Omeros Corporation (Nasdaq: OMER), a clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders such as complement-mediated diseases, cancers, and addictive and compulsive disorders, has reported recent highlights and financial results for the first quarter ended March 31, 2024.
Financial Highlights:
- Net loss for Q1 2024 was $37.2 million, or $0.63 per share, compared to $33.7 million, or $0.54 per share in Q1 2023.
- Net loss from continuing operations was $43.9 million in Q1 2024, up from $39.7 million in Q1 2023.
- In February 2024, Omeros amended the OMIDRIA royalty purchase agreement with DRI Healthcare Acquisitions LP, receiving $115.5 million in cash. DRI will now receive all U.S. royalties on OMIDRIA sales through December 31, 2031.
- As of March 31, 2024, Omeros had $230.3 million in cash and short-term investments, an increase of $58.5 million from the end of 2023. This includes $11.9 million used to repurchase 3.2 million shares of common stock.
Clinical Developments:
- The biologics license application (BLA) for narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) is being prepared for resubmission. Discussions with the FDA are ongoing regarding the analysis plan and additional requirements.
- The OMS906 program, targeting the alternative pathway of complement, is progressing well. Two Phase 2 trials in paroxysmal nocturnal hemoglobinuria (PNH) are fully enrolled, with a Phase 3 program expected to start in late 2024.
- Enrollment has begun for a Phase 2 trial of OMS906 in complement 3 glomerulopathy (C3G), with a Phase 3 program anticipated to begin in early 2025.
- OMS1029, a long-acting MASP-2 inhibitor, is advancing, with a Phase 1 multiple-ascending-dose study expected to report data this quarter. Phase 2 development is planned for later this year, with potential indications including neovascular age-related macular degeneration (wet AMD).
- The OMS527 program, targeting phosphodiesterase 7 (PDE7) for addictions and compulsive disorders, is progressing with NIDA funding. Preclinical studies for cocaine use disorder (CUD) are expected to complete by the end of 2024.
Comments from Leadership: Dr. Gregory A. Demopulos, Omeros’ chairman and CEO, highlighted the company’s strong start to 2024, noting significant milestones and the extension of the cash runway into 2026 following the OMIDRIA royalty sale. He emphasized the promising progress of OMS906 and OMS1029 and the ongoing efforts to secure BLA approval for narsoplimab in TA-TMA.
First Quarter Financial Details:
- OMIDRIA royalties for Q1 2024 were $9.4 million on U.S. net sales of $31.2 million, compared to $9.2 million on $30.7 million in Q1 2023.
- Total operating expenses increased to $39.0 million in Q1 2024 from $35.7 million in Q1 2023, primarily due to increased R&D costs and legal expenses.
- Interest expense was $8.2 million, up from $7.9 million in Q1 2023, due to the amended royalty purchase agreement.
- Interest and other income decreased to $3.4 million from $4.0 million in Q1 2023.
- Net income from discontinued operations was $6.7 million, or $0.12 per share, up from $6.0 million, or $0.09 per share, in Q1 2023.
Conference Call Details: Omeros will host a conference call and webcast to discuss the financial results and provide an update on business activities today at 1:30 p.m. Pacific Time; 4:30 p.m. Eastern Time. Access the live webcast on Omeros’ website or register for the conference call via the provided link to receive a unique PIN for dial-in or the “Call Me” option.
