As filed with the Securities and ExchangeCommission on April 25, 2022.

RegistrationNo. 333-

UNITEDSTATES

SECURITIESAND EXCHANGE COMMISSION

Washington,D.C. 20549

FORMS-1

REGISTRATIONSTATEMENT UNDER THE SECURITIES ACT OF 1933

bioAffinityTechnologies, Inc.

(Exactname of registrant as specified in its charter)

22211W Interstate 10

Suite1206

SanAntonio, Texas 78257

210-698-5334

(Address,including zip code, and telephone number, including area code, of registrant’s principal executive offices)

MariaZannes

ChiefExecutive Officer

22211W Interstate 10

Suite1206

SanAntonio, Texas 78257

210-698-5334

(Name,address, including zip code, and telephone number, including area code, of agent for service)

Copiesto:

Approximatedate of commencement of proposed sale to the public: As soon as practicable after the effective date of this registration statement.

Ifany of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under theSecurities Act of 1933 check the following box: ☐

Ifthis Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check thefollowing box and list the Securities Act registration statement number of the earlier effective registration statement for the sameoffering. ☐

Ifthis Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list theSecurities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Ifthis Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list theSecurities Act registration statement number of the earlier effective registration statement for the same offering. ☐

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

Ifan emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complyingwith any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐

TheRegistrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until theRegistrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effectivein accordance with Section 8(a) of the Securities Act of 1933 or until the Registration Statement shall become effective on such dateas the Commission, acting pursuant to said Section 8(a), may determine.

Theinformation in this prospectus is not complete and may be changed. We may not sell these securities until the registration statementfiled with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities, and it is notsoliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

Subjectto Completion, dated April 25, 2022.

PRELIMINARYPROSPECTUS

____Shares

bioAffinityTechnologies, Inc.

CommonStock

bioAffinityTechnologies, Inc., a Delaware corporation headquarteredin Texas (the “Company”), develops noninvasive, early-stage diagnostics to detect, and is researching targetedtherapies to treat cancer at the cellular level.

Thisis the initial public offering (the “Offering”) of our Common Stock, $0.001 par value per share (the “CommonStock”). We are offering ________ shares of our Common Stock at an anticipated initial public offering price between $_____and $_____ per share. The actual public offering price of the Common Stock will be determined between the underwriters and usat the time of pricing, considering our historical performance and capital structure, prevailing market conditions, and overall assessmentof our business.

Priorto this Offering, there has been no public market for our Common Stock. We have applied to list our Common Stock on the Nasdaq CapitalMarket (“Nasdaq”) under the symbol “BIAF”.

Weare an “emerging growth company” and a “smaller reporting company” under applicable federal securities laws andwill be subject to reduced public company reporting requirements.

Immediatelyafter this Offering, our officers and directors will control approximately 70% of the voting power of our Common Stock, asdetermined in accordance with the beneficial-ownership provisions of Rule 13d-3 and Item 403 of Regulation S-K under the SecuritiesExchange Act of 1934, as amended (the “Exchange Act”). See the “Principal Stockholders” sectionbeginning on page 95 of this prospectus for a description of how beneficial ownership is calculated and related matters.

For so long as 30% of the shares of our“Series A Convertible Preferred Stock,” par value $0.001 per share (our “Series A PreferredStock”), remain outstanding, the holders of our Series A Preferred Stock, voting as a separate class, are entitled toelect one director of the Company (such right, the “Series A Director Designation Right”; such director,the “Series A Representative”). Immediately prior to the closing of this Offering, all of the issued andoutstanding shares of Series A Preferred Stock will be automatically converted into fully paid and nonassessable shares of CommonStock at the then-effective conversion rate of the Series A Preferred Stock immediately prior to the closing of this Offering.Following such automatic conversion, the Company will never again issue the shares so converted, all such converted shares willcease to be part of the Company’s authorized stock, and the Series A Director Designation Right will cease to exist becausefewer than 30% of the Series A Preferred Stock shares will be outstanding. The director who currently serves as the Series ARepresentative, however, will continue to serve as a director until his earlier resignation or removal or until his successor isduly elected and qualified. The number of Board seats for election by the holders of the Common Stock will be expanded by one sothat the director position that the holders of the Series A Preferred Stock were previously entitled to elect will be subject toelection by the holders of the Common Stock following the conversion of the Series A Preferred Stock into Common Stock in connectionwith this Offering. See the “Management—Board of Directors Composition” section of this prospectus.

Investingin our Common Stock involves a high degree of risk. See the “Risk Factors” section beginning on page 14 of this prospectusfor a discussion of the factors that you should consider before investing in our Common Stock.

Neitherthe Securities and Exchange Commission (the “SEC”) nor any state securities commission has approved or disapprovedof these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

Wehave granted the representative of the underwriters a 45-day option to purchase up to a total of ___ additional shares of Common Stockfrom us at the initial public offering price less the underwriting discounts.

Theunderwriters expect to deliver the shares of Common Stock to purchasers on or about [Date], 2022 through the book-entry facilities ofThe Depository Trust Company.

SoleBook-Running Manager

WallachBethCapital, LLC

Thedate of this prospectus is April 25, 2022.

bioAffinityTechnologies, Inc.

TABLEOF CONTENTS

Market,industry, and other data

Aboutthis Prospectus

Youshould rely only on the information contained in this prospectus prepared by us or on our behalf or to which we have referred you. Wehave not, and the underwriters have not, authorized any other person to provide you with information different from that contained inthis prospectus. If anyone provides you with different or inconsistent information, you should not rely on it. We are not, and the underwritersare not, making an offer to sell the securities described herein in any jurisdiction where an offer or sale is not permitted. The informationin this prospectus is accurate only as of the date of this prospectus, regardless of the time of delivery of this prospectus or any saleof our Common Stock. Our business, financial condition, results of operations, and prospects may have changed since that date.

Thisprospectus contains forward-looking statements that are subject to a number of risks and uncertainties, many of which are beyond ourcontrol. Please read “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements.”

Unlessthe context otherwise requires, the information in this prospectus (other than in the historical financial statements) assumes that theunderwriters will not exercise their option to purchase additional shares.

Throughand including _______ , 2022 (the 25^th day after the date of this prospectus), all dealers effecting transactions in thesesecurities, whether or not participating in this Offering, may be required to deliver a prospectus. This is in addition to a dealer’sobligation to deliver a prospectus when acting as an underwriter and with respect to an unsold allotment or subscription.

Forinvestors outside of the United States: Neither we nor any of the underwriters have done anything that would permit this Offeringor possession or distribution of this prospectus or any free writing prospectus we may provide to you in connection with this Offeringin any jurisdiction where action for that purpose is required, other than in the United States. Persons outside of the United Stateswho come into possession of this prospectus and any free writing prospectus must inform themselves about and observe any restrictionsrelating to this Offering and the distribution of this prospectus outside of the United States. See “Underwriting—Selling Restrictions” on page 111.

Industryand Market Data

Thisprospectus includes estimates regarding market and industry data. Unless otherwise indicated, information concerning our industry andthe markets in which we operate, including our general expectations, market position, market opportunity, and market size, are basedon our management’s knowledge and experience in the markets in which we operate, together with currently available informationobtained from various third-party sources, including publicly available information, industry reports and publications, surveys, ourcustomers, trade and business organizations, and other contacts in the markets in which we operate. Although we believe these third-partysources are reliable as of their respective dates, neither we nor the underwriters have independently verified the accuracy or completenessof this information. Some data is also based on our good faith estimates. The industry in which we operate is subject to a high degreeof uncertainty and risk due to a variety of factors, including those described in the section entitled “Risk Factors.” Theseand other factors could cause results to differ materially from those expressed in these publications.

Trademarksand Trade Names

Weown or have rights to various trademarks, service marks, and trade names that we use in connection with the operation of our business.This prospectus may also contain trademarks, service marks, and trade names of third parties, which are the property of their respectiveowners. Our use or display of third parties’ trademarks, service marks, trade names, or products in this prospectus is not intendedto, and does not imply a relationship with or endorsement or sponsorship by us. Solely for convenience, the trademarks, service marks,and trade names referred to in this prospectus may appear without the ®, TM or SM symbols, but such references are not intended toindicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the right of the applicablelicensor to these trademarks, service marks, and trade names.

PROSPECTUSSUMMARY

Thissummary provides an overview of information appearing elsewhere in this prospectus and highlights the key aspects of this Offering. Thissummary does not contain all of the information you should consider prior to investing in our Common Stock. You should read this entireprospectus carefully, including the sections titled “Risk Factors” and “Management’s Discussion and Analysisof Financial Condition and Results of Operations” and our consolidated financial statements and related notes appearing at theend of this prospectus, before making any investment decision. Our fiscal year ends on December 31. Unless the context otherwise requires,references to “bioAffinity,” the “Company,” “we,” “us,” and “our” in thisprospectus refer to bioAffinity Technologies, Inc. and our consolidated subsidiaries.

Overview

bioAffinityTechnologies, Inc. is a privately held company incorporated in Delaware addressing the need for noninvasive diagnosis of early-stagecancer and diseases of the lung, and targeted cancer treatment. Our Company develops proprietary noninvasive diagnostic testsand cancer therapeutics using technology that preferentially targets cancer cells and cell populations indicative of a diseased state.Research and optimization of our platform technologies are conducted in our laboratories at The University of Texas at San Antonio.We are developing our platform technologies so that, in the future, they will be able to detect and monitor diseases of the lungand other cancers and treat many cancers.

Morethan 100 different types of cancers have been identified, all marked by the abnormal and unrestricted proliferation of cells that caneventually kill a patient stricken with the disease. Lung, breast, prostate, and colorectal cancers are the most common, representingmore than half of all cancer diagnoses. Lung cancer alone, by far the deadliest, is responsible for an estimated 1.8 million deaths worldwideannually.¹

Apatient’s overall cancer survivability depends on the type of cancer and the stage at which cancer is treated. The early diagnosisof cancer, before it spreads, is a significant contributor to survival. This is true for lung cancer that is most often detected in laterstage when the cancer has spread to other parts of the body. However, if lung cancer is detected and treated early (Stage I), the currentoverall five-year survival rate of 20.5%² for Stages II-IV can leap to a 10-year survival rate of 92%.³

Currentdiagnostic protocols include lab tests, various imaging techniques, and biopsy followed by microscopic examination of tissue samples.None of these methods perfectly detects cancer cells, especially in the early stages of the disease. Low-dose computed tomography (LDCT)is recommended for screening patients at high risk for lung cancer. Results of a large clinical trial of more than 53,000 patientsshowed that screening for lung cancer by LDCT lowered the mortality rate by 20% as compared to x-ray imaging.^4,5 However,the study found that of every 100 people screened for lung cancer who received a positive LDCT result, fewer than four of those individualstruly had the disease. Consequently, there is a great and urgent need for better targeted diagnostic methods that are safe, accurate,rapid, noninvasive, and cost effective for the detection of early-stage lung cancer.

Ourfirst diagnostic test, CyPath^® Lung, addresses the need for early detection of lung cancer, the leading cause ofcancer-related deaths. In order to identify patients more confidently who need to undergo more invasive follow-up procedures, physicianswill be able to order CyPath^® Lung to assist in the assessment of the potential for the disease. CyPath^®Lung thus serves as another tool in the physician’s decision-making process to distinguish between patients who are likely to havelung cancer and will benefit from timely intervention and those who are likely without disease and should continue their annual screeningfor lung cancer.

CyPath^®Lung is a noninvasive test for the early detection of lung cancer. Our test uses flow cytometry to analyze the different type ofcells in a person’s sputum, or phlegm from the lungs, to find characteristics indicative of lung cancer, including cancerand cancer-related cells that have shed from a lung tumor. Flow cytometry is a technology to group cells into populations of cells thatlook similar, based on their size, internal structures, and the presence of certain molecules on the outside or inside of the cell. Flowcytometry does this one cell at a time, scanning a large number of cells in a relatively short time period. For example, an average sputumsample containing about 20 million cells can be profiled cell-by-cell by flow cytometry in less than 20 minutes using the CyPath^®Lung protocol. To collect a sputum sample, a patient blows into a hand-held, noninvasive assist device that acts to break up mucusin the lungs and help a person cough up the sputum from the lung into a collection cup. The sputum sample is shipped overnight to thelaboratory and processed in accordance with CyPath^® Lung protocol. Sample processing includes labeling cells with a syntheticporphyrin that attaches to cancer and cancer-associated cells (specifically, the porphyrin called meso-tetra (4-carboxyphenyl)porphine or “TCPP”). Sample processing also includes the use of antibodies that attach to specific types ofcells. The processed sputum sample is run through a flow cytometer that can identify cancer and cancer-related cells labeled by TCPPand other cell populations. The resulting data is automatically analyzed immediately after data acquisition by proprietaryautomated analysis software that is fully integrated into the test and generates both quantitative and qualitative diagnosticresults in the form of a patient report that is provided to the ordering physician.

CyPath^® Lunghas the potential to increase overall diagnostic accuracy of lung cancer leading to increased survival, lower the number ofunnecessary invasive procedures, reduce patient anxiety, and lower medical costs.⁶ bioAffinity Technologiesintends to develop the CyPath^® platform technology for use in the detection of other lung diseases, such aschronic obstructive pulmonary disease (“COPD”) and asthma. The Company further intends to developtests to detect other cancers, including prostate cancer at an early stage, and to monitor for recurrence of bladdercancer.

Throughour wholly owned subsidiary, OncoSelect^® Therapeutics, LLC, our Company is focused on expanding its broad platform technologiesto create targeted therapeutics to fight cancer. In researching how TCPP, the porphyrin used in CyPath^® Lung, enters cancercells, we discovered a novel potential therapy that kills cancer cells that have been grown in petri dishes without apparent harm tonormal cells. This approach uses RNA interference (“RNAi”), a natural mechanism for selectively silencing (eliminatingor “knocking down”) a gene. Genes provide cells with instructions for making proteins, and silencing a gene by RNAi refersto stopping or reducing production of the protein specified by that gene. We discovered that treating cells in the laboratory with certainsmall interfering RNAs (“siRNAs,” which are short, chemically synthesized nucleic acid molecules), we can silencethe two genes and thereby the production of two cell-surface proteins, causing potent and selective cancer cell death while leaving normalcells virtually unharmed. Our potential therapies will be achieved, in part, by advancing studies of the siRNA-driven silencing of twogenes encoding for the cell surface proteins CD320 and LRP2. We found that silencing these two genes resulted in cell death in multiplehuman cancer cell lines, including lung, breast, prostate, melanoma, and brain cancer cell lines, but left normal human fibroblast andbreast epithelial cells virtually unaffected.

Financial

Todate, we have devoted a substantial portion of our efforts and financial resources to the development of the CyPath^® Lungtest. As a result, since our inception in 2014, we have generated no revenue from sales of the CyPath^® Lung test and havefunded our operations principally through private sales of our equity or debt securities. We have never been profitable and, as of December31, 2021, we had an accumulated deficit of approximately $28.5 million. We currently have a total negative working capital of $11.6 million,including $8.7 million of convertible notes. We expect to continue to incur significant operating losses for the foreseeable future aswe continue the development of our diagnostic tests or therapeutic products and advance them through clinical trials.

CorporateInformation

Wewere incorporated in the State of Delaware on March 26, 2014. Our principal executive office is located at 22211 West Interstate10, Suite 1206, San Antonio, Texas 78257, and our telephone number at that address is (210) 698-5334. Our laboratory diagnostic andtherapeutic research is conducted at The Harvey Sandler Cancer Research Laboratories, which is located at Science Research Laboratories,Suite 1.424, University of Texas at San Antonio, San Antonio, Texas 78249. Our website address is https://www.bioaffinitytech.com/. Informationcontained on or that can be accessed through our website is not incorporated by reference into this prospectus. Investors should notconsider any such information to be part of this prospectus.

OrganizationalStructure

Thefollowing organizational chart depicts our principal operating subsidiaries:

Implicationsof Being an Emerging Growth Company

Wequalify as an “emerging growth company” (an “EGC”) as defined in the Jumpstart Our BusinessStartups Act of 2012. As an EGC, for up to five years, we may elect to take advantage of certain specified exemptions from reportingand other regulatory requirements that are otherwise generally applicable to public companies. For example, these exemptions would allowus to:

Certain of these reduced reporting requirements andexemptions were already available to us due to the fact that we also qualify as a “smaller reporting company” under SEC rules.For instance, smaller reporting companies are not required to obtain an auditor attestation and report regarding internal control overfinancial reporting, to provide a compensation discussion and analysis, or to provide a pay-for-performance graph or CEO pay ratiodisclosure, and they may present two, rather than three, years of audited financial statements and related MD&Adisclosure.

We may take advantage of these exemptions up untilthe last day of the fiscal year following the fifth anniversary of this Offering or until we are no longer an EGC, which would be thecase if (i) our total annual gross revenues are $1.07 billion or more; (ii) we issue more than $1 billion in non-convertible debt duringa consecutive three-year period; or (iii) we become a “large accelerated filer,” as defined in the Exchange Act. We may chooseto take advantage of some, but not all, of the available exemptions. We have taken advantage of certain reduced reporting obligationsin this prospectus. Accordingly, the information contained herein may be different than the information you receive from other publiccompanies in which you hold stock. For more information, see “Risk Factors—General Risk Factors—We are an “emerginggrowth company,” and the reduced disclosure requirements applicable to emerging growth companies may make our Common Stock lessattractive to investors.”

OurBusiness

bioAffinityTechnologies, Inc. focuses on the need for noninvasive diagnosis of early-stage cancer and diseases of the lung, and targetedcancer therapeutics. The Company has developed a proprietary platform for in vitro diagnostics of which the first is a noninvasivetest for early detection of lung cancer. The Company’s diagnostic tests are based on platform technologies that may be applicableto detecting other lung diseases such as chronic obstructive pulmonary disease (COPD) and asthma, and diagnosing other types ofcancer such as prostate and bladder cancers.

Once cancer has been diagnosed, a variety of treatment options are available,depending on the cancer type and stage. Surgery and radiation treatments are typically site-specific, while chemotherapy is usually systemicallyadministered. Chemotherapy presents a particular challenge because of a relative lack of selectivity for cancer cells and inability todifferentiate between normal, healthy cells and cancer cells. Ideally, site-specific delivery of cancer-killing drugs would treat thedisease and spare healthy cells. Our research to discover how the porphyrin used in CyPath^® Lung enters cancer cells hasled to discoveries that could lead to novel cancer therapeutics that selectively kill cancer cells of the lung, breast, brain, skin andprostate without apparent harm to normal (non-cancerous) cells.

OurFirst Diagnostic Test - CyPath^® Lung

Lungcancer remains the most commonly diagnosed cancer and the leading cause of cancer-related deaths worldwide. Globally, there were an estimated2.1 million lung cancer cases and 1.8 million lung cancer deaths in 2018.⁷ If detected and treated early (Stage I),the overall five-year survival rate of 21.5% leaps to a 10-year survival rate of 92%.⁸ Unfortunately, most lungcancer is detected in late stages. A large national clinical trial showed that screening for lung cancer using low-dose computed tomography(“LDCT”) can lower the mortality rate by 20% as compared to screening by x-ray if LDCT screeningis used by patients at high risk for lung cancer on an annual basis.⁹ LDCT is therefore recommended for screeningof an estimated 18 million Americans who are at high risk for lung cancer. However, LDCT was shown to have a low positive predictiverate of less than 4%. This means that for every 100 people who receive a positive result from LDCT screening and are suspected of havinglung cancer, only four of those patients truly have the disease. A reliable, noninvasive and cost-effective diagnostic test canincrease diagnosis of early-stage lung cancer while lowering the number of unnecessary and invasive procedures for patients with a falsepositive result from LDCT screening. (False positive means a person who does not have lung cancer but receives a positive result,in this case from LDCT screening.)

