4 unchanged sentences
summarized, and reported within the time periods specified under the rules of the SEC.
−Removed: of December 31, 2023, the end of the period covered by this Annual Report, our Chief Executive Officer and Chief Financial Officer evaluated
−Removed: the effectiveness of our “disclosure controls and procedures,” as defined in Rule 13a-15(e) under the Securities Exchange
−Removed: Act of 1934, as amended (the “Exchange Act”).
−Removed: Rules 13a-15(e)and 15d-15(e)).
+Added: As of December 31, 2024, the end of the period
+Added: covered by this Annual Report, our Chief Executive Officer and Chief Financial Officer evaluated the effectiveness of our “disclosure
+Added: controls and procedures,” as defined in Rule 13a-15(e) under the Exchange Act\.
The Chief Executive Officer and Chief Financial
−Removed: Officer assessed the effectiveness of our internal controls over financial reporting as of December31, 2023.
−Removed: Based on their assessment,
−Removed: they have concluded that, as of December 31, 2023, our internal controls over financial reporting is effective.
+Added: Officer assessed the effectiveness of our disclosure controls and procedures as of December 31, 2024.
+Added: Based on their assessment, they
+Added: have concluded that, as of December 31, 2024, our disclosure controls and procedures are effective.
Control over Financial Reporting
30 unchanged sentences
our evaluation, we concluded that our internal control over financial reporting was effective as of December 31, 2024.
−Removed: of December 31, 2023, we are a non-accelerated filer, our independent registered accounting firm is not required to issue an attestation
−Removed: report on our internal control over financial reporting .
−Removed: in Internal Control over Financial Reporting
−Removed: Company introduced several internal controls (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) over financial reporting
−Removed: during the 3 months ended December 31, 2023, covered by this Annual Report that could materially affect, or are reasonably likely to
−Removed: materially affect, our financial reporting.
−Removed: The Company increased accounting personnel and implemented segregation of preparer and approver
−Removed: duties for all material financial transactional procedures.
−Removed: Furthermore, the Company implemented several monitoring controls over financial
−Removed: reporting including, but not limited to, monthly checklist, monthly account variance analysis, management financial reporting analysis
−Removed: and dual segregated account reconciliations.
−Removed: All vendor payments have been transitioned from manual procedures to automated tool requiring
−Removed: dual roles and responsibilities for recording, approving and releasing payments.
+Added: of December 31, 2024, we are a non-accelerated filer, and our independent registered accounting firm is not required to issue an
+Added: attestation report on our internal control over financial reporting .
Other Information.
3 unchanged sentences
Directors, Executive Officers, and Corporate Governance.
−Removed: The information required by this item of Form 10-K will be included under the caption “Directors, Executive
−Removed: Officers, and Corporate Governance” in our proxy statement for our 2024 annual meeting of stockholders (the “2024 Proxy Statement”),
−Removed: and is incorporated by reference herein.
+Added: information required by this item of this Annual Report will be included under the caption “Directors, Executive Officers, and
+Added: Corporate Governance” in our 2025 Proxy Statement, and is incorporated by reference herein.
Executive Compensation.
−Removed: information required by this item of Form 10-K will be included under the caption “Executive and Director Compensation” in
−Removed: our 2024 Proxy Statement and is incorporated by reference herein.
+Added: information required by this item of this Annual Report will be included under the caption “Executive and Director Compensation”
+Added: in our 2025 Proxy Statement, and is incorporated by reference herein.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
−Removed: information required by this item of Form 10-K will be included in our 2024 Proxy Statement and is incorporated by reference herein.
+Added: information required by this item of this Annual Report will be included in our 2025 Proxy Statement and is incorporated by reference
Certain Relationships and Related Transactions, and Director Independence.
−Removed: information required by this item of Form 10-K will be included under the captions “Certain Relationships and Related Party Transactions”
−Removed: and “Board of Directors and Corporate Governance – Director Independence” in our 2024 Proxy Statement and is incorporated
−Removed: by reference herein.
+Added: information required by this item of this Annual Report will be included under the captions “Certain Relationships and Related
+Added: Party Transactions” and “Board of Directors and Corporate Governance – Director Independence” in our 2025 Proxy
+Added: Statement and is incorporated by reference herein.
Principal Accountant Fees and Services.
−Removed: information required by this item of Form 10-K will be included in our 2024 Proxy Statement and is incorporated by reference herein.
+Added: information required by this item of this Annual Report will be included in our 2025 Proxy Statement and is incorporated by reference
Exhibit and Financial Statement Schedules.
2 unchanged sentences
8 of this Annual Report.
