- Completed
patient enrollment in Phase 2 clinical study of MGL-3196, a
liver-directed thyroid hormone receptor (THR) beta selective
agonist, for treatment of NASH -
Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) today announced its
second quarter 2017 financial results, including a $35 million
financing in June. Madrigal also recently completed patient
enrollment in a Phase 2 clinical study of its lead compound,
MGL-3196, a first-in-class, oral, once-daily, liver-directed,
thyroid hormone receptor (THR) β-selective agonist, in patients
with non-alcoholic steatohepatitis (NASH). The Company had also
initiated a Phase 2 clinical study of MGL-3196 in patients with
heterozygous familial hypercholesterolemia (HeFH) in the first
quarter of 2017.
“Completion of enrollment in our Phase 2 NASH clinical study is
an important milestone, and enrollment is continuing as planned in
our Phase 2 clinical study of MGL-3196 for patients with HeFH,”
said Paul Friedman, M.D., Chief Executive Officer of Madrigal. “We
are also encouraged by the support of four top-tier institutional
investors who made a $35 million equity investment in our June 2017
financing; this positions Madrigal very well to pursue its
strategic goals through 2018.”
“Both NASH and HeFH are conditions with major unmet patient
needs that we believe can be safely and effectively addressed by
MGL-3196. We look forward to data readouts from these studies
which, if positive, should enable us to initiate Phase 3
registration trials in 2018,” said Rebecca Taub, M.D., CMO and
Executive VP, Research & Development of Madrigal. “The Data and
Safety Monitoring Board (“DSMB”) held a pre-scheduled meeting in
May to review data from our Phase 2 clinical NASH trial and
recommended that the Company continue the study with no
changes to the protocol.”
Clinical Program Summaries for MGL-3196
NASH Non-alcoholic Steatohepatitis (NASH) is a common liver
disease in the United States and worldwide, unrelated to alcohol
use, that is characterized by a build-up of fat in the liver,
inflammation, damage (ballooning) of hepatocytes and increasing
fibrosis. Although people with NASH may feel well and often do not
know they have the disease, NASH can lead to permanent damage,
including cirrhosis and impaired liver function in a high
percentage of NASH patients.
In October 2016, the first patient was treated in Madrigal’s
Phase 2 trial of MGL-3196 for the treatment of NASH. The
randomized, double-blind, placebo-controlled, multi-center study
enrolled 125 patients 18 years of age and older with
biopsy-confirmed NASH and more than 10% liver fat as confirmed by a
magnetic resonance imaging-proton density fat fraction
(MRI-PDFF).
In this trial, patients were randomized 2:1 to receive either
MGL-3196 or placebo. The primary endpoint of the trial is the
reduction of liver fat, assessed by MRI-PDFF at 12 weeks. Recent
published data show a high correlation of reduction of liver fat
measured by MRI-PDFF to NASH scoring on liver biopsy.
Efficacy will be confirmed at the end of the trial (36 weeks) by
repeat MRI-PDFF and conventional liver biopsy to examine
histological evidence for the resolution of NASH. Additional
secondary endpoints include changes in clinically relevant
biomarkers at 12 and 36 weeks, improvement in fibrosis by at least
one stage, improvement of NASH, and safety and tolerability.
Top-line results for the primary endpoint of the trial, the
reduction of liver fat, assessed by MRI-PDFF at 12 weeks, are
expected by year-end.
HeFH Heterozygous familial hypercholesterolemia (HeFH) is a
severe genetic dyslipidemia, typically caused by an inactivating
mutation in one copy of the LDL receptor gene that leads to early
onset cardiovascular disease. With conventional therapy, including
statins and ezetimibe, the majority of HeFH and virtually all
homozygous familial hypercholesterolemia (HoFH) patients fail to
reach their cholesterol (LDL-C) reduction goals. Based on evidence
of impressive LDL cholesterol lowering in Phase 1, and data
suggesting that MGL-3196 has a mechanism of action that is
different from and complementary to statins, Madrigal initiated a
Phase 2 proof-of-concept trial in HeFH. Top-line results of this
trial are also expected by year-end or in early 2018.
