Cover
Cover - shares | 6 Months Ended | |
Jun. 30, 2023 | Aug. 14, 2023 | |
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Jun. 30, 2023 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2023 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-41463 | |
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 Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Elected Not To Use the Extended Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 8,782,548 | |
Common Stock, par value $0.007 per share | ||
Title of 12(b) Security | Common Stock, par value $0.007 per share | |
Trading Symbol | BIAF | |
Security Exchange Name | NASDAQ | |
Tradeable Warrants to purchase Common Stock | ||
Title of 12(b) Security | Tradeable Warrants to purchase Common Stock | |
Trading Symbol | BIAFW | |
Security Exchange Name | NASDAQ |
Condensed Consolidated Balance
Condensed Consolidated Balance sheets (Unaudited) - USD ($) | Jun. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 8,279,182 | $ 11,413,759 |
Accounts and other receivables, net | 90,233 | 10,489 |
Inventory | 10,101 | 5,540 |
Prepaid and other current assets | 279,687 | 531,899 |
Total current assets | 8,659,203 | 11,961,687 |
Property and equipment, net | 207,377 | 214,438 |
Other assets | 6,920 | 6,000 |
Total assets | 8,873,499 | 12,182,125 |
Current liabilities: | ||
Accounts payable | 174,404 | 345,042 |
Accrued expenses | 515,663 | 541,894 |
Unearned revenue | 42,750 | |
Loan payable | 42,334 | 251,746 |
Total current liabilities | 775,151 | 1,138,682 |
Total liabilities | 775,151 | 1,138,682 |
Commitments and contingencies (See Note 9) | ||
Stockholders’ equity: | ||
Preferred stock, par value $0.001 per share; 20,000,000 shares authorized; no shares issued or outstanding at June 30, 2023, and December 31, 2022 | ||
Common stock, par value $0.007 per share; 25,000,000 shares authorized; 8,555,365 issued and outstanding at June 30, 2023; and 8,381,324 shares issued and outstanding at December 31, 2022 | 59,887 | 58,669 |
Additional paid-in capital | 47,978,892 | 47,652,242 |
Accumulated deficit | (39,940,431) | (36,667,468) |
Total stockholders’ equity | 8,098,348 | 11,043,443 |
Total liabilities and stockholders’ equity | $ 8,873,499 | $ 12,182,125 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance sheets (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 20,000,000 | 20,000,000 |
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 | 25,000,000 |
Common stock, shares issued | 8,555,365 | 8,381,324 |
Common stock, shares outstanding | 8,555,365 | 8,381,324 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Income Statement [Abstract] | ||||
Revenue | $ 19,738 | $ 1,306 | $ 20,659 | $ 1,306 |
Cost of sales | 1,234 | 146 | 1,322 | 146 |
Gross profit | 18,504 | 1,160 | 19,337 | 1,160 |
Operating expenses: | ||||
Research and development | 335,125 | 248,419 | 704,741 | 528,267 |
Clinical development | 35,260 | 28,240 | 54,888 | 80,744 |
General and administrative | 1,426,469 | 408,619 | 2,596,027 | 803,311 |
Total operating expenses | 1,796,854 | 685,279 | 3,355,657 | 1,412,322 |
Loss from operations | (1,778,350) | (684,119) | (3,336,320) | (1,411,162) |
Other income (expense): | ||||
Interest income | 44,124 | 276 | 82,778 | 847 |
Interest expense | (1,360) | (399,265) | (3,015) | (1,546,848) |
Gain on extinguishment of debt | 212,258 | 212,258 | ||
Fair value adjustments on convertible notes payable | 782,798 | 1,186,992 | ||
Net loss before provision for income taxes | (1,735,586) | (88,052) | (3,256,557) | (1,557,913) |
Income tax expense | 4,587 | 16,406 | 2,159 | |
Net loss | $ (1,740,173) | $ (88,052) | $ (3,272,963) | $ (1,560,072) |
Net loss per common share, basic | $ (0.20) | $ (0.03) | $ (0.38) | $ (0.58) |
Net loss per common share, diluted | $ (0.20) | $ (0.03) | $ (0.38) | $ (0.58) |
Weighted average common shares outstanding, basic | 8,520,714 | 2,693,511 | 8,477,656 | 2,687,431 |
