Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) today
announced its third quarter 2017 financial results and several
clinical accomplishments that occurred during the third quarter
including:
- the completion of patient enrollment in two Phase 2 clinical
studies of MGL-3196, a liver-directed thyroid hormone receptor
(THR) β-selective agonist, in patients with non-alcoholic
steatohepatitis (NASH) and heterozygous familial
hypercholesterolemia (HeFH), respectively;
- a second recommendation from the Drug Safety Monitoring Board
(DSMB) that included a review of the data from both the NASH and
HeFH Phase 2 clinical studies; and,
- the presentation of preclinical results at The Liver Meeting®
2017, American Association for the Study of Liver Diseases (AASLD)
demonstrating that MGL-3196 provides metabolic, anti-inflammatory
and anti-fibrotic benefits in a long-term, high fat diet, mouse
NASH model.
“With patient enrollment completed for the Phase 2 NASH and HeFH
clinical studies we are on track to report top-line results for
NASH late this year and HeFH early in 2018,” said Paul Friedman,
M.D., Chief Executive Officer of Madrigal. “Both indications have
serious unmet patient needs and, based on both the preclinical and
Phase 1 data that we have developed for MGL-3196, we believe our
compound has the potential to be the first-and best-in-class THR
β-selective agonist to safely and effectively meet these
needs.”
Rebecca Taub, M.D., Chief Medical Officer and Executive VP,
Research & Development of Madrigal added, “Because safety is
such an important requirement for patients with these diseases, we
are encouraged by the latest recommendation from our DSMB to
continue both the NASH and HeFH clinical trials with no
modifications to either protocol. We look forward to the upcoming
data readouts which, if positive, will enable us to initiate Phase
3 trials in 2018.”
Clinical Program Summaries for MGL-3196NASH
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.
HeFH Heterozygous familial hypercholesterolemia (HeFH), and a
much rarer form called homozygous familial hypercholesterolemia
(HoFH), are severe genetic dyslipidemias typically caused by
inactivating mutations in the LDL receptor. Both forms of FH lead
to early onset cardiovascular disease. HeFH, the most common
dominantly inherited disease, is present in up to 1 in 200 people;
the disease is found in higher frequencies in certain more
genetically homogenous populations. Treatments exist for both HeFH
and HoFH but many patients (as many as 40 percent of HeFH patients)
are not able to reach their cholesterol (LDL-C) reduction goals on
these therapies, reflecting the lifetime burden of cholesterol
buildup in their bodies. 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 in February 2017. Patient recruitment for the study was
completed in September 2017 and included 116 patients.
The 12-week, randomized, double-blind, placebo-controlled,
multi-center study was 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).
Financial Results for the Three Months and Nine Months
Ended September 30, 2017
As of September 30, 2017, Madrigal had cash, cash equivalents
and marketable securities of $62.1 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 Madrigal’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 Madrigal’s at-the-market
sales agreement, partially offset by cash used in operations of
$16.4 million.
Operating expenses were $8.6 million and $23.2 million for the
three month and nine month periods ended September 30, 2017,
compared to $14.1 million and $17.5 million in the comparable prior
year periods.
Research and development expenses for the three month and nine
month periods ended September 30, 2017 were approximately $6.7
million and $17.9 million, respectively, as compared to $7.8
million and $10.4 million in the comparable prior year periods.
The decrease for the comparable three month periods was due
primarily to lower non-cash stock based compensation in 2017,
partially offset by increased expenses for our Phase 2 clinical
development programs for MGL-3196 in NASH and HeFH. The
increase for the comparable nine month periods is primarily
attributable to increased expenses for our Phase 2 clinical
development programs for MGL-3196 in NASH and HeFH, partially
offset by lower non-cash stock based compensation.
General and administrative expenses for the three month and nine
month periods ended September 30, 2017 decreased to approximately
$2.0 million and $5.3 million, respectively, as compared to $6.3
million and $7.1 million in the comparable prior year periods.
These decreases are primarily attributable to one-time, merger
related costs in the third quarter of 2016.
Interest income (expense), net, for the three month and nine
month periods ended September 30, 2017 was $174 thousand and $342
thousand, respectively, as compared to $42 thousand and $(1.2)
million for the comparable prior year periods. The decreases in
interest expense in 2017 were due to the conversion of convertible
debt to shares of common stock in connection with Madrigal’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. Madrigal’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 StatementsThis 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.
Investor Contact:Marc Schneebaum,
Madrigal Pharmaceuticals, Inc.IR@madrigalpharma.com
Media Contact:Kristin Paulina, Sam
Brown Inc.kristinpaulina@sambrown.com610-524-2959
Madrigal Pharmaceuticals, Inc. |
Condensed Consolidated Statements of
Operations |
(in thousands, except share and per share
amounts) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
September 30, |
|
September 30, |
|
|
2017 |
|
|
2016 |
|
|
|
2017 |
|
|
2016 |
|
Revenues: |
|
|
|
|
|
Total
revenues |
$ |
- |
|
$ |
- |
|
|
$ |
- |
|
$ |
- |
|
Operating
expenses: |
|
|
|
|
|
Research
and development |
|
6,682 |
|
|
7,806 |
|
|
|
17,878 |
|
|
10,410 |
|
General
and administrative |
|
1,955 |
|
|
6,285 |
|
|
|
5,273 |
|
|
7,058 |
|
Total
operating expenses |
|
8,637 |
|
|
14,091 |
|
|
|
23,151 |
|
|
17,468 |
|
Loss from
operations |
|
(8,637 |
) |
|
(14,091 |
) |
|
|
(23,151 |
) |
|
(17,468 |
) |
Interest income (expense), net |
|
174 |
|
|
42 |
|
|
|
342 |
|
|
(1,171 |
) |
Other income |
|
100 |
|
|
- |
|
|
|
100 |
|
|
- |
|
Net
loss |
$ |
(8,363 |
) |
$ |
(14,049 |
) |
|
$ |
(22,709 |
) |
$ |
(18,639 |
) |
|
|
|
|
|
|
Basic and
diluted net loss per common share |
$ |
(0.68 |
) |
$ |
(1.59 |
) |
|
$ |
(1.87 |
) |
$ |
(6.04 |
) |
Basic and
diluted weighted average number of common shares outstanding |
|
12,378,622 |
|
|
8,847,155 |
|
|
|
12,126,008 |
|
|
3,087,588 |
|
|
|
|
|
|
|
|
|
|
Madrigal Pharmaceuticals, Inc. |
Condensed Consolidated Balance
Sheets |
(in thousands) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
September 30, |
December 31, |
|
2017 |
2016 |
|
|
|
Assets |
|
|
Cash, cash equivalents
and marketable securities |
$ |
62,137 |
$ |
40,500 |
Other current
assets |
|
583 |
|
707 |
Other non-current
assets |
|
111 |
|
3 |
Total
assets |
$ |
62,831 |
$ |
41,210 |
|
|
|
Liabilities and
Equity |
|
|
Current
liabilities |
$ |
8,523 |
$ |
4,800 |
Long-term
liabilities |
|
- |
|
- |
Stockholders’
equity |
|
54,308 |
|
36,410 |
Total
liabilities and stockholders’ equity |
$ |
62,831 |
$ |
41,210 |
|
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