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8 Protagonist Therapeutics Protagonist Therapeutics Reports Third Quarter 2021 Financial Results and Provides Corporate Update November 3 , 2021 Resumption of the Phase 2 study of rusfertide in polycythemia vera now underway , following swift removal of the FDA clinical hold Positive proof - of - concept data for rusfertide in hereditary hemochromatosis to be presented at The Liver MeetingⓇ hosted by the American Association for the Study of Liver Diseases PN - 235 moves into a psoriasis indication , Phase 2 study initiation planned for early 2022 NEWARK , Calif . , Nov. 3 , 2021 / PRNewswire / -- Protagonist Therapeutics , Inc. ( Nasdaq : PTGX ) ( " Protagonist " or " the Company " ) today reported its financial results for the third quarter ended September 30 , 2021 and provided a corporate update . " We are excited to share the substantial progress made thus far in all of our clinical programs , highlighted by the presentation of proof - of - concept data on rusfertide in hereditary hemochromatosis at the upcoming AASLD meeting , and the new rusfertide data in polycythemia vera , which will be presented by the year's end , " said Dinesh V. Patel , Ph.D. , President and Chief Executive Officer . " We were very pleased that the FDA reached a swift resolution regarding the clinical hold placed on rusfertide , and we are in the process of resuming all rusfertide clinical studies . Additionally , we are highly encouraged with the rate of enrollment in the Phase 2 study of our oral alpha - 4 - beta - 7 integrin antagonist PN - 943 , for ulcerative colitis , an indication with a large patient population and unmet treatment need . We maintain our guidance of a data readout in Q2 2022 , and in anticipation of this , we are excited that Dr. Scott Plevy has joined our team as Executive Vice President and Therapeutic Head , Gastroenterology . As a renowned gastroenterologist , Dr. Plevy will oversee the clinical development of PN - 943 and other future programs focused on gastrointestinal diseases . Finally , our oral IL - 23 receptor antagonist program , in partnership with Janssen , continues to make demonstrated progress , with PN - 235 now advancing into a Phase 2 study in psoriasis in early 2022. " Third Quarter 2021 Recent Developments and Upcoming Milestones Rusfertide : Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera ( PV ) and Other Blood Disorders • On October 11 , 2021 , Protagonist announced that the U.S. Food and Drug Administration ( FDA ) removed the full clinical hold on rusfertide's clinical studies after the Company provided the FDA with all requested information , including the individual patient clinical safety reports , updated the investigator brochure and patient informed consent forms , conducted a comprehensive review of the most recent safety database , and added new safety and stopping rules in the study protocols . This was in response to the Company receiving a communication from the FDA that Protagonist's clinical studies for rusfertide had been placed on clinical hold on September 17 , 2021. Protagonist has been working closely with study investigators and clinical trial sites to resume enrollment and dosing of patients in ongoing clinical trials with rusfertide . • An abstract highlighting new , preliminary data from a Phase 2 proof - of - concept study in hereditary hemochromatosis ( HH ) has been selected for oral presentation by Dr. Kris Kowdley , from the Liver Institute Northwest in Seattle . These data will be presented on November 13 , 2021 at The Liver MeetingⓇ 2021 , hosted by the American Association for the Study of Liver Diseases ( AASLD ) . • The Company intends to report updated data from the Phase 2 study of rusfertide in polycythemia vera ( PV ) by the end of 2021 . • The Company is on track to initiate the Phase 3 study of rusfertide in PV in Q1 2022 . • The Company resolved its collaboration agreement dispute with Zealand Pharma , reducing future development and sales milestone payments and royalties owed to Zealand for rusfertide under the companies ' 2012 collaboration agreement . Under the new terms of the agreement , future development and sales milestone payments ( other than $ 2.5 million in near - term milestones ) and royalties for rusfertide have been reduced by 50 percent . Milestones and royalty payments will be due for sales and milestones achieved by either Protagonist or any future rusfertide licensee or partner . Protagonist will also make a $ 1.5 million payment to Zealand in August 2022 . PN - 943 : Oral , gut - restricted , alpha - 4 - Beta - 7 Integrin Antagonist for Ulcerative Colitis • We are continuing to see steady progress in the enrollment and execution of the Phase 2 IDEAL study of PN - 943 in ulcerative colitis . This study includes a 12 - week induction period and a 40 - week open label extension . Topline data from the 12 - week induction period is expected in the second quarter of 2022 . • Scott Plevy , M.D. , renowned expert in translational and clinical research in gastroenterology and immunology , was appointed Executive Vice President and Therapeutic Head , Gastroenterology , and he will oversee clinical operations and