The 12-week, randomized, double-blind, placebo-controlled,
multi-center study is expected to enroll up to 105 patients with
HeFH randomized in a 2:1 ratio to receive either MGL-3196 or
placebo, in addition to their current drug regimen (including high
dose statins and ezetimibe). The primary endpoint of the study is
reduction of LDL cholesterol, with secondary endpoints including
reductions in triglycerides, Lp(a), and ApoB, as well as safety.
Lp(a) is a severely atherogenic lipid particle, commonly elevated
in familial hypercholesterolemia patients and poorly controlled by
existing lipid lowering therapies. THR-β agonism is one of the few
therapeutic approaches that can substantially lower Lp(a). As
previously announced, the first patient in this study was dosed in
February 2017.
HoFH Homozygous familial hypercholesterolemia (HoFH) is a much
rarer form of severe genetic dyslipidemia, which results from
inactivating mutations in both copies of the LDL receptor gene, and
can produce cardiovascular disease before age 20. The protocol for
a Phase 2, open-label study of MGL-3196 in HoFH is in
development.
Financial Results for the Three Months and Six Months
Ended June 30, 2017
As of June 30, 2017, Madrigal had cash, cash equivalents and
marketable securities of $67.2 million, compared to $40.5 million
at December 31, 2016. The increase in cash and marketable
securities resulted primarily from the net proceeds of $34.9
million from the Company's private placement of equity in June
2017, and $3.4 million of net proceeds from issuances of common
stock in the first quarter of 2017 pursuant to the Company’s
at-the-market sales agreement, partially offset by cash used in
operations of $11.4 million.
Operating expenses were $8.4 million and $14.5 million for the
three month and six month periods ended June 30, 2017, compared to
$2.6 million and $3.4 million in the comparable prior year
periods.
Research and development expenses for the three month and six
month periods ended June 30, 2017 increased to approximately $6.8
million and $11.2 million, respectively, as compared to $2.1
million and $2.6 million in the comparable prior year periods.
These increases are primarily attributable to higher expenses for
personnel, particularly non-cash stock based compensation, and
increased expenses for our Phase 2 clinical development programs
for MGL-3196 in NASH and HeFH.
General and administrative expenses for the three month and six
month periods ended June 30, 2017 increased to approximately $1.6
million and $3.3 milion, respectively, as compared to $0.6 million
and $0.8 million in the comparable prior year periods. These
increases are primarily attributable to higher expenses for
personnel, particularly non-cash stock based compensation, and
professional services related to Madrigal becoming a public company
in mid-2016.
Interest income (expense), net, for the three month and six
month periods ended June 30, 2017 was $92 thousand and $168
thousand, respectively, as compared to $(238) thousand and $(1.2)
million for the comparable prior year periods. These decreases in
interest expense in 2017 were due to the conversion of convertible
debt to shares of common stock in connection with the Company’s
merger, which closed on July 22, 2016.
About Madrigal Pharmaceuticals Madrigal
Pharmaceuticals, Inc. (Nasdaq:MGDL) is a clinical-stage
biopharmaceutical company pursuing novel therapeutics that target a
specific thyroid hormone receptor pathway in the liver, which is a
key regulatory mechanism common to a spectrum of cardio-metabolic
and fatty liver diseases with high unmet medical need. The
Company’s lead candidate, MGL-3196, is a first-in-class, orally
administered, small-molecule, liver-directed, thyroid hormone
receptor (THR) β-selective agonist that is currently in Phase
2 development for NASH and HeFH. For more information, visit
www.madrigalpharma.com.
Forward-Looking Statements
This communication contains “forward-looking
statements” made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. Such statements
contain words such as “expect,” “could,” “may,” “will,” “believe,”
“estimate,” "continue," "future,”or the negative thereof or
comparable terminology and the use of future dates. Forward-looking
statements reflect management's current knowledge, assumptions,
judgment and expectations regarding future performance or events.
