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On track to achieve 250 patient enrollment target in March 2024 Top-line data for 32-week primary endpoint expected in the first quarter of 2025 NEWARK, CA / ACCESSWIRE / March 26, 2024 / Protagonist Therapeutics, Inc. ("Protagonist" or the "Company") announced it has randomized 241 patients in the ongoing Phase 3 VERIFY clinical trial evaluating rusfertide in polycythemia vera ("PV") as of today and expects to meet the trial's 250 patient enrollment target by the end of March 2024. Eligible patients in screening as of March 31, 2024 will be randomized by the end of April 2024. The Company expects to announce top-line data for the study's 32-week primary efficacy endpoint by the end of the first quarter of 2025. "Currently available therapies provide suboptimal hematocrit and symptom control in patients with PV, and we believe rusfertide has the potential to meet these unmet medical needs. We are looking forward to the results of the VERIFY phase 3 study in anticipation of filing an NDA for rusfertide in 2025 together with our partner Takeda," said Arturo Molina, M.D., M.S., Protagonist's Chief Medical Officer. "We wish to thank the principal investigators and study staff for their dedication and contributions towards completing enrollment, and the patients who have agreed to participate in this important research study." The Phase 3 VERIFY trial (NCT05210790) is a global Phase 3 randomized, double-blind, placebo-controlled trial designed to enroll approximately 250 patients. The trial evaluates the efficacy, symptom burden and safety of once-weekly, subcutaneously self-administered rusfertide in patients with uncontrolled hematocrit who are phlebotomy dependent despite standard of care treatment. The trial enrolled patients in 20 countries across North and South America, Europe, Asia and Australia. This Phase 3 study along with the REVIVE Phase 2 trial and other completed studies will comprise the clinical data package planned for NDA filing. "2024 has been a very busy year for the rusfertide program, and we are pleased to announce our Phase 3 VERIFY trial is advancing as planned," said Dinesh V. Patel, Ph.D., the Company's President and CEO. "Rusfertide has performed very well in the Phase 2 REVIVE study as further confirmed by the long-term follow-up data showing the durability of hematocrit control. We look forward to data from the 52-week endpoint for VERIFY including the durability of response in the first half of 2025, and potentially filing an NDA in the fourth quarter of 2025. Dr. Patel continued, "We are in a very exciting phase for the Company as we anticipate a series of announcements and data disclosures in the second half of 2024 and throughout 2025, centering on our late stage partnered assets, as well as our fully owned discovery programs like Oral IL-17 antagonist, and other programs in hematology and metabolic diseases." About Protagonist Protagonist Therapeutics is a biopharmaceutical company with peptide-based new chemical entities (NCEs) rusfertide and JNJ-2113 (formerly PN-235) in advanced Phase 3 stages of clinical development, both derived from the Company's proprietary technology platform. Protagonist and JNJ scientists jointly discovered PN-235 (now known as JNJ-2113) as part of Protagonist's Interleukin-23 receptor (IL-23R) collaboration with JNJ and followed it through IND-enabling pre-clinical and Phase 1 studies, with JNJ 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 randomized portion of the Phase 2 REVIVE study has been successfully completed, and results were published in The New England Journal of Medicine in February 2024. The open-label extension component of Phase 2 is ongoing, as is the global Phase 3 VERIFY study of rusfertide in polycythemia vera. Rusfertide is being co-developed and co-commercialized with Takeda pursuant to a worldwide collaboration and license agreement with Takeda announced in January 2024. More information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at . 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 clinical benefits of rusfertide, the timing of top-line data and other data disclosures. 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 Johnson & Johnson, 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 virginiaamann@ententeinc.com SOURCE: Protagonist Therapeutics, Inc. View the original press release on accesswire.com

Top-line results from AURORA, the placebo-controlled phase 2 study of bitopertin in erythropoietic porphyrias (EPP), expected March / April 2024On track to deliver multiple read-outs in 2024, including updated results from phase 1b/2 study of DISC-0974 in anemia of myelofibrosis (MF) 1H’24Strengthened leadership team with the appointments of Jean Franchi as Chief Financial Officer and Pamela Stephenson as Chief Commercial Officer, and the promotion of Jonathan Yu to Chief Operating OfficerWell-capitalized, ending 2023 with approximately $360M in cash and cash equivalents, which provides runway well into 2026 WATERTOWN, Mass., March 21, 2024 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided an update on recent program and corporate developments. “The past year has been truly remarkable for Disc and marks another important chapter in our company’s story. During 2023, we provided the first evidence of the therapeutic potential of our programs, with positive read-outs in patients for both bitopertin and DISC-0974. In addition, we advanced a third program, DISC-3405, into the clinic and fortified our balance sheet, so we can execute our strategy with confidence,” said John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc. “These achievements have positioned us well for 2024, which promises to be another transformational year, and I want to