Omeros Corporation

Good afternoon, and welcome to today's earnings call for Omeros Corporation. At this time, all participants are in a 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 turn the call over to Jennifer Williams, investor relations for Omeros.

Good afternoon, and thank you for joining the call today. I'd like to remind you that some of the statements that will be made on the call today will be forward-looking. These statements are based on management's beliefs and expectations as of today only and are subject to change. All forward-looking statements involve risks and uncertainties that could cause the company's actual results to differ materially. Please refer to the special notes in the risk factor section regarding forward-looking statements in the company's quarterly report on Form 10-Q, which was filed today with the SEC. and the risk factor section of the company's most recent annual report on Form 10-K for a discussion of these risks and uncertainties. Now, I would like to turn the call over to Dr. Greg Dimopoulos, Chairman and CEO of O'Meara.

Thank you, Jennifer, and good afternoon, everyone. I'm joined on today's call by David Borges, our Chief Accounting Officer, Nadia Dock, our Chief Commercial Officer, Andreas Grauer, our Chief Medical Officer, Kathy Melfi, our Chief Regulatory Officer, and Steve Whitaker, our Vice President of Clinical. Today I'll start with an overview of our first quarter financial results and provide updates across our development programs. David will then go through our financials in more detail and will open the call for questions. Now let's look at our financial results for the first quarter. Our net loss was $33.5 million or 58 cents per share compared to a net loss of 31.4 million or 54 cents per share in the fourth quarter of last year. As of March 31, 2025, we had $52.5 million of cash and investments on hand. I'd like to start with how we are strengthening our balance sheet and addressing our liquidity position. and the options available to us for raising capital. While we've been focused on achieving significant milestones across our development programs, which I'll discuss shortly, we've also been actively pursuing ways to strengthen our balance sheet and manage our debt maturities. Earlier this week, we announced an exchange agreement with certain holders of our 2026 convertible notes exchanging about $71 million in principal for new 9.5% convertible senior notes due out in 2029. We also reached an agreement with two affiliated holders to convert $10 million of their 2026 notes into equity over a period of 90 to 120 days, with the entire amount to be converted by September of this year. As a result, the outstanding balance on the 2026 notes will be reduced to approximately $17 million, eliminating the need to make a $20 million mandatory prepayment of our existing term loan by November 1 to avoid triggering an accelerated maturity of the term loan balance. Overall, this will reduce our total debt by $10 million and lower our near-term repayment obligations by over $100 million, reducing it from approximately $118 million to $17 million. The debt extension moves maturity out to 2029 and removes a major overhang for all routes of securing near-term capital. We also have an active at the market facility in place with the capacity to raise up to $150 million in aggregate, providing meaningful flexibility to access additional capital when needed. With the debt exchange now having been completed, we're in the process of securing additional capital to support our operations through the anticipated approval and launch of NAR Supplement. including active discussions around partnerships, which would bring non-dilutive funding. As we assess capital raising alternatives, we're also keeping a close eye on costs across the organization. We've taken meaningful steps to lower expenses while continuing to advance key initiatives and position the company for long-term growth. We've made good progress. but we know it's critical to remain disciplined. We are carefully managing our cash and liquidity to ensure we have the flexibility to deliver on our priorities and are committed to using our resources wisely, focusing investment on the areas that matter most to our shareholders and for near-term success of the company. This means that certain activities and programs have been suspended or paused in order to prioritize the allocation of our currently available capital to the development of commercial infrastructure and capacities needed to ensure the successful launch of narsoplumab for the treatment of hematopoietic stem cell transplant associated thrombotic microangiopathy. or TATMA, following the anticipated approval by FDA of our resubmitted biologics license application and to the completion of our ongoing Zoltenibar clinical trials with enrolled patients. As recently announced, FDA has accepted our resubmitted BLA for narsoplimab and TATMA and has assigned a target date for FDA action of September 25th. We have received and are responding to information requests as part of the process. Our primary analysis results show a hazard ratio of 0.32 with a p-value of less than 0.00001, meaning that narsoplimab resulted in a statistically significant threefold greater improvement in survival compared to the well-matched control group. All sensitivity analyses, including the analyses directed to our expanding access program, or EAP, are strikingly consistent and strong, and we look forward to working closely with FDA to bring narsoplimab to market as the first approved treatment for TATMA. Additionally, the ICD-10 codes established through our collaborative efforts with transplant experts and professional societies will create reimbursement hurdles for off-label treatments since narsoplumab will be the only approved treatment for TATMA. We're also moving forward to complete and submit a marketing authorization application, or MAA, to the European Medicines Authority for narsoplumab in TATMA. We're targeting to complete that submission later this quarter. Although