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Omeros Corporation Reports Third Quarter 2012 Financial Results

       Omeros Corporation Reports Third Quarter 2012 Financial Results

PR Newswire

SEATTLE, Nov. 9, 2012

SEATTLE, Nov. 9, 2012 /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 third quarter of 2012.

Financial Results

Total operating expenses for the quarter ended September 30, 2012 were $14.5
million compared to $7.2 million for the same period in 2011. The increase in
operating expenses primarily relates to a one-time litigation settlement
payment of $3.95 million, which our insurance company has agreed to reimburse
to us subject to a reservation of rights, increased Phase 3 clinical trial
expenses for OMS302 and increased employee expenses, partially offset by a
decrease in expenses in connection with preclinical work for other programs.
Given that the $3.95 million that Omeros' insurer has agreed to reimburse had
not been received by Omeros as of September 30, 2012, that amount is not
included in operating expenses for the 2012 period. For the quarter ended
September 30, 2012, Omeros reported a net loss of $13.3 million, or $0.51 per
share, compared to a net loss of $6.5 million, or $0.29 per share, for the
same period in 2011. At September 30, 2012, Omeros had cash, cash equivalents
and short-term investments of $30.6 million. 

"Now with positive results from both of our two pivotal Phase 3 clinical
trials evaluating OMS302, Omeros is becoming a commercial company," said
Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros.
"We are working to file an NDA in the first quarter of 2013 followed by an MAA
in mid-year, and we look forward to releasing data from two more clinical
programs before year-end – our Phase 3 meniscectomy and our Phase 1 PDE10
programs. Our clinical pipeline is expanding, and as many as three additional
programs could enter the clinic in 2013. We continue to execute on our
strategy of creating multiple opportunities for success."

Third Quarter and Recent Highlights

  oCompleted a public offering pursuant to which it sold 3,365,854 shares of
    common stock at a price of $10.25 per share. Omeros' net proceeds from
    the transaction were $32.3 million.
  oReported the completion of enrollment in the first of two planned pivotal
    Phase 3 clinical trials evaluating OMS103HP in patients undergoing
    arthroscopic partial meniscectomy surgery. OMS103HP is a proprietary drug
    product added to standard irrigation solutions and delivered to the
    operative site throughout arthroscopy to preemptively block the
    molecular-signaling and biochemical cascade caused by surgical trauma and
    to improve postoperative functional outcomes. Omeros expects to announce
    data from this Phase 3 trial before year-end.
  oAnnounced the identification of compounds that interact selectively with
    nine additional orphan G protein-coupled receptors (GPCRs), bringing the
    total number of orphans GPCRs unlocked by Omeros to 46, representing over
    half of the Class A orphan GPCRs and equaling the number of GPCRs targeted
    by over 30 percent of all currently marketed drugs. These nine orphans are
    linked to a series of important indications, including several types of
    cancer, autism, pain, osteoarthritis, neuropsychiatric disorders, and
    appetite and body weight.
  oBegan enrolling patients in a Phase 1 dose-ranging clinical trial of
    OMS824, Omeros' lead compound from its phosphodiesterase 10 (PDE10)
    program for schizophrenia and other cognitive disorders. This study will
    evaluate the drug's safety, tolerability and pharmacokinetics in healthy
    subjects, and Omeros expects data before year-end.
  oAnnounced that Omeros, its chief executive officer and its former chief
    financial officer entered into an agreement settling their respective
    claims. A description of this settlement agreement and the related lawsuit
    are included in Omeros' Current Report on Form 8-K filed with the U.S.
    Securities and Exchange Commission on November 1, 2012. 
  oReported positive data from the second of its two pivotal Phase 3 clinical
    trials evaluating OMS302 in patients undergoing intraocular lens
    replacement surgery. In this second Phase 3 clinical trial comparing
    OMS302 to placebo, OMS302 met its co-primary endpoints by demonstrating
    statistically significant (p<0.00001) maintenance of intraoperative
    mydriasis (pupil dilation) and statistically significant (p=0.0002)
    reduction of pain in the early postoperative period. Now with positive
    data from both trials in the OMS302 Phase 3 clinical program, Omeros is
    targeting submission of a New Drug Application to the U.S. Food and Drug
    Administration in the first quarter of 2013 and of a Marketing
    Authorization Application to the European Medicines Agency in mid-2013,
    with a planned market launch in 2014.

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 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 four ongoing 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 when it will submit an NDA and MAA
for OMS302; when sales may commence for OMS302; when it will announce the
results from its Phase 3 OMS103HP and Phase 1 PDE10 clinical trials; the
number of its programs that will enter the clinic in 2013; and that Omeros may
have 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 November 9, 2012. 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      Nine Months Ended
                               September 30,           September 30,
                               2012        2011        2012        2011
                               (unaudited)             (unaudited)
Revenue                        $      $      $      $     
                               1,417        987        4,439     3,381
Operating expenses:
Research and development       7,764       5,321       22,568      14,823
General and administrative     2,736       1,830       7,270       6,121
Loss on settlement             3,953       -           3,953       -
Total operating expenses       14,453      7,151       33,791      20,944
Loss from operations           (13,036)    (6,164)     (29,352)    (17,563)
Investment income              14          9           32          40
Interest expense               (413)       (528)       (1,360)     (1,348)
Other income, (expense) net    159         171         (30)        526
Net loss                       $         $        $      $    
                               (13,276)   (6,512)    (30,710)    (18,345)
Basic and diluted net loss per $      $       $      $     
common share                   (0.51)      (0.29)       (1.30)    (0.83)
Weighted-average shares used
to compute basic and diluted   25,834,730  22,246,430  23,578,724  22,156,883
net loss per common share



OMEROS CORPORATION
CONSOLIDATED BALANCE SHEET DATA
(In thousands)
                                     September 30,        December31,
                                     2012                 2011
Cash and cash equivalents and        $       30,629 $       24,570
short-term investments
Total assets                         32,761               26,982
Total notes payable                  15,052               19,446
Total current liabilities            21,811               18,985
Accumulated deficit                  (206,843)            (176,133)
Total shareholders' equity (deficit) (820)                (5,554)



SOURCE Omeros Corporation

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