Rezolute Reports First Quarter Fiscal 2023 Results and Highlights Company Progress
November 09 2022 - 04:05PM
GlobeNewswire Inc.
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 first
quarter of fiscal 2023 ended September 30, 2022.
“I am extremely pleased with our progress this year, having
reported positive data from both our clinical programs, Phase 1b
study of RZ402 for Diabetic Macular Edema and Phase 2b study of
RZ358 for Congenital Hyperinsulinism (HI), as well as completing a
$130 million financing to advance both the molecules into the next
phase of clinical studies,” said Nevan Charles Elam, Chief
Executive Officer and Founder of Rezolute. “We are on track to
initiate a Phase 2 proof-of-concept study for RZ402 by the end of
this year, and we are aligning with regulatory authorities in the
U.S. and in Europe on next steps in our Phase 3 clinical program
for RZ358.”
Corporate and Clinical Highlights
- RZ358, monoclonal antibody for the treatment of
congenital hyperinsulinism
- The results of the Phase 2b RIZE study of RZ358 in patients
with congenital HI were presented at the 2022 Pediatric Endocrine
Society Annual Meeting as well as at the 60th European Society for
Paediatric Endocrinology (ESPE). RZ358 demonstrated good
safety and tolerability across all doses with no study
discontinuations or adverse drug reactions. Results exceeded
expectations for correction of hypoglycemia, including a highly
significant reduction of ~75% in hypoglycemia events by blood
glucometer (BGM) as well as time in hypoglycemia by continuous
glucose monitoring (CGM) at anticipated therapeutics doses.
- RZ402, oral plasma kallikrein inhibitor to treat
diabetic macular edema (DME)
- Rezolute presented clinical data from its Phase 1b
multiple-ascending dose (MAD) study of RZ402 in Diabetic Macular
Edema (DME) in a podium presentation at The Retina Society
55th Annual Scientific Meeting. The data further validated and
supported the potential for once daily oral dosing and enables
Rezolute to initiate a Phase 2 proof-of-concept study by the end of
the year.
First Quarter Fiscal 2023 Financial Results
- Cash and cash
equivalents totaled $154.3 million as of September 30, 2022.
- Research and
development (R&D) expenses were $7.7 million for the first
quarter of fiscal 2023, compared to $5.8 million for the same
period in fiscal 2022. The increase was primarily due to increased
spending in compensation and benefits, and clinical trial
costs.
- General and
administrative (G&A) expenses were $2.5 million for the first
quarter of fiscal 2023, compared to $1.9 million for the same
period in fiscal 2022. The increase was primarily due to an
increase in share-based compensation expense.
- Net loss was $9.8
million for the first quarter of fiscal 2023, compared to $7.8
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 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. 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:
Chiti ChopraDirector, Corporate
StrategyInvestor-relations@rezolutebio.com 408-606-0789
Kimberly Minarovich/Carrie McKimArgot
Partnersrezolute@argotpartners.com212-600-1902
Media:
Ingrid MezoCanale Communications, Inc.
ingrid.mezo@canalecomm.com301-473-2881
Rezolute, Inc. |
Condensed Consolidated Financial Statements
Data |
(in thousands, except per share data) |
(Unaudited) |
|
|
|
|
|
Three Months Ended |
|
|
|
|
September 30, |
|
|
|
|
|
2022 |
|
|
|
2021 |
|
|
|
|
|
|
|
|
Condensed Consolidated Statements of Operations
Data: |
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
Research and development |
|
|
$ |
7,704 |
|
|
$ |
5,774 |
|
General and administrative |
|
|
|
2,514 |
|
|
|
1,866 |
|
Total operating expenses |
|
|
|
10,218 |
|
|
|
7,640 |
|
Loss from operations |
|
|
|
(10,218 |
) |
|
|
(7,640 |
) |
|
|
|
|
|
|
|
Non-operating income (expense), net |
|
|
|
387 |
|
|
|
(196 |
) |
Net loss |
|
|
|
$ |
(9,831 |
) |
|
$ |
(7,836 |
) |
|
|
|
|
|
|
|
Basic and diluted net loss per common share |
|
|
$ |
(0.19 |
) |
|
$ |
(0.92 |
) |
|
|
|
|
|
|
|
Shares used to compute basic and diluted net loss per common
share |
|
|
|
50,528 |
|
|
|
8,513 |
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
June 30, |
|
|
|
|
|
2022 |
|
|
|
2022 |
|
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheets Data: |
|
|
|
|
|
Cash and cash equivalents |
|
|
$ |
154,322 |
|
|
$ |
150,410 |
|
Working capital |
|
|
|
|
153,198 |
|
|
|
149,642 |
|
Total assets |
|
|
|
|
155,988 |
|
|
|
152,420 |
|
Accumulated deficit |
|
|
|
|
(219,029 |
) |
|
|
(209,198 |
) |
Total stockholders’ equity |
|
|
|
153,090 |
|
|
|
149,471 |
|
|
|
|
|
|
|
|
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