1. – 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

    )

     

    View Full Article Hide Full Article
  2. 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.

    View Full Article Hide Full Article
  3. 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.

    View Full Article Hide Full Article
  4. -- 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.

    View Full Article Hide Full Article
  5. Omeros Corporation (NASDAQ:OMER) today announced that Gregory A. Demopulos, M.D., chairman and chief executive officer, will present at the 39th Annual J.P. Morgan Healthcare Conference this week. This conference is being held as a virtual conference this year. The presentation is scheduled for Wednesday, January 13, 2021 at 10:50 a.m. EST.

    The presentation will be webcast. The live and archived webcasts can be accessed on the investor relations section of the company's website at www.omeros.com under "Events." The archived webcast will be available for 30 days.

    About Omeros Corporation

    Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for…

    Omeros Corporation (NASDAQ:OMER) today announced that Gregory A. Demopulos, M.D., chairman and chief executive officer, will present at the 39th Annual J.P. Morgan Healthcare Conference this week. This conference is being held as a virtual conference this year. The presentation is scheduled for Wednesday, January 13, 2021 at 10:50 a.m. EST.

    The presentation will be webcast. The live and archived webcasts can be accessed on the investor relations section of the company's website at www.omeros.com under "Events." The archived webcast will be available for 30 days.

    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 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.

    View Full Article Hide Full Article
  6. Separate payment for OMIDRIA retroactively effective as of October 1, 2020 —

    Omeros Corporation (NASDAQ:OMER) announced today that the Centers for Medicare & Medicaid Services (CMS) confirmed separate payment in ambulatory surgery centers (ASCs) for Omeros' cataract surgery drug OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1%/0.3%. In its final rule directed to the Medicare outpatient prospective payment system (OPPS) and the ASC payment system for calendar year 2021, CMS confirmed that OMIDRIA qualifies for separate payment under CMS' policy for non-opioid pain management surgical drugs when used in the ASC setting. This separate payment for OMIDRIA is effective retroactively beginning October 1, 2020.

    "Omeros appreciates…

    Separate payment for OMIDRIA retroactively effective as of October 1, 2020 —

    Omeros Corporation (NASDAQ:OMER) announced today that the Centers for Medicare & Medicaid Services (CMS) confirmed separate payment in ambulatory surgery centers (ASCs) for Omeros' cataract surgery drug OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1%/0.3%. In its final rule directed to the Medicare outpatient prospective payment system (OPPS) and the ASC payment system for calendar year 2021, CMS confirmed that OMIDRIA qualifies for separate payment under CMS' policy for non-opioid pain management surgical drugs when used in the ASC setting. This separate payment for OMIDRIA is effective retroactively beginning October 1, 2020.

    "Omeros appreciates CMS' decision to continue paying separately for our ophthalmic drug OMIDRIA," said Gregory A. Demopulos, M.D., Omeros' chairman and chief executive officer. "Having just come off its pass-through status, this is the first time that OMIDRIA qualifies under CMS' payment policy for non-opioid pain-management surgical drugs in the ASC setting. In addition to reducing patient exposure to opioids, CMS' decision continues to provide important access to OMIDRIA for Medicare beneficiaries and to allow ophthalmic surgeons to use their best medical judgment to treat those patients. This is a good outcome for surgical facilities, surgeons and their patients."

    OMIDRIA is the first and only FDA-approved product for use during cataract or lens replacement surgery that prevents pupil constriction during surgery and reduces postoperative ocular pain. In post-marketing studies, OMIDRIA has been shown to have a broad range of benefits, including the reduction of sight-threatening complications and mitigating the need for intra- and postoperative steroids. OMIDRIA is approved for use in both adults and children.

    About OMIDRIA®

    Omeros' OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1% / 0.3% is the first and only FDA-approved product of its kind and is marketed in the U.S. for use during cataract surgery or intraocular lens replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. OMIDRIA also is the only NSAID-containing product FDA-approved for intraocular use. In post-launch studies across conventional and femtosecond laser-assisted cataract surgery, OMIDRIA has been shown to (1) prevent intraoperative floppy iris syndrome (IFIS) and iris prolapse, (2) significantly reduce complication rates (including sight-threatening cystoid macular edema and breakthrough iritis), use of pupil-expansion devices, and surgical times, (3) significantly reduce intraoperative use of the opioid fentanyl and postoperative prescription opioids, (4) enable performance of surgery and postoperative care without the use of steroids, and (5) significantly improve uncorrected visual acuity on the first day following cataract surgery. While OMIDRIA is broadly indicated for use in cataract surgery, the post-launch outcomes cited above are not in its currently approved labeling.

    Important Safety Information for OMIDRIA®

    Systemic exposure of phenylephrine may cause elevations in blood pressure. In clinical trials, the most common reported ocular adverse reactions at two percent or greater are eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation; incidence of adverse events was similar between placebo-treated and OMIDRIA-treated patients. OMIDRIA must be added to irrigation solution prior to intraocular use.

    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 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.

    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.

    Source: Omeros Corporation

    View Full Article Hide Full Article
  7. -- Priority Review Requested --

    Omeros Corporation (NASDAQ:OMER) announced that it has completed the rolling submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). 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 designation and orphan drug designation from FDA for HSCT-TMA.

    This final portion of the rolling BLA submission, comprised of the BLA's clinical sections, follows the previously submitted chemistry, manufacturing and controls (CMC) and nonclinical…

    -- Priority Review Requested --

    Omeros Corporation (NASDAQ:OMER) announced that it has completed the rolling submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). 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 designation and orphan drug designation from FDA for HSCT-TMA.

    This final portion of the rolling BLA submission, comprised of the BLA's clinical sections, follows the previously submitted chemistry, manufacturing and controls (CMC) and nonclinical sections, which are under review by FDA. The clinical sections are based on previously reported results of the pivotal trial of narsoplimab in HSCT-TMA in which the drug met its primary endpoint and demonstrated similarly strong response across its secondary endpoints.

    Omeros has requested priority review for the BLA, and applicable regulations provide FDA up to 60 days to determine the filing and review designation for the application.

    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 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) has been submitted to 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.

    View Full Article Hide Full Article
  8. 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 third quarter ended September 30, 2020, which include:

    • Revenues for the third quarter of 2020 were $26.1 million following an $8.7 million deduction as a return reserve associated with the expiration of pass-through reimbursement for OMIDRIA on October 1, 2020. Omeros believes that it qualifies…

    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 third quarter ended September 30, 2020, which include:

    • Revenues for the third quarter of 2020 were $26.1 million following an $8.7 million deduction as a return reserve associated with the expiration of pass-through reimbursement for OMIDRIA on October 1, 2020. Omeros believes that it qualifies for and is pursuing separate payment from the Centers for Medicare and Medicaid Services (CMS) for OMIDRIA. For comparison, third quarter 2019 and second quarter 2020 revenues were $29.9 million and $13.5 million, respectively.
    • Net loss in the third quarter of 2020 was $38.5 million, or $0.66 per share, of which $13.6 million, or $0.23 per share, were non-cash expenses. This compares to a net loss of $16.5 million, or $0.33 per share, in the third quarter of 2019. On a non-GAAP basis, adjusted net loss for the third quarter of 2020 was $19.9 million, or $0.34 per share, after excluding non-cash expenses and a $5.0 million technology access fee. Net loss and adjusted net loss include the $8.7 million deduction in third quarter 2020 revenues for the return reserve.
    • At September 30, 2020, the company had cash, cash equivalents and short-term investments available for operations of $153.5 million. This includes $93.7 million in proceeds from a common stock offering and $76.9 million in proceeds from the issuance of convertible notes, following the use of a portion of the proceeds to repurchase a portion of our previously outstanding convertible notes and enter into certain derivative transactions, all of which took place during the third quarter.
    • Omeros will complete submission next week to the U.S. Food and Drug Administration (FDA) of its rolling Biologics License Application (BLA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA or TA-TMA). Final clinical data from the BLA were presented in a webcast last month, as described below.
    • In August, Omeros reported results from a study evaluating narsoplimab for treatment of COVID-19-associated acute respiratory distress syndrome (ARDS). Six COVID-19 patients in Bergamo, Italy were treated with narsoplimab. All six patients required mechanical ventilation prior to narsoplimab treatment, and each recovered, survived and was discharged from the hospital following treatment. Two historical control groups that had similar baseline characteristics showed mortality rates of 32 percent and 53 percent. The results of the trial were published in the peer-reviewed journal Immunobiology. Five to six months after cessation of narsoplimab dosing, all patients were doing well and none showed clinical or laboratory evidence of longer-term effects from COVID-19.
    • In September, Omeros initiated its Phase 1 clinical trial for OMS906, the company's MASP-3 inhibitor targeting the alternative pathway, and has completed dosing in the first patient cohort.

    "The final clinical study results for narsoplimab in the treatment of transplant-associated TMA speak for themselves. The non-clinical and CMC sections of the BLA are under review by FDA, and the clinical sections, which will be submitted next week, are complete, comprehensive and compelling," said Gregory A. Demopulos, M.D., Omeros' chairman and chief executive officer. "In anticipation of priority review, our team is readying for a successful commercial launch. Beyond TA-TMA and its Phase 3 trials in IgA nephropathy and aHUS, narsoplimab is increasingly recognized as a likely answer to severe COVID-19. Our complement franchise continues expanding with our MASP-3 inhibitor OMS906 on course and marching through its Phase 1 program. Confident that OMIDRIA qualifies for separate payment from CMS, we expect that the drug will increasingly support our unique portfolio of complement inhibitors and the rest of our exciting pipeline programs. Developing a life-saving drug is a rare opportunity, and all of us at Omeros are energized and inspired by the patients – children and adults – who are alive today because of our team's efforts."

    Third Quarter and Recent Developments

    • Recent developments regarding narsoplimab, Omeros' lead fully human monoclonal antibody targeting 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:
      • In October, Professor Alessandro Rambaldi of the University of Milan and Papa Giovanni XXIII Hospital and Dr. Miguel Perales of Memorial Sloan Kettering Cancer Center presented the final efficacy and safety data from the pivotal trial of narsoplimab in the treatment of HSCT-TMA, which form the basis of the clinical sections of the rolling BLA.
        • The complete response rates of 61 percent in patients receiving at least one dose of narsoplimab (the full analysis set) and 74 percent in patients receiving the protocol-specified narsoplimab treatment of at least four weeks (the per-protocol population) are higher than what was previously reported.
        • Median overall survival was 274 days in the full analysis set, 361 days in the per-protocol population and could not be estimated for complete responders because more than half of the responders were still alive at last follow-up, out to as long as roughly four years following treatment.
      • Omeros applied to the Centers for Disease Control and Prevention (CDC) for an International Classification of Diseases (ICD-10) diagnosis code for HSCT-TMA, and CDC has preliminarily indicated its support for the diagnosis code. Omeros also applied to CMS for an ICD-10 procedure code for the administration of narsoplimab, and CMS has indicated its support for issuance of the procedure code.
      • In addition to the six COVID-19 patients who were treated with narsoplimab, Omeros has continued to treat critically ill COVID-19 patients under compassionate use. Omeros has also received requests and is in discussions to include narsoplimab in platform trials for COVID-19.
      • Omeros' discussions regarding the use of narsoplimab in COVID-19 have progressed with leadership across BARDA, NIAID, NCAT and NIH regarding narsoplimab for the treatment of critically ill COVID-19 patients. With COVID-19 surging again globally and other therapeutics having failed to show benefit in critically ill COVID-19 patients, there is increasing focus on narsoplimab.
    • Recent developments regarding OMIDRIA include the following:
      • Pass-through reimbursement status for OMIDRIA expired on October 1, 2020. Omeros met with CMS and the Department of Health and Human Services to assert that OMIDRIA meets the objective criteria specified by CMS and must be paid separately in the ambulatory surgery center (ASC) setting. Omeros also submitted to CMS a comment letter on the proposed 2021 Outpatient Prospective Payment System/ASC Rule along with a legal memorandum from an outside law firm reiterating this position and seeking confirmation of separate payment status for OMIDRIA in the ASC setting for the fourth quarter of 2020 and calendar year 2021.
      • An article entitled "Real-world opioid prescribing after cataract surgery among patients who received intracameral phenylephrine and ketorolac 1.0%/0.3%" was published in the peer-reviewed journal Current Medical Research and Opinion. The study demonstrates that patients who received OMIDRIA during cataract surgery were prescribed fewer opioid pills following surgery than patients who did not receive OMIDRIA, despite the OMIDRIA-treated group having a greater incidence of preoperative comorbidities and higher risk for surgical complexity.
    • Updates regarding Omeros' other development programs and platforms include the following:
      • Omeros has completed, on schedule, dosing in the first cohort in a Phase 1, placebo-controlled, double-blind, single-ascending-dose and multiple-ascending-dose study for OMS906, the company's MASP-3 inhibitor. The second cohort in the Phase 1 study has begun dosing. Omeros expects to achieve a once-monthly subcutaneous dosing regimen. Data readout from the Phase 1 study is planned for next year.
      • Omeros presented data on the OMS906 program at the 4th Complement-based Drug Development Summit in October.

    Financial Results

    For the third quarter of 2020, OMIDRIA revenues were $26.1 million, down from $29.9 million for the same period in 2019 and up from $13.5 million for the second quarter of 2020. The decrease compared to the third quarter of 2019 was due to an $8.7 million deduction as a reserve for product returns related to the expiration of pass-through reimbursement on October 1, 2020.

    Total costs and expenses for the third quarter of 2020 were $51.5 million compared to $41.0 million for the same period in 2019. The increase reflects a fee payable under a technology license agreement related to Omeros' MASP-3 program and increased pre-commercialization marketing activities for narsoplimab. Selling, general and administrative expenses were $19.8 million in the third quarter of 2020, compared to $16.9 million in the corresponding period in 2019.

    For the three months ended September 30, 2020, Omeros reported a net loss of $38.5 million, or $0.66 per share, compared to a net loss of $16.5 million, or $0.33 per share, for the same period in 2019. On a non-GAAP basis, adjusted net loss for the three months ended September 30, 2020 was $19.9 million, or $0.34 per share, after excluding non-cash expenses of $13.6 million, or $0.23 per share, and a technology access fee of $5.0 million, or $0.09 per share. Both net loss and adjusted net loss include the $8.7 million deduction in the third quarter of 2020 for the return reserve.

    As of September 30, 2020, Omeros had $153.5 million of cash, cash equivalents and short-term investments available for operations and accounts receivable of $37.4 million.

    During the third quarter, Omeros issued approximately $225.0 million aggregate principal amount 5.25% convertible senior notes due February 2026 (the 2026 Notes). Concurrently, Omeros repurchased $115.0 million aggregate principal amount of previously outstanding 6.25% convertible senior notes due November 2023. Omeros recorded a $13.4 million non-cash loss on early extinguishment of debt and a $7.9 million non-cash income tax benefit associated with these transactions. Omeros also entered into capped call contracts associated with the 2026 Notes that cover, subject to anti-dilution adjustments that may not match those applicable to the conversion price of the 2026 Notes, the number of shares of Omeros' common stock underlying the 2026 Notes when Omeros' common stock is trading between the initial conversion price of approximately $18.49 and the $26.10 cap price.

    In August, Omeros sold 6.9 million shares in an underwritten public offering and received $93.7 million in net proceeds from the offering.

    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 for 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 Phase 1. 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.

    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 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.

    Non-GAAP Information

    This press release includes financial measures that are not calculated in accordance with U.S. generally accepted accounting principles (GAAP). To supplement Omeros' consolidated financial statements presented in accordance with GAAP, Omeros is presenting adjusted net loss and adjusted net loss per share, which are non-GAAP financial measures. Adjusted net loss consists of GAAP net loss excluding non-cash expenses and a technology access fee.

    Omeros believes that the presentation of these non-GAAP financial measures provides important supplemental information to investors regarding financial trends relating to Omeros' results of operations and facilitates comparisons of the company's core operating performance against prior periods. The non-GAAP measures should be considered supplemental to, and not a substitute for or superior to, financial measures calculated in accordance with GAAP because non-GAAP financial measures used in this press release have limitations in that they do not reflect all costs associated with the operations of Omeros' business. In addition, these measures may be different from, and therefore not comparable to, similarly titled measures used by other companies. The accompanying table provides more detail on the GAAP financial measures that are most directly comparable to the non-GAAP financial measures described above and the related reconciliations between these financial measures.

