Esperion Therapeutics Provides ETC-1002 Development Program Update; Reports Second Quarter 2014 Financial Results
Esperion Therapeutics Provides ETC-1002 Development Program Update; Reports Second Quarter 2014 Financial Results
August 12, 2014
Conference Call and Webcast on
"Top-line results are expected in early October from our Phase 2b
ETC-1002-008 clinical trial in statin intolerant patients. Results from
our 2-year carcinogenicity studies are anticipated late in the fourth
quarter, while top-line results from two additional Phase 2 studies are
expected in the first half of 2015," said
Second Quarter Development Program Highlights
- In May, we completed enrollment in the Phase 2b ETC-1002-008 study in 349 patients with hypercholesterolemia with or without statin intolerance. The randomized, double-blind, parallel-group, multicenter study is evaluating parallel doses of ETC-1002 over 12 weeks as monotherapy or in combination with ezetimibe.
- Advanced patient enrollment in the Phase 2b ETC-1002-009 study in 132 patients with hypercholesterolemia already taking a statin and who are not yet at their LDL-cholesterol goal. The randomized, double-blind, parallel-group, multicenter study is evaluating parallel doses of ETC-1002 added-on to statin therapy over 12 weeks.
- In July, we initiated enrollment in the Phase 2 ETC-1002-014 study in 144 patients with hypercholesterolemia and hypertension. The randomized, double-blind, parallel group, multicenter study is evaluating 180 mg of ETC-1002 as monotherapy compared with placebo for six weeks.
-
The Company held its inaugural analyst and investor day event on July
29th in
New York City .
Upcoming Milestones
- In early October, report top-line results from the Phase 2b ETC-1002-008 clinical study.
-
In
December 2014 , results from the two-year carcinogenicity studies will be submitted toFDA . - In the first quarter of 2015, report top-line results from the Phase 2b ETC-1002-009 clinical study.
- In the second quarter of 2015, report top-line results from the Phase 2 ETC-1002-014 clinical study.
2014 Second Quarter Financial Results
As of
Research and development expenses were
General and administrative expenses were
Net loss was
Esperion had approximately 15.4 million shares of common stock and
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 second quarter
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 pre-clinical 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 ETC-1002,
the anticipated timing for reporting top-line results from Esperion's
ongoing studies, including ETC-1002-008, ETC-1002-009 and ETC-1002-014
and for submitting results from its two-year nonclinical carcinogenicity
studies to the
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Balance Sheet Data | |||||||
(In thousands) | |||||||
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2014 | 2013 | ||||||
(Unaudited) | |||||||
Cash and cash equivalents | $ | 47,944 | $ | 56,537 | |||
Working capital | 55,863 | 56,417 | |||||
Investments | 18,841 | 21,063 | |||||
Total assets | 69,287 | 78,294 | |||||
Total debt | 4,922 | - | |||||
Common stock | 15 | 15 | |||||
Accumulated deficit | (85,175 | ) | (68,063 | ) | |||
Total stockholders' equity | 58,909 | 74,091 |
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Statement of Operations |
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(In thousands, except share and per share data) | ||||||||||||||||
Three Months Ended |
Six Months Ended |
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2014 | 2013 | 2014 | 2013 | |||||||||||||
(Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 6,528 | $ | 3,100 | $ | 11,928 | $ | 5,193 | ||||||||
General and administrative | 2,726 | 1,172 | 5,216 | 2,423 | ||||||||||||
Total operating expenses | 9,254 | 4,272 | 17,144 | 7,616 | ||||||||||||
Loss from operations | (9,254 | ) | (4,272 | ) | (17,144 | ) | (7,616 | ) | ||||||||
Interest expense | (1 | ) | (108 | ) | (1 | ) | (936 | ) | ||||||||
Change in fair value of warrant liability | — | (2,545 | ) | — | (2,587 | ) | ||||||||||
Other income (expense), net | 17 | 4 | 33 | (21 | ) | |||||||||||
Net loss | $ | (9,238 | ) | $ | (6,921 | ) | $ | (17,112 | ) | $ | (11,160 | ) | ||||
Net loss per common share (basic and diluted) | $ | (0.60 | ) | $ | (19.82 | ) | $ | (1.11 | ) | $ | (32.09 | ) | ||||
Weighted average shares outstanding
(basic and diluted) |
15,399,018 | 349,170 | 15,385,009 | 347,831 |
Media Contact:
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or
Investor
Contact:
jordan.kohnstam@westwicke.com
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