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Dec 31, 2023
Akero Q4 2023 Earnings Report
Akero Therapeutics reported its Q4 and full year 2023 financial results, highlighting the initiation of Phase 3 SYNCHRONY studies and progress in MASH treatment development.
Key Takeaways
Akero Therapeutics reported increased research and development expenses due to ongoing clinical trials and manufacturing for potential marketing applications. The company's cash, cash equivalents, and marketable securities were $569.3 million as of December 31, 2023, expected to fund operations into 2026.
First patients dosed in Phase 3 SYNCHRONY studies evaluating EFX for pre-cirrhotic MASH.
Results from the second on-treatment biopsy in the 96-week Phase 2b HARMONY study are expected in the first half of 2024.
Initiation of the third Phase 3 SYNCHRONY study in patients with cirrhosis due to MASH is planned for the first half of 2024.
Week 36 results from the Phase 2b SYMMETRY study in patients with cirrhosis due to MASH showed a trend towards improvement in liver fibrosis and statistically significant rates of MASH resolution.
Akero
Akero
Forward Guidance
Akero anticipates reporting topline results from the HARMONY study in Q1 2025 and initiating a third Phase 3 SYNCHRONY study in 1H 2024.
Positive Outlook
- Expected reporting of week 96 results of Phase 2b HARMONY study.
- Advancement of EFX in clinical trials.
- Potential therapeutic effects of EFX.
- Plans related to use of a new formulation designed for self-administration in Phase 3 clinical trials.
- Initiation of SYNCHRONY Outcomes study in 1H 2024.
Challenges Ahead
- Uncertainties related to the success, cost, and timing of product development activities and clinical trials.
- Risk of actual results differing materially from forward-looking statements.
- Dependence on Akero's ability to execute its strategy.
- Possibility that positive results from clinical studies may not predict future results.
- Risks related to regulatory developments and Akero's ability to fund operations and enroll patients in clinical trials.