CyPath^®Lung is a test for early-stage lung cancer that is designed to meet the need for greater diagnostic certainty. Itsuse in conjunction with LDCT is predicted to improve the positive predictive value (the probability that patients with a positive LDCTscan truly have the disease) by a factor of five.¹⁰ Our analysis concludes that improving the positive predictive valueof LDCT with the use of CyPath^® Lung has the potential to subject fewer patients to the stresses of misdiagnosisor unnecessary diagnostic procedures such as biopsies, while also reducing healthcare costs.¹¹

TheCyPath^® Lung diagnostic process usessputum, or phlegm, that is obtained noninvasively in the privacy of a patient’s home. Physicians can order the test for patientsthey suspect have lung cancer or patients with a positive LDCT screening result. CyPath^® Lung uses flow cytometry to analyzecell populations in a person’s sputum to find characteristics indicative of lung cancer, including cancer or cancer-related cellsthat have shed from a lung tumor. A patient collects his or her sample using a hand-held, noninvasive assist device that acts to breakup mucus in the lungs and help a person cough up their sputum from the lung into a collection cup. The sputum sample is shippedovernight to a clinical pathology laboratory that is accredited by the College of American Pathologists (“CAP”)and certified by the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) program, and processedwith CyPath^® that includes antibodies that distinguish different cell types and the synthetic porphyrin TCPP that identifiescancer cells and/or cancer-associated cells. The sputum sample is analyzed using flow cytometry, a well-established technology that analyzesthe properties of single cells in minutes. An average sputum sample containing about 20 million cells can be profiled by flow cytometryin less than 20 minutes. Proprietary automated analysis software developed by the Company analyzes sample data in minutes, resultingin a patient report provided to the physician who orders the test.

A150-patient test validation trial of people at high risk for lung cancer including patients with the disease and those cancer-free resultedin CyPath^® Lung’s overall 88% specificity, meaning the ability to correctly identify a person withoutcancer, and 82% sensitivity, meaning the ability to correctly identify cancer in a person with the disease. For thesubset of high-risk patients in this trial who had lung nodules smaller than 20 millimeters (“mm”) orno nodules at all, this trial resulted in 92% sensitivity and 87% specificity. The detection of small lung nodules in people who haveearly-stage cancer can increase lung cancer survival.¹² CyPath^® Lung can be used with LDCT to find early-stagelung cancer. The CyPath^® technology is based on scientific work originating at Los Alamos National Laboratory in collaborationwith St. Mary’s Hospital (Colorado) in which cancer samples were differentiated from non-cancer samples with 100% accuracy.¹³The Los Alamos studies examined the active ingredient of CyPath^®, the synthetic porphyrin TCPP. Porphyrins arepigments that can be taken up by cells and can result in the cell fluorescing a red or purplish color that can be detected undera microscope or by flow cytometry. Porphyrins can be manmade, like TCPP, or they can be naturally occurring, like heme that is responsiblefor the red color in red blood cells. Cancer cells are known to take up certain porphyrins in higher amounts than non-cancer cells, andthe high affinity for cancer cells displayed by TCPP makes it an excellent bio-label for cancer.¹⁴

Weconducted market research with pulmonologists, oncologists, cardiothoracic surgeons, radiologists, and internists engaged in thediagnosis and treatment of lung cancer to help assess these stakeholders’ reactions to the new diagnostic test.Research revealed a strong interest in CyPath^® Lung, driven by the high level of unmet clinical need for noninvasivediagnostics. A survey conducted with 240 pulmonologists and internists, the primary audience for the test, showed that 96% would useCyPath^® Lung if it were available today as an adjunct with LDCT screening and diagnosis. Physicians respondedfavorably to a noninvasive diagnostic technology that gives them more confidence in their decision to proceed with moreaggressive follow-up procedures if the test comes back positive. If test results are negative, physicians could rule out lungcancer, thus reducing the number of costly invasive procedures that result from the LDCT false-positive rate.

TheCyPath^® Lung laboratory test will be ordered by a physician for use by people at high risk for lung cancer who are recommendedfor annual screening by LDCT. While LDCT is shown to lower the mortality rate of lung cancer by at least 20% as compared to x-rayscreening,¹⁵ the LDCT screening method has a low positive predictive value that can result in many people undergoing unnecessaryinvasive diagnostic procedures to confirm or rule out the presence of lung cancer. A physician who orders a CyPath^® Lungtest can have greater confidence in determining the next steps in patient care.¹⁶ Noninvasive sample collection and thetest’s three-day turnaround in providing patient results after sample receipt make CyPath^® Lung wellsuited for both sophisticated and less developed markets. Existing Current Procedural Terminology (“CPT”) codeshave been identified for reimbursement for CyPath^® Lung as a laboratory-developed test (an “LDT”)based on the test’s use of flow cytometry to detect lung cancer.

Patients will use the Smiths Medical’s acapella^®Choice Blue device with CyPath^® Lung to assist patients in opening lung passageways and expelling sputum into acollection cup noninvasively. The acapella^® Choice Blue has been 510(k) cleared by the U.S. Food and Drug Administration(the “FDA”) as a positive expiratory pressure device to help mobilize lung secretions in people with certainlung conditions. bioAffinity Technologies has an agreement with GO2 Partners to produce patient collection kits and to provide warehousingand distributions services for sending out the kits. Laboratory reagents, supplies and equipment are commercially available through multiplevendors. Sample processing, labeling, and data collection can be accomplished by a laboratory technician skilled in general laboratorytechniques. Data analysis leading to a physician’s report is done by automated analysis software fully integrated into the test.

The Company’s business-development plan (our “Business Plan”) envisions four phases of expanding market entry that are timed to maximize Company resources and minimize market risk. Each of the four phases are discussed in detail in the “Business—CyPath^® Lung Business Development Plan” section of this prospectus beginning on page 61.

OncoSelect^®Therapeutics Research

OncoSelect^®Therapeutics, LLC, a Delaware limited liability company and wholly owned subsidiary of bioAffinity (“OncoSelect^®”),is a preclinical stage biopharmaceutical discovery company with a focus on therapeutics that deliver cytotoxic (cell-killing) effectson a broad selection of human cancers from diverse tissues while having little or no effect on normal cells.

Unlikemany of our industry competitors, OncoSelect^® does not pursue therapies that depend on specific mutations, biomarkers,or other genetic or epigenetic abnormalities for their effect. We pursue research based on our own scientific discoveries demonstratingthat inhibition of the expression of two specific cell membrane proteins result in the selective killing of various cancer cell typesgrown in the laboratory with little or no effect on normal (non-cancerous) cells.

Ourscientific discoveries stemmed from research we conducted to better understand the mechanism by which TCPP, the synthetic porphyrin usedin CyPath^® Lung, selectively enters cancer cells. We have established several specific areas of therapeutic research thathave evolved from our TCPP experiments.

OncoSelect^®therapies offer the possibility of broad applications in cancer treatment. OncoSelect^® will use a licensingbusiness model for selective chemotherapeutic compounds to be developed by the Company.

TheCompany will pursue its therapeutics business through OncoSelect^®. Initial therapeutic compositions to be developed willbe based on market and cost factors. Composition synthesis is being outsourced to one of several select vendors. bioAffinity will conductinitial testing of promising compounds with assistance from select vendors who have contractually relinquished any claim to discoveries,data, or intellectual property. Additional patents will be filed based on testing, and results will be publicized to evaluate the interestin individual compounds and pursue licensing opportunities. The Company will continue to develop, test, publish its findings, and partnerto maximize revenues and contain expenses.

IntellectualProperty (“IP”) Portfolio

Asof April 25, 2022, the Company and its subsidiary OncoSelect^® have a patent estate that includes 12 issuedU.S. and foreign counterpart patents, including three U.S. patents and nine foreign counterpart patents in Canada, China, France,Germany, Hong Kong, Italy, Spain, Sweden, and the United Kingdom. Two awarded patents directed at diagnostic applications expire in 2022,and one U.S. patent and nine counterpart foreign patents directed at diagnostic applications expire in 2030. One therapeutic patent acceptedin Australia expires in 2037 once issued. One therapeutic patent application that has been accepted in Mexico expires in 2037 onceissued.

Withregard to our diagnostic test CyPath^® Lung and other diagnostic candidates, we have three issued U.S. patents andnine foreign counterpart patents in Canada, China, France, Germany, Hong Kong, Italy, Spain, Sweden, and the United Kingdom. Withregard to our diagnostic patent applications, one of two families is directed at diagnosing lung health using flow cytometry, and theother is directed at proprietary compensation beads used to calibrate the flow cytometry instrument and used in CyPath^® Lungdata acquisition. Pending applications directed at diagnosing lung health include one pending U.S. patent application andeight foreign counterpart patent applications in Australia, Canada, China, European Patent Office, Hong Kong, Japan, Mexico, and Singaporefiled in 2019, and one provisional patent application filed in 2021. The patent application directed at the composition of compensationbeads was filed as a provisional application in 2021.

Withregard to our therapeutic product candidates, we have two pending U.S. patent applications, three pending Patent Cooperation Treaty Internationalpatent applications, and ten foreign applications pending in Australia, Canada, China, European Patent Office, Hong Kong,India, Japan, and Mexico. The therapeutic IP is made up of four families directed at our therapeutic product candidates, including twofamilies directed at siRNA product candidates, one family directed at soluble CD320 used in the treatment of cancer, and one family directedat porphyrin conjugates for treating cancer.

Industry,Business Development, and Competition

IndustryOpportunity

Theglobal market for cancer diagnostic tests is expected to grow dramatically in coming years. Cancer diagnostic tests, including devices,grew from $156.27 billion in 2020 to $170.21 billion in 2021, with a compound annual growth rate of 8.9%, and is projected to reach $239.23billion in 2025.¹⁷ Lung cancer is the most common cancer globally and its incidence continues to increase in some large nationsincluding China.¹⁸ The global market for lung cancer diagnostic tests was estimated at $2.5 billion in 2020 and is projectedto reach a value of $4.3 billion by 2027, with a compounded annual growth rate of 8.1% over 2020-2027.¹⁹ Clinical diagnosticsplay an important role in disease prevention, detection, and management. bioAffinity’s first test, CyPath^® Lung,focuses on the leading cause of cancer death among both men and women. Each year, more people die of lung cancer than of colon, breast,and prostate cancers combined, making up almost 18% of all cancer deaths worldwide. Lung cancer typically may not be symptomatic in itsearly stages when it is most treatable. An estimated 18 million patients at high risk for lung cancer in the U.S. are recommended forannual screening. Initially, physicians would order CyPath^® Lung for those high-risk patients as an adjunct to LDCT screeningto aid in the decision whether or not to pursue more aggressive follow-up procedures. A more accurate and reliable lung diagnostic pathwayusing LDCT and noninvasive methods could result in fewer patients being subjected to the stresses of unnecessary, invasive diagnosticprocedures such as biopsies. CyPath^® Lung is well suited for use in both sophisticated and less-developed markets becausesample collection is noninvasive and conducted at home, the sample can be shipped overnight by commercial carriers and sample processingand automated analysis can be completed by laboratory technicians skilled in general laboratory techniques. Patient reports are providedto the ordering physician within three days of sample receipt at the laboratory.

CompetitiveStrengths

bioAffinityTechnologies conducts an ongoing competitive analysis of companies in the lung cancer diagnostic sector of the clinical diagnostics market.In 2022, the Company evaluated companies that reported an interest in diagnosing lung cancer, focusing on 67 companies and academicinstitutions it identified as active in the early lung cancer diagnostic sector. A thorough evaluation of the early lung cancer diagnosticlandscape reveals multiple reasons why CyPath^® Lung is positioned to be a market leader. CyPath^® Lung performanceshown in a test validation trial resulted in 92% sensitivity and 87% specificity in high-risk patients who had lung nodules 20 mm orsmaller. Eight out of ten (80%) Stage I tumors were correctly identified, indicating that CyPath^® Lung can find lung cancerat its earliest stage. Overall, when diagnosing lung cancer in all stages, the clinical trial resulted in CyPath^® Lungspecificity of 88% and sensitivity of 82%, similar to far more invasive procedures and surgery currently used to diagnose lung cancer.(See the “Comparison of CyPath^® Lung to Current Standards of Care” chart in the “Business” sectionof this prospectus.) The majority of competitors’ tests either incorrectly classify a high proportion of people without canceras having the disease (known as false negatives) more than 50% of the time or misdiagnose people as cancer-free (known as false positives)more than 50% of the time. It is important to note that most competitors who have conducted clinical trials also have not designed theirtrials to evaluate the test’s measure of accuracy – such as sensitivity and specificity – in the high-risk populationfor whom the test is intended. CyPath^® Lung has identified existing CPT codes for use with CyPath^® Lungthat have a reimbursable track record. A patient collects his or her sample at home, which is a particular benefit during a pandemic.Sample processing for CyPath^® Lung can be done by laboratory technicians, and reagents used by the test are widely available.Data acquisition and analysis and test results are fully automated.

BusinessStrategies

TheCompany is moving forward with commercialization of CyPath^® Lung in a systematic, four-phased Business Plan thatis expected to maximize resources and minimize market risk. Briefly, Phase 1 of the Business Plan begins with a market launchin Texas of CyPath^® Lung as an LDT under the CLIA program administered by the Centers for Medicare and Medicaid Services(“CMS”), in partnership with the states, and standards issued by CAP. An LDT is a type of in vitro diagnostic(“IVD”) test that is developed, validated and performed within a single laboratory. CyPath^®Lung has been validated and is being performed by Precision Pathology Services (“Precision Pathology”), a CAP-accredited,CLIA-certified clinical pathology laboratory in San Antonio, Texas, pursuant to a licensing agreement with the Company. Precision Pathologyhas completed the required analytical validation in accordance with CLIA, which looks at the performance characteristics of atest used to describe the quality of patient test results and includes an analysis of accuracy, precision, analytical sensitivity, analyticalspecificity, reportable range, reference interval, and other performance characteristics that the test system must be evaluatedby in the laboratory that intends to offer the test system for sale. This analytical validation is limited to the specificconditions, staff, equipment and patient population of the particular laboratory. Having completed the CLIA analytical validation,Precision Pathology is offering the CyPath^® Lung test for sale with a controlled rollout beginning in Texas,which we anticipate will require six months, before expanding throughout the Southwest region of the U.S. through the first half of 2023.After establishing CyPath^® Lung in the Southwest market, the laboratory will expand sales in 2023 toadditional states with plans to market the test nationwide.

InPhase 2, the Company will launch CyPath^® Lung as a CE-marked IVD test in the European Union (the “EU”).We intend to execute an agreement in Phase 2 with one or more commercial laboratories to sell CyPath^® Lung in the EU market.In Phase 3, we will submit a request for de novo classification to the FDA to classify CyPath® Lung as a Class II IVDmedical device for the detection of lung cancer. In order to seek de novo classification and marketing approval of CyPath^®Lung by the FDA, we must conduct a “pivotal clinical trial” to demonstrate the safety and efficacy of CyPath^®Lung. We are currently working with a contract research organization (a “CRO”) to finalize the designof the pivotal clinical trial and plan to submit a pre-submission package to the FDA in the third quarter of 2022 to obtain the FDA’sfeedback on the study design. A pivotal clinical trial is scheduled to begin in early 2023. Final design of the pivotal clinicaltrial has not been determined at this time. We expect to conduct a pivotal clinical trial that requires between two to three yearsdepending on the clinical trial’s size, objectives and endpoints. Assuming the study is successful, we intend to submit a requestfor de novo classification to the FDA within six months of study completion. If the de novo request is granted by theFDA, we expect FDA clearance will result in a larger market and greater market share for CyPath^® Lung. FDA clearance alsocan lead to higher reimbursement, expanded claims and additional indications for use of CyPath^® Lung for the early detectionof lung cancer. Phase 4 will accelerate the diagnostic’s market presence to expand into other global markets, including China,Southeast Asia, and Australia. The timeline for commercialization is discussed in the “Business—CyPath^®Lung Business Development Plan” section on page 61.

Summaryof Risk Factors

Likeany emerging growth company, we face significant risk factors that may impede our plans for successful commercialization of our diagnosticand therapeutic products. These risks are discussed in detail under the “Risk Factors” discussion beginning on page 14of this prospectus.

Thefollowing summarizes the principal factors that make an investment in our Company speculative or risky, all of which are more fully describedin the section below titled “Risk Factors.” This summary should be read in conjunction with the section below titled “RiskFactors” and should not be relied upon as an exhaustive summary of the material risks facing our business. The following factorscould result in harm to our business, reputation, revenue, financial results, and prospects, among other impacts:

THEOFFERING

Exceptas otherwise indicated, all information in this prospectus assumes:

SUMMARYFINANCIAL DATA

Wehave derived the following summary of our consolidated statement of operations data for the years ended December 31, 2021 and 2020, andthe balance sheet data as of December 31, 2021 and 2020, from our audited consolidated financial statements appearing elsewhere in thisprospectus. Our historical results are not necessarily indicative of the results that may be expected in the future.

You should read the following summary financialdata together with our financial statements and the related notes appearing elsewhere in this prospectus and the MD&A sectionof this prospectus.

Thefollowing table summarizes our results of operations for the years ended December 31, 2021 and 2020 (amounts in thousands, except shareand per share data):

The following table summarizes our balance sheetsat December 31, 2021 and 2020 (amounts in thousands):

CautionaryNote Regarding Forward-Looking Statements

Thisprospectus contains forward-looking statements. Statements that are predictive in nature, that depend upon or refer to future eventsor conditions, or that include the words “may,” “could,” “plan,” “project,” “budget,”“predict,” “pursue,” “target,” “seek,” “objective,” “believe,”“expect,” “anticipate,” “intend,” “estimate,” and other expressions that are predictionsof or indicate future events and trends and that do not relate to historical matters identify forward-looking statements. Our forward-lookingstatements include statements about our business strategy, our industry, our future profitability, our expected capital expendituresand the impact of such expenditures on our performance, the costs of being a publicly traded corporation, and our capital programs.

Aforward-looking statement may include a statement of the assumptions or bases underlying the forward-looking statement. We believe thatwe have chosen these assumptions or bases in good faith and that they are reasonable. You are cautioned not to place undue reliance onany forward-looking statements. You should also understand that it is not possible to predict or identify all such factors and shouldnot consider the following list to be a complete statement of all potential risks and uncertainties. Factors that could cause our actualresults to differ materially from the results contemplated by such forward-looking statements include, but are not limited to, statementsabout:

Inaddition, statements such as “we believe” and similar statements reflect our beliefs and opinions on the relevant subject.These statements are based upon information available to us as of the date of this prospectus and, although we believe such informationforms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read toindicate that we have conducted a thorough inquiry into, or review of, all potentially available relevant information. These statementsare inherently uncertain and investors are cautioned not to unduly rely upon these statements. Furthermore, if our forward-looking statementsprove 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 objectivesand plans in any specified time frame, or at all. Except as required by applicable law, we do not plan to publicly update or revise anyforward-looking statements contained herein until after we distribute this prospectus, whether as a result of any new information, futureevents or otherwise.

