Form 8-K

8-K — Rezolute, Inc.

Accession: 0001104659-26-054943

Filed: 2026-05-04

Period: 2026-05-01

CIK: 0001509261

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

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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):

May 1, 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.

May 1, 2026, Rezolute, Inc. (the “Company”) issued a press release to announce oral presentation results from its Phase 3

sunRIZE 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 May 1, 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: May 4, 2026

By:

/s/ Nevan Charles Elam

Nevan Charles Elam

Chief Executive Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2613408d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Rezolute Announces Oral Presentation of Results

From its Phase 3 sunRIZE Study of Ersodetug in Patients with Congenital Hyperinsulinism at the Pediatric Endocrine Society Annual Meeting

Includes results from additional continuous

glucose monitoring (CGM)-based outcomes which demonstrate significant and consistent improvements in glycemic control in ersodetug treatment

arms compared to placebo, across multiple pre-specified and post-hoc endpoints

Participation, retention, and treatment duration

in the open-label extension (OLE) phase of the study is high and has resulted in continued glycemic benefit, concurrent with the reduction

and/or discontinuation of background standard of care (SOC) therapies

REDWOOD

CITY, Calif., May 1, 2026 – Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a

late-stage rare disease company focused on treating hypoglycemia caused by all forms of hyperinsulinism (HI), today announced that expanded

analyses from the Phase 3 sunRIZE study of ersodetug in patients with congenital HI were presented at the Pediatric Endocrine Society

(PES) 2026 Annual Meeting. The oral presentation was made by Diva D. De León-Crutchlow, M.D., M.S.C.E., Chief of the Division

of Endocrinology and Diabetes, Director of the Congenital Hyperinsulinism Center at Children’s Hospital of Philadelphia, and Principal

Investigator of the sunRIZE study. In addition to the previously reported topline results, the presentation included additional results

from pre-specified and post-hoc sunRIZE analyses, which the Company believes reiterates evidence of target engagement and highlights the

potential therapeutic benefit of ersodetug.

As discussed in today’s presentation, although statistical significance

for the secondary endpoint (% time in hypoglycemia by CGM) was not achieved at the Week 24/End of Treatment evaluation window, larger

and often nominally statistically significant glycemic improvements were consistently observed throughout the maintenance dosing phase

of the study, across time and numerous pre-specified and post-hoc CGM-based endpoints. These outcomes are summarized below and depicted

by the Forest Plot in Figure 1.

Summary of Key Additional Data Presented

· Average daily percent time in hypoglycemia by CGM: clinically relevant and nominally statistically significant reductions of

>50% (Full Analysis Set [FAS]) and ~60-80% (Per Protocol Set [PPS]), compared to placebo across multiple timepoints

· Average weekly hypoglycemia events by CGM: clinically relevant and nominally statistically significant reductions of ~50-65%

(FAS) and ~50-80% (PPS), compared to placebo across multiple timepoints

· Average daily AUC 70 to 180 mg/dL (Exposure to Normoglycemia) by CGM: clinically relevant and nominally statistically significant

increases of ~25-50% (FAS and PPS), compared to placebo across multiple timepoints

· Average blood glucose (mg/dL) by CGM: clinically relevant and nominally statistically significant increases of ~10-15% (~10-15

mg/dL) in both the FAS and PPS, compared to placebo across multiple timepoints

Figure 1: Consistent and Clinically Relevant Glycemic Improvements

in Ersodetug Treatment Groups Compared to Placebo Across Time & Multiple CGM Outcomes (LS-Mean [95% CI] Percent Change from Baseline;

FAS Population)

The Company is also assessing the longer-term efficacy and safety of

ersodetug in a real-world setting in an ongoing OLE phase of the study, including the roll-over of placebo participants. Following the

conclusion of the randomized and placebo-controlled phase of sunRIZE, all 59 study completers elected to enter the OLE, as previously

reported by the Company. Reflecting no change since last reported, 57 participants continue to attend regular study visits at sunRIZE

study centers to receive ersodetug in the OLE, now representing a cumulative ersodetug exposure duration in the study ranging from approximately

6 to 24 months. Preliminary OLE observations demonstrate continued glycemic benefit, including a clinically significant change in glycemic

control in the rolled-over placebo participants compared to the controlled period of the study. These glycemic benefits have enabled a

concurrent significant overall reduction in background SOC therapies (e.g. diazoxide, somatostatin analogs, and/or regular tube feeds),

with a significant number of patients now receiving ersodetug as monotherapy.

