Omeros Corporation recently announced its third-quarter 2024 financial results and provided updates on its clinical development programs. The company anticipates resubmitting its Biologics License Application (BLA) for narsoplimab in Hematopoietic Stem Cell Transplant-associated Thrombotic Microangiopathy (TA-TMA) following a productive pre-submission meeting with the FDA in September. Minor revisions to the analysis plan, requested by the FDA, have been incorporated.
Beyond narsoplimab, Omeros reported substantial progress in other clinical programs. For zaltenibart, successful end-of-Phase 2 meetings with both FDA and European regulators and sufficient drug supply pave the way for Phase 3 Paroxysmal Nocturnal Hemoglobinuria (PNH) enrollment in early 2025. Phase 3 trials for C3G with zaltenibart are expected to follow soon after. The company is preparing to initiate Phase 2 clinical trials for its long-acting MASP-2 inhibitor, OMS1029, upon identification of a suitable large-market indication. In the OMS527 program, addressing addictive and compulsive disorders, a NIDA-funded trial in adults with cocaine-use disorder is anticipated to begin next year. Preclinical oncology programs are also showing promising in vitro and in vivo results, strengthening Omeros’s patent portfolio.
Omeros reported a net loss of $32.2 million ($0.56 per share) for the third quarter of 2024, compared to a net loss of $37.8 million ($0.60 per share) for the same period in 2023. The net loss for the nine months ended September 30, 2024, was $125.5 million ($2.15 per share), compared to $108.8 million ($1.73 per share) in the prior year period. This nine-month period included an $18.4 million charge for narsoplimab drug substance, a $21.2 million debt repurchase payment, and $1.9 million in debt transaction costs. Omeros expenses all manufacturing activities until U.S. or European approval is reasonably certain.
As of September 30, 2024, Omeros held $123.2 million in cash and short-term investments, a decrease of $48.7 million from the end of 2023. OMIDRIA royalties for the third quarter of 2024 totaled $9.3 million on Rayner’s U.S. net sales of $31.0 million, compared to $10.0 million in royalties on $33.3 million in sales during the same quarter of 2023. Total operating expenses for the third quarter of 2024 were $35.4 million, a decrease from $48.2 million in the third quarter of 2023. This decrease primarily stems from a $5.0 million milestone payment to a third-party licensor in the prior year related to the zaltenibart program, reduced narsoplimab clinical spending due to the termination of the IgA nephropathy program, and lower employee compensation expenses. Interest expense decreased to $4.1 million in the third quarter of 2024, down from $7.9 million in the prior-year quarter, due to the retirement of convertible notes in 2023 and repurchase of 2026 notes. Interest and other income for the third quarter of 2024 was $2.3 million, compared to $4.4 million in 2023, largely due to a reduction in available cash and investments. Net income from discontinued operations, net of tax, was $4.9 million ($0.08 per share) in the third quarter of 2024, compared to $13.9 million ($0.22 per share) in the same quarter of 2023. This decrease primarily resulted from a higher remeasurement adjustment on the OMIDRIA contract royalty asset in the prior year, partially offset by increased non-cash interest earned.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
