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 June 30, 2026
☐
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.)
3300 Nacogdoches
Road , Suite 216 , San Antonio , Texas
78217
(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 Section 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 August 3, 2026, was 8,101,725 .
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;
●
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, 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 impact of a 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;
2
●
anticipated uses of net
proceeds from our financings;
●
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, 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, www.cypathlung.com and www.precisionpath.us/) to share Company information.
Information contained on or that can be accessed through our websites is not, however, incorporated by reference in this Quarterly Report.
Investors should not consider any such information to be part of this Quarterly Report.
3
bioAffinity
Technologies, Inc.
FORM
10-Q
TABLE
OF CONTENTS
PART I
FINANCIAL INFORMATION
ITEM 1 -
Condensed Consolidated Financial Statements (unaudited)
5
Condensed Consolidated Balance Sheets at June 30, 2026 (unaudited) and December 31, 2025
5
Unaudited Condensed Consolidated Statements of Operations for the Three and Six Months ended June 30, 2026 and 2025
6
Unaudited Condensed Consolidated Statements of Changes in Stockholders’ Equity for the Three and Six Months ended June 30, 2026 and 2025
7
Unaudited Condensed Consolidated Statements of Cash Flows for the Six Months ended June 30, 2026 and 2025
9
Notes to Unaudited Condensed Consolidated Financial Statements
10
ITEM 2 -
Management’s Discussion and Analysis of Financial Condition and Results of Operations
22
ITEM 3 -
Quantitative and Qualitative Disclosures about Market Risk
32
ITEM 4 -
Controls and Procedures
32
PART II
OTHER INFORMATION
ITEM 1 -
Legal Proceedings
33
ITEM 1A -
Risk Factors
33
ITEM 2 -
Unregistered Sales of Equity Securities and Use of Proceeds
35
ITEM 3 -
Defaults Upon Senior Securities
35
ITEM 4 -
Mine Safety Disclosures
35
ITEM 5 -
Other Information
35
ITEM 6 -
Exhibits
36
Signatures
37
4
PART
I
FINANCIAL
INFORMATION
ITEM
1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS.
bioAffinity
Technologies, Inc.
Condensed
Consolidated Balance Sheets
June 30,
2026
December 31,
2025
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$ 2,429,719
$ 6,449,782
Accounts and other receivables, net
894,823
541,962
Inventory
82,378
53,548
Prepaid expenses and other current assets
458,360
519,916
Total current assets
3,865,280
7,565,208
Non-current assets:
Property and equipment, net
313,708
265,593
Operating lease right-of-use asset, net
769,270
334,289
Finance lease right-of-use asset, net
562,187
661,575
Goodwill
1,404,486
1,404,486
Intangible assets, net
687,639
716,806
Other assets
16,709
12,815
Total assets
$ 7,619,279
$ 10,960,772
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$ 969,845
$ 761,901
Accrued expenses
1,414,492
1,717,989
Unearned revenue
31,140
42,405
Operating lease liability, current portion
163,276
139,220
Finance lease liability, current portion
79,592
139,490
Notes payable, current portion
22,561
105,161
Total current liabilities
2,680,906
2,906,166
Non-current liabilities:
Operating lease liability, net of current portion
637,643
202,878
Finance lease liability, net of current portion
495,468
532,759
Notes payable, net of current portion
36,465
41,313
Total liabilities
3,850,482
3,683,116
Commitments and contingencies (Note 11)
-
-
Stockholders’ equity:
Preferred Stock, par value $ 0.001 per share; 20,000,000 shares authorized; 450 shares and 700 shares issued and outstanding at June 30, 2026, and December 31, 2025, respectively
1
1
Common Stock, par value $ 0.007 per share; 350,000,000 shares authorized; 6,783,061 and 4,498,675 issued and outstanding at June 30, 2026, and December 31, 2025, respectively
47,454
31,461
Additional paid-in capital
79,272,098
75,800,258
Accumulated deficit
( 75,550,756 )
( 68,554,064 )
Total stockholders’ equity
3,768,797
7,277,656
Total liabilities and stockholders’ equity
$ 7,619,279
$ 10,960,772
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5
bioAffinity
Technologies, Inc.
Unaudited
Condensed Consolidated Statements of Operations
2026
2025
2026
2025
Three Months Ended
June 30,
Six Months Ended
June 30,
2026
2025
2026
2025
Net revenue
$ 1,510,579
$ 1,269,483
$ 2,862,106
$ 3,123,080
Operating expenses:
Direct costs and expenses
1,087,837
1,016,602
2,016,473
2,384,462
Research and development
361,575
311,372
711,282
678,758
Clinical development
475,885
129,279
809,925
267,632
Selling, general and administrative
2,858,590
2,214,561
6,100,192
4,667,110
Depreciation and amortization
61,556
113,229
176,074
267,817
Total operating expenses
4,845,443
3,785,043
9,813,946
8,265,779
Loss from operations
( 3,334,864 )
( 2,515,560 )
( 6,951,840 )
( 5,142,699 )
Other income (expense):
Interest income
3,358
2,025
13,384
2,567
Interest expense
( 11,688 )
( 10,460 )
( 26,410 )
( 25,945 )
Other income
4,738
38,053
3,372
38,055
Other expense
( 27,626 )
( 483,043 )
( 35,198 )
( 492,685 )
Change in fair value of warrants issued
—
( 1,062,818 )
—
( 1,062,818 )
Total other income (expense), net
( 31,218 )
( 1,516,243 )
( 44,852 )
( 1,540,826 )
Net loss before provision for income tax expense
( 3,366,082 )
( 4,031,803 )
( 6,996,692 )
( 6,683,525 )
Income tax expense
—
28,984
—
37,679
Net loss
$ ( 3,366,082 )
$ ( 4,060,787 )
$ ( 6,996,692 )
$ ( 6,721,204 )
Net loss per common share, basic and diluted
$ ( 0.64 )
$ ( 5.07 )
$ ( 1.44 )
$ ( 10.01 )
Weighted average common shares outstanding
5,226,753
800,637
4,860,753
671,529
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
6
bioAffinity
Technologies, Inc.
Unaudited
Condensed Consolidated Statements of Changes in Stockholders’ Equity
Shares
Amount
Shares
Amount
Capital
Deficit
Equity
For the Six Months Ended June 30, 2026
Preferred Stock
Common Stock
Additional
Paid-in
Accumulated
Stockholders’
Shares
Amount
Shares
Amount
Capital
Deficit
Equity
Balance at December 31, 2025
700
$ 1
4,494,304
$ 31,461
$ 75,800,258
$ ( 68,554,064 )
$ 7,277,656
Stock-based compensation expense
—
—
161,567
1,131
290,493
—
291,624
Sale of Common Stock, net
—
—
2,040,000
14,280
3,185,720
—
3,200,000
Conversion of Preferred
( 250 )
—
83,331
582
( 582 )
—
—
Issuance of Stock Options
—
—
—
—
507,657
—
507,657
Offering costs
—
—
—
—
( 511,448 )
—
( 511,448 )
Net loss
—
—
—
—
—
( 6,996,692 )
( 6,996,692 )
Balance at June 30, 2026 (unaudited)
450
$ 1
6,779,202
$ 47,454
$ 79,272,098
$ ( 75,550,756 )
$ 3,768,797
For the Three Months Ended June 30, 2026
Preferred
Stock
Common Stock
Additional
Paid-in
Accumulated
Stockholders’
Equity
Shares
Amount
Shares
Amount
Capital
Deficit
(Deficit)
Balance at March 31, 2026 (unaudited)
700
$ 1
4,494,816
$ 31,464
$ 75,800,281
$ ( 72,184,674 )
$ 3,647,072
Stock-based compensation expense
—
—
161,055
1,128
290,470
—
291,598
Sale of Common Stock, net
—
—
2,040,000
14,280
3,185,720
—
3,200,000
Conversion of Preferred
( 250 )
—
83,331
582
( 582 )
—
—
Issuance of Stock Options
—
—
—
—
507,657
—
507,657
Offering costs
—
—
—
—
( 511,448 )
—
( 511,448 )
Net loss
—
—
—
—
—
( 3,366,082 )
( 3,366,082 )
Balance at June 30, 2026 (unaudited)
450
$ 1
6,779,202
$ 47,454
$ 79,272,098
$ ( 75,550,756 )
$ 3,768,797
7
Shares
Amount
Shares
Amount
Capital
Deficit
Equity
For the Six Months Ended June 30, 2025
Preferred Stock
Common Stock
Additional
Paid-in
Accumulated
Stockholders’
Shares
Amount
Shares
Amount
Capital
Deficit
Equity
Balance at December 31, 2024
—
$ —
507,520
$ 3,553
$ 56,242,793
$ ( 53,644,310 )
$ 2,602,036
Stock-based compensation expense
—
—
9,798
68
538,155
—
538,224
Exercise of stock warrants
—
—
83,623
585
1,557,991
—
1,558,576
Sale of Common Stock
—
—
338,204
2,367
239,961
—
242,328
Offering costs
—
—
—
—
( 356,067 )
—
( 356,067 )
Net loss
—
—
—
—
—
( 6,721,204 )
( 6,721,204 )
Balance at June 30, 2025 (unaudited)
—
$ —
939,145
$ 6,573
$ 58,222,833
$ ( 60,365,514 )
$ ( 2,136,108 )
For the Three Months Ended June 30, 2025
Preferred Stock
Common Stock
Additional
Paid-in
Accumulated
Stockholders’
Shares
Amount
Shares
Amount
Capital
Deficit
Equity
Balance at March 31, 2025
—
$ —
594,098
$ 4,159
$ 57,739,972
$ ( 56,304,727 )
$ 1,439,404
Stock-based compensation expense
—
—
4,500
31
211,576
—
211,607
Sale of Common Stock
—
—
338,204
2,367
239,961
—
242,328
Exercise of stock warrants
—
—
2,343
16
40,093
—
40,109
Offering costs
( 8,769 )
( 8,769 )
Net loss
—
—
—
—
—
( 4,060,787 )
( 4,060,787 )
Balance at June 30, 2025 (unaudited)
—
$ —
939,145
$ 6,573
$ 58,222,833
$ ( 60,365,514 )
$ ( 2,136,108 )
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
8
bioAffinity
Technologies, Inc.
Unaudited
Condensed Consolidated Statements of Cash Flows
2026
2025
Six Months Ended June 30,
2026
2025
Cash flows from operating activities
Net loss
$ ( 6,996,692 )
$ ( 6,721,204 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
176,074
267,817
Stock-based compensation expense
799,281
538,223
Fair value adjustment on warrants
—
1,062,818
Changes in operating assets and liabilities:
Accounts and other receivables
( 352,861 )
717,335
Inventory
( 28,830 )
( 16,363 )
Prepaid expenses and other assets
57,662
29,706
Accounts payable
207,944
182,526
Accrued expenses
( 303,497 )
( 350,688 )
Unearned revenue
( 11,265 )
—
Operating lease right-of-use asset
23,840
849
Net cash used in operating activities
( 6,428,344 )
( 4,288,981 )
Cash flows from investing activities
Purchase of property and equipment
( 95,633 )
( 64,213 )
Net cash used in investing activities
( 95,633 )
( 64,213 )
Cash flows from financing activities
Proceeds from issuance of Common Stock from direct offering, net of underwriting discounts, commissions, and offering expenses of $ 511,448 in 2026 and $ 112,922 in 2025
2,688,552
2,798,354
Proceeds from exercise of warrants, net of underwriting discounts, commissions, and offering expenses of $ 243,145 in 2025
—
1,558,576
Payment on loans payable
( 87,448 )
( 112,951 )
Principal repayments on finance leases
( 97,190 )
( 193,241 )
Net cash provided by financing activities
2,503,914
4,050,738
Net decrease in cash and cash equivalents
( 4,020,063 )
( 302,456 )
Cash and cash equivalents at beginning of period
6,449,782
1,105,291
Cash and cash equivalents at end of period
$ 2,429,719
$ 802,835
Supplemental disclosures of cash flow information:
Interest expense paid in cash
$ 13,384
$ 2,567
Income taxes paid in cash
$ —
$ 37,679
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
9
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 lung cancer at early stage and other diseases of the lung. bioAffinity Technologies’ proprietary platform
uses flow cytometry and automated data analysis built by machine learning, a form of artificial intelligence (“AI”), to preferentially
target cancer cell populations and other 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”).
The Company is developing noninvasive tests using its flow cytometry platform to quantify lung inflammation with the aim of commercializing
precision diagnostics that assist physicians when determining the most effective drug to prescribe patients with asthma and chronic obstructive
pulmonary disease (COPD). The Company also is advancing its proprietary therapeutic discoveries and recently presented results from preliminary
studies to advance treatments delivered topically for squamous cell skin cancer. The studies showed that self-delivering, stabilized
siRNAs selectively kill squamous and basal carcinoma cells while leaving non-cancerous cutaneous cells unharmed. Commercial operations
and product development are conducted in laboratories at PPLS and other leased laboratory space.
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. (“Village Oaks”), a Texas professional association d/b/a Precision Pathology Services,
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 (“GAAP”) in the United States and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission
(“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, 2025, was derived from the audited consolidated
financial statements at that date but does not include all the information and footnotes required in annual consolidated financial statements
prepared in accordance with GAAP. Operating results for the periods presented are not necessarily indicative of the results that may
be expected for the fiscal year ending December 31, 2026, 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 Annual Report on Form
10-K for the year ended December 31, 2025, filed with the SEC on March 16, 2026 (the “2025 Form 10-K”).
All
share and per-share amounts in the accompanying footnotes have been retroactively adjusted to reflect the Company’s 1-for-30 reverse
stock split, which occurred on September 18, 2025.
Correction
of Immaterial Error
In
the first quarter ended March 31, 2026, the Company identified an error related to the recognition of a lease amendment executed in April
2024 for laboratory space. Management evaluated the error in accordance with SEC Staff Accounting Bulletin No. 108 under both the rollover
and iron curtain methods and concluded the error was not material to any previously issued interim or annual financial statements, nor
was it material to the period ended March 31, 2026. As a result, the Company recorded an out-of-period adjustment in the first quarter
of 2026 of approximately $336,000 to both Operating lease right-of-use asset, net and Operating lease liability to correct the error,
and expense of approximately $28,000 in the condensed consolidated statement of operations. The correction did not result in a material
misstatement of the current period condensed consolidated financial statements, and therefore, the Company did not revise prior period
amounts or amend any previously issued filings.
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 approximately $ 75.6 million
at June 30, 2026. The Company’s cash and cash equivalents at June 30, 2026, were approximately $ 2.4 million. Based on the Company’s
current expected level of operating expenditures and the cash and cash equivalents on hand at June 30, 2026, 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. The Company will 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 revenue from operations does not significantly increase. If such funding is
not available or not available on terms acceptable to the Company, the Company’s current development plan may be curtailed. Furthermore,
an alternative source of funding to the sale of additional equity or debt securities is the exercise of outstanding warrants for which
there can be no guarantee. No adjustments have been made to the presented condensed consolidated financial statements as a result of
this uncertainty.
10
Note
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Use
of Estimates
The
preparation of financial statements in conformity with GAAP in the U.S. 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.
Principles
of Consolidation
The
Company’s consolidated financial statements reflect its financial statements, those of its wholly owned subsidiaries, and certain
variable interest entities where the Company is the primary beneficiary. The accompanying consolidated financial statements include all
the accounts of the Company, its wholly owned subsidiaries, OncoSelect ® Therapeutics, LLC and PPLS, and the variable interest
entity, Village Oaks. 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.
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 $ 192,859 and $ 171,822 for the six months ended June 30, 2026
and 2025, respectively, and $ 94,410 and $ 143,616 for the three months ended June 30, 2026 and 2025, 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 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, unvested restricted stock, and warrants based on the average stock
price for each period using the treasury stock method.
11
The
following potentially dilutive securities have been excluded from the computations of weighted-average shares of Common Stock outstanding
as of June 30, 2026 and 2025, as they would be anti-dilutive:
SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES
2026
2025
As of June 30,
2026
2025
Shares underlying options outstanding
352,835
9,531
Shares underlying convertible Preferred Stock
150,000
—
Shares underlying warrants outstanding
1,833,894
429,029
Shares underlying unvested restricted stock
3,859
14,348
Anti-dilutive securities
2,340,588
452,908
Revenue
Recognition
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.
PPLS
generates three sources of revenue: (1) patient service fees, (2) histology service fees, and (3) medical director fees. The Company
recognizes as revenue the amount that reflects the consideration to which it expects to be entitled in exchange for goods sold or services
rendered primarily upon completion of the testing process (when results are reported) or when services have been rendered.
The
Company follows a standard process, which considers historical denial and collection experience and other factors (including the period
of time that the receivables have been outstanding), to estimate contractual allowances and implicit price concessions, recording adjustments
in the current period as changes in estimates. The process for estimating revenues and the ultimate collection of accounts receivable
involves significant judgment and estimation.
SCHEDULE OF REVENUE RECOGNITION
2026
2025
2026
2025
Six
Months Ended
June 30,
Three
Months Ended
June 30,
2026
2025
2026
2025
Patient service fees 1
$ 2,326,352
$ 2,512,449
$ 1,244,142
$ 942,067
Histology service fees
498,776
572,358
248,260
308,604
Medical director fees
35,005
33,897
17,544
17,309
Department of War observational studies
1,131
—
—
—
Other revenues
842
4,376
633
1,503
Total net revenue
$ 2,862,106
$ 3,123,080
$ 1,510,579
$ 1,269,483
1
Patient services fees include
direct billing for CyPath ® Lung diagnostic test of approximately $ 835,000 and $ 323,000 for the six months ended June
30, 2026 and 2025, respectively, and $ 474,000 and $ 153,000 for the three months ended June 30, 2026 and 2025, 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 three and six months ended June 30, 2026, or for the fiscal year ended December 31, 2025.
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
12
Intangible
Assets
The
Company’s acquisition of PPLS on September 18, 2023, identified goodwill and intangible assets. Goodwill represents the purchase
price in excess of fair values assigned to the underlying identifiable net assets of the acquired business. The Company tests goodwill
for impairment annually and, therefore, does not record amortization. The intangible assets and their respective useful lives are as
follows: trade names and trademarks ( 18 years) and customer relationships ( 14 years). Intangible assets, net of accumulated amortization,
are summarized as follows as of June 30, 2026, and December 31, 2025:
SCHEDULE OF INTANGIBLE ASSETS
June 30,
2026
December 31,
2025
Cost
Trade names and trademarks
150,000
150,000
Customer relationships
700,000
700,000
Cost
850,000
850,000
Accumulated amortization
Trade names and trademarks
( 23,194 )
( 19,028 )
Customer relationships
( 139,167 )
( 114,166 )
Accumulated amortization
( 162,361 )
( 133,194 )
Total finite-lived intangible assets, net
687,639
716,806
Goodwill
1,404,486
1,404,486
The
Company incurred amortization of intangible assets of $ 29,167 for each of the six months ended June 30, 2026, and 2025, and $ 14,583 for
each of the three months ended June 30, 2026, and 2025.
