OMER Omeros Corporation

15.55
+0.4  (+3%)
Previous Close 15.15
Open 15.35
52 Week Low 8.5
52 Week High 20.92
Market Cap $847,640,872
Shares 54,510,667
Float 51,795,119
Enterprise Value $967,595,605
Volume 183,349
Av. Daily Volume 462,377
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Upcoming Catalysts

Drug Stage Catalyst Date
OMS721
Hematopoietic stem cell-associated TMA (HSCT-TMA)
BLA Filing
BLA Filing
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OMS721
IgA nephropathy
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
OMS527
Nicotine Addiction
Phase 1
Phase 1
Phase 1 data September 16, 2019 noted treatment was safe and well-tolerated.
OMS721
Atypical hemolytic uremic syndrome (aHUS)
Phase 3
Phase 3
Phase 3 enrollment has opened - noted March 16, 2017.
OMS721
Kidney disorders
Phase 2
Phase 2
Phase 2 data released October 2016.
Omidria
Cataract surgery
Approved
Approved
Approved June 2, 2014.

Latest News

  1. Omeros Corporation (NASDAQ:OMER) today announced that the results of its pivotal trial of narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) were shared during an oral presentation at the virtual edition of the 25th Congress of the European Hematology Association (EHA). The EHA oral presentation, entitled Narsoplimab (OMS721) for the Treatment of Adult Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy was delivered by Alessandro Rambaldi, MD, Professor, Department of Oncology and Hematology-Oncology at the University of Milan and Head of the Hematology and Bone Marrow Transplant Unit at ASST Papa Giovanni XXIII in Bergamo, Italy.

    "I was excited to present…

    Omeros Corporation (NASDAQ:OMER) today announced that the results of its pivotal trial of narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) were shared during an oral presentation at the virtual edition of the 25th Congress of the European Hematology Association (EHA). The EHA oral presentation, entitled Narsoplimab (OMS721) for the Treatment of Adult Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy was delivered by Alessandro Rambaldi, MD, Professor, Department of Oncology and Hematology-Oncology at the University of Milan and Head of the Hematology and Bone Marrow Transplant Unit at ASST Papa Giovanni XXIII in Bergamo, Italy.

    "I was excited to present narsoplimab data demonstrating that targeted upstream inhibition of the lectin pathway of complement – specifically MASP-2 – is a promising treatment strategy for HSCT-TMA," said Professor Rambaldi. "Narsoplimab demonstrated a 54 percent complete response rate in all patients and a 65 percent complete response rate in patients receiving at least 4 weeks of narsoplimab treatment. In this population of very sick patients, those treated with at least one dose of narsoplimab and the responder group showed remarkable 100-day survival rates of 68 and 93 percent, respectively. We also saw marked and clinically significant improvements in laboratory markers and organ function. HSCT-TMA is a devastating post-transplant complication with high morbidity and mortality. We look forward to having this new treatment option available soon for our patients."

    There is no approved therapy or standard of care for HSCT-TMA. HSCT-TMA 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. Recent reports in both adult and pediatric allogeneic stem cell transplant populations have reported an approximately 40-percent incidence of TMA following stem cell transplantation. At least one high-risk feature is 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 chronic organ injury and other conditions can persist.

    The detailed clinical trial data presented underscore the importance of narsoplimab as a potentially significant advance in the treatment of often-fatal HSCT-TMA. The data include:

    • 54 percent complete response rate in all patients (n = 28) and 65 percent complete response rate in patients receiving at least 4 weeks of narsoplimab treatment (n = 23)
    • 100-day survival rate of 68 percent among all patients receiving any dose of narsoplimab
    • 83 percent 100-day survival in patients receiving at least 4 weeks of narsoplimab treatment
    • 93 percent 100-day survival among complete responders
    • Statistically and clinically significant improvements from baseline in platelet count (p = 0.001), lactate dehydrogenase (LDH) (p = 0.008), and haptoglobin (p < 0.001)
    • A well-tolerated safety profile: no infusion side effects reported in patients receiving narsoplimab; most common adverse events were nausea, vomiting, diarrhea, hypokalemia, neutropenia, and fever – all common in this patient population; 6 patents died during the study, again all due to causes common in HSCT with most early in the course of narsoplimab treatment

    A high-risk population was enrolled in this pivotal single-arm open-label trial of patients with HSCT-TMA. High-risk features included persistence of HSCT-TMA despite modification of immunosuppression (which was a criterion for trial inclusion), graft-versus-host-disease, significant infections, non-infectious pulmonary complications and neurological findings.

