Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) today announced its
second quarter 2019 financial results and highlights:
“Madrigal has continued to progress on several important fronts
during the second quarter. We have moved forward with our
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 were also fortunate to add
Jim Daly to our Board of Directors. Jim’s deep commercial
expertise will be invaluable as we move forward with development of
resmetirom in NASH and Non-Alcoholic Fatty Liver Disease
(NAFLD). In addition, in recognition of our clinical
development progress and corresponding growth of the Company, we
promoted Becky Taub, M.D., to President of R&D.”
Becky Taub, M.D.,CMO, President, Research & Development of
Madrigal, added, “Madrigal is enrolling patients in our
MAESTRO-NASH Phase 3 clinical study, and although it’s early in the
process, we are encouraged by the rate of site openings and patient
screening numbers. We are also pleased to announce that our
abstract "Effects of Resmetirom (MGL-3196) on Hepatic Fat, Lipids,
Liver Enzymes and Markers of Liver Fibrosis in an Open-Label
36-Week Extension Study in NASH Patients" has been selected
for oral presentation at the Liver Meeting® AASLD
2019 in Boston, November 2019. A poster, "Steatosis and
Fibrosis Measured as Continuous Variables on Paired, Serial Liver
Biopsies in the Resmetirom (MGL-3196) 36-Week Phase 2 NASH Study"
will also be presented at AASLD meeting.”
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 and Six Months
Ended June 30, 2019
As of June 30, 2019, Madrigal had cash, cash equivalents and
marketable securities of $466.4 million, compared to $483.7 million
at December 31, 2018. Cash used in operating activities
during the first six months of 2019 was $18.0 million.
Operating expenses were $22.7 million and $40.8 million for the
three and six month periods ended June 30, 2019, compared to $7.8
million and $14.9 million in the comparable prior year periods.
Research and development expenses for the three and six month
periods ended June 30, 2019 were $15.6 million and $28.0 million
compared to $5.1 million and $10.3 million in the comparable prior
year periods. The increase is primarily attributable to additional
activities related to initiation of our Phase 3 clinical trial in
NASH, including a payment due related to a milestone achieved under
our agreement with Roche, an increase in headcount and increased
non-cash stock compensation from stock option awards.
General and administrative expenses for the three and six month
periods ended June 30, 2019 were $7.1 million and $12.9 million
compared to $2.7 million and $4.6 million in the comparable prior
year periods. The increase is due primarily to higher non-cash
stock compensation expense from stock option awards.
Interest income for the three and six month periods ended June
30, 2019 was $3.0 million and $6.0 million compared to $1.2 million
and $1.9 million in the comparable prior year periods. 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
initiated 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, that are based on our beliefs and
assumptions and on information currently available to us.
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; 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 for our studies; potential
NASH or NAFLD patient risk profile benefits; 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,” “estimates,” “expects,” “future,” “intends,”
“may,” “might,” “plans,” “potential,” “predicts,” “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, 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 |
|
Six Months Ended |
|
June 30, |
|
June 30, |
|
|
2019 |
|
|
2018 |
|
|
|
2019 |
|
|
2018 |
|
Revenues: |
|
|
|
|
|
Total revenues |
$ |
- |
|
$ |
- |
|
|
$ |
- |
|
$ |
- |
|
Operating expenses: |
|
|
|
|
|
Research and development |
|
15,594 |
|
|
5,109 |
|
|
|
27,967 |
|
|
10,307 |
|
General and administrative |
|
7,110 |
|
|
2,717 |
|
|
|
12,856 |
|
|
4,588 |
|
Total operating expenses |
|
22,704 |
|
|
7,826 |
|
|
|
40,823 |
|
|
14,895 |
|
Loss from operations |
|
(22,704 |
) |
|
(7,826 |
) |
|
|
(40,823 |
) |
|
(14,895 |
) |
Interest income (expense), net |
|
3,005 |
|
|
1,166 |
|
|
|
6,044 |
|
|
1,871 |
|
Other income |
|
- |
|
|
200 |
|
|
|
- |
|
|
200 |
|
Net loss |
$ |
(19,699 |
) |
$ |
(6,460 |
) |
|
$ |
(34,779 |
) |
$ |
(12,824 |
) |
|
|
|
|
|
|
Basic and diluted net loss per common share |
$ |
(1.28 |
) |
$ |
(0.45 |
) |
|
$ |
(2.26 |
) |
$ |
(0.90 |
) |
Basic and diluted weighted average number of common shares
outstanding |
|
15,368,986 |
|
|
14,383,720 |
|
|
|
15,366,738 |
|
|
14,256,501 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Madrigal Pharmaceuticals, Inc. |
Condensed Consolidated Balance
Sheets |
(in thousands) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
December 31, |
|
|
|
|
|
2019 |
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
Cash,
cash equivalents and marketable securities |
$ |
466,396 |
|
$ |
483,718 |
|
|
|
|
Other
current assets |
|
2,389 |
|
|
1,483 |
|
|
|
|
Other
non-current assets |
|
1,037 |
|
|
227 |
|
|
|
|
Total assets |
$ |
469,822 |
|
$ |
485,428 |
|
|
|
|
|
|
|
|
|
|
Liabilities and Equity |
|
|
|
|
|
Current liabilities |
$ |
12,316 |
|
$ |
8,444 |
|
|
|
|
Long-term liabilities |
|
520 |
|
|
- |
|
|
|
|
Stockholders’ equity |
|
456,986 |
|
|
476,984 |
|
|
|
|
Total liabilities and stockholders’ equity |
$ |
469,822 |
|
$ |
485,428 |
|
|
|
|
|
|
|
|
|
|
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