DISC-0974

Pursuing a traditional approval path for bitopertin in erythropoietic protoporphyria (EPP); Phase 3 APOLLO study is expected to complete enrollment in March 2026 with topline data expected in Q4 2026 Initial data from Phase 2 study of DISC-0974 in patients with anemia of myelofibrosis (MF) presented at the American Society of Hematology (ASH) conference demonstrating meaningful overall anemia responses across all patient subgroups, regardless of baseline transfusion status or concomitant JAK inhibitor therapy use Progressing ongoing Phase 2 study of DISC-3405 in polycythemia vera (PV) and initiated a Phase 1b study of DISC-3405 in sickle cell disease (SCD) in Q4 2025, with data from both studies expected in 2H 2026 Strong financial position ending Q4 with approximately $791 million in cash, cash equivalents, and marketable securities, providing runway into 2029 WATERTOWN, Mass., Feb. 26, 2026 (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, 2025, and provided a review of recent program and corporate developments. “We remain confident in the bitopertin program and the Phase 3 APOLLO study. We are fully committed to working closely with the FDA to position bitopertin for approval following the completion of APOLLO at the end of the year,” said John Quisel, J.D., Ph.D., Chief Executive Officer and President of Disc. “At the same time, our broader pipeline continues to deliver meaningful momentum. DISC-0974 generated powerful data in MF anemia that further reinforces its potential to transform the treatment landscape and we look forward to providing additional updates later this year. We are also excited about DISC-3405 with first in-patient data in both polycythemia vera and sickle cell disease expected later this year.” Recent Highlights and Anticipated Milestones: Bitopertin: GlyT1 Inhibitor (Heme Synthesis Modulator) Received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) in February 2026 related to sufficiency of evidence of association between percent change in PPIX and sunlight exposure-based endpoints Progressing Phase 3 APOLLO clinical trial of bitopertin in adults and adolescents with EPP, with topline data expected Q4 2026 Following completion of APOLLO, expect to submit a response to the CRL and receive an FDA decision by mid-2027 DISC-0974: Anti-Hemojuvelin Antibody (Hepcidin Suppression) Initial data from Phase 2 RALLY-MF trial of DISC-0974 in patients with anemia of myelofibrosis (MF) presented at ASH Annual Meeting in December Positive, durable benefits on hemoglobin and transfusion burden in anemia of MF across a broad range of patients Demonstrated efficacy regardless of concomitant JAK inhibitor use, setting up for utilization across all anemic MF patients Phase 2 study in patients with inflammatory bowel disease (IBD) and anemia initiated in Q1 2026 with initial data expected in 2027 DISC-3405: Anti-TMPRSS6 Antibody (Hepcidin Induction) Progressing ongoing Phase 2 study in patients with polycythemia vera with initial data expected in 2H 2026 Initiated Phase 1b study in sickle cell disease in Q4 2025 with initial data expected in 2H 2026 Full Year 2025 Financial Results: Cash Position: Cash, cash equivalents, and marketable securities were $791.2 million as of December 31, 2025, compared to $489.9 million as of December 31, 2024. The increase was largely due to net proceeds of $454.4 million from underwritten offerings in January and October 2025, partially offset by cash utilized in operating activities. We expect that our existing cash, cash equivalents, and marketable securities as of December 31, 2025 will be sufficient to fund operational plans into 2029. Research and Development Expenses: R&D expenses were $170.6 million for the full year ended December 31, 2025, as compared to $96.7 million for the full year ended December 31, 2024. The increase in R&D expenses was primarily driven by the progression of Disc’s portfolio, including bitopertin’s clinical studies and drug manufacturing, the advancement of the DISC-0974 program, and increased headcount, as well as $23.0 million in payments related to the achievement of development milestones. Selling, General and Administrative Expenses: SG&A expenses were $65.4 million for the full year ended December 31, 2025, as compared to $33.0 million for the full year ended December 31, 2024. The increase in SG&A expenses was primarily due to increased headcount including establishing infrastructure to support potential commercialization. Net Loss : Net loss was $212.2 million for the full year ended December 31, 2025, as compared to $109.4 million for the full year ended December 31, 2024. 