Esperion Therapeutics, Inc. (NASDAQ: ESPR), a clinical-stage
biopharmaceutical company focused on developing and commercializing
first-in-class, oral, low-density lipoprotein cholesterol (LDL-C)
lowering therapies for the treatment of hypercholesterolemia, today
provided a corporate update and reported its financial results for
the second quarter ended June 30, 2013.
"The second quarter was transformative for Esperion. We
completed a successful private financing ending the period with
$16.6 million in cash and cash equivalents and in early July
received net proceeds of $74.9 million from the closing of our IPO
resulting in pro forma cash and cash equivalents of $91.5 million,"
said Tim M. Mayleben, president and chief executive officer of
Esperion. “We also continued to advance the clinical development of
ETC-1002. We completed and reported positive top-line results from
our ETC-1002-006 Phase 2a clinical study in patients with
hypercholesterolemia and a history of statin intolerance. Further,
we completed enrollment and dosing in our ETC-1002-007 Phase 2a
clinical study in patients with hypercholesterolemia and expect to
report top-line results in the first half of September. We are in
an excellent position to complete the Phase 2b clinical development
of ETC-1002."
“I’m excited about the work that we are doing with ETC-1002, an
oral, once-daily, small molecule therapy that represents a new
approach to lowering LDL-C and reducing patients’ cardiovascular
disease risk. Patients with hypercholesterolemia and a history of
statin intolerance have few good treatment options today and need
alternative therapies," said Roger S. Newton, Ph.D., FAHA, founder,
executive chairman and chief scientific officer of Esperion. “With
the resources now available to us through our recent financing and
IPO, we are in an excellent position to advance ETC-1002 to address
this high unmet medical need.”
Recent Business Highlights
- Completed a successful initial public
offering (IPO) raising $74.9 million in net proceeds.
- Completed a $33 million preferred
financing.
- Reported positive top-line results from
the ETC-1002-006 Phase 2a clinical study in patients with
hypercholesterolemia and a history of intolerance to two or more
statins. This randomized, double-blind, placebo-controlled,
multicenter, proof-of-concept clinical study met its primary
endpoint, with results demonstrating that ETC-1002 lowered LDL-C by
an average of 32 percent and was well tolerated.
- Completed enrollment and dosing in the
ETC-1002-007 Phase 2a clinical study in patients with
hypercholesterolemia taking a 10 mg dose of atorvastatin calcium.
This randomized, double-blind, placebo-controlled, multicenter
clinical study was designed to evaluate the tolerability and safety
of ETC-1002 when added to atorvastatin, and the effects of ETC-1002
on the pharmacokinetics of atorvastatin. The LDL-C lowering
efficacy of ETC-1002 when added to atorvastatin also will be
measured.
- Presented full results of ETC-1002-005,
a Phase 2a clinical study in patients with hypercholesterolemia and
Type 2 diabetes in an oral session at the Arteriosclerosis,
Thrombosis and Vascular Biology (ATVB) 2013 Scientific Sessions.
The study met its primary endpoint, with results demonstrating that
ETC-1002 lowered LDL-C by up to 43 percent and was well
tolerated.
- Published full results from the
ETC-1002-003 Phase 2 clinical study in patients with
hypercholesterolemia online in the Journal of the American College
of Cardiology. Findings from this randomized, double-blind,
placebo-controlled, multicenter, parallel-group study showed that
ETC-1002 significantly lowered LDL-C levels up to 27 percent across
a broad range of baseline triglyceride levels and was well
tolerated. Summary results from this study were previously
presented at the March 2012 American College of Cardiology
Scientific Sessions.
- Published a paper in the Journal of
Lipid Research that demonstrated, for the first time, the
effectiveness of ETC-1002 in reducing chronic inflammation in
preclinical models of inflammation.
Upcoming Milestones Expected
- In the first half of September 2013,
report top-line results from the ETC-1002-007 Phase 2a clinical
study in approximately 52 patients with hypercholesterolemia taking
a 10 mg dose of atorvastatin.
- In October 2013, initiate the
ETC-1002-008 Phase 2b clinical study in approximately 322 patients
with hypercholesterolemia and either a history of statin
intolerance or a history of statin tolerance. The goal of this
study is to demonstrate comparable tolerability and superior
efficacy to ezetimibe for the treatment of patients with elevated
LDL-C levels and intolerance to two or more statins due to
muscle-related adverse events.
- Later in 2013, present full results of
the ETC-1002-006 Phase 2a clinical study in patients with
hypercholesterolemia and a history of statin intolerance at a major
scientific meeting.