Youshould not place undue reliance on our forward-looking statements. Although forward-looking statements reflect our good-faith beliefsat the time they are made, forward-looking statements involve known and unknown risks, uncertainties, and other factors, including thefactors described under “Risk Factors,” which may cause our actual results, performance or achievements to differ materiallyfrom anticipated future results, performance, or achievements expressed or implied by such forward-looking statements. We undertake noobligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changedcircumstances, or otherwise, unless required by law. These cautionary statements qualify all forward-looking statements attributableto us or persons acting on our behalf.

RISKFACTORS

Investingin our Company involves a high degree of risk. You should carefully consider the following information about these risks, together withthe other information appearing elsewhere in this Prospectus before deciding to invest in our Company. The occurrence of any of the followingrisks could have a material and adverse effect on our business, reputation, financial condition, results of operations, and future growthprospects, as well as our ability to accomplish our strategic objectives. As a result, the market value of our Common Stock could decline,and you could lose all or part of your investment. Additional risks and uncertainties not presently known to us or that we currentlydeem immaterial may also impair our business operations and market value.

RisksRelated to Our Business

OurBusiness Plan relies upon our ability to obtain additional sources of capital and financing. If the amount of capital we are ableto raise from financing activities, together with our revenues from operations, is not sufficient to satisfy our capital needs, we maybe required to cease operations.

Tobecome and remain profitable, we must succeed in developing and commercializing our diagnostic tests and therapeutic products that generatesignificant income in the planned timeframe. This will require us to be successful in a range of challenging activities, including completingpreclinical testing and clinical trials of our diagnostic and therapeutic technologies, obtaining regulatory approval for our diagnosticand therapeutic technologies, manufacturing, marketing and selling any diagnostic tests and therapeutic products for which we may obtainregulatory approval, and establishing and managing our collaborations at various phases of each diagnostic test and therapeutic productcandidate’s development. We are in the preliminary phases of these activities. We may never succeed in these activities and, evenif we do, may never generate sufficient income to achieve profitability.

Tobecome profitable, we must develop our diagnostic tests and therapeutic products, which will depend in large part on our ability to:

Evenif we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure tobecome and remain profitable would depress the value of our Company and could impair our ability to raise capital, expand ourbusiness, maintain the research and development efforts that will be initially funded by the proceeds of this Offering, diversify ourdiagnostic tests and therapeutic product offerings, or even continue our operations. A decline in the value of our Company couldalso cause you to lose all or part of your investment.

Wemust raise additional capital to fund our operations in order to continue as a going concern.

WithumSmith+Brown,PC, our independent registered public accounting firm for the fiscal year ended December 31, 2021, has included an explanatory paragraphin their opinion that accompanies our audited consolidated financial statements as of and for the year ended December 31, 2021, indicatingthat our current liquidity position raises substantial doubt about our ability to continue as a going concern. As of December 31, 2021,we had total negative working capital of $11.6 million, including $11.2 million of convertible notes, and a stockholders’deficit of $15.8 million. If we are unable to improve our liquidity position we may not be able to continue as a going concern.Our ability to continue as a going concern is dependent upon our ability to generate revenue and raise capital from financing transactions.Without funding from the proceeds of this Offering, management anticipates that our cash resources are sufficient to continue operationsthrough June 2022. The future of the Company is dependent upon its ability to obtain financing and upon future profitable operationsfrom the development of its new business opportunities. There can be no assurance that we will be successful in accomplishing these objectives.Without such additional capital, we may be required to curtail or cease operations and be required to realize our assets and dischargeour liabilities other than in the normal course of business which could cause investors to suffer the loss of all or a substantial portionof their investment.

Wehave a limited operating history, which makes it difficult to evaluate our current business and future prospects.

Weare a company with limited operating history, and our operations are subject to all of the risks inherent in establishing a new businessenterprise. The likelihood of our success must be considered in light of the problems, expenses, difficulties, complications, and delaysfrequently encountered in connection with the formation of a new business, the development of new technologies or those subject to clinicaltesting, and the competitive and regulatory environment in which we will operate. We may not be able to maintain certification of CyPath^®Lung as an LDT in accordance with CAP/CLIA guidance and regulations, or obtain approval of our diagnostic tests in developmentby the CMS, the FDA, European Medicines Agency, or Chinese National Medical Products Administration. Even if we do so and are also ableto commercialize our diagnostic tests, we may never generate revenue sufficient to become profitable. Our failure to generate revenueand profit would likely cause our securities to decrease in value or become worthless.

Wewill require additional financing to implement our Business Plan, which may not be available on favorable terms or at all, andwe may have to accept financing terms that would place restrictions on us.

Webelieve that we must raise additional funds to be able to continue our business operations. We may not be able to obtain equity or debtfinancing on acceptable terms or at all to implement our growth strategy. As a result, adequate capital may not be available to financeour current development plan, take advantage of business opportunities or respond to competitive pressures. If we are unable to raiseadditional funds, we may be forced to curtail or even abandon our Business Plan and focus on fewer commercial opportunities thatmay result in more limited growth than forecast.

Untilsuch time, if ever, as we can generate substantial income from sale of our diagnostic test(s) and therapeutic product candidates, weexpect to finance our cash needs through a combination of equity offerings, debt financings, and license and collaboration agreements.To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of existingstockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect therights of the holders of our Common Stock (the “Common Stockholders”). In addition, the terms of anyfuture financings may impose restrictions on our right to declare dividends or on the manner in which we conduct our business. Debt financingand preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to takespecific actions, such as incurring additional debt, making capital expenditures, declaring dividends, or making acquisitions or significantasset sales.

Ifwe raise additional funds through collaborations, strategic alliances or marketing, or distribution or licensing arrangements with thirdparties, we may have to relinquish valuable rights to our technologies, future revenue streams, or research programs or grant licenseson terms that may not be favorable to us and/or that may reduce the value of our Common Stock.

Ifwe experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvalscould be delayed or prevented.

Wemay not be able to initiate or continue clinical trials if we are unable to locate and enroll a sufficient number of eligible patientsto participate in these trials as required by the FDA or similar regulatory authorities outside the United States, such as the EuropeanMedicines Agency.

Patientenrollment is affected by many other factors, including:

Weare unable to forecast with precision our ability to enroll patients. Our inability to enroll a sufficient number of patients for ourclinical trials would result in significant delays and could require us to abandon one or more clinical trials altogether. Enrollmentdelays in our clinical trials may result in increased development costs, which would cause the value of our Company to declineand limit our ability to obtain additional financing.

Clinicaltrials are expensive, time-consuming, and may not be successful.

Clinicaltrials are expensive, time-consuming, and may not be successful. They involve the evaluation of diagnostic tests and testing of potentialtherapeutic agents and effective treatments in humans to determine the safety and efficacy of the diagnostic tests and therapeutic productsnecessary for an approved diagnostic and therapeutic technology. Many tests and products in human clinical trials fail to demonstratethe desired safety and efficacy characteristics. Even if our tests and products progress successfully through initial or subsequent humantesting, they may fail in later phases of development. We may engage others to conduct our clinical trials, including clinical researchorganizations and government-sponsored agencies. These trials may not start or be completed as we forecast or may not achieve desiredresults.

Wemay experience numerous unforeseen events during, or as a result of, clinical trials that could delay or prevent our ability to receivemarketing approval or commercialize our diagnostic and therapeutic technologies, including:

Ifwe are required to conduct additional clinical trials or other testing beyond those that we currently contemplate, if we are unable tosuccessfully complete clinical trials or other testing, if the results of these trials or tests are not positive or are only modestlypositive or if there are safety concerns, we may:

Ourproduct and test development costs will increase if we experience delays in clinical testing or marketing approvals. We do not know whetherany of our preclinical studies or clinical trials will begin as planned, will need to be restructured, or will be completed on scheduleor at all. Significant preclinical or clinical trial delays also could shorten any periods during which we may have the exclusive rightto commercialize our diagnostic technology or allow our competitors to bring diagnostic tests and therapeutic products to market beforewe do, potentially impairing our ability to successfully commercialize our diagnostic and therapeutic technologies and harming our businessand results of operations.

Iftesting of a particular diagnostic test or therapeutic product candidate does not yield successful results, then we will be unable tocommercialize that test or product candidate.

Wemust demonstrate that the product safety and efficacy of our candidates for diagnostic tests and therapeutic products in humans throughextensive clinical testing. Our research and development programs are at an early stage of development. We may experience numerous unforeseenevents during, or as a result of, the testing process that could delay or prevent commercialization of any test or product, includingthe following:

Evenif our diagnostic tests or therapeutic products receive marketing approval, they may fail to achieve the degree of market acceptanceby physicians, patients, third-party payers and others in the medical community necessary for commercial success.

Evenif our products receive marketing approval, they may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-partypayers, and others in the medical community. If we do not generate significant product revenues, we may not become profitable. The degreeof market acceptance of our products and tests, if approved for commercial sale, will depend on a number of factors, including:

Ifwe are unable to address and overcome these and similar concerns, our business and results of operations could be substantially harmed.

Ifwe are unable to establish effective sales, marketing, and distribution capabilities or enter into agreements with third parties withsuch capabilities, we may not be successful in commercializing our diagnostic tests or therapeutic products if and when they are approved.

Wedo not have a sales or marketing infrastructure and have limited experience in the sale, marketing, or distribution of our diagnostictests or therapeutic products. To achieve commercial success for any diagnostic test or therapeutic product for which we obtain marketingapproval, we will need to successfully establish and maintain relationships directly and with third parties to perform sales and marketingfunctions.

Factorsthat may inhibit our efforts to commercialize our diagnostic tests or therapeutic products on our own include:

Ifwe do not establish sales, marketing, and distribution capabilities successfully, either on our own or in collaboration with third parties,we will not be successful in commercializing our diagnostic tests or therapeutic products.

Ifwe are unable to convince physicians as to the benefits of our proposed diagnostic tests or therapeutic products, we may incur delaysor additional expense in our attempt to establish market acceptance.

Broaduse of our proposed diagnostic tests and products may require pathology laboratories and physicians to be informed regarding our proposeddiagnostic tests and products and the intended benefits. Inability to carry out this physician education process may adversely affectmarket acceptance of our proposed diagnostic tests or therapeutic products. We may be unable to timely educate physicians regarding ourproposed diagnostic tests or therapeutic products in sufficient numbers to achieve our marketing plans or to achieve acceptance of ourdiagnostic tests or therapeutic products. Any delay in physician education may materially delay or reduce demand for our diagnostic testsor therapeutic products. In addition, we may expend significant funds toward physician education before any acceptance or demand forour proposed diagnostic tests or therapeutic products is created, if at all.

Weface substantial competition, which may result in others discovering, developing, or commercializing competing diagnostic tests or therapeuticproducts before or more successfully than we do.

Thedevelopment and commercialization of new diagnostic and therapeutic technologies is highly competitive. We face competition and willface competition with respect to any diagnostic and therapeutic technology that we may seek to develop or commercialize in the future,from major diagnostic and pharmaceutical companies, LDT laboratories, smaller diagnostic and pharmaceutical companies, and biotechnologycompanies worldwide. Potential competitors also include academic institutions, government agencies, and other public and private researchorganizations that conduct research, seek patent protection, and establish collaborative arrangements for research, development, manufacturing,and commercialization.

Asubstantial number of the companies against which we are competing have or, against which we may compete in the future may have, significantlygreater financial resources, established presence in the market, and expertise in research and development, manufacturing, preclinicaltesting, conducting clinical trials, obtaining regulatory approvals, and marketing approved diagnostic tests or therapeutic productsthan we do. Mergers and acquisitions in the diagnostic, pharmaceutical, and biotechnology industries may result in even more resourcesbeing concentrated among a smaller number of our competitors.

Smallerand other early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with largeand established companies. These third parties compete with us in recruiting and retaining qualified scientific, sales, marketing, andmanagement personnel, establishing clinical trial sites and patient registration for clinical trials, and acquiring technologies complementaryto, or necessary for, our programs.

Ourcommercial opportunity could be reduced or eliminated if our competitors develop and commercialize diagnostic tests or therapeutic productsthat are more accurate, more convenient, or less expensive than any diagnostic tests or therapeutic products that we may develop. Ourcompetitors also may obtain FDA or other regulatory approval for their diagnostic tests or therapeutic products more rapidly than wemay obtain approval for ours, which could result in our competitors establishing a stronger market position. In addition, our abilityto compete may be affected in many cases by insurers or other third-party payors.

Wemay be unable to compete in our target marketplaces, which could impair our ability to generate revenues, thus causing a material adverseimpact on our results of operations.

Oursuccess depends upon our ability to retain key executives and to attract, retain, and motivate qualified personnel, and the loss of thesepersons could adversely affect our operations and results.

Weare highly dependent on the principal members of our management, scientific, and clinical teams, including Maria Zannes, J.D., our Presidentand Chief Executive Officer, and Vivienne Rebel, M.D., Ph.D., our Chief Science and Medical Officer and Executive Vice President.

Theloss of the services of any of our executive officers could impede the achievement of our research, development, and commercializationobjectives and seriously harm our ability to successfully implement our business strategy. Furthermore, replacing executive officersand key employees may be difficult and may take an extended period of time because of the limited number of individuals in our industrywith the breadth of skills and experience required to successfully develop, gain regulatory approval of, and commercialize diagnostictests or therapeutic products. Competition to hire from this limited pool is intense, and we may be unable to hire, train, retain, ormotivate key personnel on acceptable terms given the competition among numerous biotechnology companies for similar expertise. We alsoface competition from universities and research institutions for qualified scientific and clinical personnel. In addition, we rely andexpect to continue to rely to a significant degree on consultants and advisors, including scientific and clinical advisors, to assistus in formulating our research and development and commercialization strategies. Our consultants and advisors may be engaged by otherentities and may have commitments under consulting or advisory contracts that may limit their availability to us. If we are unable tocontinue to attract and retain high-quality personnel, our ability to pursue our growth strategy will be limited.

Ourlack of operating experience may make it difficult to manage our growth which could lead to our inability to implement our BusinessPlan.

Wehave limited experience in marketing and the selling of diagnostic tests and pharmaceutical products. Any growth will require us to expandour management and our operational and financial systems and controls. If we are unable to do so, our business and financial conditionwould be materially harmed. If rapid growth occurs, it may strain our operational, managerial, and financial resources.

Ifwe fail to comply with our obligations imposed by any intellectual property licenses with third parties that we may need in the future,we could lose rights that are important to our business.

Wemay in the future require licenses to third-party technology and materials. Such licenses may not be available in the future or may notbe available on commercially reasonable terms, or at all, which could have a material adverse effect on our business and financial condition.We may rely on third parties from whom we license proprietary technology to file and prosecute patent applications and maintain patentsand otherwise protect the intellectual property we license from them. We may have limited control over these activities or any otherintellectual property that may be related to our in-licensed intellectual property. For example, we cannot be certain that such activitiesby these licensors will be conducted in compliance with applicable laws and regulations or will result in valid and enforceable patentsand other intellectual property rights. We may have limited control over the manner in which our licensors initiate an infringement proceedingagainst a third-party infringer of the intellectual property rights, or defend certain of the intellectual property that may be licensedto us. It is possible that the licensors’ infringement proceeding or defense activities may be less vigorous than if we conductthem ourselves. Even if we acquire the right to control the prosecution, maintenance and enforcement of the licensed and sublicensedintellectual property relating to our diagnostic tests or therapeutic product candidates, we may require the cooperation of our licensorsand any upstream licensor, which may not be forthcoming. Therefore, we cannot be certain that the prosecution, maintenance and enforcementof these patent rights will be in a manner consistent with the best interests of our business. If we or our licensor fail to maintainsuch patents, or if we or our licensor lose rights to those patents or patent applications, the rights we have licensed may be reducedor eliminated and our right to develop and commercialize any of our diagnostic tests or therapeutic product candidates that are the subjectof such licensed rights could be adversely affected. In addition to the foregoing, the risks associated with patent rights that we licensefrom third parties will also apply to patent rights we may own in the future. Further, if we fail to comply with our diligence, developmentand commercialization timelines, milestone payments, royalties, insurance and other obligations under our license agreements, we maylose our patent rights with respect to such agreement, which would affect our patent rights worldwide.

Terminationof our current or any future license agreements would reduce or eliminate our rights under these agreements and may result in our havingto negotiate new or reinstated agreements with less favorable terms or cause us to lose our rights under these agreements, includingour rights to important intellectual property or technology. Any of the foregoing could prevent us from commercializing our other diagnostictests or therapeutic product candidates, which could have a material adverse effect on our operating results and overall financial condition.

Inaddition, intellectual property rights that we in-license in the future may be sublicenses under intellectual property owned by thirdparties, in some cases through multiple tiers. The actions of our licensors may therefore affect our rights to use our sublicensed intellectualproperty, even if we are in compliance with all of the obligations under our license agreements. Should our licensors or any of the upstreamlicensors fail to comply with their obligations under the agreements pursuant to which they obtain the rights that are sublicensed tous, or should such agreements be terminated or amended, our ability to develop and commercialize our diagnostic tests or therapeuticproduct candidates may be materially harmed.

Inthe future, we may need to obtain additional licenses of third-party technology that may not be available to us or are available onlyon commercially unreasonable terms, and which may cause us to operate our business in a more costly or otherwise adverse manner thatwas not anticipated.

Wecurrently own intellectual property directed to our diagnostic tests or therapeutic product candidates and other proprietary technologies.Other pharmaceutical companies and academic institutions may also have filed or are planning to file patent applications potentiallyrelevant to our business. From time to time, in order to avoid infringing these third-party patents, we may be required to license technologyfrom additional third parties to further develop or commercialize our diagnostic tests or therapeutic product candidates. Should we berequired to obtain licenses to any third-party technology, including any such patents required to manufacture, use or sell our productcandidates, such licenses may not be available to us on commercially reasonable terms, or at all. The inability to obtain any third-partylicense required to develop or commercialize any of our product candidates could cause us to abandon any related efforts, which couldseriously harm our business and operations. The licensing or acquisition of third-party intellectual property rights is a competitivearea, and several more established companies may pursue strategies to license or acquire third-party intellectual property rights wemay consider attractive or necessary. These established companies may have a competitive advantage over us due to their size, capitalresources and greater clinical development and commercialization capabilities. In addition, companies that perceive us to be a competitormay be unwilling to assign or license rights to us. Even if we are able to obtain a license under such intellectual property rights,any such license may be non-exclusive, which may allow our competitors access to the same technologies licensed to us.

Moreover,some of our owned and in-licensed patents or patent applications or future patents may be co-owned with third parties. If we are unableto obtain an exclusive license to any such third-party co-owners’ interest in such patents or patent applications, such co-ownersmay be able to license their rights to other third parties, including our competitors, and our competitors could market competing diagnostictests or therapeutic products and technology. In addition, we may need the cooperation of any such co-owners of our patents in orderto enforce such patents against third parties, and such cooperation may not be provided to us. Furthermore, our owned and in-licensedpatents maybe subject to a reservation of rights by one or more third parties. Any of the foregoing could have a material adverse effecton our competitive position, business, financial conditions, results of operations and prospects.

Wewill depend on third parties to manufacture and market our diagnostic tests and to design trial protocols, arrange for and monitor theclinical trials, and collect and analyze data.

Wedo not have, and do not now intend to develop, facilities for the manufacture of the contents of our collection kits needed for clinicalor commercial production. In addition, we are not a party to any long-term agreement with any of our suppliers, and accordingly, we havethe products used in our diagnostic tests manufactured on a purchase-order basis from primary suppliers. We have entered into relationshipswith manufacturers on a contract basis but will need to expand those relationships. We expect to depend on such collaborators to supplyus with reagents and other materials manufactured in compliance with standards imposed by the CMS, FDA, and foreign regulators.

