Disc Medicine — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash, cash equivalents, and marketable securities totaled $682.8 million as of September 30, 2026.
• Net loss was $59.5 million for the three months ended September 30, 2026, compared to $62.3 million for the same period in 2025.
• Research and development expenses were $44.1 million for the three months ended September 30, 2026, a decrease from $50.3 million in the prior-year period.
• Selling, general and administrative (SG&A) expenses were $20.1 million for the three months ended September 30, 2026, an increase from $17.4 million in the prior-year period.
• Net loss per share (basic and diluted) was $1.53 for the three months ended September 30, 2026, compared to $1.77 in the prior-year period.
• Total operating expenses were $64.2 million for the three months ended September 30, 2026, down from $67.7 million in the prior-year period.
• Other income, net was $4.7 million for the three months ended September 30, 2026, compared to $5.5 million in the prior-year period.
• Total assets were $699.5 million as of September 30, 2026, compared to $806.9 million as of December 31, 2025.
• Total liabilities were $95.2 million as of September 30, 2026, compared to $67.1 million as of December 31, 2025.

Guidance and Future Outlook:

• Plans to resubmit a New Drug Application (NDA) for bitopertin by the end of 2026, with an FDA decision anticipated by mid-2027.
• Feedback from an end-of-phase 2 meeting with the FDA regarding selcodebart in anemia of myelofibrosis and plans for pivotal development to be announced by the end of 2026.
• Initial data from a Phase 1b study of DISC-3405 in sickle cell disease and updated data from the RESTORE-PV study to be presented at the 68th American Society of Hematology (ASH) annual meeting in December 2026.
• Progressing a Phase 2 study of selcodebart in inflammatory bowel disease (IBD) with initial data expected in 2027.
• Cash runway extended into 2030 following a public offering completed in October 2026 with net proceeds of approximately $486 million.
• Management anticipates advancing two additional programs toward pivotal-stage development in 2027.

Business Segments and Product Lines:

• Bitopertin (GlyT1 Inhibitor): The Phase 3 APOLLO trial in erythropoietic protoporphyria (EPP) met all primary and secondary endpoints. Bitopertin reduced whole-blood metal-free PPIX by 41.4% versus placebo (p<0.0001) and increased average monthly total time in sunlight without pain by 12.2 hours during month 6 (p=0.0010). The drug was generally well-tolerated with dizziness as the most common treatment-emergent adverse event (50%), all mild or moderate.
• Selcodebart (DISC-0974): An anti-Hemojuvelin antibody targeting hepcidin suppression. Updated data from the RALLY-MF trial in anemia of myelofibrosis will be presented at ASH in December 2026.
• DISC-3405: An anti-TMPRSS6 antibody targeting hepcidin induction. Initial results from the Phase 2 RESTORE-PV study in polycythemia vera (PV) showed controlled hematocrit, reduced phlebotomy, and improved symptoms. The drug was generally well-tolerated with a low rate of mild, self-limited injection site reactions.

Market and Competitive Landscape:

• Disc Medicine is a clinical-stage biopharmaceutical company focused on novel treatments for serious hematologic diseases, specifically targeting heme biosynthesis and iron homeostasis pathways.
• The company aims to build a portfolio of potentially first-in-class therapeutic candidates addressing a wide spectrum of hematologic diseases.

Risks and Challenges:

• Forward-looking statements regarding development programs, regulatory pathways, and financial position are subject to risks including the adequacy of capital, ability to complete clinical trials, and unpredictability of development timelines and costs.
• Risks include the potential for clinical trial results to be negative or not predictive of future results, delays in FDA decisions, and the inability to identify additional product candidates with commercial potential.
• Specific risks include the content and timing of regulatory decisions and the risk that results may not support further development or marketing approval.

Management Commentary and Tone:

• CEO John Quisel described the APOLLO trial results as "strong and compelling evidence of the potential clinical benefit" and expressed a goal to bring the medicine to the community "as efficiently as possible."
• Management characterized the company as "well positioned" to support the anticipated launch of bitopertin and advance other programs, citing a strengthened balance sheet and significant pipeline progress.
• Dr. Quisel noted encouraging initial RESTORE-PV data reinforcing the potential of DISC-3405 to maintain target hematocrit levels and improve symptoms in PV patients.

Other Key Points:

• Disc Medicine completed a public offering in October 2026 with net proceeds of approximately $485.9 million.
• The company reported a decrease in R&D expenses primarily driven by a $10.0 million milestone payment and drug manufacturing costs in the comparative period that did not recur in the current period.
• SG&A expense increases were primarily attributed to increased headcount.
• The company's stock trades on the NASDAQ under the ticker symbol IRON.