SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): September 17 , 2021
PROTAGONIST THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
|(State or other jurisdiction|
Protagonist Therapeutics, Inc.
7707 Gateway Blvd., Suite 140
Newark, California 94560-1160
(Address of principal executive offices, including zip code)
(Registrant’s telephone number, including area code)
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
|¨||Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)|
|¨||Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)|
|¨||Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))|
|¨||Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))|
Securities registered pursuant to Section 12(b) of the Act:
|Title of each class||Trading Symbol(s)||Name of each exchange on which|
|Common Stock, par value $0.00001||PTGX||The Nasdaq Stock Market LLC|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company x
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. x
|Item 8.01||Other Events.|
On September 17, 2021, Protagonist Therapeutics, Inc. (the “Company”) issued a press release announcing that the Company’s clinical studies for rusfertide, an investigational product candidate currently in development, have been placed on a clinical hold. A copy of the press release titled “Protagonist Therapeutics Reports FDA Clinical Hold on Rusfertide Clinical Development Program” is attached hereto as Exhibit 99.1 and incorporated by reference herein. The Company has begun to provide the FDA with the information requested, including additional information related to four cases of cancer observed to date across all rusfertide clinical trials. These four cases relate to distinct forms of cancer and were assessed to be unrelated to rusfertide due to a preexisting condition or natural disease progression.
In accordance with General Instruction B.2 of Form 8-K, the information in this Item 8.01, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
|Item 9.01||Financial Statements and Exhibits|
|99.1||Press release, dated September 17, 2021, titled “Protagonist Therapeutics Reports FDA Clinical Hold on Rusfertide Clinical Development Program”|
|104||Cover Page Interactive Data File (embedded within the Inline XBRL document).|
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|Protagonist Therapeutics, Inc.|
|Date: September 17, 2021||By:||/s/ Don Kalkofen|
|Chief Financial Officer|