Latest news with #Omeros
Business Wire
12-05-2025
- Business
- Business Wire
Omeros Corporation to Announce First Quarter Financial Results on May 15, 2025
SEATTLE--(BUSINESS WIRE)--Omeros Corporation (NASDAQ: OMER), today announced that the company will issue its financial results for the quarter ended March 31, 2025, on Thursday, May 15, 2025, after the market closes. Omeros management will host a conference call and webcast that same day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results as well as recent developments and highlights. Conference Call Details For online access to the live webcast of the conference call, go to Omeros' website at To access the live conference call via phone, participants must register at this link to receive a unique PIN. Once registered, you will have two options: (1) Dial in to the conference line provided at the registration site using the PIN provided to you, or (2) choose the 'Call Me' option, which will instantly dial the phone number you provide. Should you lose your PIN or registration confirmation email, simply re-register to receive a new PIN. A replay of the call will be made accessible online at About Omeros Corporation Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing first-in-class small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders, including complement-mediated diseases and cancers, as well as addictive and compulsive disorders. Omeros' lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application under review by FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Omeros' long-acting MASP-2 inhibitor OMS1029 has successfully completed Phase 1 single- and multiple-ascending dose clinical studies. Zaltenibart, Omeros' inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in clinical development for treatment of paroxysmal nocturnal hemoglobinuria and complement 3 glomerulopathy. Funded by the National Institute on Drug Abuse, Omeros' lead phosphodiesterase 7 inhibitor OMS527 is in clinical development for the treatment of cocaine use disorder. Omeros also is advancing a broad portfolio of novel cellular and molecular immuno-oncology programs. For more information about Omeros and its programs, visit
Yahoo
12-05-2025
- Business
- Yahoo
Omeros Corporation to Announce First Quarter Financial Results on May 15, 2025
SEATTLE, May 12, 2025--(BUSINESS WIRE)--Omeros Corporation (NASDAQ: OMER), today announced that the company will issue its financial results for the quarter ended March 31, 2025, on Thursday, May 15, 2025, after the market closes. Omeros management will host a conference call and webcast that same day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results as well as recent developments and highlights. Conference Call Details For online access to the live webcast of the conference call, go to Omeros' website at To access the live conference call via phone, participants must register at this link to receive a unique PIN. Once registered, you will have two options: (1) Dial in to the conference line provided at the registration site using the PIN provided to you, or (2) choose the "Call Me" option, which will instantly dial the phone number you provide. Should you lose your PIN or registration confirmation email, simply re-register to receive a new PIN. A replay of the call will be made accessible online at About Omeros Corporation Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing first-in-class small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders, including complement-mediated diseases and cancers, as well as addictive and compulsive disorders. Omeros' lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application under review by FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Omeros' long-acting MASP-2 inhibitor OMS1029 has successfully completed Phase 1 single- and multiple-ascending dose clinical studies. Zaltenibart, Omeros' inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in clinical development for treatment of paroxysmal nocturnal hemoglobinuria and complement 3 glomerulopathy. Funded by the National Institute on Drug Abuse, Omeros' lead phosphodiesterase 7 inhibitor OMS527 is in clinical development for the treatment of cocaine use disorder. Omeros also is advancing a broad portfolio of novel cellular and molecular immuno-oncology programs. For more information about Omeros and its programs, visit View source version on Contacts Jennifer Cook WilliamsCook Williams Communications, and Media RelationsIR@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
12-05-2025
- Business
- Yahoo
Omeros Corporation Announces Agreements to Acquire $80.5 Million of its Convertible Senior Notes Due 2026
SEATTLE, May 12, 2025--(BUSINESS WIRE)--Omeros Corporation (Nasdaq: OMER) ("Omeros" or the "Company") today announced that it has entered into exchange agreements (the "Exchange Agreements") with a limited number of investors who are holders of the Company's 5.25% Convertible Senior Notes due 2026 (the "2026 Convertible Notes") to exchange, on a one-for-one basis, $70.5 million aggregate principal amount of the 2026 Convertible Notes for newly issued 9.50% Convertible Senior Notes due 2029, with a conversion rate set at a 35% premium as described below (the "New Convertible Notes"). The exchange, which extends the maturity of a significant portion of the Company's outstanding indebtedness, is expected to close on or about May 14, 2025. In addition, Omeros today announced that it has entered into an agreement (the "Note Conversion Agreement") with an investor to convert $10 million aggregate principal amount of 2026 Convertible Notes into shares of the Company's common stock, par value $0.01 per share (the "Equitization Transaction"). Following the completion of these transactions, approximately $17.4 million aggregate principal amount of the 2026 Convertible Notes will remain outstanding. This reduction in principal balance of the 2026 Convertible Notes outstanding will prevent the Company from being required to make a $20.0 million prepayment of the term loan outstanding under its 2024 Credit and Guaranty Agreement. This prepayment otherwise would have become due in November 2025. As a result of these transactions, the Company expects that its outstanding debt will be reduced by $10.0 million and its potential debt repayment obligations over