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Sep 30, 2023
Akero Q3 2023 Earnings Report
Akero Therapeutics reported third quarter financial results and provided a business update.
Key Takeaways
Akero Therapeutics reported its third quarter financial results, highlighting the ongoing Phase 3 SYNCHRONY studies and the progress of its lead product candidate, EFX, in treating NASH. The company's cash position is strong, expected to fund operations into 2026.
Phase 3 SYNCHRONY Histology and SYNCHRONY Real-World studies are actively screening and on track to begin enrolling by the end of 2023.
Week 36 results from the Phase 2b SYMMETRY study showed statistically significant results for NASH resolution and improvements in non-invasive markers.
Week 96 results from the Phase 2b HARMONY study are expected to be reported in the first quarter of 2024.
Cash, cash equivalents, and marketable securities totaled $613.0 million as of September 30, 2023, expected to fund operations into 2026.
Akero
Akero
Forward Guidance
Akero Therapeutics anticipates several key milestones, including the initiation of Phase 3 trials and the reporting of Phase 2b study results. However, these plans are subject to various risks and uncertainties.
Positive Outlook
- The company expects to begin enrollment of its Phase 3 SYNCHRONY program by the end of 2023.
- Akero anticipates potential communications with the FDA regarding its clinical trial designs.
- The long-term follow-up week 96 results of Akero’s Phase 2b HARMONY and SYMMETRY studies are expected to be reported.
- Akero believes that its current cash, cash equivalents, short-term and long-term marketable securities will be sufficient to fund its current operating plan into 2026.
- Ongoing clinical trials are evaluating the efficacy and safety of EFX.
Challenges Ahead
- The success, cost, and timing of Akero’s product candidate development activities and planned clinical trials are uncertain.
- Akero’s ability to execute on its strategy is subject to risks.
- Positive results from any of its clinical studies 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 Akero’s plans.
- Akero’s ability to fund operations is subject to risks.