Item 9A. Controls and Procedures
Item
9A. Controls and Procedures.
Evaluation
of Disclosure Controls and Procedures
Our
principal executive officer and principal financial officer evaluated the effectiveness of our “disclosure controls and procedures”
as of December 31, 2025, the end of the period covered by this Annual Report on Form 10-K. 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 under the Exchange Act is recorded, processed,
summarized and reported, within the time periods specified in the SEC’s rules and forms. 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 under the Exchange Act is accumulated and communicated to a company’s management, including its principal executive
officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. In designing and evaluating
the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated,
cannot provide absolute assurance that the objectives of the controls system are met, and no evaluation of controls can provide absolute
assurance that all control issues and instances of fraud, if any, within a company have been detected. Based on the evaluation of our
disclosure controls and procedures as of December 31, 2025, our Chief Executive Officer and our Chief Financial Officer concluded that,
as of such date, our disclosure controls and procedures were effective.
Internal
Control over Financial Reporting
Management’s
Annual Report on Internal Control over Financial Reporting
Our
management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined
in Rule 13a-15(f) of the Exchange Act. Our internal control system is designed to provide reasonable assurance regarding the preparation
and fair presentation of financial statements for external purposes in accordance with GAAP. All internal control systems, no matter
how well designed, have inherent limitations and can provide only reasonable assurance that the objectives of the internal control system
are met.
Our
management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures
and our internal control processes will prevent all errors or fraud. A control system, no matter how well conceived and operated, can
provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control
system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs.
Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control
issues and instances of error or fraud, if any, within the Company have been detected. These inherent limitations include the realities
that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls
can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control.
The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there
can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls
may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate.
Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and may not be
detected. However, these inherent limitations are known features of the financial reporting process. Therefore, it is possible to design
into the processes, safeguards to reduce, though not eliminate, this risk.
Under
the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted
an evaluation of the effectiveness of our internal control over financial reporting, based on criteria established by the Committee of
Sponsoring Organizations of the Treadway Commission (“COSO”) in its 2013 Internal Control-Integrated Framework. Based on
our evaluation, we concluded that our internal control over financial reporting was effective as of December 31, 2025.
As
of December 31, 2025, we are a non-accelerated filer, and our independent registered public accounting firm is not required to issue
an attestation report on our internal control over financial reporting .
Item
9B. Other Information.
During
the three months ended December 31, 2025, 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.
Item
9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
None.
63
PART
III
Item
10. Directors, Executive Officers, and Corporate Governance.
The
information required by this item is incorporated herein by reference to the Proxy Statement.
Item
11. Executive Compensation.
The
information required by this item is incorporated herein by reference to the Proxy Statement.
Item
12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The
information required by this item is incorporated herein by reference to the Proxy Statement.
Item
13. Certain Relationships and Related Transactions, and Director Independence.
The
information required by this item is incorporated herein by reference to the Proxy Statement.
Item
14. Principal Accountant Fees and Services.
The
information required by this item is incorporated herein by reference to the Proxy Statement.
64
PART
IV
Item
15. Exhibit and Financial Statement Schedules.
(a)
Financial Statements and Schedules.
See
“Index to Consolidated Financial Statements” beginning on page F-1 following the signature page as required by Part II, Item
8 of this Annual Report.
(b)
Exhibits.
Exhibit
Number
Description
3.1
Certificate of Incorporation of the Registrant as filed with the Delaware Secretary of State on March 26, 2014 (incorporated by reference as Exhibit 3.1 to the Registrant’s Annual Report on Form 10-K filed with the SEC on April 1, 2024)
3.2
Amended and Restated Bylaws of Registrant (Incorporated by reference as Exhibit 3.6 to the Registrant’s Form S-1/A (File No. 333-264463) filed with the SEC on June 16, 2022)
3.3
Certificate of Amendment to the Certificate of Incorporation of Registrant, as filed with the Delaware Secretary of State on May 31, 2016 (incorporated by reference as Exhibit 3.3 to the Registrant’s Annual Report on Form 10-K filed with the SEC on April 1, 2024)
3.4
Certificate of Designation of Series A Convertible Preferred Stock of the Registrant filed with the Delaware Secretary of State on July 13, 2017 (Incorporated by reference as Exhibit 3.4 to the Registrant’s Form S-1/A (File No. 333-264463) filed with the SEC on May 25, 2022)
3.5
Certificate of Amendment to the Certificate of Incorporation of Registrant, as filed with the Delaware Secretary of State on November 29, 2021 (incorporated by reference as Exhibit 3.5 to the Registrant’s Annual Report on Form 10-K filed with the SEC on April 1, 2024)
3.6
Certificate of Amendment to the Certificate of Incorporation of Registrant, as filed with the Delaware Secretary of State on June 23, 2022 (Incorporated by reference as Exhibit 3.2 to the Registrant’s Form S-1/A (File No. 333-264463) filed with the SEC on May 25, 2022)
3.7
Certificate of Amendment to the Certificate of Incorporation of Registrant, as filed with the Delaware Secretary of State on June 6, 2023 (Incorporated by reference as Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on June 7, 2023)
3.8
Certificate of Amendment to the Certificate of Incorporation of Registrant, as filed with the Delaware Secretary of State on June 5, 2024 (Incorporated by reference as Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on June 5, 2024)
3.9
Amendment to Amended and Restated By-Laws of bioAffinity Technologies Inc., dated October 17, 2024 (Incorporated by reference as Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on October 21, 2024)
3.10
Certificate of Amendment to the Certificate of Incorporation (Incorporated by reference as Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on August 14, 2025)
3.11
Certificate of Designations of Series B Convertible Preferred Stock (Incorporated by reference as Exhibit 3.2 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on August 14, 2025)
3.12
Certificate of Amendment to Certificate of Incorporation of bioAffinity Technologies, Inc. (Incorporated by reference as Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 17, 2025)
4.1
Form of Registrant’s Common Stock Certificate (Incorporated by reference as Exhibit 4.1 to the Registrant’s Form S-1/A filed with the SEC on June 16, 2022)
4.2
Common Stock Purchase Warrant issued to San Antonio Economic Development Corporation dated March 17, 2017 (Incorporated by reference as Exhibit 4.2 to the Registrant’s Form S-1/A filed with the SEC on May 25, 2022).
4.3
Form of Common Stock Purchase Warrant issued to Holders of the Registrant’s Convertible Promissory Notes (Incorporated by reference as Exhibit 4.3 to the Registrant’s Form S-1/A filed with the SEC on May 25, 2022)
4.4
Form of Placement Agent’s Warrant issued to WallachBeth Capital, LLC (Incorporated by reference as Exhibit 4.4 to the Registrant’s Form S-1/A filed with the SEC on August 5, 2022)
4.5
Form of Representative’s Warrant issued to WallachBeth Capital, LLC, in connection with the Registrant’s Initial Public Offering (Incorporated by reference as Exhibit 4.5 to the Registrant’s Form S-1/A filed with the SEC on July 28, 2022).
