Omeros Corporation (OMER)

Omeros Corporation Announces Update on European Marketing Authorization Application for Narsoplimab in TA-TMAJune 26, 2026 8:30 AM
Business Wire Omeros Corporation (Nasdaq: OMER) announced today an update on the review by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) of the company’s marketing authorization application (MAA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). Following an oral explanation meeting with the CHMP held this week, at which Omeros presented its position together with four international experts in hematopoietic cell transplantation, Omeros was informed that the CHMP has adopted a negative opinion on the MAA for narsoplimab in TA-TMA. Omeros intends to request re-examination of the CHMP opinion and, as part of that procedure, to seek review of the matter by an Ad Hoc Expert Group (AHEG), an independent panel of external scientific and clinical experts to be convened by EMA based on relevant expertise in the indication and related clinical considerations. Narsoplimab was approved under the brand name YARTEMLEA® by the U.S. Food and Drug Administration (FDA) in December 2025. Broadly indicated for all TA-TMA patients two years of age and older, it is the first and only treatment to receive regulatory approval for TA-TMA. YARTEMLEA targets MASP-2, the effector enzyme of the lectin pathway of complement and, with a unique safety profile, is the only systemic complement inhibitor on the market without a boxed warning, risk evaluation and mitigation strategy (REMS), or vaccination requirement. “We are disappointed by the CHMP’s opinion, particularly given the lethal nature of TA-TMA, the absence of an approved treatment for this condition in Europe, and the totality of the clinical trial and real-world data supporting narsoplimab’s efficacy and safety,” said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “We look forward to meeting with the AHEG and believe strongly that YARTEMLEA warrants approval in Europe, just as it received approval in the U.S. In the meantime, we plan to continue providing YARTEMLEA to TA-TMA patients under our global compassionate use program, prioritizing children. Given drug supply and access constraints, however, compassionate use in Europe can reach only a fraction of the patients who could be treated following EMA approval. While regulatory review progresses, we will work to make YARTEMLEA available to patients who need it and to prevent avoidable deaths from TA-TMA.” The MAA is supported by clinical data from Omeros’ pivotal trial of narsoplimab in TA-TMA, together with analyses comparing survival in narsoplimab-treated patients to survival in an external registry of TA-TMA patients who did not receive narsoplimab, as well as by the company’s compassionate use program. These are the same data on which FDA based its approval of narsoplimab for TA-TMA. About Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy Hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) is a severe and often-fatal complication of hematopoietic stem cell transplantation in adults and children. TA-TMA is driven by systemic endothelial injury triggered by conditioning regimens, immunosuppressants, infection, graft-versus-host disease, and other transplant-related factors, with activation of the lectin pathway of complement playing a central role in disease pathogenesis. TA-TMA can occur following both autologous and allogeneic transplant, with higher prevalence after allogeneic procedures. Approximately 30,000 allogeneic transplants are performed annually in the U.S. and Europe. Recent studies estimate that TA-TMA develops in up to 56 percent of allogeneic transplant recipients. Mortality in severe TA-TMA can exceed 90 percent, and survivors frequently face long-term renal complications, including dialysis dependence. About YARTEMLEA® (narsoplimab-wuug) YARTEMLEA® (narsoplimab-wuug), a fully human monoclonal antibody, is the first and only approved inhibitor of the lectin pathway of complement. YARTEMLEA inhibits mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway. In hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), MASP-2 inhibition prevents lectin pathway-mediated cellular injury, including endothelial damage in small blood vessels, and thrombus formation. By selectively blocking activation of the lectin pathway, YARTEMLEA preserves classical and alternative pathway activity, including functions essential to the adaptive immune response. YARTEMLEA is approved by the U.S. FDA for the treatment of TA-TMA in adults and children ages two years and older. IMPORTANT SAFETY INFORMATION FOR YARTEMLEA Contraindications None. Warnings and Precautions Serious and life-threatening infections, regardless of causality or relatedness to YARTEMLEA, were reported in 36% (10/28) of clinical trial patients treated with YARTEMLEA, including sepsis, viral infections, pneumonia, bacteremia, fungal infection, gastroenteritis, respiratory tract infections, and urosepsis. If YARTEMLEA is administered to patients with active infections, monitor closely for signs and symptoms of worsening infection and treat promptly. Adverse Reactions The most common adverse reactions (≥ 20%), regardless of causality or relatedness to YARTEMLEA, were viral infections, sepsis, hemorrhage, diarrhea, vomiting, nausea, neutropenia, pyrexia, fatigue, and hypokalemia. Use in Specific Populations Pregnancy: Available data on the use of YARTEMLEA during pregnancy are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Lactation: There are no data on the presence of YARTEMLEA in human milk, the effects on the breastfed child, or the effects on milk production. To report suspected adverse reactions, contact Omeros Corporation at 1-844-YARTEM1 (1-844-927-8361), or contact FDA at 1-800-FDA-1088 or through FDA MedWatch. Please see the Full Prescribing Information for YARTEMLEA. 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 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 aged two years and older. OMS1029, Omeros’ long-acting MASP-2 inhibitor, has successfully completed Phase 1 clinical trials. Under a recently announced 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 www.omeros.com. 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 commercialization of narsoplimab in the European Union following any EMA approval, 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. View source version on businesswire.com: https://www.businesswire.com/news/home/20260626549696/en/ Jennifer Cook Williams
Cook Williams Communications, Inc.
Investor and Media Relations
IR@omeros.com Original: Omeros Corporation Announces Update on European Marketing Authorization Application for Narsoplimab in TA-TMA