Moreover,as we develop our diagnostic tests or therapeutic products eligible for clinical trials, we intend to contract with independent partiesto design the trial protocols, arrange for and monitor the clinical trials, and collect and analyze the data. In addition, certain clinicaltrials for our products may be conducted by government-sponsored agencies and will be dependent on governmental participation and funding.Our dependence on independent parties and clinical sites involves risks including reduced control over the timing and other aspects ofour clinical trials.

Weare exposed to product liability and pre-clinical and clinical liability risks which could place a substantial financial burden uponus, should we be sued.

Ourbusiness exposes us to potential product liability and other liability risks that are inherent in the testing, manufacturing, and marketingof diagnostic tests and therapeutic products. Such claims may be asserted against us. In addition, using diagnostic tests and therapeuticproducts that may be developed with potential collaborators in our clinical trials and the subsequent sale of these tests and productsby bioAffinity or our potential collaborators may cause us to bear a portion of or all product liability risks. A successful liabilityclaim, or series of claims, brought against us could have a material adverse effect on our business, financial condition, and resultsof operations.

Whilewe have obtained product liability insurance covering CyPath^® Lung as a commercialized LDT to be sold by Precision Pathology,a CAP-accredited, CLIA-certified clinical pathology laboratory, in the future we may not be able to obtain or maintain adequate productliability insurance, when needed, on acceptable terms, if at all, or such insurance may not provide adequate coverage against our potentialliabilities. Furthermore, potential partners with whom we intend to have collaborative or strategic agreements or our future licenseesmay not be willing to indemnify us against these types of liabilities and may not themselves be sufficiently insured or have sufficientliquidity to satisfy any product liability claims. Claims or losses in excess of any product liability insurance coverage that we mayobtain could have a material adverse effect on our business, financial condition, and results of operations.

Inaddition, we may be unable to obtain or to maintain clinical trial liability insurance on acceptable terms, if at all. Any inabilityto obtain and/or maintain insurance coverage on acceptable terms could prevent or limit the commercialization of any tests or productswe develop.

Ourcollection, use and disclosure of personal information, including health and employee information, is subject to U.S. state and federalprivacy and security regulations, and our failure to comply with those regulations or to adequately secure the information we hold couldresult in significant liability or reputational harm.

Theprivacy and security of personal information stored, maintained, received or transmitted, including electronically, is a major issuein the United States and abroad. Numerous federal and state laws and regulations govern the collection, dissemination, use and confidentialityof personal information, including genetic, biometric and health information, including state privacy, data security and breach notificationlaws, federal and state consumer protection and employment laws, the Health Insurance Portability and Accountability Act of 1996, asamended by the Health Information Technology for Economic and Clinical Health Act of 2009 and the Genetic Information NondiscriminationAct of 2008. These laws and regulations are increasing in complexity and number, may change frequently and sometimes conflict. Penaltiesfor violations of these laws vary, but can be severe.

Whilewe strive to comply with all applicable privacy and security laws and regulations, including our own posted privacy policies, these lawsand regulations continue to evolve and any failure or perceived failure to comply may result in proceedings or actions against us bygovernment entities or others, or could cause us to lose customers, which could have a material adverse effect on our business. Recently,there has been an increase in public awareness of privacy issues in the wake of revelations about the data-collection activities of variousgovernment agencies and in the number of private privacy-related lawsuits filed against companies. Concerns about our practices withregard to the collection, use, retention, disclosure or security of personal information or other privacy-related matters, even if unfoundedand even if we are in compliance with applicable laws, could damage our reputation and harm our business.

Ifusers of our proposed diagnostic tests or therapeutic products are unable to obtain adequate reimbursement from third-party payers orif new restrictive legislation is adopted, market acceptance of our proposed tests or products may be limited, and we may not achieverevenues.

Thecontinuing efforts of government and insurance companies, health maintenance organizations (“HMOs”) and otherpayers of healthcare costs to contain or reduce costs may affect our future revenues and profitability, as well as the future revenuesand profitability of our potential customers, suppliers, and collaborative partners and the availability of capital. For example, incertain international markets, pricing or profitability of diagnostic tests and therapeutic products is subject to government control.In the U.S., given recent federal and state government initiatives directed at lowering the total cost of healthcare, the U.S. Congressand state legislatures will likely continue to focus on healthcare reform, the cost of medical devices, tests and prescription pharmaceuticals,and Medicare and Medicaid reforms. While we cannot predict whether any such legislative or regulatory proposals will be adopted, theannouncement or adoption of such proposals could materially harm our business, financial condition, and results of operations.

Ourability to commercialize our proposed tests or products will depend in part on the extent to which appropriate reimbursement levels forthe cost of our tests or products are obtained by governmental authorities, private health insurers, and other organizations such asHMOs. Third-party payers are increasingly challenging the prices charged for medical tests, drugs, and services. Also, the trend towardmanaged healthcare in the U.S. and the concurrent growth of organizations such as HMOs, which could control or significantly influencethe purchase of healthcare services, diagnostics, and drugs, as well as legislative proposals to reform healthcare or reduce governmentinsurance programs, may all result in lower prices for or rejection of our tests or products.

Ouremployees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities,including noncompliance with regulatory standards and requirements.

Ourbusiness operations and current and future relationships with investigators, healthcare professionals, consultants, third-party payorsand customers will be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, healthinformation privacy and security laws, and other healthcare laws and regulations. If we are unable to comply, or have not fully complied,with such laws, we could face substantial penalties. We are exposed to the risk of employee fraud or other illegal activity by our employees,independent contractors, consultants, commercial partners, vendors and agents acting on behalf of us or our affiliates. Misconduct bythese parties could include intentional, reckless and/or negligent conduct that fails to: comply with the regulations of the FDA or foreignhealth authorities; provide true, complete and accurate information to the FDA or foreign health authorities; comply with manufacturingstandards we have established; comply with healthcare fraud and abuse laws in the United States and similar foreign fraudulent misconductlaws; or report financial information or data accurately or to disclose unauthorized activities to us.

Ourbusiness operations and current and future relationships with investigators, healthcare professionals, consultants, third-party payorsand customers are subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, transparency laws and otherhealthcare laws and regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.

Healthcareproviders and others play a primary role in the recommendation and ordering of prescription of any diagnostic tests or therapeutic productsfor which we obtain marketing approval. Although we do not currently have any products on the market, our operations and current andfuture arrangements with investigators, healthcare professionals, customers and third-party payors, may be subject to various U.S. federaland state healthcare laws and regulations, including, without limitation, the U.S. federal Anti-Kickback Statute, the U.S. federal civiland criminal false claims laws and the Physician Payments Sunshine Act and regulations. These laws may impact, among other things, ourcurrent business operations, including our clinical research activities, and proposed sales, marketing and education programs and constrainthe business of financial arrangements and relationships with healthcare providers and other parties through which we may market, selland distribute our diagnostic tests or therapeutic products for which we obtain marketing approval. In addition, we may be subject toadditional healthcare, statutory and regulatory requirements and enforcement by foreign regulatory authorities in jurisdictions in whichwe conduct our business.

Ensuringthat our internal operations and future business arrangements with third parties comply with applicable healthcare laws and regulationswill involve substantial costs. It is possible that governmental authorities will conclude that our business practices, including certainarrangements with physicians who receive stock, warrants or stock options as compensation for services provided to us, do not complywith current or future statutes, regulations, agency guidance or case law involving applicable fraud and abuse or other healthcare lawsand regulations. If our operations are found to be in violation of any of the laws described above or any other governmental laws andregulations that may apply to us, we may be subject to significant penalties, including civil, criminal and administrative penalties,damages, fines, exclusion from U.S. government funded healthcare programs, such as Medicare and Medicaid, or similar programs in othercountries or jurisdictions, disgorgement, imprisonment, contractual damages, reputational harm, diminished profits, additional reportingrequirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliancewith these laws and the delay, reduction, termination or restructuring of our operations. Further, defending against any such actionscan be costly and time-consuming, and may require significant financial and personnel resources. Therefore, even if we are successfulin defending against any such actions that may be brought against us, our business may be impaired. If any of the physicians or otherproviders or entities with whom we expect to do business is found to not be in compliance with applicable laws, they may be subject tosignificant criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs and imprisonment.If any of the above occur, it could adversely affect our ability to operate our business and our results of operations.

Weface intense competition in the biotechnology and pharmaceutical industries.

Thebiotechnology and pharmaceutical industries are intensely competitive. We face direct competition from U.S. and foreign companies focusingon diagnostic tests and pharmaceutical products, which are rapidly evolving. Our competitors include major multinational diagnostic andpharmaceutical companies, specialized biotechnology firms, and universities and other research institutions. Many of these competitorshave greater financial and other resources, larger research and development staffs, and more effective marketing and manufacturing organizationsthan we do. In addition, academic and government institutions are increasingly likely to enter into exclusive licensing agreements withcommercial enterprises, including our competitors, to market commercial tests or products based on technology developed at such institutions.Our competitors may succeed in developing or licensing technologies, tests and products that are more effective or less costly than oursor succeed in obtaining CAP/CLIA-validation or FDA or other regulatory approvals for diagnostic test and therapeutic product candidatesbefore we do. Acquisitions of, or investments in, competing diagnostic, pharmaceutical, or biotechnology companies by large corporationscould increase such competitors’ financial, marketing, manufacturing, and other resources.

Themarket for our proposed tests and products is competitive and rapidly changing, and new diagnostic technologies which may be developedby others could impair our ability to maintain and grow our business and remain competitive.

Thediagnostic, pharmaceutical, and biotechnology industries are subject to rapid and substantial technological change. Developments by othersmay render our proposed tests or products noncompetitive or obsolete, or we may be unable to keep pace with technological developmentsor other market factors. Technological competition from diagnostic, pharmaceutical and biotechnology companies, universities, governmentalentities, and others diversifying into the field is intense and is expected to increase.

Asa pre-revenue company engaged in the development of diagnostic technology, our resources are limited, and we may experience technicalchallenges inherent in such technologies. Competitors have developed or are in the process of developing technologies that are, or inthe future may be, the basis for competition. Some of these technologies may have an entirely different approach or means of accomplishingsimilar diagnostic efficacy compared to our proposed tests or products. Our competitors may develop diagnostic technologies that aremore effective or less costly than our proposed tests or products and therefore present a serious competitive threat.

Thepotential widespread acceptance of diagnostic tests or therapies that are alternatives to ours may limit market acceptance of our proposedtests or products, even if commercialized. Many of our targeted diseases and conditions can also be detected by other tests ortreated by other medications. These tests and treatments may be widely accepted in medical communities and have a longer history of use.The established use of these competitive technologies may limit the potential for our technologies, formulations, tests and productsto receive widespread acceptance if commercialized.

Healthcarecost containment initiatives and the growth of managed care may limit our returns.

Ourability to commercialize our diagnostic tests and therapeutic products successfully may be affected by the ongoing efforts of governmentaland third-party payers to contain the cost of healthcare. These entities are challenging prices of healthcare products and services,denying or limiting coverage and reimbursement amounts for new diagnostic tests and therapeutic products, and CAP/CLIA-validatedLDTs and FDA-approved diagnostic tests and therapeutic products considered experimental or investigational or which are used for diseaseindications without FDA marketing approval. Even if we succeed in bringing any tests or products to the market, they may not be consideredcost-effective, and third-party reimbursement might not be available or sufficient. If adequate third-party coverage is not available,we may not be able to maintain price levels sufficient to realize an appropriate return on our investment in research and test or productdevelopment. In addition, legislation and regulations affecting the pricing of diagnostic tests, pharmaceuticals, or healthcare servicesmay change in ways adverse to us before or after any of our proposed tests and products are approved for marketing.

Ourcompetitive position depends on protection of our intellectual property.

Developmentand protection of our intellectual property are critical to our business. If we do not adequately protect our intellectual property,or if competitors develop technologies incorporating the same or similar technologies that already are in the public domain, those competitorsmay be able to develop similar technologies to our own. Our success depends in part on our ability to obtain patent protection for ourdiagnostic tests, therapeutic products, or processes in the U.S. and other countries, protect trade secrets, and prevent others frominfringing on our proprietary rights.

Sincepatent applications in the U.S. are maintained in secrecy for at least portions of their pendency periods (published on U.S. patent issuanceor, if earlier, 18 months from earliest filing date for most applications) and since other publication of discoveries in the scientificor patent literature often lags behind actual discoveries, we cannot be certain that we are or will be the first to make the inventionsto be covered by our patent applications. The patent position of biopharmaceutical and biotechnology firms generally is highly uncertainand involves complex legal and factual questions. The U.S. Patent and Trademark Office has not established a consistent policy regardingthe breadth of claims that it will allow in biotechnology patents.

Thepatent applications we file, including applications that will follow the filing of provisional patents, may not issue as patents or theclaims of any issued patents may not afford meaningful protection for our technologies, tests, or products. In addition, patents issuedto us or to any future licensors may be challenged and subsequently narrowed, invalidated, or circumvented. Patent litigation is widespreadin the biotechnology industry and could harm our business. Litigation might be necessary to protect our patent position or to determinethe scope and validity of third-party proprietary rights, and we may not have the required resources to pursue such litigation or toprotect our patent rights.

Althoughwe have executed assignment of invention agreements with current scientific and technical employees and in the future will require ourscientific and technical employees and consultants to enter into broad assignment of invention agreements, and all of our employees,consultants, and corporate partners with access to proprietary information to enter into confidentiality agreements, these agreementsmay not be honored.

Diagnostictests and therapeutic products we develop could be subject to infringement claims asserted by others.

Wecannot assure that diagnostic tests and therapeutic products based on our patents or intellectual property that we license from otherswill not be challenged by a third-party claiming infringement of its proprietary rights. If we are not able to successfully defend patentsthat may be issued to us, that we may acquire, or that we may license in the future, we may have to pay substantial damages or licensingfees, possibly including treble damages, for past infringement.

Wemay become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consumingand ultimately unsuccessful.

Competitorsmay infringe our issued patents or other intellectual property. To counter infringement or unauthorized use, we intend to file infringementclaims, which can be expensive and time-consuming. Any claims we assert against perceived infringers could provoke these parties to assertcounterclaims against us alleging that we infringe their intellectual property. In addition, in a patent infringement proceeding, a courtmay decide that a patent of ours is invalid or unenforceable, in whole or in part, construe the patent’s claims narrowly, or refuseto stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. Anadverse result in any litigation proceeding could put one or more of our patents at risk of being invalidated or interpreted narrowly,which could adversely affect us.

Ifwe are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.

Inaddition to seeking patents for some of our technology, we also intend to rely on trade secrets, including unpatented know-how, technology,and other proprietary information, to maintain our competitive position. We have executed and will continue to seek to protect thesetrade secrets, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such asour employees, corporate collaborators, outside scientific collaborators, contract manufacturers, consultants, advisors, and other thirdparties. We also have executed and will continue to seek to enter into confidentiality and invention or patent assignment agreementswith our employees and consultants. Despite these efforts, any of these parties may breach the agreements and disclose our proprietaryinformation, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches. Our trade secrets mayalso be obtained by third parties by other means, such as breaches of our physical or computer security systems.

Enforcinga claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive, and time-consuming, and the outcomeis unpredictable. In addition, some courts inside and outside the U.S. are less willing or unwilling to protect trade secrets. If anyof our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent them,or those to whom they communicate it, from using that technology or information to compete with us. If any of our trade secrets wereto be disclosed to or independently developed by a competitor, our competitive position would be harmed.

Intellectualproperty rights do not necessarily address all potential threats to our competitive advantage.

Thedegree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitationsand may not adequately protect our business or permit us to maintain our competitive advantage. For example:

Changesin patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our abilityto protect our diagnostic tests and therapeutic product candidates.

Asis the case with other biopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents.Obtaining and enforcing patents in the biopharmaceutical industry involves both technological and legal complexity and is therefore costly,time consuming and inherently uncertain. Changes in either the patent laws or interpretation of the patent laws in the United Statescould increase the uncertainties and costs, and may diminish our ability to protect our inventions, obtain, maintain, and enforce ourintellectual property rights and, more generally, could affect the value of our intellectual property or narrow the scope of our ownedand licensed patents. Patent reform legislation in the United States and other countries, including the Leahy-Smith America Invents Act(the “Leahy-Smith Act”), signed into law on September 16, 2011, could increase those uncertainties and costssurrounding the prosecution of our patent applications and the enforcement or defense of our issued patents. The Leahy-Smith Act includesa number of significant changes to U.S. patent law. These include provisions that affect the way patent applications are prosecuted,redefine prior art and provide more efficient and cost-effective avenues for competitors to challenge the validity of patents. Theseinclude allowing third-party submission of prior art to the United States Patent and Trademark Office (the “USPTO”)during patent prosecution and additional procedures to attack the validity of a patent by USPTO administered post-grant proceedings,including post-grant review, inter partes review, and derivation proceedings. Further, because of a lower evidentiary standardin these USPTO post-grant proceedings compared to the evidentiary standard in United States federal courts necessary to invalidate apatent claim, a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalideven though the same evidence would be insufficient to invalidate the claim if first presented in a district court action. Accordingly,a third party may attempt to use the USPTO procedures to invalidate our patent claims that would not have been invalidated if first challengedby the third party as a defendant in a district court action. Thus, the Leahy-Smith Act and its implementation could increase the uncertaintiesand costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which couldhave a material adverse effect on our business, financial condition, results of operations and prospects.

AfterMarch 2013, under the Leahy-Smith Act, the United States transitioned to a first inventor to file system in which, assuming that theother statutory requirements are met, the first inventor to file a patent application will be entitled to the patent on an inventionregardless of whether a third-party was the first to invent the claimed invention. A third party that files a patent application in theUSPTO after March 2013, but before we file an application covering the same invention, could therefore be awarded a patent covering aninvention of ours even if we had made the invention before it was made by such third party. This will require us to be cognizant goingforward of the time from invention to filing of a patent application, but circumstances could prevent us from promptly filing patentapplications on our inventions. Since patent applications in the United States and most other countries are confidential for a periodof time after filing or until issuance, we cannot be certain that we or our licensors were the first to either (i) file any patent applicationrelated to our diagnostic tests and therapeutic product candidates and other proprietary technologies we may develop or (ii) invent anyof the inventions claimed in our or our licensor’s patents or patent applications. Even where we have a valid and enforceable patent,we may not be able to exclude others from practicing the claimed invention where the other party can show that they used the inventionin commerce before our filing date. Thus the Leahy-Smith Act and its implementation could increase the uncertainties and costs surroundingthe prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverseeffect on our business, financial condition, results of operations and prospects.

Inaddition, the patent positions of companies in the development and commercialization of biologics and pharmaceuticals are particularlyuncertain. The U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protectionavailable in certain circumstances or weakening the rights of patent owners in certain situations. Depending on future actions by theU.S. Congress, the U.S. courts, the USPTO and the relevant law-making bodies in other countries, the laws and regulations governing patentscould change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patentsthat we might obtain in the future. For example, in the 2013 case Assoc. for Molecular Pathology v. Myriad Genetics, Inc., theU.S. Supreme Court held that certain claims to DNA molecules are not patentable. While we do not believe that any of the patents ownedor licensed by us will be found invalid based on this decision, we cannot predict how future decisions by the courts, the U.S. Congressor the USPTO may impact the value of our patents.

