On February 24, 2022 Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), reported a summary of corporate accomplishments and reports its fourth quarter and full year 2021 financial results (Press release, Synta Pharmaceuticals, FEB 24, 2022, View Source [SID1234608991]).

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Paul Friedman, M.D., Chief Executive Officer of Madrigal, stated, "2021 was a year of significant progress for Madrigal as we continued to advance our industry-leading NASH clinical development program, setting up two critical readouts from our Phase 3 MAESTRO trials in 2022, one of which we have already delivered. Additionally, we expanded our leadership team, deepened relationships with the NASH community and enhanced our capabilities to support the commercialization of resmetirom."

Becky Taub, M.D., Chief Medical Officer and President of Research & Development at Madrigal stated, "The positive MAESTRO-NAFLD-1 safety study results we announced in January support our conviction that resmetirom has the potential to be the first medication approved for the treatment of patients with NASH. The data reinforce our expectation that the second Phase 3 trial of resmetirom, the MAESTRO-NASH liver biopsy study, will also produce positive safety and efficacy data later this year."

Clinical Trial Results and Updates

Primary and key secondary endpoints from the double-blind placebo-controlled 969-patient MAESTRO-NAFLD-1 safety study were achieved and demonstrate that resmetirom:

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Was safe and well-tolerated at 80 and 100 mg in patients treated for 52 weeks;

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Provided significant and, we believe, clinically relevant reductions in liver fat as measured by magnetic resonance imaging proton density fat-fraction (MRI-PDFF);

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Significantly reduced atherogenic lipids, including LDLc, apolipoprotein B and triglycerides.

Adverse events were generally mild to moderate in severity. The frequency of serious adverse events was similar across placebo and active treatment arms and discontinuation for adverse events was low. Serious adverse events occurred at expected rates based on the patient population.

Madrigal will continue to generate safety and efficacy data from the MAESTRO-NAFLD-1 trial and intends to provide at least one additional public disclosure prior to publication/presentation at a major medical meeting.

LOGO

The Phase 3 MAESTRO-NASH trial continues to progress with the Subpart H cohort patients scheduled to complete the 52-week dosing regimen on time. Based on more conservative timeline assumptions for analysis of biopsies and other data from the trial, topline results are now expected in Q4 2022.

Leadership Team Expanded

Dominic F. Labriola, PhD, has joined Madrigal as Chief Data and Analytics Officer. Dr. Labriola has 35 years of experience in clinical development overseeing the global registration of 20 medicines. He spent more than 20 years at Bristol Myers Squibb as Head of Global Biometric Sciences where he was responsible for the team overseeing the company’s NASH program among many other programs. Prior to joining Bristol Myers Squibb, he held positions of increasing responsibility at DuPont Pharmaceutical Company, managing biostatisticians and programmers for multiple therapeutic areas. Dr. Labriola began his career as a research biostatistician at Memorial Sloan Kettering Cancer Center and earned his Ph.D. in Mathematical Statistics from the University of Delaware.

Sunil Kadam, PhD, has joined Madrigal as Senior Vice President of Global Regulatory Affairs. Dr. Kadam has successfully built and directed Global Regulatory Affairs teams at both large and emerging biopharmaceutical companies. Most recently, he was Senior Vice President of Global Regulatory Affairs at Telix Pharmaceuticals Limited. As the Regulatory Affairs lead for gastroenterology at Shire/Takeda, he led FDA Advisory Committee and secured FDA approval for Motegrity (prucalopride). As the Head of Regulatory Affairs for Takeda’s endocrine and metabolic rare disease products, he managed the global development of multiple pipeline projects. Prior to joining Takeda, he led Regulatory Affairs teams at IQVIA and Eli Lilly & Company.

Financial Results for the Three and Twelve Months Ended December 31, 2021

As of December 31, 2021, Madrigal had cash, cash equivalents and marketable securities of $270.3 million, compared to $284.1 million at December 31, 2020. The decrease in cash and marketable securities resulted primarily from cash used in operations of $183.9 million.

Operating expenses were $64.6 million and $242.5 million for the three and twelve month periods ended December 31, 2021, compared to $59.6 million and $206.7 million in the comparable prior year periods.

Research and development expenses for the three and twelve month periods ended December 31, 2021 were $52.9 million and $205.2 million, compared to $53.4 million and $184.8 million in the comparable prior year periods. The increases are primarily attributable to additional activities related to the Phase 3 clinical trials, an increase in manufacturing costs to support ongoing clinical trials and to prepare for commercialization, and an increase in head count and related expenses.

General and administrative expenses for the three and twelve month periods ended December 31, 2021 were $11.7 million and $37.3 million, compared to $6.1 million and $21.9 million in the comparable prior year periods. The increases are primarily attributable to an increase in non-cash stock compensation from stock option awards, head count and consulting costs.

Interest income for the three and twelve month periods ended December 31, 2021 was $0.1 million and $0.4 million, compared to $0.4 million and $4.3 million in the comparable prior year periods. The decreases in interest income for the latest three and twelve month periods were due primarily to lower average principal balances in our investment accounts in 2021, and decreased interest rates.