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IRON

Disc MedicineD
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-07-30
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Investor releaseQuarter not tagged2026-07-30

Disc Medicine Reports Second Quarter 2026 Financial Results and Provides Business Update

GlobeNewswire
Completed Type A meeting with the FDA on bitopertin and aligned that the Phase 3 APOLLO study, if successful, can serve as the basis for CRL response; topline data expected in Q4 2026 Launched Expanded Access Program (EAP) for bitopertin for eligible erythropoietic protoporphyria (EPP) patients Presented positive clinical data updates from the RALLY-MF Phase 2 trial of selcodebart (DISC-0974) in anemia of myelofibrosis and the HELIOS open-label extension trial of bitopertin in EPP Completed enrollment for RESTORE-PV Phase 2 study of DISC-3405 in polycythemia vera (PV) with initial data expected in Q3 2026 and progressing Phase 1b study of DISC-3405 in sickle cell disease (SCD) with initial data expected in Q4 2026 Strong financial position ending Q2 with approximately $718 million in cash, cash equivalents, and marketable securities, providing runway into 2029 WATERTOWN, Mass., July 30, 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 second quarter ended June 30, 2026, and provided a review of recent program and corporate developments. “The anticipated readout of the Phase 3 APOLLO trial of bitopertin in EPP in Q4 marks a significant milestone. We have continued driving forward on this program over the past quarter with the launch of our EAP,” said John Quisel, J.D., Ph.D., Chief Executive Officer and President of Disc. “We also look forward to significant advancement across the rest of our pipeline in the second half of 2026. We saw strong demand for the Phase 2 RESTORE-PV trial of DISC-3405 in polycythemia vera, which is now fully enrolled with initial data coming ahead of schedule in Q3. Along with an expected end of Phase 2 FDA interaction on selcodebart in MF anemia in Q4, we will potentially be positioned to advance two more programs into pivotal-stage development in 2027.” Recent Highlights and Anticipated Milestones: Bitopertin: GlyT1 Inhibitor (Heme Synthesis Modulator) Completed Type A meeting with the FDA to discuss the CRL for bitopertin in erythropoietic protoporphyria (EPP) and aligned that the Phase 3 APOLLO study, if successful, can serve as the basis for CRL response and could potentially support a traditional…Read full document

