OMER Omeros Corporation

18.23
+0.52  (+3%)
Previous Close 17.71
Open 17.63
52 Week Low 9.25
52 Week High 25.46
Market Cap $1,129,053,283
Shares 61,933,806
Float 59,218,258
Enterprise Value $1,230,734,704
Volume 327,459
Av. Daily Volume 740,110
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Upcoming Catalysts

Drug Stage Catalyst Date
OMS906
MASP-3 inhibitor
Phase 1
Phase 1
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Narsoplimab
Hematopoietic stem cell-associated TMA (HSCT-TMA)
PDUFA priority review
PDUFA priority review
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Drug Pipeline

Drug Stage Notes
Narsoplimab (I-SPY COVID-19)
COVID-19
Phase 2
Phase 2
Phase 2 initiation of dosing announced March 23, 2021.
Narsoplimab
IgA nephropathy
Phase 3
Phase 3
Phase 3 trial ongoing.
Narsoplimab
Atypical hemolytic uremic syndrome (aHUS)
Phase 3
Phase 3
Phase 3 trial ongoing.
OMS527
Nicotine Addiction
Phase 1
Phase 1
Phase 1 data September 16, 2019 noted treatment was safe and well-tolerated.
Omidria
Cataract surgery
Approved
Approved
Approved June 2, 2014.

Latest News

  1. -- Adaptive Platform Trial is Evaluating Drugs and Investigational Products in the Treatment of Critically Ill COVID-19 Patients --

    Omeros Corporation (NASDAQ:OMER) and Quantum Leap Healthcare Collaborative announced that dosing of patients with narsoplimab in the I-SPY COVID-19 Trial began earlier this month. The I-SPY COVID-19 Trial is an adaptive platform trial sponsored by Quantum Leap Healthcare Collaborative. The goal of the trial is to screen rapidly, in parallel, multiple promising agents in order to identify drugs that will have a high impact on reducing mortality and avoid or reduce the duration of mechanical ventilation for critically ill COVID-19 patients.

    "We're excited that narsoplimab is one of the agents that has entered the…

    -- Adaptive Platform Trial is Evaluating Drugs and Investigational Products in the Treatment of Critically Ill COVID-19 Patients --

    Omeros Corporation (NASDAQ:OMER) and Quantum Leap Healthcare Collaborative announced that dosing of patients with narsoplimab in the I-SPY COVID-19 Trial began earlier this month. The I-SPY COVID-19 Trial is an adaptive platform trial sponsored by Quantum Leap Healthcare Collaborative. The goal of the trial is to screen rapidly, in parallel, multiple promising agents in order to identify drugs that will have a high impact on reducing mortality and avoid or reduce the duration of mechanical ventilation for critically ill COVID-19 patients.

    "We're excited that narsoplimab is one of the agents that has entered the I-SPY COVID-19 Trial," said Laura Esserman, MD, MBA, co-founder of Quantum Leap Healthcare Collaborative, Principal Investigator of the I-SPY trial program, and Professor of Surgery and Radiology at the University of California – San Francisco. "The mechanism of action, specifically targeting endothelial injury, along with its safety profile and initial data generated in critically ill COVID-19 patients make a compelling case for this agent. The pulmonary and critical care investigators leading the I-SPY COVID Trial uniformly endorsed narsoplimab and made it a high-priority candidate for the trial. Together, we will be able to generate data on the ability of the agent to reduce the time to recovery and lower mortality."

    Narsoplimab is Omeros' lead antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of complement. It is the only complement inhibitor invited to participate in the I-SPY COVID-19 Trial. Narsoplimab has been administered under compassionate use to treat severely ill COVID-19 patients requiring mechanical ventilation, with impressive outcomes.

    "Omeros is pleased to be working with Quantum Leap Healthcare Collaborative in this important effort," said Gregory Demopulos, MD, Omeros' chairman and chief executive officer. "With the multiple variants of SARS-CoV-2 already spreading globally, it is clear that vaccines alone likely will not be sufficient. Drs. Esserman, Calfee, and Liu and their team have established an innovative, efficient and rapidly enrolling platform trial to help identify treatments that can be useful in the fight against COVID-19, and we look forward to learning the outcomes of I-SPY study patients treated with narsoplimab."

