Disc Medicine (NASDAQ: IRON) posts Q1 2026 loss and advances late-stage trials

Rhea-AI Filing Summary

Disc Medicine, Inc. reported first quarter 2026 results showing increased investment in its hematology pipeline and a larger net loss, supported by a strong cash position. Cash, cash equivalents, and marketable securities were $730.2 million as of March 31, 2026, expected to fund operations into 2029.

Research and development expenses rose to $45.9 million and selling, general and administrative expenses to $23.6 million, reflecting expanded clinical activity and commercialization preparation. Net loss widened to $63.5 million or $1.65 per share. Operationally, the company completed enrollment in its Phase 3 APOLLO bitopertin trial in EPP and advanced multiple Phase 1/2 studies, with several data readouts anticipated in late 2026.

Insights

Biotech equity analyst

Disc is stepping up spend to advance late-stage hematology programs, backed by substantial cash.

Disc Medicine ended Q1 2026 with $730.2 million in cash, cash equivalents, and marketable securities, which it expects to fund operations into 2029. This supports an expanded clinical portfolio, including a Phase 3 program and multiple Phase 1/2 trials.

Operating expenses grew sharply as R&D reached $45.9 million and SG&A $23.6 million, driving a quarterly net loss of $63.5 million. Management links this to progressing bitopertin, DISC-0974, and DISC-3405 and building potential commercialization infrastructure.

Key upcoming milestones include Phase 3 APOLLO topline data for bitopertin in EPP in Q4 2026, RALLY-MF Phase 2 topline data for DISC-0974 also in Q4 2026, and initial data for DISC-3405 in PV and SCD in Q4 2026. These clinical readouts will be important for assessing the future trajectory of the pipeline.

8-K Event Classification

2 items: 2.02, 9.01

2 items

Item 2.02 Results of Operations and Financial Condition Financial

Disclosure of earnings results, typically an earnings press release or preliminary financials.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Key Figures

Cash & securities: $730.2 million Research & development expenses: $45.9 million SG&A expenses: $23.6 million +5 more

8 metrics

Cash & securities $730.2 million Cash, cash equivalents, and marketable securities as of March 31, 2026

Research & development expenses $45.9 million Three months ended March 31, 2026

SG&A expenses $23.6 million Three months ended March 31, 2026

Net loss $63.5 million Three months ended March 31, 2026

Net loss per share $1.65 Basic and diluted, three months ended March 31, 2026

Weighted-average shares 38,491,433 shares Basic and diluted, three months ended March 31, 2026

Total assets $750.2 million As of March 31, 2026

Total stockholders’ equity $688.4 million As of March 31, 2026

Key Terms

Phase 3 APOLLO study, erythropoietic protoporphyria, anemia of myelofibrosis, polycythemia vera, +2 more

6 terms

Phase 3 APOLLO study medical

"Completed enrollment of the Phase 3 APOLLO study of bitopertin in erythropoietic protoporphyria (EPP)"

erythropoietic protoporphyria medical

"Phase 3 APOLLO study of bitopertin in erythropoietic protoporphyria (EPP)"

A rare inherited condition in which the body accumulates a light-sensitive molecule, causing painful and immediate reactions to sunlight and, in some people, damage to the liver. For investors, EPP matters because its small but well-defined patient population, clear clinical endpoints, and serious unmet medical needs create focused markets for diagnostics and treatments and can attract regulatory incentives and premium pricing for successful therapies.

anemia of myelofibrosis medical

"Phase 2 study of DISC-0974 in patients with anemia of myelofibrosis (MF)"

polycythemia vera medical

"Phase 2 study of DISC-3405 in polycythemia vera (PV)"

A rare, long-term blood disorder in which the body makes too many red blood cells, thickening the blood and raising the risk of clots, bleeding, fatigue and other complications. Think of it like a faucet left partially open that slowly overfills a sink — the excess cells create strain and danger over time. Investors care because the condition drives demand for diagnostics, treatments and ongoing care, influences clinical trial and regulatory outcomes, and can affect revenue and costs for drugmakers, hospitals and insurers.

sickle cell disease medical

"Phase 1b study of DISC-3405 in sickle cell disease (SCD)"

Sickle cell disease is an inherited blood disorder where red blood cells become rigid and crescent-shaped, causing them to clump and block small blood vessels; this leads to recurrent pain, organ damage and higher risk of infection. For investors it matters because the condition drives ongoing healthcare costs, creates demand for new drugs, gene therapies and diagnostics, affects payer and hospital economics, and can influence workforce productivity and insurance liabilities—making progress or setbacks in treatments a market-moving factor.

hematologic diseases medical

"novel treatments for patients suffering from serious hematologic diseases"

Hematologic diseases are disorders that affect the blood, bone marrow or the systems that make blood work—including red and white blood cells, platelets and clotting. Like problems in a building’s delivery pipes, they disrupt delivery of oxygen, immune defense or clotting and can require long-term treatment, specialized drugs or devices. For investors, these conditions drive demand for diagnostics, therapies and clinical trials, so advances or setbacks can materially affect company revenues and valuations.