Although management believes that the expectations reflected in
such statements are reasonable, they give no assurance that such
expectations will prove to be correct and you should be aware that
actual results could differ materially from those contained in the
forward-looking statements. Forward-looking statements are subject
to a number of risks and uncertainties including, but not limited
to, the company's clinical development of MGL-3196, the timing and
outcomes of clinical studies of MGL-3196, and the uncertainties
inherent in clinical testing. Undue reliance should not be placed
on forward-looking statements, which speak only as of the date they
are made. Madrigal undertakes no obligation to update any forward
looking statements to reflect new information, events or
circumstances after the date they are made, or to reflect the
occurrence of unanticipated events. Please refer to Madrigal's
filings with the U.S. Securities and Exchange Commission for more
detailed information regarding these risks and uncertainties and
other factors that may cause actual results to differ materially
from those expressed or implied.
|
|
Madrigal Pharmaceuticals, Inc. |
|
Condensed Consolidated Statements of
Operations |
|
(in thousands, except share and per share
amounts) |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
|
March 31, |
|
June 30, |
|
|
|
|
2017 |
|
|
2016 |
|
|
|
2017 |
|
|
2016 |
|
|
Revenues: |
|
|
|
|
|
|
|
Total
revenues |
|
$ |
- |
|
$ |
- |
|
|
$ |
- |
|
$ |
- |
|
|
Operating
expenses: |
|
|
|
|
|
|
|
Research
and development |
|
|
6,816 |
|
|
2,088 |
|
|
|
11,196 |
|
|
2,604 |
|
|
General
and administrative |
|
|
1,623 |
|
|
551 |
|
|
|
3,318 |
|
|
773 |
|
|
Total
operating expenses |
|
|
8,439 |
|
|
2,639 |
|
|
|
14,514 |
|
|
3,377 |
|
|
Loss from
operations |
|
|
(8,439 |
) |
|
(2,639 |
) |
|
|
(14,514 |
) |
|
(3,377 |
) |
|
Interest income (expense), net |
|
|
92 |
|
|
(238 |
) |
|
|
168 |
|
|
(1,213 |
) |
|
Net
loss |
|
$ |
(8,347 |
) |
$ |
(2,877 |
) |
|
$ |
(14,346 |
) |
$ |
(4,590 |
) |
|
|
|
|
|
|
|
|
|
Basic and
diluted net loss per common share |
|
$ |
(0.69 |
) |
$ |
(16.33 |
) |
|
$ |
(1.20 |
) |
$ |
(26.06 |
) |
|
Basic and
diluted weighted average number of common shares outstanding |
|
|
12,039,005 |
|
|
176,158 |
|
|
|
11,997,602 |
|
|
176,158 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Madrigal Pharmaceuticals, Inc. |
|
Condensed Consolidated Balance
Sheets |
|
(in thousands) |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
December 31, |
|
|
|
|
|
|
|
2017 |
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
Cash, cash equivalents
and marketable securities |
|
$ |
67,166 |
|
$ |
40,500 |
|
|
|
|
|
Other current
assets |
|
|
781 |
|
|
707 |
|
|
|
|
|
Other non-current
assets |
|
|
120 |
|
|
3 |
|
|
|
|
|
Total
assets |
|
$ |
68,067 |
|
$ |
41,210 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
Equity |
|
|
|
|
|
|
|
Current
liabilities |
|
$ |
6,436 |
|
$ |
4,800 |
|
|
|
|
|
Long-term
liabilities |
|
|
- |
|
|
- |
|
|
|
|
|
Stockholders’
equity |
|
|
61,631 |
|
|
36,410 |
|
|
|
|
|
Total
liabilities and stockholders’ equity |
|
$ |
68,067 |
|
$ |
41,210 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Investor Contact:
Marc Schneebaum, Madrigal Pharmaceuticals, Inc.
IR@madrigalpharma.com
Media Contact:
Kristin Paulina, Sam Brown Inc.
kristinpaulina@sambrown.com
610-524-2959
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