      

    OMEROS CORPORATION

    UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS

    (In thousands, except share and per share data)

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Three Months Ended

    September 30,

     

    Nine Months Ended

    September 30,

     

     

    2020

     

    2019

     

    2020

     

    2019

    Revenue:

     

     

     

     

     

     

     

     

     

     

     

     

    Product sales, net

     

    $

    26,114

     

     

    $

    29,856

     

     

    $

    63,181

     

     

    $

    78,389

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Costs and expenses:

     

     

     

     

     

     

     

     

     

     

     

     

    Cost of product sales

     

     

    401

     

     

     

    278

     

     

     

    815

     

     

     

    464

     

    Research and development

     

     

    31,316

     

     

     

    23,746

     

     

     

    84,359

     

     

     

    69,108

     

    Selling, general and administrative

     

     

    19,825

     

     

     

    16,933

     

     

     

    54,792

     

     

     

    48,493

     

    Total costs and expenses

     

     

    51,542

     

     

     

    40,957

     

     

     

    139,966

     

     

     

    118,065

     

    Loss from operations

     

     

    (25,428

    )

     

     

    (11,101

    )

     

     

    (76,785

    )

     

     

    (39,676

    )

    Loss on early extinguishment of debt

     

     

    (13,374

    )

     

     

     

     

     

    (13,374

    )

     

     

     

    Interest expense

     

     

    (6,882

    )

     

     

    (5,715

    )

     

     

    (18,763

    )

     

     

    (16,846

    )

    Other (expense) income

     

     

    (633

    )

     

     

    353

     

     

     

    280

     

     

     

    1,261

     

    Loss before income taxes

     

     

    (46,317

    )

     

     

    (16,463

    )

     

     

    (108,642

    )

     

     

    (55,261

    )

    Income tax benefit

     

     

    7,854

     

     

     

     

     

     

    7,854

     

     

     

     

    Net loss

     

    $

    (38,463

    )

     

    $

    (16,463

    )

     

    $

    (100,788

    )

     

    $

    (55,261

    )

    Comprehensive loss

     

    $

    (38,463

    )

     

    $

    (16,463

    )

     

    $

    (100,788

    )

     

    $

    (55,261

    )

    Basic and diluted net loss per share

     

    $

    (0.66

    )

     

    $

    (0.33

    )

     

    $

    (1.81

    )

     

    $

    (1.12

    )

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

     

     

    58,233,988

     

     

     

    49,373,156

     

     

     

    55,682,379

     

     

     

    49,157,055

     

      

    OMEROS CORPORATION

    UNAUDITED CONSOLIDATED BALANCE SHEET DATA

    (In thousands)

     

     

     

    September 30,

     

     

    December 31,

     

     

     

    2020

     

     

    2019

     

    Cash, cash equivalents and short-term investments

     

    $

    153,523

     

     

    $

    60,788

     

    Working capital

     

     

    148,266

     

     

     

    48,286

     

    Restricted investments

     

     

    1,154

     

     

     

    1,154

     

    Total assets

     

     

    227,075

     

     

     

    136,969

     

    Total current liabilities

     

     

    47,719

     

     

     

    55,459

     

    Lease liabilities

     

     

    33,471

     

     

     

    35,822

     

    Unsecured convertible senior notes, net

     

     

    232,808

     

     

     

    158,213

     

    Accumulated deficit

     

     

    (835,399

    )

     

     

    (734,611

    )

    Total shareholders' deficit

     

     

    (87,326

    )

     

     

    (109,021

    )

      

    RECONCILIATION OF

    ADJUSTED NET LOSS AND ADJUSTED NET LOSS PER SHARE

    TO NET LOSS AND EARNINGS PER SHARE

    (In thousands, except per share data)

     

     

     

    Three Months Ended

    September 30, 2020

     

     

     

    Reported

    Amount

     

     

    Per Share

     

    GAAP net loss

     

    $

    (38,463

    )

     

    $

    (0.66

    )

    Non-cash expenses:

     

     

     

     

     

     

     

     

    Stock-based compensation expense

     

     

    3,824

     

     

     

    0.07

     

    Non-cash interest expense

     

     

    3,010

     

     

     

    0.05

     

    Depreciation and amortization

     

     

    404

     

     

     

    0.01

     

    Loss on early extinguishment of debt

     

     

    13,374

     

     

     

    0.23

     

    Fair value settlement upon termination of cap call contract

     

     

    838

     

     

     

    0.01

     

    Income tax benefit

     

     

    (7,854

    )

     

     

    (0.13

    )

    Technology license fee

     

     

    5,000

     

     

     

    0.19

     

    Adjusted net loss

     

    $

    (19,867

    )

     

    $

    (0.34

    )

     

    View Full Article Hide Full Article
  9. Omeros Corporation (NASDAQ:OMER) today announced that the company will issue its third quarter financial results for the period ended September 30, 2020, on Monday, November 9, 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 1738549. Please dial in approximately 10 minutes prior to the start of the call. A webcast replay will be available following the call.

    To access the…

    Omeros Corporation (NASDAQ:OMER) today announced that the company will issue its third quarter financial results for the period ended September 30, 2020, on Monday, November 9, 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 1738549. Please dial in approximately 10 minutes prior to the start of the call. A webcast replay will be available following the call.

    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. In addition to its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3%, Omeros has multiple late-stage clinical development programs focused on complement-mediated disorders, including COVID-19, and substance abuse. A rolling biologics license application for narsoplimab, the company's lead MASP-2 inhibitor, in hematopoietic stem cell transplant-associated thrombotic microangiopathy is being completed for submission to the U.S. FDA. 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.

    View Full Article Hide Full Article
  10. Omeros Corporation (NASDAQ:OMER) announced that results from its compassionate use study evaluating narsoplimab in COVID-19 patients in Italy will be shared during a virtual event being hosted today for registered participants only by ROTH Capital Partners entitled COVID-19 Therapeutics in Development: Beyond Gilead, Regeneron and Lilly. The presentation, which is part of a session on immune modulators to ameliorate COVID-19, is being made by Gregory A. Demopulos, M.D., Omeros' chairman and chief executive officer. Dr. Demopulos' slide presentation from the conference session can be viewed at https://investor.omeros.com/presentations.

    Omeros previously announced positive results from the treatment with narsoplimab of six critically ill COVID-19…

    Omeros Corporation (NASDAQ:OMER) announced that results from its compassionate use study evaluating narsoplimab in COVID-19 patients in Italy will be shared during a virtual event being hosted today for registered participants only by ROTH Capital Partners entitled COVID-19 Therapeutics in Development: Beyond Gilead, Regeneron and Lilly. The presentation, which is part of a session on immune modulators to ameliorate COVID-19, is being made by Gregory A. Demopulos, M.D., Omeros' chairman and chief executive officer. Dr. Demopulos' slide presentation from the conference session can be viewed at https://investor.omeros.com/presentations.

    Omeros previously announced positive results from the treatment with narsoplimab of six critically ill COVID-19 patients under a compassionate use protocol in Bergamo, Italy. All patients initially required mechanical ventilation and, following treatment with narsoplimab, all recovered, survived and were discharged from the hospital. Five to six months following discharge, none of the patients showed any clinical or laboratory evidence of longer-term effects from COVID-19. Additional compassionate use with narsoplimab is ongoing in Bergamo.

    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 hematopoietic stem cell transplant-associated thrombotic microangiopathy (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 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 late-stage clinical development programs focused on complement-mediated disorders, including COVID-19, and substance abuse. A rolling biologics license application for narsoplimab, the company's lead MASP-2 inhibitor, in hematopoietic stem cell transplant-associated thrombotic microangiopathy is being completed for submission to the U.S. FDA. 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, 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 August 10, 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.

    View Full Article Hide Full Article
  11. -- Webcast Scheduled for Today at 8:30am ET--

    Omeros Corporation (NASDAQ:OMER) today announced final data from its pivotal trial for narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), an often-lethal complication of stem-cell transplantation for which there is no approved therapy. Narsoplimab, an inhibitor of mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway and activator of the coagulation cascade, is being studied for the treatment of HSCT-TMA patients at high risk for poor outcomes. Narsoplimab has been awarded Breakthrough Therapy designation by U.S. FDA and is the subject of a rolling Biologics License Application (BLA) for HSCT-TMA…

    -- Webcast Scheduled for Today at 8:30am ET--

    Omeros Corporation (NASDAQ:OMER) today announced final data from its pivotal trial for narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), an often-lethal complication of stem-cell transplantation for which there is no approved therapy. Narsoplimab, an inhibitor of mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway and activator of the coagulation cascade, is being studied for the treatment of HSCT-TMA patients at high risk for poor outcomes. Narsoplimab has been awarded Breakthrough Therapy designation by U.S. FDA and is the subject of a rolling Biologics License Application (BLA) for HSCT-TMA. The nonclinical and CMC modules of the rolling BLA have already been submitted, and the final sections of the clinical module are in the publishing phase during which finalized documents are electronically processed and integrated for submission in the format required by FDA.

    Omeros previously presented preliminary data from its pivotal HSCT-TMA trial. The final data reported today are those that are included in the BLA. In the 28-patient single-arm, open-label pivotal trial in adult HSCT-TMA patients, treatment consisted of narsoplimab administered intravenously once weekly for up to 8 weeks with an extended follow-up period. The study's patient population was very ill, with the large majority of study patients having multiple comorbidities at baseline (e.g., graft-versus-host disease, significant infections, multi-organ dysfunction, etc.). The FDA-agreed primary endpoint (complete response) required clinical improvement in TMA markers (platelet count and lactate dehydrogenase [LDH]) and in organ function (renal, pulmonary, gastrointestinal or neurological) or freedom from transfusion. Secondary endpoints included 100-day and overall survival as well as change from baseline for individual laboratory markers (platelets, LDH, haptoglobin, hemoglobin and creatinine).

    The final results on primary and key secondary endpoints include:

    • 61% (95% CI: 40.6% to 78.5%) complete response rate (CRR) in the full analysis set (FAS; patient receiving at least one dose of narsoplimab; p<0.0001 compared to 15% efficacy threshold agreed with FDA)
    • 74% (95% CI: 51.6% to 89.8%) CRR in the per-protocol (PP) population (patients receiving the protocol-specified narsoplimab treatment for at least 4 weeks; p<0.0001 compared to the 15% threshold)
    • 100-day survival was 68% in the FAS, 83% in the PP population and 94% in complete responders
    • Median overall survival was 274 days in the FAS, 361 days in the PP population and, for complete responders, was not estimable (more than half of the responders were alive at last follow-up)

    Similar responses were observed across all patient subgroups defined by baseline characteristics, transplant characteristics and transplant complications. The majority of individual laboratory markers showed statistically significant improvement with the remainder numerically improving. Adverse events were typical of the post-HSCT population (e.g., fever, diarrhea, vomiting, nausea and neutropenia) and no safety signal of concern was identified. Six deaths occurred in the study, all from causes common in HSCT.

    The data will be presented today at 8:30 a.m. ET by Miguel Perales, M.D, Chief of the Adult Bone Marrow Transplant Service at Memorial Sloan Kettering Cancer Center, and 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.

    Webcast 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 7876969. Please dial in approximately 10 minutes prior to the start of the call.

    To access the live or subsequently archived webcast and presentation materials on the internet, click here or go to the company's website at www.omeros.com and select "Events" under the Investors section of the website.

    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 late-stage clinical development programs focused on complement-mediated disorders, including COVID-19, and substance abuse. A rolling biologics license application for narsoplimab, the company's lead MASP-2 inhibitor, in hematopoietic stem cell transplant-associated thrombotic microangiopathy is being completed for submission to the U.S. FDA. 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, 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 August 10, 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.

    View Full Article Hide Full Article
  12.  

    Omeros Corporation (NASDAQ:OMER) presented data from its OMS906 program yesterday at the 4th Complement-based Drug Development Summit. OMS906 is the company's lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-3 (MASP-3), the key activator of the complement system's alternative pathway. The presentation about the inhibition of the alternative pathway by targeting MASP-3 was made by Jason Cummings, Ph.D., Omeros' Associate Director for Research. Dr. Cummings' slide presentation can be viewed at https://investor.omeros.com/presentations.

    Believed to be the premier target in the alternative pathway, MASP-3 is responsible for the conversion of pro-complement factor D to mature complement factor D (CFD…

     

    Omeros Corporation (NASDAQ:OMER) presented data from its OMS906 program yesterday at the 4th Complement-based Drug Development Summit. OMS906 is the company's lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-3 (MASP-3), the key activator of the complement system's alternative pathway. The presentation about the inhibition of the alternative pathway by targeting MASP-3 was made by Jason Cummings, Ph.D., Omeros' Associate Director for Research. Dr. Cummings' slide presentation can be viewed at https://investor.omeros.com/presentations.

    Believed to be the premier target in the alternative pathway, MASP-3 is responsible for the conversion of pro-complement factor D to mature complement factor D (CFD), and OMS906 is designed to block that conversion. The presentation included data demonstrating that a single dose of OMS906 in an animal study demonstrated a decrease of mature CFD and an increase and accumulation in pro-CFD levels that remained detectable for more than three weeks. Data also showed that lowest levels of detectable mature CFD correlated with complete inactivation of the alternative pathway.

    Omeros expects OMS906 to have broad application in conditions involving inflammation and tissue damage as well as disorders associated with dysregulation of the alternative pathway. Paroxysmal nocturnal hemoglobinuria (PNH) is targeted as the initial indication, and OMS906 has shown greater potency compared to C5 and C3 inhibitors in PNH models. OMS906, by leaving intact the adaptive immune effector function of complement, is also expected to have a more favorable safety profile than C5 and C3 inhibitors.

    The targeted OMS906 long-term dosing regimen is once monthly subcutaneous administration. A Phase 1, placebo-controlled, double-blind, single-ascending-dose and multiple-ascending-dose study of OMS906 began dosing subjects last month.

    About OMS906

    OMS906 is an investigational human monoclonal antibody targeting mannan-binding lectin-associated serine protease-3 (MASP-3), the key activator of the complement system's alternative pathway. The complement system plays a central role in inflammation and becomes activated as a result of tissue damage or microbial infection. Responsible for the conversion of pro-complement factor D to complement factor D, MASP-3 is believed to be the premier target in the alternative pathway – it has the lowest native circulating level and low relative clearance compared to the other alternative pathway proteins and, unlike C5 and C3 blockers, MASP-3 inhibition leaves intact the lytic arm of the classical pathway, important for fighting infection. MASP-3 inhibitors are thought to have preventive or therapeutic effects across a broad range of diseases including paroxysmal nocturnal hemoglobinuria (PNH), hemolytic uremic syndrome (HUS), atypical HUS, traumatic brain injury, arthritis, wet age-related macular degeneration, ischemia-reperfusion injury, transplant-related complications and other immune-related disorders. Through its growing intellectual property position, Omeros controls the use of MASP-3 inhibitors across a wide range of alternative pathway-related and other diseases and disorders.

    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 late-stage clinical development programs focused on complement-mediated disorders, including COVID-19, and substance abuse. A rolling biologics license application for narsoplimab, the company's lead MASP-2 inhibitor, in hematopoietic stem cell transplant-associated thrombotic microangiopathy is being completed for submission to the U.S. FDA. 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, 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 August 10, 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.

    View Full Article Hide Full Article
  13. -- Efficacy Results Surpass Those from Preliminary Analysis Previously Reported --

    Omeros Corporation (NASDAQ:OMER) today announced that the final results of its pivotal trial of narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) will be presented in a webcast on Thursday, October 22, 2020 at 8:30 a.m. ET by Miguel Perales, M.D, Chief of the Adult Bone Marrow Transplant Service at Memorial Sloan Kettering Cancer Center, and 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.

    The data to be presented are from the final…

    -- Efficacy Results Surpass Those from Preliminary Analysis Previously Reported --

    Omeros Corporation (NASDAQ:OMER) today announced that the final results of its pivotal trial of narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) will be presented in a webcast on Thursday, October 22, 2020 at 8:30 a.m. ET by Miguel Perales, M.D, Chief of the Adult Bone Marrow Transplant Service at Memorial Sloan Kettering Cancer Center, and 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.

    The data to be presented are from the final analyses included in the narsoplimab Biologics Licensing Application (BLA) being submitted to the U.S. Food and Drug Administration (FDA) for the treatment of HSCT-TMA. The primary efficacy endpoint of complete response rate, as well as the secondary endpoints of 100-day and median overall survival, were updated based on additional data collected to provide detailed patient narratives as requested by FDA during initial discussions regarding pivotal study design and endpoints. These updated data and analyses form the basis of regulatory review and product labeling. The BLA also includes data from the HSCT-TMA compassionate-use program, which are highly consistent with the clinical trial data. The safety profile observed in the final data set remains consistent with data previously presented.

    To make the final data from the BLA first accessible to all members of the public at next week's webcast discussion by Drs. Perales and Rambaldi, rather than only to registered conference participants attending today's 4th Complement-based Drug Development Summit, the presentation that Dr. Whitaker was previously scheduled to give at today's Summit has been replaced with a presentation by Jason Cummings, Ph.D., Associate Director of Research, on Omeros' OMS906 MASP-3 inhibitor program today at 8:30 a.m. EDT.

    Webcast 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 7876969. Please dial in approximately 10 minutes prior to the start of the call.

    To access the live or subsequently archived webcast and presentation materials on the internet, click here or go to the company's website at www.omeros.com and select "Events" under the Investors section of the website.

    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 late-stage clinical development programs focused on complement-mediated disorders, including COVID-19, and substance abuse. A rolling biologics license application for narsoplimab, the company's lead MASP-2 inhibitor, in hematopoietic stem cell transplant-associated thrombotic microangiopathy is being completed for submission to the U.S. FDA. 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, 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 August 10, 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.

