8-K: Akero Therapeutics Announces Positive Phase 2b Results and Provides Business Update

Akero Therapeutics reported positive week 96 results from its Phase 2b HARMONY study and provided updates on its Phase 3 SYNCHRONY program, along with first quarter 2024 financial results.

Summary

• Akero Therapeutics announced its first quarter 2024 financial results and provided a business update, highlighting progress in its clinical programs.
• The company reported statistically significant week 96 results from the Phase 2b HARMONY study of efruxifermin (EFX) in patients with pre-cirrhotic MASH, showing increased rates of fibrosis improvement with longer treatment.
• The Phase 3 SYNCHRONY program, consisting of three trials, is progressing with two trials enrolling patients and the third on track to start in the second quarter of 2024.
• Akero completed a public offering in March 2024, raising approximately $366.9 million in gross proceeds.
• As of March 31, 2024, Akero had $903.7 million in cash, cash equivalents, and short-term marketable securities.
• The company believes its current funds will support the Phase 3 SYNCHRONY studies through their primary endpoints and fund operations into the second half of 2027.
• Research and development expenses for the first quarter of 2024 were $50.7 million, compared to $21.8 million in the same period of 2023.
• Total operating expenses for the first quarter of 2024 were $60.0 million, compared to $28.8 million in the same period of 2023.

Sentiment

Score: 8

Explanation: The document presents very positive clinical trial results and a strong financial position, indicating a favorable outlook for the company. The increase in operating expenses is expected for a company in this stage of development.

Positives

• The Phase 2b HARMONY study demonstrated significant improvements in fibrosis with EFX treatment at week 96.
• The Phase 3 SYNCHRONY program is progressing with two trials enrolling patients and the third on track to start soon.
• Akero has a strong cash position of $903.7 million, providing financial stability.
• The company's cash runway extends into the second half of 2027.
• EFX was generally well-tolerated in the HARMONY study, with a tolerability profile comparable to that observed at week 24.

Negatives

• Research and development expenses increased significantly to $50.7 million in the first quarter of 2024, compared to $21.8 million in the same period of 2023.
• Total operating expenses increased to $60.0 million in the first quarter of 2024, compared to $28.8 million in the same period of 2023.
• The company reported a net loss of $53.3 million for the first quarter of 2024, compared to a net loss of $25.8 million for the same period in 2023.

Risks

• The success of Akeros product candidate development activities and planned clinical trials is subject to risks and uncertainties.
• Positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies.
• Regulatory developments in the United States and foreign countries could impact the company's plans.
• The company's ability to fund operations is subject to risks and uncertainties.
• There is a risk that actual results may differ materially from forward-looking statements.

Future Outlook

Akero expects its current cash to fund its Phase 3 SYNCHRONY Histology and Real-World studies through their primary endpoints and its current operating plan into the second half of 2027. The company also anticipates reporting week 96 results from the Phase 2b SYMMETRY study in the first quarter of 2025.

Management Comments

• We continued to make significant advancements in the clinical development of EFX during the first quarter of this year, said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero.
• The increased improvements in fibrosis stage observed from weeks 24 to 96 in the Phase 2b HARMONY study in patients with pre-cirrhotic MASH (F2-F3) showed EFXs potential to result in higher rates of fibrosis improvement after longer treatment.

Industry Context

The announcement is significant in the context of the growing need for effective treatments for MASH, a serious liver disease with limited therapeutic options. Akero's EFX is a promising candidate, and the positive results from the HARMONY study and the progress of the SYNCHRONY program position the company as a key player in this space.

Comparison to Industry Standards

• The 75% fibrosis improvement rate at week 96 for the 50mg EFX dose in the HARMONY study is highly competitive compared to other MASH treatments in development.
• Companies like Madrigal Pharmaceuticals with their drug Resmetirom have shown positive results in MASH, but Akero's EFX demonstrates a different mechanism of action and potentially higher efficacy in fibrosis improvement.
• The Phase 3 SYNCHRONY program is designed to meet regulatory requirements for accelerated approval, similar to other companies in the space, but Akero's approach with multiple studies targeting different stages of MASH is unique.
• The cash runway into the second half of 2027 is a strong position compared to many other biotech companies in the clinical stage.

Stakeholder Impact

• Shareholders are likely to react positively to the strong clinical results and financial position.
• Employees may feel more secure due to the company's extended cash runway.
• Patients with MASH may benefit from the potential approval of EFX.
• The company's suppliers and partners may see increased business opportunities.

Next Steps

• Continue enrollment in the Phase 3 SYNCHRONY Histology and Real-World studies.
• Initiate the Phase 3 SYNCHRONY Outcomes study in the second quarter of 2024.
• Report week 96 results from the Phase 2b SYMMETRY study in the first quarter of 2025.

Key Dates

Keywords

MASH, efruxifermin, EFX, fibrosis, clinical trials, SYNCHRONY, HARMONY, liver disease, biotechnology, metabolic disease