The
estimated amortization expense related to amortizable intangible assets for each of the five succeeding fiscal years and thereafter as
of June 30, 2026 is as follows:
SCHEDULE OF ESTIMATED AMORTIZATION OF INTANGIBLE ASSETS
2026
$ 29,167
2027
58,333
2028
58,333
2029
58,333
2030
58,333
Thereafter
425,140
Total
$ 687,639
Recent
Accounting Pronouncements
The
Company continues to monitor new accounting pronouncements issued by the Financial Accounting Standards Board (“FASB”) and
does not believe new accounting pronouncements issued through the date of this Quarterly Report will have a material impact on the Company’s
condensed consolidated financial statements.
Segment
Information
The
Company is organized in two operating segments , Diagnostic Research and Development (“R&D”) and Laboratory Services,
whereby its chief operating decision maker (“CODM”) uses operating income as the primary measure of segment profit or loss
to assess performance and make resource allocation decisions, in addition to monitoring revenue growth and research and development progress.
The CODM is the Chief Executive Officer.
Diagnostic
R&D includes research and development and clinical development of diagnostic tests. Any revenues assigned to Diagnostic R&D are
proceeds received from observational studies. Laboratory services include all the operations from Village Oaks and PPLS in addition to
sales and marketing costs of CyPath® Lung from bioAffinity.
SCHEDULE OF SEGMENT INFORMATION
2026
2025
2026
2025
Three months ended
June 30,
Six months ended
June 30,
2026
2025
2026
2025
Net revenue:
Diagnostic R&D
$ —
$ —
$ 1,131
$ —
Laboratory services 1
1,510,579
1,269,483
2,860,975
3,123,080
Total net revenue
1,510,579
1,269,483
2,862,106
3,123,080
Operating expenses:
Diagnostic R&D
( 837,460 )
( 440,651 )
( 1,521,207 )
( 946,390 )
Laboratory services
( 1,787,865 )
( 1,646,471 )
( 3,620,457 )
( 3,914,127 )
General corporate activities
( 2,220,118 )
( 1,697,921 )
( 4,672,282 )
( 3,405,262 )
Total operating loss
( 3,334,864 )
( 2,515,560 )
( 6,951,840 )
( 5,142,699 )
Non-operating (expense), net
( 31,218 )
( 1,516,243 )
( 44,852 )
( 1,540,826 )
Net loss before income tax expense
( 3,366,082 )
( 4,031,803 )
( 6,996,692 )
( 6,683,525 )
Income tax expense
—
( 28,984 )
—
( 37,679 )
Net loss
$ ( 3,366,082 )
$ ( 4,060,787 )
$ ( 6,996,692 )
$ ( 6,721,204 )
1
The majority of the
decrease versus the prior year is primarily due to discontinuing certain unprofitable pathology services to focus on CyPath ®
Lung and other high-margin services.
13
Research
and Development
Research
and development costs are charged to expense as incurred. The Company’s research and development expenses consist primarily of
expenditures for laboratory operations, preclinical studies, compensation, and consulting costs.
Accrued
Research and Development Costs
The
Company records accrued liabilities for estimated costs of research and development activities conducted by service providers, which
include preclinical studies. The Company records the estimated costs of research and development activities based upon the estimated
amount of services provided but not yet invoiced and includes these costs in accrued expenses in the accompanying condensed consolidated
balance sheets and within research and development expense in the accompanying condensed consolidated statements of operations.
The
Company accrues for these costs based on factors such as estimates of the work completed and in accordance with agreements established
with service providers. The Company makes significant judgments and estimates in determining the accrued expenses balance in each reporting
period. As actual costs become known, the Company adjusts its accrued liabilities. The Company has not experienced any material differences
between accrued costs and actual costs incurred since its inception.
Regulatory
Matters
Regulations
imposed by federal, state, and local authorities in the U.S. are a significant factor in providing medical care. In the U.S., drugs,
biological products, and medical devices are regulated by the Federal Food, Drug, and Cosmetic Act (“FDCA”), which is administered
by the Food and Drug Administration (“FDA”) and the Centers for Medicare and Medicaid Services (“CMS”). CyPath ®
Lung is commercially available as a laboratory developed test (“LDT”) offered by PPLS, the Company’s wholly owned clinical
pathology laboratory, under the regulatory framework applicable to LDTs. PPLS is accredited by the College of American Pathologists (“CAP”)
and certified under the Clinical Laboratory Improvement Amendments (“CLIA”).
Note
3. ACCOUNTS AND OTHER RECEIVABLES, NET
The
following is a summary of accounts receivables and other receivables:
SCHEDULE OF ACCOUNTS AND OTHER RECEIVABLES
June 30,
2026
December 31,
2025
Patient service fees
$ 726,070
$ 356,432
Histology service fees
133,422
142,889
Medical director fees
16,031
16,346
Other receivables
19,300
26,295
Total accounts and other receivables, net
$ 894,823
$ 541,962
14
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
June 30,
2026
December 31,
2025
Prepaid insurance
$ 137,154
$ 227,950
Legal and professional
32,146
21,530
Other
289,060
270,436
Total prepaid expenses and other current assets
$ 458,360
$ 519,916
Note
5. PROPERTY AND EQUIPMENT, NET
Property
and equipment are summarized below:
SCHEDULE OF PROPERTY AND EQUIPMENT
June 30,
2026
December 31,
2025
Lab equipment
$ 735,569
$ 679,995
Computers and software
46,441
81,433
Leasehold improvements
104,392
32,781
Vehicles
130,590
175,630
Property and equipment, gross
1,016,992
969,839
Less: accumulated depreciation and amortization
( 703,284 )
( 704,246 )
Total property and equipment, net
$ 313,708
$ 265,593
Depreciation
expense was $ 47,519 and $ 88,231 for the six months ended June 30, 2026 and 2025, respectively, and $ 23,108 and $ 44,468 for the three
months ended June 30, 2026 and 2025, respectively.
Note
6. ACCRUED EXPENSES
Accrued
expenses are summarized below:
SCHEDULE OF ACCRUED EXPENSES
June 30,
2026
December 31,
2025
Compensation
$ 869,289
$ 1,309,738
Legal and professional
226,225
337,936
Clinical
295,613
46,177
Other
23,365
24,138
Total accrued expenses
$ 1,414,492
$ 1,717,989
Note
7. UNEARNED REVENUE
The
Company engaged in an observational study of CyPath ® Lung with the Department of War. 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 43 units
as of June 30, 2026. The performance obligation is deemed complete after samples have been collected and processed and results analyzed.
The unearned revenue balance amounted to $ 22,696 and $ 23,827 as of June 30, 2026, and December 31, 2025, respectively.
15
During
August 2025, the Company engaged with Veterans Administration (“VA”) medical centers to purchase CyPath ® Lung
tests. A total of 30 tests were ordered and shipped. However, in compliance with FASB ASC 606, the performance obligation was complete
for 20 tests as of June 30, 2026. The performance obligation is deemed complete after samples have been collected, processed, and analyzed
and results communicated to patients. The unearned revenue balance amounted to $ 8,444 and $ 18,578 as of June 30, 2026 and December 31,
2025, respectively.
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
three levels of the hierarchy and the related inputs are as follows:
Level
Inputs
1
Unadjusted quoted prices
in active markets for identical assets and liabilities;
Unadjusted quoted prices
in active markets for similar assets and liabilities.
2
Unadjusted quoted prices
for identical or similar assets or liabilities in markets that are not active; or
inputs other than quoted
prices that are observable for the asset or liability.
3
Unobservable inputs for
the asset or liability.
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 note 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 for the CAP/CLIA laboratory, as well as multiple finance leases
for lab equipment in Texas that were acquired through the September 18, 2023, acquisition. In April 2024, the Company amended the lab
space lease agreement which included two options to extend the lease for an additional three years on the exercise of each option. Management
has not included these options in calculating the operating lease right-of-use assets and operating lease liabilities. During the first
quarter of 2026, operating lease assets and liabilities increased as a result of amending the lease due to an out-of-period adjustment
described previously in Note 1 . Additionally, the Company entered into an operating lease on September 1, 2024, for additional
office space. The Company entered into a new operating lease agreement for additional lab space in June 2026. The Company’s operating
leases consist of office and lab space with remaining lease terms of 4.2 to 5 years as of June 30, 2026. The Company has finance leases
consisting of office and lab equipment with remaining lease terms ranging from approximately 0.58 to 6.3 years as of June 30, 2026, 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 the date
of inception of the leases 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 6.41 %
to 7.97 % for the lease term lengths.
Leases
with an initial term of 12 months or less are not recorded on the balance sheets. 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.
