{"url_path":"/sec/rzlt/10-q/2026/item-1a","section_key":"item-1a","section_title":"Item 1A Risk Factors.","topic":"sec","document":{"doc_type":"10-Q","doc_date":"2026-05-12","source_url":"https://www.sec.gov/Archives/edgar/data/1509261/0001104659-26-059422-index.html","accession_number":"0001104659-26-059422","cik":"0001509261","ticker":"RZLT","issuer_name":"Rezolute, Inc.","edgar_url":"https://www.sec.gov/Archives/edgar/data/1509261/0001104659-26-059422-index.html","primary_entity_key":"0001509261","primary_entity_name":"Rezolute, Inc."},"word_count":279,"has_tables":true,"body_markdown":"Item 1A. Risk Factors.\n\nOur Risk Factor disclosures are set forth in (i) Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended June 30, 2025 filed with the Securities and Exchange Commission (“SEC”) on September 17, 2025, and (ii) in Part II, Item 1A of our Quarterly Report on Form 10-Q for the fiscal quarter ended December 31, 2025 filed with the SEC on February 12, 2026. The risk factors included in the 2025 Form 10-K have not materially changed, except as reflected in the following new risk factors:\n\n**Risks Related to our Clinical Trials**\n\nModifications to the upLIFT trial may fail to produce effective results.\n\nIn 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.\n\nThe FDA may reject the additional datasets we are preparing in support of the sunRIZE trial.\n\nThe 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."}