Protagonist Therapeutics Earns $7.5 Million Milestone Payment from IL-23 Receptor Collaboration with Janssen

NEWARK, Calif., Oct. 26, 2021 /PRNewswire/ -- Protagonist Therapeutics, Inc. (Nasdaq: PTGX) ("Protagonist" or "the Company") today announced that it will receive a $7.5 million milestone payment from Janssen Biotech, Inc. (Janssen) triggered by the completion of the clinical data collection-related Phase 1 activities for PN-235 (JNJ-2113). This investigational drug candidate is one of the three IL-23 receptor antagonists that are part of Protagonist's collaboration agreement with Janssen, which provides for concurrent development of multiple oral IL-23 receptor antagonists against a broad range of indications.

"The completion of these Phase 1 activities reflects our continued strength of execution as our collaboration of four-plus years, encompassing three assets in parallel development for multiple indications, continues to make steady progress," said Dinesh Patel, PhD, President and Chief Executive Officer at Protagonist. "This latest milestone marks $87.5 million in total milestones we have earned to date through this strategic partnership with Janssen. Our teams are guided by a shared commitment to improving and expanding therapeutic options for the many patients who may one day benefit from the oral therapies we are advancing in development today."

This collaboration provides for the concurrent development of multiple oral IL-23 receptor antagonists against a broad range of both IBD (inflammatory bowel disease) and non-IBD indications that can be treated through blockade of the IL-23 pathway. 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. Future milestones for Phase 2 and Phase 3 successes are contemplated in the collaboration agreement, as are royalties for Protagonist on products from this portfolio that achieve market approval and entry.

Janssen Biotech, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, has exclusive, worldwide rights to develop and commercialize PTG-200, PN-232, PN-235 and any other second-generation compounds derived from this research collaboration. Protagonist will have the right to co-detail up to two licensed products in ulcerative colitis and CD in the U.S. market.

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 which is currently in Phase 2 development for the treatment of polycythemia vera and hereditary hemochromatosis. 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.  In addition, Protagonist 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 which is currently in Phase 2 development for Crohn's disease. PN-235 and PN-232, both second-generation oral interleukin-23 receptor antagonist candidates, are currently in Phase 1 studies.  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 Company's clinical collaboration with Janssen and the potential of collaboration compounds. 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.

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SOURCE Protagonist Therapeutics, Inc.