Rezolute, Inc. (RZLT) 10-K Annual Report September 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

RZ358, monoclonal antibody for the treatment of congenital hyperinsulinism (HI)

Following the successful Phase 2b RIZE study of RZ358 in congenital HI, which demonstrated that RZ358 safely and substantially improved hypoglycemia, the Company plans to initiate sunRIZE, a pivotal Phase 3 clinical study of RZ358, in Europe and other geographies outside the US in Q4 2023. Topline results from the sunRIZE study are expected in the first half of 2025.

RZ402, oral plasma kallikrein inhibitor to treat diabetic macular edema (DME)

In December 2022, Rezolute announced the initiation of a Phase 2 study of RZ402 in patients with DME. This is a multi-center, randomized, double-masked, placebocontrolled, parallel-arm study to evaluate the safety, efficacy, and pharmacokinetics of RZ402 administered as a monotherapy over a 12-week treatment period in participants with DME who are naïve to or have received limited anti-VEGF injections. Study enrollment is ongoing, and the Company anticipates topline results from this study in the first quarter of 2024.

Fourth Quarter and Full Year Fiscal 2023 Financial Results

Cash and cash equivalents totaled $16.0 million and investments in marketable debt securities totaled $102.3 million as of June 30, 2023.

The following information was filed by Rezolute, Inc. (RZLT) on Thursday, September 14, 2023 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside Rezolute, Inc.'s 10-K Annual Report:

Financial - Expense Highlight
Nonrefundable advance payments for goods and services that will be used or rendered in future research and development activities are deferred and recognized as expense in the period that the related goods are delivered, or services are performed.

Financial - Debt Highlight
This increase was primarily due to our decision in January 2023 to invest an aggregate of approximately $115.0 million in marketable debt securities and an overnight money market mutual fund that bear interest at a weighted average effective rate of approximately 5.0%, whereas our temporary cash investments as of June 30, 2022 provided for earnings that were less than 1.0%.
Financial - Expense Highlight
G&A expenses for the fiscal years ended June 30, 2023 and 2022 were as follows (in thousands, except percentages): The increase in G&A expenses of $2.8 million for the fiscal year ended June 30, 2023 was primarily attributable to an increase in G&A compensation and benefits related to our administrative workforce of $2.8 million.
Financial - Expense Highlight
Intangible assets related to in-licensing costs under license agreements with third parties are charged to expense unless we are able to determine that the licensing rights have an alternative future use in other research and development projects or otherwise.
Financial - Shares Highlight
This authorized share deficiency existed until June 16, 2022 when our shareholders approved an increase in our authorized shares of common stock.
Financial - Expense
R&D expenses for the fiscal...Read more
Other - Other
We cannot assure you that...Read more
Revenue - Product
Additionally, upon the future commercialization...Read more
Financial - Expense
The components of interest expense...Read more
Financial - Debt
Accordingly, we reinvested an aggregate...Read more
Other - Other
As is customary in pediatric...Read more
Financial - Expense
Research and development ("R&D") expenses...Read more
Financial - Expense
Our R&D costs include an...Read more
Other - Other
These items are monitored and...Read more
Financial - Expense
The RZ402 program cost increase...Read more
Financial - Debt
DDIC arises from the issuance...Read more
Financial - Debt
Investment in Marketable Debt Securities...Read more
Other - Other
In January 2019, the XOMA...Read more
Revenue - Product
Due to the time required...Read more
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Investments in Marketable Debt Securities...Read more
Financial - Income
Interest and other income consist...Read more
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Subsequently, in the RIZE study...Read more
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Upon the achievement of certain...Read more
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For the fiscal year ended...Read more
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Gain from change in fair...Read more

Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Material Contracts, Statements, Certifications & more

Rezolute, Inc. provided additional information to their SEC Filing as exhibits

Exhibit 4: Instruments Defining The Rights Of Security Holders, Including Indentures

Exhibit 21.1: Subsidaries Of The Registrant

Exhibit 23.1: Consents Of Experts And Counsel

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32.1: Section 1350 Certification

Ticker: RZLT
CIK: 1509261
Form Type: 10-K Annual Report
Accession Number: 0001558370-23-015755
Submitted to the SEC: Thu Sep 14 2023 4:22:42 PM EST
Accepted by the SEC: Thu Sep 14 2023
Period: Friday, June 30, 2023
Industry: Pharmaceutical Preparations