Form 8-K

8-K — Rezolute, Inc.

Accession: 0001104659-26-069206

Filed: 2026-06-02

Period: 2026-06-02

CIK: 0001509261

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

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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):

June 2, 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.

June 2, 2026, Rezolute, Inc. (the “Company”) issued a press release to announce an interim update on its upLIFT study.

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.

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 June 2, 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:

June 2, 2026

By:

/s/ Nevan Charles Elam

Nevan Charles Elam

Chief Executive Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2616579d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Rezolute Announces

Positive Interim Data for its Phase 3 upLIFT Study of Ersodetug in Tumor Hyperinsulinism

Study now 50%

enrolled

6 of 8 participants

have already met the responder criterion for the study’s primary endpoint

Topline results

for the fully enrolled open-label study are expected in the second half of 2026

REDWOOD CITY, Calif., June 2, 2026 –

Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage ultra-rare disease company focused

on treating refractory hypoglycemia caused by a congenital or any acquired form of hyperinsulinism (HI), today provided an interim update

on its ongoing open-label Phase 3 study (upLIFT) of ersodetug in tumor HI.

With 8 participants

enrolled in upLIFT to date, comprising both insulinoma and non-islet cell tumor hypoglycemia, the Company is midway through enrollment

of the planned study sample size of 16 participants.

Of the 8 participants

enrolled, 6 have already met the responder criterion for the study’s primary endpoint, which is the number of participants achieving

at least a 50 percent reduction from baseline in intravenous glucose requirements (glucose infusion rate; GIR) 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.

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.

The 8th participant

was recently enrolled and is still dosing in the pivotal phase of the study. All participants that have completed the 8-week pivotal

treatment period have elected to continue into the open-label extension, with a cumulative treatment duration of up to 6 months. Ersodetug

has been well-tolerated in the pivotal and extension phases of the study, with no drug-related adverse events or other safety findings

reported to date.

“We are very

excited by the interim observations from the upLIFT study as they largely mirror what we previously observed and reported from an initial

case series of patients from our expanded access program for compassionate use,” said Dr. Brian Roberts, Chief Medical Officer of

Rezolute. “These results reveal the clinically impactful hypoglycemia-correcting activity of ersodetug in an unbiased GIR assessment

in patients with HI caused by varying tumor types. This further highlights the aberrant outcome from the recently completed randomized,

placebo-controlled, Phase 3 sunRIZE study in pediatric congenital HI, where we believe that self-monitored glycemic measures were confounded

by divergent caretaker behaviors stemming from functional unblinding to treatment status by real-time glucose monitoring. Importantly,

these findings continue to support the potential for ersodetug to be a universal treatment option for patients with serious and refractory

hypoglycemia caused by congenital and a variety of acquired forms of hyperinsulinism, including tumor HI and following bariatric and

non-bariatric gastrointestinal surgeries. We look forward to announcing topline results of the fully enrolled upLIFT study in tumor HI

in the second half of 2026, as well as continuing our engagement with FDA to determine the path forward for the congenital HI indication.”

About

upLIFT

The

Phase 3 registrational study is a single-arm, open-label, pivotal trial in approximately 16 participants with insulinoma or non-islet

cell tumors who have uncontrolled hypoglycemia caused by tumor hyperinsulinism (HI). Eligible participants requiring continuous intravenous

(IV) glucose will receive ersodetug 9 mg/kg per week for 8 weeks, as an add-on to standard of care. Following this 8-week pivotal treatment

period, all participants may receive ersodetug in long-term extension. The primary endpoint is the proportion of participants achieving

at least a 50 percent reduction from baseline in IV glucose requirements (glucose infusion rate; GIR). Additional endpoints include the

number of participants and time to discontinuation of GIR, time to discharge from the hospital, extent of hypoglycemia events and hypoglycemia

time in the outpatient setting by self-monitored blood glucose and continuous glucose monitor, respectively, and patient reported quality

of life.

About

Tumor Hyperinsulinism

Tumor

hyperinsulinism (HI) is a rare disease that may be caused by two distinct types of tumors: islet cell tumors (ICTs) and non-islet cell

tumors (NICTs), both of which lead to hypoglycemia as a result of over-activation of the insulin receptor. Insulinomas are the most common

type of ICT and cause hypoglycemia by stimulating the over production of insulin. A variety of different NICTs, particularly hepatocellular

carcinoma, can cause hypoglycemia by producing and secreting insulin-like paraneoplastic substances such as variants of IGF-2 that bind

to and activate the insulin receptor. With high morbidity and mortality rates within tumor HI, there remains a significant unmet need

for new therapies directed at hypoglycemia treatment. Ersodetug has shown real-world benefit in patients with insulinoma and NICTs.

About Ersodetug

Ersodetug is a

fully human monoclonal antibody that binds allosterically to the insulin receptor to decrease receptor over-activation by insulin

and related substances (such as IGF-2) in the setting of hyperinsulinism (HI), thereby improving hypoglycemia. Because ersodetug

acts downstream from glucose absorption, gastrointestinal incretin hormones, and pancreatic insulin secretion, it has the potential

to be universally effective at treating refractory hypoglycemia due to a congenital or any acquired form of HI, including tumor HI

(insulinoma, NICTH) or hypoglycemia as a complication of a variety of bariatric or non-bariatric gastrointestinal

surgeries.

About Rezolute,

Inc.

Rezolute is a late-stage ultra-rare disease company

focused on treating refractory hypoglycemia caused by a congenital or any acquired form of hyperinsulinism (HI). The Company’s

antibody therapy, ersodetug, has been studied in clinical trials and used in real-world cases for the treatment of refractory hypoglycemia

due to a variety of causes of HI. For more information, visit www.rezolutebio.com.

Forward-Looking

Statements

This release,

like many written and oral communications presented by Rezolute and our authorized officers, may contain certain forward-looking

statements regarding our prospective performance and strategies within the meaning of Section 27A of the Securities Act and Section

21E of the Securities Exchange Act of 1934, as amended. We intend such forward-looking statements to be covered by the safe harbor

provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and are including this

statement for purposes of said safe harbor provisions. Forward-looking statements, which are based on certain assumptions and

describe future plans, strategies, and expectations of Rezolute, are generally identified by use of words such as

“anticipate,” “believe,” “estimate,” “expect,” “intend,”

“plan,” “project,” “seek,” “strive,” “try,” or future or conditional

verbs such as “could,” “may,” “should,” “will,” “would,” or similar

expressions. These forward-looking statements include, but are not limited to, the potential efficacy of ersodetug in treating

hypoglycemia associated with either a congenital or any acquired form of HI or the timing of the release of topline results for

upLIFT. Our ability to predict results or the actual effects of our plans or strategies is inherently uncertain. Accordingly, actual

results may differ materially from anticipated results. Readers are cautioned not to place undue reliance on these forward-looking

statements, which speak only as of the date of this release. Except as required by applicable law or regulation, Rezolute 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 our filings with the

SEC, including the Risk Factors contained in Rezolute’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which

are available at the U.S. Securities and Exchange Commission’s website at www.sec.gov. You are urged to consider these factors

carefully in evaluating the forward-looking statements in this release and are cautioned not to place undue reliance on such

forward-looking statements, which are qualified in their entirety by this cautionary statement.

Rezolute Contacts:

Christen Baglaneas

cbaglaneas@rezolutebio.com

508-272-6717

Carrie McKim

cmckim@rezolutebio.com

336-608-9706

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