Loading...
•
Jun 30
Amylyx Q2 2025 Earnings Report
Amylyx Pharmaceuticals reported its second quarter 2025 financial results, highlighting progress in its clinical trials and a strong cash position.
Key Takeaways
Amylyx Pharmaceuticals reported a net loss of $41.4 million for Q2 2025, an improvement from the $72.7 million net loss in Q2 2024. The company had no product revenue for the quarter. Research and development expenses increased, while selling, general, and administrative expenses decreased. The company maintains a strong cash position of $180.8 million, with a cash runway expected through the end of 2026.
Net loss for Q2 2025 was $41.4 million, a significant reduction from $72.7 million in Q2 2024.
The company reported no product revenue for the second quarter of 2025.
Cash, cash equivalents, and marketable securities stood at $180.8 million as of June 30, 2025, providing a cash runway through the end of 2026.
Research and development expenses increased to $27.2 million, primarily due to clinical development of avexitide in PBH and AMX0035 in PSP.
Amylyx
Amylyx
Forward Guidance
Amylyx Pharmaceuticals expects to complete recruitment for the pivotal Phase 3 LUCIDITY trial of avexitide in PBH in 2025, with topline data anticipated in the first half of 2026. An unblinded analysis from the Phase 2b portion of the ORION trial of AMX0035 in PSP is expected in Q3 2025. The company also anticipates an update on its Wolfram syndrome program and early cohort data from the Phase 1 LUMINA trial for AMX0114 in ALS later in 2025. The cash runway is expected to last through the end of 2026.
Positive Outlook
- Completion of recruitment for pivotal Phase 3 LUCIDITY trial of avexitide in PBH expected in 2025.
- Topline data from LUCIDITY trial anticipated in first half of 2026.
- Unblinded analysis from Phase 2b portion of ORION trial for AMX0035 in PSP expected in Q3 2025.
- Update on AMX0035 Wolfram syndrome program expected in 2025, informing Phase 3 trial design.
- Early cohort data from Phase 1 LUMINA trial of AMX0114 in ALS expected in 2025.
Challenges Ahead
- Commercial launch of avexitide, if approved, not anticipated until 2027.
- Go/no-go decision for Phase 3 portion of ORION trial dependent on Phase 2b data.
- No specific revenue guidance provided for future periods.
- Continued net losses are expected as the company focuses on R&D.
- Reliance on clinical trial success for future product approvals and revenue generation.