−Removed: Agency Agreement, dated March 6, 2024, by and among the Company and WallachBeth Capital LLC
−Removed: (Incorporated by reference as Exhibit 1.1 to the Registrant’s Form 8-K filed with the
−Removed: SEC on March 8, 2024)
−Removed: Certificate of Incorporation of the Registrant as filed with the Delaware Secretary of State on March 26, 2014
−Removed: and Restated Bylaws of Registrant (Incorporated by reference as Exhibit 3.6 to the Registrant’s Form S-1/A (File No.
+Added: 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)
+Added: 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)
−Removed: Certificate of Amendment to the Certificate of Incorporation of Registrant, as filed with the Delaware Secretary of State on May 31, 2016
−Removed: of Designation of Series A Convertible Preferred Stock of the Registrant filed with the Delaware Secretary of State on July 13, 2017
−Removed: (Incorporated by reference as Exhibit 3.4 to the Registrant’s Form S-1/A (File No.
+Added: 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)
+Added: 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)
−Removed: Certificate of Amendment to the Certificate of Incorporation of Registrant, as filed with the Delaware Secretary of State on November 29, 2021
−Removed: of Amendment to the Certificate of Incorporation of Registrant, as filed with the Delaware Secretary of State on June 23, 2022 (Incorporated
−Removed: by reference as Exhibit 3.2 to the Registrant’s Form S-1/A (File No.
+Added: 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)
+Added: 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)
−Removed: of Amendment to the Certificate of Incorporation of Registrant, as filed with the Delaware Secretary of State on June 6, 2023 (Incorporated
−Removed: by reference as Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No.
+Added: 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)
−Removed: of Registrant’s Common Stock Certificate (Incorporated by reference as Exhibit 4.1 to the Registrant’s Form S-1/A filed
−Removed: with the SEC on June 16, 2022)
−Removed: Stock Purchase Warrant issued to San Antonio Economic Development Corporation dated March
−Removed: 17, 2017 (Incorporated by reference as Exhibit 4.2 to the Registrant’s Form S-1/A filed
−Removed: with the SEC on May 25, 2022).
−Removed: of Common Stock Purchase Warrant issued to Holders of the Registrant’s Convertible Promissory Notes (Incorporated by reference
−Removed: as Exhibit 4.3 to the Registrant’s Form S-1/A filed with the SEC on May 25, 2022)
−Removed: of Placement Agent’s Warrant issued to WallachBeth Capital, LLC (Incorporated by reference
−Removed: as Exhibit 4.4 to the Registrant’s Form S-1/A filed with the SEC on August 5, 2022)
−Removed: of Representative’s Warrant issued to WallachBeth Capital, LLC, in connection with the Registrant’s Initial Public Offering
−Removed: (Incorporated by reference as Exhibit 4.5 to the Registrant’s Form S-1/A filed with the SEC on July 28, 2022).
−Removed: of (Tradeable) Common Stock Purchase Warrant issued as part of the Units sold in the Registrant’s
−Removed: Initial Public Offering (Incorporated by reference as Exhibit 4.1 to the Registrant’s
−Removed: Form 8-K filed with the SEC on September 6, 2022)
−Removed: of Warrant Agent Agreement for the Warrants issued as part of the Units sold in the Registrant’s
−Removed: Initial Public Offering (Incorporated by reference as Exhibit 4.3 to the Registrant’s
−Removed: Form 8-K filed with the SEC on September 6, 2022)
−Removed: of (Non-tradeable) Common Stock Purchase Warrant issued as part of the Units sold in the
−Removed: Registrant’s Initial Public Offering (Incorporated by reference as Exhibit 4.2 to the
−Removed: Registrant’s Form 8-K filed with the SEC on September 6, 2022)
−Removed: of Amendment to Common Share Purchase Warrants with schedule of warrant holders and warrants
−Removed: (Incorporated by reference as Exhibit 4.1 to the Registrant’s Current Report on
−Removed: Form 8-K (File No.
+Added: 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.
+Added: 001-41463) filed with the SEC on June 5, 2024)
+Added: 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.
+Added: 001-41463) filed with the SEC on October 21, 2024)
+Added: 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)
+Added: 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).
+Added: 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)
+Added: 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)
+Added: 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).
+Added: 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)
+Added: 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)
+Added: 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)
+Added: 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)
−Removed: of Amendment to Initial Public Offering Warrants with schedule of warrant holders and warrants (Incorporated by reference as Exhibit
−Removed: 4.2 to the Registrant’s Current Report on Form 8-K (File No.
