Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) today announced its
second quarter 2020 financial results and highlights:
“The Madrigal team and our CRO’s are focused on completing
enrollment of both of our Phase 3 MAESTRO clinical trials as
rapidly as possible,” said Becky Taub, M.D., CMO and President,
Research & Development of Madrigal. “MAESTRO-NAFLD-1, a
52-week study in which NASH is diagnosed non-invasively, has
enrolled well throughout 2020, and we anticipate completion of
enrollment as scheduled by the end of 2020. We expect to
report data from an open label 100 mg arm of MAESTRO-NAFLD-1 by the
end of this year, including selected data from noninvasive tests:
liver fat (MRI-PDFF) at week 16, fibrosis biomarkers, liver
enzymes, and atherogenic lipids and lipoproteins, key endpoints
from the trial.”
“The global coronavirus pandemic has presented significant
challenges to the entire pharmaceutical industry in the conduct of
clinical studies in 2020,” stated Paul Friedman, M.D., Chief
Executive Officer of Madrigal. “Consistent with guidance from
regulatory agencies, we put in place more flexible processes
at clinical sites early on to allow patients to continue
participating in our Phase 3 NASH studies. Screening
for MAESTRO-NASH was negatively impacted for some months by
temporary closures of liver biopsy facilities that occurred
globally. Screening and new enrollment are again underway. We have
been and are continuing to apply multiple mitigation strategies to
increase patient recruitment rates, including opening new trial
sites and enrolling patients with existing biopsies from NASH
trials which were discontinued and/or in which the drug was
inactive in NASH. We are hopeful that positive developments
will allow us to make up the deficit that has occurred. However,
the pandemic remains unpredictable, and completion of targeted
enrollment for the serial liver biopsy portion of MAESTRO-NASH may
be delayed past the end of 2020 by a few months.” Dr. Friedman
continued, “On a different topic, we are also pleased to report
that, effective today, NASDAQ has upgraded the listing of
Madrigal’s common stock from the NASDAQ Capital Market (Tier 3) to
the NASDAQ Global Select Market (Tier 1). The Global Select
Market is for public companies that meet the highest listing
standards in the world.”
Financial Results for the Three and Six Months
Ended June 30, 2020
As of June 30, 2020, Madrigal had cash, cash equivalents and
marketable securities of $384.4 million, compared to $439.0 million
at December 31, 2019. The decrease in cash and marketable
securities resulted primarily from cash used in operations of $54.8
million.
Operating expenses were $50.3 million and $88.3 million for the
three and six month periods ended June 30, 2020, compared to $22.7
million and $40.8 million in the comparable prior year periods.
Research and development expenses for the three and six month
periods ended June 30, 2020 were $44.7 million and $78.1 million,
compared to $15.6 million and $28.0 million in the comparable prior
year periods. The increases are primarily attributable to
additional activities related to the Phase 3 clinical trials
initiated in 2019, and an increase in head count.
General and administrative expenses for the three and six month
periods ended June 30, 2020 were $5.6 million and $10.2 million,
compared to $7.1 million and $12.9 million in the comparable prior
year periods. The decreases in general and administrative
expenses for the latest three and six month periods were due
primarily to a decrease in non-cash stock compensation from stock
option awards, which was partially offset by increases in other
general and administrative expenses.
Interest income for the three and six month periods ended June
30, 2020 was $1.2 million and $3.1 million, compared to $3.0
million and $6.0 million in the comparable prior year periods. The
decreases in interest income for the latest three and six month
periods were due primarily to lower average principal balances in
our investment accounts in 2020, and decreased interest rates.
About Resmetirom (MGL-3196) Thyroid hormone,
through activation of its β-receptor in hepatocytes, plays a
central role in liver function impacting a range of health
parameters from levels of serum cholesterol and triglycerides to
the pathological buildup of fat in the liver. Thyroid hormone
receptor (THR)-β action in the liver is key to proper function of
the liver, including regulation of mitochondrial activity such as
breakdown of liver fat and control of the level of normal, healthy
mitochondria. Patients with NASH have reduced levels of thyroid
hormone activity in the liver with resultant impaired hepatic
function, in part due to the inflamed state of the liver that
causes degradation of thyroid hormone.
To exploit the thyroid hormone receptor (THR)-β pathway for
therapeutic purposes in cardio-metabolic and liver diseases, it is
important to avoid activity at the THR-α receptor, the predominant
systemic receptor for thyroid hormone that is responsible for
activity outside the liver including in heart and bone. The
lack of selectivity of older thyromimetic compounds,
chemically-related toxicities and undesirable distribution in the
body led to safety concerns. 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. Resmetirom has been shown
to be highly selective based on 1) THR- β receptor functional
selectivity based on both in vitro and in vivo assays 2) specific
uptake into the liver, its site of action, virtually avoiding any
uptake into tissues outside the liver. In short and long term human
and animal studies, resmetirom has been confirmed to be safe and
devoid of activity at the THR-α receptor and without impact on bone
or cardiac parameters. Resmetirom does not impact the thyroid axis
hormones, including the central thyroid axis. Madrigal believes
that resmetirom is the first orally administered, small-molecule,
liver-directed, truly β-selective THR agonist.
