MDGL Madrigal Pharmaceuticals Inc.

105.15
-0.1  -0%
Previous Close 105.25
Open 105.45
52 Week Low 56.82
52 Week High 127.25
Market Cap $1,623,318,739
Shares 15,438,124
Float 7,906,121
Enterprise Value $1,240,482,551
Volume 39,362
Av. Daily Volume 121,739
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Upcoming Catalysts

Drug Stage Catalyst Date
Resmetirom - MAESTRO-NAFLD-1
Non-Alcoholic Fatty Liver Disease
Phase 3
Phase 3
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MGL-3196 (resmetirom)
Non-alcoholic steatohepatitis (NASH)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
MGL-3196
Heterozygous familial hypercholesterolemia (HeFH)
Phase 2
Phase 2
Phase 2 top-line data released February 8, 2018 - primary endpoint met.

Latest News

  1. CONSHOHOCKEN, Pa., Aug. 06, 2020 (GLOBE NEWSWIRE) -- 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…

    CONSHOHOCKEN, Pa., Aug. 06, 2020 (GLOBE NEWSWIRE) -- 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 patients

    Additionally, 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.

    Media Contact:

    Mike Beyer, Sam Brown Inc.  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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  2. CONSHOHOCKEN, Pa., May 07, 2020 (GLOBE NEWSWIRE) -- 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…

    CONSHOHOCKEN, Pa., May 07, 2020 (GLOBE NEWSWIRE) -- 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 patients
    Additionally, 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.

    Media Contact:
    Mike Beyer, Sam Brown Inc.  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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  3. -- MAESTRO Phase 3 clinical studies proceed, with more flexible allowances in visits and study drug dispensing for enrolled and screened patients at impacted sites, intended to maintain patient safety and trial integrity during the COVID pandemic.

    -- Abstracts accepted for oral presentations at postponed or cancelled scientific meetings (EASL 2020; AASLD, Emerging Topics, 2020 are described here. Key findings include:

    • New analyses demonstrate that liver fat reduction at 3 months after starting treatment has clear predictive power for NASH resolution and fibrosis reduction on subsequent liver biopsy.
    • 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…

    -- MAESTRO Phase 3 clinical studies proceed, with more flexible allowances in visits and study drug dispensing for enrolled and screened patients at impacted sites, intended to maintain patient safety and trial integrity during the COVID pandemic.

    -- Abstracts accepted for oral presentations at postponed or cancelled scientific meetings (EASL 2020; AASLD, Emerging Topics, 2020 are described here. Key findings include:

    • New analyses demonstrate that liver fat reduction at 3 months after starting treatment has clear predictive power for NASH resolution and fibrosis reduction on subsequent liver biopsy.
    • 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.
    • New data demonstrate that resmetirom robustly and statistically significantly (p<0.001) reduces markers of net collagen deposition in the liver supporting the anti-fibrotic action of resmetirom.

    CONSHOHOCKEN, Pa., April 14, 2020 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) today announced that in response to guidance from regulatory agencies, measures for COVID-19 at impacted sites have been put in place for its Phase 3 MAESTRO-NASH and MAESTRO-NAFLD-1 studies, allowing both studies to continue without changes to the protocol. Both MAESTRO studies are well-established and have been recruiting according to plan. At a recently conducted Data Monitoring Committee (DMC) meeting it was recommended that Phase 3 studies proceed without modification.
               
    "In response to direction from regulatory agencies, a guidance to allow more flexible processes at sites impacted by COVID-19 was rapidly put in place to allow patients to progress through the screening process or continue their enrollment in the study," stated Paul Friedman, M.D., Madrigal's Chief Executive Officer.  "Thus far, except for a slow down in new screening at impacted sites, the effect has been minimal on patients already in screening or enrolled in the studies."                
              
    Dr. Friedman continued, "The recent DMC meeting gave the go ahead with no recommended changes to the protocols. We have sufficient drug supplies in hand to complete both studies without interruption and sufficient cash available to complete both the non-invasive 52 week MAESTRO-NAFLD-1 study and the 900 patient 52-week serial biopsy MAESTRO-NASH study that support the planned subpart H submission to FDA for accelerated approval."