    The pivotal trial protocol specified that patients receive narsoplimab intravenously once weekly for 4 or 8 weeks, with a 6-week follow-up period. As presented today, the FDA-agreed primary endpoint is a response-based composite measure requiring improvement in laboratory markers of TMA (platelet count and LDH) and improvement in clinical status (i.e., organ function [renal, pulmonary, gastrointestinal, or neurological] and transfusion burden). The FDA-agreed efficacy threshold for the primary endpoint is 15 percent. Secondary endpoints were survival and changes in laboratory TMA markers. Submission of a rolling Biologics License Application for marketing authorization is underway and completion is expected next quarter.

    Dr. Rambaldi's slide presentation can be viewed at https://www.omeros.com/scientific-publications/.

    About Narsoplimab

    Narsoplimab, also known as "OMS721," is an investigational human monoclonal antibody targeting mannose-binding lectin-associated serine protease-2 (MASP-2), a novel proinflammatory 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.

    In September 2019, Omeros announced that the FDA had agreed with the company's proposed schedule for the rolling submission of its Biologics License Application (BLA) for narsoplimab in the treatment of HSCT-TMA. The rolling submission enables Omeros to submit sections of the BLA as they are completed, which may accelerate the time to approval; the FDA can review sections as they are submitted rather than wait to begin its review until the entire BLA has been submitted. Omeros anticipates completion of the BLA submission process next quarter.

    In addition to the BLA for HSCT-TMA, narsoplimab is in Phase 3 clinical programs for narsoplimab in immunoglobulin A (IgA) nephropathy and in 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 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. In addition to its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3%, Omeros has multiple phase 3 and phase 2 clinical-stage development programs focused on complement-mediated disorders and substance abuse. Omeros also has a diverse group of preclinical programs including GPR174, a novel target in immuno-oncology that modulates a new cancer immunity axis recently discovered by Omeros. Small-molecule inhibitors of GPR174 are part of Omeros' proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and their corresponding compounds. The company also exclusively possesses a novel antibody-generating platform.

    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, expectations regarding regulatory exclusivities, 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, availability and timing of data from clinical trials and the results of such trials, unproven preclinical and clinical development activities, 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 for the year ended December 31, 2019, filed with the Securities and Exchange Commission (SEC) on March 2, 2020, as supplemented by its Quarterly Report on Form 10-Q filed with the SEC on May 11, 2020 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 any new information, future events or otherwise, except as required by applicable law.

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  2. Omeros Corporation (NASDAQ:OMER): The results of Omeros' pivotal trial of narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) will be shared as an oral presentation at the virtual edition of the 25th annual European Hematology Association Congress.

    The presentation, entitled Narsoplimab (OMS721) for the Treatment of Adult Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy, will be delivered by Alessandro Rambaldi, M.D., Professor of Hematology at the University of Milan and Head of the Hematology and Bone Marrow Transplant Unit at ASST Papa Giovanni XXIII in Bergamo, Italy.

    Due to the worldwide impact of COVID-19, the 25th Congress of the European Hematology…

    Omeros Corporation (NASDAQ:OMER): The results of Omeros' pivotal trial of narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) will be shared as an oral presentation at the virtual edition of the 25th annual European Hematology Association Congress.

    The presentation, entitled Narsoplimab (OMS721) for the Treatment of Adult Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy, will be delivered by Alessandro Rambaldi, M.D., Professor of Hematology at the University of Milan and Head of the Hematology and Bone Marrow Transplant Unit at ASST Papa Giovanni XXIII in Bergamo, Italy.