Earnings Snapshot

Net loss: $63.5 million

Q1 2026

Net loss $63.5 million

Net loss per share (basic and diluted) $1.65

Research and development expenses $45.9 million

Selling, general and administrative expenses $23.6 million

Cash, cash equivalents, and marketable securities $730.2 million

Understanding 8-K Material Events →

false000181673600018167362026-05-052026-05-05

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 05, 2026

DISC MEDICINE, INC.

(Exact name of Registrant as Specified in Its Charter)

Delaware			001-39438	85-1612845
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
321 Arsenal Street Suite 101
Watertown, Massachusetts				02472
(Address of Principal Executive Offices)				(Zip Code)

Registrant’s Telephone Number, Including Area Code: 617 674-9274

N/A

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol		Name of each exchange on which registered
Common Stock, par value $0.0001 per share		IRON		The Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition.

On May 5, 2026, Disc Medicine, Inc. announced its financial results for the first quarter ended March 31, 2026 and provided a corporate update. A copy of the press release in connection with the announcement is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1 attached hereto) is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1		Press release issued by Disc Medicine, Inc. on May 5, 2026, furnished herewith.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

			DISC MEDICINE, INC.
Date:	May 5, 2026	By:	/s/ John Quisel, J.D., Ph.D.
			Name: John Quisel, J.D., Ph.D. Title: Chief Executive Officer

Exhibit 99.1

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

•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 5, 2026 – 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 top-line 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.

DISC MEDICINE, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share amounts)
(Unaudited)
		Three months ended March 31,
		2026				2025
Operating expenses:
Research and development		$	45,904			$	27,763
Selling, general and administrative			23,620				12,183
Total operating expenses			69,524				39,946
Loss from operations			(69,524	)			(39,946	)
Other income (expense), net			6,071				5,980
Income tax expense			(51	)			(119	)
Net loss		$	(63,504	)		$	(34,085	)
Net loss per share, basic and diluted		$	(1.65	)		$	(1.02	)
Weighted-average common shares outstanding, basic and diluted			38,491,433				33,324,745

DISC MEDICINE, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
		March 31, 2026				December 31, 2025
		(Unaudited)
Assets
Cash, cash equivalents, and marketable securities		$	730,158			$	791,152
Other current assets			17,297				12,746
Total current assets			747,455				803,898
Non-current assets			2,758				2,981
Total assets		$	750,213			$	806,879
Liabilities and Stockholders’ Equity
Current liabilities		$	31,142			$	36,641
Non-current liabilities			30,642				30,412
Total liabilities			61,784				67,053
Total stockholders’ equity			688,429				739,826
Total liabilities and stockholders’ equity		$	750,213			$	806,879

Media Contact

Peg Rusconi

Deerfield Group

peg.rusconi@deerfieldgroup.com

Investor Relations Contact

Christina Tartaglia

Precision AQ christina.tartaglia@precisionaq.com

FAQ

How did Disc Medicine (IRON) perform financially in Q1 2026?

Disc Medicine reported a larger net loss in Q1 2026 as it increased spending on its pipeline. Net loss was $63.5 million, or $1.65 per share, driven mainly by higher research and development and selling, general and administrative expenses versus the prior-year quarter.

What is Disc Medicine’s (IRON) cash runway after Q1 2026?

Disc Medicine ended Q1 2026 with a strong cash position supporting a long runway. Cash, cash equivalents, and marketable securities totaled $730.2 million as of March 31, 2026, which the company expects will fund its operational plans into 2029, including multiple late-stage clinical programs.

Which key clinical milestones did Disc Medicine (IRON) highlight in this update?

Disc Medicine completed enrollment of the Phase 3 APOLLO trial of bitopertin in EPP. The company expects topline APOLLO data in Q4 2026, RALLY-MF Phase 2 topline data for DISC-0974 in Q4 2026, and initial DISC-3405 data in PV and SCD also in Q4 2026.

How did research and development spending change for Disc Medicine (IRON) in Q1 2026?

Research and development expenses increased significantly as Disc expanded its clinical activities. R&D expenses were $45.9 million for the three months ended March 31, 2026, compared with $27.8 million in the same period of 2025, reflecting progress in bitopertin, DISC-0974, and DISC-3405 programs.

What were Disc Medicine’s (IRON) selling, general and administrative expenses in Q1 2026?

Disc Medicine’s SG&A expenses rose as it builds commercialization infrastructure. Selling, general and administrative expenses reached $23.6 million in the quarter ended March 31, 2026, up from $12.2 million a year earlier, mainly due to increased headcount and preparation for potential product launches.

What is the status of Disc Medicine’s DISC-0974 program mentioned in the filing?

Disc Medicine is advancing DISC-0974 through mid-stage clinical development. Updated Phase 2 RALLY-MF anemia data in myelofibrosis will be presented orally at ASCO in June, with topline RALLY-MF data expected in Q4 2026 and an end of Phase 2 FDA meeting anticipated by year-end.

Filing Exhibits & Attachments

2 documents

Press Releases

• EX-99.1 EX-99.1 126.0 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA WITH EMBEDDED LINKBASES DOCUMENT 25.4 KB