Two oral presentations and three poster presentations elucidate new data relevant to rusfertide, a hepcidin mimetic with potential therapeutic value in the treatment of Polycythemia Vera and other disease indications

NEWARK, CA / ACCESSWIRE / November 2, 2023 / Protagonist Therapeutics, Inc. (NASDAQ:PTGX) ("Protagonist" or "the Company") announced today that five abstracts relevant to the Company's rusfertide program have been accepted for presentation at the 65^th American Society of Hematology Annual Meeting and Exposition (ASH), taking place December 9-12, 2023 in San Diego, California.

"We are extremely pleased to present a broad cross-section of new data at ASH this year," said Dinesh V. Patel, Ph.D., President and Chief Executive Officer of Protagonist. "Among these presentations are data which underscore the potential for rusfertide to improve markers of iron deficiency in polycythemia vera, and to sustain improved outcomes such as hematocrit control in PV patients over a two-year time horizon.

Additionally, we look forward to sharing data that elucidate important epidemiological aspects of PV, drawing upon an extensive analysis of claims data and other resources. Finally, we look forward to presenting new preclinical data demonstrating improved disease parameters with a hepcidin mimetic treatment in a mouse model for sickle cell disease."

Dr. Patel continued: "Congratulations to our internal team and external partners for the dedication and rigor they have applied to these important areas of scientific research. Taken together, these presentations constitute major contributions to the field of hematology."

Oral presentation details are as follows:

• Oral Presentation 1:

Title: Real-World Analysis of Thromboembolic Event Rates in Patients in the United States with Polycythemia Vera
Presenting author: Andrew T. Kuykendall, MD (Moffitt Cancer Center, Tampa, FL)
Session Name: 904. Outcomes Research - Non-Malignant Conditions: Across the Age Spectrum: Thromboembolism Outcomes in Adult and Pediatric Patients
Session Date: Saturday, December 9, 2023
Session Time: 9:30-11:00 AM PST
Presentation Time: 10:30 AM PST
Room: Marriott Marquis San Diego Marina, Pacific Ballroom Salons 18-19
Publication Number: 137
Submission ID: 180309

• Oral Presentation 2:

Title: Durability of Hematocrit Control in Polycythemia Vera with the First-in-Class Hepcidin Mimetic Rusfertide: Two-Year Follow up Results from the Revive Study
Presenting author: Ellen K. Ritchie, MD (Weill Cornell Medical College New York Presbyterian, NY)
Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Treatment and Outcomes in MPNs
Session Date: Monday, December 11, 2023
Session Time: 10:30 AM - 12:00 PM PST
Presentation Time: 10:30 AM PST
Room: San Diego Convention Center, Ballroom 20CD
Publication Number: 745
Submission ID: 178253

Poster presentation details are as follows:

• Poster Presentation 1:

Title: Iron Restricted Erythropoiesis Under Hepcidin Mimetic Treatment (PN23114) Improved Disease Parameters in a Mouse Model for Sickle Cell Disease
Presenting author: Roopa Taranath, PhD (Protagonist Therapeutics, Inc., Newark, CA)
Session Name: 113. Sickle Cell Disease, Sickle Cell Trait and Other Hemoglobinopathies, Excluding Thalassemias: Basic and Translational: Poster I
Session Date: Saturday, December 9, 2023
Presentation Time: 5:30-7:30 PM PST
Location: San Diego Convention Center, Halls G-H
Publication Number: 1117
Submission ID: 182472

• Poster Presentation 2:

Title: Rusfertide Improves Markers of Iron Deficiency in Patients with Polycythemia Vera
Presenting author: Yelena Ginzburg, MD (Mount Sinai, New York, NY)
Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster II
Session Date: Sunday, December 10, 2023
Presentation Time: 6:00-8:00 PM PST
Location: San Diego Convention Center, Halls G-H
Publication Number: 3208
Submission ID: 178334

• Poster Presentation 3:

Title: Prevalence of Second Cancers in Patients with Polycythemia Vera (PV): A Retrospective Analysis of US Real-World Claims Data
Presenting author: Naveen Pemmaraju, MD (MD Anderson Cancer Center, Houston, TX)
Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster II
Session Date: Sunday, December 10, 2023
Presentation Time: 6:00-8:00 PM PST
Location: San Diego Convention Center, Halls G-H
Publication Number: 3190
Submission ID: 180045

About Protagonist

Protagonist Therapeutics, Inc. is a biopharmaceutical company with peptide-based new chemical entities (NCEs) rusfertide and JNJ-2113 (formerly PN-235) in advanced stages of clinical development, both derived from the Company's proprietary technology platform. Protagonist scientists jointly discovered PN-235 (now known as JNJ-2113) as part of Protagonist's Interleukin-23 receptor (IL-23R) collaboration with Janssen and followed it through IND-enabling pre-clinical and Phase 1 studies, with Janssen assuming responsibility for further clinical development. Rusfertide, a mimetic of the natural hormone hepcidin, is the Company's lead drug candidate currently in a global Phase 3 development program. The Phase 2 REVIVE study is now complete, with an open-label extension underway. The global Phase 3 VERIFY study of rusfertide in polycythemia vera is ongoing. Protagonist retains all worldwide development and commercialization rights to rusfertide.

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 potential benefits of 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 agreement with Janssen, 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.

Contact

Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com

SOURCE: Protagonist Therapeutics, Inc.