16
The
components of lease expense, which are included in selling, general and administrative expense and depreciation and amortization for
the three months and six months ended June 30, 2026 and 2025, are as follows:
SCHEDULE OF COMPONENTS OF LEASE EXPENSE
2026
2025
2026
2025
Three months ended June 30,
Six months ended June 30,
2026
2025
2026
2025
Amortization of right-of-use asset - finance lease
$ 24,638
$ 54,177
$ 100,165
$ 150,420
Interest on lease liabilities - finance lease
8,688
7,410
20,957
20,491
Operating lease cost
46,255
39,764
89,539
79,529
Total lease cost
$ 79,581
$ 101,351
$ 210,611
$ 250,440
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash paid from finance leases
$ ( 29,941 )
$ ( 92,975 )
$ ( 119,251 )
$ ( 193,241 )
Operating cash paid from operating leases
( 40,914 )
( 31,443 )
( 81,829 )
( 56,238 )
SCHEDULE OF BALANCE SHEET INFORMATION RELATING TO LEASES
Operating leases:
June 30,
2026
December 31,
2025
Operating lease right-of-use, assets
$ 769,270
$ 334,289
Operating lease liability, current
$ 163,276
$ 139,220
Operating lease liability, non-current
$ 637,643
$ 202,878
Total operating lease liabilities
$ 800,919
$ 342,098
Finance leases:
June 30,
2026
December 31,
2025
Finance lease right-of-use asset, gross
$ 642,677
$ 1,184,598
Accumulated amortization
( 80,490 )
( 523,023 )
Finance lease right-of-use asset, net
$ 562,187
$ 661,575
Finance lease liability, current portion
$ 79,592
$ 139,490
Finance lease liability, long-term
495,468
532,759
Total finance lease liabilities
$ 575,060
$ 672,249
Weighted-average remaining lease term:
June 30,
2026
December 31,
2025
Operating leases (in years)
4.33
3.04
Finance leases (in years)
6.29
6.18
Weighted-average discount rate:
June 30,
2026
December 31,
2025
Operating leases
6.84 %
7.28 %
Finance leases
6.76 %
6.86 %
Future
minimum lease payments under non-cancellable lease as of June 30, 2026, are as follows:
SCHEDULE OF FUTURE MINIMUM LEASE PAYMENT UNDER NON-CANCELLABLE
Operating
Leases
Finance
Leases
Remaining for 2026
$ 100,693
$
59,881
2027
206,615
111,708
2028
214,859
111,708
2029
223,465
111,708
2030
166,039
111,708
2031 and thereafter
19,637
197,893
Total undiscounted cash flows
931,308
704,606
Less discounting
( 130,389 )
( 129,546
)
Present value of lease liabilities
$ 800,919
$
575,060
17
Note
10. NOTES PAYABLE
Vehicles
Notes Payable
On
January 10, 2025, the Company entered into a second finance agreement to purchase a 2024 Toyota Corolla for $ 33,517 with a maturity
date of January 18, 2031 . The loan bears fixed interest at a rate of 11.65 % per annum, with monthly payments of $ 651 , which is
comprised of principal and interest. This loan is collateralized by the underlying vehicle. The balance of this loan as of June 30,
2026, and December 31, 2025, was $ 27,546 and $ 29,774 , respectively. The current portion of the balance of this loan as of June 30,
2026, and December 31, 2025, was $ 4,861 and $ 4,588 , respectively.
On
March 18, 2024, the Company entered into a finance agreement to purchase a 2024 Toyota Corolla for $ 33,620 with a maturity date of February
18, 2030 . The loan bears fixed interest at a rate of 5.99 % per annum, with monthly payments of $ 467 , which is comprised of principal
and interest. This loan is collateralized by the underlying vehicle. The balance of this loan as of June 30, 2026, and December 31, 2025,
was $ 18,406 and $ 20,618 , respectively. The current portion of the balance of this loan as of June 30, 2026, and December 31, 2025, was
$ 4,627 and $ 4,491 , respectively.
Directors
and Officers Insurance Policy – 2025
In
September 2025, the Company obtained short-term financing of approximately $ 260,000 with 11 monthly payments of approximately $ 24,000
and interest at a 6.7 % fixed annual rate for director and officer insurance policies. The current portion of the balance of this loan
as of June 30, 2026, and December 31, 2025, was $ 13,073 and $ 90,002 , respectively.
Note
11. COMMITMENTS AND CONTINGENCIES
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
12. CONVERTIBLE PREFERRED AND COMMON STOCK
Convertible
Preferred Stock
The
Company has authorized a total of 20,000,000 shares of $ 0.001 per share par value Preferred Stock. The Company has issued 450 shares
of Preferred Stock, designated as Series B. In August 2025, the Company entered into a securities purchase agreement with certain institutional
and accredited investors, pursuant to which the Company agreed to issue and sell, in a private placement, (i) 990 shares of the Company’s
newly designated Series B Convertible Preferred Stock, with a par value $ 0.001 per share and stated value of $ 1,000 per share initially
convertible into 143,476 shares of the Company’s Common Stock, par value $ 0.007 per share at an initial conversion price of $ 6.90
per share and (ii) warrants to purchase up to 223,824 shares of the Company’s Common Stock at an exercise price of $ 10.56 per share
of Common Stock. As of June 30, 2026, the investors have converted 540 of the 990 Series B Convertible Preferred Stock in exchange for
125,359 shares of Common Stock. The holders of the Series B Preferred Stock have various rights as follows:
Voting
Rights . Except as otherwise required by law, holders of Series B Preferred Stock shall not be entitled to any voting rights.
18
Dividends.
The holders of Series B Preferred Stock shall be entitled to receive dividends on shares of Series B Preferred Stock equal (on an as-if-converted-to-Common-Stock
basis) to and in the same form as dividends actually paid on shares of the Common Stock when, as, and if such dividends are paid on shares
of the Common Stock.
Conversion.
The Series B Preferred Stock will be convertible into shares of Common Stock at an initial conversion price of $ 6.90 per share (the
“Conversion Price”). Each share of Series B Preferred Stock shall be convertible into such number of shares of Common Stock
that results from dividing the Stated Value by the Conversion Price. Holders of Series B Preferred Stock are prohibited from converting
shares of Series B Preferred Stock into shares of Common Stock if, as a result of such conversion, such holder, together with its affiliates,
would beneficially own in excess of 4.99% of the total number of shares of Common Stock issued and outstanding immediately after giving
effect to such conversion. If and whenever on or after the date on which the Company obtains the Preferred Stockholder Approval, the
Company is deemed to have issued or sold any shares of Common Stock for a consideration per share less than the Conversion Price, the
Conversion Price will be reduced to such new issuance price subject to a floor price of $ 3.00 per share.
Common
Stock
The
Company has authorized a total of 350,000,000 shares of Common Stock, $ 0.007 par value per share. The Company has issued 6,783,061 shares
of Common Stock, of which 3,859 are unvested restricted stock awards as of June 30, 2026, and 4,498,675 shares of Common Stock, of which
4,371 are unvested restricted stock awards as of December 31, 2025.
On
May 22, 2025, the Company entered into an at-the-market issuance sales agreement (the “ATM Agreement”) with WallachBeth Capital
LLC (“WallachBeth”), as sales agent providing for the sale of Common Stock from time to time in an “at the market offering”
program. The aggregate market value of the shares of Common Stock eligible for sale is currently $ 5,801,000 . The ATM Agreement provides
that WallachBeth will receive 3.0 % of the gross sales price sold under the ATM Agreement. From May 22, 2025, through June 30, 2026, the
Company sold 114,672 shares of Common Stock through the ATM Agreement which accumulated approximately $ 1.2 million in gross proceeds.
In
June 2026, the Company consummated a best efforts public offering of an aggregate of (i) 1,040,000 shares of Common Stock, par value
$ 0.007 per share and (ii) pre-funded warrants to purchase up to 2,960,000 shares of Common Stock in lieu of Shares. Each Share was sold
at a public offering price of $ 0.80 . Each Pre-Funded Warrant was sold at a public offering price of $ 0.793 . The aggregate gross proceeds
from the Offering were approximately $ 3.2 million, before deducting placement agent fees and other offering expenses. The Company intends
to use the proceeds of the Offering for working capital and other general corporate purposes. The Company issued 4,000,000 shares of
Common Stock at $ 0.80 , of which 2,960,000 were issued as prefunded warrants. As of June 30, 2026, 1,000,000 prefunded warrants had been
exercised.
19
Note
13. STOCK-BASED COMPENSATION
Under
the Company’s 2024 Equity Incentive Plan (the “2024 Plan”), the Company is authorized to grant options or restricted
stock for up to 1,000,000 shares of Common Stock. On April 30, 2026, at the Company’s annual meeting of shareholders, the Company’s
shareholders approved an amendment to the 2024 Plan to increase the number of shares of Common Stock authorized for issuance under the
2024 Plan from 66,666 shares to 1,000,000 shares. 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. The Company’s 2024 Plan was approved at the Annual
Meeting of Shareholders on June 4, 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 statements of operations:
SUMMARY OF STOCK-BASED COMPENSATION EXPENSE RECOGNIZED FOR STOCK OPTION AWARDS
2026
2025
2026
2025
Three Months Ended
June 30,
Six Months Ended
June 30,
2026
2025
2026
2025
Research and development
$ 17,780
$ ( 8,334 )
$ 18,854
$ 12,916
General and administrative
767,161
219,941
780,427
525,307
Total stock-based compensation
expense
$ 784,941
$ 211,607
$ 799,281
$ 538,223
The
following table summarizes stock option activity under the 2014 Plan and 2024 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, 2025
9,055
$ 211.56
3.67
—
Granted
343,780
1.59
9.94
—
Exercised
—
—
—
—
Forfeited
—
—
—
—
Outstanding at June 30, 2026
352,835
$ 6.98
9.76
—
Vested and exercisable at June 30, 2026
352,835
$ 6.98
9.76
—
As
of June 30, 2026, there was no unrecognized compensation cost related to unvested stock options.