    Becky Taub, M.D., Chief Medical Officer and President of Research & Development of Madrigal, stated, "As shown in our EASL abstract publication now rescheduled for oral presentation at the end of August, fat reduction as measured by week 12 MRI-PDFF predicts NASH resolution on biopsy at week 36. This finding, incorporating data from both placebo and resmetirom treated patients, was confirmed by two independent blinded central pathology readers. Higher fat reduction ( >50%) was correlated with a greater than 60% likelihood of NASH resolution with fibrosis reduction. Liver fat reductions at 80 mg and 100 mg, the Phase 3 doses, are impressive with relative: absolute fat reductions of 50%: 9.7% and 64%: 15.7%, respectively, as demonstrated in Phase 2. Available data, including our own, also indicate that liver fat reduction and NASH resolution are directly associated to a reduction in fibrosis.  

    Dr. Stephen Harrison, M.D., Principal Investigator of the study, and Medical Director for Pinnacle Clinical Research, San Antonio, Texas, and Visiting Professor of Hepatology, Oxford University, and Principal Investigator of the MAESTRO studies commented, "There is significant rationale for NASH patients to continue in clinical trials during the COVID-19 pandemic. With their high prevalence of diabetes and metabolic syndrome, NASH patients are at higher risk for developing life-threatening complications from COVID-19 infection. Controlling the liver disease and metabolic risk of such patients may help them survive COVID-19.  Moreover, NASH patients in clinical trials can be well-managed for safety. Because resmetirom is in Phase 3, supported by substantial safety data and has shown benefit in NASH and parameters of metabolic syndrome, I believe MAESTRO trials are well-positioned to maintain enrolled patients in the studies, continue recruiting at unaffected sites and restart quickly at affected sites once the pandemic conditions are alleviated."

    He added, "I am particularly excited about the high predictive power of liver fat reduction on NASH resolution with fibrosis reduction demonstrated in resmetirom's Phase 2 study. Moreover, PRO-C3 is a robust non-invasive biomarker demonstrated to be strongly correlated with NASH fibrosis. New analyses show that resmetirom statistically significantly reduces markers (PRO-C3/C3M) of net collagen deposition in the liver further supporting the potential anti-fibrotic action of resmetirom."

    EASL (European Association for the Study of the Liver) Abstract Publication - Magnetic resonance imaging-proton density fat fraction (MRI-PDFF) to predict treatment response on NASH liver biopsy: a secondary analysis of the resmetirom randomized placebo controlled Phase 2 clinical trial. Loomba, R, Bedossa, P, Guy, C, Taub, R, Bashir, M, Harrison, SA

    Summary and findings:

    Resmetirom treatment resulted in significant reduction in hepatic fat as assessed by MRI-PDFF after 12 and 36 weeks that was associated with higher rates of NASH resolution compared to placebo on week 36 liver biopsy assessment. The aim of this secondary analysis was to examine the potential of early reduction in MRI-PDFF to predict histologic response in patients with NASH including both placebo and resmetirom treated patients. The study cohort was assessed for those who had a ≥ 30, ≥ 40 and ≥ 50 % decline in MRI-PDFF between baseline and week 12 as predictors of NASH resolution.  

    To determine the potential predictive power of liver fat reduction on NASH resolution, data were analyzed from 107 NASH patients (n=34 placebo, n=73 resmetirom) with paired baseline/week 36 liver biopsies (read by two blinded central pathologists) and paired baseline/week 12 MRI-PDFFs. Including the MRI-PDFF/biopsy data from both MRI-PDFF responders and non-responders (including placebo patients) the relationship to a NASH resolution response was assessed.

