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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
|
☒ |
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
|
|
|
|
|
For
the quarterly period ended September 30, 2023 |
|
|
|
|
☐ |
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
|
|
|
|
|
For
the transition period from ______ to ______. |
COMMISSION
FILE NUMBER: 001-41463
bioAffinity
Technologies, Inc.
(Exact
name of registrant as specified in its charter)
Delaware |
|
46-5211056 |
(State
or other jurisdiction of
incorporation or organization) |
|
(I.R.S.
Employer
Identification No.) |
|
|
|
22211
W. Interstate 10, Suite 1206, San Antonio, Texas |
|
78257 |
(Address
of principal executive offices) |
|
(Zip
Code) |
(210)
698-5334
(Registrant’s
telephone number, including area code)
Not
Applicable
(Former
name, former address and former fiscal year, if changed since last report)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, par value $0.007 per share |
|
BIAF |
|
The
Nasdaq Stock Market LLC |
Tradeable
Warrants to purchase Common Stock |
|
BIAFW |
|
The
Nasdaq Stock Market LLC |
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to the filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
|
Large
accelerated filer ☐ |
Accelerated
filer ☐ |
|
Non-accelerated
filer ☒ |
Smaller
reporting company ☒ |
|
|
Emerging
growth company ☒ |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Sec 13(a) of the Exchange Act.
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The
number of shares of the issuer’s common stock outstanding as of November 8, 2023, was 9,502,243.
Throughout
this Quarterly Report on Form 10-Q (this “Quarterly Report”), the terms “bioAffinity,” “bioAffinity Technologies,”
“we,” “us,” “our” or “the Company” refer to bioAffinity Technologies, Inc., a Delaware
corporation, and its wholly owned subsidiaries, OncoSelect® Therapeutics, LLC, a Delaware limited liability company, and
Precision Pathology Laboratory Services, LLC, a Texas limited liability company.
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
Quarterly Report contains forward-looking statements within the meaning of the federal securities laws. Forward-looking statements are
predictive in nature, depend on or refer to future events or conditions, and are sometimes identified by words such as “may,”
“could,” “plan,” “project,” “predict,” “pursue,” “believe,” “expect,”
“estimate,” “anticipate,” “intend,” “target,” “seek,” “potentially,”
“will likely result,” “outlook,” “budget, “objective,” “trend,” or similar expressions
of a forward-looking nature and the negative versions of such expressions. The forward-looking information contained in this report is
generally located under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations”
but may be found in other locations as well. The forward-looking statements in this report generally relate to the plans and objectives
for future operations of bioAffinity Technologies, Inc. and are based on our management’s reasonable estimates of future results
or trends. Although we believe these forward-looking statements are reasonable, all forward-looking statements are subject to various
risks and uncertainties, and our projections and expectations may be incorrect. The factors that may affect our expectations regarding
our operations include, among others, the following:
|
● |
our
projected financial position and estimated cash burn rate; |
|
|
|
|
● |
our
estimates regarding expenses, future revenues, and capital requirements; |
|
|
|
|
● |
our
ability to successfully integrate our newly acquired laboratory services business; |
|
|
|
|
● |
our
ability to successfully operate the clinical pathology laboratory and generate significant profit or revenue from such business operation; |
|
|
|
|
● |
the
success, cost, and timing of our clinical trials; |
|
|
|
|
● |
our
ability to obtain funding for our operations necessary to complete further development and commercialization of our diagnostic tests
or therapeutic product candidates; |
|
|
|
|
● |
our
dependence on third parties, including the conduct of our clinical trials; |
|
|
|
|
● |
our
ability to obtain the necessary regulatory approvals to market and commercialize our diagnostic tests or therapeutic product candidates; |
|
|
|
|
● |
the
potential that the results of our pre-clinical and clinical trials indicate our current diagnostic tests or any future diagnostic
tests or therapeutic product candidates we may seek to develop are unsafe or ineffective; |
|
|
|
|
● |
the
results of market research conducted by us or others; |
|
|
|
|
● |
our
ability to obtain and maintain intellectual property (“IP”) protection for our current diagnostic test or future diagnostic
tests and therapeutic product candidates; |
|
|
|
|
● |
our
ability to protect our IP rights and the potential for us to incur substantial costs from lawsuits to enforce or protect our IP rights; |
|
|
|
|
● |
the
possibility that a third party may claim we or our third-party licensors have infringed, misappropriated, or otherwise violated their
IP rights and that we may incur substantial costs and be required to devote substantial time defending against such claims; |
|
|
|
|
● |
the
success of competing therapies, diagnostic tests, and therapeutic products that are or will become available; |
|
|
|
|
● |
our
ability to expand our organization to accommodate potential growth and to retain and attract key personnel; |
|
|
|
|
● |
our
potential to incur substantial costs resulting from product liability lawsuits against us and the potential for such lawsuits to
cause us to limit the commercialization of our diagnostic tests and therapeutic product candidates; |
|
|
|
|
● |
market
acceptance of our diagnostic test and diagnostic tests in development and therapeutic product candidates, the size and growth of
the potential markets for our current diagnostic test and diagnostic tests in development and therapeutic product candidates, and
any future diagnostic tests and therapeutic product candidates we may seek to develop, and our ability to serve those markets; |
|
|
|
|
● |
the
successful development of our commercialization capabilities, including sales and marketing capabilities; |
|
|
|
|
● |
compliance
with government regulations, including environmental, health, and safety regulations and liabilities thereunder; |
|
|
|
|
● |
the
ultimate impact of the COVID-19 pandemic, or any other health epidemic, on our business, our clinical trials, our research programs,
healthcare systems, or the global economy as a whole; |
|
|
|
|
● |
general
instability of economic and political conditions in the United States, including inflationary pressures, increased interest rates,
economic slowdown or recession, and escalating geopolitical tensions; |
|
● |
compliance
with government regulations, including environmental, health, and safety regulations, and liabilities thereunder; |
|
|
|
|
● |
the
increased expenses associated with being a public company; and |
|
|
|
|
● |
other
factors discussed elsewhere in this Quarterly Report. |
Many
of the foregoing risks and uncertainties, as well as risks and uncertainties that are currently unknown to us, are, and may be, exacerbated
by factors such as the ongoing conflict between Ukraine and Russia, the war in the Middle East, escalating tensions between China and
Taiwan, increasing economic uncertainty and inflationary pressures, the evolving nature of the COVID-19 endemic and the emergence of
new viral variants, and any consequent worsening of the global business and economic environment. New factors emerge from time to time,
and it is not possible for us to predict all such factors. Should one or more of the risks or uncertainties described in this Quarterly
Report or any other filing with the Securities and Exchange Commission (the “SEC”) occur or should the assumptions underlying
the forward-looking statements we make herein and therein prove incorrect, our actual results and plans could differ materially from
those expressed in any forward-looking statements. We undertake no obligation to update publicly any forward-looking statements, whether
as a result of new information, future events, or otherwise, except as required by law
You
should read this Quarterly Report and the documents that we reference within it with the understanding that our actual future results,
performance, and events and circumstances may be materially different from what we expect.
Website
and Social Media Disclosure
We
use our websites (www.bioaffinitytech.com, ir.bioaffinitytech.com and www.precisionpath.us/) and at times our corporate X account (@bioAffinity),
LinkedIn account (www.linkedin.com/company/bioaffinitytechnologies) and Facebook account (https://www.facebook.com/bioaffinitytechnologies)
to distribute company information. Information contained on or that can be accessed through our websites and social media channels is
not, however, incorporated by reference in this Quarterly Report. Investors should not consider any such information to be part of this
Quarterly Report.
bioAffinity
Technologies, Inc.
FORM
10-Q
TABLE
OF CONTENTS
PART
I
FINANCIAL
INFORMATION
ITEM
1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS.
bioAffinity
Technologies, Inc.
Condensed
Consolidated Balance Sheets
| |
September 30, 2023 | | |
December 31, 2022 | |
| |
(unaudited) | | |
| |
ASSETS | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 4,509,236 | | |
$ | 11,413,759 | |
Accounts and other receivables, net | |
| 1,108,414 | | |
| 10,489 | |
Inventory | |
| 9,908 | | |
| 5,540 | |
Prepaid expenses and other current assets | |
| 382,651 | | |
| 531,899 | |
Total current assets | |
| 6,010,209 | | |
| 11,961,687 | |
| |
| | | |
| | |
Non-current assets: | |
| | | |
| | |
Property and equipment, net | |
| 512,152 | | |
| 214,438 | |
Operating lease right-of-use asset, net | |
| 392,347 | | |
| — | |
Finance lease right-to-use, net | |
| 1,262,087 | | |
| — | |
Goodwill | |
| 1,148,553 | | |
| — | |
Intangible assets, net | |
| 848,056 | | |
| — | |
Other assets | |
| 16,060 | | |
| 6,000 | |
| |
| | | |
| | |
Total assets | |
$ | 10,189,464 | | |
$ | 12,182,125 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
| |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 827,407 | | |
$ | 345,042 | |
Accrued expenses | |
| 643,786 | | |
| 541,894 | |
Unearned revenue | |
| 38,250 | | |
| — | |
Operating lease liability, current portion | |
| 90,863 | | |
| — | |
Finance lease liability, current portion | |
| 358,282 | | |
| — | |
Loan payable | |
| — | | |
| 251,746 | |
Total current liabilities | |
| 1,958,588 | | |
| 1,138,682 | |
| |
| | | |
| | |
Non-current liabilities: | |
| | | |
| | |
Finance lease liability, net of current portion | |
| 929,570 | | |
| — | |
Operating lease liability, net of current portion | |
| 307,397 | | |
| — | |
| |
| | | |
| | |
Total liabilities | |
| 3,195,555 | | |
| 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 September 30, 2023, and December 31, 2022 | |
| — | | |
| — | |
Common stock, par value $0.007
per share; 25,000,000 and 14,285,714
shares authorized; 9,216,883 and 8,381,324
issued and outstanding at September 30, 2023 and at December 31, 2022, respectively. | |
| 64,535 | | |
| 58,669 | |
Additional paid-in capital | |
| 49,160,689 | | |
| 47,652,242 | |
Accumulated deficit | |
| (42,231,315 | ) | |
| (36,667,468 | ) |
| |
| | | |
| | |
Total stockholders’ equity | |
| 6,993,909 | | |
| 11,043,443 | |
| |
| | | |
| | |
Total liabilities and stockholders’ equity | |
$ | 10,189,464 | | |
$ | 12,182,125 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
bioAffinity
Technologies, Inc.
Unaudited
Condensed Consolidated Statements of Operations
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended
September 30, | | |
Nine Months Ended
September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
(unaudited) | | |
(unaudited) | |
Net Revenue | |
$ | 298,484 | | |
$ | 1,150 | | |
$ | 319,143 | | |
$ | 2,457 | |
Cost of sales | |
| 74,704 | | |
| 146 | | |
| 76,025 | | |
| 292 | |
Gross profit | |
| 223,780 | | |
| 1,004 | | |
| 243,118 | | |
| 2,165 | |
| |
| | | |
| | | |
| | | |
| | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 330,376 | | |
| 319,744 | | |
| 1,035,118 | | |
| 949,388 | |
Clinical development | |
| 106,422 | | |
| 60,941 | | |
| 161,310 | | |
| 141,684 | |
Selling, general and administrative | |
| 2,023,917 | | |
| 595,702 | | |
| 4,576,708 | | |
| 1,295,558 | |
Depreciation and amortization | |
| 57,569 | | |
| 773 | | |
| 100,805 | | |
| 2,852 | |
| |
| | | |
| | | |
| | | |
| | |
Total operating expenses | |
| 2,518,284 | | |
| 977,160 | | |
| 5,873,941 | | |
| 2,389,482 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (2,294,504 | ) | |
| (976,156 | ) | |
| (5,630,823 | ) | |
| (2,387,317 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other income (expense): | |
| | | |
| | | |
| | | |
| | |
Interest income | |
| 27,193 | | |
| 7,414 | | |
| 109,971 | | |
| 8,261 | |
Interest expense | |
| (8,785 | ) | |
| (896,502 | ) | |
| (11,801 | ) | |
| (2,443,350 | ) |
Other income | |
| 4,606 | | |
| — | | |
| 4,606 | | |
| — | |
Other expense | |
| (17,100 | ) | |
| — | | |
| (17,100 | ) | |
| — | |
Gain on extinguishment of debt | |
| — | | |
| — | | |
| — | | |
| 212,258 | |
Fair value adjustments on convertible notes payable | |
| — | | |
| (3,053,914 | ) | |
| — | | |
| (1,866,922 | ) |
| |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Income tax expense | |
| (2,294 | ) | |
| (300 | ) | |
| (18,700 | ) | |
| (2,460 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (2,290,884 | ) | |
$ | (4,919,458 | ) | |
$ | (5,563,847 | ) | |
$ | (6,479,530 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per common share, basic and diluted | |
$ | (0.26 | ) | |
$ | (1.17 | ) | |
$ | (0.65 | ) | |
$ | (2.03 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average common shares outstanding, basic and diluted | |
| 8,696,554 | | |
| 4,203,781 | | |
| 8,551,154 | | |
| 3,194,765 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
bioAffinity
Technologies, Inc.
Unaudited
Condensed Consolidated Statements of Stockholders’ Equity (Deficit)
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
| |
For
the Nine Months Ended September 30, 2023 | |
| |
Preferred Stock | | |
Common Stock | | |
Additional
Paid-in | | |
Accumulated | | |
Stockholders’ | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| |
Balance at December 31, 2022 | |
| — | | |
$ | — | | |
| 8,381,324 | | |
$ | 58,669 | | |
$ | 47,652,242 | | |
$ | (36,667,468 | ) | |
$ | 11,043,443 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation expense | |
| — | | |
| — | | |
| 270,587 | | |
| 1,911 | | |
| 512,402 | | |
| — | | |
| 514,313 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock issued for acquisition | |
| — | | |
| — | | |
| 564,972 | | |
| 3,955 | | |
| 996,045 | | |
| — | | |
| 1,000,000 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (5,563,847 | ) | |
| (5,563,847 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance at September 30, 2023 (unaudited) | |
| — | | |
$ | — | | |
| 9,216,883 | | |
$ | 64,535 | | |
$ | 49,160,689 | | |
$ | (42,231,315 | ) | |
$ | 6,993,909 | |
| |
For
the Three Months Ended September 30, 2023 | |
| |
Preferred Stock | | |
Common Stock | | |
Additional
Paid-in | | |
Accumulated | | |
Stockholders’ | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| |
Balance at June 30, 2023 | |
| — | | |
$ | — | | |
| 8,555,365 | | |
$ | 59,887 | | |
$ | 47,978,892 | | |
$ | (39,940,431 | ) | |
$ | 8,098,348 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation expense | |
| — | | |
| — | | |
| 96,546 | | |
| 693 | | |
| 185,752 | | |
| — | | |
| 186,445 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock issued for acquisition | |
| — | | |
| — | | |
| 564,972 | | |
| 3,955 | | |
| 996,045 | | |
| — | | |
| 1,000,000 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (2,290,884 | ) | |
| (2,290,884 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance at September 30, 2023 (unaudited) | |
| — | | |
$ | — | | |
| 9,216,883 | | |
$ | 64,535 | | |
$ | 49,160,689 | | |
$ | (42,231,315 | ) | |
$ | 6,993,909 | |
| |
For
the Nine Months Ended September 30, 2022 | |
| |
Convertible Preferred Stock | | |
Common Stock | | |
Additional
Paid-in | | |
Accumulated | | |
Stockholders’ | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Deficit | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| |
Balance at December 31, 2021 | |
| 756,558 | | |
$ | 4,044,318 | | |
| 2,677,140 | | |
$ | 18,740 | | |
$ | 12,703,896 | | |
$ | (28,513,355 | ) | |
$ | (15,790,719 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation expense | |
| — | | |
| — | | |
| 18,154 | | |
| 127 | | |
| 211,618 | | |
| — | | |
| 211,745 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Beneficial conversion feature for bridge notes | |
| — | | |
| — | | |
| — | | |
| — | | |
| 348,219 | | |
| — | | |
| 348,219 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Return of capital from stock split | |
| — | | |
| — | | |
| — | | |
| — | | |
| (185 | ) | |
| — | | |
| (185 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Debt discount for warrants issued | |
| — | | |
| — | | |
| — | | |
| — | | |
| 383,696 | | |
| — | | |
| 383,696 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Common stock issued upon initial public offering, net of underwriters’ commission and offering costs of $1.8 million | |
| — | | |
| — | | |
| 1,282,600 | | |
| 8,978 | | |
| 6,018,436 | | |
| — | | |
| 6,027,414 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Common stock issued on conversion of convertible preferred stock | |
| (756,558 | ) | |
| (4,044,318 | ) | |
| 756,558 | | |
| 5,296 | | |
| 4,039,022 | | |
| — | | |
| 4,044,318 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Common stock issued on conversion of notes payable | |
| — | | |
| — | | |
| 2,533,964 | | |
| 17,738 | | |
| 16,047,594 | | |
| — | | |
| 16,065,332 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Exercise of warrants | |
| — | | |
| — | | |
| 1,036,486 | | |
| 7,255 | | |
| 7,706,055 | | |
| — | | |
| 7,713,310 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Exercise of stock options | |
| — | | |
| — | | |
| 64,848 | | |
| 454 | | |
| 74,446 | | |
| — | | |
| 74,900 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (6,479,530 | ) | |
| (6,479,530 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance at September 30, 2022 (unaudited) | |
| — | | |
$ | — | | |
| 8,369,750 | | |
$ | 58,588 | | |
$ | 47,532,797 | | |
$ | (34,992,885 | ) | |
$ | 12,598,500 | |
| |
For
the Three Months Ended September 30, 2022 | |
| |
Convertible Preferred Stock | | |
Common Stock | | |
Additional
Paid-in | | |
Accumulated | | |
Stockholders’ | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Deficit | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| |
Balance at June 30, 2022 | |
| 756,558 | | |
$ | 4,044,318 | | |
| 2,694,459 | | |
$ | 18,861 | | |
$ | 13,268,237 | | |
$ | (30,073,427 | ) | |
$ | (16,786,329 | ) |
Balance, value | |
| 756,558 | | |
$ | 4,044,318 | | |
| 2,694,459 | | |
$ | 18,861 | | |
$ | 13,268,237 | | |
$ | (30,073,427 | ) | |
$ | (16,786,329 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation expense | |
| — | | |
| — | | |
| 835 | | |
| 6 | | |
| 79,007 | | |
| — | | |
| 79,013 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Beneficial conversion feature for bridge notes | |
| — | | |
| — | | |
| — | | |
| — | | |
| 134,277 | | |
| — | | |
| 134,277 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Debt discount for warrants issued | |
| — | | |
| — | | |
| — | | |
| — | | |
| 165,723 | | |
| — | | |
| 165,723 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Common stock issued upon initial public offering, net of underwriters’ commission and offering costs of $1.8 million | |
| — | | |
| — | | |
| 1,282,600 | | |
| 8,978 | | |
| 6,018,436 | | |
| — | | |
| 6,027,414 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Common stock issued on conversion of convertible preferred stock | |
| (756,558 | ) | |
| (4,044,318 | ) | |
| 756,558 | | |
| 5,296 | | |
| 4,039,022 | | |
| — | | |
| 4,044,318 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Common stock issued on conversion of notes payable | |
| — | | |
| — | | |
| 2,533,964 | | |
| 17,738 | | |
| 16,047,594 | | |
| — | | |
| 16,065,332 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Exercise of warrants | |
| — | | |
| — | | |
| 1,036,486 | | |
| 7,255 | | |
| 7,706,055 | | |
| — | | |
| 7,713,310 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Exercise of stock options | |
| — | | |
| — | | |
| 64,848 | | |
| 454 | | |
| 74,446 | | |
| — | | |
| 74,900 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (4,919,458 | ) | |
| (4,919,458 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance at September 30, 2022 (unaudited) | |
| — | | |
$ | — | | |
| 8,369,750 | | |
$ | 58,588 | | |
$ | 47,532,797 | | |
$ | (34,992,885 | ) | |
$ | 12,598,500 | |
Balance, value | |
| — | | |
$ | — | | |
| 8,369,750 | | |
$ | 58,588 | | |
$ | 47,532,797 | | |
$ | (34,992,885 | ) | |
$ | 12,598,500 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
bioAffinity
Technologies, Inc.
Unaudited
Condensed Consolidated Statements of Cash Flows
| |
2023 | | |
2022 | |
| |
Nine
Months Ended September 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
Cash flows from operating activities | |
| | | |
| | |
Net loss | |
$ | (5,563,847 | ) | |
$ | (6,479,530 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation and amortization | |
| 100,805 | | |
| 2,852 | |
Accretion of debt issuance costs | |
| — | | |
| 1,972,948 | |
Fair value adjustments on convertible notes payable | |
| — | | |
| 1,866,922 | |
Stock-based compensation expense | |
| 514,313 | | |
| 211,745 | |
Gain on extinguishment of debt | |
| — | | |
| (212,258 | ) |
Changes in operating assets and liabilities: | |
| | | |
| | |
Accounts and other receivables | |
| 71,840 | | |
| (8,400 | ) |
Inventory | |
| (4,368 | ) | |
| (5,715 | ) |
Prepaid expenses and other assets | |
| 152,768 | | |
| (502,177 | ) |
Accounts payable | |
| 406,836 | | |
| (80,725 | ) |
Accrued expenses | |
| (144,013 | ) | |
| (1,524 | ) |
Accrued interest | |
| — | | |
| 465,653 | |
Unearned revenue | |
| 38,250 | | |
| — | |
Operating lease right-of-use asset | |
| 5,913 | | |
| — | |
Net cash used in operating activities | |
| (4,421,503 | ) | |
| (2,770,209 | ) |
| |
| | | |
| | |
Cash flows from investing activities | |
| | | |
| | |
Purchase of property and equipment | |
| (36,344 | ) | |
| — | |
Acquisition of subsidiary, net cash acquired | |
| (2,186,497 | ) | |
| — | |
Net cash used in investing activities | |
| (2,222,841 | ) | |
| — | |
| |
| | | |
| | |
Cash flows from financing activities | |
| | | |
| | |
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 | |
Proceeds from loans payable | |
| — | | |
| 555,148 | |
Payment on loans payable | |
| (251,746 | ) | |
| (31,612 | ) |
Principle repayments on finance leases | |
| (8,433 | ) | |
| — | |
Proceeds from issuance of convertible notes payable | |
| — | | |
| 724,000 | |
Repayment of convertible loan payable | |
| — | | |
| (100,000 | ) |
Payment of debt issuance costs | |
| — | | |
| (55,651 | ) |
Net cash (used in) provided by financing activities | |
| (260,179 | ) | |
| 14,907,509 | |
| |
| | | |
| | |
Net (decrease)/increase in cash and cash equivalents | |
| (6,904,523 | ) | |
| 12,137,300 | |
Cash and cash equivalents at beginning of period | |
| 11,413,759 | | |
| 1,360,638 | |
Cash and cash equivalents at end of period | |
$ | 4,509,236 | | |
$ | 13,497,938 | |
| |
| | | |
| | |
Supplemental disclosures of cash flow information: | |
| | | |
| | |
Interest expense paid in cash | |
$ | 11,801 | | |
$ | 2,459 | |
Income taxes paid in cash | |
| 18,700 | | |
| 3,945 | |
Noncash investing and financing activities: | |
| | | |
| | |
Common stock issuance for acquisition of subsidiary | |
| 1,000,000 | | |
| — | |
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 | |
| — | | |
| 383,696 | |
Beneficial conversion feature for bridge notes | |
| — | | |
| 348,219 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
bioAffinity
Technologies, Inc.
Notes
To Condensed Consolidated Financial Statements
(unaudited)
Note
1. NATURE OF OPERATIONS, ORGANIZATION, AND BASIS OF PRESENTATION
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® Lung, is a noninvasive test for early detection of lung cancer,
the leading cause of cancer-related deaths. CyPath® Lung is offered for sale to physicians by the Company’s subsidiary,
Precision Pathology Laboratory Services, LLC (“PPLS”). Research and optimization of the Company’s proprietary platform
for in vitro diagnostics and technologies are conducted in laboratories at The University of Texas at San Antonio and PPLS. The
Company is developing its platform technologies so that in the future they will be able to detect, monitor, and treat diseases of the
lung and other cancers.