    View Full Article Hide Full Article
  14. —OMIDRIA meets all objective criteria established by CMS—

    Omeros Corporation (NASDAQ:OMER) today provided an update on the status of reimbursement for its cataract surgery drug OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1%/0.3%. The two-year extension of pass-through status provided by Congress through the Consolidated Appropriations Act of 2018 for OMIDRIA expired today. Omeros is actively engaged in requesting from the Centers for Medicare and Medicaid Services (CMS) and the Department of Health and Human Services (HHS) confirmation of separate payment status for OMIDRIA in the ambulatory surgery center (ASC) setting for 4Q 2020.

    Omeros has also submitted to CMS both a comment letter on the proposed Outpatient Prospective…

    —OMIDRIA meets all objective criteria established by CMS—

    Omeros Corporation (NASDAQ:OMER) today provided an update on the status of reimbursement for its cataract surgery drug OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1%/0.3%. The two-year extension of pass-through status provided by Congress through the Consolidated Appropriations Act of 2018 for OMIDRIA expired today. Omeros is actively engaged in requesting from the Centers for Medicare and Medicaid Services (CMS) and the Department of Health and Human Services (HHS) confirmation of separate payment status for OMIDRIA in the ambulatory surgery center (ASC) setting for 4Q 2020.

    Omeros has also submitted to CMS both a comment letter on the proposed Outpatient Prospective Payment System/ASC Rule for Calendar Year (CY) 2021 and a legal opinion from the law firm Foley Hoag LLP, reiterating that CMS regulations require non-opioid drugs that meet the objective regulatory criteria specified by CMS, including OMIDRIA, to be paid separately when used in the ASC setting. Omeros and its advisors are confident that (1) CMS is required by law to apply its separate payment policy for non-opioid pain management surgical drugs to OMIDRIA for 4Q 2020 and for CY 2021 and (2) CMS will address this issue soon and no later than its CY 2021 Final Rule, which is expected to be released on or shortly after November 1.

    CMS' policy for separate payment applies to non-opioid pain management surgical drugs that are used in the ASC setting and that are policy-packaged under CMS' Outpatient Prospective Payment System. Now that its pass-through status has expired, OMIDRIA meets each of the objective regulatory criteria established by CMS for separate payment in the ASC payment system both for the remainder of 2020 and for CY 2021 – CMS has confirmed in previous annual rules that OMIDRIA is a non-opioid pain management drug used in the ASC setting that is policy packaged as a drug that functions as a supply in a surgical procedure. For further details, please see the comment letters referenced above, which can be found on the investor relations section of Omeros' website at www.investor.omeros.com under "featured reports" or, once posted by the government, at https://www.regulations.gov/docket?D=CMS-2020-0090.

    CMS is the primary insurer for 40-45 percent of cataract surgery patients. The large majority of cataract surgery procedures are performed in ASCs. In addition to Omeros' current request with CMS and HHS for confirmation of separate payment in the ASCs, the Non-Opioids Prevent Addiction In the Nation (NOPAIN) Act (H.R.5172 and S. 3067) is continuing to make progress through both chambers of Congress. The bill has strong and growing bipartisan support, currently with over 50 sponsors and co-sponsors in the House of Representatives and more than 20 in the Senate. If enacted, the bill would provide separate Medicare reimbursement for non-opioid treatments to manage pain, like OMIDRIA, in both ASCs and hospital outpatient departments, renewable every five years. In any event, Omeros will remain committed to physicians' ability to select the best medical care for their patients and to providing access to OMIDRIA for all cataract surgery patients.

    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 late-stage clinical development programs focused on complement-mediated disorders, including COVID-19, and substance abuse. A rolling biologics license application for narsoplimab, the company's lead MASP-2 inhibitor, in hematopoietic stem cell transplant-associated thrombotic microangiopathy is being completed for submission to the U.S. FDA. 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.

    About OMIDRIA®

    Omeros' OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1% / 0.3% is the first and only FDA-approved product of its kind and is marketed in the U.S. for use during cataract surgery or intraocular lens replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. OMIDRIA also is the only NSAID-containing product FDA-approved for intraocular use. In post-launch studies across conventional and femtosecond laser-assisted cataract surgery, OMIDRIA has been shown to (1) prevent intraoperative floppy iris syndrome (IFIS) and iris prolapse, (2) significantly reduce complication rates (including sight-threatening cystoid macular edema and breakthrough iritis), use of pupil-expansion devices, and surgical times, (3) significantly reduce intraoperative use of the opioid fentanyl and postoperative prescription opioids, and (4) significantly improve uncorrected visual acuity on the first day following cataract surgery. While OMIDRIA is broadly indicated for use in cataract surgery, the post-launch outcomes cited above are not in its currently approved labeling.

    Important Safety Information for OMIDRIA®

    Systemic exposure of phenylephrine may cause elevations in blood pressure. In clinical trials, the most common reported ocular adverse reactions at two percent or greater are eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation; incidence of adverse events was similar between placebo-treated and OMIDRIA-treated patients. OMIDRIA must be added to irrigation solution prior to intraocular use.

    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," "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 payment and reimbursement status, expectations for continued separate payment for OMIDRIA and expected qualification for an exception from packaged payment, 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 ongoing clinical trials and the results of such trials, changes in regulatory policy, political factors, 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 on March 2, 2020, as supplemented by its subsequently filed Quarterly Reports on Form 10-Q. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future.

    Source: Omeros Corporation

    View Full Article Hide Full Article
  15. Omeros Corporation (NASDAQ:OMER) today announced that Gregory A. Demopulos, M.D., chairman and chief executive officer, will present at the Cantor Virtual Global Healthcare Conference next week. The presentation is scheduled for Tuesday, September 15, 2020 at 11:20 a.m. EDT.

    The presentation will be webcast. The live and archived webcasts can be accessed on the investor relations section of the company's website at www.omeros.com under "Events."

    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…

    Omeros Corporation (NASDAQ:OMER) today announced that Gregory A. Demopulos, M.D., chairman and chief executive officer, will present at the Cantor Virtual Global Healthcare Conference next week. The presentation is scheduled for Tuesday, September 15, 2020 at 11:20 a.m. EDT.

    The presentation will be webcast. The live and archived webcasts can be accessed on the investor relations section of the company's website at www.omeros.com under "Events."

    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 late-stage clinical development programs focused on complement-mediated disorders, including COVID-19, and substance abuse. A rolling biologics license application for narsoplimab, the company's lead MASP-2 inhibitor, in hematopoietic stem cell transplant-associated thrombotic microangiopathy is being completed for submission to the U.S. FDA. 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.

    View Full Article Hide Full Article
  16. - Omeros' investigational agent narsoplimab discussed as a potentially highly effective therapy -

    Omeros Corporation (NASDAQ:OMER) today announced that the Demy-Colton Virtual Salon Series featured an expert discussion of developments in the treatment of severe COVID-19. The panel session, entitled Lessons from Bergamo: Discoveries in Treating Critically-ill COVID-19 Patients, was held on September 2, 2020 and included international experts in hematology, oncology and complement science. The panel was moderated by Sara Jane Demy, founder and chief executive officer of Demy-Colton. A replay of the panel can be viewed here (free registration required).

    The panel discussed the emerging evidence that endothelial injury and the activation of…

    - Omeros' investigational agent narsoplimab discussed as a potentially highly effective therapy -

    Omeros Corporation (NASDAQ:OMER) today announced that the Demy-Colton Virtual Salon Series featured an expert discussion of developments in the treatment of severe COVID-19. The panel session, entitled Lessons from Bergamo: Discoveries in Treating Critically-ill COVID-19 Patients, was held on September 2, 2020 and included international experts in hematology, oncology and complement science. The panel was moderated by Sara Jane Demy, founder and chief executive officer of Demy-Colton. A replay of the panel can be viewed here (free registration required).

    The panel discussed the emerging evidence that endothelial injury and the activation of the lectin pathway of complement are central drivers of the acute respiratory distress syndrome (ARDS) and thrombosis seen in critically ill COVID-19 patients. Narsoplimab, Omeros' investigational human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the key effector of the lectin pathway of complement, was identified as a potentially highly effective therapy to treat critically ill COVID-19 patients.

    Omeros previously announced positive results from the treatment with narsoplimab of six critically ill COVID-19 patients under a compassionate use protocol. All patients initially required mechanical ventilation and, following treatment with narsoplimab, all recovered, survived and were discharged from the hospital.

    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 hematopoietic stem cell transplant-associated thrombotic microangiopathy (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 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 late-stage clinical development programs focused on complement-mediated disorders, including COVID-19, and substance abuse. A rolling biologics license application for narsoplimab, the company's lead MASP-2 inhibitor, in hematopoietic stem cell transplant-associated thrombotic microangiopathy is being completed for submission to the U.S. FDA. 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, 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 August 10, 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.

    View Full Article Hide Full Article
  17. -- Paroxysmal Nocturnal Hemoglobinuria Slated as Initial Indication --

    Omeros Corporation today announced that its Investigational New Drug Application (IND) to begin clinical trials with OMS906 has been cleared by the U.S. Food and Drug Administration (FDA). OMS906 is the company's lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-3 (MASP-3), the key activator of the complement system's alternative pathway.

    FDA's clearance of the IND allows the initiation of the clinical program for OMS906. A Phase 1, placebo-controlled, double-blind, single-ascending-dose and multiple-ascending-dose study will evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of OMS906 administered subcutaneously…

    -- Paroxysmal Nocturnal Hemoglobinuria Slated as Initial Indication --

    Omeros Corporation today announced that its Investigational New Drug Application (IND) to begin clinical trials with OMS906 has been cleared by the U.S. Food and Drug Administration (FDA). OMS906 is the company's lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-3 (MASP-3), the key activator of the complement system's alternative pathway.

    FDA's clearance of the IND allows the initiation of the clinical program for OMS906. A Phase 1, placebo-controlled, double-blind, single-ascending-dose and multiple-ascending-dose study will evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of OMS906 administered subcutaneously and intravenously to healthy subjects. Enrollment is planned to begin in early September. The trial will provide additional information regarding the anticipated OMS906 dosing regimen in patients, which is targeted for once monthly subcutaneous administration. Following adequate Phase 1 data collection and analysis, the initial Phase 2 clinical trial is planned in patients with life-threatening paroxysmal nocturnal hemoglobinuria (PNH), a rare disease characterized by red blood cell destruction, blood clots and impaired bone marrow function.

    "FDA's decision clears the way for us to begin clinical trials with OMS906," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "Based on its mechanism of action, we believe that OMS906 will demonstrate a better safety profile and/or more convenient dosing than other drugs on the market or in development for PNH. By inhibiting MASP-3, the key activator of the alternative pathway of complement, the potential indications for OMS906 are expansive. The therapeutic rationale for MASP-3 inhibition and OMS906 are sound, and we look forward to seeing what the drug will do in the clinic."

    MASP-3 is responsible for the conversion of pro-factor D to factor D. It is believed to be the premier target in the alternative pathway with the lowest native circulating level and low relative clearance compared to the other alternative pathway proteins. Also, unlike C5 and C3 blockers, MASP-3 inhibition leaves intact the lytic arm of the classical pathway, important for fighting infection. Omeros has created a broad intellectual property position directed to the use of MASP-3 inhibitors, including OMS906, for the treatment of a wide range of disorders related to dysfunction or excessive activation of the complement system's alternative pathway. As part of its complement franchise, Omeros also broadly controls the inhibition of MASP-2, the effector enzyme of the lectin pathway of complement. A rolling biologics license application (BLA) for Omeros' lead MASP-2 inhibitor narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) is targeted for completion this quarter. Narsoplimab is also in Phase 3 clinical programs for immunoglobulin A (IgA) nephropathy and atypical hemolytic uremic syndrome and is being advanced to treat critically ill patients with COVID-19.

    About OMS906

    OMS906 is an investigational human monoclonal antibody targeting mannan-binding lectin-associated serine protease-3 (MASP-3), the key activator of the complement system's alternative pathway. The complement system plays a central role in inflammation and becomes activated as a result of tissue damage or microbial infection. Responsible for the conversion of pro-factor D to factor D, MASP-3 is believed to be the premier target in the alternative pathway – it has the lowest native circulating level and low relative clearance compared to the other alternative pathway proteins and, unlike C5 and C3 blockers, MASP-3 inhibition leaves intact the lytic arm of the classical pathway, important for fighting infection. MASP-3 inhibitors are thought to have preventive or therapeutic effects across a broad range of diseases including paroxysmal nocturnal hemoglobinuria (PNH), hemolytic uremic syndrome (HUS), atypical HUS, traumatic brain injury, arthritis, wet age-related macular degeneration, ischemia-reperfusion injury, transplant-related complications and other immune-related disorders. Through its growing intellectual property position, Omeros controls the use of MASP-3 inhibitors across a wide range of alternative pathway-related diseases and disorders.

    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 late-stage clinical development programs focused on complement-mediated disorders, including COVID-19, and substance abuse. A rolling biologics license application for narsoplimab, the company's lead MASP-2 inhibitor, in hematopoietic stem cell transplant-associated thrombotic microangiopathy is being completed for submission to the U.S. FDA. 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.

     

    View Full Article Hide Full Article
  18. --6,900,000 Shares of Common Stock--
    --$210,000,000 of 5.25% Convertible Senior Notes due 2026--

    Omeros Corporation (NASDAQ:OMER) ("Omeros") today announced that it has priced concurrent underwritten public offerings of 6,900,000 of shares of its common stock (the "Shares") at a public offering price of $14.50 per Share for proceeds of approximately $100,050,000, prior to the deduction of underwriting discounts and commissions and estimated offering expenses payable by Omeros (the "Equity Offering"), and $210,000,000 aggregate principal amount of 5.25% convertible senior notes due 2026 (the "2026 Convertible Notes" and such offering, the "Notes Offering"). In addition, Omeros has granted to the underwriters of the Equity Offering a 30-day…

    --6,900,000 Shares of Common Stock--

    --$210,000,000 of 5.25% Convertible Senior Notes due 2026--

    Omeros Corporation (NASDAQ:OMER) ("Omeros") today announced that it has priced concurrent underwritten public offerings of 6,900,000 of shares of its common stock (the "Shares") at a public offering price of $14.50 per Share for proceeds of approximately $100,050,000, prior to the deduction of underwriting discounts and commissions and estimated offering expenses payable by Omeros (the "Equity Offering"), and $210,000,000 aggregate principal amount of 5.25% convertible senior notes due 2026 (the "2026 Convertible Notes" and such offering, the "Notes Offering"). In addition, Omeros has granted to the underwriters of the Equity Offering a 30-day option to purchase up to an additional 1,035,000 Shares and to the underwriters of the Notes Offering a 30-day option, solely to cover over-allotments, to purchase up to an additional $31,500,000 aggregate principal amount of 2026 Convertible Notes. The Equity Offering and the Notes Offering are each expected to close on August 14, 2020, subject to customary closing conditions. Neither offering is contingent on the completion of the other offering.

    BofA Securities and JP Morgan are acting as the book-running managers for the Equity Offering. Cantor Fitzgerald is also acting as a book-running manager, and WBB Securities is acting as co-manager, for the Equity Offering. BofA Securities, JP Morgan and RBC Capital Markets are acting as the book-running managers for the Notes Offering.

    The 2026 Convertible Notes will be senior unsecured obligations of Omeros and will bear interest at a rate of 5.25% per year, payable semi-annually in arrears. The 2026 Convertible Notes will mature on February 15, 2026, unless earlier converted, repurchased or redeemed in accordance with their terms, and will be convertible, subject to the satisfaction of certain conditions, into cash, shares of Omeros' common stock or a combination thereof as elected by Omeros in its sole discretion.

    The initial conversion rate for the 2026 Convertible Notes is 54.0906 shares of Omeros' common stock per $1,000 principal amount of 2026 Convertible Notes (which is equivalent to an initial conversion price of approximately $18.49 per share, which represents a premium of approximately 27.5% over the public offering price of Omeros' common stock in the Equity Offering of $14.50 per share). Omeros will have the right to redeem the 2026 Convertible Notes on or after August 15, 2023, subject to certain conditions and limitations.

    The Equity Offering is expected to result in approximately $93.7 million in net proceeds to Omeros, and the Notes Offering is expected to result in approximately $203.7 million in net proceeds to Omeros, in each case, after deducting underwriting discounts and commissions and estimated offering expenses payable by Omeros, and in each case, assuming no exercise of the underwriters' option to purchase additional Shares or 2026 Convertible Notes.

    Omeros intends to use approximately $21.7 million of the net proceeds of the Notes Offering to fund the cost of entering into capped call transactions with the option counterparties, as described below. In addition, Omeros intends to use approximately $127.4 million of the net proceeds of the Notes Offering to repurchase approximately $115 million aggregate principal amount of its existing 6.25% Convertible Senior Notes due 2023 (the "2023 Convertible Notes") in privately negotiated transactions as described below, and expects to receive approximately $8.4 million from unwinding a proportionate amount of the capped call transaction that it entered into with a financial institution (the "existing option counterparty") in connection with the issuance of the 2023 Convertible Notes (the "existing capped call transaction").

