Form 8-K

8-K — Rezolute, Inc.

Accession: 0001104659-26-110412

Filed: 2026-09-24

Period: 2026-09-24

CIK: 0001509261

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — tm2625842d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2625842d1_ex99-1.htm)

GRAPHIC (tm2625842d1_ex99-1img001.jpg)

XML — IDEA: XBRL DOCUMENT (R1.htm)

8-K — FORM 8-K

8-K (Primary)

Filename: tm2625842d1_8k.htm · Sequence: 1

false

0001509261

2026-09-24

iso4217:USD

xbrli:shares

iso4217:USD

xbrli:shares

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 24, 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 2.02

Results of Operations and Financial Condition.

September 24, 2026, Rezolute, Inc. issued a press release announcing its financial results for the fourth quarter and fiscal

year ended June 30, 2026. A copy of this press release is attached hereto as Exhibit 99.1.

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.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.

Description

99.1

Press Release, dated September 24, 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:

September 24, 2026

By:

/s/ Nevan Charles Elam

Nevan Charles Elam

Chief Executive Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2625842d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Rezolute Reports

Fourth Quarter and Full Year Fiscal 2026 Financial Results and Provides Business Update

REDWOOD CITY,

Calif., September 24, 2026 – Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”),

a late-stage ultra-rare rare disease company focused on treating refractory hypoglycemia caused by any form of hyperinsulinism (HI),

today reported financial results and provided a business update for the fourth quarter and full fiscal year ended June 30, 2026.

Tumor HI

· upLIFT,

a Phase 3, single-arm, open label study in up to 16 hospitalized participants for the treatment

of tumor HI, is ongoing.

· Enrollment

is in progress and topline results are expected before the end of 2026.

· In

June 2026, the Company shared positive interim data from the upLIFT study, announcing

that of the 8 participants enrolled, 6 had already met the responder criterion for the study’s

primary endpoint 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. Since the time of this announcement, the seventh participant has also met

the responder criterion for the study’s primary endpoint.

· 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.

· In

June 2026 at the Annual Meeting of the Endocrine Society (ENDO), Rezolute delivered

a poster presentation highlighting favorable outcomes from a case series report of 9 patients

with refractory hypoglycemia due to malignant insulinoma and non-islet cell tumors (tumor

HI), demonstrating that 75% of the patients receiving IV dextrose/total parenteral nutrition

(TPN) in the EAP achieved a complete discontinuation of IV dextrose/TPN.

· The

outcomes of this case series were also recently published in manuscript form in The Journal

of Clinical Endocrinology & Metabolism (JCEM), titled Ersodetug for refractory hypoglycemia

due to malignant insulin-secreting tumors.

Congenital HI

· In

September 2026, the Company provided an update that data from the Phase 3 sunRIZE study

in congenital HI, which did not meet its primary endpoint, remains under review with the U.S. Food and Drug Administration (FDA or

Agency).

· In

June 2026, the Company provided additional study data for the Agency’s independent

review, including source and analysis datasets and summary results from a substantial number

of pre-specified, post-hoc, and sensitivity analyses with a focus on continuous glucose monitoring

(CGM) based glucose outcomes from the pivotal portion of the study.

· The

open-label extension (OLE) phase of the sunRIZE study is ongoing, with a high participation

rate and several indicators of improved glycemic control, including a notable reduction in

the use of background standard of care therapies.

· Rezolute

will continue to await feedback and reserves the ability to request a formal meeting under

a regulatory timeline, as needed.

· In

June 2026 at ENDO, Rezolute delivered three data presentations focused on congenital

HI.

· In

an oral presentation, Huseyin Demirbilek, M.D., Professor, Department of Pediatric Endocrinology,

Hacettepe University Faculty of Medicine, Ankara, Turkey, and Principal Investigator of the

Phase 3 sunRIZE study, reviewed previously reported results from the study.

· Two

poster presentations highlighted results from systematic analyses of natural history and

adverse neurologic and health-economic outcomes resulting from congenital HI, using a meta-analysis

of the literature as well as a claims-based approach to quantifying congenital HI complications,

respectively.

