OMEROS CORP Q1 FY2025 earnings call

• Financial results for Q1 2025 were presented, with a net loss of $33.5 million. - The company strengthened its balance sheet through a debt exchange of 2026 convertible notes, reducing debt and near-term repayment obligations. - FDA accepted the resubmitted BLA for narsoplimab and assigned a target date of September 25th for action. - Narsoplimab's primary analysis showed a statistically significant threefold improvement in survival. - The EAP for narsoplimab was suspended, but ongoing studies in pediatric patients continue. - Zaltenibart's Phase III PNH program was paused, while its other trials continued. - PDE7 inhibitor program for cocaine use disorder continues with NIDA funding. - OncotoX program in oncology progresses with preclinical and IND-enabling work.

Net loss for Q1 2025 was $33.5 million or $0.58 per share, compared to a net loss of $31.4 million or $0.54 per share in the fourth quarter of the previous year. As of March 31st, 2025, cash and investments on hand were $52.5 million. The company completed a debt exchange, reducing the 2026 convertible notes principal to approximately $17 million, avoiding a $20 million mandatory prepayment on the term loan. Research and development expenses were focused on narsoplimab and zaltenibart. Interest expense and other income were also discussed in detail.

• FDA target date for narsoplimab BLA is September 25th. - Plan to submit MAA to EMA for narsoplimab in TA-TMA later this quarter. - Zaltenibart's Phase III PNH program is paused temporarily. - PDE7 inhibitor program's inpatient clinical trial data expected late this year/early next. - OncotoX program expected in clinic in 18-24 months.

Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. Refer to the company's SEC filings for detailed risk factors.

Q: Steve Brozak asked about launch plans, patient access, and costs related to narsoplimab.

A: Gregory Demopulos and Nadia Dac responded, discussing the commercial team's preparation, payer engagement, details on TA-TMA patients, and the cost implications of untreated patients and outpatient dosing benefits of narsoplimab