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Rezolute, Inc. (RZLT) SEC Filing 10-K Annual Report for the fiscal year ending Thursday, June 30, 2022

Rezolute, Inc.

CIK: 1509261 Ticker: RZLT

 

Exhibit 99.1

 

 

Rezolute Reports Fourth Quarter and Full Year Fiscal 2022 Results and Highlights Company Progress

 

Announced a $130 million registered direct offering and concurrent private placement priced at-the-market

 

Late-breaking oral presentation from Phase 2b RIZE study of RZ358 presented at ESPE 2022

 

Phase 2 proof-of-concept study of RZ402 expected to be initiated later this year

 

REDWOOD CITY, Calif., September 15, 2022 (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 fourth quarter and full fiscal year ended June 30, 2022.

 

“This quarter marked steady progress as we continue to drive our clinical programs forward, including RZ358 for congenital hyperinsulinism and RZ402 for diabetic macular edema,” said Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute. “With the $130 million financing that we completed, we are well-capitalized to advance RZ358 into a Phase 3 trial and to initiate a Phase 2 proof-of-concept study for RZ402. We believe these candidates hold the potential to create a new standard of care for patient populations in need of better therapeutic options.”

 

Corporate and Clinical Highlights

 

Financing Update

 

oRezolute raised gross proceeds of $130 million in a registered direct offering and concurrent private placement backed by notable growth and life science investors.

 

RZ358, monoclonal antibody for the treatment of congenital hyperinsulinism

 

oThe results of the Phase 2b RIZE study of RZ358 in patients with congenital hyperinsulinism (HI) were revealed in a late-breaking oral presentation at the 2022 Pediatric Endocrine Society Annual Meeting in May and discussed by management in a conference call following the presentation. RZ358 demonstrated good safety and tolerability across all doses with no study discontinuations or adverse drug reactions. Results exceeded expectations for correction of hypoglycemia, including a highly significant reduction of ~75% in hypoglycemia events by blood glucometer (BGM) as well as time in hypoglycemia by continuous glucose monitoring (CGM) at anticipated therapeutics doses. Rezolute also presented additional data from the RIZE study at the 60th European Society for Paediatric Endocrinology (ESPE) meeting this month.

 

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

 

oPositive topline data from the Phase 1b multiple-ascending dose study of RZ402 were announced earlier this year. These data further validate and support the potential for once daily oral dosing and enable Rezolute to initiate a Phase 2 proof-of-concept study in the fourth calendar quarter of this year.

 

Key leadership announcement

 

oRezolute announced the promotion of Brian Roberts, M.D., previously Senior Vice President and Head of Clinical Development, to Chief Medical Officer of Rezolute. Dr. Roberts joined Rezolute in 2017 as Vice President of Clinical Development and a member of the founding management team.

 


The following information was filed by Rezolute, Inc. (RZLT) on Thursday, September 15, 2022 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 Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Document And Entity Information
Consolidated Balance Sheets
Consolidated Balance Sheets (Parenthetical)
Consolidated Statements Of Cash Flows
Consolidated Statements Of Operations
Consolidated Statements Of Shareholders' Equity
Commitments And Contingencies
Commitments And Contingencies (Details)
Derivative Liabilities For Authorized Share Deficiencies
Derivative Liabilities For Authorized Share Deficiencies (Tables)
Derivative Liabilities For Authorized Share Deficiencies - Deficiency Triggered By Charter Revision (Details)
Derivative Liabilities For Authorized Share Deficiencies - Deficiency Triggered By Issuance Of Class B Pre-Funded Warrants (Details)
Derivative Liabilities For Authorized Share Deficiencies - Derivative Liability Associated With Stock Options (Details)
Derivative Liabilities For Authorized Share Deficiencies - Weighted-Average Assumption For Valuations By Charter Revision (Details)
Derivative Liabilities For Authorized Share Deficiencies - Weighted-Average Assumption For Valuations Of Class B Pre-Funded Warrants (Details)
Financial Instruments And Significant Concentrations
Financial Instruments And Significant Concentrations (Tables)
Financial Instruments And Significant Concentrations - Summary Of Changes In The Fair Value (Details)
Income Taxes
Income Taxes (Tables)
Income Taxes - Additional Information (Details)
Income Taxes - Deferred Income Tax Assets And Liabilities (Details)
Income Taxes - Income Tax Expense (Details)
Leases
Leases (Tables)
Leases - Assets And Operating Lease Liabilities (Details)
Leases - Future Operating Lease Payments (Details)
Leases - Future Payments Of Lease Yet To Commence (Details)
Leases - Headquarters Lease (Details)
Leases - Office Space (Details)
Leases - Operating Lease Expense (Details)
License Agreements
License Agreements (Details)
Liquidity
Liquidity (Details)
Loan And Security Agreement
Loan And Security Agreement (Details)
Nature Of Operations And Summary Of Significant Accounting Policies
Nature Of Operations And Summary Of Significant Accounting Policies (Details)
Nature Of Operations And Summary Of Significant Accounting Policies (Policies)
Net Loss Per Share
Net Loss Per Share (Tables)
Net Loss Per Share - Anti-Dilutive (Details)
Net Loss Per Share - Schedule Of Basic And Diluted Net Loss Per Share (Details)
Related Party Transactions
Related Party Transactions (Details)
Share-Based Compensation And Warrants
Share-Based Compensation And Warrants (Tables)
Share-Based Compensation And Warrants - Additional Information (Details)
Share-Based Compensation And Warrants - Share Based Compensation Expense (Details)
Share-Based Compensation And Warrants - Stock Option Plans (Details)
Share-Based Compensation And Warrants - Stock Options Outstanding (Details)
Share-Based Compensation And Warrants - Warrants (Details)
Share-Based Compensation And Warrants - Weighted Average Assumptions (Details)
Shareholders' Equity
Shareholders' Equity - 2021 Pre-Funded Warrants (Details)
Shareholders' Equity - 2021 Registered Direct Offering (Details)
Shareholders' Equity - 2021 Underwritten Public Offering (Details)
Shareholders' Equity - 2022 Pre-Funded Warrants (Details)
Shareholders' Equity - Changes In Authorized Capital Stock (Details)
Shareholders' Equity - Equity Distribution Agreement (Details)
Shareholders' Equity - Fiscal 2021 Equity Financing (Details)
Shareholders' Equity - Lpc Purchase Agreement (Details)
Shareholders' Equity - May 2022 Registered Direct Offering (Details)
Shareholders' Equity - Registration Rights Agreement (Details)
Shareholders' Equity - Required Shareholder Approval (Details)
Subsequent Events
Subsequent Events - July 2022 Financing (Details)
Supplemental Financial Information
Supplemental Financial Information (Tables)
Supplemental Financial Information - Property And Equipment (Details)
Ticker: RZLT
CIK: 1509261
Form Type: 10-K Annual Report
Accession Number: 0001558370-22-014432
Submitted to the SEC: Thu Sep 15 2022 4:45:43 PM EST
Accepted by the SEC: Thu Sep 15 2022
Period: Thursday, June 30, 2022
Industry: Pharmaceutical Preparations

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