    About Omeros Corporation

    Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. Its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3% continues to gain market share in cataract surgery. Omeros' lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application under priority review by FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19. Omeros' MASP-3 inhibitor OMS906, which targets the complement system's alternative pathway, recently entered the clinic, and the company's PDE7 inhibitor OMS527 has successfully completed its Phase 1 trial. Omeros' pipeline holds a diverse group of preclinical programs including a novel antibody-generating technology and a proprietary GPCR platform through which it controls 54 new GPCR drug targets and their corresponding compounds. One of these novel targets, GPR174, modulates a new cancer immunity axis recently discovered by Omeros, and the company is advancing small-molecule GPR174 inhibitors. For more information about Omeros and its programs, visit www.omeros.com.

    About Narsoplimab

    Narsoplimab, also known as "OMS721," is an investigational 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 does not appear to interfere with the antibody-dependent classical complement activation pathway, which is a critical component of the acquired immune response to infection. Omeros controls the worldwide rights to MASP-2 and all therapeutics targeting MASP-2.

    A biologics license application (BLA) is under priority review by the U.S. FDA for use of narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), and the drug is in Phase 3 clinical programs for immunoglobulin A (IgA) nephropathy and atypical hemolytic uremic syndrome (aHUS). The FDA has granted narsoplimab breakthrough therapy designations for HSCT-TMA and for IgA nephropathy; orphan drug status for the prevention (inhibition) of complement-mediated thrombotic microangiopathies, for the treatment of HSCT-TMA and for the treatment of IgA nephropathy; and fast track designation for the treatment of patients with aHUS. The European Medicines Agency has granted orphan drug designation to narsoplimab for treatment in HSCT and for treatment of primary IgA nephropathy.

    About the I-SPY TRIALS

    The I-SPY 2 TRIAL for stage II and III breast cancer is the longest running and most successful adaptive platform trial in oncology. Quantum Leap was able to use the existing I-SPY 2 TRIAL infrastructure methodology to develop the I-SPY COVID Trial (Investigation of Serial studies to Predict Your COVID Therapeutic Response with biomarker Integration and Adaptive Learning). The I-SPY COVID Trial is designed to rapidly screen promising experimental treatments, and re-purpose existing agents to identify the most effective treatments for severely ill COVID-19 patients. The trial is a unique collaborative effort by a consortium that includes the U.S. Food and Drug Administration (FDA), industry, patient advocates, philanthropic donors, and clinicians from multiple major U.S. research centers. Under the terms of the collaboration agreement, Quantum Leap Healthcare Collaborative is the trial sponsor and manages all study operations. For more information, visit www.quantumleaphealth.org and www.ispytrials.org.

    About Quantum Leap Healthcare Collaborative

    Quantum Leap Healthcare Collaborative (Quantum Leap) is a 501c(3) charitable organization established in 2005 as a collaboration between medical researchers at University of California, San Francisco and Silicon Valley entrepreneurs. Our mission is to integrate high-impact research with clinical processes and systems technology, resulting in improved data management and information systems, greater access to clinical trial matching and sponsorship, and greater benefit to providers, patients, and researchers. Quantum Leap provides operational, financial, and regulatory oversight to all I-SPY Trials. For more information, visit www.quantumleaphealth.org.

    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," "can," "could," "estimate," "expect," "goal," "intend," "likely", "look forward to," "may," "on track," "plan," "potential," "predict," "project," "prospects," "scheduled," "should," "slated," "targeting," "will," "would" and similar expressions and variations thereof. Forward-looking statements, including statements regarding anticipated regulatory submissions, the timing and results of ongoing or anticipated clinical trials, and the therapeutic application of Omeros' investigational product, 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, risks associated with product commercialization and commercial operations, unproven preclinical and clinical development activities, the impact of COVID-19 on our business, financial condition and results of operations, regulatory oversight, 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 the company's Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 1, 2021, as supplemented by our Quarterly Reports on Form 10-Q filed with the SEC and subsequent filings with the SEC. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the company assumes 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.