Completed Type A meeting with the FDA on bitopertin and aligned that the Phase 3 APOLLO study, if successful, can serve as the basis for CRL response; topline data expected in Q4 2026 Launched Expanded Access Program (EAP) for bitopertin for eligible erythropoietic protoporphyria (EPP) patients Presented positive clinical data updates from the RALLY-MF Phase 2 trial of selcodebart (DISC-0974) in anemia of myelofibrosis and the HELIOS open-label extension trial of bitopertin in EPP Completed enrollment for RESTORE-PV Phase 2 study of DISC-3405 in polycythemia vera (PV) with initial data expected in Q3 2026 and progressing Phase 1b study of DISC-3405 in sickle cell disease (SCD) with initial data expected in Q4 2026 Strong financial position ending Q2 with approximately $718 million in cash, cash equivalents, and marketable securities, providing runway into 2029 WATERTOWN, Mass., July 30, 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 second quarter ended June 30, 2026, and provided a review of recent program and corporate developments. “The anticipated readout of the Phase 3 APOLLO trial of bitopertin in EPP in Q4 marks a significant milestone. We have continued driving forward on this program over the past quarter with the launch of our EAP,” said John Quisel, J.D., Ph.D., Chief Executive Officer and President of Disc. “We also look forward to significant advancement across the rest of our pipeline in the second half of 2026. We saw strong demand for the Phase 2 RESTORE-PV trial of DISC-3405 in polycythemia vera, which is now fully enrolled with initial data coming ahead of schedule in Q3. Along with an expected end of Phase 2 FDA interaction on selcodebart in MF anemia in Q4, we will potentially be positioned to advance two more programs into pivotal-stage development in 2027.” Recent Highlights and Anticipated Milestones: Bitopertin: GlyT1 Inhibitor (Heme Synthesis Modulator) Completed Type A meeting with the FDA to discuss the CRL for bitopertin in erythropoietic protoporphyria (EPP) and aligned that the Phase 3 APOLLO study, if successful, can serve as the basis for CRL response and could potentially support a traditional approval Presented updated data from the HELIOS open-label extension trial of bitopertin in EPP at the European Hematology Association (EHA) Annual Meeting, demonstrating sustained reductions in protoporphyrin IX (PPIX), significant improvement in light tolerance measures, and favorable longer-term safety Launched an Expanded Access Program (EAP) for bitopertin in the US and select other geographies, providing eligible patients with EPP and XLP access to treatment prior to a regulatory decision On track to report APOLLO topline results in Q4 2026 and expect to submit CRL response and receive an FDA decision by mid-2027 Selcodebart (DISC-0974): Anti-Hemojuvelin Antibody (Hepcidin Suppression) Shared updated data from RALLY-MF trial of selcodebart in anemia of myelofibrosis (MF) in oral presentations at the American Society of Clinical Oncology (ASCO) and European Hematology Association (EHA) annual meetings, solidifying selcodebart’s differentiated emerging profile in MF. Data showed: Additional data from RALLY-MF anticipated in Q4 2026, with an end-of-Phase 2 meeting with the FDA expected to occur by year-end Received EU Orphan Drug Designation for selcodebart for the treatment of myelofibrosis Progressing Phase 2 study in patients with inflammatory bowel disease (IBD) with initial data expected in 2027 DISC-3405: Anti-TMPRSS6 Antibody (Hepcidin Induction) Completed enrollment for RESTORE-PV Phase 2 study in patients with polycythemia vera with initial data expected in Q3 2026 Progressing Phase 1b study in patients with sickle cell disease with initial data expected in Q4 2026 Second Quarter 2026 Financial Results: Cash Position: Cash, cash equivalents, and marketable securities were $717.7 million as of June 30, 2026, which are expected to fund operational plans into 2029. Research and Development Expenses: R&D expenses were $46.9 million for the three months ended June 30, 2026, as compared to $46.3 million for the three months ended June 30, 2025. The increase in R&D expenses was primarily driven by the progression of Disc's portfolio, including the advancement of the selcodebart (DISC-0974) and DISC-3405 clinical studies and drug manufacturing, as well as increased headcount. These increases were partially offset by a decrease in manufacturing costs related to bitopertin and a $10.0 million milestone payment incurred upon initiation of the APOLLO study during the comparative period. Selling, General and Administrative Expenses: SG&A expenses were $18.1 million for the three months ended June 30, 2026, as compared to $15.1 million for the three months ended June 30, 2025. The increase in SG&A expenses was primarily due to increased headcount. Net Loss: Net loss was $59.5 million for the three months ended June 30, 2026, as compared to $55.2 million for the three months ended June 30, 2025. 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 the next stages of its development programs for bitopertin, selcodebart (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 the CRL response and 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. Media Contact Peg RusconiDeerfield [email protected] Investor Relations Contact Christina TartagliaPrecision AQ [email protected]

Investor releaseQuarter not tagged2026-05-05

Disc Medicine Reports First Quarter 2026 Financial Results and Provides Business Update

GlobeNewswire
Completed enrollment of the Phase 3 APOLLO study of bitopertin in erythropoietic protoporphyria (EPP); topline data expected in Q4 2026 Updated data from Phase 2 study of DISC-0974 in patients with anemia of myelofibrosis (MF) to be shared at the American Society of Clinical Oncology (ASCO) Annual Meeting as an oral presentation Progressing ongoing Phase 2 study of DISC-3405 in polycythemia vera (PV) and Phase 1b study of DISC-3405 in sickle cell disease (SCD), with data from both studies expected in Q4 2026 Strong financial position ending Q1 with approximately $730 million in cash, cash equivalents, and marketable securities, providing runway into 2029 WATERTOWN, Mass., May 05, 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 first quarter ended March 31, 2026, and provided a review of recent program and corporate developments. “We continue to make strong progress across the portfolio, completing enrollment in our Phase 3 trial of bitopertin in EPP and remaining on track to report topline data in the fourth quarter of 2026. We were also pleased to have our Phase 2 data for DISC-0974 in MF anemia selected for oral presentation at ASCO, while continuing to advance multiple additional clinical trials across our pipeline,” said John Quisel, J.D., Ph.D., Chief Executive Officer and President of Disc. “Together, these milestones reflect the strength of our execution and position us to deliver multiple important catalysts in the second half of this year.” Recent Highlights and Anticipated Milestones: Bitopertin: GlyT1 Inhibitor (Heme Synthesis Modulator) Completed enrollment of Phase 3 APOLLO clinical trial of bitopertin in adults and adolescents with EPP, with topline data expected Q4 2026; study size was expanded to 183 patients due to patient and physician demand Following completion of APOLLO, expect to submit a response to the CRL and receive an FDA decision by mid-2027 Type A meeting with the US FDA to review approach for resubmission scheduled for Q2 2026 DISC-0974: Anti-Hemojuvelin Antibody (Hepcidin Suppression) Updated data from Phase 2 RALLY-MF trial of DISC-0974 in patients with anemia of myelofibrosis (MF) to be shared i…Read full document

