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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 10, 2010
OMEROS CORPORATION
(Exact name of registrant as specified in its charter)
         
Washington
(State or other jurisdiction of
incorporation)
  001-34475
(Commission File Number)
  91-1663741
(IRS Employer
Identification No.)
1420 Fifth Avenue, Suite 2600
Seattle, Washington 98101

(Address of principal executive offices, including zip code)
(206) 676-5000
(Registrant’s telephone number, including area code)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
o   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 

 


 

Item 2.02   Results of Operation and Financial Condition.
     On August 10, 2010, Omeros Corporation issued a press release announcing financial results for the three and six months ended June 30, 2010. A copy of such press release is furnished herewith as Exhibit 99.1 and is incorporated herein by reference.
     The information in this Current Report on Form 8-K, including the exhibit hereto, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained herein and in the accompanying exhibit shall not be incorporated by reference into any filing with the United States Securities and Exchange Commission made by Omeros, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 9.01   Financial Statements and Exhibits.
          (d) Exhibits.
         
Exhibit    
Number   Description
  99.1    
Press release dated August 10, 2010 relating to Omeros’ financial results for the three and six months ended June 30, 2010.

 


 

SIGNATURES
     Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
         
  OMEROS CORPORATION
 
 
  By:   /s/ Gregory A. Demopulos    
    Gregory A. Demopulos, M.D.   
    President, Chief Executive Officer and Chairman of the Board of Directors   
 
Date: August 10, 2010

 


 

EXHIBIT INDEX
         
Exhibit    
Number   Description
  99.1    
Press release dated August 10, 2010 relating to Omeros’ financial results for the three and six months ended June 30, 2010.

 

exv99w1
Exhibit 99.1
(OMEROS LOGO)
OMEROS REPORTS SECOND QUARTER 2010 FINANCIAL RESULTS
Seattle, WA — August 10, 2010 — Omeros Corporation (NASDAQ: OMER), a biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation and disorders of the central nervous system, today announced financial results for the three and six months ended June 30, 2010.
Total operating expenses for the three and six months ended June 30, 2010 were $8.1 million and $14.9 million, respectively, compared to $6.1 and $11.5 million for the same periods in 2009. The increases in operating expenses were primarily due to higher contract service and consulting costs associated with several of the Company’s clinical and preclinical programs as well as increased costs associated with being a public company. In addition, the increases included a one-time payment of $500,000 to Affitech AS in the first quarter of 2010 and a one-time payment of $500,000 to Helion Biotech ApS in the second quarter of 2010 related to the Company’s MASP-2 program.
For the three and six months ended June 30, 2010, Omeros reported a net loss of $7.8 million, or $0.36 per share, and $14.5 million, or $0.68 per share, respectively. This is compared to a net loss of $6.1 million, or $2.09 per share, and $11.6 million, or $3.96 per share, for the same periods in 2009. At June 30, 2010, Omeros had cash, cash equivalents and short-term investments of $41.9 million.
“We made significant progress during the second quarter across many of our programs — perhaps most notably the successful identification of molecules that interact with, and modulate the signaling of, three orphan GPCRs linked to cancer, metabolic disorders and appetite control,” said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “We expect that the second half of 2010 will be equally productive as we prepare for data from at least two of our five clinical programs currently underway, including our Phase 3 clinical trials evaluating OMS103HP in patients undergoing arthroscopic ACL reconstruction and our Phase 1/Phase 2 trial of OMS201 in ureteroscopy.”
Second Quarter and Recent Highlights
    Secured a committed equity financing facility under which Omeros may, at its sole discretion, sell up to $40 million of its shares of common stock to Azimuth Opportunity, Ltd. over a 24-month period.
 
    Enrolled the first patient in a Phase 2b, full-factorial clinical trial evaluating OMS302 in patients undergoing cataract surgery. OMS302, added to standard irrigation solution used during ophthalmological procedures, is the Company’s proprietary PharmacoSurgery™ product in development to maintain mydriasis (pupil dilation) and reduce postoperative pain and inflammation following cataract and other lens replacement surgery.

 


 

    Successfully unlocked three orphan G protein-coupled receptors (GPCRs) linked to cancer, metabolic disorders and appetite control.
 
