Zaltenibart

– Conference Call Today at 4:30 p.m. ET SEATTLE--(BUSINESS WIRE)--Omeros Corporation (Nasdaq: OMER) today announced recent highlights and developments as well as financial results for the second quarter ended June 30, 2026, which include: Second Quarter and Recent Highlights YARTEMLEA ® , the first and only approved treatment for stem cell transplant-associated thrombotic microangiopathy (TA-TMA), an often-lethal complication of stem cell transplantation, generated gross revenues of $32.2 million in the second quarter of 2026, an increase of 190% from $11.1 million in the first quarter. Net revenue was $28.5 million, reflecting gross-to-net adjustments of approximately 11.5%, compared with $9.9 million and 11.0%, respectively, in the first quarter. Net income for the second quarter of 2026 was $13.2 million, or $0.18 per share, compared to net income of $56.1 million, or $0.78 per share for the first quarter of 2026. Results for the second and first quarters of 2026 included non-cash gains of $11.5 million and $73.1 million, respectively, primarily related to the mark-to-market adjustment of the embedded derivative associated with our unsecured convertible notes due 2029 (the “2029 Notes”). Excluding these non-cash gains, non-GAAP adjusted net income for the second quarter of 2026 was $1.8 million, or $0.02 per share, compared with a non-GAAP adjusted net loss of $17.1 million, or $0.24 per share, for the first quarter. At June 30, 2026, we had $132.0 million of cash and short-term investments. For the three months ended June 30, 2026, company-wide net cash provided by operations was $4.1 million. In July 2026, we completed the repurchase of $30.5 million aggregate principal amount of our 2029 Notes for a total purchase price of $60.2 million, reducing the outstanding principal amount to approximately $40.3 million. The transactions also reduced the aggregate number of shares issuable upon conversion of the 2029 Notes from approximately 11.4 million to 6.5 million and eliminated $8.6 million in future interest payments. During the three and six months ended June 30, 2026, we repurchased and retired approximately 0.5 million and 0.8 million shares of common stock, respectively, at an average cost of $11.70 per share, respectively, for aggregate purchase prices of $5.7 million and $9.9 million, respectively. In June, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a negative opinion on our marketing authorization application (MAA) for narsoplimab in TA-TMA. We believe the clinical evidence supports approval and have requested re-examination. As part of the re-examination procedure, an Ad Hoc Expert Group (AHEG), expected to comprise external scientific and clinical experts in hematology and stem cell transplantation, will review the evidence and address questions central to CHMP’s assessment. We continue to make YARTEMLEA available to transplant physicians and their patients in Europe through our expanded access program, prioritizing children with TA-TMA. “We are very pleased with the strong momentum and growing market acceptance in the first full quarter of YARTEMLEA’s commercial launch,” said Gregory A. Demopulos, M.D., Omeros’ Chairman and Chief Executive Officer. “Equally gratifying are the consistent reports from transplant physicians nationwide describing responses to YARTEMLEA in their adult and pediatric patients, including those who had not responded to prior off-label C5 inhibitor administration. YARTEMLEA is saving lives and, with FDA approval, is now broadly accessible in the U.S. Substantial second-quarter YARTEMLEA revenues have enabled us to continue strengthening our capital structure. We repurchased an additional 489,000 shares of common stock in the open market and reduced the outstanding principal amount of our 2029 convertible notes by 43%, eliminating nearly $9 million in future cash interest payments and approximately 5 million additional shares of potential dilution. At the same time, our work with Novo Nordisk on the MASP-3 inhibitor zaltenibart remained on track toward Phase 3 trial initiation, while our complement, addiction, oncology, and infectious disease programs continued advancing. Collectively, these programs position Omeros for a broad range of value-driving milestones over the next 18 months.” ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Recent Developments YARTEMLEA and our broader MASP-2 inhibitor platform On July 1, 2026, the permanent Healthcare Common Procedure Coding System J-code specific for YARTEMLEA became effective. Also in July, the Centers for Medicare & Medicaid Services (CMS) granted New Technology Add-on Payment (NTAP) status to YARTEMLEA, effective October 1, 2026. The NTAP designation provides eligible hospitals with additional Medicare reimbursement for inpatient cases involving YARTEMLEA and is expected to support patient access to this first-in-class treatment for TA-TMA. We are assessing further development opportunities for YARTEMLEA across indications involving endothelial injury, lectin pathway activation, or thrombo-inflammation, including solid organ transplant-related TMA, chemotherapy-induced TMA, acute respiratory distress syndrome (ARDS), sickle cell disease, acute kidney injury, delayed graft function, and stem cell transplant-related endothelial syndromes beyond TA-TMA, including diffuse alveolar hemorrhage, capillary leak syndrome, graft-versus-host disease, and sinusoidal obstruction syndrome. By year-end 2026, we expect enrollment to begin in two investigator-sponsored and Omeros-supported studies, one evaluating YARTEMLEA in hyperinflammatory ARDS, and the other assessing prophylactic YARTEMLEA in pediatric patients with predictably severe TA-TMA. In parallel, we are finalizing the initial indication for a Phase 2 clinical program for OMS1029, our long-acting antibody targeting MASP-2. In our MASP-2 small-molecule inhibitor program, following completion of one ongoing study, we expect to select a drug development candidate. OMS527 for the treatment of addiction — cocaine use disorder program funded by the National Institute on Drug Abuse (“NIDA”) We are developing, at NIDA’s request, our lead orally administered phosphodiesterase 7 (“PDE7”) inhibitor for the treatment of cocaine use disorder. Preclinical studies, designed with NIDA toxicologists, were completed and showed no drug-interaction or safety issues, supporting the scheduled in-patient human study of OMS527 in cocaine users. We are initiating a nonclinical study responsive to FDA’s request for additional nonclinical information prior to beginning the inpatient clinical trial. We expect to be able start enrollment in the inpatient clinical trial by year-end 2026. Oncology platform — OncotoX-AML/OMS805 We continue to progress development within our OncotoX-AML/OMS805 program targeting acute myeloid leukemia (“AML”), an aggressive and highly fatal bone marrow and blood cancer. A first-in-human Phase 1b clinical trial evaluating OMS805, the lead drug development candidate in our OncotoX-AML program, is targeted to begin in late 2027. IND-enabling studies are underway, and we have entered into an agreement with a leading contract biologics manufacturer for process development and initial clinical supply of OMS805 drug substance. Across tumor-bearing animal models and in vitro human AML cell-line studies, OMS805 demonstrated efficacy superior to current AML standards of care. This efficacy was independent of AML-related genetic mutations, including TP53, NPM1, KMT2A, and FLT3, collectively found in approximately 90% of AML patients. In February 2026, we announced the successful completion of our initial study in nonhuman primates evaluating the efficacy and safety of OncotoX-AML. Administration of only one course of OncotoX-AML treatment to immunocompetent primates produced the desired pharmacologic response, selectively reducing myeloid progenitor cells by up to 99%. OncotoX-AML was well tolerated. There were no observed safety signals or meaningful changes in blood chemistry values. Targeted Complement Activating Therapy (“T-CAT”) platform Our T-CAT platform is a new class of recombinant antibodies designed to target and directly kill pathogens, including bacteria, fungi, viruses, and parasites. Our T-CAT antibodies are expected to treat drug-resistant organisms without enhancing drug resistance. Our initial focus is on developing T-CAT antibodies against infections caused by multidrug-resistant organisms (“MDROs”), one of the most critical unmet needs in medicine. The first peer-reviewed manuscript describing our T-CAT technology, titled “ Engineered Antibodies Bypass Bacterial Immune Evasion to Drive Complement-Mediated Protection Against Lethal Infections ,” was published in Science Translational Medicine on June 17, 2026. The manuscript underscores T-CAT’s potential as