RZLT

EX-99.1

2 tm2625842d1_ex99-1.htm

EXHIBIT 99.1

Exhibit 99.1

Rezolute Reports Fourth Quarter and Full Year Fiscal 2026 Financial Results and Provides Business Update

REDWOOD CITY,

Calif., September 24, 2026 – Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage ultra-rare rare disease company focused on treating refractory hypoglycemia caused by any form of hyperinsulinism (HI), today reported financial results and provided a business update for the fourth quarter and full fiscal year ended June 30, 2026.

Tumor HI

·upLIFT, a Phase 3, single-arm, open label study in up to 16 hospitalized participants for the treatment of tumor HI, is ongoing.

·Enrollment is in progress and topline results are expected before the end of 2026.

·In June 2026, the Company shared positive interim data from the upLIFT study, announcing that of the 8 participants enrolled, 6 had already met the responder criterion for the study’s primary endpoint within the 8-week pivotal treatment phase. Each of these 6 participants also achieved a complete discontinuation of intravenous glucose requirements with the administration of ersodetug. Since the time of this announcement, the seventh participant has also met the responder criterion for the study’s primary endpoint.

·One of the 8 enrolled participants withdrew study consent and discontinued ersodetug and all other non-palliative therapies prior to completion of the pivotal treatment phase. This patient had Stage 4 metastatic colon cancer and a poor Eastern Cooperative Oncology Group performance status (ECOG 4). The participant elected to be discharged from the hospital to receive hospice care at home, where they died one week later due to cancer progression. The reduction and eventual discontinuation of intravenous glucose were undertaken in the setting of hospice transition, so the participant is being counted as a non-responder for purposes of assessing the primary endpoint.

·In June 2026 at the Annual Meeting of the Endocrine Society (ENDO), Rezolute delivered a poster presentation highlighting favorable outcomes from a case series report of 9 patients with refractory hypoglycemia due to malignant insulinoma and non-islet cell tumors (tumor HI), demonstrating that 75% of the patients receiving IV dextrose/total parenteral nutrition (TPN) in the EAP achieved a complete discontinuation of IV dextrose/TPN.

·The outcomes of this case series were also recently published in manuscript form in The Journal of Clinical Endocrinology & Metabolism (JCEM), titled Ersodetug for refractory hypoglycemia due to malignant insulin-secreting tumors.

Congenital HI

·In September 2026, the Company provided an update that data from the Phase 3 sunRIZE study in congenital HI, which did not meet its primary endpoint, remains under review with the U.S. Food and Drug Administration (FDA or Agency).

·In June 2026, the Company provided additional study data for the Agency’s independent review, including source and analysis datasets and summary results from a substantial number of pre-specified, post-hoc, and sensitivity analyses with a focus on continuous glucose monitoring (CGM) based glucose outcomes from the pivotal portion of the study.

·The open-label extension (OLE) phase of the sunRIZE study is ongoing, with a high participation rate and several indicators of improved glycemic control, including a notable reduction in the use of background standard of care therapies.

·Rezolute will continue to await feedback and reserves the ability to request a formal meeting under a regulatory timeline, as needed.

·In June 2026 at ENDO, Rezolute delivered three data presentations focused on congenital HI.

·In an oral presentation, Huseyin Demirbilek, M.D., Professor, Department of Pediatric Endocrinology, Hacettepe University Faculty of Medicine, Ankara, Turkey, and Principal Investigator of the Phase 3 sunRIZE study, reviewed previously reported results from the study.

·Two poster presentations highlighted results from systematic analyses of natural history and adverse neurologic and health-economic outcomes resulting from congenital HI, using a meta-analysis of the literature as well as a claims-based approach to quantifying congenital HI complications, respectively.

Fourth Quarter and Full Year Fiscal 2026 Financial Results

Cash, cash equivalents and investments in marketable securities were $107.8 million as of June 30, 2026, compared with $167.9 million as of June 30, 2025.

Research and development (R&D) expenses were $14.9 million for the fourth quarter of fiscal 2026, compared with $20.9 million for the same period a year ago. Full fiscal year 2026 R&D expenses were $53.8 million, compared to $61.5 million in fiscal year 2025. The decrease from fiscal year 2025 to fiscal year 2026 was primarily due to decreased manufacturing costs for ersodetug, partially offset by increased employee-related stock-based compensation expense. R&D expenses include $6.5 million of share-based co

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of report (Date of earliest event reported): February 12, 2026

REZOLUTE, INC.

(Exact Name of Registrant as Specified in Charter)

Nevada

001-39683

27-3440894

(State or Other Jurisdiction

of Incorporation)

(Commission

File Number)

(I.R.S. Employer

Identification No.)

275 Shoreline Drive, Suite 500, Redwood City, CA 94065

(Address of Principal Executive Offices, and Zip Code)

650-206-4507

Registrant’s Telephone Number, Including Area Code

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

¨ Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class Trading Symbol(s) Name of each exchange on which registered

Common Stock, par value $0.001 per share

RZLT

Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter).

Emerging growth company ¨

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 2.02 Results of Operations and Financial Condition.

On February 12, 2026, Rezolute, Inc. issued a press release announcing its financial results for the second quarter ended December 31, 2025. A copy of this press release is attached hereto as Exhibit 99.1.

The information in this Current Report on Form 8-K, including Exhibit 99.1, 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.

Item 9.01Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.

Description

99.1

Press Release, dated February 12, 2026

104

Cover Page Interactive Data File (formatted as inline XBRL)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

REZOLUTE, INC.

DATE:  February 12, 2026 By: /s/ Nevan Charles Elam

Nevan Charles Elam

Chief Executive Officer