Key Highlights

  • Third quarter loss per share was USD 0.38, with positive Phase 3 LUCIDITY results for avexitide in PBH reported.
  • The Phase 3 LUCIDITY trial showed a 55% reduction in Level 2 and Level 3 hypoglycemic events versus placebo.
  • Research and development expenses were USD 28.4 million versus USD 19.9 million, and SG&A expenses were USD 21.3 million.
  • An Equity offering of 16,203,500 shares at USD 35.50 per share supports launch readiness for 2027.

Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) reported a third quarter 2026 loss per share of USD 0.38. The company said it continued to make progress against its objectives and now looks ahead to another potential milestone year in 2027.

Co-Chief Executive Officers Justin Klee and Josh Cohen highlighted the LUCIDITY results for avexitide in post-bariatric hypoglycemia (PBH) and said the team is focused on launch preparations to potentially commercialize the first approved therapy for PBH in 2027.

Trial Results and Financing

The pivotal Phase 3 LUCIDITY trial met its prespecified primary endpoint, showing a 55% reduction in the composite rate of Level 2 and Level 3 hypoglycemic events compared with placebo, with a p-value of 0.000003. Following the data, the company completed an equity offering of 16,203,500 shares of common stock at USD 35.50 per share, including the full exercise of the underwriters' option to purchase an additional 2,113,500 shares.

Management said the company believes it is well funded to execute on its goals and to enter potential commercialization from a position of financial strength, with the Capital needed for its launch priorities.

Operating Expenses

Research and development expenses were USD 28.4 million for the quarter versus USD 19.9 million. The increase reflected USD 5.8 million more in expenses for the pivotal LUCIDITY trial and other avexitide costs and USD 3.3 million more for other programs, partly offset by a USD 3.4 million decrease for AMX0035 in progressive supranuclear palsy after its discontinuation.

Selling, general and administrative expenses were USD 21.3 million versus USD 16.2 million, driven by USD 3.2 million in higher Payroll and personnel-related costs, including stock-based compensation, and USD 1.9 million in higher consulting and professional services.

For the nine months, Research and Development expenses were USD 79.7 million versus USD 69.2 million, including a USD 12.6 million increase for LUCIDITY and avexitide, a USD 7.4 million increase for other programs and milestone payments totaling USD 4.0 million to Gubra following the selection and handover of AMX0318.

Launch Readiness and Pipeline Factors

Management said launch preparation centers on three areas and that it anticipates a potential 2027 approval and launch of avexitide. Later-stage programs such as avexitide generally carry higher development costs than earlier-stage programs such as AMX0114 and AMX0318.

IND-enabling studies are underway for one early-stage candidate, and the company is targeting a 2027 IND filing. The disclosed items include the regulatory path for avexitide, launch readiness hiring and the progression of AMX0114 and AMX0318. Reported detail: Research and development expenses were USD 28.4 million versus USD 19.9 million, and SG&A expenses were USD 21.3 million. An equity offering of 16,203,500 shares at USD 35.50 per share supports launch readiness for 2027. The Phase 3 LUCIDITY trial showed a 55% reduction in Level 2 and Level 3 hypoglycemic events versus placebo.