Weighted average common shares outstanding, diluted | 8,520,714 | 2,693,511 | 8,477,656 | 2,687,431 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity (Deficit) (Unaudited) - USD ($) | Preferred Stock [Member] | Preferred Stock [Member] Convertible Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Balance, value at Dec. 31, 2021 | $ 4,044,318 | $ 18,740 | $ 12,703,896 | $ (28,513,355) | $ (15,790,719) | |
Balance, shares at Dec. 31, 2021 | 756,558 | 2,677,140 | ||||
Stock-based compensation expense | $ 121 | 132,426 | 132,732 | |||
Stock-based compensation expense, shares | 17,319 | |||||
Net loss | (1,560,072) | (1,560,072) | ||||
Beneficial conversion feature for bridge notes | 213,942 | 213,942 | ||||
Debt discount for warrants issued | 217,973 | 217,973 | ||||
Balance, value at Jun. 30, 2022 | $ 4,044,318 | $ 18,861 | 13,268,237 | (30,073,427) | (16,786,329) | |
Balance, shares at Jun. 30, 2022 | 756,558 | 2,694,459 | ||||
Balance, value at Mar. 31, 2022 | $ 4,044,318 | $ 18,850 | 13,241,748 | (29,985,375) | (16,724,777) | |
Balance, shares at Mar. 31, 2022 | 756,558 | 2,692,912 | ||||
Stock-based compensation expense | $ 11 | 26,674 | 26,685 | |||
Stock-based compensation expense, shares | 1,547 | |||||
Net loss | (88,052) | (88,052) | ||||
Debt discount for warrants issued | (185) | (185) | ||||
Balance, value at Jun. 30, 2022 | $ 4,044,318 | $ 18,861 | 13,268,237 | (30,073,427) | (16,786,329) | |
Balance, shares at Jun. 30, 2022 | 756,558 | 2,694,459 | ||||
Balance, value at Dec. 31, 2022 | $ 58,669 | 47,652,242 | (36,667,468) | 11,043,443 | ||
Balance, shares at Dec. 31, 2022 | 8,381,324 | |||||
Stock-based compensation expense | $ 1,218 | 326,650 | 327,868 | |||
Stock-based compensation expense, shares | 174,041 | |||||
Net loss | (3,272,963) | (3,272,963) | ||||
Balance, value at Jun. 30, 2023 | $ 59,887 | 47,978,892 | (39,940,431) | 8,098,348 | ||
Balance, shares at Jun. 30, 2023 | 8,555,365 | |||||
Balance, value at Mar. 31, 2023 | $ 59,241 | 47,809,283 | (38,200,258) | 9,668,266 | ||
Balance, shares at Mar. 31, 2023 | 8,463,052 | |||||
Stock-based compensation expense | $ 646 | 169,609 | 170,255 | |||
Stock-based compensation expense, shares | 92,313 | |||||
Net loss | (1,740,173) | (1,740,173) | ||||
Balance, value at Jun. 30, 2023 | $ 59,887 | $ 47,978,892 | $ (39,940,431) | $ 8,098,348 | ||
Balance, shares at Jun. 30, 2023 | 8,555,365 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Cash flows from operating activities | ||
Net loss | $ (3,272,963) | $ (1,560,072) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 43,236 | 2,079 |
Accretion of debt issuance costs | 1,205,255 | |
Fair value adjustments on convertible notes payable | (1,186,992) | |
Stock-based compensation expense | 327,868 | 132,732 |
Gain on extinguishment of debt | (212,258) | |
Changes in operating assets and liabilities: | ||
Accounts and other receivables | (79,743) | (6,287) |
Inventory | (4,561) | (5,657) |
Prepaid expenses and other assets | 251,292 | 28,304 |
Accounts payable | (170,638) | 354,560 |
Accrued expenses | (26,231) | (42,730) |
Accrued interest | 337,566 | |
Unearned revenue | 42,750 | |
Net cash used in operating activities | (2,888,990) | (1,010,108) |
Cash flows from investing activities | ||
Purchase of equipment | (36,175) | |
Net cash used in investing activities | (36,175) | |
Cash flows from financing activities | ||
Payment on loan payable | (209,412) | |
Payment of debt | (100,000) | |
Issuance of loan payable | 65,031 | |
Proceeds from issuance of convertible notes payable | 475,000 | |
Payment of deferred offering costs | (520,506) | |
Payment of debt issuance costs | (55,651) | |
Net cash used in financing activities | (209,412) | (136,126) |
Net decrease in cash and cash equivalents | (3,134,577) | (1,146,234) |
Cash and cash equivalents at beginning of period | 11,413,759 | 1,360,638 |
Cash and cash equivalents at end of period | 8,279,182 | 214,404 |
Supplemental disclosures of cash flow information: | ||
Income taxes paid in cash | 16,406 | 2,159 |
Interest expense paid in cash | 3,015 | |
Noncash financing activities: | ||
Fair value of warrants issued to placement agents | 217,973 | |
Beneficial conversion feature for bridge notes | $ 213,942 |
NATURE OF OPERATIONS, ORGANIZAT
NATURE OF OPERATIONS, ORGANIZATION, AND BASIS OF PRESENTATION | 6 Months Ended |
