8-K: Akero Therapeutics Announces Positive Phase 2b SYMMETRY Results and First Quarter 2025 Financials

Akero Therapeutics reports statistically significant reversal of compensated cirrhosis in Phase 2b SYMMETRY study and a strong cash position following a public offering.

Summary

• Akero Therapeutics announced its first quarter 2025 financial results and provided a business update.
• The Phase 2b SYMMETRY study showed statistically significant reversal of compensated cirrhosis (F4) due to MASH following 96 weeks of treatment with efruxifermin (EFX).
• The company presented data from the SYMMETRY and HARMONY clinical studies at the EASL Congress 2025.
• The SYMMETRY study results were published in the New England Journal of Medicine.
• Akero raised $402.5 million in gross proceeds from a follow-on public offering in January 2025.
• The company's cash, cash equivalents, and marketable securities totaled $1,128 million as of March 31, 2025.
• Akero believes its cash reserves will fund operations into 2028.
• Research and development expenses for the quarter were $69.6 million, compared to $50.7 million in the same period of 2024.
• General and administrative expenses for the quarter were $11.3 million, compared to $9.3 million in the same period of 2024.
• Total operating expenses were $80.9 million for the quarter, compared to $60.0 million in the same period of 2024.

Sentiment

Score: 8

Explanation: The document presents positive clinical trial results and a strong financial position, indicating a favorable outlook for the company.

Positives

• The Phase 2b SYMMETRY study showed statistically significant reversal of compensated cirrhosis (F4) due to MASH with efruxifermin (EFX) treatment.
• Akero has a strong cash position of $1,128 million, expected to fund operations into 2028.
• The company is advancing its Phase 3 SYNCHRONY program.
• The SYMMETRY study results were published in the New England Journal of Medicine.
• EFX is the only known investigational MASH drug evaluated in a randomized, placebo-controlled clinical trial in patients with cirrhosis due to MASH that has been reported to show statistically significant reversal of compensated cirrhosis (F4).

Negatives

• Research and development expenses increased to $69.6 million for the quarter, compared to $50.7 million in the same period of 2024.
• General and administrative expenses increased to $11.3 million for the quarter, compared to $9.3 million in the same period of 2024.
• The company reported a net loss of $70.725 million for the quarter.

Risks

• The success of Akero's product candidate development activities and planned clinical trials is uncertain.
• Positive results from clinical studies may not be predictive of future results.
• Regulatory developments in the United States and foreign countries could impact Akero's plans.
• Akero's ability to fund operations is subject to risks and uncertainties.

Future Outlook

Akero expects to report preliminary topline results from the SYNCHRONY Real-World study in the first half of 2026 and 52-week results from the SYNCHRONY Histology study in the first half of 2027; the company believes its cash reserves will fund operations into 2028.

Management Comments

• In the first quarter of 2025, we reported an unprecedented statistically significant reversal of cirrhosis due to MASH following 96 weeks of treatment with EFX in the Phase 2b SYMMETRY studya defining moment not only for Akero, but more broadly for the treatment of MASH, said Andrew Cheng, president and chief executive officer.
• We believe the SYMMETRY week 96 results highlight the potential of EFX to transform the treatment of MASH, offering new hope to patients facing a disease with few meaningful treatment options.

Industry Context

Akero's focus on MASH and cirrhosis addresses a significant unmet medical need, as MASH is a growing cause of liver transplants and liver cancer; the positive results from the SYMMETRY study position EFX as a potential firstand best-in-class therapy in this space.

Comparison to Industry Standards

• The statistically significant reversal of compensated cirrhosis (F4) due to MASH with efruxifermin (EFX) treatment is a notable achievement, as cirrhosis had previously been viewed as an irreversible condition.
• Other companies such as Intercept Pharmaceuticals and Genfit have been developing treatments for NASH/MASH, but Akero's EFX has shown promising results in reversing cirrhosis, which could differentiate it from competitors.
• The $1.128 billion in cash, cash equivalents, and marketable securities provides Akero with a strong financial position to advance its Phase 3 SYNCHRONY program.

Stakeholder Impact

• Shareholders may benefit from the positive clinical trial results and strong financial position.
• Patients with MASH and cirrhosis may have a new treatment option if EFX is approved.
• Employees may benefit from the company's growth and success.

Next Steps

• Continue enrollment in the Phase 3 SYNCHRONY program.
• Report preliminary topline results from the SYNCHRONY Real-World study in the first half of 2026.
• Report 52-week results from the SYNCHRONY Histology study in the first half of 2027.

Key Dates

Keywords

efruxifermin, MASH, cirrhosis, SYMMETRY, SYNCHRONY, AKRO, Akero Therapeutics, clinical trial, fibrosis, liver disease