The
following table summarizes restricted stock award activity under the 2014 Plan and 2024 Plan:
SUMMARY OF RESTRICTED STOCK AWARD
As of June 30, 2026
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, 2025
51,810
$ 51.87
$ 2,709,982
47,951
3,859
Granted
161,055
1.56
251,246
161,055
—
Forfeited
—
—
—
—
—
Balance at June 30, 2026
212,865
$ 13.91
$ 2,961,228
209,006
3,859
During
the six months ended June 30, 2026, the Company issued restricted stock awards (“RSAs”) for 161,567 shares of Common Stock
to employees, non-employees, and the board of directors. The shares vested immediately. During the six months ended June 30, 2026, 512
shares vested from RSAs granted prior to January 1, 2026, and 161,055 shares vested from RSAs granted during the six months ended June
30, 2026.
20
Note
14. WARRANTS
The
Company’s outstanding Common Stock warrants are equity classified. As of June 30, 2026, and December 31, 2025, the Company had
1,833,894 warrants outstanding to purchase one share of the Company’s Common Stock for each warrant at an average exercise price
of $ 22.35 and 1,348,494 warrants outstanding at a weighted average exercise price of $ 28.44 , respectively, and expire at various dates
through June 2031. During the six months ended June 30, 2026, no warrants were exercised compared to the six months ended June 30, 2025,
and a total number of 162,333 warrants were exercised into an equivalent number of shares of Common Stock.
As
of June 30, 2026, there were tradeable warrants to purchase up to an aggregate of 53,375 shares of Common Stock outstanding and non-tradeable
warrants to purchase an aggregate of up to 1,780,519 shares of Common Stock outstanding.
SCHEDULE OF CLASS OF WARRANT
Number of
warrants
issued
Weighted-
average
exercise price
Number of
warrants exercised
Number of
warrants outstanding
Pre-IPO convertible notes
96,616
$ 159.35
—
96,616
IPO tradeable
77,561
91.95
( 24,186 )
53,375
IPO non-tradeable
100,515
91.95
( 10,366 )
90,149
Direct offering March 2024
53,330
37.50
( 35,553 )
17,777
Placement agent direct offering March 2024
1,066
2.40
—
1,066
Inducement/direct offering August 2024
58,402
—
( 58,402 )
—
Placement agent direct offering August 2024
1,659
2.40
—
1,659
Direct offering October 2024
88,757
23.92
( 59,544 )
29,213
Warrant inducement February 2025
97,538
25.50
—
97,538
Public offering May 2025
1,470,673
4.50
( 781,262 )
689,411
PIPE/Inducement offering August 2025
637,090
4.5
—
637,090
Placement agent direct offering June 2026
120,000
0.88
—
120,000
Balance at June 30, 2026
2,803,207
$ 21.46
( 969,313 )
1,833,894
Note
15. SUBSEQUENT EVENTS
In
December 2025, the Company entered into a services agreement with IRTH Communication, LLC for investor relations, financial communications
and strategic consulting. Per the agreement, the Company was to issue $ 125,000 worth of Common Stock calculated by the average closing
price of the Company’s common stock on its principal exchange for the ten (10) trading days immediately prior to execution of the
Agreement. In July 2026, the Company issued 92,524 shares of Common Stock at $ 1.35 per the consulting agreement.
In
July 2026, holders of the Company’s Series B Convertible Preferred Stock elected to convert 150 shares of such Series B Convertible
Preferred Stock into an aggregate of 49,999 shares of Common Stock in accordance with the Convertible Preferred Stock described in Note
12 .
In
July and August 2026, investors in the June direct offering, described in Note 12, exercised an additional 1,180,000 pre-funded
warrants convertible into an equivalent number of Common Stock.
In
July 2026, the Company announced a collaboration with Pictor®, Inc. (“Pictor”), a targeted proteomic platform company,
to support development and commercialization of bioAffinity Technologies’ next-generation diagnostic tests designed to provide
a more complete picture of lung inflammation in patients with asthma and COPD. Pictor. is led by CEO and Managing Director Jamie Platt,
PhD, a recognized diagnostics executive who joined bioAffinity Technologies’ Board of Directors in 2023.
In July 2026, the
Company received notice from Nasdaq noting the Company’s bid price for its Common Stock closed at less than $1 per share over
the previous 30 consecutive business days as of July 29, 2026, and has not regained compliance according to Listing Rule 5550(a)(2).
As of August 6, 2026 the Company requested a hearing appeal on the determination. Such request will stay any further action by Nasdaq
and will allow the Company’s ordinary shares to continue to trade on Nasdaq under the symbol “BIAF” at least pending
the issuance of the Panel’s decision and the expiration of any extension the Panel may grant to the Company following the appeal.
21
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, 2025, included in the
2025 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
2025 Form 10-K.
Data
as of and for the three and six months ended June 30, 2026 and 2025, 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 three months and six months ended June 30, 2026, to the comparable
period in 2025.
●
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
We
develop noninvasive diagnostics to detect early-stage lung cancer and other diseases of the lung using flow cytometry and automated analysis
developed by machine learning, a form of AI. Our commercial test, CyPath ® Lung, is a noninvasive diagnostic that analyzes
sputum using flow cytometry and automated analysis built with machine learning. Building on this proprietary platform, the Company is
developing noninvasive tests to quantify lung inflammation with the aim of commercializing precision diagnostics to assist physicians
when determining the most effective drug to prescribe patients with asthma and COPD. bioAffinity Technologies also is advancing its proprietary
therapeutic discoveries, focusing on developing the dermal delivery of drugs developed by the Company containing self-delivering, stabilized
siRNAs that selectively kill squamous and basal carcinoma cells while leaving non-cancerous cutaneous cells unharmed.
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 worldwide. Physicians 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 identify patients who
will likely benefit from timely intervention and more invasive follow-up procedures and those who are likely without lung cancer and
should continue routine 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.
Commercial
laboratory services, including CyPath ® Lung, are performed at our wholly owned subsidiary PPLS which we acquired by purchasing
the assets of Village Oaks Pathology Services, P.A., a Texas professional association d/b/a Precision Pathology Services, that included
the CAP-accredited and CLIA-certified commercial laboratory it owned. We now own and operate the clinical anatomic and clinical pathology
laboratory. CyPath ® Lung is offered for sale to physicians by PPLS.
22
Through
our wholly owned subsidiary, OncoSelect ® Therapeutics, LLC, we have conducted research that has led to discoveries and
advancement of novel cancer therapeutic approaches that specifically and selectively target cancer cells. We will continue to present
our findings at academic and industry conferences and expect to publish our research findings in peer-reviewed journals. We intend to
seek strategic partners as we progress into in vivo studies to develop our therapeutics targeted at squamous and basal cell skin cancers.
Research
and optimization of our platform technologies are now conducted in laboratories at our wholly owned subsidiary PPLS and leased laboratory
space.
Current
Year Financial Highlights
Key
financial results for the six months ended June 30, 2026, include:
●
Unit
sales for CyPath® Lung diagnostic in the second quarter of 2026 achieved 216% growth compared to the second quarter of 2025,
reflecting accelerating physician adoption and expanding clinical use of the Company’s noninvasive lung cancer diagnostic test.
●
CyPath ®
Lung testing revenue increased approximately 156% to $835,000 for the six months ended June 30, 2026, as compared to $323,000 for
the six months ended June 30, 2025.
●
The
Company raised approximately $3.2 million in gross proceeds from an equity transaction in the second quarter to fund operating activities.
Recent
Developments
● In July 2026, the Company surpassed the total number of tests completed in all of 2025, delivering more than 1,200
CyPath ® Lung test reports to physicians.
● The
number of physician offices and clinics ordering CyPath ® Lung for their patients
increased 122% during the second quarter of 2026 compared to the same period in 2025.
● In July 2026, the Company received notice from Nasdaq noting the Company’s bid price for its Common Stock closed at less than $1
per share over the previous 30 consecutive business days as of July 29, 2026, and has not regained compliance according to Listing Rule
5550(a)(2). As of August 6, 2026 the Company requested a hearing appeal on the determination. Such request will stay any further action
by Nasdaq and will allow the Company’s ordinary shares to continue to trade on Nasdaq under the symbol “BIAF” at least
pending the issuance of the Panel’s decision and the expiration of any extension the Panel may grant to the Company following the
appeal.
● On
July 27, 2026, the Company published a comprehensive clinical review and white paper authored
by Chief Medical Officer Gordon H. Downie, MD, PhD, that presents a practical clinical framework
for incorporating CyPath ® Lung into pulmonary nodule evaluation and cancer
surveillance. The review is titled “Lung Nodules, Lung Microenvironment, Predictive
Models and Clinician Risk Stratification Using CyPath® Lung Testing for Early Diagnosis
of Lung Cancer.”
● On July 22, 2026, the Company announced a collaboration with Pictor®,
Inc., a targeted proteomic platform company, to support development and commercialization of bioAffinity Technologies’ next-generation
diagnostic tests designed to provide a more complete picture of lung inflammation in patients with asthma and COPD.
● As
of June 30, 2026, 11 clinical sites have been activated for the CyPath ® Lung
longitudinal clinical trial that opened in March 2026, including nine Department of Veterans
Affairs (VA) and military medical centers that have begun patient enrollment. Financial support
for the trial has been provided by the John P. Murtha Cancer Center Research Program (MCCRP),
a research program within the Department of Surgery at the Uniformed Services University
of the Health Sciences in Bethesda, Maryland.
