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 set. 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.

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 factor sections 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 measures is included with O'Marris' earnings press release issued earlier today, which is available on the Investor Relations page of our website and has been furnished with the form 8k we filed with SEC earlier today with that I'll now turn the call over to Dr. Greg Dimopoulos chairman and CEO of Omeros thank you Jennifer and good afternoon everyone joining me today are David Borges our chief accounting officer Nadia Dock chief commercial officer Dr. Andreas Grauer chief medical officer Dr. Kathy Melfi chief Regulatory Officer and Dr. Steve Whitaker, Vice President.

I'll begin with an overview of some key corporate developments, followed by an update on our... David will then provide more details on the financials before we open the call for questions. For the third quarter, reported a net loss of $30.9 million, or 47 cents per share, compared to a net loss of $25.4 million or 43 cents per share in the second quarter. The third quarter results include $8.8 million in non-cash charges related to a mark-to-market adjustment of embedded derivatives associated with our debt. Excluding this 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 finance 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 MASC-3 antibody Zoltanobart. The deal is valued at up to $2.1 billion in upfront and milestone fees in the high single digit to high teen percentages on global net sales. It remains subject to customary closing conditions, including expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. HSR filings continued to be accepted during the government shutdown and the applicable waiting periods continued to run as usual during the shutdown. We anticipate closing later this quarter. Upon closing, Omeros will receive $240 million in upfront cash with an additional $100 million in achievable near-term milestones. With the upfront $240 million alone, we intend to fully repay our $67.1 secured term loan, repay at maturity the remaining $17.1 million principal balance on our 2026 convertible notes, and of post including the anticipated U.S. launch of narsoplimab or the treatment of transplant associated thrombotic microangiopathy or TATMA. In exchange, Novo Nordisk will receive exclusive global rights in all indications to develop and commercialize and antigen binding fragments. Omeros will be restricted from exploiting antibodies against MASP-3 as well as against other specific alternative pathway targets in a small number of indications that are of high priority to Novo Nord. Omeros retains rights to continue development and commercialization of our MASP-3 small molecule inhibitor program with only limited restrictions on indications. We've also retained rights to certain research antibodies and monitored MASP-3 antibodies with temporal and indication-related restrictions on commercialization. This transaction is a strategic and financial milestone that provides capital, including MASP2, oncology, TCAT, and PDE7, while validating the depth of our science and development expertise. Zoltanobar companies expect it to become the premier alternative pathway inhibitor, significantly advancing Novo Nordisk's rare disease franchise. Novo is a global leader in therapeutic innovation and development. Its commitment and global reach will help fully unlock Zaltanobard's therapeutic potential, maximizing its benefits for patients. Let's turn now to our MASP2 antibody in our which, when approved, will be marketed as Yartemlia. The Biologics License Application, or BLA, for the treatment of TATMA remains under FDA review with a December 26, 2025 PIDUFA date. Because PIDUFA reviews are funded by industry fees, the current government shutdown, which just ended was is not expected this timeline we remain optimistic for before December 26 in Europe the marketing authorization application or MAA for artemlia in TATMA was validated in June by the European Medicines Agency or EMA and is under review by the Committee for Medicinal Products for Human Use. We will participate in EMA decision in mid-2026. While regulatory review proceeds toward anticipated approval of Yartemlia in both the U.S. and Europe, Omeros is preparing to execute on our commercial launch plan. from leadership and market access to field teams and market development liaisons is assembled and launch ready. We have established a national ICD-10 diagnostic code for TATMA and an associated CPT procedural code specific together these position Yartemlia once approved as the only reimbursable TATMA