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

• 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.

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 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

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