Akero Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Core Insights - Akero Therapeutics reported its fourth quarter and full year financial results for 2023, highlighting advancements in its clinical programs for metabolic diseases, particularly MASH [1][4]. Clinical Development - The company initiated dosing for the first patients in two Phase 3 SYNCHRONY studies targeting pre-cirrhotic MASH, with results from a Phase 2b study expected in the first half of 2024 [1][2]. - The SYNCHRONY Histology study aims to evaluate the safety and efficacy of EFX in improving liver fibrosis after 52 weeks, supporting an application for accelerated approval [2]. - The SYNCHRONY Real-World study will assess EFX's safety in patients with non-invasively diagnosed MASH, while the SYNCHRONY Outcomes study will focus on patients with compensated cirrhosis, expected to start in early 2024 [2]. Financial Performance - Akero's cash and marketable securities totaled $569.3 million as of December 31, 2023, sufficient to fund operations into 2026 [4]. - Research and development expenses increased significantly to $141.8 million for the year, up from $85.3 million in 2022, driven by ongoing clinical trials and related activities [5]. - General and administrative expenses also rose to $31.1 million for the year, compared to $29.9 million in 2022, reflecting higher personnel and operational costs [5]. Product Candidate Overview - Efruxifermin (EFX) is Akero's lead candidate, designed to address MASH by reducing liver fat, inflammation, and fibrosis while improving insulin sensitivity [6]. - EFX is engineered to provide a balanced biological activity profile similar to native FGF21, with a convenient once-weekly dosing regimen [6]. Disease Context - MASH is projected to affect over 25 million Americans by 2030, with no approved treatments currently available, making it a significant area of unmet medical need [7]. - The condition can lead to severe complications, including cirrhosis and liver cancer, highlighting the urgency for effective therapies [7]. Company Overview - Akero Therapeutics is focused on developing treatments for serious metabolic diseases, with a particular emphasis on MASH, which lacks approved therapies [8]. - The company is headquartered in South San Francisco and is advancing multiple clinical trials to address this critical health issue [8].