Esperion Therapeutics Provides ETC-1002 Development Program Update; Reports First Quarter 2014 Financial Results
Esperion Therapeutics Provides ETC-1002 Development Program Update; Reports First Quarter 2014 Financial Results
May 12, 2014
Conference Call and Webcast Today,
"We are pleased with the progress of the ETC-1002 development program,"
said
First Quarter Development Program Highlights
- Randomized approximately 350 patients at 62 sites across the U.S. in the Company's Phase 2b ETC-1002-008 study in patients with hypercholesterolemia with or without statin intolerance. The randomized, double-blind, parallel-group, multicenter study is evaluating parallel doses of ETC-1002 as monotherapy or in combination with ezetimibe.
- Initiated ETC-1002-009, the Company's second Phase 2b clinical study, to evaluate the potential of ETC-1002 to provide incremental LDL-C lowering for patients already taking a statin and who are not at their LDL-C goal. The randomized, double-blind, parallel-group, multicenter study is evaluating parallel doses of ETC-1002 in approximately 132 patients with hypercholesterolemia over 12 weeks.
- Completed nonclinical safety studies resulting in no unexpected findings.
Upcoming Milestones Expected
-
During the fourth quarter of 2014, the Company expects to report
results of the two-year nonclinical carcinogenicity studies. These
results will be shared with the
FDA as part of the
End-of-Phase 2 meeting in 2015. -
During the fourth quarter of 2014, the Company expects to announce
top-line results from the
Phase 2b ETC-1002-008 clinical study. -
During the fourth quarter of 2014, the Company expects to announce
top-line results from the
Phase 2b ETC-1002-009 clinical study.
2014 First Quarter Financial Results
As of
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 continues to expect that full-year 2014 net cash used in
operating activities will be approximately
Conference Call and Webcast Information
Esperion's management will conduct a conference call to discuss
Esperion's financial and operational results for the first quarter
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 ETC-1002-008 clinical study and its Phase 2b ETC-1002-009
clinical study, the anticipated timing for reporting final results of
Esperion's two-year carcinogenicity studies, and expectations regarding
Esperion's 2014 financial outlook and its ability to fund its operations
through at least the end of 2015. 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) | ||||||||
Balance Sheet Data | ||||||||
(In thousands) | ||||||||
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2014 | 2013 | |||||||
(Unaudited) | ||||||||
Cash and cash equivalents | $ | 48,638 | $ | 56,537 | ||||
Working capital | 55,091 | 56,417 | ||||||
Investments | 19,592 | 21,063 | ||||||
Total assets | 70,223 | 78,294 | ||||||
Common stock | 15 | 15 | ||||||
Deficit accumulated during the development stage | (75,937 | ) | (68,063 | ) | ||||
Total stockholders' equity | 67,035 | 74,091 |
|
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(A Development Stage Company) | ||||||||
Statement of Operations | ||||||||
(In thousands, except share and per share data) | ||||||||
Three Months Ended | ||||||||
|
||||||||
2014 | 2013 | |||||||
(Unaudited) | (Unaudited) | |||||||
Operating expenses: | ||||||||
Research and development | $ | 5,400 | $ | 2,093 | ||||
General and administrative | 2,490 | 1,251 | ||||||
Total operating expenses | 7,890 | 3,344 | ||||||
Loss from operations | (7,890 | ) | (3,344 | ) | ||||
Interest expense | - | (828 | ) | |||||
Change in fair value of warrant liability | - | (42 | ) | |||||
Other income (expense), net | 16 | (25 | ) | |||||
Net loss | $ | (7,874 | ) | $ | (4,239 | ) | ||
Net loss per common share (basic and diluted) | $ | (0.51 | ) | $ | (12.24 | ) | ||
Weighted average shares outstanding
(basic and diluted) |
15,369,055 | 346,478 |
Media Contact:
212.257.6724
efox@w2ogroup.com
or
Investor
Contact:
443.450.4189
jordan.kohnstam@westwicke.com
Source:
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