bioAffinity Technologies Inc

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

About this filing

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$2.26-16.8%Stored close · as of Nov 9, 2026

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Contents

Cautionary Note Regarding Forward-Looking Statements

This Annual Report contains forward-looking statements within the meaning of the federal securities laws. Forward-looking statements are predictive in nature, depend on or refer to future events or conditions, and are sometimes identified by words such as “may,” “could,” “plan,” “project,” “predict,” “pursue,” “believe,” “expect,” “estimate,” “anticipate,” “intend,” “target,” “seek,” “potentially,” “will likely result,” “outlook,” “budget, “objective,” “trend,” or similar expressions of a forward-looking nature and the negative versions of such expressions. The forward-looking information contained in this report is generally located under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations” but may be found in other locations as well. The forward-looking statements in this report generally relate to the plans and objectives for future operations of bioAffinity Technologies, Inc. and are based on our management’s reasonable estimates of future results or trends. Although we believe these forward-looking statements are reasonable, all forward-looking statements are subject to various risks and uncertainties, and our projections and expectations may be incorrect. The factors that may affect our expectations regarding our operations include, among others, the following:

●	our projected financial position and estimated cash burn rate;
●	our estimates regarding expenses, future revenues, and capital requirements;
●	the success, cost, and timing of our clinical trials;
●	our ability to obtain funding for our operations necessary to complete further development and commercialization of our diagnostic tests or therapeutic product candidates;
●	our dependence on third parties in the conduct of our clinical trials;
●	our ability to obtain the necessary regulatory approvals to market and commercialize our diagnostic tests or therapeutic product candidates;
●	the potential that the results of our pre-clinical and clinical trials indicate our current diagnostic tests or any future diagnostic tests or therapeutic product candidates we may seek to develop are unsafe or ineffective;
●	the results of market research conducted by us or others;
●	our ability to obtain and maintain intellectual property protection for our diagnostic and therapeutic inventions or future diagnostic and therapeutic inventions to expand our product offerings;
●	our ability to protect our intellectual property (“IP”) rights and the potential for us to incur substantial costs from lawsuits to enforce or protect our IP rights;
●	the possibility that a third party may claim we or our third-party licensors have infringed, misappropriated, or otherwise violated their IP rights and that we may incur substantial costs and be required to devote substantial time defending against such claims;
●	our reliance on third parties;
●	the success of competing therapies, diagnostic tests, and therapeutic products that are or will become available;
●	our ability to expand our organization to accommodate potential growth and to retain and attract key personnel;
●	our potential to incur substantial costs resulting from product liability lawsuits against us and the potential for such lawsuits to cause us to limit the commercialization of our diagnostic tests and therapeutic product candidates;
●	market acceptance of our diagnostic tests and therapeutic product candidates, the size and growth of the potential markets for our current diagnostic tests and therapeutic product candidates, and any future diagnostic tests and therapeutic product candidates we may seek to develop, and our ability to serve those markets;
●	the successful development of our commercialization capabilities, including sales and marketing capabilities;
●	compliance with government regulations, including environmental, health, and safety regulations and liabilities thereunder;
●	the impact of a health epidemic on our business, our clinical trials, our research programs, healthcare systems, or the global economy as a whole;
●	general instability of economic and political conditions in the United States (“U.S.”), including inflationary pressures, increased interest rates, economic slowdown or recession, and escalating geopolitical tensions;
●	our anticipated uses of net proceeds from our initial public offering (“the IPO”) and subsequent direct offering (“the Direct Offering”);
●	the increased expenses associated with being a public company; and

Many of the foregoing risks and uncertainties, as well as risks and uncertainties that are currently unknown to us, are or may be exacerbated by factors such as the ongoing conflict between Ukraine and Russia, escalating tensions between China and Taiwan, the war in the Middle East, increasing economic uncertainty and inflationary pressures, and any consequent worsening of the global business and economic environment. New factors emerge from time to time, and it is not possible for us to predict all such factors. Should one or more of the risks or uncertainties described in this Annual Report or any other filing with the Securities and Exchange Commission (the “SEC”) occur, or should the assumptions underlying the forward-looking statements we make herein and therein prove incorrect, our actual results and plans could differ materially from those expressed in any forward-looking statements. We undertake no obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

You should read this Annual Report and the documents that we reference within it with the understanding that our actual future results, performance, and events and circumstances may be materially different from what we expect.