    Omeros intends to use the net proceeds from the Equity Offering and the remainder of the net proceeds from the Notes Offering for general corporate purposes, including funding clinical trials, pre-clinical studies, manufacturing, build-out of commercial infrastructure and other costs associated with advancing its development programs and product candidates toward regulatory submissions and potential commercialization.

    In connection with the pricing of the 2026 Convertible Notes, Omeros entered into privately negotiated capped call transactions with certain financial institutions ("option counterparties"). The capped call transactions are intended to reduce the potential dilution with respect to Omeros' common stock or, at its election (subject to certain conditions), offset potential cash payments in excess of the principal amount of the converted 2026 Convertible Notes, upon conversion of the 2026 Convertible Notes, with such reduction or offset subject to a cap of $26.10, representing a premium of 80% over the public offering price of Omeros' common stock in the Equity Offering. If the underwriters exercise their option to purchase additional 2026 Convertible Notes, Omeros expects to enter into additional capped call transactions with the option counterparties.

    Omeros has been informed that in connection with establishing their initial hedges of the capped call transactions, the option counterparties and/or their affiliates expect to purchase shares of Omeros' common stock and/or enter into various derivative transactions with respect to Omeros' common stock concurrently with or shortly after the pricing of the 2026 Convertible Notes. This activity could increase (or reduce the size of any decrease in) the market price of Omeros' common stock or the 2026 Convertible Notes at that time.

    In addition, the option counterparties and/or their affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to Omeros' common stock and/or purchasing or selling Omeros' common stock or other securities of Omeros' in secondary market transactions prior to the maturity of the 2026 Convertible Notes (and are likely to do so on each exercise date of the capped call transactions, which are expected to occur during the 50-trading day period beginning on the 51st scheduled trading day prior to the maturity date of the notes, or following any termination of any portion of the capped call transactions in connection with any repurchase, redemption or conversion of the 2026 Convertible Notes if Omeros makes the relevant election under the capped call transactions). This activity could also cause or avoid an increase or a decrease in the market price of Omeros' common stock or the 2026 Convertible Notes, which could affect a noteholder's ability to convert the 2026 Convertible Notes and, to the extent the activity occurs during any observation period related to a conversion of the 2026 Convertible Notes, could affect the amount and value of the consideration that a noteholder will receive upon conversion of the 2026 Convertible Notes.

    Concurrently with the Notes Offering, Omeros intends to use approximately $127.4 million of the proceeds from the offering to repurchase approximately $115 million aggregate principal amount of its outstanding 2023 Convertible Notes in privately negotiated transactions. Omeros expects that holders of the 2023 Convertible Notes that sell their 2023 Convertible Notes to Omeros in any note repurchase transaction may enter into or unwind various derivatives with respect to Omeros' common stock and/or purchase or sell shares of Omeros' common stock in the market to hedge their exposure in connection with these transactions. This activity could increase (or reduce the size of any decrease in) the market price of Omeros' common stock or the 2026 Convertible Notes at that time and could result in a higher effective conversion price for the 2026 Convertible Notes.

    In connection with the repurchase of the 2023 Convertible Notes, Omeros intends to terminate a portion of the existing capped call transaction in a notional amount corresponding to the amount of such 2023 Convertible Notes repurchased. In connection with the partial termination of the existing capped call transaction and the related unwinding of the existing hedge position of the existing option counterparty with respect to such transaction, the existing option counterparty and/or its respective affiliates are expected to sell shares of Omeros' common stock in secondary market transactions, and/or enter into or unwind various derivative transactions with respect to Omeros' common stock. This activity could decrease (or reduce the size of any increase in) the market price of Omeros' common stock or the 2026 Convertible Notes at that time.

    The Equity Offering and the Notes Offering are being made pursuant to Omeros' shelf registration statement on Form S-3 (File No. 333-235349) including the base prospectus contained therein, and a prospectus supplement related to the Equity Offering (together with such base prospectus, the "Equity Prospectus") and a prospectus supplement related to the Notes Offering (together with such base prospectus, the "Notes Prospectus"), all of which Omeros filed or will file with the Securities and Exchange Commission ("SEC"). Before investing in the Shares or the 2026 Convertible Notes, investors should read the Equity Prospectus and the Notes Prospectus, respectively, in each case, including the documents incorporated by reference therein, and any free writing prospectus related to the Equity Offering and the Notes Offering, as the case may be. These documents may be freely obtained by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, copies may be obtained, when available, from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or via email: and J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by e-mail at .

    This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities of Omeros. The Shares and the 2026 Convertible Notes (and any shares of Omeros' common stock issuable upon conversion of the 2026 Convertible Notes) are not being offered in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

    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 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, including, without limitation, statements regarding expectations with respect to granting the underwriters options to purchase additional shares or notes, completion of the proposed offerings, the anticipated use of proceeds of the proposed offerings, any expected selling or hedging activities of various counterparties or other market participants and the potential impact on trading in or the market price of Omeros' stock, constitute forward-looking statements. These forward-looking statements are often indicated by terms such as "anticipate," "believe," "could," "estimate," "expect," "goal," "intend," "likely," "may," "plan," "potential," "predict," "project," "should," "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, 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 SEC on March 2, 2020, as supplemented by the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, which was filed with the SEC on August 10, 2020, and subsequent reports filed 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.

    View Full Article Hide Full Article
  19. Omeros Corporation (NASDAQ:OMER) ("Omeros") today announced that it has commenced concurrent underwritten public offerings of $125,000,000 of shares of its common stock (the "Shares") and $200,000,000 aggregate principal amount of convertible senior notes due 2026 (the "2026 Convertible Notes"). In addition, Omeros has granted to the underwriters of the offering of Shares (the "Equity Offering") a 30-day option to purchase up to an additional $18,750,000 of Shares and to the underwriters of the offering of 2026 Convertible Notes (the "Notes Offering") a 30-day option, solely to cover over-allotments, to purchase up to an additional $30,000,000 aggregate principal amount of 2026 Convertible Notes. The offerings are subject to market and other…

    Omeros Corporation (NASDAQ:OMER) ("Omeros") today announced that it has commenced concurrent underwritten public offerings of $125,000,000 of shares of its common stock (the "Shares") and $200,000,000 aggregate principal amount of convertible senior notes due 2026 (the "2026 Convertible Notes"). In addition, Omeros has granted to the underwriters of the offering of Shares (the "Equity Offering") a 30-day option to purchase up to an additional $18,750,000 of Shares and to the underwriters of the offering of 2026 Convertible Notes (the "Notes Offering") a 30-day option, solely to cover over-allotments, to purchase up to an additional $30,000,000 aggregate principal amount of 2026 Convertible Notes. The offerings are subject to market and other conditions, and there can be no assurance as to whether or when the offerings may be completed or as to the actual size or terms of the offerings. Neither offering is contingent on the completion of the other offering.

    BofA Securities and JP Morgan are acting as the book-running managers for each of the offerings.

    The 2026 Convertible Notes will mature on February 15, 2026, unless earlier converted, repurchased or redeemed in accordance with their terms, and will be convertible, subject to the satisfaction of certain conditions, into cash, shares of Omeros' common stock or a combination thereof as elected by Omeros in its sole discretion. The 2026 Convertible Notes will be senior unsecured obligations of Omeros. Interest will be payable on the 2026 Convertible Notes semi-annually in arrears. Omeros will have the right to redeem the 2026 Convertible Notes on or after August 15, 2023, subject to certain conditions and limitations. Final terms of the 2026 Convertible Notes, including the interest rate, initial conversion rate and other terms, will be determined upon pricing of the Notes Offering.

    Omeros intends to use a portion of the net proceeds of the Notes Offering to fund the cost of entering into capped call transactions with the option counterparties, as described below. In addition, Omeros intends to use a portion of the net proceeds of the Notes Offering to repurchase a portion of its existing 6.25% Convertible Senior Notes due 2023 (the "2023 Convertible Notes") in privately negotiated transactions as described below.

    Omeros intends to use the net proceeds from the Equity Offering and the remainder of the net proceeds from the Notes Offering, if any, for general corporate purposes, including funding clinical trials, pre-clinical studies, manufacturing, build-out of commercial infrastructure and other costs associated with advancing its development programs and product candidates toward regulatory submissions and potential commercialization.

    In connection with the pricing of the 2026 Convertible Notes, Omeros expects to enter into one or more privately negotiated capped call transactions with one or more financial institutions ("option counterparties"). The capped call transactions are intended to reduce the potential dilution with respect to Omeros' common stock or, at its election (subject to certain conditions), offset potential cash payments in excess of the principal amount of the converted 2026 Convertible Notes, upon conversion of the 2026 Convertible Notes, with such reduction or offset subject to a cap. If the underwriters exercise their option to purchase additional 2026 Convertible Notes, Omeros expects to enter into additional capped call transactions with the option counterparties.

    Omeros has been informed that in connection with establishing their initial hedges of the capped call transactions, the option counterparties and/or their affiliates expect to purchase shares of Omeros' common stock and/or enter into various derivative transactions with respect to Omeros' common stock concurrently with or shortly after the pricing of the 2026 Convertible Notes. This activity could increase (or reduce the size of any decrease in) the market price of Omeros' common stock or the 2026 Convertible Notes at that time.

    In addition, the option counterparties and/or their affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to Omeros' common stock and/or purchasing or selling Omeros' common stock or other securities of Omeros' in secondary market transactions following the pricing of the 2026 Convertible Notes and prior to the maturity of the 2026 Convertible Notes (and are likely to do so on each exercise date of the capped call transactions, which are expected to occur during the 50-trading day period beginning on the 51st scheduled trading day prior to the maturity date of the notes, or following any termination of any portion of the capped call transactions in connection with any repurchase, redemption or conversion of the 2026 Convertible Notes if Omeros makes the relevant election under the capped call transactions). This activity could also cause or avoid an increase or a decrease in the market price of Omeros' common stock or the 2026 Convertible Notes, which could affect a noteholder's ability to convert the 2026 Convertible Notes and, to the extent the activity occurs during any observation period related to a conversion of the 2026 Convertible Notes, could affect the amount and value of the consideration that a noteholder will receive upon conversion of the 2026 Convertible Notes.

    Concurrently with the Notes Offering, Omeros expects to use a portion of the proceeds from the offering to repurchase a portion of its outstanding 2023 Convertible Notes in privately negotiated transactions. Omeros expects that holders of the 2023 Convertible Notes that sell their 2023 Convertible Notes to Omeros in any note repurchase transaction may enter into or unwind various derivatives with respect to Omeros' common stock and/or purchase or sell shares of Omeros' common stock in the market to hedge their exposure in connection with these transactions. This activity could increase (or reduce the size of any decrease in) the market price of Omeros' common stock or the 2026 Convertible Notes at that time and could result in a higher effective conversion price for the 2026 Convertible Notes.

    In connection with any repurchase of the 2023 Convertible Notes, Omeros expects to terminate, concurrently with or shortly after the pricing of the notes, a portion of the existing capped call transaction (the "existing capped call transaction") that Omeros entered into with a financial institution (the "existing option counterparty") when the 2023 Convertible Notes were issued in a notional amount corresponding to the amount of such 2023 Convertible Notes repurchased, if any. In connection with any termination of the existing capped call transaction and the related unwinding of the existing hedge position of the existing option counterparty with respect to such transaction, the existing option counterparty and/or its respective affiliates are expected to sell shares of Omeros' common stock in secondary market transactions, and/or enter into or unwind various derivative transactions with respect to Omeros' common stock. This activity could decrease (or reduce the size of any increase in) the market price of Omeros' common stock or the 2026 Convertible Notes at that time and could result in a lower effective conversion price for the 2026 Convertible Notes.

    The Equity Offering and the Notes Offering are being made pursuant to Omeros' shelf registration statement on Form S-3 (File No. 333-235349) including the base prospectus contained therein, a preliminary prospectus supplement related to the Equity Offering (together with such base prospectus, the "Equity Prospectus") and a preliminary prospectus supplement related to the Notes Offering (together with such base prospectus, the "Notes Prospectus"), all of which Omeros filed or will file with the Securities and Exchange Commission ("SEC"). Before investing in the Shares or the 2026 Convertible Notes, investors should read the Equity Prospectus and the Notes Prospectus, respectively, in each case, including the documents incorporated by reference therein, and any free writing prospectus related to the Equity Offering and the Notes Offering, as the case may be. These documents may be freely obtained by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, copies may be obtained, when available, from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or via email: and J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by e-mail at .

    This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities of Omeros. The Shares and the 2026 Convertible Notes (and any shares of Omeros' common stock issuable upon conversion of the 2026 Convertible Notes) are not being offered in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

    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 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, including, without limitation, statements regarding the size of the proposed offerings, expectations with respect to granting the underwriters options to purchase additional shares or notes, completion of the proposed offerings, the anticipated use of proceeds of the proposed offerings, any expected selling or hedging activities of various counterparties or other market participants and the potential impact on trading in or the market price of Omeros' stock, constitute forward-looking statements. These forward-looking statements are often indicated by terms such as "anticipate," "believe," "could," "estimate," "expect," "goal," "intend," "likely," "may," "plan," "potential," "predict," "project," "should," "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, 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 SEC on March 2, 2020, as supplemented by the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, which was filed with the SEC on August 10, 2020, and subsequent reports filed 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.

    View Full Article Hide Full Article
  20. 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 second quarter ended June 30, 2020, which include:

    • Revenues for the second quarter of 2020 were $13.5 million, compared to $26.8 million in the second quarter of 2019 and $23.5 million in the first quarter of 2020. The decreases reflect the impact of the postponement of cataract procedures by ASCs…

    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 second quarter ended June 30, 2020, which include:

    • Revenues for the second quarter of 2020 were $13.5 million, compared to $26.8 million in the second quarter of 2019 and $23.5 million in the first quarter of 2020. The decreases reflect the impact of the postponement of cataract procedures by ASCs and hospitals due to COVID-19. Cataract surgery resumed beginning in the second half of May 2020, and by the end of June 2020, the run rate of weekly OMIDRIA sales approximated levels seen prior to the pandemic.
    • Net loss in the second quarter of 2020 was $33.3 million, or $0.61 per share. This compares to a net loss of $14.5 million, or $0.29 per share, in the second quarter of 2019. Net loss in the second quarter of 2020 included non-cash expenses of $6.9 million, or $0.13 per share.
    • Six COVID-19 patients in Italy with acute respiratory distress syndrome (ARDS) were treated with narsoplimab under a compassionate use program. All patients, who initially required mechanical ventilation, recovered, survived and were discharged from the hospital. Narsoplimab treatment was associated with rapid and sustained improvement across all assessed markers of endothelial/cellular damage and/or inflammation.
    • Omeros completed submission to FDA of the chemistry, manufacturing and controls (CMC) information for the Company's rolling Biologic License Application (BLA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
    • Omeros submitted a clinical trial application to European regulators and an investigational new drug application to the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial for OMS906, the company's MASP-3 inhibitor.

    "The data from COVID-19 patients treated with narsoplimab clearly support the growing body of scientific literature pointing to the central role of MASP-2 and the lectin pathway in COVID-19-related lung injury," said Gregory A. Demopulos, M.D., Omeros' chairman and chief executive officer. "Narsoplimab represents the first time that a lectin pathway inhibitor has been used to treat COVID-19 and, in addition to complement inhibition, brings what appears to be a unique benefit – anticoagulant effects, which may also prove to be very important in the treatment of this disease and other endothelial injury syndromes. Discussions with U.S. government agencies are underway with the objective of expanding the availability of narsoplimab to COVID-19 patients. We are also rapidly advancing toward regulatory approval for narsoplimab in the treatment of transplant-associated TMA. We have recently completed submission of the remaining CMC portion of our rolling BLA. We are targeting this quarter for the completion of the BLA, and preparations for anticipated commercial launch are proceeding well. We also reached a key milestone in our OMS906 program, with the on-schedule submission of the clinical trial application. In addition, we filed an IND to FDA to increase the likelihood of initiating enrollment next month. I am immensely proud of our team – they've continued to adapt to the challenges imposed by COVID-19, advancing our clinical and development programs and improving the lives of patients."

    Second Quarter and Recent Developments

    • In response to a request from physicians in Bergamo, Italy, Omeros implemented a compassionate use program for narsoplimab to treat six COVID-19 patients with ARDS requiring continuous positive airway pressure (CPAP) or intubation prior to treatment. All narsoplimab-treated patients recovered and survived. Narsoplimab was associated with rapid and sustained reduction of circulating endothelial cell counts and concurrent reduction of serum levels of IL-6, IL-8, LDH, D-dimer and AST. Narsoplimab was well tolerated and no adverse drug reactions were reported. A retrospective comparison of two control groups with similar entry criteria and baseline characteristics showed significantly higher mortality rates, at 32 percent and 53 percent, than the narsoplimab-treated group. A manuscript detailing the results of the study has been accepted for publication in the peer-reviewed journal Immunobiology.



