Omeros Corporation (NASDAQ:OMER) Q3 2023 Earnings Call Transcript

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Operator: All right. Thank you. And we have a follow-up question from Steve Brozak of WBB Securities. Your line is open.

Steve Brozak: Hey. Thanks again for taking the follow-up. The question just – ask in terms of your plan as far as following up on the statistical review. But just to go over everything you’ve got in terms of other items in the submission CMC and everything else those you have and have prepared concurrently. So there would be no delay by anything that you would see with that. And just to go over it that – you would be basically looking at that as something that would frankly be already accomplished is that correct as well?

Greg Demopulos: We have been in the process of assembling all of the information that we plan to include in the resubmission. So in direct answer to your question, none of those should represent any kind of delay. So again, as Cathy pointed out, everything that we built in or was built into the analysis plan is really consistent with the guidance we’ve received not only from the division, not only from the Office of New Drugs where you recall we had appealed the initial CRL but also with the guidance documents set forth by FDA in the recent past. So we think we have done what we need to do. The pieces of the BLA are coming together now. We don’t want to delay. So we don’t see any of those other components resulting in a delay.

Steve Brozak: Got it. Great. Thank you for the clarity

Operator: Thank you so much. And there are no further questions at this time. I would now like to turn the conference back to Dr. Demopulos for his closing remarks.

Greg Demopulos: All right. Thank you. Thank you operator, and thank you all for joining this afternoon. Everyone at Omeros is working hard to recover, sustain and ultimately grow value for our shareholders following the ARTEMIS-IGAN results. I hope that today’s presentation helped to identify the opportunities for value creation across our late-stage and even our earlier-stage programs. I remember for those of you who have or can obtain access to ASH either in person or remotely the Phase 2 clinical update on OMS906 program will be presented by Dr. Jens Panse on Sunday, December 10, at 5:00 PM Pacific Time. The presentation will provide a good sense of where our MASP-3 alternative pathway inhibitor program stands relative to other alternative pathway inhibitor programs.

As underscored today, we believe that we control the premier target in MASP-3 in the premier drug and OMS906 in the alternative pathway space. The other two ASH abstracts on our programs one, detailing the outcomes of the high-risk TA-TMA patients treated with narsoplimab under compassionate use that we were just discussing and the other describing the mechanistic support for MASP-3 inhibition in PNH, those both will be presented on Sunday, December 10, and then Monday, December 11, respectively. The time slot for both is 6:00 PM to 8:00 PM Pacific Time. Details of all presentations can be found in our press releases issued on November 2 and on November 3. So with that thanks again and as always we appreciate your continued support. Have a good day.

Thank you.

Operator: Thank you, presenters. And that concludes today’s conference call. Thank you for participating and you may now disconnect. Have a good day.

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