Disc Medicine reports Q3 2026 financial results and pipeline updates

Item 2.02 Results of Operations and Financial Condition.

On November 5, 2026, Disc Medicine, Inc. announced its financial results for the third quarter ended September 30, 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-K¹.

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 November 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:

November 5, 2026

By:

/s/ John Quisel, J.D., Ph.D.

Name: John Quisel, J.D., Ph.D.

Title: Chief Executive Officer

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

• Pivotal Phase 3 APOLLO trial of bitopertin in erythropoietic protoporphyria (EPP) successfully met all primary and secondary endpoints⁴

• Bitopertin NDA resubmission planned by end of 2026, with an FDA decision for potential approval in EPP anticipated by mid-2027

• Feedback from the upcoming end of phase 2 meeting with the FDA on selcodebart in anemia of myelofibrosis (MF) and plans for pivotal development in anemia of MF to be announced by the end of the year

• Presented positive initial results from the Phase 2 RESTORE-PV study of DISC-3405 in polycythemia vera (PV)

WATERTOWN, Mass., November 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 third quarter ended September 30, 2026, and provided a review of recent program and corporate developments.

"In our first pivotal trial readout as a company, APOLLO delivered strong and compelling evidence of the potential clinical benefit of bitopertin for patients with EPP," said John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc. "We look forward to engaging with regulators with the goal of bringing an important, innovative medicine to this community as efficiently as possible."

"We also made significant progress across our broader pipeline, including encouraging initial RESTORE-PV data that reinforce the potential of DISC-3405 to maintain target hematocrit levels and improve symptoms for patients with polycythemia vera," Dr. Quisel added. "Alongside our anticipated end-of-Phase 2 FDA meeting for selcodebart in anemia of myelofibrosis in the fourth quarter and a strengthened balance sheet, we are well positioned to support the anticipated launch of bitopertin and advance two additional programs toward pivotal-stage development in 2027."

Recent Highlights and Anticipated Milestones:

Bitopertin: GlyT1 Inhibitor (Heme Synthesis Modulator)

• Positive topline data from the Phase 3 APOLLO clinical trial of bitopertin in EPP achieved statistical significance on both co-primary endpoints of reduction in whole blood metal-free PPIX from baseline and average monthly total time in sunlight without pain during month 6 of treatment vs. placebo. The data showed:

o Bitopertin reduced whole-blood metal-free PPIX by 41.4% versus placebo⁵ (p<0.0001) and increased average monthly total time in light without pain by 12.2 hours during month 6 (p=0.0010) o Positive and statistically significant results from all secondary endpoints, including reductions in phototoxic reactions and improvements on multiple measures of light tolerance. Exploratory endpoints of quality-of-life benefits were also positive and statistically significant.

• Bitopertin was generally well-tolerated. Consistent with prior studies, dizziness was the most commonly reported treatment emergent adverse event (TEAE) in the bitopertin group (50%) and was mild or moderate and generally transient. There were no TEAEs above Grade 3.

• Successful APOLLO results add to bitopertin's robust clinical data package. Based on these results, Disc plans to resubmit a New Drug Application (NDA) to the U.S. FDA by the end of 2026⁶, with a decision from the agency anticipated by mid-2027

Selcodebart (DISC-0974): Anti-Hemojuvelin Antibody (Hepcidin Suppression)

• Updated data from the RALLY-MF trial to be presented at ASH in December

• Feedback from an end of phase 2 meeting with the FDA and plans for pivotal development in anemia of MF to be announced by the end of the year

• Progressing Phase 2 study of selcodebart in patients with inflammatory bowel disease (IBD) with initial data expected in 2027

DISC-3405: Anti-TMPRSS6 Antibody (Hepcidin Induction)

• Presented positive initial results from the RESTORE-PV Phase 2 clinical trial of DISC-3405 in patients with PV at the SOHO Annual Meeting. Efficacy data was presented for the Q2 weekly dosed cohort. Across escalation and maintenance periods, results demonstrated:

o DISC-3405 increased hepcidin and lowered serum iron, translating to controlled hematocrit, reduced phlebotomy, and improved symptoms in PV patients o Generally well-tolerated with adverse events that are consistent with underlying disease and a low rate of injection site reactions which were mild and self-limited

• Updated data from RESTORE-PV, including initial efficacy data on the Q4 weekly dosed cohort, to be presented at ASH in December

• Initial data from Phase 1b study of DISC-3405 in patients with sickle cell disease also to be presented at ASH

Third Quarter 2026 Financial Results:

• Cash Position: Cash, cash equivalents, and marketable securities were $682.8 million as of September 30, 2026². In October 2026,