Rezolute Reports Fourth Quarter and Full Year Fiscal 2024 Financial Results and Provides Business Update FDA lifts partial clinical holds on ersodetug for the treatment of congenital HI; Phase 3 sunRIZE study to proceed

Fourth Quarter and Full Year Fiscal 2024 Financial Results and Provides Business Update

lifts partial clinical holds on ersodetug for the treatment of congenital HI; Phase 3 sunRIZE study to proceed in the U.S.

3 study for ersodetug for the treatment of tumor HI expected to commence in the first half of 2025

REDWOOD CITY, Calif.,

September 19, 2024 - Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage biopharmaceutical company dedicated to developing transformative therapies for rare diseases with serious unmet needs, today reported financial results and provided a business update

for the fourth quarter and full fiscal year ended June 30, 2024.

to close out the year with FDA alignment to advance ersodetug in two Phase 3 rare disease programs for the treatment of hypoglycemia

resulting from congenital and acquired forms of hyperinsulinism," said Nevan Elam, Chief Executive Officer and Founder of Rezolute. "The

Phase 3 sunRIZE study remains on track for ex-U.S. participant enrollment and we expect U.S. enrollment to begin in the first part of

2025. We look forward to progressing both Phase 3 studies and remain excited at the prospect of ersodetug as a best-in-class treatment

for hyperinsulinism based on the success we've seen to date."

Progress and Anticipated Milestones

Diabetic Macular Edema (DME)

and Full Year Fiscal 2024 Financial Results

Cash, cash equivalents

and investments in marketable securities were $127.1 million as of June 30, 2024, compared with $118.4 million as of June 30,

Research and development

(R&D) expenses were $19.1 million for the fourth quarter of fiscal 2024, compared with $10.9 million for the same period a year ago.

Full fiscal year 2024 R&D expenses were $55.7 million, compared to $43.8 million in fiscal year 2023. The increase from fiscal year

2023 to fiscal year 2024 was primarily due to (i) increased expenditures in clinical trial activities, (ii) manufacturing costs

for ersodetug, (iii) milestone payments due to license agreement partners, and (iv) higher employee-related expenses, which

included employee compensation and stock-based compensation.

General and administrative

(G&A) expenses were $4.0 million for the fourth quarter of fiscal 2024, compared with $3.3 million for the same period a year ago.

Full fiscal year 2023 G&A expenses were $14.7 million, compared to $12.2 million in fiscal year 2023. The increase was primarily

attributable to employee-related expenses due to increased headcount and professional fees.

million for the fourth quarter of fiscal 2024 compared with a net loss of $12.7 million for the same period a year ago. Full year fiscal

2024 net loss was $68.5 million compared to net loss of $51.8 million for the fiscal year 2023.

Ersodetug is a fully

human monoclonal antibody that binds to a unique allosteric site on insulin receptors to counteract the effects of insulin receptor over-activation

by insulin and related substances (such as IGF-2), thereby improving hypoglycemia in the setting of hyperinsulinism (HI). Because ersodetug

acts downstream from the pancreas, it has the potential to be universally effective at treating hypoglycemia due to any form of HI.

study is a multi-center, randomized, double-blind, placebo-controlled, parallel arm study designed to evaluate the efficacy and safety

of ersodetug in patients with congenital HI who are experiencing poorly controlled hypoglycemia. Participants between the ages of 3 months

to 45 years old are eligible to participate. The study is enrolling up to 56 participants in more than a dozen countries around the world.

About Rezolute, Inc.

Rezolute is a late-stage

rare disease company focused on significantly improving outcomes for individuals with 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.

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 fourth quarter and

fiscal year financial results of Rezolute, the full year financial results of Rezolute, the ersodetug Expanded Access Program, ersodetug as a sunRIZE Phase 3 study, the ability of ersodetug to become an effective treatment

for congenital hyperinsulinism, the effectiveness or future effectiveness of ersodetug for the treatment of congenital hyperinsulinism,

statements regarding clinical trial timelines for ersodetug , the RZ402 study, the ability of RZ402 to become an effective treatment

for diabetic macular edema, the effectiveness or future effectiveness of RZ402 to become an effective treatment for diabetic macular

edema, and statements regarding clinical trial timelines for RZ402. 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.

LHA Investor Relations

Consolidated Financial Statements Data

thousands, except per share data)