Rezolute Reports Fourth Quarter and Full Year Fiscal 2025 Financial Results and Provides Business Update

Fourth Quarter and Full Year Fiscal 2025 Financial Results and Provides Business Update

CITY, Calif., September 17, 2025 - Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"),

a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism, today reported

financial results and provided a business update for the fourth quarter and full fiscal year ended June 30, 2025.

made substantial progress this year across our two indications for ersodetug in both congenital and tumor hyperinsulinism," said

Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute. "We believe that FDA alignment on a streamlined Phase 3 trial

in tumor hyperinsulinism is further recognition of ersodetug's broad applicability across multiple forms of hyperinsulinism and

highlights both the urgent need and the transformative potential of our therapy for patients and families living with this condition.

We remain on track to report topline results from the sunRIZE trial in December and look forward to progressing towards potential

Progress and Anticipated Milestones

Congenital Hyperinsulinism

and Full Year Fiscal 2025 Financial Results

Cash, cash equivalents

and investments in marketable securities were $167.9 million as of June 30, 2025, compared with $127.1 million as of June 30,

Research and development

(R&D) expenses were $20.9 million for the fourth quarter of fiscal 2025, compared with $19.1 million for the same period a year ago.

Full fiscal year 2025 R&D expenses were $61.5 million, compared to $55.7 million in fiscal year 2024. The increase from fiscal year

2024 to fiscal year 2025 was primarily due to (i) increased expenditures in clinical trial activities, (ii) manufacturing costs

for ersodetug, and (iii) higher employee-related expenses, which included employee compensation and stock-based compensation.

General and administrative

(G&A) expenses were $5.0 million for the fourth quarter of fiscal 2025, compared with $4.0 million for the same period a year ago.

Full fiscal year 2025 G&A expenses were $18.4 million, compared to $14.7 million in fiscal year 2024. The increase was primarily

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

million for the fourth quarter of fiscal 2025 compared with a net loss of $23.0 million for the same period a year ago. Full year fiscal

2025 net loss was $74.4 million compared to net loss of $68.5 million for the fiscal year 2024.

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

About Rezolute, Inc.

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 meaningful benefit in clinical trials and real-world use for the treatment

of both congenital 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 the timing of the release of topline results

from the sunRIZE trial, the applicability of ersodetug across multiple forms of hyperinsulinism, the timing of the release of topline

results from the upLIFT 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, 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)