Rezolute (NASDAQ: RZLT) details sunRIZE trial, EAP data update

Rhea-AI Filing Summary

Rezolute, Inc. furnished an update focused on its sunRIZE clinical trial and early access program for tumor hyperinsulinism (HI). The company issued a press release providing further insights into the sunRIZE trial, a cumulative table summarizing data from the initial nine tumor HI participants in its expanded access program, and an updated corporate presentation deck.

These materials, furnished as Exhibits 99.1, 99.2 and 99.3, include patient characteristics, ersodetug dosing information and observed outcomes for the early participants, as well as broader corporate information. The company states that this information is being furnished rather than filed under the Exchange Act, which limits how it is treated for certain liability and incorporation-by-reference purposes.

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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): January 7, 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 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.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.	Description
99.1	Press Release, dated January 7, 2026
99.2	EAP Data
99.3	Corporate Deck
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: January 7, 2026	By:	/s/ Nevan Charles Elam
		Nevan Charles Elam
		Chief Executive Officer

FAQ

What did Rezolute (RZLT) disclose in this 8-K filing?

Rezolute furnished a press release with further insights into the sunRIZE trial, a cumulative data table for the first nine tumor HI participants in its expanded access program, and an updated corporate deck.

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

The filing states that Rezolute released a press release with further insights into the sunRIZE trial, indicating that this study is a key part of the company’s clinical development efforts, though detailed results are contained in the exhibits.

What data did Rezolute share on tumor HI participants in the EAP?

Rezolute provided a cumulative table outlining data from the initial nine tumor hyperinsulinism participants in its expanded access program, including patient characteristics, ersodetug dosing and observed outcomes.

How did Rezolute (RZLT) present the information in this report?

The company furnished, rather than filed, Exhibits 99.1, 99.2 and 99.3, meaning they are not deemed filed for purposes of Section 18 of the Exchange Act or automatically incorporated into other securities filings.

What are the exhibits included in Rezolute’s January 7, 2026 8-K?

The exhibits are: 99.1 a press release dated January 7, 2026, 99.2 EAP data for tumor HI participants, 99.3 an updated corporate deck, and 104 the cover page interactive data file in inline XBRL format.

Does this Rezolute 8-K include detailed financial results for RZLT?

No, the filing describes clinical and corporate updates related to the sunRIZE trial, tumor HI expanded access data and a corporate deck; it does not present financial tables or earnings data.