ADDED
As of March 27, 2026, the number of outstanding shares of the registrant s common stock, par value $0.01 per share, was 71,996,171 .
BUSINESS Overview Omeros Corporation ( Omeros, the Company or we ) is an innovative, commercial-stage biotechnology company that discovers and develops first-in-class protein and small-molecule therapeutics for large-market and orphan indications, with particular emphasis on complement-mediated diseases, cancers, and addictive or compulsive disorders.
Our complement-targeted product, product candidates, and therapeutic programs are primarily focused on diseases and disorders associated with the lectin and/or alternative pathways of complement.
Our Commercial Product: YARTEMLEA (narsoplimab-wuug) YARTEMLEA (narsoplimab-wuug) is the first and only approved therapy for hematopoietic stem cell transplant-associated thrombotic microangiopathy ( TA-TMA ), an often-fatal complication of stem cell transplantation driven by activation of the lectin pathway of complement.
YARTEMLEA selectively inhibits MASP-2, the effector enzyme of the lectin pathway, blocking the pathway s activation while preserving classical and alternative complement functions important for host defense against infection.
Food and Drug Administration ( FDA ) on December 23, 2025 for the treatment of TA-TMA in adult and pediatric patients aged two years and older.
Unlike other complement inhibitors, YARTEMLEA has no boxed warning and no Risk Evaluation and Mitigation Strategy ( REMS ), and vaccinations are not required prior to treatment.
Commercial distribution and sales of YARTEMLEA began in January 2026.
A marketing authorization application ( MAA ) for YARTEMLEA in TA-TMA has been submitted to the European Medicines Agency ( EMA ) and is being reviewed under EMA s centralized review procedure, which allows review of a single marketing authorization application.
If the MAA is approved, it would authorize the product to be marketed in all EU member states and European Economic Area countries.
REMOVED
As of March 25, 2025, the number of outstanding shares of the registrant s common stock, par value $0.01 per share, was 58,063,901 .
SUMMARY RISK FACTORS The risk factors described below are a summary of the principal risk factors associated with an investment in our company.
You should carefully consider the risk factors discussed in this summary, as well as the risk factors described in Item 1A.
Risks related to our product candidates, programs and operations include, but are not limited to, the following: management has concluded that there is substantial doubt regarding our ability to continue as a going concern; inability to raise capital when needed; restrictions imposed by our secured credit facility and our ability to comply with such restrictions; our indebtedness and liabilities could limit the cash flow available for our operations; failure to obtain and maintain regulatory approval for marketing of future commercial products in the U.S.
( Rayner ) will become payable; unpredictability of our operating results; changes to the size, structure, powers and operations of the U.S.
BUSINESS Overview Omeros Corporation ( Omeros, the Company or we ) is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting immunologic diseases, including complement-mediated diseases and cancers related to dysfunction of the immune system, as well as addictive and compulsive disorders.
Complement-targeted Therapeutic Development Programs We are advancing multiple development programs focused on diseases and disorders associated with the complement system, a group of specialized proteins that protect against invasive pathogens as well as damaged cells inside the body and comprise an important part of the body s immune system.
There are three distinct pathways of complement, each activated via one or more unique mechanisms: Classical pathway: activated by antigen-antibody complexes Lectin pathway: activated by lectin binding of carbohydrate patterns on the surfaces of damaged cells and microbes Alternative pathway: constitutively active and amplifies classical and lectin pathway activation Our complement-targeted therapeutic development programs are primarily focused on diseases and disorders associated with the lectin and/or alternative pathways of complement.
Narsoplimab (OMS721), the lead product candidate in our pipeline of complement-targeted therapeutics, is a proprietary, patented human monoclonal antibody inhibitor of MASP-2, the key activator of the lectin pathway.
Clinical development of narsoplimab is currently focused primarily on hematopoietic stem cell transplant-associated thrombotic microangiopathy ( TA-TMA ).