CONSHOHOCKEN, PA — Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL) this week provided a summary of recent corporate accomplishments, previews new Phase 3 MAESTRO study data scheduled for presentation at the AASLD Liver Meeting, and reports third quarter 2023 financial results.
Bill Sibold, Chief Executive Officer of Madrigal, stated, “Over the last several months, the Madrigal team has made significant progress advancing key regulatory and commercial activities in preparation for a potential approval of resmetirom in March 2024. Our New Drug Application is supported by the largest and most advanced development program in NASH and our commercial strategy is grounded in resmetirom’s profile as a liver-directed oral therapy that treats the underlying drivers of the disease. The $500 million financing we closed in October provides Madrigal with the resources necessary to execute a first-to-market launch of resmetirom in the U.S.”
Becky Taub, M.D., Chief Medical Officer and President of Research & Development of Madrigal, stated, “In addition to advancing our regulatory strategy, we are focused on sharing new data and insights to help clinicians manage patients in the real world setting following a potential approval of resmetirom. At the AASLD Liver Meeting next week, we will present a comprehensive analysis of noninvasive tests and imaging from the MAESTRO-NASH trial. Resmetirom demonstrated a broad and consistent treatment response across a range of noninvasive measures, including simple biomarkers that are widely available to clinicians.”
Recent Corporate Highlights
- Madrigal announced that the FDA accepted its New Drug Application and granted Priority Review for resmetirom for the treatment of adult patients with NASH with liver fibrosis. The FDA assigned a Prescription Drug User Fee Act date for resmetirom of March 14, 2024. The Agency noted that it is not currently planning to hold an advisory committee meeting to discuss the application.
- Bill Sibold was appointed Chief Executive Officer of Madrigal, succeeding Dr. Paul Friedman, who served as Madrigal’s CEO since 2016 and continues to serve on the Board of Directors. Mr. Sibold was previously Executive Vice President, Specialty Care of Sanofi and President, Sanofi North America, where he led a global organization of approximately 10,000 employees across five specialty therapeutic areas and served as a member of the Sanofi Executive Committee. While at Sanofi, Mr. Sibold led the launch of Dupixent, a first-in-class therapy which has grown into an industry-leading medicine.
- Madrigal executed a public offering that generated gross proceeds of $500 million to be used for clinical and commercial activities in preparation for a potential launch of resmetirom in the U.S. and for general corporate purposes.
- Positive results from the Phase 3 MAESTRO-NAFLD-1 safety study were published in Nature Medicine. MAESTRO-NAFLD-1 was a 52-week multicenter, randomized, placebo-controlled, double-blind Phase 3 study of resmetirom in ~1,200 patients with NAFLD, presumed NASH.
Resmetirom Data Presentations at AASLD
Multiple Madrigal abstracts have been accepted at the AASLD Liver Meeting, taking place November 10-14 in Boston:
- Oral presentation: “Relationship of Non-Invasive Measures with Histological Response in Patients with Nonalcoholic Steatohepatitis and Fibrosis: 52-Week Data from the Phase 3 MAESTRO-NASH Trial” [Monday, November 13 at 8:30 AM. Presenter: Rohit Loomba]
- Oral presentation: “Artificial Intelligence to Measure Fibrosis Change on Liver Biopsy in MAESTRO-NASH: A Phase 3 Serial Liver Biopsy Study in 966 Patients with NASH Treated with Resmetirom or Placebo” [Sunday, November 12 at 11:00 AM. Presenter: Stephen Harrison]
- Late-Breaking poster: “Artificial Intelligence-Based Measurement of NASH Histology (AIM-NASH) Recapitulates Primary Results from Phase 3 Study of Resmetirom for Treatment of NASH/MASH” [Presenter: Janani Iyer]
- Poster of Distinction: “Resmetirom Treatment Helps Restore Thyroid Hormone Levels in Patients with Nonalcoholic Steatohepatitis: 52-Week Data from the Phase 3 MAESTRO-NASH Trial” [Presenter: Stephen Harrison]
- Poster: “Resmetirom Improves the Atherogenic Lipid/Lipoprotein Profile in Patients with Nonalcoholic Steatohepatitis: 52-Week Data from the Phase 3 MAESTRO-NASH Trial” [Presenter: Naim Alkhouri]
- Poster: “The Next Generation of HepQuant Tests Measure Reduction in Risk for Clinical Events in Compensated NASH Cirrhosis Subjects Treated with Resmetirom” [Presenter: Michael McRae]
- Poster: “Understanding the Incremental Costs of Nonalcoholic Steatohepatitis and Diabetes Using Electronic Health Records and Closed Claims Data” [Presenter: Jesse Fishman]
- Poster: “Characterizing the Management of Patients with NASH (With Versus Without Cirrhosis) in Real-World Clinical Practice: Rare Assessment by Hepatologists and Low Frequency of Imaging” [Presenter: Christina Qian]
Financial Results for the Nine Months Ended September 30, 2023
As of September 30, 2023, Madrigal had cash, cash equivalents and marketable securities of $232.4 million, compared to $358.8 million at December 31, 2022. In October 2023, the Company completed a public offering and received an additional $472.0 million in net cash proceeds.
Operating expenses were $98.5 million and $263.3 million for the three month and nine month periods ended September 30, 2023, compared to $80.4 million and $208.3 million in the comparable prior year periods.
Research and development expenses for the three and nine month periods ended September 30, 2023 were $71.0 million and $201.7 million, compared to $68.3 million and $174.7 million in the comparable prior year periods. The increase is attributable primarily to additional activities related to the Phase 3 clinical trials, and an increase in head count.
General and administrative expenses for the three and nine month periods ended September 30, 2023 were $27.6 million and $61.6 million, compared to $12.1 million and $33.6 million in the comparable prior year periods. The increase is due primarily to increases in commercial preparation activities, including an increase in headcount and an increase in non-cash stock compensation.
Interest income for the three and nine month periods ended September 30, 2023 was $3.3 million and $10.6 million, compared to $0.7 million and $1.1 million in the comparable prior year periods. These increases in interest income were due primarily to higher average interest rates in 2023.
Interest expense for the three and nine month periods ended September 30, 2023 was $3.5 million and $8.7 million, compared to $1.5 million and $2.3 million in the comparable prior year periods.
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