Cover
Cover | 12 Months Ended |
Dec. 31, 2023 | |
Entity Addresses [Line Items] | |
Document Type | S-1 |
Amendment Flag | false |
Entity Registrant Name | bioAffinity Technologies, Inc. |
Entity Central Index Key | 0001712762 |
Entity Tax Identification Number | 46-5211056 |
Entity Incorporation, State or Country Code | DE |
Entity Address, Address Line One | 22211 W Interstate 10 |
Entity Address, Address Line Two | Suite 1206 |
Entity Address, City or Town | San Antonio |
Entity Address, State or Province | TX |
Entity Address, Postal Zip Code | 78257 |
City Area Code | (210) |
Local Phone Number | 698-5334 |
Entity Filer Category | Non-accelerated Filer |
Entity Small Business | true |
Entity Emerging Growth Company | true |
Elected Not To Use the Extended Transition Period | false |
Business Contact [Member] | |
Entity Addresses [Line Items] | |
Entity Address, Address Line One | 22211 W Interstate 10 |
Entity Address, Address Line Two | Suite 1206 |
Entity Address, City or Town | San Antonio |
Entity Address, State or Province | TX |
Entity Address, Postal Zip Code | 78257 |
City Area Code | (210) |
Local Phone Number | 698-5334 |
Contact Personnel Name | Maria Zannes |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 2,821,570 | $ 11,413,759 |
Accounts and other receivables, net | 811,674 | 10,489 |
Inventory | 18,484 | 5,540 |
Prepaid expenses and other current assets | 321,017 | 531,899 |
Total current assets | 3,972,745 | 11,961,687 |
Non-current assets: | ||
Property and equipment, net | 458,633 | 214,438 |
Operating lease right-of-use asset, net | 370,312 | |
Finance lease right-of-use asset, net | 1,165,844 | |
Goodwill | 1,404,486 | |
Intangible assets, net | 833,472 | |
Other assets | 16,060 | 6,000 |
Total assets | 8,221,552 | 12,182,125 |
Current liabilities: | ||
Accounts payable | 604,789 | 345,042 |
Accrued expenses | 1,149,811 | 541,894 |
Unearned revenue | 33,058 | |
Operating lease liability, current portion | 94,708 | |
Finance lease liability, current portion | 365,463 | |
Loan payable | 251,746 | |
Total current liabilities | 2,247,829 | 1,138,682 |
Non-current liabilities | ||
Operating lease liability, net of current portion | 283,001 | |
Finance lease liability, net of current portion | 835,467 | |
Total liabilities | 3,366,297 | 1,138,682 |
Commitments and contingencies (See Note 10) | ||
Stockholders’ equity: | ||
Preferred stock, no shares issued or outstanding at December 31, 2023 and 2022, respectively | ||
Common stock, par value $0.007 per share; 25,000,000 and 14,285,714 shares authorized; 9,394,610 and 8,381,324 shares issued and outstanding as of December 31, 2023 and 2022, respectively | 65,762 | 58,669 |
Additional paid-in capital | 49,393,972 | 47,652,242 |
Accumulated deficit | (44,604,479) | (36,667,468) |
Total stockholders’ equity | 4,855,255 | 11,043,443 |
Total liabilities and stockholders’ equity | $ 8,221,552 | $ 12,182,125 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.007 | $ 0.007 |
Common stock, shares authorized | 25,000,000 | 14,285,714 |
Common stock, shares issued | 9,394,610 | 8,381,324 |
Common stock, shares outstanding | 9,394,610 | 8,381,324 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Statement [Abstract] | ||
Net Revenue | $ 2,532,499 | $ 4,803 |
Operating expenses: | ||
Direct costs and expenses | 1,740,884 | 467 |
Research and development | 1,467,936 | 1,378,624 |
Clinical development | 256,661 | 145,546 |
Selling, general and administrative | 6,790,654 | 2,481,042 |
Depreciation and amortization | 249,592 | 10,182 |
Total operating expenses | 10,505,727 | 4,015,861 |
Loss from operations | (7,973,228) | (4,011,058) |
Other income (expense): | ||
Interest income | 122,131 | 46,708 |
Interest expense | (37,125) | (2,532,640) |
Other Income | 3,325 | |
Other Expense | (31,121) | |
Gain on extinguishment of debt | 212,258 | |
Fair value adjustments on convertible notes payable | (1,866,922) | |
Loss before income taxes | (7,916,018) | (8,151,654) |
Income tax expense | (20,993) | (2,459) |
Net loss | $ (7,937,011) | $ (8,154,113) |
Net loss per common share, basic | $ (0.91) | $ (1.81) |
Net loss per common share, diluted | $ (0.91) | $ (1.81) |
Weighted average common shares outstanding, basic | 8,747,509 | 4,498,964 |
Weighted average common shares outstanding, diluted | 8,747,509 | 4,498,964 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Convertible Preferred Stock and Stockholders' Equity - USD ($) | Preferred Stock [Member] Convertible Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Beginning balance, value at Dec. 31, 2021 | $ 4,044,318 | $ 18,740 | $ 12,703,896 | $ (28,513,355) | $ (15,790,719) |
Beginning balance, shares at Dec. 31, 2021 | 756,558 | 2,677,140 | |||
Stock-based compensation | $ 208 | 248,384 | 248,592 | ||
Stock-based compensation, shares | 29,728 | ||||
Fair value of warrants issued | 462,344 | 462,344 | |||
Beneficial conversion feature for bridge notes | (185) | (185) | |||
Debt discount for warrants issued | 352,250 | 352,250 | |||
Common stock issued upon initial public offering, net of underwriters’ commission and offering costs of $1.8 million | $ 8,978 | 6,018,436 | 6,027,414 | ||
Common stock issued upon initial public offering, net of underwriters' commission and offering costs of $1.8 million, shares | 1,282,600 | ||||
Common stock issued on conversion of convertible preferred stock | $ (4,044,318) | $ 5,296 | 4,039,022 | 4,044,318 | |
Common stock issued on conversion of convertible preferred stock, shares | (756,558) | 756,558 | |||
Common stock issued on conversion of notes payable | $ 17,738 | 16,047,594 | 16,065,332 | ||
Common stock issued on conversion of notes payable, shares | 2,533,964 | ||||
Exercise of warrants | $ 7,255 | 7,706,055 | 7,713,310 | ||
Exercise of warrants, shares | 1,036,486 | ||||
Exercise of stock options | $ 454 | 74,446 | 74,900 | ||
Exercise of stock options, shares | 64,848 | ||||
Net loss | (8,154,113) | (8,154,113) | |||
Ending balance, value at Dec. 31, 2022 | $ 58,669 | 47,652,242 | (36,667,468) | 11,043,443 | |
Ending balance, shares at Dec. 31, 2022 | 8,381,324 | ||||
Stock-based compensation | $ 3,138 | 745,685 | 748,823 | ||
Stock-based compensation, shares | 448,314 | ||||
Net loss | (7,937,011) | (7,937,011) | |||
Stock issued in connection with the acquisition | $ 3,955 | 996,045 | 1,000,000 | ||
Stock issued in connection with the acquisition, shares | 564,972 | ||||
Ending balance, value at Dec. 31, 2023 | $ 65,762 | $ 49,393,972 | $ (44,604,479) | $ 4,855,255 | |
Ending balance, shares at Dec. 31, 2023 | 9,394,610 |
Consolidated Statements of Ch_2
Consolidated Statements of Changes in Convertible Preferred Stock and Stockholders' Equity (Parenthetical) $ in Millions | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Statement of Stockholders' Equity [Abstract] | |
Underwriting discounts, commissions and offering expenses | $ 1.8 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Cash flows from operating activities | ||
Net loss | $ (7,937,011) | $ (8,154,113) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 249,592 | 10,182 |
Accretion of debt issuance costs | 2,055,627 | |
Fair value adjustments on convertible notes payable | 1,866,922 | |
Stock-based compensation expense | 748,823 | 248,592 |
Fair value of warrants issued | ||
Gain on extinguishment of debt | (212,258) | |
Changes in operating assets and liabilities: | ||
Accounts and other receivables | 311,366 | (8,959) |
Inventory | (12,944) | (5,540) |
Prepaid expenses and other assets | 214,402 | (492,753) |
Accounts payable | (14,501) | 114,635 |
Accrued expenses | 362,012 | 66,335 |
Unearned revenue | 33,058 | |
Accrued interest | 440,485 | |
Operating lease right-of-use asset | 7,397 | |
Net cash used in operating activities | (6,037,806) | (4,070,845) |
Cash flows from investing activities | ||
Purchase of property and equipment | (22,902) | (219,987) |
Acquisition, net of cash acquired | (2,186,497) | |
Net cash used in investing activities | (2,209,399) | (219,987) |
Cash flows from financing activities | ||
Proceeds from loan payable | (251,746) | 555,148 |
Payment on loans payable | (269,983) | |
Proceeds from issuance of convertible notes payable | 724,000 | |
Repayment of convertible loan payable | (425,000) | |
Proceeds from issuance of common stock from the initial public offering, net of underwriting discounts, commissions and offering expenses of approximately $1.8 million | 6,027,414 | |
Exercise of warrants | 7,713,310 | |
Exercise of stock options | 74,900 | |
Return of capital from stock split | (185) | |
Payment of debt issuance costs | (55,651) | |
Principle repayments on finance leases | (93,238) | |
Net cash provided (used) by financing activities | (344,984) | 14,343,953 |
Net increase (decrease) in cash and cash equivalents | (8,592,189) | 10,053,121 |
Cash and cash equivalents at beginning of year | 11,413,759 | 1,360,638 |
Cash and cash equivalents at end of year | 2,821,570 | 11,413,759 |
Supplemental disclosures of cash flow information: | ||
Income taxes paid in cash | 20,993 | 30,637 |
Interest paid | 37,125 | 2,459 |
Noncash investing activities: | ||
Stock issuance in connection with the acquisition | 1,000,000 | |
Noncash financing activities: | ||
Conversion of convertible preferred stock into common stock | 4,044,318 | |
