Officer and our Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level. Management’s Report on Internal Control over Financial Reporting Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Rule 13a-15(f) under the Exchange Act. Our management, including our Chief Executive Officer and Chief Financial Officer, conducted an evaluation of the effectiveness of our internal control over financial reporting based on the 2013 framework in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this evaluation, our management concluded that our internal control over financial reporting was effective as of December 31, 2021. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risks that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. Changes in Internal Control over Financial Reporting There were no changes in our internal control over financial reporting that occurred during the quarter ended December 31, 2021 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. 117 Item 9B. Other Information. On March 28, 2022, our board of directors approved a corporate restructuring plan to discontinue our clinical development programs for SBT6050 and SBT6290 and to prioritize resources on the development of SBT8230 and early-stage discovery programs (the Restructuring Plan). In connection with the Restructuring Plan, our workforce will be reduced by 27%, with substantially all of the reduction in personnel expected to be completed by July 15, 2022. We initiated the reduction in force on March 31, 2022 and expect to provide severance payments, continuation of group health insurance coverage, and other benefits for a specified period to the affected employees. We currently estimate that we will incur costs of approximately $2.0 million for termination benefits related to the Restructuring Plan, all of which will be cash expenditures. Item 9C. Disclosure regarding Foreign Jurisdictions that Prevent Inspections. Not applicable. 118 PART III Item 10. Directors, Executive Officers and Corporate Governance. Information required by this item and not set forth below will be set forth in the sections headed Election of Directors and Executive Officers contained in our definitive Proxy Statement to be filed with the Commission within 120 days after the conclusion of our year ended December 31, 2021 (the Proxy Statement) pursuant to General Instructions G(3) of Form 10-K and is incorporated herein by reference. We have adopted a Code of Business Conduct and Ethics that applies to all officers, directors and employees, including our principal executive officer, principal financial officer, principal accounting officer or controller, or person performing similar functions. A current copy of the Code of Business Conduct and Ethics is available on the Corporate Governance section of our website at www.silverbacktx.com. If we make any substantive amendments to the Code of Business Conduct and Ethics or grants any waiver from a provision of the Code of Business Conduct and Ethics to any executive officer or director that are required to be disclosed pursuant to SEC rules, we will promptly disclose the nature of the amendment or waiver on our website or in a current report on Form 8-K. Item 11. Executive Compensation. The information required by this item will be set forth in our Proxy Statement in the sections headed Executive Compensation and Summary Compensation Table for Fiscal 2021 and 2020 contained in our Proxy Statement 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 set forth in the sections headed Security Ownership of Certain Beneficial Owners and Management, Executive Compensation, and Non-Employee Director Compensation contained in our Proxy Statement and is incorporated herein by reference. Item 13. Certain Relationships and Related Transactions, and Director Independence. Information required by this item will be set forth in the sections headed Certain Related-Person Transactions and Information Regarding the Board of Directors and Corporate Governance contained in our Proxy Statement and is incorporated herein by reference. Item 14. Principal Accountant Fees and Services. Information required by this item will be set forth in the sections headed Ratification of Selection of Independent Registered Public Accounting Firm contained in our Proxy Statement and is incorporated herein by reference. 