Item 9A. Controls and Procedures
Item
9A. Controls and Procedures.
Evaluation
of Disclosure Controls and Procedures
The
Company has adopted and maintains disclosure controls and procedures that are designed to provide reasonable assurance that information
required to be disclosed in the reports filed under the Exchange Act, such as this Annual Report, is collected, recorded, processed,
summarized, and reported within the time periods specified under the rules of the SEC. As of December 31, 2024, the end of the period
covered by this Annual Report, our Chief Executive Officer and Chief Financial Officer evaluated the effectiveness of our “disclosure
controls and procedures,” as defined in Rule 13a-15(e) under the Exchange Act\. The Chief Executive Officer and Chief Financial
Officer assessed the effectiveness of our disclosure controls and procedures as of December 31, 2024. Based on their assessment, they
have concluded that, as of December 31, 2024, our disclosure controls and procedures are 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 process 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, 2024.
As
of December 31, 2024, we are a non-accelerated filer, and our independent registered 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, 2024, 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.
62
PART
III
Item
10. Directors, Executive Officers, and Corporate Governance.
The
information required by this item of this Annual Report will be included under the caption “Directors, Executive Officers, and
Corporate Governance” in our 2025 Proxy Statement, and is incorporated by reference herein.
Item
11. Executive Compensation.
The
information required by this item of this Annual Report will be included under the caption “Executive and Director Compensation”
in our 2025 Proxy Statement, and is incorporated by reference herein.
Item
12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The
information required by this item of this Annual Report will be included in our 2025 Proxy Statement and is incorporated by reference
herein.
Item
13. Certain Relationships and Related Transactions, and Director Independence.
The
information required by this item of this Annual Report will be included under the captions “Certain Relationships and Related
Party Transactions” and “Board of Directors and Corporate Governance – Director Independence” in our 2025 Proxy
Statement and is incorporated by reference herein.
Item
14. Principal Accountant Fees and Services.
The
information required by this item of this Annual Report will be included in our 2025 Proxy Statement and is incorporated by reference
herein.
63
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)
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).
64
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
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)
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)
65
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 10.9 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)
66
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)
67
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)
68
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
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.
+
Indicates
management contract or compensatory plan.
69
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 31 st day of March, 2025.
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
31, 2025
Maria
Zannes
/s/
J. Michael Edwards
Chief
Financial Officer
March
31, 2025
J.
Michael Edwards
(Principal
Financial and Accounting Officer)
/s/
Steven Girgenti
Executive
Chairman and Director
March
31, 2025
Steven
Girgenti
/s/
Robert Anderson
Director
March
31, 2025
Robert
Anderson
/s/
Stuart Diamond
Director
March
31, 2025
Stuart
Diamond
/s/
Peter S. Knight
Director
March
31, 2025
Peter
S. Knight
/s/
Gary Rubin
Director
March
31, 2025
Gary
Rubin
/s/
Roby Joyce, M.D.
Director
March
31, 2025
Roby
Joyce
/s/
Jamie Platt
Director
March
31, 2025
Jamie
Platt
70
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, 2024 and 2023
F-3
Consolidated Statements of Operations for the years ended December 31, 2024 and 2023
F-4
Consolidated Statements of Changes in Convertible Preferred Stock and Stockholders’ Equity for the years ended December 31, 2024 and 2023
F-5
Consolidated Statements of Cash Flows for the years ended December 31, 2024 and 2023
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, 2024 and 2023, 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, 2024, 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, 2024 and 2023, and the results
of its operations and its cash flows for each of the two years in the period ended December 31, 2024, 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
31, 2025
PCAOB
ID Number 100
F- 2
bioAffinity
Technologies, Inc.