Conversion of convertible notes payable into common stock | 16,065,332 | |
Fair value of warrants issued to placement agents | 352,250 | |
Beneficial conversion feature for bridge notes | $ 462,344 |
Consolidated Statements of Ca_2
Consolidated Statements of Cash Flows (Parenthetical) $ in Millions | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Statement of Cash Flows [Abstract] | |
Underwriting discounts, commissions and offering expenses | $ 1.8 |
BASIS OF PRESENTATION, ORGANIZA
BASIS OF PRESENTATION, ORGANIZATION AND NATURE OF OPERATIONS | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
BASIS OF PRESENTATION, ORGANIZATION AND NATURE OF OPERATIONS | BASIS OF PRESENTATION, ORGANIZATION AND NATURE OF OPERATIONS Description of Business bioAffinity Technologies, Inc., a Delaware corporation (the “Company,” or “bioAffinity Technologies”), addresses the need for noninvasive diagnosis of early-stage cancer and diseases of the lung. The Company also is conducting early-stage research focused on advancing therapeutic discoveries that could result in broad-spectrum cancer treatments. bioAffinity Technologies develops proprietary noninvasive diagnostic tests using technology that preferentially targets cancer cells and cell populations indicative of a diseased state. The Company’s first diagnostic test, CyPath ® ® Organization and Initial Public Offering The Company was formed on March 26, 2014, as a Delaware corporation with its corporate offices located in San Antonio, Texas. On June 15, 2016, the Company formed a wholly owned subsidiary, OncoSelect ® Basis of Presentation The consolidated financial statements of the Company have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). Going Concern In accordance with Accounting Standards Update (“ASU”) 2014-15, Presentation of Financial Statements – Going Concern The Company has incurred significant losses and negative cash flows from operations since inception and expects to continue to incur losses and negative cash flows for the foreseeable future. As a result, the Company had an accumulated deficit of $ 44.6 2.8 34 1,600,000 0.007 1,600,000 1.64 2.05 |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | Note 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Use of Estimates The preparation of 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 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 consolidated financial statements include all the accounts of the Company, its wholly owned subsidiaries, OncoSelect ® 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 Roby P. Joyce, MD, dated September 18, 2023, acquired substantially all the assets and assumed certain liabilities of Village Oaks in exchange for total consideration of $ 3,500,000 , which consists of: (1) $ 2.5 million in cash paid at closing and (2) 564,972 shares of the Company’s common stock valued at $ 1 million The Company recognized goodwill of $ 1,404,000 The following table summarizes the purchase price and preliminary purchase price allocations relating to the acquisition: SCHEDULE OF PURCHASE PRICE AND PRELIMINARY PURCHASE PRICE ALLOCATIONS Cash $ 2,500,000 Common Stock 1,000,000 Total purchase consideration $ 3,500,000 Assets Net working capital (including cash) $ 912,000 Property and equipment 326,000 Other assets 8,000 Customer relationships 700,000 Trade names and trademarks 150,000 Goodwill 1,404,000 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. Consolidated unaudited pro-forma operating results as if the business combination began on January 1, 2022 are net revenues of $ 7.9 6.9 8.6 8.6 0.99 1.91 The preliminary purchase price allocations relating to the acquisition previously reported in the 10-Q filed, October 14, 2023, reported Net Working Capital of $ 1,167,000 1,149,000 811,000 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 Advertising Expense The Company expenses all advertising costs as incurred. Advertising expenses were approximately $ 89,000 39,000 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 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 December 31, 2023 and 2022, as they would be anti-dilutive: SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES 2023 2022 As of December 31, 2023 2022 Shares underlying options outstanding 683,695 806,392 Shares underlying warrants outstanding 4,649,952 4,649,952 Anti-dilutive securities 5,333,647 5,456,344 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 pre-acquisition: (1) royalties from the Company’s diagnostic test, CyPath ® ® ® ® ® To determine revenue recognition for the arrangements that the Company determines are within the scope of ASC 606, Revenue from Contracts with Customers SCHEDULE OF REVENUE RECOGNITION 2023 2022 As of December 31, 2023 2022 Patient service fees 1 $ 2,199,558 $ — Histology service fees 272,660 — Medical director fees 19,324 — Department of Defense observational studies 19,442 — Other revenues 2 21,515 4,803 Total net revenue $ 2,532,499 $ 4,803 1 Patient services fees includes direct billing for CyPath® Lung diagnostic test. 2 Other revenues include pre-acquisition CyPath® Lung royalty income and laboratory services. Reclassifications Certain prior year balances have been reclassified to conform to current year presentation. The Company reclassified legal fees and annuity costs relating to patents of approximately $ 236,000 Property and Equipment, Net In accordance with ASC 360-10, Accounting for the Impairment of Long-Lived Assets 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: SCHEDULE OF PROPERTY AND EQUIPMENT USEFUL LIFE Asset Category Useful Life Computer equipment 3 5 Computer software 3 Equipment 3 5 Furniture and fixtures 5 7 Vehicles 5 Leasehold improvements Lesser of lease term or useful life Intangible Assets Intangible assets, net of accumulated amortization, are summarized as follows as of December 31, 2023: SCHEDULE OF INTANGIBLE ASSETS ADJUSTMENTS Description Date Acquired Useful Life Cost Amortization Net Goodwill 9/18/2023 $ 1,404,486 $ — $ 1,404,486 Trade names and trademarks 9/18/2023 18 150,000 (2,361 ) 147,639 Customer relationships 9/18/2023 14 700,000 (14,167 ) 685,833 Total Intangible Assets $ 2,254,486 $ (16,528 ) $ 2,237,958 For the year ended December 31, 2023, amortization of intangible assets totaled $ 16,528 0 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 Annual Report will have a material impact on the Company’s consolidated financial statements. The Company adopted FASB issued Accounting Standards Update (ASU) No. 2016-13, accounting considerations of Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“CECL”) on September 18, 2023, with the business combination of Village Oaks and PPLS. The Company has patient service fees that are billed to commercial insurance companies, governmental payors, and patients. Under the CECL model, the Company estimates potential credit losses from the patient service fees billed using historical data. The Company adopted FASB issued Accounting Standards Update (ASU) No. 2016-02, Leases (Topic 842) on January 1, 2022, with the business combination of Village Oaks and 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. Income Taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income and the reversal of deferred tax liabilities during the period in which the related temporary difference becomes deductible. The Company includes interest and penalties related to uncertain tax positions as part of income tax expense, if any. No such interest or penalties were recognized during the years ended December 31, 2023 and 2022, and the Company had no accruals for interest and penalties at December 31, 2023 or 2022. Segment Information The Company is organized in two operating segments, Diagnostic Research and Development (R&D) and Laboratory Services, whereby its chief operating decision maker (“CODM”) assesses the performance of and allocates resources. The CODM is the Chief Executive Officer. Diagnostic R&D includes research and development and clinical development on diagnostic tests. Any revenues assigned to Diagnostic R&D are proceeds received from observational studies. Laboratory services include all the operations from Village Oaks and PPLS in addition to sales and marketing costs of CyPath® Lung from bioAffinity. SCHEDULE OF SEGMENT INFORMATION 2023 2022 As of December 31, 2023 2022 Net revenues: Diagnostic R&D $ 19,442 $ — Laboratory services 2,513,057 4,803 Total net revenues 2,532,499 4,803 Operating expenses: Diagnostic R&D (1,724,597 ) (1,524,170 ) Laboratory services (3,769,783 ) (95,041 ) General corporate activities (5,011,347 ) (2,396,650 ) Total operating loss (7,973,228 ) (4,011,058 ) Non-operating income (expense), net 57,210 (4,140,596 ) Net loss before income taxes (7,916,018 ) (8,151,654 ) Income tax expense (20,993 ) (2,459 ) Net Loss $ (7,937,011 ) $ (8,154,113 ) Research and Development Research and development costs are charged to expense as incurred. The Company’s research and development expenses consist primarily of expenditures for lab operations, preclinical studies, compensation, and consulting costs. The Company incurred research and development expenses of $ 1.5 1.4 Accrued Research and Development Costs The Company records accrued liabilities for estimated costs of research and