Full Press Release Details
Rezolute Reports Full Year
Fiscal 2023 Results and Highlights Company Progress
Planning to initiate Phase 3 Study for RZ358 ("sunRIZE study")
in the fourth quarter of 2023
REDWOOD CITY, Calif., Sept. 14, 2023 (GLOBE NEWSWIRE) -- Rezolute,
Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to
disrupt treatment paradigms for devastating metabolic diseases, today announced its financial results for the fourth quarter and full
fiscal year ended June 30, 2023.
"We are delighted that we are poised to initiate sunRIZE -- our
Phase 3 study of RZ358, which we hope will bring us one step closer to making this therapy available to patients and their families suffering
from congenital hyperinsulinism. We are also anticipating results from our Phase 2 study of RZ402 in the first quarter of 2024, where
we hope to demonstrate the safety and proof-of-concept of our oral therapy for diabetic macular edema," said Nevan Charles Elam,
Chief Executive Officer and Founder of Rezolute. "As we look ahead to these upcoming milestones, we remain committed to our mission
of delivering transformative therapies to patients with devastating metabolic diseases."
Corporate and Clinical Highlights
Fourth Quarter and Full Year Fiscal 2023 Financial Results
About Rezolute, Inc.
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
Twitter or LinkedIn.
Forward-Looking Statements
The information provided herein contain "forward-looking
statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking
statements can be identified by words such as "anticipate," "intend," "plan," "goal," "seek,"
"believe," "project," "estimate," "expect," "strategy," "future," "likely,"
"may," "should," "will" and similar references to future periods. The "forward-looking statements" include, but are not limited to, statements regarding receiving results from the Phase 2
study of RZ402 in the first quarter of 2024, the ability of RZ358 to treat congenital hyperinsulinism, the timing of the release topline
results from sunRIZE, and our ability to meet trial enrollment goals.
Forward-looking statements are neither
historical facts nor assurances of future performance. Instead, they are based only on Rezolute's current beliefs, expectations
and assumptions regarding the future of its businesses, results of and timing of clinical trials, financial condition and results of
operations, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because
forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that
are difficult to predict and many of which are outside of Rezolute's control. Rezolute's actual results including the timing
and results of clinical trials may differ materially from those indicated in the forward-looking statements. Therefore, you should not
place undue reliance on any of these forward-looking statements. Important factors that could cause Rezolute's actual results including
the timing and results of clinical trials to differ materially from those indicated in the forward-looking statements are discussed or
identified in Rezolute's filings made with the U.S. Securities and Exchange Commission. Any forward-looking statements made by
Rezolute in this information are based only on information currently available to Rezolute and speak only as of the date on which the
statement is made. Rezolute undertakes no obligation to update any forward-looking statement, whether written or oral, that may be made
from time to time, whether as a result of new information, future developments or otherwise except as required by applicable law.
Consolidated Financial Statements Data
thousands, except per share data)
| Three Months Ended | Year Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Condensed Consolidated Statements of Operations Data: | ||||||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 10,933 | $ | 8,574 | $ | 43,813 | $ | 32,486 | ||||||||
| General and administrative | 3,305 | 2,725 | 12,177 | 9,357 | ||||||||||||
| Total operating expenses | 14,238 | 11,299 | 55,990 | 41,843 | ||||||||||||
| Loss from operations | (14,238 | ) | (11,299 | ) | (55,990 | ) | (41,843 | ) | ||||||||
| Non-operating income (expense), net | 1,510 | 1,876 | 4,203 | 783 | ||||||||||||
| Net loss | $ | (12,728 | ) | $ | (9,423 | ) | $ | (51,787 | ) | $ | (41,060 | ) | ||||
| Net loss per common share | ||||||||||||||||
| Basic | $ | (0.25 | ) | $ | (0.30 | ) | $ | (1.01 | ) | $ | (2.26 | ) | ||||
| Diluted | $ | (0.25 | ) | $ | (0.37 | ) | $ | (1.01 | ) | $ | (2.32 | ) | ||||
| Weighted average number of common shares outstanding: | ||||||||||||||||
| Basic | 51,410 | 31,429 | 51,188 | 18,197 | ||||||||||||
| Diluted | 51,410 | 36,302 | 51,188 | 19,487 |
| June 30, | June 30, | |||||||
| 2023 | 2022 | |||||||
| Condensed Consolidated Balance Sheets Data: | ||||||||
| Cash and cash equivalents | $ | 16,036 | $ | 150,410 | ||||
| Investments in marketable debt securities | 102,330 | - | ||||||
| Working capital | 99,710 | 149,642 | ||||||
| Total assets | 123,721 | 152,420 | ||||||
| Accumulated deficit | (260,984 | ) | (209,198 | ) | ||||
| Total stockholders' equity | 123,721 | 149,471 |