8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) ofthe

Securities Exchange Act of 1934

Date of report (Date of earliest eventreported): March 29, 2022

REZOLUTE, INC.

(Exact Name of Registrant as Specified in Charter)

201 Redwood Shores Pkwy, Suite 315, RedwoodCity, CA 94065

(Address of Principal Executive Offices,and Zip Code)

650-206-4507

Registrant’s Telephone Number, IncludingArea Code

Not Applicable

(FormerName 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):

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

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. ¨

On March 29, 2022, Rezolute, Inc. issued a press release announcing it joined the Rare Disease Company Coalition. A copy of this press release is attached hereto as Exhibit 99.1.

(d) Exhibits.

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.

EXHIBIT INDEX

Exhibit 99.1

Rezolute Joins the Rare Disease Company Coalition

Rezolutejoins group aimed at helping advance timely access to life-saving therapies for those impacted by rare diseases

REDWOOD CITY, Calif., March 29, 2022 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to disrupt current treatment paradigms for devastating metabolic diseases, today announced that it has joined the Rare Disease Company Coalition. As an alliance of life science companies formed in May of 2021, the Rare Disease Company Coalition is committed to discovering, developing, and delivering rare disease treatments for the patients they collectively serve.

“Rezolute is honored to be a part of the Rare Disease Company Coalition and to join other companies that are mission driven to foster greater understanding of the specific challenges of rare disease drug development,” said Nevan Charles Elam, Chief Executive Officer, and Founder of Rezolute. Mr. Elam continued, “We believe that the coalition is a great forum to advocate for the need to develop therapeutics for patients that suffer from serious diseases that are often overlooked, and the promise of our work.”

About the Rare Disease Company Coalition

The Rare Disease Company Coalition represents life science companies committed to discovering, developing, and delivering rare disease treatments for the patients we serve. As an education and advocacy-focused coalition of companies, our goal is to inform policymakers of the unique challenges and promises of rare disease drug discovery, development, and manufacturing for small population sizes so that critical innovation can continue and positive changes can be enacted for the rare disease community. To achieve this goal, we will use our unified voice to advocate for long-term, consistent, equitable and sustainable government policies that enable life science companies to continue to bring hope and provide access to approved treatments to people living with rare diseases. For more information, please visit www.rarecoalition.com.

About Rezolute, Inc.

Rezolute strives to disrupt current treatment paradigms by developing transformative therapies for devastating rare and chronic metabolic diseases. Its novel therapies hold the potential to both significantly improve outcomes and reduce the treatment burden for patients, the treating physician, and the healthcare system. Patient, clinician, and advocate voices are integrated in the Company’s drug development process, enabling Rezolute to boldly address a range of severe conditions. Rezolute is steadfast in its mission to create profound, positive, and lasting impact on patients’ lives. The Company’s lead clinical asset, RZ358, is in late-stage development for the treatment of congenital hyperinsulinism, a rare pediatric endocrine disorder. Rezolute is also developing RZ402, an orally available plasma kallikrein inhibitor, for the treatment of diabetic macular edema. For more information, visit www.rezolutebio.com or follow us on Twitter.

Investor Contact

Kimberly Minarovich/Carrie McKim

Argot Partners

rezolute@argotpartners.com

212-600-1902

Media Contact

Ingrid Mezo

Canale Communications, Inc.

ingrid.mezo@canalecomm.com

301-473-2881