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Date

Thursday, November 13, 2025 at 4:30 p.m. ET

Call participants

  • Chairman & Chief Executive Officer — Gregory Demopulos
  • Chief Accounting Officer — David Borges
  • Chief Commercial Officer — Nadia Dac
  • Chief Medical Officer — Andreas Grauer
  • Chief Regulatory Officer — Catherine Melfi
  • Vice President of Clinical — Steven Whitaker

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Takeaways

  • Net loss in the third quarter of 2025 -- $30.9 million or $0.47 per share, including $8.8 million in noncash charges related to mark-to-market adjustment of embedded derivatives associated with debt, compared to $25.4 million or $0.43 per share in the second quarter of 2025.
  • Adjusted net loss in the third quarter of 2025 -- $22.1 million, excluding the noncash charge, with adjusted loss per share of $0.34.
  • Cash and Investments -- $36.1 million as of September 30, 2025.
  • Cash Burn -- $22 million for the quarter.
  • Registered Direct Offering -- $20.3 million net proceeds raised at a 14% premium to market with no warrant coverage.
  • ATM Program Proceeds -- $9 million in additional funding secured during the quarter.
  • Novo Nordisk transaction -- Definitive agreement for MASP-3 antibody program provides up to $2.1 billion in upfront and milestones plus high single-digit to high-teen percentage royalties on global net sales; $240 million upfront payment expected at closing, and $100 million in near-term milestones.
  • Debt Repayment Plan -- $67.1 million secured term loan will be repaid at closing of the Novo Nordisk (NYSE:NVO) transaction, and the $17.1 million principal balance of 2026 convertible notes will be repaid at maturity, leaving only $70.8 million of 2029 notes outstanding.
  • Operating Expenses -- $26.4 million (before interest and other income), a $6 million decrease sequentially from the prior quarter.
  • Interest Expense -- Net credit of $13.4 million, driven by a $22.3 million noncash remeasurement adjustment related to the DRI OMIDRIA royalty obligation.
  • Expected Q4 Operating Expenses -- Anticipated to be higher due to increased marketing costs associated with the launch of Yartemlia.
  • Expected Q4 Other Income -- Significantly higher, reflecting the expected gain from the Novo Nordisk transaction.
  • FDA Review & PDUFA Date -- Biologics license application for narsoplimab (Yartemlia) for TATMA under FDA review with a December 26, 2025 PDUFA date; company anticipates an approval decision by or before this date.
  • EMA Review -- Marketing authorization application for Yartemlia in TATMA under review; EMA decision expected mid-2026.
  • Commercial Launch Readiness -- U.S. commercial organization fully assembled and prepared to launch Yartemlia immediately upon FDA approval; reimbursement infrastructure includes established ICD-10 and CPT codes and NTAP application submitted.
  • Clinical Evidence -- Multiple publications in top peer-reviewed journals highlight significant survival benefits and strong safety outcomes of Yartemlia in both adult and pediatric TATMA patients.
  • Molecule Pipeline Progress -- OMS 1029 (long-acting MASP-2 antibody) is Phase II ready with drug manufactured; lead MASP-2 small molecule inhibitor is near IND-enabling studies.
  • PDE7 Inhibitor Program -- OMS527 for cocaine use disorder progressing with animal studies completed; FDA requested additional data; first-in-human trial now planned for 2026.
  • TCAT Platform -- Preclinical data show broad anti-pathogen potential and enthusiasm from infectious disease experts, especially for multidrug-resistant organisms.
  • Oncotox Oncology Platform -- AML lead candidate demonstrates superior efficacy to standard treatments and broad activity across genotypes; nonhuman primate safety study underway; clinical entry targeted for 2027.
  • Debt Structure -- May 2025 note exchange extended the maturity of $70.8 million to June 2029; $10 million of 2026 notes converted to equity in September; after repayment of the $67.1 million secured term loan and $17.1 million of 2026 notes at closing, only $70.8 million of 2029 notes remain as debt.
  • Loss from Discontinued Operations -- $9.7 million, primarily from a remeasurement adjustment following Rayner’s downward revision of U.S. Midrea royalty forecasts.
  • Royalty Deal Structure -- All U.S. OMIDRIA royalties through Dec 31, 2031, pass through to DRI; Omeros Corporation resumes global OMIDRIA royalties in 2032.
  • Liquidity Covenant Removal -- Repayment of the term loan will eliminate the $25 million minimum liquidity covenant.
  • Q4 Interest Expense Guidance -- Expected to be about $8 million, excluding noncash adjustments related to OMIDRIA royalty obligation and debt issuance costs.
  • Expected Q4 Income from Discontinued Operations -- Guided to a $5 million to $6 million range, excluding noncash remeasurement adjustments.
  • 2027 Cash Flow Outlook -- Demopulos stated, “we would expect to potentially be cash flow positive in 2027” contingent on Novo Nordisk transaction and Yartemlia approval.