express my deep gratitude to our team for their determination and hard work. We’re looking forward to sharing AURORA data in the coming weeks, as well as updated data for DISC-0974 in MF and initial data for DISC-3405 in healthy volunteers in the first half of this year.” Recent Business Highlights and Upcoming Milestones: Bitopertin: GlyT1 Inhibitor (Heme Synthesis Modulator) Completed enrollment of its phase 2 program of bitopertin in erythropoietic porphyrias: BEACON, an open-label phase 2 clinical study of bitopertin in patients with EPP and X-linked protoporphyria (XLP), which was expanded to include adolescentsAURORA a phase 2 randomized, placebo-controlled clinical study of bitopertin in adults with EPP Presented positive results from the phase 2 BEACON trial at ASH 2023, showing: Significant, sustained reductions in whole blood protoporphyrin IX (PPIX) levels >40%Robust and consistent improvements across all measures of sunlight tolerance, including >3x improvement over historical control of precedented pivotal endpointBitopertin was generally well-tolerated with stable hemoglobin at both dose levels Topline AURORA data planned for press release and corporate presentation in March/April 2024 DISC-0974: Anti-Hemojuvelin Antibody (Hepcidin Suppression) Presented positive, initial data from ongoing phase 1b/2 clinical study in MF patients with severe anemia at ASH 2023: Treatment at initial dose levels (14 mg, 28 mg, 50 mg) resulted in substantial, dose-dependent decreases in hepcidin and increases in serum ironHematologic activity was observed in MF patients, regardless of concomitant JAK inhibitor use. Four of seven (57%) evaluable non-transfusion-dependent (NTD) patients reached a >1.5g/dL hemoglobin increase and one of two transfusion-dependent (TD) patients achieved transfusion independence.DISC-0974 was generally well-toleratedEnrollment and dose escalation is ongoing Presented initial data from the 28 mg cohort of the ongoing phase 1b/2 clinical study of patients with anemia of chronic kidney disease who are not receiving dialysis (NDD-CKD) Data demonstrated meaningful reductions in serum hepcidin and corresponding increases in serum iron with a similar PK/PD profile as seen in Disc’s healthy volunteer studyEnrollment and dose escalation is ongoing Updated phase 1b/2 data from DISC-0974 in anemia in MF patients is expected to be presented in the first half of 2024Updated phase 1b/2 data from DISC-0974 in anemia in NDD-CKD is expected to be shared in the second half of 2024Received FDA fast track designation in February 2024 for DISC-0974 for the treatment of anemia in NDD-CKD DISC-3405: Anti-TMPRSS6 Antibody (Hepcidin Induction) Initiated a phase 1 SAD / MAD study in healthy volunteers in October 2023Initial SAD data expected to be presented in the first half of 2024Received FDA orphan drug designation in February 2024 for DISC-3405 for the treatment of PV Corporate: As the company enters late-stage development and begins planning for commercialization, Disc expanded its leadership team with the appointments of industry veterans Jean Franchi as Chief Financial Officer and Pamela Stephenson as Chief Commercial Officer, and the promotion of Jonathan Yu to Chief Operating Officer Full Year 2023 Financial Results: Cash Position: Cash and cash equivalents were $360.4 million as of December 31, 2023, which are expected to fund our operational plans well into 2026, compared to $194.6 million as of December 31, 2022. The increase was primarily due to the completion of a registered direct offering in February 2023 and a publicly marketed follow-on offering in June 2023.Research and Development Expenses: R&D expenses were $69.3 million for the full year ended December 31, 2023, as compared to $33.4 million for the full year ended December 31, 2022. The increase in R&D expenses were primarily driven by the progression of Disc’s portfolio, including bitopertin’s ongoing two phase 2 clinical studies and drug manufacturing, phase 1 study initiation for DISC-3405, and increased headcount.General and Administrative Expenses: G&A expenses were $21.9 million for the full year ended December 31, 2023, as compared to $14.0 million for the full year ended December 31, 2022. The increase in G&A expenses was primarily due to increased headcount and increased costs as a public company.Net Loss: Net loss was $76.4 million for the full year ended December 31, 2023, as compared to $46.8 million for the full year ended December 31, 2022. The increase was primarily due to higher operating costs in the current period to support the continued advancement of our pipeline. About Disc Medicine Disc Medicine (NASDAQ:IRON) is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, potentially first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis. For more information, please visit www.discmedicine.com. Available Information Disc announces material information to the public about the Company, its products and services, and other matters through a variety of means, including filings with the U.S. Securities and Exchange Commission (SEC), press releases, public conference calls, webcasts and the investor relations section of the Company website at ir.discmedicine.com in order to achieve broad, non-exclusionary distribution of information to the public and for complying with its disclosure obligations under Regulation FD. Disc Cautionary Statement Regarding Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, express or implied statements regarding Disc’s expectations with respect to its AURORA phase 2 and BEACON phase 2 clinical studies of bitopertin and the results thereof, and its phase 1b/2 study of bitopertin in Diamond-Blackfan Anemia, its phase 1b/2 clinical studies of DISC-0974 in patients with MF and NDD-CKD patients