      Endothelial damage, which can play an early and central pathogenic role in ARDS and thrombosis, activates the lectin pathway of complement. Mannan-binding lectin-associated serine protease-2 (MASP-2), the lectin pathway's effector enzyme and the target for narsoplimab, binds the nucleocapsid protein of severe acute respiratory syndrome-associated coronavirus-2 (SARS-CoV-2) – the virus responsible for COVID-19 – resulting in complement activation and lung injury.



      Discussions are progressing between Omeros and offices in the Department of Health and Human Services, including the Biomedical Advanced Research and Development Authority (BARDA), along with the National Institutes of Health Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program regarding potential funding to accelerate large-scale manufacturing to enable broader availability of narsoplimab for COVID-19 patients and for other COVID-19-related programmatic activities.
    • Recent developments regarding narsoplimab, Omeros' lead human monoclonal antibody targeting 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:
      • In preparation for the anticipated commercial launch of narsoplimab, Omeros is working closely with the transplant community, patient advocacy groups and payers.
      • Results from the pivotal trial of narsoplimab in the treatment of HSCT-TMA will be presented at the virtual annual meeting of the European Society of Bone Marrow Transplant (EBMT) in August by Dr. Rafael Duarte, chair of the 2020 EBMT meeting.
      • Professor Alessandro Rambaldi of the University of Milan and the Director of the Department of Hematology and Oncology at the Papa Giovanni XXIII Hospital presented results from the HSCT-TMA pivotal trial at the 25th Annual Congress of the European Hematology Association in June.
      • An article authored by a group from the University of Leicester led by Dr. Jonathan Barratt PhD, FCRP, Professor of Renal Medicine, has been published in the peer-reviewed journal Drugs of the Future. The manuscript describes the beneficial effects of narsoplimab in IgA vasculitis-associated nephritis, a rapidly progressive glomerulonephritis.
      • An article titled "Inhibition of the lectin pathway of the complement system as a novel approach in the management of IgA vasculitis associated nephritis" was published in Nephron.
      • A 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 in IgA nephropathy, has been accepted for publication by the peer-reviewed journal Kidney International Reports.



    • Recent developments regarding OMIDRIA include the following:
      • Data from a study demonstrating the effect of OMIDRIA on reducing instances of postoperative cystoid macular edema, breakthrough iritis and pain as well as the need for postoperative topical steroids was presented at the virtual American Society of Cornea and Refractive Surgery Congress in May.
    • Updates regarding Omeros' other development programs and platforms include the following:
      • Omeros submitted a clinical trial application in June to European regulators as well as an investigational new drug application to FDA in July to initiate a Phase 1 clinical trial for OMS906, the company's MASP-3 inhibitor and currently expects to begin enrollment in the Phase 1 trial in September.

    Financial Results

    For the second quarter of 2020, revenues, all related to sales of OMIDRIA, were $13.5 million, down from $26.8 million for the same period in 2019 and $23.5 million for the first quarter of 2020. The decrease in the current quarter is due to ambulatory centers (ASCs) and hospitals postponing nearly all cataract surgeries from mid-March until mid-May due to the COVID-19 pandemic. Cataract surgeries resumed beginning in the second half of May 2020 and by the end of June 2020, the run rate of weekly OMIDRIA sales approximated levels seen prior to the pandemic.

    Total costs and expenses for the first quarter of 2020 were $41.2 million compared to $36.1 million for the same period in 2019. The increase reflects incremental narsoplimab manufacturing costs together with increased costs supporting the preparation of our rolling BLA for HSCT-TMA in the U.S. Selling, general and administrative expenses were $16.9 million for both the second quarter of 2020 and the corresponding period in 2019.

    For the three months ended June 30, 2020, Omeros reported a net loss of $33.3 million, or $0.61 per share, compared to a net loss of $14.5 million, or $0.29 per share, for the same period in 2019. Net loss in the second quarter of 2020 included non-cash expenses of $6.9 million, or $0.13 per share, while net loss in the second quarter of 2019 included non-cash expenses of $6.3 million, or $0.13 per share.

    As of June 30, 2020, Omeros had $16.1 million of cash, cash equivalents and short-term investments available for operations and accounts receivable of $15.8 million.

    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 inflammation, 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 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 August 10, 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

    June 30,

     

    Six Months Ended

    June 30,

     

     

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

     

    Revenue:

     

     

     

     

     

     

     

     

     

     

     

     

     

    Product sales, net

     

    $

    13,530

     

     

    $

    26,753

     

     

    $

    37,067

     

     

    $

    48,532

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Costs and expenses:

     

     

     

     

     

     

     

     

     

     

     

     

     

    Cost of product sales

     

     

    147

     

     

     

    55

     

     

     

    414

     

     

     

    186

     

     

    Research and development

     

     

    24,132

     

     

     

    19,108

     

     

     

    53,043

     

     

     

    45,363

     

     

    Selling, general and administrative

     

     

    16,931

     

     

     

    16,928

     

     

     

    34,967

     

     

     

    31,560

     

     

    Total costs and expenses

     

     

    41,210

     

     

     

    36,091

     

     

     

    88,424

     

     

     

    77,109

     

     

    Loss from operations

     

     

    (27,680

    )

     

     

    (9,338

    )

     

     

    (51,357

    )

     

     

    (28,577

    )

     

    Interest expense

     

     

    (5,978

    )

     

     

    (5,530

    )

     

     

    (11,880

    )

     

     

    (11,130

    )

     

    Other income

     

     

    364

     

     

     

    415

     

     

     

    912

     

     

     

    909

     

     

    Net loss

     

    $

    (33,294

    )

     

    $

    (14,453

    )

     

    $

    (62,325

    )

     

    $

    (38,798

    )

     

    Comprehensive loss

     

    $

    (33,294

    )

     

    $

    (14,453

    )

     

    $

    (62,325

    )

     

    $

    (38,798

    )

     

    Basic and diluted net loss per share

     

    $

    (0.61

    )

     

    $

    (0.29

    )

     

    $

    (1.14

    )

     

    $

    (0.79

    )

     

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

     

     

    54,513,337

     

     

     

    49,084,093

     

     

     

    54,406,575

     

     

     

    49,048,432

     

     

    OMEROS CORPORATION

    UNAUDITED CONSOLIDATED BALANCE SHEET DATA

    (In thousands)

     

     

     

    June 30,

     

     

    December 31,

     

     

     

    2020

     

     

    2019

     

    Cash, cash equivalents and short-term investments

     

    $

    16,088

     

     

    $

    60,788

     

    Working capital

     

     

    880

     

     

     

    48,286

     

    Restricted investments

     

     

    1,154

     

     

     

    1,154

     

    Total assets

     

     

    70,689

     

     

     

    136,969

     

    Total current liabilities

     

     

    38,047

     

     

     

    55,459

     

    Lease liabilities

     

     

    34,242

     

     

     

    35,822

     

    Unsecured convertible senior notes and lease financing obligations, net

     

     

    163,372

     

     

     

    158,213

     

    Accumulated deficit

     

     

    (796,936

    )

     

     

    (734,611

    )

    Total shareholders' deficit

     

     

    (161,270

    )

     

     

    (109,021

    )

     

    View Full Article Hide Full Article
  21. -- All six patients, requiring mechanical ventilation prior to treatment, recovered, survived and were discharged from the hospital

    -- Narsoplimab treatment was associated with rapid and sustained improvement across all assessed markers of endothelial/cellular damage and/or inflammation

    -- Omeros is in discussions with U.S. government agencies regarding acceleration of narsoplimab manufacturing for use in COVID-19 patients

    -- Conference call and webcast today at 8:30 a.m. ET, 5:30 a.m. PT

    Omeros Corporation (NASDAQ:OMER) today reported the results of a compassionate-use study evaluating narsoplimab, Omeros' investigational human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), in the treatment…

    -- All six patients, requiring mechanical ventilation prior to treatment, recovered, survived and were discharged from the hospital

    -- Narsoplimab treatment was associated with rapid and sustained improvement across all assessed markers of endothelial/cellular damage and/or inflammation

    -- Omeros is in discussions with U.S. government agencies regarding acceleration of narsoplimab manufacturing for use in COVID-19 patients

    -- Conference call and webcast today at 8:30 a.m. ET, 5:30 a.m. PT

    Omeros Corporation (NASDAQ:OMER) today reported the results of a compassionate-use study evaluating narsoplimab, Omeros' investigational human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), in the treatment of COVID-19 patients with Acute Respiratory Distress Syndrome (ARDS), a severe and life-threatening symptom of COVID-19. All patients initially required mechanical ventilation, and all recovered and survived with narsoplimab treatment. A manuscript detailing the results of the study has been accepted for publication in the peer-reviewed journal Immunobiology. A pre-publication copy of the manuscript can be accessed at https://www.sciencedirect.com/science/article/pii/S0171298520304459.

    Rationale for the use of narsoplimab for treatment of COVID-19 patients with ARDS

    In COVID-19, ARDS and thrombotic events are frequent, life-threatening complications. Autopsies commonly show arterial thrombosis and severe endothelial damage. Endothelial damage, which can play an early and central pathogenic role in ARDS and thrombosis, activates the lectin pathway of complement. MASP-2, the lectin pathway's effector enzyme and the target for narsoplimab, binds the nucleocapsid protein of severe acute respiratory syndrome-associated coronavirus-2 (SARS-CoV-2) – the virus responsible for COVID-19 – resulting in complement activation and lung injury. Numerous articles have been published detailing and further confirming specific aspects of the central role of endothelial injury, activation of the complement system and the lectin pathway and thrombosis development in COVID-19.

    Narsoplimab also has been evaluated in patients in hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), another often-lethal thrombotic disorder associated with endothelial damage. In its pivotal HSCT-TMA trial, narsoplimab-treated patients demonstrated marked improvement in laboratory and clinical endpoints and unexpected survival. With FDA's Breakthrough Therapy designation, submission of a rolling Biologics Licensing Application for narsoplimab is underway in this indication.

    In addition to its inhibitory effect on lectin pathway activation, narsoplimab has been shown to block microvascular injury-associated thrombus formation as well as MASP-2-mediated activation of thrombin, kallikrein and factor XII. These unique anticoagulant effects may provide therapeutic benefits in both HSCT-TMA and COVID-19. Importantly, narsoplimab leaves the complement system's classical pathway and adaptive immune response fully intact, and does not appear to increase infection risk.

    Study Origin

    The study was initiated in response to a request from treating physicians at the Papa Giovanni XXIII Hospital in Bergamo, Italy. The principal investigator, Alessandro Rambaldi, MD, Professor of Hematology at the University of Milan and Head of the Department of Hematology and Oncology at Papa Giovanni, was a lead investigator in the pivotal trial for narsoplimab in HSCT-TMA. Given the clinical and pathologic similarities between COVID-19 and HSCT-TMA, Professor Rambaldi requested that narsoplimab be made available under compassionate use for patients at his hospital in Bergamo, the initial epicenter of the COVID-19 pandemic in Europe.

    "The patients that we treated with narsoplimab were critically ill, and the uniformly successful outcomes were truly impressive," said Professor Rambaldi. "Also of importance in this terribly sick population studied, the drug was well tolerated, showing no adverse effects. The pathophysiology of COVID-19 appears to be consistent with that of stem cell transplant-associated TMA, and the mechanism of the lectin pathway inhibitor narsoplimab looks to be well suited to treat the often-lethal manifestations of both disorders. The outcomes in these six patients provide further evidence of the potential role of narsoplimab in treating diseases caused by endothelial damage."

    Study Results

    In this study, the first time a lectin-pathway inhibitor was used to treat COVID-19, six COVID-19 patients with ARDS requiring continuous positive airway pressure (CPAP) or intubation received narsoplimab. The median age of the patients was 57 years (range 47 – 63 years), 83 percent were men, and all had comorbidities. At baseline, circulating endothelial cell (CEC) counts and serum levels of interleukin-6 (IL-6), interleukin-8 (IL-8), C-reactive protein (CRP), lactate dehydrogenase (LDH), D-dimer and aspartate aminotransferase (AST) – all markers of endothelial/cellular damage and/or inflammation – were significantly elevated. Narsoplimab treatment was begun within 48 hours of initiation of mechanical ventilation. Dosing occurred twice weekly for two to four weeks.

    • All narsoplimab-treated patients recovered, survived and were discharged from the hospital
    • Narsoplimab treatment was associated with rapid and sustained reduction across all assessed markers of endothelial/cellular damage and/or inflammation – CEC, IL-6, IL-8, CRP, LDH, D-dimer and AST
      • Temporal patterns of laboratory markers were consistent with the observed clinical improvement
      • In particular, CEC counts appear to be a reliable tool to evaluate endothelial damage and treatment response in this disease
      • The temporal improvement of IL-6 and IL-8 with narsoplimab treatment suggests that lectin pathway activation may precede cytokine elevation in COVID-19 and that lectin pathway inhibition has a beneficial effect on the cytokine storm described in patients with COVID-19 infection
    • The courses of two patients (one requiring intubation and the other on CPAP) were further complicated by massive bilateral pulmonary thromboses, and both patients recovered with narsoplimab, possibly benefitting from the drug's anticoagulant effects
    • Narsoplimab was well tolerated in the study and no adverse drug reactions were reported
    • Two control groups with similar entry criteria and baseline characteristics were used for retrospective comparison, both showing substantial mortality rates at 32 percent and 53 percent

    "We are excited by the results in Bergamo," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "The work at Papa Giovanni, for the first time, puts many of the COVID-19 pieces together – endothelial injury and the pathophysiology of COVID-19, complement activation and clinical evidence of the potential therapeutic role of the lectin pathway inhibitor narsoplimab in treating this disease. We look forward to being able to make narsoplimab broadly available to hospitalized COVID-19 patients."

    U.S. Government Support

    Discussions are progressing between Omeros and offices in the Department of Health and Human Services, including the Biomedical Advanced Research and Development Authority (BARDA), along with the National Institutes of Health Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program regarding potential funding to accelerate large-scale manufacturing to enable broader availability of narsoplimab for COVID-19 patients and for other COVID-19-related programmatic activities.

    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, in clinical studies, inhibition of MASP-2 has not appeared 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.

    Omeros has completed a pivotal trial of narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) and submission of a rolling Biologics License Application is underway. Phase 3 clinical programs are also in progress 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.

    Conference Call and Webcast Details

    Omeros' management will host a webcast and conference call to present the results of a compassionate-use study evaluating narsoplimab in the treatment of COVID-19 patients with ARDS. The call will be held today at 8:30 a.m. Eastern Time; 5:30 a.m. Pacific Time. To access the live conference call via phone, please dial (888) 771-4371 from the United States and Canada or (847) 585-4405 internationally. The participant passcode is 49889435. Please dial in approximately 10 minutes prior to the start of the call.

    To access the live or subsequently archived webcast and presentation materials on the internet, go to https://edge.media-server.com/mmc/p/drfb96md or 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 product OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1%/0.3%, Omeros has multiple clinical-stage development programs focused on complement-mediated disorders and substance abuse. In addition, the company 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, anticipated outcomes of discussions with government agencies, and the expectations regarding the therapeutic utility of Omeros' investigational product in COVID-19 and other indications, 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 on March 2, 2020, as supplemented by the Company's quarterly reports on Form 10-Q. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and 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.

    View Full Article Hide Full Article
  22. 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.

    View Full Article Hide Full Article
  23. 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.

    View Full Article Hide Full Article
  24. 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.

    View Full Article Hide Full Article
  25. – 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

    )

     

    View Full Article Hide Full Article
  26. 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
  27. Ranpak Holdings Corp. ("Ranpak") (NYSE:PACK), a leading provider of environmentally sustainable, systems-based, product protection solutions for e-commerce and industrial supply chains, today announced that on March 3, 2020, Kurt Zumwalt was appointed to the company's board of directors, effective immediately. Most recently, Mr. Zumwalt was Global Treasurer of Amazon.com, where he spent 15 years managing the company's cash, investments and debt financings, in addition to other finance-related duties.

    Mr. Zumwalt brings extensive experience in executive leadership and scaling global businesses to Ranpak's board. At Amazon, Mr. Zumwalt played an integral role in facilitating growth at Amazon by building and scaling the company's treasury and…

    Ranpak Holdings Corp. ("Ranpak") (NYSE:PACK), a leading provider of environmentally sustainable, systems-based, product protection solutions for e-commerce and industrial supply chains, today announced that on March 3, 2020, Kurt Zumwalt was appointed to the company's board of directors, effective immediately. Most recently, Mr. Zumwalt was Global Treasurer of Amazon.com, where he spent 15 years managing the company's cash, investments and debt financings, in addition to other finance-related duties.

    Mr. Zumwalt brings extensive experience in executive leadership and scaling global businesses to Ranpak's board. At Amazon, Mr. Zumwalt played an integral role in facilitating growth at Amazon by building and scaling the company's treasury and financing capability as its revenue grew from $8 billion to over $250 billion on an annualized basis. He left Amazon in August 2019 and is currently on the board of directors of Omeros Corporation (NASDAQ:OMER), an innovative biopharmaceutical company, as well as both the United States Tennis Association (USTA) and the USTA Foundation.