the next 12 months will be reduced from $117.9 million to approximately $17.4 million. The New Convertible Notes The New Convertible Notes will be senior, unsecured obligations of the Company. Interest will be payable semi-annually in arrears at a rate of 9.50% per annum on each June 15 and December 15, beginning on December 15, 2025. The New Convertible Notes will mature on June 15, 2029 unless earlier converted, redeemed or repurchased in accordance with their terms prior to such date. The New Convertible Notes will be convertible at the option of the holder into shares of common stock of the Company, cash or a combination of shares of common stock and cash. The initial conversion rate of the New Convertible Notes will be based on a premium of 35% above the higher of the volume-weighted average price ("VWAP") of the common stock on May 12, 2025, or $6.18, and is subject to adjustment in certain circumstances. Holders who convert their New Convertible Notes after six months will be entitled to an interest make-whole payment. In addition, holders will have the right to cause all New Convertible Notes then outstanding to be converted upon the occurrence of certain corporate events or in the event the New Convertible Notes are called for redemption. Subject to certain conditions, the Company may redeem the New Convertible Notes on or after June 20, 2027. In connection with the Exchange, the Company intends to enter into an indenture establishing the terms of the New Convertible Notes. The Equitization Transaction Under the terms of the Note Conversion Agreement, on each of three conversion dates, the holder of $10 million aggregate principal amount of 2026 Convertible Notes will convert approximately one-third of such principal amount in exchange for a number of shares of common stock based in part on the VWAP of the Company's common stock on May 12, 2025 and in part on the 20-day VWAP applicable to each conversion date, subject to a floor conversion price. The Company expects that the Equitization Transaction will be completed by September 15, 2025. This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities of the Company. The offer and sale of the New Convertible Notes, the shares of common stock issuable upon their conversion, and the shares issuable in the Equitization Transaction have not been registered under the Securities Act of 1933 (the "Securities Act") or the securities laws of any other jurisdiction, and these securities may not be offered or sold in the United States absent registration or an applicable exemption from the Securities Act and applicable state laws. Moelis & Company LLC and Cantor Fitzgerald & Co. are acting as the Company's financial advisors for the Exchange and Equitization Transaction. Covington & Burling LLP is acting as the Company's legal advisor. About Omeros Corporation Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing first-in-class small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders, including complement-mediated diseases and cancers, as well as addictive and compulsive disorders. Omeros' lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application under review by FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Omeros' long-acting MASP-2 inhibitor OMS1029 has successfully completed Phase 1 single- and multiple-ascending dose clinical studies. Zaltenibart, Omeros' inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in clinical development for treatment of paroxysmal nocturnal hemoglobinuria and complement 3 glomerulopathy. Funded by the National Institute on Drug Abuse, Omeros' lead phosphodiesterase 7 inhibitor OMS527 is in clinical development for the treatment of cocaine use disorder. Omeros also is advancing a broad portfolio of novel cellular and molecular immuno-oncology programs. 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, including statements regarding the anticipated closing of the Exchange and the Equitization Transaction and the anticipated impact of the reduction in the principal balance of 2026 Convertible Notes outstanding, including the reduction in potential debt repayment obligations. These forward-looking statements are often indicated by terms such as "aim," "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 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, 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, 2025, as amended on April 30, 2025. 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 Contacts Jennifer Cook WilliamsCook Williams Communications, and Media RelationsIR@
Business Wire
06-05-2025
- Business
- Business Wire
FDA Accepts Resubmission of BLA for Narsoplimab for Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy (TA-TMA) and Assigns Late September PDUFA Date
SEATTLE--(BUSINESS WIRE)--Omeros Corporation (Nasdaq: OMER) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). The resubmission was classified as a Class 2 resubmission and pursuant to the Prescription Drug User Fee Act (PDUFA) has been assigned a target action date for the FDA decision in late September 2025. The BLA resubmission includes the primary set of analyses comparing overall survival for narsoplimab-treated patients to overall survival for an external control group of TA-TMA patients. Results of those analyses showed clinically meaningful and statistically significant improvements in survival associated with narsoplimab treatment. Also included in the resubmission are data describing survival in Omeros' expanded access program in which adult and pediatric TA-TMA patients were treated with narsoplimab. Since resubmission of the BLA in late March, Omeros has received and is responding to information requests from FDA and expects an interactive review by FDA. Omeros is also preparing a marketing authorization application (MAA) for narsoplimab in TA-TMA, which is targeted for submission to the European Medicines Agency later this quarter. About Narsoplimab Narsoplimab, also known as 'OMS721,' is an investigational fully human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), a novel pro-inflammatory protein target and the effector enzyme of the lectin pathway of complement. Importantly, inhibition of MASP-2 has been demonstrated to leave intact the antibody-dependent classical complement activation pathway, which is a critical component of the acquired