Rezolute Reports Second Quarter Fiscal 2025 Financial Results and Provides Business Update Ersodetug, a novel, fully human monoclonal antibody for the treatment of hyperinsulinism (HI), receives Breakthrough Therapy Desi

Rezolute Reports Second Quarter Fiscal 2025

Financial Results and Provides Business Update

Ersodetug, a novel, fully

human monoclonal antibody for the treatment of hyperinsulinism (HI), receives Breakthrough Therapy Designation and Orphan Drug Designation

Open-label arm (infant

participants < 1 year old) of the sunRIZE study has been reviewed by a Data Monitoring Committee (DMC); target drug concentrations

were safely reached at tested doses and infants are approved for enrollment into the double-blind portion of the study

REDWOOD CITY, Calif., February 12, 2025 -- 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 three months ended December 31, 2024.

have made significant regulatory progress with ersodetug and our focus in 2025 remains squarely

on advancing both Phase 3 trials for patients with congenital HI and tumor HI," said

Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute. "We are encouraged

by our momentum and remain dedicated to providing meaningful and innovative treatments for

patients with limited options."

Recent Pipeline Progress and Anticipated Milestones

Fiscal Second Quarter Financial Results

Cash, cash equivalents and investments in marketable securities were

$105.3 million as of December 31, 2024, compared to $127.1 million as of June 30, 2024.

Research and development expenses were $12.6 million for the second

quarter of fiscal 2025, compared with $12.0 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 $4.5 million for the second

quarter of fiscal 2025, compared with $3.2 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 $15.7 million for the second quarter of fiscal 2025 compared

with a net loss of $13.9 million for the same period a year ago.

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.

The Phase 3 sunRIZE 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.

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 second quarter financial results of Rezolute, the efficacy of ersodetug

in infant patient populations, the DMC approval and timeline of enrollment of infants into a double-blind and placebo-controlled study

of ersodetug, the FDA's grant of the Breakthrough Therapy Designation for ersodetug, the Phase 3 sunRIZE study of ersodetug, 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, and statements regarding clinical trial timelines for 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.

Consolidated Financial Statements Data

thousands, except per share data)