    "We're excited to welcome Kurt to Ranpak's board of directors," said Omar Asali, Chairman and Chief Executive Officer of Ranpak. "Kurt is a recognized leader in the e-Commerce industry whose extensive commercial and corporate strategy experience will be instrumental as we execute on our vision of growth and expansion at Ranpak."

    "Ranpak is at the forefront of improving the environmental sustainability of supply chains throughout the world." said Zumwalt. "I'm thrilled to be part of a company with the goal of helping businesses improve efficiency while reducing their environmental footprint and I look forward to helping Omar and the Ranpak team bring their vision to organizations around the world."

    About Ranpak

    Founded in 1972, Ranpak's goal was to create the first environmentally responsible system to protect products during shipment. The development and improvement of materials, systems and total solution concepts have earned Ranpak a reputation as an innovative leader in e-commerce and industrial supply chain solutions. Ranpak is headquartered in Concord Township, Ohio and has approximately 550 employees.

    Additional Information and Where to Find It

    Additional information about Ranpak can be found on its website: https://www.ranpak.com

    View Full Article Hide Full Article
  28. – 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, 2019, which include:

    • 4Q 2019 OMIDRIA® revenues were $33.4 million, Omeros' highest revenue quarter to date and representing another quarter of double-digit growth of 12 percent compared to 3Q 2019.
    • Full year…

    – 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, 2019, which include:

    • 4Q 2019 OMIDRIA® revenues were $33.4 million, Omeros' highest revenue quarter to date and representing another quarter of double-digit growth of 12 percent compared to 3Q 2019.
    • Full year 2019 OMIDRIA revenues were $111.8 million, a 274 percent increase from the prior year.
    • Net loss in 4Q 2019 was $29.2 million, or $0.58 per share. Net loss for the full year 2019 was $84.5 million, or $1.71 per share. Non-cash expenses for the fourth quarter and the full year of 2019 were $6.3 million, or $0.12 per share, and $24.8 million, or $0.50 per share, respectively. Included in both 4Q and full year net loss is $12.6 million, or $0.25 per share, in connection with Omeros' election to accelerate the manufacturing schedule for a one-time set of five narsoplimab process validation and commercial lots. These lots were successfully manufactured, provide data to satisfy the BLA process validation requirements, and can be used for commercial sales following approval.
    • At December 31, 2019, the company had cash, cash equivalents and short-term investments available for operations of $60.8 million.
    • Data from the narsoplimab pivotal registration trial met the FDA-agreed primary efficacy endpoint, with complete response rates of 54 percent (p<0.0001) in all patients receiving at least one dose of narsoplimab and 65 percent (p<0.0001) in all patients receiving at least the protocol-specified four weeks of dosing, well surpassing the FDA-agreed threshold for efficacy of 15 percent.



      On the secondary endpoint of 100-day survival, 68 percent of all patients receiving at least one dose of narsoplimab achieved 100-day survival, with 83 percent of patients receiving at least the protocol-specified four weeks of dosing and 93 percent of responders achieving the endpoint. Experts familiar with the pivotal trial data would expect a 100-day survival rate of less than 20 percent in this population.

    "2019 was a year of tremendous accomplishment for Omeros," stated Gregory A. Demopulos, M.D., Omeros' chairman and chief executive officer. "Our pivotal trial in HSCT-TMA generated data that substantially surpass FDA's agreed threshold for efficacy and enabled submission of the first sections of our rolling BLA, OMIDRIA delivered record annual sales of $112 million, and we discovered a cancer immunity axis controlled by GPR174, a target that we control and expect could change the immuno-oncology landscape. And 2020 is shaping up to be an even better year. We are on track to complete submission of the narsoplimab BLA for HSCT-TMA and look forward to FDA's review and approval as we move the drug toward two additional indications in IgA nephropathy and aHUS. We expect that 2020 will also bring continued growth in OMIDRIA sales, further clinical development of our OMS527 addiction program, a Phase 1 trial for our MASP-3 inhibitor OMS906, and ongoing progress with our MASP-2 small-molecule inhibitor and next-generation antibody as well as our GPR174 antagonists, driving them toward the clinic. We've built a top-tier group of first-in-kind assets, are delivering on their promise, and expect that they will significantly improve the lives of patients and their families."

    Fourth Quarter and Recent Developments

    • 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 hematopoietic stem-cell transplant-associated thrombotic microangiopathy (HSCT-TMA), Immunoglobulin A (IgA) nephropathy, and atypical hemolytic uremic syndrome (aHUS), include the following:
      • Omeros recently announced positive data across primary and secondary endpoints in its pivotal trial of narsoplimab in HSCT-TMA patients.
        • The primary endpoint is a set of rigorous response criteria requiring improvements in HSCT-TMA laboratory markers and improvement in clinical status. The FDA-agreed threshold for the efficacy primary endpoint in the very sick patient population treated in this trial is a response rate of 15 percent. Across all patients receiving at least one dose of narsoplimab, 54 percent (p<0.0001) were complete responders; in patients receiving at least the protocol-specified four weeks of narsoplimab treatment, the complete response rate was 65 percent (p<0.0001).
        • The secondary endpoints include survival rates and change from baseline in laboratory markers. The 100-day survival rate was 68 percent in all patients who received at least one dose of narsoplimab, 83 percent in patients who received at least the protocol-specified 4 weeks of narsoplimab treatment, and 93 percent in responders. Experts familiar with the pivotal trial data would expect a 100-day survival rate of less than 20 percent in this population. Across all patients, statistically significant improvement was seen in platelet count and LDH and haptoglobin levels (p<0.01 for each marker).
        • The most commonly reported adverse events in the trial were diarrhea, nausea, vomiting, hypokalemia, neutropenia and fever – all common in stem-cell transplant patients. Six deaths also occurred during the trial and were due to sepsis, progression of the underlying disease and graft-versus-host disease. All of these are common causes of death in this patient population.
      • In February 2020, Omeros met with FDA to discuss the chemistry, manufacturing and controls aspects of the Biologics License Application (BLA) for narsoplimab in HSCT-TMA. At the meeting, FDA requested near-term manufacturing dates for narsoplimab so that FDA's pre-approval inspections could be scheduled. FDA and Omeros also reached agreement on requirements for stability data and release assays for the BLA
      • Data from the narsoplimab pivotal trial in HSCT-TMA were presented and discussed by a panel of international experts in hematopoietic stem-cell transplantation at a recent continuing medical education symposium held at the Transplant and Cellular Therapy Conference in Orlando.
      • Omeros initiated a collaboration with myTomorrows, a global health technology company, to broaden its expanded access program to support international availability of narsoplimab to eligible patients who have no other treatment options.
      • The ARTEMIS-IGAN Phase 3 clinical trial for narsoplimab in IgA nephropathy is ongoing at 91 sites in the U.S. and internationally, with additional sites coming on line. Data readout is expected next year.
      • Multiple manuscripts directed to narsoplimab in IgA nephropathy have been accepted for publication or are under review by peer-reviewed journals. Most recently, a review article entitled "MASP-2 Inhibition as Potential Strategy for IgA Nephropathy Management" authored by Drs. Jonathan Barratt of University of Leicester and Richard Lafayette of Stanford University was accepted for publication in the journal Drugs of the Future.
    • Recent developments regarding OMIDRIA include the following:
      • The Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act was introduced in the both the U.S. House of Representatives and the U.S. Senate during the fourth quarter. The proposed legislation has strong bipartisan backing in both chambers of Congress and is supported by a diverse group of grassroots organizations. If passed, the legislation would mandate separate payment by Centers for Medicare and Medicaid Services (CMS) for a period of five years for non-opioid pain treatments used during surgery, like OMIDRIA.
      • The new product-specific permanent J-code for OMIDRIA became effective on October 1, 2019. J-codes standardize the submission and payment of insurance claims across Medicare, Medicare Advantage, Medicaid and commercial insurance plans.
    • Updates regarding Omeros' other development programs and platforms include the following:
      • Omeros' MASP-3 inhibitor OMS906 is on track for clinical entry in June of this year. Initially targeting paroxysmal nocturnal hemoglobinuria (PNH), OMS906 is expected to allow monthly subcutaneous dosing.
      • Following positive results from the Phase 1 study, Omeros is planning for a Phase 2 trial of its phosphodiesterase 7 inhibitor OMS527 in nicotine addiction.
      • In the fourth quarter of 2019, Omeros presented new data on its GPR174 immuno-oncology program at international medical congresses. Data from human ex vivo studies demonstrate that GPR174 inhibition results in downregulation of checkpoint and tumor-promoting factors. In addition, data from animal models reveal enhanced anti-tumor immune responses in GPR174-deficient mice and synergism between adenosine receptor antagonists and GPR174 antagonists in promoting interleukin-2 (IL-2) and interferon-γ (IFN-γ) production from human T cells. Omeros discovered a cancer-immunity axis controlled by GPR174 and is building an exclusive intellectual property position directed to modulation of GPR174 for the treatment of cancer.
    • In December 2019, Omeros raised $54.2 million in net proceeds in an underwritten offering of common stock.

    Financial Results

    Fourth Quarter 2019

    For the quarter ended December 31, 2019, revenues were $33.4 million, all relating to sales of OMIDRIA. This compares to OMIDRIA revenue of $22.0 million for the same period in 2018. On a sequential quarter-over-quarter basis, OMIDRIA revenue increased by $3.6 million or 12 percent. The increases from the prior year and from the prior quarter are primarily due to a growing number of purchasing accounts as well as deeper penetration within accounts across hospitals, ambulatory surgery centers and government payers.

    Total operating costs and expenses for the quarter ended December 31, 2019 were $57.1 million compared to $40.5 million for the comparable period in 2018 and $41.0 million in the preceding quarter. The increase in both cases primarily reflects $12.6 million of expenses incurred ahead of schedule due to Omeros' election to accelerate the manufacturing schedule for a one-time set of five narsoplimab process validation and commercial lots. These lots were successfully manufactured, provide data to satisfy the BLA process validation requirements, and can be used for commercial sales following approval.

    For the three months ended December 31, 2019, Omeros reported a net loss of $29.2 million or $0.58 per share, which included non-cash expenses of $6.3 million ($0.12 per share) and the aforementioned manufacturing expenses of $12.6 million ($0.25 per share). This compares to the prior year's fourth quarter when Omeros reported a net loss of $23.5 million, or $0.48 per share, which included non-cash expenses of $4.9 million ($0.10 per share).

    Full Year 2019

    Revenues for the full year 2019 were $111.8 million compared to $29.9 million for full year 2018. The significant increase year-over-year is primarily due to the status of pass-through reimbursement. During the period January 1, 2018 to September 30, 2018, OMIDRIA was not reimbursed separately under Medicare Part B. This had a significant negative impact on revenues during 2018. Following reinstatement of pass-through reimbursement on October 1, 2018, OMIDRIA revenues quickly returned to and exceeded previous levels.

    For the year ending December 31, 2019, total costs and expenses were $175.2 million compared to $142.1 million in the prior year. The increase for the current year compared to the prior year is due primarily to the additional narsoplimab manufacturing, an increase in spending on preclinical research and development in our OMS906 program and the resumption of OMIDRIA marketing activities following reinstatement of pass-through reimbursement on October 1, 2018.

    At December 31, 2019, the company had cash, cash equivalents and short-term investments available for operations of $60.8 million and an accounts receivable balance of $35.2 million. The company also has an accounts receivable-based line of credit which permits borrowing up to the lesser of $50.0 million and 85 percent of eligible accounts receivable, subject to applicable reserves. We have 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 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 4870947. 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 4870947.

    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, 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 on March 2, 2020. 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

    December 31,

     

    Year Ended

    December 31,

     

     

    2019

     

    2018

     

    2019

     

    2018

    Revenues:

     

     

     

     

     

     

     

     

     

     

     

     

    Product sales, net

     

    $

    33,417

     

    $

    22,017

     

    $

    111,805

     

    $

    29,868

     

     

     

     

     

     

     

     

     

     

     

     

     

    Costs and expenses:

     

     

     

     

     

     

     

     

     

     

     

     

    Cost of product sales

     

     

    401

     

     

    157

     

     

    865

     

     

    512

    Research and development

     

     

    40,588

     

     

    25,446

     

     

    109,696

     

     

    89,860

    Selling, general and administrative

     

     

    16,132

     

     

    14,888

     

     

    64,626

     

     

    51,718

    Total costs and expenses

     

     

    57,121

     

     

    40,491

     

     

    175,187

     

     

    142,090

    Loss from operations

     

     

    (23,704)

     

     

    (18,474)

     

     

    (63,382)

     

     

    (112,222)

    Loss on early extinguishment of debt

     

     

     

     

    (12,993)

     

     

     

     

    (12,993)

    Interest expense

     

     

    (5,811)

     

     

    (5,149)

     

     

    (22,657)

     

     

    (16,252)

    Other income

     

     

    290

     

     

    153

     

     

    1,553

     

     

    1,781

    Loss before income taxes

     

     

    (29,225)

     

     

    (36,463)

     

     

    (84,486)

     

     

    (139,686)

    Income tax benefit

     

     

     

     

    12,929

     

     

     

     

    12,929

    Net loss

     

    $

    (29,225)

     

    $

    (23,534)

     

    $

    (84,486)

     

    $

    (126,757)

    Basic and diluted net loss per share

     

    $

    (0.58)

     

    $

    (0.48)

     

    $

    (1.71)

     

    $

    (2.61)

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

     

     

    50,622,516

     

     

    48,029,195

     

     

    49,523,444

     

     

    48,582,636

    OMEROS CORPORATION

    UNAUDITED CONSOLIDATED BALANCE SHEET DATA

    (In thousands)

     

     

     

     

     

     

     

     

     

    December 31,

    2019

     

    December 31,

    2018

    Cash, cash equivalents and short-term investments

     

    $

    60,788

     

    $

    60,498

    Working capital

     

     

    48,286

     

     

    52,511

    Restricted investments

     

     

    1,154

     

     

    1,154

    Total assets

     

     

    136,969

     

     

    95,936

    Total current liabilities

     

     

    55,459

     

     

    37,356

    Lease liability

     

     

    35,822

     

     

    2,467

    Unsecured convertible senior notes, net

     

     

    158,213

     

     

    148,981

    Accumulated deficit

     

     

    (734,611)

     

     

    (650,125)

    Total shareholders' deficit

     

     

    (109,021)

     

     

    (100,156)

     

    View Full Article Hide Full Article
  29. Results Surpass FDA-Agreed Efficacy Threshold –

    Omeros Corporation (NASDAQ:OMER) today reports an update on clinical data from its pivotal trial of narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), markedly exceeding the FDA-agreed threshold for the primary efficacy endpoint. While an overview of preliminary data submitted to FDA was made public on December 4, 2019 in a press release from the company, all patients have now completed treatment and trial enrollment has been closed. Narsoplimab is Omeros' human monoclonal antibody targeting mannan-binding lectin-associated serine protease 2 (MASP-2).

    In recent meetings with FDA focused on clinical as well as chemistry, manufacturing…

    Results Surpass FDA-Agreed Efficacy Threshold –

    Omeros Corporation (NASDAQ:OMER) today reports an update on clinical data from its pivotal trial of narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), markedly exceeding the FDA-agreed threshold for the primary efficacy endpoint. While an overview of preliminary data submitted to FDA was made public on December 4, 2019 in a press release from the company, all patients have now completed treatment and trial enrollment has been closed. Narsoplimab is Omeros' human monoclonal antibody targeting mannan-binding lectin-associated serine protease 2 (MASP-2).

    In recent meetings with FDA focused on clinical as well as chemistry, manufacturing and controls (CMC) data, FDA confirmed important aspects of Omeros' rolling Biologics License Application (BLA) for narsoplimab in HSCT-TMA. The BLA continues on its clear path to completion.

    The efficacy threshold agreed with FDA, the updated results from the 28-patient trial, and highlights of the recent FDA meetings are the following:

    Primary Endpoint

    • 15% is the FDA-agreed efficacy threshold for the primary endpoint (i.e., the complete response rate [CRR]) in the clinical trial
    • The CRR for the study population, and the lower limit of the 95 percent confidence interval (95% CI), significantly exceed the efficacy threshold:
      • 54 percent CRR (95% CI = 34 percent to 72 percent, p-value < 0.0001) in patients who received at least one dose of narsoplimab
      • 65 percent CRR (95% CI = 43 percent to 84, p-value < 0.0001) in patients who received the protocol-specified narsoplimab treatment of at least 4 weeks of dosing
    • As described in the December 4, 2019 press release, the FDA-agreed primary endpoint (the CRR) is the proportion of patients who fully achieve a rigorous set of response criteria, requiring both improvement in HSCT-TMA laboratory markers (platelet count and lactate dehydrogenase [LDH] levels) and improvement in clinical status comprised of organ (renal, pulmonary, gastrointestinal and neurological) function and transfusions (platelet and red blood cells). The full response criteria are provided below.

