REZOLUTE, INC.

Red flags

• sunRIZE failed its primary endpoint based on SMBG hypoglycemia events and its key secondary endpoint based on CGM time in hypoglycemia at the Week 24 evaluation window.
• FDA review of the supplemental sunRIZE package is occurring outside the customary formal meeting process, with no specific timeline and no assurance that a new randomized study will not be required.
• The upLIFT interim signal is based on only eight initial participants, seven of whom had met the responder criterion after the update; the modified study may include as few as 16 participants and is single-arm/open-label.
• Rezolute reported a $77.6 million FY2026 net loss and stated that it expects operating losses and additional capital raises for the foreseeable future.
• Weighted-average shares outstanding increased to 103.9 million in FY2026 from 76.0 million in FY2025; an additional 15.5 million options, RSUs and legacy warrants were excluded as antidilutive, and 8.2 million pre-funded warrants remained outstanding at June 30, 2026.
• Change-in-control severance obligations for certain executives totaled approximately $6.7 million as of FY2026, before potential bonus, accelerated vesting and tax gross-up costs.