65
4.6
Form of (Tradeable) Common Stock Purchase Warrant issued as part of the Units sold in the Registrant’s Initial Public Offering (Incorporated by reference as Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on September 6, 2022)
4.7
Form of Warrant Agent Agreement for the Warrants issued as part of the Units sold in the Registrant’s Initial Public Offering (Incorporated by reference as Exhibit 4.3 to the Registrant’s Current Report on Form 8-K filed with the SEC on September 6, 2022)
4.8
Form of (Non-tradeable) Common Stock Purchase Warrant issued as part of the Units sold in the Registrant’s Initial Public Offering (Incorporated by reference as Exhibit 4.2 to the Registrant’s Current Report on Form 8-K filed with the SEC on September 6, 2022)
4.9
Form of Amendment to Common Share Purchase Warrants with schedule of warrant holders and warrants (Incorporated by reference as Exhibit 4.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 20, 2023)
4.10
Form of Amendment to Initial Public Offering Warrants with schedule of warrant holders and warrants (Incorporated by reference as Exhibit 4.2 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 20, 2023)
4.11
Form of Warrant to Purchase Common Stock (Incorporated by reference as Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on March 8, 2024)
4.12
Form of Placement Agent Warrant (Incorporated by reference as Exhibit 4.2 to the Registrant’s Current Report on Form 8-K filed with the SEC on March 8, 2024)
4.13
Description of Securities (Incorporated by reference as Exhibit 4.13 to the Registrant’s Annual Report on Form 10-K filed with the SEC on March 31, 2025)
4.14
Form of Purchase Warrant (Incorporated by reference as Exhibit 4.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on August 5, 2024)
4.15
Form of Placement Agent Warrant (Incorporated by reference as Exhibit 4.2 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on August 5, 2024)
4.16
Form of Common Warrant (Incorporated by reference as Exhibit 4.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on October 21, 2024)
4.17
Form of Placement Agent Warrant (Incorporated by reference as Exhibit 4.2 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on October 21, 2024)
4.18
Form of New Warrant (Incorporated by reference as Exhibit 4.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on February 27, 2025)
4.19
Form of Advisor Warrant (Incorporated by reference as Exhibit 4.2 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on February 27, 2025)
4.20
Form of April 2025 Warrant (Incorporated by reference as Exhibit 4.19 to the Registrant’s Form S-1 filed May 2, 2025)
4.21
Form of Pre-Funded Arrant (Incorporated by reference as Exhibit 4.20 to the Registrant’s Form S-1 filed May 2, 2025)
4.22
Form of Placement Agent Warrant (Incorporated by reference as Exhibit 4.21 to the Registrant’s Form S-1 filed May 2, 2025)
4.23
Form of Warrant Agent Agreement for the April 2025 Warrants (Incorporated by reference as Exhibit 4.22 to the Registrant’s Form S-1 filed May 2, 2025)
4.24
Form of Pre-Funded Warrant (Incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on May 8, 2025)
4.25
Form of May 2025 Warrant (Incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on May 8, 2025)
4.26
Form of Placement Agent Warrant (Incorporated by reference to Exhibit 4.3 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on May 8, 2025)
4.27
Form of Warrant (Incorporated by reference as Exhibit 4.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on August 14, 2025)
4.28
Form of Placement Agent Warrant (Incorporated by reference as Exhibit 4.2 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on August 14, 2025)
4.29
Form of New Warrant (Incorporated by reference as Exhibit 4.3 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on August 14, 2025)
4.30
Form of Warrant Amendment (Incorporated by reference as Exhibit 4.4 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on August 14, 2025)
4.31
Form of May 2025 Warrant Amendment (Incorporated by reference as Exhibit 4.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 2, 2025)
4.32
Form of August 2025 Warrant Amendment (Incorporated by reference as Exhibit 4.2 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 2, 2025)
4.33
Form of Pre-Funded Warrant (Incorporated by reference as Exhibit 4.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 30, 2025)
10.1+
2014 Equity Incentive Plan of Registrant, as amended. (Incorporated by reference as Exhibit 10.1 to the Registrant’s Form S-1 filed with the SEC on April 25, 2022)
10.2+
Executive Chairman Employment Agreement dated January 1, 2020, by and between Registrant and Steven Girgenti, as amended. (Incorporated by reference as Exhibit 10.2 to the Registrant’s Form S-1 filed with the SEC on April 25, 2022)
66
10.3+
Employment Agreement dated February 1, 2015, by and between Registrant and Maria Zannes. (Incorporated by reference as Exhibit 10.3 to the Registrant’s Form S-1 filed with the SEC on April 25, 2022)
10.4+
Employment Agreement dated April 4, 2016, by and between Registrant and Vivienne Rebel, as amended. (Incorporated by reference as Exhibit 10.4 to the Registrant’s Form S-1 filed with the SEC on April 25, 2022)
10.5+
Employment Agreement dated February 1, 2015, by and between Registrant and Timothy Zannes. (Incorporated by reference as Exhibit 10.5 to the Registrant’s Form S-1 filed with the SEC on April 25, 2022)
10.6+
Consulting Agreement dated May 25, 2017, by and between Registrant and Michael Edwards, as amended. (Incorporated by reference as Exhibit 10.6 to the Registrant’s Form S-1 filed with the SEC on May 25, 2022)
10.7
License Agreement to Participate in the UTSA New Venture Incubator Program dated June 15, 2015, by and between Registrant and the University of Texas at San Antonio. (Incorporated by reference as Exhibit 10.7 to the Registrant’s Form S-1 filed with the SEC on April 25, 2022)
10.8
Joint Development Agreement dated October 1, 2018, by and between the Registrant and Village Oaks Pathology Services, P.A. d/b/a Precision Pathology Services (Incorporated by reference as Exhibit 3.2 to the Registrant’s Form S-1/A filed with the SEC on July 27, 2022)
10.9
Agreement dated October 17, 2020, by and between Registrant and GO2 Partners (Incorporated by reference as Exhibit 10.9 to the Registrant’s Form S-1/A filed with the SEC on July 27, 2022)
10.10
Form of Note Purchase Agreement used by the Registrant in its private offering of Convertible Promissory Notes issued between October 2021 and January 2022 (Incorporated by reference as Exhibit 10.10 to the Registrant’s Form S-1 filed with the SEC on May 25, 2022)
10.11+
Offer Letter between bioAffinity Technologies, Inc. and Michael Dougherty dated April 11, 2023 (Incorporated by reference as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on May 1, 2023)
10.12+
bioAffinity Technologies, Inc. Amended and Restated 2014 Equity Incentive Plan Incorporated by reference as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on June 7, 2023)
10.13+
Amendment, effective as of August 1, 2023, to Employment Agreement, dated February 1, 2015, by and between bioAffinity Technologies, Inc. and Maria Zannes (Incorporated by reference as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on July 28, 2023)
10.14
Asset Purchase Agreement, effective September 18, 2023, by and among, Precision Pathology Laboratory Services, LLC, Dr. Roby P. Joyce and Village Oaks Pathology Services, P.A. (Incorporated by reference as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 20, 2023)
10.15
Subscription Agreement, dated September 18, 2023, by and between The Joyce Living Trust, dated March 19, 2013, and bioAffinity Technologies, Inc. (Incorporated by reference as Exhibit 10.2 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 20, 2023)
10.16
Management Services Agreement, effective as of September 18, 2023, by and between Precision Pathology Laboratory Services, LLC and Village Oaks Pathology Services, P.A. (Incorporated by reference as Exhibit 10.3 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 20, 2023)
67
10.17
Succession Agreement, effective September 18, 2023, by and among, Precision Pathology Laboratory Services, LLC, Dr. Roby P. Joyce and Village Oaks Pathology Services, P.A. (Incorporated by reference as Exhibit 10.4 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 20, 2023)
10.18
Professional Services Agreement, effective as of September 18, 2023, by and between Precision Pathology Laboratory Services, LLC and Village Oaks Pathology Services, P.A. (Incorporated by reference as Exhibit 10.5 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 20, 2023)
10.19+
Executive Employment Agreement, dated September 18, 2023, by and between the Registrant and Roby Joyce, M.D. (Incorporated by reference as Exhibit 10.6 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 20, 2023)
10.20
Assignment and Assumption of Lease Agreement, effective September 18, 2023, by and between Precision Pathology Laboratory Services, LLC and Village Oaks Pathology Services, P.A. (Incorporated by reference as Exhibit 10.7 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 20, 2023)
10.21
Office Lease, dated July 31, 2019, by and between Village Oaks Pathology Services, P.A. and 343 West Sunset, LLC (Incorporated by reference as Exhibit 10.8 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 20, 2023)
10.22