About the Phase 3 Registration Program for the Treatment
of NASH (Non-alcoholic steatohepatitis)Analyses from the
resmetirom Phase 2 NASH study demonstrate that the magnitude of
liver fat reduction accurately predicts NASH resolution and liver
fibrosis reduction and, specifically, that the resmetirom doses
being used in Madrigal’s Phase 3 MAESTRO-NASH trial could achieve
the level of fat reduction predictive of NASH resolution and
fibrosis reduction [Madrigal COVID and ABSTRACT Press
Release_20200414].
The Phase 3 MAESTRO-NASH trial is expected to enroll 900
patients with biopsy-proven NASH (fibrosis stage 2 or 3),
randomized 1:1:1 to receive resmetirom 80 mg once a day, 100 mg
once a day, or placebo. After 52 weeks of treatment a second biopsy
is performed. The primary surrogate endpoint on biopsy will
be NASH resolution, with at least a 2-point reduction in
NAS (NASH Activity Score), and with no worsening of fibrosis. Two
key secondary endpoints are liver fibrosis improvement of at least
one stage, with no worsening of NASH, and lowering of
LDL-cholesterol [ClinicalTrials.gov/NCT03900429].
A second 52-week Phase 3 multi-center, double-blind, randomized,
placebo-controlled study of resmetirom, MAESTRO-NAFLD-1, was
initiated in December 2019 in 700 patients with non-alcoholic fatty
liver disease (NAFLD), presumed NASH, randomized 1:1:1 to receive
resmetirom 80 mg once a day, 100 mg once a day, or placebo.
MAESTRO-NAFLD-1 also includes a 100 mg resmetirom open label arm in
up to 100 patients. Unlike MAESTRO-NASH, MAESTRO-NAFLD-1 is a
non-biopsy study and represents a “real-life” NASH study. NASH or
presumed NASH is documented using historical liver biopsy or
non-invasive techniques including fibroscan and MRI-PDFF. Using
non-invasive measures, MAESTRO-NAFLD-1 is designed to provide
incremental safety information to support the NASH indication as
well as provide additional data regarding clinically relevant key
secondary efficacy endpoints to better characterize the potential
clinical benefits of resmetirom on cardiovascular and liver related
endpoints. These key secondary endpoints include LDL-cholesterol,
apolipoprotein B and triglyceride (TG) lowering; reduction of liver
fat as determined by magnetic resonance imaging, proton density fat
fraction (MRI-PDFF); and reduction of PRO-C3, a NASH fibrosis
biomarker. [ClinicalTrials.gov/NCT04197479] Additional
secondary and exploratory endpoints will be assessed including
reduction in liver enzymes, fibroscan scores and other fibrosis and
inflammatory biomarkers. These and other data, including safety
parameters, form the basis for potential subpart H submission
to FDA for accelerated approval for the treatment of
NASH. The original 900 patients in the MAESTRO-NASH study will
continue on therapy after the initial 52-week treatment period; up
to another 1,100 patients are to be added using the same
randomization plan and the study is expected to continue for up to
54 months to accrue and measure clinical events, most relevantly
progression to cirrhosis.
About Resmetirom’s Potential to Confer Cardiovascular
Risk Reduction in NASH patientsAdditionally, resmetirom
lowers multiple atherogenic lipids, including LDL cholesterol,
apolipoprotein B, triglycerides, and lipoprotein (a), as
demonstrated in Phase 2, a key differentiating factor compared with
other NASH therapeutics. The magnitude of reduction of these lipids
support a potential indication for treatment of hyperlipidemia in
NASH patients and predicts a potential for benefit on
cardiovascular (CV) events in NASH patients who die most frequently
of CV, not liver disease.
Because of their diabetes, dyslipidemia, hypertension, obesity
in concert with an inflamed, fatty liver, NASH patients,
particularly those with advanced fibrosis, are at a substantially
increased CV risk compared to the general population. Resmetirom’s
ability to decrease liver fat, which is an independent risk factor
for CV events, and resmetirom’s effect to reduce atherogenic lipids
are being further evaluated in several key secondary endpoints in
both MAESTRO Phase 3 clinical studies.