Second Quarter Financial Results
Research and development expenses were $3.1 million for the
second quarter of 2013 and $5.2 million for the six months ended
June 30, 2013, compared with $2.3 million and $3.9 million for the
comparable periods in 2012. The increase in research and
development expenses was largely driven by the advancement of the
ETC-1002 program through Phase 2 development.
General and administrative expenses were $1.2 million for the
second quarter of 2013 and $2.4 million for the six months ended
June 30, 2013, compared with $0.5 million and $1.2 million for the
comparable periods in 2012. The increase in general and
administrative expenses was largely driven by incremental expenses
to support public company operations, changes in headcount, which
includes increased stock-based compensation expense, and other
costs to support Esperion’s growth.
Esperion reported a net loss of $6.9 million for the second
quarter of 2013 and $11.2 million for the six months ended June 30,
2013, compared with a net loss of $3.2 million and $5.6 million for
the comparable periods in 2012.
At June 30, 2013, cash and cash equivalents totaled $16.6
million compared with $6.5 million at December 31, 2012. The
increase was primarily driven by net cash proceeds of $17.0 million
from a preferred stock financing in April. Cash and cash
equivalents at June 30, 2013, did not include the net proceeds of
$74.9 million resulting from the completion of the IPO and the
exercise of the underwriters’ over-allotment option in July 2013,
which is net of underwriting discounts and commissions.
2013 Financial Outlook
Esperion expects that its cash and cash equivalents will be
approximately $75 million at December 31, 2013. The Company
believes that existing cash resources will fund the Company until
at least the end of 2015. Full-year 2013 net cash used in operating
activities is expected to be approximately $25 million.
About Esperion Therapeutics
Esperion Therapeutics, Inc. is a biopharmaceutical company
focused on the research, development and commercialization of
therapies for the treatment of patients with elevated levels of
low-density lipoprotein cholesterol (LDL-C) and other
cardiometabolic risk factors. ETC-1002, Esperion’s lead product
candidate, is a unique, first-in-class, orally available,
once-daily small molecule therapy designed to lower levels of LDL-C
and to avoid side effects associated with existing LDL-C lowering
therapies. ETC-1002 is targeted for statin intolerant patients with
elevated levels of LDL-C. Esperion has completed seven clinical
studies to date, including four Phase 2a studies, and expects to
initiate a robust Phase 2b clinical program in the fourth quarter
of 2013. For more information, please visit www.esperion.com.
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 and Esperion’s financial position. 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 Securities and Exchange
Commission, including our Quarterly Report on Form 10-Q filed with
Securities and Exchange Commission on August 12, 2013. You are
cautioned not to place undue reliance on the forward-looking
statements, which speak only as of the date of this release.
Esperion disclaims any obligation or undertaking to update or
revise any forward-looking statements contained in this press
release, other than to the extent required by law.
Esperion Therapeutics, Inc. (A Development Stage
Company)
Condensed Balance Sheet Data
(In thousands)
June 30, December
31, 2013 2012 (Unaudited)
(Unaudited) Cash and cash equivalents $ 16,627 $
6,512 Working capital (deficit) 12,745 (10,035 ) Total assets
19,534 7,312 Total convertible short-term debt - 15,241 Total
convertible long-term debt - 7,529 Convertible preferred stock
65,228 23,975 Deficit accumulated during the development stage
(53,135 ) (41,975 ) Total stockholders' (deficit) equity (52,338 )
(41,365 )
Esperion Therapeutics, Inc. (A
Development Stage Company) Condensed Statement of
Operations
(Unaudited)
(In thousands, except share and per
share data)
Three Months EndedJune
30,
Six Months EndedJune 30,
2013 2012 2013
2012 Grant income $ – $ – $ – $ –
Operating expenses: Research and development 3,100
2,330 5,193 3,887 General and administrative 1,172 534 2,423 1,166
Acquired in-process research and development –
– – – Total
operating expenses 4,272 2,864
7,616 5,053
Loss from
operations (4,272 ) (2,864 ) (7,616 ) (5,053 ) Interest
expense (108 ) (303 ) (936 ) (564 ) Change in fair value of warrant
liability (2,545 ) – (2,587 ) – Other income (expense), net
4 1 (21 ) 2
Net loss $ (6,921 ) $ (3,166 ) $
(11,160 ) $ (5,615 ) Net loss per common share (basic and
diluted) $ (19.82 ) $ (9.94 ) $ (32.09 ) $
(17.92 ) Weighted average shares outstanding(basic and diluted)
349,170 318,654
347,831 313,258
Media and Investor Contact:BrewLifeDenise Powell,
510-703-9491dpowell@brewlife.com
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