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, 2024. 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, 2024, 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, 2024. 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, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. 150 Item 9B. Other Information. Trading Arrangements During the quarter ended December 31, 2024, our executive officers adopted, modified or terminated trading plans for the orderly disposition of the Company’s securities as set forth in the table below. Type of Trading Arrangement Name and Position Action Adoption/Termination Date Rule 10b5-1 (1) Non-Rule 10b5-1 (2) Total Shares of Common Stock to be Sold Expiration Date Eric Karas , Chief Commercial Officer Adoption November 22, 2024 X 60,000 January 30, 2026 Alexander Fitzpatrick , Chief Legal Officer Termination (3) November 26, 2024 X 120,000 December 31, 2024 Alexander Fitzpatrick , Chief Legal Officer Adoption November 27, 2024 X 100,000 December 31, 2025 Alexander Fitzpatrick , Chief Legal Officer Termination (4) December 13, 2024 X 100,000 December 31, 2025 Alexander Fitzpatrick , Chief Legal Officer Adoption (4) December 13, 2024 X 100,000 December 31, 2025 Brian Dorsey , Chief Operating Officer Adoption December 13, 2024 X 300,000 December 31, 2025 (1) Contract, instruction or written plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act. (2) "Non-Rule 10b5-1 trading arrangement" as defined in Item 408(c) of Regulation S-K under the Exchange Act. (3) Represents the termination of a trading plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) adopted on March 31, 2023 and amended on September 29, 2023. (4) Represents the modification, as described in Rule 10b5-1(c)(1)(iv) under the Exchange Act, of a written plan adopted on November 27, 2024 that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act. Item 9C. Disclosure regarding Foreign Jurisdictions that Prevent Inspections. Not applicable. 151 PART III Item 10. Directors, Executive Officers and Corporate Governance. The information required by this item and not set forth below will be set forth in the proposal headed Election of Directors and section headed Executive Officers contained in our definitive proxy statement for our 2025 annual meeting of stockholders to be filed with the Securities and Exchange Commission on or before April 30, 2025 (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 ir.ars-pharma.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 the sections headed Executive Compensation and Non-Employee Director Compensation contained in the Proxy Statement and is incorporated herein by reference. Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters. The information required by this item will be set forth in the sections headed Security Ownership of Certain Beneficial Owners and Management and E x ecutive Compensation contained in the Proxy Statement and is incorporated herein by reference. Item 13. Certain Relationships and Related Transactions, and Director Independence. The 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 the Proxy Statement and is incorporated herein by reference. Item 14. Principal Accountant Fees and Services. The information required by this item will be set forth in the proposal headed Ratification of Selection of Independent Registered Public Accounting Firm contained in the Proxy Statement and is incorporated herein by reference. 152 PART IV Item 15. Exhibits and Financial Statement Schedules. (a) Documents filed as part of this report. (1) Financial Statements. The following financial statements of ARS Pharmaceuticals, 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 are included on the following pages: Page Report of Independent Registered Public Accounting Firm (PCAOB ID: 42) 121 Consolidated Balance Sheets 122 Consolidated Statements of Operations and Comprehensive Income (Loss) 123 Consolidated Statements of Stockholders’ Equity 124 Consolidated Statements of Cash Flows 125 Notes to Consolidated Financial Statements 126 (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 2.1 ‡ Agreement and Plan of Merger and Reorganization, dated as of July 21, 2022, by and among Silverback Therapeutics, Inc., Sabre Merger Sub, Inc. and ARS Pharmaceuticals, Inc., as amended by the First Amendment, dated August 11, 2022 and the Second Amendment, dated October 25, 2022 (incorporated by reference to Exhibit 2.1 to the registrant’s Current Report on Form 8-K, as amended, filed with the SEC on November 8, 2022). 3.1 Amended and Restated Certificate of Incorporation, as amended (incorporated by reference to Exhibit 3.1 to the registrant’s Annual Report on Form 10-K, filed with the SEC on March 23, 2023). 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 Description of Registrant’s Common Stock (incorporated by reference to Exhibit 4.3 to the registrant’s Annual Report on Form 10-K, filed with the SEC on March 23, 2023). 