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 that is in currently in two
Phase 3 clinical studies, MAESTRO-NASH and MAESTRO-NAGLD-1,
designed to demonstrate multiple benefits across a broad spectrum
of NASH (non-alcoholic steatohepatitis) and NAFLD (non-alcoholic
fatty liver disease) patients. 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, that are based on our beliefs and assumptions and on
information currently available to us, but are subject to factors
beyond our control. Forward-looking statements include but are not
limited to statements or references concerning: our clinical
trials; research and development activities; the timing and results
associated with the future development of our lead product
candidate, MGL-3196 (resmetirom); our primary and secondary study
endpoints for resmetirom and the potential for achieving such
endpoints and projections; optimal dosing levels for resmetirom;
projections regarding potential future NASH resolution, safety,
fibrosis treatment, cardiovascular effects, lipid treatment or
biomarker effects with resmetirom; the predictive power of liver
fat reduction on NASH resolution with fibrosis reduction or
improvement; the achievement of enrollment objectives concerning
patient number, safety database and/or timing for our studies;
potential NASH or NAFLD patient risk profile benefits with
resmetirom; and our possible or assumed future results of
operations and expenses, business strategies and plans, capital
needs and financing plans, trends, market sizing, competitive
position, industry environment and potential growth opportunities,
among other things. Forward-looking statements: reflect
management’s current knowledge, assumptions, judgment and
expectations regarding future performance or events; include all
statements that are not historical facts; and can be identified by
terms such as “anticipates,” “be,” “believes,” “continue,” “could,”
“demonstrates,” ”design,” “estimates,” “expects,”
“forecasts,” “future,” “goal,” “hopeful,” “intends,” “may,”
“might,” “plans,” “potential,” “predicts,” ”predictive,”
“projects,” “seeks,” “should,” “will,” “would” or similar
expressions and the negatives of those terms. Although
management presently believes that the expectations reflected in
such forward-looking statements are reasonable, it can 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: our clinical
development of resmetirom; enrollment uncertainties, generally and
in relation to COVID-19 shelter-in-place and social distancing
measures and individual precautionary measures that may be
implemented or continued for an uncertain period of time; outcomes
or trends from competitive studies; the risks of achieving
potential benefits in studies that includes substantially
more patients than our prior studies; 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 our Annual Report on Form 10-K for the year ended
December 31, 2019 and our Quarterly Report on Form 10-Q for the
period ended June 30, 2020, 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 |
|
Six Months
Ended |
|
|
June 30, |
|
June 30, |
|
|
|
2020 |
|
|
2019 |
|
|
|
2020 |
|
|
2019 |
|
|
Revenues: |
|
|
|
|
|
|
Total
revenues |
$ |
- |
|
$ |
- |
|
|
$ |
- |
|
$ |
- |
|
|
Operating
expenses: |
|
|
|
|
|
|
Research and development |
|
44,688 |
|
|
15,594 |
|
|
|
78,088 |
|
|
27,967 |
|
|
General and administrative |
|
5,639 |
|
|
7,110 |
|
|
|
10,244 |
|
|
12,856 |
|
|
Total operating expenses |
|
50,327 |
|
|
22,704 |
|
|
|
88,332 |
|
|
40,823 |
|
|
Loss from operations |
|
(50,327 |
) |
|
(22,704 |
) |
|
|
(88,332 |
) |
|
(40,823 |
) |
|
Interest income (expense), net |
|
1,204 |
|
|
3,005 |
|
|
|
3,074 |
|
|
6,044 |
|
|
Other income |
|
100 |
|
|
- |
|
|
|
100 |
|
|
- |
|
|
Net loss |
$ |
(49,023 |
) |
$ |
(19,699 |
) |
|
$ |
(85,158 |
) |
$ |
(34,779 |
) |
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share |
$ |
(3.18 |
) |
$ |
(1.28 |
) |
|
$ |
(5.52 |
) |
$ |
(2.26 |
) |
|
Basic and diluted weighted average number of common shares
outstanding |
|
15,433,348 |
|
|
15,368,986 |
|
|
|
15,431,251 |
|
|
15,366,738 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Madrigal
Pharmaceuticals, Inc. |
|
Condensed
Consolidated Balance Sheets |
|
(in
thousands) |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June
30, |
December
31, |
|
|
|
|
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
Cash, cash
equivalents and marketable securities |
$ |
384,380 |
|
$ |
439,045 |
|
|
|
|
|
Other
current assets |
|
2,223 |
|
|
1,152 |
|
|
|
|
|
Other
non-current assets |
|
1,785 |
|
|
1,859 |
|
|
|
|
|
Total
assets |
$ |
388,388 |
|
$ |
442,056 |
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Equity |
|
|
|
|
|
|
Current
liabilities |
$ |
45,275 |
|
$ |
25,130 |
|
|
|
|
|
Long-term
liabilities |
|
197 |
|
|
361 |
|
|
|
|
|
Stockholders’ equity |
|
342,916 |
|
|
416,565 |
|
|
|
|
|
Total
liabilities and stockholders’ equity |
$ |
388,388 |
|
$ |
442,056 |
|
|
|
|
|
|
|
|
|
|
|
|
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