OMER Omeros Corporation

18.62
-0.37  -2%
Previous Close 18.99
Open 18.84
52 Week Low 8.5
52 Week High 25.46
Market Cap $1,147,966,310
Shares 61,652,326
Float 58,936,778
Enterprise Value $1,283,533,670
Volume 1,126,616
Av. Daily Volume 884,758
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Upcoming Catalysts

Drug Stage Catalyst Date
Narsoplimab
Hematopoietic stem cell-associated TMA (HSCT-TMA)
PDUFA priority review
PDUFA priority review
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OMS906
MASP-3 inhibitor
Phase 1
Phase 1
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OMS721
IgA nephropathy
Phase 3
Phase 3
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Drug Pipeline

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

Latest News

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

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

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

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

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

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

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

    About Omeros Corporation

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

    About Hematopoietic Stem Cell Transplant-associated Thrombotic Microangiopathy

    Hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) is a significant and often lethal complication of stem cell transplantation. This condition is a systemic, multifactorial disorder caused by endothelial cell damage induced by conditioning regimens, immunosuppressant therapies, infection, graft-versus-host disease, and other factors associated with stem cell transplantation. Endothelial damage, which activates the lectin pathway of complement, plays a central role in the development of HSCT-TMA. The condition occurs in both autologous and allogeneic transplants but is more common in the allogeneic population. In the United States and Europe, approximately 25,000 to 30,000 allogeneic transplants are performed annually. Recent reports in both adult and pediatric allogeneic stem cell transplant populations have found an approximately 40-percent incidence of HSCT-TMA, and high-risk features may be present in up to 80 percent of these patients. In severe cases of HSCT-TMA, mortality can exceed 90 percent and, even in those who survive, long-term renal sequalae (e.g., dialysis) are common. There is no approved therapy or standard of care for HSCT-TMA.

    About Narsoplimab

    Narsoplimab, also known as "OMS721," is an investigational human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), a novel pro-inflammatory protein target and the effector enzyme of the lectin pathway of complement. Importantly, inhibition of MASP-2 does not appear to interfere with the antibody-dependent classical complement activation pathway, which is a critical component of the acquired immune response to infection. Omeros controls the worldwide rights to MASP-2 and all therapeutics targeting MASP-2.

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

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the "safe harbor" created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as "anticipate," "believe," "can," "could," "estimate," "expect," "goal," "intend," "likely", "look forward to," "may," "on track," "plan," "potential," "predict," "project," "prospects," "scheduled," "should," "slated," "targeting," "will," "would" and similar expressions and variations thereof. Forward-looking statements, including statements regarding anticipated regulatory submissions, the timing and results of ongoing or anticipated clinical trials, and the therapeutic application of Omeros' investigational product, are based on management's beliefs and assumptions and on information available to management only as of the date of this press release. Omeros' actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, risks associated with product commercialization and commercial operations, unproven preclinical and clinical development activities, the impact of COVID-19 on our business, financial condition and results of operations, regulatory oversight, changes in reimbursement and payment policies by government and commercial payers or the application of such policies, intellectual property claims, competitive developments, litigation, and the risks, uncertainties and other factors described under the heading "Risk Factors" in the company's Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 2, 2020, as supplemented by our Quarterly Reports on Form 10-Q filed with the SEC and subsequent filings with the SEC. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the company assumes no obligation to update these forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

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  2. 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.

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  3. 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

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  4. -- 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.

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  5. 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

    )

     

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