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 March 31, 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 Sec 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The
number of shares of the issuer’s common stock outstanding as of May 4, 2026, was 4,534,906 .
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 in 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 diagnostic and therapeutic inventions
or future diagnostic and therapeutic inventions to expand our product offerings;
●
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;
●
our
reliance on third parties;
●
the
success of competing 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;
2
●
market
acceptance of our diagnostic tests and therapeutic product candidates, the size and growth of the potential markets for our current
diagnostic tests 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 (“U.S.”), including inflationary pressures, increased
interest rates, economic slowdown or recession, and escalating geopolitical tensions;
●
our
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 or may be exacerbated
by factors such as the ongoing conflict between Ukraine and Russia, escalating tensions between China and Taiwan, conflict in the Middle
East, 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 Annual 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 March 31, 2026 (unaudited) and December 31, 2025
5
Unaudited Condensed Consolidated Statements of Operations for the Three Months ended March 31, 2026 and 2025
6
Unaudited
Condensed Consolidated Statements of Changes in Stockholders’ Equity for the Three Months ended March 31, 2026 and
2025
7
Unaudited Condensed Consolidated Statements of Cash Flows for the Three Months ended March 31, 2026 and 2025
8
Notes to Unaudited Condensed Consolidated Financial Statements
9
ITEM
2 -
Management’s Discussion and Analysis of Financial Condition and Results of Operations
18
ITEM
3 -
Quantitative and Qualitative Disclosures about Market Risk
24
ITEM
4 -
Controls and Procedures
24
PART II
OTHER
INFORMATION
ITEM
1 -
Legal Proceedings
25
ITEM
1A -
Risk Factors
25
ITEM
2 -
Unregistered Sales of Equity Securities and Use of Proceeds
27
ITEM
3 -
Defaults Upon Senior Securities
27
ITEM
4 -
Mine Safety Disclosure
27
ITEM
5 -
Other Information
27
ITEM
6 -
Exhibits
28
Signatures
29
4
PART
I
FINANCIAL
INFORMATION
ITEM
1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS.
bioAffinity
Technologies, Inc.
Condensed
Consolidated Balance Sheets
March 31, 2026
December 31, 2025
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$ 3,098,366
$ 6,449,782
Accounts and other receivables, net
685,235
541,962
Inventory
77,887
53,548
Prepaid expenses and other current assets
479,913
519,916
Total current assets
4,341,401
7,565,208
Non-current assets:
Property and equipment, net
246,849
265,593
Operating lease right-of-use asset, net
651,430
334,289
Finance lease right-of-use asset, net
586,048
661,575
Goodwill
1,404,486
1,404,486
Intangible assets, net
702,222
716,806
Other assets
12,816
12,815
Total assets
$ 7,945,252
$ 10,960,772
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$ 836,211
$ 761,901
Accrued expenses
2,033,924
1,717,989
Unearned revenue
31,140
42,405
Operating lease liability, current portion
142,303
139,220
Finance lease liability, current portion
80,241
139,490
Notes payable, current portion
61,141
105,161
Total current liabilities
3,184,960
2,906,166
Non-current liabilities
Operating lease liability, net of current portion
545,157
202,878
Finance lease liability, net of current portion
514,834
532,759
Notes payable, net of current portion
38,915
41,313
Total liabilities
4,283,866
3,683,116
Commitments and contingencies (See Note 11)
-
-
Stockholders’ equity:
Preferred stock, par value $ 0.001 per share; 20,000,000 shares authorized; 700
shares issued and outstanding at March 31, 2026, and December 31, 2025, respectively
1
1
Common stock, par value $ 0.007 per share; 350,000,000 shares authorized; 4,498,675 shares issued and outstanding as of March 31, 2026, and December 31, 2025
31,464
31,461
Additional paid-in capital
75,814,595
75,800,258
Accumulated deficit
( 72,184,674 )
( 68,554,064 )
Total stockholders’ equity
3,661,386
7,277,656
Total liabilities, and stockholders’ equity
$ 7,945,252
$ 10,960,772
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5
bioAffinity
Technologies, Inc.
