Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) today announced its
first quarter 2019 financial results and highlights:
“Madrigal continued to make significant progress in the first
quarter of 2019, initiating a Phase 3 study of MGL-3196
(resmetirom) in patients with biopsy-proven non-alcoholic
steatohepatitis (NASH) and liver fibrosis (MAESTRO-NASH),” stated
Paul Friedman, M.D., Chief Executive Officer of Madrigal. “We
also look forward to advancing our planned Phase 3 clinical trial
in patients with NAFLD/NASH and dyslipidemia in the latter
half of this year.”
Becky Taub, M.D., CMO and Executive VP, Research &
Development of Madrigal added, “An experienced group of NASH
investigators and clinical sites around the world are participating
in MAESTRO-NASH, and we are encouraged regarding timely
enrollment. We believe the pleiotropic effects of resmetirom
provide the potential to resolve NASH and improve liver fibrosis,
and in addition, by reducing the levels of multiple atherogenic
lipids and liver fat, also reduce cardiovascular risk.”
Additional information about Madrigal’s Phase 3 study in
patients with NASH [NCT03900429] can be obtained at
www.clinicaltrials.gov.
Financial Results for the Three Months Ended March
31, 2019
As of March 31, 2019, Madrigal had cash, cash equivalents and
marketable securities of $477.8 million, compared to $483.7 million
at December 31, 2018. Cash used in operating activities
during the first quarter of 2019 was $6.5 million.
Operating expenses were $18.1 million for the three month period
ended March 31, 2019, compared to $7.1 million in the comparable
prior year period.
Research and development expenses for the three month period
ended March 31, 2019 were $12.4 million compared to $5.2 million in
the comparable prior year period. The increase is primarily
attributable to additional activities related to initiation of our
Phase 3 clinical trial in NASH, including an increase in headcount
and increased non-cash stock compensation from stock option
awards.
General and administrative expenses for the three month period
ended March 31, 2019 were $5.7 million compared to $1.9 million in
the comparable prior year period. The increase is due primarily to
higher non-cash stock compensation expense from stock option
awards.
Interest income for the three month period ended March 31, 2019
was $3.0 million compared to $705 thousand in the comparable prior
year period. The change in interest income was due primarily to a
higher average principal balance in our investment portfolio in
2019, and increased interest rates.
About resmetirom (MGL-3196)
Among its many functions in the human body, thyroid hormone,
through activation of its beta receptor, plays a central role in
controlling lipid metabolism, impacting a range of health
parameters from levels of serum cholesterol and triglycerides to
the pathological buildup of fat in the liver. Attempts to exploit
this pathway for therapeutic purposes in cardio-metabolic and liver
diseases have been hampered by the lack of selectivity of older
compounds for the thyroid hormone receptor (THR)-β,
chemically-related toxicities and undesirable distribution in the
body.
Madrigal recognized that greater selectivity for thyroid hormone
receptor (THR)-β and liver targeting might overcome these
challenges and deliver the full therapeutic potential of THR-β
agonism. Madrigal believes that resmetirom is the first orally
administered, small-molecule, liver- directed, truly β-selective
THR agonist.
Based on the positive Phase 2 clinical study results in patients
with NASH (Phase 2 36-Week Results Press Release), Madrigal
recently announced the initiation of a Phase 3 multinational,
double-blind, randomized, placebo-controlled study of resmetirom in
patients with non-alcoholic steatohepatitis (NASH) and fibrosis to
resolve NASH and reduce progression to cirrhosis and/or hepatic
decompensation (Phase 3 Initiation Press Release and
ClinicalTrials.gov NCT03900429). Additionally, in both the NASH
Phase 2 study, and a second positive Phase 2 clinical study in
patients with heterozygous familial hypercholesterolemia (Phase 2
HeFH Results Press Release), significant reductions in multiple
atherogenic lipids were observed. As a result, Madrigal is
designing a Phase 3 study intended to treat the prevalent
dyslipidemias in NAFLD and NASH patients and improve the fatty
liver phenotype in this population.
About Madrigal Pharmaceuticals
Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) 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, resmetirom, is a
first-in- class, orally administered, small-molecule,
liver-directed, thyroid hormone receptor (THR)-β selective agonist.
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,” “might,” “will,” “be, “predict,”
“project,” “intend,” “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. Such forward-looking statements
include but are not limited to statements or references concerning:
our primary and secondary study endpoints and their achievement
potential; optimal dosing levels for resmetirom; projections
regarding potential future NASH resolution, fibrosis treatment,
cardiovascular effects and lipid treatment; the achievement of
enrollment objectives concerning patient number and/or timing; and
potential NASH or NAFLD patient risk profile benefits.
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 resmetirom, enrollment uncertainties, outcomes or
trends from competitive studies, the risks of achieving potential
benefits in a study that includes substantially more patients than
our prior study, the timing and outcomes of clinical studies of
resmetirom, 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. We specifically
discuss these risks and uncertainties in greater detail in the
section entitled "Risk Factors" in Part I, Item 1A of our Annual
Report on Form 10-K for the year ended December 31, 2018, as well
as in our other filings with the SEC.
Investor Contact: Marc Schneebaum, Madrigal
Pharmaceuticals, Inc. IR@madrigalpharma.com
Media Contact: Mike Beyer, Sam Brown Inc.
mikebeyer@sambrown.com 312 961 2502
(Tables Follow)
|
Madrigal Pharmaceuticals, Inc. |
Condensed Consolidated Statements of
Operations |
(in thousands, except share and per share
amounts) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
March 31, |
|
|
2019 |
|
|
2018 |
|
Revenues: |
|
|
Total revenues |
$ |
- |
|
$ |
- |
|
Operating expenses: |
|
|
Research and development |
|
12,373 |
|
|
5,198 |
|
General and administrative |
|
5,746 |
|
|
1,871 |
|
Total operating expenses |
|
18,119 |
|
|
7,069 |
|
Loss from operations |
|
(18,119 |
) |
|
(7,069 |
) |
Interest income (expense),
net |
|
3,039 |
|
|
705 |
|
Net loss |
$ |
(15,080 |
) |
$ |
(6,364 |
) |
|
|
|
Basic and diluted net loss per common share |
$ |
(0.98 |
) |
$ |
(0.45 |
) |
Basic and diluted weighted average number of common shares
outstanding |
|
15,364,465 |
|
|
14,127,868 |
|
|
|
|
|
|
|
|
|
|
Madrigal Pharmaceuticals, Inc. |
Condensed Consolidated Balance
Sheets |
(in thousands) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
March 31, |
December 31, |
|
|
2019 |
|
|
2018 |
|
|
|
|
Assets |
|
|
Cash, cash equivalents and
marketable securities |
$ |
477,825 |
|
$ |
483,718 |
|
Other current assets |
|
565 |
|
|
1,483 |
|
Other non-current assets |
|
1,170 |
|
|
227 |
|
Total
assets |
$ |
479,560 |
|
$ |
485,428 |
|
|
|
|
Liabilities and
Equity |
|
|
Current liabilities |
$ |
10,456 |
|
$ |
8,444 |
|
Long-term
liabilities |
|
598 |
|
|
- |
|
Stockholders’
equity |
|
468,506 |
|
|
476,984 |
|
Total liabilities and stockholders’ equity |
$ |
479,560 |
|
$ |
485,428 |
|
|
|
|
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