development activities conducted by service providers, which include preclinical studies. The Company records the estimated costs of research and development activities based upon the estimated amount of services provided but not yet invoiced and includes these costs in accrued expenses in the accompanying balance sheets and within research and development expense in the accompanying consolidated statements of operations. The Company accrues for these costs based on factors such as estimates of the work completed and in accordance with agreements established with service providers. The Company makes significant judgments and estimates in determining the accrued expenses balance in each reporting period. As actual costs become known, the Company adjusts its accrued liabilities. The Company has not experienced any material differences between accrued costs and actual costs incurred since its inception. Regulatory Matters Regulations imposed by federal, state, and local authorities in the U.S. are a significant factor in providing medical care. In the U.S., drugs, biological products, and medical devices are regulated by FDCA, which is administered by the FDA and the Centers for Medicare and Medicaid Services. The Company has not yet obtained marketing authorization from the FDA but is able to market its CyPath® Lung test as a laboratory developed test sold by Precision Pathology Laboratory Services, a CAP-accredited, CLIA-certified clinical pathology laboratory and wholly owned subsidiary. |
ACCOUNTS AND OTHER RECEIVABLES,
ACCOUNTS AND OTHER RECEIVABLES, NET | 12 Months Ended |
Dec. 31, 2023 | |
Credit Loss [Abstract] | |
ACCOUNTS AND OTHER RECEIVABLES, NET | Note 3. ACCOUNTS AND OTHER RECEIVABLES, NET Accounts and other receivables at December 31, 2023 and 2022, are summarized below: SCHEDULE OF ACCOUNTS RECEIVABLE 2023 2022 December 31, 2023 2022 Patient service fees $ 657,717 $ — Histology service fees 121,301 — Medical director fees 3,103 — Other receivables 29,553 10,489 Total accounts and other receivables, net $ 811,674 $ 10,489 |
PREPAID EXPENSES AND OTHER CURR
PREPAID EXPENSES AND OTHER CURRENT ASSETS | 12 Months Ended |
Dec. 31, 2023 | |
Prepaid Expenses And Other Current Assets | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | Note 4. PREPAID EXPENSES AND OTHER CURRENT ASSETS Prepaid expenses and other current assets at December 31, 2023 and 2022, are summarized below: SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS 2023 2022 December 31, 2023 2022 Prepaid insurance $ 171,855 $ 340,078 Legal and professional 24,476 72,048 Other 124,686 119,773 Total prepaid expenses and other current assets $ 321,017 $ 531,899 |
PROPERTY AND EQUIPMENT, NET
PROPERTY AND EQUIPMENT, NET | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT, NET | Note 5. PROPERTY AND EQUIPMENT, NET Property and equipment at December 31, 2023 and 2022, are summarized below: SCHEDULE OF PROPERTY AND EQUIPMENT 2023 2022 December 31, 2023 2022 Lab equipment $ 647,214 $ 462,155 Computers and software 68,682 21,463 Leasehold improvements 9,941 — Vehicles 105,919 — Property and equipment, gross 831,756 483,618 Less: accumulated depreciation and amortization (373,123 ) (269,180 ) Total property and equipment, net $ 458,633 $ 214,438 Total Property and equipment depreciation expense was $ 233,064 10,182 |
ACCRUED EXPENSES
ACCRUED EXPENSES | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
ACCRUED EXPENSES | Note 6. ACCRUED EXPENSES Accrued expenses at December 31, 2023 and 2022, are summarized below: SCHEDULE OF ACCRUED EXPENSES 2023 2022 December 31, 2023 2022 Compensation $ 857,037 $ 340,680 Legal and professional 257,926 144,440 Clinical 15,350 50,922 Other 19,498 5,852 Total accrued expenses $ 1,149,811 $ 541,894 |
UNEARNED REVENUE
UNEARNED REVENUE | 12 Months Ended |
Dec. 31, 2023 | |
Revenue Recognition and Deferred Revenue [Abstract] | |
UNEARNED REVENUE | Note 7. UNEARNED REVENUE The Company engaged in an observational study of CyPath ® ® 33,058 0 |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENTS | Note 8. FAIR VALUE MEASUREMENTS The Company analyzes all financial instruments with features of both liabilities and equity under the FASB accounting standard for such instruments. Under this standard, financial assets and liabilities are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The estimated fair value of certain financial instruments, including cash and cash equivalents, accounts and other receivables, prepaid and other current assets, accounts payable, accrued expenses, and loan payable, are carried at historical cost basis, which approximates their fair values because of the short-term nature of these instruments. |
LEASES
LEASES | 12 Months Ended |
Dec. 31, 2023 | |
Leases [Abstract] | |
LEASES | Note 9. LEASES 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. The operating lease has a remaining lease term of 3.58 2.25 4.0 The lease agreements generally do not provide an implicit borrowing rate. Therefore, the Company used a benchmark approach as of December 31, 2023, to derive an appropriate incremental borrowing rate to discount remaining lease payments. The Company benchmarked itself against other companies of similar credit ratings and comparable quality and derived imputed interest rates ranging from 7.97 8.13 Leases with an initial term of 12 months or less are not recorded on the balance sheet. There are no material residual guarantees associated with any of the Company’s leases, and there are no significant restrictions or covenants included in the Company’s lease agreements. Certain leases include variable payments related to common area maintenance and property taxes, which are billed by the landlord, as is customary with these types of charges for office space. The Company has not entered into any lease arrangements with related parties, and the Company is not the sublessor in any arrangement. The Company’s existing leases contain escalation clauses and renewal options. The Company has evaluated several factors in assessing whether there is reasonable certainty that the Company will exercise a contractual renewal option. For leases with renewal options that are reasonably certain to be exercised, the Company included the renewal term in the total lease term used in calculating the right-of-use asset and lease liability. Prior to adoption of ASU 2016-02 effective January 1, 2022, the Company accounted for operating lease transactions by recording lease expense on a straight-line basis over the expected term of the lease. The components of lease expense, which are included in selling, general and administrative expense and depreciation and amortization for the year ended December 31, 2023, and 2022 are as follows: SCHEDULE OF COMPONENTS OF LEASE EXPENSE Components of lease expense: 2023 2022 Amortization of right-of-use assets - finance lease $ 128,324 $ — Interest on lease liabilities - finance lease 33,838 — Operating lease cost 39,887 — Total lease cost $ 202,049 $ — Operating leases: 2023 2022 Operating lease right-of-use, assets $ 370,312 $ — Operating lease liability, current 94,708 — Operating lease liability, non-current 283,001 — Total operating lease liabilities $ 377,709 $ — Financing leases: 2023 2022 Financing lease right-of-use assets, gross $ 1,294,168 $ — Accumulated amortization (128,324 ) Finance lease right-of-use assets, net $ 1,165,844 $ — Financing lease liability, current 365,463 — Financing lease liability, non-current 835,467 — Financing lease liability, long-term $ 1,200,930 $ — Weighted-average remaining lease term: 2023 2022 Operating leases (in years) 3.58 — Finance leases (in years) 3.25 — Weighted-average discount rate: 2023 2022 Operating leases 8.07 % — Finance leases 8.01 % — SCHEDULE OF FUTURE MINIMUM LEASE PAYMENT UNDER NON-CANCELLABLE Operating Leases Finance Leases 2024 $ 121,726 $ 448,505 2025 121,726 448,505 2026 121,726 270,395 2027 and thereafter 71,007 202,970 Total undiscounted cash flows 436,185 1,370,375 Less discounting (58,476 ) (169,445 ) Present value of lease liabilities $ 377,709 $ 1,200,930 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | Note 10. COMMITMENTS AND CONTINGENCIES Operating Leases In addition to the operating lease listed in Note 9, the Company leases its corporate offices under a month-to-month agreement and leases its laboratory and additional office space under an operating lease that is renewable annually by written notice by the Company and will require renewal in February 2024. Rent expense for office and lab space amounted to $ 112,124 65,043 Legal Matters From time to time, the Company is involved in various disputes and litigation matters that arise in the ordinary course of business. To date, the Company has no material pending legal proceedings. |
COMMON STOCK
COMMON STOCK | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
COMMON STOCK | Note 11. COMMON STOCK The Company has authorized a total of 25,000,000 0.007 14,285,715 25,000,000 9,505,255 110,645 8,381,324 |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
