Q3 2025 Omeros Corp Earnings Call

Speaker #1: At this time, all

Speaker #1: remarks, we will conduct a question-and-answer session. Please be advised recorded and the company's request and replay will be available on the that this call is being I'll now turn the call over to Omeros.

Speaker #2: Thank you. And good afternoon,

Speaker #2: forward-looking statements. These statements week from today. materially. For a detailed discussion of these risks Jennifer Williams, investor relations for risks and uncertainties that could cause actual special note regarding forward-looking statements and the risk factors sections in our and uncertainties, please refer to the quarterly report on Form well as our most recent annual report on Form 10K.

Speaker #2: certain non-GAAP financial 10Q filed today with the SEC, as measures. A reconciliation of these non-GAAP measures to the corresponding GAAP measures is included with Omeros' earnings Today's call will include a discussion of press release issued earlier today.

Speaker #2: relations page of our website and has Which is available on the investor been furnished with the Form 8K we filed with the SEC earlier today.

Speaker #2: With that, I'll now turn the call over to Dr. Greg Demopulos, Chairman and CEO of

Speaker #3: Thank you,

Speaker #3: Officer; Nadia Jennifer, and good afternoon, Omeros. Officer; Dr. Andreas Grauer, Chief Medical everyone. Officer; Dr. Kathy Joining me today are David Borges, our Chief Accounting Melfi, Chief Regulatory Officer; and Dr. Steve Whitaker, Vice President of our third quarter results Clinical.

Speaker #3: followed by an update on our development programs. David will then provide I'll begin with an overview of more details on the financials before we open the call for questions.

Speaker #3: For the third quarter of a net loss of $30.9 million or 47 cents per share, compared to a net loss 2025, Omeros reported of $25.4 per share in the second million or 43 cents quarter.

Speaker #3: 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 charge, our adjusted net loss was $22.1 million, and our adjusted loss per share was $0.34.

Speaker #3: 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 priced at a market, and was completed without warrant coverage.

Speaker #3: This net proceeds, was financing supports our ongoing operation 14% premium to the 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 MASK 3 antibody Xeltenavir.

Speaker #3: The deal is valued at up to $2.1 milestone payments plus single-digit to high-teen percentages on global net sales. The transaction remains subject to customary closing royalties in the high conditions including expiration of the applicable waiting period under the Hart Scott Rodino billion in upfront and Act, HSR filings during the government shutdown, periods continued to run and the applicable waiting as usual during the continued to be accepted shutdown.

Speaker #3: We anticipate closing later this quarter. Upon closing, Omeros will receive $240 million in upfront cash, with an additional achievable near-term $100 million in milestones.

Speaker #3: With the upfront $240 million alone, we intend to fully repay our $67.1 million secured term loan, maturity the remaining repay at $17.1 million principal balance on our 2026 convertible notes, and fund more than 12 months of post-closing operations including the anticipated US launch of Narsopalamab for the treatment of transplant-associated thrombotic microangiopathy or TATMA.

Speaker #3: In exchange, Novo Nordisk will rights in all indications to develop and commercialize Xeltenavir and certain related antibodies and antigen binding fragments. Omeros will, with certain exceptions, be broadly receive exclusive global restricted from exploiting antibodies against MASK 3 as well as against other specific alternative pathway targets in a small number of indications that are of high Nordisk.

Speaker #3: our MASK 3 small priority to Novo molecule inhibitor program restrictions on rights to continue with only limited to grandfathered MASK Omeros retains temporal and indication-related restrictions on commercialization.

Speaker #3: This transaction represents a strategic and financial Omeros. It provides capital to advance our indications. programs including MASK 2 oncology TCAT and PD7, milestone for while validating the depth of We've also our science and development expertise.

Speaker #3: Xeltenavir is a pipeline in a drug, and both companies expect it to premier alternative pathway become the inhibitor. Significantly advancing Novo Nordisk's rare disease franchise.

Speaker #3: Novo is a global leader in therapeutic innovation and development. Its commitment and global reach will help fully unlock Xeltenavir's therapeutic potential, maximizing its benefits for patients.

Speaker #3: Let's turn now to our MASK 2 antibody Narsopalamab, 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, PDUFA date.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: We anticipate in EMA decision in mid-2026. While regulatory review proceeds toward anticipated approval of Yartemlia in both the US and Europe, Omeros is preparing to execute on our commercial launch plan.

Speaker #3: 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.

