Thank you for your patience. Today's conference call will begin momentarily. Good afternoon. And welcome to today's earnings call for Omeros Corporation. At this time, all participants are in listen-only mode. After the company's remarks, we will conduct a question and answer session. 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 now turn the call over to Jennifer Williams, Investor Relations for Omeros Corporation. Thank you, and good afternoon, everyone.

Before we begin, please note that today's discussion will include forward-looking statements. These statements reflect management's current expectations and beliefs as of today and are subject to risks and uncertainties that could cause actual results to differ materially. For a detailed discussion of these risks and uncertainties, please refer to the special note regarding forward-looking statements and the Risk Factors section in our quarterly report on Form 10-Q filed today with the SEC as well as our most recent annual report on Form 10-K. Today's call will include a discussion of certain non-GAAP financial measures. A reconciliation of these non-GAAP measures to the corresponding GAAP is included with Omeros Corporation's earnings press release issued earlier today. Which is available on the Investor Relations page of our website and has been furnished with the Form 8-K we filed with the SEC earlier today. With that, I will now turn the call over to Dr. Gregory Demopulos, Chairman and CEO of Omeros Corporation.

Thank you, Jennifer, and good afternoon, everyone. Joining me today are David Borges, our Chief Accounting Officer, Nadia Dac, our Chief Commercial Officer, Dr. Andreas Grauer, Chief Medical Officer, Dr. Catherine Melfi, Chief Regulatory Officer, and Dr. Steven Whitaker, Vice President of Clinical. I'll begin with an overview of our third quarter results and key corporate developments followed by an update on our development programs. David will then provide more details on the financials before we open the call for questions. For the 2025, Omeros Corporation reported a net loss of $30.9 million or $0.47 per share compared to a net loss of $25.4 million or $0.43 per share in the second quarter. The third quarter results include $8.8 million in noncash charges related to a mark-to-market adjustment of embedded derivatives associated with our debt. Excluding this charge, our adjusted net loss was $22.1 million and our adjusted loss per share was $0.34. Cash burn for the quarter was $22 million and as of September 30, we had $36.1 million in cash and investments. During the third quarter, we continued to strengthen our balance sheet including a registered direct offering that generated $20.3 million in net proceeds was priced at a 14% premium to the market and was completed without warrant coverage. This financing supports our ongoing operation and commercial launch preparations. In October, we announced a definitive agreement with Novo Nordisk for an asset purchase and license transaction centered on our late clinical stage MASP-3 antibody, sultanobar. The deal is valued at up to $2.1 billion in upfront and milestone payments plus royalties in the high single-digit to high teen percentages on global net sales. The transaction remains subject to customary closing conditions, including expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. HSR filings continued…

Thanks, Greg. Our net loss for the 2025 was $30.9 million or $0.47 per share compared to a net loss of $25.4 million or $0.43 per share in the second quarter of this year. Third quarter results include non-cash charges of $8.8 million associated with marking to market our embedded derivatives related to our debt. Excluding this charge from current quarter results, our adjusted net loss was $22.1 million and our adjusted loss per share was $0.34 per share. The $8.8 million charge is solely a non-cash remeasurement adjustment, and removing it provides a more accurate measure engaging the company's operating performance. As of September 30, 2025, we had $36.1 million of cash and investments on hand, and as Greg mentioned, we closed our registered direct offering in July, in which we received net proceeds of $20.3 million. We also raised net proceeds of $9 million from our ATM program during the quarter. The closing of our agreement with Novo Nordisk, which is expected to occur in the fourth quarter of this year, will provide Omeros Corporation with $240 million in upfront cash at closing. A portion of the proceeds will be used to fully repay all outstanding obligations under our secured credit agreement. This includes the $67.1 million outstanding under the term loan, along with an applicable prepayment premium accrued interest. The repayment will eliminate all liens, covenants associated with the credit agreement, including the $25 million minimum liquidity covenant. In connection with the May 2025 conversion of our 2026 convertible notes, we exchanged $70.8 million in aggregate principal amount of those notes on a one-for-one basis for newly issued 2029 notes, extending the maturity to June 2029, a period more than three years out. Additionally, we reached agreements with two holders to convert $10 million of their 2026…

Alright, David. Thank you. Operator, would you please open the call to questions?

To ask a question, please press 11 on your telephone. And wait for your name to be announced. To withdraw your question, please press 11 again. Our first question comes from Brandon Folkes with H. C. Wainwright. Your line is open.

Hi. Thanks for taking my questions, and congrats on all the progress in the quarter. Greg, I want to just understand sort of post-approval kind of you know, till launch and sort of maybe till we see significant revenue pull through on narsoplimab. You know, once you gain approval maybe when would you look to launch? Do you need to get into any guidelines, or can you just begin detailing narsoplimab at launch? And then can you just help me understand selling to these transplant centers? Is it a sort of similar process to the hospitals in terms of formularies? Anything you can help just in terms of thinking about this launch activities post-approval.