STOCK-BASED COMPENSATION | Note 12. STOCK-BASED COMPENSATION The Company grants options and restricted stock awards under its 2014 Equity Incentive Plan (the “Plan”). Under the Plan, the Company is authorized to grant options or restricted stock for up to 2,000,000 1,142,857 2,000,000 The Company has recorded stock-based compensation expense related to the issuance of restricted stock awards in the following line items in the accompanying consolidated statement of operations: SUMMARY OF STOCK-BASED COMPENSATION EXPENSE RECOGNIZED FOR STOCK OPTION AWARDS 2023 2022 Research and development $ 37,131 $ 7,832 Selling, general and administrative 711,692 240,760 Total stock-based compensation expense $ 748,823 $ 248,592 The following table summarizes stock option activity under the Plan: SUMMARY OF OPTION ACTIVITY Number of options Weighted- average exercise price Weighted- average remaining contractual term (in years) Aggregate intrinsic value Outstanding at December 31, 2022 806,392 $ 4.33 4.0 164,255 Granted — — — — Exercised — — — — Forfeited (122,697 ) 5.86 — — Outstanding at December 31, 2023 683,695 $ 3.99 2.9 $ 158,332 Vested and exercisable at December 31, 2023 682,306 $ 3.98 2.9 $ 158,010 As of December 31, 2023, there was $ 322 During the year ended December 31, 2023, no 7,142 2.84 64,848 75,000 The following table summarizes weighted-average assumptions using the Black-Scholes option-pricing model used on the date of the grants issued during the years ended December 31, 2023, and 2022, respectively: SCHEDULE OF FAIR VALUE ASSUMPTIONS 2023 2022 Fair value of Common Stock $ — $ 4.62 Volatility — % 63.9 % Expected term (years) — 6.0 Risk-free interest rate — % 2.20 % Dividend yield — % 0 % Black-Scholes requires the use of subjective assumptions which determine the fair value of stock-based awards. These assumptions include: Fair value of Common Stock Expected term Expected volatility Risk-free interest rate Expected dividend Restricted Stock Awards The following table summarizes restricted stock award activity under the Plan: SUMMARY OF RESTRICTED STOCK AWARD Number of restricted stock awards (RSA) Weighted- average grant price FMV on grant date Vested number of RSA Unvested number of RSA Balance at December 31, 2022 114,920 $ 3.56 $ 409,437 96,041 18,879 Granted 431,028 1.89 813,717 339,263 91,765 Forfeited (4,979 ) 2.76 (13,754 ) (4,979 ) — Balance at December 31, 2023 540,969 $ 2.24 $ 1,209,400 430,325 110,644 During the year ended December 31, 2023, the Company issued restricted stock awards (RSAs) for 431,028 three years 59,051 339,263 During the year ended December 31, 2022, the Company issued RSAs for 77,195 one year 29,728 |
WARRANTS
WARRANTS | 12 Months Ended |
Dec. 31, 2023 | |
Warrants | |
WARRANTS | Note 13. WARRANTS We account for Common Stock warrants as either equity instruments or derivative liabilities depending on the specific terms of the warrant agreement. Warrants are accounted for as derivative liabilities if the warrants allow for cash settlement or provide for modification of the warrant exercise price in the event subsequent sales of Common Stock by the Company are at a lower price per share than the then-current warrant exercise price. We classify derivative warrant liabilities on the balance sheet at fair value, and changes in fair value during the periods presented in the consolidated statement of operations, which is revalued at each consolidated balance sheet date subsequent to the initial issuance of the stock warrant. As of December 31, 2023, and December 31, 2022, the Company had 4,649,952 5.03 no 1,036,486 On September 17, 2023, the Company entered into a warrant amendment with certain holders of (1) tradeable warrants (the “Tradeable Warrants”) who have the right to purchase 73,568 73,568 1,109,475 |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | Note 14. INCOME TAXES Deferred tax assets and valuation allowance The Company had, subject to limitation, approximately $ 30 0.67 24 100 3.0 0.8 SCHEDULE OF DEFERRED TAX ASSETS AND LIABILITIES 2023 2022 December 31, 2023 2022 Deferred tax assets: Net operating loss carryover $ 6,479,696 $ 3,871,192 Stock compensation 325,320 477,055 Capitalized R&E costs 525,463 260,560 Other 204,013 5,708 Operating lease liabilities 79,319 — Tax credits 582,206 443,867 Total deferred tax assets 8,196,018 5,058,382 Deferred tax liability: Right-of-use asset tax liability $ (77,766 ) $ — Depreciation and amortization (59,248 ) (7,337 ) Total deferred tax liability (137,014 (7,337 ) Less: valuation allowance (8,059,004 ) (5,051,045 ) Total property and equipment, net $ 0 $ 0 The reconciliation of the statutory federal income tax rate to the Company’s effective tax rate for the years ended December 31, 2023 and 2022, was as follows: SCHEDULE OF RECONCILIATION OF STATUTORY FEDERAL INCOME TAX RATE 2023 2022 December 31, 2023 2022 Tax at federal statutory rate -21.00 % -21.00 % Permanent differences 0.03 % 10.40 % Research and development credits 0.83 % 2.20 % Deferred balance true-up 16.07 % 0.00 % Change in valuation allowance -37.87 % 10.10 % Effective income tax rate 0.00 % 0.00 % Unrecognized tax benefits As of December 31, 2023, and 2022, the Company has unrecognized tax benefits related to tax credits of $ 249,517 190,229 SCHEDULE OF UNRECOGNIZED TAX BENEFITS 2023 2022 December 31, 2023 2022 Beginning balance $ 190,229 $ 49,646 Additions based on tax positions related to the prior year 30,897 110,681 Additions based on tax positions related to the current year 28,391 29,902 Ending balance $ 249,517 $ 190,229 |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | Note 15. SUBSEQUENT EVENTS On March 8, 2024, the Company issued to certain investors, (i) in a registered direct offering, 1,600,000 1,600,000 1.64 Section 3(b) of the Warrants provides that in the event of a Dilutive Issuance, the Exercise Price of the Warrants shall be reduced and only reduced to equal the effective price per share of the Dilutive Issuance (the “Base Share Price”) and the number of Warrant Shares issuable thereunder shall be increased such that the aggregate Exercise Price payable pursuant to the Warrant, after taking into account the decrease in the Exercise Price, shall be equal to the aggregate Exercise Price prior to such adjustment, provided that the Base Share Price shall not be less than $3.0625 (50% of the public offering price of the Units sold in the Company’s initial public offering) (subject to adjustment for reverse and forward stock splits, recapitalizations and similar transactions). The effect of the Transaction is such that the Exercise Price of the Warrants shall be reduced to $ 3.0625 3.0625 As of March 8, 2024 and prior to the Transaction, there were Tradeable Warrants to purchase up to an aggregate of 1,601,258 2,704,554 |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Use of Estimates | Use of Estimates The preparation of 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 | Principles of Consolidation The Company’s 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 consolidated financial statements include all the accounts of the Company, its wholly owned subsidiaries, OncoSelect ® 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 | Business Combination On September 18, 2023, the Company, in connection with the Asset Purchase Agreement it entered into with Village Oaks (the “Seller”) and Roby P. Joyce, MD, dated September 18, 2023, acquired substantially all the assets and assumed certain liabilities of Village Oaks in exchange for total consideration of $ 3,500,000 , which consists of: (1) $ 2.5 million in cash paid at closing and (2) 564,972 shares of the Company’s common stock valued at $ 1 million The Company recognized goodwill of $ 1,404,000 The following table summarizes the purchase price and preliminary purchase price allocations relating to the acquisition: SCHEDULE OF PURCHASE PRICE AND PRELIMINARY PURCHASE PRICE ALLOCATIONS Cash $ 2,500,000 Common Stock 1,000,000 Total purchase consideration $ 3,500,000 Assets Net working capital (including cash) $ 912,000 Property and equipment 326,000 Other assets 8,000 Customer relationships 700,000 Trade names and trademarks 150,000 Goodwill 1,404,000 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. Consolidated unaudited pro-forma operating results as if the business combination began on January 1, 2022 are net revenues of $ 7.9 6.9 8.6 8.6 0.99 1.91 The preliminary purchase price allocations relating to the acquisition previously reported in the 10-Q filed, October 14, 2023, reported Net Working Capital of $ 1,167,000 1,149,000 811,000 |
Cash and Cash Equivalents | 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 | 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 |
Advertising Expense | Advertising Expense The Company expenses all advertising costs as incurred. Advertising expenses were approximately $ 89,000 39,000 |
Loss Per Share | 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 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 December 31, 2023 and 2022, as they would be anti-dilutive: SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES 2023 2022 As of December 31, 2023 2022 Shares underlying options outstanding 683,695 806,392 Shares underlying warrants outstanding 4,649,952 4,649,952 Anti-dilutive securities 5,333,647 5,456,344 |
