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Mar 31, 2021
Madrigal Q1 2021 Earnings Report
Madrigal reported first quarter 2021 financial results and provided highlights.
Key Takeaways
Madrigal Pharmaceuticals reported an increase in cash, cash equivalents, and marketable securities to $307.2 million. Operating expenses increased to $53.0 million, driven by higher research and development and general and administrative costs.
Madrigal expects to complete enrollment for MAESTRO-NASH by the end of Q2 2021.
Topline 52-week data from MAESTRO-NAFLD-1 blinded arms is expected by the end of the year.
Madrigal believes it has emerged as a leader in developing a drug to treat NASH.
Open label arms of MAESTRO-NAFLD-1 are expected to generate compelling results.
Madrigal
Madrigal
Forward Guidance
Madrigal anticipates several important events in 2021, including completing enrollment for MAESTRO-NASH and releasing topline data from MAESTRO-NAFLD-1.
Positive Outlook
- Completing enrollment of MAESTRO-NASH 52-week serial liver biopsy population by the end of Q2.
- Releasing topline 52 week data from the blinded arms of MAESTRO-NAFLD-1 by the end of the year.
- Potential application for accelerated approval to FDA.
- Growing dataset from researchers to support noninvasive diagnostic approaches.
- Resmetirom's potential to confer cardiovascular risk reduction in NASH patients
Challenges Ahead
- Clinical development of resmetirom faces uncertainties.
- Enrollment uncertainties related to COVID-19.
- Outcomes or trends from competitive studies may impact results.
- Future topline data timing or results are uncertain.
- Achieving potential benefits in studies with more patients poses risks.