Gregory Demopulos
Analyst · WBB
Thank you, Jennifer, and good afternoon, everyone. Joining me today are David Borges, our Chief Accounting Officer; Dr. Cathy Melfi, our Chief Regulatory Officer; and Dr. Steve Whitaker, Vice President of Clinical. I'll start with an overview of our first quarter 2026 operations and financial results, followed by program updates. After that, David will cover the financials in more detail and then we'll open the call for questions. We entered 2026 with 2 catalysts: the closing of our previously announced transaction with Novo Nordisk for zaltenibart, our lead investigational MASP-3 inhibitor and the FDA approval of YARTEMLEA, our lead MASP-2 inhibitor for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy, or TA-TMA. This approval made YARTEMLEA the first and only approved treatment for this often fatal complication and the first and only approved inhibitor of the lectin pathway of complement. We launched in January with initial shipments to distributors beginning mid-month, followed shortly by first sales. In the first quarter, YARTEMLEA gross revenues were $11.1 million with net revenues of $9.9 million, reflecting gross to net adjustments of approximately 11%. Early demand and uptake are strong. YARTEMLEA became cash flow positive in the first quarter despite a mid-January launch and we expect it to drive company-wide positive cash flow within 18 months. Net income for the first quarter was $56.1 million, or $0.78 per share, including a $73.1 million noncash mark-to-market gain on the embedded derivative associated with our 2029 convertible notes. Excluding this noncash item, adjusted net gross loss was -- or net loss was $17.1 million, or $0.24 per share. We ended the quarter with $135.3 million in cash and investments after retiring our remaining 2026 convertible notes. During the first quarter, we repurchased and retired approximately 360,000 shares of our common stock at an average price of $11.70 per share for a total of $4.2 million. We may continue to repurchase shares from time to time, subject to market conditions and other considerations. Our transaction with Novo Nordisk provided substantial nondilutive capital to support our growth. At closing, we received $240 million in upfront cash, funding operations, including the YARTEMLEA launch. We are also eligible for another $100 million in near-term milestone payments from Novo. 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 range. Our early launch has been focused on 4 priorities: first, educating transplant care teams to drive earlier recognition and treatment of TA-TMA. Second, securing rapid institutional access through pharmacy and therapeutics, or P&T committee approvals and streamlined ordering. Third, ensuring consistent, timely reimbursement; and finally, demonstrating strong economic value through health economics and outcomes research, or HEOR. Execution is ahead of plan. Our field force is fully deployed, detailing all 175 transplant centers nationwide. By March 31, 30 unique accounts had ordered YARTEMLEA, reflecting accelerated adoption. Despite the typical 6- to 9-month time line for P&T committee approvals, accounts are moving faster than expected. By quarter end, we understand that 60% of the top 10 centers, 40% of the top 20, 38% of the top 40 and approximately 30% of the top 80 U.S. centers had received P&T committee approval. Looking at reimbursement, all prior authorization requests submitted to third-party commercial payers to date have been approved and centers have begun receiving full payment. HEOR analyses, which support YARTEMLEA pricing and show compelling quality of life improvements are being finalized and prepared for publication. Early indicators, including strong receptivity from transplant centers, formulary momentum and payer alignment with the label support our expectation that YARTEMLEA can become standard of care for TA-TMA. In April, the U.S. Centers for Medicare and Medicaid Services, or CMS, assigned a permanent health care common procedure coding system, J-code for YARTEMLEA. This simplifies billing and reimbursement across payers, reduces administrative burden, supports faster patient access and improves reimbursement predictability. The J-code becomes effective July 1. Also in April, CMS in its Inpatient Prospective Payment System proposed rule, recommended approval of the New Technology Add-On Payment, or NTAP for YARTEMLEA. NTAP provides additional payments to hospitals for certain high-cost innovative technologies, helping bridge the gap until standard payment systems incorporate them. The final rule is expected in August with NTAP effective October 1 of this year. We remain focused on expansion opportunities for YARTEMLEA and our MASP-2 program. Beyond the U.S., our marketing authorization application for YARTEMLEA in TA-TMA is under review by the European Medicines Agency. We continue to expect a decision midyear. We are evaluating potential partnerships, including broad ex-U.S. and regional collaborations to support commercialization outside the U.S. Beyond TA-TMA, we're assessing opportunities to expand the YARTEMLEA label to other indications involving lectin pathway activation, including acute respiratory distress syndrome, or ARDS, sickle cell disease, acute kidney injury, solid organ transplant-related TMA and delayed graft function. We're also broadening our MASP-2 inhibitor platform beyond YARTEMLEA, advancing both our Phase II ready long-acting MASP-2 antibody, OMS1029 and our oral MASP-2 small molecule program. Both are well suited for chronic indications, including membranous nephropathy, other renal diseases and neurological disorders such as Parkinson's and Alzheimer's. We're finalizing the initial Phase II indication for once-quarterly OMS1029. We're now also working to advance our small molecule program to IND-enabling studies, targeting once-daily oral delivery. Let's now turn to development programs beyond our complement inhibitor franchise. Our PDE7 inhibitor program evaluating OMS527 for cocaine use disorder remains fully funded by a grant from the National Institute on Drug Abuse, or NIDA. We successfully completed animal cocaine interaction studies, supporting a scheduled inpatient human study evaluating OMS527 in cocaine users. Recently, together with NIDA representation, we met with FDA to discuss the agency's request for additional nonclinical information before starting the inpatient study. The meeting was productive and we are working with FDA to streamline the path to initiate the inpatient clinical trial, which is targeted to start by year-end. Based on its mechanism of action and our extensive preclinical data, we believe that OMS527 could be effective across a wide range of addictions and compulsive disorders. Turning to our Targeted Complement Activating Therapy, or T-CAT platform. This represents a novel class of recombinant antibodies designed to target and directly kill pathogens, including bacteria, fungi, viruses and parasites. Our initial focus is on multidrug-resistant organisms, or MDROs, one of the most critical unmet needs in medicine. Unlike marketed antimicrobials, T-CAT is designed to kill pathogens regardless of resistance profile without promoting resistance. Data from our T-CAT platform were recently featured in a podium presentation at the annual congress of the European Society of Clinical Microbiology and Infectious Diseases and the seminal manuscript describing our T-CAT technology was accepted for publication in Science Translational Medicine. Last but not least, we're pleased with the continued progress of OncotoX-AML, the lead development program in our OncotoX oncology platform. OncotoX-AML is an engineered biologic agent designed to treat acute myeloid leukemia, or AML, the most common and deadliest form of adult leukemia. In both human, tumor-bearing animal and in vitro human AML cell line studies, OncotoX-AML has consistently shown superior efficacy to current standard-of-care treatments, even at very low doses and across mutations associated with AML, such as TP53 and FLT3, which have historically been difficult to treat. In a nonhuman primate study, a single course of OncotoX-AML demonstrated the desired pharmacologic response, a marked selective, reversible and dose-related reduction in myeloid progenitor cells, the cells that can mutate and lead to AML by up to 99%. Safety was equally strong. The treatment was well tolerated with no safety signal of concern. IND-enabling studies are underway and we are preparing for a first in-human trial targeted for late 2027. So 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 discussion of our financial results. David?