Unaudited
Consolidated Statements of Operations
2026
2025
Three Months Ended
March 31,
2026
2025
Net Revenue
$ 1,351,527
$ 1,853,597
Operating expenses:
Direct costs and expenses
928,636
1,367,860
Research and development
349,707
367,386
Clinical development
334,040
138,353
Selling, general and administrative
3,241,602
2,452,549
Depreciation and amortization
114,518
154,588
Total operating expenses
4,968,503
4,480,736
Loss from operations
( 3,616,976 )
( 2,627,139 )
Other income (expense):
Interest income
10,026
542
Interest expense
( 14,722 )
( 15,485 )
Other income
—
2
Other expense
( 8,938 )
( 9,642 )
Total other expense
( 13,634 )
( 24,583 )
Net loss before provision for income taxes
( 3,630,610 )
( 2,651,722 )
Income tax expense
—
( 8,695 )
Net loss
$ ( 3,630,610 )
$ ( 2,660,417 )
Net loss per common share, basic and diluted
$ ( 0.81 )
$ ( 4.80 )
Weighted average common shares outstanding, basic and diluted
4,494,752
541,841
The
accompanying notes are an integral part of these unaudited 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 Three Months Ended March 31, 2026
Convertible
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
—
—
512
3
14,337
—
14,340
Net loss
—
—
—
—
—
( 3,630,610 )
( 3,630,610 )
Balance at March 31, 2026 (unaudited)
700
$ 1
4,494,816
$ 31,464
$ 75,814,595
$ ( 72,184,674 )
$ 3,661,386
For the Three Months Ended March 31, 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
—
—
5,298
37
326,579
—
326,616
Exercise of stock warrants
—
—
81,280
569
1,517,898
—
1,518,467
Offering costs
—
—
—
—
( 347,298 )
—
( 347,298 )
Net loss
—
—
—
—
—
( 2,660,417 )
( 2,660,417 )
Balance at March 31, 2025 (unaudited)
—
$ —
594,098
$ 4,159
$ 57,739,972
$ ( 56,304,727 )
$ 1,439,404
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
7
bioAffinity
Technologies, Inc.
Unaudited
Condensed Consolidated Statements of Cash Flows
(unaudited)
2026
2025
Three
Months Ended March 31,
2026
2025
Cash flows
from operating activities
Net
loss
$ ( 3,630,610 )
$ ( 2,660,417 )
Adjustments
to reconcile net loss to net cash used in operating activities:
Depreciation
and amortization
114,518
154,588
Stock-based
compensation expense
14,340
326,616
Changes
in operating assets and liabilities:
Accounts
and other receivables
( 143,274 )
175,460
Inventory
( 24,339 )
( 11,174 )
Prepaid
expenses and other assets
40,002
6,446
Accounts
payable
74,310
394,267
Accrued
expenses
310,857
( 27,987 )
Unearned
revenue
( 11,265 )
—
Operating
lease right-of-use asset
28,221
426
Net
cash used in operating activities
( 3,227,240 )
( 1,641,775 )
Cash flows
from investing activities
Purchase
of property and equipment
( 5,663 )
( 50,786 )
Net
cash used in investing activities
( 5,663 )
( 50,786 )
Cash flows
from financing activities
Proceeds
from exercise of warrants, net of underwriting discounts, commissions, and offering expenses of $ 347,298
in 2025
—
1,171,169
Payment
on loans payable
( 41,339 )
( 38,927 )
Principal
repayments on finance leases
( 77,174 )
( 100,266 )
Net
cash (used) provided by financing activities
( 118,513 )
1,031,976
Net decrease
in cash and cash equivalents
( 3,351,416 )
( 660,585 )
Cash
and cash equivalents at beginning of period
6,449,782
1,105,291
Cash
and cash equivalents at end of period
$ 3,098,366
$ 444,706
Supplemental
disclosures of cash flow information:
Interest
expense paid in cash
$ 10,026
$ 542
Income
taxes paid in cash
$ —
$ 8,695
Supplemental
disclosures of non-cash activities:
Recognition
of operating lease right-of-use assets
$ 335,827
—
Recognition
of operation lease liabilities
$ 335,827
—
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
8
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 its flow cytometry platform to address the need to identify patients who can benefit from new and emerging
therapies for asthma and chronic obstructive pulmonary disease (“COPD”) with noninvasive precision diagnostic tests. Research
also is advancing the Company’s therapeutic discoveries that could in the future result in broad-spectrum cancer treatments, beginning
with treatment delivered topically for squamous cell skin cancer. Commercial operations and product development are conducted in laboratories
at PPLS and laboratory space leased at The University of Texas at San Antonio.
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 in the United States (“GAAP”) 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 by 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
During the three months ended March 31,
2026, the Company identified an error related to the recognition of a lease amendment executed in April 2024 for lab 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 is it material
to the current period. As a result, the Company recorded an out-of-period adjustment in the current quarter 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 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
amended 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 $ 72.2 million
at March 31, 2026. The Company’s cash and cash equivalents at March 31, 2026, were approximately $ 3.1 million. Based on the Company’s
current expected level of operating expenditures and the cash and cash equivalents on hand at March 31, 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.