    Due to the worldwide impact of COVID-19, the 25th Congress of the European Hematology Association (EHA) will be held as a virtual meeting. Dr. Rambaldi's oral presentation can be accessed on demand by registered meeting attendees on the EHA Virtual Congress platform beginning Friday, June 12, at 08:30 a.m. CEST / 2:30 a.m. EDT. Also on Friday, the presentation slides will be publicly available on Omeros' website at https://www.omeros.com/scientific-publications/.

    About HSCT-TMA

    Hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) is a significant and often lethal complication of stem cell transplants. This condition is a systemic, multifactorial disorder caused by endothelial cell damage induced by conditioning regimens, immunosuppressant therapies, infection, GvHD, 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 HSCT-TMA incidence of approximately 40 percent, 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 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.

    Phase 3 clinical programs are in progress for narsoplimab in HSCT-TMA, in immunoglobulin A (IgA) nephropathy, and in 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 Omeros Corporation

    Omeros is 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. In addition to its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1% / 0.3%, Omeros has multiple Phase 3 and Phase 2 clinical-stage development programs focused on complement-mediated disorders and substance abuse. In addition, Omeros has a diverse group of preclinical programs including GPR174, a novel target in immuno-oncology that modulates a new cancer immunity axis recently discovered by Omeros. Small-molecule inhibitors of GPR174 are part of Omeros' proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and their corresponding compounds. The company also exclusively possesses a novel antibody-generating platform.

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  3. Omeros Corporation (NASDAQ:OMER) today announced that the results of its pivotal trial of narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy will be presented at the 25th Annual Congress of the European Hematology Association (EHA) to be held June 11-14, 2020. This year the congress will be held virtually.

    The presentation, entitled Narsoplimab (OMS721) for the Treatment of Adult Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy, will be delivered by Alessandro Rambaldi, M.D., Professor of Hematology at the University of Milan and Head of the Hematology and Bone Marrow Transplant Unit at ASST Papa Giovanni XXIII in Bergamo, Italy. Selected by EHA for a podium presentation…

    Omeros Corporation (NASDAQ:OMER) today announced that the results of its pivotal trial of narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy will be presented at the 25th Annual Congress of the European Hematology Association (EHA) to be held June 11-14, 2020. This year the congress will be held virtually.

    The presentation, entitled Narsoplimab (OMS721) for the Treatment of Adult Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy, will be delivered by Alessandro Rambaldi, M.D., Professor of Hematology at the University of Milan and Head of the Hematology and Bone Marrow Transplant Unit at ASST Papa Giovanni XXIII in Bergamo, Italy. Selected by EHA for a podium presentation, it will include efficacy data not previously presented.

    About HSCT-TMA

    Hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) is a significant and often lethal complication of stem cell transplants. This condition is a systemic, multifactorial disorder caused by endothelial cell damage induced by conditioning regimens, immunosuppressant therapies, infection, GvHD, 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 HSCT-TMA incidence of approximately 40 percent, 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 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.

    Phase 3 clinical programs are in progress for narsoplimab in HSCT-TMA, in immunoglobulin A (IgA) nephropathy, and in 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 Omeros Corporation

    Omeros is 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. In addition to its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1% / 0.3%, Omeros has multiple Phase 3 and Phase 2 clinical-stage development programs focused on complement-mediated disorders and substance abuse. In addition, Omeros has a diverse group of preclinical programs including GPR174, a novel target in immuno-oncology that modulates a new cancer immunity axis recently discovered by Omeros. Small-molecule inhibitors of GPR174 are part of Omeros' proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and their corresponding compounds. The company also exclusively possesses a novel antibody-generating platform.