119 PART IV Item 15. Exhibits, Financial Statement Schedules. (a) Documents filed as part of this report. (1) Financial Statements. The following financial statements of Silverback Therapeutics, Inc., together with the report of Ernst & Young LLP, an independent registered public accounting firm, required to be filed pursuant to Part II, Item 8 of this Annual Report on Form 10-K are included on the following pages: Page Report of Independent Registered Public Accounting Firm (PCAOB ID: 42) 99 Balance Sheets 100 Statements of Operations and Comprehensive Loss 101 Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) 102 Statements of Cash Flows 103 Notes to Financial Statements 104 (2) Financial Statement Schedules. None. (3) List of exhibits required by Item 601 of Regulation S-K . See part (b) below. (b) Exhibits. Exhibit Number Description 3.1 Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to the registrant’s Current Report on Form 8-K, filed with the SEC on December 8, 2020). 3.2 Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 to the registrant’s Current Report on Form 8-K, filed with the SEC on December 8, 2020). 4.1 Reference is made to Exhibit 3.1 and 3.2 . 4.2 Form of Common Stock Certificate of the registrant (incorporated by reference to Exhibit 4.1 to the registrant’s Registration Statement on Form S-1 (File No. 333-250009), as amended, filed with the SEC on November 30, 2020). 4.3 Amended and Restated Investors’ Rights Agreement, by and between the registrant and certain of its stockholders, dated September 22, 2020 (incorporated by reference to Exhibit 4.2 to the registrant’s Registration Statement on Form S-1 (File No. 333-250009), as amended, filed with the SEC on November 10, 2020). 4.4 Description of Registrant’s Common Stock (incorporated by reference to Exhibit 4.6 to the registrant’s Annual Report on Form 10-K, filed with the SEC on March 29, 2021). 10.1+ Form of Indemnity Agreement, by and between the registrant and its directors and officers (incorporated by reference to Exhibit 10.1 to the registrant’s Registration Statement on Form S-1 (File No. 333-250009), as amended, filed with the SEC on November 10, 2020). 10.2+ Silverback Therapeutics, Inc. 2016 Equity Incentive Plan, as amended, and Forms of Option Agreement, Notice of Exercise, Notice of Early Exercise, Restricted Stock Grant Notice and Restricted Stock Award Agreement thereunder (incorporated by reference to Exhibit 10.2 to the registrant’s Registration Statement on Form S-1 (File No. 333-250009), as amended, filed with the SEC on November 10, 2020). 10.3+ Silverback Therapeutics, Inc. 2020 Equity Incentive Plan, and Forms of Option Grant Notice, Option Agreement and Notice of Exercise thereunder (incorporated by reference to Exhibit 10.3 to the registrant’s Registration Statement on Form S-1 (File No. 333-250009), as amended, filed with the SEC on November 30, 2020). 10.4+ Silverback Therapeutics, Inc. 2020 Employee Stock Purchase Plan (incorporated by reference to Exhibit 10.4 to the registrant’s Registration Statement on Form S-1 (File No. 333-250009), as amended, filed with the SEC on November 30, 2020). 10.5+¥ Letter Agreement, by and between the registrant and Laura Shawver, Ph.D., dated March 6, 2020, as amended (incorporated by reference to Exhibit 10.5 to the registrant’s Registration Statement on Form S-1 (File No. 333-250009), as amended, filed with the SEC on November 10, 2020). 120 10.6+¥ Letter Agreement, by and between the registrant and Valerie Odegard, Ph.D., dated July 23, 2016 (incorporated by reference to Exhibit 10.6 to the registrant’s Registration Statement on Form S-1 (File No. 333-250009), as amended, filed with the SEC on November 10, 2020). 10.7+¥ Letter Agreement, by and between the registrant and Naomi Hunder, M.D., dated December 22, 2018 (incorporated by reference to Exhibit 10.7 to the registrant’s Registration Statement on Form S-1 (File No. 333-250009), as amended, filed with the SEC on November 10, 2020). 10.8+¥ Letter Agreement, by and between the registrant and Jonathan Piazza, dated November 3, 2020 (incorporated by reference to Exhibit 10.8 to the registrant’s Registration Statement on Form S-1 (File No. 333-250009), as amended, filed with the SEC on November 10, 2020). 10.9¥ Lease, by and between the registrant and BMR-500 Fairview Avenue LLC, dated June 8, 2016 (incorporated by reference to Exhibit 10.9 to the registrant’s Registration Statement on Form S-1 (File No. 333-250009), as amended, filed with the SEC on November 10, 2020). 