Consolidated
Balance Sheets
as of December 31, 2024 and 2023
December
31,
2024
2023
ASSETS
Current assets:
Cash and
cash equivalents
$ 1,105,291
$ 2,821,570
Accounts and other receivables,
net
1,139,204
811,674
Inventory
27,608
18,484
Prepaid
expenses and other current assets
422,995
321,017
Total current assets
2,695,098
3,972,745
Non-current assets:
Property and equipment,
net
375,385
458,633
Operating lease right-of-use
asset, net
463,011
370,312
Finance lease right-of-use
asset, net
780,872
1,165,844
Goodwill
1,404,486
1,404,486
Intangible assets, net
775,139
833,472
Other
assets
19,676
16,060
Total assets
$ 6,513,667
$ 8,221,552
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable
$ 987,311
$ 604,789
Accrued expenses
1,398,722
1,149,811
Unearned revenue
24,404
33,058
Operating lease liability,
current portion
127,498
94,708
Finance lease liability,
current portion
395,301
365,463
Notes
payable, current portion
171,669
—
Total current liabilities
3,104,905
2,247,829
Non-current liabilities
Operating lease liability,
net of current portion
342,098
283,001
Finance lease liability,
net of current portion
444,448
835,467
Notes payable, net of current portion
20,180
—
Total liabilities
3,911,631
3,366,297
Commitments and contingencies (See Note
11)
-
-
Stockholders’ equity:
Preferred stock, no
shares issued or outstanding at December 31, 2024 and 2023, respectively
—
—
Common stock, par value
$ 0.007 per share; 100,000,000 shares authorized; 15,576,674 and 9,394,610 shares issued and outstanding as of December 31, 2024 and
2023, respectively
106,593
65,762
Additional paid-in capital
56,139,753
49,393,972
Accumulated
deficit
( 53,644,310 )
( 44,604,479 )
Total
stockholders’ equity
2,602,036
4,855,255
Total liabilities, and
stockholders’ equity
$ 6,513,667
$ 8,221,552
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, 2024 and 2023
2024
2023
Net
Revenue
$ 9,362,022
$ 2,532,499
Operating expenses:
Direct costs and expenses
5,983,475
1,740,884
Research and development
1,461,227
1,467,936
Clinical development
321,655
256,661
Selling, general and
administrative
9,943,473
6,790,654
Depreciation
and amortization
605,637
249,592
Total
operating expenses
18,315,467
10,505,727
Loss
from operations
( 8,953,445 )
( 7,973,228 )
Other income (expense):
Interest income
17,610
122,131
Interest expense
( 92,475 )
( 37,125 )
Other income
10,323
3,325
Other expense
( 10,194 )
( 31,121 )
Loss
before income taxes
( 9,028,181 )
( 7,916,018 )
Income tax expense
( 11,650 )
( 20,993 )
Net
loss
$ ( 9,039,831 )
$ ( 7,937,011 )
Net loss per common share, basic and diluted
$ ( 0.75 )
$ ( 0.91 )
Weighted average common shares outstanding
12,125,029
8,747,509
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, 2024 and 2023
Convertible
Additional
Stockholders’
Preferred
Stock
Common
Stock
Paid-in
Accumulated
Equity
Shares
Amount
Shares
Amount
Capital
Deficit
(Deficit)
Balance at December 31, 2022
—
—
8,381,324
$ 58,669
$ 47,652,242
$ ( 36,667,468 )
$ 11,043,443
Stock-based compensation
—
—
448,314
3,138
745,685
—
748,823
Stock issued in connection with the acquisition
—
—
564,972
3,955
996,045
—
1,000,000
Net loss
—
—
—
—
—
( 7,937,011 )
( 7,937,011 )
Balance at December 31, 2023
—
—
9,394,610
$ 65,762
$ 49,393,972
$ ( 44,604,479 )
$ 4,855,255
Balance
—
—
9,394,610
$ 65,762
$ 49,393,972
$ ( 44,604,479 )
$ 4,855,255
Stock-based compensation
—
—
549,917
3,849
985,832
—
989,681
Exercise of stock options
—
—
208,031
1,456
73,443
—
74,899
Exercise of stock warrants
—
—
1,066,767
7,467
1,363,680
—
1,371,147
Sale of common stock
—
—
4,008,294
28,059
5,584,724
—
5,612,782
Offering costs
—
—
( 1,261,898 )
—
( 1,261,898 )
Net loss
—
—
—
—
—
( 9,039,831 )
( 9,039,831 )
Balance at December 31, 2024
—
—
15,227,619
$ 106,593
$ 56,139,753
$ ( 53,644,310 )
$ 2,602,036
Balance
—
—
15,227,619
$ 106,593
$ 56,139,753
$ ( 53,644,310 )
$ 2,602,036
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, 2024 and 2023
2024
2023
Cash flows from operating
activities
Net loss
$ ( 9,039,831 )
$ ( 7,937,011 )
Adjustments to reconcile
net loss to net cash used in operating activities:
Depreciation and amortization
605,637
249,592
Stock-based compensation
expense
989,681
748,823
Changes in operating
assets and liabilities:
Accounts and other receivables
( 327,530 )
311,366
Inventory
( 9,124 )
( 12,944 )
Prepaid expenses and
other assets
( 105,594 )
214,402
Accounts payable
382,521
( 14,501 )
Accrued expenses
248,911
362,012
Unearned revenue
( 8,654 )
33,058
Accrued interest
—
—
Operating
lease right-of-use asset
( 812 )
7,397
Net
cash used in operating activities
( 7,264,795 )
( 6,037,806 )
Cash flows from investing
activities
Purchase of property
and equipment
( 79,083 )
( 22,902 )
Acquisition,
net of cash acquired
—
( 2,186,497 )
Net
cash used in investing activities
( 79,083 )
( 2,209,399 )
Cash flows from financing
activities
Proceeds from issuance
of common stock from direct offering, net of underwriting discounts, commissions, and offering expenses of $ 1,334,811
4,350,885
—
Proceeds from exercised
stock options
74,899
—
Proceeds from exercise
of warrants
1,371,147
—
Payment on loans payable
—
( 251,746 )
Proceeds from loans
payable
191,849
—
Principal
repayments on finance leases
( 361,181 )
( 93,238 )
Net cash provided by (used in) by financing activities
5,627,599
( 344,984 )
Net decrease in cash and cash equivalents
( 1,716,279 )
( 8,592,189 )
Cash and cash equivalents
at beginning of year
2,821,570
11,413,759
Cash
and cash equivalents at end of year
$ 1,105,291
$ 2,821,570
Supplemental disclosures
of cash flow information:
Income taxes paid in
cash
$ 11,650
$ 20,993
Interest paid
17,610
37,125
Noncash investing activities:
Stock issuance in connection
with the acquisition
$ —
$ 1,000,000
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, 2024 and 2023
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, 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 also conducted and intends to seek strategic partners to advance therapeutic discoveries that could
in the future result in broad-spectrum cancer treatments. Research and optimization of the Company’s proprietary platform technologies
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”).
