CAMBRIDGE, Mass. — Amylyx Pharmaceuticals reported a wider second-quarter loss as the company prepared to release pivotal Phase 3 data for avexitide, its experimental treatment for post-bariatric hypoglycemia.
The company posted a net loss of $43.4 million, or 39 cents per share, for the quarter ended June 30, compared with a loss of $41.4 million, or 46 cents per share, a year earlier.
Research and development expenses declined to $23.8 million from $27.2 million, largely because of lower spending on AMX0035 in progressive supranuclear palsy. The decline was partly offset by increased spending on avexitide.
Selling, general and administrative expenses rose to $21.9 million from $15.6 million, reflecting higher legal costs and greater investment in commercial preparations.
Amylyx ended the quarter with $250.8 million in cash, cash equivalents and short-term investments, down from $279.8 million at the end of March. The company expects its current resources to fund operations into 2028.
The final participant recently completed the last visit in the 16-week double-blind portion of the Phase 3 LUCIDITY trial. Amylyx expects to report topline results in late August or early September.
LUCIDITY enrolled 78 adults with post-bariatric hypoglycemia following Roux-en-Y gastric bypass surgery. The randomized, placebo-controlled study is evaluating whether avexitide reduces moderate and severe hypoglycemic events through 16 weeks.
Avexitide is a GLP-1 receptor antagonist that has received breakthrough therapy designation from the U.S. Food and Drug Administration for post-bariatric hypoglycemia.
Amylyx said it is preparing for a potential new drug application and commercial launch in 2027, subject to favorable trial results and regulatory approval.
“With the last participant’s final study visit recently completed, we are eagerly anticipating the expected topline data readout,” Co-CEOs Joshua Cohen and Justin Klee said.
The company also launched a U.S. expanded-access program in May for certain adults with post-bariatric hypoglycemia who previously participated in avexitide trials.
Amylyx is separately advancing AMX0114, an antisense oligonucleotide targeting calpain-2 for amyotrophic lateral sclerosis. Early Phase 1 data showed no drug-related serious adverse events in the first dosing cohort, and enrollment is continuing at higher dose levels.
The company also reported longer-term findings from the Phase 2 HELIOS study of AMX0035 in Wolfram syndrome. At 96 weeks, measures of pancreatic function and glycemic control were stable or improved in most participants, although interpretation was limited by the small, open-label study.
Amylyx said it continues to work with the FDA on the design of a Phase 3 Wolfram syndrome trial.
The company is also conducting preclinical studies of AMX0318, a longer-acting GLP-1 receptor antagonist being developed for post-bariatric hypoglycemia and other rare diseases. An investigational new drug application is targeted for 2027.