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 condensed consolidated financial
statements include all the accounts of the Company, its wholly owned subsidiaries, OncoSelect ® Therapeutics, LLC and
PPLS, and the variable interest entity, Village Oaks. All significant intercompany balances and transactions have been
eliminated.
9
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 condensed consolidated 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 $ 98,449 and $ 28,206 for the three months ended March 31,
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.
10
The
following potentially dilutive securities have been excluded from the computations of weighted average shares of Common Stock outstanding
as of March 31, 2026 and 2025, respectively, as they would be anti-dilutive:
SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES
2026
2025
As of March 31,
2026
2025
Shares underlying options outstanding
9,055
9,531
Shares underlying convertible preferred stock
101,448
—
Shares underlying warrants outstanding
1,348,294
429,029
Shares underlying unvested restricted stock
3,859
14,348
Anti-dilutive securities
1,462,656
452,908
Revenue
Recognition
To
determine revenue recognition for the arrangements that the Company determines are within the scope of Accounting Standards Codification (“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.
Post-acquisition
of PPLS, additional revenue streams have been consolidated starting September 19, 2023. PPLS generates three sources of revenue: (1)
patient service fees, (2) histology service fees, and (3) medical director fees. The 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
For the Three
Months Ended March 31,
2026
2025
Patient service fees 1
$ 1,082,210
$ 1,570,382
Histology service fees
250,516
263,754
Medical director fees
17,461
16,588
Department of Defense observational studies
1,131
—
Other revenues
209
2,873
Total net revenue
$ 1,351,527
$ 1,853,597
1
Patient
services fees include direct billing for CyPath ® Lung diagnostic test of approximately $ 361,000 and $ 169,000 for the
three months ended March 31, 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 months ended March 31, 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
11
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, 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 March 31, 2026 and December 31, 2025:
SCHEDULE OF INTANGIBLE ASSETS
March 31,
December 31,
2026
2025
Cost
Trade names and trademarks
150,000
150,000
Customer relationships
700,000
700,000
Cost
2,254,486
2,254,486
Accumulated amortization
Trade names and trademarks
( 21,111 )
( 19,028 )
Customer relationships
( 126,667 )
( 114,166 )
Accumulated amortization
( 147,778 )
( 133,194 )
Total finite-lived intangible assets, net
$ 702,222
$ 716,806
Goodwill
$ 1,404,486
$ 1,404,486
Total intangibles assets, net
$ 2,106,708
$ 2,121,292
The
Company incurred amortization of intangible assets of $ 14,583 for each of the three months ended March 31, 2026 and 2025.
The estimated amortization expense related to
amortizable intangible assets for each of the five succeeding fiscal years and thereafter as of March 31, 2026 is as follows:
SCHEDULE OF ESTIMATED AMORTIZATION
OF INTANGIBLE ASSETS
As of March 31, 2026
2026
$ 43,750
2027
58,333
2028
58,333
2029
58,333
2030
58,333
Thereafter
425,140
Total
$ 702,222
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
As of March 31,
2026
2025
Net revenues:
Diagnostic R&D
$ 1,131
$ —
Laboratory services
1,350,396
1,853,597
Total net revenues
1,351,527
1,853,597
Operating expenses:
Diagnostic R&D
( 683,747 )
( 505,739 )
Laboratory services
( 1,832,592 )
( 2,267,656 )
General corporate activities
( 2,452,164 )
( 1,707,341 )
Total operating loss
( 3,616,976 )
( 2,627,139 )
Non-operating income (expense), net
( 13,634 )
( 24,583 )
Net loss before income taxes
( 3,630,610 )
( 2,651,722 )
Income tax expense
—
( 8,695 )
Net loss
$ ( 3,630,610 )
$ ( 2,660,417 )
12
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 CMS. The Company has not yet obtained marketing authorization from the
FDA but is able to market its CyPath ® Lung test as a laboratory developed test (“LDT”) sold by Precision Pathology
Laboratory Services, a CAP-accredited, CLIA-certified clinical pathology laboratory and wholly owned subsidiary.