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  2. – Conference Call Today at 4:30 p.m. ET –

    Omeros Corporation (NASDAQ:OMER), a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers, today announced recent highlights and developments as well as financial results for the fourth quarter and year ended December 31, 2020, which include:

    • Revenues for the fourth quarter of 2020 were $10.6 million compared to $26.1 million in the third quarter of 2020. The decrease from the prior period is primarily due to the expiration, on…

    – Conference Call Today at 4:30 p.m. ET –

    Omeros Corporation (NASDAQ:OMER), a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers, today announced recent highlights and developments as well as financial results for the fourth quarter and year ended December 31, 2020, which include:

    • Revenues for the fourth quarter of 2020 were $10.6 million compared to $26.1 million in the third quarter of 2020. The decrease from the prior period is primarily due to the expiration, on October 1, 2020, of pass-through reimbursement for OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1%/0.3%. In December, the Centers for Medicare and Medicaid Services (CMS) confirmed that OMIDRIA qualifies for separate payment, effective retroactively as of October 1, 2020, when used in the ASC setting under its policy for non-opioid pain management surgical drugs.
    • Full year 2020 OMIDRIA revenues were $73.8 million, compared to $111.8 million in the prior year. The decrease was due to the reduction in cataract surgeries performed as a result of the COVID-19 pandemic and uncertainty regarding Medicare Part B reimbursement for OMIDRIA after its pass-through status expired on October 1, 2020.
    • At December 31, 2020, the company had cash, cash equivalents and short-term investments available for operations of $135.0 million.
    • Omeros' Biologics License Application (BLA) for narsoplimab was accepted and granted priority review by the U.S. Food and Drug Administration (FDA) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA or TA-TMA). The Prescription Drug User Fee Act (PDUFA) date is July 17, 2021.
    • Narsoplimab entered the I-SPY COVID-19 platform trial sponsored by Quantum Leap Healthcare Collaborative, which is evaluating drugs and investigational products for the treatment of critically ill COVID-19 patients. Narsoplimab is the only complement inhibitor invited to participate in this trial.
    • Initial data are expected next quarter from the Phase 1 clinical trial evaluating the pharmacokinetics, pharmacodynamics, safety and tolerability of OMS906, the company's inhibitor of MASP-3, the key activator of the alternative pathway of complement.

    "2020 was a challenging year for everyone, but our team's list of accomplishments is impressive – submission of the BLA for transplant-associated TMA and life-saving treatment of critically ill COVID-19 patients with narsoplimab, reinstatement of separate payment for our ophthalmic product OMIDRIA, entry into the clinic for our MASP-3 inhibitor OMS906, and the addition of substantial working capital to our balance sheet," said Gregory A. Demopulos, M.D., Omeros' chairman and chief executive officer. "As we entered the new year, the team maintained its momentum, continuing to build on these achievements. The BLA was granted priority review and our commercial launch plan is on track to bring narsoplimab to patients as soon as we receive approval. The only complement inhibitor in the I-SPY COVID-19 trial, narsoplimab is the focus of growing attention from international government agencies and global organizations in the fight against COVID, and we are advancing the drug across IgA nephropathy, aHUS and an expanding set of indications. Once again secured, OMIDRIA revenues are increasing and will continue to provide working capital to fund our pipeline, including OMS906, which remains on schedule to read out initial data next quarter, and the rest of our programs. 2021 has started strong, and we expect that it will finish even stronger."