Completed enrollment of the Phase 3 APOLLO study of bitopertin in erythropoietic protoporphyria (EPP); topline data expected in Q4 2026 Updated data from Phase 2 study of DISC-0974 in patients with anemia of myelofibrosis (MF) to be shared at the American Society of Clinical Oncology (ASCO) Annual Meeting as an oral presentation Progressing ongoing Phase 2 study of DISC-3405 in polycythemia vera (PV) and Phase 1b study of DISC-3405 in sickle cell disease (SCD), with data from both studies expected in Q4 2026 Strong financial position ending Q1 with approximately $730 million in cash, cash equivalents, and marketable securities, providing runway into 2029 WATERTOWN, Mass., May 05, 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 first quarter ended March 31, 2026, and provided a review of recent program and corporate developments. “We continue to make strong progress across the portfolio, completing enrollment in our Phase 3 trial of bitopertin in EPP and remaining on track to report topline data in the fourth quarter of 2026. We were also pleased to have our Phase 2 data for DISC-0974 in MF anemia selected for oral presentation at ASCO, while continuing to advance multiple additional clinical trials across our pipeline,” said John Quisel, J.D., Ph.D., Chief Executive Officer and President of Disc. “Together, these milestones reflect the strength of our execution and position us to deliver multiple important catalysts in the second half of this year.” Recent Highlights and Anticipated Milestones: Bitopertin: GlyT1 Inhibitor (Heme Synthesis Modulator) Completed enrollment of Phase 3 APOLLO clinical trial of bitopertin in adults and adolescents with EPP, with topline data expected Q4 2026; study size was expanded to 183 patients due to patient and physician demand Following completion of APOLLO, expect to submit a response to the CRL and receive an FDA decision by mid-2027 Type A meeting with the US FDA to review approach for resubmission scheduled for Q2 2026 DISC-0974: Anti-Hemojuvelin Antibody (Hepcidin Suppression) Updated data from Phase 2 RALLY-MF trial of DISC-0974 in patients with anemia of myelofibrosis (MF) to be shared in an oral presentation at ASCO in June covering N=61 patients with data through April 27, 2026 Topline data from the RALLY-MF study to be shared in Q4 2026, with an end of Phase 2 meeting with the FDA expected to occur by end of year Progressing Phase 2 study in patients with inflammatory bowel disease (IBD) with initial data expected in 2027 DISC-3405: Anti-TMPRSS6 Antibody (Hepcidin Induction) Progressing ongoing Phase 2 study in patients with polycythemia vera and Phase 1b study in patients with sickle cell disease with initial data expected in Q4 2026 First Quarter 2026 Financial Results: Cash Position: Cash, cash equivalents, and marketable securities were $730.2 million as of March 31, 2026, which are expected to fund operational plans into 2029. Research and Development Expenses: R&D expenses were $45.9 million for the three months ended March 31, 2026, as compared to $27.8 million for the three months ended March 31, 2025. 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 and DISC-3405 programs, and increased headcount. Selling, General and Administrative Expenses: SG&A expenses were $23.6 million for the three months ended March 31, 2026, as compared to $12.2 million for the three months ended March 31, 2025. The increase in SG&A expenses was primarily due to increased headcount and establishing infrastructure to support potential commercialization. Net Loss: Net loss was $63.5 million for the three months ended March 31, 2026, as compared to $34.1 million for the three months ended March 31, 2025. 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 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. Media Contact Peg Rusconi Deerfield Group [email protected] Investor Relations Contact Christina Tartaglia Precision AQ [email protected]