    In patients with NASH resolution, the mean week 12 fat reduction (MRI-PDFF) was 56%. The predictive accuracy was determined by calculating the area under the receiver operating characteristic curve (AUROC) and its 95% confidence intervals (CI)s. The AUROC was 0.89, the optimal MRI-PDFF reduction with best balance of true positive and false negative rates was 41.5% (p<0.001) with a sensitivity of 82% (95% confidence interval (CI) 61%, 93%) and specificity of 83% (95%CI 0.74%, 90%) (Figure), and was similarly observed by both central readers. Compared to MRI-PDFF non-responders with <30% fat reduction (n=56), MRI-PDFF responders (≥30% fat reduction) (n=51) had significantly higher odds of NASH resolution (40% versus 3.7%) with odds ratio (OR) of 18.0, 95% CI (3.9-82.3), p <0.0001. Additionally, the percentages with NASH resolution were higher with greater reductions in liver fat content, ≥ 40% and ≥50% MRI-PDFF reduction showing an OR of 16.5, and 25.3, respectively, compared to PDFF non-responders, p<0.0001. In patients with ≥50% fat reduction at week 12 (placebo=2; resmetirom= 22) 64% had NASH resolution with a component response driven primarily by ballooning and inflammation reduction. The positive predictive values of PDFF reduction for NASH resolution at cutoffs of ≥30%, ≥40%, ≥50% were 40%, 50% and 67%, respectively, and the negative predictive values were >90% for all three cutoffs.   Importantly, the analysis also confirmed the direct association of NASH resolution to fibrosis reduction, with fibrosis reduction in 61% of resmetirom treated patients with NASH resolution. Reductions in other biomarkers (e.g. ALT) were not strongly associated with NASH resolution or fibrosis reduction.

    In conclusion, the early MRI-PDFF response in resmetirom and placebo treated patients achieved good sensitivity and specificity for the identification of patients with NASH resolution and corresponding fibrosis reduction. Compared with the Phase 2 dose of 60 mg (39% PDFF reduction), the higher doses of resmetirom (80 mg and 100 mg) being used in the ongoing  Phase 3 MAESTRO-NASH study demonstrated an average PDFF reduction of 50% and 64%, respectively, that associate with high rates of NASH resolution and liver fibrosis reduction.

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d2656c0a-e309-4d39-aa52-7fc3ff9c5e94

    American Association for the Study of Liver Diseases (AASLD) Emerging Topic Conference 2020---Nuclear Receptors in Nonalcoholic Fatty Liver Diseases (conference cancelled), Resmetirom, a beta selective thyroid hormone receptor agonist, reduces net collagen III deposition in nonalcoholic Steatohepatitis Harrison SA, Taub R, Barbone JM, Franc, J, Karsdal, MA

    Summary and findings:

    Type III collagen is a key component of liver fibrosis in NASH patients. N-terminal type III collagen pro-peptide (PRO-C3) are serum markers reflecting formation of type III collagen (pathologic collagen that is increased in the liver in advanced NASH fibrosis). Matrix metalloproteinase-degraded collagen III (C3M) degrades existing collagen III which is present in fibrotic livers. A reduction in PRO-C3 and/or elevation in C3M levels reflected by the PRO-C3/C3M ratio may be indicative of an overall decrease in liver fibrosis. We evaluated the effect of resmetirom treatment on PRO-C3, C3M and PRO-C3/C3M ratio in the Phase 2 study. 

    MGL-3196-05 (NCT02912260) was a 36-week multicenter, randomized, double-blind, placebo-controlled serial MRI-PDFF, paired liver biopsy Phase 2 study in adults with biopsy-confirmed NASH (NAS ≥4, F1-F3) and hepatic fat fraction ≥10%, assessed by MRI- PDFF (main study). Thirty-one patients (including 14 former placebo patients) received open-label MGL-3196 in the 36-week extension study.

    Baseline PRO-C3 and PRO-C3/C3M ratio levels were significantly correlated with baseline fibrosis stage (Correlation coefficient (cc)= 0.24, p = 0.001) and ballooning (cc=0.29, p=0.003). PRO-C3 levels declined in patients treated with resmetirom relative to placebo (p < 0.0001) in the main study [Lancet 394, 2012-2024, 2019]. C3M levels increased slightly with resmetirom treatment, with no change in placebo. The PRO-C3/C3M ratio declined in resmetirom compared with placebo treatment in the main study (resmetirom, -0.24; placebo, 0.42, p<0.001) and significantly decreased in the extension study, in which all patients were treated with resmetirom (-0.50, p < 0.0001) (figure).