Note
3. ACCOUNTS AND OTHER RECEIVABLES, NET
The
following is a summary of accounts receivables and other receivables:
SCHEDULE OF ACCOUNTS AND OTHER RECEIVABLES
March 31, 2026
December 31, 2025
Patient service fees
$ 500,153
$ 356,432
Histology service fees
136,500
142,889
Medical director fees
16,085
16,346
Other receivables
32,497
26,295
Total accounts and other receivables, net
$ 685,235
$ 541,962
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
March 31, 2026
December 31, 2025
Prepaid insurance
$ 175,176
$ 227,950
Legal and professional
19,060
21,530
Other
285,677
270,436
Total prepaid expenses and other current assets
$ 479,913
$ 519,916
13
Note
5. PROPERTY AND EQUIPMENT, NET
Property
and equipment are summarized below:
SCHEDULE OF PROPERTY AND EQUIPMENT
March 31, 2026
December 31, 2025
Lab equipment
$ 708,027
$ 679,995
Computers and software
81,433
81,433
Leasehold improvements
32,781
32,781
Vehicles
130,590
175,630
Property
and equipment, gross
952,831
969,839
Less: accumulated depreciation and amortization
( 705,982 )
( 704,246 )
Total property and equipment, net
$ 246,849
$ 265,593
Depreciation
expense was $ 24,408 and $ 43,763 for the three months ended March 31, 2026 and 2025, respectively.
Note
6. ACCRUED EXPENSES
Accrued
expenses are summarized below:
SCHEDULE OF ACCRUED EXPENSES
March 31, 2026
December 31, 2025
Compensation
$ 1,719,677
$ 1,309,738
Legal and professional
155,554
337,936
Clinical
135,063
46,177
Other
23,630
24,138
Total accrued expenses
$ 2,033,924
$ 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 March 31, 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 March 31,
2026, and December 31, 2025, respectively.
During
August 2025, the Company engaged with Veterans Administration (“VA”) medical centers to purchase CyPath ® Lung
tests. A total of 20 tests were ordered and shipped. However, in compliance with FASB ASC 606, the performance obligation was complete
for ten tests as of March 31, 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 as of March 31, 2026.
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’s operating leases consist of office and lab space with remaining
lease terms of 4.4
years as of March 31, 2026. The Company has finance leases consisting of office and lab equipment with remaining lease terms ranging
from approximately 0.83
to 6.6
years as of March 31, 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.
14
The
components of lease expense, which are included in selling, general and administrative expense and depreciation and amortization for
the three months ended March 31, 2026 and 2025, are as follows:
SCHEDULE OF COMPONENTS OF LEASE EXPENSE
Components of lease expense:
2026
2025
Amortization of right-of-use assets - finance lease
$ 75,527
$ 96,243
Interest on lease liabilities - finance lease
12,269
13,081
Operating lease cost
43,284
29,793
Total lease cost
$ 131,080
$ 139,117
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from finance leases
$ 77,174
$ 100,266
Operating cash flows from operating leases
$ 36,451
$ 29,197
SCHEDULE OF BALANCE SHEET INFORMATION RELATING TO LEASES
Operating leases:
March 31, 2026
December 31, 2025
Operating lease right-of-use, assets
$ 651,430
$ 334,289
Operating lease liability, current
$ 142,303
$ 139,220
Operating lease liability, non-current
$ 545,157
$ 202,878
Total operating lease liabilities
$ 687,460
$ 342,098
Finance leases:
March 31, 2026
December 31, 2025
Finance lease right-of-use asset, gross
$ 1,184,598
$ 1,184,598
Accumulated amortization
( 598,550 )
( 523,023 )
Finance lease right-of-use asset, net
$ 586,048
$ 661,575
Finance lease liability, current portion
$ 80,241
$ 139,490
Finance lease liability, long-term
514,834
532,759
Total finance lease liabilities
$ 595,075
$ 672,249
Weighted-average remaining lease term:
March 31, 2026
December 31, 2025
Operating leases (in years)
4.42
3.04
Finance leases (in years)
6.53
6.18
Weighted-average discount rate:
March 31, 2026
December 31, 2025
Operating leases
6.87 %
7.28 %
Finance leases
6.76 %
6.86 %
Future
minimum lease payments under non-cancellable lease as of March 31, 2026, are as follows:
SCHEDULE OF FUTURE MINIMUM LEASE PAYMENT UNDER NON-CANCELLABLE
Operating Leases
Finance
Leases
Remaining for 2026
$ 124,933
$ 89,822
2027
172,488
111,708
2028
179,367
111,708
2029
186,553
111,708
2030
127,651
111,708
2031 and thereafter
—
201,495
Total undiscounted cash flows
790,992
738,149
Less discounting
( 103,532 )
( 143,074 )
Present value of lease liabilities
$ 687,460
$ 595,075
15
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 March 31, 2026, and December
31, 2025, was $ 28,676 and $ 29,774 , respectively. The current portion of the balance of this loan as of March 31, 2026, and December 31,
2025, was $ 4,723 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 March 31, 2026, and December 31,
2025, was $ 19,520 and $ 20,618 , respectively. The current portion of the balance of this loan as of March 31, 2026, and December 31, 2025,
was $ 4,559 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 March 31, 2026, and December 31, 2025, was $ 51,859 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 700 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. The investors have converted 290 of the 990 Series B Convertible Preferred Stock in exchange for 42,028 shares of Common
Stock as of March 31, 2026. 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.
