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

Akero Therapeutics reports significant reversal of compensated cirrhosis in MASH patients treated with efruxifermin (EFX) and provides an update on its Phase 3 SYNCHRONY program.

Summary

• Akero Therapeutics announced its fourth quarter and full year 2024 financial results and provided a business update.
• The company reported statistically significant reversal of compensated cirrhosis (F4) due to MASH after 96 weeks of treatment with efruxifermin (EFX) in the Phase 2b SYMMETRY study.
• Enrollment was completed for the double-blinded portion of the Phase 3 SYNCHRONY Real-World Study, which evaluates EFX in patients with either MASLD or MASH.
• New analyses of the Week 96 Phase 2b HARMONY study in patients with pre-cirrhotic (F2-F3) MASH were presented at the 75th Annual AASLD The Liver Meeting 2024.
• In the SYMMETRY study, 39% of patients in the 50mg EFX group demonstrated a 1-stage improvement in fibrosis with no worsening of MASH, compared to 15% for placebo (p=0.009).
• By ITT analysis, 29% of the 50mg EFX group showed a 1-stage improvement in fibrosis with no worsening of MASH, compared to 12% for placebo (p=0.031).
• In a subgroup of patients not taking GLP-1 at baseline, 45% of the 50mg EFX group experienced reversal of cirrhosis with no worsening of MASH (p=0.009) compared to 17% for placebo.
• The 50mg EFX group showed a 24% relative reduction in liver stiffness by VCTE (FibroScan) compared to 8% for placebo (p<0.05).
• The SYNCHRONY Histology study is on track to report 52-week results for primary histology endpoints during the first half of 2027.
• Preliminary topline results from SYNCHRONY Real-World are expected in the first half of 2026.
• Akero's cash, cash equivalents, and marketable securities were $797.8 million as of December 31, 2024.
• A follow-on offering of common stock closed on January 30, 2025, raising gross proceeds of $402.5 million.
• The company believes its cash resources will fund its operating plan into 2028.
• Research and development expenses for 2024 were $247.5 million, compared to $141.8 million in 2023.
• General and administrative expenses for 2024 were $37.9 million, compared to $31.1 million in 2023.
• Total operating expenses for 2024 were $285.4 million, compared to $172.9 million in 2023.

Sentiment

Score: 8

Explanation: The document presents positive clinical trial results, a strong cash position, and progress in the Phase 3 program, indicating a favorable outlook for the company. The successful capital raise further strengthens the positive sentiment.

Positives

• The Phase 2b SYMMETRY study showed statistically significant reversal of compensated cirrhosis (F4) due to MASH with EFX treatment.
• A significant percentage of patients treated with EFX experienced improvement in fibrosis and reduction in liver stiffness.
• The company has a strong cash position of $797.8 million as of December 31, 2024, which is expected to fund operations into 2028.
• The Phase 3 SYNCHRONY program is progressing, with enrollment completed for the Real-World study and the Histology study on track to report results in 2027.
• A follow-on offering of common stock raised gross proceeds of $402.5 million.

Negatives

• Operating expenses increased significantly in 2024 compared to 2023, with research and development expenses rising from $141.8 million to $247.5 million.
• The company reported a net loss of $252.06 million for the year ended December 31, 2024, compared to a net loss of $151.759 million for the year ended December 31, 2023.

Risks

• The success of Akero's product candidate development activities and planned clinical trials is subject to risks and uncertainties.
• Positive results from clinical studies may not be predictive of future results.
• 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.

Future Outlook

Akero believes its current cash resources will be sufficient to fund its operating plan into 2028 and is focused on advancing the Phase 3 SYNCHRONY program and reporting results from ongoing studies.

Management Comments

• The preliminary topline results from our Phase 2b SYMMETRY study, which we reported last month, showed an unprecedented, statistically significant reversal of compensated cirrhosis due to MASH in patients treated with 50mg EFX for 96 weeks, said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero.
• These exciting results, which build on last years week 96 results for the Phase 2b HARMONY study in patients with pre-cirrhotic MASH, show EFXs potential to improve outcomes not only for patients with pre-cirrhotic fibrosis, but also for those with compensated cirrhosisa population in urgent need of effective therapeutic options.
• We remain committed to advancing EFX as a potential therapeutic breakthrough for individuals living with advanced MASH and look forward to building upon this momentum as we progress our Phase 3 SYNCHRONY program.

Industry Context

The announcement is significant in the context of the growing MASH market, where there are currently no approved treatments. Akero's EFX shows promise in reversing cirrhosis, a key unmet need in this patient population, potentially positioning the company as a leader in the field.

Comparison to Industry Standards

• The reported reversal of compensated cirrhosis in 39% of patients in the 50mg EFX group represents a significant improvement compared to existing treatments and other investigational therapies in development for MASH.
• Companies like Intercept Pharmaceuticals (prior to its acquisition) and Madrigal Pharmaceuticals are also developing treatments for MASH, but Akero's data suggests a potentially more impactful effect on cirrhosis reversal.
• The 7.3 kPa mean reduction in liver stiffness observed for the 50mg EFX group is the largest absolute reduction reported to date in clinical trials in patients with compensated cirrhosis (F4) due to MASH.

Stakeholder Impact

• Shareholders: The positive clinical trial results and strong financial position are likely to be viewed favorably by shareholders.
• Patients: The potential for EFX to reverse cirrhosis offers hope for patients with advanced MASH.
• Employees: The company's progress and financial stability provide job security and opportunities for growth.
• The results could lead to increased investment and interest in the MASH treatment space.

Next Steps

• Continue enrollment and execution of the Phase 3 SYNCHRONY program.
• Report preliminary topline results from SYNCHRONY Real-World in the first half of 2026.
• Report 52-week results for primary histology endpoints from the SYNCHRONY Histology study in the first half of 2027.
• Advance EFX as a potential therapeutic breakthrough for individuals living with advanced MASH.

Key Dates