+Added: 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)
−Removed: of Warrant to Purchase Common Stock (Incorporated by reference as Exhibit 4.1 to the Registrant’s Form 8-K filed with the SEC
−Removed: on March 8, 2024)
−Removed: of Placement Agent Warrant (Incorporated by reference as Exhibit 4.2 to the Registrant’s
−Removed: Form 8-K filed with the SEC on March 8, 2024)
+Added: 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)
+Added: 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)
Description of Securities
+Added: Form of Purchase Warrant (Incorporated by reference as Exhibit 4.1 to the Registrant’s Current Report on Form 8-K (File No.
+Added: 001-41463) filed with the SEC on August 5, 2024)
+Added: Form of Placement Agent Warrant (Incorporated by reference as Exhibit 4.2 to the Registrant’s Current Report on Form 8-K (File No.
+Added: 001-41463) filed with the SEC on August 5, 2024)
+Added: Form of Common Warrant (Incorporated by reference as Exhibit 4.1 to the Registrant’s Current Report on Form 8-K (File No.
+Added: 001-41463) filed with the SEC on October 21, 2024)
+Added: Form of Placement Agent Warrant (Incorporated by reference as Exhibit 4.2 to the Registrant’s Current Report on Form 8-K (File No.
+Added: 001-41463) filed with the SEC on October 21, 2024)
+Added: Form of New Warrant (Incorporated by reference as Exhibit 4.1 to the Registrant’s Current Report on Form 8-K (File No.
+Added: 001-41463) filed with the SEC on February 27, 2025)
+Added: Form of Advisor Warrant (Incorporated by reference as Exhibit 4.2 to the Registrant’s Current Report on Form 8-K (File No.
+Added: 001-41463) filed with the SEC on February 27, 2025)
2014 Equity Incentive Plan of Registrant, as amended.
−Removed: (Incorporated by reference as Exhibit 10.1 to the Registrant’s Form S-1 filed
−Removed: with the SEC on April 25, 2022)
−Removed: Chairman Employment Agreement dated January 1, 2020, by and between Registrant and Steven Girgenti, as amended.
−Removed: (Incorporated by
−Removed: reference as Exhibit 10.2 to the Registrant’s Form S-1 filed with the SEC on April 25, 2022)
−Removed: Agreement dated February 1, 2015, by and between Registrant and Maria Zannes.
−Removed: (Incorporated by reference as Exhibit 10.3 to the Registrant’s
−Removed: Form S-1 filed with the SEC on April 25, 2022)
−Removed: Agreement dated April 4, 2016, by and between Registrant and Vivienne Rebel, as amended.
−Removed: (Incorporated by reference as Exhibit 10.4
−Removed: to the Registrant’s Form S-1 filed with the SEC on April 25, 2022)
−Removed: Agreement dated February 1, 2015, by and between Registrant and Timothy Zannes.
−Removed: (Incorporated by reference as Exhibit 10.5 to the
−Removed: Registrant’s Form S-1 filed with the SEC on April 25, 2022)
−Removed: Agreement dated May 25, 2017, by and between Registrant and Michael Edwards, as amended.
−Removed: (Incorporated by reference as Exhibit 10.6
−Removed: to the Registrant’s Form S-1 filed with the SEC on May 25, 2022)
−Removed: Agreement to Participate in the UTSA New Venture Incubator Program dated June 15, 2015, by and between Registrant and the University
−Removed: of Texas at San Antonio.
(Incorporated by reference as Exhibit 10.1 to the Registrant’s Form S-1 filed with the SEC on April 25, 2022)
−Removed: Development Agreement dated October 1, 2018, by and between the Registrant and Village Oaks Pathology Services, P.A.
−Removed: d/b/a Precision
−Removed: Pathology Services (Incorporated by reference as Exhibit 3.2 to the Registrant’s Form S-1/A filed with the SEC on July 27,
−Removed: dated October 17, 2020, by and between Registrant and GO2 Partners (Incorporated by reference as Exhibit 10.9 to the Registrant’s
−Removed: Form S-1/A filed with the SEC on July 27, 2022)
−Removed: of Note Purchase Agreement used by the Registrant in its private offering of Convertible Promissory Notes issued between October
−Removed: 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,
−Removed: Letter between bioAffinity Technologies, Inc.
−Removed: and Michael Dougherty dated April 11, 2023 (Incorporated by reference as Exhibit 10.1
−Removed: to the Registrant’s Current Report on Form 8-K (File No.
+Added: Executive Chairman Employment Agreement dated January 1, 2020, by and between Registrant and Steven Girgenti, as amended.
+Added: (Incorporated by reference as Exhibit 10.2 to the Registrant’s Form S-1 filed with the SEC on April 25, 2022)
+Added: Employment Agreement dated February 1, 2015, by and between Registrant and Maria Zannes.
