Disc Medicine (IRON) Q3 2026 earnings summary

Executive summary

• Phase 3 APOLLO met both co-primary endpoints for bitopertin in EPP, with positive secondary results; NDA resubmission is planned by year-end 2026.

• DISC-3405 and selcodebart advanced; the October 2026 offering is expected to extend funding runway into 2030.

Financial highlights

• Q3 2026 operating expenses and operating loss were each $64.2m, down from $67.7m a year earlier; R&D was $44.1m vs. $50.3m and SG&A was $20.1m vs. $17.4m.

• Q3 net loss was $59.5m, or $1.53 per share, vs. $62.3m, or $1.77 per share, in Q3 2025.

• 9M 2026 operating expenses were $198.8m vs. $169.1m; net loss was $182.6m vs. $151.7m, with loss per share of $4.72 vs. $4.39.

• No product-sales revenue had been generated; Q3 interest income of $6.5m partly offset $1.7m interest expense.

Outlook and guidance

• Bitopertin NDA resubmission is planned by year-end 2026 following FDA engagement; a potential FDA decision is anticipated by mid-2027.

• Selcodebart anemia-of-MF data and FDA end-of-Phase 2 feedback are expected by year-end 2026; Phase 3 is targeted for H1 2027, subject to FDA discussions.

• RALLY-IBD initial data are expected in 2027; additional DISC-3405 RESTORE-PV data by year-end 2026 and topline data in 2027; initial SCD data are expected in Q4 2026.

• R&D and SG&A costs are expected to rise as clinical programs and commercialization capabilities advance; product revenue is not expected in the near future.