Amylyx Pharmaceuticals Q2 2024 Financial Results

Amylyx Pharmaceuticals Inc. (Nasdaq: AMLX) has announced its financial results for the second quarter ended June 30, 2024. The company has made significant strides in expanding its pipeline and advancing its clinical development programs.

Joshua Cohen, Co-CEO of Amylyx, highlighted the company's acquisition of avexitide, a Phase 3-ready GLP-1 receptor antagonist. Avexitide has received FDA Breakthrough Therapy Designation for post-bariatric hypoglycemia (PBH) and congenital hyperinsulinism (HI). This acquisition brings Amylyx's portfolio to three assets targeting orphan indications. Cohen emphasized the urgent need for PBH treatments, which affects approximately 160,000 individuals in the United States. Avexitide is set to enter Phase 3 development in early 2025, with topline data expected in 2026.

Co-CEO Justin Klee also commented on the company's progress, noting the focus on efficient and targeted clinical development following a recent restructuring. Amylyx is advancing programs in neurodegenerative diseases and plans to share updated data from its Wolfram syndrome program soon. The company aims to start a multiple ascending dose clinical trial of AMX0114 in ALS by the end of the year and expects interim data from AMX0035 in progressive supranuclear palsy (PSP) by mid-2025.

Corporate updates for the second quarter include the acquisition of avexitide, which has shown promising results in Phase 2 studies for PBH. Avexitide has been evaluated in five clinical trials for PBH and three for congenital HI, demonstrating significant reductions in hypoglycemic events. The FDA has suggested that a reduction in hypoglycemic events could support approval following a successful Phase 3 trial.

Amylyx also released interim data from the Phase 2 HELIOS trial of AMX0035 for Wolfram syndrome, showing improvements in glycemic control, pancreatic beta cell function, and vision. Wolfram syndrome, a rare and progressive disease, is characterized by childhood-onset diabetes, optic nerve atrophy, and neurodegeneration. The European Commission (EC) granted Orphan Drug Designation to AMX0035 for treating Wolfram syndrome, following a positive opinion from the European Medicines Agency (EMA).

Upcoming milestones for Amylyx include initiating a multiple ascending dose trial of AMX0114 in ALS in the second half of 2024 and presenting updated Phase 2 HELIOS data at the ISPAD Conference in October 2024. The company plans to start a Phase 3 program for avexitide in PBH in Q1 2025, with topline data expected in 2026. An interim analysis of the ORION study of AMX0035 in PSP is anticipated in mid-2025.

Financial results for the second quarter show a net product revenue of $(1.0) million, a significant decrease from $98.2 million in the same period in 2023. This decline is attributed to adjustments in gross-to-net revenue reserve estimates. The company had announced the voluntary discontinuation of marketing authorizations for RELYVRIO® and ALBRIOZA™ following the Phase 3 PHOENIX trial's failure to meet its endpoints.

Cost of sales increased to $7.4 million from $5.6 million in the same period in 2023, primarily due to losses on firm purchase commitments under commercial manufacturing supply agreements for AMX0035. Research and development expenses decreased to $23.3 million from $29.0 million in 2023, reflecting reduced payroll and clinical expenses. Selling, general, and administrative expenses also decreased to $21.6 million from $43.4 million, due to lower payroll and consulting costs following the restructuring plan.

Restructuring expenses for the quarter were $22.9 million, including severance and termination benefits, contract termination costs, and impairment of long-lived assets. The company reported a net loss of $72.7 million for the quarter, compared to net income of $22.1 million in the same period in 2023. Cash, cash equivalents, and short-term investments totaled $309.8 million at the end of June 2024.

Amylyx remains committed to advancing its programs and addressing unmet needs in neurodegenerative, neuroendocrine, and endocrine diseases. The company's management team will host a conference call to discuss these results and provide a business update.