    Selected a clinical candidate for the Company’s MASP-2 antibody program and initiated the cGMP manufacturing development process in preparation for clinical trials. MASP-2 appears to play a significant role in many inflammatory disorders including glomerulonephritis, macular degeneration, ischemia-reperfusion injury, transplant rejection and stroke.
 
    Reported additional data from a Phase 2 trial of OMS103HP, Omeros’ lead PharmacoSurgery™product candidate for arthroscopy, showing that patients treated with OMS103HP during arthroscopic partial meniscectomy surgery achieved statistically significant clinical benefits.
 
    Entered into an Exclusive License Agreement with Helion Biotech ApS pursuant to which Omeros received a royalty-bearing, worldwide exclusive license in and to all of Helion’s intellectual property rights related to MASP-2 antibodies, polypeptides and methods in the field of inhibition of mannan-binding lectin-mediated activation of the complement system for the prevention, treatment or diagnosis of any disease or condition. This agreement, together with the exclusive licenses of rights related to MASP-2 that Omeros already holds from the University of Leicester and the UK Medical Research Council, gives Omeros exclusive licenses to all ownership rights related to the patents and patent applications owned by these three organizations claiming antibodies that bind MASP-2, MASP-2 polypeptides, therapeutic methods and research tools, consolidating within Omeros the worldwide exclusive rights to the inhibition of MASP-2 and the antibodies targeting it.
A replay of today’s webcast of Dr. Demopulos’ presentation at the Canaccord Genuity 30th Annual Growth Conference can be accessed on the “Events” page of the Company’s website at http://www.omeros.com. Given the information presented in this webcast, the Company will not host a conference call to discuss its second quarter 2010 results.
About Omeros Corporation
Omeros is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation 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 five ongoing clinical development programs, including four from its PharmacoSurgery™ platform and one from its Addiction program, the most advanced of which is in a Phase 3 clinical program. Omeros may also have the near-term capability, through its GPCR program, to add an unprecedented number of wholly new drug targets to the market. Behind its clinical candidates and GPCR platform, Omeros is building a diverse pipeline of antibody and small-molecule preclinical programs targeting inflammation 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. 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 and include the Company’s expectation that it will have data in the second half of 2010 from its Phase 3 clinical trials evaluating OMS103HP in patients

 


 

undergoing arthroscopic ACL reconstruction and its Phase 1/Phase 2 trial of OMS201 in ureteroscopy. 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 10, 2010. 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.
Contact:
Jennifer Cook Williams
Cook Williams Communications, Inc.
Investor and Media Relations
360.668.3701
jennifer@cwcomm.org

 


 

OMEROS CORPORATION
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
(unaudited)
                                 
    Three Months Ended     Six Months Ended  
    June 30,     June 30,  
    2010     2009     2010     2009  
Grant revenue
  $ 497     $ 371     $ 875     $ 568  
Operating expenses:
                               
Research and development
    6,120       4,577       11,202       8,599  
General and administrative
    2,011       1,475       3,732       2,885  
 
                       
Total operating expenses
    8,131       6,052       14,934       11,484  
 
                       
Loss from operations
    (7,634 )     (5,681 )     (14,059 )     (10,916 )
Investment income
    21       61       38       142  
Interest expense
    (409 )     (575 )     (861 )     (1,165 )
Other income (expense), net
    218       86       417       348  
 
                       
Net loss
  $ (7,804 )   $ (6,109 )   $ (14,465 )   $ (11,591 )
 
                       
Basic and diluted net loss per common share
  $ (0.36 )   $ (2.09 )   $ (0.68 )   $ (3.96 )
 
                       
Weighted-average shares used to compute basic and diluted net loss per common share
    21,381,216       2,929,690       21,337,556       2,929,397  
 
                       

 


 

OMEROS CORPORATION
(A Development Stage Company)
CONSOLIDATED BALANCE SHEET DATA
(In thousands)
                 
    June 30,   December 31,
    2010   2009
    (unaudited)        
Cash and cash equivalents and short-term investments
  $ 41,883     $ 60,305  
Total assets
    44,786       62,062  
Total notes payable
    10,143       12,758  
Total current liabilities
    10,114       11,090  
Deficit accumulated during the development stage
    (132,801 )     (118,336 )
Total shareholders’ equity
    29,798       43,145