Esperion Therapeutics Provides Bempedoic Acid Development Program Updates; Reports First Quarter 2016 Financial Results
May 04 2016 - 8:05AM
Esperion Therapeutics, Inc. (NASDAQ:ESPR), a pharmaceutical company
focused on developing and commercializing first-in-class, oral,
low-density lipoprotein cholesterol (LDL-C) lowering therapies for
the treatment of patients with elevated LDL-C, today provided
bempedoic acid (ETC-1002) development program updates and financial
results for the first quarter ended March 31, 2016.
“The Esperion team has maintained a clear focus
on the development of bempedoic acid as evidenced by our continued
accomplishments this past quarter,” said Tim M. Mayleben, president
and chief executive officer of Esperion. “We continue to work with
major regulatory authorities and key opinion leaders around the
world to design the clinical studies that will support the
potential global approval of bempedoic acid for LDL-C lowering in
statin intolerant patients. We look forward to sharing our Phase 3
statin intolerant clinical and regulatory plans by the end of this
quarter.”
Development Program and Company Highlights
- January 12, 2016:
- Esperion announced initiation of the Phase 2
pharmacokinetics/pharmacodynamics (PK/PD) clinical study of
bempedoic acid in patients treated with atorvastatin 80 mg, the
most commonly prescribed high-dose statin (1002-035).
- January 13, 2016:
- Esperion announced initiation of the Phase 3 clinical program —
known as Cholesterol Lowering via BEmpedoic Acid, an ACL-inhibiting
Regimen (CLEAR) — with the start of the 52-week, long-term safety
and tolerability study in patients with hyperlipidemia treated with
bempedoic acid (1002-040).
- January 30, 2016:
- Full results from the completed 1002-008 study were published
on the Journal of Clinical Lipidology website, “Treatment with
ETC-1002 alone and in combination with ezetimibe lowers
LDL-cholesterol in hypercholesterolemic patients with or without
statin intolerance,” with the article in press.
- February 22, 2016:
- Esperion initiated a Phase 1 clinical pharmacology study to
assess the safety and tolerability of bempedoic acid, as well as
the effects of bempedoic acid on the PK of single doses of the
highest doses of the most commonly prescribed statins: atorvastatin
80 mg, rosuvastatin 40 mg, simvastatin 40 mg and pravastatin 80 mg
(1002-037).
Upcoming Milestones
- Q2 2016:
- By the end of June, Esperion plans to announce details of the
global clinical and regulatory development plan for the Phase 3
CLEAR program of bempedoic acid in statin intolerant patients;
- By the end of June, Esperion expects to file an Investigational
New Drug Application for the fixed-dose combination of bempedoic
acid and ezetimibe for statin intolerant patients.
- Q3 2016:
- Esperion plans to announce details of the cardiovascular
outcomes trial (CVOT) for bempedoic acid in statin intolerant
patients;
- Esperion plans to announce top-line results from the Phase 2
PK/PD clinical study of bempedoic acid in patients treated with
high-dose atorvastatin (1002-035) and top-line results from the
Phase 1 clinical pharmacology study to assess the safety and
tolerability of bempedoic acid and PK of the highest doses of the
most commonly prescribed statins (1002-037).
- Q4 2016:
- Esperion plans to initiate the Phase 3 CLEAR clinical efficacy
studies for bempedoic acid in statin intolerant patients;
- Esperion plans to initiate the CVOT for bempedoic acid in
statin intolerant patients.
2016 First Quarter Financial Results As of
March 31, 2016, cash and cash equivalents and available-for-sale
investment securities totaled $282.7 million compared with $292.6
million at December 31, 2015.
Research and development expenses were $9.8 million for the
first quarter of 2016, compared to $7.4 million for the comparable
period in 2015. The increase in research and development expenses
was primarily related to the further clinical development of
bempedoic acid, which includes increases in our headcount and
increased stock-based compensation expense.
General and administrative expenses were $5.0
million for the first quarter of 2016, compared to $4.0 million for
the comparable period in 2015. The increase in general and
administrative expenses was primarily attributable to costs to
support public company operations, increases in our headcount,
which includes increased stock-based compensation expense, and
other costs to support Esperion's growth.
Esperion had a net loss of $14.6 million for the
first quarter of 2016, compared to $11.5 million for the comparable
period in 2015.
Esperion had approximately 22.5 million shares
of common stock outstanding, with another 3.2 million issuable upon
exercise of stock options and warrants, and $3.9 million of debt
outstanding as of March 31, 2016.
2016 Financial
Outlook
Esperion expects full-year 2016 net cash used in
operating activities to be approximately $80 to $90 million and its
cash and cash equivalents and investment securities to be
approximately $200 million at December 31, 2016. The Company
estimates that current cash resources are sufficient to fund the
Company through at least the end of 2018 and the potential approval
of bempedoic acid.
