Good afternoon, and welcome to today's earnings call for Omeros Corporation. At this time, all participants are in a listen-only mode. After the company’s remarks, we will conduct a question-and-answer session. And please be advised that this call is being recorded at the company's request and a replay will be available on the company's website for one week from today. I'll turn the call over to Jennifer Williams, Investor Relations for Omeros. Please go ahead.

Good afternoon and thank you for joining the call today. I'd like to remind you that some of the statements that will be made on the call today will be forward looking. These statements are based on management's beliefs and expectations as of today only and are subject to change. All forward-looking statements involve risks and uncertainties that could cause the company's actual results to differ materially. Please refer to the special note regarding forward-looking statements in the company's quarterly report on Form 10-Q which was filed today with the SEC and the Risk Factors section of the company's most recent annual report on Form 10-K for a discussion of these risks and uncertainties. Now I would like to turn the call over to Dr. Greg Demopulos, Chairman and CEO of Omeros.

Thank you, Jennifer and good afternoon, everyone. I'm joined today by Mike Jacobsen, Nadia Dac and Cathy Melfi our respective heads of finance commercial and regulatory along with Steve Whitaker, our VP of Clinical Development and Andreas Grauer, who recently joined Omeros as Chief Medical Officer. Again, welcome Andreas. We'll have a brief overview of our financial results for the third quarter followed by a corporate update. Mike will then provide a more detailed financial summary before we open the call to questions. First though in the wake of our stopping the ARTEMIS-IGAN trial I'd like to address our near to mid-term high level program strategy. To anyone paying attention to our programs and their development progress, it should be clear that our company is strong and well-positioned for success. Of course we're conducting a deep dive into our ARTEMIS-IGAN trial data. And there's more work to be done there to learn what specifically happened, why we see an outsized placebo effect whether there are subgroups of patients who responded well to narsoplimab and how we can make use of newly developing biomarkers to understand better the role of lectin pathway inhibition in IgA nephropathy and in kidney diseases more broadly. This examination will not only pay benefits to our MASP-2 program, including OMS1029, but will also help us design and execute clinical trials in kidney diseases for OMS906 our MASP-3 inhibitor. While we expect to resolve these and other questions that we have on the ARTEMIS-IGAN trial, our top priorities are focused on near-term value-driving catalysts, specifically one, achieving approval and successful market launch for our narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangiopathy or TA-TMA mid next year. Two, driving two Phase-3 clinical trials for our MASP-3 inhibitor OMS906 both in Paroxysmal Nocturnal Hemoglobinuria or PNH and in…

Yeah. Thanks, Greg. Our net loss for the third quarter was $37.8 million or $0.60 per share compared to a net loss of $37.3 million or $0.59 per share in the second quarter of this year. Cash burn as Greg mentioned for the third quarter was $31 million. As of September 30, 2023, we had $310 million of cash and investments on hand and $7 million in receivables primarily consisting of OMIDRIA royalties. Cost and expenses from continuing operations for the third quarter were $48.2 million, an increase of $7.3 million from the second quarter of this year. The increase was primarily due to a licensing milestone payment made in connection with our OMS906 program and compensation expense. Interest expense for the third quarter was $7.9 million consistent with the second quarter of this year. The primary drivers of interest expense are the 2023 and 2026 convertible notes and our OMIDRIA royalty obligation to DRI. Our 2023 notes totaling $95 million are due next week. We plan on retiring the notes with a portion of our existing cash and investments. Now let's look at OMIDRIA royalties. Under our contract with Rayner, we are entitled to receive royalties on net sales of OMIDRIA for the duration of the relevant patent terms, which in the US now extend into 2035. Under the terms of the contract, the applicable royalty rate decreased from 50% to 30% of US net sales, upon earning the $200 million milestone payment at the end of last year. The 30% royalty rate will continue to apply while separate payment for OMIDRIA is in effect and while sales of OMIDRIA have not been materially affected by the entry of a generic competitor. Under our settlement agreements with the generic manufacturers, we do not expect generic entry into the market…

Thanks Mike. Operator, let's open the call to questions.

[Operator Instructions] Your first question comes from the line of Steve Brozak of WBB Securities. Your line is now open.

Hey. Good afternoon and thank you for taking questions. There's a word that keeps coming up compassionate use. And you've mentioned it a couple of times obviously in the number of patients you've been treating but also as far as in the ASH document that is being published. Can you go into as much detail as is possible on that please?

