Item 7.01. Regulation FD.

On January 9, 2023, Sonnet BioTherapeutics Holdings, Inc. (the "Company") issued a press release announcing a clinical collaboration agreement with Roche for the clinical evaluation of the Company's SON-1010 with Roche's atezolizumab in patients with platinum-resistant ovarian cancer ("PROC"). A copy of the press release is attached hereto as Exhibit 99.1.

The information in this Current Report on Form 8-K under Item 7.01, including the information contained in Exhibit 99.1, is being furnished to the Securities and Exchange Commission, and shall not be deemed to be "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by a specific reference in such filing.




Item 8.01. Other Events.

On January 9, 2023, the Company announced a clinical collaboration agreement with Roche for the clinical evaluation of the Company's SON-1010 with Roche's atezolizumab in patients with PROC. The Company intends to raise additional capital to help fund the clinical trial ("SB221"), which will commence during the second calendar quarter of 2023.

SB221 will be conducted to assess the safety and preliminary efficacy of SON-1010 in combination with Roche's atezolizumab in patients with PROC. The companies would provide SON-1010 and atezolizumab, respectively, for use in the study. SB221 is a global Phase 1b/2a multicenter, dose-escalation and randomized proof-of-concept study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SON-1010 administered subcutaneously, either alone or in combination with atezolizumab given intravenously. The study is designed in Part 1 to rapidly establish the maximum tolerated dose of the combination in patients with advanced solid tumors in small dose-escalation groups and to expand the dataset at the recommended Phase 2 dose. This would be followed in Part 2 by an assessment in patients with PROC of the potential for improved efficacy of the combination over SON-1010 alone or the standard of care.

Item 9.01. Financial Statements and Exhibits.

(d) The following exhibit is furnished with this report:





Exhibit No.   Description
99.1            Press Release issued by Sonnet BioTherapeutics Holdings, Inc.,
              dated January 9, 2023.
104           Cover Page Interactive Data File (embedded within the Inline XBRL
              document)

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