Sure. Well, as thank you, Brandon, first of all. As I mentioned in the prepared comments, those launch preparations are already well underway. The expectation is upon what we expect and hope will be an approval. We would move very quickly to launch the product. With respect to revenues, we do not, as you know, we just customarily don't talk about our revenue projections. For a reasonable period of time until we're able to see the same revenue trend lines that everyone else is. So I'm going to beg off of the revenue question. Other than to say, that we believe that through the Novo transaction and the narsoplimab or Yartemlia approval that we would expect to potentially be cash flow positive in 2027. So that is how we're viewing it. Also, I think with respect to your question regarding hospitals and formularies, let me turn that question over to Nadia. Who will be able to give you, I think, more detail.

Thanks, Greg. As we've said on previous calls, we've identified prioritized accounts that we call ready to go. And in accounts, we know the exception process of the formulary, and we know what champion already exists for TATMA and is eager to have an approved treatment. So formulary approvals will happen over time, but they're not critical to actually having narsoplimab ordered and administered to patients in those hospitals. And we do have a process that we will be providing the formulary kits and walking the P and T committees through, but that will be happening in parallel.

Thank you, Nadia. Brendan, did that cover?

It does. That was very helpful. Thanks very much.

Thank you.

Thank you. Our next question comes from Stephen Brozak with WBB Securities. Your line is open.

Thanks for taking the question. Just wanna get used to narsoplimab for this many years. Yartemlia is now, I guess, the new way to describe it. You mentioned something on the call in the press release on NTAPs. I'm familiar with some previous NTAP awards, and you say that you would expect. Can you give us as much detail as you can on the NTAP section? Because, obviously, it's a good way for hospital systems to get additional payments. So what can you tell us about it, and your estimation of how it'll work for Yartemlia? And thanks.

Sure. Again, I'll answer that in general and then hand that over to Nadia as well. But as you know, the NTAP provides assistance in payment or subsidizes payments in the hospital setting. So to the hospital. And we are in the process of applying. And we do expect that we will receive, as I said, an NTAP for Yartemlia. So I think that is intended to obviously be helpful within the hospital system. To help defray the costs of the drug when DRGs have not yet obviously adjusted to the additional cost of a drug like Yartemlia in TATMA. So that's the purpose. Let me hand it over to Nadia who can give a little detail about perhaps next steps, timeline, etcetera.

Yeah. So you described it well, and, you know, we're very aware of the fact that we submitted on time, and as CMS has publicly shared, they will have a town hall in December where we are prepared to present our data there. And then the decisions, which we're very confident in a positive decision, would then go into effect in their fiscal year that begins in 2026.

Alright. Thank you, Nadia. Did that answer, Steve?

That's exactly spot on. Great. Thank you.

Thank you. Our next question comes from Olivia Brayer with Cantor. Your line is open.

Hi, good afternoon. Thank you for the questions, and congratulations on the recent Novo deal. Can you comment, Greg, on whether or not you all have had labeling discussions with the FDA yet? And is there anything that we should be taking into consideration as we think about what a potential label might look like? Just based on the historical control analysis that you ran. And then I did have a quick question on that control database. I noticed that those data from the Kyoto transplantation group are from 2000 to 2016. Is there any reason that it didn't include data from beyond 2016?

Sure. Let me take those questions. I believe, in order. I caught the first and the third. But I may ask you then to repeat the second. So maybe I'll go one three, come back to two. With respect to labeling, we do not I mean, just historically and consistent with Omeros Corporation's guidelines, we really just do not comment on play by play discussions with FDA. With respect to your question about the Kyoto data and the years that those data were collected, frankly, there's good overlap with the data from our trial. And the reason that those data are running that time frame for Kyoto is remember, those data came the initiation of accessing those data came from the publication. And the stem cell transplant group pulled all those data from 17 different institutions throughout Kyoto. So the amount of data that is really well beyond anything that we could find anywhere else. Not only the amount of the data, but, frankly, the quality of the data. Significantly beyond what we would have been able to grab or could grab since we actually attempted this from CIBMTR EBMT, None of those really collect the patient level data and the specificity detail of TATMA. So that's how those data were collected. That's really what's driving the time frame, but I'll come back to my initial comment, which is that the overlap is there between our patients treated and Kyoto patients. And, Kathy, do you wanna have any further statement on that?

Well, on Kyoto, as you said, Greg, the database was collected very rigorously up to a particular point and published. And so to try to start that up again would take years. And, you know, for asking me to comment on the first question, again, the communications with FDA have been interactive and collaborative, and we've been able to provide FDA what they've asked for in their information request.

Okay. And I'm sorry, Olivia. The third, I caught something about what it might look like with respect to the control. You're speaking about what we would labeling looks like.

Correct. Is there anything for us to kind of keep in mind as we go into that PDUFA and as we potentially get a label in December?