Omeros Announces Webcast Details for Annual Meeting of ShareholdersJune 15, 2026 8:30 AM
Business Wire Omeros Corporation (Nasdaq: OMER) today announced that the company will host a live webcast of its Annual Meeting of Shareholders, which will be held virtually on Thursday, June 18, 2026, beginning at 10:00 a.m. Pacific Time. The live webcast can be accessed through the virtual shareholder meeting website at www.virtualshareholdermeeting.com/OMER2026. A general corporate overview and question-and-answer session will follow the business portion of the annual meeting. As described in the company’s proxy statement, filed April 30, 2026, only shareholders of record as of the close of business on April 17, 2026 are entitled to vote at the Annual Meeting of Shareholders and any adjournment or postponement thereof. Shareholders of record will be able to attend the meeting, vote and submit questions through the virtual shareholder meeting website by using the 16-digit control number provided on their proxy card or in the instructions accompanying their proxy materials. Guests without a 16-digit control number may also attend the Annual Meeting by accessing the virtual shareholder meeting website but will not be able to vote or submit questions. For those unable to attend the live event, a recording will be archived following conclusion of the meeting and accessible on the investor relations page of Omeros’ corporate website. 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 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 aged two years and older. A marketing authorization application seeking approval of YARTEMLEA for TA-TMA is currently under review at the European Medicines Agency. OMS1029, Omeros’ long-acting MASP-2 inhibitor, has successfully completed Phase 1 clinical trials. Under a recently announced 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 www.omeros.com. View source version on businesswire.com: https://www.businesswire.com/news/home/20260615512303/en/ Jennifer Cook Williams
Cook Williams Communications, Inc.
Investor and Media Relations
IR@omeros.com Original: Omeros Announces Webcast Details for Annual Meeting of Shareholders

CMS Assigns Permanent Reimbursement J-Code for YARTEMLEA® (narsoplimab-wuug)April 16, 2026 8:45 AM
Business Wire
– Permanent, product-specific J-code facilitates efficient claims and reimbursement –


Omeros Corporation (NASDAQ: OMER) today announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has assigned a permanent Healthcare Common Procedure Coding System (HCPCS) J-code for YARTEMLEA®. The J-code for YARTEMLEA (J1289) simplifies and streamlines billing and reimbursement for patients covered by U.S. government programs (e.g., Medicare) and commercial payers. The J-code will become effective July 1, 2026.


“For patients with TA-TMA, access to effective treatment without unnecessary delay is critical,” said Gregory A. Demopulos, M.D., Chairman and Chief Executive Officer of Omeros. “The assignment of a permanent, product-specific J-code for YARTEMLEA establishes a clear and consistent reimbursement pathway across payors, reducing administrative burden, supporting faster access for patients, and delivering more predictable reimbursement for providers.”


YARTEMLEA is the first and only approved treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), an often-fatal complication of hematopoietic stem cell transplantation. TA-TMA is driven by activation of the lectin pathway of complement. YARTEMLEA inhibits MASP-2, the effector enzyme of the lectin pathway, and is indicated for treatment of TA-TMA in adults and children ages two years and older.


Together with the ICD-10-CM diagnosis code for TA-TMA (M31.11), the availability of the HCPCS J-code for YARTEMLEA (J1289) will support accurate and standardized coding and billing. The permanent J-code for YARTEMLEA has been published by CMS and is available here.


Omeros is committed to supporting patient and provider access to YARTEMLEA. The YARTEMLEAssist® patient support program helps identify potential financial assistance options. Providers and patient representatives can call 1-844-YARTEM1 (1-844-927-8361) or visit YARTEMLEA.com for more information.


About Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy


Hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) is a severe and often-fatal complication of hematopoietic stem cell transplantation in adults and children. TA-TMA is driven by systemic endothelial injury triggered by conditioning regimens, immunosuppressants, infection, graft-versus-host disease, and other transplant-related factors, with activation of the lectin pathway of complement playing a central role in disease pathogenesis.


TA-TMA can occur following both autologous and allogeneic transplant, with higher prevalence after allogeneic procedures. Approximately 30,000 allogeneic transplants are performed annually in the U.S. and Europe. Recent studies estimate that TA-TMA develops in up to 56 percent of allogeneic transplant recipients. Mortality in severe TA-TMA can exceed 90 percent, and survivors frequently face long-term renal complications, including dialysis dependence.


YARTEMLEA® is the only approved treatment for TA-TMA.


IMPORTANT SAFETY INFORMATION FOR YARTEMLEA


Contraindications

None.


Warnings and Precautions

Serious and life-threatening infections, regardless of causality or relatedness to YARTEMLEA, were reported in 36% (10/28) of clinical trial patients treated with YARTEMLEA, including sepsis, viral infections, pneumonia, bacteremia, fungal infection, gastroenteritis, respiratory tract infections, and urosepsis. If YARTEMLEA is administered to patients with active infections, monitor closely for signs and symptoms of worsening infection and treat promptly.


Adverse Reactions

The most common adverse reactions (≥ 20%), regardless of causality or relatedness to YARTEMLEA, were viral infections, sepsis, hemorrhage, diarrhea, vomiting, nausea, neutropenia, pyrexia, fatigue, and hypokalemia.


Use in Specific Populations


Pregnancy: Available data on the use of YARTEMLEA during pregnancy are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.


Lactation: There are no data on the presence of YARTEMLEA in human milk, the effects on the breastfed child, or the effects on milk production.


To report suspected adverse reactions, contact Omeros Corporation at 1-844-YARTEM1 (1-844-927-8361), or contact FDA at 1-800-FDA-1088 or through FDA MedWatch.


Please see the Full Prescribing Information for YARTEMLEA.


About YARTEMLEA®


YARTEMLEA® (narsoplimab-wuug), a fully human monoclonal antibody, is the first and only approved inhibitor of the lectin pathway of complement. YARTEMLEA inhibits mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway. In hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), MASP-2 inhibition prevents lectin pathway-mediated cellular injury, including endothelial damage in small blood vessels, and thrombus formation. By selectively blocking activation of the lectin pathway, YARTEMLEA preserves classical and alternative pathway activity, including functions essential to the adaptive immune response.


YARTEMLEA is approved by the U.S. FDA for the treatment of TA-TMA in adults and children ages two years and older. A marketing authorization application for YARTEMLEA for TA-TMA is under review by the European Medicines Agency (EMA) with a decision expected in mid-2026.


YARTEMLEA has received breakthrough therapy and orphan drug designations from the FDA for TA-TMA, and the EMA has granted it orphan drug designation in hematopoietic stem-cell transplantation.


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 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 aged two years and older. A marketing authorization application seeking approval of YARTEMLEA for TA-TMA is currently under review at the European Medicines Agency. OMS1029, Omeros’ long-acting MASP-2 inhibitor, has successfully completed Phase 1 clinical trials.


Under a recently announced 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 www.omeros.com.


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,” “target,” “will,” “would,” and similar expressions and variations thereof. Forward-looking statements, including statements regarding the marketing authorization application for YARTEMLEA® in Europe, prospects for obtaining EMA approval of YARTEMLEA in any indication, 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, 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 the YARTEMLEA MAA, inability to respond satisfactorily to information requests during regulatory review of the YARTEMLEA MAA, potential differences between the diagnostic criteria used in our pivotal trial and in the external registry, and whether the EMA determines the registry used in our statistical analysis is sufficiently representative of TA-TMA patients, 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. 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 because of new information, future events or otherwise, except as required by applicable law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260416836277/en/
Jennifer Cook Williams

Cook Williams Communications, Inc.

