Quarterly report pursuant to Section 13 or 15(d)


9 Months Ended
Sep. 30, 2023
Accounting Policies [Abstract]  



Use of Estimates


The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant estimates include the valuation allowance on the Company’s deferred tax assets, stock-based compensation, valuation of goodwill and intangible assets related to the business combination, allowance for contractual adjustments and discounts related to service revenues, and the useful lives of fixed assets.


Principles of Consolidation


The Company’s condensed consolidated financial statements reflect its financial statements, those of its wholly owned subsidiaries and certain variable interest entities where the Company is the primary beneficiary. The accompanying condensed consolidated financial statements include all the accounts of the Company, its wholly owned subsidiaries, OncoSelect® Therapeutics, LLC and PPLS, and the variable interest entity, Village Oaks Pathology Services, P.A. All significant intercompany balances and transactions have been eliminated.



In determining whether the Company is the primary beneficiary of a variable interest entity, it applies a qualitative approach that determines whether it has both (1) the power to direct the economically significant activities of the entity and (2) the obligation to absorb losses of, or the right to receive benefits from, the entity that could potentially be significant to that entity. The Company continuously assesses whether it is the primary beneficiary of a variable interest entity as changes to existing relationships or future transactions may result in the Company consolidating or deconsolidating one or more of its collaborators or partners.


Business Combination


On September 18, 2023, the Company, in connection with the Asset Purchase Agreement it entered into with Village Oaks (the Seller”) and Dr. Roby P. Joyce, M.D., dated September 18, 2023, acquired substantially all the assets and assumed certain liabilities of Village Oaks (the “Acquisition”) in exchange for total consideration of $3,500,000, which consists of: (i) $2.5 million in cash paid at closing and (ii) 564,972 shares of the Company’s common stock valued at $1 million, reduced by (iii) the assumption of assumed liabilities totaling $321,000. The assets purchased included a clinical pathology laboratory regulated by the Centers for Medicare and Medicaid Services (“CMS”) and accredited by the College of American Pathologists (“CAP”) and certified under the Clinical Laboratory Improvement Amendments (“CLIA”) of 1988.


The Company recognized goodwill of $1,149,000 arising from the Acquisition. The Acquisition is being accounted for as a business combination in accordance with ASC 805. The Company has determined the preliminary fair values of the assets acquired and liabilities assumed in the Acquisition. These values are subject to change as the Company performs additional reviews of its assumptions utilized.


The following table summarizes the purchase price and preliminary purchase price allocations relating to the Acquisition:


Cash   $ 2,500,000  
Common Stock     1,000,000  
Total purchase consideration   $ 3,500,000  


Net working capital (including cash)   $ 1,167,000  
Property and equipment     326,000  
Other assets     8,000  
Customer relationships     700,000  
Trade names and trademarks     150,000  
Goodwill     1,149,000  
Total net assets   $ 3,500,000  


Goodwill represents the excess fair value after the allocation to the identifiable net assets. The calculated goodwill is not deductible for tax purposes.


Cash and Cash Equivalents


For the purpose of the statement of cash flows, the Company considers all highly liquid investments with original maturities of three months or less at the time of purchase to be cash equivalents. Cash equivalents are stated at cost, which approximates market value, because of the short maturity of these instruments.


Concentration of Risk


The Company has significant cash balances at financial institutions which throughout the year regularly exceed the federally insured limit of $250,000. Any loss incurred or a lack of access to such funds could have a significant adverse impact on the Company’s financial condition, results of operations, and cash flow.


Advertising expense


The Company expenses all advertising costs as incurred. Advertising expense was approximately $43,000 and $13,000 for the nine months and $10,000 and $5,000 for the three months ended September 30, 2023 and 2022, respectively.


Loss Per Share


Basic loss per share is computed by dividing net loss attributable to common stockholders by the weighted-average number of shares of the Company’s common stock, par value $0.007 per share (the “Common Stock”) outstanding during the period. Diluted loss per share is computed by dividing net loss attributable to common stockholders by the sum of the weighted-average number of shares of Common Stock outstanding during the period and the weighted-average number of dilutive Common Stock equivalents outstanding during the period, using the treasury stock method. Dilutive Common Stock equivalents are comprised of in-the-money stock options, convertible notes payable, and warrants based on the average stock price for each period using the treasury stock method.



The following potentially dilutive securities have been excluded from the computations of weighted average shares of Common Stock outstanding as of September 30, 2023 and 2022, as they would be anti-dilutive:


    2023     2022  

As of September 30,

    2023     2022  
Shares underlying options outstanding     683,695       806,392  
Shares underlying warrants outstanding     4,649,952       4,624,952  
Shares underlying convertible notes           83,373  
Anti-dilutive securities     5,333,647       5,514,717  


Revenue Recognition


Post-acquisition of PPLS, additional revenue streams have been consolidated starting September 19, 2023. PPLS generates three sources of revenue: (1) patient service fees, (2) histology service fees, and (3) medical director fees. The revenue is recognized on the date of service (meeting the performance requirement of ASC 606). Pre-acquisition, bioAffinity’s revenue was generated in three ways for the nine months and three months ended September 30, 2023: (1) royalties from the Company’s diagnostic test, CyPath® Lung, (2) clinical flow cytometry services provided to Village Oaks related to the Company’s CyPath® Lung test, and (3) CyPath® Lung tests purchased by the U.S. Department of Defense (“DOD”) for an observational study, “Detection of Abnormal Respiratory Cell Populations in Lung Cancer Screening Patients Using the CyPath® Lung Assay (NCT05870592),” and research and development on using bronchoalveolar lavage fluid as a biological sample to assess cardiopulmonary function and exercise performance in military personnel post COVID-19 infection. The royalty income from CyPath® Lung and clinical flow cytometry services income, beginning September 19, 2023, are related-party income and, therefore, eliminated from consolidated net revenues.


