Earnings ·
Rezolute reports $18.5M Q1 loss and cash of $90M; FDA recommends BLA for congenital HI
RZLTRezolute, Inc.
Rezolute reported a net loss of $18.5 million, or $0.18 per share, for the first quarter ended September 30, 2026, compared to a $18.2 million loss in the prior year period. Cash and investments decreased to $90.0 million from $107.8 million as research and development expenses fell slightly to $12.8 million. The company provided key clinical updates for its investigational therapy ersodetug, noting that enrollment is complete for the Phase 3 upLIFT study in tumor HI with topline results expected by mid-December 2026. Additionally, the FDA recommended filing a Biologics License Application (BLA) for congenital hyperinsulinism following a pre-BLA meeting, despite the prior sunRIZE trial missing its primary statistical endpoint. Rezolute plans to submit the BLA in 2027 and highlighted a potential $5 billion combined market opportunity.