Positive Phase II Data for Wolfram Syndrome
Reported positive top-line data from the open-label Phase II HELIOS trial of AMX0035 in 12 participants with Wolfram syndrome, showing improvement in pancreatic function and stabilization across all secondary endpoints.
Strong Financial Position
Ended Q3 with $234.4 million in cash and investments, with a cash runway expected to extend into 2026.
Avexitide Phase III Trial Progress
On track to initiate a pivotal Phase III trial for avexitide in post-bariatric hypoglycemia (PBH) in Q1 2025, with primary efficacy outcome agreed upon by FDA.
Reduction in R&D and SG&A Expenses
Research and development expenses decreased from $30 million to $21.2 million, and SG&A expenses decreased from $48.7 million to $17.8 million compared to the same period in 2023.
Regulatory Progress for ALS Program
Received clearance from Health Canada for the clinical trial application for AMX0114 in ALS and initiated the Phase I LUMINA trial in Canada.