OMS824 / Omeros - LARVOL DELTA

Omeros announces enrollment in phase 1 clinical trial evaluating OMS824 (Omeros) - Omeros has enrolled the first subject in P1 clinical trial for OMS824; Data is expected before year end

Anticipated P1 data • Trial initiation date • Schizophrenia

FDA grants orphan drug designation to Omeros' OMS824 for Huntington's disease (Omeros Press Release) - "Omeros Corporation (NASDAQ: OMER) announced that OMS824, its phosphodiesterase 10 (PDE10) inhibitor, has received orphan drug designation from the U.S. Food and Drug Administration for the treatment of Huntington's disease....Omeros plans to begin a phase 2 clinical trial evaluating OMS824 in patients with Huntington's disease later this year."

Anticipated new P2 trial • FDA event • Schizophrenia

Omeros reports additional positive results from OMS824 program (Omeros Press Release) - P1, N=200; Sponsor: Omeros; "Omeros ...announced positive data from the company's phase 1 clinical trial evaluating the pharmacokinetics of OMS824...further supporting that OMS824 can achieve superior target engagement with lesser side effects compared to other PDE10 inhibitors in development....The data announced today are at the highest multiple-dose level administered and, at this dose, OMS824 was well tolerated....Omeros is well positioned to initiate phase 2 programs in schizophrenia and Huntington's disease before year-end."

Anticipated new P2 trial • P1 data • Schizophrenia

Investigational New Drug Application cleared for Omeros' lead compound in PDE10 program (Omeros) - Omeros's OMS824 IND has been cleared by the FDA; Omeros may commence enrollment in its P1 trial for OMS824; The P1 dose-ranging study will evaluate the drug's safety, tolerability and pharmacokinetics in healthy subjects, and data is expected before year end

Anticipated P1 data • Anticipated trial initiation date • IND • Phase shift • Schizophrenia

Omeros files Investigational New Drug Application for lead compound in PDE10 program (Omeros) - Omeros has filed an IND with FDA to initiate clinical trials evaluating OMS824 for schizophrenia and other cognitive disorders; The first trial which will evaluate OMS824 is expected to commence following FDA's review of IND; The P1 dose-ranging study will evaluate the drug's safety, tolerability and pharmacokinetics in healthy subjects; Omeros plans to begin enrollment in Q4 2012 with data expected before year end

Anticipated P1 data • IND • Schizophrenia

Omeros reports positive results from OMS824 phase 2a clinical trial (Omeros Press Release) - P2a, N=33; NCT01952132; Sponsor: Omeros; "...announced positive results from a Phase 2a clinical trial of OMS824...in which the drug was well tolerated and demonstrated comparable systemic pharmacokinetics when administered alone and concomitantly with approved antipsychotic agents in patients with schizophrenia....Based on the favorable tolerability...we are considering evaluating additional higher dose levels in patients with schizophrenia....In addition to its schizophrenia program, Omeros expects to begin enrollment this quarter in a Phase 2 clinical trial...Huntington's disease."

Anticipated new P2 trial • P2a data • Schizophrenia

Omeros reports positive results from OMS824 positron emission tomography clinical trial (Omeros) - P1, N=NA, Sponsor: Omeros; "Omeros...announced positive results from its phase 1 clinical program evaluating OMS824...The results show that the selected dose of OMS824 achieved approximately 50 percent occupancy of PDE10 without triggering the extrapyramidal symptoms...OMS824 is Omeros' proprietary compound that selectively inhibits PDE10, and the Company plans to advance into Phase 2 clinical trials in Huntington's disease and schizophrenia later this year."

Anticipated new P2 trial • P1 data • Schizophrenia

Omeros announces successful completion of PDE10 phase 1 multiple ascending dose trial (Omeros) - P1, N=64; "Omeros...positive data from the multiple-ascending-dose (MAD) portion of the company's phase 1 clinical trial evaluating OMS824...With these data and the previously announced successful single-ascending-dose portion of this clinical trial, Omeros is advancing OMS824 toward a phase 2 clinical program...Pharmacokinetic parameters (Cmax and AUC) increased linearly with the dose and that OMS824 had a long half-life that is consistent with once daily dosing. The drug concentration in the cerebrospinal fluid is predicted to achieve near-complete inhibition of the PDE10 target in the brain...Phase 2a trial in patients with schizophrenia is expected to follow shortly thereafter."

Anticipated new P2 trial • P1 data • Schizophrenia

Omeros reports initiation of phase 2 clinical trial with OMS824 (Omeros Press Release) - "Omeros Corporation (NASDAQ:OMER) today announced initiation of enrollment in a phase 2 clinical trial of OMS824....The trial will evaluate the compound's tolerability, safety, pharmacokinetics, potential interactions with concomitant antipsychotic medications, and a battery of cognitive tests in patients with stable schizophrenia....We look forward to completing the current trial later this year."

Anticipated P2 data • New P2 trial • Schizophrenia

Omeros: Cowen & Company Health Care Conference (Omeros) - Anticipated data from multiple-ascending-dose P1 trial for schizophrenia in Q1 2013

P1 data • Schizophrenia