4.3 Warrant to purchase stock issued to Silicon Valley Bank, dated as of September 30, 2019, as amended on December 7, 2020 (incorporated by reference to Exhibit 4.1 to the registrant's Current Report on Form 8-K, filed with the SEC on November 8, 2022). 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+ ARS Pharmaceuticals, 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+ ARS Pharmaceuticals, 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/A (File No. 333-250009), as amended, filed with the SEC on November 30, 2020). 10.4+ Forms of Restricted Stock Unit Grant Notice and Restricted Stock Unit Award Agreement under the ARS Pharmaceuticals, Inc. 2020 Equity Incentive Plan (incorporated by reference to Exhibit 10.15 to the Registrant’s Annual Report on Form 10-K, filed with the SEC on March 31, 2022). 10.5+ ARS Pharmaceuticals, 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). 153 10.6+ ARS Pharmaceuticals, Inc. 2018 Equity Incentive Plan, as amended (incorporated by reference to Exhibit 99.1 to the registrant’s Registration Statement on Form S-8 (File No. 333-269262) filed with the SEC on January 17, 2023). 10.7+ Forms of Stock Option Grant Notice, Option Agreement, Notice of Exercise and Early Exercise Stock Purchase Agreement under the ARS Pharmaceuticals, Inc. 2018 Equity Incentive Plan, as amended (incorporated by reference to Exhibit 99.2 to the registrant’s Registration Statement on Form S-8 (File No. 333-269262) filed with the SEC on January 17, 2023). 10.8+ ARS Pharmaceuticals Inc. Change in Control and Severance Benefit Plan (incorporated by reference to Exhibit 10.8 to the registrant’s Annual Report on Form 10-K, filed with the SEC on March 23, 2023). 10.9+ Non-Employee Director Compensation Policy, as amended (incorporated by reference to Exhibit 10.1 to the registrant’s Quarterly Report on Form 10-Q, filed with the SEC on August 6, 2024). 10.10 ‡ * Termination Agreement, dated as of February 22, 2023, by and between ARS Pharmaceuticals, Inc. and Recordati Ireland, Ltd (incorporated by reference to Exhibit 10.10 to the registrant’s Annual Report on Form 10-K, filed with the SEC on March 23, 2023). 10.11 ‡ * License Agreement, dated as of June 18, 2018, by and between ARS Pharmaceuticals, Inc. and Aegis Therapeutics, LLC, as amended by the First Amendment to License Agreement, dated as of July 15, 2020, and the Second Amendment to License Agreement, dated as of January 6, 2021 (incorporated by reference to Exhibit 10.1 to the registrant’s Current Report on Form 8-K, filed with the SEC on November 8, 2022). 10.12 ‡ * Collaboration and License Agreement, dated as of April 30, 2020, by and between ARS Pharmaceuticals, Inc. and Alfresa Pharma Corporation (incorporated by reference to Exhibit 10.2 to the registrant’s Current Report on Form 8-K, filed with the SEC on November 8, 2022). 10.13 ‡ * Collaboration and Distribution Agreement, dated as of March 1, 2021, by and between ARS Pharmaceuticals, Inc. and Pediatrix Therapeutics (incorporated by reference to Exhibit 10.3 to the registrant’s Current Report on Form 8-K, filed with the SEC on November 8, 2022). 10.14 ‡ * Manufacturing Agreement, dated as September 9, 2020, by and between ARS Pharmaceuticals, Inc. and Renaissance Lakewood, LLC (incorporated by reference to Exhibit 10.5 to the registrant’s Current Report on Form 8-K, filed with the SEC on November 8, 2022). 10.15+ Executive Employment Agreement, dated as of September 14, 2018, by and between ARS Pharmaceuticals, Inc. and Richard E. Lowenthal (incorporated by reference to Exhibit 10.6 to the registrant’s Current Report on Form 8-K, filed with the SEC on November 8, 2022). 10.16+ Executive Employment Agreement, dated as of February 9, 2022, by and between ARS Pharmaceuticals, Inc. and Kathleen Scott (incorporated by reference to Exhibit 10.7 to the registrant’s Current Report on Form 8-K, filed with the SEC on November 8, 2022). 10.17+ Executive Employment Agreement, dated as of September 14, 2018, by and between ARS Pharmaceuticals, Inc. and Dr. Sarina Tanimoto, as amended by Amendment No. 1 to Executive Employment Agreement, dated as of September 1, 2021 (incorporated by reference to Exhibit 10.8 to the registrant’s Current Report on Form 8-K, filed with the SEC on November 8, 2022). 10.18+ Executive Employment Agreement, as of February 16, 2022, by and between ARS Pharmaceuticals, Inc. and Eric Karas (incorporated by reference to Exhibit 10.9 to the registrant’s Current Report on Form 8-K, filed with the SEC on November 8, 2022). 10.19+ Executive Employment Agreement, dated as of June 1, 2019, by and between ARS Pharmaceuticals, Inc. and Justin Chakma (incorporated by reference to Exhibit 10.10 to the registrant’s Current Report on Form 8-K, filed with the SEC on November 8, 2022). 