Revenue Recognition | 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 pre-acquisition: (1) royalties from the Company’s diagnostic test, CyPath ® ® ® ® ® To determine revenue recognition for the arrangements that the Company determines are within the scope of ASC 606, Revenue from Contracts with Customers SCHEDULE OF REVENUE RECOGNITION 2023 2022 As of December 31, 2023 2022 Patient service fees 1 $ 2,199,558 $ — Histology service fees 272,660 — Medical director fees 19,324 — Department of Defense observational studies 19,442 — Other revenues 2 21,515 4,803 Total net revenue $ 2,532,499 $ 4,803 1 Patient services fees includes direct billing for CyPath® Lung diagnostic test. 2 Other revenues include pre-acquisition CyPath® Lung royalty income and laboratory services. |
Reclassifications | Reclassifications Certain prior year balances have been reclassified to conform to current year presentation. The Company reclassified legal fees and annuity costs relating to patents of approximately $ 236,000 |
Property and Equipment, Net | Property and Equipment, Net In accordance with ASC 360-10, Accounting for the Impairment of Long-Lived Assets 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: SCHEDULE OF PROPERTY AND EQUIPMENT USEFUL LIFE Asset Category Useful Life Computer equipment 3 5 Computer software 3 Equipment 3 5 Furniture and fixtures 5 7 Vehicles 5 Leasehold improvements Lesser of lease term or useful life |
Intangible Assets | Intangible Assets Intangible assets, net of accumulated amortization, are summarized as follows as of December 31, 2023: SCHEDULE OF INTANGIBLE ASSETS ADJUSTMENTS Description Date Acquired Useful Life Cost Amortization Net Goodwill 9/18/2023 $ 1,404,486 $ — $ 1,404,486 Trade names and trademarks 9/18/2023 18 150,000 (2,361 ) 147,639 Customer relationships 9/18/2023 14 700,000 (14,167 ) 685,833 Total Intangible Assets $ 2,254,486 $ (16,528 ) $ 2,237,958 For the year ended December 31, 2023, amortization of intangible assets totaled $ 16,528 0 |
Recent Accounting Pronouncements | 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 Annual Report will have a material impact on the Company’s consolidated financial statements. The Company adopted FASB issued Accounting Standards Update (ASU) No. 2016-13, accounting considerations of Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“CECL”) on September 18, 2023, with the business combination of Village Oaks and PPLS. The Company has patient service fees that are billed to commercial insurance companies, governmental payors, and patients. Under the CECL model, the Company estimates potential credit losses from the patient service fees billed using historical data. The Company adopted FASB issued Accounting Standards Update (ASU) No. 2016-02, Leases (Topic 842) on January 1, 2022, with the business combination of Village Oaks and 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. |
Income Taxes | Income Taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income and the reversal of deferred tax liabilities during the period in which the related temporary difference becomes deductible. The Company includes interest and penalties related to uncertain tax positions as part of income tax expense, if any. No such interest or penalties were recognized during the years ended December 31, 2023 and 2022, and the Company had no accruals for interest and penalties at December 31, 2023 or 2022. |
Segment Information | Segment Information The Company is organized in two operating segments, Diagnostic Research and Development (R&D) and Laboratory Services, whereby its chief operating decision maker (“CODM”) assesses the performance of and allocates resources. The CODM is the Chief Executive Officer. Diagnostic R&D includes research and development and clinical development on diagnostic tests. Any revenues assigned to Diagnostic R&D are proceeds received from observational studies. Laboratory services include all the operations from Village Oaks and PPLS in addition to sales and marketing costs of CyPath® Lung from bioAffinity. SCHEDULE OF SEGMENT INFORMATION 2023 2022 As of December 31, 2023 2022 Net revenues: Diagnostic R&D $ 19,442 $ — Laboratory services 2,513,057 4,803 Total net revenues 2,532,499 4,803 Operating expenses: Diagnostic R&D (1,724,597 ) (1,524,170 ) Laboratory services (3,769,783 ) (95,041 ) General corporate activities (5,011,347 ) (2,396,650 ) Total operating loss (7,973,228 ) (4,011,058 ) Non-operating income (expense), net 57,210 (4,140,596 ) Net loss before income taxes (7,916,018 ) (8,151,654 ) Income tax expense (20,993 ) (2,459 ) Net Loss $ (7,937,011 ) $ (8,154,113 ) |
Research and Development | Research and Development Research and development costs are charged to expense as incurred. The Company’s research and development expenses consist primarily of expenditures for lab operations, preclinical studies, compensation, and consulting costs. The Company incurred research and development expenses of $ 1.5 1.4 |
Accrued Research and Development Costs | Accrued Research and Development Costs The Company records accrued liabilities for estimated costs of research and development activities conducted by service providers, which include preclinical studies. The Company records the estimated costs of research and development activities based upon the estimated amount of services provided but not yet invoiced and includes these costs in accrued expenses in the accompanying balance sheets and within research and development expense in the accompanying consolidated statements of operations. The Company accrues for these costs based on factors such as estimates of the work completed and in accordance with agreements established with service providers. The Company makes significant judgments and estimates in determining the accrued expenses balance in each reporting period. As actual costs become known, the Company adjusts its accrued liabilities. The Company has not experienced any material differences between accrued costs and actual costs incurred since its inception. |
Regulatory Matters | Regulatory Matters Regulations imposed by federal, state, and local authorities in the U.S. are a significant factor in providing medical care. In the U.S., drugs, biological products, and medical devices are regulated by FDCA, which is administered by the FDA and the Centers for Medicare and Medicaid Services. The Company has not yet obtained marketing authorization from the FDA but is able to market its CyPath® Lung test as a laboratory developed test sold by Precision Pathology Laboratory Services, a CAP-accredited, CLIA-certified clinical pathology laboratory and wholly owned subsidiary. |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
SCHEDULE OF PURCHASE PRICE AND PRELIMINARY PURCHASE PRICE ALLOCATIONS | The following table summarizes the purchase price and preliminary purchase price allocations relating to the acquisition: SCHEDULE OF PURCHASE PRICE AND PRELIMINARY PURCHASE PRICE ALLOCATIONS Cash $ 2,500,000 Common Stock 1,000,000 Total purchase consideration $ 3,500,000 Assets Net working capital (including cash) $ 912,000 Property and equipment 326,000 Other assets 8,000 Customer relationships 700,000 Trade names and trademarks 150,000 Goodwill 1,404,000 Total net assets $ 3,500,000 |
SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES | The following potentially dilutive securities have been excluded from the computations of weighted average shares of Common Stock outstanding as of December 31, 2023 and 2022, as they would be anti-dilutive: SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES 2023 2022 As of December 31, 2023 2022 Shares underlying options outstanding 683,695 806,392 Shares underlying warrants outstanding 4,649,952 4,649,952 Anti-dilutive securities 5,333,647 5,456,344 |
SCHEDULE OF REVENUE RECOGNITION | SCHEDULE OF REVENUE RECOGNITION 2023 2022 As of December 31, 2023 2022 Patient service fees 1 $ 2,199,558 $ — Histology service fees 272,660 — Medical director fees 19,324 — Department of Defense observational studies 19,442 — Other revenues 2 21,515 4,803 Total net revenue $ 2,532,499 $ 4,803 1 Patient services fees includes direct billing for CyPath® Lung diagnostic test. 2 Other revenues include pre-acquisition CyPath® Lung royalty income and laboratory services. |
SCHEDULE OF PROPERTY AND EQUIPMENT USEFUL LIFE | 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: SCHEDULE OF PROPERTY AND EQUIPMENT USEFUL LIFE Asset Category Useful Life Computer equipment 3 5 Computer software 3 Equipment 3 5 Furniture and fixtures 5 7 Vehicles 5 Leasehold improvements Lesser of lease term or useful life |
SCHEDULE OF INTANGIBLE ASSETS ADJUSTMENTS | Intangible assets, net of accumulated amortization, are summarized as follows as of December 31, 2023: SCHEDULE OF INTANGIBLE ASSETS ADJUSTMENTS Description Date Acquired Useful Life Cost Amortization Net Goodwill 9/18/2023 $ 1,404,486 $ — $ 1,404,486 Trade names and trademarks 9/18/2023 18 150,000 (2,361 ) 147,639 Customer relationships 9/18/2023 14 700,000 (14,167 ) 685,833 Total Intangible Assets $ 2,254,486 $ (16,528 ) $ 2,237,958 |
SCHEDULE OF SEGMENT INFORMATION | SCHEDULE OF SEGMENT INFORMATION 2023 2022 As of December 31, 2023 2022 Net revenues: Diagnostic R&D $ 19,442 $ — Laboratory services 2,513,057 4,803 Total net revenues 2,532,499 4,803 Operating expenses: Diagnostic R&D (1,724,597 ) (1,524,170 ) Laboratory services (3,769,783 ) (95,041 ) General corporate activities (5,011,347 ) (2,396,650 ) Total operating loss (7,973,228 ) (4,011,058 ) Non-operating income (expense), net 57,210 (4,140,596 ) Net loss before income taxes (7,916,018 ) (8,151,654 ) Income tax expense (20,993 ) (2,459 ) Net Loss $ (7,937,011 ) $ (8,154,113 ) |
