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Akero Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update
GlobeNewswire News Room· 2025-05-12 11:00
Core Insights - Akero Therapeutics reported statistically significant results from the Phase 2b SYMMETRY study, demonstrating the potential of efruxifermin (EFX) to reverse compensated cirrhosis (F4) due to metabolic dysfunction-associated steatohepatitis (MASH) after 96 weeks of treatment [1][2][7] - The company raised $402.5 million in a follow-on public offering, increasing its cash reserves to $1,128 million as of March 31, 2025 [1][4][12] - The SYMMETRY study results were published in the New England Journal of Medicine, highlighting the importance of EFX in treating MASH [5][7] Financial Performance - For the first quarter of 2025, Akero reported total operating expenses of $80.9 million, up from $60.0 million in the same period of 2024, driven by increased research and development costs [12][20] - The net loss for the first quarter of 2025 was $70.7 million, compared to a net loss of $53.3 million in the first quarter of 2024 [20] Clinical Study Results - In the SYMMETRY study, 39% of patients in the 50mg EFX group showed a ≥1-stage improvement in fibrosis with no worsening of MASH, representing a 24% effect size over placebo [6] - The study also indicated a mean reduction in ELF score of 0.53 for the 50mg EFX group, compared to an increase of 0.22 for placebo [6] - EFX is the only investigational drug evaluated in a randomized, placebo-controlled trial that has shown statistically significant reversal of compensated cirrhosis due to MASH [6][15] Future Developments - Akero is advancing its Phase 3 SYNCHRONY program, which includes three ongoing trials evaluating EFX for both compensated cirrhosis (F4) and pre-cirrhotic (F2-F3) MASH [11][16] - Preliminary topline results from the SYNCHRONY Real-World study are expected in the first half of 2026, while the SYNCHRONY Histology study aims to report results in the first half of 2027 [11][16] Industry Context - MASH is estimated to affect 17 million Americans and is the fastest-growing cause of liver transplants and liver cancer in the US and Europe [13][14] - By 2030, an estimated 3 million Americans are projected to have MASH cirrhosis, highlighting the urgent need for effective treatments [14]