    In conclusion, PRO-C3 levels and PRO-C3/C3M ratios were correlated to fibrosis stage and NAS components at baseline. Treatment of NASH patients with resmetirom produced significant reductions in PRO-C3 levels and PRO-C3/C3M ratio, which may reflect a net reduction in collagen deposition and fibrosis.

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/c7bce372-1dda-4e08-8414-a0b6001f1cae

    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)
    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 patients
    Additionally, resmetirom lowers multiple atherogenic lipids, including LDL cholesterol, apolipoprotein B, triglycerides, 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; the achievement of enrollment objectives concerning patient number, safety database and/or timing for our studies; the risks attendant with conducting trials that are substantially larger than our past trials; potential NASH or NAFLD patient risk profile benefits with resmetirom; 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 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, 2019, as well as in our other filings with the SEC.

    Investor Contact:
    Marc Schneebaum, Madrigal Pharmaceuticals, Inc.

    Media Contact:
    Mike Beyer, Sam Brown Inc.   312 961 2502

     

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  4. CONSHOHOCKEN, Pa., Feb. 26, 2020 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) today announced its fourth quarter and full year 2019 financial results and highlights:

    "Madrigal made significant progress during 2019 in executing our business strategy and advancing the development of resmetirom. We initiated two Phase 3 studies in NASH: the liver biopsy endpoint study, MAESTRO-NASH, and a non-invasive study in NAFLD patients with presumed NASH, MAESTRO-NAFLD-1," stated Paul Friedman, M.D., Chief Executive Officer of Madrigal.  "We filled vital organizational needs including expansion of our medical operations team and the addition of Jim Daly, who has deep commercial expertise, to our Board.  Further, we believe we have sufficient…

    CONSHOHOCKEN, Pa., Feb. 26, 2020 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) today announced its fourth quarter and full year 2019 financial results and highlights:

    "Madrigal made significant progress during 2019 in executing our business strategy and advancing the development of resmetirom. We initiated two Phase 3 studies in NASH: the liver biopsy endpoint study, MAESTRO-NASH, and a non-invasive study in NAFLD patients with presumed NASH, MAESTRO-NAFLD-1," stated Paul Friedman, M.D., Chief Executive Officer of Madrigal.  "We filled vital organizational needs including expansion of our medical operations team and the addition of Jim Daly, who has deep commercial expertise, to our Board.  Further, we believe we have sufficient financial resources to fund our two ongoing Phase 3 clinical studies."

    Becky Taub, M.D., CMO and President, Research & Development of Madrigal added, "According to plan, we initiated our Phase 3 MAESTRO-NASH clinical study in the first quarter, and our Phase 3 MAESTRO-NAFLD-1 study in the fourth quarter.  Both Phase 3 studies are on track to complete enrollment this year for the 52 week readout by the end of 2021.  In addition, MAESTRO-NAFLD-1 includes an open label active treatment arm that will provide data on lipids and non-invasive NASH biomarkers in 2020.  We were also pleased with the publication of our successful Phase 2 NASH study in The Lancet in 2019.  We continue to believe resmetirom has the potential to resolve NASH and reduce liver fibrosis while decreasing cardiovascular risk, through reduction of levels of multiple atherogenic lipids including LDL-C and triglycerides, and through the reduction of inflammatory fat in the liver.  Realization of this potential could provide an important new therapy that delivers benefit to patients across the spectrum of early and late-stage NASH." 

    Financial Results for the Three Months and Twelve Months Ended December 31, 2019

    As of December 31, 2019, Madrigal had cash, cash equivalents and marketable securities of $439.0 million, compared to $483.7 million at December 31, 2018. The decrease in cash and marketable securities resulted primarily from cash used in operations of $41.6 million.

    Operating expenses were $30.0 million and $95.0 million, respectively, for the three month and twelve month periods ended December 31, 2019, compared to $14.5 million and $40.7 million in the comparable prior year periods.

    Research and development expenses for the three month and twelve month periods ended December 31, 2019 were $24.9 million and $72.3 million, respectively, compared to $8.9 million and $25.4 million in the comparable prior year periods. The increases are primarily attributable to increases in clinical costs resulting from initiation of our Phase 3 studies, and personnel costs, including non-cash stock compensation.

    General and administrative expenses for the three month and twelve month periods ended December 31, 2019 were $5.0 million and $22.6 million, respectively, compared to $5.6 million and $15.3 million in the comparable prior year periods. The decrease in general and administrative expenses for the latest three month period was due primarily to lower stock compensation expense, the effect of which was partially offset by higher personnel costs.  The increase in general and administrative expenses for the latest twelve month period was due primarily to higher stock compensation, and personnel costs. 

    Interest income for the three month and twelve month periods ended December 31, 2019 was $2.2 million and $11.0 million, respectively, as compared to $3.0 million and $7.7 million in the comparable prior year periods. The decrease in interest income for the latest three month period was due primarily to lower average principal balances in our investment accounts in 2019, and lower interest rates.  The increase in interest income for 2019 was due primarily to higher average principal balances in our investment accounts, the effects of which were partially offset by lower 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 NASH 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 MAESTRO-NASH 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 Phase 2 HeFH Results Press Release), significant reductions in multiple atherogenic lipids were observed. Based on the foregoing positive results, Madrigal also initiated MAESTRO-NAFLD-1, a 52-week, double-blind, placebo controlled Phase 3 clinical study in patients with biopsy-confirmed or presumed NASH (Phase 3 MAESTRO-NAFLD-1 Initiation Press Release and ClinicalTrials.gov NCT04197479).  Key MAESTRO-NAFLD-1 endpoints are safety, including safety biomarkers, LDL cholesterol, lipid biomarkers, and fibrosis biomarkers. Except for serial liver biopsies, the study protocol is similar to the MAESTRO-NASH study and includes key secondary lipid, MRI-PDFF and NASH biomarker endpoints. In addition, MAESTRO-NAFLD-1 includes an open label arm in which up to 100 patients will be dosed with 100 mg resmetirom.  The MAESTRO -NAFLD-1 study will help support the adequacy of the safety database at the time of NDA submission for subpart H approval for treatment of NASH in patients with F2 or F3 fibrosis (MAESTRO-NASH, NASH resolution surrogate endpoint).

    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, 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 and lipid treatment with resmetirom; the achievement of enrollment objectives concerning patient number, safety database and/or timing for our studies; the risks attendant with conducting trials that are substantially larger than our past trials; potential NASH or NAFLD patient risk profile benefits with resmetirom; 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," "forecasts," "future," "goal," "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, our 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, 2019, as well as in our other filings with the SEC.

    Investor Contact:
    Marc Schneebaum, Madrigal Pharmaceuticals, Inc.

    Media Contact:
    Mike Beyer, Sam Brown Inc.  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   Twelve Months Ended  
      December 31,   December 31,  
        2019     2018       2019     2018    
    Revenues:            
    Total revenues $ -   $ -     $ -   $ -    
    Operating expenses:            
    Research and development   24,910     8,871       72,324     25,389    
    General and administrative   5,044     5,583       22,648     15,293    
    Total operating expenses   29,954     14,454       94,972     40,682    
    Loss from operations   (29,954 )   (14,454 )     (94,972 )   (40,682 )  
    Interest income (expense), net   2,214     2,979       11,024     7,671    
    Other income   -     -       -     200    
    Net loss $ (27,740 ) $ (11,475 )   $ (83,948 ) $ (32,811 )  
                 
    Basic and diluted net loss per common share $ (1.80 ) $ (0.75 )   $ (5.45 ) $ (2.22 )  
    Basic and diluted weighted average number of common shares outstanding   15,429,154     15,348,358       15,394,659     14,796,712    
                 
                 
                 
    Madrigal Pharmaceuticals, Inc.  
    Condensed Consolidated Balance Sheets  
    (in thousands)  
    (unaudited)  
                 
                 
      December 31, December 31,        
        2019     2018          
                 
    Assets            
    Cash, cash equivalents and marketable securities $ 439,045   $ 483,718          
    Other current assets   1,152     1,483          
    Other non-current assets   1,859     227          
    Total assets $ 442,056   $ 485,428          
                 