Investor and Media Relations

IR@omeros.com


Original: CMS Assigns Permanent Reimbursement J-Code for YARTEMLEA® (narsoplimab-wuug)

Omeros Corporation Reports Fourth Quarter and Year-End 2025 Financial ResultsMarch 31, 2026 4:02 PM
Business Wire
– Conference Call Today at 4:30 p.m. ET


Omeros Corporation (Nasdaq: OMER) today announced recent highlights and developments as well as financial results for the fourth quarter and year ended December 31, 2025, which include:



Net income for the fourth quarter of 2025 was $86.5 million, or $1.22 per share, compared to a net loss of $31.4 million, or $0.54 per share, for the fourth quarter of 2024. For the year ended December 31, 2025, net loss was $3.4 million, or $0.05 per share, compared to a net loss of $156.8 million, or $2.70 per share, in the prior year.



Fourth quarter results include a net gain of $237.6 million tied to the zaltenibart transaction with Novo Nordisk. The fourth quarter also includes a $136.0 million non-cash charge associated with the mark-to-market adjustment on the embedded derivatives related to our 2029 Notes and Term Loan. Excluding the non-cash charge associated with the embedded derivatives, non-GAAP adjusted net income for the three months and year ended December 31, 2025 was $222.5 million, or $3.14 per share, and $133.4 million, or $2.10 per share, respectively.



At December 31, 2025, we had $171.8 million of cash and short-term investments. We had $87.9 million in aggregate principal amount of debt at December 31, 2025, reflecting a decrease of $77.1 million, or 47%, compared to $164.9 million in aggregate principal amount of debt at December 31, 2024.



Fourth Quarter and Recent Highlights



On November 25, 2025, we closed the previously announced transaction with Novo Nordisk Health Care AG (“Novo Nordisk”). Pursuant to the Asset Purchase and License Agreement (“APLA”), Novo Nordisk received exclusive global rights in all indications to develop and commercialize zaltenibart (formerly OMS906), our lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-3 (“MASP-3”) and certain related antibodies and products. Omeros retains rights to its MASP-3 small-molecule program unrelated to zaltenibart, including the ability to develop and commercialize small-molecule MASP-3 inhibitors with limited restrictions on indications. Omeros also retains rights to its “grandfathered” MASP-3 antibodies, with temporal and indication restrictions on commercialization and for use in advancing its small-molecule therapeutics.
At closing, we received an upfront cash payment of $240.0 million. In addition, we are eligible to receive:




Up to $100.0 million in near-term milestone payments and an additional $410.0 million in one-time milestone payments upon the first achievement by Novo Nordisk or its affiliates or sublicensees of each of the development and approval milestone events as set forth in the APLA;



Up to $1.3 billion in one-time milestone payments upon the achievement by Novo Nordisk or its affiliates or sublicensees of certain sales-based and commercial milestone events; plus



Tiered royalties on annual global net sales of applicable products at rates ranging from a high single-digit to high-teens.




Omeros used a portion of the cash received at closing of the Novo Nordisk transaction to repay the entire $67.1 million principal amount outstanding under its senior secured term loan, along with a related prepayment premium, accrued and unpaid interest, and expenses. The prepayment resulted in the termination of the corresponding credit agreement and the release in full of all liens and covenants thereunder. Another portion of the cash was subsequently used to repay the remaining $17.1 million aggregate principal amount outstanding of our 2026 convertible notes at maturity in February 2026.



On December 23, 2025, the U.S. Food and Drug Administration (“FDA”) approved YARTEMLEA® (narsoplimab-wuug) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (“TA-TMA”) in adults and in children ages two years and older. YARTEMLEA is the first and only approved therapy for TA-TMA, an often-fatal complication of stem cell transplantation driven by activation of the lectin pathway of complement. YARTEMLEA selectively inhibits MASP-2, the effector enzyme of the lectin pathway, blocking pathway activation while preserving classical and alternative complement functions important for host defense against infection.



Commercial distribution and sales of YARTEMLEA began in January 2026. Both adult and pediatric patients with TA-TMA are now receiving YARTEMLEA, including patients who have recently failed prior off-label C5- and C3-inhibitor regimens, in both hospital and outpatient settings.



We are commercializing YARTEMLEA in the U.S. market and have deployed our field force of account managers and directors, market development managers, access leads, and medical science liaisons to engage directly with transplant centers across the United States.



A marketing authorization application (“MAA”) for YARTEMLEA for the treatment of TA-TMA is currently under review by EMA with a decision expected in mid-2026. If approved, the MAA authorizes the product to be marketed in all EU member states and European Economic Area countries.



“In the fourth quarter of 2025, Omeros delivered transformative achievements for our shareholders,” said Gregory A. Demopulos, M.D., Omeros’ Chairman and Chief Executive Officer. “Following FDA approval of YARTEMLEA with a broad label and no boxed warning, REMS, or required vaccinations, our commercial launch is well underway, and patients who urgently need the drug are now able to access it. Our partnership with Novo Nordisk expands the breadth of indications being pursued for zaltenibart and has provided — and should continue to provide — substantial operating capital while underscoring the value of our science. These successes are expected to fuel the development of a growing portfolio of commercial products from our robust pipeline as we target positive cash flow in 2027.”