Speaker #3: And in association with the CPT procedural code specific to Yartemlia, these developments 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.

Speaker #3: Engagement with transplant centers, payers, 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.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: The first paper "Survival in Adults with High-Risk TATMA: A Comparative Analysis of Narsopalamab versus Supportive Care" was published last month in Blood Advances; the Journal of the American Society of Hematology.

Speaker #3: 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.

Speaker #3: The second publication titled "Narsopalamab Results in Excellent Survival in Adults and Children with Hematopoietic Cell Transplant Associated Thrombotic Microangiopathy" appeared earlier this month in the American Journal of Hematology.

Speaker #3: 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 defibrillators.

Speaker #3: 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.

Speaker #3: The study by Shetler et al. at Emory University looked specifically at the C5 inhibitor reculizumab in pediatric TATMA and reported a remarkably high infection rate.

Speaker #3: In this perspective, matched analysis eculizumab-treated patients showed an 8.5-fold increase in bacteremia and about a 6-fold increase in infection-related mortality compared with controls. This likely reflects the mechanism of C5 inhibition, which impairs host defense.

Speaker #3: In contrast, MASP2 inhibition by Yartemlia preserves immune protection. With the Yartemlia approval decision approaching, in TATMA, we've identified other commercially attractive MASP2-related indications for our pursuit.

Speaker #3: Our MASP2 franchise includes Yartemlia, optimized for acute conditions like TATMA, OMS 1029, our long-acting MASP2 antibody for chronic diseases designed for dosing as infrequently as once quarterly, and our MASP2 small molecule inhibitors intended for those indications in which once-daily oral dosing would be preferable.

Speaker #3: OMS 1029 is phase two ready. With both active drug and placebo already manufactured and released. Our lead small molecule MASP2 inhibitor is close to beginning IND-enabling studies.

Speaker #3: Okay, turning now to programs beyond our complement franchise. Our PD7 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.

Speaker #3: 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.

Speaker #3: FDA has requested additional preclinical information and we now expect to begin this inpatient clinical trial in the second half of 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.

Speaker #3: 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, excitement continues to grow among infectious disease experts.

Speaker #3: Particularly, regarding TCAT's 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 and TCAT has the potential to address it without contributing to drug resistance.

Speaker #3: 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.

Speaker #3: Our oncotox therapeutics demonstrate broad activity across AML genotypes, including TP53, NPM1, KMT2A, and FLT3 mutations. A non-human primate safety study is underway, with encouraging results to date.

Speaker #3: 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.

Speaker #3: I'll now turn the call over to David Borges, our chief accounting officer for a detailed description of our financial results. David?

Speaker #2: Thanks, Greg. Our 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 43 cents per share in the second quarter of this year.

Speaker #2: 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 $34 cents per share.

Speaker #2: 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.

Speaker #2: 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 with $240 million in upfront cash.

Speaker #2: 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 and accrued interest.

Speaker #2: 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.

Speaker #2: 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 Common Stock, which was completed in September 2025.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: Research and development expenses in the third quarter were primarily focused on Zoltana Bart and Yrtymlia. The primary components of interest expense include the 2026 notes, the DRI Midria royalty obligation, the secured term loan, and the 2029 notes.

Speaker #2: 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 Midria royalty obligation.

Speaker #2: This adjustment reflects updated forecasts of royalty receipts provided by Raynor. Excluding the DRI royalty obligation, which is entirely pass-through interest from Raynor to DRI, and amortization of debt issuance cost discounts and premiums, contractual cash interest expense was $4.2 million compared to $3.9 million in the prior quarter.

Speaker #2: 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.

Speaker #2: 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 put/call option on our unsecured 2029 notes and represent the conversion and interest make-hold features available to holders allowing them to convert the notes into common stock.

Speaker #2: 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 Raynor's downward revision of its forecast for US-based royalties of the Midria.

Speaker #2: result, we were required under GAAP to revise downward our Midria As a 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 Midria royalties from Raynor through December 31st of 2031.

Speaker #2: Omeros retains royalties from ex-US sales and will receive all global Midria 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.

Speaker #2: Raynor remits these royalties to DRI via an escrow agent. However, because both Raynor and DRI are contractual counterparties to us, we are required to recognize these amounts as assets and liabilities on our balance sheet.

Speaker #2: 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 in the third quarter, primarily due to increased marketing costs associated with the anticipated launch of Yrtymlia.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: Interest expense, excluding any non-cash adjustments related to the Midria royalty obligation and amortization of debt discounts and issuance costs, should be around $8 million.