Assignment and Assumption Agreement, effective September 18, 2023, by and between Precision Pathology Laboratory Services, LLC and Village Oaks Pathology Services, P.A. (Incorporated by reference as Exhibit 10.9 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 20, 2023)
10.23
Equipment Usage Attachment, dated effective as of August 9, 2019, by and between Gen-Probe Sales & Service, Inc., together with its subsidiaries and affiliates and Village Oaks Pathology Services, P.A. d/b/a Precision Pathology, as amended by that certain Amendment No. 1 to Equipment Usage Attachment dated November 2, 2020, as further amended by that certain Amendment No. 2 to Equipment Usage Attachment dated November 2, 2020, and as further amended by that certain Amendment No. 3 to Equipment Usage Attachment dated December 21, 2022 (Incorporated by reference as Exhibit 10.10 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 20, 2023)
10.24
Master Agreement, dated as of January 29, 2015, by and between Leica Microsystems, Inc. and Precision Pathology, as amended by Amendment No. 1 to the Master Agreement, dated on or about April 4, 2018, as further amended by that certain Amendment No. 2 to Master Agreement, dated March 23, 2021 (Incorporated by reference as Exhibit 10.11 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 20, 2023)
10.25
Strategic Relationship License Agreement, dated December 1, 2022, by and between Pathology Watch, Inc. and Precision Pathology Services (Incorporated by reference as Exhibit 10.12 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 20, 2023)
10.26
Bill of Sale signed by Village Oaks Pathology Services, P.A., effective as of September 18, 2023 (Incorporated by reference as Exhibit 10.13 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 20, 2023)
68
10.27
Jamie Platt Offer Letter (Incorporated by reference as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on December 5, 2023)
10.28+
bioAffinity Technologies, Inc. Management Incentive Bonus Plan (Incorporated by reference as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on January 31, 2024)
10.29+
Amendment to Michael Dougherty Offer Letter (Incorporated by reference as Exhibit 10.2 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on January 31, 2024)
10.30
Form of Securities Purchase Agreement, dated as of March 6, 2024, by and among the Company and the investors parties thereto (Incorporated by reference as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on March 8, 2024)
10.31
Form of Support Agreement with schedule of signatories (Incorporated by reference as Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed with the SEC on March 8, 2024)
10.32+
bioAffinity Technologies, Inc. 2024 Incentive Compensation Plan (Incorporated by reference as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on June 5, 2024)
10.33
Form of Securities Purchase Agreement, dated as of August 2, 2024, by and among the Company and the investor listed on the signature page thereto (Incorporated by reference as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on August 5, 2024)
10.34
Form of Warrant Inducement Agreement (Incorporated by reference as Exhibit 10.2 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on August 5, 2024)
10.35
Form of Support Agreement with schedule of signatories (Incorporated by reference as Exhibit 10.3 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on August 5, 2024)
10.36+
Consulting Agreement, dated August 21, 2024, by and between bioAffinity Technologies, Inc. and Michael Edwards (Incorporated by reference as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on August 23, 2024)
10.37+
Employment Agreement between bioAffinity Technologies, Inc. and Michael Edwards, dated as of October 9, 2024 (Incorporated by reference as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on October 10, 2024)
10.38
Form of Securities Purchase Agreement, dated as of October 18, 2024, by and between the Company and the purchasers listed on the signature pages thereto (Incorporated by reference as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on October 21, 2024)
10.39
Form of Support Agreement (Incorporated by reference as Exhibit 10.2 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on October 21, 2024)
10.40+
Amendment No. 2 to Employment Agreement with Maria Zannes (Incorporated by reference as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on January 14, 2025)
10.41
Form of Warrant Inducement Agreement (Incorporated by reference as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on February 27, 2025)
10.42
Form of Securities Purchase Agreement (Incorporated by reference as Exhibit 10.42 to the Registrant’s Form S-1 filed May 2, 2025)
10.43
Placement Agency Agreement, dated as of May 5, 2025, by and between bioAffinity Technologies, Inc. and WallachBeth Capital LLC (Incorporated by reference to Exhibit 1.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on May 8, 2025)
10.44
Form of Securities Purchase Agreement (Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on May 8, 2025)
10.45
At-The-Market Issuance Sales Agreement by and between bioAffinity Technologies, Inc. and WallachBeth Capital LLC (Incorporated by reference as Exhibit 1.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on May 27, 2025)
10.46
Placement Agency Agreement dated August 13, 2025 (Incorporated by reference as Exhibit 1.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on August 14, 2025)
10.47
Form of Securities Purchase Agreement (Incorporated by reference as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on August 14, 2025)
10.48
Form of Registration Rights Agreement (Incorporated by reference as Exhibit 10.2 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on August 14, 2025)
10.49
Form of Warrant Inducement Agreement (Incorporated by reference as Exhibit 10.3 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on August 14, 2025)
10.50
Financial Advisory Agreement dated August 13, 2025 (Incorporated by reference as Exhibit 10.4 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on August 14, 2025)
10.51
Placement Agency Agreement dated as of September 25, 2025, by and between bioAffinity Technologies, Inc. and WallachBeth Capital LLC (Incorporated by reference as Exhibit 1.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 30, 2025)
10.52
Form of Securities Purchase Agreement (Incorporated by reference as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on September 30, 2025)
10.53
Placement Agency Agreement, dated October 8, 2025, by and between bioAffinity Technologies Inc. and WallachBeth Capital LLC (Incorporated by reference as Exhibit 1.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on October 9, 2025)
10.54
Form of Securities Purchase Agreement, dated as of October 8, 2025, by and between the Company and the purchasers listed on the signature pages thereto (Incorporated by reference as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41463) filed with the SEC on October 9, 2025)
69
14.1
Code of Business Conduct of the Registrant (Incorporated by reference as Exhibit 14.1 to the Registrant’s Form S-1 filed with the SEC on May 25, 2022)
19.1
Amended and Restated Insider Trading Policy of the Registrant (Incorporated by reference as Exhibit 19.1 to the Registrant’s Annual Report on Form 10-K filed with the SEC on March 31, 2025)
21.1
List of Subsidiaries of the Registrant (Incorporated by reference as Exhibit 21.1 to the Registrant’s Annual Report on Form 10-K filed with the SEC on April 1, 2024)
23.1*
Consent of WithumSmith+Brown, PC, independent registered public accounting firm
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 pursuant to Section 906 of Sarbanes-Oxley Act of 2002
32.2**
Certification of Chief Financial Officer pursuant to Section 906 of Sarbanes-Oxley Act of 2002
97.1
Clawback Policy (incorporated by reference as Exhibit 97.1 to the Registrant’s Annual Report on Form 10-K filed with the SEC on April 1, 2024)
101.INS
Inline
XBRL Instance Document
101.SCH
Inline
XBRL Taxonomy Extension Schema Document
101.CAL
Inline
XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF
Inline
XBRL Taxonomy Extension Definition Linkbase Document
101.LAB
Inline
XBRL Taxonomy Extension Label Linkbase Document
101.PRE
Inline
XBRL Taxonomy Extension Presentation Linkbase Document
104
Cover
Page Interactive Data File (embedded within the Inline XBRL document)
*
Filed
herewith.
**
Furnished
herewith
+
Indicates
management contract or compensatory plan.
70
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) 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 on the 13 th day of March, 2026.
bioAffinity
Technologies, Inc.
By:
/s/
Maria Zannes
Maria
Zannes
Chief
Executive Officer, President, and Director
Pursuant
to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the
registrant and in the capacities and on the dates indicated.
Signature
Title
Date
/s/
Maria Zannes
President,
Chief Executive Officer, and Director
(Principal
Executive Officer)
March
13, 2026
Maria
Zannes
/s/
J. Michael Edwards
Chief
Financial Officer
March
13, 2026
J.
Michael Edwards
(Principal
Financial and Accounting Officer)
/s/
Steven Girgenti
Executive
Chairman and Director
March
13, 2026
Steven
Girgenti
/s/
Robert Anderson
Director
March
13, 2026
Robert
Anderson
/s/
John Oppenheimer
Director
March
13, 2026
John
Oppenheimer
/s/
Peter S. Knight
Director
March
13, 2026
Peter
S. Knight
/s/
Roberto Rios
Director
March
13, 2026
Roberto
Rios
/s/
Jamie Platt
Director
March
13, 2026
Jamie
Platt
71
bioAffinity
Technologies, Inc.