Recent Developments



Recent developments in other programs include the following:




We were previously awarded a three-year, $6.24 million grant from the National Institute on Drug Abuse (“NIDA”), part of the National Institutes of Health, to develop, at NIDA’s request, our lead orally administered phosphodiesterase 7 (“PDE7”) inhibitor for the treatment of cocaine use disorder. The grant is intended to support (i) preclinical cocaine interaction/toxicology studies to assess safety of the therapeutic candidate in the presence of concomitant cocaine administration and (ii) an in-patient, placebo-controlled clinical study evaluating the safety and effectiveness of OMS527 in adult cocaine users who receive concurrent intravenous cocaine. The 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. FDA subsequently requested additional preclinical information prior to initiating the clinical in-patient study in cocaine users. Together with our collaborators at NIDA, we are scheduled to meet with FDA in the coming quarter to discuss that request.



We continue to progress preclinical studies within our novel oncology program, which is focused on developing novel, proprietary large-molecule therapeutics designed to selectively target and kill dividing cancer cells. The lead indication for development is acute myeloid leukemia (“AML”), an aggressive and highly fatal bone marrow and blood cancer. We have completed selection of a drug development candidate, and IND-enabling studies are underway for this program, which we refer to as OncotoX-AML.




OncotoX-AML shows broad application across AML regardless of genetic mutation, including TP53, NPM1, KMT2A, and FLT3, collectively found in approximately 90% of AML patients. In human tumor-bearing animal and in vitro human AML cell-line studies, our AML therapeutic candidate has demonstrated superior efficacy to current AML standard of care treatments.



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 demonstrated the desired pharmacologic response, specifically marked, selective, reversible, and dose-related reduction in myeloid progenitor cells — the cells that can mutate and lead to AML — by up to 99%. OncotoX-AML was well tolerated. There were no observed safety signals or meaningful changes in blood chemistry values.




Our Targeted Complement Activating Therapy (“T-CAT”) platform — a new class of recombinant antibodies designed to target and directly kill bacteria, fungi, viruses, and parasites — continues to amass animal data across multiple pathogen classes and species. Our initial focus is on multidrug-resistant organisms (“MDROs”), widely recognized as one of the most critical unmet needs in medicine. In well-established in vivo animal models considered predictive of efficacy in humans, T-CAT recombinant antibodies demonstrated effectiveness in treating life-threatening infections caused by Gram-negative and Gram-positive bacteria, including those designated by the World Health Organization as priority pathogens. A publication on our T-CAT platform is expected in the coming weeks.



Financial Results


During the fourth quarter, we recognized $237.6 million in net proceeds from the sale of zaltenibart to Novo Nordisk. This represents $240.0 million in upfront cash from Novo Nordisk net of transaction related costs of $2.4 million.


With funds received from Novo Nordisk, we fully repaid $67.1 million in principal outstanding under our senior secured credit agreement in November 2025.


At December 31, 2025, we had $171.8 million of cash and short-term investments. We used available cash on hand to repay the remaining $17.1 million aggregate principal amount outstanding of our 2026 convertible notes at maturity in February 2026.


We had $87.9 million in aggregate principal amount of debt at December 31, 2025, reflecting a decrease of $77.1 million, or 46.7%, compared to $164.9 million in aggregate principal amount of debt at December 31, 2024.


Net income for the fourth quarter of 2025 was $86.5 million, or $1.22 per share, compared to a net loss of $31.4 million, or $0.54 per share for the fourth quarter of 2024. For the year ended December 31, 2025, our net loss was $3.4 million, or $0.05 per share, compared to a net loss of $156.8 million, or $2.70 per share in the prior year.


The change in fair value of financial instruments as shown in our statement of operations and comprehensive loss reflects marking to market the embedded derivative on our 2029 Notes under GAAP. Excluding the net loss on change in fair value of financial instruments which is non-cash, our non-GAAP adjusted net income for the three months and year ended December 31, 2025 was $222.5 million, or $3.14 per share, and $133.4 million, or $2.10 per share, respectively.