Notably, a summary of these same CGM-based study outcomes and preliminary

observations from the OLE phase of the study were recently discussed with the U.S. Food and Drug Administration (FDA) as part of the Company’s

Type B meeting held on March 17, 2026. The meeting resulted in the agency acknowledging challenges associated with the study primary

endpoint (events by finger-stick self-monitored blood glucose [SMBG]), and concluded with the agency requesting that the Company submit

the broader study data for the agency’s comprehensive evaluation to inform next steps for the program.

“We are pleased to highlight that deeper analyses of the sunRIZE

outcomes and ongoing observations from the extension phase of the study consistently indicate evidence of target engagement, drug activity,

and the potential for meaningful therapeutic benefit from ersodetug,” said Brian Roberts, M.D., Chief Medical Officer of Rezolute.

“These results underscore our confidence in the potential of ersodetug to transform the HI treatment landscape and embolden our

mission to achieve alignment with FDA on an acceptable path to approval in this indication, so that we can keep delivering ersodetug to

patients and families living with congenital HI.”

The

Company’s full data presentation from PES can be found on the Publications and Presentations page of the Rezolute website

here.

About sunRIZE

The Phase 3 sunRIZE study (RZ358-301) was a multi-center, randomized,

double-blind, placebo-controlled, parallel arm study designed to evaluate the efficacy and safety of ersodetug in patients with congenital

hyperinsulinism (HI), ages 3 months to 45 years old, who were experiencing continued hypoglycemia on currently available standard of care

(SOC). Eligible participants were randomized to one of three treatment arms to receive either ersodetug (5 or 10 mg/kg) or matched placebo-control

as add on to existing SOC. Study drug was administered every other week during an initial loading phase, and then every 4 weeks during

the 6-month controlled pivotal treatment period. Following the pivotal treatment phase of the study, participants could roll-over into

an optional open-label extension phase to continue to receive ersodetug.

The study enrolled 63 participants in more than a dozen countries around

the world, inclusive of U.S. patients. The primary and key secondary efficacy endpoints in the study were the change from baseline in

the average number of hypoglycemia events per week and the average percent time in hypoglycemia, respectively, over six months of treatment.

Although sunRIZE demonstrated reductions from baseline in hypoglycemia events,

the study did not meet its primary endpoint, which assessed change in average weekly hypoglycemia events by self-monitored blood

glucose (SMBG) compared to placebo. The reductions observed were not statistically significant, which the Company believes was a

result of functional unblinding of the SMBG endpoint, leading to divergent and confounding glucose-modifying behaviors between

treatment groups, and a pronounced study effect in the placebo arm.

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 the pancreas, it has the potential to be universally effective

at treating hypoglycemia due to any congenital or acquired form of HI.

About Rezolute, Inc.

Rezolute

is a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI). The Company’s antibody therapy,

ersodetug, is designed to treat all forms of HI and has been studied in clinical trials and used in real-world cases for the treatment

of both congenital and tumor 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 sufficiency of CGM data to support a potential

path forward in the congenital HI program with FDA, the predictive nature of the CGM data as it relates to the potential efficacy of ersodetug

in treating hypoglycemia, the ability of the Company to provide study reports and analysis datasets for the FDA’s independent evaluation,

the persuasiveness of the study reports and analysis datasets and the possibility of FDA agreeing to advance the congenital HI program

based on those study reports and analysis datasets notwithstanding the lack of statistical significance in the sunRIZE study. 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.

Diva D. De León-Crutchlow, M.D., M.S.C.E., is a paid consultant

to Rezolute Inc., and served as the site Principal Investigator for the Phase 3 sunRIZE study at Children’s Hospital of Philadelphia.

Rezolute Contacts:

Christen Baglaneas

cbaglaneas@rezolutebio.com

508-272-6717

Carrie McKim

cmckim@rezolutebio.com

336-608-9706

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