    Fourth Quarter and Recent Developments

    • Narsoplimab is Omeros' lead antibody targeting MASP-2 to inhibit activation of the lectin pathway of complement and is under review by FDA for the treatment of TA-TMA and is in Phase 3 clinical programs in immunoglobulin A (IgA) nephropathy, atypical hemolytic uremic syndrome (aHUS) and critically ill COVID-19 patients. Recent narsoplimab-related developments include the following:
      • FDA accepted and granted priority review to the BLA for narsoplimab for the treatment of TA-TMA and set a PDUFA date of July 17, 2021. FDA also indicated in its filing letter that FDA is not currently planning to hold an advisory committee meeting to discuss the BLA. Priority review is granted to applications for therapies that, if approved, would be significant improvements in the safety or effectiveness of the treatment, prevention or diagnosis of serious conditions.
      • Omeros completed the application for a New Technology Add-On Payment (NTAP) for narsoplimab, which, if granted, would provide for special payment to hospitals for narsoplimab when administered in the hospital inpatient setting. The NTAP interim rule is expected in the second quarter of 2021. As part of our reimbursement efforts, we applied, and received preliminary support from CMS, for ICD-10 procedural and diagnostic codes in connection with the use of narsoplimab in the treatment of TA-TMA.
      • At the 2020 American Society of Hematology Annual Meeting, Omeros made a presentation directed to the pharmacodynamics of narsoplimab in humans and primates, which subsequently was published in the peer-reviewed journal Blood.
      • Omeros also had a significant presence at the 2021 Annual Meeting of the American Society of Transplantation and Cellular Therapy in February, including a podium presentation by Dr. Samer Khaled of City of Hope on the pivotal clinical trial results with narsoplimab in TA-TMA.
      • Narsoplimab entered the I-SPY COVID-19 platform trial, which is evaluating drugs and investigational products for the treatment of critically ill COVID-19 patients. Narsoplimab is the only complement inhibitor invited to participate in this trial. The trial utilizes Quantum Leap Healthcare Collaborative's adaptive platform trial design, which is intended to increase trial efficiency by minimizing the number of participants and time required to evaluate potential treatments.
      • Omeros has continued treating COVID-19 patients with narsoplimab under compassionate use – to date, nine more in Bergamo, Italy and four in the U.S. All of these patients prior to receiving narsoplimab were severely ill, intubated, had multiple comorbidities, and had failed other therapies, including anti-virals, targeted anti-inflammatory therapeutics, convalescent plasma and steroids. Following treatment with narsoplimab, the laboratory improvements and clinical outcomes of these patients are consistent with those seen in the initial cohort of Bergamo patients and published in Immunobiology. A manuscript detailing the findings and clinical outcomes of the second cohort of patients is in preparation.
    • Recent developments regarding Omeros' ophthalmic drug OMIDRIA include the following:
      • In December 2020, CMS confirmed that OMIDRIA qualifies for separate payment in the ASC setting under its policy for non-opioid pain management surgical drugs, effective retroactively from October 1, 2020, when pass-through reimbursement for OMIDRIA expired.
      • A new study showing that OMIDRIA significantly decreases retinal thickness and macular edema caused by cataract surgery has been selected for a podium presentation at the 2021 Congress of American Society of Cataract and Refractive Surgery in August. This study further confirms previously published clinical data showing that OMIDRIA significantly reduces the incidence of sight-threatening cystoid macular edema while precluding the need for perioperative steroids.
    • Updates regarding Omeros' other development programs and platforms include the following:
      • Initial data are expected next quarter from the Phase 1 clinical trial evaluating OMS906, the company's inhibitor of MASP-3, the key activator of the alternative pathway of complement. The placebo-controlled, double-blind, single-ascending-dose and multiple-ascending-dose trial is assessing the pharmacokinetics, pharmacodynamics, safety and tolerability of OMS906. Omeros has completed all of the intravenous dosing cohorts in the single ascending dose study and expects to begin subcutaneous dosing this month.

    Financial Results

    Fourth Quarter 2020

    For the fourth quarter of 2020, OMIDRIA revenues were $10.6 million. This compares to OMIDRIA revenues of $26.1 million for the third quarter of 2020. The decrease was primarily due to the expiration of pass-through reimbursement for OMIDRIA on October 1, 2020 and the uncertainty around separate payment for OMIDRIA until CMS confirmed in December that OMIDRIA qualifies for separate payment when used in the ASC setting under CMS' policy for non-opioid pain management surgical drugs.

    Total costs and expenses for the fourth quarter of 2020 were $44.4 million, compared to $51.5 million in the preceding quarter. The decrease was primarily due to a technology license payment related to the OMS906 program in that earlier quarter.

    For the three months ended December 31, 2020, Omeros reported a net loss of $37.3 million, or $0.60 per share, which included non-cash expenses of $3.5 million, or $0.06 per share. This compares to the prior year fourth quarter, when Omeros reported a net loss of $29.2 million or $0.58 per share, which included non-cash expenses of $6.3 million, or $0.12 per share.