Investor releaseQuarter not tagged2026-02-26

Disc Medicine Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update

GlobeNewswire
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 bito…Read full document

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 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 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. Media Contact Peg Rusconi Deerfield Group [email protected] Investor Relations Contact Christina Tartaglia Precision AQ [email protected]

Investor releaseQuarter not tagged2026-02-18

Disc Medicine Plans FDA Response on Bitopertin With Phase 3 Results; Shares Rise

MT Newswires

Disc Medicine (DSCM) said Tuesday it plans to respond to the US Food and Drug Administration's compl

Investor releaseQuarter not tagged2025-11-06

Disc Medicine Reports Third Quarter 2025 Financial Results and Provides Business Update

GlobeNewswire
Submitted a New Drug Application (NDA) for accelerated approval of bitopertin in erythropoietic protoporphyria (EPP) on September 29, 2025; Awarded the FDA Commissioner’s National Priority Voucher (CNPV), which is designed to shorten the expected NDA review period to 1-2 months from NDA acceptance Acceleration of ongoing efforts to support the potential earlier approval and commercialization of bitopertin for EPP in the US, expected in late 2025 or early 2026 Initial data from Phase 2 study of DISC-0974 in patients with anemia of myelofibrosis (MF) to be presented at the American Society of Hematology (ASH) conference in December 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 October Strong financial position ending Q3 with approximately $616 million in cash, cash equivalents, and marketable securities; completed a public offering in October 2025, with net proceeds of approximately $211M expected to extend cash runway into 2029 WATERTOWN, Mass., Nov. 06, 2025 (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 third quarter ended September 30, 2025, and provided a review of recent program and corporate developments. “We are incredibly proud of the progress across our entire pipeline this quarter, most notably around our NDA submission for bitopertin in EPP at the end of September and subsequent receipt of the CNPV,” said John Quisel, J.D., Ph.D., Chief Executive Officer and President of Disc. “Achieving this milestone is a strong testament to our team’s commitment to execution and dedication to bringing a potential new treatment option to the EPP patient community. We continue to work with the Agency on their review of our application, and we are furthering our commercial infrastructure in preparation for a potential launch.” “Beyond bitopertin, our broader pipeline is progressing well, as we expect new data from the Phase 2 trial of DISC-0974 in MF anemia by the end of the year and data from studies of DISC-3405 in PV and SCD next year. With a strong balance sheet providing cash runway into 2029, we are well-positioned to prepare for t…Read full document