Liquidity
and Capital Resources
In
accordance with Accounting Standards Update (“ASU”) 2014-15, Presentation of Financial Statements – Going Concern
(Subtopic 205-40), the Company has evaluated whether there are conditions and events that raise substantial doubt about the Company’s
ability to continue as a going concern for at least one year after the date the 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 $ 53.6 million at December
31, 2024. The Company’s cash and cash equivalents at December 31, 2024, were approximately $ 1.1 million. Based on the Company’s
current expected level of operating expenditures and the cash and cash equivalents on hand at December 31, 2024, 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 of a capital raise or strategic relationship
or grant, management anticipates that the Company’s cash resources are sufficient to continue operations through April 2025. The Company may need to raise further
capital through the sale of additional equity or debt securities or other debt instruments, strategic relationships or grants, or other
arrangements to support its future operations, if revenue from operations does not significantly increase. If such funding is not available
or not available on terms acceptable to the Company, the Company’s current development plan may be curtailed. Furthermore, an alternative
source of funding to the sale of additional equity or debt securities is the exercise of outstanding warrants for which there can be
no guarantee. No adjustments have been made to the presented 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.
Business
Combination
On
September 18, 2023, the Company, in connection with the Asset Purchase Agreement it entered into with Village Oaks and Roby P. Joyce,
M.D., dated September 18, 2023, acquired substantially all the assets and assumed certain liabilities of Village Oaks in exchange for
total consideration of $ 3,500,000 , which consists of: (1) $ 2.5 million in cash paid at closing and (2) 564,972 shares of the Company’s
Common Stock valued at $ 1 million. The assets purchased included a clinical pathology laboratory regulated by the Centers for Medicare
and Medicaid Services (“CMS”) and accredited by the College of American Pathologists (“CAP”) and certified under
the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”). The primary reason for the acquisition was control of the
laboratory in which CyPath ® Lung is ordered and processed.
The
Company recognized goodwill of $ 1,404,000 arising from the acquisition. The acquisition is being accounted for as a business combination
in accordance with ASC 805. The Company has determined the fair values of the accounts receivable, accounts payable, and accrued expenses
that make up the majority of the net working capital assumed in the acquisition.
The
following table summarizes the purchase price and finalized purchase price allocations relating to the acquisition:
SCHEDULE
OF PURCHASE PRICE AND FINALIZED PURCHASE PRICE ALLOCATIONS
Cash
$ 2,500,000
Common Stock
1,000,000
Total
purchase consideration
$ 3,500,000
Assets
Net working capital (including
cash)
$ 912,000
Property and equipment
326,000
Other assets
8,000
Customer relationships
700,000
Trade names and trademarks
150,000
Goodwill
1,404,000
Total
net assets
$ 3,500,000
Goodwill
represents the excess fair value after the allocation to the identifiable net assets. The calculated goodwill is not deductible for tax
purposes.
The
Company incurred and expensed approximately $ 811,000
in acquisition costs.
Cash
and Cash Equivalents
For
the purpose of the consolidated statement of cash flows, the Company considers all highly liquid investments with original
maturities of three months or less at the time of purchase to be cash equivalents. Cash equivalents are stated at cost, which
approximates market value because of the short maturity of these instruments.
Concentration
of Risk
The
Company has significant cash balances at financial institutions which throughout the year regularly exceed the federally insured limit
of $ 250,000 . Any loss incurred or a lack of access to such funds could have a significant adverse impact on the Company’s financial
condition, results of operations, and cash flows.
Advertising
Expense
The
Company expenses all advertising costs as incurred. Advertising expenses were approximately $ 267,201 and $ 88,832 for the years ended
December 31, 2024 and 2023, 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 notes payable, and warrants based on the average stock price for each period
using the treasury stock method.
