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Item 9A. Controls and Procedures

2024-03-21 compared with 2023-03-23 · 75 added, 58 removed, 119 unchanged (53% of the section changed)

2 unchanged sentences

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, 2023.

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.

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.

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, 2023, 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, 2023.

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Other Information.

Trading Arrangements

During the quarter ended December 31, 2023, one of our executive officers modified an existing trading plan for the orderly disposition of the Company’s securities as set forth in the table below.

Such modification of the existing trading plan was treated as the termination of an existing plan and the adoption of a new plan pursuant to Rule 10b5-1(c)(iv) under the Exchange Act.

Type of Trading Arrangement

Name and Position

Adoption/Termination Date

Rule 10b5-1 (1)

Non-Rule 10b5-1 (2)

Total Shares of Common Stock to be Sold

Expiration Date

Brian Dorsey , Chief Operating Officer

Termination (3)

December 8, 2023

March 31, 2025

Brian Dorsey, Chief Operating Officer

December 8, 2023

March 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 modification , as described in Rule 10b5-1(c)(1)(iv) under the Exchange Act, of a written plan

adopted on March 31, 2023 that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act.

Disclosure regarding Foreign Jurisdictions that Prevent Inspections.

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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 for our 2023 annual meeting of stockholders to be filed with the Securities and Exchange Commission on or before May 1, 2023 (the “Proxy Statement”) pursuant to General Instructions G(3) of Form 10-K and is incorporated herein by reference.

The 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 for our 2024 annual meeting of stockholders to be filed with the Securities and Exchange Commission on or before April 29, 2024 (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.

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Executive Compensation.

The information required by this item will be set forth in the section headed Executive and Director Compensation contained in the Proxy Statement and is incorporated herein by reference.

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.

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 and Ex ecutive and Director Compensation contained in the Proxy Statement and is incorporated herein by reference.

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.

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 the Proxy Statement and is incorporated herein by reference.

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.

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 the Proxy Statement and is incorporated herein by reference.

The information required by this item will be set forth in the sections headed Ratification of Selection of Independent Registered Public Accounting Firm contained in the Proxy Statement and is incorporated herein by reference.

Exhibits, Financial Statement Schedules.

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Consolidated Statements of Operations and Comprehensive Loss

Consolidated Statements of Convertible Preferred Stock and Stockholders’

Equity (Deficit)

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

Consolidated Statements of Cash Flows

5 unchanged sentences

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).

Amended and Restated Certificate of Incorporation, as amended.

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).

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).

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).

Reference is made to Exhibit 3.1 and 3.2 .

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.

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).

Description of Registrant’s Common Stock.

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).

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).

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).

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).

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 (File No.

333-250009), as amended, filed with the SEC on November 30, 2020).

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).

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).

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).

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).

ARS Pharmaceuticals Inc.

Change in Control and Severance Benefit Plan.

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 May 12, 2022).

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).

Non-Employee Director Compensation Policy, as amended.

Termination Agreement, dated as of February 22, 2023, by and between ARS Pharmaceuticals, Inc.

and Recordati Ireland, Ltd.

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).

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).

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).

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).

Manufacturing Agreement, dated as September 9, 2020, by and between ARS Pharmaceuticals, Inc.

and Renaissance Lakewood, LLC (incorporated by reference to Exhibit 10.4 to the registrant’s Current Report on Form 8-K, filed with the SEC on November 8, 2022).

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).

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).

Executive Employment Agreement, dated as of September 14, 2018, by and between ARS Pharmaceuticals, Inc.

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).

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).

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).

Executive Employment Agreement, by and between the ARS Pharmaceuticals, Inc.

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).

Executive Employment Agreement, by and between ARS Pharmaceuticals, Inc.

and Alex Fitzpatrick, effective as of December 1, 2022.

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).

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).

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).

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).

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)

Subsidiaries of the registrant.

Consent of Independent Registered Public Accounting Firm.

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Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

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Incentive Compensation Recoupment Policy .

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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 because it is both not material and is the type that the registrant treats as private or confidential.

* 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.

Form 10-K Summary

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March 21, 2024

/s/ Richard Lowenthal, M.S., MBA

Richard Lowenthal, M.S., MBA

/s/ Richard Lowenthal, M.S., MSEL

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 Kathy 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.

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.

/s/ Richard Lowenthal, M.S., MBA

/s/ Richard Lowenthal, M.S., MSEL

President, Chief Executive Officer, and Director

March 21, 2024

Richard Lowenthal, M.S., MBA

Richard Lowenthal, M.S., MSEL

(Principal Executive Officer)

/s/ Kathy Scott

/s/ Kathleen D.

Chief Financial Officer

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Michael Kelly

/s/ Jonathan S.

March 23, 2023

/s/ Laura Shawver, Ph.D.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures