Item 8.01 Other Information.



PN-943 Phase 2 Trial Data

Protagonist Therapeutics, Inc. (the "Company") expects to announce top-line data from its Phase 2 clinical trial evaluating its product candidate PN-943 for ulcerative colitis in the first half of the second quarter of 2022.

Rusfertide Breakthrough Therapy Designation

The Company has received a letter from United States Food and Drug Administration (the "FDA") indicating the FDA's intent to rescind Breakthrough Therapy Designation for the Company's rusfertide product candidate in polycythemia vera. The Company has submitted a meeting request to the FDA, along with a briefing document articulating why the Company believes rusfertide continues to warrant Breakthrough Therapy Designation. The FDA letter does not relate to the rusfertide Fast Track Designation, which remains active. Initiation of the Company's rusfertide Phase 3 study in polycythemia vera is underway and no changes to the development plan or timeline are anticipated at this stage. Additional details are available in the Company's updated corporate presentation, which is attached hereto as Exhibit 99.1.




Item 9.01  Financial Statements and Exhibits.



(d) Exhibits



Exhibit No.                                Description
  99.1          Protagonist Therapeutics, Inc. Corporate Presentation, as of April
              13, 2022
104           Cover Page Interactive Data File (embedded within the Inline XBRL
              document).

The information in this report, including the exhibit hereto, shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of Section 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained herein and in the accompanying exhibit shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by Protagonist Therapeutics, Inc., whether made before or after the date hereof, regardless of any general incorporation language in such filing.

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