Rezolute Reports Third Quarter Fiscal 2023 Results and Highlights Company Progress
May 11 2023 - 4:05PM
Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical
company dedicated to developing transformative therapies with the
potential to shift the treatment paradigms of devastating metabolic
diseases, today announced its financial results for the third
quarter of fiscal 2023 ended March 31, 2023.
“We are continuing to make progress across our pipeline,
including preparation for a Phase 3 study for RZ358 as well as
enrollment of patients in our Phase 2 study for RZ402,” said Nevan
Charles Elam, Chief Executive Officer and Founder of Rezolute. “The
quarter was punctuated by a Rezolute-hosted virtual key opinion
leader event that explored the therapeutic landscape of diabetic
macular edema and the rationale for treating with an oral plasma
kallikrein inhibitor such as RZ402. I am excited and encouraged by
the support of key thought leaders in the ophthalmology space who,
like all of us at Rezolute, wish to change the treatment paradigm
of DME.”
Third Quarter Fiscal 2023 Financial Results
- Cash and cash equivalents totaled $33.7 million and investments
in marketable debt securities totaled $95.5 million as of March 31,
2023.
- Research and development (R&D) expenses were $14.2 million
for the third quarter of fiscal 2023, compared to $8.7 million for
the same period in fiscal 2022. The increase was primarily due 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 (G&A) expenses were $2.9 million
for the third quarter of fiscal 2023, compared to $2.1 million for
the same period in fiscal 2022. The increase was primarily due to
higher personnel-related expenses, including employee compensation
and stock-based compensation.
- Net loss was $15.7 million for the third quarter of fiscal
2023, compared to $11.2 million for the same period in fiscal
2022.
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, the treating physician, and the
healthcare system. Patient, clinician, and advocate voices are
integrated in the Company’s drug development process, enabling
Rezolute to boldly address a range of severe conditions. Rezolute
is steadfast in its mission to create profound, positive, and
lasting impact on patients’ lives. The Company’s lead clinical
asset, RZ358, is in late-stage development for the treatment of
congenital hyperinsulinism, a rare pediatric endocrine disorder.
Rezolute is also developing RZ402, an orally available plasma
kallikrein inhibitor, for the treatment of diabetic macular edema.
For more information, visit www.rezolutebio.com or follow us
on Twitter.
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.
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 Rezolute’s
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.
Investor:Kimberly
MinarovichArgot Partnersrezolute@argotpartners.com212-600-1902
Media:Jennifer ArcureCanale
Communications, Inc.jennifer.arcure@evokegroup.com917-603-0681
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Rezolute, Inc. |
Condensed Consolidated Financial Statements
Data |
(in thousands, except per share data) |
|
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|
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Three Months Ended |
|
Nine Months Ended |
|
March 31, |
|
March 31, |
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|
2023 |
|
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|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
(unaudited) |
|
(unaudited) |
Condensed Consolidated Statements of Operations
Data: |
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Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
14,231 |
|
|
$ |
8,686 |
|
|
$ |
32,880 |
|
|
$ |
23,912 |
|
General and administrative |
|
2,911 |
|
|
|
2,068 |
|
|
|
8,872 |
|
|
|
6,632 |
|
Total operating expenses |
|
17,142 |
|
|
|
10,754 |
|
|
|
41,752 |
|
|
|
30,544 |
|
Loss from operations |
|
(17,142 |
) |
|
|
(10,754 |
) |
|
|
(41,752 |
) |
|
|
(30,544 |
) |
Non-operating income (expense), net |
|
1,470 |
|
|
|
(454 |
) |
|
|
2,693 |
|
|
|
(1,093 |
) |
Net loss |
$ |
(15,672 |
) |
|
$ |
(11,208 |
) |
|
$ |
(39,059 |
) |
|
$ |
(31,637 |
) |
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share |
$ |
(0.30 |
) |
|
$ |
(0.65 |
) |
|
$ |
(0.76 |
) |
|
$ |
(2.30 |
) |
|
|
|
|
|
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|
Shares used to compute basic and diluted net loss per common
share |
|
51,409 |
|
|
|
17,218 |
|
|
|
51,113 |
|
|
|
13,748 |
|
|
|
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|
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March 31, |
|
June 30, |
|
|
|
|
|
|
2023 |
|
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|
2022 |
|
|
|
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(unaudited) |
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Condensed Consolidated Balance Sheets Data: |
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Cash and cash equivalents |
|
|
|
|
$ |
33,743 |
|
|
$ |
150,410 |
|
Investments in marketable debt securities |
|
|
|
|
|
95,529 |
|
|
|
- |
|
Working capital |
|
|
|
|
|
101,139 |
|
|
|
149,642 |
|
Total assets |
|
|
|
|
|
134,205 |
|
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|
152,420 |
|
Accumulated deficit |
|
|
|
|
|
(248,257 |
) |
|
|
(209,198 |
) |
Total stockholders’ equity |
|
|
|
|
|
127,316 |
|
|
|
149,471 |
|
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