Key Points

• Akero Therapeutics (NASDAQ:AKRO) reported a GAAP net loss per share of ($0.86) for Q2 2025, narrower than the consensus estimate of ($0.92).

• Key clinical trial results for efruxifermin (EFX) were published in the New England Journal of Medicine and highlighted at major scientific conferences.

• Operating expenses (GAAP) rose 23% year over year, driven by manufacturing scale-up and three concurrent Phase 3 trials.

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Akero Therapeutics (NASDAQ:AKRO), a biotechnology company focused on developing medicines for fatty liver diseases, released its second-quarter results on August 8, 2025. The most notable news in this quarter was continued progress in clinical trials for its lead drug candidate, efruxifermin (EFX), including positive data publications and conference presentations. Akero reported a GAAP net loss per share of ($0.86), $0.06 less than analysts had estimated. The company did not report revenue, as expected given its pre-commercial status. Akero’s operating expenses (GAAP) climbed to $80.9 million, mainly reflecting higher research spending as Phase 3 trials scaled up. Overall, the quarter saw meaningful scientific and operational milestones, with financial performance largely tracking expectations given the stage of development.

Source: Analyst estimates for the quarter provided by FactSet.

Company Overview and Business Focus

Akero Therapeutics’ main objective is developing new treatments for liver diseases resulting from abnormal fat accumulation, specifically conditions such as metabolic dysfunction-associated steatohepatitis (MASH). The company’s strategy revolves around its lead drug candidate, efruxifermin (EFX), a biological drug designed to mimic the natural hormone FGF21 and target both fibrotic and metabolic elements of MASH.

Akero’s recent business efforts have centered on advancing EFX through multiple late-stage clinical trials to support regulatory approval. The success of these trials is crucial for both future revenue and regulatory clearance. Key business drivers include demonstrating the efficacy and safety of EFX, building strong scientific credibility, securing strategic manufacturing partnerships, and maintaining financial flexibility as operational costs rise during the transition to late-stage development.

Quarter Highlights: Operations, Financials, and Clinical Progress

This period marked important validation for Akero’s main product candidate, efruxifermin. Data from the Phase 2b SYMMETRY study in patients with advanced liver scarring (compensated cirrhosis) due to MASH was published in the New England Journal of Medicine on May 9, 2025. That publication in a leading medical journal highlighted EFX’s potential to reverse advanced fibrosis—a disease stage without available treatments today.

Results from both the SYMMETRY and HARMONY Phase 2b studies were featured at the 2025 European Association for the Study of the Liver (EASL) Congress, with conference presentations underlining EFX’s impact across several patient subgroups, including those with diabetes and cryptogenic cirrhosis. For example, week 96 data showed a statistically significant portion of patients receiving the 50mg EFX dose achieved cirrhosis reversal compared to placebo: 39% in the 50mg EFX group versus 15% in the placebo group (p=0.009), among patients with baseline and week 96 biopsies. These analyses also used artificial intelligence (AI) for deeper biopsy review and consistently reinforced efficacy signals, strengthening scientific confidence in the results.

The company reported that all three pivotal Phase 3 trials -- SYNCHRONY Histology, SYNCHRONY Real-World, and SYNCHRONY Outcomes -- remain ongoing. Importantly, 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. These trials are designed to generate data for both U.S. and international regulatory submissions and address a wide spectrum of MASH patients, ranging from early liver damage to advanced cirrhosis.

Financially, Akero’s operating expenses (GAAP) were $80.9 million for the three-month period ended June 30, 2025, compared to $65.7 million in the same period of 2024, representing a 23% increase as the company invested further in large-scale clinical trials and manufacturing preparations. Research and development spending saw the largest increase, up 25.3% for the three-month period ended June 30, 2025 compared to the same period in 2024, reflecting the cost of running several complex global studies simultaneously and efforts to scale production. General and administrative costs for the three-month period ended June 30, 2025 were $11.6 million, compared to $10.4 million in the same period of 2024. Akero ended Q2 2025 with $1.09 billion in cash, cash equivalents, and marketable securities, which management states will fund current activities into 2028.

No notable one-time financial events were highlighted for the period, except for a previously disclosed capital raise in January, which helped strengthen the company’s cash position for ongoing trials and future commercial plans.

Product Pipeline and Strategic Context

EFX is a biologic drug, meaning it is produced using living cells and targets the hormone pathways that underlie metabolic and fibrotic liver diseases. The SYMMETRY and HARMONY studies have confirmed EFX’s ability to reduce or reverse liver scarring, which is the main driver of poor outcomes in advanced fatty liver disorders.

Results showed that a significant portion of patients taking the highest dose regimen experienced clear benefits in liver health, measured both by traditional biopsy and new imaging and AI-based techniques. These findings were consistent across patients with pre-cirrhotic disease and advanced cirrhosis, even in groups considered difficult to treat. Akero’s ongoing Phase 3 SYNCHRONY program now includes approximately 3,500 participants and features a mix of traditional and real-world-data trial approaches.

Akero has also secured important U.S. Food and Drug Administration (FDA) regulatory designations—namely Fast Track and Breakthrough Therapy status—which signal that EFX may offer major advancements over existing care and can be reviewed more quickly by regulators. The company’s pipeline continues to rely on EFX, which carries both the promise of first-mover advantage in a large disease market and the typical risks seen with single-product biopharma firms.

Building for commercialization, Akero has struck manufacturing agreements with established industry partners and is working to develop a commercial infrastructure for potential drug launch in the U.S. The firm is evaluating further market entry strategies in Europe, Japan, and China, using both internal resources and partnerships. Intellectual property agreements, including an exclusive license deal with Amgen and a robust patent portfolio, help protect and extend the commercial lifespan of EFX if it is approved and launched.

Outlook and What to Watch Next

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 regardless of near-term trial results. (As stated in Akero's Q2 2025 and Q1 2025 earnings releases, the company believes its cash, cash equivalents, and short- and long-term marketable securities will be sufficient to fund its current operating plan into 2028.) The next anticipated event is the data release from the SYNCHRONY Real-World Phase 3 study in the first half of 2026, followed by the histology study readout in 2027. No additional financial guidance was provided for the remainder of the year or next quarter.

With no revenue until EFX is approved and launched, investor attention remains on the success of ongoing Phase 3 trials, the pace of clinical enrollment and data read-outs, and management’s ability to balance cash burn with operational progress. 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.

Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.

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