Hi Steve. Sure. We went through I think the data from that compassionate-use abstract during the prepared comments, but I can summarize those for you. These were 15 compassionate-use patients. They were adult and children 14 of them were high risk. When we looked or when those investigators looked at those patients, the response rate was high. The 100-day survival across the study was 80%. So, that's all patients in the study including non-responders. And when you look only at responders, the survival rate was 100%. So, again, similar to what we had seen in our pivotal trial. And we think again consistent and clearly underscoring the role of lectin pathway inhibition in this disease. We have as we mentioned over 120 patients that we have treated with compassionate-use narsoplimab. Many of those are from sites that have put in multiple requests. So, if you're getting multiple requests from a large number of sites, you would expect that those sites are having success with the treatment otherwise I would expect you would not receive multiple requests. Further, to that point, you have to think about the patients for whom compassionate-use narsoplimab is being requested. These are for the most part obviously very sick patients. They may be patients or in the case of a good number of these they are patients who have failed prior treatments either with eculizumab, ravulizumab, defibrotide, pegcetacoplan. And we are being asked effectively to catch a falling knife. We do not deny treatment. We tried to get the treatment there as quickly as possible. So I think the results are even more impressive, given what we would expect to be the severity of the patients and the fact that a good number of them have failed prior treatment with other off-label drugs and then we see this response with narsoplimab. That I guess you could explain that. If it happened once it could be just chance two may be an act of God. But at some point the number of those patients responding to narsoplimab, I think really point to what the drug is doing to help these patients. And that's why we genuinely believe it's important that we make it available. It is at our cost. And that cost is substantial. So we want to continue to do it throughout the regulatory process. But at some point it really does become I think, untenable. But we try to do, what we can here.

Just along those lines and I'll hop back in the queue. Thank you. The clinicians because you're mentioning, these patients that are obviously in critical states. The clinicians what are -- I'm sure that these are the people that have been convinced. So what feedback are you getting from them? And I'll hop back in the queue. Thank you.

Yeah. It's a good question. Clearly we're receiving positive feedback from them. And that feedback is not only coming to us, its being put into abstracts and potentially publications or already published on these patients and their responses. So this is what we're -- this is what we're seeing and this is -- it's all consistent I guess would be my point. And I think if you look at the data I think those are pretty clear.

Got it. Thank you. I'll hop back in the queue.

Thank you, Steve.

Thank you so much. And you next question comes from the line of Serge Belanger of Needham. Your line is now open.

Hi. Good afternoon. Just one question for us, on HSCT-TMA, what kind of feedback, are you expecting from FDA, regarding the analysis plan? And is this something that could drag out beyond year end this year? Thanks.

Yeah. Hi Serge. Look, I think clearly, what we hope, to receive from FDA is, acknowledgment and alignment on the statistical analysis plan that's been submitted. As I stated earlier, this analysis plan has been put together not by Omeros, but by an external and very well-respected, well-known bio statistical group. We believe that it is frankly conservative. We think it should be acceptable. So what we are hoping to hear back in the near-term is that the approach that has been proposed is acceptable. We can go ahead and run the analyses which have not yet been run. And based on the outcome of those analyses, if those analyses are supportive of a BLA we will resubmit the BLA. So with respect to timing, I think what we have guided to, is what we continue to hold to and drive to which is we are really pushing to get an FDA response on a resubmitted BLA in mid next year which would be followed very shortly thereafter by the commercial launch of narsoplimab for TA-TMA. Did that answer your question? Cathy, do you want to add anything to that or Andreas or Steve?

Sure Greg.

Sorry go ahead.

No. Go ahead, Serge. Ask and then I'll

All right. I was just saying so re-filing it's still pending analysis of the data. That hasn't been completed at this point.

Sure. We have not analyzed the data. We have built the analysis plan or I should say our external biostatisticians have built the analysis plan but we are waiting to get alignment with FDA, so that we can analyze those data. And it is then done without foreknowledge of the outcome. That has been -- that's been our approach. We think it's the right approach. Frankly, the analysis – after having built the programs that analysis should take one to two days to complete. So that's not going to be a – any kind of meaningful time delay in moving forward. But Cathy do you want to add to that?

Sure. I think you had asked about what feedback we expect that sort of thing and the plan that we've put together, the proposal is consistent with the feedback that we received not just from the Office of New Drugs but following the meeting that we had with the review division in the summer. And also as you may know, FDA has come out with a lot of recent guidance documents on use of external control groups and real-world data and our proposal is consistent with all of those things. So we feel confident in what we've proposed to FDA and we await their response.

Thanks, Cathy.

I appreciate this clarity.

All right. Thank you. Andreas anything you want to add to that.

No. I think that sums it up and we're awaiting FDA feedback and are excited to interact with them on this.

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

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?

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.

Got it. Great. Thank you for the clarity

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.

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.

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