Omeros (OMER) Q3 2025 earnings summary

Executive summary

• Reported a Q3 2025 net loss of $30.9M ($0.47/share), with adjusted net loss at $22.1M ($0.34/share), and cash/investments of $36.1M as of September 30, 2025.

• Entered a definitive asset purchase and license agreement with Novo Nordisk for zaltenibart, with $240M upfront and up to $2.1B in milestone and royalty payments, closing expected Q4 2025.

• Resubmitted BLA for narsoplimab in TA-TMA to FDA; PDUFA date extended to December 26, 2025, with EMA review ongoing and opinion expected mid-2026.

• Pipeline includes OMS1029 (long-acting MASP-2 antibody), OMS527 (PDE7 inhibitor for cocaine use disorder), and preclinical oncology and T-CAT programs.

• U.S. commercial team is launch-ready for narsoplimab, with positive pre-approval engagement from stakeholders.

Financial highlights

• Q3 2025 net loss: $30.9M ($0.47/share); nine-month net loss: $89.8M ($1.47/share), both improved year-over-year.

• Adjusted net loss for Q3: $22.1M ($0.34/share); cash burn for Q3: $22M.

• Cash and investments: $36.1M as of September 30, 2025.

• Raised $20.3M via direct offering and $9M from ATM program in Q3; $15.3M raised YTD via ATM.

• Operating expenses for Q3: $26.4M, down 25% year-over-year.

Outlook and guidance

• Expect higher Q4 2025 operating expenses due to narsoplimab launch marketing; R&D expenses to remain steady.

• Novo Nordisk upfront payment and cash on hand expected to cover debt repayment and fund operations for over 12 months.

• FDA decision on narsoplimab BLA for TA-TMA expected by December 26, 2025; EMA opinion expected mid-2026.

• Substantial doubt exists regarding ability to continue as a going concern without closing the Novo Nordisk transaction or raising additional capital.

• Projected to be cash flow positive in 2027, contingent on Novo deal and narsoplimab approval.