Full Press Release Details
Third Quarter Fiscal 2022 Financial Results and Highlights Company Progress
million registered direct offering and concurrent private placement
topline results from Phase 2b RIZE study of RZ358 exceeded expectations and demonstrated highly significant reduction in hypoglycemia
events, ~75% at anticipated therapeutic doses
from Phase 1b multiple-ascending dose study of RZ402 enable Phase 2 proof-of-concept study initiation later this year
CITY, Calif., May 12, 2022 (GLOBE NEWSWIRE) - 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
"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."
Third Quarter Fiscal 2022 Financial
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
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.
Director, Finance & Strategy
Kimberly Minarovich/Carrie McKim
Canale Communications, Inc.
| Rezolute, Inc. |
| Condensed Consolidated Financial Statements Data |
| (in thousands, except per share data) |
| Three Months Ended | Nine Months Ended | |||||||||||||||
| March 31, | March 31, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| (unaudited) | (unaudited) | |||||||||||||||
| Condensed Consolidated Statements of Operations Data: | ||||||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 8,686 | 3,758 | 23,912 | 10,598 | ||||||||||||
| General and administrative | 2,068 | 1,725 | 6,632 | 5,660 | ||||||||||||
| Total operating expenses | 10,754 | 5,483 | 30,544 | 16,258 | ||||||||||||
| Loss from operations | (10,754 | ) | (5,483 | ) | (30,544 | ) | (16,258 | ) | ||||||||
| Non-operating income (expense), net | (454 | ) | 1,788 | (1,093 | ) | 1,846 | ||||||||||
| Net loss | $ | (11,208 | ) | $ | (3,695 | ) | $ | (31,637 | ) | $ | (14,412 | ) | ||||
| Basic and diluted net loss per common share | $ | (0.65 | ) | $ | (0.44 | ) | $ | (2.30 | ) | $ | (1.94 | ) | ||||
| Shares used to compute basic and diluted net loss per common share | 17,218 | 8,352 | 13,748 | 7,445 |
| March 31, | June 30, | |||||||
| 2022 | 2021 | |||||||
| (unaudited) | ||||||||
| Condensed Consolidated Balance Sheets Data: | ||||||||
| Cash and cash equivalents | $ | 63,416 | $ | 41,047 | ||||
| Working capital | 61,453 | 40,025 | ||||||
| Total assets | 69,573 | 42,609 | ||||||
| Long term debt, net of discount (1) | 14,286 | 13,968 | ||||||
| Accumulated deficit | (199,775 | ) | (168,138 | ) | ||||
| Total stockholders' equity | 51,907 | 26,099 |
(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.