OMEROS CORP Q3 FY2024 earnings call

Financial Results

• Net loss decreased quarter-over-quarter due to lower narsoplimab drug substance expense. Cash and investments decreased. OMIDRIA royalties and net sales had a slight decrease from Q2.

Development Programs

• Narsoplimab: Had pre-submission meeting with FDA, received minor feedback on statistical analysis plan, awaiting FDA reply. Preparations for BLA resubmission ongoing. European MAA in preparation. Panels preparing manuscripts for publication.
• Zaltenibart (OMS906): Phase 2 studies in PNH and C3G showing compelling data. Phase 3 program in PNH underway, with enrollment expected in early 2025. Received positive feedback from FDA and European regulators. Zaltenibart in C3G has rare pediatric disease designation, Phase 3 planned for H1 2025.
• OMS1029: Completed Phase 1 studies, confident in efficacy and safety. Assessing indications.
• OMS527: Ongoing work in cocaine use disorder and movement disorders, with toxicology study results expected later in 2024.
• Oncology Programs: Developing signaling driven immunomodulators, oncotoxins, and adoptive T-cell technology, with programs advancing in stealth development.

Net loss for the third quarter of 2024 was $32.2 million or $0.56 per share, a $23.8 million quarter-over-quarter decrease compared to a net loss of $56 million or $0.97 per share in Q2 2024. The decrease was primarily due to $17.6 million of narsoplimab drug substance expense in Q2. As of September 30, 2024, cash and investments were $123.2 million, a decrease of $35.8 million from June 30, 2024. OMIDRIA royalties in Q3 were $9.3 million with net sales of $31 million, compared to $10.9 million in royalties on $36.4 million net sales in Q2.

Guidance

• Expect resubmission of narsoplimab BLA soon after FDA's reply and alignment on analysis plan. Targeting commercialization of narsoplimab in 2025. Phase 3 trials for zaltenibart in PNH and C3G expected to enroll in early 2025. Income from discontinued operations expected in $7 million to $8 million range in Q4.

Risks

• Uncertainty in regulatory approval timelines for narsoplimab and zaltenibart. Potential challenges in clinical trial enrollment and data interpretation. Market competition for complement inhibitors and other therapies.

Q: Can you comment on the timeline for commercializing narsoplimab in 2025?

A: Hope to resubmit BLA quickly after FDA's reply, assuming alignment on analysis plan, targeting commercialization in 2025.

Q: What more can you tell about Phase 3 trial designs for zaltenibart?

A: Phase 3 trials include switch-over trial for PNH patients not responding to C5 inhibitors and trial for untreated patients. Designs followed established precedent, with positive feedback from FDA and European regulators. Population enrichment focuses on patients needing treatment.