+Added: (Incorporated by reference as Exhibit 10.3 to the Registrant’s Form S-1 filed with the SEC on April 25, 2022)
+Added: Employment Agreement dated April 4, 2016, by and between Registrant and Vivienne Rebel, as amended.
+Added: (Incorporated by reference as Exhibit 10.4 to the Registrant’s Form S-1 filed with the SEC on April 25, 2022)
+Added: Employment Agreement dated February 1, 2015, by and between Registrant and Timothy Zannes.
+Added: (Incorporated by reference as Exhibit 10.5 to the Registrant’s Form S-1 filed with the SEC on April 25, 2022)
+Added: Consulting Agreement dated May 25, 2017, by and between Registrant and Michael Edwards, as amended.
+Added: (Incorporated by reference as Exhibit 10.6 to the Registrant’s Form S-1 filed with the SEC on May 25, 2022)
+Added: 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.
+Added: (Incorporated by reference as Exhibit 10.9 to the Registrant’s Form S-1 filed with the SEC on April 25, 2022)
+Added: Joint Development Agreement dated October 1, 2018, by and between the Registrant and Village Oaks Pathology Services, P.A.
+Added: 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)
+Added: 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)
+Added: 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)
+Added: Offer Letter between bioAffinity Technologies, Inc.
+Added: 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)
−Removed: Technologies, Inc.
−Removed: Amended and Restated 2014 Equity Incentive Plan Incorporated by reference as Exhibit 10.1 to the Registrant’s
−Removed: Current Report on Form 8-K (File No.
+Added: bioAffinity Technologies, Inc.
+Added: 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)
−Removed: effective as of August 1, 2023, to Employment Agreement, dated February 1, 2015, by and between bioAffinity Technologies, Inc.
−Removed: Maria Zannes (Incorporated by reference as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No.
+Added: Amendment, effective as of August 1, 2023, to Employment Agreement, dated February 1, 2015, by and between bioAffinity Technologies, Inc.
+Added: 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)
−Removed: Purchase Agreement, effective September 18, 2023, by and among, Precision Pathology Laboratory
−Removed: Services, LLC, Dr.
+Added: Asset Purchase Agreement, effective September 18, 2023, by and among, Precision Pathology Laboratory Services, LLC, Dr.
Joyce and Village Oaks Pathology Services, P.A.
−Removed: (Incorporated
−Removed: by reference as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No.
+Added: (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)
−Removed: Agreement, dated September 18, 2023, by and between The Joyce Living Trust, dated March 19, 2013, and bioAffinity Technologies, Inc.
+Added: 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.
−Removed: 001-41463) filed with the
−Removed: SEC on September 20, 2023)
−Removed: Services Agreement, effective as of September 18, 2023, by and between Precision Pathology
−Removed: Laboratory Services, LLC and Village Oaks Pathology Services, P.A.
−Removed: (Incorporated by reference
−Removed: 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)
+Added: Management Services Agreement, effective as of September 18, 2023, by and between Precision Pathology Laboratory Services, LLC and Village Oaks Pathology Services, P.A.
+Added: (Incorporated by reference as Exhibit 10.3 to the Registrant’s Current Report on Form 8-K (File No.
+Added: 001-41463) filed with the SEC on September 20, 2023)
Succession Agreement, effective September 18, 2023, by and among, Precision Pathology Laboratory Services, LLC, Dr.
5 unchanged sentences
001-41463) filed with the SEC on September 20, 2023)
−Removed: Employment Agreement, dated September 18, 2023, by and between the Registrant and Roby Joyce,
−Removed: (Incorporated by reference as Exhibit 10.6 to the Registrant’s Current Report
−Removed: on Form 8-K (File No.
+Added: Executive Employment Agreement, dated September 18, 2023, by and between the Registrant and Roby Joyce, M.D.
+Added: (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)
−Removed: and Assumption of Lease Agreement, effective September 18, 2023, by and between Precision
−Removed: Pathology Laboratory Services, LLC and Village Oaks Pathology Services, P.A.
−Removed: (Incorporated
−Removed: by reference as Exhibit 10.7 to the Registrant’s Current Report on Form 8-K (File No.
+Added: 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.
+Added: (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)
−Removed: Lease, dated July 31, 2019, by and between Village Oaks Pathology Services, P.A.
−Removed: West Sunset, LLC (Incorporated by reference as Exhibit 10.8 to the Registrant’s Current
−Removed: Report on Form 8-K (File No.
+Added: Office Lease, dated July 31, 2019, by and between Village Oaks Pathology Services, P.A.
+Added: 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)
−Removed: and Assumption Agreement, effective September 18, 2023, by and between Precision Pathology
−Removed: Laboratory Services, LLC and Village Oaks Pathology Services, P.A.