For the fourth quarter of 2025, we earned OMIDRIA royalties of $9.2 million from Rayner Surgical Inc. on U.S. net sales of $30.7 million. This compares to earned OMIDRIA royalties of $10.1 million during the fourth quarter of 2024 on U.S. net sales of $33.6 million. Per the terms of our original 2022 and amended 2024 agreements with DRI Health Acquisition LP, (“DRI”), all U.S.-based royalties through 2031 are remitted from Rayner to DRI through an escrow agent.


Total operating expenses for the year ended December 31, 2025 were $122.8 million compared to $167.0 million for the year ended December 31, 2024. The $44.2 million decrease was primarily due to timing of manufacturing batches, as Omeros released approximately $21.9 million of drug substance in the prior year as well as completed work on the Phase 1 OMS1029 and IgA nephropathy studies. In addition, we reduced expenditures on certain activities in the current year to conserve capital in anticipation of our expected commercial launch of YARTEMLEA.


Interest expense decreased $25.6 million in 2025 compared to 2024. The decrease primarily relates to a $27.8 million change in non-cash remeasurement costs on the OMIDRIA royalty obligation to reflect a change in forecasted OMIDRIA cash flows from Rayner. Excluding any non-cash remeasurement adjustments of the DRI royalty obligation and any amortization of debt discount, premium, or issuance costs, contractual interest expense remained relatively unchanged from the prior year.


Interest and other income was $4.1 million in 2025 compared to $11.3 million in 2024. The difference is primarily due to lower average cash and investments balances available to invest in the current year.


Net income from discontinued operations, net of tax, was $1.5 million, or $0.02 net income per share, in 2025 compared to net income from discontinued operations, net of tax of $25.8 million, or $0.44 net income per share, in 2024. The decrease was primarily attributable to non-cash remeasurements.


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 https://events.q4inc.com/attendee/106692151 or go to Omeros’ website at https://investor.omeros.com/upcoming-events.


A replay of the call will be made accessible online for 90 days at https://investor.omeros.com/archived-events.


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 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 aged two years and older. A marketing authorization application seeking approval of YARTEMLEA for TA-TMA is currently under review at the European Medicines Agency. OMS1029, Omeros’ long-acting MASP-2 inhibitor, has successfully completed Phase 1 clinical trials.


Under a recently announced 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 www.omeros.com.


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, expectations regarding our marketing authorization application for YARTEMLEA® in Europe, plans and expectations regarding the commercial launch of YARTEMLEA in the U.S., and in the EU following any EMA approval, 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 inability to respond satisfactorily to information requests during regulatory review of the thereof, 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. 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 and use the non-GAAP financial measure of Adjusted Net Loss which represents net loss adjusted to remove the non-cash remeasurement on the fair value of financial instruments. We believe Adjusted Net Loss and Adjusted Net Loss from Continuing Operations to be a more accurate measure in gauging the Company’s performance because it excludes the fluctuation in the fair value of Omeros’ embedded derivatives. These are 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 CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)




(In thousands, except share and per share data)








 






 






 






 






 








 






 






Three Months Ended






 






Twelve Months Ended








 






 






December 31,






 






December 31,








 






 






2025






 






2024






 






2025






 






2024








 






 






 






 






 






 






 






 






 








Costs and expenses:






 






 






 






 






 






 






 






 






 






 








Research and development






 






$






19,446






 






 






$






23,320






 






 






$






81,296






 






 






$






119,523






 








Selling, general and administrative






 






 






9,635






 






 






 






10,035






 






 






 






41,500






 






 






 






47,430






 








Total costs and expenses






 






 






29,081






 






 






 






33,355






 






 






 






122,796






 






 






 






166,953






 








Loss from operations






 






 






(29,081






)






 






 






(33,355






)






 






 






(122,796






)






 






 






(166,953






)








Gain on sale of zaltenibart






 






 






237,594






 






 






 






—






 






 






 






237,594






 






 






 






—






 








Gain on early extinguishment of term debt, net






 






 






17,035






 






 






 






—






 






 






 






17,035






 






 






 






—






 








Loss on early extinguishment of 2026 Notes






 






 






—






 






 






 






—






 






 






 






(2,968






)






 






 






—






 








Interest and other income






 






 






1,118






 






 






 






2,296






 






 






 






4,096






 






 






 






11,285






 








Interest expense, net of remeasurement adjustments and other






 






 






(8,726






)






 






 






(3,177






)






 






 






960






 






 






 






(24,675






)








Gain (loss) on change in fair value of financial instruments, net






 






 






(136,038






)






 






 






—






 






 






 






(136,717






)






 






 






19






 








Loss from continuing operations before income tax expense






 






 






81,902






 






 






 






(34,236






)






 






 






(2,796






)