Jun. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
NATURE OF OPERATIONS, ORGANIZATION, AND BASIS OF PRESENTATION | Note 1. NATURE OF OPERATIONS, ORGANIZATION, AND BASIS OF PRESENTATION Description of Business bioAffinity Technologies, Inc., a Delaware corporation (the “Company,” “we,” “our” 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 target cancer cells and cell populations indicative of a diseased state. Our first diagnostic test, CyPath ® in vitro Organization 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 accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) and pursuant to the rules and regulations of the SEC for interim financial reporting. The condensed consolidated financial statements are unaudited and in management’s opinion include all adjustments, including normal recurring adjustments and accruals, necessary for a fair presentation of the results for the interim periods presented. Operating results for the periods presented are not necessarily indicative of the results that may be expected for the fiscal year ended December 31, 2023, or any future period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited annual consolidated financial statements and notes included in the 2022 Form 10-K filed with the SEC. Liquidity and Capital Resources In accordance with Accounting Standards Update (“ASU”) 2014-15, Presentation of Financial Statements – Going Concern (Subtopic 205-40), the Company has evaluated whether there are conditions and events that raise substantial doubt about the Company’s ability to continue as a going concern for at least one year after the date the condensed consolidated financial statements are issued. 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 $ 39.9 8.3 93 COVID-19 The rapid global spread of the COVID-19 virus since December 2019 has affected production and sales worldwide, disrupted supply chains across a range of industries, and created significant economic volatility. The impact of COVID-19 on the Company’s operational and financial performance will depend on numerous factors, including the spread, duration, and intensity of the pandemic (including resurgences), the emergence of new viral variants, and the impact of the pandemic on the Company’s customers, employees, clinical trial sites, and vendors. As the COVID-19 pandemic continues to evolve, the ultimate impact on the Company’s operations is highly uncertain and subject to change and will depend on future developments, which cannot be accurately predicted, including the duration of the pandemic, additional or modified government actions, and the actions taken to contain COVID-19 or address its impact, among others. Management does not yet know the full extent of potential delays or impacts on the Company, clinical trials, research programs, healthcare systems, or the global economy but continues to monitor the situation closely. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | Note 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Use of Estimates The preparation of condensed consolidated financial statements in conformity with U.S. 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, and the useful lives of fixed assets. Principles of Consolidation The accompanying condensed consolidated financial statements include all of the accounts of the Company and its wholly owned subsidiary, OncoSelect ® 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 expense was approximately $ 28,000 3,000 22,000 0 Loss Per Share Basic earnings (loss) per share is computed by dividing net income (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 earnings per share is computed by dividing net income 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 June 30, 2023 and 2022, as they would be anti-dilutive: SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES 2023 2022 As of June 30, 2023 2022 Convertible preferred stock — 776,871 Shares underlying options outstanding 806,392 883,690 Shares underlying warrants outstanding 4,649,952 2,057,740 Shares underlying convertible notes — 2,552,435 Anti-dilutive