Protagonist Announces Two New Phase 3 ICONIC Studies in Psoriasis Evaluating JNJ-2113 in Head-to-Head Comparisons with Deucravacitinib - Seite 2

License and Collaboration Agreement

JNJ-2113 is a first and only targeted oral peptide that is designed to selectively block the IL-23 receptor that was jointly discovered and is being developed pursuant to the license and collaboration agreement between Protagonist and Janssen. Protagonist completed a Phase 1 study of JNJ-2113 in 2021 and Janssen retains exclusive, worldwide rights to develop in Phase 2 and beyond, and to commercialize compounds derived from the research conducted pursuant to the agreement which covers a broad range of indications.

In October 2023, Protagonist earned a $50 million milestone payment related to initiation of the ICONIC Phase 3 program. In addition, Protagonist will earn a $10 million milestone payment upon dosing of the third patient in the ANTHEM UC Phase 2b study and remains eligible for up to an additional $795 million in other development and sales milestone payments with respect to JNJ-2113. This includes a $115 million milestone to be paid upon successfully achieving the co-primary endpoints in any of the Phase 3 psoriasis clinical trials, a $50 million milestone upon NDA submission and a $35 million milestone upon NDA approval. The Company is also eligible to earn upward tiering royalties of 6%-10%, with the 10% tier applicable for net sales of greater than $4 billion.

About Protagonist

Protagonist Therapeutics is a biopharmaceutical company with peptide-based new chemical entities (NCEs) rusfertide and JNJ-2113 (formerly PN-235) in advanced stages of clinical development, both derived from the Company's proprietary technology platform. Protagonist and Janssen scientists jointly discovered JNJ-2113 as part of Protagonist's interleukin-23 receptor (IL-23R) collaboration with Janssen and followed it through IND-enabling pre-clinical and Phase 1 studies, with Janssen assuming responsibility for further clinical development. Rusfertide, a mimetic of the natural hormone hepcidin, is the Company's lead drug candidate currently in a global Phase 3 development program. The randomized portion of the Phase 2 REVIVE study showed positive results and is now complete, with an open-label extension underway. The global Phase 3 VERIFY study of rusfertide in polycythemia vera is ongoing. Protagonist retains all worldwide development and commercialization rights to rusfertide.