Summary

Omeros Corporation (OMER +9.15%) executed a transformative transaction with Novo Nordisk (NYSE:NVO) for up to $2.1 billion plus royalties and expects to close and receive a $240 million upfront milestone in the current quarter, which will retire nearly all short-term debt and provide over twelve months of post-closing operational funding. The company’s commercial launch preparations for Yartemlia are complete, with FDA and EMA reviews progressing toward key regulatory milestones and no stated delays from the government shutdown. Management reported that several high-impact clinical publications have strengthened Yartemlia’s evidence base for both efficacy and safety in TATMA, and that reimbursement infrastructure—including NTAP and diagnostic coding—is in place for launch readiness. Pipeline progress includes a Phase II-ready MASP-2 antibody, near-term IND studies for MASP-2 small molecules, initiation plans for PDE7 inhibitor clinical trials in 2026, and a 2027 clinical entry for Oncotox, while the TCAT platform is generating increasing specialist interest with positive preclinical results.

  • Demopulos stated, “We remain optimistic for an approval decision by or before December 26.”
  • Borges indicated noncash mark-to-market adjustments from debt-embedded derivatives will continue to cause volatility in reported GAAP earnings but are excluded from adjusted net loss and internal operational forecasts.
  • Nadia Dac confirmed NTAP application was timely filed and the company will present at CMS’s December town hall, with the expectation the reimbursement benefit will be effective in 2026.
  • Omeros Corporation retains MASP-3 small molecule rights with only limited restrictions, preserving future R&D optionality outside of the Novo Nordisk-exclusively licensed antibodies.

Industry glossary

  • MASP-2: Mannan-binding lectin-associated serine protease-2; a complement system target implicated in inflammation and TMA.
  • TATMA: Transplant-associated thrombotic microangiopathy; a severe complication following hematopoietic cell transplantation.
  • ICD-10: International Classification of Diseases, Tenth Revision; diagnostic coding system used in healthcare reimbursement.
  • CPT code: Current Procedural Terminology code; used for reporting medical procedures and services.
  • NTAP: New Technology Add-on Payment; a U.S. Medicare reimbursement program providing additional payments for innovative hospital therapies.
  • PDUFA date: Prescription Drug User Fee Act date; the FDA’s target action date for new drug applications.
  • IND-enabling studies: Preclinical studies required before submitting an Investigational New Drug application to begin clinical trials.
  • DRI OMIDRIA royalty obligation: A pass-through royalty arrangement involving U.S. OMIDRIA sales revenues being remitted to DRI under contract.
  • AML: Acute Myeloid Leukemia; a cancer of the blood and bone marrow.
  • Expanded access program: A pathway for patients to receive investigational drugs outside clinical trials, typically for serious or life-threatening conditions.

Full Conference Call Transcript

Gregory Demopulos: 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 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 Corporation 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 million secured term loan, repay at maturity the remaining $17.1 million principal balance on our 2026 convertible notes, and fund more than twelve months of post-closing operations including the anticipated US launch of narsoplimab for 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 altenobart and certain related antibodies and antigen-binding fragments.

