Akero Therapeutics Q2 Loss Narrows by 6%, EFX Clinical Trials Progress

Akero Therapeutics (AKRO) reported a Q2 net loss per share of ($0.86), narrowing from ($0.92) estimate. Operating expenses rose to $80.9mln, mainly due to higher research spending for Phase 3 trials. The company did not report revenue, as expected. Akero's focus is on developing medicines for fatty liver diseases, with its lead drug candidate, efruxifermin (EFX), demonstrating positive data in clinical trials.

Akero Therapeutics (NASDAQ:AKRO), a biotechnology company focused on developing treatments for fatty liver diseases, reported its second-quarter (Q2) 2025 financial results on August 8, 2025. The company reported a GAAP net loss per share of ($0.86), narrowing from the consensus estimate of ($0.92). Operating expenses (GAAP) rose to $80.9 million, primarily driven by increased research spending for Phase 3 trials. Notably, the company did not report revenue, as expected given its pre-commercial status.

The most significant news in this quarter was the continued progress of Akero's lead drug candidate, efruxifermin (EFX), in clinical trials. Key clinical trial results for EFX were published in the New England Journal of Medicine and highlighted at major scientific conferences. The SYMMETRY study, which evaluated EFX in patients with advanced liver scarring (compensated cirrhosis) due to metabolic dysfunction-associated steatohepatitis (MASH), demonstrated promising results. Week 96 data showed a statistically significant portion of patients receiving the 50mg EFX dose achieved cirrhosis reversal compared to placebo (39% vs. 15%, p=0.009).

Akero’s operating expenses (GAAP) climbed to $80.9 million, up 23% year over year, driven by a 25.3% increase in research and development expenses. General and administrative expenses also increased, rising by 11.5% to $11.6 million. Akero ended Q2 2025 with $1.09 billion in cash, cash equivalents, and marketable securities, which management expects to fund current activities into 2028.

The company has ongoing pivotal Phase 3 trials, including SYNCHRONY Histology, SYNCHRONY Real-World, and SYNCHRONY Outcomes, designed to generate data for regulatory submissions. Management expects preliminary results from the Real-World study in the first half of 2026 and key histology results in the first half of 2027.

Akero's focus on developing medicines for fatty liver diseases, particularly MASH, positions it as a leader in this growing market. The company's strategic partnerships and robust intellectual property portfolio further strengthen its position. Management projects that current cash reserves are sufficient to fund Akero’s operating plan through at least 2028, supporting late-stage clinical work and pre-commercialization activities.

Investors should continue to monitor the success of ongoing Phase 3 trials, the pace of clinical enrollment, and data read-outs. Risks include the inherent uncertainties of clinical development and the company’s dependence on its sole lead asset. Akero Therapeutics does not currently pay a dividend.

References:
[1] https://www.nasdaq.com/articles/akero-akro-q2-loss-narrows-6
[2] https://www.stocktitan.net/news/KPRX/kiora-pharmaceuticals-reports-second-quarter-2025-company-8eq7epvyz2q2.html