Index
to the Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm (PCAOB ID NO. 100)
F-2
Consolidated Balance Sheets as of December 31, 2025 and 2024
F-3
Consolidated Statements of Operations for the years ended December 31, 2025 and 2024
F-4
Consolidated Statements of Changes in Stockholders’ Equity for the years ended December 31, 2025 and 2024
F-5
Consolidated Statements of Cash Flows for the years ended December 31, 2025 and 2024
F-6
Notes to Consolidated Financial Statements
F-7
F- 1
Report
of Independent Registered Public Accounting Firm
To
the Board of Directors and Stockholders of
bioAffinity
Technologies, Inc.:
Opinion
on the Consolidated Financial Statements
We
have audited the accompanying consolidated balance sheets of bioAffinity Technologies, Inc. (the “Company”)
as of December 31, 2025 and 2024, and the related consolidated statements of operations, changes in stockholders’ equity and cash
flows, for each of the two years in the period ended December 31, 2025, and the related notes (collectively referred to as the “consolidated
financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial
position of the Company as of December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the two years in
the period ended December 31, 2025, in conformity with principles generally accepted in the United States of America.
Substantial
Doubt Regarding the Company’s Ability to Continue as a Going Concern
The accompanying consolidated financial statements
have been prepared assuming the Company will continue as a going concern. As discussed in Note 1 to the consolidated financial statements,
the Company has incurred significant losses and negative cash flows from operations since inception, has an accumulated deficit, and needs
to raise additional funds to meet its obligations and sustain its operations. These conditions raise substantial doubt about the Company’s
ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 1. The consolidated
financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis
for Opinion
These consolidated financial statements are the responsibility
of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our
audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”)
and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable
rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards
of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated
financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we
engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding
of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s
internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess
the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures
that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the
consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by
management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide
a reasonable basis for our opinion.
/s/ WithumSmith+Brown,
PC
We have served as the Company’s
auditor since 2021.
New York, New York
March 13, 2026
PCAOB ID Number 100
F- 2
bioAffinity
Technologies, Inc.
Consolidated
Balance Sheets
As
of December 31, 2025 and 2024
December 31,
2025
2024
ASSETS
Current assets:
Cash and cash equivalents
$ 6,449,782
$ 1,105,291
Accounts and other receivables, net
541,962
1,139,204
Inventory
53,548
27,608
Prepaid expenses and other current assets
519,916
422,995
Total current assets
7,565,208
2,695,098
Non-current assets:
Property and equipment, net
265,593
375,385
Operating lease right-of-use asset, net
334,289
463,011
Finance lease right-of-use asset, net
661,575
780,872
Goodwill
1,404,486
1,404,486
Intangible assets, net
716,806
775,139
Other assets
12,815
19,676
Total assets
$ 10,960,772
$ 6,513,667
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$ 761,901
$ 987,311
Accrued expenses
1,717,989
1,398,722
Unearned revenue
42,405
24,404
Operating lease liability, current portion
139,220
127,498
Finance lease liability, current portion
139,490
395,301
Notes payable, current portion
105,161
171,669
Total current liabilities
2,906,166
3,104,905
Non-current liabilities
Operating lease liability, net of current portion
202,878
342,098
Finance lease liability, net of current portion
532,759
444,448
Notes payable, net of current portion
41,313
20,180
Total liabilities
3,683,116
3,911,631
Commitments and contingencies (Note 11)
-
-
Stockholders’ equity:
Preferred stock, $ 0.001
per share; 20,000,000
shares authorized; 700
and 0
shares issued and outstanding at December 31, 2025 and 2024, respectively
1
—
Common Stock, par value $ 0.007
per share; 350,000,000 shares authorized; 4,498,675
and 519,158 issued and outstanding at December
31, 2025 and 2024, respectively( 1 )
31,461
3,553
Additional paid-in capital(1)
75,800,258
56,242,793
Accumulated deficit
( 68,554,064 )
( 53,644,310 )
Total stockholders’ equity
7,277,656
2,602,036
Total liabilities and stockholders’ equity
$ 10,960,772
$ 6,513,667
(1)
The
values of Common Stock and paid-in capital, as well as the number of shares issued and outstanding, have been retroactively adjusted
in order to give effect to the Company’s 1-for-30 reverse stock split.
The
accompanying notes are an integral part of these consolidated financial statements.
F- 3
bioAffinity
Technologies, Inc.
Consolidated
Statements of Operations
For
the Years Ended December 31, 2025 and 2024
2025
2024
Net Revenue
$ 6,161,959
$ 9,362,022
Operating expenses:
Direct costs and expenses
4,226,799
5,983,475
Research and development
1,383,359
1,461,227
Clinical development
705,744
321,655
Selling, general and administrative
9,913,729
9,943,473
Depreciation and amortization
504,836
605,637
Total operating expenses
16,734,467
18,315,467
Loss from operations
( 10,572,508 )
( 8,953,445 )
Other income (expense):
Interest income
23,385
17,610
Interest expense
( 44,372 )
( 92,475 )
Other income
40,490
10,323
Other expense
( 502,429 )
( 10,194 )
Change in fair value of warrants issued
( 3,810,278 )
—
Loss before income tax expense
( 14,865,712 )
( 9,028,181 )
Income tax expense
( 44,042 )
( 11,650 )
Net loss
$ ( 14,909,754 )
$ ( 9,039,831 )
Net loss per common share, basic and diluted (2)
$ ( 8.66 )
$ ( 22.50 )
Weighted average common shares outstanding (2)
1,721,082
404,167
(2)
The
values of Common Stock and paid-in capital, as well as the number of shares issued and outstanding, have been retroactively adjusted
in order to give effect to the Company’s 1-for-30 reverse stock split.
The
accompanying notes are an integral part of these consolidated financial statements.
F- 4
bioAffinity
Technologies, Inc.
Consolidated
Statements of Changes in Stockholders’ Equity
For
the Years Ended December 31, 2025 and 2024
Convertible
Additional
Preferred Stock
Common Stock (3)
Paid-in
Accumulated
Stockholders’
Shares
Amount
Shares
Amount
Capital (3)
Deficit
Equity
Balance at December 31, 2023
—
—
313,153
$ 2,192
$ 49,457,542
$ ( 44,604,479 )
$ 4,855,255
Stock-based compensation
—
—
18,308
128
989,553
—
989,681
Exercise of stock options
6,931
49
74,850
74,899
Exercise of stock warrants
—
—
35,558
249
1,370,898
—
1,371,147
Sale of Common Stock
—
—
133,570
935
5,611,848
—
5,612,783
Offering Costs
—
—
( 1,261,898 )
—
( 1,261,898 )
Net loss
—
—
—
—
—
( 9,039,381 )
( 9,039,831 )
Balance at December 31, 2024
—
—
507,520
$ 3,553
$ 56,242,793
$ ( 53,644,310 )
$ 2,602,036
Stock-based compensation
—
—
14,816
104
671,370
—
671,474
Sale of common stock
—
—
2,788,933
19,523
8,110,609
—
8,130,132
Exercise of stock warrants
—
—
1,140,947
7,987
4,806,040
—
4,814,027
Issuance of preferred stock
990
1
—
—
989,999
—
990,000
Conversion of preferred stock
( 290 )
42,028
294
( 294 )
—
—
Offering costs
—
—
( 1,771,939 )
—
( 1,771,939 )
Reclass of warrant liability to equity
6,751,680
6,751,680
Net loss
—
—
—
—
—
( 14,909,754 )
( 14,909,754 )
Balance at December 31, 2025
700
1
4,494,304
$ 31,461
$ 75,800,258
$ ( 68,554,064 )
$ 7,277,656
(3)
The
values of Common Stock and paid-in capital, as well as the number of shares issued and outstanding, have been retroactively adjusted
in order to give effect to the Company’s 1-for-30 reverse stock split.
The
accompanying notes are an integral part of these consolidated financial statements.
F- 5
bioAffinity
Technologies, Inc.