Speaker #2: 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 Midria royalty obligation.

Speaker #2: 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.

Speaker #2: Because they’re non-cash and unpredictable, they’re excluded from our adjusted net loss and don’t affect our operational guidance. Finally, income from discontinued operations is expected to be in the $5 million to $6 million range, excluding any non-cash remeasurement adjustments to the Midria contract asset.

Speaker #2: With that, I'll turn it back over to you, Greg. All right, David. Thank you. Operator, would you please open the call to...

Speaker #2: questions? You ask a

Speaker #3: question, please press star 11 on your telephone and wait for your name to be announced. Do we draw your question, please press star 11 again.

Speaker #3: Please stand by while we compile the Q&A roster. Our first question comes from Brandon Folks with HC Wainwright. Your line is up.

Speaker #4: 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 supplement.

Speaker #4: 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 our supplement at launch?

Speaker #4: 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?

Speaker #4: You know, anything you can help just in terms of thinking about this launch activities

Speaker #4: post-approval. Sure.

Speaker #5: 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.

Speaker #5: move very quickly We would to launch the product. With respect to revenues, we do not, as you know, we just customarily don't talk about our revenue projections.

Speaker #5: 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.

Speaker #5: we believe that through Other than to say that the Novo transaction and the supplement or Yrtymlia, approval that we would expect to positive in 27.

Speaker #5: So that potentially be cash flow is how we're viewing. Also, I think with respect to your hospitals and question over to Nadia, who will be able to give you, I think, more detail.

Speaker #5: So that potentially be cash flow is how we're viewing Also, I think with it. respect to your hospitals and question over to Nadia, who will be able to give you, I think, more detail.

Speaker #6: Thanks, Greg. You know, as we've said identified and prioritized on previous calls, we've process to the formulary and we know what know the exception champion already exists for TATMA and is eager to have an approved treatment.

Speaker #6: parallel.

Speaker #5: Nadia. Brandon, did

Speaker #4: That was very helpful. Thanks very

Speaker #5: Thank that cover Thank you, It does.

Speaker #5: you.

Speaker #3: you. Our next question comes from Thank Steve Brozak with open.

Speaker #7: taking the question. I just want to get used to our supplement

Speaker #7: 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 Thanks for would expect.

Speaker #7: Can you give us as

Speaker #7: 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 WBB Securities.

Speaker #5: Nadia. As well, but as you know, the NTAP assistance in payment for provides subsidizes payments in the hospital setting. So to the hospital. And we of applying and have we are in the process we do expect that we will

Speaker #5: said, an NTAP for that is intended Yrtymlia. So I think to obviously be helpful within the hospital system costs of the Your line is to help defray the drug when

Speaker #5: DRGs have not yet obviously adjusted to the additional cost of a drug like Yrtymlia 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.

Speaker #5: cetera.

Speaker #6: Yeah. So you described it well

Speaker #6: and we're very proud of the fact that we submitted on time and as CMS, as publicly shared, they will have a town hall in December where we are prepared to present our data there.

Speaker #6: 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.

Speaker #5: Right. Thank you, Nadia.

Speaker #5: Did that answer Steve?

Speaker #7: I

Speaker #7: I think that's exactly spot

Speaker #7: on. Thank you. Great.

Speaker #5: Thank you. Thank

Speaker #5: you.

Speaker #3: Thank

Speaker #3: you. Our next question comes from Olivia Brayer with Cantor. Your line is open.

Speaker #8: Hi. Good afternoon. Thank you for the question 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?

Speaker #8: 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?

Speaker #8: 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.

Speaker #8: Is there any reason that it didn't include data from beyond

Speaker #8: 2016? Sure.

Speaker #5: 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.

Speaker #5: 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 guidelines, we really just do not comment on play-by-play discussions with FDA.

Speaker #5: With respect to, well, 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.

Speaker #5: And the reason that those data are running that timeframe for Kyoto is, remember, those data came the initiation of accessing those data came from the publication.

Speaker #5: And the Kyoto stem cell transplant group pulled all that data from 17 different institutions throughout Kyoto. So the amount of data that is really well beyond anything that we could find anywhere else.

Speaker #5: 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.

Speaker #5: So that's how those data were collected. That's really what's driving the timeframe. But I'll come back to my initial comment, which is that the overlap is there between our patients treated and the Kyoto patients.