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  4. – 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 first quarter ended March 31, 2020, which include:

    • Revenues for the first quarter of 2020 were $23.5 million, compared to $21.8 million and $33.4 million in the first and fourth quarters of 2019, respectively. The decrease from the fourth quarter of 2019…

    – 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 first quarter ended March 31, 2020, which include:

    • Revenues for the first quarter of 2020 were $23.5 million, compared to $21.8 million and $33.4 million in the first and fourth quarters of 2019, respectively. The decrease from the fourth quarter of 2019 reflects the COVID-19-related postponement of cataract procedures by ASCs and hospitals in early March.
    • Net loss in the first quarter of 2020 was $29.0 million, or $0.53 per share, including non-cash expenses of $6.4 million, or $0.12 per share. This compares to a net loss of $24.3 million, or $0.50 per share, which included non-cash expenses of $6.0 million, or $0.12 per share, for the comparable quarter in 2019.
    • At March 31, 2020, Omeros had cash, cash equivalents and short-term investments available for operations of $54.0 million, a decrease of $6.8 million from December 31, 2019.
    • Omeros submitted the second part of its rolling biologics license application (BLA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). The submission was on schedule and consisted of information relating to the chemistry, manufacturing and controls (CMC) of narsoplimab.

    "I am immensely proud of how Omeros' employees have responded to the unprecedented challenges presented by the global pandemic, adapting to a changing work environment while continuing to meet program milestones with the same commitment, sense of urgency and level of productivity," said Gregory A. Demopulos, M.D., Omeros' chairman and chief executive officer. "We already are seeing rapid resumption of OMIDRIA purchases by ASCs and hospitals as they reopen and begin addressing the backlog of cataract surgery patients. For narsoplimab, we just submitted the second part of our rolling BLA as scheduled and continue to target next quarter for its completion. Our ongoing and upcoming clinical programs have weathered COVID-19 well, and we continue to target the start of our OMS906 clinical program next month and data readout from our ARTEMIS-IGAN trial next year. Our research laboratories and nonclinical functions have also remained fully operational. Our preparations for the commercial launch of narsoplimab have accelerated and, with the addition of recent hires, we continue to build top-tier sales, marketing and medical affairs teams. We look forward to adding narsoplimab to what we expect will be a long line of commercial products."

