Disc Medicine (IRON) Q1 2026 earnings summary

Executive summary

• Focused on developing novel treatments for serious hematologic diseases, with a pipeline including bitopertin, DISC-0974, and DISC-3405 targeting various blood disorders.

• Completed enrollment of Phase 3 APOLLO study for bitopertin in EPP; topline data expected Q4 2026, with potential NDA resubmission and FDA decision by mid-2027.

• Completed Phase 2 trials for bitopertin in EPP and XLP; FDA issued a CRL in Feb 2026, requiring additional clinical evidence for approval.

• DISC-0974 and DISC-3405 advancing in Phase 2 and Phase 1b/2 trials, with multiple data readouts expected in late 2026.

• Strong cash position of $730 million as of March 31, 2026, providing runway into 2029.

Financial highlights

• Cash, cash equivalents, and marketable securities totaled $730.2 million as of March 31, 2026.

• Net loss for Q1 2026 was $63.5 million, compared to $34.1 million in Q1 2025.

• Research and development expenses rose to $45.9 million (Q1 2026) from $27.8 million (Q1 2025), driven by milestone payments, clinical progress, and increased headcount.

• Selling, general and administrative expenses increased to $23.6 million from $12.2 million year-over-year, reflecting higher headcount and commercialization infrastructure.

• Net loss per share was $1.65, compared to $1.02 in the prior year quarter.

Outlook and guidance

• Topline data from APOLLO (bitopertin) and key DISC-0974 and DISC-3405 trials anticipated in Q4 2026.

• Cash runway projected to fund operations and debt service into 2029, excluding potential product revenue.

• FDA decision on bitopertin anticipated by mid-2027 following APOLLO study completion.

• Additional capital may be required if development expands or timelines accelerate.