The
following potentially dilutive securities have been excluded from the computations of weighted average shares of Common Stock outstanding
as of December 31, 2024 and 2023, as they would be anti-dilutive:
SCHEDULE
OF POTENTIALLY DILUTIVE SECURITIES
As
of December 31,
2024
2023
Shares underlying options outstanding
304,125
683,695
Shares underlying warrants outstanding
12,298,124
—
Shares underlying unvested
restricted stock outstanding
349,057
4,649,952
Anti-dilutive
securities
12,951,306
5,333,647
Revenue
Recognition
To
determine revenue recognition for the arrangements that the Company determines are within the scope of ASC 606, Revenue from Contracts
with Customers , the Company performs the following five steps: (1) identify the contract(s) with a customer, (2) identify the performance
obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in
the contract, and (5) recognize revenue when (or as) the entity satisfies a performance obligation.
Post-acquisition
of PPLS, additional revenue streams have been consolidated starting September 19, 2023. PPLS generates three sources of revenue: (1)
patient service fees, (2) histology service fees, and (3) medical director fees. The Company recognizes as revenue the amount that reflects
the consideration to which it expects to be entitled in exchange for goods sold or services rendered primarily upon completion of the
testing process (when results are reported) or when services have been rendered.
The
Company follows a standard process, which considers historical denial and collection experience and other factors (including the period
of time that the receivables have been outstanding), to estimate contractual allowances and implicit price concessions, recording adjustments
in the current period as changes in estimates. The process for estimating revenues and the ultimate collection of accounts receivable
involves significant judgment and estimation.
Pre-acquisition, bioAffinity’s revenue was generated in three ways: (1) royalties from
the Company’s diagnostic test, CyPath ® Lung, (2) clinical flow cytometry services provided to Village Oaks related
to the Company’s CyPath ® Lung test, and (3) CyPath ® Lung tests purchased by the U.S. Department of
Defense (“DOD”) for an observational study, “Detection of Abnormal Respiratory Cell Populations in Lung Cancer Screening
Patients Using the CyPath ® Lung Assay (NCT05870592),” and research and development on using bronchoalveolar lavage
fluid as a biological sample to assess cardiopulmonary function and exercise performance in military personnel post COVID-19 infection.
The royalty income from CyPath ® Lung and clinical flow cytometry services income, beginning September 19, 2023, are related
party income and, therefore, eliminated from consolidated net revenues.
SCHEDULE
OF REVENUE RECOGNITION
Year Ended
December 31,
2024
2023
Patient service
fees 1
$ 8,175,670
$ 2,199,558
Histology service fees
1,103,751
272,660
Medical director fees
66,576
19,324
Department of Defense observational studies
8,654
19,442
Other revenues
7,371
21,515
Total
net revenue
$ 9,362,022
$ 2,532,499
1
Patient
services fees include direct billing for CyPath® Lung diagnostic test of approximately $ 516,000 and $ 35,000 for the years
ended December 31, 2024 and 2023.
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 income or stockholders’ equity.
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,
2024 or 2023.
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, 2024 and 2023:
SCHEDULE
OF INTANGIBLE ASSETS
2024
2023
December 31,
2024
2023
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
Goodwill
—
—
Trade names and trademarks
( 10,694 )
( 2,361 )
Customer relationships
( 64,167 )
( 14,167 )
Accumulated amortization
( 74,861 )
( 16,528 )
Intangible assets, net
$ 2,179,625
$ 2,237,958
For
the year ended December 31, 2024, amortization of intangible assets totaled $ 58,333 compared to $ 16,528 in the prior year comparative
period.
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, 2024. 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.
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 Accounting Standards Update (“ASU”) No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable
Segment Disclosures on December 31, 2024, on a retrospective basis. The Company used the five steps to ASC 280 to evaluate what, if any, segment reporting
would be beneficial for shareholders. These five steps included: 1) evaluate operating segments for aggregation, 2) perform quantitative
threshold tests, 3) evaluate remaining operating segments for aggregation, 4) ensure that 75% of revenue is reported, and 5) consider
practical limit. Based on the analysis above against those five steps, management concludes that segment reporting is required for two
segment operations: 1) diagnostic R&D and 2) laboratory services (See Note 2).
The FASB issued Accounting Standards Update (“ASU”)
No. ASU 2023-09, Income Taxes (Topic 740): Improvement to Income Tax Disclosures which requires public business entities
to disclose annually a tabular rate reconciliation, including specific items such as state and local income tax, tax credits, nontaxable
or nondeductible items, among others, and a separate disclosure requiring disaggregation of reconciling items as described above which
equal or exceed 5% of the product of multiplying income from continuing operations by the applicable statutory income tax rate. The ASU
is effective for all public business entities for annual periods beginning after December 15, 2024. The adoption of this standard
is not expected to have a material effect on the Company’s operating results or financial condition.
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, 2024 and 2023, and the Company had no accruals for interest and penalties at December 31, 2024 or 2023.
