Esperion Therapeutics Reports Third Quarter 2013 Financial Results and Provides Development Program Updates
Esperion Therapeutics Reports Third Quarter 2013 Financial Results and Provides Development Program Updates
November 6, 2013
"During the third quarter, we delivered on key milestones for our lead
product candidate, ETC-1002, reporting positive top-line results from
our Phase 2a clinical study of ETC-1002 added on to statin therapy in
patients with elevated LDL-C levels," said
Development Program Highlights
- Reported positive top-line results from the ETC-1002-007 Phase 2a clinical study of ETC-1002 when added on to statin therapy in patients with elevated levels of LDL-C. The study demonstrated that oral, once-daily ETC-1002 achieved incremental LDL-C lowering of 22 percent at eight weeks, compared with 0 percent in the placebo group, when added to 10 mg of atorvastatin (p < 0.0001). ETC-1002 was well tolerated over eight weeks of treatment when added to a statin and no serious adverse events were reported.
- Initiated ETC-1002-008, the Company's first Phase 2b clinical study, in patients with hypercholesterolemia and a history with or without statin intolerance (to two or more statins due to muscle-related adverse events). The study is evaluating parallel doses of ETC-1002 over 12 weeks as monotherapy or in combination with ezetimibe in approximately 322 patients. The goals of this study are to compare the LDL-C lowering efficacy of ETC-1002 with ezetimibe and to characterize tolerability. Top-line results are expected in late 2014.
Upcoming Milestones Expected
- In early 2014, the Company expects to initiate the ETC-1002-009 Phase 2b clinical study of parallel doses over 12 weeks of ETC-1002 added on to statin therapy in patients with elevated levels of LDL-C. This study is designed to demonstrate the ability of ETC-1002 to achieve incremental LDL-C lowering in statin resistant patients with elevated levels of LDL-C.
- Later this month, the Company will present the full results of the ETC-1002-006 Phase 2a clinical study in patients with hypercholesterolemia and a history of statin intolerance at a major scientific meeting.
Third Quarter Financial Results
Research and development expenses were
General and administrative expenses were
Esperion reported a net loss of
At
Esperion had approximately 15.4 million shares of common stock
outstanding as of
2013 Financial Outlook
Esperion continues to expect that its cash and cash equivalents and
investments securities will be approximately
About
Forward Looking Statements
This press release contains forward-looking statements that are made
pursuant to the safe harbor provisions of the federal securities laws,
including statements regarding the therapeutic potential of ETC-1002,
the anticipated timing for reporting top-line results from Esperion's
Phase 2b program, the planned initiation and study design of Esperion's
Phase 2b ETC-1002-009 clinical study, Esperion's plans to present the
full results of its Phase 2a ETC-1002-006 clinical study at a major
scientific meeting and Esperion's financial position. Any statements
contained in this press release that are not statements of historical
fact may be deemed to be forward-looking statements. Forward-looking
statements involve risks and uncertainties that could cause Esperion's
actual results to differ significantly from those projected, including,
without limitation, the risk that unanticipated developments could
interfere with the development (and commercialization) of ETC-1002, as
well as other risks detailed in Esperion's filings with the
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(A Development Stage Company) | ||||||||||||
Condensed Balance Sheet Data | ||||||||||||
(In thousands) | ||||||||||||
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2013 | 2012 | |||||||||||
(Unaudited) | (Unaudited) | |||||||||||
Cash and cash equivalents | $ | 71,896 | $ | 6,512 | ||||||||
Working capital (deficit) | 69,621 | (10,035 | ) | |||||||||
Investments | 13,477 | - | ||||||||||
Total assets | 86,576 | 7,312 | ||||||||||
Total convertible short-term debt | - | 15,241 | ||||||||||
Total convertible long-term debt | - | 7,529 | ||||||||||
Convertible preferred stock | - | 23,975 | ||||||||||
Common stock | 15 | - | ||||||||||
Deficit accumulated during the development stage | (58,374 | ) | (41,975 | ) | ||||||||
Total stockholders' equity (deficit) | 83,233 | (41,365 | ) |
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(A Development Stage Company) | ||||||||||||||||||||||
Condensed Statement of Operations | ||||||||||||||||||||||
(Unaudited) | ||||||||||||||||||||||
(In thousands, except share and per share data) | ||||||||||||||||||||||
Three Months Ended
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Nine Months Ended
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2013 | 2012 | 2013 | 2012 | |||||||||||||||||||
Grant income | $ | — | $ | — | $ | — | $ | — | ||||||||||||||
Operating expenses: | ||||||||||||||||||||||
Research and development | 3,483 | 2,456 | 8,676 | 6,344 | ||||||||||||||||||
General and administrative | 1,924 | 534 | 4,347 | 1,700 | ||||||||||||||||||
Acquired in-process research and development | - | - | - | - | ||||||||||||||||||
Total operating expenses | 5,407 | 2,990 | 13,023 | 8,044 | ||||||||||||||||||
Loss from operations | (5,407 | ) | (2,990 | ) | (13,023 | ) | (8,044 | ) | ||||||||||||||
Interest expense | - | (361 | ) | (936 | ) | (925 | ) | |||||||||||||||
Change in fair value of warrant liability | - | - | (2,587 | ) | - | |||||||||||||||||
Other income (expense), net | 168 | - | 147 | 3 | ||||||||||||||||||
Net loss | $ | (5,239 | ) | $ | (3,351 | ) | $ | (16,399 | ) | $ | (8,966 | ) | ||||||||||
Net loss per common share (basic and diluted) | $ | (0.34 | ) | $ | (10.31 | ) | $ | (3.05 | ) | $ | (28.27 | ) | ||||||||||
Weighted average shares outstanding
(basic and diluted) |
15,253,704 | 325,023 | 5,371,335 | 317,208 |
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