Rezolute Reports First Quarter Fiscal 2024 Results
13 Novembre 2023 - 10:05PM
Rezolute, Inc. (Nasdaq: RZLT), a
clinical-stage biopharmaceutical company committed to
developing novel, transformative therapies for serious
metabolic and rare diseases, today announced its financial results
for the first quarter of fiscal 2024 ended September 30, 2023.
“We are on track to commence our Phase 3 study
for RZ358 to treat congenital hyperinsulinism prior to year-end and
are delighted to have recently obtained PRIME eligibility from the
European Medicines Agency for this indication,” said Nevan Charles
Elam, Chief Executive Officer and Founder of Rezolute. “We also
anticipate completing enrollment this quarter for our ongoing Phase
2 study of RZ402 for the treatment of diabetic macular edema and
plan to provide an update on the study prior to year end.”
Clinical Highlights
- RZ358, a monoclonal antibody for the treatment of
hyperinsulinism
- Received EMA priority medicines (PRIME) designation for the
treatment of congenital hyperinsulinism (cHI) from the European
Medicines Agency
- Plan to initiate sunRIZE, a pivotal Phase 3 clinical study in
patients with cHI, in Europe and other geographies outside the US
in the fourth quarter 2023
- Continuing the administration of RZ358 in the US with FDA
approval under a compassionate use program to treat patients with
tumor associated hyperinsulinism, including for a patient with
refractory hypoglycemia due to metastatic insulinoma who has
remained on RZ358 for nearly a year
- RZ402, an oral plasma kallikrein inhibitor in Phase 2 to treat
diabetic macular edema (DME)
- Multi-center, randomized, double-masked, placebo-controlled,
parallel-arm study ongoing to evaluate the safety, efficacy, and
pharmacokinetics of RZ402 administered as a monotherapy over a
12-week treatment period in participants with DME who are naïve to
or have received limited anti-VEGF injectionsStudy is in the latter
stages of patient recruitment and an update on the study will be
provided prior to year end
First Quarter Fiscal 2024 Financial
Results
- Cash, cash equivalents and
investments in marketable debt securities totaled $106.9 million as
of September 30, 2023, compared to $118.4 million as of June 30,
2023
- Research and development expenses
were $12.2 million for the first quarter of fiscal 2024, compared
to $7.7 million for the same period in fiscal 2023, with the
increase primarily attributable to increased expenditures in
clinical trial activities, manufacturing costs and higher
personnel-related expenses which included employee compensation and
stock-based compensation
- General and administrative expenses
were $3.7 million for the first quarter of fiscal 2024, compared to
$2.5 million for the same period in fiscal 2023, with the increase
primarily attributable to higher personnel-related expenses,
including employee compensation and stock-based compensation
- Net loss was $14.5 million for the
first quarter of fiscal 2024, compared to $9.8 million for the same
period in fiscal 2023
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 both significantly improve outcomes
and reduce the treatment burden for patients, treating physicians,
and the healthcare system. Rezolute is steadfast in its mission to
create profound, positive, and lasting impacts on patients’ lives.
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 StatementsThis 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 and statements regarding PRIME designation and the
designation’s meaning on the ability of RZ358 to become an
effective treatment to congenital HI, the effectiveness or future
effectiveness of RZ358 for the treatment of congenital HI, and
statements regarding clinical trial timelines for RZ358. 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.
Investors:Stephanie CarringtonICR
WestwickeRezoluteIR@westwicke.com(646)277-1282
Media:media-relations@rezolutebio.com
Rezolute, Inc. |
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Condensed Consolidated Financial Statements
Data |
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(in
thousands, except per share data) |
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Three Months
Ended |
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September 30, |
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2023 |
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2022 |
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Condensed Consolidated Statements of Operations
Data: |
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Operating
expenses: |
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Research and development |
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$ |
12,214 |
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$ |
7,704 |
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General and administrative |
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3,700 |
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2,514 |
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Total operating expenses |
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15,914 |
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10,218 |
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Loss from
operations |
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(15,914 |
) |
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(10,218 |
) |
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Non-operating income (expense), net |
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1,390 |
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387 |
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Net
loss |
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$ |
(14,524 |
) |
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$ |
(9,831 |
) |
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Basic and
diluted net loss per common share |
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$ |
(0.28 |
) |
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$ |
(0.19 |
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Shares used
to compute basic and diluted net loss per common share |
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51,409 |
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50,528 |
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September
30, |
June
30, |
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2023 |
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2023 |
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Condensed Consolidated Balance Sheets Data: |
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Cash and
cash equivalents |
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$ |
8,057 |
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$ |
16,036 |
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Investments
in marketable debt securities |
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98,817 |
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102,330 |
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Working
capital |
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95,450 |
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99,710 |
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Total
assets |
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112,999 |
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123,721 |
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Accumulated
deficit |
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(275,509 |
) |
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(260,985 |
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Total
stockholders’ equity |
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103,564 |
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116,172 |
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Grafico Azioni Rezolute (NASDAQ:RZLT)
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