Omeros Corporation Reports Third Quarter 2024 Financial Results

About this update from Omeros Corporation

[{"type":"text","content":"\n– Conference Call Today at 4:30 p.m. ET\n\n\n SEATTLE--(BUSINESS WIRE)--\nOmeros Corporation (Nasdaq: OMER) today announced recent highlights and developments as well as financial results for the third quarter ended September 30, 2024, which include:\n\n\n\nNet loss for the third quarter of 2024 was $32.2 million, or $0.56 per share, compared to a net loss of $37.8 million, or $0.60 per share for the third quarter of 2023. For the nine months ended September 30, 2024, net loss was $125.5 million, or $2.15 per share, compared to a net loss of $108.8 million, or $1.73 per share in the prior year period.\n\n\n\nAt September 30, 2024, we had $123.2 million of cash and short-term investments available for operations and debt servicing, a decrease of $48.7 million from December 31, 2023. During the year, we paid an $18.4 million charge related to delivery of narsoplimab drug substance, the manufacturing of which commenced in October 2023, a $21.2 million payment for term loan-related debt repurchase, and $1.9 million of term loan-related transaction costs.\n\n\n\nIn September, we held a presubmission meeting with FDA for our biologics license application (“BLA”) for narsoplimab, our lead antibody targeting MASP-2 and the lectin pathway of complement, in hematopoietic stem cell transplant-associated thrombotic microangiopathy (“TA-TMA”). The meeting was both collaborative and productive. As part of the meeting, we received additional minor feedback on our proposed statistical analysis plan for the primary endpoint – patient survival in our pivotal narsoplimab trial compared to that in an external registry of patients with TA-TMA. FDA had previously reviewed the plan and all comments had been incorporated. The additional feedback was limited to requesting a few additional sensitivity analyses. We accordingly revised and resubmitted our statistical analysis plan shortly thereafter and expect to receive FDA's reply imminently. Assuming general alignment on the revised plan, we intend to proceed with conducting the primary and secondary efficacy analyses after incorporating, as appropriate any additional agency feedback on the plan. If the results support resubmission, we intend to finalize and resubmit our BLA as soon as possible. We expect to provide a further update on our plans for resubmission and relevant timing after the efficacy ...

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