Obtainingand maintaining patent protection depends on compliance with various procedural, document submissions, fee payment and other requirementsimposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

Periodicmaintenance fees, renewal fees, annuities fees and various other governmental fees on patents and/or patent applications are due to bepaid to the USPTO and foreign patent agencies in several stages over the lifetime of the patent and/or patent application. The USPTOand various foreign governmental patent agencies also require compliance with a number of procedural, documentary, fee payment and othersimilar provisions during the patent application process. While an inadvertent lapse, including due to the effect of the COVID-19 pandemicon us or our patent maintenance vendors, can in many cases be cured by payment of a late fee or by other means in accordance with theapplicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application,resulting in partial or complete loss of patent rights in the relevant jurisdiction. Non-compliance events that could result in abandonmentor lapse of a patent or patent application include, but are not limited to, failure to respond to official actions within prescribedtime limits, non-payment of fees and failure to properly legalize and submit formal documents. If we fail to maintain the patents andpatent applications covering our diagnostic tests or therapeutic product candidates, our competitive position would be adversely affected.

Patentterms may be inadequate to protect our competitive position on our diagnostic tests or therapeutic product candidates for an adequateamount of time.

Theterm of any individual patent depends on applicable law in the country where the patent is granted. In the United States, provided allmaintenance fees are timely paid, a patent generally has a term of 20 years from its application filing date or earliest claimed non-provisionalfiling date. Extensions may be available under certain circumstances, but the life of a patent and, correspondingly, the protection itaffords is limited. Even if we or our licensors obtain patents covering our diagnostic tests and therapeutic product candidates, whenthe terms of all patents covering a diagnostic test or therapeutic product expire, our business may become subject to competition fromcompetitive medications, including generic medications. Given the amount of time required for the development, testing and regulatoryreview and approval of new diagnostic test or therapeutic product candidates, patents protecting such candidates may expire before orshortly after such candidates are commercialized. As a result, our owned and licensed patent portfolio may not provide us with sufficientrights to exclude others from commercializing diagnostic tests and therapeutic products similar or identical to ours.

Issuedpatents covering our product candidates could be found invalid or unenforceable if challenged in court or the USPTO.

Ifwe or a licensee initiate legal proceedings against a third party to enforce a patent covering one of our diagnostic tests or therapeuticproduct candidates, the defendant could counterclaim that the patent covering our diagnostic tests or therapeutic product candidate,as applicable, is invalid and/or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidityand/or unenforceability are commonplace, and there are numerous grounds upon which a third party can assert invalidity or unenforceabilityof a patent. Third parties may also raise similar claims before administrative bodies in the United States or abroad, even outside thecontext of litigation. Such mechanisms include re-examination, inter partes review, post grant review, and equivalent proceedingsin foreign jurisdictions (e.g., opposition proceedings). Such proceedings could result in revocation or amendment to our patents in sucha way that they no longer cover our diagnostic tests or therapeutic product candidates. The outcome following legal assertions of invalidityand unenforceability is unpredictable. With respect to the validity question, for example, we cannot be certain that there is no invalidatingprior art, of which we, our patent counsel and the patent examiner were unaware during prosecution. If a defendant were to prevail ona legal assertion of invalidity and/or unenforceability, we would lose at least part, and perhaps all, of the patent protection on ourdiagnostic tests or therapeutic product candidates. Such a loss of patent protection could have a material adverse impact on our business.

Ifwe do not obtain patent term extension in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation,thereby potentially extending the term of marketing exclusivity for our diagnostic tests or therapeutic product candidates, our businessmay be harmed.

Inthe United States, a patent that covers an FDA-approved drug or biologic may be eligible for a term extension designed to restore theperiod of the patent term that is lost during the premarket regulatory review process conducted by the FDA. Depending upon the timing,duration and conditions of FDA marketing approval of our diagnostic tests or therapeutic product candidates, one or more of our U.S.patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984 (the“Hatch-Waxman Act”), which permits a patent term extension of up to five years for a patent covering an approveddiagnostic test or therapeutic product as compensation for effective patent term lost during diagnostic test or therapeutic product developmentand the FDA regulatory review process. A patent term extension cannot extend the remaining term of a patent beyond a total of 14 yearsfrom the date of diagnostic test or therapeutic product approval, and only claims covering such approved diagnostic test or drug product,a method for using it or a method for manufacturing it may be extended. In Europe, our diagnostic test or therapeutic product candidatesmay be eligible for term extensions based on similar legislation. In either jurisdiction, however, we may not receive an extension ifwe fail to apply within applicable deadlines, fail to apply prior to expiration of relevant patents or otherwise fail to satisfy applicablerequirements. Even if we are granted such extension, the duration of such extension may be less than our request. If we are unable toobtain a patent term extension, or if the term of any such extension is less than our request, the period during which we can enforceour patent rights for that product will be in effect shortened and our competitors may obtain approval to market competing diagnostictests or products sooner. The resulting reduction of years of revenue from applicable diagnostic tests or products could be substantial.

Weenjoy only limited geographical protection with respect to certain patents and we may not be able to protect our intellectual propertyrights throughout the world.

Filing,prosecuting and defending patents covering our diagnostic tests and therapeutic product candidates in all countries throughout the worldwould be prohibitively expensive, and even in countries where we have sought protection for our intellectual property, such protectioncan be less extensive than those in the United States. The requirements for patentability may differ in certain countries, particularlydeveloping countries, and the breadth of patent claims allowed can be inconsistent. In addition, the laws of some foreign countries donot protect intellectual property rights to the same extent as federal and state laws in the United States. In-licensing patents coveringour diagnostic tests and therapeutic product candidates in all countries throughout the world may similarly be prohibitively expensive,if such opportunities are available at all. And in-licensing or filing, prosecuting and defending patents even in only those jurisdictionsin which we develop or commercialize our diagnostic tests and therapeutic product candidates may be prohibitively expensive or impractical.Competitors may use our and our licensors’ technologies in jurisdictions where we have not obtained patent protection or licensedpatents to develop their own diagnostic tests and therapeutic products and, further, may export otherwise infringing products to territorieswhere we and our licensors have patent protection, but where enforcement is not as strong as that in the United States or Europe. Thesediagnostic tests and products may compete with our diagnostic tests and therapeutic product candidates, and our or our licensors’patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Thelaws of some jurisdictions do not protect intellectual property rights to the same extent as the laws or regulations in the United Statesand Europe, and many companies have encountered significant difficulties in protecting and defending proprietary rights in such jurisdictions.Moreover, the legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents,trade secrets or other forms of intellectual property, particularly those relating to biotechnology tests and products, which could makeit difficult for us to prevent competitors in some jurisdictions from marketing competing tests and products in violation of our proprietaryrights generally. Proceedings to enforce our patent rights in foreign jurisdictions, whether or not successful, are likely to resultin substantial costs and divert our efforts and attention from other aspects of our business, and additionally could put at risk ouror our licensors’ patents of being invalidated or interpreted narrowly, could increase the risk of our or our licensors’patent applications not issuing, or could provoke third parties to assert claims against us. We may not prevail in any lawsuits thatwe initiate, while damages or other remedies may be awarded to the adverse party, which may be commercially significant. If we prevail,damages or other remedies awarded to us, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectualproperty rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that wedevelop or license. Furthermore, while we intend to protect our intellectual property rights in our expected significant markets, wecannot ensure that we will be able to initiate or maintain similar efforts in all jurisdictions in which we may wish to market our diagnostictests and product candidates. Accordingly, our efforts to protect our intellectual property rights in such countries may be inadequate,which may have an adverse effect on our ability to successfully commercialize our diagnostic tests and product candidates in all of ourexpected significant foreign markets. If we or our licensors encounter difficulties in protecting, or are otherwise precluded from effectivelyprotecting, the intellectual property rights important for our business in such jurisdictions, the value of these rights may be diminishedand we may face additional competition in those jurisdictions.

Insome jurisdictions including European countries, compulsory licensing laws compel patent owners to grant licenses to third parties. Inaddition, some countries limit the enforceability of patents against government agencies or government contractors. In these countries,the patent owner may have limited remedies, which could materially diminish the value of such patent. If we or any of our licensors areforced to grant a license to third parties under patents relevant to our business, or if we or our licensors are prevented from enforcingpatent rights against third parties, our competitive position may be substantially impaired in such jurisdictions.

Ifour trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interestand our business may be adversely affected.

Ourcurrent or future trademarks or trade names may be challenged, infringed, circumvented or declared generic or descriptive or determinedto be infringing on other marks. We may not be able to protect our rights to these trademarks and trade names or may be forced to stopusing these names, which we need for name recognition by potential partners or customers in our markets of interest. During trademarkregistration proceedings, we may receive rejections of our applications by the USPTO or in other foreign jurisdictions.

Althoughwe would be given an opportunity to respond to those rejections, we may be unable to overcome such rejections. In addition, in the USPTOand in comparable agencies in many foreign jurisdictions, third parties are given an opportunity to oppose pending trademark applicationsand to seek to cancel registered trademarks. Opposition or cancellation proceedings may be filed against our trademarks, and our trademarksmay not survive such proceedings. If we are unable to establish name recognition based on our trademarks and trade names, we may notbe able to compete effectively and our business may be adversely affected. We may license our trademarks and tradenames to third parties,such as distributors. Although these license agreements may provide guidelines for how our trademarks and tradenames may be used, a breachof these agreements or misuse of our trademarks and tradenames by our licensees may jeopardize our rights in or diminish the goodwillassociated with our trademarks and trade names.

Moreover,any name we have proposed to use with our therapeutic product candidate in the United States must be approved by the FDA, regardlessof whether we have registered it, or applied to register it, as a trademark. The FDA typically conducts a review of proposed productnames, including an evaluation of potential for confusion with other product names. If the FDA (or an equivalent administrative bodyin a foreign jurisdiction) objects to any of our proposed proprietary product names, we may be required to expend significant additionalresources in an effort to identify a suitable substitute name that would qualify under applicable trademark laws, not infringe the existingrights of third parties and be acceptable to the FDA. Furthermore, in many countries, owning and maintaining a trademark registrationmay not provide an adequate defense against a subsequent infringement claim asserted by the owner of a senior trademark. At times, competitorsor other third parties may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity andpossibly leading to market confusion. In addition, there could be potential trade name or trademark infringement claims brought by ownersof other registered trademarks or trademarks that incorporate variations of our registered or unregistered trademarks or trade names.If we assert trademark infringement claims, a court may determine that the marks we have asserted are invalid or unenforceable, or thatthe party against whom we have asserted trademark infringement has superior rights to the marks in question. In this case, we could ultimatelybe forced to cease use of such trademarks.

Ourinternal information technology systems, or those of our third-party clinical research organizations or other contractors or consultants,may fail or suffer security breaches, loss or leakage of data, and other disruptions, which could result in a material disruption ofour diagnostic tests’ or therapeutic product candidates’ development programs, compromise sensitive information related toour business or prevent us from accessing critical information, potentially exposing us to liability or otherwise adversely affectingour business.

Weare increasingly dependent upon information technology systems, infrastructure and data to operate our business. In the ordinary courseof business, we collect, store and transmit confidential information (including but not limited to intellectual property, proprietarybusiness information and personal information). It is critical that we do so in a secure manner to maintain the confidentiality and integrityof such confidential information. We have also outsourced elements of our operations to third parties, and as a result we manage a numberof third-party contractors who have access to our confidential information.

Despitethe implementation of security measures, given their size and complexity and the increasing amounts of confidential information thatthey maintain, our internal information technology systems and those of our third-party clinical research organizations and other contractorsand consultants are potentially vulnerable to breakdown or other damage or interruption from service interruptions, system malfunction,natural disasters, terrorism, war and telecommunication and electrical failures, as well as security breaches from inadvertent or intentionalactions by our employees, contractors, consultants, business partners, and/or other third parties, or from cyber-attacks by maliciousthird parties (including the deployment of harmful malware, ransomware, extortion, account takeover attacks, degradation of service attacks,denial-of-service attacks, “phishing,” or social engineering and other means to affect service reliability and threaten theconfidentiality, integrity and availability of information), which may compromise our system infrastructure or lead to data leakage.We have technology security initiatives and disaster recovery plans in place to mitigate our risk to these vulnerabilities, but thesemeasures may not be adequately designed or implemented to ensure that our operations are not disrupted or that data security breachesdo not occur. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications,or inappropriate disclosure of confidential or proprietary information, we could incur liability and reputational damage.

Hackersand data thieves are increasingly sophisticated and operate large-scale and complex automated attacks which may remain undetected untilafter they occur. We cannot assure you that our data protection efforts and our investment in information technology will prevent significantbreakdowns, data leakages, breaches in our systems or other cyber incidents that could have a material adverse effect upon our reputation,business, operations or financial condition. For example, if such an event were to occur and cause interruptions in our operations, itcould result in a material disruption of our programs and the development of our diagnostic tests and therapeutic product candidatescould be delayed. In addition, the loss of clinical trial data for our diagnostic tests and therapeutic product candidates could resultin delays in our marketing approval efforts and significantly increase our costs to recover or reproduce the data. Furthermore, significantdisruptions of our internal information technology systems or security breaches could result in the loss, misappropriation, and/or unauthorizedaccess, use, or disclosure of, or the prevention of access to, confidential information (including trade secrets or other intellectualproperty, proprietary business information, and personal information), which could result in financial, legal, business, and reputationalharm to us. Like all businesses we may be increasingly subject to ransomware or other malware that could significantly disrupt our businessoperations, or disable or interfere with necessary access to essential data or processes. Numerous recent attacks of this nature havealso involved exfiltration and disclosure of sensitive or confidential personal or proprietary information, or intellectual property,when victim companies have not paid the cyber criminals substantial ransom payments. For example, any such event that leads to unauthorizedaccess, use, disclosure, unavailability, or compromised integrity of personal or other sensitive or essential information, includingpersonal information regarding our clinical trial subjects or employees, could harm our reputation directly, compel us to comply withfederal and/or state breach notification laws and foreign law equivalents, subject us to mandatory corrective action, increase the costswe incur to protect against such information security breaches, such as increased investment in technology, render key personnel unableto perform duties or communicate throughout the organization and otherwise subject us to fines and other liability under laws and regulationsthat protect the privacy and security of personal information, which could result in significant legal and financial exposure and reputationaldamages that could potentially have an adverse effect on our business.

Thecosts of mitigating cybersecurity risks are significant and are likely to increase in the future. These costs include, but are not limitedto, retaining the services of cybersecurity providers; compliance costs arising out of existing and future cybersecurity, data protectionand privacy laws and regulations; and costs related to maintaining redundant networks, data backups and other damage-mitigation measures.We also cannot be certain that our existing insurance coverage will continue to be available on acceptable terms or in amounts sufficientto cover the potentially significant losses that may result from a security incident or breach or that the insurer will not deny coverageof any future claim.

Ourbusiness is affected by the ongoing COVID-19 pandemic and may be significantly adversely affected as the pandemic continues or if otherevents out of our control disrupt our business or that of our third-party providers.

Whilethe extent of the impact of the COVID-19 pandemic on our business and financial results is uncertain, a continued and prolonged publichealth crisis such as the COVID-19 pandemic could have a material negative impact on our business, financial condition and operatingresults. We have experienced and may in the future experience disruptions from COVID-19 to our business in a number of ways, including:

Themost significant impact of the COVID-19 pandemic has been closure of clinical collection sites during the test validation trial. Shouldthe pandemic continue and result in closure of clinical collection sites during the pivotal clinical trial, the trial may be delayeddue to a lack of collecting sputum samples necessary to conduct the trial. Further delays could result if we arerequired to develop and implement additional clinical trial policies and procedures designed to help protect subjects from the COVID-19virus. For example, in March 2020, the FDA issued a guidance on conducting clinical trials during the pandemic, which was updated inJuly 2020, January 2021, and August 2021. The guidance describes a number of considerations for sponsors of clinical trials impactedby the pandemic, including the requirement to include in the clinical trial report (or as a separate document): contingency measuresimplemented to manage the trial and any disruption of the trial as a result of the COVID-19 pandemic; a list of all subjects affectedby the COVID-19 pandemic-related trial disruptions by unique subject identifier and by investigational site and a description of howthe individual’s participation was altered; and analyses and corresponding discussions that address the impact of implemented contingencymeasures (e.g., participant discontinuation from investigational diagnostic test and therapeutic product and/or trial; alternative proceduresused to collect critical safety and/or efficacy data) on the safety and efficacy results reported for the trial. In its most recent updateto this guidance, the FDA addressed questions from clinical practitioners aiming to adapt their operations in a pandemic environment.The questions focused on when to suspend, continue, or initiate a trial, how to handle remote-site monitoring visits, and related matters.There is no assurance that the FDA’s guidance governing clinical trials during the pandemic will remain in effect or, even if itdoes, help address the risks and challenges enumerated above.

Otherpotential impacts of the COVID-19 pandemic on our future planned clinical trials could relate to the prioritization of healthcare resourcestoward pandemic efforts, potentially resulting in the diminished attention of physicians serving as our clinical trial investigatorsand the reduced availability of site staff supporting the conduct of our clinical trials, and interruptions or delays in the operationsof the FDA.

Ifthe COVID-19 pandemic continues, other aspects of our future planned clinical trials may be adversely affected, delayed or interrupted,including, for example, site initiation, patient recruitment and enrollment, availability of clinical trial materials, clinical trialsite data monitoring and efficacy, safety and translational data collection, and data analysis. Some patients and clinical investigatorsmay not be able to comply with clinical trial protocols and patients may choose to withdraw from our trials or we may have to pause enrollmentor we may choose to or be required to pause enrollment and/or patient dosing in our ongoing or planned clinical trials in order to preservehealth resources and protect trial participants. It is unknown how long these pauses or disruptions could continue. Patients may needto withdraw due to COVID-19 infections or experience increased adverse events and deaths in our clinical trials due to COVID-19-relatedinfections.

Inaddition, we currently rely on third parties to, among other things, manufacture materials used in our patient collection kit, ship clinicaltrial samples, perform quality testing, and supply other goods and services to run our business. If the operations of any third partyin our supply chain for materials is adversely impacted by the COVID-19 pandemic, including due to staffing shortages, production slowdowns.and disruptions in delivery systems, our supply chain may be disrupted and our costs could be increased for future clinical trials andfor our research and development operations as planned.

Wepreviously closed our offices and requested that most of our personnel work remotely, excepting researchers, laboratory personnel andcontractors who must perform essential activities that must be completed on-site. bioAffinity Technologies’ research laboratoriesare located on The University of Texas at San Antonio campus and have followed safety procedures as instructed by the university. Ourincreased reliance on personnel working from home could increase our cyber security risk, create data accessibility concerns, and makeus more susceptible to communication disruptions, any of which could adversely impact our business operations or delay necessary interactionswith local and federal regulators, ethics committees, research or clinical trial sites, and other important agencies and contractors.Further, we and our third-party service providers, including the clinical trial sites, our manufacturers and suppliers, may experiencestaffing shortages.

Ouremployees and contractors conducting research and development activities may not be able to access our laboratory for an extended periodof time as a result of the possibility that governmental authorities further modify current restrictions. In addition, when our facilitiesare open, we could encounter delays in connection with implementing precautionary measures to mitigate the risk of exposing our facilitiesand employees to COVID-19 or otherwise in connection with addressing an actual or potential exposure to COVID-19. As a result, this maydelay research and development initiatives.