Consolidated
Statements of Cash Flows
For
the Years Ended December 31, 2025 and 2024
2025
2024
Cash flows from operating activities
Net loss
$ ( 14,909,754 )
$ ( 9,039,831 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
504,836
605,637
Stock-based compensation expense
671,474
989,681
Fair value adjustment on warrants
3,810,278
—
Changes in operating assets and liabilities:
Accounts and other receivables
597,242
( 327,530 )
Inventory
( 25,940 )
( 9,124 )
Prepaid expenses and other assets
( 90,060 )
( 105,594 )
Accounts payable
( 225,410 )
382,521
Accrued expenses
319,267
248,911
Unearned revenue
18,001
( 8,654 )
Operating lease right-of-use asset
1,224
( 812 )
Net cash used in operating activities
( 9,328,842 )
( 7,264,795 )
Cash flows from investing activities
Purchase of property and equipment
( 60,568 )
( 79,083 )
Net cash used in investing activities
( 60,568 )
( 79,083 )
Cash flows from financing activities
Proceeds from issuance of Common Stock from direct offering
11,071,534
5,612,783
Proceeds from exercised stock options
—
74,899
Proceeds from exercise of warrants
4,814,027
1,371,147
Proceeds from issuance of Convertible Preferred Stock
990,000
—
Payment of offering costs for financing activities
( 1,771,939 )
( 1,261,898 )
(Payments) proceeds from loans payable
( 45,375 )
191,849
Principal repayments on finance leases
( 324,346 )
( 361,181 )
Net cash provided by financing activities
14,733,901
5,627,599
Net change in cash and cash equivalents
5,344,491
( 1,716,279 )
Cash and cash equivalents at beginning of year
1,105,291
2,821,570
Cash and cash equivalents at end of year
$ 6,449,782
$ 1,105,291
Supplemental disclosures of cash flow information:
Income taxes paid in cash
$ 44,042
$ 11,650
Interest paid
23,385
17,610
Noncash financing activities:
Fair value of warrants issued to placement agents
$ —
$ 74,281
The
accompanying notes are an integral part of these consolidated financial statements.
F- 6
bioAffinity
Technologies, Inc.
Notes
to Consolidated Financial Statements
For
the Years Ended December 31, 2025 and 2024
Note
1. BASIS OF PRESENTATION, ORGANIZATION AND NATURE OF OPERATIONS
Description
of Business
bioAffinity
Technologies, Inc., a Delaware corporation (the “Company,” or “bioAffinity Technologies”), addresses the need
for noninvasive diagnosis of 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
consolidated financial statements of the Company have been prepared in accordance with U.S. generally accepted accounting principles
(“GAAP”) and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”).
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.
Going Concern
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 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 $ 68.6
million at December 31, 2025. The Company’s cash and cash equivalents at December 31, 2025, were approximately $ 6.4
million. Based on the Company’s current expected level of operating expenditures and the cash and cash equivalents on hand at
December 31, 2025, 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 consolidated financial
statements. Without funding from the proceeds from the issuance of equity or debt securities, exercise of outstanding warrants,
funding from a potential strategic relationship or grants, management anticipates that the Company’s cash resources are
sufficient to continue operations through June 2026. 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. No adjustments have been made to the presented 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 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.
F- 7
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 consolidated statements 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 flows.
Advertising
Expense
The
Company expenses all advertising costs as incurred. Advertising expenses were approximately $ 340,000 and $ 267,000 for the years ended
December 31, 2025 and 2024, respectively.
F- 8
Loss
Per Share
Basic
loss per share is computed by dividing net loss attributable to common stockholders by the weighted-average number of shares of the Company’s
Common Stock, par value $ 0.007 per share outstanding during the period. Diluted loss per share is computed by dividing net loss attributable
to common stockholders by the sum of the weighted-average number of shares of Common Stock outstanding during the period and the weighted-average
number of dilutive Common Stock equivalents outstanding during the period, using the treasury stock method. Dilutive Common Stock equivalents
are comprised of in-the-money stock options, convertible preferred stock, warrants, and unvested restricted stock based on the average stock price for each period
using the treasury stock method.
The
following potentially dilutive securities have been excluded from the computations of weighted average shares of Common Stock outstanding
as of December 31, 2025 and 2024, as they would be anti-dilutive:
SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES
As of December 31,
2025
2024
Shares underlying options outstanding
9,055
9,649
Shares underlying convertible preferred stock
101,448
—
Shares underlying warrants outstanding
1,348,494
409,847
Shares underlying unvested restricted stock
4,371
11,638
Anti-dilutive securities
1,463,368
431,134
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 since 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
Year Ended
December 31,
2025
2024
Patient
service fees 1
$ 4,971,342
$ 8,175,670
Histology service fees
1,116,912
1,103,751
Medical director fees
68,268
66,576
Department of Defense observational studies
577
8,654
Other revenues
4,860
7,371
Total net revenue
$ 6,161,959
$ 9,362,022
1
Patient
services fees include direct billing for CyPath® Lung diagnostic test of approximately $ 963,000 and $ 516,000 for the years ended
December 31, 2025 and 2024.
Reclassifications
Certain
prior year balances have been reclassified to conform to current year presentation. Any reclassifications had an immaterial effect
on the Company’s consolidated financial statements and had no effect on prior periods net loss or stockholders’
equity.
Accounts and other receivables, net
Substantially all accounts receivable are due from
insurance companies, U.S. and state governmental agencies, and patients. The Company believes credit risks are mitigated as a result of
the large number customers. The portion of the Company’s accounts receivable due from patients comprises the largest portion of
credit risk, assumptions and judgments are used to assess collectability from patients.
Property
and Equipment, Net
In
accordance with ASC 360-10, Accounting for the Impairment of Long-Lived Assets ( “ASC 360” ) , 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 years ended December 31, 2025 or 2024.
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
F- 9
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 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 December 31, 2025 and 2024:
SCHEDULE OF INTANGIBLE ASSETS
-
December 31,
2025
2024
Cost
Goodwill
$ 1,404,486
$ 1,404,486
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
( 19,028 )
( 10,694 )
Customer relationships
( 114,166 )
( 64,167 )
Accumulated amortization
( 133,194 )
( 74,861 )
Intangible assets, net
$ 2,121,292
$ 2,179,625
For
the years ended December 31, 2025 and 2024, amortization of intangible assets totaled $ 58,334 .
Goodwill
is reviewed annually for impairment in accordance with ASC 350, Intangibles – Goodwill and Other , and intangible assets are
reviewed annually for impairment in accordance with ASC 360 unless circumstances dictate the need for more frequent assessment. The Company
elected to perform a quantitative impairment analysis as of December 31, 2025. The annual quantitative assessment of the intangible assets
was performed utilizing a discounted cash flow analysis (“income approach”) . The
income approach measures the fair value of an interest in a business by discounting expected future cash flows to present value. The
results of the annual quantitative impairment analysis indicated that the fair value exceeded the carrying value of the reporting unit
and therefore resulted in no impairment needed.
The
estimated amortization expense related to amortizable intangible assets for each of the five succeeding fiscal years and thereafter as
of December 31, 2025 is as follows:
SCHEDULE OF ESTIMATED AMORTIZATION
OF INTANGIBLE ASSETS
Year Ending December 31,
2026
$ 58,333
2027
58,333
2028
58,333
2029
58,333
2030
58,333
Thereafter
425,141
Total
$ 716,806
Recent
Accounting Pronouncements
The
Company continues to monitor new accounting pronouncements issued by the Financial Accounting Standards Board (“FASB”) and
does not believe any accounting pronouncements issued through the date of this Annual Report will have a material impact on the Company’s
consolidated financial statements.
The
Company adopted FASB issued ASU No. ASU 2023-09, Income Taxes (Topic 740): Improvement to Income Tax Disclosures. The standard
requires enhanced annual disclosures, including: (i) disaggregated information in the rate reconciliation, (ii) disaggregation of income
(loss) from continuing operations before income tax expense (benefit) between domestic and foreign, (iii) disaggregation of income tax
expense (benefit) from continuing operations by federal, state, and foreign, and (iv) disaggregated disclosure of income taxes paid by
jurisdiction. The Company adopted ASU 2023-09 on January 1, 2025 prospectively. The adoption of ASU 2023-09 resulted in expanded
income tax disclosures in Note 15. Income Taxes.
Income
Taxes
Income
taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences
attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective
tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected
to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred
tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. A valuation
allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. The ultimate
realization of deferred tax assets is dependent upon the generation of future taxable income and the reversal of deferred tax liabilities
during the period in which the related temporary difference becomes deductible. The Company includes interest and penalties related to
uncertain tax positions as part of income tax expense, if any. No such interest or penalties were recognized during the years ended December
31, 2025 and 2024, and the Company had no accruals for interest and penalties at December 31, 2025 or 2024.