Submitted a New Drug Application (NDA) for accelerated approval of bitopertin in erythropoietic protoporphyria (EPP) on September 29, 2025; Awarded the FDA Commissioner’s National Priority Voucher (CNPV), which is designed to shorten the expected NDA review period to 1-2 months from NDA acceptance Acceleration of ongoing efforts to support the potential earlier approval and commercialization of bitopertin for EPP in the US, expected in late 2025 or early 2026 Initial data from Phase 2 study of DISC-0974 in patients with anemia of myelofibrosis (MF) to be presented at the American Society of Hematology (ASH) conference in December 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 October Strong financial position ending Q3 with approximately $616 million in cash, cash equivalents, and marketable securities; completed a public offering in October 2025, with net proceeds of approximately $211M expected to extend cash runway into 2029 WATERTOWN, Mass., Nov. 06, 2025 (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 third quarter ended September 30, 2025, and provided a review of recent program and corporate developments. “We are incredibly proud of the progress across our entire pipeline this quarter, most notably around our NDA submission for bitopertin in EPP at the end of September and subsequent receipt of the CNPV,” said John Quisel, J.D., Ph.D., Chief Executive Officer and President of Disc. “Achieving this milestone is a strong testament to our team’s commitment to execution and dedication to bringing a potential new treatment option to the EPP patient community. We continue to work with the Agency on their review of our application, and we are furthering our commercial infrastructure in preparation for a potential launch.” “Beyond bitopertin, our broader pipeline is progressing well, as we expect new data from the Phase 2 trial of DISC-0974 in MF anemia by the end of the year and data from studies of DISC-3405 in PV and SCD next year. With a strong balance sheet providing cash runway into 2029, we are well-positioned to prepare for the anticipated launch of bitopertin and ultimately advancing towards our goal of delivering new treatment options to patients suffering from hematological diseases.” Recent Highlights and Anticipated Milestones: Bitopertin: GlyT1 Inhibitor (Heme Synthesis Modulator) Submitted NDA for bitopertin in EPP seeking priority review and accelerated approval with reduction in protoporphyrin IX (PPIX) as the surrogate endpoint for approval supported by clinical results from BEACON and AURORA Phase 2 trials Received the CNPV, which is designed to shorten the NDA review process to 1-2 months from NDA acceptance Accelerating activities to support a potential US approval and launch in late 2025 or early 2026 Progressing confirmatory Phase 3 APOLLO clinical trial of bitopertin in adults and adolescents with EPP 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) to be presented at ASH Annual Meeting in December, with topline data expected in 2026 Data from recently completed multiple-dose cohorts of Phase 1b study of DISC-0974 in patients with anemia of NDD-CKD to be presented at ASN Kidney Week DISC-0974 was generally well-tolerated with substantial decreases in hepcidin, increases in iron, and improvements in markers of erythropoiesis Meaningful hemoglobin increases observed in only a subset of patients were in part driven by those with higher baseline erythropoietin (EPO) levels Disc is assessing options for the program based on full analysis of the data Phase 2 study in patients with inflammatory bowel disease (IBD) and anemia anticipated to begin in Q1 2026 DISC-3405: Anti-TMPRSS6 Antibody (Hepcidin Induction) Progressing ongoing Phase 2 study of DISC-3405 in patients with PV with initial data expected in 2026 Initiated Phase 1b study of DISC-3405 in patients with SCD in October 2025 with initial data expected in 2026 Third Quarter 2025 Financial Results: Cash Position: Cash, cash equivalents, and marketable securities were $615.9 million as of September 30, 2025. In October 2025, Disc completed a public offering with net proceeds of approximately $211 million, extending cash runway into 2029. Research and Development Expenses: R&D expenses were $50.3 million for the three months ended September 30, 2025, as compared to $24.7 million for the three months ended September 30, 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 a payment of a $10.0 million milestone upon first administration to a patient in the Phase 2 trial of DISC-3405. Selling, General and Administrative Expenses: SG&A expenses were $17.4 million for the three months ended September 30, 2025, as compared to $8.2 million for the three months ended September 30, 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 $62.3 million for the three months ended September 30, 2025, as compared to $26.6 million for the three months ended September 30, 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 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 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; anticipated discussions with regulatory agencies; ongoing preparations for the potential launch of bitopertin; 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, 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 [email protected] Investor Relations Contact Christina Tartaglia Precision AQ [email protected]

Investor releaseQuarter not tagged2025-08-07

Disc Medicine Reports Second Quarter 2025 Financial Results and Provides Business Update

GlobeNewswire
Company on track to submit NDA for bitopertin in erythropoietic protoporphyria (EPP) under accelerated approval pathway in October 2025, supported by successful pre-NDA meeting Expect initial data from Phase 2 study of DISC-0974 in patients with anemia of myelofibrosis (MF) and multiple dose data from Phase 1b study of DISC-0974 in patients with anemia of non-dialysis-dependent chronic kidney disease (NDD-CKD) in Q4 2025 Initiated Phase 2 study of DISC-3405 in polycythemia vera (PV) with initial data expected in 2026 Presented positive clinical data updates across the portfolio at the European Hematology Association (EHA) Annual Congress, including longer term efficacy and safety data from the HELIOS trial of bitopertin in EPP, durability data from Phase 1b study of DISC-0974 in MF anemia, and healthy volunteer data from DISC-3405 studies Strong financial position ending Q2 with $650.0 million in cash, cash equivalents, and marketable securities; expected to fund operations into 2028 WATERTOWN, Mass., Aug. 07, 2025 (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 second quarter ended June 30, 2025, and provided a recap of recent program and corporate developments. “We are pleased with the continued momentum this past quarter, highlighted by clinical data presentations that support further advancement across our programs and continued progress toward our first NDA submission. Following positive feedback from our pre-NDA meeting, we are on track to submit an NDA for bitopertin in EPP under the accelerated approval pathway in October,” said John Quisel, J.D., Ph.D., Chief Executive Officer and President of Disc. “We have also made great progress across the rest of our pipeline, initiating a Phase 2 study of DISC-3405 in polycythemia vera, and looking ahead to data from the Phase 2 trial of DISC-0974 in MF anemia and Phase 1b trial in NDD-CKD anemia in the second half of the year. Our team’s commitment to execution, supported by a strong balance sheet that provides cash runway into 2028, has positioned Disc to prepare for the potential commercialization of bitopertin and advance pipeline development as we enter the next phase of growth.”…Read full document