    As of December 31, 2020, Omeros had $135.0 million of cash, cash equivalents and short-term investments available for operations.

    Full Year 2020

    Revenues for 2020 were $73.8 million compared to $111.8 million for 2019. The decrease was due to the reduction in cataract surgeries performed due to the COVID-19 pandemic and the uncertainty regarding Medicare Part B reimbursement for OMIDRIA after its pass-through status expired on October 1, 2020. In December 2020, CMS confirmed separate payment for OMIDRIA in the ASC setting effective retroactively as of October 1.

    For the year ending December 31, 2020, total costs and expenses were $184.4 million, compared to $175.2 million in the prior year.

    Conference Call Details

    Omeros' management will host a conference call to discuss the financial results and to provide an update on business activities. The call will be held today at 4:30 p.m. Pacific Time; 1:30 p.m. Eastern Time. To access the live conference call via phone, please dial (844) 831-4029 from the United States and Canada or (920) 663-6278 internationally. The participant passcode is 3399452. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week following the call and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 3399452.

    To access the live or subsequently archived webcast of the conference call on the internet, go to the company's website at www.omeros.com and select "Events" under the Investors section of the website. To access the live webcast, please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.

    About Omeros Corporation

    Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. Its commercial product OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1%/0.3% continues to gain market share in cataract surgery. Omeros' lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application under priority review by FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19. OMS906, Omeros' inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in a Phase 1 clinical trial, and the company's PDE7 inhibitor program OMS527, targeting addiction and movement disorders, has successfully completed a Phase 1 trial. Omeros' pipeline holds a diverse group of preclinical programs including a proprietary-asset-enabled antibody-generating technology and a proprietary GPCR platform through which it controls 54 GPCR drug targets and their corresponding compounds. One of these novel targets, GPR174, modulates a new cancer immunity axis recently discovered by Omeros, and the company is advancing GPR174-targeting antibodies and small-molecule inhibitors. 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 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, risks associated with product commercialization and commercial operations, unproven preclinical and clinical development activities, the impact of COVID-19 on our business, financial condition and results of operations, regulatory processes and oversight, 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 the company's Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 1, 2021. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the company assumes 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.

    OMEROS CORPORATION

    UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS

    (In thousands, except share and per share data)

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Three Months Ended

    December 31,

     

    Year Ended

    December 31,

     

     

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

     

    Revenue:

     

     

     

     

     

     

     

     

     

     

     

     

     

    Product sales, net

     

    $

    10,632

     

     

    $

    33,417

     

     

    $

    73,813

     

     

    $

    111,805

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Costs and expenses:

     

     

     

     

     

     

     

     

     

     

     

     

     

    Cost of product sales

     

     

    87

     

     

     

    401

     

     

     

    902

     

     

     

    865

     

     

    Research and development

     

     

    26,458

     

     

     

    40,588

     

     

     

    110,817

     

     

     

    109,696

     

     

    Selling, general and administrative

     

     

    17,903

     

     

     

    16,132

     

     

     

    72,695

     

     

     

    64,626

     

     

    Total costs and expenses

     

     

    44,448

     

     

     

    57,121

     

     

     

    184,414

     

     

     

    175,187

     

     

    Loss from operations

     

     

    (33,816

    )

     

     

    (23,704

    )

     

     

    (110,601

    )

     

     

    (63,382

    )

     

    Loss on early extinguishment of debt

     

     

     

     

     

     

     

     

    (13,374

    )

     

     

     

     

    Interest expense

     

     

    (7,988

    )

     

     

    (5,811

    )

     

     

    (26,751

    )

     

     

    (22,657

    )

     

    Other income

     

     

    374

     

     

     

    290

     

     

     

    654

     

     

     

    1,553

     

     

    Loss before income taxes

     

     

    (41,430

    )

     

     

    (29,225

    )

     

     

    (150,072

    )

     

     

    (84,486

    )

     

    Income tax benefit

     

     

    4,157

     

     

     

     

     

     

    12,011

     

     

     

     

     

    Net loss

     

    $

    (37,273

    )

     

    $

    (29,225

    )

     

    $

    (138,061

    )

     