Omeros Corporation will, with certain exceptions, be broadly 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 Nordisk. Omeros Corporation 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 to grandfathered MASP-3 antibodies with temporal and indication-related restrictions on commercialization. This transaction represents a strategic and financial milestone for Omeros Corporation. It provides capital to advance our other high-value programs, including MASP-2, oncology, TCAT, and PDE-7, while validating the depth of our science and development expertise.

Sultanobar is a pipeline and a drug, and both 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 sultanobar's therapeutic potential maximizing its benefits for patients. Let's turn now to our MASP-2 antibody and narsoplimab, which when approved, will be marketed as Yartemlia. Biologics license application or BLA for the treatment of TATMA remains under FDA review with a December 26, 2025 PDUFA date. Because PDUFA reviews are funded by industry fees, the current government shutdown, which just ended, was not expected to affect this timeline.

We remain optimistic for an approval decision by or before December 26. In Europe, the marketing authorization application or MAA for Yartemlia 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 anticipate an EMA decision in mid-2026. While regulatory review proceeds toward anticipated approval of Yartemlia in both the US and Europe, Omeros Corporation is preparing to execute on our commercial launch plan. Our US commercial organization from leadership and market access to field teams and market development liaisons is assembled and launch-ready. We've established a national ICD-10 diagnostic code for TATMA and an associated CPT procedural code specific to Yartemlia.

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 reimbursement. Engagement with transplant centers, payors, and key hospital decision-makers on Yartemlia has been highly positive. This has been driven by the drug's demonstrated response and survival benefits, clean safety profile, and clear dosing regimen. Our team stands ready to initiate the commercial launch of Yartemlia upon FDA approval. Awareness and support for Yartemlia in the transplant community continue to grow. Several recent publications in leading peer-reviewed journals by global transplant experts further strengthen the profile of Yartemlia, specifically its compelling survival outcomes and strong safety record.

The first paper, "Survival in Adults with High-Risk TATMA, a Comparative Analysis of Narsoplimab versus Supportive Care," 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 Yartemlia, both in the pivotal clinical trial and the global expanded access program, compared to a well-matched external control group receiving standard supportive care. A second publication titled "Narsoplimab Results in Excellent Survival in Adult and Children with Hematopoietic Cell Transplant Associated Thrombotic Microangiopathy" appeared earlier this month in the American Journal of Hematology.

It reports strong survival outcomes in patients treated under expanded access with Yartemlia 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, focused on increasingly recognized safety concerns with the use of off-label C5 inhibitors. The study by Schettler et al at Emory University looked specifically at the C5 inhibitor eculizumab in pediatric TATMA and reported a remarkably high infection rate.

In this perspective matched analysis, eculizumab-treated patients showed an eight and a half fold increase in 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, MASP-2 inhibition by Yartemlia preserves immune protection. With the Yartemlia approval decision approaching in TATMA, we've identified other commercially attractive MASP-2 related indications for our pursuit. Our MASP-2 franchise includes Yartemlia, optimized for acute conditions like TATMA, OMS 1029, our long-acting MASP-2 antibody for chronic diseases designed for dosing as infrequently as once quarterly, and our MASP-2 small molecule inhibitors intended for those indications in which once daily oral dosing would be preferable.

OMS 1029 is phase two ready, with both active drug and placebo already manufactured and released. Our lead small molecule MASP-2 inhibitor is close to beginning IND enabling studies. Okay. Turning now to programs beyond our complement franchise. Our PDE7 inhibitor program evaluating OMS 527 for cocaine 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 2026.

We are also advancing our targeted complement 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 continued to accumulate across multiple pathogen classes and species, excitement continues to grow among infectious disease experts, particularly regarding TCAT's potential against multidrug-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. And TCAT has the potential to address it without contributing to drug resistance.

