secwatch.observer — SEC 8-K summary
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Issuer:     Rezolute, Inc. (RZLT)
CIK:        0001509261
Form:       8-K
Filed at:   2026-02-12T23:59:59+00:00
Accession:  0001104659-26-014287
Event type: earnings
Sentiment:  negative
Materiality: 0.85
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Rezolute Q2 net loss $22.8M; Phase 3 congenital HI study misses primary endpoint
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- Net loss $22.8M vs $15.7M YoY; R&D $14.3M, G&A $9.9M; cash $132.9M down from $167.9M.
- Phase 3 sunRIZE study of ersodetug for congenital HI did not meet primary or key secondary endpoints.
- Reduction in hypoglycemia by CGM was statistically significant at Week 16 but not at Week 24 endpoint.
- FDA meeting planned under Breakthrough Therapy designation before end of Q1 to discuss next steps.
- Enrollment ongoing for tumor HI Phase 3 upLIFT study; topline results expected H2 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1509261/000110465926014287/0001104659-26-014287-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1509261/000110465926014287/tm265567d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-014287

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer