Protagonist Therapeutics Announces Amendment of Agreement with Janssen Biotech for the Continued Development and Commercialization of IL-23 Antagonists

NEWARK, Calif., July 28, 2021 /PRNewswire/ -- Protagonist Therapeutics, Inc. (Nasdaq:PTGX) ("Protagonist" or "the Company") today announced its entry into an amended collaboration agreement (the "Restated Agreement") with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, relating to research, development, manufacture and commercialization of multiple oral Interleukin (IL)-23 receptor antagonist drug candidates. The compounds currently in development are PTG-200, an oral IL-23 receptor antagonist in Phase 2 development for the treatment of Crohn's disease (CD), and PN-232 and PN-235, two second-generation oral IL-23 receptor antagonist candidates. PN-232 and PN-235 are currently in Phase 1 clinical development.

The amended agreement provides for the concurrent development of multiple oral IL-23 receptor antagonists against a broad range of indications. As such, certain development milestones have been reconfigured based on multiple drug candidates advancing in parallel. Protagonist remains eligible to potentially receive approximately $900 million in future development and sales milestones, in addition to the $80 million in payments already received under the original agreement. Royalty rates remain unchanged. Janssen will have the right to continue research on IL-23 receptor antagonists developed during the collaboration for three years from the closing of the Restated Agreement.

Under the terms of the Restated Agreement, Janssen will conduct all future studies beyond those that are currently ongoing with PTG-200, PN-232 and PN-235 and will be solely financially responsible for any such studies. Accordingly, Protagonist's development and expense obligations will be limited to its relative share of the currently ongoing studies with these candidates. With this revised agreement, Janssen will continue to deploy the breadth of its established global capabilities and proven experience toward further clinical development of these assets.

"We are very pleased with this amendment to our agreement, which reflects the successful trajectory of the collaboration to date, giving rise to the parallel development of multiple oral IL-23 receptor antagonists," said Dinesh Patel, PhD, President and Chief Executive Officer of Protagonist. "The progress from de novo discovery to development validates our innovative technology platform and its potential to develop oral peptide drugs for diverse clinical indications. We look forward to supporting our Janssen counterparts in their parallel development efforts for PTG-200, PN-232, and PN-235 in multiple indications, which may ultimately provide significant benefit to patients."

Janssen retains exclusive, worldwide rights to develop and commercialize PTG-200, PN-232, PN-235 and any other second-generation compounds derived from the research collaboration conducted under the Original Agreement, or Janssen's further research under the Restated Agreement. Protagonist will have the right to co-detail up to two licensed products in ulcerative colitis (UC) and CD in the U.S. market.

Further details related to the Restated Agreement are available on the Company's Form 8-K as submitted to the U.S. Securities and Exchange Commission.

Conference Call and Webcast Information

Protagonist management will host a conference call and webcast today at 5:00 p.m. ET to provide a brief overview of the amended collaboration agreement. To access the live call, dial (877) 870-4263 (U.S./Canada) or (412) 317-0790 (international) five minutes prior to the call and ask to be joined to the Protagonist Therapeutics call. A live and archived webcast will also be accessible in the Investors section of the Company's website at www.protagonist-inc.com.

About Protagonist Therapeutics

Protagonist Therapeutics is a biopharmaceutical company with multiple peptide-based investigational new chemical entities in different stages of development, all derived from the Company's proprietary technology platform.

Protagonist's pipeline includes rusfertide (PTG-300), an investigational, injectable hepcidin mimetic currently in a Phase 2 proof-of-concept clinical trial for polycythemia vera (PV), a Phase 2 study in PV subjects with high hematocrit levels, and a Phase 2 study for hereditary hemochromatosis. Based on the feedback provided by the FDA and EU regulatory authorities, the Company plans to initiate a single, global Phase 3 randomized, placebo-controlled trial evaluating the efficacy and safety of a once weekly, subcutaneously self-administered dose of rusfertide.

The Company is also evaluating an orally delivered, gut-restricted alpha-4-beta-7 integrin specific antagonist peptide (PN-943) currently in a Phase 2 study in adults with moderate to severe active ulcerative colitis (UC). The Company is targeting ulcerative colitis as the initial indication.

The Company has a worldwide license and collaboration agreement with Janssen Biotech, Inc., for the development of oral peptide IL-23 receptor antagonists. Compounds included in this agreement are PTG-200, PN-235 and PN-232. PTG-200 is an orally delivered interleukin-23 receptor specific antagonist peptide in a Phase 2 clinical trial for Crohn's disease. PN-235 and PN-232, both second-generation oral interleukin-23 receptor antagonist candidates, are currently in Phase 1 studies.

Protagonist is headquartered in Newark, California. For further information, please visit www.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 our intentions or current expectations concerning, among other things, the Restated Agreement, the development of PTG-200, PN-232 and PN-235, and our plans conduct a Phase 3 trial evaluating rusfertide for PV. 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 agreements, the impact of the current COVID-19 pandemic on our discovery and development efforts, 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.

SOURCE Protagonist Therapeutics, Inc.