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    Stephen Brozak • WBB Securities

    Stephen Brozak's questions to Omeros Corp (OMER) leadership

    Stephen Brozak's questions to Omeros Corp (OMER) leadership • Q1 2025

    Question

    Stephen Brozak inquired about the commercial launch preparations for narsoplimab, including the go-to-market strategy and patient access plans. He also asked for more detail on the TA-TMA patient population and the economic value proposition of narsoplimab, considering the high costs already associated with stem cell transplant patients.

    Answer

    Chief Commercial Officer Nadia Dac detailed the launch strategy, which focuses on the top 40-80 transplant centers responsible for the majority of allogeneic transplant volume. She noted proactive engagement from payers and highlighted the drug's potential for both inpatient and outpatient use. CEO Gregory Demopulos described TA-TMA as a sudden, unpredictable, and often fatal complication with no currently approved treatments. Nadia Dac added that narsoplimab's economic value is driven by preventing costly outcomes like organ failure and death, with its outpatient potential offering further cost savings.

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    Stephen Brozak's questions to Omeros Corp (OMER) leadership • Q4 2024

    Question

    Stephen Brozak of Rodman & Renshaw asked for a detailed explanation of the company's confidence in its resubmitted Biologics License Application (BLA) for narsoplimab.

    Answer

    Chairman and CEO Gregory Demopulos and Chief Regulatory Officer Catherine Melfi responded. Dr. Demopulos emphasized that the statistical analysis plan was developed with FDA agreement and the results were "impressively strong," showing a more than threefold improvement in survival with a p-value of less than 0.00001. Ms. Melfi added that the package is solid due to strong FDA collaboration, a well-matched external control group, and robust statistical modeling that consistently showed positive results.

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    Stephen Brozak's questions to Omeros Corp (OMER) leadership • Q3 2024

    Question

    Stephen Brozak of WBB Securities asked if it is reasonable to assume Omeros will be commercially selling narsoplimab in 2025, given the minor nature of the FDA's recent requests and the company's plan for a swift BLA resubmission.

    Answer

    Executive Gregory Demopulos confirmed that commercializing narsoplimab in 2025 is the company's hope and expectation, targeting the earlier part of the year. He explained that the FDA's request was limited to additional sensitivity analyses. Once Omeros receives alignment on the statistical analysis plan (SAP), their external consultants will run the analyses, enabling a quick resubmission of the Biologics License Application (BLA).

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