What changed in this filing

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Item 9A. Controls and Procedures

2023-03-23 compared with 2022-03-31 · 94 added, 78 removed, 83 unchanged (67% of the section changed)

16 unchanged sentences

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.

Disclosure regarding Foreign Jurisdictions that Prevent Inspections.

1 unchanged sentence

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 our Proxy Statement and is incorporated herein by reference.

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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(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:

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:

Report of Independent Registered Public Accounting Firm (PCAOB ID:

Balance Sheets

Statements of Operations and Comprehensive Loss

Statements of Redeemable Convertible Preferred Stock and Stockholders’

Consolidated Balance Sheets

Consolidated Statements of Operations and Comprehensive Loss

Consolidated Statements of Convertible Preferred Stock and Stockholders’

Equity (Deficit)

Statements of Cash Flows

Consolidated Statements of Cash Flows

Notes to Financial Statements

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(b) Exhibits.

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).

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).

Reference is made to Exhibit 3.1 and 3.2 .

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).

Amended and Restated Investors’

1 unchanged sentence

333-250009), as amended, filed with the SEC on November 10, 2020).

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).

Description of Registrant’s Common Stock.

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).

Silverback Therapeutics, Inc.

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).

Silverback Therapeutics, Inc.

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).

Silverback Therapeutics, Inc.

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).

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).

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).

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).

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).

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).

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).

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).

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).

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).

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.

Forms of Restricted Stock Unit Grant Notice and Restricted Stock Unit Award Agreement under the Silverback Therapeutics, Inc.

2020 Equity Incentive Plan.

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).

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

and Recordati Ireland, Ltd.

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.

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).

Consent of Independent Registered Public Accounting Firm.

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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.

1 unchanged sentence

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.

ARS Pharmaceuticals, Inc.

March 23, 2023

/s/ Laura Shawver, Ph.D.

Laura Shawver, Ph.D.

Chief Executive Officer

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

Richard Lowenthal, M.S., MBA

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 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.

/s/ Laura Shawver, Ph.D.

Chief Executive Officer and Director

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.

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

President, Chief Executive Officer, and Director

March 23, 2023

Laura Shawver, Ph.D.

Richard Lowenthal, M.S., MBA

(Principal Executive Officer)

/s/ Jonathan Piazza

/s/ Kathy Scott

Chief Financial Officer

March 23, 2023

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.

(Principal Financial and Accounting Officer)

/s/ Pratik Shah, Ph.D.

Chairman of the Board of Directors

March 23, 2023

Peter Thompson, M.D.

/s/ Vickie L.

Pratik Shah, Ph.D.

/s/ Peter Kolchinsky, Ph.D.

March 23, 2023

/s/ Robert Hershberg, M.D., Ph.D.

Peter Kolchinsky, Ph.D.

/s/ Rajeev Dadoo, Ph.D.

March 23, 2023

Robert Hershberg, M.D., Ph.D.

/s/ Saqib Islam, J.D.

Rajeev Dadoo, Ph.D.

/s/ Brenton L.

March 23, 2023

Saqib Islam, J.D.

/s/ Andrew Powell, J.D.

/s/ Phillip Schneider

March 23, 2023

Andrew Powell, J.D.

/s/ Jonathan Root, M.D.

Phillip Schneider

/s/ Michael Kelly

March 23, 2023

Jonathan Root, M.D.

/s/ Thilo Schroeder, Ph.D.

Michael Kelly

/s/ Jonathan S.

March 23, 2023

Thilo Schroeder, Ph.D.

/s/ Maria Koehler, M.D., Ph.D.

/s/ Laura Shawver, Ph.D.

March 23, 2023

Maria Koehler, M.D., Ph.D.

Laura Shawver, Ph.D.

Thompson, M.D.

March 23, 2023

Thompson, M.D.

/s/ Saqib Islam, J.D.

March 23, 2023

Saqib Islam, J.D.

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