Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) today announced its
first quarter 2020 financial results and highlights:
“Madrigal continued to make progress toward our clinical
development and business objectives during the first quarter of
2020, despite challenges associated with the COVID-19 pandemic.
Importantly, we continued to screen and enroll patients in our
Phase 3 studies, MAESTRO-NASH and MAESTRO-NAFLD-1,” stated Paul
Friedman, M.D., Chief Executive Officer of Madrigal. “We are
also pleased that Remy Sukhija has joined Madrigal as Senior Vice
President and Chief Commercial Officer. Remy brings extensive
commercial experience to Madrigal, having successfully launched
multiple products in specialty, primary care and rare disease
markets over his 27 years in pharmaceutical/biotech industry.
His expertise in product launch, sales and marketing, and market
access will be valuable as we continue to execute our Phase 3
clinical programs and continue to explore the market opportunity
for resmetirom.”
Becky Taub, M.D., CMO and President, Research & Development
of Madrigal stated, “In response to the COVID-19 pandemic, and
related direction from regulatory agencies, we rapidly implemented
guidance to permit more flexible processes at those clinical sites
impacted and allow patients to progress through the screening
process or continue their enrollment in our Phase 3 NASH
studies. Also, as a result of the pandemic and the resulting
postponement or cancellation of two significant medical
conferences, we were pleased to have the opportunity to announce
new data from previous studies, which demonstrate that reductions
in liver fat achieved by resmetirom predict NASH resolution and
fibrosis improvement. Specifically, as we have showed, once
daily oral 80 mg and 100 mg Phase 3 doses of resmetirom deliver at
least 50% to more than 60% reductions in liver fat, respectively,
and, based on new analyses of Phase 2 data, are associated with a
statistically significant 64% NASH resolution (p<0.0001), of
which >60% had fibrosis reduction.”
Financial Results for the Three Months Ended March
31, 2020
As of March 31, 2020, Madrigal had cash, cash equivalents and
marketable securities of $408.5 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 $30.5
million.
Operating expenses were $38.0 million for the three month period
ended March 31, 2020, compared to $18.1 million in the comparable
prior year period.
Research and development expenses for the three month period
ended March 31, 2020 were $33.4 million, compared to $12.4 million
in the comparable prior year period. The increases are primarily
attributable to the initiation of the Phase 3 clinical trial in
NASH, an increase in head count, and an increase in non-cash stock
compensation from stock option awards.
General and administrative expenses for the three month period
ended March 31, 2020 were $4.6 million, compared to $5.7 million in
the comparable prior year period. The decrease in general and
administrative expenses for the latest three month period was 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 month period ended March 31, 2020
was $1.9 million, as compared to $3.0 million in the comparable
prior year period. The decrease in interest income for the latest
three month period was due primarily to lower average principal
balances in our investment accounts in 2020, and lower 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, and 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,” “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 mandatory lock-down measures and individual
precautionary measures that may be implemented 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 Part I, Item 1A of our Annual Report on Form 10-K
for the year ended December 31, 2019, 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, |
|
|
2020 |
|
|
2019 |
|
Revenues: |
|
|
Total revenues |
$ |
- |
|
$ |
- |
|
Operating
expenses: |
|
|
Research and development |
|
33,400 |
|
|
12,373 |
|
General and administrative |
|
4,605 |
|
|
5,746 |
|
Total operating expenses |
|
38,005 |
|
|
18,119 |
|
Loss from operations |
|
(38,005 |
) |
|
(18,119 |
) |
Interest income (expense), net |
|
1,870 |
|
|
3,039 |
|
Other income |
|
- |
|
|
- |
|
Net loss |
$ |
(36,135 |
) |
$ |
(15,080 |
) |
|
|
|
Basic and diluted net loss per common share |
$ |
(2.34 |
) |
$ |
(0.98 |
) |
Basic and diluted weighted average number of common shares
outstanding |
|
15,429,154 |
|
|
15,364,465 |
|
|
|
|
|
|
|
|
|
|
Madrigal
Pharmaceuticals, Inc. |
Condensed
Consolidated Balance Sheets |
(in
thousands) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
March
31, |
December
31, |
|
|
2020 |
|
|
2019 |
|
|
|
|
Assets |
|
|
Cash, cash
equivalents and marketable securities |
$ |
408,510 |
|
$ |
439,045 |
|
Other
current assets |
|
976 |
|
|
1,152 |
|
Other
non-current assets |
|
1,971 |
|
|
1,859 |
|
Total assets |
$ |
411,457 |
|
$ |
442,056 |
|
|
|
|
Liabilities and Equity |
|
|
Current
liabilities |
$ |
25,703 |
|
$ |
25,130 |
|
Long-term
liabilities |
|
279 |
|
|
361 |
|
Stockholders’ equity |
|
385,475 |
|
|
416,565 |
|
Total liabilities and stockholders’ equity |
$ |
411,457 |
|
$ |
442,056 |
|
|
|
|
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