Thetrading prices for shares of other biotechnology companies have been highly volatile as a result of the COVID-19 pandemic andfollowing this Offering the trading prices for shares of our Common Stock could also experience high volatility. As a result, we mayface difficulties raising capital through sales of our Common Stock or such sales may be on unfavorable terms. In addition, a recession,depression or other sustained adverse market event resulting from the spread of the COVID-19 could materially and adversely affect ourbusiness and the value of our Common Stock.

TheCOVID-19 pandemic continues to evolve. The ultimate impact of the COVID-19 pandemic on our business operations is highly uncertain andsubject to change and will depend on future developments, which cannot be accurately predicted, including the duration of the pandemic,additional or modified government actions, and the actions taken to contain COVID-19 or address its impact, among others. We do not yetknow the full extent of potential delays or impacts on our business, our clinical trials, our research programs, healthcare systems orthe global economy. We will continue to monitor the situation closely.

Inaddition, our business could be significantly adversely affected by other business disruptions to us or our third-party providers thatcould seriously harm our potential future revenue and financial condition and increase our costs and expenses. Our operations and contractors,consultants, and third parties could be subject to other global pandemics, earthquakes, power shortages, telecommunications failures,water shortages, floods, hurricanes, typhoons, fires, extreme weather conditions, medical epidemics, and other natural or man-made disastersor business interruptions, for which we are predominantly self-insured. The occurrence of any of these business disruptions could seriouslyharm our operations and financial condition and increase our costs and expenses.

RisksRelated to Government Regulations

CyPath^®Lung is currently being offered as an LDT by Pathology Laboratory Services pursuant to a licensing agreement with the Company.Should the FDA disagree that CyPath^® Lung is an LDT, or if the FDA’s regulatory approach to LDTs should change inthe future, our commercialization strategy may be adversely affected, which would negatively affect our results of operations and financialcondition.

TheFDA considers an LDT to be a test that is developed, validated, and performed within a single laboratory. The FDA has historically assertedits authority to regulate LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act (the “FDCA”),but it has generally exercised enforcement discretion with regard to LDTs. This means that even though the FDA believes it can imposeregulatory requirements on LDTs, such as requirements to obtain premarket approval, de novo classification, or clearance of LDTs,it has generally chosen not to enforce those requirements. The FDA has, on occasion, sent warning letters to laboratories offering LDTsthat the agency believed were not eligible for enforcement discretion because of how they were developed, validated, performed or marketedand consequent risks to the public.

Therehave been numerous legislative proposals to clarify the FDA’s regulatory authority over medical devices. These include two billsreintroduced in 2021: the VALID Act, which would expressly grant the FDA authority to regulate LDTs under a risk-based framework; andthe VITAL Act, which would assign LDTs to regulation solely under CLIA and would direct CMS to update its CLIA regulations. We cannotpredict if either of these bills will be enacted in their current (or any other) form and cannot quantify the effect of these bills onour business. In the meantime, the regulation by the FDA of LDTs remains uncertain.

IfFDA premarket review, classification or approval is required for CyPath^® Lung before we obtain de novo classification,our phased strategy for market entry would be adversely affected. Our laboratory licensee could be forced to stop performing CyPath^®Lung while we worked to obtain de novo classification. Our business, results of operations and financial condition wouldbe negatively affected unless and until such review were completed and our request for de novo classification were granted.

Delayby or failure of the FDA to grant our request for de novo classification, or failure on our part to comply with applicable requirements,would adversely affect our business, results of operations and financial condition.

TheFDCA requires that medical devices introduced to the United States market, unless exempted by regulation, be authorized by the FDA pursuantto either the premarket notification pathway, known as 510(k) clearance, the de novo classification pathway, or the PremarketApproval (“PMA”) pathway. We plan to seek de novo classification for the CyPath^® Lungtest in the second quarter of 2026. The FDA may not agree that agree that CyPath^® Lung meets the criteria for de novoclassification, in which case we would be required to submit a PMA to obtain marketing approval, which would require manufacturinginformation and a pre-approval inspection of the manufacturing facilities and could require review by an FDA advisory panel comprisedof experts outside the FDA. Any delay by or failure of the FDA to grant our de novo request or PMA could adversely affect ourconsolidated revenues, results of operations and financial condition.

Additionally,obtaining FDA clearance, approval or de novo classification for diagnostics can be expensive, time consuming and uncertain, andfor higher-risk devices can take several years and requires detailed and comprehensive scientific and clinical data. In addition, medicaldevices are subject to ongoing FDA obligations and continued regulatory oversight and review. Ongoing compliance with FDA regulationsincreases the cost of conducting our business and subjects us to heightened regulation by the FDA and penalties for failure to complywith these requirements.

Failureby us or our laboratory licensee to comply with applicable laws pertaining to LDTs or IVDs could adversely affect our business,results of operations and financial condition.

Theclinical laboratory testing sector is highly regulated in the United States. Our laboratory licensee, Pathology Laboratory Services,is accredited by CAP and holds a CLIA certificate of accreditation. Any failure by our laboratory licensee to comply with CLIA/CAP requirementscould result in adverse findings on inspection that, if not timely corrected, could result in loss of accreditation and the inabilityto perform laboratory testing.

Additionally,certain states, including California, Maryland, Nevada, Pennsylvania, and Rhode Island, require laboratories testing specimens from theirjurisdictions to hold an out-of-state laboratory license or permit. New York is exempt from, and imposes requirements in addition to,CLIA, including a requirement for test-specific permits of LDTs before they can be used to test specimens from patients in New York.The failure of our laboratory licensee to obtain state licenses or permits, where required, could interfere with our strategy for a nationalrollout of CyPath^® Lung.

SmithsMedicals is providing the acapella^® Choice Blue device to assist patients in expelling sputum out of the lungs into acollection cup noninvasively. This device is 510(k) cleared as a positive expiratory pressure device to help mobilize lung secretionsin people with certain lung conditions. The device does not have a cleared indication for use as a specimen collection device. Promotionof the device by us or our partners for use of the device for specimen collection could cause the FDA to consider the device to be adulteratedor misbranded in violation of the FDCA, and to require a 510(k) clearance for a specimen collection indication as a condition of distributingthe device. Any disruption to our ability to distribute the acapella^® Choice Blue could interfere with our ability tocollect adequate patient samples necessary for CyPath^® Lung.

CyPath^® Lung also relies on aproprietary algorithm, which has been licensed to Pathology Laboratory Services and used by the laboratory to develop and validate softwareintegrated into the test procedure that generates the quantitative and qualitative diagnostic results that are includedin their laboratory report. Certain types of standalone diagnostics software are subject to FDA regulation as a medical device (specifically,software as a medical device or “SaMD”). Some types of SaMD are subject to premarket authorization requirements.If the FDA were to conclude that we or our laboratory licensee is required to obtain premarket authorization for the software, our abilityto offer CyPath^® Lung as an LDT could be delayed or prevented, which would adversely affect our business.

Thethird-party licensors of our future therapeutic products, when ready, may be unable to obtain regulatory approval. The denial or delayof any such approval would delay commercialization of our future therapeutic products and have a material adverse effect on our potentialto generate revenue, our business and our results of operations.

Weplan to license our therapeutic candidates to third parties for development including clinical testing, manufacturing, labeling, packaging,approval, promotion, advertising, storage, recordkeeping, marketing, distribution, post-approval monitoring and reporting, and exportand import. These activities that are to be undertaken by third-party licensees of our future therapeutic products are subject to extensiveregulation by the FDA, and by foreign health authorities in other countries. These regulations differ from country to country. In theUnited States, we are not permitted to market our therapeutic product candidates until we receive regulatory approval from the FDA. Theprocess of obtaining regulatory approval is expensive, often takes many years following research and development, and thereafter thecommencement of clinical trials and can vary substantially based upon the type, complexity and novelty of the product candidates involved,as well as the target indications and patient population. Despite the time and expense invested in clinical development of product candidates,regulatory approval is never guaranteed. For our licensors to gain approval to market our product candidates, they must provide clinicaldata that adequately demonstrate the safety and efficacy of the product for the intended indication. We or any third party has not yetobtained regulatory approval to market any of our product candidates in the United States or any other country. Our business dependsupon licensing our therapeutic products to third-party pharmaceutical companies that would obtain these regulatory approvals. The FDAcan delay, limit or deny approval of these product candidates for many reasons, including:

Evenif eventually clinical testing approval of any regulatory filing for our product candidates is completed, the FDA may grant approvalcontingent on the performance of costly additional post-approval clinical trials. The FDA may also approve our product candidates fora more limited indication or a narrower patient population than the third party originally requested, and the FDA may not approve thelabeling that we believe is necessary or desirable for the successful commercialization of our product candidates. If the FDA requiresthe licensors to narrow the indications to smaller patient subsets, the market opportunities for our product candidates, if approved,and the ability to generate revenues and royalties may be materially limited. To the extent the licensors seeks regulatory approval inforeign countries, they may face challenges similar to those described above with regulatory authorities in applicable jurisdictions.

Obtainingand maintaining regulatory approval of our diagnostic tests or therapeutic product candidates in one jurisdiction does not mean thatwe will be successful in obtaining regulatory approval of our product candidates in other jurisdictions. Failure to obtain regulatoryapproval in foreign jurisdictions would prevent our product candidates from being marketed abroad.

Inaddition to regulations in the United States, to market and sell our diagnostic tests and therapeutic products in the EU, many Asiancountries and other jurisdictions, we must obtain separate regulatory approvals and comply with numerous and varying regulatory requirements,both from a clinical and manufacturing perspective. Approval by the FDA does not ensure approval by regulatory or payor authorities inother countries or jurisdictions, and approval by one regulatory or payor authority outside the United States does not ensure approvalby regulatory authorities in other countries or jurisdictions or by the FDA. However, a failure or delay in obtaining regulatory approvalin one jurisdiction may have a negative effect on the regulatory approval process in others. For example, even if the FDA grants marketingapproval of a diagnostic test or therapeutic product candidate, comparable regulatory authorities in foreign jurisdictions must alsoapprove the manufacturing, marketing and promotion of the diagnostic test or therapeutic product candidate in those countries. Approvalprocedures vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than,those in the United States, including additional preclinical studies or clinical trials as clinical trials conducted in one jurisdictionmay not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States, a diagnostic testor therapeutic product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In somecases, the price that we intend to charge for our diagnostic tests or therapeutic products is also subject to approval. A diagnostictest or therapeutic product candidate that has been approved for sale in a particular country may not receive reimbursement approvalin that country. We may not be able to obtain approvals from regulatory authorities or payor authorities outside the United States ona timely basis, if at all.

Wemay also submit marketing applications in other countries, such as countries in Europe or Asia. We may not be able to file for regulatoryapprovals and may not receive necessary approvals to commercialize our diagnostic tests or therapeutic products in any jurisdiction.Regulatory authorities in jurisdictions outside of the United States have requirements for approval of diagnostic tests or therapeuticproduct candidates with which we must comply prior to marketing in those jurisdictions. Obtaining foreign regulatory approvals and compliancewith foreign regulatory requirements could result in significant delays, difficulties and costs for us and could delay or prevent theintroduction of our diagnostic tests or therapeutic products in certain countries. We do not have any diagnostic tests or therapeuticproduct candidates approved for sale in any foreign jurisdiction, including international markets, and we do not have experience in obtainingregulatory approval in international markets. If we are unable to obtain approval of any of our diagnostic tests or therapeutic productcandidates by regulatory or payor authorities in the EU, Asia or elsewhere, or if we fail to comply with the regulatory requirementsin foreign jurisdictions, the commercial prospects of that diagnostic test or therapeutic product candidate may be significantly diminished,and our target market will be reduced and our ability to realize the full market potential of our diagnostic tests or therapeutic productcandidates will be harmed.

Evenif we obtain FDA approval of any of our diagnostic tests or therapeutic product candidates, we may never obtain approval or commercializesuch products outside of the United States, which would limit our ability to realize their full market potential.

Inorder to market any diagnostic test or therapeutic product outside of the United States, we must establish and comply with numerous andvarying regulatory requirements of other countries regarding safety and efficacy. Clinical trials conducted in one country may not beaccepted by regulatory authorities in other countries, and regulatory approval in one country does not mean that regulatory approvalwill be obtained in any other country. Approval procedures vary among countries and can involve additional diagnostic and therapeuticproduct testing and validation and additional administrative review periods. Seeking foreign regulatory approvals could result in significantdelays, difficulties and costs for us and may require additional preclinical studies or clinical trials, which would be costly and timeconsuming. Regulatory requirements can vary widely from country to country and could delay or prevent the introduction of our diagnostictests or therapeutic products in those countries. Satisfying these and other regulatory requirements is costly, time consuming, uncertainand subject to unanticipated delays. In addition, our failure to obtain regulatory approval in any country may delay or have negativeeffects on the process for regulatory approval in other countries. We do not have any diagnostic test or therapeutic product candidateapproved for sale in any jurisdiction, including international markets, and we do not have experience in obtaining regulatory approvalin international markets. If we fail to comply with regulatory requirements in international markets or fail to obtain and maintain requiredapprovals, our ability to realize the full market potential of our diagnostic tests or therapeutic products will be harmed.

Theimpact of recent healthcare reform legislation and other changes in the healthcare industry and in healthcare spending on us is currentlyunknown, and may adversely affect our business model.

Ourrevenue prospects could be affected by changes in healthcare spending and policy in the United States and abroad. We operate in a highlyregulated industry and new laws, regulations or judicial decisions, or new interpretations of existing laws, regulations or decisions,related to healthcare availability, the method of delivery or payment for healthcare tests, products and services could negatively impactour business, operations and financial condition.

Therehave been, and likely will continue to be, legislative and regulatory proposals at the foreign, federal and state levels directed atbroadening the availability of healthcare and containing or lowering the cost of healthcare, including proposals aimed at lowering prescriptiondrug prices and increasing competition for prescription drugs, as well as additional regulation on pharmaceutical transparency and reportingrequirements, any of which could negatively impact our future profitability and increase our compliance burden. We cannot predict theinitiatives that may be adopted in the future, including future challenges or significant revisions to the Affordable Care Act. The continuingefforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reducecosts of healthcare and/or impose price controls may adversely affect:

Anyreduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors,which may adversely affect our future profitability.

RisksRelated to Ownership of Our Common Stock

Therehas been no prior public market for our Common Stock, the stock price of our Common Stock may be volatile or may decline regardless ofour operating performance and you may not be able to resell your shares at or above the IPO price.

There has been no public market for our Common Stockprior to this Offering. The IPO price for our Common Stock will be determined through negotiations between the underwriter andus and may vary from the market price of our Common Stock following this Offering. If you purchase shares of our Common Stock in thisOffering, you may not be able to resell those shares at or above the IPO price. An active or liquid market in our Common Stockmay not develop upon the completion of this Offering or, if it does develop, it may not be sustainable. Further, an inactive market mayalso impair our ability to raise capital by selling shares of our Common Stock and may impair our ability to enter into strategic partnershipsor acquire companies or products by using our shares of Common Stock as consideration.

Wedo not expect to pay dividends in the foreseeable future. Any return on investment may be limited to the value of our Common Stock.

We do not anticipate paying cash dividends on ourCommon Stock in the foreseeable future. The payment of dividends on our Common Stock will depend on earnings, financial condition, andother business and economic factors affecting it at such time as our Board of Directors (our “Board”)may consider relevant. If we do not pay dividends, our Common Stock may be less valuable because a return on your investment will occuronly if our stock price appreciates.

Wewill have broad discretion in the use of the net proceeds of this Offering and may not use them effectively or in ways that increasethe value of our share price.

Whilewe believe that our use of the net proceeds that we will receive from this Offering will be accomplished, we cannot assure you that circumstancescould result in a change of such use. As a result, we will have discretion in the application of the net proceeds, including workingcapital and other general corporate purposes, and you and other stockholders may disagree with how we spend or invest these proceeds.The failure by our management to apply these funds effectively could adversely affect our business and financial condition. Pending theiruse, we may invest the net proceeds from our Offering in a manner that does not produce income or that loses value. These investmentsmay not yield a favorable return to our investors.

Futuresales of substantial amounts of the shares of Common Stock by existing shareholders could adversely affect the price of our Common Stock.

Ifour existing shareholders sell substantial amounts of the shares following an IPO, the market price of our Common Stock couldfall. Such sales by our existing shareholders might make it more difficult for us to issue new equity or equity-related securities inthe future at a time and place we deem appropriate. At this time, the overhang from existing shares is 10-12%. The shares of Common Stockoffered in this Offering will be eligible for immediate resale in the public market without restrictions. All remaining shares, whichare currently held by our existing shareholders, may be sold in the public market in the future subject to the lock-up agreements andthe restrictions contained in Rule 144 under the Securities Act of 1933, as amended (the “Securities Act”).If any existing shareholders sell a substantial amount of shares, the prevailing market price for our shares could be adversely affected.

Ifyou purchase our Common Stock in this Offering, you will incur immediate and substantial dilution in the book value of your shares.

TheIPO price will be substantially higher than the net tangible book value per share of our Common Stock. Investors purchasing CommonStock in this Offering will pay a price per share that substantially exceeds the book value of our tangible assets after subtractingour liabilities. As a result, investors purchasing Common Stock in this Offering will incur immediate dilution of $               per share, based on the assumed IPO price of $               per share of our Common Stock, which is the midpoint of the price range set forth on the cover page of this prospectus. Further, investorspurchasing Common Stock in this Offering will contribute approximately                %of the total amount invested by stockholders since our inception, but will own only approximately                %of the total number of shares of our Common Stock outstanding after this Offering.

Thisdilution is due to our investors who purchased shares prior to this Offering having paid substantially less when they purchased theirshares than the price offered to the public in this Offering and the exercise of stock options granted to our employees. To the extentthat our convertible notes, bridge notes, or Preferred Stock shares are converted into Common Stock or outstanding warrants or stockoptions are exercised, we issue restricted stock to our employees under our equity incentive plan or if we otherwise issue additionalshares of our Common Stock in each case at per share prices below the price to the public in this Offering, there will be further dilutionto new investors. As a result of the dilution to investors purchasing Common Stock in this Offering, investors may receive significantlyless than the purchase price paid in this Offering, if anything, in the event of our liquidation. For a further description of the dilutionthat you will experience immediately after this Offering, see “Dilution.”

Thefinancial and operational projections that we may make from time to time are subject to inherent risks.

Theprojections that we provide herein or our management may provide from time to time (including, but not limited to, those relating topotential peak sales amounts, clinical and regulatory timelines, production and supply matters, commercial launch dates, and other financialor operational matters) reflect numerous assumptions made by management, including assumptions with respect to our specific as well asgeneral business, regulatory, economic, market, and financial conditions and other matters, all of which are difficult to predict andmany of which are beyond our control. Accordingly, there is a risk that the assumptions made in preparing the projections, or the projectionsthemselves, will prove inaccurate. There may be differences between actual and projected results, and actual results may be materiallydifferent from those contained in the projections.

Themarket price of our Common Stock may be subject to fluctuation and you could lose all or part of your investment.

Ourpublic offering price has been arbitrarily determined by us and may not be indicative of prices that will prevail in the trading market.The price of our shares may decline following our public offering. The stock market in general has been, and the market price of ourCommon Stock shares in particular, will likely be subject to fluctuation, whether due to, or irrespective of, our operating resultsand financial condition. The market price of our shares may fluctuate as a result of a number of factors, some of which are beyond ourcontrol, including, but not limited to:

Thesefactors and any corresponding price fluctuations may materially and adversely affect the market price of our shares and result in substantiallosses being incurred by our investors. In the past, following periods of market volatility, public company shareholders have often institutedsecurities class action litigation. If we were involved in securities litigation, it could impose a substantial cost upon us and divertthe resources and attention of our management from our business.

