Positive topline data from the Phase 2b FASCINATE-2 trial was reported, with denifanstat meeting both primary efficacy endpoints and demonstrating a statistically significant reduction in fibrosis at week 52.

A late-breaking poster was presented at AASLD showcasing the beneficial shift in lipid profile in denifanstat-treated patients.

An End-of-Phase 2 meeting with the FDA is expected in the first half of 2024, and preparations are underway to initiate a pivotal Phase 3 trial evaluating denifanstat in MASH patients in the second half of 2024.

The anticipated cash runway was extended through 2025 by completing a follow-on offering in January 2024 for $104.7 million in net proceeds; cash, cash equivalents, and marketable securities totaled $94.9 million as of December 31, 2023.