a next-generation platform with broad applicability across microbial species, including MDROs. Financial Results YARTEMLEA gross revenues were $32.2 million during the second quarter of 2026, an increase of $21.1 million, or 190%, from gross revenues of $11.1 million in the first quarter of 2026. Net revenue was $28.5 million, reflecting gross-to-net adjustments of approximately 11.5%, compared with $9.9 million, and gross-to-net adjustments of approximately 11.0% in the first quarter of 2026. Net income for the second quarter of 2026 was $13.2 million, or $0.18 per share, compared to net income of $56.1 million, or $0.78 per share, for the first quarter of 2026. Results for the second and first quarters of 2026 included non-cash gains of $11.5 million and $73.1 million, respectively, primarily related to the mark-to-market adjustment of the embedded derivative associated with our 2029 Notes. Excluding these non-cash gains, non-GAAP adjusted net income for the second quarter of 2026 was $1.8 million, or $0.02 per share, compared with a non-GAAP adjusted net loss of $17.1 million, or $0.24 per share, for the first quarter of 2026. At June 30, 2026, we had $132.0 million of cash and short-term investments. For the three months ended June 30, 2026, company-wide net cash provided by operations was $4.1 million. On June 17, 2026, we entered into privately negotiated agreements to repurchase $16.0 million aggregate principal amount of 2029 Notes from certain holders. On July 2, 2026, we entered into additional privately negotiated agreements with the same holders to repurchase $14.5 million aggregate principal amount of 2029 Notes. Both transactions were completed in July 2026 for a total purchase price of $60.2 million, plus accrued and unpaid interest of $0.2 million. Approximately $40.3 million aggregate principal amount of 2029 Notes remains outstanding. The aggregate number of shares issuable on conversion of the 2029 Notes was reduced from approximately 11.4 million to 6.5 million as a result of the transactions. We achieved this reduction at a weighted average cost of $12.21 per share and concurrently eliminated $8.6 million in future interest payments. Research and development and selling, general and administrative expenses totaled approximately $27.7 million in the second quarter, compared with $26.7 million in the first quarter. We reported operating income of $0.1 million for the second quarter compared with an operating loss of $17.4 million for the first quarter. Interest and other income was $4.6 million for the second quarter of 2026 as compared to $1.5 million during the first quarter of 2026. The $3.1 million increase was primarily the result of a reimbursement from Novo Nordisk for the transfer of zaltenibart inventory. During the three months ended June 30, 2026, we repurchased and retired approximately 0.5 million shares of common stock pursuant to our share repurchase program, at an average cost of $11.70 per share, for an aggregate purchase price of $5.7 million. During the six months ended June 30, 2026, we repurchased and retired approximately 0.8 million shares of common stock pursuant to our share repurchase program, at an average cost of $11.70 per share, for an aggregate purchase price of $9.9 million. Conference Call Details Omeros’ management will host a conference call and webcast to discuss the financial results and to provide an update on business activities. The call will be held today at 1:30 p.m. Pacific Time; 4:30 p.m. Eastern Time. For online access to the live webcast of the conference call, please register at the following URL or go to Omeros’ website at . A replay of the call will be made accessible online for 90 days at . About Omeros Corporation Omeros is an innovative biotechnology company that discovers and develops first-in-class protein and small-molecule therapeutics for both large-market and orphan indications, with a focus on the treatment of complement-mediated diseases, cancers, and addictive or compulsive disorders. Omeros’ lead complement inhibitor YARTEMLEA® (narsoplimab-wuug), which targets the lectin pathway’s effector enzyme MASP-2, is FDA-approved and commercially available in the U.S. for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adult and pediatric patients two years of age and older. OMS1029, Omeros’ long-acting MASP-2 inhibitor, has successfully completed Phase 1 clinical trials. Under an asset