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 . 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 the next stages of its development programs for bitopertin, DISC-0974 and DISC-3405, including projected timelines for the initiation and completion of its clinical trials, anticipated timing of release of data, and other clinical activities; the registrational pathway for bitopertin, including the potential for traditional approval, the potential for the APOLLO clinical trial to serve as the basis for any such approval, and the timing of any such approval, if granted; anticipated discussions with regulatory agencies; and the strength of its financial position and its anticipated cash runway. 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; the timing of initiation of Disc’s planned preclinical studies and clinical trials; 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 preclinical studies and 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 content and timing of decisions made by the FDA and other regulatory authorities; and the other risks and uncertainties described in Disc’s filings with the Securities and Exchange Commission, including in the “Risk Factors” section of Disc’s Annual Report on Form 10-K for the year ended December 31, 2025, and in subsequent Quarterly Reports on Form 10-Q. 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, ​ 2025 ​ 2024 ​ 2023 Operating expenses: ​ ​ ​ Research and development ​ $ 170,640 $ 96,671 $ 69,264 Selling, general and administrative ​ 65,382 33,049 21,861 Total operating expenses ​ 236,022 ​ 129,720 ​ 91,125 Loss from operations ​ (236,022) ​ (129,720) ​ (91,125) Other income (expense), net 24,199 ​ 20,718 ​ 14,795 Income tax expense ​ (361) (355) (99) Net loss ​ $ (212,184) ​ $ (109,357) ​ $ (76,429) Net loss per share, basic and diluted ​ $ (6.01) ​ $ (3.96) ​ $ (3.42) Weighted-average common shares outstanding, basic and diluted ​ 35,295,663 27,606,022 22,315,877 DISC MEDICINE, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands) December 31, December 31, ​ 2025 2024 Assets ​ Cash, cash equivalents, and marketable securities ​ $ 791,152 $ 489,881 Other current assets ​ 12,746 3,734 Total current assets ​ 803,898 493,615 Non-current assets ​ 2,981 3,158 Total assets ​ $ 806,879 $ 496,773 Liabilities and Stockholders’ Equity ​ Current liabilities ​ $ 36,641 $ 23,316 Non-current liabilities ​ 30,412 29,870 Total liabilities ​ 67,053 53,186 Total stockholders’ equity ​ 739,826 443,587 Total liabilities and stockholders’ equity ​ $ 806,879 $ 496,773 Media Contact Peg Rusconi Deerfield Group peg.rusconi@deerfieldgroup.com Investor Relations Contact Christina Tartaglia Precision AQ christina.tartaglia@precisionaq.com

Bitopertin was awarded the Commissioner’s National Priority Review Voucher (CNPV) and NDA is currently under FDA reviewUpdated data from the Phase 2 study of DISC-0974 in patients with myelofibrosis (MF) and anemia expected in H2 2026, followed by an End of Phase 2 MeetingInitial data from the ongoing Phase 2 study of DISC-3405 in polycythemia vera (PV) and Phase 1b study in sickle cell disease (SCD) expected in H2 2026 WATERTOWN, Mass., Jan. 12, 2026 (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 outlined its recent pipeline progress and strategic priorities for 2026. “2025 was a transformative year for Disc, marked by strong execution across our portfolio and meaningful progress toward becoming a fully integrated clinical and commercial organization,” said John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc. “Most notably, bitopertin received CNPV designation and we submitted our NDA under the accelerated approval pathway, positioning the NDA for rapid review by the FDA. We also reported positive initial Phase 2 data from the RALLY-MF study of DISC-0974 in anemia of myelofibrosis, demonstrating robust and broad hematologic activity, and advanced our third program DISC-3405 into proof-of-concept studies for polycythemia vera and sickle cell disease.” “As we look ahead to 2026, we are entering an exciting and pivotal period for Disc,” continued Dr. Quisel. “We are preparing to execute a successful US launch of bitopertin for EPP while continuing enrollment in