Form 8-K

8-K — Rezolute, Inc.

Accession: 0001104659-26-059392

Filed: 2026-05-12

Period: 2026-05-12

CIK: 0001509261

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

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 12, 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.

May 12, 2026, Rezolute, Inc. issued a press release announcing its financial results for the third quarter ended March 31,

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 May 12, 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 12, 2026

By:

/s/ Nevan Charles Elam

Nevan Charles Elam

Chief Executive Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2614169d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Rezolute

Reports Third Quarter Fiscal 2026 Financial Results and Provides Business Update

REDWOOD CITY, Calif., May 12,

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 reported financial results and provided a business

update for the three months ended March 31, 2026.

Congenital Hyperinsulinism (HI)

● In May 2026, expanded analyses from the Phase 3 sunRIZE study of ersodetug in patients with congenital HI were presented via

oral presentation at the Pediatric Endocrine Society (PES) 2026 Annual Meeting 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 results from additional continuous glucose monitoring

(CGM)-based outcomes, which demonstrated significant and consistent improvements in glycemic control in ersodetug treatment arms compared

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

● 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

● Participation, retention, and treatment duration in the open-label extension (OLE) following the completions of the study is high

and has resulted in continued glycemic benefit, concurrent with the reduction and/or discontinuation of background standard of care therapies.

● In March 2026, Rezolute announced outcomes from an in-person Type B meeting with the U.S. Food and Drug Administration (FDA) held on March 17,

2026, related to the sunRIZE study.

● FDA acknowledged the challenges posed by the potential impact of varied behavioral factors on clinical trials in this heterogeneous

patient population, including the associated limitations of self-monitored blood glucose (SMBG) based metrics in measuring hypoglycemia

in congenital HI.

● FDA encouraged Rezolute to submit comprehensive analysis datasets and summary outcomes for the agency’s independent evaluation.

Tumor HI

● The Company expects to have an update on the program in the second half of 2026.

● 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 in the second half of 2026.

● In January 2026, the Company shared aggregate

data from the initial 9 tumor HI patients treated under the historical Expanded Access Program

(EAP). The full EAP data table, filed on Form 8-K with the U.S. Securities and Exchange

Commission, can be found here.

Third Quarter Fiscal 2026 Financial Results

Cash, cash equivalents and investments

in marketable securities were $120.3 million as of March 31, 2026, compared with $167.9 million as of June 30, 2025.

Research and development (R&D)

expenses were $11.4 million for the third quarter of fiscal 2026, compared with $15.3 million for the same period a year ago. The decrease

from fiscal year 2025 to fiscal year 2026 was primarily due to (i) decreased manufacturing costs for ersodetug and (ii) decreased

clinical trial activities. R&D expenses include $1.9 million of share-based compensation expense for the third quarter of fiscal 2026,

compared with $0.9 million for the same period a year ago.

General and administrative (G&A)

expenses were $6.0 million for the third quarter of fiscal 2026, compared with $4.7 million for the same period a year ago. The increase

was primarily attributable to increased employee-related stock-based compensation expense, partially offset by a decrease in professional

fees. G&A expenses include $2.5 million of share-based compensation expense for the third quarter of fiscal 2026, compared with $1.0

million for the same period a year ago.

Net loss was $16.2 million for the

third quarter of fiscal 2026 compared with a net loss of $18.9 million for the same period a year ago.

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 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.

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

Nine Months Ended

March 31,

2026

2025

2026

2025

Condensed Consolidated Statements of Operations Data:

Operating expenses:

Research and development

$ 11,412

$ 15,283

$ 38,909

$ 40,664

General and administrative

5,954

4,740

22,495

13,380

Total operating expenses

17,366

20,023

61,404

54,044

Loss from operations

(17,366 )

(20,023 )

(61,404 )

(54,044 )

Non-operating income, net

1,195

1,109

4,309

4,022

Net loss

$ (16,171 )

$ (18,914 )

$ (57,095 )

$ (50,022 )

Basic and diluted net loss per common share

$ (0.16 )

$ (0.27 )

$ (0.55 )

$ (0.72 )

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

104,040

70,031

103,714

69,902

March 31,

June 30,

2026

2025

Condensed Consolidated Balance Sheets Data:

Cash and cash equivalents

$ 11,236

$ 94,107

Investments in marketable debt securities

109,032

73,751

Working capital

114,345

159,233

Total assets

125,459

175,490

Accumulated deficit

(460,951 )

(403,856 )

Total stockholders’ equity

116,834

162,127

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