(RTTNews) - Omeros Corp. (OMER), a clinical-stage biopharmaceutical company focused on complement-mediated diseases, oncology, and addictive disorders, today announced its financial results for the third quarter ended September 30, 2025, and provided a comprehensive update on its advancing pipeline.
Omeros' pipeline is anchored by two late-stage monoclonal antibody programs targeting the lectin pathway of complement.
The company's lead candidate, narsoplimab, is under regulatory review by the U.S. Food and Drug Administration (FDA) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), with a decision expected on December 26, 2025.
A parallel marketing authorization application is under review by the European Medicines Agency, with an opinion expected in mid-2026.
Narsoplimab is a human monoclonal antibody that inhibits MASP-2, a key enzyme in the lectin pathway of complement activation. It has completed a pivotal Phase 3 trial in TA-TMA, where treatment was associated with a significant survival benefit compared to external controls. TA-TMA is a rare and life-threatening complication of stem cell transplantation, driven by endothelial injury and uncontrolled complement activation, leading to multi-organ dysfunction and high mortality.
Narsoplimab is also being evaluated in Phase 2 trials for COVID-19 and acute respiratory distress syndrome (ARDS) indications where complement activation contributes to severe lung injury and systemic inflammation.
In preparation for a potential U.S. launch, Omeros has assembled a commercial organization with a hematology-focused sales force and established reimbursement infrastructure, including a national ICD-10 diagnostic code for TA-TMA and a CPT procedural code for narsoplimab. The therapy will be marketed under the brand name YARTEMLEA once approved.
The company's second late-stage program, zaltenibart (OMS906), is a MASP-3 inhibitor in Phase 2 being developed for paroxysmal nocturnal hemoglobinuria (PNH) and C3 glomerulopathy. PNH is a rare, life-threatening blood disorder characterized by complement-mediated destruction of red blood cells, while C3 glomerulopathy is a chronic kidney disease driven by dysregulation of the complement system.
In October 2025, Omeros entered into an asset purchase and license agreement with Novo Nordisk, granting exclusive global rights to zaltenibart and related assets. The deal includes an upfront payment of $240 million, up to $2.1 billion in milestone payments, and tiered royalties on global net sales.
Omeros is also advancing OMS1029, a long-acting second-generation MASP-2 inhibitor currently in Phase 1. This antibody is designed to provide sustained inhibition of the lectin pathway for chronic complement-mediated disorders.
In addition, Omeros is developing MASP-1, MASP-3, and MASP-2/-3 inhibitors in preclinical studies for disorders of the lectin and alternative pathways of complement.
Beyond its complement programs, Omeros is advancing OMS527, a phosphodiesterase 7 (PDE7) inhibitor in Phase 1 for cocaine use disorder. Supported by a $6.24 million grant from the National Institute on Drug Abuse, preclinical toxicology studies have been completed with no safety findings, and an in-patient clinical study is targeted for the second half of 2026.
The company is also progressing OMS405, a PPAR? agonist in Phase 2 for opioid and nicotine addiction, where modulation of the PPAR? pathway has shown promise in reducing cravings and withdrawal symptoms.
In oncology, the company's OncotoX-AML program has demonstrated superior efficacy to standard of care in preclinical models of acute myeloid leukemia, including TP53 and FLT3 mutations. The OncotoX-AML program utilizes proprietary engineered biologics designed to deliver a toxic payload directly into leukemia cells, thereby selectively killing malignant cells while sparing healthy tissue. With encouraging safety data in non-human primates, Omeros expects to advance the program into the clinic within 18-24 months. The program is currently in preclinical stage.
Omeros' Biologic Therapeutics platform, including immunomodulators, oncotoxins and cancer vaccines, is in preclinical development for cancer indications, aiming to expand the company's oncology footprint.
Omeros is also progressing its Targeted Complement Activating Therapy (T-CAT) platform, designed to directly kill multidrug- resistant pathogens. The program is currently in the preclinical stage, with animal data across multiple pathogen classes continue to support broad potential in infectious disease.
At the discovery stage Omeros' GPCR platform is being applied to immunologic, CNS, metabolic, cardiovascular, musculoskeletal and other disorders, leveraging the proprietary technologies to identify novel druggable targets.
On the financial front, Omeros reported a GAAP net loss of $30.9 million, or $0.47 per share, for the third quarter of 2025, compared to a net loss of $32.2 million, or $0.56 per share, in the same period last year. Non-GAAP adjusted net loss was $22.1 million, or $0.34 per share in Q3, 2025.
This improvement was primarily driven by reduced R&D and operating expenses as the company conserved capital ahead of the anticipated U.S. launch of narsoplimab.
On September 30, 2025, Omeros has $36.1 million in cash and short-term investments. In July 2025, the company issued and sold 5,365,853 shares of common stock in a registered direct offering to Polar Asset Management Partners at $4.10 per share, representing a 14% premium to the closing price on the date of purchase agreement.
Management expects the upcoming $240 million upfront payment from Novo Nordisk to provide sufficient capital to fund operations for more than 12 months, including the anticipated U.S. launch of narsoplimab.
OMER has traded in the range of $2.95 to $13.06 over the past year. The stock closed yesterday's trading at $6.28, down 8.85%.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