−Removed: (Incorporated by reference
−Removed: as Exhibit 10.9 to the Registrant’s Current Report on Form 8-K (File No.
+Added: Assignment and Assumption Agreement, effective September 18, 2023, by and between Precision Pathology Laboratory Services, LLC and Village Oaks Pathology Services, P.A.
+Added: (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)
−Removed: Usage Attachment, dated effective as of August 9, 2019, by and between Gen-Probe Sales &
−Removed: Service, Inc., together with its subsidiaries and affiliates and Village Oaks Pathology Services,
+Added: 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.
−Removed: 1 to Equipment Usage
−Removed: Attachment dated November 2, 2020, as further amended by that certain Amendment No.
−Removed: Equipment Usage Attachment dated November 2, 2020, and as further amended by that certain
−Removed: Amendment No.
−Removed: 3 to Equipment Usage Attachment dated December 21, 2022 (Incorporated by reference
−Removed: as Exhibit 10.10 to the Registrant’s Current Report on Form 8-K (File No.
+Added: 1 to Equipment Usage Attachment dated November 2, 2020, as further amended by that certain Amendment No.
+Added: 2 to Equipment Usage Attachment dated November 2, 2020, and as further amended by that certain Amendment No.
+Added: 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)
−Removed: Agreement, dated as of January 29, 2015, by and between Leica Microsystems, Inc.
−Removed: and Precision
−Removed: Pathology, as amended by Amendment No.
−Removed: 1 to the Master Agreement, dated on or about April
−Removed: 4, 2018, as further amended by that certain Amendment No.
−Removed: 2 to Master Agreement, dated March
−Removed: 23, 2021 (Incorporated by reference as Exhibit 10.11 to the Registrant’s Current Report
−Removed: on Form 8-K (File No.
+Added: Master Agreement, dated as of January 29, 2015, by and between Leica Microsystems, Inc.
+Added: and Precision Pathology, as amended by Amendment No.
+Added: 1 to the Master Agreement, dated on or about April 4, 2018, as further amended by that certain Amendment No.
+Added: 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)
−Removed: Relationship License Agreement, dated December 1, 2022, by and between Pathology Watch, Inc.
−Removed: and Precision Pathology Services (Incorporated by reference as Exhibit 10.12 to the Registrant’s
−Removed: Current Report on Form 8-K (File No.
+Added: Strategic Relationship License Agreement, dated December 1, 2022, by and between Pathology Watch, Inc.
+Added: 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)
−Removed: of Sale signed by Village Oaks Pathology Services, P.A., effective as of September 18, 2023
−Removed: (Incorporated by reference as Exhibit 10.13 to the Registrant’s Current Report on Form
−Removed: 8-K (File No.
+Added: 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)
−Removed: Platt Offer Letter (Incorporated by reference as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No.
+Added: 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)
−Removed: Technologies, Inc.
−Removed: Management Incentive Bonus Plan (Incorporated by reference as Exhibit 10.1 to the Registrant’s Current Report
−Removed: on Form 8-K (File No.
+Added: bioAffinity Technologies, Inc.
+Added: 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)
−Removed: to Michael Dougherty Offer Letter (Incorporated by reference as Exhibit 10.2 to the Registrant’s Current Report on Form 8-K
+Added: 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)
−Removed: of Securities Purchase Agreement, dated as of March 6, 2024, by and among the Company and the investors parties thereto (Incorporated
−Removed: by reference as Exhibit 10.1 to the Registrant’s Form 8-K filed with the SEC on March 8, 2024)
−Removed: of Support Agreement with schedule of signatories (Incorporated by reference as Exhibit 10.2 to the Registrant’s Form 8-K filed
−Removed: with the SEC on March 8, 2024)
−Removed: of Business Conduct of the Registrant (Incorporated by reference as Exhibit 14.1 to the Registrant’s Form S-1 filed with the
−Removed: SEC on May 25, 2022)
−Removed: Insider Trading Policy of the Registrant
−Removed: List of Subsidiaries of the Registrant
+Added: 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)
+Added: 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)
+Added: bioAffinity Technologies, Inc.
+Added: 2024 Incentive Compensation Plan (Incorporated by reference as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No.
+Added: 001-41463) filed with the SEC on June 5, 2024)
+Added: 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.
+Added: 001-41463) filed with the SEC on August 5, 2024)
+Added: Form of Warrant Inducement Agreement (Incorporated by reference as Exhibit 10.2 to the Registrant’s Current Report on Form 8-K (File No.
+Added: 001-41463) filed with the SEC on August 5, 2024)
+Added: 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.