10.20+ Executive Employment Agreement, by and between the ARS Pharmaceuticals, Inc. and Brian T. Dorsey, effective as of October 1, 2018 (incorporated by reference to Exhibit 10.1 to the registrant’s Current Report on Form 8-K, filed with the SEC on December 9, 2022). 10.21+ Executive Employment Agreement, by and between ARS Pharmaceuticals, Inc. and Alex Fitzpatrick, effective as of December 1, 2022 (incorporated by reference to Exhibit 10.21 to the registrant’s Annual Report on Form 10-K, filed with the SEC on March 23, 2023). 10.22+ Consulting Agreement, dated as of April 26, 2021, by and between ARS Pharmaceuticals, Inc. and Brenton L. Saunders, as amended on April 25, 2022 (incorporated by reference to Exhibit 10.11 to the registrant’s Current Report on Form 8-K, filed with the SEC on November 8, 2022). 10.23+ Consulting Agreement, by and between ARS Pharmaceuticals, Inc. and Marlinspike Group, LLC, dated September 14, 2018 (incorporated by reference to Exhibit 10.12 to the registrant’s Current Report on Form 8-K, filed with the SEC on November 8, 2022). 10.24+ Consulting Agreement, by and between ARS Pharmaceuticals, Inc. and Pacific-Link Regulatory Consulting, Inc., dated July 1, 2022 (incorporated by reference to Exhibit 10.13 to the registrant’s Current Report on Form 8-K, filed with the SEC on November 8, 2022). 154 10.25 ‡ * First Amendment, dated July 26, 2023, to Manufacturing Agreement, dated as September 9, 2020, by and between ARS Pharmaceuticals, Inc. and Renaissance Lakewood, LLC. (incorporated by reference to Exhibit 10.1 to the registrant’s Quarterly Report on Form 10-Q filed with the SEC on August 10, 2023) 10.26 ‡ * Second Amendment, dated September 17, 2024, to Manufacturing Agreement, dated as September 9, 2020 and first amended July 26, 2023, by and between ARS Pharmaceuticals, Inc. and Renaissance Lakewood, LLC. (incorporated by reference to Exhibit 10.1 to the registrant’s Quarterly Report on Form 10-Q filed with the SEC on November 13, 2024). 10.27 ‡ * Collaboration, License and Distribution Agreement, dated November 9, 2024, by and between ARS Pharmaceuticals, Inc. and ALK-Abelló A/S. 10.28 ‡ * Supply Agreement, dated November 9, 2024, by and between ARS Pharmaceuticals, Inc. and ALK-Abelló A/S. 10.29 ‡ * Supply Agreement, dated as of October 8, 2024, by and between ARS Pharmaceuticals, Inc. and Nuova Ompi S.r.l. 10.30 * Letter Agreement, dated December 6, 2024, by and between ARS Pharmaceuticals, Inc. and Renaissance Lakewood, LLC (amends the Manufacturing Agreement, dated as of September 9, 2020, as amended July 25, 2023 and as further amended September 17, 2024, by and between ARS Pharmaceuticals, Inc. and Renaissance Lakewood, LLC). 19.1 Insider Trading Policy. 21.1 Subsidiaries of the registrant (incorporated by reference to Exhibit 21.1 to the registrant’s Annual Report on Form 10-K filed with the SEC on March 21, 2024). 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. 97.1 Incentive Compensation Recoupment Policy (incorporated by reference to Exhibit 97.1 to the registrant’s Annual Report on Form 10-K filed with the SEC on March 21, 2024). 101.INS Inline XBRL Instance Document–the instance document does not appear in the Interactive Data File as its XBRL tags are embedded within the Inline XBRL document 101.SCH Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents 104 Cover page formatted as Inline XBRL and contained in Exhibit 101 + 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 information in this exhibit is omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K 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. 155 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. ARS Pharmaceuticals, Inc. Date: March 20, 2025 By: /s/ Richard Lowenthal Richard Lowenthal, M.S., MSEL President, Chief Executive Officer, and Director POWER OF ATTORNEY KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Richard Lowenthal and Kathleen Scott, 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, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated. Name Title Date /s/ Richard Lowenthal President, Chief Executive Officer, and Director March 20, 2025 Richard Lowenthal, M.S., MSEL (Principal Executive Officer) /s/ Kathleen D. Scott Chief Financial Officer March 20, 2025 Kathleen D. Scott (Principal Financial and Accounting Officer) /s/ Pratik Shah Chairman of the Board of Directors March 20, 2025 Pratik Shah, Ph.D. /s/ Peter Kolchinsky Director March 20, 2025 Peter Kolchinsky, Ph.D. /s/ Rajeev Dadoo Director March 20, 2025 Rajeev Dadoo, Ph.D. /s/ Brenton L. Saunders Director March 20, 2025 Brenton L. Saunders /s/ Phillip Schneider Director March 20, 2025 Phillip Schneider /s/ Michael Kelly Director March 20, 2025 Michael Kelly /s/ Laura Shawver Director March 20, 2025 Laura Shawver, Ph.D. /s/ Peter A. Thompson Director March 20, 2025 Peter A. Thompson, M.D. /s/ Saqib Islam Director March 20, 2025 Saqib Islam, J.D. 156