10.10*¥ Cell Line License Agreement, by and between the registrant and WuXi Biologics (Hong Kong) Limited, dated October 11, 2019 (incorporated by reference to Exhibit 10.12 to the registrant’s Registration Statement on Form S-1 (File No. 333-250009), as amended, filed with the SEC on November 10, 2020). 10.11+ Silverback Therapeutics, Inc. 2020 Change in Control and Severance Benefit Plan (incorporated by reference to Exhibit 10.14 to the registrant’s Registration Statement on Form S-1 (File No. 333-250009), as amended, filed with the SEC on November 10, 2020). 10.12+ Non-Employee Director Compensation Policy (incorporated by reference to Exhibit 10.15 to the registrant’s Registration Statement on Form S-1 (File No. 333-250009), as amended, filed with the SEC on November 30, 2020). 10.13** Amendment No. 1 to Cell Line License Agreement, by and between the registrant and WuXi Biologics (Hong Kong) Limited, dated January 12, 2021 (incorporated by reference to Exhibit 10.16 to the registrant’s Annual Report on Form 10-K, filed with the SEC on March 29, 2021). 10.14¥ Sublease Agreement, by and between the registrant and Delta Dental of Washington, dated July 1, 2021 (incorporated by reference to Exhibit 10.1 to the registrant's Quarterly Report on Form 10-Q, filed with the SEC on November 10, 2021. 10.15+ Forms of Restricted Stock Unit Grant Notice and Restricted Stock Unit Award Agreement under the Silverback Therapeutics, Inc. 2020 Equity Incentive Plan. 23.1 Consent of Independent Registered Public Accounting Firm. 24.1 Power of Attorney (see signature page). 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. 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. 32.1 Certification of Principal Executive and Financial Officers Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. 101.INS Inline XBRL Instance Document 101.SCH Inline XBRL Taxonomy Extension Schema Document 101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document 101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document 101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document 101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document 104 Cover Page Interactive Data File (embedded within the Inline XBRL document) + Indicates management contract or compensatory plan. ¥ Schedules have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The registrant undertakes to furnish supplemental copies of any of the omitted schedules upon request by the SEC. * Certain portions of this exhibit are omitted because they are not material and would likely cause competitive harm to the registrant if disclosed. ** Certain information in this exhibit is omitted because it is both not material and is the type that the registrant treats as private or confidential. Item 16. Form 10-K Summary None. 121 SIGN ATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized. SILVERBACK THERAPEUTICS, INC. Date: March 31, 2022 By: /s/ Laura Shawver, Ph.D. Laura Shawver, Ph.D. Chief Executive Officer POWER OF ATTORNEY KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Laura Shawver and Jonathan Piazza, and each of them, his or her true and lawful attorneys-in-fact, each with full power of substitution, for him or her in any and all capacities, to sign any amendments to this Annual Report on Form 10-K and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, hereby ratifying and confirming all that each of said attorneys-in-fact or their substitute or substitutes may do or cause to be done by virtue hereof. Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Report has been signed below by the following persons on behalf of the Registrant in the capacities and on the dates indicated. Name Title Date /s/ Laura Shawver, Ph.D. Chief Executive Officer and Director March 31, 2022 Laura Shawver, Ph.D. (Principal Executive Officer) /s/ Jonathan Piazza Chief Financial Officer March 31, 2022 Jonathan Piazza (Principal Financial Officer) /s/ Russ Hawkinson Senior Vice President of Finance March 31, 2022 Russ Hawkinson (Principal Accounting Officer) /s/ Peter Thompson, M.D. Chairman of the Board of Directors March 31, 2022 Peter Thompson, M.D. /s/ Vickie L. Capps Director March 31, 2022 Vickie L. Capps /s/ Robert Hershberg, M.D., Ph.D. Director March 31, 2022 Robert Hershberg, M.D., Ph.D. /s/ Saqib Islam, J.D. Director March 31, 2022 Saqib Islam, J.D. /s/ Andrew Powell, J.D. Director March 31, 2022 Andrew Powell, J.D. /s/ Jonathan Root, M.D. Director March 31, 2022 Jonathan Root, M.D. /s/ Thilo Schroeder, Ph.D. Director March 31, 2022 Thilo Schroeder, Ph.D. /s/ Maria Koehler, M.D., Ph.D. Director March 31, 2022 Maria Koehler, M.D., Ph.D. 122