+Added: 001-41463) filed with the SEC on August 5, 2024)
+Added: Consulting Agreement, dated August 21, 2024, by and between bioAffinity Technologies, Inc.
+Added: and Michael Edwards (Incorporated by reference as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No.
+Added: 001-41463) filed with the SEC on August 23, 2024)
+Added: Employment Agreement between bioAffinity Technologies, Inc.
+Added: 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.
+Added: 001-41463) filed with the SEC on October 10, 2024)
+Added: 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.
+Added: 001-41463) filed with the SEC on October 21, 2024)
+Added: Form of Support Agreement (Incorporated by reference as Exhibit 10.2 to the Registrant’s Current Report on Form 8-K (File No.
+Added: 001-41463) filed with the SEC on October 21, 2024)
+Added: Amendment No.
+Added: 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.
+Added: 001-41463) filed with the SEC on January 14, 2025)
+Added: Form of Warrant Inducement Agreement (Incorporated by reference as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No.
+Added: 001-41463) filed with the SEC on February 27, 2025)
+Added: 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)
+Added: and Restated Insider Trading Policy of the Registrant
+Added: 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)
Consent of WithumSmith+Brown, PC, independent registered public accounting firm
−Removed: Certification
−Removed: of Chief Executive Officer pursuant to Section 302 of Sarbanes-Oxley Act of 2002
−Removed: Certification
−Removed: of Chief Financial Officer pursuant to Section 302 of Sarbanes-Oxley Act of 2002
−Removed: Certification
−Removed: of Chief Executive Officer pursuant to Section 906 of Sarbanes-Oxley Act of 2002
−Removed: Certification
−Removed: of Chief Financial Officer pursuant to Section 906 of Sarbanes-Oxley Act of 2002
−Removed: Clawback Policy
+Added: Certification of Chief Executive Officer pursuant to Section 302 of Sarbanes-Oxley Act of 2002
+Added: Certification of Chief Financial Officer pursuant to Section 302 of Sarbanes-Oxley Act of 2002
+Added: Certification of Chief Executive Officer pursuant to Section 906 of Sarbanes-Oxley Act of 2002
+Added: Certification of Chief Financial Officer pursuant to Section 906 of Sarbanes-Oxley Act of 2002
+Added: 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)
XBRL Instance Document
7 unchanged sentences
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
−Removed: on its behalf by the undersigned, thereunto duly authorized on the 1 st day of April, 2024.
+Added: on its behalf by the undersigned, thereunto duly authorized on the 31 st day of March, 2025.
Technologies, Inc.
4 unchanged sentences
Executive Officer)
−Removed: Michael Dougherty
+Added: Michael Edwards
Financial Officer
+Added: Michael Edwards
Financial and Accounting Officer)
6 unchanged sentences
to the Consolidated Financial Statements
−Removed: of Independent Registered Public Accounting Firm (PCAOB ID NO.
−Removed: Balance Sheets as of December 31, 2023 and 2022
−Removed: Statements of Operations for the years ended December 31, 2023 and 2022
−Removed: Statements of Changes in Convertible Preferred Stock and Stockholders’ Equity for the years ended December 31, 2023 and 2022
−Removed: Statements of Cash Flows for the years ended December 31, 2023 and 2022
+Added: Report of Independent Registered Public Accounting Firm (PCAOB ID NO.
+Added: Consolidated Balance Sheets as of December 31, 2024 and 2023
+Added: Consolidated Statements of Operations for the years ended December 31, 2024 and 2023
+Added: Consolidated Statements of Changes in Convertible Preferred Stock and Stockholders’ Equity for the years ended December 31, 2024 and 2023
+Added: Consolidated Statements of Cash Flows for the years ended December 31, 2024 and 2023
Notes to Consolidated Financial Statements
of Independent Registered Public Accounting Firm
−Removed: the Stockholders and Board of Directors of bioAffinity Technologies, Inc.:
+Added: the Board of Directors and Stockholders of
+Added: Technologies, Inc.:
on the Consolidated Financial Statements
have audited the accompanying consolidated balance sheets of bioAffinity Technologies, Inc.
−Removed: (the “Company”) as of December
−Removed: 31, 2023 and 2022, the related consolidated statements of operations, changes in stockholders’ equity, and cash flows, for each
−Removed: of the two years in the period ended December 31, 2023, and the related notes (collectively referred to as the “consolidated financial
−Removed: statements”).
−Removed: In our opinion, the consolidated financial statements present fairly, in all material respects, the consolidated
−Removed: financial position of the Company as of December 31, 2023 and 2022 and the consolidated results of its operations and its cash flows
−Removed: for each of the two years in the period ended December 31, 2023, in conformity with accounting principles generally accepted in the United
−Removed: States of America.
