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Esperion Therapeutics Provides ETC-1002 Program Update; Reports Fourth Quarter and Full Year 2013 Financial Results
Conference Call and Webcast Today,
"2013 was a successful year for Esperion both clinically and
Fourth Quarter Development Program Highlights
- Initiated ETC-1002-008, the Company's first Phase 2b clinical study, in patients with hypercholesterolemia and a history either with or without statin intolerance, which was defined as intolerance to two or more statins due to muscle-related adverse events. The study is evaluating parallel doses of ETC-1002 in approximately 322 patients for 12 weeks as monotherapy, or in combination with ezetimibe. The goals of this study are to compare the LDL-cholesterol lowering efficacy of ETC-1002 with ezetimibe and to demonstrate comparable tolerability to ezetimibe. Top-line results are expected in the fourth quarter of 2014.
Presented full results from the Phase 2a ETC-1002-006 clinical study
at the scientific sessions of the
American Heart Association2013 in Dallas.
Published full safety and efficacy results of the clinical study
ETC-1002-005 for the treatment of patients with hypercholesterolemia
and type 2 diabetes in the journal Arteriosclerosis, Thrombosis and
Vascular Biology. Dr.
Ronald Goldberg, University of Miami Miller School of Medicine, published an editorial in the March issue of the journal Arteriosclerosis, Thrombosis and Vascular Biology in response to the publication. His editorial discussed ETC-1002 as a novel approach to the management of patients with hypercholesterolemia and Type 2 diabetes, due to the effects of ETC-1002 observed on LDL-cholesterol levels and subclinical inflammation without worsening glycemic control.
Upcoming Milestones Expected
March 2014, the Company expects to initiate the ETC-1002-009 Phase 2b clinical study of parallel doses of ETC-1002 over 12 weeks added on to statin therapy in patients with elevated levels of LDL-cholesterol. This study is designed to demonstrate the ability of ETC-1002 to achieve incremental LDL-cholesterol lowering in approximately 132 patients with elevated levels of LDL-cholesterol.
- During the second quarter of 2014, we expect to provide the final results of our long-term chronic toxicology studies.
- During the fourth quarter of 2014, the Company expects to announce top-line results of ETC-1002-008, a Phase 2b clinical study in approximately 322 hypercholesterolemic patients with and without statin intolerance.
- During the fourth quarter of 2014, the Company expects to announce top-line results of ETC-1002-009, a Phase 2b clinical study.
- During the fourth quarter of 2014, the Company expects to provide the final results of our two year carcinogenicity studies.
2013 Fourth Quarter and Full-Year Financial Results
Research and development expense was
General and administrative expense was
Net loss was
Esperion had approximately 15.4 million shares of common stock
outstanding as of
2014 Financial Outlook
Esperion expects full-year 2014 net cash used in operating activities to
Conference Call and Webcast Information
Esperion's management will conduct a conference call to discuss ETC-1002
development program updates, Esperion's financial results for the fourth
quarter and full year ended
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 ETC-1002-008 clinical study, the planned initiation and study
design of Esperion's Phase 2b ETC-1002-009 clinical study and the
anticipated timing for reporting top-line results from ETC-1002-009, the
anticipated timing for providing the final results of Esperion's
long-term chronic toxicology studies and its two year carcinogenicity
studies and Esperion's financial position, including its expected net
cash used in operating activities in 2014 and its expected cash and cash
equivalents and investment securities as of
|(A Development Stage Company)|
|Condensed Balance Sheet Data|
|Cash and cash equivalents||$||56,537||$||6,512|
|Working capital (deficit)||56,417||(10,035||)|
|Total convertible short-term debt||-||15,241|
|Total convertible long-term debt||-||7,529|
|Convertible preferred stock||-||23,975|
|Deficit accumulated during the development stage||(68,063||)||(41,975||)|
|Total stockholders' equity (deficit)||74,091||(41,365||)|
|(A Development Stage Company)|
|Statement of Operations|
|(In thousands, except share and per share data)|
|Three Months Ended||Year Ended|
|Research and development||7,339||1,654||16,014||7,998|
|General and administrative||2,397||506||6,745||2,206|
|Total operating expenses||9,736||2,160||22,759||10,204|
|Loss from operations||(9,736||)||(2,160||)||(22,759||)||(10,204||)|
|Change in fair value of warrant liability||-||32||(2,587||)||32|
|Other income (expense), net||47||(86||)||194||(84||)|
|Net loss per common share (basic and diluted)||$||(0.63||)||$||(8.12||)||$||(3.31||)||$||
Weighted average shares outstanding
(basic and diluted)
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