immune response to infection. A biologics license application (BLA) for use of narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) is under review by the U.S. Food and Drug Administration (FDA) and the corresponding European marketing authorisation application (MAA) is being prepared for submission. FDA has granted narsoplimab breakthrough therapy and orphan drug designations for TA-TMA and orphan drug status for the prevention (inhibition) of complement-mediated thrombotic microangiopathies. The European Medicines Agency has granted orphan drug designation to narsoplimab for treatment in hematopoietic stem-cell transplant. About Hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) Hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) is a significant and often lethal complication of stem cell transplantation. This condition is a systemic, multifactorial disorder caused by endothelial cell damage induced by conditioning regimens, immunosuppressant therapies, infection, graft-versus-host disease, and other factors associated with stem cell transplantation. Endothelial damage, which activates the lectin pathway of complement, plays a central role in the development of TA-TMA. The condition occurs in both autologous and allogeneic transplants but is more common in the allogeneic population. In the United States and Europe, approximately 30,000 allogeneic transplants are performed annually. Recent reports in both adult and pediatric allogeneic stem cell transplant populations have found an approximately 40-percent incidence of TA-TMA, and high-risk features may be present in up to 80 percent of these patients. In severe cases of TA-TMA, mortality can exceed 90 percent and, even in those who survive, long-term renal sequalae (e.g., dialysis) are common. There is no approved therapy or standard of care for TA-TMA. About Omeros Corporation Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing first-in-class small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders, including complement-mediated diseases and cancers, as well as addictive and compulsive disorders. Omeros' lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application under review by FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Omeros' long-acting MASP-2 inhibitor OMS1029 has successfully completed Phase 1 single- and multiple-ascending dose clinical studies. Zaltenibart, Omeros' inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in clinical development for treatment of paroxysmal nocturnal hemoglobinuria and complement 3 glomerulopathy. Funded by the National Institute on Drug Abuse, Omeros' lead phosphodiesterase 7 inhibitor OMS527 is in clinical development for the treatment of cocaine use disorder. Omeros also is advancing a broad portfolio of novel cellular and molecular immuno-oncology programs. 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 'aim,' '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 review process and timing of FDA action on the resubmitted BLA for narsoplimab in the United States, the anticipated submission of a marketing authorization application with the EMA and the timing thereof, the prospects for obtaining FDA or EMA approval of narsoplimab in any indication, and expectations regarding the sufficiency and availability of our capital resources to fund current and planned operations, including the potential commercialization of narsoplimab if it is approved by FDA or the EMA, 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 narsoplimab BLA , inability to respond satisfactorily to information requests during regulatory review of the narsoplimab BLA or MAA, potential differences between the diagnostic criteria used in our pivotal trial and in the external registry, and whether FDA and the EMA determine 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 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 April 1, 2024.. 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.
Yahoo
26-03-2025
- Business
- Yahoo
Omeros Corporation to Announce Fourth Quarter and Year-end Financial Results on March 31, 2025
SEATTLE, March 26, 2025--(BUSINESS WIRE)--Omeros Corporation (NASDAQ: OMER), today announced that the company will issue its financial results for the quarter and year ended December 31, 2024, on Monday, March 31, 2025, after the market closes. Omeros management will host a conference call and webcast that same day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results as well as recent developments and highlights. Conference Call Details For online access to the live webcast of the conference call, go to Omeros' website at To access the live conference call via phone, participants must register at this link to receive a unique PIN. Once registered, you will have two options: (1) Dial in to the conference line provided at the registration site using the PIN provided to you, or (2) choose the "Call Me" option, which will instantly dial the phone number you provide. Should you lose your PIN or registration confirmation email, simply re-register to receive a new PIN. A replay of the call will be made accessible online at About Omeros Corporation Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing first-in-class small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders, including complement-mediated diseases and cancers, as well as addictive and compulsive disorders. Omeros' lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application pending before FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Omeros' long-acting MASP-2 inhibitor OMS1029 has successfully completed Phase 1 single- and multiple-ascending dose clinical studies. Zaltenibart, Omeros' inhibitor of MASP-3, the key activator of the alternative pathway of complement, is advancing toward Phase 3 clinical trials for paroxysmal nocturnal hemoglobinuria and complement 3 glomerulopathy. Funded by the National Institute on Drug Abuse, Omeros' lead phosphodiesterase 7 inhibitor OMS527 is in clinical development for the treatment of cocaine use disorder. Omeros also is advancing a broad portfolio of novel cellular and molecular immuno-oncology programs. For more information about Omeros and its programs, visit View source version on Contacts Jennifer Cook WilliamsCook Williams Communications, and Media RelationsIR@ Sign in to access your portfolio
