Omeros Corporation Reports First Quarter 2014 Financial Results
- 1Q 2014 net loss of
$16.6 million , or$0.54 per share, which included$2.6 million ($0.09 per share) of non-cash expenses - Operating expenses of
$15.8 million were primarily related to preparing for expected U.S. commercial launch of Omidria™ and to advancing OMS824 and OMS721 clinical programs - Closed
$40.3 million public offering of common stock and replaced existing loan facility with new loan facility, receiving$37.7 million and$12.7 million , respectively, in net proceeds - Commenced enrollment in Phase 2 clinical trial of OMS824, which has received both Orphan Drug and Fast Track Designations from
U.S. Food and Drug Administration (FDA ), in patients with Huntington's disease - Reported positive results from OMS824 Phase 2a clinical trial in schizophrenia patients
- Reported positive data, similar to those obtained with complement factor C5 blockers, using OMS721 in ex vivo studies of endothelial activation and complement deposition relevant to pathophysiology of human atypical hemolytic uremic syndrome (aHUS), a form of thrombotic microangiopathy (TMA)
- After receiving
FDA's Orphan Drug Designation, Investigational New Drug (IND) application cleared byFDA and initiating Phase 2 clinical trial of OMS721 in TMAs
"We continue to expect approval of Omidria this quarter," said
First Quarter and Recent Highlights
- Closed a public offering of 3,500,000 shares of common stock in
March 2014 at a public offering price of$11.50 per share. The closing included the sale of 456,521 shares of common stock sold pursuant to the overallotment option granted to the underwriters, which was fully exercised. After deducting underwriting discounts and offering expenses, the company received net proceeds of$37.7 million . - Closed a senior credit facility with Oxford Finance and MidCap Financial in
March 2014 , consisting of a$32.0 million term loan. The new loan requires interest-only payments throughMarch 2015 and thereafter calls for monthly principal and interest payments throughMarch 2018 .Omeros used a portion of the loan proceeds to repay its obligations under its prior loan and security agreement with Oxford Finance and affiliates and received net proceeds of$12.7 million . - Began enrollment in a Phase 2 clinical trial evaluating OMS824, the company's phosphodiesterase 10 (PDE10) inhibitor, in patients with Huntington's disease. OMS824 has received from the FDA Orphan Drug Designation for the treatment of Huntington's disease and Fast Track Designation for the treatment of cognitive impairment in patients with Huntington's disease.
- Reported positive results from the company's OMS824 Phase 2a clinical trial in which OMS824 was well tolerated and demonstrated comparable tolerability and systemic pharmacokinetics when administered alone and concomitantly with approved antipsychotic agents in patients with stable schizophrenia, opening the potential for OMS824 to be delivered as monotherapy or as an adjunct to commercially available antipsychotics.
- Reported positive data from
Omeros' Phase 1 clinical trial of OMS721, demonstrating that both subcutaneous and intravenous routes of administration resulted in a high degree of inhibition of lectin pathway and successfully achieved the pharmacologic target of sustained inhibition for at least one week. OMS721 is the company's lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2, the key regulator of the lectin pathway of the immune system. OMS721 has received Orphan Drug Designation from theFDA for inhibition of complement-mediated TMAs. - Announced that the
FDA clearedOmeros' IND application to evaluate OMS721 for the inhibition of complement-mediated TMAs.Omeros is initiating a Phase 2 clinical trial to evaluate OMS721 in patients with TMAs. - Received positive data using OMS721 in ex vivo studies of endothelial activation relevant to the pathophysiology of human atypical hemolytic uremic syndrome (aHUS), a form of TMA. The data demonstrated that OMS721, compared to untreated controls, significantly inhibited complement deposition on human endothelial cells using serum samples from aHUS patients obtained during the acute phase of disease (p<0.01) and during remission (p<0.001). The results were similar to those obtained by agents that block the complement factor C5.
Financial Results
For the quarter ended
Operating expenses for the three months ended
Revenue for the quarter ended
At
About
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," "look forward to", "may," "plan," "potential," "predict," "project," "should," "will," "would" and similar expressions. 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 CORPORATION |
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CONSOLIDATED STATEMENTS OF OPERATIONS |
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(In thousands, except share and per share data) |
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Three Months Ended |
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March 31, |
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2014 |
2013 |
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(unaudited) |
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Revenue |
$ 100 |
$ 1,095 |
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Operating expenses: |
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Research and development |
12,017 |
7,127 |
||
General and administrative |
3,767 |
3,988 |
||
Total operating expenses |
15,784 |
11,115 |
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Loss from operations |
(15,684) |
(10,020) |
||
Investment income |
2 |
6 |
||
Interest expense |
(672) |
(587) |
||
Other income (expense), net |
(288) |
112 |
||
Net loss |
$ (16,642) |
$ (10,489) |
||
Basic and diluted net loss per share |
$ (0.54) |
$ (0.40) |
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Weighted-average shares used to compute |
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basic and diluted net loss per share |
30,897,039 |
25,908,153 |
||
OMEROS CORPORATION |
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CONSOLIDATED BALANCE SHEET DATA |
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(In thousands) |
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March 31, |
December 31, |
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2014 |
2013 |
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(unaudited) |
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Cash and cash equivalents and short-term investments |
$ 52,189 |
$ 14,101 |
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Total assets |
56,067 |
16,535 |
||
Total notes payable |
32,212 |
20,498 |
||
Total current liabilities |
10,232 |
11,873 |
||
Accumulated deficit |
(271,015) |
(254,373) |
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Total shareholders' equity (deficit) |
5,212 |
(18,384) |
SOURCE
Jennifer Cook Williams, Cook Williams Communications, Inc., Investor and Media Relations, 360.668.3701, [email protected]