    $

    (84,486

    )

     

    Comprehensive loss

     

    $

    (37,273

    )

     

    $

    (29,225

    )

     

    $

    (138,061

    )

     

    $

    (84,486

    )

     

    Basic and diluted net loss per share

     

    $

    (0.60

    )

     

    $

    (0.58

    )

     

    $

    (2.41

    )

     

    $

    (1.71

    )

     

    Weighted-average shares used to compute basic and diluted net loss per share

     

     

    61,659,835

     

     

     

    58,233,988

     

     

     

    57,176,743

     

     

     

    49,523,444

     

     

    OMEROS CORPORATION

    UNAUDITED CONSOLIDATED BALANCE SHEET DATA

    (In thousands)

     

     

     

    December 31,

     

     

    December 31,

     

     

     

    2020

     

     

    2019

     

    Cash, cash equivalents and short-term investments

     

    $

    134,953

     

     

    $

    60,788

     

    Working capital

     

     

    114,549

     

     

     

    48,286

     

    Restricted investments

     

     

    1,055

     

     

     

    1,154

     

    Total assets

     

     

    181,042

     

     

     

    136,969

     

    Total current liabilities

     

     

    36,736

     

     

     

    55,459

     

    Lease liability

     

     

    32,552

     

     

     

    35,822

     

    Unsecured convertible senior notes, net

     

     

    236,288

     

     

     

    158,213

     

    Accumulated deficit

     

     

    (872,672

    )

     

     

    (734,611

    )

    Total shareholders' deficit

     

     

    (120,752

    )

     

     

    (109,021

    )

     

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  3. Omeros Corporation (NASDAQ:OMER), today announced that the company will issue its fourth quarter and year-end financial results for the period ended December 31, 2020, on Monday, March 1, 2021, after the market closes. Omeros management will host a conference call and webcast that 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

    To access the live conference call via phone, please dial (844) 831-4029 from the United States and Canada or (920) 663-6278 internationally. The participant passcode is 3399452. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week following…

    Omeros Corporation (NASDAQ:OMER), today announced that the company will issue its fourth quarter and year-end financial results for the period ended December 31, 2020, on Monday, March 1, 2021, after the market closes. Omeros management will host a conference call and webcast that 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

    To access the live conference call via phone, please dial (844) 831-4029 from the United States and Canada or (920) 663-6278 internationally. The participant passcode is 3399452. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week following the call and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 3399452.

    To access the live and subsequently archived webcast of the conference call, go to Omeros' website at www.omeros.com and select "Events" under the Investors section of the website. Please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.

    About Omeros Corporation

    Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. Its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3% continues to gain market share in cataract surgery. Omeros' lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a rolling biologics license application under priority review by FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19. Omeros' MASP-3 inhibitor OMS906, which targets the complement system's alternative pathway, recently entered the clinic, and the company's PDE7 inhibitor OMS527 has successfully completed its Phase 1 trial. Omeros' pipeline holds a diverse group of preclinical programs including a novel antibody-generating technology and a proprietary GPCR platform through which it controls 54 new GPCR drug targets and their corresponding compounds. One of these novel targets, GPR174, modulates a new cancer immunity axis recently discovered by Omeros, and the company is advancing small-molecule GPR174 inhibitors. For more information about Omeros and its programs, visit www.omeros.com.

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  4. Omeros Corporation (NASDAQ:OMER) today announced that Nadia Dac has joined Omeros as its Chief Commercial Officer. In this role, Ms. Dac will be responsible for all commercial operations at Omeros, including overseeing preparations for the commercial launch of narsoplimab, the company's mannan-binding lectin-associated serine protease-2 (MASP-2) inhibitor. A Biologics License Application for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy is under Priority Review by U.S. Food and Drug Administration. Ms. Dac will also be responsible for driving continued sales growth of Omeros' commercial product OMIDRIA® (phenylephrine and ketorolac intraocular solution 1%/0.3%), the only drug of its…

    Omeros Corporation (NASDAQ:OMER) today announced that Nadia Dac has joined Omeros as its Chief Commercial Officer. In this role, Ms. Dac will be responsible for all commercial operations at Omeros, including overseeing preparations for the commercial launch of narsoplimab, the company's mannan-binding lectin-associated serine protease-2 (MASP-2) inhibitor. A Biologics License Application for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy is under Priority Review by U.S. Food and Drug Administration. Ms. Dac will also be responsible for driving continued sales growth of Omeros' commercial product OMIDRIA® (phenylephrine and ketorolac intraocular solution 1%/0.3%), the only drug of its kind approved for use during cataract and lens replacement surgery.