Fourth Quarter

and Full Year Fiscal 2026 Financial Results

Cash, cash equivalents

and investments in marketable securities were $107.8 million as of June 30, 2026, compared with $167.9 million as of June 30,

2025.

Research and development

(R&D) expenses were $14.9 million for the fourth quarter of fiscal 2026, compared with $20.9 million for the same period a year ago.

Full fiscal year 2026 R&D expenses were $53.8 million, compared to $61.5 million in fiscal year 2025. The decrease from fiscal year

2025 to fiscal year 2026 was primarily due to decreased manufacturing costs for ersodetug, partially offset by increased employee-related

stock-based compensation expense. R&D expenses include $6.5 million of share-based compensation expense for the fiscal year 2026,

compared with $3.5 million for fiscal year 2025.

General and administrative

(G&A) expenses were $6.7 million for the fourth quarter of fiscal 2026, compared with $5.0 million for the same period a year ago.

Full fiscal year 2026 G&A expenses were $29.2 million, compared to $18.4 million in fiscal year 2025. The increase was primarily

attributable to increased employee-related stock-based compensation expense, and an increase in professional fees in preparation for

future ersodetug commercial activities. G&A expenses include $8.0 million of share-based compensation expense for fiscal 2026, compared

with $3.6 million for fiscal year 2025.

Net loss was $20.5

million for the fourth quarter of fiscal 2026 compared with a net loss of $24.4 million for the same period a year ago. Full year fiscal

2026 net loss was $77.6 million compared to net loss of $74.4 million for the fiscal year 2025.

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 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, no assurance can be given that FDA will agree with the Company

that there is evidence of clinically meaningful benefit observed in the sunRIZE study and accordingly the Agency could make the determination

that the only path forward for the congenital HI indication is a new randomized control trial similar to sunRIZE. Should the Agency make

such a determination, that would adversely impact the Company’s ability to further pursue that indication as well as 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.

Rezolute Contacts:

Christen Baglaneas

cbaglaneas@rezolutebio.com

508-272-6717

Carrie McKim

cmckim@rezolutebio.com

336-608-9706

Rezolute, Inc.

Condensed Consolidated Financial

Statements Data

(in thousands, except per share data)

Three Months Ended

Year Ended

June 30,

2026

2025

2026

2025

Condensed Consolidated Statements of Operations Data:

Operating expenses:

Research and development

$ 14,889

$ 20,863

$ 53,798

$ 61,527

General and administrative

6,673

4,987

29,168

18,367

Total operating expenses

21,562

25,850

82,966

79,894

Loss from operations

(21,562 )

(25,850 )

(82,966 )

(79,894 )

Non-operating income, net

1,071

1,460

5,380

5,482

Net loss

$ (20,491 )

$ (24,390 )

$ (77,586 )

$ (74,412 )

Basic and diluted net loss per common share

$ (0.20 )

$ (0.26 )

$ (0.75 )

$ (0.98 )

Shares used to compute basic and diluted net loss per common share

104,488

94,340

103,907

75,999

June 30,

2026

2025

Condensed Consolidated Balance Sheets Data:

Cash and cash equivalents

$ 10,615

$ 94,107

Investments in marketable debt securities

97,186

73,751

Working capital

99,093

159,233

Total assets

112,849

175,490

Accumulated deficit

(481,442 )

(403,856 )

Total stockholders’ equity

100,687

162,127

GRAPHIC

Filename: tm2625842d1_ex99-1img001.jpg · Sequence: 6

Binary file (13031 bytes)

Download tm2625842d1_ex99-1img001.jpg

XML — IDEA: XBRL DOCUMENT

XML

Filename: R1.htm · Sequence: 8

v3.26.3

Cover

Sep. 24, 2026

Cover [Abstract]

Document Type

8-K

Amendment Flag

false

Document Period End Date

Sep. 24, 2026

Entity File Number

001-39683

Entity Registrant Name

REZOLUTE, INC.