treatment. We also expect to receive from Medicare a new technology add-on payment or NTAP to support hospital and key hospital decision-makers on the Artemlia has been highly positive benefits clean safety profile and clear dosing regimen our team stands ready to initiate the commercial launch of the Artemlia upon FDA approval Artemlia in the transplant community continue to grow several recent publications in leading peer reviewed journals by global transplant experts. Typically, it's compelling survival outcomes and strong safety record. The first paper, Survival in Adults with High-Risk TATMA, a Comparative Analysis of Narsoplamab Versus, was published last month in Blood Advances, the Journal of the American Society of Hematology. It shows significantly improved survival in TATMA patients treated with the Artemlia, both in the Pivotal Clinical Trial and the Global Expanded Access Program, compared to the internal control group receiving standard support. The second publication, titled Narsoplimab Results in Excellent Survival in Adults and Children with Hematopoietic Cell Transplant-Associated Thrombotic Microangiopathy, appeared earlier Earlier this month, in the American, it reports outcomes in patients treated under expanded access with the Artemlia used as both first-line and as salvage therapy in those who failed one or more prior regimens with other complement agents, including C5 inhibitors and or defibrotide. Importantly, no safety concerns were identified, consistent with all prior Yartemlia studies. The third paper, also published last month in the American Journal of Hematology, on increasingly recognized safety concerns with the use of off-label C5 inhibitors. The study by Shetler et al. at Emory University looked specifically at the C5 inhibitor eculizumab in pediatric TATMA and reported a remarkably high infection rate. In this prospective matched analysis, eculizumab-treated patients showed an eight-and-a-half-fold increase bacteremia and about a six-fold increase in infection related mortality compared with controls this likely reflects the mechanism of C5 inhibition which impairs host defense in contrast mask to inhibition in protection in TATMA we've identified other commercially attractive MASC-2-related indications for pursuit. Our MASC-2 franchise includes Yartemlia, optimized for acute conditions like TATMA, OMS, long-acting MASC-2 antibody for chronic diseases designed for dosing as infrequently, small molecule inhibitors intended for those indications in which once daily oral dosing would be preferable. Active drug and placebo already manufactured elite small molecule MASP2 inhibitor is close to beginning IND enabling studies. Okay, turning now to franchise our Our PD-7 inhibitor program use disorder continues to progress under a fully funded grant from the National Institute on Drug Abuse, or NIDA. Animal cocaine interaction studies designed with NIDA toxicologists have been completed and show no drug interaction or safety issues, supporting the planned inpatient human study in cocaine users. FDA has requested additional preclinical information, and we now expect to begin this inpatient clinical trial in the second half. Activating therapy, or TCAT, platform, a new class of pathogen-targeting recombinant antibodies designed for broad action against bacteria, fungi, viruses, and parasites. TCAT represents a novel approach to infectious disease treatment, harnessing complement activation to kill pathogens directly. As preclinical animal data continue to accumulate across multiple pathogen classes and species, disease, excitement among infectious diseases, particularly regarding TCAS potential against multi-drug resistant organisms or MDROs. These pathogens represent a global health crisis with enormous mortality and cost burdens. Effective MDRO therapies remain one of the most urgent and unmet needs in medicine. TCAT has the potential without contributing. According to our oncology platform, our Oncotox Biologics program is advancing rapidly with acute myeloid leukemia, or AML, as the lead indication. Our Oncatox AML therapeutic has consistently shown superior efficacy to current standard of care in vivo in human tumor-bearing mice and in vitro in human AML cell lines. Broncotox Therapeutics demonstrate broad activity across AML genotypes, including TP53, NPM1, KMT2A, and FLINT3 mutations. A non-human primate safety study is underway with encouraging results to date. By our clinical steering committee of AML leaders, we remain on track in 2027. That concludes our financial, corporate, and development program update. I'll now turn the call over to David Borges, our Chief Accounting Officer, for a detailed description of our financial results.

