Item 1.01 Entry into a Material Definitive Agreement

ARS Pharma previously entered into various material collaboration and license agreements with its collaboration and licensing partners in connection with the development, manufacturing and potential commercialization of the Company's product candidate neffy for the emergency treatment of Type I allergic reactions, including anaphylaxis. Such material collaboration and license agreements are summarized below.

License Agreement with Aegis

In June 2018, ARS Pharma entered into a license agreement with Aegis Therapeutics, LLC ("Aegis"), which was amended in July 2020 and January 2021 (as amended, the "Aegis License Agreement"). Pursuant to the Aegis License Agreement, Aegis granted ARS Pharma an exclusive, worldwide, sublicensable license under patents and know-how relating to the INTRAVAIL drug delivery technology to research, develop, make (subject to Aegis supplying the INTRAVAIL drug delivery technology to ARS Pharma under a supply agreement), use, sell, offer for sale, import, and otherwise commercialize products incorporating epinephrine compounds ("Aegis Licensed Compounds"), including the neffy nasal spray. During the term of the Aegis License Agreement, ARS Pharma is required to use commercially reasonable efforts to obtain regulatory approval for products containing one or more Aegis Licensed Compounds and using the excipient (including INTRAVAIL) ("Aegis Licensed Products") and to thereafter maximize sales of the Aegis Licensed Products, and Aegis may not directly or indirectly exploit an Aegis Licensed Product or Aegis Licensed Compound or derivatives thereof without ARS Pharma's consent.

Under the Aegis License Agreement, Aegis received an upfront license fee of $50,000 and is entitled to receive development milestone payments of up to $3.95 million in aggregate and commercialization milestone payments up to $16.0 million in the aggregate for each Aegis Licensed Product. ARS Pharma made a $0.5 million milestone payment to Aegis upon the achievement of a regulatory milestone during 2019. ARS Pharma will also be required to pay Aegis a milestone payment of $1.0 million to Aegis upon the U.S. Food and Drug Administration's ("FDA's") acceptance of ARS Pharma's New Drug Application for neffy, which occurred in the third quarter of 2022, a milestone payment of $2.5 million contingent upon the FDA approval of the first Aegis Licensed Product and a milestone payment of $5.0 million contingent upon first commercial sale of the first Aegis Licensed Product. Additionally, Aegis is entitled to receive a low- to mid-single-digit percentage royalty, subject to reductions under certain conditions including due to generic competition or below threshold levels of profitability in specific countries around the world, on net sales of all Aegis Licensed Products during the applicable royalty term, which commences on the first commercial sale of a Aegis Licensed Product in a country and ends upon the later of the expiration of all licensed patents covering such Aegis Licensed Product in such country or 15 years after the date of the first commercial sale of the Aegis Licensed Product in such country ("Aegis Royalty Term").

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The Aegis License Agreement will continue until the expiration of the last-to-expire Aegis Royalty Term, unless sooner terminated. ARS Pharma has the right to terminate the Aegis License Agreement at any time after a specified notice period to Aegis. Either party may terminate the Aegis License Agreement for uncured material breach of the other party, or upon notice for . . .

Item 3.02 Unregistered Sales of Securities

Pursuant to the Merger Agreement, Silverback issued 57,229,022 shares of common stock to the stockholders of ARS Pharma in accordance with the terms and conditions set forth in the Merger Agreement. In addition, Silverback assumed each option to purchase ARS Pharma common stock and each warrant to purchase ARS Pharma capital stock which became options and warrants to purchase shares of Silverback common stock. The nature of the transaction and the nature and amount of consideration received by ARS Pharma's equityholders are described in Item 2.01 of this Form 8-K, which is incorporated by reference into this Item 3.02. Such issuances were exempt from registration under Section 4(a)(2) of the Securities Act and the rules promulgated thereunder.

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Item 5.01 Changes in Control of Registrant

The disclosures contained in Items 2.01 and 3.02 above and Items 5.02 and 5.07 below are incorporated herein by reference.

Immediately following the consummation of the Merger, the prior ARS Pharma equityholders collectively owned approximately 62% of the Company and the prior Silverback equityholders collectively own approximately 38% of the Company, in each case on a fully diluted basis using the treasury stock method and excluding out-of-the-money options of Silverback. In addition, the eleven-member board of directors of the Company includes eight individuals who are designees of ARS Pharma and served as members of the board of directors of ARS Pharma immediately prior to the Merger. These directors possess a majority control of the board of directors of the Company.