purchase and licensing agreement, Novo Nordisk acquired global rights to zaltenibart (formerly OMS906), an inhibitor of MASP-3, the alternative pathway’s key activator, which is in clinical development for PNH and other alternative pathway indications, along with associated intellectual property and related assets. Omeros’ pipeline also includes OMS527, a phosphodiesterase 7 inhibitor in clinical development for cocaine use disorder, which is fully funded by the National Institute on Drug Abuse, and a growing portfolio of novel recombinant antibodies targeting multidrug-resistant organisms and novel molecular and cellular therapeutic programs for oncology. For more information about Omeros and its programs, visit . Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the “safe harbor” created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “likely,” “look forward to,” “may,” “objective,” “plan,” “potential,” “predict,” “project,” “should,” “slate,” “target,” “will,” “would,” and similar expressions and variations thereof. Forward-looking statements, including statements regarding the anticipated therapeutic benefits of drug candidates within our development pipeline, statements of intention or expectations regarding our marketing authorization application for narsoplimab in Europe, plans and expectations regarding the commercial launch of YARTEMLEA ® in the U.S., and in the EU following any EMA approval, our expectations regarding the effectiveness of the J-code and its utility, our ability to consummate licensing, partnering or other transactions and the benefits, if any, we would receive from any such transactions, expectations regarding the sufficiency and availability of our capital resources to fund current and planned operations, including the commercialization of YARTEMLEA are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. Omeros’ actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, unfavorable or unexpected regulatory conclusions or interpretations related to the clinical data, external registry data, statistical analyses or other information and data included in our marketing authorization application or our inability to respond satisfactorily to information requests during regulatory review, unanticipated or unexpected outcomes or requirements of regulatory processes in relevant jurisdictions, our financial condition and results of operations, including our ability to raise additional capital for our operations or complete other transactions on favorable terms or at all, regulatory processes and oversight, challenges associated with manufacture or supply of our products to support clinical trials, regulatory inspections and/or commercial sale following any marketing approval, changes in reimbursement and payment policies by government and commercial payers or the application of such policies, intellectual property claims, competitive developments, litigation, and the risks, uncertainties, and other factors described under the heading “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 31, 2026 and in our subsequently filed Quarterly Reports on Form 10-Q. Given these risks, uncertainties, and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. Non-GAAP Financial Measures This press release includes financial measures that are not calculated in accordance with U.S. generally accepted accounting principles (GAAP). A non-GAAP financial measure is generally defined as one that purports to measure historical or future financial position, results of operations or cash flows but excludes or includes amounts that would not be included in most GAAP measures. We define non-GAAP adjusted net income (loss) as GAAP net income (loss) adjusted to exclude the non-cash remeasurement of the fair value of financial instruments. We believe non-GAAP adjusted net income (loss) to be a more accurate measure in evaluating the Company’s performance because it excludes the fluctuation in the fair value of Omeros’ embedded derivatives. This is not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read in conjunction with Omeros’ financial statements prepared in accordance with GAAP. These non-GAAP measures differ from GAAP measures with the same captions, may be different from non-GAAP financial measures with the same or similar captions that are used by other companies, and do not reflect a comprehensive system of accounting. OMEROS CORPORATION UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) (In thousands, except share and per share data) Three Months Ended Six Months Ended June 30, June 30, 2026 2025 2026 2025 Product sales, net $ 28,529 $ — $ 38,422 $ — Costs and expenses: Cost of product sales 798 — 1,385 — Research and development 13,798 22,009 27,156 45,855 Selling, general and administrative 13,859 10,345 27,228 21,468 Total costs and expenses 28,455 32,354 55,769 67,323 Income (loss) from operations 74 (32,354 ) (17,347 ) (67,323 ) Interest and other income 4,626 1,241 6,101 2,363 Interest expense, net of remeasurement adjustments and other (7,585 ) (15 ) (13,479 ) (3,669 ) Net gain on change in fair value of financial instruments 11,447 8,207 84,593 8,142 Loss on early extinguishment of 2029 Notes (1,896 ) — (1,896 ) — Loss on early extinguishment of 2026 Notes — (2,968 ) — (2,968 ) Income (loss) from continuing operations before income tax expense 6,666 (25,889 ) 57,972 (63,455 ) Income tax expense (29 ) — (86 ) — Net income (loss) from continuing operations 6,637 (25,889 ) 57,886 (63,455 ) Net income from discontinued operations, net of tax 6,595 465 11,406 4,571 Net income (loss) $ 13,232 $ (25,424 ) $ 69,292 $ (58,884 ) Basic net income (loss) per share: Net income (loss) from continuing operations $ 0.09 $ (0.44 ) $ 0.80 $ (1.09 ) Net income from discontinued operations 0.09 0.01 0.16 0.08 Net income (loss) $ 0.18 $ (0.43 ) $ 0.96 $ (1.01 ) Diluted net income (loss) per share: Net income (loss) from continuing operations $ 0.08 $ (0.44 ) $ 0.64 $ (1.09 ) Net income from discontinued operations 0.07 0.01 0.13 0.08 Net income (loss) $ 0.15 $ (0.43 ) $ 0.77 $ (1.01 ) Weighted-average shares used in per share computation: Basic 72,131,526 58,585,083 72,025,096 58,323,586 Diluted 89,625,663 58,585,083 89,881,452 58,323,586 OMEROS CORPORATION UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands) June 30, December 31, 2026 2025 Assets Current assets: Cash and cash equivalents $ 1,988 $ 9,660 Short-term investments 129,965 162,144 OMIDRIA contract royalty asset, short-term 25,603 25,351 Receivables 21,301 10,917 Inventory 842 — Prepaid expense and other assets 5,541 7,595 Total current assets 185,240 215,667 OMIDRIA contract royalty asset 90,875 96,435 Right of use assets 8,284 10,708 Property and equipment, net 1,380 1,768 Restricted investments 1,054 1,054 Total assets $ 286,833 $ 325,632 Liabilities and shareholders’ deficit Current liabilities: Accounts payable $ 6,341 $ 4,764 Accrued expenses 29,269 29,388 OMIDRIA royalty obligation 21,511 20,547 2029 Notes repurchase obligation, net 31,259 — 2026 Notes, net — 17,063 Lease liabilities 6,583 6,300 Total current liabilities 94,963 78,062 OMIDRIA royalty obligation, non-current 136,370 147,319 2029 Notes, non-current, net 42,032 51,364 2029 Notes embedded derivative, non-current 55,216 157,171 Lease liabilities, non-current 3,899 7,245 Other accrued liabilities, non-current 5,702 5,702 Shareholders’ deficit: Common stock and additional paid-in capital 793,054 792,464 Accumulated deficit (844,403 ) (913,695 ) Total shareholders’ deficit (51,349 ) (121,231 ) Total liabilities and shareholders’ deficit $ 286,833 $ 325,632 OMEROS CORPORATION UNAUDITED SCHEDULE OF INTEREST EXPENSE, NET OF REMEASUREMENT ADJUSTMENTS AND OTHER (In thousands) Three Months Ended Six Months Ended June 30, June 30, 2026 2025 2026 2025 (In thousands) OMIDRIA royalty obligation Pass through interest remitted to administrative agent $ 3,885 $ 5,069 7,898 10,286 Non-cash remeasurement adjustment 556 (8,506 ) (853 ) (11,878 ) Interest expense, net of remeasurement on OMIDRIA royalty obligation 4,441 (3,437 ) 7,045 (1,592 ) 2029 Notes Contractual interest expense 1,681 859 3,362 859 Amortization of debt discount and issuance costs 1,438 748 2,883 748 Interest expense on 2029 Notes 3,119 1,607 6,245 1,607 2026 Notes Contractual interest expense — 790 112 2,074 Amortization of debt discount and issuance costs — 92 14 240 Interest expense on 2026 Notes — 882 126 2,314 Term Loan Contractual interest expense — 2,231 — 4,464 Amortization of debt premium and issuance costs — (1,306 ) — (3,214 ) Interest expense on Term Loan — 925 — 1,250 Finance leases and other 25 38 63 90 Total interest expense, net of remeasurement adjustments and other $ 7,585 $ 15 $ 13,479 $ 3,669 Contacts Jennifer Cook Williams Cook Williams Communications, Inc. 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