prelaunch commercialization activities within our narsoplumab program will continue, We are suspending our expanded access program for narsoplumab, also known as compassionate use. Physician requests for access to narsoplumab under this program continue, and we are mindful that the TA, TMA patients who lack an approved treatment for this often fatal condition will be most affected by cessation of access to narsoplumab prior to approval. Nevertheless, suspension of the program is necessary to eliminate direct costs associated with supplying the drug and the external management of the EAP. We remain committed to support patients who are currently being treated under the EAP. This discontinuation of the program will not affect these currently treated patients. Additionally, our ongoing study of norsoplumab in pediatric patients with PATMA will continue. A manuscript detailing the data related to the primary analysis authored by an international group of leaders in the transplant field has been submitted for publication in a top-tier journal. A second manuscript directed to the EAP results, again authored by international transplant leaders, is planned for submission early next week. A manuscript from Weill Cornell describing the role of MASP2 in the lectin pathway in long COVID is also under review in a major peer-reviewed journal. We expect that narsoplimab will be the first approved therapy in TATMA, a nearly $1 billion annual market opportunity. Narsoplimab is positioned to become a cornerstone asset for transplant experts with label expansion opportunity in other transplant complications and to other disease fields. Our focus remains bringing narsoplimab to market as quickly as possible. Transplanters and their patients globally are waiting for it. Our other prioritized program is the development of Zoltenibart, our lead antibody targeting MASK3, the most proximal and key inhibitor of the alternative pathway of complement. The initial indication for Zoltenibart is paroxysmal nocturnal hemoglobinuria, or PNH. The global market for PNH, including multiple treatment modalities, is estimated to grow about 11% annually to over $10 billion in 2032. There remains significant unmet need for PNH patients, and the complement inhibitor market specifically is expected to more than double from about 2.2 billion today to 4.7 billion in that same timeframe. We expect Zaltanabart to carve out a significant share of that growing market. Our ongoing clinical trial evaluating Zaltanabart for the treatment of PNH and treatment naive patients will continue. Also continuing is the extension study which enrolls PNH patients treated with Zaltanabart who have completed any of our prior Zaltanabart studies in this indication. Our Phase II study in C3G will also remain ongoing. Our Phase III Zoltenebar program in PNH began initiating clinical trial sites last quarter, and based on capital considerations, the anticipated ramp-up in spending as well on those trials, we are pausing our Phase III PNH program temporarily. and are working with our vendors and investigators to ensure that the program is ready to restart with as little disruption to the timeline as possible after securing capital. Market research confirms that Zaltanabart's target profile is differentiated from the evolving P&H landscape. Preference drivers for Zaltanabart include a compelling efficacy and safety profile with low treatment burden, four to six times per year dosing, which minimizes how often patients have to think about their disease, and infrequent IV administration, which minimizes both the risk of noncompliance and subsequent breakthrough disease while aligning with the existing economic and treatment model of physicians' practices in PNH. Development spending on our long-acting next-generation MASK2 inhibitor, OMS1029, remains limited. That asset is Phase II ready, with drug product needed to support Phase II trials having already been manufactured and stored, pending the selection of the first indication and the resources to initiate Phase II studies. We've also reduced spending in our other areas of complement franchise, including our small molecule MASK2 and MASK3 programs as part of our effort to focus resources on core development priorities. Apart from our complement programs, our PDE7 inhibitor program evaluating OMS527 for cocaine use disorder, or CUD, will continue moving forward, funded entirely by a grant from the National Institute on Drug Abuse, or NIDA. Work on an upcoming inpatient clinical trial evaluating safety and preliminary efficacy of OMS 527 in patients with CUD is ongoing, with readout of those clinical data expected late this year or early next. In addition, we continue on a limited basis preclinical studies in our novel oncology platform. including IND enabling studies in our Oncotox program. Oncotox is designed to target and kill only dividing cancer cells. Treatment of acute myeloid leukemia or AML is the lead indication. Our Oncotox AML therapeutic has consistently demonstrated superior efficacy to current AML standard of care treatments both in vitro and in vivo with human cell lines. Oncotox AML shows broad application across AML regardless of genetic mutations, including TP53, NPM1, KMT2A, and FLT3. This broad application certainly appears to be unique. Well tolerated in preliminary tolerability studies, IND enabling work is ongoing, and we expect to be in the clinic in 18 to 24 months. This work, as well as clinical trials, will be aided and guided by our distinguished clinical steering committee, all of whom lead AML treatment and research at their respective premier cancer centers. Based on positive feedback from stealth unveiling of our Oncotox data last month at the American Association of Cancer Research with prospective partners, we believe that this program has potential to drive substantial value at an early stage of development, meaning in the near term. I'll now turn the call over to David, our Chief Accounting Officer, to go through a more detailed discussion of our financial results. David?