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NEWARK, CA / ACCESS Newswire / March 18, 2025 / Protagonist Therapeutics, Inc. ("Protagonist" or the "Company"), a clinical-stage biopharmaceutical company pioneering the discovery and development of peptide-based therapeutics, today announced its inclusion in Fast Company's prestigious annual list of the World's Most Innovative Companies for 2025.

Fast Company's annual list of the World's Most Innovative Companies spotlights organizations across various industries that are driving meaningful change through groundbreaking ideas and transformative technologies. The 2025 edition highlights businesses leading the way in sustainability, healthcare, artificial intelligence, and more.

Protagonist has been recognized as a Most Innovative Company and a top 5 Most Innovative Biotechnology company for its groundbreaking work in peptide-based drug development that led to the creation of multiple differentiated, first-in-class, and best-in-class assets targeting validated disease pathways. The company's peptide-based therapeutics offer the potential for targeted, orally administered solutions for diseases that have historically required injectable treatments as well as highly differentiated therapies for patients with unmet medical needs. As a public company, Protagonist's strategic aims include strong balance sheet management, and the company currently has a cash runway through at least the end of 2028.

The company's peptide development platform has successfully delivered multiple candidates, including:

• Rusfertide, a mimetic of the hormone hepcidin that recently had a successful outcome in a Phase 3 trial for the potential treatment of the rare disease polycythemia vera. Rusfertide is being jointly developed with Takeda Pharmaceuticals and is moving towards an NDA filing with the FDA this year.

• Icotrokinra (JNJ-2113), the first-ever oral IL-23 receptor antagonist developed in collaboration with Johnson & Johnson, which has shown substantial efficacy in multiple Phase 3 trials for psoriasis and a Phase 2 trial for ulcerative colitis, and has potential to transform the treatment paradigm for these disease indications. An NDA filing of icotrokinra for psoriasis is expected this year.

• PN-881, an oral IL-17 antagonist with potential best-in-class properties, is moving towards first-in-human trials.

• An anti-obesity program aimed at providing oral drugs in a market currently dominated by injectables.

"Our list of the Most Innovative Companies offers a comprehensive look at innovation today and a playbook for the future," said Fast Company editor-in-chief Brendan Vaughan. "This year, we recognize companies that are harnessing AI in deep and meaningful ways, brands that are turning customers into superfans by overdelivering for them, and challengers that are introducing bold ideas and vital competition to their industries. At a time when the world is rapidly shifting, these companies are charting the way forward."

"Being named to Fast Company's Most Innovative Companies list is a testament to the relentless dedication of our team and our mission to bring truly differentiated peptide therapeutics to patients," said Dinesh V. Patel, Ph.D., President and CEO of Protagonist Therapeutics. "With the recent announcement of positive late-stage data from our two homegrown assets and a robust pipeline of next-generation candidates, we remain at the forefront of scientific innovation in immunology, hematology, and metabolic diseases. Our work is driven by the pursuit of life-changing therapies, and we are honored to be recognized for these efforts."

The full list of Fast Company's Most Innovative Companies honorees can now be found at fastcompany.com. It will also be available on newsstands beginning March 25.

About Protagonist

Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company. Two novel peptides, icotrokinra and rusfertide, derived from Protagonist's proprietary discovery platform are currently in advanced Phase 3 clinical development, with New Drug Application submissions to the FDA expected in 2025. Icotrokinra (JNJ-2113) is a first-in-class investigational targeted oral peptide that selectively blocks the Interleukin-23 receptor ("IL-23R") which is licensed to Janssen Biotech, Inc., a Johnson & Johnson company. Following icotrokinra's joint discovery by Protagonist and Johnson & Johnson scientists pursuant to the companies' IL-23R collaboration, Protagonist was primarily responsible for development of icotrokinra through Phase 1, with Johnson & Johnson assuming responsibility for development in Phase 2 and beyond. Rusfertide, a mimetic of the natural hormone hepcidin, is currently in Phase 3 development for the rare blood disorder polycythemia vera (PV). Rusfertide is being co-developed and will be co-commercialized with Takeda Pharmaceuticals pursuant to a worldwide collaboration and license agreement entered into in 2024 under which the Company remains primarily responsible for development through NDA filing. The Company also has a number of pre-clinical stage oral drug discovery programs addressing clinically and commercially validated targets, including the IL-17 oral peptide antagonist PN-881, an oral hepcidin program, and an oral obesity program.

More information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at 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 the expected timing of regulatory filings and the potential benefits of our discovery candidates. 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 with Janssen and Takeda, 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 Contact

Virginia Amann, Founder/CEO
ENTENTE Network of Companies
+1 833 500 0061 ext 1
virginiaamann@ententeinc.com

SOURCE: Protagonist Therapeutics

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