CytoDyn Inc. Files 2024 Annual Report

TL;DR

CYDY filed its 2024 10-K. All systems go for pharma prep.

AI Summary

CytoDyn Inc. filed its 10-K for the fiscal year ending May 31, 2024. The company, previously known as Rexray Corp, is incorporated in Delaware and operates in the pharmaceutical preparations sector. Its principal executive offices are located at 1111 Main Street, Suite 660, Vancouver, WA 98660.

Why It Matters

This filing provides a comprehensive overview of CytoDyn Inc.'s financial performance and business operations for the fiscal year, which is crucial for investors and stakeholders to assess the company's current standing and future prospects.

Risk Assessment

Risk Level: medium — As a pharmaceutical company, CytoDyn Inc. faces inherent risks related to drug development, regulatory approvals, and market competition, which are typical for the industry.

Key Players & Entities

• CytoDyn Inc. (company) — Filer
• Rexray Corp (company) — Former company name
• 20240531 (date) — Fiscal year end
• 1111 Main Street, Suite 660, Vancouver, WA 98660 (address) — Business and mailing address
• 2834 (industry_code) — Standard Industrial Classification for Pharmaceutical Preparations

FAQ

Key Financial Figures

• $0.001 — itle of class Common Stock, par value $0.001 per share Indicate by check mark if t
• $99.2 million — 4, the Company has written-off the full $99.2 million 4 Table of Contents of previously
• $43,821,231.32 — tructured under the Letter Agreement is $43,821,231.32. Except for a single $250,000 payment d
• $250,000 — is $43,821,231.32. Except for a single $250,000 payment due on or before December 31, 2
• $12,000,000 — t include: (i) the payment by Amarex of $12,000,000 to the Company, of which $10,000,000 wa
• $10,000,000 — of $12,000,000 to the Company, of which $10,000,000 was paid on execution of the Settlement
• $6,500,000 — pany's cash collateral in the amount of $6,500,000 provided as security to the surety; (ii
• $14,000,000 — ts CRO services, totaling approximately $14,000,000, reducing the Company's outstanding bal

Filing Documents

• cydy-20240531x10k.htm (10-K) — 2516KB
• cydy-20240531xex21.htm (EX-21) — 4KB
• cydy-20240531xex23d1.htm (EX-23.1) — 6KB
• cydy-20240531xex23d2.htm (EX-23.2) — 4KB
• cydy-20240531xex31d1.htm (EX-31.1) — 9KB
• cydy-20240531xex31d2.htm (EX-31.2) — 9KB
• cydy-20240531xex32.htm (EX-32) — 6KB
• cydy-20240531x10k004.jpg (GRAPHIC) — 3KB
• 0001558370-24-012328.txt ( ) — 11003KB
• cydy-20240531.xsd (EX-101.SCH) — 89KB
• cydy-20240531_cal.xml (EX-101.CAL) — 66KB
• cydy-20240531_def.xml (EX-101.DEF) — 334KB
• cydy-20240531_lab.xml (EX-101.LAB) — 580KB
• cydy-20240531_pre.xml (EX-101.PRE) — 569KB
• cydy-20240531x10k_htm.xml (XML) — 1867KB

FORWARD-LOOKING STATEMENTS

FORWARD-LOOKING STATEMENTS 3 PART I ITEM 1.

BUSINESS

BUSINESS 4 ITEM 1A.

RISK FACTORS

RISK FACTORS 23 ITEM 1B. UNRESOLVED STAFF COMMENTS 37 ITEM 1C. CYBERSECURITY 37 ITEM 2.

PROPERTIES

PROPERTIES 37 ITEM 3.

LEGAL PROCEEDINGS

LEGAL PROCEEDINGS 38 ITEM 4. MINE SAFETY DISCLOSURES 38 PART II 38 ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES 38 ITEM 6. [RESERVED] 39 ITEM 7.

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 39 ITEM 7A.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 47 ITEM 8.

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 48 ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE 84 ITEM 9A.

CONTROLS AND PROCEDURES

CONTROLS AND PROCEDURES 84 ITEM 9B. OTHER INFORMATION 85 PART III 85 ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 85 ITEM 11.

EXECUTIVE COMPENSATION

EXECUTIVE COMPENSATION 85 ITEM 12.

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS 85 ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE 85 ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES 86 PART IV 86 ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES 86 ITEM 16. FORM 10-K SUMMARY 90 2 Table of Contents FORWARD-LOOK ING STATEMENTS This annual report contains certain forward-looking statements that involve risks, uncertainties, and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction, or disappointment with current prospects, as well as words such as "believes," "intends," "estimates," "expects," "projects," "plans," "anticipates" and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Our forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements. In evaluating all such statements, we urge you to specifically consider various risk factors identified in this annual report, including the matters set forth under the heading Risk Factors, any of which could cause actual results to differ materially from those indicated by our forward-looking statements. Our forward-looking statements reflect our current views with respect to future events and are based on currently available financial, economic, scientific, and competitive data and information on current business plans. Forward-looking statements may include, among others, statements about leronlimab, its ability to provide positive health outcomes, the Company's ability to implement a successful operating strategy for the development of leronlimab and thereby create shareholder value, the ability to obtain regulatory approval of the Company's drug products for commercial sales, and the strength o

BUSINESS

Item 1. BUSINESS Corporate History/Business Overview CytoDyn Inc. (the "Company") was originally incorporated under the laws of Colorado on May 2, 2002, under the name RexRay Corporation and, effective August 27, 2015, reincorporated under the laws of Delaware. The Company is a clinical-stage biotechnology company focused on the clinical development of innovative treatments for multiple therapeutic indications based on its product candidate, leronlimab (also referred to as PRO 140), a novel humanized monoclonal antibody targeting the C-C chemokine receptor type 5 ("CCR5"). The pre-clinical and early clinical development of PRO 140 was led by Progenics through 2011. The Company acquired the asset from Progenics in October 2012. In November 2018, the United States Adopted Names Council adopted "leronlimab" as the official nonproprietary name for PRO 140. The Company has conducted clinical trials of leronlimab as a viral entry inhibitor for human immunodeficiency virus ("HIV"), believed to competitively bind to the N-terminus and second extracellular loop of the CCR5 receptor. For immunology, the CCR5 receptor is believed to be implicated in immune-mediated illnesses such as Metabolic dysfunction-associated steatohepatitis ("MASH"), formerly known as nonalcoholic steatohepatitis ("NASH"). The CCR5 receptor may also be present on cells that undergo malignant transformation and in the tumor microenvironment. Studies of leronlimab have also been conducted in MASH and solid tumors in oncology, in addition to HIV, where CCR5 is believed to play an integral role. Our principal business office is located at 1111 Main Street, Suite 660, Vancouver, Washington 98660. Our website can be found at www.cytodyn.com. We make available on our website, free of charge, the proxy statements and reports on Forms 8-K, 10-K, and 10-Q that we file with the Securities and Exchange Commission ("SEC"), as soon as reasonably practicable after such materials are electronically filed with or fu

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View this 10-K filing on SEC EDGAR