    Secondary Endpoints

    • The 100-day survival (defined as survival from the day of HSCT-TMA diagnosis) is 68 percent in all treated patients, 83 percent in patients who received at least 4 weeks of narsoplimab treatment as specified by the protocol, and 93 percent in patients who responded to narsoplimab treatment. Experts familiar with the pivotal trial data would expect a 100-day survival rate of less than 20 percent in the trial population.
    • Preliminary results of the laboratory secondary efficacy endpoints (change from pre-treatment baseline for each laboratory value) continue to demonstrate meaningful improvement and meet statistical significance in platelet count, LDH and haptoglobin (p < 0.01 in all treated patients).

    Safety

    • The most commonly reported adverse events in the trial were diarrhea, nausea, vomiting, hypokalemia, neutropenia and fever – all common in stem-cell transplant patients.
    • Six deaths occurred during the trial. These were due to sepsis, progression of the underlying disease, and graft-versus-host disease, all common causes of death in this patient population.

    The treated population had multiple high-risk features that portend a poor outcome, including the persistence of HSCT-TMA despite modification of immunosuppression (which was a criterion for entry into the trial), graft-versus-host disease, significant infections, non-infectious pulmonary complications and neurological findings. Patients in the trial had a high expected mortality rate, with 93% of them having multiple risk factors.

    "The efficacy and safety data from the pivotal trial with narsoplimab are encouraging," said Miguel-Angel Perales, M.D., Deputy Chief of the Adult Bone Marrow Transplantation Service and Director of the Adult Stem Cell Transplantation Fellowship at Memorial Sloan Kettering Cancer Center. "Given the trial's stringent response criteria across laboratory markers and organ function, the complete response rate seen with narsoplimab is remarkable, as is the 100-day survival. There currently is no approved treatment for HSCT-TMA. Current therapy is generally limited to supportive care and withdrawal of drugs critical for GVHD prophylaxis. Not only could narsoplimab become central to the treatment of HSCT-TMA, it might well allow us to maintain that needed GVHD prophylaxis."

    Complete clinical trial data will be presented by Dr. Perales later this month at the Annual Meeting of the European Society for Blood and Marrow Transplantation in Madrid.

    Recent FDA Meeting Highlights and CMC Updates

    • FDA confirmed that the number of HSCT-TMA patients enrolled is sufficient for the BLA's filing and review for approval. FDA agreed to stopping enrollment.
    • FDA requested near-term manufacturing dates for narsoplimab so that FDA's pre-approval inspections could be scheduled.
    • FDA and Omeros' reached agreement on CMC requirements for stability data and release assays.
    • Omeros elected to accelerate the manufacturing schedule for a one-time set of five narsoplimab process validation and commercial lots. These lots were successfully manufactured by Omeros' manufacturing partner Lonza, satisfy the BLA requirements and can be used for commercial sale following approval.

    "The non clinical sections of our BLA have been submitted, our CMC campaign is progressing well with process validation and commercial lots already manufactured, and our pivotal trial is complete," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "The efficacy threshold agreed with FDA reflects both the primary endpoint's stringent response criteria and the poor outcomes expected in the patients enrolled in our trial. Of course, we're very pleased that the response rates and confidence intervals seen with narsoplimab are well above that efficacy threshold. We look forward to continuing to work closely with regulators to make the drug commercially available to transplanters and their patients in the U.S. and internationally as quickly as possible."

    In addition to its HSCT-TMA program, Omeros is enrolling its narsoplimab Phase 3 clinical trials for immunoglobulin A (IgA) nephropathy and atypical hemolytic uremic syndrome (aHUS). Narsoplimab has been granted, for both HSCT-TMA and IgA nephropathy, FDA's breakthrough therapy designation as well as orphan drug designations from FDA and the European Medicines Agency. The drug also holds FDA's fast-track designation for aHUS.

    Primary Efficacy Endpoint

    To be considered a responder, a patient must achieve the primary endpoint of complete HSCT-TMA response defined by improvement in laboratory markers and improvement in clinical status.

    Laboratory Markers

    • Criteria for improvement in laboratory markers are LDH less than 1.5 x upper limit of normal AND improvement of platelet count measures:
      • For patients with baseline platelet count ≤20,000/μL, response requires tripling over baseline platelet count, a post-baseline platelet count >30,000/μL, and freedom from platelet transfusion
      • For patients with baseline platelet count >20,000/ μL, response requires: an increase in platelet count by ≥50%, a post-baseline platelet count >75,000 /μL, and freedom from platelet transfusion

    Clinical Status

    • Criteria for improvement in clinical status requires at least one of the following:
      • Renal response requires >40% reduction in creatinine, or normalization of creatinine and >20% reduction in creatinine, or discontinuation of renal replacement therapy
      • Pulmonary response requires extubation and discontinuation of ventilator support, or discontinuation of non-invasive mechanical ventilation (continuous positive pressure ventilation)
      • Gastrointestinal response applicable only to patients with biopsy-proven gastrointestinal HSCT-TMA and requires improvement in gastrointestinal function as determined by the Mount Sinai Acute GVHD International Consortium (MAGIC) criteria
      • Neurological response requires improvement in reversible neurological conditions (e.g., cessation of seizures), or stabilization of irreversible neurological conditions (e.g., stability of neurological deficits following stroke without further deterioration or subsequent strokes)
      • Freedom from transfusion only applicable if patient was undergoing transfusion at baseline

    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 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, the company 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.

    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 hematopoietic stem cell transplant-associated thrombotic microangiopathy (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.

    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 on March 2, 2020. 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.

    Dr. Miguel-Angel Perales has received compensation from Omeros for advisory services.

    View Full Article Hide Full Article
  30. Omeros Corporation (NASDAQ:OMER) today announced that the company will issue its fourth quarter and year-end 2019 financial results for the period ended December 31, 2019, on Monday, March 2, 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 4870947. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week…

    Omeros Corporation (NASDAQ:OMER) today announced that the company will issue its fourth quarter and year-end 2019 financial results for the period ended December 31, 2019, on Monday, March 2, 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 4870947. 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 4870947.

    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 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, 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
  31. -- Zumwalt Also to Serve as Consultant, Bringing Extensive Capital Markets Background to Omeros --

    Omeros Corporation (NASDAQ:OMER) today announced the appointment of Kurt Zumwalt, former global treasurer of Amazon.com, Inc., to Omeros' Board of Directors. He will also serve in a consulting role at Omeros. Mr. Zumwalt brings significant expertise in developing comprehensive business relationships with major banks and financial institutions.

    A 15-year veteran of Amazon, Mr. Zumwalt was responsible for managing the company's cash, investments and debt financings, in addition to other finance-related duties. During his tenure, he led his team in raising short- and long-term financings in excess of $40 billion for Amazon. Mr. Zumwalt built…

    -- Zumwalt Also to Serve as Consultant, Bringing Extensive Capital Markets Background to Omeros --

    Omeros Corporation (NASDAQ:OMER) today announced the appointment of Kurt Zumwalt, former global treasurer of Amazon.com, Inc., to Omeros' Board of Directors. He will also serve in a consulting role at Omeros. Mr. Zumwalt brings significant expertise in developing comprehensive business relationships with major banks and financial institutions.

    A 15-year veteran of Amazon, Mr. Zumwalt was responsible for managing the company's cash, investments and debt financings, in addition to other finance-related duties. During his tenure, he led his team in raising short- and long-term financings in excess of $40 billion for Amazon. Mr. Zumwalt built and scaled Amazon's treasury and financing capability as the company's revenue grew from $8 billion to over $250 billion on an annualized basis. Mr. Zumwalt managed Amazon's relationships with more than 45 banks globally. He left Amazon in August 2019.

    "Literally down the street from Amazon is Omeros – I have followed the company for years and recognize what the Omeros team is building," said Mr. Zumwalt. "I am impressed by the company's cutting-edge science, remarkable pipeline and strong leadership. I know Greg well, understand his vision for Omeros and am confident that I can contribute significantly. It's exciting to join a company focused on improving patients' lives, and I am eager to help further the continued success of Omeros."

    Prior to joining Amazon in 2004, Mr. Zumwalt was Assistant Treasurer at PACCAR, Treasurer at ProBusiness Services until its acquisition by ADP in 2003, and has also held various financial roles at Wind River Systems, Intel Corporation and Bank of America.

    "We are excited to welcome Kurt to Omeros," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "In his 15 years at Amazon, Kurt helped build one of the most successful companies in history and a world class treasury organization. His reputation and network of contacts throughout the financial world are stellar, and I know that he will play an important role in Omeros' ongoing growth as we prepare to commercialize the first of multiple products in our pipeline behind OMIDRIA. I look forward to working closely with Kurt to continue expanding our strategic financial relationships and capitalizing on growing business opportunities."

    An avid tennis player, Mr. Zumwalt is on the board of directors of both the United States Tennis Association (USTA) and the USTA Foundation. He played an instrumental role in securing $750 million of financing for the USTA from 2014 to 2018 to complete the funding for the organization's strategic transformation. He earned his B.A. degree in economics and political science from the University of Pennsylvania and his M.B.A. in finance and accounting from the University of Washington.

    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 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, 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," "plan," "potential," "predict," "project," "prospects," "should," "slated," "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, regulatory oversight, the impact of pricing, coverage and reimbursement policies of government and private payers on our revenues generated through sales of OMIDRIA or any other drug product approved in the future, 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 on March 1, 2019. 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.

    View Full Article Hide Full Article
  32. myTomorrows, a global health technology company, and Omeros Corporation (NASDAQ:OMER), an innovative biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics, today announced a collaboration. The collaboration broadens Omeros' expanded access program to support availability of Omeros' novel investigational complement inhibitor narsoplimab in several countries around the world. Narsoplimab is being developed by Omeros as a treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) and may be provided to eligible patients who have no other treatment options and when prescribed on a Named Patient basis.

    "Through our Medical Team, we engage…

    myTomorrows, a global health technology company, and Omeros Corporation (NASDAQ:OMER), an innovative biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics, today announced a collaboration. The collaboration broadens Omeros' expanded access program to support availability of Omeros' novel investigational complement inhibitor narsoplimab in several countries around the world. Narsoplimab is being developed by Omeros as a treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) and may be provided to eligible patients who have no other treatment options and when prescribed on a Named Patient basis.

    "Through our Medical Team, we engage with physicians looking for treatment options for their patients with high unmet needs and who cannot access an existing clinical trial," said Steve Glass, COO of myTomorrows. "Our collaboration with Omeros is an important step in growing our expanded access programs and providing physicians information on potential treatment options."

    "We are pleased to partner with myTomorrows to broaden our expanded access program," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "We are excited by the results seen with narsoplimab in patients with HSCT-TMA, and this partnership with myTomorrows advances our mission to help patients with this devastating condition by continuing to provide them access to narsoplimab."

    Narsoplimab has been granted Breakthrough Therapy designation by the US Food and Drug Administration (FDA) in patients with high-risk HSCT-TMA and has orphan drug designation in both the US and Europe. Omeros has initiated submission of a rolling biologics license application (BLA) to the FDA to be followed by a marketing authorization application for HSCT-TMA in Europe. In preparation for completing its BLA submission, Omeros recently stopped enrollment of its pivotal clinical trial of narsoplimab for the treatment of HSCT-TMA.

    About Expanded Access Programs

    An Expanded Access Program (sometimes called "compassionate use") supports in a compliant and controlled way the treatment with a medicine currently not licensed in a patient's country of residence. Such treatment can be an option for patients who have high unmet medical need and have exhausted all registered treatment options and cannot participate in a clinical trial.

    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 myTomorrows

    myTomorrows operates as a two-sided platform. It serves the interests of both patients and healthcare providers, as well as drug development. On one side, the company provides information on all treatment options to patients and physicians when registered treatments have been exhausted. Requests may come in to myTomorrows by phone, email, or through an online portal. After which physicians and patients will be directed to a member of our Medical Team for more information regarding treatment options. And on the other side, myTomorrows specializes in expanded access regulations and administration and real-world data collection, evolving scientific clinical development. myTomorrows has gained experience in running over 25 EAPs over the past 5 years, in more than 40 countries across 5 continents. For more information, please visit www.mytomorrows.com.

    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 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, 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.

    For specific questions regarding the Omeros' expanded access program, please contact myTomorrows at .

    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," "plan," "potential," "predict," "project," "prospects," "should," "slated," "targeting," "will," "would" and similar expressions and variations thereof. Forward-looking statements, including statements regarding Omeros' research and development programs and the therapeutic application of Omeros' research findings, 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, unproven preclinical and clinical development activities, availability and timing of data from preclinical or clinical studies and the results of such studies, risks associated with product commercialization and commercial operations, regulatory actions and 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 on March 1, 2019. 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.

    View Full Article Hide Full Article
  33. Omeros Corporation (NASDAQ:OMER) last week presented new data directed to its novel cancer immunotherapy target GPR174 at the European Society for Medical Oncology (ESMO) 2019 Immuno-Oncology Congress in Geneva, Switzerland. In addition to previously reported findings, which revealed enhanced anti-tumor immune responses in GPR174-deficient mice and synergism between adenosine receptor antagonists and GPR174 antagonists in promoting interleukin-2 (IL-2) and interferon-γ (IFN-γ) production from human T cells, this presentation included new data from human ex vivo studies demonstrating that GPR174 inhibition results in downregulation of checkpoint and tumor-promoting factors.

    The findings, presented by Marc Gavin, Ph.D., Omeros' Director of…

    Omeros Corporation (NASDAQ:OMER) last week presented new data directed to its novel cancer immunotherapy target GPR174 at the European Society for Medical Oncology (ESMO) 2019 Immuno-Oncology Congress in Geneva, Switzerland. In addition to previously reported findings, which revealed enhanced anti-tumor immune responses in GPR174-deficient mice and synergism between adenosine receptor antagonists and GPR174 antagonists in promoting interleukin-2 (IL-2) and interferon-γ (IFN-γ) production from human T cells, this presentation included new data from human ex vivo studies demonstrating that GPR174 inhibition results in downregulation of checkpoint and tumor-promoting factors.

    The findings, presented by Marc Gavin, Ph.D., Omeros' Director of Immunology, show that GPR174 suppresses T lymphocytes through the cyclic adenosine monophosphate (cAMP) signaling pathway. In addition to suppressing T-cell function, cAMP signaling is known to enhance production of both cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) and amphiregulin (AREG), both important drivers of tumor development. CTLA-4 is an immune checkpoint molecule targeted by FDA-approved drugs such as Yervoy® (ipilimumab), and AREG is a cell growth factor involved in promoting tumor growth. The data demonstrate that, using either GPR174 small-molecule inhibitors or in GPR174-deficient mice, the T cell-suppressing effect of cAMP is blocked, resulting in enhanced "tumor-killing" T-cell activation. In addition, the new data show that GPR174 inhibitors reduce both CTLA-4 and AREG levels in T cells, suggesting that multiple pathways – including checkpoint and tumor-promoting factors – downstream of GPR174 inhibition may be inactivated, further augmenting anti-tumor immunity and blocking tumor growth.

    "The data show that GPR174 inhibitors enhance anti-tumor immune responses through multiple pathways, including increased production of tumor-fighting cytokines IL-2, IFN-γ, and TNF while suppressing expression of CTLA-4 and AREG," said Gregory A. Demopulos, M.D., Omeros' chairman and chief executive officer. "Among our ongoing activities, we are exploring the effect of GPR174 inhibition on other checkpoints, including PD-1, and their inhibitors. We are increasingly confident in the role of GPR174 in immuno-oncology and look forward to moving our GPR174 inhibitors into the clinic as quickly as possible with the hope of improving survival for cancer patients."

    Dr. Gavin's recent presentation at ESMO can be accessed on the company's website at https://investor.omeros.com/presentations.

    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 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, 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," "plan," "potential," "predict," "project," "prospects," "should," "slated," "targeting," "will," "would" and similar expressions and variations thereof. Forward-looking statements, including statements regarding Omeros' research and development programs and the therapeutic application of Omeros' research findings, 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, unproven preclinical and clinical development activities, availability and timing of data from preclinical or clinical studies and the results of such studies, risks associated with product commercialization and commercial operations, regulatory actions and 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 on March 1, 2019. 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.

    View Full Article Hide Full Article
  34. Omeros Corporation (NASDAQ:OMER) ("Omeros"), 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, announced today the full exercise and closing of the sale of 572,518 shares of common stock to the underwriter of its previously announced public offering pursuant to the underwriter's option under the underwriting agreement to purchase additional shares of common stock. When combined with shares sold in the closing that occurred on December 9, 2019, Omeros sold an aggregate…

    Omeros Corporation (NASDAQ:OMER) ("Omeros"), 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, announced today the full exercise and closing of the sale of 572,518 shares of common stock to the underwriter of its previously announced public offering pursuant to the underwriter's option under the underwriting agreement to purchase additional shares of common stock. When combined with shares sold in the closing that occurred on December 9, 2019, Omeros sold an aggregate of 4,389,311 shares of common stock in the offering at $13.10 per share and the total gross proceeds to Omeros, before deduction of underwriting discounts and other estimated offering expenses, were approximately $57.5 million.

    Cantor Fitzgerald & Co. acted as the sole book-running manager for the offering.

