-- 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, December 31,
2026 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
(END) Dow Jones Newswires
May 05, 2026 08:30 ET (12:30 GMT)