Akero Therapeutics, Inc. reported a net loss of $81.6 million for the third quarter of 2025, compared to a loss of $72.7 million in the same period of 2024, reflecting a 12% increase in losses year-over-year. For the nine months ending September 30, 2025, the company recorded a net loss of $222.8 million, up from $182.0 million in the prior year. The increase in losses is attributed to higher operating expenses, which rose to $90.2 million for the quarter, a 10% increase from $81.7 million in the previous year. Research and development expenses accounted for the majority of this increase, totaling $78.9 million, up from $72.2 million, driven by costs associated with the ongoing Phase 3 SYNCHRONY program for its lead product candidate, efruxifermin (EFX).
In terms of financial position, Akero's total assets increased to $1.01 billion as of September 30, 2025, compared to $825.9 million at the end of 2024. This growth was primarily due to an increase in marketable securities, which rose to $812.3 million from $457.6 million. The company’s cash and cash equivalents decreased to $176.0 million from $340.2 million, reflecting significant cash outflows for operating activities. The accumulated deficit also widened to $1.05 billion, indicating ongoing challenges in achieving profitability.
Strategically, Akero announced a merger agreement with Novo on October 9, 2025, which is expected to close by year-end, subject to customary conditions. Under the terms of the merger, Akero shareholders will receive $54.00 in cash per share, along with contingent value rights tied to future milestones. This merger is seen as a pivotal move for the company, potentially providing the necessary capital and resources to advance its clinical programs and product development.
Operationally, Akero is advancing its SYNCHRONY program, which includes three global clinical trials aimed at supporting marketing approval for EFX in patients with metabolic dysfunction-associated steatohepatitis (MASH). The company has reported significant progress in patient enrollment and expects to report results from the SYNCHRONY Real-World trial in the first half of 2026. As of September 30, 2025, Akero had approximately 80.1 million shares outstanding, reflecting an increase from 72.4 million shares at the end of 2024, largely due to equity financing activities.
Looking ahead, Akero anticipates continued operating losses as it invests heavily in the development of EFX and other potential product candidates. The company has indicated that if the merger with Novo does not proceed, it will require additional funding to support its ongoing operations and clinical development efforts. The successful completion of the merger is viewed as critical for Akero's future, as it seeks to navigate the complexities of the biotechnology landscape while advancing its innovative therapies.
About Akero Therapeutics, Inc.
Akero Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing treatments for serious metabolic diseases, primarily metabolic dysfunction-associated steatohepatitis (MASH). Its lead product candidate, efruxifermin (EFX), is an engineered analog of the hormone FGF21 designed to reverse liver fibrosis and cirrhosis while improving metabolic health. Akero’s business model centers on advancing EFX through clinical trials and eventual commercialization targeting patients with advanced liver disease and related metabolic conditions.
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