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

Rhea-AI Summary

Disc Medicine (NASDAQ:IRON) completed enrollment in its Phase 3 APOLLO trial of bitopertin in EPP (expanded to 183 patients) and expects topline APOLLO data in Q4 2026. The company will present updated Phase 2 DISC-0974 data at ASCO and anticipates multiple Q4 2026 readouts. Cash, cash equivalents, and marketable securities were $730.2 million as of March 31, 2026, funding operations into 2029.

Positive

• Completed Phase 3 enrollment for bitopertin (183 patients)
• $730.2M cash supports runway into 2029
• DISC-0974 Phase 2 data selected for ASCO oral presentation
• Multiple clinical readouts expected in Q4 2026

Negative

• R&D expenses rose to $45.9M in Q1 2026
• SG&A expenses rose to $23.6M in Q1 2026
• Net loss increased to $63.5M in Q1 2026
• Pending FDA decision following CRL with response planned mid-2027

News Market Reaction – IRON

-0.07%

-0.07% Session close to close

In the May 5 session, IRON declined 0.07%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights completion of enrollment in the Phase 3 APOLLO trial for EPP, upcoming ...

Analysis

This announcement highlights completion of enrollment in the Phase 3 APOLLO trial for EPP, upcoming Phase 2 DISC-0974 data at ASCO, and continued progress for DISC-3405, all backed by $730.2M in cash funding plans into 2029. Historically, earnings updates have produced modest share-price moves. Key factors to watch include the Q4 2026 topline readouts, the planned FDA Type A meeting and response to the CRL, and how rising R&D and SG&A spending tracks against clinical milestones.

Key Figures

Cash & securities: $730.2M R&D expenses: $45.9M SG&A expenses: $23.6M +5 more

8 metrics

Cash & securities $730.2M As of March 31, 2026; runway into 2029

R&D expenses $45.9M Q1 2026; vs. $27.8M in Q1 2025

SG&A expenses $23.6M Q1 2026; vs. $12.2M in Q1 2025

Net loss $63.5M Q1 2026; vs. $34.1M in Q1 2025

APOLLO study size 183 patients Phase 3 bitopertin trial in EPP; enrollment completed

RALLY-MF sample size N=61 patients Phase 2 DISC-0974 trial data through April 27, 2026

Topline bitopertin data Q4 2026 Phase 3 APOLLO trial in EPP; expected readout timing

FDA decision timing Mid-2027 Expected FDA decision after APOLLO and CRL response

Previous Earnings Reports

5 past events · Latest: Feb 26 (Neutral)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Feb 26	Earnings and update	Neutral	+1.5%	Q4 2025 results, strong cash, APOLLO progress, and February 2026 CRL disclosure.
Nov 06	Earnings and NDA	Positive	-1.5%	Q3 2025 results with bitopertin NDA filing and CNPV priority voucher details.
Aug 07	Quarterly results	Positive	-3.3%	Q2 2025 financials, strong cash, and progress across DISC-0974 and DISC-3405 programs.
May 07	Quarterly results	Positive	+2.3%	Q1 2025 results, bitopertin NDA planning and APOLLO trial initiation, equity financing.
Feb 27	Full-year results	Positive	+0.1%	2024 results, expanded pipeline data and strengthened balance sheet extending runway.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Earnings updates have produced modest, mixed reactions, with an average move of about -0.17% and a blend of aligned and divergent days.

Recent Company History

Recent earnings and business updates for Disc Medicine have centered on advancing bitopertin for EPP, DISC-0974 for MF anemia, and DISC-3405 for PV and SCD, while maintaining substantial cash runway into 2028–2029. Past reports highlighted NDA submission, a subsequent FDA CRL, and ongoing APOLLO Phase 3 enrollment. Price reactions around these earnings events have generally been small, with both positive and negative single-day moves, indicating measured investor responses to updates similar in scope to this quarter’s report.

Key Terms

phase 3, phase 2, erythropoietic protoporphyria, myelofibrosis, +4 more

8 terms

phase 3 medical

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

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

phase 2 medical

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

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

erythropoietic protoporphyria medical

"Phase 3 APOLLO study of bitopertin in erythropoietic protoporphyria (EPP); topline data expected"

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.

myelofibrosis medical

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

A bone marrow disorder in which healthy, spongy marrow is gradually replaced by scar tissue, like a garden soil turned to concrete so seeds can’t grow. That replacement reduces production of red and white blood cells and platelets, causing anemia, fatigue, infections and an enlarged spleen. Investors care because the condition creates demand for therapies, clinical trials and regulatory decisions that can materially affect drug sales and company valuations.

polycythemia vera medical

"Progressing ongoing 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), with data from both studies"

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.

complete response letter regulatory

"Following completion of APOLLO, expect to submit a response to the CRL and receive an FDA decision"

A complete response letter is an official communication from a drug or medical-device regulator, such as the U.S. Food and Drug Administration (FDA), telling a company that a marketing application cannot be approved in its current form and listing the specific deficiencies to be fixed. For investors it matters because it pauses or delays a product’s path to market—like a building inspector issuing a list of repairs before a certificate of occupancy—affecting revenue timing, costs and stock value.

type a meeting regulatory

"Type A meeting with the US FDA to review approach for resubmission scheduled for Q2 2026"

A Type A meeting is an urgent, short-notice session requested between a company and a regulatory agency (for example, the FDA in the U.S.) to resolve critical issues that block a development program, such as a clinical hold or safety concern. Investors care because the outcome can immediately affect whether a clinical trial or approval process resumes, changing timelines, costs and the company’s near-term value — like calling an emergency mechanic when a car won’t start so a trip can continue.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

• 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.

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

When will Disc Medicine (IRON) report topline APOLLO Phase 3 bitopertin data?

Disc Medicine expects topline APOLLO data in Q4 2026. According to Disc Medicine, the Phase 3 study completed enrollment (expanded to 183 patients) and topline readout timing targets the fourth quarter of 2026.

How much cash does Disc Medicine (IRON) have and how long will it last?

$730.2 million in cash, equivalents, and marketable securities as of March 31, 2026. According to Disc Medicine, this cash position is expected to fund the company's operational plans into 2029.

What clinical data will Disc Medicine (IRON) present at ASCO 2026?

Updated Phase 2 data for DISC-0974 in MF anemia will be presented orally at ASCO in June. According to Disc Medicine, the ASCO presentation covers N=61 patients with data through April 27, 2026.

Which Disc Medicine (IRON) programs expect initial data in Q4 2026?

Topline APOLLO bitopertin, DISC-3405 PV and SCD studies, and RALLY-MF topline are targeted for Q4 2026. According to Disc Medicine, multiple program readouts are expected across those studies in the fourth quarter.

What drove Disc Medicine's higher operating expenses in Q1 2026?

Increased R&D and SG&A spending to advance clinical programs and build commercial infrastructure. According to Disc Medicine, R&D rose to $45.9M and SG&A to $23.6M due to program progression and increased headcount.

What are the upcoming regulatory milestones for Disc Medicine (IRON)?

A Type A FDA meeting is scheduled in Q2 2026 and a mid-2027 FDA decision is expected after the CRL response. According to Disc Medicine, the company plans a resubmission pathway and expects an FDA decision by mid-2027.