Esperion’s Commitment to Cardiometabolic
Disease
Esperion is committed to improving the lives of patients by
developing therapies to lower elevated LDL-C. Esperion scientists
discovered bempedoic acid and the LDL-C lowering therapy is in late
stage development. Esperion plans to develop both bempedoic acid
and a fixed-dose combination of bempedoic acid and ezetimibe with a
particular focus on patients with elevated LDL-C who are considered
intolerant of statin therapy. It is estimated that approximately
10% of patients who are prescribed statins, 3.5 million patients in
the U.S., are considered statin intolerant.
About Esperion Therapeutics
Esperion Therapeutics, Inc. is a pharmaceutical company
focused on developing and commercializing first-in-class, oral,
LDL-C lowering therapies for the treatment of patients with
elevated LDL-C. Bempedoic acid, the Company’s lead product
candidate, is an inhibitor of ATP Citrate Lyase, a
well-characterized enzyme on the cholesterol biosynthesis pathway.
Bempedoic acid inhibits cholesterol synthesis in the liver,
decreases intracellular cholesterol and up-regulates LDL-receptors,
resulting in increased LDL-C clearance and reduced plasma levels of
LDL-C. For more information, please
visit www.esperion.com and follow us on Twitter
at https://twitter.com/EsperionInc.
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, bempedoic acid and
the fixed-dose combination of bempedoic acid and ezetimibe,
including the expected IND application filing for the fixed-dose
combination, the design and timing of the announcement of top-line
results from 1002-035 and 1002-037, the Company’s plans regarding
its Phase 3 program and the timing and design of the planned
cardiovascular outcomes trial, and the Company’s expected cash and
liquidity position and outlook. Any express or implied 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, delays or failures
in patient enrollment in the Company’s studies, the risk that FDA
may require additional studies or data, including prior to approval
that might cause approval to be delayed, that Esperion may need to
change the design of its Phase 3 program, including upon feedback
from regulatory authorities, that positive results from a clinical
study of bempedoic acid and the fixed-dose combination of bempedoic
acid and ezetimibe may not necessarily be predictive of the results
of future clinical studies, particularly in different or larger
patient populations, or in all statin doses, including high-doses,
that existing cash resources may be used more quickly than
anticipated, that the planned cardiovascular outcomes trial may not
demonstrate that bempedoic acid leads to cardiovascular risk
reduction, or the risk that other unanticipated developments or
data could interfere with the scope of development and
commercialization of bempedoic acid and the fixed-dose combination
of bempedoic acid and ezetimibe, as well as other risks detailed in
Esperion’s filings with the Securities and Exchange Commission,
including our Annual Report on Form 10-K. 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.
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Esperion Therapeutics, Inc. |
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|
|
|
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Balance Sheet Data |
|
(In thousands) |
|
(Unaudited) |
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
$ |
37,207 |
|
|
$ |
77,336 |
|
|
|
Working
capital |
|
191,061 |
|
|
|
208,769 |
|
|
|
Investments |
|
245,446 |
|
|
|
215,240 |
|
|
|
Total
assets |
|
286,036 |
|
|
|
295,572 |
|
|
|
Total
long-term debt |
|
2,283 |
|
|
|
2,688 |
|
|
|
Common
stock |
|
23 |
|
|
|
23 |
|
|
|
Accumulated deficit |
|
(168,807 |
) |
|
|
(154,222 |
) |
|
|
Total
stockholders' equity |
|
277,760 |
|
|
|
287,259 |
|
|
|
|
|
|
|
|
|
Esperion Therapeutics, Inc. |
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Statement of Operations |
(In thousands, except share and per share
data) |
(Unaudited) |
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Three Months Ended
March 31, |
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2016 |
|
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2015 |
|
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Operating
expenses: |
|
|
|
|
Research and development |
$ |
9,791 |
|
|
$ |
7,390 |
|
|
General and administrative |
|
5,031 |
|
|
|
4,035 |
|
|
Total
operating expenses |
|
14,822 |
|
|
|
11,425 |
|
|
Loss from operations |
|
(14,822 |
) |
|
|
(11,425 |
) |
|
|
|
|
|
|
Interest
expense |
|
(110 |
) |
|
|
(134 |
) |
|
Other
income, net |
|
347 |
|
|
|
93 |
|
|
Net
loss |
$ |
(14,585 |
) |
|
$ |
(11,466 |
) |
|
Net loss per common
share (basic and diluted) |
$ |
(0.65 |
) |
|
$ |
(0.56 |
) |
|
Weighted average shares
outstanding (basic and diluted) |
|
22,532,031 |
|
|
|
20,589,293 |
|
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Media Contact:
Elliot Fox
W2O Group
212.257.6724
efox@w2ogroup.com
Investor Contact:
Mindy Lowe
Esperion Therapeutics, Inc.
734.887.3903
mlowe@esperion.com
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