Rezolute, Inc.

Current report

Although the FDA has recommended a pre-Biologics License Application meeting as a precursor to a Biologics License Application (“BLA”) submission there can be no guarantee that the FDA will agree with the Company that the totality of evidence from the sunRIZE program demonstrates a clinically meaningful benefit or is sufficient to support the approval for ersodetug in congenital HI.

Current report

On October 5, 2026, we announced that the FDA recommended a pre-BLA meeting as a precursor to a BLA submission as it relates to ersodetug for congenital HI. Although we believe this is a positive development, the FDA has not opined on the approvability of ersodetug for congenital HI, and its recommendation that we proceed to a pre-BLA meeting does not mean that the FDA has determined that the existing data is sufficient to support the submission or approval of a BLA. Accordingly, there can be no guarantee that the FDA will agree with us that the totality of evidence from the sunRIZE program and the supplemental information that we have provided to the FDA or that we will provide as part of the pre-BLA meeting will be sufficient to support the approval of ersodetug for congenital HI. The FDA may require us to provide additional information or conduct additional clinical studies, including another study similar to sunRIZE, which could delay the submission or approval of a BLA, increase our costs and require changes to our operating plans.

Current report

We have completed enrollment in the Phase 3 upLIFT study and expect to report topline results in December 2026. Although interim results from the initial participants enrolled in the study were encouraging, such results may not be predictive of final results, and there can be no guarantee that the final results will be consistent with the interim results or that the study will meet its primary or secondary endpoints. Even if the study meets its endpoints, there can be no guarantee that the FDA will determine that the results are sufficient to support regulatory approval of ersodetug for tumor HI.

Previous report

In an effort to align with FDA guidance and improve the likelihood of demonstrating efficacy, the FDA allowed us to modify the upLIFT trial design. Such modifications include, without limitation to, removing the need to conduct a randomized, double-blind, placebo-controlled trial with hypoglycemia events as the endpoint. However, there can be no guarantees that these modifications are better able to demonstrate drug efficacy or that the upLIFT trial will meet its primary or secondary endpoints.

Previous report

The FDA may reject the additional datasets we are preparing in support of the sunRIZE trial.

Previous report

The FDA has expressed a willingness to accept additional datasets as it assesses the results of the sunRIZE trial to chart a path forward. The FDA encouraged us to submit study reports and analysis datasets from sunRIZE for the agency’s independent evaluation. However, there can be no guarantees that the datasets that we submit to the FDA will be acceptable to the FDA as adequate to support a finding of regulatory approval, efficacy or commercialization.