Protagonist Therapeutics, Inc. announced it has earned a $10 million milestone payment following the dosing of the third patient in ANTHEM-UC, a Phase 2b trial to evaluate the safety and effectiveness of JNJ-2113 compared with placebo in participants with moderately to severely active ulcerative colitis. With this additional payment, the Company has now earned $60 million in payments in the fourth quarter of 2023 for milestones achieved in the JNJ-2113 Phase 2b and Phase 3 clinical programs led by the Company's collaboration partner, Janssen Biotech, Inc., a Johnson & Johnson company ("Johnson & Johnson"). In addition to the $10 million milestone payment related to the ANTHEM-UC trial, Protagonist earned a $50 million milestone payment related to initiation of the ICONIC Phase 3 psoriasis program in October 2023.

The Company remains eligible for up to an additional $795 million in other development and sales milestone payments with respect to JNJ-2113 or other licensed IL-23 receptor antagonist oral peptides. The additional $795 million in potential milestones include a $115 million milestone for meeting the co-primary endpoints in any of the ICONIC 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.

JNJ-2113 (formerly known as PN-235), a first-in-class targeted oral peptide designed to selectively block the IL-23 receptor, was discovered and is being developed pursuant to the license and collaboration agreement between Protagonist and Johnson & Johnson. Protagonist completed a Phase 1 study of JNJ-2113 in October of 2021 and Johnson & Johnson retains exclusive, worldwide rights to develop in Phase 2 and beyond, and to commercialize compounds derived from the research conducted pursuant to the agreement against a broad range of indications. JNJ-2113 is currently being studied in the Phase 2b ANTHEM-UC study and in the ICONIC program, which includes four Phase 3 studies for moderate-to-severe psoriasis.