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,
2024
2023
Net revenues:
Diagnostic
R&D
$ 8,654
$ 19,442
Laboratory
services
9,353,368
2,513,057
Total
net revenues
9,362,022
2,532,499
Operating expenses:
Diagnostic R&D
( 1,782,882 )
( 1,724,597 )
Laboratory services
( 9,946,452 )
( 3,769,783 )
General
corporate activities
( 6,586,133 )
( 5,011,347 )
Total operating loss
( 8,953,445 )
( 7,973,228 )
Non-operating
income (expense), net
( 74,736 )
57,210
Net loss before income taxes
( 9,028,181 )
( 7,916,018 )
Income
tax expense
( 11,650 )
( 20,993 )
Net loss
$ ( 9,039,831 )
$ ( 7,937,011 )
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, 2024 and 2023, are summarized below:
SCHEDULE
OF ACCOUNTS AND OTHER RECEIVABLES
December
31,
2024
2023
Patient service fees
$ 915,488
$ 657,717
Histology service fees
190,648
121,301
Medical director fees
5,194
3,103
Other receivables
27,874
29,553
Total
accounts and other receivables, net
$ 1,139,204
$ 811,674
Note
4. PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid
expenses and other current assets at December 31, 2024 and 2023, are summarized below:
SCHEDULE
OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
December
31,
2024
2023
Prepaid insurance
$ 248,364
$ 171,855
Legal and professional
27,448
24,476
Other
147,183
124,686
Total
prepaid expenses and other current assets
$ 422,995
$ 321,017
Note
5. PROPERTY AND EQUIPMENT, NET
Property
and equipment at December 31, 2024 and 2023, are summarized below:
SCHEDULE OF PROPERTY AND EQUIPMENT
December
31,
2024
2023
Lab equipment
$ 662,747
$ 647,214
Computers and software
81,433
68,682
Leasehold improvements
19,353
9,941
Vehicles
148,103
105,919
Property
and equipment, gross
911,636
831,756
Less: accumulated depreciation
and amortization
( 536,251 )
( 373,123 )
Total
property and equipment, net
$ 375,385
$ 458,633
Total
property and equipment depreciation and amortization expense was $ 162,332 and $ 233,064 for the years ended December 31, 2024 and 2023,
respectively.
Note
6. ACCRUED EXPENSES
Accrued
expenses at December 31, 2024 and 2023, are summarized below:
SCHEDULE OF ACCRUED EXPENSES
December
31,
2024
2023
Compensation
$ 1,079,839
$ 857,037
Legal and professional
98,477
257,926
Clinical
160,371
15,350
Other
60,035
19,498
Total
accrued expenses
$ 1,398,722
$ 1,149,811
Note
7. UNEARNED REVENUE
The
Company engaged in an observational study of CyPath ® Lung with the DOD. A total of 70 CyPath ® Lung units
were ordered and shipped. However, in compliance with FASB ASC 606, the performance obligation was complete for only 40 units as of December
31, 2024. The performance obligation is deemed complete after samples have been collected and processed and results analyzed. The unearned
revenue balance amounted to $ 24,404 and $ 33,058 as of December 31, 2024 and 2023, respectively.
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 loan payable, are carried at historical cost basis, which approximates
their fair values because of the short-term nature of these instruments.
Note
9. LEASES
The
Company has one operating lease for its real estate and office space 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. 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 3.1 to 5.9 years as of December 31, 2024. The Company has finance leases consisting of office and lab equipment
with remaining lease terms ranging from approximately 1.25 to 3.0 years as of December 31, 2024, 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 7.41 %
to 8.03 % for the lease term lengths.
Leases
with an initial term of 12 months or less are not recorded on the consolidated balance sheets. There are no material residual guarantees associated
with any of the Company’s leases, and there are no significant restrictions or covenants included in the Company’s lease
agreements. Certain leases include variable payments related to common area maintenance and property taxes, which are billed by the landlord,
as is customary with these types of charges for office space. The Company has not entered into any lease arrangements with related parties,
and the Company is not the sublessor in any arrangement.
The
Company’s existing leases contain escalation clauses and renewal options. The Company has evaluated several factors in assessing
whether there is reasonable certainty that the Company will exercise a contractual renewal option. For leases with renewal options that
are reasonably certain to be exercised, the Company included the renewal term in the total lease term used in calculating the right-of-use
asset and lease liability.
