DURECT Corporation Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update

Core Insights - DURECT Corporation has made significant progress in the development of larsucosterol for alcohol-associated hepatitis (AH), with the publication of Phase 2b AHFIRM trial results in a prestigious journal, validating its potential as a treatment [2][9] - The company has strengthened its financial position by selling the ALZET product line, using the proceeds to repay its term loan, which aligns with its strategic goal of advancing larsucosterol development [2][9] - DURECT is planning a Phase 3 trial for larsucosterol, contingent on securing sufficient funding, with topline results expected within two years of trial initiation [9] Financial Highlights - For Q4 2024, DURECT reported total revenues of $0.5 million, a decrease from$0.9 million in Q4 2023, while net income was $7.8 million compared to a net loss of$1.4 million in the same period last year [9] - For the full year 2024, total revenues were $2.0 million, down from$2.6 million in 2023, with a net loss of $7.9 million compared to a net loss of$27.6 million in 2023 [9] - As of December 31, 2024, the company had cash, cash equivalents, and investments totaling $12.0 million, a significant decrease from$29.8 million at the end of 2023 [9] AHFIRM Trial Overview - The AHFIRM trial was a Phase 2b study involving 307 patients with severe AH, evaluating the safety and efficacy of larsucosterol [6] - The primary outcome measure was the 90-day incidence of mortality or liver transplantation, with key secondary endpoints including 90-day survival [6] - The trial received Fast Track and Breakthrough Therapy Designation from the U.S. FDA, highlighting the urgent need for effective treatments for AH [6][11] Larsucosterol Mechanism - Larsucosterol is an epigenetic modulator that inhibits DNA methylation, potentially improving cell survival and reducing inflammation in patients with AH [8][10] - The drug's mechanism of action provides a scientific rationale for its development in treating acute organ injury and chronic diseases [10][11] Future Plans - DURECT aims to initiate the Phase 3 trial for larsucosterol in 2025, with the design incorporating feedback from the FDA and insights from the AHFIRM trial [9] - The company is actively exploring funding options to support the continued development of larsucosterol [2][9]