with anemia, its phase 1 clinical study of DISC-3405 in healthy volunteers; projected timelines for the initiation and completion of its clinical trials, anticipated timing of release of data, and other clinical activities; Disc’s business plans, objectives and expected contributions of management; and Disc’s beliefs about operating expenses and that it will have capital to fund Disc well into 2026. The use of words such as, but not limited to, “believe,” “expect,” “estimate,” “project,” “intend,” “future,” “potential,” “continue,” “may,” “might,” “plan,” “will,” “should,” “seek,” “anticipate,” or “could” or the negative of these terms and other similar words or expressions that are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Disc’s current beliefs, expectations and assumptions regarding the future of Disc’s business, future plans and strategies, clinical results and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Disc may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and investors should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements as a result of a number of material risks and uncertainties including but not limited to: the adequacy of Disc’s capital to support its future operations and its ability to successfully initiate and complete clinical trials; the nature, strategy and focus of Disc; the difficulty in predicting the time and cost of development of Disc’s product candidates; Disc’s plans to research, develop and commercialize its current and future product candidates; that enrollment timelines of both the BEACON and AURORA studies may not necessarily be predictive of future enrollment timelines; the timing of initiation of Disc’s planned clinical trials; Disc’s ability to retain and recognize the intended incentives conferred by Fast Track Designation for its product candidates including DISC-3405 and DISC-0974; Disc’s ability to retain and recognize the intended incentives conferred by Orphan Drug Designation for DISC-3405 and bitopertin; the timing of the availability of data from Disc’s clinical trials; Disc’s ability to identify additional product candidates with significant commercial potential and to expand its pipeline in hematological diseases; the timing and anticipated results of Disc’s preclinical studies and clinical trials and the risk that the results of Disc’s clinical trials may not be predictive of future results in connection with future studies or clinical trials and may not support further development and marketing approval; the other risks and uncertainties described in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2023, and other documents filed by Disc from time to time with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in Disc’s subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. None of Disc, nor its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. DISC MEDICINE, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(In thousands, except share and per share amounts) ​Year Ended December 31, ​ 2023 ​ 2022 Operating expenses:​ ​ Research and development​$69,264 ​$33,437 General and administrative​ 21,861 ​ 14,038 Total operating expenses​ 91,125 ​ 47,475 Loss from operations​ (91,125)​ (47,475)Other income (expense), net 14,795 ​ 648 Income tax expense​ (99) — Net loss​$(76,429)​$(46,827)Weighted-average common shares outstanding-basic and diluted​ 22,315,877 1,039,490 Net loss per share-basic and diluted​$(3.42)​$(45.05) DISC MEDICINE, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands) ​December 31, December 31, ​ 2023 ​ 2022 Assets​ ​ Cash and cash equivalents​$360,382 ​$194,611 Other current assets​ 5,280 ​ 3,880 Total current assets​ 365,662 ​ 198,491 Non-current assets​ 2,334 1,714 Total assets​$367,996 ​$200,205 Liabilities and Stockholders’ Equity​ ​ Current liabilities​$21,439 ​$22,578 Non-current liabilities​ 1,436 ​ 1,027 Total liabilities​ 22,875 ​ 23,605 Total stockholders’ equity​ 345,121 ​ 176,600 Total liabilities and stockholders’ equity​$367,996 ​$200,205 Media Contact Peg RusconiVerge Scientific Communicationsprusconi@vergescientific.com Investor Relations Contact Christina TartagliaStern Investor Relationschristina.tartaglia@sternir.com

NEWARK, CA / ACCESSWIRE / March 18, 2024 / Protagonist Therapeutics, Inc. ("Protagonist" or the "Company") today announces the closing of the worldwide collaboration and license agreement for rusfertide with Takeda, a leading values-based, R&D-driven biopharmaceutical company, disclosed on January 31, 2024. Closing of the transaction was contingent on completion of review under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the United States. Protagonist will receive the $300 million upfront payment associated with the transaction in the second quarter of 2024. About Protagonist Protagonist Therapeutics 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 and JNJ scientists jointly discovered PN-235 (now known as JNJ-2113) as part of Protagonist's Interleukin-23 receptor (IL-23R) collaboration with JNJ and followed it through IND-enabling pre-clinical and Phase 1 studies, with JNJ 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 randomized portion of the Phase 2 REVIVE study was unblinded, showing positive results and is now complete, with an open-label extension underway. The global Phase 3 VERIFY study of rusfertide in polycythemia vera is ongoing. Rusfertide will be co-developed and co-commercialized with Takeda pursuant to a worldwide collaboration and license agreement with Takeda entered into in January 2024. More information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at . 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 virginiaamann@ententeinc.com SOURCE: Protagonist Therapeutics, Inc. View the original press release on accesswire.com