No. I mean, again, I just will I'll just default back to the same answer, which is that we don't discuss labeling. We don't discuss the play by play interactions with FDA. We just don't think frankly, that's a wise thing for Omeros Corporation to do. But you know, I think look. What I'm gonna speak now generally about the data that we have provided to FDA. We've provided adult data. We have also provided substantial pediatric data through the expanded access program. Certainly, our objective would be to include both adult and pediatric patients in any kind of label. I think that that is clear, and I think we've said something to that same effect previously.

Okay. Thank you both. Appreciate the color.

Thanks. Thanks, Olivia.

Thank you. Our next question comes from Serge Belanger with Needham and Co. Your line is open.

Hi. Good afternoon. This is John Gionco on for Serge today. Thanks for taking our questions. So first, just to piggyback a bit on the previous question. Curious whether there's been any recent FDA commentary to you guys on your data package and the use of the historical controls. I only ask you as of, you know, just trying to gain some clarity around it considering some of the recent CRLs have come out for products that use historical controls. And then second on operating expenses, just curious whether you're at steady state there or expect changes heading into 2026. You mentioned there should be a little bit of a bump in 4Q this year. Curious what your outlook is for '26? Thanks.

Yeah. First, with respect to our interactions or information requests, whatever may come, from FDA. We're in a review process. One would expect that throughout that period, information requests come. Information requests are responded to in a timely manner. And I don't think it's any different for our application than for any others. So I think that that is, that's pretty clear. I think that the other products which have run into issues around historical control. I think you may be referring to potentially. Is that the Biohaven product that you're referencing?

Yeah. That's correct. And, also, you know, UniCure as well.

UniCure and Biohaven. Yeah. I mean, when you look closely at those, John, it's a very different situation, I think, than what we have. And I think it's very different broadly. Than just kind of pointing out historical control. Historical control therefore, these two things must be the same. These are very different products. I think the packages are yeah. We haven't seen all of the package for either of those products, either UniCure's or Biohaven's. They haven't made those public. But what is that are publicly I think, makes it pretty clear that, you know, there are differences here. So we really don't see those as having any impact or any meaningful impact on our application or on our drug. With respect to our expenses moving into 26, you know, I would expect, again, that I think as David went through, those we would expect to increase. But, again, everything is being predicated on really two events. One is the closing of the Novo deal. And the second is the approval decision from FDA. And we can dial up or dial down as needed. But, certainly, what we're expecting to do are sort of the things that I went through in the prepared comments. There are a number of programs that we intend to push. And those include OMS 1029. They include the MASP-2 small molecules as well. They include our PDE-7 program, our TCAT program, and, you know, they very much include what we have as our oncology platform. We're really excited about all of these programs. But I think there's a breadth of applicability across each of these programs. But, you know, we are excited. We do expect at some point to share more information on these programs. I would just sort of say stay tuned. And we'll share information as it becomes available. And appropriate to share. Did that satisfy John?

Yeah. That was great. Thank you very much.

Okay. Good. Thank you.

Thank you. I'm showing no further questions at this time. I would now like to turn it back to Dr. Demopulos for closing remarks.

Alright. Thank you, operator, and thanks to all of our panelists for their questions. You know, before ending today's call, I'd like to just step back and reflect on what's been accomplished and what lies ahead. Today, Omeros Corporation is entering one of the most exciting phases in our history. With Yartemlia, approaching an approval decision, we're preparing to deliver the first and only approved treatment for TATMA. A therapy that we expect will really transform outcomes for transplant patients worldwide. The continued recognition from the global transplant community highlights the impact we expect Yartemlia to have once launched. Equally important are strength our strategic transaction with Novo Nordisk underscores the scientific and cultural value of our complement franchise. This collaboration not only provides substantial nondilutive capital, but also brings the strength scale, and expertise of one of the world's leading biopharmaceutical companies to accelerate and expand the reach of zoltenobar and MASP-3 inhibition globally. It is a strong external validation of our science, our platform, and our team's ability to translate innovation into long-term value. At the same time, we continue to advance a deep and diversified pipeline. From OMS 1029 and our MASP-2 small molecules to our PDE-7 program, the TCAT platform, and our oncology franchise. Each targets major unmet needs and carries significant potential to create both clinical and shareholder value. Our focus now is clear, securing the Yartemlia approval, executing a successful commercial launch, and driving forward the next wave of programs that will define Omeros Corporation's future. We are scientifically differentiated and upon closing, the Novo Nordisk transaction will be financially strong. And well-positioned to deliver sustained growth. I want to thank our employees for their dedication, collaborators and partners, including Novo Nordisk, for their confidence in our science, and our shareholders for their continued support. We look forward to updating you again as we continue to execute on what we expect will be a truly transformative period for Omeros Corporation. Have a good evening.

This concludes today's conference call. Thank you for participating. You may now disconnect.