Omeros Corporation

Good afternoon and welcome to today's earnings call for O'Meara's Corporation. At this time, all participants are on a listen-only mode. After the company's remarks, we will conduct a question and answer session. Please be advised this call is being recorded at the company's request and the replay will be available on the company's website one week from today. I will now turn the call over to Jennifer Williams, Investor Relations for O'Meara's.

Good afternoon and thank you for joining us or sticking with us. Before we begin, I'd like to remind you that certain statements made during this call are for... These statements reflect management's current beliefs and expectations as of today and are subject to change. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially. For discussion of these risks and uncertainties, please refer to the special notes and the risk factors section regarding forward-looking statements in our quarterly report on Form 10-Q filed today with the SEC and the risk factors section of our most recent annual report on Form 10-K. With that, I'll turn the call over to Chairman and CEO of Omeros, Dr. Greg Dimopoulos.

Thank you, Jennifer, and good afternoon, everyone. Joining me today are David Borges, our Chief Accounting Officer, Nadia Dock, Chief Commercial Officer, Dr. Andreas Grauer, Chief Medical Officer, Dr. Kathy Melfi, Chief Regulatory Officer, and Dr. Steve Whitaker, Vice President of Clinical. I'll begin with an overview of our second quarter 2025 financial results and provide updates across our development programs. David will then walk through the financials in more detail and will open the call for questions. Our net loss for the second quarter of 2025 was $25.4 million or 43 cents per share. compared to a net loss of $33.5 million, or 58 cents per share, in the first quarter of this year. As of June 30, 2025, we had $28.7 million in cash and investments. This was further strengthened by a registered direct offering completed on July 28, 2025, which raised $20.6 million in net proceeds. During the quarter, we took decisive steps to strengthen our balance sheet and extend our debt maturity profile. Through a combination of convertible note exchanges and equity conversions, we reduced the outstanding principal on our 2026 notes from $98 million to $17 million. eliminated a $20 million mandatory prepayment on our term loan, and extended the large majority of our debt out to 2029. These actions, including the July offering with Polar Asset Management Partners, reduced our near-term payment obligations by over $100 million. This further positions us to focus capital on advancing key programs and supporting the anticipated launch of NARS Supplement. We've removed a major structural overhang, streamlined our balance sheet, and are now better positioned to access additional capital through partnerships, equity or debt offerings, or sales under our active ATM facility. As previously disclosed, we're in discussions regarding potential asset acquisition and or licensing agreements involving certain of our clinical assets. The most advanced of these discussions is driving toward a multi-billion dollar transaction exclusive of royalties. Upon closing, we expect to receive an upfront cash payment sufficient to repay in full a $67.1 million term loan outstanding under our senior secured credit facility, repay at maturity the remaining $17.1 million principal balance of our 2026 convertible notes, and provide sufficient capital for over 12 months of post-closing operations. This transaction is also expected to include near and longer-term milestones, and if regulatory approval is obtained, sales-based milestones and royalties. Let's now turn to the anticipated approval and launch of narsoplimab, our proprietary human monoclonal antibody against MASK2, the key activator of the lectin pathway of complement. While we've identified several commercially attractive follow-on indications for narsoplimab. The initial indication is stem cell transplant associated thrombotic microangiopathy, or TATMA, a life-threatening complication of stem cell transplant. In March, we resubmitted our biologic license application, or BLA, for narsoplimab in TATMA. The FDA accepted the submission for review and assigned a PDUFA target action date of September 25th. Following our submission of additional information requested by FDA, the agency extended the PDUFA date to December 26th. We continue to work collaboratively with FDA. Our objective is to expedite the review and potential approval process. To date, results of all requested analyses have been shown to be statistically significant and are consistent with and supportive of narsoplimab benefits as demonstrated in our BLA resubmission. Assuming no major deficiencies are identified during its review, FDA has indicated that labeling discussions are planned to begin no later than October 2025. In June, we submitted our marketing authorization application, or MAA, for narsoplimab in TATMA to the European Medicines Agency. The MAA has been validated. initiating formal review process by the Committee for Medicinal Products for Human Use. We expect a decision on the MAA in mid-2026. We continue to expect that narsopalimab will be the first approved therapy for TATMA and that it is well positioned to address a substantial market opportunity. Awareness is growing among transplant physicians regarding the risks of C5 inhibitors like eculizumab and ravulizumab, which are often used off-label in TATMA and have been shown to be associated with increased infection rates and related complications. A retrospective single center case control study published last month in the American Journal of Hematology found that pediatric TATMA patients treated with the C5 inhibitor eculizumab had significantly higher infection rates