−Removed: accompanying consolidated financial statements have been prepared assuming that the entity will continue as a going concern.
−Removed: in Note 1 to the consolidated financial statements, the entity has incurred recurring losses from operations and expects to continue
−Removed: to incur operating losses that raise substantial doubt about its ability to continue as a going concern.
−Removed: Management’s plans in
−Removed: regard to these matters are also described in Note 1.
−Removed: The consolidated financial statements do not include any adjustments that might
−Removed: result from the outcome of this uncertainty.
+Added: (the “Company”) as of
+Added: December 31, 2024 and 2023, and the related consolidated statements of operations, changes in stockholders’ equity, and cash
+Added: flows, for each of the two years in the period ended December 31, 2024, and the related notes (collectively referred to as the
+Added: “consolidated financial statements”).
+Added: In our opinion, the consolidated financial statements present fairly, in all
+Added: material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results
+Added: 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.
+Added: Substantial Doubt Regarding the Company’s
+Added: Ability to Continue as a Going Concern
+Added: The accompanying consolidated financial statements
+Added: have been prepared assuming the Company will continue as a going concern.
+Added: As discussed in Note 1 to the consolidated financial statements,
+Added: the Company has incurred significant losses and negative cash flows from operations since inception, has an accumulated deficit, and needs
+Added: to raise additional funds to meet its obligations and sustain its operations.
+Added: These conditions raise substantial doubt about the Company’s
+Added: ability to continue as a going concern.
+Added: Management’s plans in regard to these matters are also described in Note 1.
+Added: The consolidated
+Added: financial statements do not include any adjustments that might result from the outcome of this uncertainty.
consolidated financial statements are the responsibility of the Company’s management.
Our responsibility is to express an opinion
−Removed: on the Company’s consolidated financial statements based on our audits.
+Added: on these consolidated financial statements based on our audits.
We are a public accounting firm registered with the Public
3 unchanged sentences
and the PCAOB.
−Removed: conducted our audits in accordance with the standards of the PCAOB and in accordance with auditing standards generally accepted in the
−Removed: United States of America.
+Added: 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
8 unchanged sentences
due to error or fraud, and performing procedures that respond to those risks.
−Removed: Such procedures included examining, on a test basis, evidence
−Removed: regarding the amounts and disclosures in the consolidated financial statements.
−Removed: Our audits also included evaluating the accounting principles
−Removed: used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.
+Added: Such procedures included examining, on a test basis,
+Added: evidence regarding the amounts and disclosures in the consolidated financial statements.
+Added: Our audits also included evaluating the
+Added: accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the
+Added: consolidated financial statements.
We believe that our audits provide a reasonable basis for our opinion.
−Removed: /s/ WithumSmith+Brown,
+Added: WithumSmith+Brown, PC
have served as the Company’s auditor since 2021.
York, New York
−Removed: April 1, 2024
ID Number 100
1 unchanged sentence
Balance Sheets
+Added: as of December 31, 2024 and 2023
Current assets:
17 unchanged sentences
current portion
+Added: payable, current portion
Total current liabilities
2 unchanged sentences
net of current portion
−Removed: lease liability, net of current portion
+Added: Finance lease liability,
+Added: net of current portion
+Added: Notes payable, net of current portion
Total liabilities
5 unchanged sentences
$ 0.007 per share;
−Removed: 25,000,000 and 14,285,714 shares authorized;
−Removed: 9,394,610 and 8,381,324 shares issued and outstanding as of December
−Removed: 31, 2023 and 2022, respectively
+Added: 100,000,000 shares authorized;
+Added: 15,576,674 and 9,394,610 shares issued and outstanding as of December 31, 2024 and
+Added: 2023, respectively
Additional paid-in capital
22 unchanged sentences
Interest expense
−Removed: ( 2,532,640 )
Other expense
−Removed: Gain on extinguishment
−Removed: value adjustments on convertible notes payable
−Removed: ( 1,866,922 )
before income taxes
8 unchanged sentences
Technologies, Inc.