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangement of Certain Officers

Resignation of Directors and Termination of Executive Officers

In accordance with the terms of the Merger Agreement, (i) each of Vicki L. Capps, Robert Hershberg, M.D., Ph.D., Maria Koehler, M.D., Ph.D., Andrew Powell, J.D. and Jonathan Root, M.D. resigned from the Company's board of directors and any respective committee membership of the Company's board of directors, effective as of the consummation of the Merger, and (ii) each of Jeffrey Pepe, Ph.D., J.D., the Company's Interim Chief Executive Officer, General Counsel and Corporate Secretary, and Russ Hawkinson, the Company's Interim Chief Financial Officer, were terminated in connection with the Company's previously announced reduction in force.

Appointment of Directors and Executive Officers

At the effective time of the Merger, the Company's board of directors (and its committees) and executive officers were reconstituted to include the following directors and executive officers:



Name                            Age                           Position
Executive Officers
Richard Lowenthal, M.S., MSEL   56    President, Chief Executive Officer and Class II Director
Kathleen Scott                  53    Chief Financial Officer
Sarina Tanimoto, M.D., M.B.A.   54    Chief Medical Officer
Eric Karas                      50    Chief Commercial Officer
Justin Chakma                   33    Chief Business Officer and Secretary

Non-Employee Directors
Pratik Shah, Ph.D.              52    Chair of the Board and Class I Director
Rajeev Dadoo, Ph.D.             52    Class I Director
Saqib Islam, J.D.               53    Class III Director
Michael Kelly                   57    Class I Director

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Peter Kolchinsky, Ph.D.   46   Class II Director
Jonathan S. Leff          53   Class III Director
Brenton L. Saunders       52   Class II Director
Phillip Schneider         66   Class III Director
Laura Shawver, Ph.D.      65   Class III Director
Peter A. Thompson, M.D.   63   Class II Director

Class III directors have a term expiring in 2023, Class I directors have a term expiring in 2024 and Class II directors have a term expiring in 2025.

The members of the Audit Committee are Phillip Schneider (Chair), Michael Kelly and Rajeev Dadoo, Ph.D. The members of the Compensation Committee are Rajeev Dadoo, Ph.D. (Chair) and Saqib Islam, J.D. The members of the Nominating and Corporate Governance Committee are Peter Kolchinsky, Ph.D. (Chair) and Jonathan S. Leff.

Pursuant to the terms of the Merger Agreement, each of (i) Mr. Lowenthal, Dr. Shah, Dr. Dadoo, Mr. Kelly, Dr. Kolchinsky, Mr. Leff, Mr. Saunders and Mr. Schneider were appointed to the board of directors of the Company as designees of ARS Pharma and (ii) Mr. Islam, Dr. Shawver and Dr. Thompson remained on the board of directors of the Company as designees of Silverback.

Executive Officers

Richard Lowenthal, M.S., MSEL is a co-founder of ARS Pharma and has served as its President and a member of the board of directors of ARS Pharma since ARS Pharma's inception in August 2015 and as ARS Pharma's Chief Executive Officer since September 2018. From August 2015 to November 2007, Mr. Lowenthal served as President of Pacific-Link Regulatory Consulting and Research, Inc., a medicinal product development consultancy founded by Mr. Lowenthal, where he provided leadership and mentoring on clinical development, regulatory affairs, quality assurance, licensing and investment opportunities, including supporting the clinical and regulatory development of Valtoco (diazepam nasal spray). Prior to Pacific-Link Regulatory Consulting and Research, Inc., Mr. Lowenthal held many leadership roles at several biopharmaceutical and pharmaceutical companies that included Chief Executive Officer and President of MTG Biotherapeutics Inc.; Vice President of Regulatory Affairs and quality assurance for Cadence Pharmaceuticals, Inc.; Head of Worldwide Regulatory Affairs, Quality Assurance and Drug Safety for Maxim Pharmaceuticals, Inc.; Vice President of Regulatory Affairs and Quality Assurance for AnGes, MG, Inc.; Global Project Leader and Global Director of Regulatory Affairs for Janssen Research Foundation; Director of Regulatory Affairs and Quality Assurance for Somerset Pharmaceuticals Inc.; and New Drug Review Chemist for the U.S. Food and Drug Administration in the Division of Neuropharmacologic Drug Products and the Division of Oncology and Pulmonary Drug Products. Mr. Lowenthal holds an M.Sc. in organic chemistry from Florida State University and a Master's in Business Science for Executive . . .

Item 5.03 Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year

Immediately prior to the consummation of the Merger, on November 8, 2022, Silverback filed the Charter Amendment changing its name from "Silverback Therapeutics, Inc." to "ARS Pharmaceuticals, Inc." The foregoing description of the Charter Amendment is not complete and is subject to and qualified in its entirety by reference to such Charter Amendment, a copy of which is attached to this filing as Exhibit 3.1 hereto and is incorporated herein by reference.

Item 5.07 Submission of Matters to a Vote of Security Holders.

On November 4, 2022, Silverback held a special meeting of stockholders (the "Special Meeting") to consider two proposals related to the Merger. Each of Silverback's proposals was approved by the requisite vote of Silverback's stockholders as described below.