The
components of lease expense, which are included in selling, general and administrative expense and depreciation and amortization for
the year ended December 31, 2024, and 2023 are as follows:
SCHEDULE OF COMPONENTS OF LEASE EXPENSE
Components
of lease expense:
2024
2023
Amortization of right-of-use assets
- finance lease
$ 384,971
$ 128,324
Interest on lease liabilities - finance lease
83,041
33,838
Operating lease cost
93,029
39,887
Total lease cost
$ 561,041
$ 202,049
Cash paid for amounts included in the measurement
of lease liabilities:
Operating cash flows from finance leases
$ 361,181
$ 93,238
Operating cash flows from operating leases
133,605
32,489
SCHEDULE OF BALANCE SHEET INFORMATION RELATING TO LEASES
Operating
leases:
2024
2023
Operating
lease right-of-use, assets
$ 463,011
$ 370,312
Operating lease liability, current
127,498
94,708
Operating lease liability,
non-current
342,098
283,001
Total operating lease
liabilities
$ 469,596
$ 377,709
Financing
leases:
2024
2023
Financing lease right-of-use assets,
gross
$ 1,294,168
$ 1,294,168
Accumulated amortization
( 513,296 )
( 128,324 )
Finance lease right-of-use
assets, net
$ 780,872
$ 1,165,844
Financing lease liability, current
395,301
365,463
Financing lease liability,
non-current
444,448
835,467
Total finance lease
liabilities
$ 839,749
$ 1,200,930
Weighted-average
remaining lease term:
2024
2023
Operating leases (in years)
4.21
3.58
Finance leases (in years)
2.39
3.25
Weighted-average
discount rate:
2024
2023
Operating leases
7.41 %
8.07 %
Finance leases
8.03 %
8.01 %
SCHEDULE OF FUTURE MINIMUM LEASE PAYMENT UNDER NON-CANCELLABLE
Operating
Leases
Finance
Leases
2025
$ 157,837
$ 448,505
2026
159,282
270,395
2027
110,063
202,970
2028
40,616
—
2029
42,252
—
2030 and thereafter
28,919
—
Total undiscounted cash flows
538,969
921,870
Less discounting
( 69,373 )
( 82,121 )
Present value of lease
liabilities
$ 469,596
$ 839,749
F- 13
Note
10. NOTES PAYABLE
Toyota
Corolla - 2024
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, 2024, and 2023 was $ 24,849 and $ 0 , respectively. The current portion of the balance of this loan as of December 31, 2024, and 2023
was $ 5,603 and $ 0 , respectively.
Directors
and Officers Insurance Policy – 2024
In
September 2024, the Company obtained short-term financing of approximately $ 0.26 million with 11 monthly payments of approximately $ 24,000
and interest at a 6.7 % fixed annual rate for director and officer insurance policies. The current portion of the balance of this loan
as of December 31, 2024, and December 31, 2023, was $ 167,000 and $ 0 , respectively.
Note
11. COMMITMENTS AND CONTINGENCIES
Legal
Matters
From
time to time, the Company is involved in various disputes and litigation matters that arise in the ordinary course of business. To date,
the Company has no material pending legal proceedings.
Note
12. COMMON STOCK
The
Company has authorized a total of 100,000,000 shares of Common Stock, $ 0.007 par value per share. On June 4, 2024, the Company received
stockholder approval to increase the number of authorized shares of Common Stock from 25,000,000 shares to 100,000,000 shares, and on
June 5, 2024, 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 15,576,674 shares of Common Stock, of which 349,057 are unvested restricted stock awards
as of December 31, 2024, and 9,505,255 shares of Common Stock, of which 110,645 are unvested restricted stock awards as of December 31,
2023.
Note
13. STOCK-BASED COMPENSATION
The
Company granted options and restricted stock awards under its 2014 Equity Incentive Plan (the “2014 Plan”). Under the 2014
Plan, the Company was authorized to grant options or restricted stock for up to 2,000,000 shares of Common Stock. On June 6, 2023, the
Company received stockholder approval to increase the number of authorized shares from 1,142,857 to 2,000,000 . Options or restricted
stock awards may be granted to employees, the Company’s board of directors, and external consultants who provide services to the
Company. Options and restricted stock awards granted under the 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 according to the respective 10-year
term of the 2014 Plan 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 condensed consolidated statements of operations:
SUMMARY OF STOCK-BASED COMPENSATION EXPENSE RECOGNIZED FOR STOCK OPTION AWARDS
2024
2023
Research and development
$ 99,174
$ 37,131
Selling, general and
administrative
890,507
711,692
Total
stock-based compensation expense
$ 989,681
$ 748,823
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,
2023
683,695
$ 3.99
2.9
$ 158,332
Granted
—
—
—
—
Exercised
( 208,031 )
1.16
—
—
Forfeited
( 171,539 )
2.16
—
—
Outstanding at December
31, 2024
304,125
$ 6.95
4.20
$ —
Vested and exercisable
at December 31, 2024
304,125
$ 6.95
4.20
$ —
As
of December 31, 2024, there was no unrecognized compensation cost related to non-vested stock options.
During the year ended December 31, 2024, 208,031 options were exercised at an exercise price of $ 1.155 , of which 143,183 options were from a cashless exercise, and 137,854 options were forfeited due to a cashless exercise.
F- 14
Restricted
Stock Awards
The
following table summarizes restricted stock award activity under the 2014 and 2024 Plan:
SUMMARY OF RESTRICTED STOCK AWARD
As of December 31, 2024
Number
of
restricted
stock awards
(RSA)
Weighted-
average
grant price
FMV
on
grant date
Vested
number
of RSA
Unvested
number
of RSA
Balance at December 31, 2023
540,969
$ 2.24
$ 1,209,400
462,298
78,671
Granted
865,423
1.81
1,570,834
517,941
347,482
Forfeited
( 77,096 )
1.80
( 139,173 )
—
( 77,096 )
Balance at December 31, 2024
1,329,296
$ 2.24
$ 2,641,061
980,239
349,057
During
the year ended December 31, 2024, the Company issued restricted stock awards (“RSAs”) for 865,423 shares of Common Stock to employees,
non-employees, and the Board of Directors. The shares vest in equal monthly installments over terms of between immediately up to three
years , subject to the employees and non-employees providing continuous service through the vesting date. During the year ended December
31, 2024, 31,973 shares vested from RSAs granted prior to January 1, 2024, and 517,943 shares vested from RSAs granted during the year
ended December 31, 2024.
