Protagonist Earns $10 Million Payment for Achievement of Clinical Milestone in Phase 2b ANTHEM-UC Study of JNJ-2113 in Adults with Moderately to Severely Active Ulcerative Colitis

NEWARK, CA / ACCESSWIRE / December 13, 2023 / Protagonist Therapeutics, Inc. ("Protagonist" or the "Company") today 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").

"We are extremely pleased with the pace of clinical development of JNJ-2113, now in multiple late-stage clinical studies in two distinct indications," said Dinesh V. Patel, Ph.D., President and CEO of Protagonist. "We look forward to future data readouts in both psoriasis and ulcerative colitis, as well as the prospect of bringing JNJ-2113 to patients who can benefit from an oral treatment option for IL-23-mediated diseases."

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. Details regarding ANTHEM-UC and the ICONIC Phase 3 psoriasis trials can be found on clinicaltrials.gov.

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 scientists jointly discovered PN-235 (now known as JNJ-2113) as part of Protagonist's Interleukin-23 receptor (IL-23R) collaboration with Johnson & Johnson and followed it through IND-enabling pre-clinical and Phase 1 studies, with Johnson & Johnson 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 was unblinded, showing 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.

More information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at protagonist-inc.com.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the potential benefits of JNJ-2113, our expectations regarding the clinical development of JNJ-2113, and our potential receipt of milestone and royalty payments under our collaboration agreement with Johnson & Johnson. In some cases, you can identify these statements by forward-looking words such as "anticipate," "believe," "may," "will," "expect," or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreement with Johnson & Johnson, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates. Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading "Risk Factors" contained in our most recently filed periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release.

Investor Relations Contact

Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com

Media Relations Contact

Virginia Amann
ENTENTE Network of Companies
virginiaamann@ententeinc.com
+1 833 500 0061

SOURCE: Protagonist Therapeutics, Inc.