ACCOUNTS AND OTHER RECEIVABLE_2
ACCOUNTS AND OTHER RECEIVABLES, NET (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Credit Loss [Abstract] | |
SCHEDULE OF ACCOUNTS RECEIVABLE | Accounts and other receivables at December 31, 2023 and 2022, are summarized below: SCHEDULE OF ACCOUNTS RECEIVABLE 2023 2022 December 31, 2023 2022 Patient service fees $ 657,717 $ — Histology service fees 121,301 — Medical director fees 3,103 — Other receivables 29,553 10,489 Total accounts and other receivables, net $ 811,674 $ 10,489 |
PREPAID EXPENSES AND OTHER CU_2
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Prepaid Expenses And Other Current Assets | |
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS | Prepaid expenses and other current assets at December 31, 2023 and 2022, are summarized below: SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS 2023 2022 December 31, 2023 2022 Prepaid insurance $ 171,855 $ 340,078 Legal and professional 24,476 72,048 Other 124,686 119,773 Total prepaid expenses and other current assets $ 321,017 $ 531,899 |
PROPERTY AND EQUIPMENT, NET (Ta
PROPERTY AND EQUIPMENT, NET (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
SCHEDULE OF PROPERTY AND EQUIPMENT | Property and equipment at December 31, 2023 and 2022, are summarized below: SCHEDULE OF PROPERTY AND EQUIPMENT 2023 2022 December 31, 2023 2022 Lab equipment $ 647,214 $ 462,155 Computers and software 68,682 21,463 Leasehold improvements 9,941 — Vehicles 105,919 — Property and equipment, gross 831,756 483,618 Less: accumulated depreciation and amortization (373,123 ) (269,180 ) Total property and equipment, net $ 458,633 $ 214,438 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
SCHEDULE OF ACCRUED EXPENSES | Accrued expenses at December 31, 2023 and 2022, are summarized below: SCHEDULE OF ACCRUED EXPENSES 2023 2022 December 31, 2023 2022 Compensation $ 857,037 $ 340,680 Legal and professional 257,926 144,440 Clinical 15,350 50,922 Other 19,498 5,852 Total accrued expenses $ 1,149,811 $ 541,894 |
LEASES (Tables)
LEASES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Leases [Abstract] | |
SCHEDULE OF COMPONENTS OF LEASE EXPENSE | The components of lease expense, which are included in selling, general and administrative expense and depreciation and amortization for the year ended December 31, 2023, and 2022 are as follows: SCHEDULE OF COMPONENTS OF LEASE EXPENSE Components of lease expense: 2023 2022 Amortization of right-of-use assets - finance lease $ 128,324 $ — Interest on lease liabilities - finance lease 33,838 — Operating lease cost 39,887 — Total lease cost $ 202,049 $ — |
SCHEDULE OF BALANCE SHEET INFORMATION RELATING TO LEASES | Operating leases: 2023 2022 Operating lease right-of-use, assets $ 370,312 $ — Operating lease liability, current 94,708 — Operating lease liability, non-current 283,001 — Total operating lease liabilities $ 377,709 $ — Financing leases: 2023 2022 Financing lease right-of-use assets, gross $ 1,294,168 $ — Accumulated amortization (128,324 ) Finance lease right-of-use assets, net $ 1,165,844 $ — Financing lease liability, current 365,463 — Financing lease liability, non-current 835,467 — Financing lease liability, long-term $ 1,200,930 $ — Weighted-average remaining lease term: 2023 2022 Operating leases (in years) 3.58 — Finance leases (in years) 3.25 — Weighted-average discount rate: 2023 2022 Operating leases 8.07 % — Finance leases 8.01 % — |
SCHEDULE OF FUTURE MINIMUM LEASE PAYMENT UNDER NON-CANCELLABLE | SCHEDULE OF FUTURE MINIMUM LEASE PAYMENT UNDER NON-CANCELLABLE Operating Leases Finance Leases 2024 $ 121,726 $ 448,505 2025 121,726 448,505 2026 121,726 270,395 2027 and thereafter 71,007 202,970 Total undiscounted cash flows 436,185 1,370,375 Less discounting (58,476 ) (169,445 ) Present value of lease liabilities $ 377,709 $ 1,200,930 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
SUMMARY OF STOCK-BASED COMPENSATION EXPENSE RECOGNIZED FOR STOCK OPTION AWARDS | The Company has recorded stock-based compensation expense related to the issuance of restricted stock awards in the following line items in the accompanying consolidated statement of operations: SUMMARY OF STOCK-BASED COMPENSATION EXPENSE RECOGNIZED FOR STOCK OPTION AWARDS 2023 2022 Research and development $ 37,131 $ 7,832 Selling, general and administrative 711,692 240,760 Total stock-based compensation expense $ 748,823 $ 248,592 |
SUMMARY OF OPTION ACTIVITY | The following table summarizes stock option activity under the Plan: SUMMARY OF OPTION ACTIVITY Number of options Weighted- average exercise price Weighted- average remaining contractual term (in years) Aggregate intrinsic value Outstanding at December 31, 2022 806,392 $ 4.33 4.0 164,255 Granted — — — — Exercised — — — — Forfeited (122,697 ) 5.86 — — Outstanding at December 31, 2023 683,695 $ 3.99 2.9 $ 158,332 Vested and exercisable at December 31, 2023 682,306 $ 3.98 2.9 $ 158,010 |
SCHEDULE OF FAIR VALUE ASSUMPTIONS | The following table summarizes weighted-average assumptions using the Black-Scholes option-pricing model used on the date of the grants issued during the years ended December 31, 2023, and 2022, respectively: SCHEDULE OF FAIR VALUE ASSUMPTIONS 2023 2022 Fair value of Common Stock $ — $ 4.62 Volatility — % 63.9 % Expected term (years) — 6.0 Risk-free interest rate — % 2.20 % Dividend yield — % 0 % |
SUMMARY OF RESTRICTED STOCK AWARD | The following table summarizes restricted stock award activity under the Plan: SUMMARY OF RESTRICTED STOCK AWARD Number of restricted stock awards (RSA) Weighted- average grant price FMV on grant date Vested number of RSA Unvested number of RSA Balance at December 31, 2022 114,920 $ 3.56 $ 409,437 96,041 18,879 Granted 431,028 1.89 813,717 339,263 91,765 Forfeited (4,979 ) 2.76 (13,754 ) (4,979 ) — Balance at December 31, 2023 540,969 $ 2.24 $ 1,209,400 430,325 110,644 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
SCHEDULE OF DEFERRED TAX ASSETS AND LIABILITIES | SCHEDULE OF DEFERRED TAX ASSETS AND LIABILITIES 2023 2022 December 31, 2023 2022 Deferred tax assets: Net operating loss carryover $ 6,479,696 $ 3,871,192 Stock compensation 325,320 477,055 Capitalized R&E costs 525,463 260,560 Other 204,013 5,708 Operating lease liabilities 79,319 — Tax credits 582,206 443,867 Total deferred tax assets 8,196,018 5,058,382 Deferred tax liability: Right-of-use asset tax liability $ (77,766 ) $ — Depreciation and amortization (59,248 ) (7,337 ) Total deferred tax liability (137,014 (7,337 ) Less: valuation allowance (8,059,004 ) (5,051,045 ) Total property and equipment, net $ 0 $ 0 |
SCHEDULE OF RECONCILIATION OF STATUTORY FEDERAL INCOME TAX RATE | The reconciliation of the statutory federal income tax rate to the Company’s effective tax rate for the years ended December 31, 2023 and 2022, was as follows: SCHEDULE OF RECONCILIATION OF STATUTORY FEDERAL INCOME TAX RATE 2023 2022 December 31, 2023 2022 Tax at federal statutory rate -21.00 % -21.00 % Permanent differences 0.03 % 10.40 % Research and development credits 0.83 % 2.20 % Deferred balance true-up 16.07 % 0.00 % Change in valuation allowance -37.87 % 10.10 % Effective income tax rate 0.00 % 0.00 % |
SCHEDULE OF UNRECOGNIZED TAX BENEFITS | SCHEDULE OF UNRECOGNIZED TAX BENEFITS 2023 2022 December 31, 2023 2022 Beginning balance $ 190,229 $ 49,646 Additions based on tax positions related to the prior year 30,897 110,681 Additions based on tax positions related to the current year 28,391 29,902 Ending balance $ 249,517 $ 190,229 |
BASIS OF PRESENTATION, ORGANI_2
BASIS OF PRESENTATION, ORGANIZATION AND NATURE OF OPERATIONS (Details Narrative) - USD ($) | Mar. 08, 2024 | Dec. 31, 2023 | Dec. 31, 2022 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Accumulated deficit | $ 44,604,479 | $ 36,667,468 | |
Cash and cash equivalents | $ 2,821,570 | $ 11,413,759 | |
Total assets, percent | 34% | ||
Common stock par value | $ 0.007 | $ 0.007 | |
Securities Purchase Agreement [Member] | Subsequent Event [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Number of shares issued | 1,600,000 | ||
Common stock par value | $ 0.007 | ||
Warrants to purchase common stock | 1,600,000 | ||
Exercise price | $ 1.64 | ||
Proceeds from direct offerings | $ 2,050,000 |
SCHEDULE OF PURCHASE PRICE AND
SCHEDULE OF PURCHASE PRICE AND PRELIMINARY PURCHASE PRICE ALLOCATIONS (Details) - USD ($) | Sep. 18, 2023 | Dec. 31, 2023 | Dec. 31, 2022 |
Assets | |||
Goodwill | $ 1,404,486 | ||
Village O aks [Member] | |||
Restructuring Cost and Reserve [Line Items] | |||
Cash | $ 2,500,000 | ||
Common Stock | 1,000,000 | ||
Total net assets | 3,500,000 | ||
Assets | |||
Net working capital (including cash) | 912,000 | ||
Property and equipment | 326,000 | ||
Other assets | 8,000 | ||
Customer relationships | 700,000 | ||
Trade names and trademarks | 150,000 | ||
Goodwill | 1,404,000 | ||
Total net assets | $ 3,500,000 |
SCHEDULE OF POTENTIALLY DILUTIV
SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES (Details) - shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 5,333,647 | 5,456,344 |
