Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) today announced its
fourth quarter and year-end 2016 financial results. These results
reflect the successful merger with Synta Pharmaceuticals on July
22, 2016, and the establishment of Madrigal as a leading
cardiovascular-metabolic disease public company focused on NASH and
other related lipid disorders, including heterozygous familial
hypercholesterolemia (HeFH) and homozygous familial
hypercholesterolemia (HoFH). During the second half of 2016,
Madrigal initiated Phase 2 clinical development 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 NASH.
“The completion of the merger with Synta has allowed us to
rapidly advance MGL-3196 into two Phase 2 proof-of-concept clinical
trials for patients with NASH and HeFH, while planning for a third
Phase 2 trial in HoFH,” said Paul Friedman, M.D., President and
Chief Executive Officer of Madrigal. “Data from the NASH and HeFH
trials are expected by year-end and should enable us to move
forward with Phase 3 registration trials for these indications in
2018.”
In 2016, Madrigal:
- Positioned the Company with sufficient capital to complete its
NASH and HeFH Phase 2 trials and initiate the third Phase 2 trial
in HoFH (more than $40M at December 31, 2016);
- Established an experienced management team with proven track
records in drug discovery, development and commercialization and
significant expertise in liver diseases;
- Executed an exclusive worldwide license agreement with Tarveda
for products based on the HSP90 Drug Conjugate program, reflecting
Madrigal’s strategy to create additional shareholder value by
out-licensing its novel oncology assets; and
- Formed a strong Board of Directors with relevant expertise in
drug development, strategic alliances and finance.
Clinical Program Updates for MGL-3196
NASH 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 is expected to enroll up to
117 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). Patients are
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.
“Because MGL-3196 selectively agonizes THR-β, it has the
potential to safely address key pathological mechanisms responsible
for the progression of liver injury in NASH,” said Rebecca Taub,
M.D., CMO and Executive VP, Research & Development of Madrigal.
“This activity includes reductions of lipid and lipotoxicity,
inflammation, dysregulated liver cell death (apoptosis) and,
ultimately, fibrosis.”
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 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 is conducting
a Phase 2 trial in HeFH. The 12-week, randomized, double-blind,
placebo-controlled, multi-center study will 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.
The 12-week trial will have endpoints similar to the HeFH study and
is expected to begin enrolling patients by the end of 2017.
Summary of 2016 Financial Results
Financial Results for the Three Months and Twelve Months
Ended December 31, 2016
Operating expenses were $7.8 million and $25.2 million for the
three month and twelve month periods ended December 31, 2016,
respectively, compared to $0.9 million and $3.2 million in the
comparable prior year periods.
Research and development expenses for the three month and twelve
month periods ended December 31, 2016 increased to approximately
$5.5 million and $15.9 million in 2016, as compared to $0.8 million
and $2.4 million, respectively, in 2015. The increases are
primarily attributable to higher expenses for personnel,
particularly non-cash stock based compensation, and increased
expenses for our preclinical and clinical development programs for
MGL-3196 in both the three and twelve month periods ended December
31, 2016, as compared to the same periods in 2015.
General and administrative expenses for the three month and
twelve month periods ended December 31, 2016 increased to
approximately $2.2 million and $9.3 million in 2016 as compared to
$0.1 million and $0.8 million, respectively, in 2015. The increase
is primarily attributable to higher expenses for personnel,
particularly non-cash stock based compensation, and professional
services and other costs associated with the merger, in both the
three and twelve month periods ended December 31, 2016, as compared
to the same periods in 2015.
Interest income (expense), net, for the three month and twelve
month periods ended December 31, 2016 was $7 thousand and $(1.2)
million, respectively, as compared to $(1.0) million and $(3.6)
million, respectively, for the same periods in 2015. The decreases
in interest expense in the 2016 periods were due to the conversion
of convertible debt to shares of common stock in connection with
the merger, which closed on July 22, 2016.
Forward-Looking StatementsThis communication
contains “forward-looking statements” made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995. 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.
(Tables Follow)
|
|
Madrigal Pharmaceuticals, Inc. |
|
Condensed Consolidated Statements of
Operations |
|
(in thousands, except share and per share
amounts) |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Twelve Months Ended |
|
|
December 31, |
|
December 31, |
|
|
|
2016 |
|
|
2015 |
|
|
|
2016 |
|
|
2015 |
|
|
Revenues: |
|
|
|
|
|
|
Total
revenues |
$ |
- |
|
$ |
- |
|
|
$ |
- |
|
$ |
- |
|
|
Operating
expenses: |
|
|
|
|
|
|
Research
and development |
|
5,524 |
|
|
773 |
|
|
|
15,934 |
|
|
2,427 |
|
|
General
and administrative |
|
2,232 |
|
|
145 |
|
|
|
9,290 |
|
|
806 |
|
|
Total
operating expenses |
|
7,756 |
|
|
918 |
|
|
|
25,224 |
|
|
3,233 |
|
|
Loss from
operations |
|
(7,756 |
) |
|
(918 |
) |
|
|
(25,224 |
) |
|
(3,233 |
) |
|
Interest income (expense), net |
|
7 |
|
|
(965 |
) |
|
|
(1,164 |
) |
|
(3,612 |
) |
|
Net
loss |
$ |
(7,749 |
) |
$ |
(1,883 |
) |
|
$ |
(26,388 |
) |
$ |
(6,845 |
) |
|
|
|
|
|
|
|
|
Basic and
diluted net loss per common share |
$ |
(0.67 |
) |
$ |
(10.86 |
) |
|
$ |
(5.07 |
) |
$ |
(40.03 |
) |
|
Basic and
diluted weighted average number of common shares outstanding
|
|
11,509,791 |
|
|
173,341 |
|
|
|
5,204,644 |
|
|
171,012 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Madrigal Pharmaceuticals, Inc. |
|
Condensed Consolidated Balance
Sheets |
|
(in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
December 31, |
|
|
|
|
|
|
2016 |
|
|
2015 |
|
|
|
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
Cash, cash equivalents
and marketable securities |
$ |
40,499 |
|
$ |
306 |
|
|
|
|
|
Other current
assets |
|
708 |
|
|
58 |
|
|
|
|
|
Other non-current
assets |
|
3 |
|
|
- |
|
|
|
|
|
Total
assets |
$ |
41,210 |
|
$ |
364 |
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
Equity |
|
|
|
|
|
|
Current
liabilities |
$ |
4,800 |
|
$ |
49,277 |
|
|
|
|
|
Long-term
liabilities |
|
- |
|
|
- |
|
|
|
|
|
Stockholders’
equity |
|
36,410 |
|
|
(48,913 |
) |
|
|
|
|
Total
liabilities and Stockholders’ equity |
$ |
41,210 |
|
$ |
364 |
|
|
|
|
|
|
|
|
|
|
|
|
Investor Contact:
Marc Schneebaum, Madrigal Pharmaceuticals, Inc.
IR@madrigalpharma.com
Media Contact:
Mike Beyer, Sam Brown Inc.
mikebeyer@sambrown.com
312-961-2502
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