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Dec 31, 2024
Amylyx Q4 2024 Earnings Report
Amylyx reported financial results for Q4 2024, highlighting progress in pipeline development and extension of cash runway.
Key Takeaways
Amylyx Pharmaceuticals reported a net loss of $37.5 million for the fourth quarter of 2024, compared to a net income of $4.7 million for the same period in 2023. The company highlighted progress in its pipeline development, including the initiation of a pivotal Phase 3 trial for avexitide and the advancement of other programs in Wolfram syndrome, PSP, and ALS. A public offering extended the company's cash runway through the end of 2026.
Pivotal Phase 3 LUCIDITY trial of avexitide in post-bariatric hypoglycemia is underway, with recruitment expected to complete in 2025 and topline data anticipated in the first half of 2026.
A public offering of common stock was completed, yielding net proceeds of approximately $65.5 million and extending the company’s cash runway through the end of 2026.
Dan Monahan was appointed as Chief Commercial Officer to lead commercialization strategy, including preparation for the potential launch of avexitide for the treatment of PBH.
Phase 1 LUMINA clinical trial of AMX0114 in ALS began, with recruitment starting in February 2025.
Amylyx
Amylyx
Forward Guidance
Amylyx anticipates several milestones in the coming months, including data readouts and regulatory interactions.
Positive Outlook
- Completion of enrollment for the pivotal Phase 3 LUCIDITY clinical trial of avexitide in PBH is expected in 2025, with a data readout anticipated in the first half of 2026 and, if approved, commercial launch anticipated in 2027.
- Amylyx plans to share Week 48 data from the ongoing Phase 2 HELIOS trial of AMX0035 in Wolfram syndrome in the coming months.
- Unblinded interim analysis of the Phase 2b portion of the Phase 2b/3 ORION trial evaluating AMX0035 for progressive supranuclear palsy (PSP) in the third quarter of 2025.
- Early cohort data from the Phase 1 LUMINA clinical trial of AMX0114 in ALS is expected in 2025.
- The company's cash runway extends through the end of 2026.
Challenges Ahead
- The company reported a net loss for the quarter and the year.
- Payments of $31.0 million were made in the fourth quarter of 2024 related to revenue returns and rebates.
- Purchase commitments for AMX0035 that were established prior to the voluntary discontinuation of RELYVRIO®/ALBRIOZA™ in April 2024 impacted the cash position.
- Remaining residual obligations related to the discontinuation of RELYVRIO/ALBRIOZA are $7.8 million, expected to be paid through 2025.
- The company faces risks and uncertainties related to the success, cost, and timing of its program development activities.