-- Completed Type A meeting with the FDA on bitopertin and aligned that the
Phase 3 APOLLO study, if successful, can serve as the basis for CRL
response; topline data expected in Q4 2026
-- Launched Expanded Access Program (EAP) for bitopertin for eligible
erythropoietic protoporphyria $(EPP)$ patients
-- Presented positive clinical data updates from the RALLY-MF Phase 2 trial
of selcodebart (DISC-0974) in anemia of myelofibrosis and the HELIOS
open-label extension trial of bitopertin in EPP
-- Completed enrollment for RESTORE-PV Phase 2 study of DISC-3405 in
polycythemia vera (PV) with initial data expected in Q3 2026 and
progressing Phase 1b study of DISC-3405 in sickle cell disease $(SCD)$ with
initial data expected in Q4 2026
-- Strong financial position ending Q2 with approximately $718 million in
cash, cash equivalents, and marketable securities, providing runway into
2029
WATERTOWN, Mass., July 30, 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 second quarter ended June 30, 2026, and provided a review of recent program and corporate developments.
"The anticipated readout of the Phase 3 APOLLO trial of bitopertin in EPP in Q4 marks a significant milestone. We have continued driving forward on this program over the past quarter with the launch of our EAP, " said John Quisel, J.D., Ph.D., Chief Executive Officer and President of Disc. "We also look forward to significant advancement across the rest of our pipeline in the second half of 2026. We saw strong demand for the Phase 2 RESTORE-PV trial of DISC-3405 in polycythemia vera, which is now fully enrolled with initial data coming ahead of schedule in Q3. Along with an expected end of Phase 2 FDA interaction on selcodebart in MF anemia in Q4, we will potentially be positioned to advance two more programs into pivotal-stage development in 2027."
Recent Highlights and Anticipated Milestones:
Bitopertin: GlyT1 Inhibitor (Heme Synthesis Modulator)
-- Completed Type A meeting with the FDA to discuss the CRL for bitopertin
in erythropoietic protoporphyria (EPP) and aligned that the Phase 3
APOLLO study, if successful, can serve as the basis for CRL response and
could potentially support a traditional approval
-- Presented updated data from the HELIOS open-label extension trial of
bitopertin in EPP at the European Hematology Association (EHA) Annual
Meeting, demonstrating sustained reductions in protoporphyrin IX (PPIX),
significant improvement in light tolerance measures, and favorable
longer-term safety
-- Launched an Expanded Access Program (EAP) for bitopertin in the US and
select other geographies, providing eligible patients with EPP and XLP
access to treatment prior to a regulatory decision
-- On track to report APOLLO topline results in Q4 2026 and expect to submit
CRL response and receive an FDA decision by mid-2027
-- APOLLO completed enrollment in March 2026 and enrolled ahead of
schedule with a final N of 183
Selcodebart (DISC-0974): Anti-Hemojuvelin Antibody (Hepcidin Suppression)
-- Shared updated data from RALLY-MF trial of selcodebart in anemia of
myelofibrosis $(MF)$ in oral presentations at the American Society of
Clinical Oncology (ASCO) and European Hematology Association (EHA) annual
meetings, solidifying selcodebart's differentiated emerging profile in
MF. Data showed:
-- Major anemia response rate of 56% and overall anemia response rate
of 72% across evaluable patients
-- Similar, strong response rates across transfusion cohorts and with
or without background JAK inhibitor therapy
-- Additional data from RALLY-MF anticipated in Q4 2026, with an
end-of-Phase 2 meeting with the FDA expected to occur by year-end
-- Received EU Orphan Drug Designation for selcodebart for the treatment of
myelofibrosis
-- Progressing Phase 2 study in patients with inflammatory bowel disease
$(IBD)$ with initial data expected in 2027
DISC-3405: Anti-TMPRSS6 Antibody (Hepcidin Induction)
-- Completed enrollment for RESTORE-PV Phase 2 study in patients with
polycythemia vera with initial data expected in Q3 2026
-- Progressing Phase 1b study in patients with sickle cell disease with
initial data expected in Q4 2026
Second Quarter 2026 Financial Results:
-- Cash Position: Cash, cash equivalents, and marketable securities were
$717.7 million as of June 30, 2026, which are expected to fund
operational plans into 2029.
-- Research and Development Expenses: R&D expenses were $46.9 million for
the three months ended June 30, 2026, as compared to $46.3 million for
the three months ended June 30, 2025. The increase in R&D expenses was
primarily driven by the progression of Disc's portfolio, including the
advancement of the selcodebart (DISC-0974) and DISC-3405 clinical studies
and drug manufacturing, as well as increased headcount. These increases
were partially offset by a decrease in manufacturing costs related to
bitopertin and a $10.0 million milestone payment incurred upon initiation
of the APOLLO study during the comparative period.
-- Selling, General and Administrative Expenses: SG&A expenses were $18.1
million for the three months ended June 30, 2026, as compared to $15.1
million for the three months ended June 30, 2025. The increase in SG&A
expenses was primarily due to increased headcount.
-- Net Loss: Net loss was $59.5 million for the three months ended June 30,
2026, as compared to $55.2 million for the three months ended June 30,
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, selcodebart (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 the CRL response and 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.
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