● On
June 22, 2026, the Company presented positive results from preliminary therapeutic studies
to advance treatments delivered topically for squamous and basal cell skin cancers showing
that their self-delivering, stabilized siRNAs selectively kill squamous and basal carcinoma
cells while leaving non-cancerous cutaneous cells unharmed.
● On
June 16, 2025, The Society for Advanced Bronchoscopy (“SAB”) and on July 21,
2026, the National Association of Veterans’ Research Education Foundations (“NAVREF”)
hosted webinars featuring multi-disciplinary panels of physicians who discussed CyPath Lung’s
expanding role in the lung nodule care continuum.
● On
May 27, 2026, bioAffinity announced it received notification of allowance from the Mexican
Institute of Industrial Property for a patent application protecting the use of defined antibodies
and the porphyrin TCPP to label cell populations in sputum and the use of flow cytometry
to determine the presence of lung cancer cells in sputum.
23
Recent
Financings
On
June 16, 2026, the Company consummated a best-efforts public offering of an aggregate of (i) 1,040,000 shares of Common Stock, par value
$0.007 per share and (ii) pre-funded warrants to purchase up to 2,960,000 shares of Common Stock in lieu of shares. Each share was sold
at a public offering price of $0.80. Each pre-funded warrant was sold at a public offering price of $0.793. The aggregate gross proceeds
from the offering were approximately $3.2 million, before deducting placement agent fees and other offering expenses. The Company intends
to use the proceeds of the Offering for working capital and other general corporate purposes. As of June 30, 2026, 1,000,000 of the prefunded
warrants had been exercised.
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 and public sales of our
equity, issuance of debt, and the exercise of outstanding warrants and stock options. As of June 30, 2026, we had cash and cash equivalents
of $2.4 million. As of August 3, 2026, we had cash and cash equivalents of $1.0 million, which we expect will support our operations
through August 2026. We have incurred significant losses and negative cash flows from operations since inception and expect to continue
to incur losses and negative cash flows for the foreseeable future. Based on the Company’s current expected level of operating
expenditures and the cash and cash equivalents on hand at June 30, 2026, 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 condensed consolidated financial statements.
Prior
to acquisition of the clinical pathology laboratory by PPLS, Village Oaks, under the trade name Precision Pathology Services, had licensed
and developed CyPath ® Lung as a laboratory developed test (“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 June 30, 2026, we had working capital of approximately $1.2 million and an accumulated
deficit of approximately $75.6 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.
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.
24
Results
of Operations
Three
Months Ended June 30, 2026, Compared to Three Months Ended June 30, 2025
Net
loss for the three months ended June 30, 2026, was approximately $3.4 million, compared to a net loss of approximately $4.1 million for
the three months ended June 30, 2025.
Revenue
PPLS
generates three sources of revenue: (1) patient service fees, (2) histology service fees, and (3) medical director fees. The Company
recognizes as revenue the amount that reflects the consideration to which it expects to be entitled in exchange for goods sold or services
rendered primarily upon completion of the testing process (when results are reported) or when services have been rendered.
For the Three Months Ended
June 30,
2026
2025
Patient service fees 1
$ 1,244,142
$ 942,067
Histology service fees
248,260
308,604
Medical director fees
17,544
17,309
Department of War observational studies
—
—
Other revenues
633
1,503
Total net revenue
$ 1,510,579
$ 1,269,483
1
Patient services fees include direct billing for CyPath ® Lung diagnostic tests and anatomical testing and pathology
services wholly unrelated to CyPath ® Lung including those services discontinued due to unprofitability.
Net
revenue totaled approximately $1.5 million and $1.3 million for the three months ended June 30, 2026 and 2025, respectively. Consolidated
revenue increased approximately $0.2 million, or 19%, to $1.5 million for the three months ended June 30, 2026, as compared to $1.3 million
for the three months ended June 30, 2025, primarily as a result of growth in CyPath ® Lung testing revenue, partially offset
by the Company’s targeted strategic actions taken in March 2025 to discontinue certain unprofitable pathology services. CyPath ®
Lung testing revenue increased approximately $321,000, or 210%, to $474,000 for the three months ended June 30, 2026, compared to $153,000
for the three months ended June 30, 2025, as a result of a total of 622 test results delivered for the three months ended June 30, 2026,
compared to 197 tests for the three months ended June 30, 2025
Operating
Expenses
Three Months Ended
Change in 2026
June 30,
Versus 2025
2026
2025
$
%
Operating expenses:
Direct costs and expenses
$ 1,087,837
$ 1,016,602
$ 71,235
7 %
Research and development
361,575
311,372
50,203
16 %
Clinical development
475,885
129,279
346,606
268 %
Selling, general and administrative
2,858,590
2,214,561
644,029
29 %
Depreciation and amortization
61,556
113,229
(51,673 )
(46 )%
Total operating expenses
$ 4,845,443
$ 3,785,043
$ 1,060,400
28 %
Operating
expenses totaled approximately $4.8 million and $3.8 million during the three months ended June 30, 2026 and 2025, respectively. The
increase in operating expenses is the result of the following factors:
Direct
costs and expenses
Our
direct costs and expenses consist primarily of direct labor for pathology services, laboratory supplies and reagents, laboratory equipment,
and allocated shared facilities. Direct costs and expenses totaled $1.1 million and $1.0 million during the three months ended June 30,
2026 and 2025, respectively. The costs were consistent compared to the same period in prior year, with an increase of $70,000 attributable
to the addition of personnel to process tests related to the sale of CyPath ® Lung, as well as to process tests related
to our clinical study.
25
Research
and Development Expenses
Our
research and development expenses consist primarily of expenditures for lab operations, preclinical studies, compensation, and consulting
costs.
Research
and development expenses totaled approximately $362,000 and $311,000 for the three months ended June 30, 2026 and 2025, respectively.
The increase of $50,000, or 16%, for the three months ended June 30, 2026, compared to the same period in 2025 was primarily attributable
to an increase in lab supplies and moving costs related to relocating our laboratory facilities in June 2026.
Clinical
Development
Clinical
development expenses totaled approximately $476,000 and $129,000 for the three months ended June 30, 2026 and 2025, respectively. The
increase of $347,000, or 268%, for the three months ended June 30, 2026, compared to the same period in 2025 was primarily attributable
to opening clinical trial sites and enrolling patients in our longitudinal clinical trial opened in March 2026. As of June 30, 2026,
11 clinical sites have been activated for enrollment, including nine Department of Veterans Affairs (VA) and military medical centers
that have begun patient enrollment. Financial support for the trial has been provided by t he John P. Murtha Cancer Center Research Program
(MCCRP), a research program within the Department of Surgery at the Uniformed Services University of the Health Sciences in Bethesda,
Maryland.
Selling,
General and Administrative
Our
selling, general and administrative expenses consist primarily of expenditures related to employee compensation, selling and marketing
costs, legal, accounting, tax and other professional services, and general operating expenses.
Selling,
general and administrative expenses totaled approximately $2.9 million and $2.2 million for the three months ended June 30, 2026 and
2025, respectively. The increase of approximately $644,000, or 29%, for the three months ended June 30, 2026, compared to the same period
in 2025 was primarily attributable to an increase in stock compensation expense, sales and marketing costs due to additional
personnel and support services to expand sales of our diagnostic test, CyPath ® Lung.
Depreciation
and Amortization
Depreciation
and amortization expenses totaled $62,000 and $113,000 for the three months ended June 30, 2026 and 2025, respectively. The decrease
of approximately $51,000, or 46%, for the three months ended June 30, 2026, compared to the same period in 2025 was primarily attributable
to the termination of a financing lease in April 2025 due to the Company’s targeted strategic actions announced in March 2025.
Other
Income (Expense)
Three Months Ended
Change in 2026
June 30,
Versus 2025
2026
2025
$
%
Interest (expense) income, net
$ (8,330 )
$ (8,435 )
$ 105
(1 )%
Other income (expense), net
(22,888 )
(444,990 )
422,102
(95 )%
Gain (loss) on remeasurement of warrant liabilities
—
(1,062,818 )
1,062,818
— %
Total other (expense) income
$ (31,218 )
$ (1,516,243 )
$ 1,485,025
(98 )%
Total
other income (expense), net totaled approximately ($30,000) and ($1.5 million) for the three months ended June 30, 2026 and 2025, respectively.
The decrease in the total other expenses of approximately $1.5 million is mostly attributable to the remeasurement of warrant liability
and offering costs related to the May 2025 public offering.
26
Six
Months Ended June 30, 2026, Compared to Six Months Ended June 30, 2025
Net
loss for the six months ended June 30, 2026, was approximately $7.0 million, compared to a net loss of approximately $6.7 million for
the six months ended June 30, 2025.
Revenue
PPLS
generates three sources of revenue: (1) patient service fees, (2) histology service fees, and (3) medical director fees. The Company
recognizes as revenue the amount that reflects the consideration to which it expects to be entitled in exchange for goods sold or services
rendered primarily upon completion of the testing process (when results are reported) or when services have been rendered.
For the Six Months Ended
June 30,
2026
2025
Patient service fees 1
$ 2,326,352
$ 2,512,449
Histology service fees
498,776
572,358
Medical director fees
35,005
33,897
Department of War observational studies
1,131
—
Other revenues
843
4,376
Total net revenue
$ 2,862,106
$ 3,123,080
1
Patient services fees include direct billing for CyPath ® Lung diagnostic tests and anatomical testing and pathology
services wholly unrelated to CyPath ® Lung. Revenues for 2025 include PPLS anatomical services discontinued in March 2025
due to unprofitability.
