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Omeros Corporation Reports First Quarter 2013 Financial Results

       Omeros Corporation Reports First Quarter 2013 Financial Results

PR Newswire

SEATTLE, May 10, 2013

SEATTLE, May 10, 2013 /PRNewswire/ --Omeros Corporation (NASDAQ: OMER), a
clinical-stage biopharmaceutical company committed to discovering, developing
and commercializing products targeting inflammation, coagulopathies and
disorders of the central nervous system, today announced its financial results
for the first quarter of 2013.

Financial Results

Total operating expenses for the quarter ended March 31, 2013 were $11.1
million compared to $9.6 million for the same period in 2012. The increase is
primarily due to research and development expenses associated with advancing
Omeros' MASP-2 program toward the clinic, employee costs and non-cash rent
expense, and to selling, general and administrative expenses related to legal
matters and Omeros' planned commercial launch of OMS302 in 2014. These higher
costs were partially offset by lower clinical trial expenses related to the
completion of Phase 3 clinical trials for Omeros' OMS302 and OMS103HP programs
in January 2013 and December 2012, respectively. For the quarter ended March
31, 2013, Omeros reported a net loss of $10.5 million, or $0.40 per share,
compared to a net loss of $8.9 million, or $0.40 per share, for the same
period in 2012.

At March 31, 2013, Omeros had cash, cash equivalents and short-term
investments of $13.3 million. On May 9, Omeros announced that it priced a
public offering of 3,903,004 shares of its common stock at a price of $4.14
per share, a two percent premium over the closing price on May 8, 2013, for
estimated net proceeds of $16.1 million. The offering is expected to close on
or about May 14, 2013. The shares were offered and are expected to be sold to
RA Capital Management and other investors in a registered direct offering
conducted without an underwriter or placement agent. Omeros also did not use
its at-the-market sales facility or its committed equity line financing
facility, neither of which Omeros has accessed to date.

"We are pleased with the progress across our pipeline during the first
quarter, including successfully completing both our OMS302 intraocular lens
replacement Phase 3 clinical program and the multiple ascending dose study for
our OMS824 program," said Gregory A. Demopulos, M.D., chairman and chief
executive officer of Omeros. "Looking ahead, we expect to submit the NDA for
OMS302 this quarter, which will set the stage for a potential commercial
launch in 2014. Our MASP-2 and PDE7 programs are also slated for the clinic
this year. There are multiple near-term milestones on the horizon, and 2013
promises to be an exciting year."

First Quarter Highlights

  oAnnounced the successful completion of the multiple-ascending-dose (MAD)
    portion of its Phase 1 clinical study evaluating OMS824, the lead compound
    in Omeros' phosphodiesterase 10 (PDE10) program. OMS824 inhibits PDE10 and
    is being developed for the treatment of cognitive disorders, including
    Huntington's disease and schizophrenia. The results of the MAD study and
    earlier single-ascending dose study showed that the pharmacokinetic
    parameters (Cmax and AUC) of OMS824 increased linearly with the dose and
    that the compound had a long half-life consistent with once daily dosing.
    OMS824 was detected in the cerebrospinal fluid at the expected
    concentration relative to that in the blood. The drug concentration in the
    cerebrospinal fluid is predicted to achieve near-complete inhibition of
    the PDE10 target in the brain. These results show that OMS824, at
    well-tolerated doses, achieves concentrations that are anticipated to
    effectively inhibit PDE10 and support continuing development.
  oReported data from toxicology studies evaluating OMS721, the lead human
    monoclonal antibody in Omeros' mannan-binding lectin-associated serine
    protease-2 (MASP-2) program. The studies provide the primary safety data
    expected to support the initiation of OMS721 clinical studies in mid-year
    2013. The pharmacokinetic results in primates demonstrated that
    subcutaneous administration of OMS721 resulted in maximal inhibition of
    the lectin pathway within six hours of administration and maintained it
    for two or more weeks. In addition, the bioavailability and
    pharmacokinetics observed in both species are expected to support
    subcutaneous administration in patients at a frequency of once weekly,
    bi-monthly or possibly at even longer intervals.
  oAnnounced the successful completion of the 90-day safety database lock in
    the second of Omeros' two pivotal Phase 3 clinical trials evaluating
    OMS302 in patients undergoing intraocular lens replacement surgery.
    OMS302, added to standard irrigation solution used during ophthalmological
    procedures, is Omeros' proprietary PharmacoSurgery™ product designed to
    maintain intraoperative mydriasis and reduce postoperative pain and
    irritation resulting from cataract and other lens replacement surgery.
    Omeros intends to submit a New Drug Application for OMS302 to the U.S.
    Food and Drug Administration this quarter and a Marketing Authorization
    Application to the European Medicines Agency in mid-2013.
  oReported that its proprietary Cellular Redistribution Assay technology,
    which to date has successfully "unlocked" 46 of the 80 total Class A
    orphan G protein-coupled receptors (GPCRs) for drug development, has
    identified small molecules that interact with a Class B GPCR. Like the
    Class A GPCRs, Class B receptors are important players in a broad range of
    disorders, having been linked to various types of cancer (e.g., breast,
    brain, prostate, kidney, liver, pancreatic and gastrointestinal); multiple
    sclerosis, attention deficit-hyperactivity, learning and memory
    impairments, depression and other neuropsychiatric disorders; multiple
    metabolic disorders including diabetes and obesity; immunologic disorders;
    osteoporosis and infertility.

About Omeros Corporation
Omeros is a clinical-stage biopharmaceutical company committed to discovering,
developing and commercializing products targeting inflammation, coagulopathies
and disorders of the central nervous system. The Company's most clinically
advanced product candidates, OMS302 for lens replacement surgery and OMS103HP
for arthroscopy, are derived from its proprietary PharmacoSurgery™ platform
designed to improve clinical outcomes of patients undergoing a wide range of
surgical and medical procedures. Omeros has five clinical development
programs. Omeros may also have the near-term capability, through its GPCR
program, to add a large number of new drug targets and their corresponding
compounds to the market. Behind its clinical candidates and GPCR platform,
Omeros is building a diverse pipeline of protein and small-molecule
preclinical programs targeting inflammation, coagulopathies and central
nervous system disorders.

Forward-Looking Statements
This press release contains forward-looking statements as defined within the
Private Securities Litigation Reform Act of 1995, which are subject to the
"safe harbor" created by those sections. These statements include, but are not
limited to, Omeros' expectations regarding the closing date of the public
offering; the submission dates for the OMS302 New Drug Application and
Marketing Authorization Application; when it will be able to market and sell
OMS302; when it will commence clinical trials for its MASP-2 and PDE7; the
potential benefits of its potential products; and its capability, through its
GPCR program, to add a large number of new drug targets and their
corresponding compounds to the market. Forward-looking statements are based on
management's beliefs and assumptions and on information available to
management only as of the date of this press release. Omeros' actual results
could differ materially from those anticipated in these forward-looking
statements for many reasons, including, without limitation, the risks,
uncertainties and other factors described under the heading "Risk Factors" in
the Company's Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission on May 9, 2013. 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 publicly, even if new information becomes available
in the future.

OMEROS CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
                                       Three Months Ended
                                       March 31,
                                       2013                2012
                                       (unaudited)
Revenue                                $            $       
                                       1,095               1,496
Operating expenses:
Research and development               7,127               7,246
General and administrative             3,988               2,322
Total operating expenses               11,115              9,568
Loss from operations                   (10,020)            (8,072)
Investment income                      6                   12
Interest expense                       (587)               (494)
Other income, (expense) net            112                 (341)
Net loss                               $              $      
                                       (10,489)            (8,895)
Basic and diluted net loss per         $            $       
common share                           (0.40)              (0.40)
Weighted-average shares used to
compute
                                       25,908,153          22,434,903
basic and diluted net loss per
common share

OMEROS CORPORATION
CONSOLIDATED BALANCE SHEET DATA
(In thousands)
                                     March 31,            December31,
                                     2013                 2012
Cash and cash equivalents and        $       13,316 $       22,350
short-term investments
Total assets                         17,693               26,575
Total notes payable                  20,197               20,103
Total current liabilities            10,585               9,318
Accumulated deficit                  (225,066)            (214,577)
Total shareholders' equity (deficit) (15,864)             (6,531)



SOURCE Omeros Corporation

Contact: Jennifer Cook Williams, Cook Williams Communications, Inc., Investor
and Media Relations, +1-360-668-3701, jennifer@cwcomm.org
 
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