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 4,498,675 shares
of Common Stock, of which 3,859 are unvested restricted stock awards as of March 31, 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 March 31, 2026,
the Company sold 114,672 shares of Common Stock through the ATM Agreement which accumulated approximately $ 1.2 million in gross proceeds.
Note
13. STOCK-BASED COMPENSATION
Under
the Company’s 2014 Equity Incentive Plan (the “2014 Plan”), the Company is authorized to grant options or
restricted stock for up to 66,666 shares
of Common Stock. On June 6, 2023, the Company received stockholder approval to increase the number of authorized shares from 38,095 to 66,666 . Options
or restricted stock awards may be granted to employees, the Company’s board of directors, and external consultants who provide
services to the Company. Options and restricted stock awards granted under the 2014 Plan have vesting schedules with terms of one to
three years and become fully exercisable based on specific terms imposed at the date of grant. The
2014 Plan expired at the end of its 10 -year
term in March 2024. The Company’s 2024 Equity Incentive Compensation Plan (the “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
Three Months
Ended March 31,
2026
2025
Research and development
$ 1,074
$ 21,250
General and administrative
13,266
305,366
Total stock-based compensation expense
$ 14,340
$ 326,616
16
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
—
—
—
—
Exercised
—
—
—
—
Forfeited
—
—
—
—
Outstanding at March 31, 2026
9,055
$ 211.56
3.42
—
Vested and exercisable at March 31, 2026
9,055
$ 211.56
3.42
—
As
of March 31, 2026, there was no unrecognized compensation cost related to non-vested stock options.
The
following table summarizes restricted stock award activity under the 2014 Plan and 2024 Plan:
SUMMARY OF RESTRICTED STOCK AWARD
Number of
As of March 31, 2026
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
—
—
—
—
—
Forfeited
—
—
—
—
—
Balance at March 31, 2026
51,810
$ 51.87
$ 2,709,982
47,951
3,859
During
the three months ended March 31, 2026, the Company issued no restricted stock awards (“RSAs”). During the three months ended
March 31, 2026, 512 shares vested from RSAs granted prior to January 1, 2026.
During
the three months ended March 31, 2025, the Company issued RSAs for an aggregate of 8,432 shares of Common Stock to employees, non-employees,
and the board of directors. The shares vest in equal monthly installments over terms of immediately and up to three years , subject to
the employees and non-employees providing continuous service through the vesting date.
Note
14. WARRANTS
The
Company’s outstanding Common Stock warrants are equity classified. As of March 31, 2026, and December 31, 2025, the Company had
1,348,494 warrants outstanding to purchase one share of the Company’s Common Stock for each warrant at a weighted average exercise
price of $ 28.44 and expire at various dates through August 2030. During the three months ended March 31, 2026, no warrants were exercised
compared to the three months ended March 31, 2025, a total number of 81,280 warrants were exercised into an equivalent number of shares
of Common Stock.
As
of March 31, 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 90,149 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 8, 2024
53,330
37.50
( 35,553 )
17,777
Placement agent direct offering March 8, 2024
1,066
49.20
—
1,066
Inducement/direct offering August 5, 2024
58,402
—
( 58,402 )
—
Placement agent direct offering August 5, 2024
1,659
45.00
—
1,659
Direct offering October 21, 2024
88,757
23.92
( 59,544 )
29,213
Warrant inducement February 25, 2025
97,538
25.50
—
97,538
Public offering May 7, 2025
1,470,673
4.50
( 781,262 )
689,411
PIPE/Inducement offering August 13, 2025
271,490
10.56
—
271,490
Balance at March 31, 2026
2,317,607
$ 28.44
( 969,313 )
1,348,294
Note
15. SUBSEQUENT EVENTS
On
April 14, 2026, the Company entered into a new lease agreement for research and development lab space. The
lease has a commencement date of June 1, 2026 and an initial term extending through June 30, 2031. The Company’s initial
monthly lease payment is $ 2,779
per month, and contains an escalation clause over the lease term.