Consolidated
revenue decreased approximately $0.3 million, or 8%, to approximately $2.9 million for the six months ended June 30, 2026, as compared
to $3.1 million for the six months ended June 30, 2025, primarily as a result of the Company’s targeted strategic actions to discontinue
certain unprofitable pathology services, offset by continuing to drive sales growth for CyPath ® Lung. CyPath ®
Lung testing revenue increased approximately $512,000, or 159%, to $835,000 for the six months ended June 30, 2026, compared to $323,000
for the six months ended June 30, 2025, as a result of a total of approximately 1,100 test results delivered for the six months ended
June 30, 2026, compared to approximately 400 tests for the six months ended June 30, 2025.
Operating
Expenses
Six Months Ended
Change in 2026
June 30,
Versus 2025
2026
2025
$
%
Operating expenses:
Direct costs and expenses
$ 2,016,473
$ 2,384,462
$ (367,989 )
(15 )%
Research and development
711,282
678,758
32,524
5 %
Clinical development
809,925
267,632
542,293
203 %
Selling, general and administrative
6,100,192
4,667,110
1,433,082
31 %
Depreciation and amortization
176,074
267,817
(91,743 )
(34 )%
Total operating expenses
$ 9,813,946
$ 8,265,779
$ (571,292 )
19 %
Operating
expenses totaled approximately $9.8 million and $8.3 million during the six months ended June 30, 2026 and 2025, respectively. The increase
in operating expenses is the result of the following factors:
Direct
costs and expenses
Our
direct costs and expenses consist primarily of direct labor for pathology services, laboratory supplies and reagents, laboratory equipment,
and allocated shared facilities. Direct costs and expenses totaled approximately $2.0 million and $2.4 million during the six months
ended June 30, 2026 and 2025, respectively. The decrease of approximately $0.4 million, or 15%, for 2026 compared to 2025 was primarily
attributable to the targeted strategic actions which occurred in March 2025, aimed at streamlining operations and reducing costs related
to our lab operations, partially offset by increases attributable to the addition of personnel to process tests related to the sale of
CyPath ® Lung and to our clinical study.
27
Research
and Development Expenses
Our
research and development expenses consist primarily of expenditures for laboratory operations, preclinical and clinical studies, compensation,
and consulting costs.
Research
and development expenses totaled $0.7 million for the six months ended June 30, 2026 and 2025, respectively. While there was no significant
change, we expect that research and development expenses will increase as we develop our flow cytometry platform to address the need
to identify patients who may benefit from existing and emerging therapies for asthma and COPD with noninvasive precision diagnostic tests
and research pertaining to the dermal delivery of drugs developed by the Company containing self-delivering, stabilized siRNAs that selectively
kill squamous and basal carcinoma cells while leaving non-cancerous cutaneous cells unharmed..
Clinical
Development
Clinical
development expenses totaled approximately $0.8 million and $0.3 million for the six months ended June 30, 2026 and 2025, respectively.
The increase of approximately $0.5 million, or 203%, for the six months ended June 30, 2026, compared to the same period in 2025 was
primarily attributable to an increase in professional fees in 2026 related to managing our clinical strategy for our clinical trial that
began in March 2026, as well as costs to open 11 clinical trial sites that have begun patient enrollment as of June 30, 2026.
Selling,
General and Administrative
Our
selling, general and administrative expenses consist primarily of expenditures related to employee compensation, selling and marketing
costs, legal, accounting and tax, and other professional services, and general operating expenses.
Selling,
general and administrative expenses totaled approximately $6.1 million and $4.7 million for the six months ended June 30, 2026 and 2025,
respectively. Our selling, general and administrative cost increase was primarily attributable to an increase in employee compensation
related to stock compensation, administrative and sales due to additional personnel and support services to support the growth of sales
of our diagnostic test, CyPath ® Lung.
Depreciation
and Amortization
Depreciation
and amortization expenses totaled approximately $176,000 and $268,000 for the six months ended June 30, 2026 and 2025, respectively.
The decrease of approximately $92,000, or 34%, for the six months ended June 30, 2026, compared to the same period in 2025 was primarily
attributable to the termination of a financing lease in April 2025 due to the Company’s targeted strategic actions announced in
March 2025.
Six Months Ended
Change in 2026
June 30,
Versus 2025
2026
2025
$
%
Interest (expense) income, net
$ (13,026 )
$ (23,378 )
$ 10,352
(44 )%
Other income (expense), net
(31,826 )
(454,630 )
422,804
(93 )%
Gain (loss) on remeasurement of warrant liabilities
—
(1,062,818 )
1,062,818
(91 )%
Total other (expense) income
$ (44,852 )
$ (1,540,826 )
$ 1,495,974
(313 )%
28
Other
Income (Expense)
Total
other income (expense), net totaled approximately ($45,000) and ($1.5 million) for the six months ended June 30, 2026 and 2025, respectively.
The decrease in the total other expenses of approximately $1.5 million is mostly attributable to the remeasurement of warrant liability
and offering costs related to the May 2025 public offering.
Liquidity,
Capital Resources, and Going Concern
To
date, we have funded our operations primarily through our IPO, exercise of stock options and warrants, and the sale of our securities,
resulting in gross proceeds of approximately $61.4 million. We have evaluated whether there are conditions and events that raise substantial
doubt about our 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 six months ended
June 30, 2026 and 2025, we had net losses of $7.0 million and $6.7 million, respectively, and we expect to incur substantial additional
losses in future periods. We have an accumulated deficit of approximately $75.6 million as of June 30, 2026. Despite our recent financing
in June 2026 in which we raised gross proceeds of $3.2 million, we believe our current cash and anticipated revenue from operations will
not be sufficient to support our operations through August 2026. Based on our current expected level of operating expenditures, current
expected levels of revenue, and the cash and cash equivalents on hand at June 30, 2026, of $2.4 million, management concludes that there
is substantial doubt about our 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 contained in this Quarterly Report. We need to raise further
capital through the sale of additional equity or debt securities or other debt instruments, strategic relationships or grants, or through
exercised outstanding warrants to support our future operations unless our revenue increases significantly. 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:
Six Months Ended
June 30,
2026
2025
Cash and cash equivalents at beginning of period
$ 6,449,782
$ 1,105,291
Net cash used in operating activities
(6,428,344 )
(4,288,981 )
Net cash used in investing activities
(95,633 )
(64,213 )
Net cash provided by financing activities
2,503,914
4,050,738
Cash and cash equivalents at end of period
$ 2,429,719
$ 802,835
Net
Cash Used in Operating Activities
Net
cash used in operating activities was approximately $6.4 million and $4.3 million for the six months ended June 30, 2026 and 2025, respectively.
The increase of approximately $2.4 million in cash used by operations during the six months ended June 30, 2026, compared to the same
period in 2025 was primarily attributable to an increase of $0.3 million in our loss from operations offset by a decrease in accounts
receivable by $1.1 million compared to the prior year, an increase of stock based compensation of $0.3 million compared to the prior
year, and a fair value adjustment to the warrant liability by $1.1 million related to the May 2025 warrant agreement.
29
Net
Cash Used in Investing Activities
We
used approximately $96,000 for the six months ended June 30, 2026, in investing activities related primarily to purchase of computer
and lab equipment, compared to approximately $64,000 used in investing activities for the six months ended June 30, 2025.
Net
Cash Provided by Financing Activities
Cash
provided in financing activities was approximately $2.5 million compared to cash provided by financing activities of approximately $4.1
million for the six months ended June 30, 2026 and 2025, respectively. The change in proceeds from prior year was primarily related to
net proceeds from the equity transactions of $2.7 million offset by payments for loans and finance leases of $0.1 million, compared to
the prior year net proceeds of $4.4 million offset by payments for loans and finance leases of $0.2 million.
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-cancellable 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. The Company
follows a standard process, which considers historical denial and collection experience and other factors (including the period of time
that the receivables have been outstanding), to estimate contractual allowances and implicit price concessions, recording adjustments
in the current period as changes in estimates. The process for estimating revenues and the ultimate collection of accounts receivable
involves significant judgment and estimation.
Patient
Fee Receivables and Considerations for Credit Losses
We
follow accounting considerations of CECL - Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on
Financial Instruments. With the acquisition of PPLS and control of Village Oaks, the Company’s board-certified pathologists
provide anatomic and clinical pathology services for patients and other customers. The Company’s other customer types include contract
research organizations (“CROs”), hospitals, and independent laboratories. The majority of the Company’s revenues stem
from fees for services provided to patients, and thus, in those arrangements, the patient is the customer, although the services may
be requested by a physician on the patient’s behalf. Furthermore, in addition to its contracts with patients, the Company separately
contracts with third-party payors (insurance companies and governmental payors), who are typically responsible for all or the majority
of the fees agreed upon for such services provided to patients. Historically, material amounts of gross charges are not collected due
to various agreements with insurance companies, capped pricing levels for government payors, and uncollectible balances from individual
payers. To estimate these allowances of credit losses, the Company assesses the portfolio risk segments and historical data on collection
rates. These estimated allowances offset patient revenues and accounts receivables.
30
Discount
Rate for Finance Leased Equipment
We
follow ASC 842, Leases . In February 2016, the FASB issued Topic ASC 842, under which a lessee is required to recognize most leases
on its balance sheet. The Company has elected to apply a third-party valuation incremental borrowing rate (“IBR”) as the
discount rate by class of underlying assets when the rate is not implicit in the lease.
