Esperion Therapeutics Provides ETC-1002 Development Program Update; Reports Fourth Quarter and Full Year 2014 Financial Results
Esperion Therapeutics Provides ETC-1002 Development Program Update; Reports Fourth Quarter and Full Year 2014 Financial Results
March 5, 2015
"The past year has been the most impactful yet for ETC-1002 and Esperion," said
Development Program Highlights
October 1, 2014 : Esperion reported positive top-line results for ETC-1002-008, a Phase 2b clinical study in patients with hypercholesterolemia with or without statin intolerance. ETC-1002 demonstrated LDL-cholesterol lowering of up to 30% as monotherapy and nearly 50% in combination with ezetimibe.October 21, 2014 : Esperion completed a follow-on public offering raising approximately$100 million .January 12, 2015 : Esperion announced the submission of responses toFDA for both the PPAR and 240 mg partial clinical holds for ETC-1002 and the United States Adopted Names council assigned "bempedoic acid" as the non-proprietary name for ETC-1002.February 2, 2015 : Esperion announced removal of the PPAR partial clinical hold for ETC-1002 by theFDA allowing Esperion to conduct clinical studies of longer than six months in duration.
Upcoming Milestones
- Dr.
Paul Thompson , director of cardiology atHartford Hospital , will present full results from the Phase 2b ETC-1002-008 clinical study during theAmerican College of Cardiology AnnualScientific Session . The abstract "ETC-1002 Lowers LDL-C More than Ezetimibe in Patients with Hypercholesterolemia with or without Statin Intolerance" will be presented in a moderated poster session onSaturday, March 14, 2015 at3:45 p.m. PST . - The development of a fixed-dose combination with ezetimibe, as part of the development program for ETC-1002, is expected to be initiated.
- Later this month Esperion expects to announce top-line results from the Phase 2b ETC-1002-009 add-on to statin clinical study. This study enrolled approximately 134 patients and is evaluating the potential for ETC-1002 to provide incremental LDL-cholesterol lowering in patients already taking a statin who have not reached their LDL-cholesterol goal.
- Mid-year, Esperion expects to conduct an End-of-Phase 2 meeting with the
FDA for ETC-1002 and to announce top-line results from the Phase 2 ETC-1002-014 clinical study. This study will enroll more than 150 patients and is evaluating the LDL-cholesterol lowering efficacy of ETC-1002 versus placebo in patients with both hypercholesterolemia and hypertension. - Before year end, Esperion expects to initiate a Phase 3 clinical development program, including the Phase 3 long-term (104 week) safety study for ETC-1002.
2014 Fourth Quarter and Full-Year Financial Results
As of
Research and development expenses were
General and administrative expenses were
Esperion had a net loss of
Esperion had approximately 20.4 million shares of common stock outstanding, with another 2.0 million issuable upon exercise of stock options and warrants, and
2015 Financial Outlook
Esperion expects full-year 2015 net cash used in operating activities to be approximately
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
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.
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, and clinical development plan for, ETC-1002, the anticipated timing for reporting top-line results from Esperion's ongoing studies, including ETC-1002-009 and ETC-1002-014, the anticipated timing for announcing full results from Esperion's Phase 2b ETC-1002-008 clinical study, the anticipated timing for conducting an End-of-Phase 2 meeting with the
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Balance Sheet Data | ||||||||
(In thousands) | ||||||||
(Unaudited) | ||||||||
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2014 | 2013 | |||||||
Cash and cash equivalents | $ | 85,038 | $ | 56,537 | ||||
Working capital | 101,276 | 56,417 | ||||||
Investments | 56,544 | 21,062 | ||||||
Total assets | 143,344 | 78,294 | ||||||
Total debt | 4,299 | - | ||||||
Common stock | 20 | 15 | ||||||
Accumulated deficit | (104,438 | ) | (68,063 | ) | ||||
Total stockholders' equity | 133,554 | 74,091 | ||||||
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Statement of Operations | |||||||||||||||||
(In thousands, except share and per share data) | |||||||||||||||||
Three Months Ended | Year Ended | ||||||||||||||||
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2014 | 2013 | 2014 | 2013 | ||||||||||||||
(Unaudited) | (Unaudited) | (Unaudited) | |||||||||||||||
Operating expenses: | |||||||||||||||||
Research and development | $ | 6,200 | $ | 7,338 | $ | 25,302 | $ | 16,014 | |||||||||
General and administrative | 3,180 | 2,398 | 10,922 | 6,745 | |||||||||||||
Total operating expenses | 9,380 | 9,736 | 36,224 | 22,759 | |||||||||||||
Loss from operations | (9,380 | ) | (9,736 | ) | (36,224 | ) | (22,759 | ) | |||||||||
Interest expense | (134 | ) | - | (270 | ) | (936 | ) | ||||||||||
Change in fair value of warrant liability | - | - | - | (2,587 | ) | ||||||||||||
Other income, net | 57 | 46 | 119 | 194 | |||||||||||||
Net loss | $ | (9,457 | ) | $ | (9,690 | ) | $ | (36,375 | ) | $ | (26,088 | ) | |||||
Net loss per common share (basic and diluted) | $ | (0.49 | ) | $ | (0.63 | ) | $ | (2.22 | ) | $ | (3.31 | ) | |||||
Weighted average shares outstanding (basic and diluted) | 19,276,639 | 15,340,713 | 16,374,102 | 7,885,921 | |||||||||||||
Media Contact:
212.257.6724
efox@w2ogroup.com
Investor Contact:
734.887.3903
mlowe@esperion.com
Source:
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