CONSHOHOCKEN, PA — Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL) this week provided a summary of corporate updates and reports first quarter 2023 financial results.
Paul Friedman, M.D., Chief Executive Officer of Madrigal, stated, “In the first quarter of 2023, the Madrigal team made significant progress advancing our regulatory preparations, disease education initiatives, and market access strategy. Additionally, we continue to execute against our clinical development objectives, and have completed enrollment of the MAESTRO-NASH trial. We are working diligently on the resmetirom approval process and recently announced that we obtained Breakthrough Therapy designation for resmetirom, reinforcing our confidence in our regulatory strategy and the planned NDA filing in Q2 2023.”
Becky Taub, M.D., Chief Medical Officer and President of Research & Development of Madrigal, stated, “The MAESTRO-NASH primary trial data will be the opening presentation in the first general session of EASL’s International Liver Meeting in June; we look forward to sharing additional results from the study and engaging in scientific exchange at this important scientific forum. In addition to our primary oral presentation focused on the MAESTRO-NASH biopsy results, we’ll be presenting several abstracts from the MAESTRO program that provide a broader view of resmetirom treatment response.”
Recent Corporate Highlights
- Madrigal announced that resmetirom has received Breakthrough Therapy designation from the FDA for the treatment of patients with NASH with liver fibrosis. A drug that receives Breakthrough Therapy designation is eligible for more intensive guidance on an efficient drug development program and organizational commitment involving senior managers from FDA.
- The MAESTRO-NASH registrational trial in noncirrhotic NASH has completed enrollment.
- Patient recruitment remains focused on MAESTRO-NASH-OUTCOMES, a noninvasive Phase 3 clinical outcome trial evaluating resmetirom in patients with well-compensated NASH cirrhosis with goals to support an additional indication in NASH cirrhosis and support long-term clinical benefit and full approval for noncirrhotic NASH.
- The Institute for Clinical and Economic Review (ICER) published an updated Evidence Report for its value assessment of resmetirom and obeticholic acid. The Evidence Report indicates that resmetirom has the potential to be a cost-effective treatment for patients with at-risk NASH.
Resmetirom Data Presentations at EASL
Multiple resmetirom abstracts have been accepted at EASL’s International Liver Congress taking place June 21-24 in Vienna:
- Oral presentation: “Primary results from MAESTRO-NASH a pivotal phase 3 52-week serial liver biopsy study in 966 patients with NASH and fibrosis” [Thursday, June 22 at 10:30 AM. Presenter: Stephen Harrison]
- Poster: “Characterizing the histologic implications of resmetirom-induced liver volume reduction using artificial intelligence-powered digital pathology” [Presenter: Janani Iyer]
- Poster: “Resmetirom helps regulate thyroid hormone levels within the liver in patients with nonalcoholic fatty liver disease” [Presenter: Stephen Harrison]
- Poster: “Resmetirom improves the lipid/lipoprotein profile in patients with nonalcoholic fatty liver disease” [Presenter: Naim Alkhouri]
- Poster: “Imaging and biomarker thresholds to accurately diagnose NASH cirrhosis in a 180 patient biopsy confirmed cohort” [Presenter: Rohit Loomba]
NASH Epidemiology and Health Economics Outcomes Research Presentations at ISPOR
Five Madrigal posters focused on NASH epidemiology and health economics outcomes research are being presented at the ISPOR 2023 meeting taking place this week (May 7-10) in Boston:
- “NASH Progression Rates Based on Fibrosis and Inflammation (NAS): A Paired Biopsy Analysis from a Natural History Cohort in the US” [Presenter: Jesse Fishman]
- “The Impact of Treatment-related Changes in Lipids on the Cost-effectiveness of Resmetirom and Obeticholic Acid for Treatment of Nonalcoholic Steatohepatitis” [Presenter: Jesse Fishman]
- “Impact of Different Non-invasive Tests on Estimated Prevalence of Presumed Nonalcoholic Steatohepatitis Among US Adults, NHANES 2017-2020” [Presenter: Tom O’Connell]
- “Systematic Literature Review, Network Meta-analysis, and Cost-effectiveness Analysis of Resmetirom for the Treatment of Nonalcoholic Steatohepatitis” [Presenter: Jesse Fishman]]
- “Primary Cardiovascular Event Risk Associated With Nonalcoholic Steatohepatitis Among US Adults, NHANES 2017-2020” [Presenter: Tom O’Connell]
Financial Results for the Three Months Ended March 31, 2023
As of March 31, 2023, Madrigal had cash, cash equivalents and marketable securities of $329.5 million, compared to $358.8 million at December 31, 2022. The decrease in cash and marketable securities resulted primarily from cash used in operations of $84.1 million, partially offset by cash provided by financing and option exercise activities.
Operating expenses were $78.3 million for the three month period ended March 31, 2023, compared to $57.6 million in the comparable prior year period.
Research and development expenses for the three month period ended March 31, 2023 were $62.2 million, compared to $47.9 million in the comparable prior year period. The increase is attributable primarily to additional activities related to the Phase 3 clinical trial activities, including the MAESTRO-NASH Outcomes for which no expenses were incurred in the prior year quarter, and an increase in headcount.
General and administrative expenses for the three month period ended March 31, 2023 were $16.2 million, compared to $9.7 million in the comparable prior year period. The increase in general and administrative expenses for the latest three month period is due primarily to increases in commercial preparation activities, including an increase in headcount.
Interest income for the three month period ended March 31, 2023 was $3.8 million, compared to $0.1 million in the comparable prior year period. The increase in interest income was attributable primarily to higher interest rates and a greater principal balance.
Interest expense for the three month period ended March 31, 2023 was $2.3 million, compared to $0.0 million in the comparable prior year period. The increase in interest expense was attributable to the Loan Facility the Company entered into in May 2022.
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