    First Quarter and Recent Developments

    • Recent developments regarding OMIDRIA include the following:
      • Previously reported peer-reviewed published data demonstrate that OMIDRIA significantly reduces the need for intraoperative fentanyl, a potent and highly addictive opioid, while significantly decreasing pain scores. A separate study to assess the effect of OMIDRIA on use of postoperative opioid use was also recently completed. In that study an analysis of claims data over a 3-year period was performed by IBM Watson Health. Claims data were evaluated from 218,672 patients 65 years of age or older who underwent cataract surgery. All patients were required to have no opioid use during the 6 months prior to surgery. Filled opioid prescriptions in the OMIDRIA-treated group were compared to those in the non-OMIDRIA-treated group. Patients who received OMIDRIA during surgery received fewer opioid pills in the 2 days and 7 days post-surgery than patients who did not receive OMIDRIA. The median reductions seen were 56 percent (20 pills versus 45 pills) at 2 days (p = 0.015) and 33 percent (40 pills versus 60 pills) at 7 days (p = 0.029). These data provide further evidence that OMIDRIA not only reduces the need for intraoperative fentanyl but also decreases the use of postoperative opioids.
      • The results of a retrospective study of the incidence of postoperative clinical cystoid macular edema (CME), breakthrough iritis, pain and photophobia in patients receiving OMIDRIA were published in the peer-reviewed Journal of Cataract and Refractive Surgery. The study demonstrated with statistical significance that patients receiving OMIDRIA had lower incidences of clinical CME (p = 0.021), breakthrough iritis (p = 0.001) and pain (p = 0.001) compared to a control group receiving conventional perioperative steroids. Patients receiving OMIDRIA also had lower incidence of photophobia, though not statistically significant.
      • A manuscript on the safety and efficacy of OMIDRIA for pediatric cataract surgery was also published by Journal of Cataract and Refractive Surgery. The randomized double-blind study in children undergoing cataract surgery showed that OMIDRIA is safe to use in children and resulted in lower pain scores for patients receiving OMIDRIA than for the control group. As a result, the FDA-approved label for OMIDRIA has no age restriction.
    • Recent developments regarding narsoplimab, Omeros' lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2) in Phase 3 clinical programs for the treatment of HSCT-TMA, Immunoglobulin A (IgA) nephropathy, and atypical hemolytic uremic syndrome (aHUS), include the following:
      • Omeros submitted the second part of its rolling BLA for narsoplimab for the treatment of HSCT-TMA, consisting of CMC-related information, including data on manufacturing, analytical procedures, and associated method validations.
      • A manuscript authored by a group from the University of Leicester led by Dr. Jonathan Barratt PhD, FCRP, Professor of Renal Medicine, has been accepted for peer-reviewed publication. The manuscript describes the beneficial effects of narsoplimab in IgA vasculitis-associated nephritis, a rapidly progressive glomerulonephritis. A second manuscript presenting Omeros' IgA nephropathy Phase 2 clinical data and authored by the company's IgA nephropathy Academic Leadership Committee, which is comprised of international thought leaders, has also undergone journal review and is expected to be published soon.
      • Consistent with FDA guidelines and recommendations of the independent data safety monitoring committee regarding ongoing clinical trials during the COVID-19 pandemic, study sites for Omeros' ongoing Phase 3 programs for narsoplimab in IgA nephropathy and aHUS are conducting trials in a manner consistent with local recommendations and/or regulations to maintain safety of study patients. As a result, at some sites, new patient enrollment has slowed while previously enrolled patients are continuing in the trials. We continue targeting data readout for the IgA nephropathy trial next year.
    • Updates regarding Omeros' other development programs and platforms include the following:
      • First-in-human-enabling toxicology studies for the company's MASP-3 inhibitor OMS906 are complete. Omeros is on track to file a clinical trial application this quarter and to begin dosing in the first part of the third quarter.
      • As part of the strategy for life-cycle management of the company's complement franchise, Omeros continues to develop a longer-acting second generation antibody against MASP-2, which is targeted to enter the clinic in early 2022, to be followed by an orally available small molecule inhibitor against MASP-2 also under development.

    Financial Results

    For the first quarter of 2020, revenues, all related to sales of OMIDRIA, were $23.5 million, compared to $21.8 million for the same period in 2019 and a record-high $33.4 million for the fourth quarter of 2019. The decrease from the prior quarter reflects declining sales beginning in early March, as a result of inventory utilization by ASCs and hospitals in anticipation of the COVID-19-related shutdown of elective surgical procedures, which occurred in mid-March. Sales of OMIDRIA to wholesalers were minimal in March. March typically accounts for about 45 percent of total first-quarter OMIDRIA revenues, and Omeros realized only one week of March revenues. In early May, a large number of states began re-opening ASCs and hospitals to cataract surgery, and facilities in at least 36 states have already initiated re-ordering of OMIDRIA from wholesalers.

    Total costs and expenses for the first quarter of 2020 were $47.2 million compared to $41.0 million for the comparable period in 2019. The increase was due to increased research and development and pre-commercialization marketing activities for narsoplimab.

    For the three months ended March 31, 2020, Omeros reported a net loss of $29.0 million, or $0.53 per share, which included non-cash expenses of $6.4 million, or $0.12 per share. This compares to a net loss of $24.3 million, or $0.50 per share, which included non-cash expenses of $6.0 million, or $0.12 per share, for the comparable quarter in 2019.

    As of March 31, 2020, the company had $54.0 million of cash, cash equivalents and short-term investments available for operations, a decrease $6.8 million from December 31, 2019. The company also has a line of credit, which permits borrowing up to the lesser of 85 percent of eligible accounts receivable and $50 million. As of March 31, 2020, the eligible accounts receivable balance was $24.1 million, and Omeros has not borrowed under this facility.

    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 1:30 p.m. Pacific Time; 4:30 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 6549035. 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 6549035.