 






 






(180,324






)








Income tax expense






 






 






(2,012






)






 






 






(2,305






)






 






 






(2,012






)






 






 






(2,305






)








Net loss from continuing operations, net of tax






 






 






79,890






 






 






 






(36,541






)






 






 






(4,808






)






 






 






(182,629






)








Net income from discontinued operations, net of tax






 






 






6,561






 






 






 






5,183






 






 






 






1,458






 






 






 






25,814






 








Net income (loss)






 






$






86,451






 






 






$






(31,358






)






 






$






(3,350






)






 






$






(156,815






)








 






 






 






 






 






 






 






 






 








Basic net income (loss) per share:






 






 






 






 






 






 






 






 








Net income (loss) from continuing operations






 






$






1.13






 






 






$






(0.63






)






 






$






(0.08






)






 






$






(3.14






)








Net income from discontinued operations






 






 






0.09






 






 






 






0.09






 






 






 






0.03






 






 






 






0.44






 








Net income (loss)






 






$






1.22






 






 






$






(0.54






)






 






$






(0.05






)






 






$






(2.70






)








 






 






 






 






 






 






 






 






 








Diluted net income (loss) per share:






 






 






 






 






 






 






 






 








Net income (loss) from continuing operations






 






$






0.90






 






 






$






(0.63






)






 






$






(0.08






)






 






$






(3.14






)








Net income from discontinued operations






 






 






0.08






 






 






 






0.09






 






 






 






0.03






 






 






 






0.44






 








Net income (loss)






 






$






0.98






 






 






$






(0.54






)






 






$






(0.05






)






 






$






(2.70






)








 






 






 






 






 






 






 






 






 








Weighted-average shares used in per share computation:






 






 






 






 






 






 






 






 








Basic






 






 






70,829,424






 






 






 






57,987,961






 






 






 






63,510,201






 






 






 






58,170,931






 








Diluted






 






 






88,475,735






 






 






 






57,987,961






 






 






 






63,510,201






 






 






 






58,170,931






 









OMEROS CORPORATION




UNAUDITED CONSOLIDATED BALANCE SHEETS




(In thousands)








 






 






 






 






 








 






 






December 31,






 






December 31,








 






 






2025






 






2024








Assets






 






 






 






 








Current assets:






 






 






 






 








Cash and cash equivalents






 






$






9,660






 






 






$






3,400






 








Short-term investments






 






 






162,144






 






 






 






86,732






 








OMIDRIA contract royalty asset, short-term






 






 






25,351






 






 






 






29,083






 








Receivables






 






 






10,917






 






 






 






7,739






 








Prepaid expense and other assets






 






 






7,595






 






 






 






7,166






 








Total current assets






 






 






215,667






 






 






 






134,120






 








OMIDRIA contract royalty asset






 






 






96,435






 






 






 






124,266






 








Right of use assets






 






 






10,708






 






 






 






14,961






 








Property and equipment, net






 






 






1,768






 






 






 






2,678






 








Restricted investments






 






 






1,054






 






 






 






1,054






 








Total assets






 






$






325,632






 






 






$






277,079






 








 






 






 






 






 








Liabilities and shareholders’ equity/(deficit)






 






 






 






 






 






 








Current liabilities:






 






 






 






 






 






 








Accounts payable






 






$






4,764






 






 






$






5,905






 








Accrued expenses






 






 






29,388






 






 






 






26,005






 








OMIDRIA royalty obligation






 






 






20,547






 






 






 






20,645






 








2026 Notes, net






 






 






17,063






 






 






 






—






 








Term debt






 






 






—






 






 






 






21,000






 








Lease liabilities






 






 






6,300






 






 






 






5,971






 








Total current liabilities






 






 






78,062






 






 






 






79,526






 








OMIDRIA royalty obligation, non-current






 






 






147,319






 






 






 






195,612






 








2026 and 2029 Notes, non-current, net






 






 






51,364






 






 






 






97,178






 








2029 Notes embedded derivative, non-current






 






 






157,171






 






 






 






—






 








Term debt, non-current, net






 






 






—






 






 






 






69,640






 








Term debt, embedded derivative, non-current






 






 






—






 






 






 






(235






)








Lease liabilities, non-current






 






 






7,245






 






 






 






13,466






 








Other accrued liabilities, non-current






 






 






5,702






 






 






 






4,501






 








Shareholders’ equity/(deficit):






 






 






 






 






 






 








Common stock and additional paid-in capital






 






 






792,464






 






 






 






727,736






 








Accumulated deficit






 






 






(913,695






)