securities 5,556,344 6,270,736 Revenue Recognition Revenue is generated in three ways for the six months and three months, respectively, ended June 30, 2023: (1) royalties from the Company’s diagnostic test, CyPath ® 8,000 7,000 ® 3,000 3,000 ® 10,000 10,000 ® ® To determine revenue recognition for the arrangements that the Company determines are within the scope of ASC 606, Revenue from Contracts with Customers Reclassifications Certain prior year balances have been reclassified to conform to current year presentation. The Company reclassified patent expenses and annuity costs of approximately $ 101,000 59,000 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. |
PREPAID EXPENSES AND OTHER CURR
PREPAID EXPENSES AND OTHER CURRENT ASSETS | 6 Months Ended |
Jun. 30, 2023 | |
Prepaid Expenses And Other Current Assets | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | Note 3. PREPAID EXPENSES AND OTHER CURRENT ASSETS Prepaid expenses and other current assets are summarized below: SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS June 30, 2023 December 31, 2022 Prepaid insurance $ 104,294 $ 340,078 Legal and professional 47,200 72,048 Other 128,193 119,773 Total prepaid expenses and other current assets $ 279,687 $ 531,899 |
PROPERTY AND EQUIPMENT, NET
PROPERTY AND EQUIPMENT, NET | 6 Months Ended |
Jun. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT, NET | Note 4. PROPERTY AND EQUIPMENT, NET Property and equipment are summarized below: SCHEDULE OF PROPERTY AND EQUIPMENT June 30, 2023 December 31, 2022 Lab equipment $ 488,718 $ 462,155 Computers and software 31,076 21,463 Property and equipment, gross 519,794 483,618 Accumulated depreciation (312,417 ) (269,180 ) Total property and equipment, net $ 207,377 $ 214,438 Depreciation expense was approximately $ 41,000 2,000 21,000 1,000 |
ACCRUED EXPENSES
ACCRUED EXPENSES | 6 Months Ended |
Jun. 30, 2023 | |
Payables and Accruals [Abstract] | |
ACCRUED EXPENSES | Note 5. ACCRUED EXPENSES Accrued expenses are summarized below: SCHEDULE OF ACCRUED EXPENSES June 30, 2023 December 31, 2022 Compensation $ 276,519 $ 340,680 Legal and professional 179,416 144,440 Clinical 54,728 50,922 Other 5,000 5,852 Total accrued expenses $ 515,663 $ 541,894 |
UNEARNED REVENUE
UNEARNED REVENUE | 6 Months Ended |
Jun. 30, 2023 | |
Revenue Recognition and Deferred Revenue [Abstract] | |
UNEARNED REVENUE | Note 6. UNEARNED REVENUE During the three months ended June 30, 2023, the Company engaged in an observational study of CyPath ® 43,000 |
LOAN PAYABLE
LOAN PAYABLE | 6 Months Ended |
Jun. 30, 2023 | |
Debt Disclosure [Abstract] | |
LOAN PAYABLE | Note 7. LOAN PAYABLE In September 2022, the Company obtained short-term financing of approximately $ 0.5 ten monthly payments 42,000 4.3 42,000 252,000 |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 6 Months Ended |
Jun. 30, 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. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 6 Months Ended |
Jun. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | Note 9. COMMITMENTS AND CONTINGENCIES Operating Leases 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 approximately $ 53,000 26,000 26,000 13,000 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 | 6 Months Ended |
Jun. 30, 2023 | |
Common Stock | |
COMMON STOCK | Note 10. COMMON STOCK Common Stock The Company has authorized a total of 25,000,000 0.007 14,285,715 25,000,000 8,555,365 8,381,324 |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 6 Months Ended |
Jun. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