Share-Based Payment Arrangement, Option [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 683,695 | 806,392 |
Warrant [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 4,649,952 | 4,649,952 |
SCHEDULE OF REVENUE RECOGNITION
SCHEDULE OF REVENUE RECOGNITION (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | ||
Product Information [Line Items] | |||
Total net revenue | $ 2,532,499 | $ 4,803 | |
Health Care, Patient Service [Member] | |||
Product Information [Line Items] | |||
Total net revenue | [1] | 2,199,558 | |
Histology Fees [Member] | |||
Product Information [Line Items] | |||
Total net revenue | 272,660 | ||
Health Care, Other [Member] | |||
Product Information [Line Items] | |||
Total net revenue | 19,324 | ||
Department of Defense Observational Studies [Member] | |||
Product Information [Line Items] | |||
Total net revenue | 19,442 | ||
Other Revenues [Member] | |||
Product Information [Line Items] | |||
Total net revenue | [2] | $ 21,515 | $ 4,803 |
[1]Patient services fees includes direct billing for CyPath® Lung diagnostic test.[2]Other revenues include pre-acquisition CyPath® Lung royalty income and laboratory services. |
SCHEDULE OF PROPERTY AND EQUIPM
SCHEDULE OF PROPERTY AND EQUIPMENT USEFUL LIFE (Details) | 12 Months Ended |
Dec. 31, 2023 | |
Computer Equipment [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 3 years |
Computer Equipment [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 5 years |
Computer Software [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 3 years |
Equipment [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 3 years |
Equipment [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 5 years |
Furniture and Fixtures [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 5 years |
Furniture and Fixtures [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 7 years |
Vehicles [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 5 years |
Leasehold Improvements [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | Lesser of lease term or useful life |
SCHEDULE OF INTANGIBLE ASSETS A
SCHEDULE OF INTANGIBLE ASSETS ADJUSTMENTS (Details) | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Indefinite-Lived Intangible Assets [Line Items] | |
Intangible assets cost | $ 2,254,486 |
Amortization | (16,528) |
Intangible assets net | $ 2,237,958 |
Goodwill [Member] | |
Indefinite-Lived Intangible Assets [Line Items] | |
Date acquired | Sep. 18, 2023 |
Intangible assets cost | $ 1,404,486 |
Amortization | |
Intangible assets net | $ 1,404,486 |
Trademarks and Trade Names [Member] | |
Indefinite-Lived Intangible Assets [Line Items] | |
Date acquired | Sep. 18, 2023 |
Intangible assets cost | $ 150,000 |
Amortization | (2,361) |
Intangible assets net | $ 147,639 |
Useful life | 18 years |
Customer Relationships [Member] | |
Indefinite-Lived Intangible Assets [Line Items] | |
Date acquired | Sep. 18, 2023 |
Intangible assets cost | $ 700,000 |
Amortization | (14,167) |
Intangible assets net | $ 685,833 |
Useful life | 14 years |
SCHEDULE OF SEGMENT INFORMATION
SCHEDULE OF SEGMENT INFORMATION (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Product Information [Line Items] | ||
Total net revenues | $ 2,532,499 | $ 4,803 |
Total operating loss | (7,973,228) | (4,011,058) |
Non-operating income (expense), net | 57,210 | (4,140,596) |
Net loss before income taxes | (7,916,018) | (8,151,654) |
Income tax expense | (20,993) | (2,459) |
Net Loss | (7,937,011) | (8,154,113) |
Diagnostic R&D [Member] | ||
Product Information [Line Items] | ||
Total net revenues | 19,442 | |
Total operating loss | (1,724,597) | (1,524,170) |
Laboratory Services [Member] | ||
Product Information [Line Items] | ||
Total net revenues | 2,513,057 | 4,803 |
Total operating loss | (3,769,783) | (95,041) |
General Corporate Activities [Member] | ||
Product Information [Line Items] | ||
Total operating loss | $ (5,011,347) | $ (2,396,650) |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($) $ / shares in Units, shares in Millions | 12 Months Ended | |||
Oct. 14, 2023 | Sep. 18, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Goodwill | $ 1,404,486 | |||
Revenue | 6,900,000 | 7,900,000 | ||
Net loss | $ 8,600,000 | $ 8,600,000 | ||
Loss per share | $ 0.99 | $ 1.91 | ||
Federal insured limit | $ 250,000 | |||
Advertising expense | 89,000 | $ 39,000 | ||
Amortization of intangible assets | 16,528 | 0 | ||
Research and development expenses | $ 1,467,936 | 1,378,624 | ||
Previously Reported [Member] | ||||
Goodwill | $ 1,149,000 | |||
Net working capital | 1,167,000 | |||
Acquisition costs | $ 811,000 | |||
Revision of Prior Period, Adjustment [Member] | Selling, General and Administrative Expenses [Member] | ||||
Reclassified patent expenses and annuity costs | $ 236,000 | |||
Village O aks [Member] | ||||
Business Combination, Consideration Transferred | $ 3,500,000 | |||
Payments to Acquire Businesses, Gross | $ 2,500,000 | |||
Business Acquisition, Equity Interest Issued or Issuable, Number of Shares | 564,972 | |||
Business Combination, Consideration Transferred, Equity Interests Issued and Issuable | $ 1,000,000 | |||
Goodwill | $ 1,404,000 |
SCHEDULE OF ACCOUNTS RECEIVABLE
SCHEDULE OF ACCOUNTS RECEIVABLE (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Credit Loss [Abstract] | ||
Patient service fees | $ 657,717 | |
Histology service fees | 121,301 | |
Medical director fees | 3,103 | |
Other receivables | 29,553 | 10,489 |
Total accounts and other receivables, net | $ 811,674 | $ 10,489 |
SCHEDULE OF PREPAID EXPENSES AN
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Prepaid Expenses And Other Current Assets | ||
Prepaid insurance | $ 171,855 | $ 340,078 |
Legal and professional | 24,476 | 72,048 |
Other | 124,686 | 119,773 |
Total prepaid expenses and other current assets | $ 321,017 | $ 531,899 |
SCHEDULE OF PROPERTY AND EQUI_2
SCHEDULE OF PROPERTY AND EQUIPMENT (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 831,756 | $ 483,618 |
Less: accumulated depreciation and amortization | (373,123) | (269,180) |
Total property and equipment, net | 458,633 | 214,438 |
Lab Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 647,214 | 462,155 |
Computer and Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 68,682 | 21,463 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 9,941 | |
Vehicles [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 105,919 |
PROPERTY AND EQUIPMENT, NET (De
PROPERTY AND EQUIPMENT, NET (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation | $ 233,064 | $ 10,182 |
SCHEDULE OF ACCRUED EXPENSES (D
SCHEDULE OF ACCRUED EXPENSES (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Compensation | $ 857,037 | $ 340,680 |
Legal and professional | 257,926 | 144,440 |
Clinical | 15,350 | 50,922 |
Other | 19,498 | 5,852 |
Total accrued expenses | $ 1,149,811 | $ 541,894 |
UNEARNED REVENUE (Details Narra
UNEARNED REVENUE (Details Narrative) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Revenue Recognition and Deferred Revenue [Abstract] | ||
Deferred revenue | $ 33,058 | $ 0 |
SCHEDULE OF COMPONENTS OF LEASE
SCHEDULE OF COMPONENTS OF LEASE EXPENSE (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Leases [Abstract] | ||
Amortization of right-of-use assets - finance lease | $ 128,324 | |
Interest on lease liabilities - finance lease | 33,838 | |
Operating lease cost | 39,887 | |
Total lease cost | $ 202,049 |
SCHEDULE OF BALANCE SHEET INFOR
SCHEDULE OF BALANCE SHEET INFORMATION RELATING TO LEASES (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Leases [Abstract] | ||
Operating lease right-of-use, assets | $ 370,312 | |
Operating lease liability, current | 94,708 | |
Operating lease liability, non-current | 283,001 | |
Total operating lease liabilities | 377,709 | |
Financing lease right-of-use assets, gross | 1,294,168 | |
Accumulated amortization | (128,324) | |
Finance lease right-of-use assets, net | 1,165,844 | |
Financing lease liability, current | 365,463 | |
Financing lease liability, non-current | 835,467 | |
Financing lease liability, long-term | $ 1,200,930 | |
Weighted average remaining operating lease, term | 3 years 6 months 29 days | |
Weighted average remaining finance lease, term | 3 years 3 months | |
Operating leases | 8.07% | |
Finance leases | 8.01% |
SCHEDULE OF FUTURE MINIMUM LEAS
SCHEDULE OF FUTURE MINIMUM LEASE PAYMENT UNDER NON-CANCELLABLE (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Lessee, Operating Lease, Liability, to be Paid, Fiscal Year Maturity [Abstract] | ||
2024 | $ 121,726 | |
2025 | 121,726 | |
2026 | 121,726 | |
2027 and thereafter | 71,007 | |
Total undiscounted cash flows | 436,185 | |
Less discounting | (58,476) | |
Present value of lease liabilities | 377,709 | |
Finance Lease, Liability, to be Paid, Fiscal Year Maturity [Abstract] | ||
2024 | 448,505 | |
2025 | 448,505 | |
2026 | 270,395 | |
2027 and thereafter | 202,970 | |
Total undiscounted cash flows | 1,370,375 | |
Less discounting | (169,445) | |
Present value of lease liabilities | $ 1,200,930 |
LEASES (Details Narrative)
LEASES (Details Narrative) | Dec. 31, 2023 |
Operating lease, remaining lease term | 3 years 6 months 29 days |
Minimum [Member] | |
Finance lease, remaining lease term | 2 years 3 months |
Imputed interest, rate | 7.97% |
Maximum [Member] | |
Finance lease, remaining lease term | 4 years |