To determine revenue recognition for the arrangements that the Company determines are within the scope of ASC 606, Revenue from Contracts with Customers, the Company performs the following five steps: (1) identify the contract(s) with a customer, (2) identify the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract, and (5) recognize revenue when (or as) the entity satisfies a performance obligation.


    For three months ended September 30,  
    2023     2022  
    Net Revenue     Related Party1     Consolidated     Net Revenue     Related Party1     Consolidated  
Parent (bioAffinity Technologies):                                                
CyPath® Lung royalty income1   $ 5,412     $ (487 )   $ 4,925     $ 1,150       -     $ 1,150  
Laboratory services1     7,423       (1,265 )     6,158       -       -       -  
Dept. of Defense study     4,500       -       4,500       -       -       -  
Subsidiaries ((PPLS) and Controlling Interest Entity2:                                                
Patient fees     248,654       -       248,654       -       -       -  
Histology fees     31,854       -       31,854       -       -       -  
Medical director fees     2,392       -       2,393       -       -       -  
Total net revenue   $ 300,236     $ (1,752 )   $ 298,484     $ 1,150       -     $ 1,150


    For the nine months ended September 30,  
    2023     2022  
    Net Revenue     Related Party1     Consolidated     Net Revenue     Related Party1     Consolidated  
Parent (bioAffinity Technologies):                                                
CyPath® Lung royalty income1   $ 13,164     $ (487 )   $ 12,677     $ 2,457       -     $ 2,457  
Laboratory services1     10,500       (1,265 )     9,315       -       -       -  
Dept. of Defense study     14,250       -       14,250       -       -       -  
Subsidiaries (VOPS/PPLS)2:                                                
Patient fees     248,654       -       248,654       -       -       -  
Histology fees     31,854       -       31,854       -       -       -  
Medical director fees     2,393       -       2,393       -       -       -  
Total net revenue   $ 320,895     $ (1,752 )   $ 319,143     $ 2,457       -     $ 2,457



1 As of September 18, 2023 (date of the Acquisition), royalty and laboratory services income agreements are considered related parties and eliminated upon consolidation.
2 The three months ended revenue for PPLS and its controlling interest entity, Village Oaks, only recognizes partial period of September 19 through September 30, 2023.




Certain prior year balances have been reclassified to conform to current year presentation. The Company reclassified patent expenses and annuity costs of approximately $142,000 and $41,000 from research and development to selling, general and administrative for the nine months and three months ended September 30, 2022, respectively.


Property and Equipment


In accordance with ASC 360-10, Accounting for the Impairment of Long-Lived Assets, the Company periodically reviews the carrying value of its long-lived assets, such as property, equipment, and definite lived intangible assets, to test whether current events or circumstances indicate that such carrying value may not be recoverable. When evaluating assets for potential impairment, the Company compares the carrying value of the asset to its estimated undiscounted future cash flows. If an asset’s carrying value exceeds such estimated cash flows (undiscounted and with interest charges), the Company records an impairment charge for the difference. The Company did not record any impairment for the nine months ended September 30, 2023 or fiscal year ended December 31, 2022.


Property and equipment are carried at cost, net of accumulated depreciation. Depreciation is computed using the straight-line method over the estimated useful life of the asset. Amortization of leasehold improvements is computed using the shorter of the lease term or estimated useful life of the asset. Additions and improvements are capitalized, while repairs and maintenance are expensed as incurred. Useful lives of each asset class are as follows:



Asset Category   Useful Life
Computer equipment   3-5 years
Computer software   3 years
Equipment   3-5 years
Furniture and fixtures   5-7 years
Vehicles   5 years
Leasehold improvements   Lesser of lease term or useful life



Intangible Assets


Intangible assets, net of accumulated amortization, are summarized as follows as of September 30, 2023:


Description   Date Acquired   Useful Life   Cost     Amortization     Net  
Goodwill   9/18/2023       $ 1,148,553     $

    $ 1,148,553  
Trade names and trademarks   9/18/2023   18 years     150,000       (277 )     149,723  
Customer relationships   9/18/2023   14 years     700,000       (1,666 )     698,334  
Total Intangible Assets   $ 1,998,553     $ (1,943 )   $ 1,996,610  


For the three and nine months ended September 30, 2023, amortization of intangible assets totaled $1,943 compared to $0 in the prior year comparative periods.


Recent Accounting Pronouncements


The Company continues to monitor new accounting pronouncements issued by the Financial Accounting Standards Board (“FASB”) and does not believe any accounting pronouncements issued through the date of this Quarterly Report will have a material impact on the Company’s condensed consolidated financial statements.


The Company adopted FASB issued Accounting Standards Update (ASU) No. 2016-02, Leases (Topic 842) on September 18, 2023, with the business combination of Village Oaks Pathology Services, P.A. (VOPS) and Precision Pathology Laboratories Services, LLC (PPLS). The Company has one operating lease for its real estate and office space and multiple finance leases for lab equipment in Texas that was acquired through the September 18, 2023, acquisition.