Company on track to submit NDA for bitopertin in erythropoietic protoporphyria (EPP) under accelerated approval pathway in October 2025, supported by successful pre-NDA meeting Expect initial data from Phase 2 study of DISC-0974 in patients with anemia of myelofibrosis (MF) and multiple dose data from Phase 1b study of DISC-0974 in patients with anemia of non-dialysis-dependent chronic kidney disease (NDD-CKD) in Q4 2025 Initiated Phase 2 study of DISC-3405 in polycythemia vera (PV) with initial data expected in 2026 Presented positive clinical data updates across the portfolio at the European Hematology Association (EHA) Annual Congress, including longer term efficacy and safety data from the HELIOS trial of bitopertin in EPP, durability data from Phase 1b study of DISC-0974 in MF anemia, and healthy volunteer data from DISC-3405 studies Strong financial position ending Q2 with $650.0 million in cash, cash equivalents, and marketable securities; expected to fund operations into 2028 WATERTOWN, Mass., Aug. 07, 2025 (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 second quarter ended June 30, 2025, and provided a recap of recent program and corporate developments. “We are pleased with the continued momentum this past quarter, highlighted by clinical data presentations that support further advancement across our programs and continued progress toward our first NDA submission. Following positive feedback from our pre-NDA meeting, we are on track to submit an NDA for bitopertin in EPP under the accelerated approval pathway in October,” said John Quisel, J.D., Ph.D., Chief Executive Officer and President of Disc. “We have also made great progress across the rest of our pipeline, initiating a Phase 2 study of DISC-3405 in polycythemia vera, and looking ahead to data from the Phase 2 trial of DISC-0974 in MF anemia and Phase 1b trial in NDD-CKD anemia in the second half of the year. Our team’s commitment to execution, supported by a strong balance sheet that provides cash runway into 2028, has positioned Disc to prepare for the potential commercialization of bitopertin and advance pipeline development as we enter the next phase of growth.” Recent Highlights and Anticipated Milestones: Bitopertin: GlyTI Inhibitor (Heme Synthesis Modulator) Presented data from HELIOS, an ongoing open-label extension study of bitopertin in EPP, which showed favorable long-term efficacy and safety with sustained protoporphyrin IX (PPIX) reductions, improvement in quality of life, and improved liver biomarkers Progressing confirmatory Phase 3 APOLLO clinical trial of bitopertin in adults and adolescents with EPP Completed positive pre-NDA meeting with FDA, confirming alignment with the agency on the expected timing, format, and content of planned NDA submission for bitopertin in EPP Expect to submit an NDA in October 2025 under the FDA’s accelerated approval pathway based on Disc’s existing data package Publication of the results from a preclinical study conducted in collaboration with Boston Children’s Hospital showing that, in mice, bitopertin may help prevent liver disease in EPP, in addition to ameliorating blood PPIX levels. The paper, “The GLYT1 inhibitor bitopertin mitigates erythroid PPIX production and liver disease in erythroid protoporphyria,” was published in the Journal of Clinical Investigation (corresponding authors Sarah Ducamp and Paul Schmidt) DISC-0974: Anti-Hemojuvelin Antibody (Hepcidin Suppression) Hosted a virtual MF Anemia KOL event on May 9, 2025, discussing DISC-0974 and its potential to play a significant role in the treatment of anemia in patients with MF A replay of the webcast is available on the Events & Presentations page on the investor relations portion of the Company website Presented clinical data from the continuation phase of the Phase 1b trial of DISC-0974 in MF anemia demonstrating durable hematologic response at EHA 2025 Progressing RALLY-MF Phase 2 study of DISC-0974 in patients with anemia of MF with initial data expected in Q4 2025 Exploratory cohort for patients on concomitant momelotinib or pacritinib fully enrolled, and trial protocol updated to allow patients on these therapies into the main study cohorts Progressing Phase 1b study of DISC-0974 in patients with anemia of NDD-CKD with multiple-dose data expected in Q4 2025 DISC-3405: Anti-TMPRSS6 Antibody (Hepcidin Induction) Presented updated SAD/MAD data from the Phase 1 trial of DISC-3405 in healthy volunteers providing proof of mechanism to support advancement of the program at EHA 2025 Initiated a Phase 2 study of DISC-3405 in patients with PV with initial data expected in 2026 Corporate: Appointed Nadim Ahmed, President and CEO of Cullinan Therapeutics, to the Company’s Board of Directors in July, bringing to the Company over 25 years of development and commercial leadership experience including multiple product launches in the hematology space Second Quarter 2025 Financial Results: Cash Position: Cash, cash equivalents, and marketable securities were $650.0 million as of June 30, 2025, which are expected to fund operational plans into 2028. Research and Development Expenses: R&D expenses were $46.3 million for the three months ended June 30, 2025, as compared to $23.5 million for the three months ended June 30, 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 a payment of a $10 million milestone upon initiation of the APOLLO study. Selling, General and Administrative Expenses: SG&A expenses were $15.1 million for the three months ended June 30, 2025, as compared to $7.4 million for the three months ended June 30, 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 $55.2 million for the three months ended June 30, 2025, as compared to $26.4 million for the three months ended June 30, 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 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 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 and the projected timeline for an NDA submission; 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; and the other risks and uncertainties described in Disc’s filings with the SEC, 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 [email protected] Investor Relations Contact Christina Tartaglia Precision AQ [email protected]

