Omeros Corporation Reports Third Quarter 2013 Financial Results
- Received
$17.4 million in cash inOctober 2013 - Total operating expenses in 3Q 2013 were
$13.6 million including$3.2 million in non-cash expenses compared to$13.3 million including non-cash expenses of$2.1 million in 2Q 2013 - U.S. and European regulators accepted
Omeros' OMS302 marketing applications for review - OMS824 and OMS721 Phase 1 clinical programs generated positive data
- Increased the number of unlocked orphan GPCRs to 52
"Throughout the third quarter of 2013, we continued to make significant strides in development across our pipeline," stated
Third Quarter and Recent Highlights
- Reported U.S. and European regulators had accepted
Omeros' OMS302 marketing applications for review. OMS302, added to standard irrigation solution used during ophthalmological procedures, isOmeros' proprietary PharmacoSurgery® product designed to maintain intraoperative mydriasis, prevent miosis and reduce postoperative pain and irritation resulting from cataract and other lens replacement surgery.Omeros is preparing for a planned commercial launch of OMS302 in the second half of 2014. - Announced that
Omeros entered into a settlement agreement withCarolina Casualty Insurance Company , or, CCIC, datedOctober 2, 2013 , related to CCIC's defense of, and coverage obligations owed to,Omeros and its chief executive officer and chairman, Dr. Demopulos, in previously settled litigation withOmeros' former chief financial officer. The settlement included a release of each party's respective claims in the insurance coverage lawsuit and payment by CCIC of$12.5 million toOmeros , which was received onOctober 24, 2013 . - Reported positive clinical data from its Phase 1 clinical program evaluating OMS824, the lead compound from its phosphodiesterase 10 (PDE10) program. OMS824 selectively inhibits PDE10, an enzyme expressed in areas of the brain linked to a wide range of diseases that affect cognition, including Huntington's disease and schizophrenia. Omeros subsequently started a Phase 2 trial evaluating the drug in patients with schizophrenia and plans to start a Phase 2 trial in Huntington's disease in early 2014. OMS824 has received orphan drug designation from the
FDA for the treatment of Huntington's disease. - Reported positive clinical data from its Phase 1 clinical trial of OMS721, the company's lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), an important regulator of the lectin pathway of the immune system. A Phase 2 clinical program to evaluate OMS721 in the treatment of thrombotic microangiopathies (TMAs), a family of disorders that occurs in the microcirculation of the body's organs, most commonly the kidney and brain, is expected to begin enrollment in early 2014.
- Announced that its proprietary Cellular Redistribution Assay technology had "unlocked" six additional Class A orphan G protein-coupled receptors (GPCRs) for drug development, bringing the total number of Class A orphan GPCRs "unlocked" by
Omeros to 52. These six orphan GPCRs are linked to a series of important indications, including cardiovascular indications, certain types of cancer and Grave's disease.Omeros also announced that it had identified small molecules that interact with two non-orphan Class B GPCRs, the glucagon-like peptide 1 receptor (GLP-1R) and the parathyroid hormone 1 receptor (PTH-1R). Both of these receptors are established drug targets – GLP-1R for diabetes and PTH-1R for osteoporosis.
Financial Results
Total operating expenses for the quarter ended
The decrease in total operating expenses for the quarter ended
Total revenue for the quarter ended
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," "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 |
Nine Months Ended |
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September 30, |
September 30, |
|||
2013 |
2012 |
2013 |
2012 |
|
(unaudited) |
(unaudited) |
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Revenue |
$ 196 |
$ 1,417 |
$ 1,431 |
$ 4,439 |
Operating expenses: |
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Research and development |
9,420 |
7,764 |
26,111 |
22,568 |
Selling, general and administrative |
4,210 |
2,736 |
11,934 |
7,270 |
Litigation settlement |
- |
3,953 |
- |
3,953 |
Total operating expenses |
13,630 |
14,453 |
38,045 |
33,791 |
Loss from operations |
(13,434) |
(13,036) |
(36,614) |
(29,352) |
Investment income |
2 |
14 |
10 |
32 |
Interest expense |
(592) |
(413) |
(1,768) |
(1,360) |
Other income, (expense) net |
154 |
159 |
421 |
(30) |
Net loss |
$ (13,870) |
$ (13,276) |
$ (37,951) |
$ (30,710) |
Basic and diluted net loss per common share |
$ (0.46) |
$ (0.51) |
$ (1.36) |
$ (1.30) |
Weighted-average shares used to compute basic and diluted net loss per common share |
29,844,507 |
25,834,730 |
27,984,133 |
23,578,724 |
OMEROS CORPORATION |
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CONSOLIDATED BALANCE SHEET DATA |
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(In thousands) |
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September 30, |
December 31, |
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2013 |
2012 |
|||
Cash and cash equivalents and short-term investments |
$ 8,998 |
$ 22,350 |
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Total assets |
12,014 |
26,575 |
||
Total notes payable |
20,395 |
20,103 |
||
Total current liabilities |
11,900 |
8,359 |
||
Accumulated deficit |
(252,528) |
(214,577) |
||
Total shareholders' equity (deficit) |
(23,893) |
(6,531) |
SOURCE
Jennifer Cook Williams, Cook Williams Communications, Inc., Investor and Media Relations, 360.668.3701, jennifer@cwcomm.org