Financial Data and Key Metrics Changes - For Q3 2025, Omeros reported a net loss of $30.9 million, or $0.47 per share, compared to a net loss of $25.4 million, or $0.43 per share in Q2 2025 [4][16] - The adjusted net loss, excluding non-cash charges, was $22.1 million, with an adjusted loss per share of $0.34 [5][16] - Cash burn for the quarter was $22 million, with $36.1 million in cash and investments as of September 30, 2025 [5][17] Business Line Data and Key Metrics Changes - The third-quarter results included $8.8 million in non-cash charges related to embedded derivatives associated with debt [4][16] - Research and development expenses were primarily focused on Zaltenibart and Yartemlya [19] Market Data and Key Metrics Changes - The biologics license application for Yartemlya remains under FDA review, with a PDUFA date of December 26, 2025 [9][10] - The marketing authorization application for Yartemlya in Europe is under review, with an anticipated decision in mid-2026 [10] Company Strategy and Development Direction - Omeros announced a definitive agreement with Novo Nordisk for an asset purchase and license transaction valued at up to $2.1 billion [5][6] - The transaction will provide Omeros with $240 million in upfront cash, which will be used to repay existing debt and fund operations [6][17] - The company is preparing for the commercial launch of Yartemlya, having established a national ICD-10 diagnostic code and an associated CPT procedural code [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the approval decision for Yartemlya and the potential for cash flow positivity in 2027 [26] - Engagement with transplant centers and payers has been positive, driven by the drug's demonstrated benefits [11][12] - The company is focused on advancing its pipeline, including MASP-2 small molecules and oncology programs [41][42] Other Important Information - The company expects overall operating expenses in Q4 2025 to be higher than in Q3, primarily due to increased marketing costs [22] - Income from discontinued operations is expected to be in the $5-$6 million range, excluding non-cash adjustments [24] Q&A Session Summary Question: Post-approval launch timeline for narsoplimab - Management indicated that launch preparations are underway and would move quickly upon approval [25] Question: Details on NTAP for Yartemlya - Management confirmed they expect to receive NTAP, which will help defray costs for hospitals [29][30] Question: Labeling discussions with the FDA - Management stated they do not comment on specific FDA discussions but have provided substantial data for both adult and pediatric patients [31][32] Question: Outlook for operating expenses in 2026 - Management expects expenses to increase, contingent on the closing of the Novo deal and FDA approval [39]