Omeros Corporation Announces Q2 2024 Financial Results

Omeros Corporation, a clinical-stage pharmaceutical company, released its financial results and recent developments for the second quarter ending June 30, 2024. The company's focus remains on developing and commercializing small-molecule and protein therapeutics for significant market needs, orphan indications, and immunological disorders, including complement-mediated diseases, cancer, and addictive disorders.

The company reported a net loss of $56.0 million, or $0.97 per share, for the second quarter of 2024. This marks a significant increase from the $37.3 million net loss, or $0.59 per share, reported for the same period in 2023. Over the first six months of 2024, Omeros accumulated a net loss of $93.2 million, or $1.60 per share, compared to a $71.0 million net loss, or $1.13 per share, in the previous year. The increased loss for the quarter included a $17.6 million charge for narsoplimab drug substance delivered within the quarter, a $21.2 million payment for term loan-related debt repurchase, and $1.9 million in transaction costs.

On June 3, 2024, Omeros entered into a Credit and Guaranty Agreement with Athyrium Capital Management and Highbridge Capital Management, securing an initial senior secured term loan of $67.1 million. The company also paid $21.2 million to the lenders in exchange for $118.1 million of its existing 5.25 percent convertible senior notes due in 2026. Furthermore, the agreement includes provision for an additional $25.0 million delayed draw term loan contingent on regulatory approval of narsoplimab for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). Post-transaction, Omeros has approximately $98 million in outstanding principal of its 2026 notes.

At the end of June 2024, Omeros reported $158.9 million in cash and short-term investments, down $12.9 million from December 31, 2023. The company continues to engage with the FDA regarding the resubmission of its biologics license application (BLA) for narsoplimab in TA-TMA, with a new meeting scheduled to finalize the analysis plan and other evidence for the application.

In terms of clinical progress, Omeros has been advancing its MASP-3 inhibitor antibody zaltenibart (OMS906) through a Phase 2 development program for paroxysmal nocturnal hemoglobinuria (PNH), with two fully enrolled trials and a long-term extension study. The Phase 3 program for zaltenibart is expected to start later this year. Additionally, the company is enrolling participants in a Phase 2 study of zaltenibart for complement 3 glomerulopathy (C3G) and plans to begin a Phase 3 program in early 2025.

CEO Gregory A. Demopulos highlighted the company’s strengthened financial position due to the recent term loan and note repurchase transaction. This transaction significantly reduced the outstanding balance of Omeros' 2026 convertible notes and secured additional funding to support the potential commercial launch of narsoplimab. Demopulos expressed optimism about the evidence submitted for the BLA and the progress of zaltenibart, which is poised to start Phase 3 trials later this year for PNH and early next year for C3G.

Omeros also reported progress for OMS1029, their long-acting MASP-2 inhibitor. Phase 1 studies showed potential for once-quarterly dosing with no significant safety concerns. The company is evaluating large market indications for Phase 2 development, including neovascular age-related macular degeneration (wet AMD), with promising preclinical efficacy data.

For OMS527, their PDE7 inhibitor targeting addictions and compulsive disorders, Omeros was awarded a three-year $6.69 million grant by the National Institute on Drug Abuse for developing a treatment for cocaine use disorder (CUD). A preclinical cocaine interaction study is expected to be completed by the end of the year, potentially leading to a randomized clinical study funded by the NIDA grant.

In summary, Omeros Corporation has made significant strides in its clinical programs and financial management, positioning itself to address regulatory challenges and advance its therapeutic candidates into late-stage trials and potential commercialization.

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