Share-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. As such, as 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.
Assessment
of Goodwill and Intangible Assets
Our
indefinite-lived assets include goodwill and intangible assets resulting from the acquisition of PPLS. Goodwill represents the purchase
price in excess of fair values assigned to the underlying identifiable net assets of the acquired business. Goodwill and intangible assets
are reviewed annually for impairment unless circumstances dictate the need for more frequent assessment.
In
performing impairment tests for our goodwill in 2025, in accordance with ASC 350 - Intangibles – Goodwill and Other , we
opted to complete a quantitative assessment at the PPLS level as opposed to relying on a qualitative assessment as permitted in the guidance.
This quantitative assessment required that the estimated fair value of PPLS’ net assets, including goodwill, be calculated and
compared to the carrying amount. If that estimated fair value is in excess of the carrying amount, no impairment is recognized. We performed
this assessment as of December 31, 2025. We estimated the fair value of the net assets tested using a discounted cash flow model. The
income-based approach required significant judgment to estimate future cash flows, including revenue growth inclusive of long-term growth
rate assumptions and the discount rate. Significant changes in our estimates and assumptions could affect our fair value calculations.
Our estimate of fair value exceeded the carrying amount and therefore resulted in no impairment.
31
Going
Concern
Our
evaluation of our ability to continue as a going concern requires us to evaluate our future sources and uses of cash sufficient to fund
our currently expected operations in conducting research and development activities one year from the date our consolidated financial
statements are issued. We evaluate the probability associated with each source and use of cash resources in making our going concern
determination. The research and development of our diagnostic tests and therapeutic products are inherently subject to uncertainty.
Off-Balance
Sheet Arrangements
We
do not engage in transactions that generate relationships with unconsolidated entities or financial partnerships, such as entities often
referred to as structured finance or special purpose entities, as a part of our ongoing business. Accordingly, we did not have any off-balance
sheet arrangements during any of the periods presented.
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
The
Company has adopted and maintains disclosure controls and procedures that are designed to provide reasonable assurance that information
required to be disclosed in the reports filed under the Exchange Act, such as this Quarterly Report, is collected, recorded, processed,
summarized, and reported within the time periods specified under the rules of the SEC. The term “disclosure controls and procedures,”
as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed
to ensure that 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 rules and forms of the SEC. Disclosure controls and procedures
include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the
reports that it files or submits under the Exchange Act is accumulated and communicated to the Company’s management, including
its principal executive and principal financial officers, or persons performing similar functions, as appropriate, to allow timely decisions
regarding required disclosure. We have adopted and maintain disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e)
under the Exchange Act) that are designed to provide reasonable assurance that information required to be disclosed in the reports filed
under the Exchange Act, such as this Quarterly Report on Form 10-Q, is collected, recorded, processed, summarized, and reported within
the time periods specified in the rules of the SEC. The Company’s disclosure controls and procedures are also designed to ensure
that such information is accumulated and communicated to management to allow timely decisions regarding required disclosure. As of June
30, 2026, 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 Rule 13a-15(e) under the Exchange Act. The Chief
Executive Officer and Chief Financial Officer assessed the effectiveness of our disclosure controls and procedures as of June 30, 2026.
Based on their assessment, they have concluded that as of June 30, 2026, our disclosure controls and procedures are effective.
Changes
in Internal Control over Financial Reporting
There
were no changes in our internal controls (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) over financial reporting
during the three months ended June 30, 2026, the period covered by this Quarterly Report, that could materially affect, or are reasonably
likely to materially affect, our internal control over financial reporting.
32
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.
In
addition to other information set forth in this Quarterly Report, you should carefully consider the “Risk Factors” discussed
in the 2025 Form 10-K 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 2025 Form 10-K. Except as disclosed below, there have been no material changes from
the risk factors disclosed in our 2025 Form 10-K.
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 six months ended June 30, 2026, we generated revenue of approximately $2.9 million,
and $6.2 million during the year ended December 31, 2025.
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 of new diagnostic and therapeutic products;
33
●
Expand
commercialization of CyPath ® Lung as an LDT under the CAP/CLIA guidelines and regulations administered by CMS and
CAP and, if we opt to obtain FDA clearance for our CyPath ® Lung test, to expand sales in accordance with applicable
requirements.
●
Develop
and commercialize CyPath ® Lung as a CE-marked test in accordance with the In Vitro Diagnostic Regulation (“IVDR”)
of the European Union (“EU”);
●
Conduct
research studies resulting in scientific results required to successfully develop therapeutic products based on our discoveries that
the knockdown of certain cell receptors results in cancer death without harm to healthy tissue;
●
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 our value 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 operations. A decline
in our value 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 June 30, 2026, we had an accumulated deficit of $75.6 million and $2.4 million cash on hand. As of August 3, 2026, our cash and cash
equivalents were $1.0 million. Despite our recent financings, we will 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 August
2026. Based on our current expected level of operating expenditures, current expected levels of revenue, and the cash and cash equivalents
on hand at June 30, 2026, of $2.4 million, management concludes that there is substantial doubt about our 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 contained in this Quarterly Report. Our future is dependent upon our ability to obtain financing and upon future profitable
operations from the development of 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, 2025, has included an explanatory paragraph in its opinion that accompanies our audited consolidated financial statements
as of and for the year ended December 31, 2025, indicating that our current liquidity position raises substantial doubt about our ability
to continue as a going concern.
34
We
are unable to precisely estimate when we will begin to generate significant profit from revenue, if ever, from PPLS’ services,
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. Since its acquisition in September 2023, we have generated
$2.5 million in 2023, $9.4 million in 2024, $6.2 million in 2025, and $2.9 million in 2026 in revenue from PPLS. 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.
Risks
Related to Ownership of Our Common Stock and Warrants
We
have received a notice of delisting from Nasdaq due to our failure to maintain the minimum bid price requirement, and there can be no
assurance that we will be able to regain compliance or maintain our listing on The Nasdaq Capital Market.
On
July 30, 2026, we received written notice from the Listing Qualifications Department of Nasdaq indicating that the bid price of our listed
securities had closed at less than $1.00 per share over the previous thirty consecutive business days, and that, as a result, we are
not in compliance with the Minimum Bid Price Requirement for continued listing on The Nasdaq Capital Market set forth in Nasdaq Listing
Rule 5550(a)(2). Pursuant to Nasdaq Listing Rule 5810(c)(3)(A)(iv), we are not eligible for the standard 180-calendar day compliance
period because we effected a 1-for-30 reverse stock split on September 19, 2025, which occurred within the prior one-year period.
We
have submitted an appeal to Nasdaq and intend to present our plans to regain compliance with the Minimum Bid Price Requirement at a hearing
before a Nasdaq Hearings Panel (the “Panel”). However, there can be no assurance that the Panel will grant us any extension
period within which to regain compliance, or that, if any such extension period is granted, we will be able to regain compliance within
such period.
If
we are unable to regain compliance with the Minimum Bid Price Requirement or otherwise satisfy Nasdaq’s continued listing requirements,
our securities could be delisted from The Nasdaq Capital Market. A delisting of our securities could have material adverse consequences,
including, but not limited to: a limited availability of market quotations for our securities; reduced liquidity for our securities,
making it more difficult for stockholders to buy or sell our securities; a determination that our common stock is a “penny stock,”
which would require brokers trading in our common stock to adhere to more stringent rules and possibly result in a reduced level of trading
activity in the secondary trading market for our securities; a limited amount of news and analyst coverage; a decreased ability to issue
additional securities or obtain additional financing in the future; potential loss of confidence by investors, employees, and business
partners; and potential negative reputational effects that could impair our business, financial condition, and results of operations.
In
addition, we may be required to take actions to regain compliance with the Minimum Bid Price Requirement, such as effecting an additional
reverse stock split, which could result in further dilution to our stockholders and may not result in a sustained increase in the per-share
price of our common stock. We previously effected a 1-for-30 reverse stock split on September 19, 2025, and there can be no assurance
that any future reverse stock split, if undertaken, would result in a lasting increase in the market price of our common stock sufficient
to regain or maintain compliance with the Minimum Bid Price Requirement.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
None.
ITEM
3. DEFAULTS UPON SENIOR SECURITIES.
None.
ITEM
4. MINE SAFETY DISCLOSURES.
Not
applicable.
ITEM
5. OTHER INFORMATION.
Rule
10b5-1 Trading Plans
During
the fiscal quarter ended June 30, 2026, none of the Company’s directors or executive officers adopted or terminated any contract,
instruction or written plan for the purchase or sale of Company securities that was intended to satisfy the affirmative defense conditions
of Rule 10b5-1(c) or any “non-Rule 10b5-1 trading arrangement.”
35
ITEM
6. EXHIBITS.
Exhibit
No.
Title
of Document
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.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
104*
Cover
Page Interactive Data File – the cover page from the Registrant’s Quarterly Report on Form 10-Q for the quarter ended
June 30, 2026 is formatted in Inline XBRL
*
Filed herewith.
**
Furnished herewith.
36
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.
Date:
August 7, 2026
By:
/s/
Maria Zannes
Maria
Zannes
Chief
Executive Officer, President, Founder, and Director
(Principal
Executive Officer)
Date:
August 7, 2026
By:
/s/
J. Michael Edwards
J.
Michael Edwards
Vice
President and Chief Financial Officer
(Principal
Financial and Accounting Officer)
37
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.