Esperion Therapeutics Provides ETC-1002 Development Program Update; Reports Third Quarter 2014 Financial Results
Esperion Therapeutics Provides ETC-1002 Development Program Update; Reports Third Quarter 2014 Financial Results
November 10, 2014
Conference Call and Webcast on
"October proved to be truly transformational for Esperion. We announced
positive top-line results from our Phase 2b ETC-1002-008 clinical trial
in statin intolerant and statin tolerant patients, and successfully
completed a follow-on public offering raising nearly
Third Quarter Development Program Highlights
- In July, Esperion initiated enrollment in ETC-1002-014, a Phase 2 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 as compared with placebo for six weeks. Top-line results are expected in Q2 2015.
-
On
October 1 st, Esperion announced positive top-line results from the ETC-1002-008, Phase 2b clinical study in patients with hypercholesterolemia with or without statin intolerance. ETC-1002 treated patients achieved LDL-cholesterol lowering of up to 30 percent as monotherapy at 12 weeks as compared to 21 percent in the ezetimibe group, and LDL-cholesterol reductions of almost 50 percent when ETC-1002 was added to ezetimibe. -
In mid-October, Esperion completed enrollment for ETC-1002-009, a
Phase 2b study in 134 patients with hypercholesterolemia who already
take 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. Top-line results are expected in
March 2015 .
Upcoming Milestones
-
By early 2015, final reports from the two-year carcinogenicity studies
will be submitted to the
U.S. Food and Drug Administration (FDA). -
In
March 2015 , top-line results from Phase 2b of the ETC-1002-009 trial will be announced. - In the second quarter of 2015, top-line results from Phase 2 of the ETC-1002-014 trial will be announced.
2014 Third Quarter Financial Results
As of
Research and development expenses were
General and administrative expenses were
Net loss was
Esperion had approximately 15.5 million shares of common stock
outstanding, with another 2.0 million to be issued upon exercise of
options and warrants, 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 management will conduct a conference call to discuss financial
and operational results for the third 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 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, 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 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 | $ | 40,232 | $ | 56,537 | ||||
Working capital | 48,948 | 56,417 | ||||||
Investments | 17,784 | 21,062 | ||||||
Total assets | 60,530 | 78,294 | ||||||
Total debt | 4,929 | - | ||||||
Common stock | 15 | 15 | ||||||
Accumulated deficit | (94,981 | ) | (68,063 | ) | ||||
Total stockholders' equity | 50,223 | 74,091 | ||||||
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Statement of Operations | ||||||||||||||||
(In thousands, except share and per share data) | ||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
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2014 | 2013 | 2014 | 2013 | |||||||||||||
(Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 7,174 | $ | 3,483 | $ | 19,102 | $ | 8,676 | ||||||||
General and administrative | 2,526 | 1,924 | 7,742 | 4,347 | ||||||||||||
Total operating expenses | 9,700 | 5,407 | 26,844 | 13,023 | ||||||||||||
Loss from operations | (9,700 | ) | (5,407 | ) | (26,844 | ) | (13,023 | ) | ||||||||
Interest expense | (135 | ) | - | (136 | ) | (936 | ) | |||||||||
Change in fair value of warrant liability | - | - | - | (2,587 | ) | |||||||||||
Other income, net | 29 | 169 | 62 | 147 | ||||||||||||
Net loss | $ | (9,806 | ) | $ | (5,238 | ) | $ | (26,918 | ) | $ | (16,399 | ) | ||||
Net loss per common share (basic and diluted) | $ | (0.64 | ) | $ | (0.34 | ) | $ | (1.75 | ) | $ | (3.05 | ) | ||||
Weighted average shares outstanding
(basic and diluted) |
15,432,641 | 15,253,704 | 15,397,745 | 5,371,335 | ||||||||||||
Media Contact:
efox@w2ogroup.com
or
Investor
Contact:
mlowe@esperion.com
Source:
News Provided by Acquire Media