Esperion Therapeutics Reports Second Quarter Financial Results and Provides Corporate Update
Esperion Therapeutics Reports Second Quarter Financial Results and Provides Corporate Update
August 12, 2013
"The second quarter was transformative for Esperion. We completed a
successful private financing ending the period with
"I'm excited about the work that we are doing with ETC-1002, an oral,
once-daily, small molecule therapy that represents a new approach to
lowering LDL-C and reducing patients' cardiovascular disease risk.
Patients with hypercholesterolemia and a history of statin intolerance
have few good treatment options today and need alternative therapies,"
said
Recent Business Highlights
-
Completed a successful initial public offering (IPO) raising
$74.9 million in net proceeds. -
Completed a
$33 million preferred financing. - Reported positive top-line results from the ETC-1002-006 Phase 2a clinical study in patients with hypercholesterolemia and a history of intolerance to two or more statins. This randomized, double-blind, placebo-controlled, multicenter, proof-of-concept clinical study met its primary endpoint, with results demonstrating that ETC-1002 lowered LDL-C by an average of 32 percent and was well tolerated.
- Completed enrollment and dosing in the ETC-1002-007 Phase 2a clinical study in patients with hypercholesterolemia taking a 10 mg dose of atorvastatin calcium. This randomized, double-blind, placebo-controlled, multicenter clinical study was designed to evaluate the tolerability and safety of ETC-1002 when added to atorvastatin, and the effects of ETC-1002 on the pharmacokinetics of atorvastatin. The LDL-C lowering efficacy of ETC-1002 when added to atorvastatin also will be measured.
- Presented full results of ETC-1002-005, a Phase 2a clinical study in patients with hypercholesterolemia and Type 2 diabetes in an oral session at the Arteriosclerosis, Thrombosis and Vascular Biology (ATVB) 2013 Scientific Sessions. The study met its primary endpoint, with results demonstrating that ETC-1002 lowered LDL-C by up to 43 percent and was well tolerated.
-
Published full results from the ETC-1002-003 Phase 2 clinical study in
patients with hypercholesterolemia online in the
Journal of the American College of Cardiology . Findings from this randomized, double-blind, placebo-controlled, multicenter, parallel-group study showed that ETC-1002 significantly lowered LDL-C levels up to 27 percent across a broad range of baseline triglyceride levels and was well tolerated. Summary results from this study were previously presented at theMarch 2012 American College of Cardiology Scientific Sessions . -
Published a paper in the
Journal of Lipid Research that demonstrated, for the first time, the effectiveness of ETC-1002 in reducing chronic inflammation in preclinical models of inflammation.
Upcoming Milestones Expected
-
In the first half of
September 2013 , report top-line results from the ETC-1002-007 Phase 2a clinical study in approximately 52 patients with hypercholesterolemia taking a 10 mg dose of atorvastatin. -
In
October 2013 , initiate the ETC-1002-008 Phase 2b clinical study in approximately 322 patients with hypercholesterolemia and either a history of statin intolerance or a history of statin tolerance. The goal of this study is to demonstrate comparable tolerability and superior efficacy to ezetimibe for the treatment of patients with elevated LDL-C levels and intolerance to two or more statins due to muscle-related adverse events. - Later in 2013, present 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.
Second Quarter Financial Results
Research and development expenses were
General and administrative expenses were
Esperion reported a net loss of
At
2013 Financial Outlook
Esperion expects that its cash and cash equivalents 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 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 |
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(In thousands) |
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2013 | 2012 | |||||||||
(Unaudited) | (Unaudited) | |||||||||
Cash and cash equivalents | $ | 16,627 | $ | 6,512 | ||||||
Working capital (deficit) | 12,745 | (10,035 | ) | |||||||
Total assets | 19,534 | 7,312 | ||||||||
Total convertible short-term debt | - | 15,241 | ||||||||
Total convertible long-term debt | - | 7,529 | ||||||||
Convertible preferred stock | 65,228 | 23,975 | ||||||||
Deficit accumulated during the development stage | (53,135 | ) | (41,975 | ) | ||||||
Total stockholders' (deficit) equity | (52,338 | ) | (41,365 | ) | ||||||
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(A Development Stage Company) | ||||||||||||||||||
Condensed Statement of Operations | ||||||||||||||||||
(Unaudited) |
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(In thousands, except share and per share data) |
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Three Months Ended |
Six Months Ended |
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2013 | 2012 | 2013 | 2012 | |||||||||||||||
Grant income | $ | — | $ | — | $ | — | $ | — | ||||||||||
Operating expenses: | ||||||||||||||||||
Research and development | 3,100 | 2,330 | 5,193 | 3,887 | ||||||||||||||
General and administrative | 1,172 | 534 | 2,423 | 1,166 | ||||||||||||||
Acquired in-process research and development | — | — | — | — | ||||||||||||||
Total operating expenses | 4,272 | 2,864 | 7,616 | 5,053 | ||||||||||||||
Loss from operations | (4,272 | ) | (2,864 | ) | (7,616 | ) | (5,053 | ) | ||||||||||
Interest expense | (108 | ) | (303 | ) | (936 | ) | (564 | ) | ||||||||||
Change in fair value of warrant liability | (2,545 | ) | — | (2,587 | ) | — | ||||||||||||
Other income (expense), net | 4 | 1 | (21 | ) | 2 | |||||||||||||
Net loss | $ | (6,921 | ) | $ | (3,166 | ) | $ | (11,160 | ) | $ | (5,615 | ) | ||||||
Net loss per common share (basic and diluted) | $ | (19.82 | ) | $ | (9.94 | ) | $ | (32.09 | ) | $ | (17.92 | ) | ||||||
Weighted average shares outstanding (basic and diluted) |
349,170 | 318,654 | 347,831 | 313,258 |
Media and Investor Contact:
BrewLife
dpowell@brewlife.com
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