Short answer

Disc Medicine, Inc. (IRON) filed its fiscal 2025 10-K annual report with the SEC on Feb 26, 2026.

Top risk flagged: Regulatory risk: Dependency on FDA approval timing and conditions for product candidates impacts commercialization and cost structure

FY2025 key financial metrics · XBRL

Source: XBRL data from the Disc Medicine, Inc. (IRON) FY2025 10-K on SEC EDGAR. USD.

AI summary of each section, grounded in the filing text

Core business: clinical-stage biopharma developing novel treatments targeting red blood cell biology, focusing on heme biosynthesis and iron homeostasis pathways
New emphasis: submission of NDA for bitopertin in erythropoietic porphyrias (EPP and XLP) with FDA accelerated approval pursuit, ongoing Phase 3 APOLLO trial initiated May 2025
Strategic shift: pivot to address FDA complete response letter by generating Phase 3 data for traditional approval; expanding pipeline into myeloproliferative neoplasms with DISC-0974 and DISC-3405
Quantitative highlight: approx. 14,000 diagnosed EPP patients US market; Phase 2 trial of DISC-0974 in myelofibrosis anemia showed anemia responses independent of transfusion or JAK inhibitor use
Noteworthy fact: received FDA Commissioner’s National Priority Voucher in October 2025 for bitopertin, highlighting regulatory priority for this rare disease therapy

No revenue generated; net loss $212.2M in 2025 vs $109.4M in 2024, loss doubled YoY
Operating expenses up $106.3M YoY: R&D $170.6M vs $96.7M, SG&A $65.4M vs $33.0M
R&D increase driven by bitopertin ($58.8M, +$30.7M), DISC-0974 ($27.6M, +$10.6M); bitopertin lead program
Cash and equivalents $791.2M at end 2025; raised $211.0M net proceeds in Oct 2025 equity offering
FDA issued CRL for bitopertin NDA in Feb 2026; APOLLO Phase 3 topline data expected Q4 2026 to support resubmission

Regulatory risk: Dependency on FDA approval timing and conditions for product candidates impacts commercialization and cost structure
Macroeconomic threat: Cash runway extends only to 2029 with $791.2M liquidity; accelerated spending could exhaust funds earlier
Supply chain vulnerability: Reliance on third-party CROs and CDMOs for clinical trials and manufacturing with some non-cancellable fees
Competitive risk: Potential market disruption from approved therapies competing with bitopertin or other pipeline products
Financial risk: Accumulated deficit $510.2M with increasing annual net losses ($212.2M in 2025) and heavy equity reliance for funding

Generated from the filing text; verify against the original. How to read a 10-K

Compare years, dig into a risk factor or check the numbers against insider trades and fund holders.