On April 30, 2026, at the Company’s annual
meeting of shareholders, the Company’s shareholders approved an amendment to the Company’s 2024 Equity Incentive Compensation
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.
In May 2026, the Company converted 109
shares of its Series B Convertible Preferred Stock into 36,231
shares of Common Stock in accordance with the Convertible Preferred Stock described in Note 12 .
17
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 months ended March 31, 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 ended March 31, 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. One of our diagnostic tests analyzes cell populations, including cancer and cancer-related
cells, that are indicative of a specific diseased state.
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.
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 expect to present our findings
at conferences and publish our research in the near future. We intend to seek strategic partners to develop our therapeutic discoveries
which could result in broad-spectrum cancer treatments in the future.
Research
and optimization of our platform technologies are conducted in laboratories at our wholly owned subsidiary PPLS and leased laboratory
space at The University of Texas at San Antonio.
Current
Year Financial Highlights
Key
financial results for the three months ended March 31, 2026, include:
●
Unit
sales for CyPath® Lung diagnostic in the first quarter of 2026 achieved 146% growth compared to the first 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 114% to $361,000 for the three months ended March 31, 2026 as compared to $169,000 for
the three months ended March 31, 2025.
●
Consolidated
revenue decreased approximately 36% to $1.4 million for the three months ended March 31, 2026 as compared to $1.9 million for the
three months ended March 31, 2025.
18
Recent
Developments
●
In
April 2026, CyPath® Lung test was featured at the invitation-only “Advances in Early Lung Cancer Detection” symposium
at the Cleveland Clinic in Cleveland, Ohio.
●
In
March 2026, we enrolled our first patient in our clinical trial entitled “Detection of Early-Stage Lung Cancer in Sputum using
Flow Cytometry and an Automated Analysis Pipeline” (NCT07168993). 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,
is providing support and funding associated with the trial at three collection sites – Brooke Army Medical Center in San Antonio,
Texas, Walter Reed Medical Center in Bethesda, Maryland, and the South Texas Audie L. Murphy Memorial Veterans Medical Center.
●
In
March 2026, we announced an additional patient case studies where a CyPath® Lung result of “Unlikely Malignancy”
relieved patient anxiety and supported the physician’s decision to continue repeat imaging rather than subjecting patients
to invasive, risky and costly biopsies. The case study adds to a growing number of reported cases where CyPath® Lung has made
a decisive positive impact on patient care.
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 March 31, 2026, we had cash and cash equivalents of $3.0 million. As of May 4, 2026, we had cash and
cash equivalents of $1.7 million, which we expect will support our operations through June 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 March
31, 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 March 31, 2026, we had a working capital of approximately $1.2 million and an accumulated
deficit of approximately $72.2 million. We expect to continue to incur significant operating losses for the foreseeable future as we
continue the development of our diagnostic tests and advance our diagnostic tests through clinical trials.
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.
19
Results
of Operations
Three
Months Ended March 31, 2026, Compared to Three Months Ended March 31, 2025
Net
loss for the three months ended March 31, 2026, was approximately $3.6 million, compared to a net loss of approximately $2.7 million
for the three months ended March 31, 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 March 31,
2026
2025
Patient service fees 1
$ 1,082,210
$ 1,570,382
Histology service fees
250,516
263,754
Medical director fees
17,461
16,588
Department of Defense observational studies
1,131
—
Other revenues
209
2,873
Total net revenue
$ 1,351,527
$ 1,853,597
1
Patient services fees include direct billing for CyPath ® Lung diagnostic test of approximately $361,000 and $169,000
for the three months ended March 31, 2026 and 2025, respectively.
Net
revenue totaled approximately $1.4 million and $1.9 million for the three months ended March 31, 2026 and 2025, respectively. The decrease
is attributable to discontinuing certain unprofitable pathology services to focus on high-margin services in March 2025, partially offset by an increase in revenue attributable to our CyPath ® Lung diagnostic test.
Operating
Expenses
Three Months Ended
Change in 2025
March 31,
Versus 2024
2026
2025
$
%
Operating expenses:
Direct costs and expenses
$ 928,636
$ 1,367,860
$ (439,224 )
(32 )%
Research and development
349,707
367,386
(17,679 )
(5 )%
Clinical development
334,040
138,353
195,687
141 %
Selling, general and administrative
3,241,602
2,452,549
789,053
32 %
Depreciation and amortization
114,518
154,588
(40,070 )
(26 )%
Total operating expenses
$ 4,968,503
$ 4,480,736
$ 487,767
11 %
Operating
expenses totaled approximately $5.0 million and $4.5 million for the three months ended March 31, 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 are primarily direct labor for pathology services, laboratory supplies and reagents, laboratory equipment,
and allocated shared facilities. Direct costs and expenses totaled $0.9 million and $1.4 million during the three months ended March
31, 2026 and 2025, respectively. The decrease of approximately $439,000, or 32%, 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.
