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bioAffinity Technologies Inc

For the period ended Dec 31, 2023. Filed Apr 1, 2024.

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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.

FY2023 · Filed Apr 1, 2024

BIAF$2.72+4.4%Stored close · as of Nov 6, 2026
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K

(Mark One)

For the fiscal year ended December 31,2023.

OR

☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For transition period from ____ to ____.

Commission file number 001-41463

(Exact name of registrant as specified in its charter)

Delaware46-5211056
(State or other jurisdiction of incorporation)(I.R.S. Employer Identification No.)
22211 W Interstate 10 Suite 1206 San Antonio, Texas78257
(Address of principal executive offices)(Zip Code)

(210) 698-5334

**(**Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each classTrading Symbol(s)Name of each exchange on which registered
Common stock, par value $0.007 per shareBIAFThe Nasdaq Stock Market LLC
Tradeable Warrants to purchase Common StockBIAFWThe Nasdaq Stock Market LLC

Securities registered pursuant to section 12(g) of the Act:None.

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.

Yes ☐No ☒

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.

Yes ☐No ☒

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).

Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer☐Accelerated filer☐
Non-accelerated filer☒Smaller reporting company☒
Emerging growth company☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.☐

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No☒

The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant, based on the closing price of a share of the registrant’s common stock on June 30, 2023, as reported by the Nasdaq Capital Market on such date was approximately $14.0 million. Shares of the registrant’s common stock held by each executive officer, director and holder of 5% or more of the outstanding common stock have been excluded in that such persons may be deemed to be affiliates. This calculation does not reflect a determination that certain persons are affiliates of the registrant for any other purpose.

The number of shares outstanding of the issuer’s common stock, $0.007 par value, is 11,514,354 as of March 20, 2024.

DOCUMENTS INCORPORATED BY REFERENCE

Portions of the registrant’s definitive proxy statement relating to the 2024 annual meeting of stockholders are incorporated by reference into Part III of this Annual Report on Form 10-K where indicated. Such definitive proxy statement will be filed with the Securities and Exchange Commission within 120 days after the end of the registrant’s fiscal year ended December 31, 2023.

TABLE OF CONTENTS

Page
Cautionary Note Regarding Forward-Looking Statements3
PART I
Item 1.Business6
Item 1A.Risk Factors21
Item 1B.Unresolved Staff Comments46
Item 1C.Cybersecurity47
Item 2.Properties47
Item 3.Legal Proceedings47
Item 4.Mine Safety Disclosures47
PART II
Item 5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities48
Item 6.[Reserved]48
Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations48
Item 7A.Quantitative and Qualitative Disclosures About Market Risk53
Item 8.Financial Statements and Supplementary Data53
Item 9.Changes in and Disagreements With Accountants on Accounting and Financial Disclosure53
Item 9A.Controls and Procedures54
Item 9B.Other Information54
Item 9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspections54
PART III
Item 10.Directors, Executive Officers and Corporate Governance55
Item 11.Executive Compensation55
Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters55
Item 13.Certain Relationships and Related Transactions, and Director Independence55
Item 14.Principal Accountant Fees and Services55
PART IV
Item 15.Exhibit and Financial Statement Schedules56
Signatures59

Throughout this Annual Report on Form 10-K (the “Annual Report”), the terms “bioAffinity,” “bioAffinity Technologies,” “we,” “us,” “our” or “Company” refer to bioAffinity Technologies, Inc., a Delaware corporation, and its wholly owned subsidiaries, OncoSelect® Therapeutics, LLC, a Delaware limited liability company, and Precision Pathology Laboratory Services, LLC, a Texas limited liability company.

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