Aninvestment in our Company may involve tax implications, and you are encouraged to consult your own advisors as neither we norany related party is offering any tax assurances or guidance regarding our Company or your investment.

Theformation of our Company, as well as an investment in our Company generally, involves complex federal, state, and local income tax considerations.Neither the Internal Revenue Service nor any state or local taxing authority has reviewed the transactions described herein and may takedifferent positions than the ones contemplated by management. You are strongly urged to consult your own tax and other advisors priorto investing, as neither we nor any of our officers, directors, or related parties can offer tax or similar advice, nor are any suchpersons making any representations and warranties regarding such matters.

Ourability to use our net operating loss carry-forwards and certain other tax attributes may be limited.

UnderSection 382 of the Internal Revenue Code of 1986, as amended, referred to as the Internal Revenue Code, if a corporation undergoes an“ownership change” (generally defined as a greater than 50% change (by value) in its equity ownership over a three-year period),the corporation’s ability to use its pre-change net operating loss carry-forwards and other pre-change tax attributes (such asresearch tax credits) to offset its post-change income may be limited. We may experience ownership changes in the future as a resultof subsequent shifts in our stock ownership, including the completion of our offering taken together with other transactions we may consummatein the succeeding three-year period. As a result, if we earn net taxable income, our ability to use our pre-change net operating losscarry-forwards to offset U.S. federal taxable income may be subject to limitations, which potentially could result in increased futuretax liability.

OurCertificate of Incorporation permits “blank check” Preferred Stock, which can be designated by our Board withoutstockholder approval.

Weare authorized to issue 20,000,000 shares of Preferred Stock. The shares of our Preferred Stock may be issued from time to time in oneor more series, each of which shall have a distinctive designation or title as is determined by our Board prior to the issuanceof any shares thereof. The Preferred Stock may have such voting powers, full, enhanced or limited, or no voting powers, and such preferencesand relative, participating, optional, or other special rights and such qualifications, limitations, or restrictions thereof as adoptedby the Board, which may include enhanced dividend rights, rights of redemption, sinking funds to pay dividends, liquidation andother rights that would be different than, and preferential to, the rights of the Common Stockholders. Because our Board is ableto designate the powers and preferences of the Preferred Stock without the vote of a majority of our stockholders, Common Stockholderswill have no control over what designations and preferences our Preferred Stock will have. If Preferred Stock is designated and issued,then depending upon the designation and preferences, the holders of the Preferred Stock may exercise voting control. As a result, ourstockholders would have no control over the operations of our Company.

Provisionsin our corporate charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders,more difficult and may prevent attempts by our stockholders to replace or remove our current management.

Provisions in our amended and restated certificateof incorporation (our “A&R Charter”) and amended and restated bylaws (our “A&RBylaws”) that will become effective upon the closing of this Offering may discourage, delay or prevent a merger, acquisitionor other change in control of us that stockholders may consider favorable, including transactions in which you might otherwise receivea premium for your shares. These provisions also could limit the price that investors might be willing to pay in the future for sharesof our Common Stock, thereby depressing the market price of our Common Stock. In addition, because our Board is responsible forappointing the members of our management team, these provisions may frustrate or prevent any attempts by our stockholders to replaceor remove our current management by making it more difficult for stockholders to replace members of our Board. Among other things,these provisions:

Moreover, because we are incorporated in Delaware,we are governed by the provisions of Section 203 of the Delaware General Corporation Law (the “DGCL”),which prohibits a person who owns 15% or more of our outstanding voting stock from merging or combining with us for a period of threeyears after the date of the transaction in which the person acquired 15% or more of our outstanding voting stock, unless the merger orcombination is approved in a prescribed manner. These provisions could discourage potential acquisition proposals and could delay orprevent a change in control transaction. They could also have the effect of discouraging others from making tender offers for our CommonStock, including transactions that may be your best interests. These provisions may also prevent changes in our management or limit theprice that investors are willing to pay for our stock.

Certain provisions in our A&R Charterand A&R Bylaws could make a merger, tender offer, or proxy contest difficult, thereby depressing the trading price of our CommonStock.

Our A&R Charter and A&R Bylaws containprovisions that could depress the trading price of our Common Stock by acting to discourage, delay or prevent a change of control ofour Company or changes in our management that the stockholders of our Company may deem advantageous. These provisions include the following:

Any provision in our A&R Charter or A&RBylaws, that has the effect of delaying or deterring a change in control could limit the opportunity for our stockholders to receivea premium for their shares of our Common Stock and could also affect the price that some investors are willing to pay for our CommonStock.

Certain provisions of the DGCL may haveanti-takeover effects that could delay, defer, or discourage another party from acquiring control of us, prevent changes in our Boardor management, and make certain transactions more challenging that stockholders might otherwise believe to be in their best interests.

Upon completion of this Offering, we will be subjectto the provisions of Section 203 of the DGCL, which will generally prohibit us from engaging in a “business combination,”meaning a merger, asset sale, or other transaction resulting in a stockholder’s financial benefit, with an “interested stockholder”for a three-year period following the time that such stockholder becomes an interested stockholder, unless the business combination isapproved in a manner prescribed by Section 203. Section 203 defines an “interested stockholder” as a person who, togetherwith affiliates and associates, owns, or within three years did own, 15% or more of a corporation’s outstanding voting stock. Theseprovisions may have the effect of delaying, deferring, or preventing changes in control of our Company and of averting changes in ourBoard or management. They are expected to discourage certain types of coercive takeover practices and inadequate takeover bids and, asa consequence, they might also inhibit temporary fluctuations in the market price of our Common Stock that often result from actual orrumored hostile takeover attempts. These provisions could make it more difficult to accomplish transactions that stockholders might otherwisedeem to be in their best interests.

OurA&R Charter designates a state or federal court located within the state of Delaware as the exclusive forum for substantiallyall disputes between us and our stockholders, which could limit our stockholders’ ability to choose the judicial forum for disputeswith us or our directors, officers or employees.

Our A&R Charter provides that, unlesswe consent in writing to the selection of an alternative forum, to the fullest extent permitted by law, the sole and exclusive forumfor (1) any derivative action or proceeding brought on our behalf under Delaware law, (2) any action asserting a claim of breach of afiduciary duty owed by any of our directors, officers or other employees to us or our stockholders, (3) any action asserting a claimagainst us or any of our directors, officers or other employees arising pursuant to any provision of the DGCL, our A&RCharter, or our A&R Bylaws, (4) any other action against us or any of our directors, officers or other employees assertinga claim that is governed by the internal affairs doctrine, or (5) any other action asserting an “internal corporate claim,”as defined in Section 115 of the DGCL, shall be the Court of Chancery of the State of Delaware (or, if the Court of Chancery does nothave jurisdiction, the federal district court for the District of Delaware) in all cases subject to the court having jurisdiction overindispensable parties named as defendants. These exclusive-forum provisions do not apply to claims under the Securities Act or the SecuritiesExchange Act of 1934, as amended (the Exchange Act).

Tothe extent that any such claims may be based upon federal law claims, Section 27 of the Exchange Act creates exclusive federal jurisdictionover all suits brought to enforce any duty or liability created by the Exchange Act or the rules and regulations thereunder.

Section 22 of the Securities Act creates concurrentjurisdiction for federal and state courts over all suits brought to enforce any duty or liability created by the Securities Act or therules and regulations thereunder. However, our A&R Charter contains a federal forum provision which provides that unless theCompany consents in writing to the selection of an alternative forum, the federal district courts of the United States of America willbe the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act.

Anyperson or entity purchasing or otherwise acquiring any interest in any of our securities shall be deemed to have notice of and consentedto this provision. This exclusive forum provision may limit a stockholder’s ability to bring a claim in a judicial forum of itschoosing for disputes with us or our directors, officers, or other employees, which may discourage lawsuits against us and our directors,officers, and other employees. If a court were to find the exclusive forum provision in our A&R Charter to be inapplicableor unenforceable in an action, we may incur additional costs associated with resolving the dispute in other jurisdictions, which couldharm our results of operations.

Certain limitation-of-liability and indemnificationprovisions in our A&R Charter and A&R Bylaws may discourage stockholders from bringing a lawsuit against our directors and officersfor breaches of their fiduciary duties, may reduce the likelihood of derivative litigation against our directors and officers, even thoughan action, if successful, might benefit the Company and other stockholders, and may adversely impact stockholders’ investmentsto the extent that the Company pays the costs of settlement and damage awards against directors and officers as required by these indemnificationprovisions.

Our A&R Charter will contain provisions thatlimit the liability of our directors for monetary damages to the fullest extent permitted by the DGCL. Consequently, our directors willnot be personally liable to us or our stockholders for monetary damages for any breach of fiduciary duties as directors, except liabilityfor:

Our A&R Charter and our A&R Bylaws willrequire us to indemnify our directors and officers, and allow us to indemnify other employees and agents, to the fullest extent permittedby the DGCL. Subject to certain limitations and limited exceptions, our A&R Charter will also require us to advance expenses incurredby our directors and officers for the defense of any action for which indemnification is required or permitted.

While we believe that including the limitation-of-liabilityand indemnification provisions in our A&R Charter, A&R Bylaws, and indemnification agreements is necessary to attract and retainqualified persons such as directors, officers and key employees, those provisions may discourage stockholders from bringing a lawsuitagainst our directors and officers for breaches of their fiduciary duties. They may also reduce the likelihood of derivative litigationagainst our directors and officers, even though an action, if successful, might benefit us and other stockholders. Further, a stockholder’sinvestment may be adversely affected to the extent that we pay the costs of settlement and damage awards against directors and officersas required by these indemnification provisions.

Ourmanagement collectively owns a substantial majority of our Common Stock.

Basedon the provisions for determining beneficial ownership in accordance with Rule 13d-3 and Item 403 of Regulation S-K underthe Exchange Act, immediately after this Offering,our officers and directors will own or exercise control of approximately 70% of the voting power of our outstanding Common Stock. Asa result, investors may be prevented from affecting matters involving our Company, including:

Furthermore,this concentration of voting power could have the effect of delaying, deterring, or preventing a change of control or other businesscombination that might otherwise be beneficial to our stockholders. This significant concentration of share ownership may also adverselyaffect the trading price for our Common Stock because investors may perceive disadvantages in owning stock in a company that is controlledby a small number of stockholders.

Ifsecurities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock priceand trading volume could decline.

Thetrading market for our Common Stock will depend in part on the research and reports that securities or industry analysts publish aboutus or our business. Securities and industry analysts do not currently, and may never, publish research on our Company. If no or onlyvery few securities analysts commence coverage of us, or if industry analysts cease coverage of us, the trading price for our CommonStock would be negatively affected. If one or more of the analysts who cover us downgrade our Common Stock or publish inaccurate or unfavorableresearch about our business, our Common Stock price would likely decline. If one or more of these analysts cease coverage of us or failto publish reports on us regularly, demand for our Common Stock could decrease, which might cause our Common Stock price and tradingvolume to decline.

Ifwe fail to establish and maintain an effective system of internal control or disclosure controls and procedures are not effective, wemay not be able to report our financial results accurately and timely or to prevent fraud. Any inability to report and file our financialresults accurately and timely could harm our reputation and adversely impact the trading price of our Common Stock.

Effectiveinternal controls are necessary for us to provide reliable financial reports and effectively prevent fraud. Section 404 of the Sarbanes-OxleyAct of 2002 (the “Sarbanes-Oxley Act”) requires us to evaluate and report on our internal controls over financialreporting and, depending on our future growth, may require our independent registered public accounting firm to annually attest to ourevaluation, as well as issue its own opinion on our internal controls over financial reporting. The process of implementing and maintainingproper internal controls and complying with Section 404 is expensive and time consuming. We cannot be certain that the measures we willundertake will ensure that we will maintain adequate controls over our financial processes and reporting in the future. Furthermore,if we are able to rapidly grow our business, the internal controls that we will need may become more complex, and significantly moreresources will be required to ensure our internal controls remain effective. Failure to implement required controls or difficulties encounteredin their implementation could harm our operating results or cause us to fail to meet our reporting obligations. If we or our auditorsdiscover a material weakness in our internal controls, the disclosure of that fact, even if the weakness is quickly remedied, could diminishinvestors’ confidence in our financial statements and harm our stock price. In addition, non-compliance with Section 404 couldsubject us to a variety of administrative sanctions, including the suspension of trading, ineligibility for future listing on one ofthe Nasdaq Stock Markets or national securities exchanges, and the inability of registered broker-dealers to make a market in our CommonStock, which may reduce our stock price.

GeneralRisks

Weare an “emerging growth company” and a “smaller reporting company,” and the reduced disclosure requirements applicableto emerging growth companies and smaller reporting companies may make our common shares less attractive to investors.

Weare an “emerging growth company” as defined in the Jumpstart Our Business Startups Act (the “JOBS Act”),and we intend to take advantage of some of the exemptions from reporting requirements that are applicable to other public companies thatare not emerging growth companies, including:

Inaddition, as an “emerging growth company” the JOBS Act allows us to delay adoption of new or revised accounting pronouncementsapplicable to public companies until such pronouncements are made applicable to private companies, unless we later irrevocably electnot to avail ourselves of this exemption. We have elected to use this extended transition period under the JOBS Act. As a result, ourfinancial statements may not be comparable to the financial statements of issuers who are required to comply with the effective datesfor new or revised accounting standards that are applicable to public companies, which may make comparison of our financials to thoseof other public companies more difficult. We will remain an emerging growth company until the earlier of: (i) the last day of the fiscalyear (1) following the fifth anniversary of the completion of this Offering, (2) in which we have total annual gross revenue of at least$1.07 billion, or (3) in which we are deemed to be a large accelerated filer, which means the market value of our Common Stock that isheld by non-affiliates exceeds $700 million as of the prior June 30^th; and (ii) the date on which we have issued more than$1.0 billion in non-convertible debt during the prior three-year period.

Weare also a “smaller reporting company meaning that the market value of our stock held by non-affiliates plus the proposed aggregateamount of gross proceeds to us as a result of this Offering is less than $700 million and our annual revenue was less than $100 millionduring the most recently completed fiscal year. Smaller reporting companies may take advantage of certain reduced disclosure obligations,including, among other things, providing only two years of audited financial statements in our Annual Report on Form 10-K, and, similarto emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation. To theextent we take advantage of such reduced disclosure obligations, it may also make comparison of our financial statements with other publiccompanies difficult or impossible. We will remain a smaller reporting company until the last day of the fiscal year in which (i) themarket value of our common shares held by non-affiliates exceeds $250 million as of the end of that year’s second fiscal quarter,or (ii) our annual revenues exceeded $100 million during such completed fiscal year and the market value of our common shares held bynon-affiliates exceeds $700 million as of the end of that year’s second fiscal quarter.

Investorsmay find our find our Common Stock less attractive to the extent we will rely on these exemptions. If some investors find our CommonStock less attractive as a result, there may be a less active trading market for our Common Stock and our stock price may be more volatile.

Wewill incur significantly increased costs as a result of operating as a public company, and our management will be required to devotesubstantial time to new compliance initiatives.

Asa public company, we will incur significant legal, accounting and other expenses that we did not incur as a private company. In addition,the Sarbanes-Oxley Act, as well as rules subsequently implemented by the SEC, and Nasdaq have imposed various requirements on publiccompanies. In July 2010, the Dodd-Frank Wall Street Reform and Consumer Protection Act (the “Dodd-Frank Act”)was enacted. There are significant corporate governance and executive compensation related provisions in the Dodd-Frank Act that requirethe SEC to adopt additional rules and regulations in these areas such as “say on pay” and proxy access. Recent legislationpermits smaller “emerging growth companies” to implement many of these requirements over a longer period and up to five yearsfrom the pricing of this Offering. We intend to take advantage of this new legislation but cannot guarantee that we will not be requiredto implement these requirements sooner than budgeted or planned and thereby incur unexpected expenses. Stockholder activism, the currentpolitical environment and the current high level of government intervention and regulatory reform may lead to substantial new regulationsand disclosure obligations, which may lead to additional compliance costs and impact the manner in which we operate our business in wayswe cannot currently anticipate. Our management and other personnel will need to devote a substantial amount of time to these complianceinitiatives. Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activitiesmore time-consuming and costlier. For example, we expect these rules and regulations to make it more difficult and more expensive forus to obtain director and officer liability insurance and we may be required to incur substantial costs to maintain our current levelsof such coverage.

Ourdisclosure controls and procedures may not prevent or detect all errors or acts of fraud.

Uponthe completion of this Offering, we will become subject to the periodic reporting requirements of the Exchange Act. We designed our disclosurecontrols and procedures to reasonably assure that information we must disclose in reports we file or submit under the Exchange Act isaccumulated and communicated to management, and recorded, processed, summarized and reported within the time periods specified in therules and forms of the SEC. We believe that any disclosure controls and procedures or internal controls and procedures, no matter howwell-conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met.

Theseinherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because ofsimple error or mistake. For example, our directors or executive officers could inadvertently fail to disclose a new relationship orarrangement causing us to fail to make any related party transaction disclosures. Additionally, controls can be circumvented by the individualacts of some persons, by collusion of two or more people or by an unauthorized override of the controls. Accordingly, because of theinherent limitations in our control system, misstatements due to error or fraud may occur and not be detected.

Futurechanges in financial accounting standards or practices may cause adverse and unexpected revenue fluctuations and adversely affect ourreported results of operations.

Future changes in financial accounting standardsmay cause adverse, unexpected revenue fluctuations and affect our reported financial position or results of operations. Financial accountingstandards in the United States are constantly under review and new pronouncements and varying interpretations of pronouncements haveoccurred with frequency in the past and are expected to occur again in the future. As a result, we may be required to make changes inour accounting policies. Those changes could affect our financial condition and results of operations or the way in which such financialcondition and results of operations are reported. We intend to invest resources to comply with evolving standards, and this investmentmay result in increased general and administrative expenses and a diversion of management time and attention from business activitiesto compliance activities. See the “MD&A—Recent Accounting Pronouncements” section of this prospectus.

Claimsfor indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against usand may reduce the amount of money available to us.

Ouramended and restated certificate of incorporation and amended and restated bylaws that will become effective upon the closing of thisOffering will provide that we will indemnify our directors and officers, in each case, to the fullest extent permitted by Delaware law.Delaware law provides that directors of a corporation will not be personally liable for monetary damages for any breach of fiduciaryduties as directors, except liability for:

Suchlimitation of liability does not apply to liabilities arising under federal securities laws and does not affect the availability of equitableremedies such as injunctive relief or rescission.

Ouramended and restated bylaws that will be in effect upon the closing of this Offering will provide that we are required to indemnify ourdirectors and officers to the fullest extent permitted by Delaware law and may indemnify our other employees and agents. Our amendedand restated bylaws will also provide that, on satisfaction of certain conditions, we will advance expenses incurred by a director orofficer in advance of the final disposition of any action or proceeding, and permit us to secure insurance on behalf of any officer,director, employee or other agent for any liability arising out of his or her actions in that capacity regardless of whether we wouldotherwise be permitted to indemnify him or her under the provisions of Delaware law. We believe that these amended and restated certificateof incorporation and amended and restated bylaws provisions are necessary to attract and retain qualified persons as directors and officers.

