Omeros reports Q3 EPS (60c), consensus (62c)

For the third quarter of 2023, Omeros earned OMIDRIA royalties of $10M on Rayner Surgical Inc.’s U.S. net sales of $33.3M. The company said: “As part of our planned resubmission of our Biologics License Application for narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangiopathy, we have submitted to FDA a formal statistical analysis plan to compare survival data from an already-identified external source. We continue to target an FDA approval decision on our resubmitted BLA in mid-2024. We have discontinued our Phase 3 ARTEMIS-IGAN clinical trial evaluating narsoplimab for the treatment of immunoglobulin A nephropathy based on the results of a pre-specified interim analysis, as announced in October 2023. Topline results showed that narsoplimab did not reach statistically significant improvement over placebo on the primary efficacy endpoint of reduction in proteinuria. In-depth analysis of the ARTEMIS-IGAN data are ongoing.” “Having discontinued our Phase 3 ARTEMIS-IGAN trial, we are closely examining the data to learn what happened and why so that we can apply the findings to the design and conduct of future renal clinical studies across our complement franchise,” said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer. “Our primary focus is achieving regulatory approval and commercialization for our MASP-2 inhibitor narsoplimab to treat TA-TMA patients and driving our MASP-3 inhibitor OMS906, believed to be the premier alternative pathway target and drug, into multiple Phase 3 programs and completing clinical development as quickly as possible. The upcoming presentations at ASH should help to focus others on the value of these programs – a TA-TMA approval will validate both narsoplimab and our other MASP-2 programs for which there are no predicates given Omeros’ broad patent position, while the multiple indications already validated by other alternative pathway inhibitors deliver a roadmap and are accretive to OMS906 and our MASP-3 platform. We expect that Omeros has the financial runway to capitalize on value-driving milestones for these programs, and we intend to extend that runway further through cost-containment measures and other means. Having secured substantial funding from NIDA for OMS527 and with the potential to lever a relatively small investment into a large value across our immuno-oncology platforms, our pipeline of clinical and earlier-stage assets remains robust with multiple opportunities to grow shareholder value.”