Net loss for the third quarter of 2025 was $30.9 million, or 47 cents 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. September 30, 2025, we had $36.1 million of cash and investments on hand, and as Greg mentioned, we closed a 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 NOVA Nordisk, which is expected to occur in the fourth quarter of this year, will provide O'Marrows 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 end-of-the-term loan, along with an applicable prepayment premium and recruit 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 Additionally, we reached agreements with two holders to convert $10 million of their 2026 notes which was completed in September 2025. Following these transactions, the principal balance of our 2026 notes has been reduced from $97.9 million to $17.1 million which becomes due in February 2026. After repayment of the $67.1 million term loan and the $17.1 million of the 26 notes, the company's only remaining debt will be $70.8 million of the 2029 notes, which again are not due until June of 2029. Costs and expenses from continuing operations for the third quarter before interest and other income were $26.4 million, which was a decrease of $6 million from the second quarter of this year. Research and development expenses in the third quarter were primarily focused on Zoltanobart and Iertemlia. The primary components of interest expense include the 2026 notes, the DRI Midria royalty obligation, the secured term loan, and the 2029 notes. For the third quarter, interest expense was a net credit of $13.4 million, primarily due to a $22.3 million non-cash remeasurement adjustment related to our DRI Amidria Royalty Obligation. This adjustment reflects updated forecast of royalty receipts provided by Rainer. Excluding the DRI royalty obligation, which is entirely pass-through interest from Rainer to DRI and amortization of debt issuance costs, discounts, and premiums, contractual cash interest expense was $4.2 million compared to $3.9 million in a prior quarter. The increase was due to higher interest on the 29 notes relative to the 26 notes. Interest and other income totaled $616,000 in the third quarter of 25 compared to $1.2 million in the second quarter of this year. During the third quarter, we reported an $8.8 million non-cash loss on marking to market our embedded derivatives related to our debt. Our derivatives are primarily comprised of a foot-call option on our unsecured 2029 notes and represents the conversion and interest make-hole features available to holders, allowing them to convert the notes into common stock. The loss from discontinued operations in the third quarter was $9.7 million, a decrease of $10.1 million from the second quarter. This decline was primarily due to a remeasurement adjustment stemming from Rainer's downward revision of its forecast for U.S.-based royalties of the Midria. As a result, we are required under GAAP to revise downward our IMDRIA contract royalty assets and our DRI IMDRIA royalty obligation. As a reminder, in February 2024, we amended our agreement with DRI granting them rights to all U.S. IMDRIA royalties from Rainer through December 31, 2031. Ameros retains royalties from ex-U.S. sales and will receive all global IMDRIA royalties starting January 1, 2032. It's important to note that the bulk of these transactions involve U.S.-based royalties, which are pass-through in nature and net cash neutral to Ameros. Rainer remits these royalties to DRI via an escrow agent. However, because both Rainer and DRI are contractual, we are required to recognize these amounts as assets and liabilities on our balance sheet. Now let's look at our expected fourth quarter 2025 results. We expect that overall operating expenses from continuing operations in the fourth quarter of 2025 will be higher than the third quarter, primarily due to increased marketing costs associated with the anticipated launch of your Temlia. Research and development expenses in the fourth quarter are expected to be consistent with those in the third quarter of the share. Interest income in the fourth quarter should be slightly higher than in the third quarter, primarily due to higher average cash balances. Other income will be significantly higher this quarter, reflecting the expected gain on the NOVO transaction after related expenses. In addition, we expect to record a non-cash gain upon repayment of our term loan related to the removal of the unamortized premium and debt issuance cost and an embedded derivative associated with that instrument. Interest expense, excluding any non-cash adjustments related to the Amidria Royalty Obligation and amortization of debt discounts and issuance costs, should be around $8 million. This represents a non-cash increase of $23.1 million from the third quarter, primarily reflecting the absence of a significant non-cash adjustment tied to the Amidria Royalty Obligation. One thing to keep in mind, our reported results will continue to reflect non-cash mark-to-market adjustments on the embedded derivative tied to our debt. These adjustments generally move with our stock price and can create volatility quarter to quarter. Because they're non-cash and unpredictable, they're excluded from our adjusted net loss and don't affect our operational guidance. And finally, income from discontinued operations is expected to be in the $5 million to $6 million range, excluding any non-cash remasorment adjustments to the immediate contract asset. With that, I'll turn it back over to you, Greg.

