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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 |