Website and Social Media Disclosure

We use our websites (www.bioaffinitytech.com and ir.bioaffinitytech.com) to share Company information. Information contained on or that can be accessed through our websites is not, however, incorporated by reference in this Annual Report. Investors should not consider any such information to be part of this Annual Report.

Forward-Looking Statements

This Annual Report contains forward-looking statements within the meaning of 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”), that involve substantial risks and uncertainties. The forward-looking statements are contained principally in Part I, Item 1. “Business,” Part I, Item 1A. “Risk Factors,” and Part II, Item 7. “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” but are also contained elsewhere in this Annual Report. In some cases, you can identify forward-looking statements by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions. These statements are based on our current beliefs, expectations, and assumptions and are subject to a number of risks and uncertainties, many of which are difficult to predict and generally beyond our control, that could cause actual results to differ materially from those expressed, projected, or implied in or by the forward-looking statements.

You should refer to Item 1A. “Risk Factors” section of this Annual Report for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this Annual Report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. We do not undertake any obligation to update any forward-looking statements. Unless the context requires otherwise, references to “we,” “us,” “our,” and “bioAffinity,” refer to bioAffinity Technologies, Inc. and its subsidiaries.

Summary of Risk Factors

Risks Related to Our Financial Position

●	Our business plan relies upon our ability to obtain additional sources of capital and financing.
●	We must raise additional capital to fund our operations in order to continue as a going concern.
●	Our limited operating history makes it difficult to evaluate our current business and future prospects.
●	We will require additional financing to implement our business plan.

Risks Related to the Acquisition of Precision Pathology Laboratory Services (“PPLS”)

●	The combined company may not experience the anticipated strategic benefits of the acquisition.
●	We may not be able to enforce claims under the Asset Purchase Agreement.
●	We are unable to estimate when we will begin to generate significant profit from revenue.
●	Operating a clinical laboratory is a new business for us, and we have limited experience doing so.

Risks Related to our Diagnostic Product

●	The FDA could promulgate regulations that impose greater regulatory burdens on laboratory developed tests (“LDTs”) such as CyPath® Lung.
●	Clinical trials are expensive, time-consuming, and may not be successful.
●	Delays or difficulties in the enrollment of patients could delay or prevent the regulatory approvals.

Risks Related to Our Diagnostic Tests

●	If our tests do not perform as expected, our operating results, reputation, and business will suffer.
●	We may experience delays in development, introduction, or marketing of enhanced or new tests.
●	If clinical testing does not yield successful results, we will be unable to commercialize that test or product candidate.
●	Even if our tests or products receive marketing approval, they may fail to achieve market acceptance.
●	We may not be successful in commercializing our diagnostic tests or therapeutic products.
●	We are currently dependent upon PPLS to offer and perform CyPath® Lung.
●	Market acceptance may depend upon our ability to convince physicians of benefits of our tests or products.
●	We face substantial competition.
●	Our success depends upon our ability to retain and attract key executives and qualified personnel.
●	Our lack of operating experience may make it difficult to manage our growth.
●	Failure to comply with obligations imposed by intellectual property licenses could result in loss of rights.
●	We may need to obtain additional licenses of technology that may not be available to us.
●	We will depend on third parties to manufacture and market our diagnostic tests and to design trial protocols.
●	We are exposed to product liability and pre-clinical and clinical liability risks.
●	Our failure to comply with privacy and security regulations could result in significant liability.
●	Our ability to obtain adequate reimbursement from third-party payors may impact our revenues.
●	Our employees, consultants, partners, and vendors may engage in misconduct or other improper activities.
●	Failure to comply with healthcare fraud and abuse laws and regulations could result in penalties.
●	We face intense competition in the biotechnology and pharmaceutical industries.
●	The market for our proposed tests and products is competitive and rapidly changing.
●	Healthcare cost containment initiatives and the growth of managed care may limit our returns.
●	Our competitive position depends on protection of our intellectual property.
●	Diagnostic tests and therapeutic products we develop could be subject to infringement claims.