During
the year ended December 31, 2023, the Company issued RSAs for 431,028 shares of Common Stock to employees and non-employees. The shares
vest in equal monthly installments over terms of between immediately up to one year , subject to the employees and non-employees providing
continuous service through the vesting date. During the year ended December 31, 2023, 59,051 shares vested from RSAs previously issued.
Note
14. WARRANTS
The
Company’s outstanding Common Stock warrants are equity classified. As of December 31, 2024 and 2023, the Company
had 12,298,124
and 4,649,952
warrants outstanding, respectively, to purchase one share of the Company’s Common Stock for each warrant at a weighted average exercise price
of $ 2.95
and expire at various dates through October 2029. During the year ended December 31, 2024, a total number of 1,066,767
warrants were exercised into an equivalent number of shares of Common Stock as compared to no
warrants being exercised during the year ended December 31, 2023. The proceeds of the exercised warrants for the year ended December
31, 2024, was $ 1,343,390 ,
compared to no
proceeds during the year ended December 31, 2023.
On
March 8, 2024, the Company issued to certain investors (1) in a registered direct offering, 1,600,000 shares of the Company’s
Common Stock and (2) in a concurrent private placement, warrants to purchase an aggregate of 1,600,000 shares of Common Stock,
with an exercise price of $ 1.64 (collectively, the “Transaction”), which Transaction constitutes a Dilutive Issuance
under the terms of the warrants. In addition, the placement agent was granted warrants to purchase 32,000 shares of Common
Stock, with an exercise price of $ 1.64 .
On
August 5, 2024, the Company entered into warrant exercise agreements with three existing accredited investors to exercise certain outstanding
warrants to purchase an aggregate of 1,041,667 of the Company’s shares of Common Stock (the “Existing Warrants”). The
exercising holders received in a private placement new unregistered warrants (the “New Warrants”) to purchase up to an aggregate
of 1,302,082 shares of Common Stock with an exercise price of $ 1.50 per share, which are initially exercisable on the date that stockholder
approval of the exercise of the New Warrants is obtained and will expire five years from the date of such approval. In connection with
the exercise of the Existing Warrants, the Company agreed to reduce the exercise price of the Existing Warrants from $ 1.64 to $ 1.25 per
share. The exercise of the Existing Warrants and the issuance of the New Warrants occurred on August 5, 2024. The change in the exercise price of the Existing Warrants resulted in a fair value adjustment of $ 27,757 which
was recorded to Additional paid-in capital for the exercised warrants.
On
August 5, 2024, the Company also entered into a securities purchase agreement with an institutional
investor (the “Purchaser”), pursuant to which the Company issued to the Purchaser, (1) in a registered direct offering, 360,000
shares of Common Stock, and (2) in a concurrent private placement, warrants (the “Private Warrants”) to purchase an aggregate
of 450,000 shares of Common Stock (the “Private Warrant Shares”), with an exercise price of $ 1.50 (collectively, the “Offering”).
In addition, designees of the placement agent for the Offering were granted warrants to purchase an aggregate of up to 49,862 shares
of Common Stock, with an exercise price of $ 1.50 .
On
October 21, 2024, the Company issued (1) in a registered direct offering, 2,048,294 shares (the “Shares”) of the Company’s Common Stock, par value $ 0.007 per share, and (2) in a concurrent private placement, common warrants
(the “Common Warrants”) to purchase an aggregate of 2,662,782 shares of Common Stock (the “Common Warrant
Shares”), with an exercise price of $ 1.50 , pursuant to a securities purchase agreement, dated October 18, 2024 with institutional investors (the “Purchasers”). Such registered direct offering and concurrent private
placement are collectively referred to as the “Offerings.” In addition, designees of the placement agent for the Offering
were granted warrants to purchase an aggregate of up to 61,448 shares of Common Stock, with an exercise price of $ 1.50 .
