Protagonist Therapeutics Inc. filed SEC Form 8-K: Entry into a Material Definitive Agreement, Other Events, Financial Statements and Exhibits
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Item 1.01. Entry into a Material Definitive Agreement
On November 13, 2024, Protagonist Therapeutics, Inc. (the “Company”) and Janssen Biotech, Inc., a Pennsylvania corporation (“Janssen”) entered into an amendment (the “Amendment”) to their amended and restated License and Collaboration Agreement dated July 27, 2021 (the “Collaboration Agreement”).
The Amendment:
(a) increases the milestone payment set forth in Section 7.3.1(D) (for a Phase 3 clinical trial for any Licensed Product for any indication meeting its primary endpoint) by $50 million, from $115 million to $165 million;
(b) eliminates the $35 million milestone payment in Section 7.3.1(E) (for acceptance of filing of an NDA by the FDA for use of Licensed Product in any indication); and
(c) eliminates the $15 million milestone payment in Section 7.3.1(L) (for dosing of the 3rd patient in the first Phase 3 clinical trial of a Licensed Product for a second indication).
The $165 million milestone now payable pursuant to Section 7.3.1(D) of the Collaboration Agreement has been earned as a result of the Phase 3 clinical trial results described in the press release attached hereto as Exhibit 99.1. Accordingly, the Amendment has the effect of accelerating the $35 million and $15 million milestone payments set forth in Sections 7.3.1(E) and 7.3.1(L) of the Collaboration Agreement.
Item 8.01. Other Events
On November 18, 2024, the Company issued a press release related to Phase 3 clinical study results for icotrokinra (JNJ-2113, formerly PN-235), which is a Licensed Product under the Collaboration Agreement. The press release is attached hereto as Exhibit 99.1.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Press release, dated November 18, 2024, titled “Protagonist announces positive topline results from Phase 3 ICONIC studies of icotrokinra (JNJ-2113) in plaque psoriasis, a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor” | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
The information in Item 8.01 of 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 in Item 8.01 of this report 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.
SIGNATURE
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. | ||
| Dated: November 18, 2024 | ||
| By: | /s/ Asif Ali | |
| Asif Ali | ||
| Chief Financial Officer | ||