F- 10
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
As of December 31,
2025
2024
Net revenues:
Diagnostic R&D
$ 577
$ 8,654
Laboratory services
6,161,382
9,353,368
Total net revenues
6,161,959
9,362,022
Operating expenses:
Diagnostic R&D
( 2,089,103 )
( 1,782,882 )
Laboratory services
( 6,952,050 )
( 9,946,452 )
General corporate activities
( 7,693,314 )
( 6,586,133 )
Total operating loss
( 10,572,508 )
( 8,953,445 )
Non-operating expense, net
( 4,293,204 )
( 74,736 )
Net loss before income taxes
( 14,865,712 )
( 9,028,181 )
Income tax expense
( 44,042 )
( 11,650 )
Net loss
$ ( 14,909,754 )
$ ( 9,039,831 )
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 consolidated balance
sheets and within research and development expense in the accompanying consolidated statements of operations.
The
Company accrues for these costs based on factors such as estimates of the work completed and in accordance with agreements established
with service providers. The Company makes significant judgments and estimates in determining the accrued expenses balance in each reporting
period. As actual costs become known, the Company adjusts its accrued liabilities. The Company has not experienced any material differences
between accrued costs and actual costs incurred since its inception.
Regulatory
Matters
Regulations
imposed by federal, state, and local authorities in the U.S. are a significant factor in providing medical care. In the U.S., drugs,
biological products, and medical devices are regulated by the federal Food, Drug and Cosmetic Act, which is administered by the FDA and
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 sold by Precision Pathology Laboratory Services, a CAP-accredited, CLIA-certified clinical pathology laboratory
and wholly owned subsidiary.
F- 11
Note
3. ACCOUNTS AND OTHER RECEIVABLES, NET
Accounts
and other receivables at December 31, 2025 and 2024, are summarized below:
SCHEDULE
OF ACCOUNTS AND OTHER RECEIVABLES
December 31,
2025
2024
Patient service fees
$ 356,432
$ 915,488
Histology service fees
142,889
190,648
Medical director fees
16,346
5,194
Other receivables
26,295
27,874
Total accounts and other receivables, net
$ 541,962
$ 1,139,204
Note
4. PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid
expenses and other current assets at December 31, 2025 and 2024, are summarized below:
SCHEDULE
OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
December 31,
2025
2024
Prepaid insurance
$ 227,950
$ 248,364
Legal and professional
21,530
27,448
Other
270,436
147,183
Total prepaid expenses and other current assets
$ 519,916
$ 422,995
Note
5. PROPERTY AND EQUIPMENT, NET
Property
and equipment at December 31, 2025 and 2024, are summarized below:
SCHEDULE OF PROPERTY AND EQUIPMENT
December 31,
2025
2024
Lab equipment
$ 679,995
$ 662,747
Computers and software
81,433
81,433
Leasehold improvements
32,781
19,353
Vehicles
175,630
148,103
Property
and equipment, gross
969,839
911,636
Less: accumulated depreciation and amortization
( 704,246 )
( 536,251 )
Total property and equipment, net
$ 265,593
$ 375,385
Total
property and equipment depreciation and amortization expense was $ 170,359 and $ 162,332 for the years ended December 31, 2025 and 2024,
respectively.
Note
6. ACCRUED EXPENSES
Accrued
expenses at December 31, 2025 and 2024, are summarized below:
SCHEDULE OF ACCRUED EXPENSES
December 31,
2025
2024
Compensation
$ 1,309,738
$ 1,079,839
Legal and professional
337,936
98,477
Clinical
46,177
160,371
Other
24,138
60,035
Total accrued expenses
$ 1,717,989
$ 1,398,722
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 41 units
as of December 31, 2025. The performance obligation is deemed complete after samples have been collected and processed and results analyzed.
The unearned revenue balance amounted to $ 23,827 and $ 24,404 as of December 31, 2025 and 2024, respectively.
During
August 2025, the Company engaged with Veterans Administration (“VA”) medical centers to purchase CyPath ®
Lung tests. A total of 30 tests were ordered and shipped. However, in compliance with FASB ASC 606, the performance obligation
was complete for only eight tests as of December 31, 2025. 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 $ 18,578 as of December 31, 2025.
F- 12
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.
Warrants
The
Company issued liability classified warrants in connection with the issuance of the May 2025 warrants. The warrants were liability classified
as a result of certain terms in the May 2025 warrant agreement, and the terms were amended during September 2025 to trigger an equity
classification on the date of the reverse stock split. The Company uses a Black-Scholes model to estimate the fair value of the warrants.
Changes in the fair value of the warrants are recognized in “Change in fair value of warrants issued” for each reporting
period in the consolidated statements of operations.
There
were no warrant liabilities as of December 31, 2025 and 2024. The Company initially recorded a warrant liability of $ 2.9
million as a result of the May 2025 public offering. The Company revalued and recognized an aggregate of $ 3.8
million for the change in fair value of warrants issued before adjusting the warrant liability to equity classified warrants.
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. On April 1, 2025, the Company terminated one
of the finance leases and entered into a new finance lease agreement for equipment on October 20, 2025. Additionally, the Company entered
into another operating lease on September 1, 2024, with regard to office space. The Company has operating leases consisting of office
space with remaining lease terms ranging from 1.6 to 4.7 years as of December 31, 2025. The Company has finance leases consisting of
lab equipment with remaining lease terms ranging from approximately 0.3 to 6.8 years as of December 31, 2025, 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 8.07 % for the lease term lengths.
Leases
with an initial term of 12 months or less are not recorded on the balance sheet. There are no material residual guarantees associated
with any of the Company’s leases, and there are no significant restrictions or covenants included in the Company’s lease
agreements. Certain leases include variable payments related to common area maintenance and property taxes, which are billed by the landlord,
as is customary with these types of charges for office space. The Company has not entered into any lease arrangements with related parties,
and the Company is not the sublessor in any arrangement.
The
Company’s existing leases contain escalation clauses and renewal options. The Company has evaluated several factors in assessing
whether there is reasonable certainty that the Company will exercise a contractual renewal option. For leases with renewal options that
are reasonably certain to be exercised, the Company included the renewal term in the total lease term used in calculating the right-of-use
asset and lease liability.
The
components of lease expense, which are included in selling, general and administrative expense and depreciation and amortization for
the years ended December 31, 2025 and 2024 are as follows:
SCHEDULE OF COMPONENTS OF LEASE EXPENSE
Components of lease expense:
2025
2024
Amortization of right-of-use assets - finance lease
$ 275,533
$ 384,971
Interest on lease liabilities - finance lease
34,935
83,041
Operating lease cost
159,057
93,029
Total lease cost
$ 469,525
$ 561,041
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from finance leases
$ 324,346
$ 361,181
Operating cash flows from operating leases
157,368
133,605
SCHEDULE OF BALANCE SHEET INFORMATION RELATING TO LEASES
Operating leases:
2025
2024
Operating lease right-of-use assets
$ 334,289
$ 463,011
Operating lease liability, current
$ 139,220
$ 127,498
Operating lease liability, non-current
202,878
342,098
Total operating lease liabilities
$ 342,098
$ 469,596
Financing leases:
2025
2024
Financing lease right-of-use assets, gross
$ 1,184,598
$ 1,294,168
Accumulated amortization
( 523,023 )
( 513,296 )
Finance lease right-of-use assets, net
$ 661,575
$ 780,872
Financing lease liability, current
$ 139,490
$ 395,301
Financing lease liability, non-current
532,759
444,448
Total finance lease liabilities
$ 672,249
$ 839,749
Weighted-average remaining lease term:
2025
2024
Operating leases (in years)
3.04
4.21
Finance leases (in years)
6.18
2.39
Weighted-average discount rate:
2025
2024
Operating leases
7.28 %
7.41 %
Finance leases
6.86 %
8.03 %
SCHEDULE OF FUTURE MINIMUM LEASE PAYMENT UNDER NON-CANCELLABLE
Operating
Leases
Finance
Leases
2026
$
159,282
$
179,133
2027
110,065
111,708
2028
40,616
111,708
2029
42,252
111,708
2030
28,919
111,708
2031
and thereafter
—
201,495
Total
undiscounted cash flows
381,134
827,460
Less
discounting
( 39,036
)
( 155,211
)
Present
value of lease liabilities
$
342,098
$
672,249
F- 13
Note
10. NOTES PAYABLE
Vehicles
Notes Payable
On
January 10, 2025, the Company entered into a 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 December 31, 2025, was $ 29,774 . The
current portion of the balance of this loan as of December 31, 2025 was $ 4,588 .