●	We may become involved in lawsuits to protect or enforce our intellectual property.
●	If we are unable to protect our trade secrets, our business and competitive position could be harmed.
●	Disruption of our internal information technology systems will adversely affect our business.
●	Declining general economic or business conditions may have a negative impact on our business.
●	Global climate change and related regulations could negatively affect our business.

Risks Related to the Operation of a CAP/CLIA Laboratory

●	The operations of PPLS depend in part upon Roby Joyce, M.D., and his relationship with existing customers.
●	PPLS may be unable to effectively maintain equipment.
●	We will be adversely impacted if our sole laboratory facility becomes inoperable.
●	PPLS relies on commercial courier delivery services to transport sputum samples for CyPath® Lung.
●	Security breaches, loss of data, and other disruptions could compromise sensitive information.
●	If PPLS uses hazardous chemicals in a manner that causes injury, PPLS could be liable for damages.
●	If PPLS is unable to scale its operations to support demand for CyPath® Lung, its business could suffer.
●	Delays of third-party billing and collection providers could have an adverse effect on PPLS.

Risks Related to Intellectual Property Rights

●	Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
●	Changes in patent law could impair our ability to protect our tests and product candidates.
●	Our patent protection could be impacted by non-compliance with requirements of patent agencies.
●	Patent terms may be inadequate to protect our diagnostic tests or therapeutic product candidates.
●	Issued patents covering our product candidates could be found invalid or unenforceable if challenged.
●	If we do not obtain patent term extension, our business may be harmed.
●	We enjoy only limited geographical protection with respect to certain patents.
●	If our trademarks and trade names are not adequately protected, we may not be able to build name recognition.

Risks Related to Government Regulations

●	Should the FDA disagree that CyPath® Lung is an LDT our commercialization strategy may be adversely affected.
●	FDA failure to grant our request for de novo classification would adversely affect our business.
●	Noncompliance with laws pertaining to LDTs or in vitro devices (“IVDs”) could adversely affect our business.
●	The third-party licensors of our future therapeutic products, may be unable to obtain regulatory approval.
●	We may fail to obtain regulatory approval in foreign jurisdictions.
●	We may never obtain approval or commercialize such products outside of the U.S.
●	The impact of healthcare spending and recent healthcare reform legislation is currently unknown.

●	We do not expect to pay dividends in the foreseeable future.
●	The Tradeable Warrants may never have a market price that exceeds the exercise price and holders have no rights as stockholders until the warrants are exercised.
●	The provisions of the Tradeable Warrants could limit a holder’s ability to choose a judicial forum for disputes.
●	Our failure to file a registration statement to register the Common Stock issuable upon exercise of the Warrants that we issued in March 2024 or to timely hold a stockholders’ meeting to obtain stockholder approval will result in a breach of the Securities Purchase Agreement.
●	We may be unable to meet the continued listing requirements of The Nasdaq Capital Market.
●	Our stock price has been volatile and thinly traded, and may be volatile in the future.
●	An investment in our Company may involve tax implications.
●	Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
●	Our Certificate of Incorporation permits “blank check” Preferred Stock.
●	Certain provisions in our Charter and Amended and Restated (“A&R”) Bylaws could make a merger, tender offer, acquisition or proxy contest difficult and have anti-takeover effects.
●	Our Charter designates a state or federal court located within Delaware as the exclusive forum for disputes.
●	Certain provisions in our Charter and A&R Bylaws may discourage stockholder lawsuit.

●	Our management collectively owns a substantial percentage of our Common Stock.
●	Any inability to file our financial results accurately and timely could harm our reputation and stock price.

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