Entity Central Index Key

0001509261

Entity Tax Identification Number

27-3440894

Entity Incorporation, State or Country Code

Entity Address, Address Line One

275 Shoreline Drive

Entity Address, Address Line Two

Suite 500

Entity Address, City or Town

Redwood

City

Entity Address, State or Province

Entity Address, Postal Zip Code

94065

City Area Code

650

Local Phone Number

206-4507

Written Communications

false

Soliciting Material

false

Pre-commencement Tender Offer

false

Pre-commencement Issuer Tender Offer

false

Title of 12(b) Security

Common Stock, par value $0.001

per share

Trading Symbol

RZLT

Security Exchange Name

NASDAQ

Entity Emerging Growth Company

false

- Definition

Boolean flag that is true when the XBRL content amends previously-filed or accepted submission.

+ References

No definition available.

+ Details

Name:

dei_AmendmentFlag

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Area code of city

+ References

No definition available.

+ Details

Name:

dei_CityAreaCode

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Cover page.

+ References

No definition available.

+ Details

Name:

dei_CoverAbstract

Namespace Prefix:

dei_

Data Type:

xbrli:stringItemType

Balance Type:

Period Type:

duration

- Definition

For the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.

+ References

No definition available.

+ Details

Name:

dei_DocumentPeriodEndDate

Namespace Prefix:

dei_

Data Type:

xbrli:dateItemType

Balance Type:

Period Type:

duration

- Definition

The type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.

+ References

No definition available.

+ Details

Name:

dei_DocumentType

Namespace Prefix:

dei_

Data Type:

dei:submissionTypeItemType

Balance Type:

Period Type:

duration

- Definition

Address Line 1 such as Attn, Building Name, Street Name

+ References

No definition available.

+ Details

Name:

dei_EntityAddressAddressLine1

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Address Line 2 such as Street or Suite number

+ References

No definition available.

+ Details

Name:

dei_EntityAddressAddressLine2

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Name of the City or Town

+ References

No definition available.

+ Details

Name:

dei_EntityAddressCityOrTown

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Code for the postal or zip code

+ References

No definition available.

+ Details

Name:

dei_EntityAddressPostalZipCode

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Name of the state or province.

+ References

No definition available.

+ Details

Name:

dei_EntityAddressStateOrProvince

Namespace Prefix:

dei_

Data Type:

dei:stateOrProvinceItemType

Balance Type:

Period Type:

duration

- Definition

A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityCentralIndexKey

Namespace Prefix:

dei_

Data Type:

dei:centralIndexKeyItemType

Balance Type:

Period Type:

duration

- Definition

Indicate if registrant meets the emerging growth company criteria.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityEmergingGrowthCompany

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.

+ References

No definition available.

+ Details

Name:

dei_EntityFileNumber

Namespace Prefix:

dei_

Data Type:

dei:fileNumberItemType

Balance Type:

Period Type:

duration

- Definition

Two-character EDGAR code representing the state or country of incorporation.

+ References

No definition available.

+ Details

Name:

dei_EntityIncorporationStateCountryCode

Namespace Prefix:

dei_

Data Type:

dei:edgarStateCountryItemType

Balance Type:

Period Type:

duration

- Definition

The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityRegistrantName

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityTaxIdentificationNumber

Namespace Prefix:

dei_

Data Type:

dei:employerIdItemType

Balance Type:

Period Type:

duration

- Definition

Local phone number for entity.

+ References

No definition available.

+ Details

Name:

dei_LocalPhoneNumber

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 13e

-Subsection 4c

+ Details

Name:

dei_PreCommencementIssuerTenderOffer

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14d

-Subsection 2b

+ Details

Name:

dei_PreCommencementTenderOffer

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Title of a 12(b) registered security.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b

+ Details

Name:

dei_Security12bTitle

Namespace Prefix:

dei_

Data Type:

dei:securityTitleItemType

Balance Type:

Period Type:

duration

- Definition

Name of the Exchange on which a security is registered.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

+ Details

Name:

dei_SecurityExchangeName

Namespace Prefix:

dei_

Data Type:

dei:edgarExchangeCodeItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

+ Details

Name:

dei_SolicitingMaterial

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

Name:

dei_TradingSymbol

Namespace Prefix:

dei_

Data Type:

dei:tradingSymbolItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

Name:

dei_WrittenCommunications

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration