On August 7, 2019 Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) reported its second quarter 2019 financial results and highlights (Press release, Synta Pharmaceuticals, AUG 7, 2019, View Source [SID1234538288]):
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Madrigal has continued to progress on several important fronts during the second quarter. We have moved forward with our Phase 3 study of MGL-3196 (resmetirom) in patients with biopsy-proven non-alcoholic steatohepatitis (NASH) and liver fibrosis (MAESTRO-NASH)," stated Paul Friedman, M.D., Chief Executive Officer of Madrigal. "We were also fortunate to add Jim Daly to our Board of Directors. Jim’s deep commercial expertise will be invaluable as we move forward with development of resmetirom in NASH and Non-Alcoholic Fatty Liver Disease (NAFLD). In addition, in recognition of our clinical development progress and corresponding growth of the Company, we promoted Becky Taub, M.D., to President of R&D."
Becky Taub, M.D.,CMO, President, Research & Development of Madrigal, added, "Madrigal is enrolling patients in our MAESTRO-NASH Phase 3 clinical study, and although it’s early in the process, we are encouraged by the rate of site openings and patient screening numbers. We are also pleased to announce that our abstract "Effects of Resmetirom (MGL-3196) on Hepatic Fat, Lipids, Liver Enzymes and Markers of Liver Fibrosis in an Open-Label 36-Week Extension Study in NASH Patients" has been selected for oral presentation at the Liver Meeting AASLD 2019 in Boston, November 2019. A poster, "Steatosis and Fibrosis Measured as Continuous Variables on Paired, Serial Liver Biopsies in the Resmetirom (MGL-3196) 36-Week Phase 2 NASH Study" will also be presented at AASLD meeting."
Additional information about Madrigal’s Phase 3 study in patients with NASH [NCT03900429] can be obtained at www.clinicaltrials.gov.
Financial Results for the Three and Six Months Ended June 30, 2019
As of June 30, 2019, Madrigal had cash, cash equivalents and marketable securities of $466.4 million, compared to $483.7 million at December 31, 2018. Cash used in operating activities during the first six months of 2019 was $18.0 million.
Operating expenses were $22.7 million and $40.8 million for the three and six month periods ended June 30, 2019, compared to $7.8 million and $14.9 million in the comparable prior year periods.
Research and development expenses for the three and six month periods ended June 30, 2019 were $15.6 million and $28.0 million compared to $5.1 million and $10.3 million in the comparable prior year periods. The increase is primarily attributable to additional activities related to initiation of our Phase 3 clinical trial in NASH, including a payment due related to a milestone achieved under our agreement with Roche, an increase in headcount and increased non-cash stock compensation from stock option awards.
General and administrative expenses for the three and six month periods ended June 30, 2019 were $7.1 million and $12.9 million compared to $2.7 million and $4.6 million in the comparable prior year periods. The increase is due primarily to higher non-cash stock compensation expense from stock option awards.
Interest income for the three and six month periods ended June 30, 2019 was $3.0 million and $6.0 million compared to $1.2 million and $1.9 million in the comparable prior year periods. The change in interest income was due primarily to a higher average principal balance in our investment portfolio in 2019, and increased interest rates.
About resmetirom (MGL-3196)
Among its many functions in the human body, thyroid hormone, through activation of its beta receptor, plays a central role in controlling lipid metabolism, impacting a range of health parameters from levels of serum cholesterol and triglycerides to the pathological buildup of fat in the liver. Attempts to exploit this pathway for therapeutic purposes in cardio-metabolic and liver diseases have been hampered by the lack of selectivity of older compounds for the thyroid hormone receptor (THR)-ß, chemically-related toxicities and undesirable distribution in the body.
Madrigal recognized that greater selectivity for thyroid hormone receptor (THR)-ß and liver targeting might overcome these challenges and deliver the full therapeutic potential of THR-ß agonism. Madrigal believes that resmetirom is the first orally administered, small-molecule, liver- directed, truly ß-selective THR agonist.
Based on the positive Phase 2 clinical study results in patients with NASH (Phase 2 36-Week Results Press Release), Madrigal initiated a Phase 3 multinational, double-blind, randomized, placebo-controlled study of resmetirom in patients with non-alcoholic steatohepatitis (NASH) and fibrosis to resolve NASH and reduce progression to cirrhosis and/or hepatic decompensation (Phase 3 Initiation Press Release and ClinicalTrials.gov NCT03900429). Additionally, in both the NASH Phase 2 study, and a second positive Phase 2 clinical study in patients with heterozygous familial hypercholesterolemia (Phase 2 HeFH Results Press Release), significant reductions in multiple atherogenic lipids were observed. As a result, Madrigal is designing a Phase 3 study intended to treat the prevalent dyslipidemias in NAFLD and NASH patients and improve the fatty liver phenotype in this population.