Company: MIRM
Filing Date: 2025-05-07
Form Type: 10-Q
Source: 0001759425-25-000032
Chunk: 398

Company: Mirum Pharmaceuticals, Inc.
Filing Date: 2025-05-07
Form: 10-Q
Item: Part I, Item 8
Chunk 398
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also assumed license and distribution agreements with several rare disease companies for the commercialization of Cholbam and chenodiol in additional countries. 

We are developing Livmarli for certain rare cholestatic conditions through the Phase 3 EXPAND study, which we initiated in the fourth quarter of 2024. In addition, we are advancing our product candidate, volixibat, a novel, oral, minimally-absorbed agent designed to inhibit IBAT, for the treatment of adult patients with cholestatic liver diseases. We are developing volixibat in the setting of primary sclerosing cholangitis (“PSC”) and primary biliary cholangitis (“PBC”), and in October 2024, we announced that the FDA granted Breakthrough Therapy Designation for volixibat as a potential treatment for cholestatic pruritus in patients with PBC. We conducted an interim analysis of our VISTAS Phase 2b clinical trial in PSC and reported interim data from our VANTAGE Phase 2b clinical trial in PBC in June 2024. We expect the VISTAS Phase 2b clinical trial in PSC to complete enrollment in the third quarter of 2025 with topline data expected in the second quarter of 2026, and we expect the VANTAGE Phase 2b clinical trial in PBC to complete enrollment in 2026.

To date, we have focused primarily on acquiring and in-licensing our product candidates, organizing and staffing our company, business planning, raising capital, advancing our product candidates through clinical development, preparing for commercialization of our product candidates, commercializing our approved medicines, and conducting business development activities relating to, among other things, portfolio expansion through collaborations and acquisitions.

Financial Overview

Our net loss was $14.7 million and $25.3 million for the three months ended March 31, 2025 and 2024, respectively. As of March 31, 2025, we had an accumulated deficit of $658.9 million, compared to $644.2 million as of December 31, 2024. As of March 31, 2025, we had unrestricted cash, cash equivalents and investments of $298.6 million, compared to unrestricted cash, cash equivalents and investments of $292.8 million as of December 31, 2024.

We anticipate we will continue to generate net losses for the foreseeable future as we continue commercial activities for our approved medicines