Rezolute, Inc. Files 2024 Annual Report

TL;DR

Rezolute's 2024 10-K is in: check financials & biz ops for the year.

AI Summary

Rezolute, Inc. filed its 10-K for the fiscal year ending June 30, 2024, reporting financial results and business operations. The company, formerly known as AntriaBio, Inc., is based in Redwood City, CA. Key financial figures and details about its business, including its former names and incorporation in Nevada, are part of this comprehensive filing.

Why It Matters

This 10-K filing provides investors and stakeholders with a detailed overview of Rezolute, Inc.'s financial health, strategic direction, and potential risks for the fiscal year 2024.

Risk Assessment

Risk Level: medium — As a pharmaceutical preparations company, Rezolute faces inherent risks related to drug development, regulatory approvals, and market competition.

Key Numbers

• $53.246M — Prepaid Expense and Other Assets Current (Reported for the fiscal year ending 2024-06-30)
• $36.827M — Prepaid Expense and Other Assets Current (Reported for the fiscal year ending 2023-06-30)

Key Players & Entities

• Rezolute, Inc. (company) — Filer of the 10-K
• 20240630 (date) — Fiscal year end
• AntriaBio, Inc. (company) — Former company name
• 275 SHORELINE DRIVE, SUITE 500 REDWOOD CITY, CA 94065 (address) — Business and mailing address
• 650-206-4507 (phone_number) — Business phone number

FAQ

Key Financial Figures

• $0.001 — ich registered Common Stock, par value $0.001 RZLT Nasdaq Capital Market Securi
• $0.993 — sed on the last reported sales price of $0.993 as quoted on the Nasdaq Capital Market

Filing Documents

• rzlt-20240630x10k.htm (10-K) — 1957KB
• rzlt-20240630xex4d1.htm (EX-4.1) — 62KB
• rzlt-20240630xex10d4.htm (EX-10.4) — 123KB
• rzlt-20240630xex10d36.htm (EX-10.36) — 192KB
• rzlt-20240630xex10d37.htm (EX-10.37) — 143KB
• rzlt-20240630xex21d1.htm (EX-21.1) — 8KB
• rzlt-20240630xex23d1.htm (EX-23.1) — 3KB
• rzlt-20240630xex23d2.htm (EX-23.2) — 3KB
• rzlt-20240630xex31d1.htm (EX-31.1) — 18KB
• rzlt-20240630xex32d1.htm (EX-32.1) — 9KB
• rzlt-20240630xex97.htm (EX-97) — 34KB
• 0001558370-24-012901.txt ( ) — 9975KB
• rzlt-20240630.xsd (EX-101.SCH) — 70KB
• rzlt-20240630_cal.xml (EX-101.CAL) — 53KB
• rzlt-20240630_def.xml (EX-101.DEF) — 324KB
• rzlt-20240630_lab.xml (EX-101.LAB) — 508KB
• rzlt-20240630_pre.xml (EX-101.PRE) — 501KB
• rzlt-20240630x10k_htm.xml (XML) — 1637KB

Business

Item 1. Business 1

Risk Factors

Item 1A. Risk Factors 7

Unresolved Staff Comments

Item 1B. Unresolved Staff Comments 19

Cybersecurity

Item 1C. Cybersecurity 19

Properties

Item 2. Properties 20

Legal Proceedings

Item 3. Legal Proceedings 20

Mine Safety Disclosures

Item 4. Mine Safety Disclosures 20 Part II

Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 20

[Reserved]

Item 6. [Reserved] 21

Management's Discussion and Analysis of Financial Condition and Result of Operations

Item 7. Management's Discussion and Analysis of Financial Condition and Result of Operations 21

Quantitative and Qualitative Disclosures About Market Risk

Item 7A. Quantitative and Qualitative Disclosures About Market Risk 30

Financial Statements and Supplementary Data

Item 8. Financial Statements and Supplementary Data 31

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 60

Controls and Procedures

Item 9A. Controls and Procedures 60

Other Information

Item 9B. Other Information 61

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 62 Part III

Directors, Executive Officers and Corporate Governance

Item 10. Directors, Executive Officers and Corporate Governance 62

Executive Compensation

Item 11. Executive Compensation 62

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 62

Certain Relationships and Related Transactions, and Director Independence

Item 13. Certain Relationships and Related Transactions, and Director Independence 63

Principal Accounting Fees and Services

Item 14. Principal Accounting Fees and Services 63 Part IV

Exhibits and Financial Statement Schedules

Item 15. Exhibits and Financial Statement Schedules 63

Form 10-K Summary

Item 16. Form 10-K Summary 66

Signatures

Signatures 67 -i- - Table of Contents CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K for the fiscal year ended June 30, 2024 ("Annual Report") contains statements reflecting assumptions, expectations, projections, intentions or beliefs about future events that are intended as "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements included or incorporated by reference in this Annual Report, other than statements of historical fact, that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. These statements appear in a number of places, including, but not limited to " Management's Discussion and Analysis of Financial Condition and Results of Operations." These statements represent our reasonable judgment of the future based on various factors and using numerous assumptions and are subject to known and unknown risks, uncertainties and other factors that could cause our actual results and financial position to differ materially from those contemplated by the statements. You can identify these statements by the fact that they do not relate strictly to historical or current facts, and use words such as "anticipate," "believe," "estimate," "expect," "forecast," "may," "should," "plan," "project" and other words of similar meaning. In particular, these include, but are not limited to, statements relating to the following: our ability to obtain regulatory approvals or remove regulatory holds for clinical trials and our drug candidates; expectations regarding clinical development and the timing of clinical trials in the United States and outside of the United States; projected operating or financial results, including anticipated cash flows to be used in operating activities; expectations regarding capital expenditures, research and development expenses and the timin

Business

Item 1. Business. Rezolute, Inc. ("Rezolute", the "Company", "we" or "us") is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism ("HI"). Summary of Clinical Assets Ersodetug (formerly RZ358) Our lead clinical asset, ersodetug (formerly RZ358), is a potential treatment for hypoglycemia caused by multiple forms of hyperinsulinism. Ersodetug is an intravenously administered human monoclonal antibody that binds to a unique site (allosteric) on the insulin receptor in insulin target tissues, such as in the liver, fat, and muscle. The antibody down modulates insulin's binding, signaling, and action thereby counteracting the effects of elevated insulin in the body, and helping to restore glucose to a more normalized range. Ersodetug shows dose dependent pharmacokinetics with a half-life greater than 2 weeks, which has the potential for twice or even once monthly dosing. Therefore, we believe that ersodetug is ideally suited as a potential therapy for conditions characterized by excessive insulin levels, and it is being developed to treat hyperinsulinism and low blood sugar. As ersodetug acts downstream from the beta cells, it has the potential to be universally effective at treating hypoglycemia related to HI, whether genetic or caused by tumors. Ersodetug for congenital HI Congenital HI is the most common cause of recurrent and persistent hypoglycemia in children. Individuals with congenital HI typically present with signs or symptoms of hypoglycemia shortly after birth. Hypoglycemia can result in significant brain injury and death if not recognized and managed appropriately. Additionally, recurrent, or cumulative, hypoglycemia can lead to progressive and irreversible damage over time, including serious and devastating brain injury, seizures, neuro-developmental problems, feeding difficulties, and significant impact on patient and family quality of life. In cases that are unre

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View this 10-K filing on SEC EDGAR