As
of December 31, 2024, and prior to the Offering, there were tradeable warrants to purchase up to an aggregate of 1,601,255 shares of
Common Stock outstanding and non-tradeable warrants to purchase an aggregate of up to 2,704,458 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
2,900,904
$ 5.31
—
2,900,904
IPO tradeable
2,326,835
3.06
( 725,580 )
1,601,255
IPO non-tradeable
3,015,464
3.06
( 311,006 )
2,704,458
Direct offering March 8, 2024
1,600,000
1.64
( 1,066,667 )
533,333
Placement agent direct offering March 8,
2024
32,000
1.64
—
32,000
Inducement/direct offering August 5, 2024
1,752,082
1.50
—
1,752,082
Placement agent direct offering August 5,
2024
49,862
1.50
—
49,862
Direct offering October 21, 2024
2,662,782
1.50
—
2,662,782
Placement agent direct
offering October 21, 2024
61,448
1.50
—
61,448
Balance at December
31, 2024
14,401,377
$ 2.95
( 2,103,253 )
12,298,124
F- 15
Note
15. INCOME TAXES
Deferred
tax assets and valuation allowance
The
Company had, subject to limitation, approximately $ 31 million of net operating loss carryforwards at December 31, 2024, of which approximately
$ 0.67 million will begin expiring in 2034. The remaining balance of approximately $ 30 million will carry forward indefinitely. A 100 %
valuation allowance has been provided for the deferred tax benefits resulting from the net operating loss carryover due to a lack of
earnings history. In addressing the realizability of deferred tax assets, management considers whether it is more likely than not that
some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon
the generation of future taxable income during the periods in which those temporary differences are deductible. The valuation allowance
increased by approximately $ 2.0 million and $ 3.0 million for the years ended December 31, 2024 and 2023, respectively. Significant components
of deferred tax assets are as follows:
SCHEDULE
OF DEFERRED TAX ASSETS AND LIABILITIES
December
31,
2024
2023
Deferred tax assets:
Net operating
loss carryover
$ 8,185,845
$ 6,479,696
Stock compensation
247,574
325,320
Capitalized R&E
costs
662,855
525,463
Bad debt expense
203,323
145,777
Other
107,538
58,236
Operating lease liabilities
274,962
79,319
Tax
credits
480,724
332,690
Total deferred tax assets
10,162,821
7,946,501
Deferred tax liability:
Right-of-use asset tax
liability
$ ( 261,215 )
$ ( 77,766 )
Depreciation
and amortization
( 50,463 )
( 59,248 )
Total deferred tax liability
( 311,678 )
( 137,014 )
Less:
valuation allowance
( 9,851,143 )
( 7,809,487 )
Deferred
tax assets (liabilities), net
$ —
$ —
The
reconciliation of the statutory federal income tax rate to the Company’s effective tax rate for the years ended December 31, 2024
and 2023, was as follows:
SCHEDULE
OF RECONCILIATION OF STATUTORY FEDERAL INCOME TAX RATE
December
31,
2024
2023
Tax at federal statutory rate
- 21.00 %
- 21.00 %
Permanent differences
0.1 %
0.03 %
Research and development credits
- 0.8 %
- 0.83 %
Deferred balance true-up
0.00 %
- 16.07 %
Change in valuation
allowance
21.7 %
37.87 %
Effective
income tax rate
0.00 %
0.00 %
Unrecognized
tax benefits
As
of December 31, 2024, and 2023, the Company has unrecognized tax benefits related to tax credits of $ 281,207 and $ 249,516 , respectively.
None of the unrecognized tax benefits as of December 31, 2024, 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
December
31,
2024
2023
Beginning balance
$ 249,516
$ 190,228
Deductions based on tax positions related
to the prior year
—
30,897
Additions based on
tax positions related to the current year
31,691
28,391
Ending balance
$ 281,207
$ 249,516
Note
16. SUBSEQUENT EVENTS
On
March 7, 2025, the Company announced targeted strategic actions to improve financial performance and accelerate the commercial
growth of CyPath ® Lung, taking steps to deliver approximately $ 4 million in annual cost savings at its subsidiary
Precision Pathology Laboratory Services (PPLS), while increasing resources to expand CyPath ® Lung sales in
high-potential national markets. Specifically, cost savings are a result of labor cost reductions, operational efficiency
enhancements, and discontinuing certain pathology services with suboptimal profit margins to focus on high-margin services such as
CyPath ® Lung and by discontinuing certain pathology services with suboptimal profit margins.
On
February 26, 2025, pursuant to the terms of a warrant inducement agreement (the “February Inducement Agreement”), dated
February 25, 2025 that the Company entered into with certain holders of existing warrants, such holders exercised for cash (i)
warrants to purchase an aggregate of up to 1,302,082
shares of Common Stock issued on October 21, 2024 (the “October Warrants”), at the reduced exercise price of $ 0.58
per share, and (ii) warrants to purchase an aggregate of up to 1,136,391
shares of Common Stock issued on August 5, 2024 (the “August Warrants”), at the reduced exercise price of $ 0.58
per share. The Company received aggregate gross proceeds of approximately $ 1.4
million, before deducting advisory fees and other expenses payable by it. In consideration of the immediate exercise of the October
Warrants and August Warrants by the holders thereof in accordance with the February Inducement Agreement, the Company issued unregistered
common warrants to purchase an aggregate of up to 2,926,166
shares of Common Stock ( 120 %
of the number of shares of Common Stock issuable upon exercise of the October Warrants and August Warrants) to such
holders.
F- 16