compared to well-matched controls. Specifically in the eculizumab-treated group, bacteremia was eight and a half-fold higher, and one-year infection-related mortality was six-fold higher. Similar findings are being reported in adults. Mechanistically, C5 inhibitors, like C3 inhibitors, block the infection-fighting lytic arm of the classical pathway of complement, markedly increasing risk of infection and death in immunocompromised patients. In contrast, by targeting and inhibiting MASP2, narsothlomab preserves the classical pathway's lytic function and the adaptive immune response. We believe both safety and efficacy will be key differentiators and drivers of adoption for Narsoplimab. Two manuscripts will soon be published in premier peer-reviewed journals detailing Narsoplimab's safety and survival benefits in high-risk TATMA patients. The first, already accepted for publication, assesses survival in both adults and children treated under expanded access. The second is under review and compares narsoplimab treated adults in both the pivotal trial and in the expanded access program to a well-matched external control. Thanks to the continued efforts of our field-based market development and access teams, we're well-positioned to drive demand in our highest priority transplant centers upon approval. These centers are already actively monitored for signs and symptoms of TATMA and are familiar with narsoplimab and its clinical profile. We're executing a phased onboarding of hematology experience sales professionals who first will target the highest volume transplant centers expanding more broadly over time. Our sales leadership is currently in active discussions with top tier candidates with deep expertise in transplant and rare hematologic diseases. Notably, many have been closely following Narsoplimab's development and are genuinely enthusiastic to launch a product that can significantly improve outcomes. and save patients' lives. In parallel, we're engaging hospital decision-makers and payers through pre-approval information exchanges to support planning for coverage and reimbursement. Feedback has been highly encouraging. Stakeholders recognize the strong clinical safety and efficacy data for narsoplumab and are eager for an approved treatment option that avoids the risks associated with off-label C5 inhibitors. Upon approval, we will leverage our experienced field marketing team and a highly skilled sales force to drive rapid uptake. By emphasizing the compelling clinical data and proactively addressing access barriers, we're confident in our ability to deliver a successful launch and life-saving outcomes to TATMA patients and their families. Looking to the rest of our MASK2 inhibitor family, OMS1029, our long-acting, once-quarterly MASK2 antibody, is ready to restart Phase II clinical trial activities once resources are available. We have adequate supply of OMS1029 and matched placebo. to support the Phase II program. Our orally administered small molecule MAS-2 inhibitor program is nearly ready to begin IND-enabling studies. Both programs target indications suited to their respective delivery modes and pharmacologic profiles. Turning to our MAS-3 inhibitor program, Sultenibar, also known as OMS-906, is our phase three asset and lead mass three antibody. Mass three is the key activator and most proximal target in the alternative pathway of complement. The initial indication is paroxysmal nocturnal hemoglobinuria, or PNH. The global PNH market is projected to grow at 11% annually, reaching over $10 billion by 2032. The complement inhibitor segment alone is expected to more than double from 2.2 billion today to 4.7 billion over the next seven years. We believe Zoltenabart can carve out a significant share in this growing market. Phase two studies of Zoltenabart and PNH have shown efficacy at least equivalent to that of any other alternative pathway targeting agent on the market or in development. Zoltenabart's differentiators include once every two months to once quarterly dosing, improved compliance and reduced risk of life-threatening breakthrough disease, and no safety signals of concern observed in preclinical or clinical studies. The Phase III program was paused to prioritize narsoplumab approval and market launch, and is set to restart when capital is available. The potential indications for Zoltenibart are broad, and the market opportunity is substantial. Let's now look at our programs beyond our complement franchise. Our PDE7 inhibitor program is evaluating OMS527 for cocaine use disorder, or CUD, fully funded by a grant from the National Institute on Drug Abuse, or NIDA. Preclinical studies designed by NIDA toxicologists have been successfully completed with no safety findings. and provide the drug interaction safety data in support of the planned inpatient human study of 527 in cocaine users. FDA has requested additional preclinical information before initiating the inpatient trial, which we target for the first part of 2026. We're also advancing our oncology platform, including IND enabling studies for our Oncotox Biologics program. The lead indication is acute myeloid leukemia, or AML. Our Oncotox AML therapeutic has consistently demonstrated superior efficacy to current AML standard of care treatments, both in vivo in immunocompromised mice with human tumors, and in vitro with human cell lines. The lead candidate therapeutic shows broad applicability across AML regardless of genetic mutations, whether that be TP53, NPM1, KMT2A, or FLT3. We aim to enter the clinic within 18 to 24 months guided by our distinguished Clinical Steering Committee, composed of world leaders in AML treatment and research. I'll now turn the call over to David Borges, our Chief Accounting Officer, to go through a more detailed discussion of our financial results. David. Thanks, Greg.