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 December 31, 2025 and 2024, was $ 20,618
and $ 24,849 , respectively. The current portion of the balance of this loan as of December 31, 2025 and 2024, was $ 4,491 and $ 5,603 ,
respectively.
Directors
and Officers Insurance Policy – 2025
In
September 2025, the Company obtained short-term financing of approximately $ 127,500 with 10 monthly payments of approximately $ 13,000
and interest at a 6.70 % fixed annual rate for director and officer insurance policies. The current portion of the balance of the Company’s
Directors and Insurance short-term financing as of December 31, 2025, was $ 90,002 and $ 167,000 as of December 31, 2024, for the 2024
Directors and Officers Insurance Policy. In 2024, the Company financed the director and officer insurance policy.
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 December 31, 2025. 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 $ 0.23 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 $ 0.10 per share.
Common Stock
The
Company has authorized a total of 350,000,000 shares of Common Stock, $ 0.007 par value per share. On July 22, 2025, the Company received
stockholder approval to increase the number of authorized shares of Common Stock from 100,000,000 shares to 350,000,000 shares, and on
August 13, 2025, the Company filed an amendment to its Certificate of Incorporation with the Secretary of State of the State of Delaware
to effect the increase. The Company has issued 4,498,675 shares of Common Stock, of which 4,371 are unvested restricted stock awards
as of December 31, 2025, and 519,158 shares of Common Stock, of which 11,638 are unvested restricted stock awards as of December 31,
2024, adjusted for the 30-1 reverse stock split.
On
September 29, 2025, the Company consummated a best efforts public offering of an aggregate of (i) 1,047,694 shares of Common Stock and
(ii) pre-funded warrants to purchase up to 874,067 shares of Common Stock in lieu of shares of Common Stock. Each share was sold at a
public offering price of $ 2.50 . Each pre-funded warrant was sold at a public offering price of $ 2.493 . The total gross proceeds for the
transaction were approximately $ 4.8 million.
In October 2025, we entered into definitive agreements
for the purchase and sale of 720,000 shares of Common Stock, at a purchase price of $ 2.50 per share in a registered direct offering priced
at-the-market under Nasdaq rules. The gross proceeds from the offering were approximately $ 1.8 million before deducting placement agent
fees and other offering expenses payable by us.
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
December 31, 2025, 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 ,
adjusted for the 30-1 reverse split. 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. A new 2024 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 consolidated statements of operations:
SUMMARY OF STOCK-BASED COMPENSATION EXPENSE RECOGNIZED FOR STOCK OPTION AWARDS
Year Ended
December 31,
2025
2024
Research and development
$ 51,953
$ 99,174
Clinical
10,282
10,000
Selling, general and administrative
609,239
880,507
Total stock-based compensation expense
$ 671,474
$ 989,681
The
following table summarizes stock option activity under the 2014 and 2024 Plans:
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, 2024
9,649
$ 207.84
4.45
—
Granted
—
—
—
—
Exercised
—
—
—
—
Forfeited
( 594 )
147.28
—
—
Outstanding at December 31, 2025
9,055
$ 211.56
3.67
—
Vested and exercisable at December 31, 2025
9,055
$ 211.56
3.67
—
As
of December 31, 2025, there was no unrecognized compensation cost related to non-vested stock options.
F- 14
Restricted
Stock Awards
The
following table summarizes restricted stock award activity under the 2014 and 2024 Plan:
SUMMARY OF RESTRICTED STOCK AWARD
Number of
As of December 31, 2025
restricted
stock awards
(RSA)
Weighted-
average
grant price
FMV on
grant date
Vested
number
of RSA
Unvested
number
of RSA
Balance at December 31, 2024
44,261
$ 56.88
$ 2,517,630
40,244
3,859
Granted
8,598
22.37
214,003
7,195
512
Forfeited
( 1,049 )
21.30
( 21,651 )
—
—
Balance at December 31, 2025
51,810
$ 51.87
$ 2,709,982
47,439
4,371
During
the year ended December 31, 2025, the Company issued restricted stock awards (“RSAs”) for 8,598
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. During the year
ended December 31, 2025, 7,195
shares vested from RSAs granted in 2025, and 7,621
shares vested from RSA’s granted prior to 2025.
Note
14. WARRANTS
The
Company’s outstanding Common Stock warrants are equity classified. As of December 31, 2025 and 2024, the Company had 1,348,494
and 409,937
warrants outstanding to purchase one share of the Company’s Common Stock for each warrant at a weighted average price of
$ 28.44 .
These warrants expire at various dates through August 2030. During the year ended December 31, 2025, a total number of 1,204,854
warrants were exercised into 1,140,947 shares of Common Stock as compared to 35,558
being exercised during the year ended December 31, 2024. During the year ended December 31, 2025, a total of 63,907
warrants were forfeited as a result of cashless exercises. The proceeds from the exercise of warrants for the year ended December
31, 2025, was approximately $ 4.8
million, compared to proceeds of $ 1.3
million for the year ended December 31, 2024.
On
February 25, 2025, the Company entered into a warrant inducement agreement (the “February Inducement Agreement”) with certain
holders (the “Holders”) of the Company’s warrants to purchase shares of the Company’s Common Stock, issued in
a private placement offering that closed on October 21, 2024 (the “October Warrants”), and a private placement offering that
closed on August 5, 2024 (the “August Warrants” and, together with the October Warrants, collectively, the “Existing
Warrants”). In consideration of the Holders’ immediate exercise of the Existing Warrants in accordance with the February
Inducement Agreement, the Company issued unregistered Common Stock purchase warrants (the “New Warrants”) to purchase an
aggregate of up to 97,538 shares of Common Stock (the “New Warrant Shares”) to the Holders of the Existing Warrants, with
an exercise price of $ 25.50 .
On
May 7, 2025, the Company completed a public offering with warrants (“May 2025 Warrants”) to purchase of 507,812
shares of Common Stock. The May 2025 were initially recorded as liability classified until certain requirements were met, at which
time the May 2025 warrants were reclassified as equity. The May 2025 Warrants have an initial exercise price of $ 10.56
per share and are exercisable for a term of five years on a date that is five years after receiving shareholder approval. The
number of shares of Common Stock issuable upon exercise of the May 2025 Warrant Shares is subject to the following adjustments: (i)
a 30% increase in the number of shares of Common Stock that would be issuable upon exercise of the May 2025 Warrants if a reverse
stock split is effected prior to the expiration of the May 2025 Warrants (the “Reverse Stock Split Adjustment”), and
(ii) subject to Warrant Stockholder Approval (as defined below), a decrease of the exercise price of the May 2025 Warrants, if in a
subsequent offering of the Company’s securities the price paid for Common Stock, the exercise price of any options or warrants
or the conversion price of any convertible securities issued in such subsequent offering is less than the exercise price immediately
prior to such subsequent offering, to an exercise price that is equal to the lowest of the price paid for Common Stock, the exercise
price of any options or warrants, or the conversion price of any convertible securities issued in such subsequent offering (subject
to a floor of $ 4.50
per share) and an increase in the number of shares of Common Stock underlying the May 2025 Warrants upon such exercise price reset
so that the reset exercise price multiplied by the increased number of shares equals the aggregate proceeds that would have resulted
from the full exercise of the May 2025 Warrants immediately prior to the reset (the “Anti-Dilution Adjustment”). After
the adjustments, the Company issued a total of 962,862
additional warrants related to the May 2025 Warrants at an exercise price of $ 4.50 .
