Omeros Corporation

Thank you for your patience. Today's conference call will begin momentarily. Again, thank you for your patience. We will begin momentarily. Good afternoon, and welcome to today's earnings call for Omeros Corporation. At this time, all participants are in listen-only mode. After the company's remarks, we will conduct a question and answer session. Please be advised that this call is being recorded at the company's request, and a replay will be available on the company's website for one week from today. I'll now turn the call over to Jennifer Williams, Investor Relations for OMEROS.

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 OMERIS's earnings press release issued earlier today. which is available on the Investor Relations page of our website and has been furnished with the Form 8K we filed with the 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 Duff, Chief Commercial Officer, Dr. Andreas Grauer, Chief Medical Officer, Dr. Kathy Melfi, Chief Regulatory Officer, and Dr. Steve 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 third quarter of 2025, O'Meara's 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 charge our adjusted net loss was 22.1 million dollars and our adjusted loss per share was 34 cents cash burn for the quarter was 22 million dollars 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 MASC-3 antibody, Zoltenibart. 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 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 12 months of post-closing operations, including the anticipated U.S. launch of narsoplumab 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 commercialized Zoltenibart and certain related antibodies and antigen binding fragments. Omeros will, with certain exceptions, be broadly restricted from exploiting antibodies against MASC-3 as well as against other specific alternative pathway targets in a small number of indications that are of high priority to NovoNorx. Omeros retains rights to continue development and commercialization of our MASP3 small molecule inhibitor program with only limited restrictions on indications. We've also retained rights to certain research antibodies and to our grandfathered MASP3 antibodies with temporal and indication related restrictions on commercialization. This transaction represents a strategic and financial milestone for OMEROS. It provides capital to advance our other high-value programs, including MASP2, Oncology, TCAT, and PDE7, while validating the depth of our science and development expertise. Zoltenabart 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 saltinobar's therapeutic potential, maximizing its benefits for patients. Let's turn now to our MASP2 antibody in our supplement, which, when approved, will be marketed as Yartemlia. The biologics license application, or VLA, 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, is 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 Yartemliya 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 YARN-TEMLIA in both the US and Europe, OMEROS 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 have 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, 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. 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 the artemlia, specifically its compelling survival outcomes and strong safety record. The first paper, Survival in Adults with High-Risk TATMA, a Comparative Analysis of Narcoplomab 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. The second publication titled Narsoplimab 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. It reports strong survival 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 erythema 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 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 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 post-defense. In contrast, MASP2 inhibition by Yartemlia preserves C5. immune protection. With the Yartemlia approval decision approaching in TATMA, we've identified other commercially attractive MASK2-related indications for our pursuit. Our MASK2 franchise includes Yartemlia, optimized for acute conditions like TATMA, OMS 1029, our long-acting MASK2 antibody for chronic diseases designed for dosing as infrequently as once quarterly, and our MASK2 small molecule inhibitors intended for those indications in which once-daily oral dosing would be preferable. OMS 1029 is Phase II ready. with both active drug and placebo already manufactured and released. Our lead small molecule MASP2 inhibitor is close to beginning IND enabling studies. Okay, turning now to programs beyond our complement franchise, our PD7 inhibitor program evaluating OMS527 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 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. 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, 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, 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 Oncatox 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 Oncatox 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. 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?