Speaker #5: I mean, Kathy, do you want to have any further statement on that?

Speaker #2: Well, on the Kyoto as you said, Greg, database was collected very rigorously up to a particular point and published. And so to try to start that up again would certainly take years.

Speaker #2: And if you're asking me to comment on the first question, again, just 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

Speaker #2: requests. Okay.

Speaker #5: 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 anticipate labeling looks

Speaker #5: like. Correct.

Speaker #6: 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?

Speaker #5: 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.

Speaker #5: We just don't think, frankly, that's a wise thing for Omeros to do. But I think, look, I'm going to speak now generally about the data that we have provided to FDA.

Speaker #5: 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.

Speaker #5: I think that is clear, and I think we've said something to that same effect.

Speaker #5: previously. Okay.

Speaker #6: Thank you both. Appreciate the

Speaker #6: color. Thanks.

Speaker #5: Thanks, Olivia.

Speaker #3: Thank you. Our next question comes from Serge Bellinger with Needham & Co. Your line is open.

Speaker #7: Hi. Good afternoon. This is John. I'm for Serge 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.

Speaker #7: I only ask, again, as just trying to gain some clarity around it, considering some of the recent CRLs have come out for products that use historical controls.

Speaker #7: 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.

Speaker #7: Curious what your outlook is for '26. Thanks.

Speaker #5: 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.

Speaker #5: 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.

Speaker #5: I think that the other products, which have run into issues around historical controls, I think you may be referring to potentially, is that the biohaven product that you're

Speaker #5: referencing? Yeah, that's correct.

Speaker #7: And also gene therapy and UniQure as well.

Speaker #5: Yeah. Unicure and biohaven. Yeah. I mean, when you look closely at those, John, it's very different situation, I think, than what we have. And I think it's very different broadly.

Speaker #5: Then 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, yeah, we haven't seen all of the package for either of those products, either Unicores or biohavens.

Speaker #5: They haven't made those public. But what is there publicly, I think, makes it pretty clear that they're different here. So we really don't see those as having any meaningful impact on our application or on our drug.

Speaker #5: With respect to our expenses, moving into '26, 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.

Speaker #5: One is the closing of the deal. And the second is the approval decision from FDA. And we can dial up or dial down as needed.

Speaker #5: But certainly, what we're expecting to do are sort of the things that I went through in the prepared comments. I mean, there are a number of programs that we intend to push.

Speaker #5: And those include 1029. They include the Massachusetts small molecules as well. They include our PD7 program, our TCAT program. And they very much include what we have as our oncology platform.

Speaker #5: We're really excited about all of these programs. But I think there's a breadth of applicability across each of these programs but we are excited.

Speaker #5: And we do expect that 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.

Speaker #5: Did that satisfy John?

Speaker #7: Yeah, that was great. Thank you very much.

Speaker #5: Okay. Good. Thank you.

Speaker #3: 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.

Speaker #5: All right. Thank you, operator. And thanks to all of our panelists for their questions. Before ending today's call, I'd like to just step back and reflect on what's been accomplished and what lies ahead.

Speaker #5: Today, Omeros is entering one of the most exciting phases in our history. With the Artemlia approaching an approval decision, we're preparing to deliver the first and only approved treatment for TATMA.

Speaker #5: 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 the Artemlia to have once launched.

Speaker #5: Equally important, our strategic transaction with Novo Nordisk underscores the scientific and cultural value of our complement franchise. This collaboration not only provides substantial non-dilutive 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 Xeltenavir and MASK3 inhibition globally.

Speaker #5: 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.

Speaker #5: From OMS 1029 and our MASK2 small molecules to our PD7 program, the TCAT platform, and our oncology franchise. Each targets major unmet needs and carries significant potential to create both clinical and shareholder value.

Speaker #5: Our focus now is clear: securing the Artemlia approval, executing a successful commercial launch, and driving forward the next wave of programs that will define Omeros' future.

Speaker #5: We are scientifically differentiated, and upon closing the Novo Nordisk transaction, we'll be financially strong and well-positioned to deliver sustained growth. 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.

Speaker #5: We look forward to updating you again as we continue to execute on what we expect will be a truly transformative period for Omeros. Have a good evening.

Q3 2025 Omeros Corp Earnings Call

Demo

Omeros

Earnings

Q3 2025 Omeros Corp Earnings Call

OMER

Thursday, November 13th, 2025 at 9:30 PM

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