20
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 $349,000 and $367,000 for the three months ended March 31, 2026 and 2025, respectively.
The decrease of $18,000, or 5%, for the three months ended March 31, 2026, compared to the same period in 2025 was primarily attributable
to a decrease in compensation costs and benefits and lab supplies.
Clinical
Development
Clinical
development expenses totaled approximately $334,000 and $138,000 for the three months ended March 31, 2026 and 2025, respectively. The
increase of $196,000, or 141%, for the three months ended March 31, 2026, compared to the same period in 2025 was primarily attributable
to beginning our pivotal clinical trial.
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 $3.2 million and $2.5 million for the three months ended March 31, 2026 and
2025, respectively. The increase of approximately 790,000, or 32%, for the three months ended March 31, 2026, compared to the same period
in 2025 was primarily attributable an increase in employee compensation related to 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 $115,000 and $155,000 for the three months ended March 31, 2026 and 2025, respectively. The decrease
of approximately 40,000, or 26%, for the three months ended March 31, 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 2025
March 31,
Versus 2024
2026
2025
$
%
Interest (expense) income, net
$ (4,696 )
$ (14,943 )
$ 9,797
(69 )%
Other income (expense), net
(8,938 )
(9,640 )
702
(7 )%
Total other (expense) income
$ (13,634 )
$ (24,583 )
$ 10,949
(45 )%
Interest
income (expense)
Interest
expense of approximately $5,000 and $14,000 for the three months ended March 31, 2026 and 2025, respectively, decreased in the current
year due to the interest recognized related to the financing lease for laboratory equipment compared to the same period in the prior
year, partially offset by a decrease in interest income earned on cash balances.
Other
income (expense)
Other
expense totaled $8,938 and $9,640 for the three months ended March 31, 2026 and 2025, respectively. The balance remained relatively consistent
when comparing the same periods year over year.
Liquidity,
Capital Resources, and Going Concern
To date, we have funded our operations primarily
from the private and public sales of our equity, exercise of stock options and warrants, and the issuance of debt, resulting in gross
proceeds of approximately $58.2 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 three months
ended March 31, 2026 and 2025, we had net losses of $3.6 million and $2.7 million, respectively, and we expect to incur substantial additional
losses in future periods. We have an accumulated deficit of approximately $72.2 million as of March 31, 2026. Despite our recent financing
in 2025, we believe our current cash and anticipated revenue from operations will be sufficient to support our operations through June
2026. Based on our current expected level of operating expenditures, current expected levels of revenue, and the cash and cash equivalents
on hand at March 31, 2026, of $3.0 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.
21
Summary
Statements of Cash Flows
The
following information reflects cash flows for the periods presented:
Three Months Ended
March 31,
2026
2025
Cash and cash equivalents at beginning of period
$ 6,449,782
$ 1,105,291
Net cash used in operating activities
(3,227,240 )
(1,641,775 )
Net cash used in investing activities
(5,663 )
(50,786 )
Net cash used in financing activities
(118,513 )
1,031,976
Cash and cash equivalents at end of period
$ 3,098,366
$ 444,706
Net
Cash Used in Operating Activities
Net
cash used in operating activities was approximately $3.2 million and $1.6 million for the three months ended March 31, 2026 and
2025, respectively. The increase of approximately $1.6 million in cash used by operations during the three months ended March 31,
2026, compared to the same period in 2025 was primarily attributable to an increase of approximately $970,000 in our loss from
operations, a decrease of approximately $352,000 related to stock compensation and depreciation and amortization, an increase in
patient accounts receivables of approximately $318,000, offset by an increase of approximately $20,000 in accounts payable and
accrued expenses.
Net
Cash Used in Investing Activities
We
used approximately $6,000 for the three months ended March 31, 2026, in investing activities related primarily to the purchase of computer
and laboratory equipment, compared to $51,000 used in investing activities for the three months ended March 31, 2025.
Net
Cash Used in Financing Activities
Cash used in financing activities was approximately $0.1 million compared
to cash provided by financing activities of approximately $1.0 million for the three months ended March 31, 2026 and 2025, respectively.
The change is primarily attributable to the additional capital raised during the first quarter of 2025 compared to no capital raises in
the first quarter of 2026.
