Form 8-K

8-K — Rezolute, Inc.

Accession: 0001104659-26-113503

Filed: 2026-10-05

Period: 2026-10-05

CIK: 0001509261

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — tm2626976d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2626976d1_ex99-1.htm)

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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):

October 5, 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.

October 5, 2026, Rezolute, Inc. (the “Company”) issued a press release to announce an update on the Company’s ongoing

discussions with the FDA regarding the Company’s sunRIZE trial and potential next steps .

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

release 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 October 5, 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: October 5, 2026

By:

/s/ Nevan Charles Elam

Nevan Charles Elam

Chief Executive Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2626976d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Rezolute

Announces FDA Recommendation to Hold a Pre-BLA

Meeting as a Precursor to Submitting a Biologics License

Application (BLA) for Congenital

Hyperinsulinism

The

Agency reiterated its commitment to addressing the unmet need for treatment

of congenital and tumor-related hyperinsulinism and to serving

these patient communities

track to report topline results for the Phase 3 upLIFT study in tumor HI this quarter

REDWOOD CITY, Calif., October 5,

2026 – Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage ultra-rare disease

company focused on treating refractory hypoglycemia caused by any form of hyperinsulinism (“HI”), today announced that following

a preliminary review of detailed data from the Phase 3 sunRIZE study of ersodetug for the treatment of hypoglycemia due to congenital

HI, the U.S. Food and Drug Administration (“FDA” or “Agency”) recommended a pre-BLA meeting with the Company

as a precursor to submitting a biologics license application (BLA).

As previously reported, sunRIZE,

a Phase 3, multicenter, double-blind, randomized, placebo-controlled safety and efficacy study of ersodetug for the treatment of congenital

HI, demonstrated glycemic improvements, but did not meet the primary endpoint because the reductions in hypoglycemia events by finger-stick

self-monitored blood glucose were not statistically significant compared to placebo. Although the key secondary endpoint of time in hypoglycemia

by continuous glucose monitoring (CGM) was not met in the Week 24 End-of-Treatment evaluable window, consistent and clinically relevant

improvements in hypoglycemia were observed for this and multiple other CGM-based hypoglycemia endpoints in both treatment arms.

At a March 2026 Type B meeting

with FDA, the Agency acknowledged the challenges posed by behavioral factors in clinical trials in this patient population, including

limitations associated with SMBG based measures of hypoglycemia. At the meeting, the Agency requested that the Company provide the continuous

CGM data for its independent review. In June 2026, the Company submitted source and analysis datasets, and summary results from a substantial

number of pre-specified, post-hoc, and sensitivity analyses.

The Agency has reviewed the

data and, despite the trial’s failure to meet the prespecified primary and key secondary endpoints, as a next step, encouraged

the Company to request a Type B pre-BLA meeting as a precursor to submitting a BLA for congenital HI. The Agency explicitly did not

opine on the approvability of ersodetug for congenital HI and noted that any such determination would only be made as a part of an

in-depth evaluation of the supporting data during a formal BLA review, as is customary during the BLA process.

In light of expected topline

results this quarter from the Company’s upLIFT study in tumor HI and the potential for an additional pre-BLA meeting for that indication

should the study results support a submission, the Company will evaluate its overall BLA submission strategy for potentially both programs

following the announcement of upLIFT study results.

“We appreciate FDA’s

thorough review of the extensive body of data generated in sunRIZE and are encouraged by the Agency’s recognition that this data

will require in-depth evaluation during a formal BLA review,” said Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute.

“We share FDA’s commitment to addressing the significant unmet needs of individuals living with rare diseases like congenital

HI, where traditional drug development can present unique challenges. We believe this unusual process of preliminary review of detailed

data demonstrates what can be achieved when regulators, companies, clinicians, and advocacy organizations work collaboratively to evaluate

the totality of evidence for promising rare disease therapies.”

“For many people living with congenital

hyperinsulinism, the threat of severe and unpredictable hypoglycemia remains a daily reality, and existing treatments are not enough,”

said Julie Raskin, Chief Executive Officer of Congenital Hyperinsulinism International (CHI). “We are encouraged by the progress

toward potential new therapies and grateful to the patients, families, researchers, clinicians, regulators, and biotechnology companies

working together to bring better options to our community.”

The open-label extension (OLE)

phase of the study is ongoing, with a continued high retention rate, equating to an ersodetug treatment duration in sunRIZE ranging from

approximately nine months to well over two years. This, along with continued glycemic control and a notable reduction in the use of background

standard of care therapies, potentially indicate continued glycemic and clinical benefit with ersodetug in longer-term use.

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 pancreatic insulin or paraneoplastic IGF-2 secretion and from entero-incretin pathways, it has the potential to be universally

effective at treating refractory hypoglycemia due to any form of hyperinsulinism (HI), including congenital HI, tumor HI

(insulinoma, non-islet cell tumors) or bariatric/non-bariatric gastrointestinal surgery hypoglycemia. Ersodetug for the treatment of

HI is investigational. Statements about safety and efficacy have not been approved by any health authority.

About Rezolute, Inc.

Rezolute is a late-stage ultra-rare

disease company focused on treating refractory hypoglycemia caused by any 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 overall BLA process, the potential efficacy of ersodetug in treating hypoglycemia as well as our ability to

complete enrollment of the upLIFT study this year and announce topline results. Our ability to predict results or our plans or

strategies is inherently uncertain. Notably, despite the FDA encouraging us to request a pre-BLA meeting for congenital HI, there

can be no assurance that FDA will agree with the Company that the totality of evidence from the sunRIZE program demonstrates a

clinically meaningful benefit or is sufficient to support the approval for ersodetug in congenital HI. Accordingly, FDA may

determine that additional clinical data, including data from a new randomized controlled trial similar to sunRIZE, are required to

support approval. Should the Agency make such a determination, it would adversely impact the timing and feasibility of approval for

the congenital HI indication as well as the the commercial potential for ersodetug. 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.

Contacts:

Christen Baglaneas

Rezolute,

Inc.

1411 Broadway, 16th Floor

New York, NY 10018

cbaglaneas@rezolutebio.com

508-272-6717

Carrie McKim

Rezolute, Inc.

1411 Broadway, 16th Floor

New York, NY 10018

cmkim@rezolutebio.com

336-608-9706

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