Rezolute Reports Third Quarter Fiscal 2025 Financial Results and Provides Business Update sunRIZE enrollment on track including U.S. sites and expected to be completed in May 2025; topline data anticipated in December 20

Rezolute Reports Third Quarter Fiscal 2025 Financial

Results and Provides Business Update

sunRIZE enrollment on track including U.S. sites

and expected to be completed in May 2025; topline data anticipated in December 2025

U.S. Food and Drug Administration (FDA) grants

Breakthrough Therapy Designation to ersodetug for hypoglycemia due to tumor hyperinsulinism

REDWOOD CITY, Calif., May 13, 2025 -- Rezolute, Inc.

(Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company focused on treating hypoglycemia

caused by hyperinsulinism (HI), today reported financial results and provided a business update for the three months ended March 31,

"The Phase 3 sunRIZE study in congenital HI is on track to complete

enrollment this month and we are poised to start our registrational upLIFT study for tumor HI mid-year," said Nevan Charles Elam,

Chief Executive Officer and Founder of Rezolute. "Each of our programs received Breakthrough Therapy Designation from FDA this year.

We look forward to continued discussions with the agency with a focus on treating hypoglycemia caused by all forms of hyperinsulinism

with the goal of advancing our novel therapy towards approval and commercialization."

Recent Pipeline Progress and Anticipated Milestones

Fiscal Third Quarter Financial Results

Cash, cash equivalents and investments in marketable securities were

$88.4 million as of March 31, 2025, compared to $127.1 million as of June 30, 2024.

Research and development expenses were $15.3 million for the third

quarter of fiscal 2025, compared with $12.4 million for the same period a year ago, with the increase primarily attributable to increased

expenditures in clinical trial activities, manufacturing costs and higher personnel-related expenses, which include employee compensation.

General and administrative expenses were $4.7 million for the third

quarter of fiscal 2025, compared with $3.8 million for the same period a year ago, with the increase primarily attributable to professional

fees and employee-related expenses as a result of increased headcount.

Net loss was $18.9 million for the third quarter of fiscal 2025 compared

with a net loss of $17.1 million for the same period a year ago.

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 shown substantial

benefit in clinical trials and real-world use for the treatment of congenital HI 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, statements regarding the third quarter financial results of Rezolute, the efficacy of ersodetug in the congenital

or tumor patient population, the timeline for the completion of enrollment or achieving results in either of our Phase 3 programs and

the potential approval and commercialization of ersodetug. 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 the Rezolute'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. 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.

Condensed Consolidated Financial Statements Data

(in thousands, except per share data)