    "We're pleased that Nadia has joined our senior leadership team," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "Nadia has already hit the ground running, and her high-caliber expertise is a welcome and timely addition at this important juncture in our company's development. The breadth and depth of her U.S. and global commercial experience as a strategic leader will be a valuable asset to Omeros as we look ahead to bringing our second product to market and advancing our diverse pipeline."

    With deep expertise spanning all commercial functions including marketing, market access and promotion, sales, pipeline management, business development and partnerships, Ms. Dac brings almost three decades of international experience building teams and launching products as a strategic commercial leader at large and small biopharmaceutical companies. She joins Omeros from her most recent role as the chief commercial officer at Alder Pharmaceuticals where she built the commercial team to launch Vyepti® in the migraine prevention market, which later was acquired by Lundbeck. Before joining Alder, she served as vice president of global specialty commercial development at AbbVie where she led the therapeutic area and business development strategies for neuroscience, virology, hepatology, renal, cystic fibrosis and women's health. Prior to AbbVie, Nadia held several roles of increasing responsibility at Novartis, building the commercial organization that successfully launched Gilenya® and Extavia®. Before Novartis, Nadia led marketing for Biogen's multiple sclerosis products Tysabri® and Avonex® and for Pfizer's Alzheimer's product Aricept®. She also spent several years in positions of increasing responsibility at Johnson & Johnson and Eli Lilly where she started her career in marketing and sales.

    "I am excited to be part of the strong leadership team at Omeros," said Ms. Dac. "With the restoration of reimbursement for OMIDRIA, the expected launch of narsoplimab and the impressive and cutting edge assets in our pipeline, the opportunities for commercial success are tremendous. I look forward to leading Omeros' commercial efforts to capitalize on those opportunities."

    About Omeros Corporation

    Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. Its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3% continues to gain market share in cataract surgery. Omeros' lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a rolling biologics license application under priority review by FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19. Omeros' MASP-3 inhibitor OMS906, which targets the complement system's alternative pathway, recently entered the clinic, and the company's PDE7 inhibitor OMS527 has successfully completed its Phase 1 trial. Omeros' pipeline holds a diverse group of preclinical programs including a novel antibody-generating technology and a proprietary GPCR platform through which it controls 54 new GPCR drug targets and their corresponding compounds. One of these novel targets, GPR174, modulates a new cancer immunity axis recently discovered by Omeros, and the company is advancing small-molecule GPR174 inhibitors. 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," "can," "could," "estimate," "expect," "goal," "intend," "likely", "look forward to," "may," "on track," "plan," "potential," "predict," "project," "prospects," "scheduled," "should," "slated," "targeting," "will," "would" and similar expressions and variations thereof. Forward-looking statements, including statements regarding anticipated regulatory submissions, the timing and results of ongoing or anticipated clinical trials, and the therapeutic application of Omeros' investigational product, 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, risks associated with product commercialization and commercial operations, unproven preclinical and clinical development activities, financial condition and results of operations, regulatory oversight, intellectual property claims, competitive developments, litigation, and the risks, uncertainties and other factors described under the heading "Risk Factors" in the company's Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 2, 2020, as supplemented by our Quarterly Reports on Form 10-Q filed with the SEC and subsequent filings with the SEC. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the company assumes 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.

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  5. -- FDA sets PDUFA date of July 17, 2021 --

    Omeros Corporation (NASDAQ:OMER) announced today that the Biologics License Application (BLA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) has been accepted for filing by the U.S. Food and Drug Administration (FDA). The BLA has been granted Priority Review with an FDA action date of July 17, 2021 under the Prescription Drug User Fee Act (PDUFA). FDA also indicated in its filing letter that the Agency is not currently planning to hold an advisory committee meeting to discuss the BLA.

    FDA grants Priority Review to applications for therapies that, if approved, would be significant improvements in the safety or effectiveness…

    -- FDA sets PDUFA date of July 17, 2021 --

    Omeros Corporation (NASDAQ:OMER) announced today that the Biologics License Application (BLA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) has been accepted for filing by the U.S. Food and Drug Administration (FDA). The BLA has been granted Priority Review with an FDA action date of July 17, 2021 under the Prescription Drug User Fee Act (PDUFA). FDA also indicated in its filing letter that the Agency is not currently planning to hold an advisory committee meeting to discuss the BLA.

    FDA grants Priority Review to applications for therapies that, if approved, would be significant improvements in the safety or effectiveness of the treatment, prevention or diagnosis of serious conditions. Narsoplimab targets mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of complement, and has received breakthrough therapy designations and orphan drug designations from FDA for each of HSCT-TMA and IgA nephropathy.

    "The filing of our BLA by FDA marks an important milestone on the path to commercialization of narsoplimab," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "There is no FDA-approved product for the treatment of transplant-associated TMA, a frequently fatal complication of stem cell transplantation. We appreciate FDA's collaborative approach throughout the development of our breakthrough therapy-designated product narsoplimab, and we are committed to continue working closely with the FDA review team to make the drug available to patients who need it."

    About Omeros Corporation

    Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. Its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3% continues to gain market share in cataract surgery. Omeros' lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a rolling biologics license application under priority review by FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19. Omeros' MASP-3 inhibitor OMS906, which targets the complement system's alternative pathway, recently entered the clinic, and the company's PDE7 inhibitor OMS527 has successfully completed its Phase 1 trial. Omeros' pipeline holds a diverse group of preclinical programs including a novel antibody-generating technology and a proprietary GPCR platform through which it controls 54 new GPCR drug targets and their corresponding compounds. One of these novel targets, GPR174, modulates a new cancer immunity axis recently discovered by Omeros, and the company is advancing small-molecule GPR174 inhibitors. For more information about Omeros and its programs, visit www.omeros.com.

    About Hematopoietic Stem Cell Transplant-associated Thrombotic Microangiopathy

    Hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-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 HSCT-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 25,000 to 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 HSCT-TMA, and high-risk features may be present in up to 80 percent of these patients. In severe cases of HSCT-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 HSCT-TMA.

    About Narsoplimab

    Narsoplimab, also known as "OMS721," is an investigational 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 does not appear to interfere with the antibody-dependent classical complement activation pathway, which is a critical component of the acquired immune response to infection. Omeros controls the worldwide rights to MASP-2 and all therapeutics targeting MASP-2.

    A biologics license application (BLA) is under priority review by the U.S. FDA for use of narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), and the drug is in Phase 3 clinical programs for immunoglobulin A (IgA) nephropathy and atypical hemolytic uremic syndrome (aHUS). The FDA has granted narsoplimab breakthrough therapy designations for HSCT-TMA and for IgA nephropathy; orphan drug status for the prevention (inhibition) of complement-mediated thrombotic microangiopathies, for the treatment of HSCT-TMA and for the treatment of IgA nephropathy; and fast track designation for the treatment of patients with aHUS. The European Medicines Agency has granted orphan drug designation to narsoplimab for treatment in HSCT and for treatment of primary IgA nephropathy. For additional information regarding narsoplimab and its clinical trials, visit www.omeros.com/narsoplimab.

    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," "can," "could," "estimate," "expect," "goal," "intend," "likely", "look forward to," "may," "on track," "plan," "potential," "predict," "project," "prospects," "scheduled," "should," "slated," "targeting," "will," "would" and similar expressions and variations thereof. Forward-looking statements, including statements regarding anticipated regulatory submissions, the timing and results of ongoing or anticipated clinical trials, and the therapeutic application of Omeros' investigational product, 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, risks associated with product commercialization and commercial operations, unproven preclinical and clinical development activities, the impact of COVID-19 on our business, financial condition and results of operations, regulatory oversight, 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 the company's Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 2, 2020, as supplemented by our Quarterly Reports on Form 10-Q filed with the SEC and subsequent filings with the SEC. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the company assumes 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.

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