    Omeros intends to use the net proceeds from the offering for general corporate purposes, including funding clinical trials, pre-clinical studies, manufacturing, build out of commercial infrastructure and other costs associated with advancing its development programs and product candidates toward regulatory submissions and potential commercialization. Omeros may also use the net proceeds for working capital, the repayment of debt obligations, acquisitions or investments in businesses, products or technologies that are complementary to its own, and other required capital expenditures.

    The securities described above were offered by Omeros pursuant to a shelf registration statement on Form S-3 (File No. 333- 235349) that was filed with the Securities and Exchange Commission (the "SEC") on December 4, 2019, which became automatically effective upon filing. A final prospectus supplement relating to and describing the terms of the offering was filed with the SEC on December 6, 2019 and is available on the SEC's website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained by contacting Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, or by email at .

    This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be an offer, solicitation or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

    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 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, the company 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," "could," "estimate," "expect," "goal," "intend," "likely," "may," "plan," "potential," "predict," "project," "should," "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, 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 SEC on March 1, 2019, as supplemented from time to time by the company's Quarterly Reports on Form 10-Q. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future.

    View Full Article Hide Full Article
  35. Omeros Corporation (NASDAQ:OMER) today announced an upcoming presentation directed to its novel cancer immunotherapy target GPR174 at the European Society for Medical Oncology 2019 Immuno-Oncology Congress, which is being held December 11-14, 2019 in Geneva, Switzerland.

    In addition to previously presented ex vivo human and in vivo animal studies, the presentation will include new findings from human T-cells demonstrating that GPR174 inhibition results in downregulation of checkpoint and tumor promoting factors.

    The poster (#108P) will be presented on December 12, 2019, at 12:15 PM local time by Marc Gavin, Ph.D., Omeros' Director of Immunology.

    About Omeros Corporation

    Omeros is an innovative biopharmaceutical company committed to…

    Omeros Corporation (NASDAQ:OMER) today announced an upcoming presentation directed to its novel cancer immunotherapy target GPR174 at the European Society for Medical Oncology 2019 Immuno-Oncology Congress, which is being held December 11-14, 2019 in Geneva, Switzerland.

    In addition to previously presented ex vivo human and in vivo animal studies, the presentation will include new findings from human T-cells demonstrating that GPR174 inhibition results in downregulation of checkpoint and tumor promoting factors.

    The poster (#108P) will be presented on December 12, 2019, at 12:15 PM local time by Marc Gavin, Ph.D., Omeros' Director of Immunology.

    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 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, 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," "plan," "potential," "predict," "project," "prospects," "should," "slated," "targeting," "will," "would" and similar expressions and variations thereof. Forward-looking statements, including statements regarding Omeros' research and development programs and the therapeutic application of Omeros' research findings, 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, unproven preclinical and clinical development activities, availability and timing of data from preclinical or clinical studies and the results of such studies, risks associated with product commercialization and commercial operations, regulatory actions and 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 on March 1, 2019. 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.

    View Full Article Hide Full Article
  36. Omeros Corporation (NASDAQ:OMER) ("Omeros"), 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, announced today the pricing of its registered underwritten public offering of $50.0 million in shares of its common stock at a price to the public of $13.10 per share, before deducting underwriting discounts and other estimated offering expenses. The offering is expected to close on or about December 9, 2019, subject to the satisfaction of customary closing conditions. In…

    Omeros Corporation (NASDAQ:OMER) ("Omeros"), 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, announced today the pricing of its registered underwritten public offering of $50.0 million in shares of its common stock at a price to the public of $13.10 per share, before deducting underwriting discounts and other estimated offering expenses. The offering is expected to close on or about December 9, 2019, subject to the satisfaction of customary closing conditions. In addition, Omeros has granted the underwriter a 30-day option to purchase up to $7.5 million in shares of its common stock.

    Cantor Fitzgerald & Co. is acting as the sole book-running manager for the offering.

    Omeros intends to use the net proceeds of the offering for general corporate purposes, including funding clinical trials, pre-clinical studies, manufacturing, build-out of commercial infrastructure and other costs associated with advancing its development programs and product candidates toward regulatory submissions and potential commercialization. Omeros may also use the net proceeds for working capital, the repayment of debt obligations, acquisitions or investments in businesses, products or technologies that are complementary to its own, and other capital expenditures.

    A registration statement on Form S-3 (File No. 333- 235349) relating to the securities was filed with the Securities and Exchange Commission (the "SEC") on December 4, 2019 and became automatically effective upon filing. The securities may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus related to and describing the terms of the offering was filed with the SEC on December 4, 2019 and is available on the SEC's website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, by contacting Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, or by email at .

    This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be an offer, solicitation or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

    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 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, the company 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," "could," "estimate," "expect," "goal," "intend," "likely," "may," "plan," "potential," "predict," "project," "should," "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, 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 SEC on March 1, 2019, as supplemented from time to time by the company's Quarterly Reports on Form 10-Q. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future.

    View Full Article Hide Full Article
  37. Omeros Corporation (NASDAQ:OMER) ("Omeros"), 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 that it has commenced a registered underwritten public offering of its common stock. In addition, Omeros has granted the underwriter a 30-day option to purchase up to an additional 15% of the number of shares of common stock sold in connection with the offering.

    Cantor Fitzgerald & Co. is acting as the sole book-running manager for the offering.

    Omeros…

    Omeros Corporation (NASDAQ:OMER) ("Omeros"), 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 that it has commenced a registered underwritten public offering of its common stock. In addition, Omeros has granted the underwriter a 30-day option to purchase up to an additional 15% of the number of shares of common stock sold in connection with the offering.

    Cantor Fitzgerald & Co. is acting as the sole book-running manager for the offering.

    Omeros intends to use the net proceeds of the offering for general corporate purposes, including funding clinical trials, pre-clinical studies, manufacturing, build-out of commercial infrastructure and other costs associated with advancing its development programs and product candidates toward regulatory submissions and potential commercialization. Omeros may also use the net proceeds for working capital, the repayment of debt obligations, acquisitions or investments in businesses, products or technologies that are complementary to its own, and other capital expenditures.

    A registration statement on Form S-3 relating to the securities was filed with the Securities and Exchange Commission (the "SEC") on December 4, 2019 and became automatically effective upon filing. The securities may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus related to and describing the terms of the offering will be filed with the SEC on December 4, 2019 and will be available on the SEC's website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, by contacting Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, or by email at .

    This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be an offer, solicitation or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

    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. The company's drug product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1% / 0.3% is marketed in the U.S. for use during cataract surgery or intraocular lens (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. In the European Union, the European Commission has approved OMIDRIA for use in cataract surgery and other IOL replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain. 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 and a proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and corresponding compounds, a number of which are in preclinical development. 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, 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 SEC on March 1, 2019, as supplemented from time to time by the company's Quarterly Reports on Form 10-Q. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future.

    View Full Article Hide Full Article
  38. – 56 Percent of All Narsoplimab-Treated Patients Were Complete Responders by Primary Endpoint, Achieving Full Set of Response Criteria Agreed by FDA; 68 Percent Primary-Endpoint Complete Response Rate for Those Who Received Protocol-Specified Treatment of At Least 4 Weeks of Dosing –

    – 100-Day Survival Across All Narsoplimab-Treated Patients Was 65 Percent; 93 Percent for Complete Responders –

    – No Signal of Any Serious Safety Risk Observed in the Trial; Adverse Events Comparable to Those Commonly Seen in Stem-Cell Transplant –

    – Conference Call and Webcast Today at 8:30 a.m. EST –

    Omeros Corporation…

    – 56 Percent of All Narsoplimab-Treated Patients Were Complete Responders by Primary Endpoint, Achieving Full Set of Response Criteria Agreed by FDA; 68 Percent Primary-Endpoint Complete Response Rate for Those Who Received Protocol-Specified Treatment of At Least 4 Weeks of Dosing –

    – 100-Day Survival Across All Narsoplimab-Treated Patients Was 65 Percent; 93 Percent for Complete Responders –

    – Statistically Significant (p < 0.01) Improvements in Platelet Count, LDH and Haptoglobin Across All Groups of Narsoplimab-Treated Patients –

    – No Signal of Any Serious Safety Risk Observed in the Trial; Adverse Events Comparable to Those Commonly Seen in Stem-Cell Transplant –

    – Conference Call and Webcast Today at 8:30 a.m. EST –

    Omeros Corporation (NASDAQ:OMER) today announced positive data from its pivotal clinical trial of the company's novel investigational complement inhibitor narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), a frequently lethal complication of HSCT. These preliminary data were recently provided to FDA as part of the company's ongoing interactions with the Agency on the narsoplimab Biologics License Application (BLA). All safety and efficacy endpoints – including the composite primary endpoint and the secondary endpoints – are agreed with FDA. The reported data support a strongly positive benefit-risk balance.

    The primary efficacy endpoint in this single-arm open-label trial of HSCT-TMA patients is the proportion of patients who achieve a highly rigorous set of response criteria that requires both improvement in HSCT-TMA laboratory markers and improvement in clinical status (organ function and transfusions). Patients who did not fully meet these criteria were considered non-responders. The secondary endpoints include survival rates and change from baseline in HSCT-TMA laboratory markers. Consistent with the pre-specified statistical analysis plan for the trial, the primary and secondary endpoints are assessed for (1) all patients who received at least one dose of narsoplimab and (2) patients who received at least 4 weeks of narsoplimab dosing. Patients enrolled in this trial had a high expected mortality rate. In severe cases of HSCT-TMA, mortality can exceed 90 percent.

    Primary Efficacy Endpoint:

    • 56 percent of all patients receiving at least one dose of narsoplimab achieved complete responder status (met full set of FDA-agreed response criteria).
    • 68 percent of patients who received the protocol-specified narsoplimab treatment of at least 4 weeks of dosing achieved complete responder status.

    Secondary Endpoints:

    • 100-day survival following HSCT-TMA diagnosis for all patients receiving at least one dose of narsoplimab was 65 percent.
    • 100-day survival following HSCT-TMA diagnosis for patients who received the protocol-specified treatment of at least 4 weeks of narsoplimab dosing was 81 percent.
    • 100-day survival following HSCT-TMA diagnosis in the complete responder group was 93 percent.
    • Substantial and statistically significant improvements in platelet count, LDH and haptoglobin were observed across all of the following groups:
      • All patients who received at least one dose of narsoplimab (p < 0.01 for each laboratory value)
      • Patients who received protocol-specified treatment of at least 4 weeks of dosing (p ≤ 0.002 for each laboratory value)
      • Complete responders (p < 0.001 for each laboratory value).
    • Hemoglobin increased across all groups and reached statistical significance (p = 0.041) in complete responders.
    • Creatinine also improved meaningfully in all patient groups but did not reach statistical significance given the use of nephrotoxic agents in trial patients.

    Safety:

    • No signal of any serious safety risk has been observed with narsoplimab in the trial.
    • The most common adverse events seen in this trial were nausea, vomiting, diarrhea, hypokalemia, neutropenia and fever – all common in stem-cell transplant patients.
    • 21 percent of patients died during the trial due to causes common in stem cell transplant, with no additional patients discontinuing for adverse events. The data from the patients who died were not excluded from any analyses.

    The HSCT-TMA patient population enrolled in this trial had multiple high-risk features that portend a poor outcome. These include persistence of HSCT-TMA despite modification of immunosuppression (which was a criterion for entry into the trial), graft-versus-host disease, significant infections, non-infectious pulmonary complications and neurological findings. Patients in the trial had a high expected death rate, with 93 percent of them having multiple risk factors.

    Patient enrollment in the pivotal trial has been completed. The details of the endpoints, including the response criteria agreed with FDA, and the number of patients in the trial remain confidential for competitive business reasons.

    Last year the company reported data on 19 HSCT-TMA patients treated with narsoplimab on which FDA granted breakthrough therapy designation. The results reported today are even stronger. The response rate remains equally high at 56 percent, while the 100-day survival has improved from 53 percent to 65 percent.

    "The response rate in this high-risk population would be expected to be 10 to 15 percent with a 100-day survival rate of less than 20 percent. The response rate and 100-day survival achieved with narsoplimab in this trial demonstrate an unprecedented effect in this condition," said Rafael Duarte M.D., Ph.D., F.R.C.P., Associate Professor, Head of Hematology Department and Hematopoietic Transplantation Program, University Hospital Puerta de Hierro Majadahonda, Madrid, Spain, and Secretary of the European Society for Blood and Marrow Transplantation. "The other secondary endpoints are equally impressive. The data are consistent with my personal experience with narsoplimab. Patients with severe forms of HSCT-TMA have a dismal prognosis with no treatment currently available. I expect a treatment with this profile would be widely adopted for use in these patients and even lead to increased physician recognition of the disorder."

    Omeros reported the initiation of its rolling BLA in October. Narsoplimab, also referred to as OMS721, is Omeros' lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2) and has breakthrough therapy designation from FDA for this indication.

    "The striking results seen in our pivotal trial are tremendously gratifying," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "Our rolling BLA is underway – the nonclinical sections have been submitted and the data from this trial form the efficacy basis of the application. We continue to compile the remaining sections of the BLA and look forward to continued partnership with regulators to make narsoplimab widely available for the treatment of this devastating condition."

    Data from this pivotal trial will also support the narsoplimab marketing authorization application for HSCT-TMA in Europe. The data are planned for publication and for presentation at international congresses in the first part of 2020.

    In addition to breakthrough therapy designation from FDA, narsoplimab has orphan drug designation in both the U.S. and Europe for HSCT-TMA. Narsoplimab also has been awarded breakthrough therapy designation for immunoglobulin A nephropathy (IgAN), and Omeros has Phase 3 programs for narsoplimab ongoing in IgAN and in atypical hemolytic uremic syndrome (aHUS).

    Conference Call and Webcast Details

    Omeros' management will host a webcast and conference call to present data from its pivotal trial of narsoplimab in HSCT-TMA. The call will be held today at 8:30 a.m. Eastern Time; 5:30 a.m. Pacific 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 3774209. 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 3774209.

    To access the live or subsequently archived webcast and presentation materials 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 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, the company 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.

    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 hematopoietic stem cell transplant-associated thrombotic microangiopathy (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.

    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," "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 filed with the Securities and Exchange Commission on March 1, 2019. 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.

    Source: Omeros Corporation

    View Full Article Hide Full Article
  39. Omeros Corporation (NASDAQ:OMER) presented new GPR174 immuno-oncology data yesterday at the American Association for Cancer Research Conference on Tumor Immunology and Immunotherapy in Boston, Massachusetts. The positively received and well-attended presentation about the company's cell-based and animal studies related to its newly discovered cancer immunity axis was made by Marc Gavin, Ph.D., Omeros' Director of Immunology. This data can now be accessed on the company's website at https://investor.omeros.com/presentations

    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…

    Omeros Corporation (NASDAQ:OMER) presented new GPR174 immuno-oncology data yesterday at the American Association for Cancer Research Conference on Tumor Immunology and Immunotherapy in Boston, Massachusetts. The positively received and well-attended presentation about the company's cell-based and animal studies related to its newly discovered cancer immunity axis was made by Marc Gavin, Ph.D., Omeros' Director of Immunology. This data can now be accessed on the company's website at https://investor.omeros.com/presentations

    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 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, 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.

    Source: Omeros Corporation

    View Full Article Hide Full Article
  40. -- GPR174 Deficiency Improves Outcomes in Animal Tumor Models --

    Omeros Corporation (NASDAQ:OMER) today announced new findings on GPR174, its novel cancer immunotherapy target, demonstrating that GPR174-deficiency enhances anti-tumor immune responses in animals.

    The studies were conducted in mouse models of melanoma and of colon carcinoma, each of which was modified to partially deplete regulatory T cells, a subset of immunosuppressive T cells. Partial depletion of regulatory T cells in mice creates a T-cell composition more similar to that in humans. GPR174 deficiency in these mice resulted in significantly reduced tumor growth and improved survival of the animals (p=0.006 in melanoma; p=0.03 in colon cancer) versus normal mice.

    These…

    -- GPR174 Deficiency Improves Outcomes in Animal Tumor Models --

    Omeros Corporation (NASDAQ:OMER) today announced new findings on GPR174, its novel cancer immunotherapy target, demonstrating that GPR174-deficiency enhances anti-tumor immune responses in animals.

    The studies were conducted in mouse models of melanoma and of colon carcinoma, each of which was modified to partially deplete regulatory T cells, a subset of immunosuppressive T cells. Partial depletion of regulatory T cells in mice creates a T-cell composition more similar to that in humans. GPR174 deficiency in these mice resulted in significantly reduced tumor growth and improved survival of the animals (p=0.006 in melanoma; p=0.03 in colon cancer) versus normal mice.

    These findings are being presented today by Marc Gavin, Ph.D., Omeros' Director of Immunology, at the American Association for Cancer Research Conference on Tumor Immunology and Immunotherapy in Boston, Massachusetts.

    The presentation also features discoveries regarding phosphatidylserine (PS), a product of cell stress and death that is abundant in the tumor microenvironment. PS has been shown by Omeros to suppress T-cell activity through GPR174. The function of PS is similar to that of adenosine, which is also abundant in the tumor microenvironment and suppresses T cells throu