Finally, turning to our oncology platform. Our Oncotox biologics program is advancing rapidly, with acute myeloid leukemia or AML as the lead indication. Our Oncotox AML therapeutic has consistently shown superior efficacy to current standard of care treatments both in vivo in human tumor-bearing mice and in vitro in human AML cell lines. Our Oncotox therapeutics demonstrate broad activity across AML genotypes, including TP53, NPM1, KMT2A, and FLT3 mutations. A nonhuman primate safety study is underway, with encouraging results to date. Guided by our clinical steering committee of AML leaders, we remain on track to enter the clinic 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. David?

David Borges: 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 notes to Omeros Corporation's common stock which was completed in September 2025. Following these transactions, the LP 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 would be $70.8 million of the 2029 notes, which again are not due until June 2029. Costs and expenses from continuing operations in 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 zoltenobart and yertemlia. The primary components of interest expense include the 2026 notes, the DRI Midrea 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 noncash remeasurement adjustment related to our DRI, OMIDRIA royalty obligation. This adjustment reflects updated forecast of royalty receipts provided by Raynor. Excluding the DRI royalty obligation, which is entirely passed through interest from Rayner to DRI, and amortization of debt issuance costs discounts, premiums, contractual cash interest expense was $4.2 million compared to $3.9 million in the 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 '5 compared to $1.2 million in the second quarter of this year.

During the third quarter, we reported an $8.8 million noncash loss on marking to market our embedded derivatives related to our debt. Our derivatives are primarily comprised of a put call option on our unsecured twenty nine notes and represents the conversion and interest make whole 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 Rayner's downward revision of its forecast for US based royalties of the Midrea.

As a result, we're required under GAAP to revise downward our Midriah contract royalty asset and our DRI, Midria royalty obligation. As a reminder, in February 2024, we amended our agreement with DRI, granting them rights to all US Submidway royalties from Raynor through December 31, 2031. Omeros Corporation retains royalties from ex-US sales and will receive all global Amidra royalties starting January 1, 2032. It's important to note that the bulk of these transactions involve US based royalties which are pass through in nature and net cash neutral to Omeros Corporation. Rainer remits these royalties to DRI via an escrow agent.

However, because both Rayner and DRI are contractual counterparties to us, 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 2025 will be higher than the third quarter. Primarily due to increased marketing costs associated with the anticipated launch of Yertemlia. Research and development expenses in the fourth quarter are expected to be consistent with those in the third quarter of this year.

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 noncash 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 noncash adjustments related to the Amydria royalty obligation, and amortization of debt discounts and issuance costs. Should be around $8 million.

This represents a noncash increase of $23.1 million from the third quarter, primarily reflecting the absence of a significant noncash adjustment tied to the OMIDRIA royalty obligation. One thing to keep in mind our reported results will continue to reflect noncash 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 noncash 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 to $6 million range. Excluding any noncash remeasuring adjustments to the immediate contract asset.

With that, I'll turn it back over to you, Greg.

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

Operator: 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.

Brandon Folkes: 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.

Gregory Demopulos: 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.

Nadia Dac: 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.

Gregory Demopulos: Thank you, Nadia. Brendan, did that cover?

Brandon Folkes: It does. That was very helpful. Thanks very much.

Gregory Demopulos: Thank you.

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

Stephen Brozak: 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.

Gregory Demopulos: 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.

Nadia Dac: 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.

Gregory Demopulos: Alright. Thank you, Nadia. Did that answer, Steve?

Stephen Brozak: That's exactly spot on. Great. Thank you.

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

Olivia Brayer: 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?

Gregory Demopulos: 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?

Catherine Melfi: 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.

Gregory Demopulos: 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.

Olivia Brayer: 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?

Gregory Demopulos: 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 is clear, and I think we've said something to that same effect previously.

Olivia Brayer: Okay. Thank you both. Appreciate the color.

Gregory Demopulos: Thanks. Thanks, Olivia.

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

John Gionco: 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.

Gregory Demopulos: 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 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?

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

Gregory Demopulos: 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?

John Gionco: Yeah. That was great. Thank you very much.

Gregory Demopulos: Okay. Good. Thank you.

Operator: 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.

Gregory Demopulos: 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.

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