Full Press Release Details
Rezolute Reports Second Quarter Fiscal
2023 Results and Highlights Company Progress
Initiated Phase 2 proof-of-concept study of
Anticipate initiation of global Phase 3 clinical
study for RZ358 in mid 2023
REDWOOD CITY, Calif., Feb. 10, 2023 (GLOBE NEWSWIRE) -- Rezolute, Inc.
(Nasdaq: RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to transform
the treatment paradigms of devastating metabolic diseases, today announced its financial results for the second quarter of fiscal 2023
ended December 31, 2022.
"The past quarter was marked by steady execution across our pipeline
as we continue to advance toward our goal of bringing transformative therapies to patients across the spectrum of metabolic diseases,"
said Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute. "In December, we initiated a Phase 2 proof-of-concept
study for RZ402 in patients with diabetic macular edema, and we are continuing to prepare for a global Phase 3 study for RZ358 for congenital
Second 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 of diabetic macular edema.
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
Kimberly Minarovich/Carrie McKim
Canale Communications, Inc.
Condensed Consolidated Financial Statements Data
(in thousands, except per share data)
| Three Months Ended | Six Months Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| (unaudited) | (unaudited) | |||||||||||||||
| Condensed Consolidated Statements of Operations Data: | ||||||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 10,945 | $ | 9,452 | $ | 18,649 | $ | 15,226 | ||||||||
| General and administrative | 3,447 | 2,697 | 5,961 | 4,563 | ||||||||||||
| Total operating expenses | 14,392 | 12,149 | 24,610 | 19,789 | ||||||||||||
| Loss from operations | (14,392 | ) | (12,149 | ) | (24,610 | ) | (19,789 | ) | ||||||||
| Non-operating income (expense), net | 836 | (444 | ) | 1,223 | (640 | ) | ||||||||||
| Net loss | $ | (13,556 | ) | $ | (12,593 | ) | $ | (23,387 | ) | $ | (20,429 | ) | ||||
| Basic and diluted net loss per common share | $ | (0.26 | ) | $ | (0.80 | ) | $ | (0.46 | ) | $ | (1.69 | ) | ||||
| Shares used to compute basic and diluted net loss per common share | 51,410 | 15,680 | 50,969 | 12,097 |
| December 31, | June 30, | |||||||
| 2022 | 2022 | |||||||
| (unaudited) | ||||||||
| Condensed Consolidated Balance Sheets Data: | ||||||||
| Cash and cash equivalents | $ | 146,746 | $ | 150,410 | ||||
| Working capital | 141,293 | 149,642 | ||||||
| Total assets | 150,208 | 152,420 | ||||||
| Accumulated deficit | (232,585 | ) | (209,198 | ) | ||||
| Total stockholders' equity | 141,265 | 149,471 |