If you ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. Please stand by while we compile the Q&A roster. Our first question comes from Brennan Foulkes with H.C. Wainwright. Your line is up.

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 our Supplimab. 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 nosiplomab 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, Brandon, first of all, as I mentioned in the launch preparations are already well underway. The expectation is upon what we expect and hope will be an approval. We would move 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 will be cash flow positive in 27 also I think with risk regarding is let me turn that question over to Nadia who will be able to give you I think more detail thanks Correct.

As we've said on previous calls, we've identified and prioritized accounts that we call ready-to-go. And in accounts, we know the exception process to the formulary, and we know a 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 our soplumab 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&T committees through, but that will be happening in parallel.

Brendan, did that cover it?

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

Thank you.

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

Thanks for taking the question. Just when I got used to Narceplimab this many years, your Temlia is now, I guess, the new way to describe it. You mentioned something on the call and 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 will work for your TEMLIA?

Thanks.

Again, I'll answer that in general and then hand that over to Nadia as well. But as you know, the ENTAP provides assistance in payment or subsidizes payments to the hospital. And we have Yartemlia. That is of the drug when DRGs have not yet, obviously, adjusted 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, et cetera.

Yeah. You described it well, and we're very proud 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.

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

Yeah, that's exactly spot on.

Great.

Thank you. 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 And then I did have a quick question on that historical 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 cut 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 guidelines with FDA about the Kyoto data and the years that those data were collected. Frankly, there's, you know, good overlap with the data from that time is, remember, pulled all those data from 17 different institutions throughout the amount of data that is really well beyond anything that we could find, the amount of the data, but frankly, the quality of the data, been able to grab or CIBMTR, EBMT, none of those really collect the patient level data and the specific detail. So to my initial comment, which is that the overlap is there between the Kyoto and Kathy do you?

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

What it might look like with respect to the control. You're speaking about what we would anticipate 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 to do. But we can now generally about the data that we have provided to FDA. We've provided adult data, pediatric data, through the expanded access program.

Thank you both. Appreciate the color.

Thank you. Our next question comes from Serge Bellinger with Needham & Co. your line is open.

Hi, good afternoon. This is John on for surge today, and thanks for taking our questions. So first, just to piggyback a bit on the previous question, I'm curious whether there's been any recent FDA commentary to you guys on your data package and the use of historical controls. I only ask again, 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. I'm curious what your outlook is for 26. Thanks.

Yeah, first with RISM-FDA, I don't think it's any different.

Yeah, that's correct. And also, you know, Genes and Unicure as well.

Yeah, 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 I think it's very different broadly. Those are very different products. I think the packages, but what is there? Again, that I think as David went through, 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, prepared comments. I mean, there are a number of programs that we intend to pull. They include a program, and, you know, what we have, we're really excited about all of these programs. There's each of these programs, but, you know, we are excited at some point to share more information on these programs, I would just, as it becomes available and appropriate to share.

Yeah, that was great. Thank you very much.

Okay.

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

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 what's been accomplished and what lies ahead. Today, phases in our history. With the Artemilia approaching an approval decision, we're preparing to deliver the first and only approved treatment for TATMA, a therapy that we expect will plant patients worldwide. The continued recognition from the global transplant community highlights the impact we expect the Artemilia to have once launched. And our strategic transaction with Novo Nordisk of our complement franchise. This collaboration not only provides substantial non-dilutive capital, the strength expertise of one of the world's leading biopharmaceutical companies to accelerate and expand the reach of Zoltanobar and MASP3 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, from OMSU small molecules to our PDE7 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 Yartemlia approval, executing a successful commercial launch and driving forward the next wave of this future. We are scientifically differentiated and upon closing, the Novo Nordisk transaction will be financially strong and well positioned to deliver. I want to thank our employees for their dedication, our collaborators and partners, including Novo Nordisk for their confidence in our science and our shareholders for their continued support. Updating you again as we continue to execute on what we informative period for Omeros.

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