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Sep 30, 2024
Amylyx Q3 2024 Earnings Report
Reported financial results, highlighted pipeline advancements, and provided updates on clinical programs
Key Takeaways
Amylyx Pharmaceuticals reported a net product revenue of $0.4 million, which was related to adjustments to the Company’s gross-to-net accrual estimates for prior period sales of RELYVRIO® and ALBRIOZA™. The company's cash, cash equivalents, and marketable securities totaled $234.4 million, with a cash runway expected into 2026. A net loss of $72.7 million, or $1.07 per share, was reported for the quarter.
Initiation of a Phase 3 program for avexitide in post-bariatric hypoglycemia (PBH) is on track for Q1 2025.
Positive topline data from Phase 2 HELIOS clinical trial of AMX0035 in Wolfram syndrome demonstrated improvement or stabilization across all disease measures at Week 24 and sustained improvement at Weeks 36 and 48
Cash, cash equivalents and marketable securities of $234.4 million as of September 30, 2024; cash runway expected into 2026
The company plans to initiate the Phase 1 LUMINA clinical trial of AMX0114 in people living with ALS by the end of 2024 or in the beginning of 2025 in Canada.
Forward Guidance
Amylyx expects to initiate the Phase 1 LUMINA clinical trial of AMX0114 in people living with ALS by the end of 2024 or in the beginning of 2025 in Canada. Amylyx continues to expect initiation of its Phase 3 program for avexitide in PBH in the first quarter of 2025. Data from an interim analysis of the Phase 2b/3 ORION clinical trial of AMX0035 in progressive supranuclear palsy (PSP) continue to be expected in mid-2025.
Positive Outlook
- Initiate Phase 3 program for avexitide in PBH in Q1 2025.
- Report topline data from avexitide Phase 3 program in 2026.
- Expect early cohort data from LUMINA in 2025.
- Initiate Phase 1 LUMINA clinical trial of AMX0114 in people living with ALS by the end of 2024 or in the beginning of 2025 in Canada.
- Anticipate topline data in 2026
Historical Earnings Impact
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