Every material Form 8-K Rezolute, Inc. has filed with the SEC since October 14, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
Rezolute reported first quarter fiscal 2027 results for the quarter ended September 30, 2026, with a net loss of $18.5 million, compared with $18.2 million a year earlier, and cash and investments of $90.0 million, down from $107.8 million at June 30, 2026. The company expects topline results from its Phase 3 upLIFT tumor HI study by mid-December 2026 and plans to submit a BLA for ersodetug in 2027, but the congenital HI sunRIZE study did not meet its primary endpoint, and FDA's support for a filing does not guarantee approval.
Net loss was $18.5 million, or $0.18 per share, versus $18.2 million, or $0.18 per share, a year earlier.
Cash, cash equivalents and marketable investments were $90.0 million at September 30, 2026, down from $107.8 million at June 30, 2026.
upLIFT tumor HI topline results are expected by mid-December 2026.
FDA recommended a BLA for congenital HI after a pre-BLA meeting, though the sunRIZE primary endpoint was not statistically significant.
Rezolute, Inc. released an investor presentation on its website on October 29, 2026, and furnished it as Exhibit 99.1 to this Form 8-K. The presentation covers its lead candidate ersodetug for congenital and tumor hyperinsulinism, and restates the sunRIZE Phase 3 results, which missed the primary endpoint, alongside an upLIFT tumor HI interim update and an estimated market opportunity above $5 billion.
Company reports $108 million in cash with runway through Q1 2028.
sunRIZE Phase 3 primary endpoint (SMBG weekly hypoglycemia events) was not met; CGM reductions were reported at both doses, with the week 24 result not statistically significant (p=0.30 at 10 mg/kg).
upLIFT interim: 7 of the initial 8 participants met the primary endpoint; topline results are expected mid-December 2026.
Presentation cites about 2,000 addressable congenital HI patients and about 6,000 combined U.S. patients, with a combined opportunity exceeding $5 billion.
Rezolute said the open-label Phase 3 upLIFT study of ersodetug in tumor hyperinsulinism is fully enrolled, with 16 participants, and topline data are expected in mid-December 2026. The filing contains no new efficacy data, and the company said it will continue its expanded access program.
Study is fully enrolled with approximately 16 participants; topline data expected mid-December 2026
Earlier in 2026, 7 of the first 8 participants met the primary endpoint responder criterion
The eighth participant died one week after enrollment from cancer progression and is counted as a non-responder
Statistical significance requires a response rate of at least 56% (95% CI of 30-80%) for 16 participants
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