Omeros Corporation Reports Second Quarter 2013 Financial Results

       Omeros Corporation Reports Second Quarter 2013 Financial Results

PR Newswire

SEATTLE, Aug. 9, 2013

SEATTLE, Aug. 9, 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 second quarter of 2013.

Financial Results

Total operating expenses for the quarter ended June 30, 2013 were $13.3
million and included non-cash expenses of $2.1 million related to rent expense
and stock-based compensation. For the same period in 2012, total operating
expenses were $9.8 million, which included non-cash rent and stock-based
compensation expenses of $569,000.

The increase in total operating expenses for the quarter ended June 30, 2013
is primarily due to expenses related to advancing our MASP-2 program toward
the clinic, the non-cash rent expense and stock-based compensation discussed
above, preparing the NDA and MAA for OMS302, the planned commercial launch of
OMS302 in 2014, and conducting our Phase 1 clinical program evaluating OMS824.
These higher costs were partially offset by lower overall clinical trial
expenses related to the completion of our OMS302 Phase 3 clinical program in
January 2013 and the completion of our first OMS103HP Phase 3 clinical trial
in arthroscopic partial meniscectomy patients in December 2012.

Total revenue for the quarter ended June 30, 2013 was $140,000 compared to
$1.5 million for the same period in 2012. This decrease was primarily due to
lower revenue recognized from the company's GPCR platform development funding
agreement with Vulcan Inc. and its affiliate. While research continues under
the company's GPCR program, no additional deferred revenue under the Vulcan
agreement remains to be recognized after the first quarter of 2013.

For the quarter ended June 30, 2013, Omeros reported a net loss of $13.6
million, or $0.48 per share, inclusive of the above-referenced $2.1 million of
non-cash charges, compared to a net loss of $8.5 million, or $0.38 per share,
inclusive of the above-referenced $569,000 of non-cash charges, for the same
period in 2012. At June 30, 2013, Omeros had cash, cash equivalents and
short-term investments of $20.1 million.

"We continue to make significant progress in advancing Omeros along the path
to commercialization," said Gregory A. Demopulos, M.D., chairman and chief
executive officer of Omeros. "We submitted an NDA to the FDA for OMS302, a
major milestone in our plans to bring the first of our products to market, and
we remain on track to submit an MAA to the European regulators later this
quarter. Our Phase 1 OMS824 clinical program generated positive results,
demonstrating a high level of target occupancy without the movement-related
side effects exhibited by other PDE10 inhibitors, and we plan to begin a Phase
2 trial in patients with Huntington's disease in the fourth quarter. In July,
we initiated enrollment in our Phase 1 clinical program for OMS721, further
expanding our clinical franchise. We expect continued successes across our
pipeline over the remainder of the year as we prepare for a 2014 market launch
of OMS302."