STOCK-BASED COMPENSATION | Note 11. 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 (credit) related to the issuance of restricted stock awards in the following line items in the accompanying condensed consolidated statement of operations: SUMMARY OF STOCK-BASED COMPENSATION EXPENSE RECOGNIZED FOR STOCK OPTION AWARDS 2023 2022 2023 2022 Three Months Ended Six Months Ended 2023 2022 2023 2022 Research and development $ 10,620 $ 2,363 $ 21,889 $ 7,860 General and administrative 159,634 24,322 305,979 124,872 Total stock-based compensation expense $ 170,255 $ 26,685 $ 327,868 $ 132,732 The following table summarizes stock option activity under the Plan: SUMMARY OF OPTION ACTIVITY Number of Weighted-average Weighted-average Aggregate Outstanding at December 31, 2022 806,392 $ 4.33 Granted — — Exercised — — Forfeited — — Outstanding at June 30, 2023 806,392 $ 4.33 3.8 $ 271,298 Vested and exercisable at June 30, 2023 803,813 $ 4.32 3.7 $ 271,298 As of June 30, 2023, there was no no no 7,142 2.84 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 32,008 82,912 Granted 219,812 1.82 401,079 174,043 Forfeited — — — — — Balance at June 30, 2023 806,392 $ 4.33 $ 810,517 206,051 128,681 During the six months ended June 30, 2023, the Company issued restricted stock awards (RSAs) for 219,812 31,020 143,023 During the six months ended June 30, 2022, the Company issued RSAs for 14,999 5,000 The following table summarizes weighted-average assumptions using the Black-Scholes option-pricing model used on the date of the grants issued during the six months ended June 30, 2022. No stock options have been issued during the six months ended June 30, 2023: SCHEDULE OF FAIR VALUE ASSUMPTIONS 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 % |
WARRANTS
WARRANTS | 6 Months Ended |
Jun. 30, 2023 | |
Warrants | |
WARRANTS | Note 12. WARRANTS The Company accounts 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. The Company classifies derivative warrant liabilities on the condensed consolidated balance sheet at fair value, and changes in fair value during the periods presented in the condensed consolidated statement of operations, which is revalued at each balance sheet date subsequent to the initial issuance of the stock warrant. As of June 30, 2023, and December 31, 2022, the Company had 4,649,952 6.15 no |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 6 Months Ended |
Jun. 30, 2023 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | Note 13. SUBSEQUENT EVENTS The Company evaluated subsequent events and transactions that occurred after the balance sheet date up to the date that the condensed consolidated financial statements were available to be issued. Based upon this review, the Company did not identify any subsequent events that would have required adjustment or disclosure in the condensed consolidated financial statements. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Use of Estimates | Use of Estimates The preparation of condensed consolidated financial statements in conformity with U.S. 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, and the useful lives of fixed assets. |
Principles of Consolidation | Principles of Consolidation The accompanying condensed consolidated financial statements include all of the accounts of the Company and its wholly owned subsidiary, OncoSelect ® |
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 expense was approximately $ 28,000 3,000 22,000 0 |
Loss Per Share | Loss Per Share Basic earnings (loss) per share is computed by dividing net income (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 earnings per share is computed by dividing net income 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 June 30, 2023 and 2022, as they would be anti-dilutive: SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES 2023 2022 As of June 30, 2023 2022 Convertible preferred stock — 776,871 Shares underlying options outstanding 806,392 883,690 Shares underlying warrants outstanding 4,649,952 2,057,740 Shares underlying convertible notes — 2,552,435 Anti-dilutive securities 5,556,344 6,270,736 |
Revenue Recognition | Revenue Recognition Revenue is generated in three ways for the six months and three months, respectively, ended June 30, 2023: (1) royalties from the Company’s diagnostic test, CyPath ® 8,000 7,000 ® 3,000 3,000 ® 10,000 10,000 ® ® To determine revenue recognition for the arrangements that the Company determines are within the scope of ASC 606, Revenue from Contracts with Customers |
Reclassifications | Reclassifications Certain prior year balances have been reclassified to conform to current year presentation. The Company reclassified patent expenses and annuity costs of approximately $ 101,000 59,000 |