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® Therapeutics, LLC, as a Delaware limited liability company.
On August 14, 2023, the Company formed a wholly owned subsidiary, PPLS, as a Texas limited liability company, to acquire the assets of
Village Oaks Pathology Services, P.A., a Texas professional association d/b/a Precision Pathology Services (“Village Oaks”),
including the clinical pathology laboratory it owned.
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. The condensed consolidated balance sheet as of December 31, 2022 was derived from the audited consolidated
financial statements at that date but does not include all the information and footnotes required by GAAP. 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 on March 31, 2023.
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 $42.2
million at September 30, 2023. The Company’s cash and cash equivalents at September 30, 2023, were approximately $4.5
million, representing 44%
of total assets. Based on the Company’s current expected level of operating expenditures and the cash and cash equivalents on
hand at September 30, 2023, management concludes that there is substantial doubt about the Company’s ability to continue as a
going concern for a period of at least twelve (12) months subsequent to the issuance of the accompanying unaudited condensed
consolidated financial statements. Therefore, the Company may need to raise further capital through the sale of additional equity or
debt securities or other debt instruments, strategic relationships or grants, or other arrangements to support its future
operations. If such funding is not available or not available on terms acceptable to the Company, the Company’s current
development plan may be curtailed. No adjustments have been made to the presented financial statements as a result of this
uncertainty.
Note
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Use
of Estimates
The
preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions
that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated
financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from
those estimates. Significant estimates include the valuation allowance on the Company’s deferred tax assets, stock-based compensation, valuation of goodwill and intangible assets
related to the business combination, allowance for contractual adjustments and discounts related to service revenues, and the useful lives
of fixed assets.
Principles
of Consolidation
The
Company’s condensed consolidated financial statements reflect its financial statements, those of its wholly owned subsidiaries
and certain variable interest entities where the Company is the primary beneficiary. The accompanying condensed consolidated financial
statements include all the accounts of the Company, its wholly owned subsidiaries, OncoSelect® Therapeutics, LLC and PPLS,
and the variable interest entity, Village Oaks Pathology Services, P.A. All significant intercompany balances and transactions have been
eliminated.
In
determining whether the Company is the primary beneficiary of a variable interest entity, it applies a qualitative approach that determines
whether it has both (1) the power to direct the economically significant activities of the entity and (2) the obligation to absorb losses
of, or the right to receive benefits from, the entity that could potentially be significant to that entity. The Company continuously
assesses whether it is the primary beneficiary of a variable interest entity as changes to existing relationships or future transactions
may result in the Company consolidating or deconsolidating one or more of its collaborators or partners.
Business
Combination
On
September 18, 2023, the Company, in connection with the Asset Purchase Agreement it entered into with Village Oaks (the Seller”)
and Dr. Roby P. Joyce, M.D., dated September 18, 2023, acquired substantially all the assets and assumed certain liabilities of Village
Oaks (the “Acquisition”) in exchange for total consideration of $3,500,000, which consists of: (i) $2.5 million in cash paid
at closing and (ii) 564,972 shares of the Company’s common stock valued at $1 million, reduced by (iii) the assumption of assumed
liabilities totaling $321,000. The assets purchased included a clinical pathology laboratory regulated
by the Centers for Medicare and Medicaid Services (“CMS”) and accredited by the College of American Pathologists (“CAP”)
and certified under the Clinical Laboratory Improvement Amendments (“CLIA”) of 1988.
The
Company recognized goodwill of $1,149,000 arising from the Acquisition. The Acquisition is being accounted for as a business combination
in accordance with ASC 805. The Company has determined the preliminary fair values of the assets acquired and liabilities assumed in
the Acquisition. These values are subject to change as the Company performs additional reviews of its assumptions utilized.
The
following table summarizes the purchase price and preliminary purchase price allocations relating to the Acquisition:
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) | |
$ | 1,167,000 | |
Property and equipment | |
| 326,000 | |
Other assets | |
| 8,000 | |
Customer relationships | |
| 700,000 | |
Trade names and trademarks | |
| 150,000 | |
Goodwill | |
| 1,149,000 | |
Total net assets | |
$ | 3,500,000 | |
Goodwill
represents the excess fair value after the allocation to the identifiable net assets. The calculated goodwill is not deductible for tax
purposes.
Cash
and Cash Equivalents
For
the purpose of the statement of cash flows, the Company considers all highly liquid investments with original maturities of three months
or less at the time of purchase to be cash equivalents. Cash equivalents are stated at cost, which approximates market value, because
of the short maturity of these instruments.
Concentration
of Risk
The
Company has significant cash balances at financial institutions which throughout the year regularly exceed the federally insured limit
of $250,000. Any loss incurred or a lack of access to such funds could have a significant adverse impact on the Company’s financial
condition, results of operations, and cash flow.
Advertising
expense
The
Company expenses all advertising costs as incurred. Advertising expense was approximately $43,000 and $13,000 for the nine months and
$10,000 and $5,000 for the three months ended September 30, 2023 and 2022, respectively.
Loss
Per Share
Basic loss per share is computed by dividing net loss attributable to common stockholders by the weighted-average number
of shares of the Company’s common stock, par value $0.007 per share (the “Common Stock”) outstanding during the period.
Diluted loss per share is computed by dividing net loss attributable to common stockholders by the sum of the weighted-average number
of shares of Common Stock outstanding during the period and the weighted-average number of dilutive Common Stock equivalents outstanding
during the period, using the treasury stock method. Dilutive Common Stock equivalents are comprised of in-the-money stock options, convertible
notes payable, and warrants based on the average stock price for each period using the treasury stock method.
The
following potentially dilutive securities have been excluded from the computations of weighted average shares of Common Stock outstanding
as of September 30, 2023 and 2022, as they would be anti-dilutive:
SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES
| |
2023 | | |
2022 | |
| |
As of September
30, | |
| |
2023 | | |
2022 | |
Shares underlying options outstanding | |
| 683,695 | | |
| 806,392 | |
Shares underlying warrants outstanding | |
| 4,649,952 | | |
| 4,624,952 | |
Shares underlying convertible notes | |
| — | | |
| 83,373 | |
Anti-dilutive securities | |
| 5,333,647 | | |
| 5,514,717 | |
Revenue
Recognition
Post-acquisition
of PPLS, additional revenue streams have been consolidated starting September 19, 2023. PPLS generates three sources of revenue: (1)
patient service fees, (2) histology service fees, and (3) medical director fees. The revenue is recognized on the date of service (meeting
the performance requirement of ASC 606). Pre-acquisition, bioAffinity’s revenue was generated in three ways for the nine months
and three months ended September 30, 2023: (1) royalties from the Company’s diagnostic test, CyPath® Lung, (2) clinical
flow cytometry services provided to Village Oaks related to the Company’s CyPath®
Lung test, and (3) CyPath® Lung tests purchased by the U.S. Department of Defense (“DOD”) for an observational
study, “Detection of Abnormal Respiratory Cell Populations in Lung Cancer Screening Patients Using the CyPath® Lung
Assay (NCT05870592),” and research and development on using bronchoalveolar lavage fluid as a biological sample to assess cardiopulmonary
function and exercise performance in military personnel post COVID-19 infection. The royalty income from CyPath® Lung
and clinical flow cytometry services income, beginning September 19, 2023, are related-party income and, therefore, eliminated from consolidated
net revenues.
To
determine revenue recognition for the arrangements that the Company determines are within the scope of ASC 606, Revenue from Contracts
with Customers, the Company performs the following five steps: (1) identify the contract(s) with a customer, (2) identify the performance
obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in
the contract, and (5) recognize revenue when (or as) the entity satisfies a performance obligation.
SCHEDULE
OF REVENUE RECOGNITION
| |
For three months ended September 30, | |
| |
2023 | | |
2022 | |
| |
Net Revenue | | |
Related Party1 | | |
Consolidated | | |
Net Revenue | | |
Related Party1 | | |
Consolidated | |
| |
| | |
| | |
| | |
| | |
| | |
| |
Parent (bioAffinity Technologies): | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
CyPath® Lung royalty income1 | |
$ | 5,412 | | |
$ | (487 | ) | |
$ | 4,925 | | |
$ | 1,150 | | |
| - | | |
$ | 1,150 | |
Laboratory services1 | |
| 7,423 | | |
| (1,265 | ) | |
| 6,158 | | |
| - | | |
| - | | |
| - | |
Dept. of Defense study | |
| 4,500 | | |
| | |
| 4,500 | | |
| - | | |
| - | | |
| - | |
Subsidiaries ((PPLS) and Controlling Interest Entity2: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Patient fees | |
| 248,654 | | |
| - | | |
| 248,654 | | |
| - | | |
| - | | |
| - | |
Histology fees | |
| 31,854 | | |
| - | | |
| 31,854 | | |
| - | | |
| - | | |
| - | |
Medical director fees | |
| 2,392 | | |
| - | | |
| 2,393 | | |
| - | | |
| - | | |
| - | |
Total net revenue | |
$ | 300,236 | | |
$ | (1,752 | ) | |
$ | 298,484 | | |
$ | 1,150 | | |
| - | | |
$ | 1,150 | |
| |
For the nine months ended September 30, | |
| |
2023 | | |
2022 | |
| |
Net Revenue | | |
Related Party1 | | |
Consolidated | | |
Net Revenue | | |
Related Party1 | | |
Consolidated | |
| |
| | |
| | |
| | |
| | |
| | |
| |
Parent (bioAffinity Technologies): | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
CyPath® Lung royalty income1 | |
$ | 13,164 | | |
$ | (487 | ) | |
$ | 12,677 | | |
$ | 2,457 | | |
| - | | |
$ | 2,457 | |
Laboratory services1 | |
| 10,500 | | |
| (1,265 | ) | |
| 9,315 | | |
| - | | |
| - | | |
| - | |
Dept. of Defense study | |
| 14,250 | | |
| - | | |
| 14,250 | | |
| - | | |
| - | | |
| - | |
Subsidiaries (VOPS/PPLS)2: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Patient fees | |
| 248,654 | | |
| - | | |
| 248,654 | | |
| - | | |
| - | | |
| - | |
Histology fees | |
| 31,854 | | |
| - | | |
| 31,854 | | |
| - | | |
| - | | |
| - | |
Medical director fees | |
| 2,393 | | |
| - | | |
| 2,393 | | |
| - | | |
| - | | |
| - | |
Total net revenue | |
$ | 320,895 | | |
$ | (1,752 | ) | |
$ | 319,143 | | |
$ | 2,457 | | |
| - | | |
$ | 2,457 | |
Reclassifications
Certain
prior year balances have been reclassified to conform to current year presentation. The Company reclassified patent expenses and annuity
costs of approximately $142,000 and $41,000 from research and development to selling, general and administrative for the nine months
and three months ended September 30, 2022, respectively.
Property
and Equipment
In
accordance with ASC 360-10, Accounting for the Impairment of Long-Lived Assets, the Company periodically reviews the carrying
value of its long-lived assets, such as property, equipment, and definite lived intangible assets, to test whether current events or
circumstances indicate that such carrying value may not be recoverable. When evaluating assets for potential impairment, the Company
compares the carrying value of the asset to its estimated undiscounted future cash flows. If an asset’s carrying value exceeds
such estimated cash flows (undiscounted and with interest charges), the Company records an impairment charge for the difference. The
Company did not record any impairment for the nine months ended September
30, 2023 or fiscal year ended December 31, 2022.
Property
and equipment are carried at cost, net of accumulated depreciation. Depreciation is computed using the straight-line method over the
estimated useful life of the asset. Amortization of leasehold improvements is computed using the shorter of the lease term or estimated
useful life of the asset. Additions and improvements are capitalized, while repairs and maintenance are expensed as incurred. Useful
lives of each asset class are as follows:
SCHEDULE
OF PROPERTY AND EQUIPMENT USEFUL LIFE
Asset Category | |
Useful Life |
Computer equipment | |
3-5 years |
Computer software | |
3 years |
Equipment | |
3-5 years |
Furniture and fixtures | |
5-7 years |
Vehicles | |
5 years |
Leasehold improvements | |
Lesser of lease term or useful life |
Intangible
Assets
Intangible
assets, net of accumulated amortization, are summarized as follows as of September 30, 2023:
SCHEDULE
OF INTANGIBLE ASSETS ADJUSTMENTS
Description | |
Date
Acquired | |
Useful
Life | |
Cost | | |
Amortization | |
|
Net | |
Goodwill | |
9/18/2023 | |
| |
$ | 1,148,553 | | |
$ | — | |
|
$ | 1,148,553 | |
Trade names and trademarks | |
9/18/2023 | |
18
years | |
| 150,000 | | |
| (277 | ) |
|
| 149,723 | |
Customer
relationships | |
9/18/2023 | |
14
years | |
| 700,000 | | |
| (1,666 | ) |
|
| 698,334 | |
Total
Intangible Assets | |
$ | 1,998,553 | | |
$ | (1,943 | ) |
|
$ | 1,996,610 | |
For
the three and nine months ended September 30, 2023, amortization of intangible assets totaled $1,943 compared to $0
in the prior year comparative periods.
Recent
Accounting Pronouncements
The
Company continues to monitor new accounting pronouncements issued by the Financial Accounting Standards Board (“FASB”) and
does not believe any accounting pronouncements issued through the date of this Quarterly Report will have a material impact on the Company’s
condensed consolidated financial statements.
The Company adopted FASB issued Accounting Standards Update (ASU) No. 2016-02,
Leases (Topic 842) on September 18, 2023, with the business combination of Village Oaks Pathology Services, P.A. (VOPS) and Precision
Pathology Laboratories Services, LLC (PPLS). The Company has one operating lease for its real estate and office space and multiple finance
leases for lab equipment in Texas that was acquired through the September 18, 2023, acquisition.
Note
3. ACCOUNTS AND OTHER RECEIVABLES, NET
The
following is a summary of accounts receivable:
SCHEDULE
OF ACCOUNTS RECEIVABLE
| |
September 30, 2023 | | |
December 31, 2022 | |
| |
| | | |
| | |
Parent (bioAffinity):
| |
| | | |
| | |
CyPath® Lung royalty income | |
$ | 16,107 | | |
$ | 4,803 | |
Laboratory services | |
| 12,390 | | |
| — | |
Other receivables | |
| 4,730 | | |
| 5,686 | |
Subsidiary (PPLS) and Controlling Interest Entity:
| |
| | | |
| | |
Purchased receivables from acquisition, net of collections | |
| 791,852 | | |
| — | |
Net patient fees receivable | |
| 249,088 | | |
| — | |
Histology fees | |
| 31,854 | | |
| — | |
Medical director fees | |
| 2,393 | | |
| — | |
Accounts
and other receivable, net
| |
$ | 1,108,414 | | |
$ | 10,489 | |
Note
4. PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid
expenses and other current assets are summarized below:
SCHEDULE
OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
| |
September 30, 2023 | | |
December 31, 2022 | |
| |
| | |
| |
Prepaid insurance | |
$ | 240,540 | | |
$ | 340,078 | |
Legal and professional | |
| 30,847 | | |
| 72,048 | |
Other | |
| 111,264 | | |
| 119,773 | |
Total prepaid expenses and other current assets | |
$ | 382,651 | | |
$ | 531,899 | |
Note
5. PROPERTY AND EQUIPMENT, NET
Property
and equipment are summarized below:
SCHEDULE
OF PROPERTY AND EQUIPMENT
| |
September 30, 2023 | | |
December 31, 2022 | |
| |
| | |
| |
Lab equipment | |
$ | 649,499 | | |
$ | 462,155 | |
Computers and software | |
| 68,682 | | |
| 21,463 | |
Leasehold improvements | |
| 9,941 | | |
| — | |
Vehicles | |
| 119,990 | | |
| — | |
Property and equipment, gross | |
| 848,112 | | |
| 483,617 | |
Accumulated depreciation | |
| (335,960 | ) | |
| (269,180 | ) |
Total property and equipment, net | |
$ | 512,152 | | |
$ | 214,438 | |
Depreciation
expense was approximately $66,800 and $2,900 for the nine months ended and $23,500 and $800 for the three months ended September 30,
2023 and 2022, respectively
Note
6. ACCRUED EXPENSES
Accrued
expenses are summarized below:
SCHEDULE OF ACCRUED EXPENSES
| |
September 30, 2023 | | |
December 31, 2022 | |
| |
| | |
| |
Compensation | |
$ | 554,511 | | |
$ | 340,680 | |
Legal and professional | |
| 18,487 | | |
| 144,440 | |
Clinical | |
| 27,776 | | |
| 50,922 | |
Billing fees | |
| 19,525 | | |
| — | |
Other | |
| 23,487 | | |
| 5,852 | |
Total accrued expenses | |
$ | 643,786 | | |
$ | 541,894 | |
Note
7. UNEARNED REVENUE
During
the three months ended September 30, 2023, the Company engaged in an observational study of CyPath® Lung with the DOD.
A total of 70 CyPath® Lung units were ordered and shipped. However, in compliance with FASB ASC 606, the performance obligation
was complete for only 16 units as of September 30, 2023. The performance obligation is deemed complete after samples have been collected
and processed and results analyzed. The unearned revenue balance amounted to approximately $38,250 as of September 30, 2023.
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.
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 3.83 years as of September 30,
2023. The Company has finance leases consisting of office and lab equipment with remaining lease terms ranging from approximately 2.5
to 4.25 years as of September 30, 2023, for which the Company has determined that it will use the equipment for a major part of its remaining
economic life.
The
lease agreements generally do not provide an implicit borrowing rate. Therefore, the Company used a benchmark approach as of September
18, 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 8.01%
to 8.07%
for the lease term lengths.
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 nine months ended
September 30, 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 | |
$ | 32,081 | | |
$ | — | |
Interest on lease liabilities - finance lease | |
| 8,634 | | |
| — | |
Operating lease cost | |
| 9,972 | | |
| — | |
Total lease cost | |
$ | 50,687 | | |
$ | — | |
Supplemental
balance sheet information relating to leases was as follows as of September 30, 2023 and December 31,2022:
SCHEDULE OF BALANCE SHEET
INFORMATION RELATING TO LEASES
Operating leases: | |
2023
| | |
2022 | |
Operating lease right-of-use assets | |
$ | 392,347 | | |
$ | — | |
Operating lease liability, current | |
$ | 90,863 | | |
$ | — | |
Operating lease liability, long-term | |
$ | 307,397 | | |
$ | — | |
Finance leases: | |
2023
| | |
2022 | |
Finance lease right-of-use asset, gross | |
$ | 1,294,168 | | |
$ | — | |
Accumulated amortization | |
| (32,081 | ) | |
| — | |
Finance lease right-of-use asset, net | |
| 1,262,087 | | |
| — | |
Finance lease liability, current portion | |
| 358,282 | | |
| — | |
Finance lease liability, long-term | |
| 929,570 | | |
| — | |
Total finance lease liabilities | |
$ | 1,287,852 | | |
$ | — | |
Weighted-average remaining lease term: | |
2023
| | |
2022 | |
Operating leases (in years) | |
| 3.83 | | |
| — | |
Finance leases (in years) | |
| 3.50 | | |
| — | |
Weighted-average discount rate: | |
2023
| | |
2022 | |
Operating leases | |
| 8.07 | % | |
| — | |
Finance leases | |
| 8.01 | % | |
| — | |
Future
minimum lease payment under non-cancellable lease as of September 30, 2023, are as follows:
SCHEDULE OF FUTURE MINIMUM LEASE
PAYMENT UNDER NON-CANCELLABLE
| |
Operating Leases | | |
Finance Leases | |
Remaining 2023 | |
$ | 28,431 | | |
$ | 112,126 | |
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 | |
| 464,616 | | |
| 1,482,501 | |
Less discounting | |
| (66,356 | ) | |
| (194,649 | ) |
Present value of lease liabilities | |
$ | 398,260 | | |
$ | 1,287,852 | |
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 approximately $35,000 and $15,000 for the three months
and $88,000 and $41,000 for the nine months ended September 30, 2023, and 2022, respectively.
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.
Note
11. COMMON STOCK
Common
Stock
The
Company has authorized a total of 25,000,000 shares of Common Stock, $0.007 par value per share. On June 6, 2023, the Company
received stockholder approval to increase the number of authorized shares from 14,285,715 shares to 25,000,000 shares. The Company
has issued 9,350,297 shares of Common Stock of which 133,414 are unvested restricted stock shares as of September
30, 2023, and 8,381,324 shares of Common Stock as of December 31, 2022.
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
shares of Common Stock. On June 6, 2023, the Company received stockholder approval to increase the number of authorized shares from 1,142,857
to 2,000,000.
Options or restricted stock awards may be granted to employees, the Company’s board of directors, and external consultants who
provide services to the Company. Options and restricted stock awards granted under the Plan have vesting schedules with terms of one
to three years and become fully exercisable based on specific terms imposed at the date of grant. The Plan will terminate according
to the respective terms of the Plan in March 2024.
The
Company has recorded stock-based compensation expense 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
| |
| | | |
| | | |
| | | |
| | |
| |
Three
Months Ended September 30, | | |
Nine
Months Ended September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Research and development | |
$ | 10,304 | | |
$ | 4,072 | | |
$ | 32,193 | | |
$ | 3,318 | |
General and administrative | |
| 181,140 | | |
| 74,941 | | |
| 482,120 | | |
| 208,427 | |
Total stock-based compensation
expense | |
$ | 186,445 | | |
$ | 79,013 | | |
$ | 514,313 | | |
$ | 211,745 | |
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 | | |
| | | |
| | |
Granted | |
| — | | |
| — | | |
| | | |
| | |
Exercised | |
| — | | |
| — | | |
| | | |
| | |
Forfeited | |
| (122,697 | ) | |
| 5.86 | | |
| | | |
| | |
Outstanding at September 30, 2023 | |
| 683,695 | | |
$ | 3.99 | | |
| 3.2 | | |
$ | 254,225 | |
| |
| | | |
| | | |
| | | |
| | |
Vested and exercisable at September 30, 2023 | |
| 681,711 | | |
$ | 3.99 | | |
| 3.2 | | |
$ | 254,225 | |
As
of September 30, 2023, there was no unrecognized compensation cost related to non-vested stock options.
During
the nine months ended September 30, 2023, no options were exercised. During the nine months ended September 30, 2022, 64,848 options
were exercised for proceeds of $74,900. During the nine months ended September 30, 2023, no options were issued by the
Company to purchase shares of Common Stock. During the nine months ended September 30, 2022, the Company issued options to purchase 7,142
shares of Common Stock. The per share weighted-average fair value of the options granted during 2022 was estimated at $2.84 on the date
of grant.
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 | | |
| 79,814 | | |
| 35,106 | |
Granted | |
| 326,068 | | |
| 1.86 | | |
| 607,313 | | |
| 227,760 | | |
| 98,308 | |
Forfeited | |
| (4,979 | ) | |
| 2.76 | | |
| (13,742 | ) | |
| (4,979 | ) | |
| — | |
Balance at September 30, 2023 | |
| 436,009 | | |
$ | 2.30 | | |
$ | 1,003,008 | | |
| 302,595 | | |
| 133,414 | |
During
the nine months ended September 30, 2023, the Company issued restricted stock awards (RSAs) for 326,068 shares of Common Stock to employees,
non-employees, and the board of directors. The shares vest in equal monthly installments over terms of between immediately up to three
years, subject to the employees and non-employees providing continuous service through the vesting date. During the nine months ended
September 30, 2023, 42,825 shares vested from RSAs granted prior to January 1, 2023, and 227,760 shares vested from RSAs granted during
the nine months ended September 30, 2023.
During
the nine months ended September 30, 2022, the Company issued RSAs for 14,999 shares of Common Stock to employees and non-employees. The
shares vest in equal monthly installments over terms of between immediately up to one year, subject to the employees and non-employees
providing continuous service through the vesting date. During the nine months ended September 30, 2022, approximately 21,000 shares vested
from RSAs previously issued.
The
following table summarizes weighted-average assumptions using the Black-Scholes option-pricing model used on the date of the options
grants issued during the nine months ended September 30, 2022. No stock options have been issued during the nine months ended
September 30, 2023:
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 | % |
Note
13. WARRANTS
The
Company accounts for Common Stock warrants as equity instruments. As of September 30, 2023, and December 31, 2022, the Company had 4,649,952
warrants outstanding to purchase one share of the Company’s Common Stock for each warrant at a weighted average exercise price
of $5.03 and expire at various dates through September 2027. During the nine months ended September 30, 2023, no warrants were exercised
into an equivalent number of Common Shares as compared to 1,036,486 warrants being exercised during the nine months ended September 30,
2022.