Whilewe maintain directors’ and officers’ liability insurance, such insurance may not be adequate to cover all liabilities thatwe may incur, which may reduce our available funds to satisfy third-party claims and may adversely impact our cash position.

useof proceeds

Weestimate that the net proceeds to us from the sale of shares of our Common Stock in this Offering will be approximately $         million, after deducting the underwriting discounts and commissions and estimated offering expenses payable by us. This assumes a publicoffering price of $          per share. If the underwriters exercise their option to purchaseadditional shares in full, the net proceeds to us will be approximately $          million.

Weintend to use the net proceeds from this Offering for working capital and for general corporate purposes, which may include product andtest development, general and administrative matters, and capital expenditures. We may also use a portion of the net proceeds for theacquisition of, or investment in, technologies, solutions or businesses that complement our business, although we have no present commitmentsor agreements to enter into any acquisitions or investments. We expect the proceeds from this Offering together with anticipated salesof our diagnostic LDT test should be sufficient for the Company to complete the de novo pivotal clinical trial and, ifresults are positive, to submit and obtain FDA clearance of CyPath^® Lung for sale and enter the EU market forsale of CyPath^® Lung as a CE-marked IVD test.

Wecannot specify with certainty all of the uses of the net proceeds that we will receive from this Offering. Accordingly, we will havebroad discretion in the application of these proceeds and our investors will be relying on the judgment of our management regarding theapplication of the net proceeds of this Offering.

Each$1.00 increase or decrease in the assumed public offering price of $          per sharewould increase or decrease the net proceeds to us from this Offering by approximately $         million, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same, and afterdeducting underwriting discounts and commissions and the estimated offering expenses payable by us. We may also increase or decreasethe number of shares we are offering. Each 1,000,000 share increase or decrease in the number of shares offered by us would increaseor decrease the net proceeds to us from this Offering by approximately $          million,assuming that the assumed public offering price of $          per share remains the same,and after deducting underwriting discounts and commissions and the estimated offering expenses payable by us.

DividendPolicy

Wehave never declared or paid any cash dividends on our capital stock. We intend to retain all available funds and future earnings, ifany, to fund the development and expansion of our business, and we do not anticipate declaring or paying any cash dividends in the foreseeablefuture. Any future determination regarding the declaration and payment of dividends, if any, will be at the discretion of our Boardand will depend on then-existing conditions, including our financial condition, results of operations, contractual restrictions,capital requirements, business prospects, and other factors our Board may deem relevant.

CAPITALIZATION

Thefollowing table sets forth our cash and cash equivalents and capitalization as of December 31, 2021:

The information set forth in the table below is illustrativeonly and our capitalization following the completion of this Offering will be adjusted based on the actual IPO price, the numberof shares of Common Stock sold in this Offering and other terms of this Offering determined at pricing. You should read the followingtable in conjunction with our consolidated financial statements and related notes appearing at the end of this prospectus as wellas the MD&A and “Description of Securities” sections of this prospectus.

A$1.00 increase (decrease) in the assumed IPO price of $           per shareof Common Stock, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase (decrease) eachof our pro forma as adjusted cash and cash equivalents, additional paid-in capital, total stockholders’ equity (deficit) and totalcapitalization by approximately $           million, assuming that the number of sharesoffered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discountsand commissions and estimated offering expenses. Similarly, each increase (decrease) of 1.0 million shares in the number of shares ofCommon Stock offered by us would increase (decrease) each of our pro forma as adjusted cash, cash equivalents, additional paid-in capital,total stockholders’ equity (deficit) and total capitalization by approximately $          million, assuming the assumed IPO price of $           per share of Common Stockremains the same and after deducting the estimated underwriting discounts and commissions and estimated offering expenses.

dilution

Ifyou invest in our Common Stock in this Offering, your ownership interest will be immediately diluted to the extent of the differencebetween the IPO price per share of our Common Stock and the pro forma as adjusted net tangible book value per share of our CommonStock immediately after this Offering. Net tangible book value dilution per share to new investors represents the difference betweenthe amount per share paid by purchasers of shares of Common Stock in this Offering and the pro forma as adjusted net tangible book valueper share of Common Stock immediately after completion of this Offering.

Ourhistorical net tangible book value (deficit) as of December 31, 2021 was approximately $(12.8) million, or $(0.67) per share of ourCommon Stock. Our historical net tangible book value (deficit) is the amount of our total tangible assets, adjusted to remove capitalizeddeferred offering costs we expect to recognize as an offset to the proceeds from this Offering, less our total liabilities and convertiblePreferred Stock, which is not included within our stockholders’ (deficit) equity. Historical net tangible book value per sharerepresents historical net tangible book value (deficit) divided by 18,988,278, the number of shares of our Common Stock outstanding asof December 31, 2021.

After giving effect to the (i) sale and issuanceby us of shares of our Common Stock in this Offering, based on an assumed IPO price of $___ per share (the midpoint of the rangeof offering prices set forth on the cover page of this prospectus) and after deducting the estimated underwriting discounts and commissionsand estimated offering expenses payable by us, assuming the underwriter’s option is not exercised, our pro forma as adjusted nettangible book value as of _______, 2022 would have been $______, or $____per share. This represents an immediate increase in pro formanet tangible book value of $____ per share to our existing stockholders and immediate dilution of $___ per share to investors purchasingshares of our Common Stock in this Offering at the assumed IPO price. The following table illustrates this dilution:

Each$1.00 increase or decrease in the assumed IPO price of $___ per share (the midpoint of the range of offering prices set forthon the cover page of this prospectus) would increase or decrease, as applicable, our pro forma as adjusted net tangible book value pershare to new investors by approximately $___, and would increase or decrease, as applicable, dilution per share to new investors in thisOffering by approximately $___, assuming that the number of shares of our Common Stock offered by us, as set forth on the cover pageof this prospectus, remains the same and after deducting estimated underwriting discounts and commissions and estimated offering expensespayable by us. If the underwriters exercise their option to purchase additional shares of our Common Stock from us in full, the pro formaas adjusted net tangible book value per share of our Common Stock immediately after this Offering would be increased by $____ per share,and the dilution in pro forma net tangible book value per share to new investors in this Offering would be $____ per share.

We may also increase or decrease the number of shareswe are offering. A one million share increase in the number of shares offered by us, as set forth on the cover page of this prospectus,would increase the pro forma as adjusted net tangible book value per share by $___ and decrease the dilution per share to investors participatingin this Offering by $____, assuming the assumed IPO price of $____ per share (the midpoint of the range of offering prices setforth on the cover page of this prospectus) remains the same and after deducting estimated underwriting discounts and commissions andestimated offering expenses payable by us. A one million share decrease in the number of shares offered by us, as set forth on the coverpage of this prospectus, would decrease the pro forma as adjusted net tangible book value per share after this Offering by $___ and increasethe dilution per share to new investors participating in this Offering by $_____, assuming the assumed IPO price of $____ pershare (the midpoint of the range of offering prices set forth on the cover page of this prospectus) remains the same and after deductingestimated underwriting discounts and commissions and estimated offering expenses payable by us. sensitivity

The following table presents, on a pro forma as adjustedbasis as of _________, 2022, after giving effect to the new investors purchasing shares of our Common Stock in this Offering with respectto the number of shares purchased from us, the total consideration paid or to be paid to us, which includes net proceeds received fromthe issuance of Common Stock, and the average price per share paid or to be paid to us at an assumed IPO price of ____ per share(the midpoint of the range of offering prices set forth on the cover page of this prospectus) before deducting estimated underwritingdiscounts and commissions and estimated offering expenses payable by us:

Each$1.00 increase or decrease in the assumed IPO price of $____ per share (the midpoint of the range of offering prices set forthon the cover page of this prospectus) would increase or decrease, as applicable, the total consideration paid by new investors and totalconsideration paid by all stockholders by approximately $_____, assuming that the number of shares of Common Stock offered by us, asset forth on the cover page of this prospectus, remains the same and after deducting estimated underwriting discounts and commissionspayable by us.

Exceptas otherwise indicated, the above discussion and tables assume no exercise of the underwriters’ option to purchase additional sharesof Common Stock in this Offering. If the underwriters exercise their option to purchase additional shares of Common Stock in full fromus, our existing stockholders would own ___% and our new investors would own ___% of the total number of shares of our Common Stock outstandingupon the completion of this Offering.

Thenumber of shares of Common Stock that will be outstanding after this Offering is based on ___________ shares of our Common Stock outstandingas of __________, 2022, and excludes ____________ shares of Common Stock reserved for issuance under our 2014 Equity IncentivePlan and __________ shares of Common Stock reserved for issuance for ___________.

Management’sDiscussion and Analysis of Financial Conditions and Results of Operations

Youshould read the following discussion and analysis of our financial condition and results of operations together with our financial statementsand related notes appearing at the end of this prospectus. Some of the information contained in this discussion and analysis isset forth at the end of this prospectus, including information with respect to our plans and strategy for our business and related financing,includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forthin the section entitled “Risk Factors,” our actual results could differ materially from the results described in or impliedby the forward-looking statements contained in the following discussion and analysis. You should carefully read the section entitled“Risk Factors” to gain an understanding of the important factors that could cause actual results to differ materially fromour forward- looking statements. Please also see the section entitled “Cautionary Note Regarding Forward-Looking Statements”and “Market, Industry and Other Data.”

Overview

Thissection presents management’s perspective on our financial condition and results of operations. The following discussion and analysisis intended to highlight and supplement data and information presented elsewhere in this prospectus, and should be read in conjunctionwith the sections “Prospectus Summary—Summary Historical Consolidated Financial and Other Data” and our consolidatedfinancial statements and notes thereto appearing at the end of this prospectus. It is also intended to provide you with information thatwill assist you in understanding our consolidated financial statements, the changes in key items in those consolidated financial statementsfrom year to year, and the primary factors that accounted for those changes. To the extent that this discussion describes prior performance,the descriptions relate only to the periods listed, which may not be indicative of our future financial outcomes. In addition to historicalinformation, this discussion contains forward-looking statements that involve risks, uncertainties, and assumptions that could causeresults to differ materially from management’s expectations. Factors that could cause such differences are discussed in the sectionstitled “Special Note Regarding Forward-Looking Statements” and “Risk Factors.”

Data as of and for the years ended December 31, 2020 and 2021 has beenderived from our audited consolidated financial statements appearing at the end of this prospectus.

OurMD&A is organized as follows:

CompanyOverview

Business

bioAffinity Technologies, Inc. is a privately heldbiotech company incorporated in Delaware with laboratories at The University of Texas at San Antonio.

RecentDevelopments

Financial

To date, we have devoted a substantial portion of our efforts and financial resources to the development of our first diagnostic test, CyPath^® Lung. As a result, since our inception in 2014, we have generated no revenue from sales of the CyPath^® Lung test and have funded our operations principally through private sales of our equity or debt securities. We have never been profitable and, as of December 31, 2021, we had total negative working capital of $11.6 million, including $8.7 million of convertible notes, and an accumulated deficit of approximately $28.5 million. We expect to continue to incur significant operating losses for the foreseeable future as we continue the development of our diagnostic tests or therapeutic products and advance them through clinical trials.

In the fourth quarter of 2021 and the first quarterof 2022, the Company raised an additional $2.4 million through the sale of bridge notes that are convertible into the Company’sCommon Stock at the time of an IPO, or at the noteholder’s option, at $0.60 per share, adjusted to reflect any stock split,stock dividend or other similar change in the Common Stock. The bridge notes bear interest at six percent (6%) and have a maturity dateof May 31, 2022. Additionally, each noteholder received a warrant to purchase one share of Common Stock based on the investor’sbridge note principal balance investment. The warrants have a five-year term at an exercise price equal to the Company’s IPO priceor $0.75 per share if the Company does not complete an IPO by the maturity date. In connection with the sale of our convertible bridgenotes, we will pay commissions of nine percent (9.0%) and will issue to WallachBeth Capital, LLC, Placement Agent’sWarrants equal to ten percent (10.0%) of the Common Stock issuable by the Company in the private placement with substantiallythe same terms as the warrants issued to our noteholders. For noteholders who were not introduced to the Company by the PlacementAgent, we will pay commissions of four and one-half percent (4.5%) and will issue Placement Agent’s Warrantsto our Placement Agent equal to two and one-half percent (2.5%) of the Common Stock issuable by the Company in the privateplacement. The warrants will have substantially the same terms as those issued to our noteholders.

Weanticipate raising additional cash needed through the private or public sales of equity or debt securities, collaborative arrangements,or a combination thereof, to continue to fund our operations and develop our products. There is no assurance that any such collaborativearrangement will be entered into or that financing will be available to us when needed in order to allow us to continue our operations,or if available, on terms acceptable to us. If we do not raise sufficient funds in a timely manner, we may be forced to curtail operations,delay our clinical trials, cease operations altogether, or file for bankruptcy.

Development of Our Diagnostic Tests

Our first diagnostic test, CyPath^®Lung, is a noninvasive test to detect early-stage lung cancer in people at high risk for the disease.

Our current five-year Business Plan for thecommercial development of CyPath^® Lung contemplates the following major initiatives:

Notwithstandingthat initial and interim data appear promising, the outcomes of our future clinical trials are uncertain and future clinical trials mayultimately be unsuccessful.

Resultsof Operations

Year Ended December 31, 2021 Compared to the Year Ended December 31,2020

Our results of operations have varied significantly from year to year andquarter to quarter and may vary significantly in the future. We did not have revenue during the years ending December 31, 2021 and 2020.We do anticipate generating revenues during 2022. Net loss for 2021 and 2020 were $6.3 million and $7.3 million, respectively, resultingfrom the operational activities described below.

OperatingExpenses

Operatingexpenses totaled $2.2 million and $2.6 million during 2021 and 2020, respectively. The decrease in operating expenses isthe result of the following factors.

Researchand Development

Ourresearch and development expenses consist primarily of expenditures for lab operations, preclinical studies, compensation and consultingcosts.

Researchand development expenses totaled $1.2 million and $1.4 million during 2021 and 2020, respectively. The decrease of approximately $219,000,or 16%, for 2021 compared to 2020 was primarily attributable to a decrease of almost $115,000 related to compensation and benefits asa result of a decrease in personnel, as well as decreases in lab operations of $80,000 as we minimized personnel in our labs to assistin maintaining recommended social distancing requirements due to the COVID-19 pandemic. Additionally, this decrease was due toa decrease in stock compensation expense of approximately $44,000 related to option grants to employees and consultants in 2021 comparedto 2020. These decreases were partially offset by an increase of approximately $35,000 in legal costs for patents and annuitiesin 2021.

Clinicaldevelopment

Clinical development expenses totaled approximately $130,000 and $195,000during 2021 and 2020, respectively. The decrease of approximately $65,000, or 33%, for 2021, compared to 2020 was primarily attributableto a decrease of approximately $75,000 in professional fees including consulting and legal fees incurred in the prior year related tofinalizing the evaluation and output for our CyPath^® Lung test.

Generaland Administrative

Ourgeneral and administrative expenses consist primarily of expenditures related to compensation, legal, accounting and tax and other professional,and general operating.

Generaland administrative expenses totaled approximately $0.9 million and $1.0 million during 2021 and 2020, respectively. The decrease of $113,000,or 11%, for 2021 compared to 2020 was primarily attributable to a decrease of approximately $55,000 in compensation due to a change inthe number of personnel as well as decreases of approximately $190,000 for stock-based compensation related to forfeitures of stock optionspreviously granted. These decreases were partially offset by an increase of more than $100,000 in consulting and legal fees in2021, largely related to the costs of filing new patents, responding to examiner comments on applications, and utilizing consultingservices for purposes of the 2019–2020 and 2020–2021 audits.

OtherIncome (Expense)

Otherincome (expense) totaled approximately ($4.1) million and ($4.7) million for 2021 and 2020, respectively.

Interestincome (expense)

We had net interest expense of approximately $1.0million and $381,000 for the year ended December 31, 2021 and 2020, respectively. The increase of approximately $620,000, or163%, was attributable to an increase of $3.3 million in convertible notes and bridge notes outstanding compared to prioryear, partially offset by interest earned on average outstanding cash balances. Additionally, in 2022 the Company recorded interest expenseof approximately $0.5 million for the amortization of debt discount related to the issuance of bridge notes.

Gain on Extinguishment of Debt

In April 2020, the Company received an initial U.S.Small Business Administration (the “SBA”) Paycheck Protection Program Loan (the “PPP Loan”).In June 2021, the Company received forgiveness from the SBA and recorded a gain of $239,000 on the extinguishment of the PPP Loan.

Fair value of warrants

During the fourth quarter 2021, in connection with the issuance of the bridge notes, the Company amended the terms of certain convertible notes. As an inducement to amending the notes, the Company issued Common Stock warrants with the same terms and conditions as the warrants issued to the bridge note holders. The estimated fair value of the warrants was $4.1 million and immediately expensed within the accompanying statement of operations.

(Loss)gain on change in fair value of convertible notes

The gain on the change in fair value of convertible notes totaled approximately$0.7 million during 2021 compared to a loss of $4.3 million during 2020, respectively. The change in the fair value of convertible notesresulted primarily from changes in the calculation of the fair value of our stock, the reduction in the expected term and other assumptionsduring the reported periods. Refer to our notes to audited financial statements for further discussion on our convertible notes.

Liquidityand Capital Resources

We have incurred losses since our inception in 2014 as a result of significantexpenditures for operations and research and development and, prior to April 2022, the lack of any approved diagnostic test or therapeuticproducts to generate revenue. We have an accumulated deficit of approximately $28.5 million as of December 31, 2021. We anticipate thatwe will continue to incur additional losses for the foreseeable future. To date, we have funded our operations primarily through the saleof our equity and debt securities, resulting in gross proceeds of approximately $17.9 million. Cash and cash equivalents were approximately$1.4 million as of December 31, 2021.

In thefourth quarter of 2021 and the first quarter of 2022, the Company issued a total of $2.4 million in bridge notes convertible into theCompany’s Common Stock, at the time of an IPO, or at the noteholder’s option, at $0.60 per share, adjusted to reflect anystock split, stock dividend or other similar change in the Common Stock. The convertible bridge notes bear interest at six percent(6%) and have a maturity date of May 31, 2022. Additionally, each noteholder received a warrant to purchase one share of CommonStock based on the investor’s bridge note principal balance investment. The warrants have a five-year term at an exercise priceequal to the Company’s IPO price or $0.75 per share if the Company does not complete an IPO by the maturity date. In connectionwith the sale of our convertible bridge notes, we will pay commissions of nine percent (9.0%) and will issue PlacementAgent’s Warrants to our Placement Agent equal to ten percent (10%) of the Common Stock issuable by the Company inthe private placement with substantially the same terms as our noteholders.

Based on our current level of expected operating expenditures, we expect to be able to fund our operations until June of2022. This assumes that we spend minimally on general operations, and that we do not encounter any unexpected events or other circumstancesthat could shorten this time period.

We are actively seeking sources of financing, including to fund our continuedoperations and research and development programs. To raise additional capital, we may sell additional equity or debt securities, or enterinto collaborative, strategic and/or licensing transactions. There can be no assurance that we will be able to complete any financingtransaction in a timely manner or on acceptable terms or otherwise or enter into a collaborative or strategic transaction. If we are notable to raise additional cash, we may be forced to delay, curtail, or cease development of our diagnostic tests or therapeutic products,or cease operations altogether.

Ourfinancial statements include explanatory disclosures regarding substantial doubt about our ability to continue as a going concern. Futurereports on our financial statements may also include explanatory disclosures with respect to our ability to continue as a going concern.Our financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts oramounts of liabilities that might be necessary should we be unable to continue our operations.

CashFlows

The following information reflects cash flows for the years presented: