Omeros Q3 net loss $32.2M; narsoplimab BLA resubmission path cleared after FDA meeting

OMEROS CORP

2025-Q3 EPS reported -$2.15 vs consensus -$0.45 ▼ miss (-373.7%)

Net loss Q3 2024: $32.2M ($0.56/sh) vs $37.8M ($0.60/sh) in Q3 2023; nine-month loss $125.5M.
Cash and investments $123.2M at Sept 30, down $48.7M from Dec 31, 2023, including $18.4M narsoplimab drug substance charge and $21.2M debt repurchase.
Narsoplimab in TA-TMA: FDA presubmission in Sep 2024; minor feedback on statistical plan incorporated; BLA resubmission planned after efficacy analysis; European MAA in H1 2025.
Zaltenibart (OMS906): FDA and EU regulators agree on Phase 3 design for PNH; enrollment expected early 2025; rare pediatric disease designation for C3G.
OMIDRIA royalties $9.3M on Rayner’s U.S. sales $31.0M in Q3 2024 vs $10.0M on $33.3M in Q3 2023.

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