On
September 17, 2023, the Company entered into a warrant amendment with certain holders of (i) tradeable warrants (the “Tradeable
Warrants”) to who have the right to purchase 73,568 shares of Common Stock; (ii) non-tradeable warrants (the “Non-Tradeable
Warrants”) who have the right to purchase 73,568 shares of Common Stock and (iii) other outstanding warrants (the “Pre-IPO
Warrants”) who have the right to purchase 1,109,475 shares of Common Stock. The warrant amendment provides that such warrants will
not be exercisable until the date that the Company files a certificate of amendment to its certificate of incorporation with the State
of Delaware which increases the number of shares of its authorized Common Stock to allow for sufficient authorized and unissued shares
of Common Stock for the full exercise of all of the outstanding Pre-IPO Warrants, Tradeable Warrants, and Non-Tradeable Warrants of the
Company and the issuance of all of the shares of Common Stock underlying such warrants.
Note
14. 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.
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
This
section presents management’s perspective on our financial condition and results of operations. The following discussion and analysis
(the “MD&A”) is intended to highlight and supplement data and information presented elsewhere in this Quarterly Report,
and should be read in conjunction with our interim unaudited condensed consolidated financial statements and notes elsewhere in this
Quarterly Report and our audited consolidated financial statements and the related notes and the discussion under the heading “Management’s
Discussion and Analysis of Financial Condition and Results of Operations” for the year ended December 31, 2022, included in our
Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 31, 2023 (the “2022 Form 10-K”).
The MD&A is also intended to provide you with information that will assist you in understanding our consolidated financial statements,
the changes in key items in those consolidated financial statements from year to year, and the primary factors that accounted for those
changes. To the extent that this discussion describes prior performance, the descriptions relate only to the periods listed, which may
not be indicative of our future financial outcomes. In addition to historical information, this discussion contains forward-looking statements
that involve risks, uncertainties, and assumptions that could cause the Company’s financial results to differ materially from management’s
expectations. Factors that could cause such differences are discussed in the “Cautionary Note Regarding Forward-Looking Statements”
section of this Quarterly Report and in the “Risk Factors” section of the 2022 Form 10-K.
Data
as of and for the nine months ended September 30, 2023 and 2022, has been derived from our unaudited condensed consolidated financial
statements appearing at the beginning of this Quarterly Report. Results for any interim period should not be construed as an inference
of what our results would be for any full fiscal year or future period.
Our
MD&A is organized as follows:
|
● |
Company
Overview – Discussion of our business plan and strategy to provide context for the remainder of the MD&A. |
|
|
|
|
● |
Results
of Operations – Analysis of our financial results comparing the nine months ended September 30, 2023, to the comparable
period in 2022. |
|
|
|
|
● |
Liquidity
and Capital Resources – Analysis of changes in our cash flows and discussion of our financial condition and potential sources
of liquidity. |
|
|
|
|
● |
Critical
Accounting Estimates – Accounting estimates that we believe are important to understanding the assumptions and judgments
incorporated in our reported financial results and forecasts. |
Company
Overview
Business
bioAffinity
Technologies, Inc. (the “Company,” “bioAffinity Technologies,” “we,” or “our”) develops
noninvasive diagnostics to detect early-stage lung cancer and other diseases of the lung. We also are conducting early-stage research
focused on advancing therapeutic discoveries that could result in broad-spectrum cancer treatments. We develop proprietary noninvasive
diagnostic tests using technology that preferentially targets cancer cells and cell populations indicative of a diseased state. Research
and optimization of our platform technologies are conducted in laboratories at our wholly owned subsidiary, Precision Pathology Laboratory
Services, LLC (“PPLS”), and The University of Texas at San Antonio.
Our
diagnostic test, CyPath® Lung, addresses the need for noninvasive detection of early-stage lung cancer. Lung cancer is
the leading cause of cancer-related deaths. Physicians are able to order CyPath® Lung to assist in their assessment of
patients who are at high risk for lung cancer. The CyPath® Lung test enables physicians to more confidently distinguish
between patients who will likely benefit from timely intervention and more invasive follow-up procedures from patients who are likely
without lung cancer and should continue annual screening. CyPath® Lung has the potential to increase overall diagnostic
accuracy of lung cancer, which could lead to increased survival, fewer unnecessary invasive procedures, reduced patient anxiety, and
lower medical costs.
Through
our wholly owned subsidiary, OncoSelect® Therapeutics, LLC, our research has led to discoveries and advancement of novel
cancer therapeutic approaches that specifically and selectively target cancer cells. We are focused on expanding our broad-spectrum platform
technologies to develop tests that detect and therapies that target various types of cancer and potentially other diseases.
Through
our wholly owned subsidiary PPLS, we acquired the assets of Village Oaks Pathology Services, P.A., a Texas professional association d/b/a
Precision Pathology Services, including the clinical pathology laboratory it owned, and we now operate the laboratory.
Recent
Developments
In
September 2023, the Centers for Medicare and Medicaid (“CMS”) released a preliminary payment decision for a Current Procedural
Terminology (“CPT”) code for use with CyPath® Lung that had been issued by the American Medical Association
(“AMA”) in June, 2023. The CPT code became effective October 1, 2023, and is used for private payers and public health insurance
programs. The CPT Proprietary Laboratory Analyses (“PLA”) code assigned to CyPath® Lung is 0406U with the descriptor
“Oncology (lung), flow cytometry, sputum, 5 markers (meso-tetra [4- carboxyphenyl] porphyrin [TCPP], CD206, CD66b, CD3, CD19),
algorithm reported as likelihood of lung cancer.” bioAffinity Technologies submitted comments during the 30-day comment period
in support of the preliminary decision. In November 2023, CMS is expected to finalize the 2024 payment for CPT 0406U, which will be effective
January 1, 2024. The recommended CMS payment amount will favorably impact PPLS’ established fee schedule for CyPath®
Lung determining reimbursement by private insurance carriers.
On
September 18, 2023, PPLS, our wholly owned subsidiary, consummated the acquisition (the “Acquisition”) of a clinical anatomic
and clinical pathology laboratory and related services business in San Antonio, Texas (the “ Laboratory Assets”) pursuant
to the terms of an Asset Purchase Agreement (the “Asset Purchase Agreement”) dated September 18, 2023 that we entered into
with Village Oaks Pathology Services, P.A., a Texas professional association d/b/a Precision Pathology Services (“Village Oaks”)
and Dr. Roby P. Joyce, M.D. PPLS is accredited by the College of American Pathologists (“CAP”) and certified under the Clinical
Laboratory Improvement Amendments of 1988 (“CLIA”). Founded in 2007 by Dr. Roby Joyce, the Medical Director and Laboratory
Director of the clinical pathology laboratory prior to and after the Acquisition, Village Oaks has provided pathology services to physicians
practicing in a variety of outpatient settings. Since September 2021, Village Oaks, under the trade name Precision Pathology Services,
has offered CyPath® Lung for sale as a laboratory developed test (“LDT”) for the detection of early-stage
lung cancer. In addition to CyPath® Lung, PPLS intends to continue to offer a range of laboratory services including respiratory
testing for SARS-CoV-2 and influenza, anatomical pathology, morphological stains, histological services, DNA extractions, STI testing
and women’s and men’s health testing.
Pursuant
to the terms of the Asset Purchase Agreement, PPLS acquired the Laboratory Assets, which included all of the assets owned by Village
Oaks other than medical assets, including the CLIA certification and CAP accreditation, which are assets Village Oaks used in connection
with its management and operation of a clinical pathology laboratory, now owned by PPLS, and related services business and assumed certain
liabilities and obligations. Pursuant to the terms of the Asset Purchase Agreement, Village Oaks received $3,500,000 in consideration
for the assets to be purchased by PPLS, of which $1,000,000 was paid by the issuance of 564,972 shares of our restricted Common Stock
to a trust controlled by Dr. Joyce (the “Joyce Trust”), which share number was determined by dividing $1,000,000 by $1.77,
the average of the trading day closing prices for the 30 days prior to September 15, 2023, rounded to the nearest whole share.
Pursuant
to the Asset Purchase Agreement, PPLS assumed all liabilities and obligations and obtained any and all rights, title and interest of
Village Oaks in and to (i) all leases for equipment and personal property related to the Laboratory Assets (the “Assumed Leases”),
pursuant to an Assumption Agreement by and between Village Oaks and PPLS (the “Assumption Agreement”); (ii) certain other
contracts related to the Laboratory Assets, including the license to develop, manufacture, use, market, and sell CyPath® Lung
(the “Assumed Contracts”) pursuant to the Assumption Agreement; (iii) all accounts payable of Village Oaks as of September
18, 2023, that were incurred in the ordinary course of business consistent with past custom and practice; and (iv) the lease of the premises
used in connection with operation of the CLIA-certified and CAP-accredited clinical pathology laboratory, pursuant to an Assignment and
Assumption of Lease by and between Village Oaks and PPLS (the “Assignment of Lease”).
In
connection with the Asset Purchase Agreement, PPLS entered into various other agreements, including a Management Services Agreement with
Village Oaks (the “Management Services Agreement”), a Succession Agreement with Village Oaks and Dr. Joyce (the “Succession
Agreement”) and a Professional Services Agreement with Village Oaks (the “Professional Services Agreement”) pursuant
to which PPLS will provide comprehensive management and administrative services to Village Oaks in connection with the operation of Village
Oaks’ professional cytopathology, histopathology, and clinical and anatomic pathology interpretation medical services practice.
PPLS will provide space, equipment, administrative, management and clinical personnel, billing and collection, and related management
services to Village Oaks in exchange for a management fee of 70% of the net revenues received by Village Oaks from the provision of the
medical services
The
Succession Agreement provides that Dr. Joyce, as holder of 100% of the issued and outstanding stock of Village Oaks, and Village Oaks
are restricted from disposing of their equity interests in Village Oaks, subject to certain exceptions, without the prior written consent
of us and Village Oaks.
Pursuant
to a Professional Services Agreement, Village Oaks provides pathology interpretation services as requested on behalf of PPLS based on
the professional fees approved for the CPT code for the services provided under the Medicare Physician Fee Schedule in the locality where
the test is performed.
In
connection with the Asset Purchase Agreement, we entered into an Executive Employment Agreement with Dr. Joyce (the “Joyce Employment
Agreement”), for a term of three years, pursuant to which he serves as the Medical Director and Laboratory Director of PPLS, at
a base salary of $333,333 per year. Pursuant to the Joyce Employment Agreement, Dr. Joyce was also appointed to serve on our Board
of Directors
Financial
To
date, we have devoted a substantial portion of our efforts and financial resources to the development of our diagnostic test, CyPath®
Lung. As a result, since our inception in 2014, we have funded our operations principally through private sales of our equity or
debt securities. As of September 30, 2023, we had cash and cash equivalents of $4.5 million.
Prior
to the Acquisition, Village Oaks, under the trade name Precision Pathology Services, had licensed and developed CyPath®
Lung as an LDT for sale to physicians. The license agreement provided that revenues from the sale would be split evenly between the Company
and Village Oaks. In the second quarter of 2022, prior to the Acquisition, we started to recognize revenue as part of a limited beta
market testing program of the CyPath® Lung test. We have never been profitable, and as of September 30, 2023, we had total
working capital of $4.0 million and an accumulated deficit of approximately $42.2 million. We expect to continue to incur significant
operating losses for the foreseeable future as we continue the development of our diagnostic tests and advance our diagnostic tests through
clinical trials; however, we do expect revenue to increase due to the Acquisition. We intend to license our therapeutic products for
clinical development should animal and pre-clinical studies prove successful.
We
anticipate raising additional cash needed through the private or public sales of equity or debt securities, collaborative arrangements,
or a combination thereof to continue to fund our operations and develop our products. There is no assurance that any such collaborative
arrangement will be entered into or that financing will be available to us when needed in order to allow us to continue our operations
or, if available, on terms acceptable to us. If we do not raise sufficient funds in a timely manner, we may be forced to curtail operations,
delay our clinical trials, cease operations altogether, or file for bankruptcy.
Forecast
With
the acquired revenue stream from PPLS, the Company’s projected revenue over the next 12 months will significantly change. For
the year ended December 31, 2022, Village Oaks generated net revenue of approximately $6.9 million and net loss of approximately
$461,000 and for the six months ended June 30, 2023, Village Oaks generated revenue of approximately $3.6 million and net loss of
approximately $493,000. The Company has consolidated in its net revenue $283,000 of net revenues generated by PPLS for the provision
of laboratory services for the period from September 19, 2023, through September 30, 2023 (September 18, 2023, being the date of the
Acquisition). The laboratory revenue is projected to contribute between $2.1 million and $2.3 million of net revenues for 2023.
These projections are based on historical average annual growth rates of 10% net revenues.
In
addition to the forecasted PPLS revenue, CyPath® Lung adoption is expected to contribute $456,000 gross revenues the next 12 months.
The data points supporting these projections are: (1) learnings from the current beta market test of commercialization, (2) developed
branding and marketing collateral, (3) increased onboarding of sales representatives, (4) additional publications of scientific data
supporting the product, and (5) the CMS approval of payment for the AMA-approved CPT code specific for CyPath® Lung and
the increase in the test price based on the expected CMS payment decision and its resulting impact on the PPLS established fee schedule
for private insurance carriers. The table below provides the results of our beta market test program (2q2022-3q2023) on which we base our 12-month forecast (4q2023-3q2024)
that is also provided.
| |
2q2022-3q2023 | | |
4q2023-3q2024 | |
| |
Beta Test Results | | |
Forecast | |
ADOPTION METRICS | |
| | | |
| | |
HCPs - enrolled | |
| 20 | | |
| 82 | |
HCPs - ordered | |
| 15 | | |
| 61 | |
CyPath® Lung Tests ordered | |
| 44 | | |
| 284 | |
Sales Representatives | |
| 2 | | |
| 5 | |
Avg. HCP per Sales Rep | |
| 7.5 | | |
| 12.3 | |
Avg. Test per Sales Rep | |
| 22.0 | | |
| 56.8 | |
PENETRATION METRICS | |
| | | |
| | |
HCP in addressable market | |
| 1320 | | |
| 6261 | |
Target segment of HCPs | |
| 244 | | |
| 782 | |
Penetration % of target segment - enrolled | |
| 7.8 | % | |
| 10.5 | % |
Penetration % of target segment - ordered | |
| 6.1 | % | |
| 7.8 | % |
REVENUE | |
| | | |
| | |
Gross revenue | |
$ | 19,910 | | |
$ | 456,000 | |
Notes:
(1)
HCP enrolled = the number of healthcare physicians (“HCP” comprising of pulmonologist, internists, family, and general practice
physicians) who have enrolled as clients of PPLS with the purpose of ordering CyPath® Lung and, in Forecast, the
addition number of HCPs forecasted to enroll.
(2)
HCP ordered = the number of healthcare physicians who have ordered one or more CyPath® Lung tests and, in Forecast,
the additional number of HCPs who we forecast will order the test
(3)
CyPath® Lung Tests Ordered = number of CyPath® Lung tests ordered that result in revenue, and, in Forecast,
the additional number of tests we forecast to be ordered and result in revenue
(4)
Sales Representatives = number of dedicated sales representatives employed by the Company. Beta Test Results reflect one sales representative
in Austin/San Antonio area (2q2022 – present) and one sales representative in the Rio Grande Valley area, Texas (2q2023). Forecasted
results reflect recent hire of our National Sales Director (3q23) and assume one additional sales representative in Houston (hire 4q23)
and one additional sales representative in Dallas (hire 2q24)
(5)
Avg. HCP per Sales Rep = average number of HCPs who are ordering CyPath® Lung per sales representative assigned to the
market area
(6)
Avg. Test per Sales Rep = average number of tests ordered that result in revenue per sales representative assigned to the market area.
(7)
HCP in addressable market = the Beta Test Market is comprised of the total number of HCPs in the Austin, San Antonio, and the Rio Grande
Valley greater areas of Texas who have ordered procedures to diagnose pulmonary nodules.. The Forecast includes expansion of the
addressable market to Houston and Dallas, Texas. Market data used to define the addressable market is based on a third-party commissioned
report.
(8)
Target segment of HCPs = HCPs (largely pulmonologists) in the addressable markets who on an annual basis have ordered more than 50 procedures
for patients who required further diagnosis of pulmonary nodules. Market data used to define the target segment of HCPs is based on a
third-party commissioned report.
(9)
Penetration % of target segment – enrolled = the percentage of HCPs in the target segment who enrolled as clients of PPLS with
the purpose of ordering CyPath® Lung. The Forecast calculates the percentage based on the number of HCPs in the
target segment forecasted to be enrolled during the period indicated. The target segment is based on market data provided by a third-party
commissioned report.
(10)
Penetration % of target segment – ordered = the percentage of HCPs in the target segment who ordered one or more CyPath®
Lung tests. The Forecast includes HCPs forecasted to order the test as a percentage of the total target segment.
Results
of Operations
Three
Months Ended September 30, 2023, Compared to Three Months Ended September 30, 2022
Net
loss for the three months ended September 30, 2023, was approximately $2.3 million, compared to a net loss of approximately $4.9 million
for the three months ended September 30, 2022.
Revenue
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. Pre-acquisition, bioAffinity Technologies’ revenue
was generated in three ways for the nine months and three months, respectively, ended September 30, 2023: (1) royalties from the Company’s
diagnostic test, CyPath® Lung, (2) clinical flow cytometry services provided to Village Oaks related to the Company’s
CyPath® Lung test, and (3) CyPath® Lung tests purchased by the U.S. Department of Defense (“DOD”)
for an observational study, “Detection of Abnormal Respiratory Cell Populations in Lung Cancer Screening Patients Using the CyPath®
Lung Assay (NCT05870592),” and research and development on using bronchoalveolar lavage fluid as a biological sample to assess
cardiopulmonary function and exercise performance in military personnel post-COVID-19 infection. The royalty income from CyPath®
Lung and clinical flow cytometry services income, beginning September 19, 2023, are related party income, and therefore, eliminated
from consolidated net revenues. See net revenue summarized in the table below.
In
the first quarter of 2023, we engaged the marketing and advertising firms of Havas Health & You and Trinity Life Sciences to build
the CyPath® Lung brand and position it for success in the cancer diagnostics sector. Havas Health & You, a large global
health network, has created the branding to align with the need for a patient-friendly diagnostic that gives physicians another tool
to assess the potential or presence of lung cancer in their high-risk patients. Trinity Life Sciences used the insights and analytics
it gathered from healthcare practitioners to focus the short-term objectives of our marketing strategy for CyPath® Lung.
The limited test market launch in South Texas is designed to evaluate our marketing program and help us ensure each step in the care
pathway – from the initial order by physicians to sputum collection and processing, to generating and delivering the patient report
– is efficient and effective. This limited test market approach allows us to refine future positioning and develop strategic insight
for our CyPath® Lung test before expanding to a larger market.
| |
For three months ended September 30 , | |
| |
2023 | | |
2022 | |
| |
Net Revenue | | |
Related Party1 | | |
Consolidated | | |
Net Revenue | | |
Related Party1 | | |
Consolidated | |
| |
| | |
| | |
| | |
| | |
| | |
| |
Parent (bioAffinity Technologies): | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
CyPath® Lung royalty income1 | |
$ | 5,412 | | |
$ | (487 | ) | |
$ | 4,925 | | |
$ | 1,150 | | |
| - | | |
$ | 1,150 | |
Laboratory services1 | |
| 7,423 | | |
| (1,265 | ) | |
| 6,158 | | |
| - | | |
| - | | |
| - | |
Dept. of Defense study | |
| 4,500 | | |
| - | | |
| 4,500 | | |
| - | | |
| - | | |
| - | |
Subsidiaries ((PPLS) and Controlling Interest Entity2: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Patient fees | |
| 248,654 | | |
| - | | |
| 248,654 | | |
| - | | |
| - | | |
| - | |
Histology fees | |
| 31,854 | | |
| - | | |
| 31,854 | | |
| - | | |
| - | | |
| - | |
Medical director fees | |
| 2,392 | | |
| - | | |
| 2,393 | | |
| - | | |
| - | | |
| - | |
Total net revenue | |
$ | 300,236 | | |
$ | (1,752 | ) | |
$ | 298,484 | | |
$ | 1,150 | | |
| - | | |
$ | $1,150 | |
1
As of September 18, 2023 (date of the Acquisition), royalty and laboratory services income agreements are considered related parties
and eliminated upon consolidation.
2
The three months ended revenue for PPLS and its controlling interest entity, Village Oaks, only recognizes partial period of September
19 through September 30, 2023.
Cost
of Sales
Historically,
cost of sales is comprised primarily of costs related to inventory production and usage and shipment of collection kits to patients and
healthcare providers for CyPath® Lung. Starting September 19, 2023, cost of sales also consists of consumable lab supplies,
reagents, and direct labor from the patient and histology lab services.
Operating
Expenses
| |
Three
Months Ended September 30,(1) | | |
Change in 2023 Versus 2022 | |
| |
2023 | | |
2022 | | |
$ | | |
% | |
| |
| | |
| | |
| |
Operating expenses | |
| | | |
| | | |
| | | |
| | |
Research and development | |
$ | 330,400 | | |
$ | 319,800 | | |
$ | 10,600 | | |
| 3 | % |
Clinical development | |
| 106,400 | | |
| 60,900 | | |
| 45,500 | | |
| 75 | % |
Selling, general and administrative | |
| 2,023,900 | | |
| 595,700 | | |
| 1,428,200 | | |
| 240 | % |
Depreciation and amortization | |
| 57,600 | | |
| 800 | | |
| 56,800 | | |
| 7100 | % |
Total operating expenses | |
$ | 2,518,300 | | |
$ | 977,200 | | |
$ | 1,541,100 | | |
| 158 | % |
(1) |
Represents
operating expenses from our unaudited condensed consolidated financial statements for the three-month period ended September 30,
2023 and 2022, respectively. |
Operating
expenses totaled approximately $2.5 million and $1.0 million during the three months ended September 30, 2023 and 2022, respectively.
The increase in operating expenses is the result of the following factors.
Research
and Development Expenses
Our
research and development expenses consist primarily of expenditures for lab operations, preclinical and clinical studies, compensation,
and consulting costs.
Research
and development expenses totaled approximately $330,400 and $319,800 for the three months ended September 30, 2023, and 2022, respectively.
The increase of approximately $10,600, or 3%, for the three months ended September 30, 2023, compared to the same period in 2022, was
primarily due to an increase in compensation costs and benefits as we added research personnel, as well as a related increase in costs
for lab supplies and reagents. Additionally, equipment costs, including depreciation and maintenance costs, increased as we purchased
capital equipment to support research and development efforts.
Clinical
Development
Clinical
development expenses totaled approximately $106,400 and $60,900 for the nine months ended September 30, 2023 and 2022, respectively.
The increase of approximately $45,500, or 75%, for the nine months ended September 30, 2023, compared to the same period in 2022, was
primarily attributable to an increase in professional fees, including consulting fees, related to evaluating the clinical strategy in
the prior year for our pivotal clinical trial designed to confirm the sensitivity and specificity of CyPath® Lung in detecting
lung cancer in persons at high risk for the disease, including patients who display indeterminate pulmonary nodules between 6mm and 30mm
in size which often present a challenge in diagnosis.
Selling,
General and Administrative
Our
selling, general and administrative expenses consist primarily of expenditures related to employee compensation, legal, accounting and
tax, other professional services, and general operating expenses.
Selling,
general and administrative expenses totaled approximately $2.0 million and $0.6 million for the three months ended September 30, 2023
and 2022, respectively. The increase of approximately $1.4 million, or 240%, for the three months ended September 30, 2023, compared
to the same period in 2022, was primarily attributable to accounting, legal and professional fee costs associated with the acquisition
of PPLS ($595,000), the accounting, legal and professional fee costs associated with the SEC filing of a registration statement on Form
S-1 ($197,000), increase in stock-based compensation ($186,000), increase in employee compensation ($238,000), increase in branding and
marketing collateral ($117,000), as well as an increase related to board compensation, public company expense, and other operational
expenses. Patent costs increased in the current year as we maintain and expand our patent portfolio to protect our diagnostic and therapeutic
platforms. Additionally, compensation increased due to additional personnel and support services to support the launch of sales of our
diagnostic test, CyPath® Lung.