    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 an innovative biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. In addition to its commercial drug OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1%/0.3%, Omeros has multiple Phase 3 and Phase 2 clinical-stage development programs focused on complement-mediated disorders and substance abuse, as well as a diverse group of preclinical programs including GPR174, a novel target in immuno-oncology that modulates a new cancer immunity axis recently discovered by Omeros. Small-molecule inhibitors of GPR174 are part of Omeros' proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and their corresponding compounds. The company also exclusively possesses a novel antibody-generating platform.

    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 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 Report on Form 10-Q filed with the SEC on May 11, 2020 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, even if new information becomes available in the future.

    OMEROS CORPORATION

    UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS

    (In thousands, except share and per share data)

     

     

     

     

     

     

    Three Months Ended

     

     

     

    March 31,

     

     

     

     

    2020

     

     

     

    2019

     

    Revenue:

     

     

     

     

     

     

     

     

    Product sales, net

     

    $

     

    23,537

     

     

    $

     

    21,779

     

    Costs and expenses:

     

     

     

     

     

     

     

     

    Cost of product sales

     

     

    267

     

     

     

    131

     

    Research and development

     

     

    28,911

     

     

     

    26,255

     

    Selling, general and administrative

     

     

    18,036

     

     

     

    14,632

     

    Total costs and expenses

     

     

    47,214

     

     

     

    41,018

     

    Loss from operations

     

     

    (23,677

    )

     

     

    (19,239

    )

    Interest expense

     

     

    (5,903

    )

     

     

    (5,600

    )

    Other income

     

     

    549

     

     

     

    494

     

    Net loss

     

    $

     

    (29,031

    )

     

    $

     

    (24,345

    )

    Comprehensive loss

     

    $

     

    (29,031

    )

     

    $

     

    (24,345

    )

    Basic and diluted net loss per share

     

    $

     

    (0.53

    )

     

    $

     

    (0.50

    )

    Weighted-average shares used to compute basic and diluted

    net loss per share

     

     

    54,299,813

     

     

     

    49,014,009

     

    OMEROS CORPORATION

    UNAUDITED CONSOLIDATED BALANCE SHEET DATA

    (In thousands)

     

     

     

     

     

     

     

     

     

    March 31,

     

     

    December 31,

     

     

     

     

    2020

     

     

     

    2019

     

    Cash, cash equivalents and short-term investments

     

    $

     

    53,980

     

     

    $

     

    60,788

     

    Working capital

     

     

    27,675

     

     

     

    48,286

     

    Restricted investments

     

     

    1,154

     

     

     

    1,154

     

    Total assets

     

     

    118,214

     

     

     

    136,969

     

    Total current liabilities

     

     

    57,936

     

     

     

    55,459

     

    Lease liabilities

     

     

    34,993

     

     

     

    35,822

     

    Convertible Senior Notes

     

     

    160,746

     

     

     

    158,213

     

    Accumulated deficit

     

     

    (763,642

    )

     

     

    (734,611

    )

    Total shareholders' deficit

     

     

    (131,864

    )

     

     

    (109,021

    )

     

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  5. Omeros Corporation (NASDAQ:OMER), today announced that the company will issue its first quarter financial results for the period ended March 31, 2020, on Monday, May 11, 2020, 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 6549035. 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…

    Omeros Corporation (NASDAQ:OMER), today announced that the company will issue its first quarter financial results for the period ended March 31, 2020, on Monday, May 11, 2020, 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 6549035. 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 6549035.

    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 an innovative biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. In addition to its commercial drug OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1%/0.3%, Omeros has multiple Phase 3 and Phase 2 clinical-stage development programs focused on complement-mediated disorders and substance abuse, as well as a diverse group of preclinical programs including GPR174, a novel target in immuno-oncology that modulates a new cancer immunity axis recently discovered by Omeros. Small-molecule inhibitors of GPR174 are part of Omeros' proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and their corresponding compounds. The company also exclusively possesses a novel antibody-generating platform.

    View Full Article Hide Full Article
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