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Sep 30, 2020
Madrigal Q3 2020 Earnings Report
Madrigal reported third quarter financial results and completed enrollment in Phase 3 MAESTRO NAFLD-1 trial
Key Takeaways
Madrigal Pharmaceuticals announced the completion of enrollment in its MAESTRO NAFLD-1 clinical trial and reported its third quarter 2020 financial results. The company's cash, cash equivalents, and marketable securities totaled $335.9 million. Operating expenses were $58.8 million, with research and development expenses accounting for $53.3 million.
Completed enrollment in MAESTRO NAFLD-1 clinical trial.
Cash, cash equivalents and marketable securities totaled $335.9 million.
Operating expenses for the quarter were $58.8 million.
Research and development expenses for the quarter were $53.3 million.
Madrigal
Madrigal
Forward Guidance
Madrigal expects to report topline 52-week data from the blinded arms of the MAESTRO-NAFLD-1 study by the end of next year and completion of targeted enrollment in the serial liver biopsy portion of MAESTRO-NASH will be delayed past the end of 2020 by a few months.
Positive Outlook
- Completion of enrollment in MAESTRO-NAFLD-1 will enable reporting of topline 52-week data by the end of next year.
- Early data from the open label arm of MAESTRO-NAFLD-1 and Phase 2 studies suggest potential to achieve primary and secondary endpoints in Phase 3 NASH program.
- Week 16 MRE data from MAESTRO-NAFLD-1 open label arm suggests potential for a robust non-invasive imaging test to demonstrate a fibrosis benefit with resmetirom treatment.
- Resmetirom lowers multiple atherogenic lipids, including LDL cholesterol, apolipoprotein B, triglycerides, and lipoprotein (a).
- Resmetirom's ability to decrease liver fat and reduce atherogenic lipids are being further evaluated in both MAESTRO Phase 3 clinical studies.
Challenges Ahead
- COVID-19 pandemic remains unpredictable.
- Completion of targeted enrollment in the serial liver biopsy portion of MAESTRO-NASH will be delayed past the end of 2020 by a few months.
- NASH patients are at a substantially increased CV risk compared to the general population.
- Forward-looking statements are subject to a number of risks and uncertainties including clinical development of resmetirom and enrollment uncertainties.
- Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made.