Other
Income (Expense)
Other
income (expense), net totaled approximately $6,000 and $3.9 million for the three-month period ended September 30, 2023 and 2022, respectively.
Interest
Income (Expense), net
Interest
income (expense), net was approximately $18,400 for the three months ended September 30, 2023, compared to $889,100 for the
three months ended September 30, 2022.
Gain
(loss) on change in fair value of convertible notes
There
was a loss of approximately $3.1 million on the change in fair value of convertible notes during the three months ended September 30,
2022, compared to no loss during the three months ended September 30, 2023. The change in the fair value of convertible notes resulted
primarily from changes in the calculation of the fair value of our stock, the reduction in the expected term, and other assumptions during
the reported periods. All convertible and bridge notes were converted as a result of our initial public offering (the “IPO”)
in the prior year, resulting in no additional changes in fair value related to the convertible and bridge notes.
Nine
Months Ended September 30, 2023, Compared to Nine Months Ended September 30, 2022
Net
loss for the nine months ended September 30, 2023, was approximately $5.6 million, compared to a net loss of approximately $6.5 million
for the nine months ended September 30, 2022.
Revenue
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. Pre-acquisition, bioAffinity Technologies’ revenue
was generated in three ways for the nine months and three months, respectively, ended September 30, 2023: (1) royalties from the Company’s
diagnostic test, CyPath® Lung, (2) clinical flow cytometry services provided to Village Oaks related to the Company’s
CyPath® Lung test, and (3) CyPath® Lung tests purchased by the DOD for an observational study, “Detection
of Abnormal Respiratory Cell Populations in Lung Cancer Screening Patients Using the CyPath® Lung Assay (NCT05870592),”
and research and development on using bronchoalveolar lavage fluid as a biological sample to assess cardiopulmonary function and exercise
performance in military personnel post COVID-19 infection. The royalty income from CyPath® Lung and clinical flow cytometry services
income, beginning September 19, 2023, are related party income, and therefore, eliminated from consolidated net revenues. See net revenue
summarized in the table below.
In
the first quarter of 2023, we engaged the marketing and advertising firms of Havas Health & You and Trinity Life Sciences to build
the CyPath® Lung brand and position it for success in the cancer diagnostics sector. Havas Health & You, a large global
health network, has created the branding to align with the need for a patient-friendly diagnostic that gives physicians another tool
to assess the potential or presence of lung cancer in their high-risk patients. Trinity Life Sciences used the insights and analytics
it gathered from healthcare practitioners to focus the short-term objectives of our marketing strategy for CyPath® Lung.
The limited test market launch in South Texas is designed to evaluate our marketing program and help us ensure each step in the care
pathway – from the initial order by physicians to sputum collection and processing, to generating and delivering the patient report
– is efficient and effective. This limited test market approach allows us to refine future positioning and develop strategic insight
for our CyPath® Lung test before expanding to a larger market.
| |
For the nine months ended September 30, | |
| |
2023 | | |
2022 | |
| |
Net Revenue | | |
Related Party1 | | |
Consolidated | | |
Net Revenue | | |
Related Party1 | | |
Consolidated | |
| |
| | |
| | |
| | |
| | |
| | |
| |
Parent (bioAffinity Technologies): | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
CyPath® Lung royalty income1 | |
$ | 13,164 | | |
$ | (487 | ) | |
$ | 12,677 | | |
$ | 2,457 | | |
| - | | |
$ | 2,457 | |
Laboratory services1 | |
| 10,500 | | |
| (1,265 | ) | |
| 9,315 | | |
| - | | |
| - | | |
| - | |
Dept. of Defense study | |
| 14,250 | | |
| - | | |
| 14,250 | | |
| - | | |
| - | | |
| - | |
Subsidiaries (VOPS/PPLS)2: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Patient fees | |
| 248,654 | | |
| - | | |
| 248,654 | | |
| - | | |
| - | | |
| - | |
Histology fees | |
| 31,854 | | |
| - | | |
| 31,854 | | |
| - | | |
| - | | |
| - | |
Medical director fees | |
| 2,393 | | |
| - | | |
| 2,393 | | |
| - | | |
| - | | |
| - | |
Total net revenue | |
$ | 320,895 | | |
$ | (1,752 | ) | |
$ | 319,143 | | |
$ | 2,457 | | |
| - | | |
$ | $2,457 | |
1
As of September 18, 2023 (date of the Acquisition), royalty and laboratory services income agreements are considered related parties
and eliminated upon consolidation.
2
The three months ended revenue for PPLS and its controlling interest entity, Village Oaks, only recognizes partial period of September
19 through September 30, 2023.
Cost
of Sales
Historically,
cost of sales is comprised primarily of costs related to inventory production and usage and shipment of collection kits to patients and
healthcare providers for CyPath® Lung. Starting September 19, 2023, cost of sales also consists of consumable lab supplies, reagents
and direct labor from the patient and histology lab services.
Operating
Expenses
| |
Nine Months Ended September 30,(1) | | |
Change in 2023 Versus 2022 | |
| |
2023 | | |
2022 | | |
$ | | |
% | |
| |
(unaudited) | | |
| | |
| |
Operating expenses | |
| | | |
| | | |
| | | |
| | |
Research and development | |
$ | 1,035,100 | | |
$ | 949,400 | | |
$ | 85,700 | | |
| 9 | % |
Clinical development | |
| 161,300 | | |
| 141,700 | | |
| 19,600 | | |
| 14 | % |
Selling, general and administrative | |
| 4,576,700 | | |
| 1,295,600 | | |
| 3,281,100 | | |
| 253 | % |
Depreciation and amortization | |
| 100,800 | | |
| 2,800 | | |
| 98,00 | | |
| 3500 | % |
Total operating expenses | |
$ | 5,873,900 | | |
$ | 2,389,500 | | |
$ | 3,484,400 | | |
| 146 | % |
(1) |
Represents
operating expenses from our unaudited condensed consolidated financial statements for the six-month period ended September 30, 2023
and 2022, respectively. |
Operating
expenses totaled approximately $5.9 million and $2.4 million during the nine months ended September 30, 2023 and 2022, respectively.
The increase in operating expenses is the result of the following factors.
Research
and Development Expenses
Our
research and development expenses consist primarily of expenditures for lab operations, clinical and preclinical studies, compensation,
and consulting costs.
Research
and development expenses totaled approximately $1.0 million and $0.9 million for the nine months ended September 30, 2023, and 2022,
respectively. The increase of approximately $85,700, or 9%, for the nine months ended September 30, 2023, compared to the same period
in 2022, was primarily due to an increase in compensation costs and benefits due to additional research personnel, as well as a related
increase in costs for lab supplies and reagents. Additionally, equipment costs, including depreciation and maintenance costs, increased
as we purchased capital equipment to support research and development efforts.
Clinical
Development
Clinical
development expenses totaled approximately $161,300 and $141,700 for the nine months ended September 30, 2023, and 2022, respectively.
The increase of approximately $19,600, or 14%, for the nine months ended September 30, 2023, compared to the same period in 2022, was
primarily attributable to a decrease in professional fees, including consulting fees, related to evaluating the clinical strategy in
the prior year for our pivotal clinical trial designed to confirm the sensitivity and specificity of CyPath® Lung in detecting
lung cancer in persons at high risk for the disease, including patients who display indeterminate lung nodules between 6mm and 30mm in
size which often present a challenge in diagnosis.
Selling,
General and Administrative
Our
selling, general and administrative expenses consist primarily of expenditures related to employee compensation, legal, accounting and
tax, other professional services, and general operating expenses.
Selling,
general and administrative expenses totaled approximately $4.6 million and $1.3 million for the nine months ended September 30, 2023
and 2022, respectively. The increase of approximately $3.3 million, or 253%, for the nine months ended September 30, 2023, compared to
the same period in 2022, was primarily attributable to accounting, legal, and professional fee costs associated with the acquisition
of PPLS ($811,000), the accounting, legal, and professional fee costs associated with the SEC filing of a registration statement on Form
S-1 ($197,000), increase in stock-based compensation ($313,000), increase in employee compensation ($628,000), increase in branding and
marketing collateral ($391,000), increase in directors and officers (“D&O”) insurance ($290,000), increase in public
company-related expenses ($294,000) as well as an increase related to board compensation ($147,000), and other operational expenses.
Additionally, compensation increased due to additional personnel and support services to support the launch of sales of our diagnostic
test, CyPath® Lung.
Other
Income (Expense)
Other
income (expense), net totaled approximately $85,700 and $4.1 million for the nine-month period ended September 30, 2023 and 2022, respectively.
Interest
Income (Expense), net
Interest
income (expense), net was approximately $98,200 for the nine months ended September 30, 2023, compared to $2.4 million for the nine months
ended September 30, 2022.
Gain
(loss) on change in fair value of convertible notes
There
was a loss of approximately $1.9 million on the change in fair value of convertible notes during the nine months ended September 30,
2022, compared to no loss during the nine months ended September 30, 2023. The change in the fair value of convertible notes resulted
primarily from changes in the calculation of the fair value of our stock, the reduction in the expected term, and other assumptions during
the reported periods. All convertible and bridge notes were converted as a result of our IPO in the prior year, resulting in no additional
changes in fair value related to the convertible and bridge notes.
Liquidity, Capital Resources, and Going Concern
To
date, we have funded our operations primarily through our IPO, exercise of warrants, and the sale of our equity and debt securities,
resulting in gross proceeds of approximately $34.3 million. 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.
We
have incurred losses since our inception in 2014 as a result of significant expenditures for operations and research and development
and, prior to April 2022, the lack of any approved diagnostic test or therapeutic products to generate revenue. For the nine months ended
September 30, 2023 and 2022, we had net losses of $5.6 million and $6.5 million, respectively, and we expect to incur substantial additional
losses in future periods. We have an accumulated deficit of approximately $42.2 million as of September 30, 2023. Based on the Company’s current expected level of operating expenditures
and the cash and cash equivalents on hand at September 30, 2023, management concludes that there is substantial doubt about the Company’s
ability to continue as a going concern for a period of at least twelve (12) months subsequent to the issuance of the accompanying unaudited
condensed consolidated financial statements. Cash and cash equivalents
were approximately $4.5 million as of September 30, 2023. We need to raise further capital through the sale of additional equity or debt
securities or other debt instruments, strategic relationships or grants, or other arrangements to support our future operations. Our
business plan includes expansion for our commercialization efforts which will require additional funding. If we are unable to improve
our liquidity position, we may not be able to continue as a going concern. Our ability to continue as a going concern is dependent upon
our ability to generate revenue and raise capital from financing transactions. There can be no assurance that we will be successful in
accomplishing these objectives.
We
continue to seek sources of financing to fund our continued operations and research and development programs. To raise additional capital,
we may sell additional equity or debt securities, or enter into collaborative, strategic, and/or licensing transactions. There can be
no assurance that we will be able to complete any financing transaction in a timely manner or on acceptable terms or otherwise enter
into a collaborative or strategic transaction. If we are not able to raise additional cash, we may be forced to delay, curtail, or cease
development of our diagnostic tests or therapeutic products, or cease operations altogether.
Summary
Statements of Cash Flows
The
following information reflects cash flows for the periods presented:
| |
Nine Months Ended | |
| |
September 30, | |
| |
2023 | | |
2022 | |
(amounts in thousands) | |
| |
Cash and cash equivalents at beginning of period | |
$ | 11,414 | | |
$ | 1,360 | |
Net cash used in operating activities | |
| (4,431 | ) | |
| (2,770 | ) |
Net cash used in investing activities | |
| (2,216 | ) | |
| — | |
Net cash provided by (used in) financing activities | |
| (258 | ) | |
| 14,908 | |
Cash and cash equivalents at end of period | |
$ | 4,509 | | |
$ | 13,498 | |
Net
Cash Used in Operating Activities
Net
cash used in operating activities was approximately $4.4 million and $2.8 million for the nine months ended September 30, 2023 and 2022,
respectively. The increase of approximately $1.4 million in cash used by operations during the nine months ended September 30, 2023,
compared to the same period in 2022, was primarily attributable to an increase of $916,000 in our loss from operations as compared to
the prior year as described above.
Net
Cash Used in Investing Activities
The
Company used approximately $2.2 million for the nine months ended September 30, 2023, in investing activities related primarily related
to the Acquisition on September 18, 2023 and to a lesser extent to the purchase of computer and lab equipment, compared to no cash used
in investing activities for the nine months ended September 30, 2022.
Net
Cash Used by Financing Activities
Cash
used in financing activities was approximately $258,000 compared to cash proceeds in financing activities of approximately $14.9 million
for the nine months ended September 30, 2023 and 2022, respectively. The change in proceeds from prior year was primarily related to
net proceeds from the IPO and exercise of warrants totaling $13.8 million in September 2022.
Contractual
Obligations and Commitments
We
enter into contracts in the normal course of business with third-party contract organizations for clinical trials and other services
and products used for research and development and operating purposes. These contracts generally provide for termination following a
certain period after notice, and therefore we believe that any non-cancelable obligations under these agreements are not material.
Critical
Accounting Estimates
The
preparation of financial statements in conformity with U.S. GAAP requires management to make significant judgments and estimates that
affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the reporting period. Management bases these significant judgments
and estimates on historical experience and other assumptions it believes to be reasonable based upon information presently available.
Actual results could differ from those estimates under different assumptions, judgments, or conditions.
Patient Fee Revenues
We follow ASC 606, Revenue from Contracts with Customers, which
requires revenue recognition in the period in which the service was performed. To be able to report timely net revenues for the period,
estimates are used for a portion of uncollected balances. These estimates relate to 3rd party historical contractual discounts
and adjustments (e.g. insurance providers) and patient historical uncollectible amounts. There can be a significant delay from the time
a patient has been serviced to the invoicing of that service and then the net proceeds collected. Historical data is used to determine
estimates for those “in service” revenues that have not been billed or collected at the reporting period.
Stock-Based
Compensation
We
follow ASC 718, Compensation – Stock Compensation, which requires the measurement and recognition of compensation expense
for all share-based payment awards made to employees, directors, and non-employees based on estimated fair values. We have used the Black-Scholes
option pricing model to estimate grant date fair value for all option grants. The assumptions we use in calculating the fair value of
share-based payment awards represent management’s best estimates, but these estimates involve inherent uncertainties and the application
of management judgment. Since we use different assumptions based on a change in factors, our stock-based compensation expense could be
materially different in the future.
Accounting
for Income Taxes
We
are governed by U.S. income tax laws, which are administered by the Internal Revenue Service (“IRS”). We follow ASC 740,
Accounting for Income Taxes, which requires an asset and liability approach to financial accounting and reporting for income taxes.
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. 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.
Emerging
Growth Company Status
We
are both an “emerging growth company” and a “smaller reporting company” as defined by Rule 12b-2 of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”) and are therefore subject to reduced public company reporting requirements.
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
As
a smaller reporting company, pursuant to Item 305(e) of Regulation S-K promulgated under the Securities Act, we are not required to provide
the information required by this Item 3.
ITEM
4. CONTROLS AND PROCEDURES.
Evaluation
of Disclosure Controls and Procedures
As
of the end of the period covered by this Quarterly Report, our Chief Executive Officer and Chief Financial Officer evaluated the effectiveness
of our “disclosure controls and procedures” (as defined in the Exchange Act) Rules 13a-15(e)and 15d-15(e)). Rule 13a-15(e)
under the Exchange Act defines “disclosure controls and procedures” as controls and other procedures of a company that are
designed to ensure that the information required to be disclosed by a company in the reports that it files or submits under the Exchange
Act is recorded, processed, summarized, and reported, within the time periods specified in the SEC’s rules and forms, and that
such information is accumulated and communicated to a company’s management, including its Chief Executive Officer and Chief Financial
Officer, as appropriate, to allow timely decisions regarding required disclosure. Based on that evaluation, management has concluded
that due to limited resources and the limited number of employees, its internal control over financial reporting was ineffective as of
September 30, 2023, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial
statements in accordance with U.S. GAAP. To mitigate the limited resources and employees, we rely heavily on direct management oversight
of transactions, along with the use of legal and accounting professionals. As we grow, we expect to increase the number of employees,
which we believe will enable us to implement adequate segregation of duties within the internal control framework.
Changes
in Internal Control over Financial Reporting
As
previously disclosed, on May 1, 2023, Michael Dougherty, Chief Financial Officer, joined the Company. Further segregation of duty over
financial transactions and reconciliations have been put in place as of September 30, 2023. In addition, a new Senior Accountant was
hired in July 2023 to increase the resources required to implement preparer and reviewer financial controls. A risk control approach
has begun to evaluate all material risk, mitigating controls and identify any gaps related to financial reporting. In addition, the Company
will rely on direct management oversight of transactions, along with the use of legal and accounting professionals. There have been no
other changes to our internal control over financial reporting.
PART
II
ITEM
1. LEGAL PROCEEDINGS.
From
time to time, we are involved in various disputes and litigation matters that arise in the ordinary course of business. To date, we have
had no material pending legal proceedings, and we are not engaged in any legal proceedings that are expected, individually or in the
aggregate, to have a material adverse impact on our financial position or results of operations.
ITEM
1A. RISK FACTORS.
As
a smaller reporting company, we are not required to provide disclosure pursuant to this Item 1A. However, in addition to other information
set forth in this Quarterly Report, you should carefully consider the “Risk Factors” discussed in the 2022 Form 10-K filed
with the SEC on March 31, 2023, pursuant to Rule 424(b)(4) under the Securities Act, for a discussion of important factors that could
cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in this
Quarterly Report. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial might materially
adversely affect our actual business, financial condition, and operating results. The following information updates, and should be read
in conjunction with, the information disclosed in Part I, Item 1A, “Risk Factors,” contained in our 2022 Form 10-K filed
with the SEC on March 31, 2023. Except as disclosed below, there have been no material changes from the risk factors disclosed in our
2022 Form 10-K filed with the SEC on March 31, 2023.
Risks
Related to the Acquisition
The
combined company may not experience the anticipated strategic benefits of the Acquisition.
While
we anticipate benefits from the Acquisition, we may not be able to realize the expected benefits. We may not be able to integrate the
two businesses successfully, and despite due diligence we could assume previously unidentified or contingent liabilities. Ownership of
a CAP/CLIA laboratory and related services business may not have the clinical value and commercial potential which we envision. Any substantive
failure of the Acquisition to meet our expectations could have a material negative effect on our results of operations. There can be
no assurance that the anticipated benefits of the Acquisition will materialize or that if they materialize will result in increased stockholder
value or revenue stream to the combined company.
We
may be unable to successfully integrate the PPLS business with our current management and structure.
Our
failure to successfully complete the integration of PPLS could have an adverse effect on our prospects, business activities, cash flow,
financial condition, results of operations, and stock price. Integration challenges may include the following:
|
● |
assimilating
and retaining former Village Oaks personnel who joined PPLS as part of the Acquisition; |
|
|
|
|
● |
estimating
the capital, personnel, and equipment required for the operation of PPLS based on the historical experience of management with the
businesses they are familiar with; and |
|
|
|
|
● |
minimizing
potential adverse effects on existing business relationships. |
We
may not be able to enforce claims with respect to the representations, warranties, and indemnities that Village Oaks has provided to
us under the Asset Purchase Agreement.
In
connection with the Acquisition, Village Oaks has given certain representations, warranties, and indemnities. There can be no assurance
we will be able to enforce any claims against Village Oaks’ breaches of such representations, warranties, or indemnities. Village
Oaks’ liability with respect to breaches of such representations, warranties, and indemnities under the Asset Purchase Agreement
may be limited, or the amount and coverage of any insurance obtained with respect to representations and warranties may be limited. Even
if we ultimately succeed in recovering any amounts, we may temporarily be required to bear these losses ourselves.
We
are unable to precisely estimate when we will begin to generate significant profit from revenue, if ever, from PPLS’ services,
nor to estimate the amount of profit or revenue that will be generated or the expenses that will be incurred.
We
do not expect to immediately derive profit from revenue from PPLS’ services. Once we begin to generate such profit, there is no
guarantee that it will be sufficient to realize the expected financial benefits of the Acquisition. In addition, since we have limited
experience operating a clinical laboratory, we may not accurately estimate the expenses we will incur.
The
market price of our common stock following the Acquisition may decline as a result of such Acquisition.
The
market price of our common stock may decline as a result of the Acquisition for a number of reasons including if:
|
● |
investors
react negatively to the prospects of our business after the Acquisition; |
|
|
|
|
● |
the
effect that the Acquisition has on our business and prospectus is not consistent with the expectations of financial or industry analysts;
or |
|
|
|
|
● |
after
the Acquisition, the Company does not achieve the perceived benefits of the Acquisition as rapidly or to the extent anticipated by
financial or industry analysts. |
Operating
a clinical laboratory is a new business for us, and the members of our management team have limited experience operating a CAP-accredited,
CLIA-certified laboratory, which may limit the ability of investors to make an informed investment decision.
We
have never operated a clinical laboratory. To date, only our Chief Operating Officer, Xavier Reveles, has operated a CAP-accredited,
CLIA-certified clinical laboratory, and therefore it may be difficult for investors to analyze our ability to successfully operate a
clinical laboratory. Our management team may not successfully or efficiently manage our transition to operating a CAP-accredited and
CLIA-certified laboratory subject to significant regulatory oversight and reporting obligations. However, to ease the transition, Dr.
Joyce, the Medical Director and Laboratory Director of Village Oaks prior to the Acquisition, continues to serve as the Medical Director
and Laboratory Director of PPLS and continues to be an integral part of our management team. These new obligations and constituents will
require significant attention from our senior management and could divert their attention away from the day-to-day management of our
business, which could adversely affect our business, financial condition, and operating results.
Our
stockholders will experience substantial dilution from the issuance of the consideration paid in connection with the Acquisition and
may not realize a benefit from the Acquisition commensurate with the ownership dilution they will experience in connection with the Acquisition.
Our
stockholders will experience substantial dilution from the issuance of the consideration paid in connection with the Acquisition. If
after the Acquisition we are unable to realize the full strategic and financial benefits currently anticipated from the Acquisition,
our securityholders will have experienced substantial dilution of their ownership interests without receiving any commensurate benefit,
or only receiving part of the commensurate benefit to the extent the post-acquisition company is able to realize only part of the strategic
and financial benefits currently anticipated from the Acquisition.
Risks
Related to Our Financial Position
Our
business plan relies upon our ability to obtain additional sources of capital and financing. If the amount of capital we are able to
raise from financing activities, together with our revenues from operations, is not sufficient to satisfy our capital needs, we may be
required to cease operations.
Prior
to 2022, we had not generated any revenue. During the year ended December 31, 2022, we generated approximately $5,000, and during
the nine months ended September 30, 2023, we generated approximately $283,000 in revenue from laboratory services for the period
from September 19, 2023, through September 30, 2023. During the nine months ended September 30, 2023 we generated
$13,000 from royalties from sales of our first diagnostic test, CyPath® Lung, by Village Oaks, a
CAP-accredited, CLIA-certified clinical pathology laboratory to which we had previously granted a license to develop
CyPath® Lung for commercialization and to use, market, and sell CyPath® Lung as an LDT prior to the
Acquisition, which license was assigned to and assumed by PPLS in connection with the Acquisition, that began a limited market
launch in the second quarter of 2022 to pulmonologists in South Texas. During the nine months ended September 30, 2023, we also
generated revenue from clinical flow cytometry services provided to Village Oaks related to CyPath® Lung in the
approximate amount of $9,000 and in connection with CyPath® Lung tests purchased by the DOD in the approximate amount
of $14,000 for an observational study.
To
become and remain profitable, we must succeed in generating additional laboratory revenue and developing and commercializing our diagnostic
tests and therapeutic products that we expect will generate significant income in the planned timeframe. This will require us to be successful
in a range of challenging activities, including completing preclinical testing and clinical trials of our diagnostic and therapeutic
technologies, obtaining regulatory approval for our diagnostic and therapeutic technologies, manufacturing, marketing, and selling any
diagnostic tests and therapeutic products for which we may obtain regulatory approval, and establishing and managing our collaborations
at various phases of each diagnostic test and therapeutic product candidate’s development. We are in the preliminary phases of
these activities. We may never succeed in these activities and, even if we do, may never generate sufficient income to achieve profitability.