Investor releaseQuarter not tagged2025-05-07

Disc Medicine Reports First Quarter 2025 Financial Results and Provides Business Update

GlobeNewswire
Company remains on track to submit NDA for bitopertin in erythropoietic protoporphyria (EPP) in H2 2025 Initiated APOLLO, a confirmatory clinical trial of bitopertin in adults and adolescents with EPP Plan to initiate Phase 2 study of DISC-3405 in polycythemia vera (PV) in H1 2025 Expect data readouts for DISC-0974 program in H2 2025, including initial results of Phase 2 anemia of myelofibrosis (MF) study and multiple dose data from Phase 1b anemia of non-dialysis dependent chronic kidney disease (NDD-CKD) study Strong financial position supported by $259 million public offering in January 2025; ended Q1 with $695 million in cash, cash equivalents, and marketable securities, which is expected to fund operations into 2028 Company to host virtual MF Anemia KOL Day on Friday, May 9 at 1:00 PM ET / 10:00 AM PT WATERTOWN, Mass., May 07, 2025 (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 first quarter ended March 31, 2025, and provided a recap of recent program and corporate developments. “2025 is off to a strong start for Disc as we continue to make operational progress across our portfolio. On our lead program, bitopertin in EPP, we are proud to share that the APOLLO trial is officially up and running. We believe that bitopertin has the potential to be a life-altering therapy and thank the EPP physician, advocate, and patient communities for their ongoing enthusiasm and partnership in the development process,” said John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc. “We also appreciate the continued and timely engagement from regulators, including during the latest CMC-focused meeting where we reached alignment on key CMC items needed to support our plan to submit an NDA in H2 2025. “Backed by a solid financial foundation which provides a cash runway into 2028, we are well-positioned to progress our commercial preparation efforts for bitopertin as well as development of the rest of our pipeline. We expect data from ongoing trials of DISC-0974, the Phase 2 MF anemia study and the Phase 1b NDD-CKD anemia study, to read out in the second half of this year and expect to initiate a Phase 2 study of DISC-3405 in PV in t…Read full document