the global APOLLO confirmatory study. Across our pipeline, we expect multiple Phase 2 updates for DISC-0974 and DISC-3405, including important regulatory interactions and expansion into new indications. Together, we believe these milestones position Disc for sustained growth as we work to deliver meaningful new therapies to patients with serious hematologic diseases.” Summary of Key Achievements During 2025 Bitopertin NDA submitted and accepted under the accelerated approval pathway with priority reviewBitopertin awarded the Commissioner’s National Priority Voucher (CNPV), a pilot program designed to accelerate the NDA review period to 1-2 monthsTransition to commercial-ready organization through build out of marketing, market access, medical science liaison, and sales teams and related infrastructurePresentation of positive initial data from the Phase 2 RALLY-MF study of DISC-0974 for anemia of MF, demonstrating robust and broad hematologic efficacy across patient segmentsIssuance of a Composition of Matter patent for DISC-0974, providing patent exclusivity until 2041, not including potential extensionsInitiated Phase 2 study of DISC-3405 in PV and Phase 1b study of DISC-3405 in SCDStrengthened balance sheet through two equity offerings, bringing unaudited cash, cash equivalents, and marketable securities to $791 million as of December 31, 2025, which provides runway into 2029 Key Business Objectives and Milestones for 2026Bitopertin: GlyT1 Inhibitor (Heme Synthesis) Anticipate FDA approval decision regarding NDA for bitopertin for the treatment of EPP under the CNPV programSuccessful launch and initial commercialization of bitopertin in the US, if approvedContinue enrollment of the global, confirmatory APOLLO study with topline data expected by early 2027 DISC-0974: Anti-hemojuvelin Antibody (Hepcidin Suppression) Progress ongoing Phase 2 MF anemia trial with updated data expected H2 2026Conduct End of Phase 2 meeting with the FDA about DISC-0974 in MF anemia in H2 2026Initiate a Phase 2 study of DISC-0974 in patients with anemia and inflammatory bowel disease (IBD) DISC-3405: Anti-TMPRSS6 Antibody (Hepcidin Induction) Progress ongoing Phase 2 PV trial with updated data expected H2 2026Progress ongoing Phase 1b SCD trial with updated data expected H2 2026 Bitopertin, DISC-0974, and DISC-3405 are investigational agents and are not approved for use as therapies in any jurisdiction worldwide. 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. 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 the next stages of its development programs for bitopertin, DISC-0974 and DISC-3405, including projected timelines for the initiation and completion of its clinical trials, anticipated timing of release of data, and other clinical activities; the registrational pathway for bitopertin, including the potential for accelerated approval, benefits of the CNPV, expected review period and the timing of approval, if granted; Disc’s expectations with respect to the potential launch and commercialization of bitopertin, if approved; anticipated discussions with regulatory agencies; Disc’s preliminary unaudited cash, cash equivalents and marketable securities as of December 31, 2025; and the strength of its financial position and its anticipated cash runway. 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; the timing of initiation of Disc’s planned preclinical studies and clinical trials; 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 preclinical studies and 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; final audit adjustments and other developments that may arise that would cause Disc’s expectations with respect to the estimate of cash, cash equivalents and marketable securities as of December 31, 2025 to differ, perhaps materially, from the financial results that will be reflected in Disc’s audited consolidated financial statements for the fiscal year ended December 31, 2025; and the other risks and uncertainties described in Disc’s filings with the Securities and Exchange Commission, including in the “Risk Factors” section of Disc’s Annual Report on Form 10-K for the year ended December 31, 2024, and in subsequent Quarterly Reports on Form 10-Q. 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. Media Contact Peg Rusconi Deerfield Group peg.rusconi@deerfieldgroup.com Investor Relations Contact Christina TartagliaPrecision AQ Christina.tartaglia@precisionaq.com