Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage
biopharmaceutical company pursuing novel therapeutics for
non-alcoholic steatohepatitis (NASH), today provides a summary of
corporate accomplishments and reports its fourth quarter and full
year 2021 financial results.
Paul Friedman, M.D., Chief Executive Officer of Madrigal,
stated, “2021 was a year of significant progress for Madrigal as we
continued to advance our industry-leading NASH clinical development
program, setting up two critical readouts from our Phase 3 MAESTRO
trials in 2022, one of which we have already delivered.
Additionally, we expanded our leadership team, deepened
relationships with the NASH community and enhanced our capabilities
to support the commercialization of resmetirom.”
Becky Taub, M.D., Chief Medical Officer and President of
Research & Development at Madrigal stated, “The positive
MAESTRO-NAFLD-1 safety study results we announced in January
support our conviction that resmetirom has the potential to be the
first medication approved for the treatment of patients with NASH.
The data reinforce our expectation that the second Phase 3 trial of
resmetirom, the MAESTRO-NASH liver biopsy study, will also produce
positive safety and efficacy data later this year.”
Clinical Trial Results and Updates
Primary and key secondary endpoints from the double-blind
placebo-controlled 969-patient MAESTRO-NAFLD-1 safety study were
achieved and demonstrate that resmetirom:
- Was safe and well-tolerated at 80 and 100 mg in patients
treated for 52 weeks;
- Provided significant and, we believe, clinically relevant
reductions in liver fat as measured by magnetic resonance imaging
proton density fat-fraction (MRI-PDFF);
- Significantly reduced atherogenic lipids, including LDLc,
apolipoprotein B and triglycerides.
Adverse events were generally mild to moderate in severity. The
frequency of serious adverse events was similar across placebo and
active treatment arms and discontinuation for adverse events was
low. Serious adverse events occurred at expected rates based on the
patient population.
Madrigal will continue to generate safety and efficacy data from
the MAESTRO-NAFLD-1 trial and intends to provide at least one
additional public disclosure prior to publication/presentation at a
major medical meeting.
The Phase 3 MAESTRO-NASH trial continues to progress with the
Subpart H cohort patients scheduled to complete the 52-week dosing
regimen on time. Based on more conservative timeline assumptions
for analysis of biopsies and other data from the trial, topline
results are now expected in Q4 2022.
Leadership Team Expanded
Dominic F. Labriola, PhD, has joined Madrigal as Chief Data and
Analytics Officer. Dr. Labriola has 35 years of experience in
clinical development overseeing the global registration of 20
medicines. He spent more than 20 years at Bristol Myers Squibb as
Head of Global Biometric Sciences where he was responsible for the
team overseeing the company’s NASH program among many other
programs. Prior to joining Bristol Myers Squibb, he held positions
of increasing responsibility at DuPont Pharmaceutical Company,
managing biostatisticians and programmers for multiple therapeutic
areas. Dr. Labriola began his career as a research biostatistician
at Memorial Sloan Kettering Cancer Center and earned his Ph.D. in
Mathematical Statistics from the University of Delaware.
Sunil Kadam, PhD, has joined Madrigal as Senior Vice President
of Global Regulatory Affairs. Dr. Kadam has successfully built and
directed Global Regulatory Affairs teams at both large and emerging
biopharmaceutical companies. Most recently, he was Senior Vice
President of Global Regulatory Affairs at Telix Pharmaceuticals
Limited. As the Regulatory Affairs lead for gastroenterology at
Shire/Takeda, he led FDA Advisory Committee and secured FDA
approval for Motegrity (prucalopride). As the Head of Regulatory
Affairs for Takeda’s endocrine and metabolic rare disease products,
he managed the global development of multiple pipeline projects.
Prior to joining Takeda, he led Regulatory Affairs teams at IQVIA
and Eli Lilly & Company.
Financial Results for the Three and Twelve Months Ended
December 31, 2021
As of December 31, 2021, Madrigal had cash, cash equivalents and
marketable securities of $270.3 million, compared to $284.1 million
at December 31, 2020. The decrease in cash and marketable
securities resulted primarily from cash used in operations of
$183.9 million.
Operating expenses were $64.6 million and $242.5 million for the
three and twelve month periods ended December 31, 2021, compared to
$59.6 million and $206.7 million in the comparable prior year
periods.
Research and development expenses for the three and twelve month
periods ended December 31, 2021 were $52.9 million and $205.2
million, compared to $53.4 million and $184.8 million in the
comparable prior year periods. The increases are primarily
attributable to additional activities related to the Phase 3
clinical trials, an increase in manufacturing costs to support
ongoing clinical trials and to prepare for commercialization, and
an increase in head count and related expenses.
General and administrative expenses for the three and twelve
month periods ended December 31, 2021 were $11.7 million and $37.3
million, compared to $6.1 million and $21.9 million in the
comparable prior year periods. The increases are primarily
attributable to an increase in non-cash stock compensation from
stock option awards, head count and consulting costs.
Interest income for the three and twelve month periods ended
December 31, 2021 was $0.1 million and $0.4 million, compared to
$0.4 million and $4.3 million in the comparable prior year periods.
The decreases in interest income for the latest three and twelve
month periods were due primarily to lower average principal
balances in our investment accounts in 2021, and decreased interest
rates.
About Madrigal Pharmaceuticals
Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a
clinical-stage biopharmaceutical company pursuing novel
therapeutics for non-alcoholic steatohepatitis (NASH), a liver
disease with high unmet medical need. Madrigal’s lead candidate,
resmetirom, is a once daily, oral, thyroid hormone receptor (THR)-β
selective agonist that is designed to target key underlying causes
of NASH in the liver. Resmetirom is currently being evaluated in
two Phase 3 clinical studies, MAESTRO-NASH and MAESTRO- NAFLD-1,
designed to demonstrate multiple benefits in patients with NASH.