 






 






(910,345






)








Total shareholders’ equity (deficit)






 






 






(121,231






)






 






 






(182,609






)








Total liabilities and shareholders’ equity (deficit)






 






$






325,632






 






 






$






277,079






 









OMEROS CORPORATION




UNAUDITED SCHEDULE OF INTEREST EXPENSE, NET OF REMEASUREMENT ADJUSTMENTS AND OTHER




(In thousands)








 






 






 






 






 








 






 






Three Months Ended






 






Twelve Months Ended








 






 






December 31,






 






December 31,








 






 






2025






 






2024






 






2025






 






2024








 






 






(In thousands)








OMIDRIA royalty obligation






 






 






 






 






 






 






 






 






 






 






 






 








Pass through interest remitted to administrative agent






 






$






4,121






 






 






$






5,403






 






 






$






19,166






 






 






$






20,634






 








Non-cash remeasurement adjustment






 






 






736






 






 






 






(4,061






)






 






 






(33,435






)






 






 






(5,614






)








Interest expense, net of remeasurement on OMIDRIA royalty obligation






 






 






4,857






 






 






 






1,342






 






 






 






(14,269






)






 






 






15,020






 








 






 






 






 






 






 






 






 






 






 






 






 






 








2026 Notes






 






 






 






 






 






 






 






 






 






 






 






 








Contractual interest expense






 






 






224






 






 






 






1,284






 






 






 






2,547






 






 






 






7,772






 








Amortization of debt discount and issuance costs






 






 






27






 






 






 






146






 






 






 






287






 






 






 






859






 








Interest expense on 2026 Notes






 






 






251






 






 






 






1,430






 






 






 






2,834






 






 






 






8,631






 








 






 






 






 






 






 






 






 






 






 






 






 






 








Term Loan






 






 






 






 






 






 






 






 






 






 






 






 








Contractual interest expense






 






 






1,299






 






 






 






2,378






 






 






 






8,021






 






 






 






5,525






 








Amortization of debt premium and issuance costs






 






 






(852






)






 






 






(2,022






)






 






 






(5,578






)






 






 






(4,681






)








Interest expense on Term Loan






 






 






447






 






 






 






356






 






 






 






2,443






 






 






 






844






 








 






 






 






 






 






 






 






 






 






 






 






 






 








2029 Notes






 






 






 






 






 






 






 






 






 






 






 






 








Contractual interest expense






 






 






1,681






 






 






 






—






 






 






 






4,220






 






 






 






—






 








Amortization of debt discount and issuance costs






 






 






1,452






 






 






 






—






 






 






 






3,658






 






 






 






—






 








Interest expense on 2029 Notes






 






 






3,133






 






 






 






—






 






 






 






7,878






 






 






 






—






 








 






 






 






 






 






 






 






 






 






 






 






 






 








Finance leases and other






 






 






38






 






 






 






49






 






 






 






154






 






 






 






180






 








 






 






 






 






 






 






 






 






 






 






 






 






 








Total interest expense, net of remeasurement adjustments and other






 






$






8,726






 






 






$






3,177






 






 






$






(960






)






 






$






24,675






 









OMEROS CORPORATION




UNAUDITED GAAP TO NONGAAP RECONCILIATION




(In thousands)








 






 






 






 






 








 






 






Three Months Ended






 






Twelve Months Ended








 






 






December 31, 2025








Reconciliation of GAAP net income (loss) to Non-GAAP adjusted net income






 






 






 






 






 






 








 






 






 






 






 






 






 








Numerator (in thousands)






 






 






 






 






 






 








Net income (loss)






 






$






86,451






 






$






(3,350






)








Less: remeasurement of fair value of financial instruments






 






 






136,038






 






 






136,717






 








 






 






 






 






 






 






 








Non-GAAP adjusted net income






 






$






222,489






 






$






133,367






 








 






 






 






 






 






 






 








Denominator (in shares)






 






 






 






 






 






 








Basic weighted average shares






 






 






70,829,424






 






 






63,510,201






 








 






 






 






 






 






 






 








Net income (loss) per share basic






 






$






1.22






 






$






(0.05






)








 






 






 






 






 






 






 








Non-GAAP adjusted net income per share basic






 






$






3.14






 






$






2.10






 







 

View source version on businesswire.com: https://www.businesswire.com/news/home/20260331858919/en/
Jennifer Cook Williams

Cook Williams Communications, Inc.

Investor and Media Relations

IR@omeros.com


Original: Omeros Corporation Reports Fourth Quarter and Year-End 2025 Financial Results