Protagonist Announces Achievement of $50M Milestone Event After Third Patient is Dosed in Phase 3 Study of JNJ-2113 in Moderate-to-Severe Psoriasis

NEWARK, CA / ACCESSWIRE / November 1, 2023 / Protagonist Therapeutics, Inc. ("Protagonist" or the "Company") today announced the achievement of a $50 million milestone event under its license and collaboration agreement with Janssen Biotech, Inc., a Johnson & Johnson company ("Janssen"). The milestone was earned when the third patient was dosed in the ICONIC TOTAL Phase 3 clinical study of JNJ-2113 in patients with moderate-to-severe psoriasis.

"We are very pleased to see the ICONIC Phase 3 program in psoriasis proceeding rapidly and view it as a clear reflection of both the confidence in and the commitment to the continued development of JNJ-2113," said Dinesh V. Patel, Ph.D., President and CEO of Protagonist. "We look forward to the initiation in 2024 of additional Phase 3 psoriasis studies planned for JNJ-2113 as part of the broader ICONIC clinical program, and patient enrollment in the ANTHEM UC Phase 2b study in ulcerative colitis in the near term. As the first- and only-in-class targeted oral peptide designed to block the IL-23 receptor, JNJ-2113 has the potential, in our view, to serve as a vitally important treatment option for patients with IL-23 pathway mediated diseases."

ANTHEM-UC is a Phase 2b randomized control trial to evaluate the safety and effectiveness of JNJ-2113 compared with placebo in participants with moderate-to-severe active ulcerative colitis.

More information about each of the active JNJ-2113 trials can be found at the following links on clinicaltrials.gov: ICONIC-LEAD, ICONIC-TOTAL, and ANTHEM-UC; and a prior Protagonist press release.

License and Collaboration Agreement

JNJ-2113 (formerly known as PN-235) 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 healthy volunteers in October of 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 against a broad range of indications. 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 further development and sales milestone payments with respect to JNJ-2113. The Company will also 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 PN-235 (now known as 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 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 additional milestone and royalty payments under our collaboration agreement with Janssen. 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 Janssen, 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 Contact:

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

SOURCE: Protagonist Therapeutics, Inc.