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, including the anticipated timing of
disclosure, presentations of data from, or outcomes from our
trials; research and development activities; market size and
patient treatment estimates for NASH and NAFLD patients; 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; plans, objectives and timing for making
a Subpart H (Accelerated Approval of New Drugs for Serious or
Life-Threatening Illnesses) submission to FDA; optimal dosing
levels for resmetirom; projections regarding potential future NASH
resolution, safety, fibrosis treatment, cardiovascular effects,
lipid treatment and/or biomarker effects with resmetirom; the
potential efficacy and safety of resmetirom for non-cirrhotic NASH
patients and cirrhotic NASH patients; ex-U.S. launch/partnering
plans; the predictive power of liver fat reduction, as measured by
non-invasive tests, on NASH resolution with fibrosis reduction or
improvement; the predictive power of liver fat, liver volume
changes or MAST scores for NASH and/or NAFLD patients; the effects
of resmetirom’s mechanism of action; the achievement of enrollment
objectives concerning patient number, safety database and/or timing
for our studies; the predictive power of NASH resolution and/or
liver fibrosis reduction or improvement with resmetirom using
non-invasive tests, including the use of ELF, FibroScan, MRE and/or
MRI-PDFF; the ability to develop clinical evidence demonstrating
the utility of non-invasive tools and techniques to screen and
diagnose NASH and/or NAFLD patients; the predictive power of
non-invasive tests generally, including for purposes of diagnosing
NASH, monitoring patient response to resmetirom, or recruiting a
NASH clinical trial; potential NASH or NAFLD patient risk profile
benefits with resmetirom; the potential for resmetirom to become
the best-in-class and/or first-to-market treatment option for
patients with NASH and liver fibrosis; 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 “allow,” “anticipates,” “be,” “believes,” “continue,”
“could,” “demonstrate,” ”design,” “estimates,” “expectation,”
“expects,” “forecasts,” “future,” “goal,” “hopeful,” ”inform,”
“intends,” “may,” “might,” “planned”, “plans,” “positions,”
“potential,” “powers,” “predicts,” ”predictive,” “projects,”
“seeks,” “should,” “will,” “will be,” “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-related measures that may be continued for
an uncertain period of time or implemented; outcomes or trends from
competitive studies; future topline data timing or results; the
risks of achieving potential benefits in studies that include
substantially more patients, and patients with different disease
states, than our prior studies; limitations associated with early
stage or non-placebo controlled study data; 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
submissions filed or furnished 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, 2021, as well as in
our other filings with the SEC.
Investor Contact Alex Howarth, Madrigal
Pharmaceuticals, Inc., IR@madrigalpharma.com
Media ContactsChristopher Frates, Madrigal
Pharmaceuticals, Inc., cfrates@madrigalpharma.com
(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, |
|
2021 |
2020 |
|
2021 |
2020 |
Revenues: |
|
|
|
|
|
Total revenues |
$ |
- |
|
$ |
- |
|
|
$ |
- |
|
$ |
- |
|
Operating
expenses: |
|
|
|
|
|
Research and development |
|
52,889 |
|
|
53,429 |
|
|
|
205,164 |
|
|
184,809 |
|
General and administrative |
|
11,712 |
|
|
6,126 |
|
|
|
37,318 |
|
|
21,864 |
|
Total operating expenses |
|
64,601 |
|
|
59,555 |
|
|
|
242,482 |
|
|
206,673 |
|
Loss from operations |
|
(64,601 |
) |
|
(59,555 |
) |
|
|
(242,482 |
) |
|
(206,673 |
) |
Interest income, net |
|
52 |
|
|
432 |
|
|
|
363 |
|
|
4,329 |
|
Other income |
|
- |
|
|
- |
|
|
|
273 |
|
|
100 |
|
Net loss |
$ |
(64,549 |
) |
$ |
(59,123 |
) |
|
$ |
(241,846 |
) |
$ |
(202,244 |
) |
|
|
|
|
|
|
Basic and diluted net loss per common share |
$ |
(3.78 |
) |
$ |
(3.82 |
) |
|
$ |
(14.63 |
) |
$ |
(13.09 |
) |
Basic and diluted weighted average number of common shares
outstanding |
|
17,074,543 |
|
|
15,475,291 |
|
|
|
16,535,188 |
|
|
15,446,638 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Madrigal
Pharmaceuticals, Inc. |
Condensed
Consolidated Balance Sheets |
(in
thousands) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December
31, |
December
31, |
|
|
|
|
2021 |
2020 |
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
Cash, cash
equivalents and marketable securities |
$ |
270,346 |
|
$ |
284,149 |
|
|
|
|
Other
current assets |
|
1,338 |
|
|
1,014 |
|
|
|
|
Other
non-current assets |
|
1,648 |
|
|
1,832 |
|
|
|
|
Total assets |
$ |
273,332 |
|
$ |
286,995 |
|
|
|
|
|
|
|
|
|
|
Liabilities and Equity |
|
|
|
|
|
Current
liabilities |
$ |
76,838 |
|
$ |
46,557 |
|
|
|
|
Long-term
liabilities |
|
387 |
|
|
468 |
|
|
|
|
Stockholders’ equity |
|
196,107 |
|
|
239,970 |
|
|
|
|
Total liabilities and stockholders’ equity |
$ |
273,332 |
|
$ |
286,995 |
|
|
|
|
|
|
|
|
|
|
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