    Liabilities and Equity            
    Current liabilities $ 25,130   $ 8,444          
    Long-term liabilities   361     -          
    Stockholders' equity   416,565     476,984          
    Total liabilities and stockholders' equity $ 442,056   $ 485,428          
                 

     

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  5. -- MAESTRO-NAFLD-1 is the second resmetirom Phase 3 clinical trial in patients with NASH and presumed NASH and follows MAESTRO-NASH, a Phase 3 multi-center, double-blind, randomized, placebo-controlled study in patients with non-alcoholic steatohepatitis (NASH) and fibrosis, that was initiated in March 2019 --

    • The primary goals of MAESTRO-NAFLD-1 are to:
      • collect additional safety data in resmetirom treated patients with biopsy-confirmed or presumed NASH;
      • further support the broad potential therapeutic benefits of resmetirom on liver and cardiovascular endpoints that were demonstrated in Phase 2 clinical studies; and,
      • assess noninvasive lipid, fibrosis and imaging biomarkers to monitor clinical improvement in NASH patients.

    CONSHOHOCKEN, Pa…

    -- MAESTRO-NAFLD-1 is the second resmetirom Phase 3 clinical trial in patients with NASH and presumed NASH and follows MAESTRO-NASH, a Phase 3 multi-center, double-blind, randomized, placebo-controlled study in patients with non-alcoholic steatohepatitis (NASH) and fibrosis, that was initiated in March 2019 --

    • The primary goals of MAESTRO-NAFLD-1 are to:
      • collect additional safety data in resmetirom treated patients with biopsy-confirmed or presumed NASH;
      • further support the broad potential therapeutic benefits of resmetirom on liver and cardiovascular endpoints that were demonstrated in Phase 2 clinical studies; and,
      • assess noninvasive lipid, fibrosis and imaging biomarkers to monitor clinical improvement in NASH patients.

    CONSHOHOCKEN, Pa., Dec. 18, 2019 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) announced today that it has dosed the first patient in its second Phase 3 clinical trial, MAESTRO-NAFLD-1 with its first-in-class, once daily, oral thyroid hormone receptor-beta selective agonist, resmetirom (MGL-3196). Madrigal initiated its first Phase 3 clinical program, MAESTRO-NASH, in NASH patients with advanced liver fibrosis (stages F2 and F3) in March 2019. The primary endpoint for that trial, after one year of treatment, is resolution of NASH; key secondary endpoints include LDL-cholesterol lowering and reduction in liver fibrosis. Additionally, clinical benefit in reducing progression to more advanced liver disease, including cirrhosis, is a long-term goal of MAESTRO-NASH. [clinicaltrials.gov/NCT03900429]

    MAESTRO-NAFLD-1 is a 52-week Phase 3, double-blind, placebo-controlled clinical study in 700 patients designed to evaluate the safety and biomarkers in resmetirom as compared with placebo treated patients in a broad segment of patients with NASH and to support registration for the treatment of NASH. The primary endpoint of the study is safety. MAESTRO-NAFLD-1 is also expected to provide additional data regarding clinically relevant efficacy endpoints including lowering of atherogenic lipids and lipoproteins. 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. Reduction of liver enzymes, fibroscan scores, and other NASH and lipid biomarkers will be assessed.

    MAESTRO-NAFLD-1 is expected to enroll 700 patients with biopsy-proven or presumed NASH, many of whom screened for MAESTRO-NASH, all with documented metabolic risk factors and fatty liver disease on MRI-PDFF and fibroscan, but who screen failed MAESTRO-NASH because fibroscan or biopsy prerequisites were not met. Unlike MAESTRO-NASH, only non-invasive serial evaluations are included.  Patients will be randomized 1:1:1 to receive a single oral daily dose of placebo, resmetirom 80 mg or resmetirom 100 mg.  Up to 100 patients will be randomized to an open label arm and receive resmetirom 100 mg.  Treatment duration in MAESTRO-NAFLD-1 is 52 weeks. [clinicaltrials.gov/NCT04197479]