On
August 13, 2025, the Company entered into a warrant inducement agreement with the holder of a warrant to purchase 15,000 shares of Common
Stock originally issued on August 5, 2024 , with a current exercise price of $ 37.50 per share (the “August 2024 Warrant”)
and a warrant to purchase 21,667 shares of Common Stock originally issued on October 21, 2024 , with a current exercise price of $ 45.00
per share, pursuant to which the Holder agreed to exercise in cash the Existing Warrants at a reduced exercise price of $ 6.90 per share,
for gross proceeds to the Company of $ 253,000 . As an inducement to such exercise, the Company agreed to issue to the holder unregistered
warrants to purchase up to 47,666 shares of the Company’s Common Stock. The new warrants, which have an exercise price of $ 10.56
per share and will not become exercisable until the Company’s stockholders approve the issuance of shares of Common Stock. Following
stockholder approval, the warrants have a term of five years.
On
August 13, 2025, the Company entered into a securities purchase agreement with certain institutional and accredited investors, pursuant
to which the Company agreed to issue and sell, in a private placement, (i) 990 shares of the Company’s newly designated Series
B Convertible Preferred Stock, with a par value $ 0.001 per share and stated value of $ 1,000 per share initially convertible into 143,476
shares of the Company’s Common Stock, par value $ 0.007 per share at an initial conversion price of $ 6.90 per share and (ii) warrants
to purchase up to 223,824 shares of the Company’s Common Stock at an exercise price of $ 10.56 per share of Common Stock.
As
of December 31, 2025, 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
53,530
37.50
( 35,553 )
17,977
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 December 31, 2025
2,317,607
$ 28.44
( 969,313 )
1,348,494
F- 15
Note
15. INCOME TAXES
The
Company’s net loss before income taxes of $ 14.9 million and $ 9.0 million consisted entirely from U.S. operations for the years
ended December 31, 2025 and 2024, respectively. The components of income tax expense and taxes paid by jurisdiction for the years ended December 31, 2025 and 2024 were as
follows:
SCHEDULE OF INCOME TAX EXPENSE AND TAXES PAID BY JURISDICTION
2025
2024
December 31,
2025
2024
Current:
Federal
$ —
$ —
State and local (1)
44,042
11,650
Foreign
—
—
Total
$ 44,042
$ 11,650
(1)
For the year ended December 31, 2025, state and local taxes, net of federal benefit, were attributable to Texas and Delaware.
Deferred
tax assets and valuation allowance
The tax effect of significant items comprising deferred tax assets are as follows:
SCHEDULE
OF DEFERRED TAX ASSETS AND LIABILITIES
2025
2024
December 31,
2025
2024
Deferred tax assets:
Net operating loss carryover
$ 9,916,597
$ 8,185,845
Stock compensation
247,574
247,574
Capitalized R&E costs
817,594
662,855
Bad debt expense
96,680
203,323
Other
165,788
107,538
Operating lease liabilities
196,805
274,962
Tax credits
510,729
480,724
Total deferred tax assets
11,951,767
10,162,821
Deferred tax liability:
Right-of-use asset tax liability
$ ( 145,862 )
$ ( 261,215 )
Depreciation and amortization
( 39,136 )
( 50,463 )
Total deferred tax liability
( 184,998 )
( 311,678 )
Less: valuation allowance
( 11,766,769 )
( 9,851,143 )
Deferred
tax assets (liabilities), net
$ —
$ —
The Company is required to reduce its deferred tax assets by a valuation allowance if it is more likely than not that some or all of its
deferred tax assets will not be realized. Management must use judgment in assessing the potential need for a valuation allowance, which
requires an evaluation of both negative and positive evidence. The weight given to the potential effect of negative and positive evidence
should be commensurate with the extent to which it can be objectively verified. In determining the need for and amount of the valuation
allowance, if any, the Company assesses the likelihood that it will be able to recover its deferred tax assets using historical levels
of income, estimates of future income and tax planning strategies. As a result of historical cumulative losses, the Company determined
that, based on all available evidence, there was substantial uncertainty as to whether it will recover recorded net deferred taxes in
future periods. Accordingly, the Company recorded a valuation allowance against all of its net deferred tax assets as of December 31,
2025 and 2024. The net change in total valuation allowance was an increase of approximately $ 1.9 million and $ 2.0 million for the years
ended December 31, 2025 and 2024, respectively.
F- 16
The
reconciliation of the statutory federal income tax rate to the Company’s effective tax rate for the years ended December 31, 2025
and 2024, was as follows:
SCHEDULE
OF RECONCILIATION OF STATUTORY FEDERAL INCOME TAX RATE
T
December 31,
2025
2024
Tax at federal statutory rate
$
( 3,131,048
)
- 21.00 %
$
( 1,898,365
)
- 21.00 %
Permanent differences
953,106
6.4 %
7,219
0.1 %
Research and development credits
( 103,949
)
- 0.7 %
( 73,945 )
- 0.8 %
Deferred true-up
366,263
2.5 %
—
0.0 %
Change in valuation allowance
1,915,628
12.8 %
1,965,091
21.7 %
Effective income tax rate
$
—
0.00 %
$
—
0.00 %
Unrecognized
tax benefits
As
of December 31, 2025 and 2024, the Company has unrecognized tax benefits related to tax credits of $ 0.3 million and $ 0.3 million,
respectively. None
of the unrecognized tax benefits as of December 31, 2025, if recognized, would impact the effective tax rate due to the valuation
allowance, and no interest or penalties have been recognized. A reconciliation of the beginning and ending balance of unrecognized
tax benefits is as follows:
SCHEDULE
OF UNRECOGNIZED TAX BENEFITS
2024
2023
December 31,
2025
2024
Beginning balance
$ 281,207
$ 249,516
Deductions based on tax positions related to the prior year
( 31,691 )
—
Additions based on tax positions related to the current year
44,549
31,691
Ending balance
$ 294,065
$ 281,207
The
Company’s policy is to recognize interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense.
During the years ended December 31, 2025 and 2024, the Company recognized no interest and penalties associated with unrecognized tax
benefits. There are no tax positions for which it is reasonably possible that the total amounts of unrecognized tax benefits will significantly
increase or decrease within twelve months of the reporting date.
Under
the tax statute of limitations applicable to the Internal Revenue Code, the Company and its U.S. subsidiary, either standalone or as
part of the consolidated group, is no longer subject to U.S. federal income tax examinations by the Internal Revenue Service for tax
years before tax year 2021. However, because the Company is carrying forward income tax attributes, such as net operating losses and
tax credits from 2020 and earlier tax years, these attributes can still be audited when utilized on returns filed in the future.
As
of December 31, 2025 and 2024, the Company had net operating loss (“NOL”) carryforwards of $ 47.2 million and $ 38.0 million
for federal purposes, respectively. If not utilized, federal net operating losses of $ 6.0 million will begin to expire in 2034 and $ 41.2
million will be carried forward indefinitely.
As
of December 31, 2025 and 2024, the Company had research and development tax credit carryforwards for federal purposes of $ 0.5 million
and $ 0.7 million, respectively. The federal research and development tax credit carryforwards will expire at various dates between 2037
and 2045.
Sections
382 and 383 of the Internal Revenue Code provide for a limitation on the annual use of NOL and tax credit carryforwards following certain
ownership changes that could limit the Company’s ability to utilize these carryforwards. The Company continues to disclose the
NOL and tax credit carryforwards at their original amount in the table above as no potential limitation has been quantified. The Company
has also established a full valuation allowance for all deferred tax assets, including the NOL and tax credit carryforwards, since the
Company could not conclude that it was more likely than not able to generate future taxable income to realize these assets. Due to the
existence of a full valuation allowance, limitations under Section 382 and 383 will not impact the Company’s effective tax rate.
Further analyses will be performed prior to recognizing the benefits of any losses or credits in the consolidated financial statements.
Beginning
on January 1, 2022, the Tax Cuts and Jobs Act (“the Act”), enacted in December 2017, eliminated the option to deduct research
and experimentation expenditures in the current period and requires taxpayers to capitalize and amortize U.S.-based and non-U.S. based
research and experimentation expenditures over five and fifteen years, respectively. However, the enactment of the bipartisan OBBB Act,
signed into law in July 2025, repeals the mandatory capitalization requirement for domestic R&D expenditures for tax years beginning
after December 31, 2024. The Company has elected to continue to capitalize research and experimentation expenditures. This legislation
does not impact the Company's current tax obligations.
F- 17
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.