To
become profitable, we must develop our diagnostic tests and therapeutic products, which will depend in large part on our ability to:
|
● |
Develop,
enhance and protect our diagnostic tests and therapeutic products; |
|
|
|
|
● |
Raise
sufficient funding to support our diagnostic tests and therapeutic product development program(s); |
|
|
|
|
● |
Complete
pre-clinical testing; |
|
● |
Work
with our partners to expand commercialization of our first diagnostic test, CyPath® Lung, as an LDT under the CAP/CLIA
guidelines and regulations administered by CMS and CAP; |
|
|
|
|
● |
Obtain
de novo classification from FDA for our CyPath® Lung as a Class II in vitro diagnostic |
|
|
|
|
● |
Work
with our partners to develop and commercialize our first diagnostic test, CyPath® Lung, as a CE-marked test in accordance
with the In Vitro Diagnostic Device Regulation (the “IVDR”) of the EU; |
|
|
|
|
● |
Synthesize,
test, and attract licensing partners for drug conjugates, siRNAs, and other therapeutics (and methods for their use) developed by
us; |
|
|
|
|
● |
Develop
and conduct human clinical studies to support the regulatory approval and marketing of our diagnostic test(s) and therapeutic product(s); |
|
|
|
|
● |
Develop
and manufacture the test(s) and product(s) to FDA standards, appropriate EU standards, and appropriate standards required for the
commercialization of our tests and products in countries in which we seek to sell our diagnostic test(s) and therapeutic product(s); |
|
|
|
|
● |
Obtain
the necessary regulatory approvals to market our diagnostic test(s) and therapeutic product(s); |
|
|
|
|
● |
Secure
the necessary personnel and infrastructure to support the development, commercialization, and marketing of our diagnostic test(s)
and therapeutic product(s); and |
|
|
|
|
● |
Develop
strategic relationships to support development, manufacturing, and marketing of our diagnostic test(s) and therapeutic product(s). |
Even
if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to
become and remain profitable would depress the value of our Company and could impair our ability to raise capital, expand our business,
maintain the research and development efforts, diversify our diagnostic tests and therapeutic product offerings, or even continue our
operations. A decline in the value of our Company could also cause you to lose all or part of your investment.
We
must raise additional capital to fund our operations in order to continue as a going concern.
As
of December 31, 2022, we had an accumulated deficit of $36.7 million. As of September 30, 2023, we had an accumulated deficit of $42.2
million. We need to raise further capital through the sale of additional equity or debt securities or other debt instruments, strategic
relationships or grants, or other arrangements to support our future operations. Our business plan includes expansion for our commercialization
efforts which will require additional funding. If we are unable to improve our liquidity position, we may not be able to continue as
a going concern. Our ability to continue as a going concern is dependent upon our ability to generate revenue and raise capital from
financing transactions. Without funding from the proceeds of a capital raise or strategic relationship or grant, management anticipates
that our cash resources are sufficient to continue operations through May 2024. Our future is dependent upon its ability to obtain financing
and upon future profitable operations from the development of its new business opportunities. There can be no assurance that we will
be successful in accomplishing these objectives. Without such additional capital, we may be required to curtail or cease operations and
be required to realize our assets and discharge our liabilities other than in the normal course of business which could cause investors
to suffer the loss of all or a substantial portion of their investment. WithumSmith+Brown, PC, our independent registered public accounting
firm for the fiscal year ended December 31, 2022, has included an explanatory paragraph in its opinion that accompanies our audited consolidated
financial statements as of and for the year ended December 31, 2022, indicating that our current liquidity position raises substantial
doubt about our ability to continue as a going concern.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES, USE OF PROCEEDS, AND ISSUER PURCHASES OF EQUITY SECURITIES.
Unregistered
Sales of Equity Securities
We
did not sell any equity securities during the quarter ended September 30, 2023, in transactions that were not registered under the Securities
Act other than as previously disclosed in our filings with the SEC and as described below. We believe that each transaction was exempt
from the registration requirements of the Securities Act by virtue of Section 4(a)(2) thereof.
On
July 1, 2023, we issued an aggregate of 71,715 restricted shares of our Common Stock to our seven directors, which shares of restricted
stock will vest ratably over three months of continued service and which represents a restricted stock award to each director valued
at $18,750 granted by us to each of our directors each quarter during the calendar year as part of our director compensation policy.
Between
July 1, 2023, and September 30, 2023, we issued an aggregate of 8,226 shares of our Common Stock to a consultant pursuant to the terms
of a consulting agreement in consideration of services provided.
On
August 9, 2023, we issued 26,315 restricted shares of our Common Stock to an officer pursuant to the terms of his employment agreement.
On
September 18, 2023, we issued 564,972 shares of our Common Stock to the Joyce Trust pursuant to the terms of the Asset Purchase Agreement.
ITEM
3. DEFAULTS UPON SENIOR SECURITIES.
Not
applicable.
ITEM
4. MINE SAFETY DISCLOSURES.
Not
applicable.
ITEM
5. OTHER INFORMATION.
Not
applicable.
ITEM
6. EXHIBITS.
Exhibit
No. |
|
Title
of Document |
|
|
|
3.1 |
|
Certificate of Incorporation of the Registrant as filed with the Delaware Secretary of State on March 26, 2014 (Incorporated by reference as Exhibit 3.1 to the Registrant’s Registration Statement on Form S-1 (File No. 333-274608) filed with the SEC on September 20, 2023) |
3.2 |
|
Amended and Restated Bylaws of Registrant (Incorporated by reference as Exhibit 3.6 to the Registrant’s Registration Statement on Form S-1/A (File No. 333-264463) filed with the SEC on June 16, 2022) |
3.3 |
|
Certificate of Amendment to the Certificate of Incorporation of Registrant, as filed with the Delaware Secretary of State on May 31, 2016 (Incorporated by reference as Exhibit 3.3 to the Registrant’s Registration Statement on Form S-1 (File No. 333-274608) filed with the SEC on September 20, 2023) |
3.4 |
|
Certificate of Designation of Series A Convertible Preferred Stock of the Registrant filed with the Delaware Secretary of State on July 13, 2017 (Incorporated by reference as Exhibit 3.4 to the Registrant’s Registration Statement on Form S-1/A (File No. 333-264463) filed with the SEC on May 25, 2022) |
3.5 |
|
Certificate of Amendment to the Certificate of Incorporation of Registrant, as filed with the Delaware Secretary of State on November 29, 2021 (Incorporated by reference as Exhibit 3.5 to the Registrant’s Registration Statement on Form S-1 (File No. 333-274608) filed with the SEC on September 20, 2023) |
3.6 |
|
Certificate of Amendment to the Certificate of Incorporation of Registrant, as filed with the Delaware Secretary of State on June 23, 2022 (Incorporated by reference as Exhibit 3.2 to the Registrant’s Registration Statement on Form S-1/A (File No. 333-264463) filed with the SEC on May 25, 2022) |
3.7 |
|
Certificate of Amendment to the Certificate of Incorporation of Registrant, as filed with the Delaware Secretary of State on June 6, 2023 (Incorporated by reference as Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on June 7, 2023) |
4.1 |
|
Form of Amendment to Common Share Purchase Warrants with schedule of warrant holders and warrants (Incorporated by reference as Exhibit 4.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 20, 2023) |
4.2 |
|
Form of Amendment to Initial Public Offering Warrants with schedule of warrant holders and warrants (Incorporated by reference as Exhibit 4.2 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 20, 2023) |
10.1 |
|
bioAffinity Technologies, Inc. Amended and Restated 2014 Equity Incentive Plan (Incorporated by reference as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on June 7, 2023) |
10.2 |
|
Amendment, effective as of August 1, 2023, to Employment Agreement, dated February 1, 2015, by and between the Registrant and Maria Zannes (Incorporated by reference as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on July 28, 2023) |
10.3 |
|
Asset Purchase Agreement, effective September 18, 2023, by and among, Precision Pathology Laboratory Services, LLC, Dr. Roby P. Joyce and Village Oaks Pathology Services, P.A. (Incorporated by reference as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 20, 2023) |
10.4 |
|
Subscription Agreement, dated September 18, 2023, by and between The Joyce Living Trust, dated March 19, 2013, and bioAffinity Technologies, Inc. (Incorporated by reference as Exhibit 10.2 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 20, 2023) |
10.5 |
|
Management Services Agreement, effective as of September 18, 2023, by and between Precision Pathology Laboratory Services, LLC and Village Oaks Pathology Services, P.A. (Incorporated by reference as Exhibit 10.3 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 20, 2023) |
10.6 |
|
Succession Agreement, effective September 18, 2023, by and among, Precision Pathology Laboratory Services, LLC, Dr. Roby P. Joyce and Village Oaks Pathology Services, P.A. (Incorporated by reference as Exhibit 10.4 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 20, 2023) |
10.7 |
|
Professional Services Agreement, effective as of September 18, 2023, by and between Precision Pathology Laboratory Services, LLC and Village Oaks Pathology Services, P.A. (Incorporated by reference as Exhibit 10.5 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 20, 2023) |
10.8 |
|
Executive Employment Agreement, dated September 18, 2023, by and between bioAffinity Technologies, Inc. and Roby Joyce, M.D. (Incorporated by reference as Exhibit 10.6 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 20, 2023) |
10.9 |
|
Assignment and Assumption of Lease Agreement, effective September 18, 2023, by and between Precision Pathology Laboratory Services, LLC and Village Oaks Pathology Services, P.A. (Incorporated by reference as Exhibit 10.7 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 20, 2023) |
10.10 |
|
Office Lease, dated July 31, 2019, by and between Village Oaks Pathology Services, P.A. and 343 West Sunset, LLC (Incorporated by reference as Exhibit 10.8 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 20, 2023) |
10.11 |
|
Assignment and Assumption Agreement, effective September 18, 2023, by and between Precision Pathology Laboratory Services, LLC and Village Oaks Pathology Services, P.A. (Incorporated by reference as Exhibit 10.9 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 20, 2023) |
10.12 |
|
Equipment Usage Attachment, dated effective as of August 9, 2019, by and between Gen-Probe Sales & Service, Inc., together with its subsidiaries and affiliates and Village Oaks Pathology Services, P.A. d/b/a Precision Pathology, as amended by that certain Amendment No. 1 to Equipment Usage Attachment dated November 2, 2020, as further amended by that certain Amendment No. 2 to Equipment Usage Attachment dated November 2, 2020, and as further amended by that certain Amendment No. 3 to Equipment Usage Attachment dated December 21, 2022 (Incorporated by reference as Exhibit 10.10 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 20, 2023) |
10.13 |
|
Master Agreement, dated as of January 29, 2015, by and between Leica Microsystems, Inc. and Precision Pathology, as amended by Amendment No. 1 to the Master Agreement, dated on or about April 4, 2018, as further amended by that certain Amendment No. 2 to Master Agreement, dated March 23, 2021 (Incorporated by reference as Exhibit 10.11 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 20, 2023) |
10.14 |
|
Strategic Relationship License Agreement, dated December 1, 2022, by and between Pathology Watch, Inc. and Precision Pathology Services (Incorporated by reference as Exhibit 10.12 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 20, 2023) |
10.15 |
|
Bill of Sale signed by Village Oaks Pathology Services, P.A., effective as of September 18, 2023 (Incorporated by reference as Exhibit 10.13 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 20, 2023) |
31.1* |
|
Certification of Chief Executive Officer pursuant to Section 302 of Sarbanes-Oxley Act of 2002 |
31.2* |
|
Certification of Chief Financial Officer pursuant to Section 302 of Sarbanes-Oxley Act of 2002 |
32.1* |
|
Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of Sarbanes-Oxley Act of 2002 |
|
|
|
101* |
|
The
following financial statements from the bioAffinity Technologies, Inc. Quarterly Report on Form 10-Q for the quarter ended September
30, 2023, formatted in Inline XBRL: (i) Condensed Consolidated Balance Sheet, (ii) Condensed Consolidated Statement of Operations,
(iii) Condensed Consolidated Statement of Stockholders’ Equity, (iv) Condensed Consolidated Statement of Cash Flows, and (v)
Notes to Condensed Consolidated Financial Statements, tagged as blocks of text and including detailed tags. |
|
|
|
104* |
|
The
cover page from the bioAffinity Technologies, Inc. Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, formatted
in Inline XBRL |
|
|
|
101.INS |
|
Inline
XBRL Instance Document * |
|
|
|
101.SCH |
|
Inline
XBRL Taxonomy Extension Schema Document * |
|
|
|
101.CAL |
|
Inline
XBRL Taxonomy Extension Calculation Linkbase * |
|
|
|
101.DEF |
|
Inline
XBRL Taxonomy Extension Definition Linkbase Document * |
|
|
|
101.LAB |
|
Inline
XBRL Taxonomy Extension Label Linkbase Document * |
|
|
|
101.PRE |
|
Inline
XBRL Taxonomy Extension Presentation Linkbase Document * |
*
Filed herewith.
†
Indicates management contract or compensatory plan.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.
|
BIOAFFINITY
TECHNOLOGIES, INC. |
|
(Registrant) |
|
|
|
By: |
/s/
Maria Zannes |
|
|
Maria
Zannes |
|
|
Chief
Executive Officer, President, Founder, and Director |
|
Date: |
November
14, 2023 |
|
|
|
By: |
/s/
Michael Dougherty |
|
|
Vice
President and Chief Financial Officer |
|
Date: |
November
14, 2023 |
Exhibit
31.1
Certification
of Chief Executive Officer
Pursuant
to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934,
as
Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
For
the Quarterly Period Ended September 30, 2023
I,
Maria Zannes, certify that:
1. |
I
have reviewed this report on Form 10-Q of bioAffinity Technologies, Inc. (“registrant”); |
|
|
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
|
|
3. |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations, and cash flows of the registrant as of, and for, the periods presented in
this report; |
|
|
4. |
The
registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a–15(f) and 15d–15(f)) for the registrant and have: |
|
(a) |
Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
(b) |
Designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
(c) |
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
|
|
|
(d) |
Disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. |
The
registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or
persons performing the equivalent functions): |
|
(a) |
All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
|
|
|
(b) |
Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
Date:
November 14, 2023
|
/s/
Maria Zannes |
|
Maria
Zannes |
|
President
and Chief Executive Officer |
|
(Principal
Executive Officer) |
Exhibit
31.2
Certification
of the Chief Financial Officer
Pursuant
to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934,
as
Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
For
the Quarterly Period Ended September 30, 2023
I,
Michael Dougherty, certify that:
1. |
I
have reviewed this report on Form 10-Q of bioAffinity Technologies, Inc. (“registrant”); |
|
|
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
|
|
3. |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations, and cash flows of the registrant as of, and for, the periods presented in
this report; |
|
|
4. |
The
registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a–15(f) and 15d–15(f)) for the registrant and have: |
|
(a) |
Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
(b) |
Designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
(c) |
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
|
|
|
(d) |
Disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. |
The
registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or
persons performing the equivalent functions): |
|
(a) |
All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
|
|
|
(b) |
Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
Date:
November 14, 2023
|
/s/
Michael Dougherty |
|
Michael
Dougherty |
|
Vice
President and Chief Financial Officer
(Principal
Financial Officer) |
Exhibit
32.1
Certification
of Chief Executive Officer and Chief Financial Officer Pursuant to 18 U.S.C. Section 1350
As
Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
In
connection with the Quarterly Report on Form 10-Q of bioAffinity Technologies, Inc., a Delaware Corporation (“Company”),
for the period ended September 30, 2023, as filed with the Securities and Exchange Commission on the date hereof (“Report”),
each of the undersigned officers of the Company hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906
of the Sarbanes-Oxley Act of 2002, that to the best of such officer’s knowledge:
|
1) |
the
Report complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
|
|
|
|
2) |
the
information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company as of September 30, 2023 (the last date of the period covered by the Report). |
|
/s/
Maria Zannes |
|
Maria
Zannes |
|
President
and Chief Executive Officer
(Principal
Executive Officer) |
|
Date:
November 14, 2023 |
|
|
|
/s/
Michael Dougherty |
|
Michael
Dougherty |
|
Vice
President and Chief Financial Officer
(Principal
Financial Officer) |
|
Date:
November 14, 2023 |
v3.23.3
Cover - shares
|
9 Months Ended |
|
Sep. 30, 2023 |
Nov. 08, 2023 |
Document Type |
10-Q
|
|
Amendment Flag |
false
|
|
Document Quarterly Report |
true
|
|
Document Transition Report |
false
|
|
Document Period End Date |
Sep. 30, 2023
|
|
Document Fiscal Period Focus |
Q3
|
|
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 |
|
9,502,243
|
Common Stock, par value $0.007 per share |
|
|
Title of 12(b) Security |
Common
Stock, par value $0.007 per share
|
|
Trading Symbol |
BIAF
|
|
Security Exchange Name |
NASDAQ
|
|
Tradeable Warrants to purchase Common Stock |
|
|
Title of 12(b) Security |
Tradeable
Warrants to purchase Common Stock
|
|
Trading Symbol |
BIAFW
|
|
Security Exchange Name |
NASDAQ
|
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v3.23.3
Condensed Consolidated Balance Sheets - USD ($)
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Current assets: |
|
|
Cash and cash equivalents |
$ 4,509,236
|
$ 11,413,759
|
Accounts and other receivables, net |
1,108,414
|
10,489
|
Inventory |
9,908
|
5,540
|
Prepaid expenses and other current assets |
382,651
|
531,899
|
Total current assets |
6,010,209
|
11,961,687
|
Non-current assets: |
|
|
Property and equipment, net |
512,152
|
214,438
|
Operating lease right-of-use asset, net |
392,347
|
|
Finance lease right-to-use, net |
1,262,087
|
|
Goodwill |
1,148,553
|
|
Intangible assets, net |
848,056
|
|
Other assets |
16,060
|
6,000
|
Total assets |
10,189,464
|
12,182,125
|
Current liabilities: |
|
|
Accounts payable |
827,407
|
345,042
|
Accrued expenses |
643,786
|
541,894
|
Unearned revenue |
38,250
|
|
Operating lease liability, current portion |
90,863
|
|
Finance lease liability, current portion |
358,282
|
|
Loan payable |
|
251,746
|
Total current liabilities |
1,958,588
|
1,138,682
|
Non-current liabilities: |
|
|
Finance lease liability, net of current portion |
929,570
|
|
Operating lease liability, net of current portion |
307,397
|
|
Total liabilities |
3,195,555
|
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 September 30, 2023, and December 31, 2022 |
|
|
Common stock, par value $0.007 per share; 25,000,000 and 14,285,714 shares authorized; 9,216,883 and 8,381,324 issued and outstanding at September 30, 2023 and at December 31, 2022, respectively. |
64,535
|
58,669
|
Additional paid-in capital |
49,160,689
|
47,652,242
|
Accumulated deficit |
(42,231,315)
|
(36,667,468)
|
Total stockholders’ equity |
6,993,909
|
11,043,443
|
Total liabilities and stockholders’ equity |
$ 10,189,464
|
$ 12,182,125
|
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v3.23.3
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares
|
Sep. 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
|
14,285,714
|
Common stock, shares issued |
9,216,883
|
8,381,324
|
Common stock, shares outstanding |
9,216,883
|
8,381,324
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.23.3
Condensed Consolidated Statements of Operations (Unaudited) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Income Statement [Abstract] |
|
|
|
|
|
Net Revenue |
[1] |
$ 298,484
|
$ 1,150
|
$ 319,143
|
$ 2,457
|
Cost of sales |
|
74,704
|
146
|
76,025
|
292
|
Gross profit |
|
223,780
|
1,004
|
243,118
|
2,165
|
Operating expenses: |
|
|
|
|
|
Research and development |
|
330,376
|
319,744
|
1,035,118
|
949,388
|
Clinical development |
|
106,422
|
60,941
|
161,310
|
141,684
|
Selling, general and administrative |
|
2,023,917
|
595,702
|
4,576,708
|
1,295,558
|
Depreciation and amortization |
|
57,569
|
773
|
100,805
|
2,852
|
Total operating expenses |
|
2,518,284
|
977,160
|
5,873,941
|
2,389,482
|
Loss from operations |
|
(2,294,504)
|
(976,156)
|
(5,630,823)
|
(2,387,317)
|
Other income (expense): |
|
|
|
|
|
Interest income |
|
27,193
|
7,414
|
109,971
|
8,261
|
Interest expense |
|
(8,785)
|
(896,502)
|
(11,801)
|
(2,443,350)
|
Other income |
|
4,606
|
|
4,606
|
|
Other expense |
|
(17,100)
|
|
(17,100)
|
|
Gain on extinguishment of debt |
|
|
|
|
212,258
|
Fair value adjustments on convertible notes payable |
|
|
(3,053,914)
|
|
(1,866,922)
|
Net loss before provision for income taxes |
|
(2,288,590)
|
(4,919,158)
|
(5,545,147)
|
(6,477,070)
|
Income tax expense |
|
(2,294)
|
(300)
|
(18,700)
|
(2,460)
|
Net loss |
|
$ (2,290,884)
|
$ (4,919,458)
|
$ (5,563,847)
|
$ (6,479,530)
|
Net loss per common share, basic |
|
$ (0.26)
|
$ (1.17)
|
$ (0.65)
|
$ (2.03)
|
Net loss per common share, diluted |
|
$ (0.26)
|
$ (1.17)
|
$ (0.65)
|
$ (2.03)
|
Weighted average common shares outstanding, basic |
|
8,696,554
|
4,203,781
|
8,551,154
|
3,194,765
|
Weighted average common shares outstanding, diluted |
|
8,696,554
|
4,203,781
|
8,551,154
|
3,194,765
|
|
|
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v3.23.3
Condensed Consolidated Statements of Stockholders' Equity (Deficit) (Unaudited) - USD ($)
|
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 |
|
$ 127
|
211,618
|
|
211,745
|
Stock-based compensation expense, shares |
|
18,154
|
|
|
|
Net loss |
|
|
|
(6,479,530)
|
(6,479,530)
|
Beneficial conversion feature for bridge notes |
|
|
348,219
|
|
348,219
|
Return of capital from stock split |
|
|
(185)
|
|
(185)
|
Debt discount for warrants issued |
|
|
383,696
|
|
383,696
|
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, 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
|
|
|
64,848
|
Balance, value at Sep. 30, 2022 |
|
$ 58,588
|
47,532,797
|
(34,992,885)
|
$ 12,598,500
|
Balance, shares at Sep. 30, 2022 |
|
8,369,750
|
|
|
|
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
|
|
|
|
Stock-based compensation expense |
|
$ 6
|
79,007
|
|
79,013
|
Stock-based compensation expense, shares |
|
835
|
|
|
|
Net loss |
|
|
|
(4,919,458)
|
(4,919,458)
|
Beneficial conversion feature for bridge notes |
|
|
134,277
|
|
134,277
|
Debt discount for warrants issued |
|
|
165,723
|
|
165,723
|
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, 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
|
|
|
|
Balance, value at Sep. 30, 2022 |
|
$ 58,588
|
47,532,797
|
(34,992,885)
|
12,598,500
|
Balance, shares at Sep. 30, 2022 |
|
8,369,750
|
|
|
|
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 |
|
$ 1,911
|
512,402
|
|
514,313
|
Stock-based compensation expense, shares |
|
270,587
|
|
|
|
Stock issued for acquisition |
|
$ 3,955
|
996,045
|
|
1,000,000
|
Stock issued for acquisition, shares |
|
564,972
|
|
|
|
Net loss |
|
|
|
(5,563,847)
|
$ (5,563,847)
|
Common stock issued upon initial public offering, net of underwriters commission and offering costs, shares |
|
|
|
|
9,350,297
|
Exercise of stock options, shares |
|
|
|
|
0
|
Balance, value at Sep. 30, 2023 |
|
$ 64,535
|
49,160,689
|
(42,231,315)
|
$ 6,993,909
|
Balance, shares at Sep. 30, 2023 |
|
9,216,883
|
|
|
|
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
|
|
|
|
Stock-based compensation expense |
|
$ 693
|
185,752
|
|
186,445
|
Stock-based compensation expense, shares |
|
96,546
|
|
|
|
Stock issued for acquisition |
|
$ 3,955
|
996,045
|
|
1,000,000
|
Stock issued for acquisition, shares |
|
564,972
|
|
|
|
Net loss |
|
|
|
(2,290,884)
|
(2,290,884)
|
Balance, value at Sep. 30, 2023 |
|
$ 64,535
|
$ 49,160,689
|
$ (42,231,315)
|
$ 6,993,909
|
Balance, shares at Sep. 30, 2023 |
|
9,216,883
|
|
|
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v3.23.3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
|
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Cash flows from operating activities |
|
|
Net loss |
$ (5,563,847)
|
$ (6,479,530)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Depreciation and amortization |
100,805
|
2,852
|
Accretion of debt issuance costs |
|
1,972,948
|
Fair value adjustments on convertible notes payable |
|
1,866,922
|
Stock-based compensation expense |
514,313
|
211,745
|
Gain on extinguishment of debt |
|
(212,258)
|
Changes in operating assets and liabilities: |
|
|
Accounts and other receivables |
71,840
|
(8,400)
|
Inventory |
(4,368)
|
(5,715)
|
Prepaid expenses and other assets |
152,768
|
(502,177)
|
Accounts payable |
406,836
|
(80,725)
|
Accrued expenses |
(144,013)
|
(1,524)
|
Accrued interest |
|
465,653
|
Unearned revenue |
38,250
|
|
Operating lease right-of-use asset |
5,913
|
|
Net cash used in operating activities |
(4,421,503)
|
(2,770,209)
|
Cash flows from investing activities |
|
|
Purchase of property and equipment |
(36,344)
|
|
Acquisition of subsidiary, net cash acquired |
(2,186,497)
|
|
Net cash used in investing activities |
(2,222,841)
|
|
Cash flows from financing activities |
|
|
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
|
Proceeds from loans payable |
|
555,148
|
Payment on loans payable |
(251,746)
|
(31,612)
|
Principle repayments on finance leases |
(8,433)
|
|
Proceeds from issuance of convertible notes payable |
|
724,000
|
Repayment of convertible loan payable |
|
(100,000)
|
Payment of debt issuance costs |
|
(55,651)
|
Net cash (used in) provided by financing activities |
(260,179)
|
14,907,509
|
Net (decrease)/increase in cash and cash equivalents |
(6,904,523)
|
12,137,300
|
Cash and cash equivalents at beginning of period |
11,413,759
|
1,360,638
|
Cash and cash equivalents at end of period |
4,509,236
|
13,497,938
|
Supplemental disclosures of cash flow information: |
|
|
Interest expense paid in cash |
11,801
|
2,459
|
Income taxes paid in cash |
18,700
|
3,945
|
Noncash investing and financing activities: |
|
|
Common stock issuance for acquisition of subsidiary |
1,000,000
|
|
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 |
|
383,696
|
Beneficial conversion feature for bridge notes |
|
$ 348,219
|
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v3.23.3
NATURE OF OPERATIONS, ORGANIZATION, AND BASIS OF PRESENTATION
|
9 Months Ended |
Sep. 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,” 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® Lung, is a noninvasive test for early detection of lung cancer,
the leading cause of cancer-related deaths. CyPath® Lung is offered for sale to physicians by the Company’s subsidiary,
Precision Pathology Laboratory Services, LLC (“PPLS”). Research and optimization of the Company’s proprietary platform
for in vitro diagnostics and technologies are conducted in laboratories at The University of Texas at San Antonio and PPLS. The
Company is developing its platform technologies so that in the future they will be able to detect, monitor, and treat diseases of the
lung and other cancers.