At the close of business on September 19, 2022, the record date for the Special Meeting, Silverback had 35,798,117 shares of its common stock issued and outstanding. The holders of a total of 27,267,233 shares of common stock were represented at the Special Meeting by proxy or by attending the virtual meeting, representing approximately 76% of Silverback's issued and outstanding common stock as of the record date, which total constituted a quorum for the Special Meeting in accordance with Silverback's amended and restated bylaws.

The final voting results for each of the proposals voted upon at the Special Meeting is set forth below. Brokers had discretionary authority to vote for Proposal No. 2 for the shares of common stock held in street name, and as a result, no broker non-votes were received for Proposal No. 2. For more information on the proposals voted upon at the Special Meeting, please refer to Silverback's definitive proxy statement for the Special Meeting, originally filed with the Securities and Exchange Commission on October 6, 2022, as amended.

Proposal 1. To approve (i) the issuance of shares of common stock or other securities of Silverback pursuant to the Merger, which represent (or are convertible into) more than 20% of the shares of common stock outstanding immediately prior to the Merger, and (ii) the change of control resulting from the Merger, pursuant to Nasdaq Listing Rules 5635(a) and 5635(b), respectively:

27,244,219 For 9,986 Against 13,028 Abstain 0 Broker Non-Votes

Proposal 2. To approve a postponement or adjournment of the Special Meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of Proposal No. 1:

26,226,927 For 317,067 Against 723,239 Abstain 0 Broker Non-Votes

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Item 8.01. Other Events

On November 8, 2022, the Company issued a press release announcing the closing of the Merger. The press release contains statements intended as "forward-looking statements" which are subject to the cautionary statements about forward-looking statements set forth therein. The press release is attached to this filing as Exhibit 99.1.

Item 9.01 Financial Statements and Exhibits

(a) Financial Statements of Business Acquired

The financial statements and information required by this Item 9.01(a) will be filed by amendment to this report not later than 71 calendar days after the date on which this report is required to be filed.

(b) Pro Forma Financial Information

The financial statements and information required by this Item 9.01(b) will be filed by amendment to this report not later than 71 calendar days after the date on which this report is required to be filed.



(d) Exhibits

Exhibit
  No.                                    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.

 3.1         Certificate of Amendment to Amended and Restated Certificate of
           Incorporation of Silverback Therapeutics, Inc.

 3.2         Certificate of Merger.

 4.1         Warrant to purchase stock issued to Silicon Valley Bank, dated as of
           September 30, 2019, as amended on December 7, 2020.

10.1*¥       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.

10.2*¥       Collaboration and License Agreement, dated as of April 30, 2020, by
           and between ARS Pharmaceuticals, Inc. and Alfresa Pharma Corporation.

10.3*¥       Collaboration and Distribution Agreement, dated as of March 1, 2021,
           by and between ARS Pharmaceuticals, Inc. and Pediatrix Therapeutics.

10.4*¥       License and Supply Agreement, dated as of September 21, 2020, by and
           between ARS Pharmaceuticals, Inc. and Recordati Ireland, Ltd.

10.5*¥       Manufacturing Agreement, dated as September 9, 2020, by and between
           ARS Pharmaceuticals, Inc. and Renaissance Lakewood, LLC.

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10.6+       Executive Employment Agreement, dated as of September 14, 2018, by and
          between ARS Pharmaceuticals, Inc. and Richard E. Lowenthal.

10.7+       Executive Employment Agreement, dated as of February 9, 2022, by and
          between ARS Pharmaceuticals, Inc. and Kathleen Scott.

10.8+       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.

10.9+       Executive Employment Agreement, dated as of February 16, 2022, by and
          between ARS Pharmaceuticals, Inc. and Eric Karas.

10.10+      Executive Employment Agreement, dated as of June 1, 2019, by and
          between ARS Pharmaceuticals, Inc. and Justin Chakma.

10.11+      Consulting Agreement, dated as of April 26, 2021, by and between ARS
          Pharmaceuticals, Inc. and Brenton L. Saunders, as amended on April 25,
          2022.

10.12+      Consulting Agreement, by and between ARS Pharmaceuticals, Inc. and
          Marlinspike Group, LLC, dated September 14, 2018.

10.13+      Consulting Agreement, by and between ARS Pharmaceuticals, Inc. and
          Pacific-Link Regulatory Consulting, Inc., dated July 1, 2022.

99.1        Press Release of ARS Pharmaceuticals, Inc., dated November 8, 2022

104       Cover Page Interactive Data File (embedded within the Inline XBRL
          document

* Certain portions of this exhibit have been omitted pursuant to Item

601(b)(10)(iv) of Regulation S-K.

¥ 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.

+ Indicates management contract or compensatory plan.

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