Akero Therapeutics Reports $252M Net Loss for 2024, Increases R&D Spending

Akero Therapeutics, Inc. reported a net loss of $252.06 million for the year ended December 31, 2024, compared to a net loss of $151.76 million in 2023. Research and development expenses increased significantly from $141.8 million in 2023 to $247.5 million in 2024, primarily due to increased costs associated with the ongoing SYMMETRY and SYNCHRONY clinical trials and third-party contract manufacturing expenses for efruxifermin (EFX). General and administrative expenses also rose from $31.1 million to $37.9 million over the same period. Interest expense increased from $3.1 million to $4.7 million, reflecting increased borrowing costs. However, interest and other income, net, increased substantially from $24.2 million to $38.0 million due to higher investment returns.

The company's Phase 3 SYNCHRONY program, launched in the fourth quarter of 2023, comprises three trials: SYNCHRONY Outcomes, SYNCHRONY Histology, and SYNCHRONY Real-World. Enrollment in the double-blind portion of the SYNCHRONY Real-World trial concluded in January 2025, with results expected in the first half of 2026. Preliminary topline results from the Phase 2b SYMMETRY trial, reported in January 2025, showed that 39% of patients treated with 50mg EFX experienced cirrhosis reversal, compared to 15% in the placebo group. Preliminary week 96 results from the Phase 2b HARMONY trial, reported in March 2024, indicated a 75% response rate for 50mg EFX and a 46% response rate for 28mg EFX, compared to 24% for the placebo group. EFX was generally well-tolerated across all trials.

As of February 14, 2024, Akero's patent portfolio related to EFX included 209 issued patents and 17 pending patent applications worldwide. The company acquired exclusive global development and commercialization rights to EFX from Amgen Inc. in June 2018, making an upfront payment of $5 million and issuing shares of preferred stock. Subsequent milestone payments were made in August 2019 ($2.5 million) and December 2023 ($7.5 million). Akero employs 63 people, with 46 in research and development and 17 in general and administrative roles. The company has begun planning for the commercialization of EFX in the United States, if approved, and is exploring options for other key markets.

The company's financial statements show total assets of $825.89 million as of December 31, 2024, and total liabilities of $75.77 million. Stockholders' equity totaled $750.11 million. Cash, cash equivalents, and short-term and long-term marketable securities amounted to $797.8 million as of December 31, 2024. A follow-on public offering in January 2025 generated gross proceeds of $402.5 million, extending the company's projected cash runway into 2028. The company acknowledges significant risks related to clinical development, manufacturing, competition, intellectual property, regulatory approvals, commercialization, and financing. A lawsuit alleging misstatements and omissions regarding the SYMMETRY study is currently pending.

Akero Therapeutics anticipates continued losses for the foreseeable future, with expenses expected to increase as the company advances EFX through clinical development and pursues potential commercialization. The company plans to fund its operations through a combination of equity offerings, debt financings, and potential collaborations. The company's future success hinges on the successful development, regulatory approval, and market acceptance of EFX and any future product candidates.