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® Therapeutics, LLC, as a Delaware limited liability company.
On August 14, 2023, the Company formed a wholly owned subsidiary, PPLS, as a Texas limited liability company, to acquire the assets of
Village Oaks Pathology Services, P.A., a Texas professional association d/b/a Precision Pathology Services (“Village Oaks”),
including the clinical pathology laboratory it owned.
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. The condensed consolidated balance sheet as of December 31, 2022 was derived from the audited consolidated
financial statements at that date but does not include all the information and footnotes required by GAAP. 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 on March 31, 2023.
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 $42.2
million at September 30, 2023. The Company’s cash and cash equivalents at September 30, 2023, were approximately $4.5
million, representing 44%
of total assets. Based on the Company’s current expected level of operating expenditures and the cash and cash equivalents on
hand at September 30, 2023, management concludes that there is substantial doubt about the Company’s ability to continue as a
going concern for a period of at least twelve (12) months subsequent to the issuance of the accompanying unaudited condensed
consolidated financial statements. Therefore, the Company may need to raise further capital through the sale of additional equity or
debt securities or other debt instruments, strategic relationships or grants, or other arrangements to support its future
operations. If such funding is not available or not available on terms acceptable to the Company, the Company’s current
development plan may be curtailed. No adjustments have been made to the presented financial statements as a result of this
uncertainty.
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v3.23.3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
|
9 Months Ended |
Sep. 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 GAAP requires management to make estimates and assumptions
that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated
financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from
those estimates. Significant estimates include the valuation allowance on the Company’s deferred tax assets, stock-based compensation, valuation of goodwill and intangible assets
related to the business combination, allowance for contractual adjustments and discounts related to service revenues, and the useful lives
of fixed assets.
Principles
of Consolidation
The
Company’s condensed consolidated financial statements reflect its financial statements, those of its wholly owned subsidiaries
and certain variable interest entities where the Company is the primary beneficiary. The accompanying condensed consolidated financial
statements include all the accounts of the Company, its wholly owned subsidiaries, OncoSelect® Therapeutics, LLC and PPLS,
and the variable interest entity, Village Oaks Pathology Services, P.A. All significant intercompany balances and transactions have been
eliminated.
In
determining whether the Company is the primary beneficiary of a variable interest entity, it applies a qualitative approach that determines
whether it has both (1) the power to direct the economically significant activities of the entity and (2) the obligation to absorb losses
of, or the right to receive benefits from, the entity that could potentially be significant to that entity. The Company continuously
assesses whether it is the primary beneficiary of a variable interest entity as changes to existing relationships or future transactions
may result in the Company consolidating or deconsolidating one or more of its collaborators or partners.
Business
Combination
On
September 18, 2023, the Company, in connection with the Asset Purchase Agreement it entered into with Village Oaks (the Seller”)
and Dr. Roby P. Joyce, M.D., dated September 18, 2023, acquired substantially all the assets and assumed certain liabilities of Village
Oaks (the “Acquisition”) in exchange for total consideration of $3,500,000, which consists of: (i) $2.5 million in cash paid
at closing and (ii) 564,972 shares of the Company’s common stock valued at $1 million, reduced by (iii) the assumption of assumed
liabilities totaling $321,000. The assets purchased included a clinical pathology laboratory regulated
by the Centers for Medicare and Medicaid Services (“CMS”) and accredited by the College of American Pathologists (“CAP”)
and certified under the Clinical Laboratory Improvement Amendments (“CLIA”) of 1988.
The
Company recognized goodwill of $1,149,000 arising from the Acquisition. The Acquisition is being accounted for as a business combination
in accordance with ASC 805. The Company has determined the preliminary fair values of the assets acquired and liabilities assumed in
the Acquisition. These values are subject to change as the Company performs additional reviews of its assumptions utilized.
The
following table summarizes the purchase price and preliminary purchase price allocations relating to the Acquisition:
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) | |
$ | 1,167,000 | |
Property and equipment | |
| 326,000 | |
Other assets | |
| 8,000 | |
Customer relationships | |
| 700,000 | |
Trade names and trademarks | |
| 150,000 | |
Goodwill | |
| 1,149,000 | |
Total net assets | |
$ | 3,500,000 | |
Goodwill
represents the excess fair value after the allocation to the identifiable net assets. The calculated goodwill is not deductible for tax
purposes.
Cash
and Cash Equivalents
For
the purpose of the statement of cash flows, the Company considers all highly liquid investments with original maturities of three months
or less at the time of purchase to be cash equivalents. Cash equivalents are stated at cost, which approximates market value, because
of the short maturity of these instruments.
Concentration
of Risk
The
Company has significant cash balances at financial institutions which throughout the year regularly exceed the federally insured limit
of $250,000. Any loss incurred or a lack of access to such funds could have a significant adverse impact on the Company’s financial
condition, results of operations, and cash flow.
Advertising
expense
The
Company expenses all advertising costs as incurred. Advertising expense was approximately $43,000 and $13,000 for the nine months and
$10,000 and $5,000 for the three months ended September 30, 2023 and 2022, respectively.
Loss
Per Share
Basic loss per share is computed by dividing net loss attributable to common stockholders by the weighted-average number
of shares of the Company’s common stock, par value $0.007 per share (the “Common Stock”) outstanding during the period.
Diluted loss per share is computed by dividing net loss attributable to common stockholders by the sum of the weighted-average number
of shares of Common Stock outstanding during the period and the weighted-average number of dilutive Common Stock equivalents outstanding
during the period, using the treasury stock method. Dilutive Common Stock equivalents are comprised of in-the-money stock options, convertible
notes payable, and warrants based on the average stock price for each period using the treasury stock method.
The
following potentially dilutive securities have been excluded from the computations of weighted average shares of Common Stock outstanding
as of September 30, 2023 and 2022, as they would be anti-dilutive:
SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES
| |
2023 | | |
2022 | |
| |
As of September
30, | |
| |
2023 | | |
2022 | |
Shares underlying options outstanding | |
| 683,695 | | |
| 806,392 | |
Shares underlying warrants outstanding | |
| 4,649,952 | | |
| 4,624,952 | |
Shares underlying convertible notes | |
| — | | |
| 83,373 | |
Anti-dilutive securities | |
| 5,333,647 | | |
| 5,514,717 | |
Revenue
Recognition
Post-acquisition
of PPLS, additional revenue streams have been consolidated starting September 19, 2023. PPLS generates three sources of revenue: (1)
patient service fees, (2) histology service fees, and (3) medical director fees. The revenue is recognized on the date of service (meeting
the performance requirement of ASC 606). Pre-acquisition, bioAffinity’s revenue was generated in three ways for the nine months
and three months ended September 30, 2023: (1) royalties from the Company’s diagnostic test, CyPath® Lung, (2) clinical
flow cytometry services provided to Village Oaks related to the Company’s CyPath®
Lung test, and (3) CyPath® Lung tests purchased by the U.S. Department of Defense (“DOD”) for an observational
study, “Detection of Abnormal Respiratory Cell Populations in Lung Cancer Screening Patients Using the CyPath® Lung
Assay (NCT05870592),” and research and development on using bronchoalveolar lavage fluid as a biological sample to assess cardiopulmonary
function and exercise performance in military personnel post COVID-19 infection. The royalty income from CyPath® Lung
and clinical flow cytometry services income, beginning September 19, 2023, are related-party income and, therefore, eliminated from consolidated
net revenues.
To
determine revenue recognition for the arrangements that the Company determines are within the scope of ASC 606, Revenue from Contracts
with Customers, the Company performs the following five steps: (1) identify the contract(s) with a customer, (2) identify the performance
obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in
the contract, and (5) recognize revenue when (or as) the entity satisfies a performance obligation.
SCHEDULE
OF REVENUE RECOGNITION
| |
For three months ended September 30, | |
| |
2023 | | |
2022 | |
| |
Net Revenue | | |
Related Party1 | | |
Consolidated | | |
Net Revenue | | |
Related Party1 | | |
Consolidated | |
| |
| | |
| | |
| | |
| | |
| | |
| |
Parent (bioAffinity Technologies): | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
CyPath® Lung royalty income1 | |
$ | 5,412 | | |
$ | (487 | ) | |
$ | 4,925 | | |
$ | 1,150 | | |
| - | | |
$ | 1,150 | |
Laboratory services1 | |
| 7,423 | | |
| (1,265 | ) | |
| 6,158 | | |
| - | | |
| - | | |
| - | |
Dept. of Defense study | |
| 4,500 | | |
| | |
| 4,500 | | |
| - | | |
| - | | |
| - | |
Subsidiaries ((PPLS) and Controlling Interest Entity2: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Patient fees | |
| 248,654 | | |
| - | | |
| 248,654 | | |
| - | | |
| - | | |
| - | |
Histology fees | |
| 31,854 | | |
| - | | |
| 31,854 | | |
| - | | |
| - | | |
| - | |
Medical director fees | |
| 2,392 | | |
| - | | |
| 2,393 | | |
| - | | |
| - | | |
| - | |
Total net revenue | |
$ | 300,236 | | |
$ | (1,752 | ) | |
$ | 298,484 | | |
$ | 1,150 | | |
| - | | |
$ | 1,150 | |
| |
For the nine months ended September 30, | |
| |
2023 | | |
2022 | |
| |
Net Revenue | | |
Related Party1 | | |
Consolidated | | |
Net Revenue | | |
Related Party1 | | |
Consolidated | |
| |
| | |
| | |
| | |
| | |
| | |
| |
Parent (bioAffinity Technologies): | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
CyPath® Lung royalty income1 | |
$ | 13,164 | | |
$ | (487 | ) | |
$ | 12,677 | | |
$ | 2,457 | | |
| - | | |
$ | 2,457 | |
Laboratory services1 | |
| 10,500 | | |
| (1,265 | ) | |
| 9,315 | | |
| - | | |
| - | | |
| - | |
Dept. of Defense study | |
| 14,250 | | |
| - | | |
| 14,250 | | |
| - | | |
| - | | |
| - | |
Subsidiaries (VOPS/PPLS)2: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Patient fees | |
| 248,654 | | |
| - | | |
| 248,654 | | |
| - | | |
| - | | |
| - | |
Histology fees | |
| 31,854 | | |
| - | | |
| 31,854 | | |
| - | | |
| - | | |
| - | |
Medical director fees | |
| 2,393 | | |
| - | | |
| 2,393 | | |
| - | | |
| - | | |
| - | |
Total net revenue | |
$ | 320,895 | | |
$ | (1,752 | ) | |
$ | 319,143 | | |
$ | 2,457 | | |
| - | | |
$ | 2,457 | |
1 | As of September
18, 2023 (date of the Acquisition), royalty and laboratory services income agreements are considered related parties and eliminated upon
consolidation. |
2 | The three months
ended revenue for PPLS and its controlling interest entity, Village Oaks, only recognizes partial period of September 19 through September
30, 2023. |
Reclassifications
Certain
prior year balances have been reclassified to conform to current year presentation. The Company reclassified patent expenses and annuity
costs of approximately $142,000 and $41,000 from research and development to selling, general and administrative for the nine months
and three months ended September 30, 2022, respectively.
Property
and Equipment
In
accordance with ASC 360-10, Accounting for the Impairment of Long-Lived Assets, the Company periodically reviews the carrying
value of its long-lived assets, such as property, equipment, and definite lived intangible assets, to test whether current events or
circumstances indicate that such carrying value may not be recoverable. When evaluating assets for potential impairment, the Company
compares the carrying value of the asset to its estimated undiscounted future cash flows. If an asset’s carrying value exceeds
such estimated cash flows (undiscounted and with interest charges), the Company records an impairment charge for the difference. The
Company did not record any impairment for the nine months ended September
30, 2023 or fiscal year ended December 31, 2022.
Property
and equipment are carried at cost, net of accumulated depreciation. Depreciation is computed using the straight-line method over the
estimated useful life of the asset. Amortization of leasehold improvements is computed using the shorter of the lease term or estimated
useful life of the asset. Additions and improvements are capitalized, while repairs and maintenance are expensed as incurred. Useful
lives of each asset class are as follows:
SCHEDULE
OF PROPERTY AND EQUIPMENT USEFUL LIFE
Asset Category | |
Useful Life |
Computer equipment | |
3-5 years |
Computer software | |
3 years |
Equipment | |
3-5 years |
Furniture and fixtures | |
5-7 years |
Vehicles | |
5 years |
Leasehold improvements | |
Lesser of lease term or useful life |
Intangible
Assets
Intangible
assets, net of accumulated amortization, are summarized as follows as of September 30, 2023:
SCHEDULE
OF INTANGIBLE ASSETS ADJUSTMENTS
Description | |
Date
Acquired | |
Useful
Life | |
Cost | | |
Amortization | |
|
Net | |
Goodwill | |
9/18/2023 | |
| |
$ | 1,148,553 | | |
$ | — | |
|
$ | 1,148,553 | |
Trade names and trademarks | |
9/18/2023 | |
18
years | |
| 150,000 | | |
| (277 | ) |
|
| 149,723 | |
Customer
relationships | |
9/18/2023 | |
14
years | |
| 700,000 | | |
| (1,666 | ) |
|
| 698,334 | |
Total
Intangible Assets | |
$ | 1,998,553 | | |
$ | (1,943 | ) |
|
$ | 1,996,610 | |
For
the three and nine months ended September 30, 2023, amortization of intangible assets totaled $1,943 compared to $0
in the prior year comparative periods.
Recent
Accounting Pronouncements
The
Company continues to monitor new accounting pronouncements issued by the Financial Accounting Standards Board (“FASB”) and
does not believe any accounting pronouncements issued through the date of this Quarterly Report will have a material impact on the Company’s
condensed consolidated financial statements.
The Company adopted FASB issued Accounting Standards Update (ASU) No. 2016-02,
Leases (Topic 842) on September 18, 2023, with the business combination of Village Oaks Pathology Services, P.A. (VOPS) and Precision
Pathology Laboratories Services, LLC (PPLS). The Company has one operating lease for its real estate and office space and multiple finance
leases for lab equipment in Texas that was acquired through the September 18, 2023, acquisition.
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v3.23.3
ACCOUNTS AND OTHER RECEIVABLES, NET
|
9 Months Ended |
Sep. 30, 2023 |
Receivables [Abstract] |
|
ACCOUNTS AND OTHER RECEIVABLES, NET |
Note
3. ACCOUNTS AND OTHER RECEIVABLES, NET
The
following is a summary of accounts receivable:
SCHEDULE
OF ACCOUNTS RECEIVABLE
| |
September 30, 2023 | | |
December 31, 2022 | |
| |
| | | |
| | |
Parent (bioAffinity):
| |
| | | |
| | |
CyPath® Lung royalty income | |
$ | 16,107 | | |
$ | 4,803 | |
Laboratory services | |
| 12,390 | | |
| — | |
Other receivables | |
| 4,730 | | |
| 5,686 | |
Subsidiary (PPLS) and Controlling Interest Entity:
| |
| | | |
| | |
Purchased receivables from acquisition, net of collections | |
| 791,852 | | |
| — | |
Net patient fees receivable | |
| 249,088 | | |
| — | |
Histology fees | |
| 31,854 | | |
| — | |
Medical director fees | |
| 2,393 | | |
| — | |
Accounts
and other receivable, net
| |
$ | 1,108,414 | | |
$ | 10,489 | |
|
X |
- DefinitionThe entire disclosure for claims held for amounts due a entity, excluding financing receivables. Examples include, but are not limited to, trade accounts receivables, notes receivables, loans receivables. Includes disclosure for allowance for credit losses.
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v3.23.3
PREPAID EXPENSES AND OTHER CURRENT ASSETS
|
9 Months Ended |
Sep. 30, 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 are summarized below:
SCHEDULE
OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
| |
September 30, 2023 | | |
December 31, 2022 | |
| |
| | |
| |
Prepaid insurance | |
$ | 240,540 | | |
$ | 340,078 | |
Legal and professional | |
| 30,847 | | |
| 72,048 | |
Other | |
| 111,264 | | |
| 119,773 | |
Total prepaid expenses and other current assets | |
$ | 382,651 | | |
$ | 531,899 | |
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v3.23.3
PROPERTY AND EQUIPMENT, NET
|
9 Months Ended |
Sep. 30, 2023 |
Property, Plant and Equipment [Abstract] |
|
PROPERTY AND EQUIPMENT, NET |
Note
5. PROPERTY AND EQUIPMENT, NET
Property
and equipment are summarized below:
SCHEDULE
OF PROPERTY AND EQUIPMENT
| |
September 30, 2023 | | |
December 31, 2022 | |
| |
| | |
| |
Lab equipment | |
$ | 649,499 | | |
$ | 462,155 | |
Computers and software | |
| 68,682 | | |
| 21,463 | |
Leasehold improvements | |
| 9,941 | | |
| — | |
Vehicles | |
| 119,990 | | |
| — | |
Property and equipment, gross | |
| 848,112 | | |
| 483,617 | |
Accumulated depreciation | |
| (335,960 | ) | |
| (269,180 | ) |
Total property and equipment, net | |
$ | 512,152 | | |
$ | 214,438 | |
Depreciation
expense was approximately $66,800 and $2,900 for the nine months ended and $23,500 and $800 for the three months ended September 30,
2023 and 2022, respectively
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v3.23.3
ACCRUED EXPENSES
|
9 Months Ended |
Sep. 30, 2023 |
Accrued Expenses |
|
ACCRUED EXPENSES |
Note
6. ACCRUED EXPENSES
Accrued
expenses are summarized below:
SCHEDULE OF ACCRUED EXPENSES
| |
September 30, 2023 | | |
December 31, 2022 | |
| |
| | |
| |
Compensation | |
$ | 554,511 | | |
$ | 340,680 | |
Legal and professional | |
| 18,487 | | |
| 144,440 | |
Clinical | |
| 27,776 | | |
| 50,922 | |
Billing fees | |
| 19,525 | | |
| — | |
Other | |
| 23,487 | | |
| 5,852 | |
Total accrued expenses | |
$ | 643,786 | | |
$ | 541,894 | |
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v3.23.3
UNEARNED REVENUE
|
9 Months Ended |
Sep. 30, 2023 |
Revenue Recognition and Deferred Revenue [Abstract] |
|
UNEARNED REVENUE |
Note
7. UNEARNED REVENUE
During
the three months ended September 30, 2023, the Company engaged in an observational study of CyPath® Lung with the DOD.
A total of 70 CyPath® Lung units were ordered and shipped. However, in compliance with FASB ASC 606, the performance obligation
was complete for only 16 units as of September 30, 2023. The performance obligation is deemed complete after samples have been collected
and processed and results analyzed. The unearned revenue balance amounted to approximately $38,250 as of September 30, 2023.
|
X |
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v3.23.3
FAIR VALUE MEASUREMENTS
|
9 Months Ended |
Sep. 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.
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- DefinitionThe entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.
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v3.23.3
LEASES
|
9 Months Ended |
Sep. 30, 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 3.83 years as of September 30,
2023. The Company has finance leases consisting of office and lab equipment with remaining lease terms ranging from approximately 2.5
to 4.25 years as of September 30, 2023, for which the Company has determined that it will use the equipment for a major part of its remaining
economic life.
The
lease agreements generally do not provide an implicit borrowing rate. Therefore, the Company used a benchmark approach as of September
18, 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 8.01%
to 8.07%
for the lease term lengths.
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 nine months ended
September 30, 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 | |
$ | 32,081 | | |
$ | — | |
Interest on lease liabilities - finance lease | |
| 8,634 | | |
| — | |
Operating lease cost | |
| 9,972 | | |
| — | |
Total lease cost | |
$ | 50,687 | | |
$ | — | |
Supplemental
balance sheet information relating to leases was as follows as of September 30, 2023 and December 31,2022:
SCHEDULE OF BALANCE SHEET
INFORMATION RELATING TO LEASES
Operating leases: | |
2023
| | |
2022 | |
Operating lease right-of-use assets | |
$ | 392,347 | | |
$ | — | |
Operating lease liability, current | |
$ | 90,863 | | |
$ | — | |
Operating lease liability, long-term | |
$ | 307,397 | | |
$ | — | |
Finance leases: | |
2023
| | |
2022 | |
Finance lease right-of-use asset, gross | |
$ | 1,294,168 | | |
$ | — | |
Accumulated amortization | |
| (32,081 | ) | |
| — | |
Finance lease right-of-use asset, net | |
| 1,262,087 | | |
| — | |
Finance lease liability, current portion | |
| 358,282 | | |
| — | |
Finance lease liability, long-term | |
| 929,570 | | |
| — | |
Total finance lease liabilities | |
$ | 1,287,852 | | |
$ | — | |
Weighted-average remaining lease term: | |
2023
| | |
2022 | |
Operating leases (in years) | |
| 3.83 | | |
| — | |
Finance leases (in years) | |
| 3.50 | | |
| — | |
Weighted-average discount rate: | |
2023
| | |
2022 | |
Operating leases | |
| 8.07 | % | |
| — | |
Finance leases | |
| 8.01 | % | |
| — | |
Future
minimum lease payment under non-cancellable lease as of September 30, 2023, are as follows:
SCHEDULE OF FUTURE MINIMUM LEASE
PAYMENT UNDER NON-CANCELLABLE
| |
Operating Leases | | |
Finance Leases | |
Remaining 2023 | |
$ | 28,431 | | |
$ | 112,126 | |
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 | |
| 464,616 | | |
| 1,482,501 | |
Less discounting | |
| (66,356 | ) | |
| (194,649 | ) |
Present value of lease liabilities | |
$ | 398,260 | | |
$ | 1,287,852 | |
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v3.23.3
COMMITMENTS AND CONTINGENCIES
|
9 Months Ended |
Sep. 30, 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 approximately $35,000 and $15,000 for the three months
and $88,000 and $41,000 for the nine months ended September 30, 2023, and 2022, respectively.