Contractual
Obligations and Commitments
We
enter into contracts in the normal course of business with third-party contract organizations for clinical trials and other services
and products used for research and development and operating purposes. These contracts generally provide for termination following a
certain period after notice, and therefore we believe that any non-cancelable obligations under these agreements are not material.
Critical
Accounting Estimates
The
preparation of financial statements in conformity with U.S. GAAP requires management to make significant judgments and estimates that
affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the reporting period. Management bases these significant judgments
and estimates on historical experience and other assumptions it believes to be reasonable based upon information presently available.
Actual results could differ from those estimates under different assumptions, judgments, or conditions.
Patient
Fee Revenues
We
follow ASC 606, Revenue from Contracts with Customers , which requires revenue recognition in the period in which the service was
performed. To be able to report timely net revenues for the period, estimates are used for a portion of uncollected balances. 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.
22
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 (“CRO’s), 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.
Discount
Rate for Finance Leased Equipment
We
follow Leases (“ASC 842”). 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.
23
In
performing impairment tests for our Goodwill in 2024, 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.
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 March
31, 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 March 31, 2026.
Based on their assessment, they have concluded that as of March 31, 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 March 31, 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.
24
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 three months ended March 31, 2026, we generated revenue of approximately $1.4 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;
25
●
Work
with our partners to expand commercialization of our first diagnostic test, CyPath ® Lung, as an LDT under the CAP/CLIA
guidelines and regulations administered by CMS and CAP;
●
Obtain
de novo classification from FDA for our CyPath ® Lung as a Class II in vitro diagnostic;
●
Work
with our partners to develop and commercialize our first diagnostic test, CyPath ® Lung, as a CE-marked test in accordance
with the In Vitro Diagnostic Regulation (“IVDR”) of the European Union (“EU”);
●
Synthesize,
test, and attract licensing partners for drug conjugates, siRNAs, and other therapeutics (and methods for their use) developed by
the Company;
●
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 our 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 March 31, 2026, we had an accumulated deficit of $72.2 million and $3.1 million cash on hand. As of May 4, 2025, our cash and cash
equivalents were $1.7 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 June 2026.
Based on our current expected level of operating expenditures, current expected levels of revenue, and the cash and cash equivalents
on hand at March 31, 2026, of $3.1 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.
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 $1.4 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.
26
Risks
Related to Ownership of Our Common Stock and Warrants
We
are currently listed on The Nasdaq Capital Market (“Nasdaq”). If we are unable to maintain listing of our securities on Nasdaq
or any stock exchange, our stock price could be adversely affected and the liquidity of our stock and our ability to obtain financing
could be impaired and it may be more difficult for our stockholders to sell their securities.
Although
our Common Stock is currently listed on Nasdaq and we are in compliance with the exchange’s minimum listing requirement, we may
not be able to continue to meet Nasdaq’s minimum listing requirements or those of any other national exchange. The Listing Rules
of Nasdaq require listing issuers to comply with certain standards in order to remain listed on its exchange. If, for any reason, we
should fail to maintain compliance with these listing standards and Nasdaq should delist our securities from trading on its exchange
and we are unable to obtain listing on another national securities exchange, a reduction in some or all of the following may occur, each
of which could have a material adverse effect on our stockholders:
●
the
liquidity of our Common Stock;
●
the
market price of our Common Stock;
●
our
ability to obtain financing for the continuation of our operations;
●
the
number of investors that will consider investing in our Common Stock;
●
the
number of market makers in our Common Stock;
●
the
availability of information concerning the trading prices and volume of our Common Stock; and
●
the
number of broker-dealers willing to execute trades in shares of our Common Stock.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
Unregistered
Sales of Equity Securities
We
did not sell any equity securities during the quarter ended March 31, 2026, in transactions that were not registered under the Securities
Act other than as previously disclosed in our filings with the SEC.
ITEM
3. DEFAULTS UPON SENIOR SECURITIES.
Not
applicable.
ITEM
4. MINE SAFETY DISCLOSURES.
Not
applicable.
ITEM
5. OTHER INFORMATION.
During
the three months ended March 31, 2026, no director or officer of the Company adopted or terminated a “Rule 10b5-1 trading arrangement”
or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.
27
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 *
* Filed herewith.
** Furnished
herewith.
28
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.
BIOAFFINITY
TECHNOLOGIES, INC.
(Registrant)
By:
/s/
Maria Zannes
Maria
Zannes
Chief
Executive Officer, President, Founder, and Director
Date:
May
8, 2026
By:
/s/
J. Michael Edwards
J.
Michael Edwards
Vice
President and Chief Financial Officer
Date:
May
8, 2026
29
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.