Zeo Scientifix, INC. 10-K Filing

Ticker: ZEOX · Form: 10-K · Filed: Jan 29, 2025 · CIK: 1557376

Sentiment: neutral

Filing Stats: 4,443 words · 18 min read · ~15 pages · Grade level 16.1 · Accepted 2025-01-29 16:05:38

Key Financial Figures

Filing Documents

FORWARD LOOKING STATEMENTS

FORWARD LOOKING STATEMENTS ii

BUSINESS

ITEM 1. BUSINESS 1

RISK FACTORS

ITEM 1A. RISK FACTORS 19

UNRESOLVED STAFF COMMENTS

ITEM 1B. UNRESOLVED STAFF COMMENTS 38

PROPERTIES

ITEM 2. PROPERTIES 39

LEGAL PROCEEDINGS

ITEM 3. LEGAL PROCEEDINGS 39

MINE SAFETY DISCLOSURES

ITEM 4. MINE SAFETY DISCLOSURES 39 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 40

[RESERVED]

ITEM 6. [RESERVED] 41

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

ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 42

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 46

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA F-1

CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE 47

CONTROLS AND PROCEDURES

ITEM 9A. CONTROLS AND PROCEDURES 47

OTHER INFORMATION

ITEM 9B. OTHER INFORMATION 48 PART III

DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 49

EXECUTIVE COMPENSATION

ITEM 11. EXECUTIVE COMPENSATION 52

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 55

CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE

ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE 57

PRINCIPAL ACCOUNTING FEES AND SERVICES

ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES 58 PART IV

EXHIBITS, FINANCIAL STATEMENT SCHEDULES

ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES 60

FORM 10-K SUMMARY

ITEM 16. FORM 10-K SUMMARY 63

FORWARD LOOKING STATEMENTS

FORWARD LOOKING STATEMENTS This Annual Report on Form 10-K (this " Annual Report ") and certain information incorporated herein by reference contain forward-looking statements and information within the " safe harbor " provisions of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended (the " Securities Act ") and Section 21E of the Securities Exchange Act of 1934, as amended (the " Exchange Act "). This information includes assumptions made by, and information currently available to management, including statements regarding future economic performance and financial condition, liquidity and capital resources, acceptance of our products by the market, and management's plans and objectives. In addition, certain statements included in this and our future filings with the Securities and Exchange Commission (the " SEC "), in press releases, and in oral and written statements made by us or with our approval, which are not statements of historical fact, are forward-looking statements. Words such as " may ," " could ," " should ," " would ," " believe ," " expect ," " expectation ," " anticipate ," " estimate ," " intend ," " seeks ," " plan ," " project ," " continue ," " predict ," " will ," " should ," and other words or expressions of similar meaning are intended by us to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are found at various places throughout this Annual Report and in the documents incorporated herein by reference. These statements are based on our current expectations about future events or results and information that is currently available to us, involve assumptions, risks, and uncertainties, and speak only as of the date on which such statements are made.

Forward-looking statements include, but are not limited to, the following

Forward-looking statements include, but are not limited to, the following: Our products' advantages; Expectations regarding our future growth; Expectations regarding available cash resources to fund current operations and future growth; Our ability to comply with regulations governing the production and sale of our products; Our ability to receive regulatory approvals; Market opportunities for our services and products; Clinical trial outcomes; Our ability to compete effectively; Our ability to respond to market forces; and Our ability to protect our intellectual property. Actual results and outcomes may differ materially from those expressed or implied in these forward-looking statements. Factors that may cause such a difference include, but are not limited to, those discussed in Part I, Item 1A . Risk Factors , below. Except as expressly required by the federal securities laws, we undertake no obligation to update any such factors, or to publicly announce the results of, or changes to any of the forward-looking statements contained herein to reflect future events, developments, changed circumstances, or for any other reason. Various trademarks, service marks, trade names and logos of the Company appear in this Annual Report and are the property of Zeo. Other trademarks, service marks or trade names appearing in this Annual Report are the property of their respective holders. Solely for convenience, trademarks, service marks, trade names and logos referred to in this Annual Report may appear without the , and symbols, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or that the applicable owner will not assert its rights, to these trademarks, trade names, service marks and logos. Unless otherwise noted, as used in this Annual Report, the terms " Zeo ," the " Company ," " we ," " our " and " us " refer to Zeo ScientifiX, Inc., a Nevada corporation, an

Business

Item 1. Business. Overview We are a clinical-stage biopharmaceutical company principally focusing on the development of innovative biological therapeutics for the treatment of degenerative diseases and regenerative medicine. The Company's proprietary products, including Zofin, are derived from perinatal sources and manufactured to retain the naturally occurring extracellular vesicles, proteins and cell secreted nanoparticles and Patient Pure X (" PPX "), an autologous biologic containing a nanoparticle fraction that is precipitated from a patient's own peripheral blood (" RAAM Products "). Our RAAM Products and related services are principally used in the health care industry administered through doctors and clinics (" Providers "). ZEO operates an extracellular vesicle processing laboratory in Davie, Florida for the purpose of performing research and development and the manufacturing and processing of the anti-aging and cellular therapy derived products that we sell and distribute to our customers. The Company has recently developed and begun to distribute additional products that incorporate its proprietary ingredients for products to be used in topical aesthetic applications and is actively exploring further development of additional products to be used in other topical aesthetic applications. To date, the Company has obtained certain Investigational New Drug (" IND "), emergency IND (" eIND ") approvals from the FDA, including applicable Institutional Review Board (" IRB ") approvals which authorized the Company to commence clinical trials or treatments in connection with the use of Zofin and related treatment protocols. The Company is pursuing efforts to complete its already approved clinical studies as well as obtaining approval to commence additional studies for other specific indications it has identified that the use of its products will provide more favorable and desired health related benefits for patients seeking alternative treatment options tha

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