Full Press Release Details
Rezolute Reports Third Quarter Fiscal 2024 Financial
Results and Provides Business Update
enrollment underway in sunRIZE global Phase 3 clinical study of RZ358 in patients with congenital hyperinsulinism (cHI); topline results
expected in mid-2025
in-vivo toxicology study in brown Norway rats; early results show no abnormalities at highest tested dose of RZ358
to engage in productive interactions with FDA towards resolution of partial clinical holds and path forward for potential late-stage,
registrational, clinical study in tumor hyperinsulinism (HI)
REDWOOD CITY, Calif., May 15, 2024 -
Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a clinical-stage biopharmaceutical
company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today reported financial
results and provided a business update for the three months ended March 31, 2024.
"In the past few months, we have been focused
on global site activation and patient enrollment for sunRIZE, a pivotal Phase 3 clinical study of RZ358 in patients with congenital hyperinsulinism.
We have also completed dosing of patients with diabetic macular edema for our Phase 2 multi-center clinical study of RZ402 and we expect
to announce topline results from that study this month," said Nevan Elam, Chief Executive Officer and Founder of Rezolute. "Additionally,
in the U.S. we continue to have productive interactions with FDA as we work towards achieving liberalization of the partial clinical holds
Recent Pipeline Progress and Anticipated Milestones
Congenital Hyperinsulinism (cHI)
Tumor Hyperinsulinism (HI)
Diabetic Macular Edema (DME)
Fiscal Third Quarter Financial Results
Cash, cash equivalents and investments in marketable
securities were $81.6 million as of March 31, 2024, compared with $118.4 million as of June 30, 2023.
Research and development expenses were $12.4 million
for the third quarter of fiscal 2024, compared with $14.2 million for the same period a year ago, with the decrease primarily attributable
to a reduction in milestone expense of $3.0 million due to Phase 2 dosing milestone triggered in RZ402, with no comparative expense incurred
in the current year, offset partially by an increase of R&D personnel-related expenses due to increased headcount.
General and administrative expenses were $3.8
million for the third quarter of fiscal 2024, compared with $2.9 million for the same period a year ago, with the increase primarily attributable
to personnel-related expenses due to increased headcount.
Net loss was $17.1 million for the third quarter
of fiscal 2024 compared with a net loss of $15.7 million for the same period a year ago.
About Rezolute, Inc.
Rezolute strives to disrupt current treatment
paradigms by developing transformative therapies for devastating rare and chronic metabolic diseases. Its novel therapies hold the potential
to significantly improve outcomes and to reduce the treatment burden for patients, treating physicians and the healthcare system. Rezolute
is steadfast in its mission to create a profound, positive and lasting impact on the lives of patients. Patient, clinician and advocate
voices are integrated in the Company's drug development process. Rezolute places an emphasis on understanding the patient's
lived experiences, enabling the Company to boldly address a range of severe conditions. 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 RZ358
Expanded Access Program, the ability of RZ358 to become an effective treatment for congenital hyperinsulinism, the effectiveness or future
effectiveness of RZ358 for the treatment of congenital hyperinsulinism, statements regarding clinical trial timelines for RZ358, 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