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Esperion Therapeutics Provides ETC-1002 Development Program Update; Reports First Quarter 2015 Financial Results
"Esperion had another truly transformational quarter," said
First Quarter Development Program Highlights
January 12, 2015: Esperion announced the submission of responses to FDAfor both the ETC-1002 PPAR and 240 mg partial clinical holds. In addition, the United States Adopted Names Councilassigned "bempedoic acid" as the non-proprietary name for ETC-1002.
February 2, 2015: Esperion announced removal of the ETC-1002 PPAR partial clinical hold by the FDA, allowing Esperion to conduct clinical studies of longer than six months in duration.
March 14, 2015: Dr. Paul Thompson, director of cardiology at Hartford Hospital, presented full results from the Phase 2b ETC-1002-008 clinical study in patients with hypercholesterolemia, with or without statin intolerance, in a moderated poster session during the American Collegeof Cardiology Annual Scientific Session. Patients treated with a combination of ETC-1002 and ezetimibe achieved up to 50 percent LDL-cholesterol lowering.
March 17, 2015: Esperion announced positive top-line results from the Phase 2b ETC-1002-009 clinical study evaluating ETC-1002 as an add-on to statins. ETC-1002-treated patients achieved up to 24 percent incremental reductions in LDL-cholesterol along with up to 30 percent incremental reductions in hsCRP.
March 24, 2015: Esperion completed a follow-on public offering raising over $200 million.
- Mid-year 2015, Esperion expects to announce top-line results from the Phase 2 ETC-1002-014 clinical study. This study enrolled 144 patients to evaluate the LDL-cholesterol lowering efficacy of ETC-1002 versus placebo in patients with both hypercholesterolemia and hypertension.
Third quarter 2015, Esperion expects to hold an End-of-Phase 2 meeting with
- Before year end, Esperion expects to initiate a Phase 3 clinical development program for ETC-1002.
2015 First Quarter Financial Results
Research and development expenses were
General and administrative expenses were
Esperion had a net loss of
Esperion had approximately 22.5 million shares of common stock outstanding, with another 2.5 million issuable upon exercise of stock options and warrants, and
2015 Financial Outlook
Esperion expects that the net cash used to fund operating activities in 2015 will be approximately
Conference Call and Webcast Information
Esperion's management will host a conference call to provide an update on the ETC-1002 development program, review financial results for the first quarter ended
Esperion's Commitment to Cardiometabolic Disease
Esperion is committed to improving the lives of patients with cardiometabolic diseases. The Esperion team leverages its understanding of, and experience with, key biological pathways to discover and develop innovative therapies for the treatment of patients with hypercholesterolemia who have uncontrolled cholesterol levels despite the use of currently available therapies. Esperion has assembled a portfolio of programs including one product candidate in late-stage clinical evaluation (ETC-1002) and two preclinical product candidates.
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, and clinical development plan for, ETC-1002. These statements are based on management's current expectations and accordingly are subject to uncertainty and changes in circumstances. Any express or implied 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 positive results from a clinical study of ETC-1002 may not necessarily be predictive of the results of future clinical studies, particularly in different or larger patient populations, or the risk that other unanticipated developments could interfere with the development (and commercialization) of ETC-1002, as well as other risks detailed in Esperion's filings with the
|Balance Sheet Data|
|Cash and cash equivalents||$||208,641||$||85,038|
|Total long-term debt||3,855||4,231|
|Total stockholders' equity||314,427||133,554|
|Statement of Operations|
|(In thousands, except share and per share data)|
Three Months Ended
|Research and development||$||7,390||$||5,400|
|General and administrative||4,035||2,490|
|Total operating expenses||11,425||7,890|
|Loss from operations||(11,425||)||(7,890||)|
|Other income, net||93||16|
|Net loss per common share (basic and diluted)||$||(0.56||)||$||(0.51||)|
|Weighted average shares outstanding (basic and diluted)||20,589,293||15,369,055|
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