Rezolute (NASDAQ: RZLT) aligns Phase 3 Ersodetug tumor hyperinsulinism trial with FDA

Rhea-AI Filing Summary

Rezolute, Inc. reported that it has reached alignment with the U.S. Food and Drug Administration on the design of its ongoing Phase 3 trial of Ersodetug in tumor hyperinsulinism. This means the company and the regulator are now on the same page about how the late-stage study should be run, which is an important step for advancing the program.

The company also updated its corporate presentation to incorporate new information from the upLIFT study. These materials were shared through a press release and an investor presentation that are attached as exhibits to this current report.

Insights

Biotech clinical development analyst

Rezolute aligns Phase 3 Ersodetug trial design with FDA, clarifying its development path.

Rezolute states it has alignment with the FDA on the design of its ongoing Phase 3 trial of Ersodetug in tumor hyperinsulinism. In drug development, agreement on a Phase 3 protocol is a key procedural milestone because it clarifies how efficacy and safety will be evaluated before any potential approval.

The company also notes it has updated its corporate presentation to reflect changes to the upLIFT study. While no new data or timelines are described in the excerpt, refreshed presentation materials often summarize current trial status and design details for investors and partners.

Overall, the disclosure is focused on process rather than results. It indicates that the Ersodetug program is progressing within a defined regulatory framework, but it does not provide clinical outcomes or regulatory decisions beyond the design alignment.

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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): September 2, 2025

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 7.01 Regulation FD Disclosure.

On September 2, 2025, Rezolute, Inc. (the “Company”) issued a press release to announce alignment with the FDA on design for Ongoing Phase 3 Trial of Ersodetug in Tumor Hyperinsulinism. In addition, the Company updated its corporate presentation to reflect updates to the upLIFT study.

The information in this Current Report on Form 8-K, including Exhibit 99.1 and Exhibit 99.2, 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.

The poster contains forward looking statements. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, and expectations of the Company, are generally identified by use of words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “project,” “prove,” “potential,” “seek,” “strive,” “try,” or future or conditional verbs such as “predict,” “could,” “may,” “likely,” “should,” “will,” “would,” or similar expressions. The Company’s ability to predict results or the actual results of the Company’s plans or strategies is inherently uncertain. Accordingly, actual results may differ materially from anticipated results. Readers of the poster are cautioned not to place undue reliance on these forward-looking statements. Except as required by applicable law or regulation, the Company undertakes no obligation to update these forward-looking statements to reflect events or circumstances that occur after the date on which such statements were made. Important factors that may cause such a difference include any other factors discussed in the Company’s filings with the SEC, including the Risk Factors contained in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which are available at the SEC’s website at www.sec.gov.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.	Description
99.1	Press Release, dated September 2, 2025
99.2	Corporate Presentation
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:  September 2, 2025	By:	/s/ Nevan Charles Elam
		Nevan Charles Elam
		Chief Executive Officer

FAQ

What did Rezolute (RZLT) announce in this Form 8-K?

Rezolute announced that it has aligned with the FDA on the design of its ongoing Phase 3 trial of Ersodetug in tumor hyperinsulinism and that it has updated its corporate presentation to reflect changes to the upLIFT study.

What is the focus of Rezolute's Phase 3 trial mentioned for RZLT?

The Phase 3 trial is evaluating Ersodetug for the treatment of tumor hyperinsulinism, a condition in which tumors cause excessive insulin production.

How did Rezolute describe its interaction with the FDA in this filing?

Rezolute stated that it has alignment with the FDA on the design of its ongoing Phase 3 Ersodetug trial, indicating agreement on how the study will be conducted and assessed.

What additional materials did Rezolute (RZLT) provide with this 8-K?

The company attached a press release dated September 2, 2025 as Exhibit 99.1 and a corporate presentation as Exhibit 99.2, along with an inline XBRL cover page as Exhibit 104.

Does Rezolute's 8-K include forward-looking statements?

Yes. Rezolute notes that the materials contain forward-looking statements about its plans, strategies, and expectations, and cautions that actual results may differ materially due to various risk factors described in its SEC filings.

Are the exhibits in this Rezolute (RZLT) 8-K considered filed or furnished?

The company specifies that the information in this report, including Exhibits 99.1 and 99.2, is not deemed filed for purposes of Section 18 of the Exchange Act and is not automatically incorporated by reference into other filings unless expressly stated.