Second Quarter and Recent Highlights

  oAnnounced submission of a New Drug Application, or NDA, to the FDA for
    approval of OMS302 for use 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. The submission was supported by the positive
    results from two pivotal Phase 3 trials that enrolled both cataract
    surgery and refractive lens exchange patients. In these trials, OMS302
    demonstrated statistically significant superiority over placebo in
    maintenance of intraoperative mydriasis, prevention of surgically induced
    miosis and reduction of postoperative pain. Omeros intends to submit a
    Marketing Authorization Application, or MAA, to the European Medicines
    Agency, or EMA, in the third quarter of 2013, seeking approval for the
    Company to market and sell OMS302 in the European Union.
  oReported positive results from its Phase 1 clinical program evaluating
    OMS824, the lead compound from its phosphodiesterase 10 (PDE10) program.
    This study measured the extent to which OMS824 binds to PDE10 in the basal
    ganglia, a region of the brain that has been linked to a wide range of
    diseases that affect cognition. The results of this study showed that the
    selected dose of OMS824 achieved an average of approximately 50 percent
    (with a high of approximately 70 percent) occupancy of PDE10 without
    triggering the extrapyramidal symptoms (e.g., loss of muscle control,
    muscle rigidity, tremors, or involuntary muscle movements) reported as
    side effects with other PDE10 inhibitors that achieved similar or
    significantly lower occupancy levels. Omeros plans to advance OMS824 into
    Phase 2 clinical trials for Huntington's disease and for schizophrenia
    later this year. The OMS824 IND for use in patients has already been
    cleared by the FDA for use in both patient populations.
  oAnnounced positive data using OMS721, the lead human monoclonal antibody
    in Omeros' mannan-binding lectin-associated serine protease-2 (MASP-2)
    program, in a well-established animal model of thrombotic microangiopathy
    (TMA). Thrombotic microangiopathies represent a group of disorders that
    occurs in the microcirculation of the body's organs, including atypical
    hemolytic uremic syndrome (the lead indication for OMS721), hemolytic
    uremic syndrome and thrombotic thrombocytopenic purpura. Omeros submitted
    a European Clinical Trial Application (CTA) in May 2013 to seek approval
    to initiate clinical trials evaluating OMS721 in Europe, and a clinical
    trial evaluating OMS721 began in July 2013.
  oCompleted a registered direct offering of 3,903,004 shares of its common
    stock at a price of $4.14 per share. Omeros received net proceeds from the
    offering of approximately $16.1 million, after deducting offering
    expenses.
  oAnnounced positive data in the most commonly used model for studying the
    clinical and pathological features of multiple sclerosis, or MS, further
    advancing the Company's development program of GPR17-targeting compounds
    for the treatment of MS. Compounds previously discovered by Omeros that
    inhibit GPR17, an orphan G protein-coupled receptor, or GPCR, unlocked by
    Omeros, significantly improved function from experimental autoimmune
    encephalomyelitis in mice. Using its proprietary high-throughput Cellular
    Redistribution Assay, Omeros believes that it alone has identified
    compounds that functionally interact with GPR17 and has patents pending
    that are broadly directed to any such compounds active at the receptor.

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 six 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 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. These statements include, but are not limited
to, the submission date for the OMS302 Marketing Authorization Application;
when it will be able to market and sell OMS302 in the United States and in the
European Union; Omeros' expectations that it will advance OMS824 into Phase 2
clinical programs for Huntington's disease and schizophrenia this year; the
potential benefits of its potential products; the potential for
GPR17-targeting compounds to treat nervous system disorders, such as MS; 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 August 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        Six Months Ended
                               June 30                   June 30,
                               2013          2012        2013       2012
                               (unaudited)               (unaudited)
Revenue                        $        $       $      $    
                               140          1,526       1,235      3,022
Operating expenses:
Research and development       9,564         7,558       16,691     14,804
General and administrative     3,736         2,212       7,724      4,534
Total operating expenses       13,300        9,770       24,415     19,338
Loss from operations           (13,160)      (8,244)     (23,180)   (16,316)
Investment income              2             6           8          18
Interest expense               (589)         (453)       (1,176)    (947)
Other income, (expense) net    155           152         267        (189)
Net loss                       $  (13,592) $         $         $ 
                                             (8,539)    (24,081)  (17,434)
Basic and diluted net loss per $          $        $       $   
common share                   (0.48)       (0.38)     (0.89)    (0.78)
Weighted-average shares used
to compute
basic and diluted net loss per 28,199,739    22,466,540  27,053,946 22,450,722
common share



OMEROS CORPORATION
CONSOLIDATED BALANCE SHEET DATA
(In thousands)
                                                   June 30,      December31,
                                                   2013          2012
Cash and cash equivalents and short-term           $   20,062 $   22,350
investments
Total assets                                       23,058        26,575
Total notes payable                                20,294        20,103
Total current liabilities                          10,900        8,359
Accumulated deficit                                (238,658)     (214,577)
Total shareholders' deficit                        (12,256)      (6,531)

SOURCE Omeros Corporation

Contact: Jennifer Cook Williams, Cook Williams Communications, Inc., Investor
and Media Relations, 360.668.3701, jennifer@cwcomm.org
 
Press spacebar to pause and continue. Press esc to stop.