Current Report · Items 7.01, 9.01 · 8-K

Rezolute, Inc.

RZLTNASDAQEQUITYCurrent

Regulation FD Disclosure

Filed Jan 7, 2026Accepted Jan 7, 2026, 1:10 AM ESTCIK 1509261Accession 0001104659-26-001556

Press release in this filing

Rezolute Provides Insights from its Phase 3 sunRIZE Study in Congenital Hyperinsulinism and Shares Findings from its Expanded Access Program in Tumor Hyperinsulinism →

Company context

Rezolute is a late-stage ultra-rare disease company focused on treating refractory hypoglycemia caused by any form of hyperinsulinism (HI). The Company’s antibody therapy, ersodetug, has been studied in clinical trials and used in real-world cases for the treatment of refractory hypoglycemia due to a variety of causes of HI. For more information, visit www.rezolutebio.com.

Current securities

RZLTNASDAQ · EQUITY · Current

Recent company filings

Disclosure sections

Items 7.01, 9.01

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Item 7.01Item 7.01 - Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure On January 7, 2026, Rezolute, Inc. issued, (i) a press release announcing further insights into the sunRIZE trial, (ii) a cumulative table outlining data from the initial 9 tumor HI participants in the EAP, including patient characteristics, ersodetug dosing, and observed outcomes and (iii) an updated corporate deck. The information in this Current Report on Form 8-K, including Exhibits 99.1, 99.2 and 99.3 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this Current Report on Form 8-K.

Filed exhibits (2)

EX-99.1 (by filename) tm262357d1_ex99-1.htm

Exhibit 99.1 Rezolute Provides Insights from its Phase 3 sunRIZE Study in Congenital Hyperinsulinism and Shares Findings from its Expanded Access Program in Tumor Hyperinsulinism Company believes that data from sunRIZE and the Expanded Access Program (EAP) provide evidence of activity of ersodetug in both indications Company plans to meet with FDA to align on path forward for congenital HI REDWOOD CITY, Calif., January 7, 2025 - Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by all forms of hyperinsulinism (HI), today shared observations from the Phase 3 sunRIZE study in patients with congenital HI and provided details on the treatment of tumor HI patients with ersodetug under the Company’s EAP. Congenital HI While sunRIZE did not meet its primary (hypoglycemia events) or key secondary (time in hypoglycemia) endpoints, the Company believes that the totality of the data further supports previous clinical evidence that ersodetug is active against hypoglycemia in patients. Specifically, there was evidence of pharmacologic activity as target therapeutic drug concentrations were achieved in bot…

Open exhibit ↗

EX-99.2 (by filename) tm262357d1_ex99-2.htm

Exhibit 99.2 Tumor HI EAP Patient Profiles Patient 1 Patient 2 Patient 3 Patient 4 Patient 5 Patient 6 Patient 7 Patient 8# Patient 9 Gender (M/F) / Age (Years) M / 55 F / 50 F / 50 F / 43 M / 74 M / 62 M / 74 M / 53 M / 24 Diagnosis Metastatic Insulinoma Metastatic Insulinoma Neuroendocrine Carcinoma of the Cervix Metastatic Insulinoma Metastatic Insulinoma Metastatic Insulinoma Metastatic Metastatic Proinsulinoma Metastatic Insulinoma …