Protagonist Therapeutics Announces Presentation of Updated Results from Phase 2 Study of Rusfertide in Polycythemia Vera, Selected for Oral Presentation at EHA 2021

NEWARK, Calif., May 12, 2021 /PRNewswire/ -- Protagonist Therapeutics ("Protagonist" or the "Company") (Nasdaq: PTGX), today announced that an abstract highlighting updated data from its ongoing Phase 2 clinical study evaluating rusfertide in polycythemia vera ("PV") has been selected for an oral presentation at the upcoming European Hematology Association ("EHA") 2021 Annual Congress. The EHA Congress will take place virtually June 9-17, 2021. Rusfertide, a synthetic, injectable hepcidin mimetic, regulates iron homeostasis and controls the absorption, storage, and distribution of iron in the body. Rusfertide was discovered through the Company's peptide technology platform.

"We are delighted that our abstract has been selected for an oral presentation at the EHA Congress," said Sam Saks, M.D., Chief Medical Officer at Protagonist. "This is an internationally recognized event with broad attention from the worldwide hematology community. We look forward to expanding upon our previously reported Phase 2 data in eighteen patients at the American Society of Hematology meeting, which demonstrated almost complete elimination of phlebotomy treatment; reversal of iron deficiency; a decrease of symptom burden; and maintenance of hematocrit levels below 45 percent, per guidelines set by the National Comprehensive Cancer Network. We have recently announced completion of the targeted enrollment of fifty patients in this ongoing study."

Oral Presentation Details

Title: Rusfertide (PTG-300) Eliminates the Need for Therapeutic Phlebotomy in Both Low and High-Risk Polycythemia Vera (PV) Patients
Session: Novel therapies and targets in MPN
Date/Time: Available on-demand starting June 11, 2021 at 9am CEST
Abstract Number: S200
Presenter: Marina Kremyanskaya, MD, PhD, Assistant Professor of Medicine, Hematology and Medical Oncology, at the Icahn School of Medicine at Mount Sinai

The abstract can be accessed online on the EHA 2021 meeting library website, ehaweb.org. All presentations will be available on demand to registered meeting attendees on the EHA virtual Congress platform as of June 11, 2021.

About Polycythemia Vera
Polycythemia vera (PV) is a myeloproliferative neoplasm characterized primarily by the increased production of red blood cells. Well-established treatment guidelines focus on maintaining hematocrit levels continuously below 45 percent to reduce the risk of thrombotic events. Unfortunately, current treatment options are unable to maintain hematocrit to below the 45 percent target for many patients and may be associated with serious side effects. PV is a rare disease affecting approximately 160,000 patients in the U.S., with a similar prevalence in Europe.

About Protagonist Therapeutics
Protagonist Therapeutics is a clinical stage biopharmaceutical company with multiple peptide-based investigational new chemical entities in different stages of development. Rusfertide (PTG-300) is an investigational, injectable hepcidin mimetic in a Phase 2 proof-of-concept clinical trial for polycythemia vera, and a separate Phase 2 clinical 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 of a once weekly, subcutaneously self-administered dose of rusfertide.

PN-943 is an investigational orally delivered, gut-restricted alpha-4-beta-7 integrin specific antagonist peptide in a 150 patient Phase 2 study for the potential treatment of inflammatory bowel disease, with ulcerative colitis as the initial targeted indication. PTG-200 is an orally delivered, gut-restricted, interleukin-23 receptor specific antagonist peptide in a Phase 2 clinical trial for Crohn's disease. Two additional second-generation oral interleukin-23 receptor antagonist candidates, PN-235 and PN-232, are in early stages of clinical development. The Company has developed a proprietary technology platform to discover and develop novel peptide-based therapeutics to address significant unmet medical needs and transform existing treatment paradigms. 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, our plans to present updated rusfertide data at EHA and 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 agreement with Janssen, 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 Quarterly Report on Form 10-Q for the year ended March 31, 2021, 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.

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