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 Quarterly Report will have a material impact on the Company’s condensed consolidated financial statements. |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
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 June 30, 2023 and 2022, as they would be anti-dilutive: SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES 2023 2022 As of June 30, 2023 2022 Convertible preferred stock — 776,871 Shares underlying options outstanding 806,392 883,690 Shares underlying warrants outstanding 4,649,952 2,057,740 Shares underlying convertible notes — 2,552,435 Anti-dilutive securities 5,556,344 6,270,736 |
PREPAID EXPENSES AND OTHER CU_2
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Prepaid Expenses And Other Current Assets | |
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS | Prepaid expenses and other current assets are summarized below: SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS June 30, 2023 December 31, 2022 Prepaid insurance $ 104,294 $ 340,078 Legal and professional 47,200 72,048 Other 128,193 119,773 Total prepaid expenses and other current assets $ 279,687 $ 531,899 |
PROPERTY AND EQUIPMENT, NET (Ta
PROPERTY AND EQUIPMENT, NET (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
SCHEDULE OF PROPERTY AND EQUIPMENT | Property and equipment are summarized below: SCHEDULE OF PROPERTY AND EQUIPMENT June 30, 2023 December 31, 2022 Lab equipment $ 488,718 $ 462,155 Computers and software 31,076 21,463 Property and equipment, gross 519,794 483,618 Accumulated depreciation (312,417 ) (269,180 ) Total property and equipment, net $ 207,377 $ 214,438 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Payables and Accruals [Abstract] | |
SCHEDULE OF ACCRUED EXPENSES | Accrued expenses are summarized below: SCHEDULE OF ACCRUED EXPENSES June 30, 2023 December 31, 2022 Compensation $ 276,519 $ 340,680 Legal and professional 179,416 144,440 Clinical 54,728 50,922 Other 5,000 5,852 Total accrued expenses $ 515,663 $ 541,894 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 6 Months Ended |
Jun. 30, 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 (credit) related to the issuance of restricted stock awards in the following line items in the accompanying condensed consolidated statement of operations: SUMMARY OF STOCK-BASED COMPENSATION EXPENSE RECOGNIZED FOR STOCK OPTION AWARDS 2023 2022 2023 2022 Three Months Ended Six Months Ended 2023 2022 2023 2022 Research and development $ 10,620 $ 2,363 $ 21,889 $ 7,860 General and administrative 159,634 24,322 305,979 124,872 Total stock-based compensation expense $ 170,255 $ 26,685 $ 327,868 $ 132,732 |
SUMMARY OF OPTION ACTIVITY | The following table summarizes stock option activity under the Plan: SUMMARY OF OPTION ACTIVITY Number of Weighted-average Weighted-average Aggregate Outstanding at December 31, 2022 806,392 $ 4.33 Granted — — Exercised — — Forfeited — — Outstanding at June 30, 2023 806,392 $ 4.33 3.8 $ 271,298 Vested and exercisable at June 30, 2023 803,813 $ 4.32 3.7 $ 271,298 |
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 32,008 82,912 Granted 219,812 1.82 401,079 174,043 Forfeited — — — — — Balance at June 30, 2023 806,392 $ 4.33 $ 810,517 206,051 128,681 |
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 six months ended June 30, 2022. No stock options have been issued during the six months ended June 30, 2023: SCHEDULE OF FAIR VALUE ASSUMPTIONS 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 % |
NATURE OF OPERATIONS, ORGANIZ_2
NATURE OF OPERATIONS, ORGANIZATION, AND BASIS OF PRESENTATION (Details Narrative) - USD ($) | Jun. 30, 2023 | Dec. 31, 2022 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Accumulated deficit | $ 39,940,431 | $ 36,667,468 |
Cash and cash equivalents | $ 8,279,182 | $ 11,413,759 |
Total assets, percent | 93% |
SCHEDULE OF POTENTIALLY DILUTIV
SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES (Details) - shares | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 5,556,344 | 6,270,736 |
