Full Press Release Details
Rezolute Reports Third Quarter Fiscal 2023 Results and Highlights Company Progress
The Company is poised to commence Phase 3 for RZ358 in the third quarter of calendar year 2023
REDWOOD CITY, Calif., May 11, 2023 (GLOBE
NEWSWIRE) -- 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
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
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.
Canale Communications, Inc.
Condensed Consolidated Financial Statements Data
(in thousands, except per share data)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| March 31, | March 31, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| (unaudited) | (unaudited) | |||||||||||||||
| Condensed Consolidated Statements of Operations Data: | ||||||||||||||||
| 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 | ) | ||||
| Shares used to compute basic and diluted net loss per common share | 51,409 | 17,218 | 51,113 | 13,748 |
| March 31, | June 30, | |||||||
| 2023 | 2022 | |||||||
| (unaudited) | ||||||||
| Condensed Consolidated Balance Sheets Data: | ||||||||
| 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 | 152,420 | ||||||
| Accumulated deficit | (248,257 | ) | (209,198 | ) | ||||
| Total stockholders' equity | 127,316 | 149,471 |