Company remains on track to submit NDA for bitopertin in erythropoietic protoporphyria (EPP) in H2 2025 Initiated APOLLO, a confirmatory clinical trial of bitopertin in adults and adolescents with EPP Plan to initiate Phase 2 study of DISC-3405 in polycythemia vera (PV) in H1 2025 Expect data readouts for DISC-0974 program in H2 2025, including initial results of Phase 2 anemia of myelofibrosis (MF) study and multiple dose data from Phase 1b anemia of non-dialysis dependent chronic kidney disease (NDD-CKD) study Strong financial position supported by $259 million public offering in January 2025; ended Q1 with $695 million in cash, cash equivalents, and marketable securities, which is expected to fund operations into 2028 Company to host virtual MF Anemia KOL Day on Friday, May 9 at 1:00 PM ET / 10:00 AM PT WATERTOWN, Mass., May 07, 2025 (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 first quarter ended March 31, 2025, and provided a recap of recent program and corporate developments. “2025 is off to a strong start for Disc as we continue to make operational progress across our portfolio. On our lead program, bitopertin in EPP, we are proud to share that the APOLLO trial is officially up and running. We believe that bitopertin has the potential to be a life-altering therapy and thank the EPP physician, advocate, and patient communities for their ongoing enthusiasm and partnership in the development process,” said John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc. “We also appreciate the continued and timely engagement from regulators, including during the latest CMC-focused meeting where we reached alignment on key CMC items needed to support our plan to submit an NDA in H2 2025. “Backed by a solid financial foundation which provides a cash runway into 2028, we are well-positioned to progress our commercial preparation efforts for bitopertin as well as development of the rest of our pipeline. We expect data from ongoing trials of DISC-0974, the Phase 2 MF anemia study and the Phase 1b NDD-CKD anemia study, to read out in the second half of this year and expect to initiate a Phase 2 study of DISC-3405 in PV in the coming months.” Recent Highlights and Anticipated Milestones: Bitopertin: GlyT1 Inhibitor (Heme Synthesis Modulator) Initiated APOLLO, a double-blind, placebo-controlled, confirmatory trial of bitopertin in adults and adolescents with EPP. The APOLLO trial is designed to support conversion of a U.S. accelerated approval, if granted, to a full approval On track to submit NDA for bitopertin in EPP in H2 2025 under the accelerated approval pathway using protoporphyrin IX (PPIX) reduction as surrogate endpoint, based on existing clinical data, including results from BEACON and AURORA Phase 2 trials Successful manufacturing-focused end-of-Phase 2 meeting: Engaged with the FDA’s Office of Pharmaceutical Quality (OPQ) which collaborates with the Division of Dermatology and Dentistry within CDER on the review and evaluation for bitopertin Achieved alignment on proposed Chemistry, Manufacturing, and Controls (CMC) components of the NDA package Bitopertin drug substance and drug product are manufactured in the US Scheduled pre-NDA meeting to align with the FDA on format and content of the NDA package with the goal of facilitating an efficient review DISC-0974: Anti-Hemojuvelin Antibody (Hepcidin Suppression) Company to host a virtual MF Anemia KOL Day on Friday, May 9, featuring key opinion leaders Dr. Prithvi Bose and Dr. Aaron Gerds as well as Disc management, to discuss DISC-0974 and its potential to play a significant role in the treatment of anemia in patients with MF Live webcast can be accessed on the Events & Presentations page on the investor relations portion of the Company website Progressing ongoing Phase 2 study of DISC-0974 in patients with anemia of MF with initial data expected in H2 2025 Progressing ongoing Phase 1b study of DISC-0974 in patients with anemia of NDD-CKD with multiple-dose data expected in H2 2025 DISC-3405: Anti-TMPRSS6 Antibody (Hepcidin Induction) On track to initiate Phase 2 study in PV in H1 2025 Corporate: Successfully completed a public offering with gross proceeds of $259 million in January 2025, extending cash runway into 2028 First Quarter 2025 Financial Results: Cash Position: Cash, cash equivalents, and marketable securities were $694.7 million as of March 31, 2025, which are expected to fund operational plans into 2028. Research and Development Expenses: R&D expenses were $27.8 million for the three months ended March 31, 2025, as compared to $23.7 million for the three months ended March 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. Selling, General and Administrative Expenses: SG&A expenses were $12.2 million for the three months ended March 31, 2025, as compared to $7.8 million for the three months ended March 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 $34.1 million for the three months ended March 31, 2025, as compared to $26.9 million for the three months ended March 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 www.discmedicine.com. Available Information Disc announces material information to the public about the Company, its product candidates, 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 accelerated approval; 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; and the other risks and uncertainties described in Disc’s filings with the SEC, 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 [email protected] Investor Relations Contact Christina Tartaglia Precision AQ [email protected]

As of 2026-08-01 • Updated weeklySource: Earnings sourceIngestion runbook