    "The initiation of this second Phase 3 NASH safety and biomarker study is an important next step in establishing the broad therapeutic benefits of resmetirom and its unique potential among NASH drugs in development to decrease cardiovascular risk through the reduction of hepatic fat and multiple atherogenic lipids including LDL-cholesterol," stated Dr. Rebecca Taub, M.D., Chief Medical Officer and President of R & D of Madrigal.  "It is well-established that NAFLD/NASH patients are at significantly increased risk of cardiovascular morbidity and mortality.  Based on treatment effects on NASH and the cardiovascular risk reducing profile of resmetirom to date, we believe results from our Phase 3 program have the potential to support a highly favorable therapeutic benefits for resmetirom in patients with biopsy confirmed advanced NASH and, ultimately, in patients diagnosed with NASH based on noninvasive tests."

    Dr. Stephen Harrison, M.D., Principal Investigator of the study, Medical Director for Pinnacle Clinical Research, San Antonio, Texas, and Visiting Professor of Hepatology, Oxford University, commented, "The NASH community is in great need of establishing clinically relevant, noninvasive biomarkers capable of providing accurate and reproducible assessments of hepatic fat content and the formation of fibrotic tissue in the liver. I believe results from MAESTRO-NAFLD-1, along with results from MAESTRO-NASH, have the potential to add important insights about the predictive value of noninvasive tests."  

    "Because the leading cause of death for patients with NASH and NAFLD is cardiovascular disease (CVD), I believe our most effective approach to the treatment of these patients is to aggressively assess and manage their CVD risk factors.  Resmetirom has the potential to offer patients and the physicians who treat them a potentially safe and effective way to reduce the broad array of atherogenic lipids and lipoproteins in addition to reducing fatty liver, a potentially independent cardiovascular risk factor," stated Seth Baum, MD, FACC, FAHA, FASPC, Immediate Past President, American Society for Preventive Cardiology, Excel Medical Clinical Trials, LLC Founder, FNLA (Fellow National Lipid Association), Chief Medical Officer, Clinical Affiliate Professor of Biomedical Science at Charles E. Schmidt College of Medicine.  [see: Seth Baum AASLD 2019 Presentation]

    About NASH
    Non-alcoholic Steatohepatitis (NASH) is a common liver disease in the United States and worldwide, unrelated to alcohol use, that is characterized by a build-up of fat in the liver, inflammation, damage (ballooning) of hepatocytes and increasing fibrosis. Although people with NASH may feel well and often do not know they have the disease, NASH can lead to permanent damage, including cirrhosis and impaired liver function in a high percentage of patients.

    Patients with NASH are at heightened cardiovascular risk. Patients across the spectrum of non-alcoholic fatty liver disease (NAFLD) die more frequently from cardiovascular events than from their liver disease. Multiple factors may contribute to this risk, including elevated levels of LDL-C and excess liver fat. A significant segment of this large group of patients may also suffer from diabetes and metabolic syndrome, and have lipid levels that are above target despite treatment with established therapies. These patients may benefit from therapy to lower their lipid levels, including excess liver fat.

    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 in part on the positive Phase 2 clinical study results in patients with NASH [see: Madrigal Pharmaceuticals Announces Lancet Publication of Positive Phase 2 Results for resmetirom], in March 2019, Madrigal initiated MAESTRO-NASH, 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 [Madrigal Pharmaceuticals Initiates Phase 3 MAESTRO-NASH Study and clinicaltrials.gov/NCT03900429]. 

    About the Phase 3 Registration Program for the Treatment of NASH
    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 will be fibrosis improvement of at least one stage, with no worsening of NASH, and lowering of LDL-cholesterol.

    In the NASH Phase 2 study and a second positive Phase 2 clinical study in patients with heterozygous familial hypercholesterolemia [Madrigal Pharmaceuticals Phase 2 HeFH Results], significant reductions in multiple atherogenic lipids were observed.

    A second 52-week Phase 3 multi-center, double-blind, randomized, placebo-controlled study of resmetirom, MAESTRO-NAFLD-1, 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 was initiated in December 2019. 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. NASH or presumed NASH is documented using non-invasive techniques or historical liver biopsy. 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 using noninvasive measures. 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 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.  

    Media Contact: 
    Mike Beyer, Sam Brown Inc.  312 961 2502

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