Disc Medicine Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update
Rhea-AI Summary
Disc Medicine (NASDAQ:IRON) reported Q4 and full-year 2025 results and a program update on Feb 26, 2026. Key points: $791.2M cash runway into 2029, Phase 3 APOLLO for bitopertin enrolling through March 2026 with topline data expected Q4 2026, FDA issued a CRL in Feb 2026. Positive Phase 2 data presented for DISC-0974 in MF anemia; DISC-3405 studies progressing with data due 2H 2026.
Full-year 2025: R&D $170.6M, SG&A $65.4M, net loss $212.2M; cash increased from $489.9M at 2024 year-end largely from $454.4M equity offerings.
Positive
- Cash position of $791.2M, runway into 2029
- Phase 3 APOLLO ongoing; topline bitopertin data due Q4 2026
- DISC-0974 Phase 2 showed durable hemoglobin and transfusion benefits
- DISC-3405 clinical programs advancing with 2H 2026 data expected
Negative
- Received FDA Complete Response Letter (CRL) in Feb 2026
- Net loss widened to $212.2M in 2025 from $109.4M
- R&D up to $170.6M and SG&A to $65.4M, increasing cash burn
News Market Reaction – IRON
On the day this news was published, IRON gained 1.52%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
IRON gained 1.04% while key biotech peers were mostly negative: AGIO -1.64%, TARS -3.09%, TVTX -5.32%, with only OCUL up 2.32%. Scanner momentum shows just ARQT moving up, reinforcing a stock-specific reaction.
Previous Earnings Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 06 | Q3 2025 earnings | Positive | -1.5% | Reported Q3 2025 results, bitopertin NDA submission and CNPV voucher, cash runway to 2029. |
| Aug 07 | Q2 2025 earnings | Positive | -3.3% | Q2 2025 results with planned bitopertin NDA, DISC-0974 and DISC-3405 progress, strong cash. |
| May 07 | Q1 2025 earnings | Positive | +2.3% | Q1 2025 results, bitopertin NDA plan, APOLLO trial progress, $259M offering and cash runway. |
| Feb 27 | FY 2024 earnings | Positive | +0.1% | Full-year 2024 results, $490M cash, funding extension, bitopertin NDA timing and pipeline data. |
| Nov 12 | Q3 2024 earnings | Positive | -5.0% | Q3 2024 results, increased R&D and G&A, $487.4M cash plus $200M debt, positive FDA meeting. |
Earnings updates often highlight pipeline and balance sheet strength, but shares have more frequently traded down or flat on these reports.
Across prior earnings releases from Nov 2024 through Nov 2025, Disc Medicine consistently paired pipeline milestones for bitopertin, DISC-0974 and DISC-3405 with growing cash reserves and extended runway into 2028–2029. Yet market reactions around these updates were modest, with a mix of small gains and declines. Today’s full-year 2025 report continues that theme, emphasizing a strong $791.2M cash position and higher R&D spend to advance late-stage programs.
Historical Comparison
Past earnings for IRON averaged a -1.47% move. Today’s modest +1.04% gain contrasts with the usual slight post-earnings softness.
Earnings updates have tracked bitopertin’s path from planned NDA to submission and CNPV, and now to addressing a CRL via the APOLLO Phase 3 trial, while cash has risen from $487.4M in 2024 to $615.9M and now $791.2M, extending runway into 2029 as DISC-0974 and DISC-3405 advance.
Market Pulse Summary
This announcement combines a detailed pipeline update with a stronger balance sheet. Disc ended 2025 with $791.2M in cash and securities, funding operations into 2029, while R&D rose to $170.6M and net loss to $212.2M as late-stage programs advanced. Investors may focus on timelines such as APOLLO completion in March 2026, topline data in Q4 2026, and an anticipated FDA decision by mid‑2027.
Key Terms
erythropoietic protoporphyria medical
myelofibrosis medical
polycythemia vera medical
sickle cell disease medical
complete response letter regulatory
hepcidin medical
inflammatory bowel disease medical
tmprss6 medical
AI-generated analysis. Not financial advice.
- 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.
| 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
FAQ
What is the timing for Disc Medicine (IRON) Phase 3 APOLLO topline data for bitopertin?
How much cash did Disc Medicine (IRON) have at year-end 2025 and how long is runway?
What did the FDA action mean for bitopertin and what is the next regulatory step for IRON?
What were the key 2025 financial changes for Disc Medicine (IRON) investors should note?
What clinical progress did DISC-0974 report at ASH for anemia of myelofibrosis?
When will Disc Medicine (IRON) report data for DISC-3405 studies in PV and sickle cell disease?
