Amylyx Q1 2025 Earnings Report
Key Takeaways
Amylyx Pharmaceuticals reported a net loss of $35.9 million for the first quarter of 2025, a significant improvement compared to the $118.8 million net loss in the same period last year. The company's cash position strengthened to $204.1 million, extending its expected cash runway through the end of 2026. The quarter saw continued progress in clinical trials, particularly the pivotal Phase 3 LUCIDITY trial for avexitide in PBH and the initiation of the Phase 1 LUMINA trial for AMX0114 in ALS.
Net loss improved significantly to $35.9 million in Q1 2025 from $118.8 million in Q1 2024, primarily due to the discontinuation of RELYVRIO/ALBRIOZA sales and associated costs.
Cash, cash equivalents, and marketable securities increased to $204.1 million as of March 31, 2025, supported by a public offering, extending the cash runway through the end of 2026.
Progress was made in the pivotal Phase 3 LUCIDITY trial of avexitide for post-bariatric hypoglycemia (PBH), with enrollment completion expected in 2025.
The company initiated the Phase 1 LUMINA trial of AMX0114 for ALS and anticipates early cohort data in 2025.
Amylyx
Amylyx
Forward Guidance
Amylyx expects to complete enrollment for the LUCIDITY trial of avexitide in PBH in 2025, with topline data in the first half of 2026 and potential commercial launch in 2027. They also anticipate early cohort data from the LUMINA trial of AMX0114 in ALS in 2025 and unblinded analysis from the ORION trial of AMX0035 in PSP in Q3 2025. The company's cash runway is expected to last through the end of 2026.
Positive Outlook
- Completion of enrollment for pivotal Phase 3 LUCIDITY trial of avexitide in PBH expected in 2025.
- Topline data from LUCIDITY trial anticipated in first half of 2026.
- Potential commercial launch of avexitide in PBH anticipated in 2027, if approved.
- Early cohort data from Phase 1 LUMINA trial of AMX0114 in ALS expected in 2025.
- Unblinded analysis of Phase 2b ORION trial of AMX0035 in PSP expected in the third quarter of 2025.
Challenges Ahead
- No specific negative forward guidance was provided in the report.