Rezolute Reports Third Quarter Fiscal 2022 Financial Results and Highlights Company Progress
May 12 2022 - 4:05PM
Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical
company dedicated to developing transformative therapies with the
potential to disrupt current treatment paradigms for devastating
metabolic diseases, today announced its financial results for the
third quarter of fiscal 2022 ended March 31, 2022.
“The first half of 2022 has been dynamic and transformative for
us, as we have announced positive clinical results for both RZ358
as well as RZ402,” said Nevan Charles Elam, Chief Executive Officer
and Founder of Rezolute. “I am particularly pleased that the
strength of our pipeline has been recognized by the investment
community culminating in the $130 million financing that we
completed earlier this month. The injection of capital will fund
our upcoming program milestones, including Phase 3 for RZ358 and a
Phase 2 proof of concept study for RZ402.”
Business Highlights
- Financing Update
- In May, Rezolute raised gross proceeds of $130 million in a
registered direct offering and concurrent private placement backed
by notable growth and life science investors including, amongst
others, Federated Hermes Kaufmann Funds, Stonepine Capital
Management, Medical Strategy GmbH, Acuta Capital Partners, Adage
Capital Partners LP, CAM Capital, Janus Henderson Investors, Sphera
Healthcare, and Vivo Capital.
- RZ358, monoclonal antibody for the treatment of
congenital hyperinsulinism
- In a late-breaking oral presentation at the Pediatric
Endocrine Society 2022 Annual Meeting, Dr. Paul Thornton presented
results from the Phase 2b RIZE study of RZ358 in patients with
congenital hyperinsulinism (HI). RZ358 demonstrated good
safety and tolerability across all doses with no study
discontinuations or adverse drug reactions. Predictable and
dose-dependent exposures with a clear dose-response was observed.
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. These data are Phase 3 enabling and demonstrate the
potential for RZ358 to be used as a monotherapy as well as a
potential universal therapy for all forms of hyperinsulinism.
- RZ402, oral plasma kallikrein inhibitor to treat
diabetic macular edema (DME)
- Positive topline data from the Phase 1b multiple-ascending dose
study of RZ402 were announced in February. Results showed that
RZ402 was generally safe and well-tolerated without dose-limiting
toxicities, including at higher doses than previously tested in the
SAD study. There were no serious adverse events, adverse drug
reactions or identified risks. Results demonstrated dose-dependent
increases in systemic exposures, with repeat-dosing to steady-state
resulting in the highest concentrations of RZ402 explored to date.
These data further validate and support the potential for once
daily oral dosing and enable the company to initiate a Phase 2
proof-of-concept study later this year.
- Rare Disease Company Coalition
- In March, Rezolute announced its membership as part of the Rare
Disease Company Coalition, an alliance of life science companies
committed to discovering, developing, and delivering rare disease
treatments for the patients they collectively serve.
Third Quarter Fiscal 2022 Financial Results
- Cash and cash
equivalents totaled $63.4 million as of March 31, 2022.
- Research and
development (R&D) expenses were $8.7 million for the three
months ended March 31, 2022, compared to $3.8 million for the same
period in 2021. The increase was primarily due to a licensing
payment for RZ358, increased spending in clinical trial costs,
manufacturing costs, and compensation and benefits.
- General and
administrative (G&A) expenses were $2.1 million for the three
months ended March 31, 2022, compared to $1.7 million for the same
period in 2021. The increase was primarily attributable to an
increase in share-based compensation expense due to options granted
to employees in the quarter.
- Net loss was $11.2 million, or $0.65 per share for the three
months ended March 31, 2022, compared to $3.7 million, or $0.44 per
share for the same period in 2021.
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.
Contacts:
Investor:
Chiti ChopraDirector, Finance &
StrategyInvestor-relations@rezolutebio.com408-606-0789
Kimberly Minarovich/Carrie McKimArgot
Partnersrezolute@argotpartners.com212-600-1902
Media:
Ingrid MezoCanale Communications, Inc.
ingrid.mezo@canalecomm.com301-473-2881
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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Nine Months
Ended |
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March 31, |
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March 31, |
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2022 |
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2021 |
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2022 |
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2021 |
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(unaudited) |
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(unaudited) |
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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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8,686 |
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3,758 |
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23,912 |
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10,598 |
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General and administrative |
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2,068 |
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1,725 |
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6,632 |
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5,660 |
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Total operating expenses |
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10,754 |
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5,483 |
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30,544 |
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16,258 |
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Loss from operations |
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(10,754 |
) |
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(5,483 |
) |
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(30,544 |
) |
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(16,258 |
) |
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Non-operating income (expense), net |
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(454 |
) |
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1,788 |
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(1,093 |
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1,846 |
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Net
loss |
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$ |
(11,208 |
) |
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$ |
(3,695 |
) |
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$ |
(31,637 |
) |
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$ |
(14,412 |
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Basic and diluted net loss per common share |
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$ |
(0.65 |
) |
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$ |
(0.44 |
) |
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$ |
(2.30 |
) |
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$ |
(1.94 |
) |
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Shares used to compute basic and diluted net loss per common
share |
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17,218 |
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8,352 |
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13,748 |
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7,445 |
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March
31, |
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June
30, |
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2022 |
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2021 |
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(unaudited) |
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Condensed Consolidated Balance Sheets Data: |
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Cash and cash equivalents |
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$ |
63,416 |
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$ |
41,047 |
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Working
capital |
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61,453 |
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40,025 |
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Total
assets |
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69,573 |
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42,609 |
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Long term debt, net of discount (1) |
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14,286 |
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13,968 |
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Accumulated
deficit |
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(199,775 |
) |
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(168,138 |
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Total stockholders’ equity |
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51,907 |
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26,099 |
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(1) In April 2021, we
entered into a $30.0 million Loan Agreement with SLR and certain
other Lenders. $15.0 million term A loan was funded on April 14,
2021. |
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