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.
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v3.23.3
COMMON STOCK
|
9 Months Ended |
Sep. 30, 2023 |
Common Stock |
|
COMMON STOCK |
Note
11. COMMON STOCK
Common
Stock
The
Company has authorized a total of 25,000,000 shares of Common Stock, $0.007 par value per share. On June 6, 2023, the Company
received stockholder approval to increase the number of authorized shares from 14,285,715 shares to 25,000,000 shares. The Company
has issued 9,350,297 shares of Common Stock of which 133,414 are unvested restricted stock shares as of September
30, 2023, and 8,381,324 shares of Common Stock as of December 31, 2022.
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v3.23.3
STOCK-BASED COMPENSATION
|
9 Months Ended |
Sep. 30, 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
shares of Common Stock. On June 6, 2023, the Company received stockholder approval to increase the number of authorized shares from 1,142,857
to 2,000,000.
Options or restricted stock awards may be granted to employees, the Company’s board of directors, and external consultants who
provide services to the Company. Options and restricted stock awards granted under the Plan have vesting schedules with terms of one
to three years and become fully exercisable based on specific terms imposed at the date of grant. The Plan will terminate according
to the respective terms of the Plan in March 2024.
The
Company has recorded stock-based compensation expense 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
| |
| | | |
| | | |
| | | |
| | |
| |
Three
Months Ended September 30, | | |
Nine
Months Ended September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Research and development | |
$ | 10,304 | | |
$ | 4,072 | | |
$ | 32,193 | | |
$ | 3,318 | |
General and administrative | |
| 181,140 | | |
| 74,941 | | |
| 482,120 | | |
| 208,427 | |
Total stock-based compensation
expense | |
$ | 186,445 | | |
$ | 79,013 | | |
$ | 514,313 | | |
$ | 211,745 | |
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 | | |
| | | |
| | |
Granted | |
| — | | |
| — | | |
| | | |
| | |
Exercised | |
| — | | |
| — | | |
| | | |
| | |
Forfeited | |
| (122,697 | ) | |
| 5.86 | | |
| | | |
| | |
Outstanding at September 30, 2023 | |
| 683,695 | | |
$ | 3.99 | | |
| 3.2 | | |
$ | 254,225 | |
| |
| | | |
| | | |
| | | |
| | |
Vested and exercisable at September 30, 2023 | |
| 681,711 | | |
$ | 3.99 | | |
| 3.2 | | |
$ | 254,225 | |
As
of September 30, 2023, there was no unrecognized compensation cost related to non-vested stock options.
During
the nine months ended September 30, 2023, no options were exercised. During the nine months ended September 30, 2022, 64,848 options
were exercised for proceeds of $74,900. During the nine months ended September 30, 2023, no options were issued by the
Company to purchase shares of Common Stock. During the nine months ended September 30, 2022, the Company issued options to purchase 7,142
shares of Common Stock. The per share weighted-average fair value of the options granted during 2022 was estimated at $2.84 on the date
of grant.
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 | | |
| 79,814 | | |
| 35,106 | |
Granted | |
| 326,068 | | |
| 1.86 | | |
| 607,313 | | |
| 227,760 | | |
| 98,308 | |
Forfeited | |
| (4,979 | ) | |
| 2.76 | | |
| (13,742 | ) | |
| (4,979 | ) | |
| — | |
Balance at September 30, 2023 | |
| 436,009 | | |
$ | 2.30 | | |
$ | 1,003,008 | | |
| 302,595 | | |
| 133,414 | |
During
the nine months ended September 30, 2023, the Company issued restricted stock awards (RSAs) for 326,068 shares of Common Stock to employees,
non-employees, and the board of directors. The shares vest in equal monthly installments over terms of between immediately up to three
years, subject to the employees and non-employees providing continuous service through the vesting date. During the nine months ended
September 30, 2023, 42,825 shares vested from RSAs granted prior to January 1, 2023, and 227,760 shares vested from RSAs granted during
the nine months ended September 30, 2023.
During
the nine months ended September 30, 2022, the Company issued RSAs for 14,999 shares of Common Stock to employees and non-employees. The
shares vest in equal monthly installments over terms of between immediately up to one year, subject to the employees and non-employees
providing continuous service through the vesting date. During the nine months ended September 30, 2022, approximately 21,000 shares vested
from RSAs previously issued.
The
following table summarizes weighted-average assumptions using the Black-Scholes option-pricing model used on the date of the options
grants issued during the nine months ended September 30, 2022. No stock options have been issued during the nine months ended
September 30, 2023:
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 | % |
|
X |
- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.23.3
WARRANTS
|
9 Months Ended |
Sep. 30, 2023 |
Warrants |
|
WARRANTS |
Note
13. WARRANTS
The
Company accounts for Common Stock warrants as equity instruments. As of September 30, 2023, and December 31, 2022, the Company had 4,649,952
warrants outstanding to purchase one share of the Company’s Common Stock for each warrant at a weighted average exercise price
of $5.03 and expire at various dates through September 2027. During the nine months ended September 30, 2023, no warrants were exercised
into an equivalent number of Common Shares as compared to 1,036,486 warrants being exercised during the nine months ended September 30,
2022.
On
September 17, 2023, the Company entered into a warrant amendment with certain holders of (i) tradeable warrants (the “Tradeable
Warrants”) to who have the right to purchase 73,568 shares of Common Stock; (ii) non-tradeable warrants (the “Non-Tradeable
Warrants”) who have the right to purchase 73,568 shares of Common Stock and (iii) other outstanding warrants (the “Pre-IPO
Warrants”) who have the right to purchase 1,109,475 shares of Common Stock. The warrant amendment provides that such warrants will
not be exercisable until the date that the Company files a certificate of amendment to its certificate of incorporation with the State
of Delaware which increases the number of shares of its authorized Common Stock to allow for sufficient authorized and unissued shares
of Common Stock for the full exercise of all of the outstanding Pre-IPO Warrants, Tradeable Warrants, and Non-Tradeable Warrants of the
Company and the issuance of all of the shares of Common Stock underlying such warrants.
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v3.23.3
SUBSEQUENT EVENTS
|
9 Months Ended |
Sep. 30, 2023 |
Subsequent Events [Abstract] |
|
SUBSEQUENT EVENTS |
Note
14. 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.
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- DefinitionThe entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business.
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v3.23.3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
|
9 Months Ended |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
|
Use of Estimates |
Use
of Estimates
The
preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions
that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated
financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from
those estimates. Significant estimates include the valuation allowance on the Company’s deferred tax assets, stock-based compensation, valuation of goodwill and intangible assets
related to the business combination, allowance for contractual adjustments and discounts related to service revenues, and the useful lives
of fixed assets.
|
Principles of Consolidation |
Principles
of Consolidation
The
Company’s condensed consolidated financial statements reflect its financial statements, those of its wholly owned subsidiaries
and certain variable interest entities where the Company is the primary beneficiary. The accompanying condensed consolidated financial
statements include all the accounts of the Company, its wholly owned subsidiaries, OncoSelect® Therapeutics, LLC and PPLS,
and the variable interest entity, Village Oaks Pathology Services, P.A. All significant intercompany balances and transactions have been
eliminated.
In
determining whether the Company is the primary beneficiary of a variable interest entity, it applies a qualitative approach that determines
whether it has both (1) the power to direct the economically significant activities of the entity and (2) the obligation to absorb losses
of, or the right to receive benefits from, the entity that could potentially be significant to that entity. The Company continuously
assesses whether it is the primary beneficiary of a variable interest entity as changes to existing relationships or future transactions
may result in the Company consolidating or deconsolidating one or more of its collaborators or partners.
|
Business Combination |
Business
Combination
On
September 18, 2023, the Company, in connection with the Asset Purchase Agreement it entered into with Village Oaks (the Seller”)
and Dr. Roby P. Joyce, M.D., dated September 18, 2023, acquired substantially all the assets and assumed certain liabilities of Village
Oaks (the “Acquisition”) in exchange for total consideration of $3,500,000, which consists of: (i) $2.5 million in cash paid
at closing and (ii) 564,972 shares of the Company’s common stock valued at $1 million, reduced by (iii) the assumption of assumed
liabilities totaling $321,000. The assets purchased included a clinical pathology laboratory regulated
by the Centers for Medicare and Medicaid Services (“CMS”) and accredited by the College of American Pathologists (“CAP”)
and certified under the Clinical Laboratory Improvement Amendments (“CLIA”) of 1988.
The
Company recognized goodwill of $1,149,000 arising from the Acquisition. The Acquisition is being accounted for as a business combination
in accordance with ASC 805. The Company has determined the preliminary fair values of the assets acquired and liabilities assumed in
the Acquisition. These values are subject to change as the Company performs additional reviews of its assumptions utilized.
The
following table summarizes the purchase price and preliminary purchase price allocations relating to the Acquisition:
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) | |
$ | 1,167,000 | |
Property and equipment | |
| 326,000 | |
Other assets | |
| 8,000 | |
Customer relationships | |
| 700,000 | |
Trade names and trademarks | |
| 150,000 | |
Goodwill | |
| 1,149,000 | |
Total net assets | |
$ | 3,500,000 | |
Goodwill
represents the excess fair value after the allocation to the identifiable net assets. The calculated goodwill is not deductible for tax
purposes.
|
Cash and Cash Equivalents |
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. Any loss incurred or a lack of access to such funds could have a significant adverse impact on the Company’s financial
condition, results of operations, and cash flow.
|
Advertising expense |
Advertising
expense
The
Company expenses all advertising costs as incurred. Advertising expense was approximately $43,000 and $13,000 for the nine months and
$10,000 and $5,000 for the three months ended September 30, 2023 and 2022, respectively.
|
Loss Per Share |
Loss
Per Share
Basic loss per share is computed by dividing net loss attributable to common stockholders by the weighted-average number
of shares of the Company’s common stock, par value $0.007 per share (the “Common Stock”) outstanding during the period.
Diluted loss per share is computed by dividing net loss attributable to common stockholders by the sum of the weighted-average number
of shares of Common Stock outstanding during the period and the weighted-average number of dilutive Common Stock equivalents outstanding
during the period, using the treasury stock method. Dilutive Common Stock equivalents are comprised of in-the-money stock options, convertible
notes payable, and warrants based on the average stock price for each period using the treasury stock method.
The
following potentially dilutive securities have been excluded from the computations of weighted average shares of Common Stock outstanding
as of September 30, 2023 and 2022, as they would be anti-dilutive:
SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES
| |
2023 | | |
2022 | |
| |
As of September
30, | |
| |
2023 | | |
2022 | |
Shares underlying options outstanding | |
| 683,695 | | |
| 806,392 | |
Shares underlying warrants outstanding | |
| 4,649,952 | | |
| 4,624,952 | |
Shares underlying convertible notes | |
| — | | |
| 83,373 | |
Anti-dilutive securities | |
| 5,333,647 | | |
| 5,514,717 | |
|
Revenue Recognition |
Revenue
Recognition
Post-acquisition
of PPLS, additional revenue streams have been consolidated starting September 19, 2023. PPLS generates three sources of revenue: (1)
patient service fees, (2) histology service fees, and (3) medical director fees. The revenue is recognized on the date of service (meeting
the performance requirement of ASC 606). Pre-acquisition, bioAffinity’s revenue was generated in three ways for the nine months
and three months ended September 30, 2023: (1) royalties from the Company’s diagnostic test, CyPath® Lung, (2) clinical
flow cytometry services provided to Village Oaks related to the Company’s CyPath®
Lung test, and (3) CyPath® Lung tests purchased by the U.S. Department of Defense (“DOD”) for an observational
study, “Detection of Abnormal Respiratory Cell Populations in Lung Cancer Screening Patients Using the CyPath® Lung
Assay (NCT05870592),” and research and development on using bronchoalveolar lavage fluid as a biological sample to assess cardiopulmonary
function and exercise performance in military personnel post COVID-19 infection. The royalty income from CyPath® Lung
and clinical flow cytometry services income, beginning September 19, 2023, are related-party income and, therefore, eliminated from consolidated
net revenues.
To
determine revenue recognition for the arrangements that the Company determines are within the scope of ASC 606, Revenue from Contracts
with Customers, the Company performs the following five steps: (1) identify the contract(s) with a customer, (2) identify the performance
obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in
the contract, and (5) recognize revenue when (or as) the entity satisfies a performance obligation.
SCHEDULE
OF REVENUE RECOGNITION
| |
For three months ended September 30, | |
| |
2023 | | |
2022 | |
| |
Net Revenue | | |
Related Party1 | | |
Consolidated | | |
Net Revenue | | |
Related Party1 | | |
Consolidated | |
| |
| | |
| | |
| | |
| | |
| | |
| |
Parent (bioAffinity Technologies): | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
CyPath® Lung royalty income1 | |
$ | 5,412 | | |
$ | (487 | ) | |
$ | 4,925 | | |
$ | 1,150 | | |
| - | | |
$ | 1,150 | |
Laboratory services1 | |
| 7,423 | | |
| (1,265 | ) | |
| 6,158 | | |
| - | | |
| - | | |
| - | |
Dept. of Defense study | |
| 4,500 | | |
| | |
| 4,500 | | |
| - | | |
| - | | |
| - | |
Subsidiaries ((PPLS) and Controlling Interest Entity2: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Patient fees | |
| 248,654 | | |
| - | | |
| 248,654 | | |
| - | | |
| - | | |
| - | |
Histology fees | |
| 31,854 | | |
| - | | |
| 31,854 | | |
| - | | |
| - | | |
| - | |
Medical director fees | |
| 2,392 | | |
| - | | |
| 2,393 | | |
| - | | |
| - | | |
| - | |
Total net revenue | |
$ | 300,236 | | |
$ | (1,752 | ) | |
$ | 298,484 | | |
$ | 1,150 | | |
| - | | |
$ | 1,150 | |
| |
For the nine months ended September 30, | |
| |
2023 | | |
2022 | |
| |
Net Revenue | | |
Related Party1 | | |
Consolidated | | |
Net Revenue | | |
Related Party1 | | |
Consolidated | |
| |
| | |
| | |
| | |
| | |
| | |
| |
Parent (bioAffinity Technologies): | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
CyPath® Lung royalty income1 | |
$ | 13,164 | | |
$ | (487 | ) | |
$ | 12,677 | | |
$ | 2,457 | | |
| - | | |
$ | 2,457 | |
Laboratory services1 | |
| 10,500 | | |
| (1,265 | ) | |
| 9,315 | | |
| - | | |
| - | | |
| - | |
Dept. of Defense study | |
| 14,250 | | |
| - | | |
| 14,250 | | |
| - | | |
| - | | |
| - | |
Subsidiaries (VOPS/PPLS)2: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Patient fees | |
| 248,654 | | |
| - | | |
| 248,654 | | |
| - | | |
| - | | |
| - | |
Histology fees | |
| 31,854 | | |
| - | | |
| 31,854 | | |
| - | | |
| - | | |
| - | |
Medical director fees | |
| 2,393 | | |
| - | | |
| 2,393 | | |
| - | | |
| - | | |
| - | |
Total net revenue | |
$ | 320,895 | | |
$ | (1,752 | ) | |
$ | 319,143 | | |
$ | 2,457 | | |
| - | | |
$ | 2,457 | |
1 | As of September
18, 2023 (date of the Acquisition), royalty and laboratory services income agreements are considered related parties and eliminated upon
consolidation. |
2 | The three months
ended revenue for PPLS and its controlling interest entity, Village Oaks, only recognizes partial period of September 19 through September
30, 2023. |
|
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 $142,000 and $41,000 from research and development to selling, general and administrative for the nine months
and three months ended September 30, 2022, respectively.
|
Property and Equipment |
Property
and Equipment
In
accordance with ASC 360-10, Accounting for the Impairment of Long-Lived Assets, the Company periodically reviews the carrying
value of its long-lived assets, such as property, equipment, and definite lived intangible assets, to test whether current events or
circumstances indicate that such carrying value may not be recoverable. When evaluating assets for potential impairment, the Company
compares the carrying value of the asset to its estimated undiscounted future cash flows. If an asset’s carrying value exceeds
such estimated cash flows (undiscounted and with interest charges), the Company records an impairment charge for the difference. The
Company did not record any impairment for the nine months ended September
30, 2023 or fiscal year ended December 31, 2022.
Property
and equipment are carried at cost, net of accumulated depreciation. Depreciation is computed using the straight-line method over the
estimated useful life of the asset. Amortization of leasehold improvements is computed using the shorter of the lease term or estimated
useful life of the asset. Additions and improvements are capitalized, while repairs and maintenance are expensed as incurred. Useful
lives of each asset class are as follows:
SCHEDULE
OF PROPERTY AND EQUIPMENT USEFUL LIFE
Asset Category | |
Useful Life |
Computer equipment | |
3-5 years |
Computer software | |
3 years |
Equipment | |
3-5 years |
Furniture and fixtures | |
5-7 years |
Vehicles | |
5 years |
Leasehold improvements | |
Lesser of lease term or useful life |
|
Intangible Assets |
Intangible
Assets
Intangible
assets, net of accumulated amortization, are summarized as follows as of September 30, 2023:
SCHEDULE
OF INTANGIBLE ASSETS ADJUSTMENTS
Description | |
Date
Acquired | |
Useful
Life | |
Cost | | |
Amortization | |
|
Net | |
Goodwill | |
9/18/2023 | |
| |
$ | 1,148,553 | | |
$ | — | |
|
$ | 1,148,553 | |
Trade names and trademarks | |
9/18/2023 | |
18
years | |
| 150,000 | | |
| (277 | ) |
|
| 149,723 | |
Customer
relationships | |
9/18/2023 | |
14
years | |
| 700,000 | | |
| (1,666 | ) |
|
| 698,334 | |
Total
Intangible Assets | |
$ | 1,998,553 | | |
$ | (1,943 | ) |
|
$ | 1,996,610 | |
For
the three and nine months ended September 30, 2023, amortization of intangible assets totaled $1,943 compared to $0
in the prior year comparative periods.
|
Recent Accounting Pronouncements |
Recent
Accounting Pronouncements
The
Company continues to monitor new accounting pronouncements issued by the Financial Accounting Standards Board (“FASB”) and
does not believe any accounting pronouncements issued through the date of this Quarterly Report will have a material impact on the Company’s
condensed consolidated financial statements.
The Company adopted FASB issued Accounting Standards Update (ASU) No. 2016-02,
Leases (Topic 842) on September 18, 2023, with the business combination of Village Oaks Pathology Services, P.A. (VOPS) and Precision
Pathology Laboratories Services, LLC (PPLS). The Company has one operating lease for its real estate and office space and multiple finance
leases for lab equipment in Texas that was acquired through the September 18, 2023, acquisition.
