Protagonist Therapeutics Announces Updated Data from Phase 2 Study of Rusfertide in Polycythemia Vera Selected for Oral Presentations at the ASH 2021 Annual Meeting

NEWARK, Calif., Nov. 4, 2021 /PRNewswire/ -- Protagonist Therapeutics, Inc. (Nasdaq: PTGX) ("Protagonist" or "the Company") today announced that two abstracts highlighting updated data from its Phase 2 study of rusfertide in polycythemia vera (PV) have been selected for oral presentations at the American Society of Hematology (ASH) 2021 Annual Meeting taking place December 11-14, 2021. An additional three abstracts on rusfertide in PV and hereditary hemochromatosis (HH) have been accepted as poster presentations at ASH.

"We are delighted to have the opportunity to present further evidence of rusfertide's potential to improve outcomes in polycythemia vera and other diseases related to iron dysregulation," said Dinesh V. Patel, PhD, President and Chief Executive Officer of Protagonist. "Data included in these oral presentations will provide important new information about how rusfertide may reduce the need for phlebotomy and control hematocrit levels and symptoms for patients suffering from PV. The data we share at ASH this year will serve as a valuable springboard for further advancement of our rusfertide clinical programs, including the initiation of a Phase 3 clinical trial of rusfertide in PV in the first quarter of 2022."

Details for ASH 2021 oral presentations are as follows:

Title: "Rusfertide (PTG-300) Controls Hematocrit Levels and Essentially Eliminates Phlebotomy Requirement in Polycythemia Vera Patients"
Session Title: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Novel Therapies for MPNs and JAK inhibitors for Myelofibrosis
Presentation Type: Oral
Presentation Date and Time: Sunday, December 12, 2021/Session Time: 9:30 AM - 11:00 AM/Presentation Time: 10:15 AM
Authors: Ronald Hoffman, MD, Marina Kremyanskaya, MD, PhD, Yelena Ginzburg, MD, Andrew Kuykendall, MD, Naveen Pemmaraju, MD, Abdulraheem Yacoub, MD, Jay Yang, MD, Suneel Gupta, PhD, Frank Valone, MD, Sarita Khanna, PhD and Srdan Verstovsek, MD, PhD

Title: "Rusfertide (PTG-300) Induction Therapy Rapidly Achieves Hematocrit Control in Polycythemia Vera Patients without the Need for Therapeutic Phlebotomy"
Session Title: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Novel Therapies for MPNs and JAK inhibitors for Myelofibrosis
Presentation Type: Oral
Presentation Date and Time: Session Date: Sunday, December 12, 2021/Session Time: 9:30 AM - 11:00 AM/Presentation Time: 10:45 AM
Authors: Yelena Ginzburg, MD, Kamini Kirubamoorthy, Sinari Salleh, MD, Sung-Eun Lee, MD, PhD, Jae Hoon Lee, MD, PhD, Veena Selvaratnam, MD, Suneel K Gupta, PhD, Frank Valone, MD, Sarita Khanna, PhD, Nishit Modi, PhD, Ronald Hoffman, MD and Lee Ping Chew, MD

Additional details for ASH 2021 poster presentations are as follows:

Title: "A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients with Polycythemia Vera"
Session Title: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster I
Presentation Type: Poster
Presentation Date and Time: Saturday, December 11, 2021/Presentation Time: 5:30 PM - 7:30 PM
Authors: Srdan Verstovsek, MD, PhD, Andrew Kuykendall, MD, Ronald Hoffman, MD, Yelena Ginzburg, MD, Naveen Pemmaraju, MD, Frank Valone, MD, Nishit Modi, PhD, Sarita Khanna, PhD, Paula G O'Connor, MD, Suneel K Gupta, PhD and Jean-Jacques Kiladjian, MD, PhD

Title: "Regulation of Iron Homeostasis and Efficacy of Rusfertide Analog Peptide in a Mouse Model for Polycythemia Vera"
Session Title: 102. Iron Homeostasis and Biology: Poster II
Presentation Type: Poster
Presentation Date and Time: Sunday, December 12, 2021/Presentation Time: 6:00 PM - 8:00 PM
Authors: Roopa Taranath, PhD, Li Zhao, MD, PhD, Jayanthi Vengalam, MS, Lawrence Lee, BS,
Tenny Tang, MS, Celino Dion, Ahu Su, BS, James Tovera, BS, Ashok Bhandari, PhD,
Xiaoli Cheng, PhD, Larry Mattheakis, PhD and David Y Liu, PhD

Title: "Rusfertide (PTG-300), a Hepcidin Mimetic, Maintains Liver Iron Concentration in the Absence of Phlebotomies in Patients with Hereditary Hemochromatosis"
Session Title: 102. Iron Homeostasis and Biology: Poster I
Presentation Type: Poster
Presentation Date and Time: Date: Saturday, December 11, 2021/Presentation Time: 5:30 PM -7:30 PM
Authors: Kris V. Kowdley, MD, Nishit B Modi, PhD, Frank Valone, MD, Victor Priego, MD, Christopher Ferris, MD, PhD, Frank Cole, MD, and Suneel Gupta, PhD

Full abstracts can be found on the ASH website at https://www.hematology.org/meetings/annual-meeting/abstracts

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. As announced on September 17, 2021, all rusfertide studies are currently placed on clinical hold per a decision of the U.S. Food and Drug Administration. 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 development program for rusfertide. 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.

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