Imputed interest, rate | 8.13% |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Rent expense | $ 112,124 | $ 65,043 |
COMMON STOCK (Details Narrative
COMMON STOCK (Details Narrative) - $ / shares | Dec. 31, 2023 | Jun. 06, 2023 | Dec. 31, 2022 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Common stock, shares authorized | 25,000,000 | 14,285,715 | 14,285,714 |
Common stock par value | $ 0.007 | $ 0.007 | |
Common stock, shares issued including unvested restricted stock | 9,505,255 | ||
Common stock, shares issued | 9,394,610 | 8,381,324 | |
Restricted Stock Units Unvested [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Common stock, shares issued | 110,645 |
SUMMARY OF STOCK-BASED COMPENSA
SUMMARY OF STOCK-BASED COMPENSATION EXPENSE RECOGNIZED FOR STOCK OPTION AWARDS (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | $ 748,823 | $ 248,592 |
Research and Development Expense [Member] | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | 37,131 | 7,832 |
Selling, General and Administrative Expenses [Member] | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | $ 711,692 | $ 240,760 |
SUMMARY OF OPTION ACTIVITY (Det
SUMMARY OF OPTION ACTIVITY (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Options Granted | 7,142 | |
Equity Incentive Plan [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Options Outstanding, beginning balance | 806,392 | |
Weighted-Average Exercise Price Outstanding, beginning balance | $ 4.33 | |
Weighted- Average Remaining Contractual Term, Outstanding | 2 years 10 months 24 days | 4 years |
Aggregate Intrinsic Value Outstanding, beginning balance | $ 164,255 | |
Options Granted | 0 | |
Weighted-Average Exercise Price, Granted | ||
Options Exercised | 0 | |
Weighted-Average Exercise Price, Exercised | ||
Options, Forfeited | (122,697) | |
Weighted-Average Exercise Price,Forfeited | $ 5.86 | |
Options Outstanding, ending balance | 683,695 | 806,392 |
Weighted-Average Exercise Price Outstanding, ending balance | $ 3.99 | $ 4.33 |
Aggregate Intrinsic Value Outstanding, ending balance | $ 158,332 | $ 164,255 |
Options, Vested and exercisable | 682,306 | |
Weighted-Average Exercise Price, Vested and exercisable | $ 3.98 | |
Weighted- Average Remaining Contractual Term, Vested and exercisable | 2 years 10 months 24 days | |
Aggregate Intrinsic Value, Vested and exercisable | $ 158,010 |
SCHEDULE OF FAIR VALUE ASSUMPTI
SCHEDULE OF FAIR VALUE ASSUMPTIONS (Details) | 12 Months Ended |
Dec. 31, 2022 $ / shares | |
Share-Based Payment Arrangement [Abstract] | |
Fair value of Common Stock | $ 4.62 |
Volatility | 63.90% |
Expected term (in years) | 6 years |
Risk-free interest rate | 2.20% |
Dividend yield | 0% |
SUMMARY OF RESTRICTED STOCK AWA
SUMMARY OF RESTRICTED STOCK AWARD (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Unvested number of RSA, Granted | 7,142 | |
Equity Incentive Plan [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Unvested number of RSA, Granted | 0 | |
Restricted Stock [Member] | Equity Incentive Plan [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Restricted stock awards, Beginning Balance | 114,920 | |
Weighted-average grant price, Beginning Balance | $ 3.56 | |
FMV on grant date, Beginning Balance | 409,437 | |
Vested number of RSA, Beginning Balance | 96,041 | |
Unvested number of RSA, Beginning Balance | 18,879 | |
Restricted stock awards, Granted | 431,028 | |
Weighted-average grant price, Granted | $ 1.89 | |
FMV on grant date, Granted | 813,717 | |
Vested number of RSA, Granted | 339,263 | |
Unvested number of RSA, Granted | 91,765 | |
Restricted stock awards, Forfeited | (4,979) | |
Weighted-average grant price, Forfeited | $ 2.76 | |
FMV on grant date, Forfeited | (13,754) | |
Vested number of RSA, Forfeited | (4,979) | |
Unvested number of RSA, Forfeited | ||
Restricted stock awards, Ending Balance | 540,969 | 114,920 |
Weighted-average grant price, Ending Balance | $ 2.24 | $ 3.56 |
FMV on grant date, Ending Balance | 1,209,400 | 409,437 |
Vested number of RSA, Ending Balance | 430,325 | 96,041 |
Unvested number of RSA, Ending Balance | 110,644 | 18,879 |
STOCK-BASED COMPENSATION (Detai
STOCK-BASED COMPENSATION (Details Narrative) - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Jun. 06, 2023 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Unrecognized compensation | $ 322 | ||
Grant date fair value of options granted | 7,142 | ||
Weighted-average grant date fair value of options granted | $ 2.84 | ||
Options exercised, value | $ 74,900 | ||
Restricted Stock Units (RSUs) [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Numbet of vested options | 59,051 | 29,728 | |
Vested number of RSA, Granted | 339,263 | ||
Restricted Stock Units (RSUs) [Member] | Employees, Non-Employees and Board of Directors [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Grant date fair value of options granted | 431,028 | ||
Stock options, vested period | 3 years | ||
Restricted Stock Units (RSUs) [Member] | Employees and Non Employees [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Grant date fair value of options granted | 77,195 | ||
Stock options, vested period | 1 year | ||
Common Stock [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Options exercised, shares | 64,848 | ||
Options exercised, value | $ 75,000 | ||
Equity Incentive Plan [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Grant option, outstanding | 2,000,000 | ||
Number of shares authorized | 2,000,000 | 1,142,857 | |
Grant date fair value of options granted | 0 | ||
Options exercised, shares | 0 |
WARRANTS (Details Narrative)
WARRANTS (Details Narrative) - $ / shares | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Sep. 17, 2023 | |
Warrant outstanding | 4,649,952 | 4,649,952 | |
Warrant [Member] | |||
Weighted average exercise price | $ 5.03 | $ 5.03 | |
Exercise of warrants | 0 | 1,036,486 | |
Tradeable Warrant [Member] | |||
Warrants to purchase common stock | 73,568 | ||
Non-Tradeable Warrant [Member] | |||
Warrants to purchase common stock | 73,568 | ||
Pre-IPO Warrant [Member] | |||
Warrants to purchase common stock | 1,109,475 |
SCHEDULE OF DEFERRED TAX ASSETS
SCHEDULE OF DEFERRED TAX ASSETS AND LIABILITIES (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Income Tax Disclosure [Abstract] | ||
Net operating loss carryover | $ 6,479,696 | $ 3,871,192 |
Stock compensation | 325,320 | 477,055 |
Capitalized R&E costs | 525,463 | 260,560 |
Other | 204,013 | 5,708 |
Operating lease liabilities | 79,319 | |
Tax credits | 582,206 | 443,867 |
Total deferred tax assets | 8,196,018 | 5,058,382 |
Right-of-use asset tax liability | (77,766) | |
Depreciation and amortization | (59,248) | (7,337) |
Total deferred tax liability | (137,014) | (7,337) |
Less: valuation allowance | (8,059,004) | (5,051,045) |
Total property and equipment, net | $ 0 | $ 0 |
SCHEDULE OF RECONCILIATION OF S
SCHEDULE OF RECONCILIATION OF STATUTORY FEDERAL INCOME TAX RATE (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Tax at federal statutory rate | (21.00%) | (21.00%) |
Permanent differences | 0.03% | 10.40% |
Research and development credits | 0.83% | 2.20% |
Deferred balance true-up | 16.07% | 0% |
Change in valuation allowance | (37.87%) | 10.10% |
Effective income tax rate | 0% | 0% |
SCHEDULE OF UNRECOGNIZED TAX BE
SCHEDULE OF UNRECOGNIZED TAX BENEFITS (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Beginning balance | $ 190,229 | $ 49,646 |
Additions based on tax positions related to the prior year | 30,897 | 110,681 |
Additions based on tax positions related to the current year | 28,391 | 29,902 |
Ending balance | $ 249,517 | $ 190,229 |
INCOME TAXES (Details Narrative
INCOME TAXES (Details Narrative) - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Tax Credit Carryforward [Line Items] | |||
Net operating loss carryforwards | $ 30,000,000 | ||
Valuation allowance percentage | 100% | ||
Increased in valuation allowance | $ 3,000,000 | $ 800,000 | |
Unrecognized tax benefits | 249,517 | $ 190,229 | $ 49,646 |
Expiring In 2034 [Member] | |||
Tax Credit Carryforward [Line Items] | |||
Net operating loss carryforwards | 670,000 | ||
Indefinitely [Member] | |||
Tax Credit Carryforward [Line Items] | |||
Net operating loss carryforwards | $ 24,000,000 |
SUBSEQUENT EVENTS (Details Narr
SUBSEQUENT EVENTS (Details Narrative) - $ / shares | Mar. 08, 2024 | Sep. 17, 2023 |
Tradeable Warrant [Member] | ||
Subsequent Event [Line Items] | ||
Warrants issued | 73,568 | |
Non-Tradeable Warrant [Member] | ||
Subsequent Event [Line Items] | ||
Warrants issued | 73,568 | |
Subsequent Event [Member] | Tradeable Warrant [Member] | ||
Subsequent Event [Line Items] | ||
Warrants issued | 1,601,258 | |
Subsequent Event [Member] | Non-Tradeable Warrant [Member] | ||
Subsequent Event [Line Items] | ||
Warrants issued | 2,704,554 | |
Securities Purchase Agreement [Member] | Subsequent Event [Member] | ||
Subsequent Event [Line Items] | ||
Number of shares issued | 1,600,000 | |
Warrants issued | 1,600,000 | |
Exercise price | $ 1.64 | |
Warrants description | Base Share Price shall not be less than $3.0625 (50% of the public offering price of the Units sold in the Company’s initial public offering) (subject to adjustment for reverse and forward stock splits, recapitalizations and similar transactions). | |
Exercise price, reduced | $ 3.0625 |