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v3.23.3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)
|
9 Months Ended |
Sep. 30, 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) | |
$ | 1,167,000 | |
Property and equipment | |
| 326,000 | |
Other assets | |
| 8,000 | |
Customer relationships | |
| 700,000 | |
Trade names and trademarks | |
| 150,000 | |
Goodwill | |
| 1,149,000 | |
Total net assets | |
$ | 3,500,000 | |
|
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 September 30, 2023 and 2022, as they would be anti-dilutive:
SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES
| |
2023 | | |
2022 | |
| |
As of September
30, | |
| |
2023 | | |
2022 | |
Shares underlying options outstanding | |
| 683,695 | | |
| 806,392 | |
Shares underlying warrants outstanding | |
| 4,649,952 | | |
| 4,624,952 | |
Shares underlying convertible notes | |
| — | | |
| 83,373 | |
Anti-dilutive securities | |
| 5,333,647 | | |
| 5,514,717 | |
|
SCHEDULE OF REVENUE RECOGNITION |
SCHEDULE
OF REVENUE RECOGNITION
| |
For three months ended September 30, | |
| |
2023 | | |
2022 | |
| |
Net Revenue | | |
Related Party1 | | |
Consolidated | | |
Net Revenue | | |
Related Party1 | | |
Consolidated | |
| |
| | |
| | |
| | |
| | |
| | |
| |
Parent (bioAffinity Technologies): | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
CyPath® Lung royalty income1 | |
$ | 5,412 | | |
$ | (487 | ) | |
$ | 4,925 | | |
$ | 1,150 | | |
| - | | |
$ | 1,150 | |
Laboratory services1 | |
| 7,423 | | |
| (1,265 | ) | |
| 6,158 | | |
| - | | |
| - | | |
| - | |
Dept. of Defense study | |
| 4,500 | | |
| | |
| 4,500 | | |
| - | | |
| - | | |
| - | |
Subsidiaries ((PPLS) and Controlling Interest Entity2: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Patient fees | |
| 248,654 | | |
| - | | |
| 248,654 | | |
| - | | |
| - | | |
| - | |
Histology fees | |
| 31,854 | | |
| - | | |
| 31,854 | | |
| - | | |
| - | | |
| - | |
Medical director fees | |
| 2,392 | | |
| - | | |
| 2,393 | | |
| - | | |
| - | | |
| - | |
Total net revenue | |
$ | 300,236 | | |
$ | (1,752 | ) | |
$ | 298,484 | | |
$ | 1,150 | | |
| - | | |
$ | 1,150 | |
| |
For the nine months ended September 30, | |
| |
2023 | | |
2022 | |
| |
Net Revenue | | |
Related Party1 | | |
Consolidated | | |
Net Revenue | | |
Related Party1 | | |
Consolidated | |
| |
| | |
| | |
| | |
| | |
| | |
| |
Parent (bioAffinity Technologies): | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
CyPath® Lung royalty income1 | |
$ | 13,164 | | |
$ | (487 | ) | |
$ | 12,677 | | |
$ | 2,457 | | |
| - | | |
$ | 2,457 | |
Laboratory services1 | |
| 10,500 | | |
| (1,265 | ) | |
| 9,315 | | |
| - | | |
| - | | |
| - | |
Dept. of Defense study | |
| 14,250 | | |
| - | | |
| 14,250 | | |
| - | | |
| - | | |
| - | |
Subsidiaries (VOPS/PPLS)2: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Patient fees | |
| 248,654 | | |
| - | | |
| 248,654 | | |
| - | | |
| - | | |
| - | |
Histology fees | |
| 31,854 | | |
| - | | |
| 31,854 | | |
| - | | |
| - | | |
| - | |
Medical director fees | |
| 2,393 | | |
| - | | |
| 2,393 | | |
| - | | |
| - | | |
| - | |
Total net revenue | |
$ | 320,895 | | |
$ | (1,752 | ) | |
$ | 319,143 | | |
$ | 2,457 | | |
| - | | |
$ | 2,457 | |
1 | As of September
18, 2023 (date of the Acquisition), royalty and laboratory services income agreements are considered related parties and eliminated upon
consolidation. |
2 | The three months
ended revenue for PPLS and its controlling interest entity, Village Oaks, only recognizes partial period of September 19 through September
30, 2023. |
|
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 years |
Computer software | |
3 years |
Equipment | |
3-5 years |
Furniture and fixtures | |
5-7 years |
Vehicles | |
5 years |
Leasehold improvements | |
Lesser of lease term or useful life |
|
SCHEDULE OF INTANGIBLE ASSETS ADJUSTMENTS |
Intangible
assets, net of accumulated amortization, are summarized as follows as of September 30, 2023:
SCHEDULE
OF INTANGIBLE ASSETS ADJUSTMENTS
Description | |
Date
Acquired | |
Useful
Life | |
Cost | | |
Amortization | |
|
Net | |
Goodwill | |
9/18/2023 | |
| |
$ | 1,148,553 | | |
$ | — | |
|
$ | 1,148,553 | |
Trade names and trademarks | |
9/18/2023 | |
18
years | |
| 150,000 | | |
| (277 | ) |
|
| 149,723 | |
Customer
relationships | |
9/18/2023 | |
14
years | |
| 700,000 | | |
| (1,666 | ) |
|
| 698,334 | |
Total
Intangible Assets | |
$ | 1,998,553 | | |
$ | (1,943 | ) |
|
$ | 1,996,610 | |
|
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v3.23.3
ACCOUNTS AND OTHER RECEIVABLES, NET (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Receivables [Abstract] |
|
SCHEDULE OF ACCOUNTS RECEIVABLE |
The
following is a summary of accounts receivable:
SCHEDULE
OF ACCOUNTS RECEIVABLE
| |
September 30, 2023 | | |
December 31, 2022 | |
| |
| | | |
| | |
Parent (bioAffinity):
| |
| | | |
| | |
CyPath® Lung royalty income | |
$ | 16,107 | | |
$ | 4,803 | |
Laboratory services | |
| 12,390 | | |
| — | |
Other receivables | |
| 4,730 | | |
| 5,686 | |
Subsidiary (PPLS) and Controlling Interest Entity:
| |
| | | |
| | |
Purchased receivables from acquisition, net of collections | |
| 791,852 | | |
| — | |
Net patient fees receivable | |
| 249,088 | | |
| — | |
Histology fees | |
| 31,854 | | |
| — | |
Medical director fees | |
| 2,393 | | |
| — | |
Accounts
and other receivable, net
| |
$ | 1,108,414 | | |
$ | 10,489 | |
|
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v3.23.3
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Tables)
|
9 Months Ended |
Sep. 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
| |
September 30, 2023 | | |
December 31, 2022 | |
| |
| | |
| |
Prepaid insurance | |
$ | 240,540 | | |
$ | 340,078 | |
Legal and professional | |
| 30,847 | | |
| 72,048 | |
Other | |
| 111,264 | | |
| 119,773 | |
Total prepaid expenses and other current assets | |
$ | 382,651 | | |
$ | 531,899 | |
|
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v3.23.3
PROPERTY AND EQUIPMENT, NET (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Property, Plant and Equipment [Abstract] |
|
SCHEDULE OF PROPERTY AND EQUIPMENT |
Property
and equipment are summarized below:
SCHEDULE
OF PROPERTY AND EQUIPMENT
| |
September 30, 2023 | | |
December 31, 2022 | |
| |
| | |
| |
Lab equipment | |
$ | 649,499 | | |
$ | 462,155 | |
Computers and software | |
| 68,682 | | |
| 21,463 | |
Leasehold improvements | |
| 9,941 | | |
| — | |
Vehicles | |
| 119,990 | | |
| — | |
Property and equipment, gross | |
| 848,112 | | |
| 483,617 | |
Accumulated depreciation | |
| (335,960 | ) | |
| (269,180 | ) |
Total property and equipment, net | |
$ | 512,152 | | |
$ | 214,438 | |
|
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v3.23.3
ACCRUED EXPENSES (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Accrued Expenses |
|
SCHEDULE OF ACCRUED EXPENSES |
Accrued
expenses are summarized below:
SCHEDULE OF ACCRUED EXPENSES
| |
September 30, 2023 | | |
December 31, 2022 | |
| |
| | |
| |
Compensation | |
$ | 554,511 | | |
$ | 340,680 | |
Legal and professional | |
| 18,487 | | |
| 144,440 | |
Clinical | |
| 27,776 | | |
| 50,922 | |
Billing fees | |
| 19,525 | | |
| — | |
Other | |
| 23,487 | | |
| 5,852 | |
Total accrued expenses | |
$ | 643,786 | | |
$ | 541,894 | |
|
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v3.23.3
LEASES (Tables)
|
9 Months Ended |
Sep. 30, 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 nine months ended
September 30, 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 | |
$ | 32,081 | | |
$ | — | |
Interest on lease liabilities - finance lease | |
| 8,634 | | |
| — | |
Operating lease cost | |
| 9,972 | | |
| — | |
Total lease cost | |
$ | 50,687 | | |
$ | — | |
|
SCHEDULE OF BALANCE SHEET INFORMATION RELATING TO LEASES |
Supplemental
balance sheet information relating to leases was as follows as of September 30, 2023 and December 31,2022:
SCHEDULE OF BALANCE SHEET
INFORMATION RELATING TO LEASES
Operating leases: | |
2023
| | |
2022 | |
Operating lease right-of-use assets | |
$ | 392,347 | | |
$ | — | |
Operating lease liability, current | |
$ | 90,863 | | |
$ | — | |
Operating lease liability, long-term | |
$ | 307,397 | | |
$ | — | |
Finance leases: | |
2023
| | |
2022 | |
Finance lease right-of-use asset, gross | |
$ | 1,294,168 | | |
$ | — | |
Accumulated amortization | |
| (32,081 | ) | |
| — | |
Finance lease right-of-use asset, net | |
| 1,262,087 | | |
| — | |
Finance lease liability, current portion | |
| 358,282 | | |
| — | |
Finance lease liability, long-term | |
| 929,570 | | |
| — | |
Total finance lease liabilities | |
$ | 1,287,852 | | |
$ | — | |
Weighted-average remaining lease term: | |
2023
| | |
2022 | |
Operating leases (in years) | |
| 3.83 | | |
| — | |
Finance leases (in years) | |
| 3.50 | | |
| — | |
Weighted-average discount rate: | |
2023
| | |
2022 | |
Operating leases | |
| 8.07 | % | |
| — | |
Finance leases | |
| 8.01 | % | |
| — | |
|
SCHEDULE OF FUTURE MINIMUM LEASE PAYMENT UNDER NON-CANCELLABLE |
Future
minimum lease payment under non-cancellable lease as of September 30, 2023, are as follows:
SCHEDULE OF FUTURE MINIMUM LEASE
PAYMENT UNDER NON-CANCELLABLE
| |
Operating Leases | | |
Finance Leases | |
Remaining 2023 | |
$ | 28,431 | | |
$ | 112,126 | |
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 | |
| 464,616 | | |
| 1,482,501 | |
Less discounting | |
| (66,356 | ) | |
| (194,649 | ) |
Present value of lease liabilities | |
$ | 398,260 | | |
$ | 1,287,852 | |
|
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v3.23.3
STOCK-BASED COMPENSATION (Tables)
|
9 Months Ended |
Sep. 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 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
| |
| | | |
| | | |
| | | |
| | |
| |
Three
Months Ended September 30, | | |
Nine
Months Ended September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Research and development | |
$ | 10,304 | | |
$ | 4,072 | | |
$ | 32,193 | | |
$ | 3,318 | |
General and administrative | |
| 181,140 | | |
| 74,941 | | |
| 482,120 | | |
| 208,427 | |
Total stock-based compensation
expense | |
$ | 186,445 | | |
$ | 79,013 | | |
$ | 514,313 | | |
$ | 211,745 | |
|
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 | | |
| | | |
| | |
Granted | |
| — | | |
| — | | |
| | | |
| | |
Exercised | |
| — | | |
| — | | |
| | | |
| | |
Forfeited | |
| (122,697 | ) | |
| 5.86 | | |
| | | |
| | |
Outstanding at September 30, 2023 | |
| 683,695 | | |
$ | 3.99 | | |
| 3.2 | | |
$ | 254,225 | |
| |
| | | |
| | | |
| | | |
| | |
Vested and exercisable at September 30, 2023 | |
| 681,711 | | |
$ | 3.99 | | |
| 3.2 | | |
$ | 254,225 | |
|
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 | | |
| 79,814 | | |
| 35,106 | |
Granted | |
| 326,068 | | |
| 1.86 | | |
| 607,313 | | |
| 227,760 | | |
| 98,308 | |
Forfeited | |
| (4,979 | ) | |
| 2.76 | | |
| (13,742 | ) | |
| (4,979 | ) | |
| — | |
Balance at September 30, 2023 | |
| 436,009 | | |
$ | 2.30 | | |
$ | 1,003,008 | | |
| 302,595 | | |
| 133,414 | |
|
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 options
grants issued during the nine months ended September 30, 2022. No stock options have been issued during the nine months ended
September 30, 2023:
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 | % |
|
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v3.23.3
NATURE OF OPERATIONS, ORGANIZATION, AND BASIS OF PRESENTATION (Details Narrative) - USD ($)
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
|
Accumulated deficit |
$ 42,231,315
|
$ 36,667,468
|
Cash and cash equivalents |
$ 4,509,236
|
$ 11,413,759
|
Total assets, percent |
44.00%
|
|
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v3.23.3
SCHEDULE OF PURCHASE PRICE AND PRELIMINARY PURCHASE PRICE ALLOCATIONS (Details)
|
Sep. 30, 2023
USD ($)
|
Accounting Policies [Abstract] |
|
Cash |
$ 2,500,000
|
Common Stock |
1,000,000
|
Total net assets |
3,500,000
|
Assets |
|
Net working capital (including cash) |
1,167,000
|
Property and equipment |
326,000
|
Other assets |
8,000
|
Customer relationships |
700,000
|
Trade names and trademarks |
150,000
|
Goodwill |
$ 1,149,000
|
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SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES (Details) - shares
|
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Anti-dilutive securities |
5,333,647
|
5,514,717
|
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
|
4,624,952
|
Convertible Debt Securities [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Anti-dilutive securities |
|
83,373
|
X |
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v3.23.3
SCHEDULE OF REVENUE RECOGNITION (Details) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Product Information [Line Items] |
|
|
|
|
|
Revenue related party |
[1] |
$ 300,236
|
$ 1,150
|
$ 320,895
|
$ 2,457
|
Revenue consolidated |
[1] |
298,484
|
1,150
|
319,143
|
2,457
|
Related Party [Member] |
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
Revenue related party |
[1],[2] |
(1,752)
|
|
(1,752)
|
|
Royalty Income [Member] |
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
Revenue related party |
[2] |
5,412
|
1,150
|
13,164
|
2,457
|
Revenue consolidated |
[2] |
4,925
|
1,150
|
12,677
|
2,457
|
Royalty Income [Member] | Related Party [Member] |
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
Revenue related party |
[2] |
(487)
|
|
(487)
|
|
Laboratory Services [Member] |
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
Revenue related party |
[2] |
7,423
|
|
10,500
|
|
Revenue consolidated |
[2] |
6,158
|
|
9,315
|
|
Laboratory Services [Member] | Related Party [Member] |
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
Revenue related party |
[2] |
(1,265)
|
|
(1,265)
|
|
Defense Study [Member] |
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
Revenue related party |
|
4,500
|
|
14,250
|
|
Revenue consolidated |
|
4,500
|
|
14,250
|
|
Defense Study [Member] | Related Party [Member] |
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
Revenue related party |
[2] |
|
|
|
|
Health Care, Patient Service [Member] | Precision Pathology Laboratories Services LLC [Member] |
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
Revenue related party |
[1] |
248,654
|
|
|
|
Revenue consolidated |
[1] |
248,654
|
|
248,654
|
|
Health Care, Patient Service [Member] | Village Oaks Pathology Services P.A And Precision Pathology Laboratories Services LLC [Member] |
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
Revenue related party |
[1] |
|
|
248,654
|
|
Health Care, Patient Service [Member] | Related Party [Member] | Precision Pathology Laboratories Services LLC [Member] |
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
Revenue related party |
[1],[2] |
|
|
|
|
Health Care, Patient Service [Member] | Related Party [Member] | Village Oaks Pathology Services P.A And Precision Pathology Laboratories Services LLC [Member] |
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
Revenue related party |
[1],[2] |
|
|
|
|
Histology Fees [Member] | Precision Pathology Laboratories Services LLC [Member] |
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
Revenue related party |
[1] |
31,854
|
|
|
|
Revenue consolidated |
[1] |
31,854
|
|
31,854
|
|
Histology Fees [Member] | Village Oaks Pathology Services P.A And Precision Pathology Laboratories Services LLC [Member] |
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
Revenue related party |
[1] |
|
|
31,854
|
|
Histology Fees [Member] | Related Party [Member] | Precision Pathology Laboratories Services LLC [Member] |
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
Revenue related party |
[1],[2] |
|
|
|
|
Histology Fees [Member] | Related Party [Member] | Village Oaks Pathology Services P.A And Precision Pathology Laboratories Services LLC [Member] |
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
Revenue related party |
[1],[2] |
|
|
|
|
Health Care, Other [Member] | Precision Pathology Laboratories Services LLC [Member] |
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
Revenue related party |
[1] |
2,392
|
|
|
|
Revenue consolidated |
[1] |
2,393
|
|
2,393
|
|
Health Care, Other [Member] | Village Oaks Pathology Services P.A And Precision Pathology Laboratories Services LLC [Member] |
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
Revenue related party |
[1] |
|
|
2,393
|
|
Health Care, Other [Member] | Related Party [Member] | Precision Pathology Laboratories Services LLC [Member] |
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
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[1],[2] |
|
|
|
|
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|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
Revenue related party |
[1],[2] |
|
|
|
|
|
|
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v3.23.3
SCHEDULE OF PROPERTY AND EQUIPMENT USEFUL LIFE (Details)
|
9 Months Ended |
Sep. 30, 2023 |
Property, Plant and Equipment [Line Items] |
|
Property, plant and equipment, useful life |
Lesser of lease term or useful life
|
Computer Equipment [Member] | Minimum [Member] |
|
Property, Plant and Equipment [Line Items] |
|
Property, plant and equipment, useful life |
3 years
|
Computer Equipment [Member] | Maximum [Member] |
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Property, Plant and Equipment [Line Items] |
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Property, plant and equipment, useful life |
5 years
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|
Property, plant and equipment, useful life |
3 years
|
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|
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] |
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|
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v3.23.3
SCHEDULE OF INTANGIBLE ASSETS ADJUSTMENTS (Details)
|
9 Months Ended |
Sep. 30, 2023
USD ($)
|
Indefinite-Lived Intangible Assets [Line Items] |
|
Intangible assets cost |
$ 1,998,553
|
Amortization |
(1,943)
|
Intangible assets net |
$ 1,996,610
|
Goodwill [Member] |
|
Indefinite-Lived Intangible Assets [Line Items] |
|
Date acquired |
Sep. 18, 2023
|
Intangible assets cost |
$ 1,148,553
|
Amortization |
|
Intangible assets net |
$ 1,148,553
|
Trademarks and Trade Names [Member] |
|
Indefinite-Lived Intangible Assets [Line Items] |
|
Date acquired |
Sep. 18, 2023
|
Intangible assets cost |
$ 150,000
|
Amortization |
(277)
|
Intangible assets net |
$ 149,723
|
Useful life |
18 years
|
Customer Relationships [Member] |
|
Indefinite-Lived Intangible Assets [Line Items] |
|
Date acquired |
Sep. 18, 2023
|
Intangible assets cost |
$ 700,000
|
Amortization |
(1,666)
|
Intangible assets net |
$ 698,334
|
Useful life |
14 years
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v3.23.3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($)
|
|
3 Months Ended |
9 Months Ended |
|
Sep. 18, 2023 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Dec. 31, 2022 |
Assets net |
|
$ 3,500,000
|
|
$ 3,500,000
|
|
|
Cash |
|
2,500,000
|
|
2,500,000
|
|
|
Stock issued during period, value |
|
1,000,000
|
|
1,000,000
|
|
|
Goodwill |
|
1,148,553
|
|
1,148,553
|
|
|
Federal insured limit |
|
250,000
|
|
250,000
|
|
|
Advertising expense |
|
$ 10,000
|
$ 5,000
|
$ 43,000
|
$ 13,000
|
|
Common stock par value |
|
$ 0.007
|
|
$ 0.007
|
|
$ 0.007
|
Amortization of intangible assets |
|
$ 1,943
|
0
|
$ 1,943
|
0
|
|
Selling, General and Administrative Expenses [Member] | Revision of Prior Period, Adjustment [Member] |
|
|
|
|
|
|
Reclassified patent expenses and annuity costs |
|
|
$ 41,000
|
|
$ 142,000
|
|
Village O aks [Member] |
|
|
|
|
|
|
Assets net |
$ 3,500,000
|
|
|
|
|
|
Cash |
$ 2,500,000
|
|
|
|
|
|
Shares acquisitions for common stock |
564,972
|
|
|
|
|
|
Stock issued during period, value |
$ 1,000,000
|
|
|
|
|
|
Liabilities assumed |
321,000
|
|
|
|
|
|
Goodwill |
$ 1,149,000
|
|
|
|
|
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v3.23.3
SCHEDULE OF ACCOUNTS RECEIVABLE (Details) - USD ($)
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Receivables [Abstract] |
|
|
CyPath® Lung royalty income |
$ 16,107
|
$ 4,803
|
Laboratory services |
12,390
|
|
Other receivables |
4,730
|
5,686
|
Purchased receivables from acquisition, net of collections |
791,852
|
|
Net patient fees receivable |
249,088
|
|
Histology fees |
31,854
|
|
Medical director fees |
2,393
|
|
Accounts and other receivable, net |
$ 1,108,414
|
$ 10,489
|
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v3.23.3
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS (Details) - USD ($)
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Prepaid Expenses And Other Current Assets |
|
|
Prepaid insurance |
$ 240,540
|
$ 340,078
|
Legal and professional |
30,847
|
72,048
|
Other |
111,264
|
119,773
|
Total prepaid expenses and other current assets |
$ 382,651
|
$ 531,899
|
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v3.23.3
SCHEDULE OF PROPERTY AND EQUIPMENT (Details) - USD ($)
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
$ 848,112
|
$ 483,617
|
Accumulated depreciation |
(335,960)
|
(269,180)
|
Total property and equipment, net |
512,152
|
214,438
|
Lab Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
649,499
|
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 |
$ 119,990
|
|
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v3.23.3
SCHEDULE OF ACCRUED EXPENSES (Details) - USD ($)
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Accrued Expenses |
|
|
Compensation |
$ 554,511
|
$ 340,680
|
Legal and professional |
18,487
|
144,440
|
Clinical |
27,776
|
50,922
|
Billing fees |
19,525
|
|
Other |
23,487
|
5,852
|
Total accrued expenses |
$ 643,786
|
$ 541,894
|
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v3.23.3
SCHEDULE OF BALANCE SHEET INFORMATION RELATING TO LEASES (Details) - USD ($)
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Leases [Abstract] |
|
|
Operating lease right-of-use assets |
$ 392,347
|
|
Operating lease liability, current |
90,863
|
|
Operating lease liability, long-term |
307,397
|
|
Finance lease right-of-use asset, gross |
1,294,168
|
|
Accumulated amortization |
(32,081)
|
|
Finance lease right-of-use asset, net |
1,262,087
|
|
Finance lease liability, current portion |
358,282
|
|
Finance lease liability, long-term |
929,570
|
|
Total finance lease liabilities |
$ 1,287,852
|
|
Weighted average remaining operating lease, term |
3 years 9 months 29 days
|
|
Weighted average remaining finance lease, term |
3 years 6 months
|
|
Operating leases |
8.07%
|
|
Finance leases |
8.01%
|
|
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v3.23.3
SCHEDULE OF FUTURE MINIMUM LEASE PAYMENT UNDER NON-CANCELLABLE (Details) - USD ($)
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Lessee, Operating Lease, Liability, to be Paid, Fiscal Year Maturity [Abstract] |
|
|
Remaining 2023 |
$ 28,431
|
|
2024 |
121,726
|
|
2025 |
121,726
|
|
2026 |
121,726
|
|
2027 and thereafter |
71,007
|
|
Total undiscounted cash flows |
464,616
|
|
Less discounting |
(66,356)
|
|
Present value of lease liabilities |
398,260
|
|
Finance Lease, Liability, to be Paid, Fiscal Year Maturity [Abstract] |
|
|
Remaining 2023 |
112,126
|
|
2024 |
448,505
|
|
2025 |
448,505
|
|
2026 |
270,395
|
|
2027 and thereafter |
202,970
|
|
Total undiscounted cash flows |
1,482,501
|
|
Less discounting |
(194,649)
|
|
Present value of lease liabilities |
$ 1,287,852
|
|
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- DefinitionContractual interest rate for funds borrowed, under the debt agreement.
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v3.23.3
COMMON STOCK (Details Narrative) - $ / shares
|
9 Months Ended |
|
|
|
Sep. 30, 2023 |
Jun. 06, 2023 |
Jun. 05, 2023 |
Dec. 31, 2022 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Common stock, shares authorized |
25,000,000
|
25,000,000
|
14,285,715
|
14,285,714
|
Common stock par value |
$ 0.007
|
|
|
$ 0.007
|
Shares issued |
9,350,297
|
|
|
|
Common stock, shares issued |
9,216,883
|
|
|
8,381,324
|
Restricted Stock Units Unvested [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Common stock, shares issued |
133,414
|
|
|
|
X |
- DefinitionFace amount or stated value per share of common stock.
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|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Total stock-based compensation expense |
$ 186,445
|
$ 79,013
|
$ 514,313
|
$ 211,745
|
Research and Development Expense [Member] |
|
|
|
|
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
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10,304
|
4,072
|
32,193
|
3,318
|
Selling, General and Administrative Expenses [Member] |
|
|
|
|
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Total stock-based compensation expense |
$ 181,140
|
$ 74,941
|
$ 482,120
|
$ 208,427
|
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v3.23.3
SUMMARY OF OPTION ACTIVITY (Details) - USD ($)
|
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
Options Granted |
0
|
7,142
|
Options Exercised |
0
|
64,848
|
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 |
(122,697)
|
|
Weighted-Average Exercise Price,Forfeited |
$ 5.86
|
|
Options Outstanding, ending balance |
683,695
|
|
Weighted-Average Exercise Price Outstanding, ending balance |
$ 3.99
|
|
Weighted- Average Remaining Contractual Term, Outstanding |
3 years 2 months 12 days
|
|
Aggregate Intrinsic Value Outstanding, ending balance |
$ 254,225
|
|
Options, Vested and exercisable |
681,711
|
|
Weighted-Average Exercise Price, Vested and exercisable |
$ 3.99
|
|
Weighted- Average Remaining Contractual Term, Vested and exercisable |
3 years 2 months 12 days
|
|
Aggregate Intrinsic Value, Vested and exercisable |
$ 254,225
|
|
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v3.23.3
SUMMARY OF RESTRICTED STOCK AWARD (Details) - $ / shares
|
9 Months Ended |
Sep. 30, 2023 |
Sep. 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 |
(227,760)
|
|
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 |
(42,825)
|
|
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 |
79,814
|
|
Unvested number of RSA, Beginning Balance |
35,106
|
|
Restricted stock awards, Granted |
326,068
|
|
Weighted-average grant price, Granted |
$ 1.86
|
|
FMV on grant date, Granted |
607,313
|
|
Vested number of RSA, Granted |
227,760
|
|
Unvested number of RSA, Granted |
98,308
|
|
Restricted stock awards, Forfeited |
(4,979)
|
|
Weighted-average grant price, Forfeited |
$ 2.76
|
|
FMV on grant date, Forfeited |
(13,742)
|
|
Vested number of RSA, Forfeited |
(4,979)
|
|
Unvested number of RSA, Forfeited |
|
|
Restricted stock awards, Ending Balance |
436,009
|
|
Weighted-average grant price, Ending Balance |
$ 2.30
|
|
FMV on grant date, Ending Balance |
1,003,008
|
|
Vested number of RSA, Ending Balance |
302,595
|
|
Unvested number of RSA, Ending Balance |
133,414
|
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STOCK-BASED COMPENSATION (Details Narrative) - USD ($)
|
9 Months Ended |
|
|
|
|
Sep. 30, 2023 |
Sep. 30, 2022 |
Jun. 30, 2023 |
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
|
14,285,714
|
Unrecognized compensation |
$ 0
|
|
|
|
|
|
Options exercised, shares |
0
|
64,848
|
|
|
|
|
Proceeds from stock options, exercised |
|
$ 74,900
|
|
|
|
|
Grant date fair value of options granted |
0
|
7,142
|
|
|
|
|
Weighted-average grant date fair value of options granted |
|
$ 2.84
|
|
|
|
|
Restricted stock awards |
227,760
|
|
|
|
|
|
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 |
42,825
|
|
|
|
|
|
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 |
326,068
|
|
|
|
|
|
Restricted stock awards |
4,979
|
|
|
|
|
|
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 |
|
21,000
|
|
|
|
|
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
|
|
|
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- DefinitionAggregate number of common shares reserved for future issuance.
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v3.23.3
WARRANTS (Details Narrative) - $ / shares
|
9 Months Ended |
|
|
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 17, 2023 |
Dec. 31, 2022 |
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] |
|
|
|
|
Warrant outstanding |
|
|
73,568
|
|
Non-Tradeable Warrant [Member] |
|
|
|
|
Warrant outstanding |
|
|
73,568
|
|
Pre-IPO Warrant [Member] |
|
|
|
|
Warrant outstanding |
|
|
1,109,475
|
|
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bioAffinity Technologies (NASDAQ:BIAF)
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