Convertible Preferred Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 776,871 | |
Share-Based Payment Arrangement, Option [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 806,392 | 883,690 |
Warrant [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 4,649,952 | 2,057,740 |
Convertible Debt Securities [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 2,552,435 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Product Information [Line Items] | ||||
Insured limit | $ 250,000 | $ 250,000 | ||
Advertising expense | 22,000 | $ 0 | 28,000 | $ 3,000 |
Selling, General and Administrative Expenses [Member] | Revision of Prior Period, Adjustment [Member] | ||||
Product Information [Line Items] | ||||
Reclassified patent expenses and annuity costs | $ 59,000 | $ 101,000 | ||
Diagnostic Test [Member] | ||||
Product Information [Line Items] | ||||
Revenues | 7,000 | 8,000 | ||
Cytometry Services [Member] | ||||
Product Information [Line Items] | ||||
Revenues | 3,000 | 3,000 | ||
U.S. Department Of Defense [Member] | ||||
Product Information [Line Items] | ||||
Revenues | $ 10,000 | $ 10,000 |
SCHEDULE OF PREPAID EXPENSES AN
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS (Details) - USD ($) | Jun. 30, 2023 | Dec. 31, 2022 |
Prepaid Expenses And Other Current Assets | ||
Prepaid insurance | $ 104,294 | $ 340,078 |
Legal and professional | 47,200 | 72,048 |
Other | 128,193 | 119,773 |
Total prepaid expenses and other current assets | $ 279,687 | $ 531,899 |
SCHEDULE OF PROPERTY AND EQUIPM
SCHEDULE OF PROPERTY AND EQUIPMENT (Details) - USD ($) | Jun. 30, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 519,794 | $ 483,618 |
Accumulated depreciation | (312,417) | (269,180) |
Total property and equipment, net | 207,377 | 214,438 |
Lab Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 488,718 | 462,155 |
Computer And Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 31,076 | $ 21,463 |
PROPERTY AND EQUIPMENT, NET (De
PROPERTY AND EQUIPMENT, NET (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Property, Plant and Equipment [Abstract] | ||||
Depreciation | $ 21,000 | $ 1,000 | $ 41,000 | $ 2,000 |
SCHEDULE OF ACCRUED EXPENSES (D
SCHEDULE OF ACCRUED EXPENSES (Details) - USD ($) | Jun. 30, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Compensation | $ 276,519 | $ 340,680 |
Legal and professional | 179,416 | 144,440 |
Clinical | 54,728 | 50,922 |
Other | 5,000 | 5,852 |
Total accrued expenses | $ 515,663 | $ 541,894 |
UNEARNED REVENUE (Details Narra
UNEARNED REVENUE (Details Narrative) | Jun. 30, 2023 USD ($) |
Revenue Recognition and Deferred Revenue [Abstract] | |
Deferred revenue | $ 43,000 |
LOAN PAYABLE (Details Narrative
LOAN PAYABLE (Details Narrative) - USD ($) | 1 Months Ended | ||
Sep. 30, 2022 | Jun. 30, 2023 | Dec. 31, 2022 | |
Short-Term Debt [Line Items] | |||
Loan payable | $ 42,334 | $ 251,746 | |
Short-Term Debt [Member] | |||
Short-Term Debt [Line Items] | |||
Loan payable | $ 500,000 | ||
Loan payment term | ten monthly payments | ||
Loan periodic payment amount | $ 42,000 | ||
Loan interest rate | 4.30% | ||
Loan periodic payment amount | $ 42,000 | $ 252,000 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | ||||
Rent expense | $ 26,000 | $ 13,000 | $ 53,000 | $ 26,000 |
COMMON STOCK (Details Narrative
COMMON STOCK (Details Narrative) - $ / shares | Jun. 30, 2023 | Jun. 06, 2023 | Jun. 05, 2023 | Dec. 31, 2022 |
Common Stock | ||||
Common stock, shares authorized | 25,000,000 | 25,000,000 | 14,285,715 | 25,000,000 |
Common stock par value | $ 0.007 | $ 0.007 | ||
Common stock, shares issued | 8,555,365 | 8,381,324 |
SUMMARY OF STOCK-BASED COMPENSA
SUMMARY OF STOCK-BASED COMPENSATION EXPENSE RECOGNIZED FOR STOCK OPTION AWARDS (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | $ 170,255 | $ 26,685 | $ 327,868 | $ 132,732 |
Research and Development Expense [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | 10,620 | 2,363 | 21,889 | 7,860 |
Selling, General and Administrative Expenses [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | $ 159,634 | $ 24,322 | $ 305,979 | $ 124,872 |
SUMMARY OF OPTION ACTIVITY (Det
SUMMARY OF OPTION ACTIVITY (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Options Granted | 0 | 7,142 |
Options Exercised | 0 | 0 |
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 | |
Options Granted | 0 | |
Weighted-Average Exercise Price, Granted | ||
Options Exercised | 0 | |
Weighted-Average Exercise Price, Exercised | ||
Options, Forfeited | ||
Weighted-Average Exercise Price,Forfeited | ||
Options Outstanding, ending balance | 806,392 | |
Weighted-Average Exercise Price Outstanding, ending balance | $ 4.33 | |
Weighted- Average Remaining Contractual Term, Outstanding | 3 years 9 months 18 days | |
Aggregate Intrinsic Value Outstanding, ending balance | $ 271,298 | |
Options, Vested and exercisable | 803,813 | |
Weighted-Average Exercise Price, Vested and exercisable | $ 4.32 | |
Weighted- Average Remaining Contractual Term, Vested and exercisable | 3 years 8 months 12 days | |
Aggregate Intrinsic Value, Vested and exercisable | $ 271,298 |
SUMMARY OF RESTRICTED STOCK AWA
SUMMARY OF RESTRICTED STOCK AWARD (Details) - $ / shares | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Restricted stock awards, Granted | 0 | 7,142 |
Vested number of RSA, Forfeited | 143,023 | |
Equity Incentive Plan [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Restricted stock awards, Granted | 0 | |
Restricted Stock [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Vested number of RSA, Forfeited | 31,020 | |
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 | 32,008 | |
Unvested number of RSA, Beginning Balance | 82,912 | |
Restricted stock awards, Granted | 219,812 | |
Weighted-average grant price, Granted | $ 1.82 | |
FMV on grant date, Granted | 401,079 | |
Vested number of RSA, Granted | 174,043 | |
Restricted stock awards, Forfeited | ||
Weighted-average grant price, Forfeited | ||
FMV on grant date, Forfeited | ||
Vested number of RSA, Forfeited | ||
Unvested number of RSA, Forfeited | ||
Restricted stock awards, Ending Balance | 806,392 | |
Weighted-average grant price, Ending Balance | $ 4.33 | |
FMV on grant date, Ending Balance | 810,517 | |
Vested number of RSA, Ending Balance | 206,051 | |
Unvested number of RSA, Ending Balance | 128,681 |
SCHEDULE OF FAIR VALUE ASSUMPTI
SCHEDULE OF FAIR VALUE ASSUMPTIONS (Details) | 3 Months Ended |
Mar. 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% |
STOCK-BASED COMPENSATION (Detai
STOCK-BASED COMPENSATION (Details Narrative) - USD ($) | 6 Months Ended | ||||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 06, 2023 | Jun. 05, 2023 | Dec. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Grant option, outstanding | 2,000,000 | ||||
Common stock, shares authorized | 25,000,000 | 25,000,000 | 14,285,715 | 25,000,000 | |
Unrecognized compensation | $ 0 | ||||
Options exercised, shares | 0 | 0 | |||
Grant date fair value of options granted | 0 | 7,142 | |||
Weighted-average grant date fair value of options granted | $ 2.84 | ||||
Restricted stock awards | 143,023 | ||||
Equity Incentive Plan [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Options exercised, shares | 0 | ||||
Grant date fair value of options granted | 0 | ||||
Restricted Stock [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Restricted stock awards | 31,020 | ||||
Restricted Stock [Member] | Equity Incentive Plan [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Grant date fair value of options granted | 219,812 | ||||
Restricted stock awards | |||||
Restricted Stock Units (RSUs) [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Grant date fair value of options granted | 14,999 | ||||
Unissued shares | 5,000 | ||||
Minimum [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Common stock, shares authorized | 1,142,857 | ||||
Maximum [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Common stock, shares authorized | 2,000,000 |
WARRANTS (Details Narrative)
WARRANTS (Details Narrative) - $ / shares | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Warrant outstanding | 4,649,952 | 4,649,952 | |
Warrant [Member] | |||
Weighted average exercise price | $ 6.15 | $ 6.15 | |
Exercise of warrants | 0 | 0 |