−Removed: Statements of Changes in Convertible Preferred Stock and Stockholders’ Equity
+Added: Statements of Changes in Stockholders’ Equity
the Years Ended December 31, 2024 and 2023
2 unchanged sentences
$ ( 36,667,468 )
−Removed: $ ( 15,790,719 )
Stock-based compensation
−Removed: Fair value of warrants issued
−Removed: Beneficial conversion feature for bridge notes
−Removed: Debt discount for warrants issued
−Removed: Common stock issued upon initial public offering,
−Removed: net of underwriters’ commission and offering costs of $ 1.8 million
−Removed: Common stock issued on conversion of convertible
−Removed: preferred stock
−Removed: $ ( 4,044,318 )
−Removed: Common stock issued on conversion of notes
−Removed: Exercise of warrants
−Removed: Exercise of stock options
+Added: Stock issued in connection with the acquisition
( 7,937,011 )
2 unchanged sentences
$ ( 44,604,479 )
+Added: $ ( 44,604,479 )
Stock-based compensation
−Removed: Stock issued in connection with the acquisition
+Added: Exercise of stock options
+Added: Exercise of stock warrants
+Added: Sale of common stock
+Added: Offering costs
( 1,261,898 )
( 1,261,898 )
+Added: ( 9,039,831 )
+Added: ( 9,039,831 )
Balance at December 31, 2024
$ ( 53,644,310 )
+Added: $ ( 53,644,310 )
accompanying notes are an integral part of these consolidated financial statements.
5 unchanged sentences
$ ( 7,937,011 )
−Removed: Adjustments to reconcile net loss to net
−Removed: cash used in operating activities:
+Added: Adjustments to reconcile
+Added: net loss to net cash used in operating activities:
Depreciation and amortization
−Removed: Accretion of debt issuance
−Removed: Fair value adjustments
−Removed: on convertible notes payable
Stock-based compensation
−Removed: Fair value of warrants
−Removed: Gain on extinguishment
−Removed: Changes in operating assets and liabilities:
+Added: Changes in operating
+Added: assets and liabilities:
Accounts and other receivables
16 unchanged sentences
Cash flows from financing
−Removed: Proceeds from loan payable
−Removed: Payment on loans payable
Proceeds from issuance
−Removed: of convertible notes payable
−Removed: Repayment of convertible
−Removed: Proceeds from issuance
−Removed: of common stock from the initial public offering, net of underwriting discounts, commissions and offering expenses of approximately
−Removed: $ 1.8 million
−Removed: Exercise of warrants
−Removed: Exercise of stock options
−Removed: Return of capital from
−Removed: Payment of debt issuance
+Added: of common stock from direct offering, net of underwriting discounts, commissions, and offering expenses of $ 1,334,811
+Added: Proceeds from exercised
+Added: stock options
+Added: Proceeds from exercise
+Added: Payment on loans payable
+Added: Proceeds from loans
repayments on finance leases
−Removed: cash provided (used) by financing activities
−Removed: Net increase (decrease)
−Removed: in cash and cash equivalents
+Added: Net cash provided by (used in) by financing activities
+Added: Net decrease in cash and cash equivalents
( 1,716,279 )
+Added: ( 8,592,189 )
Cash and cash equivalents
9 unchanged sentences
Noncash financing activities:
−Removed: Conversion of convertible
−Removed: preferred stock into common stock
−Removed: Conversion of convertible
−Removed: notes payable into common stock
Fair value of warrants
issued to placement agents
−Removed: Beneficial conversion
−Removed: feature for bridge notes
accompanying notes are an integral part of these consolidated financial statements.
3 unchanged sentences
BASIS OF PRESENTATION, ORGANIZATION AND NATURE OF OPERATIONS
−Removed: Technologies, Inc., a Delaware corporation (the “Company,” or “bioAffinity Technologies”), addresses the need
−Removed: for noninvasive diagnosis of early-stage cancer and diseases of the lung.
−Removed: The Company also is conducting early-stage research focused
−Removed: on advancing therapeutic discoveries that could result in broad-spectrum cancer treatments.
−Removed: bioAffinity Technologies develops proprietary
−Removed: noninvasive diagnostic tests using technology that preferentially targets cancer cells and cell populations indicative of a diseased
−Removed: The Company’s first diagnostic test, CyPath ® Lung, is a noninvasive test for early detection of lung cancer,
−Removed: the leading cause of cancer-related deaths.
−Removed: CyPath ® Lung is offered for sale to physicians by the Company’s subsidiary,
−Removed: Precision Pathology Laboratory Services, LLC (“PPLS”).
−Removed: Research and optimization of the Company’s proprietary platform
−Removed: for in vitro diagnostics and technologies are conducted in laboratories at The University of Texas at San Antonio and PPLS.
−Removed: is developing its platform technologies so that in the future they will be able to detect, monitor, and treat diseases of the lung and
−Removed: other cancers.
−Removed: and Initial Public Offering
+Added: bioAffinity Technologies, Inc., a Delaware corporation (the “Company,” or “bioAffinity Technologies”),
+Added: addresses the need for noninvasive diagnosis of lung cancer at early stage and other diseases of the lung.
+Added: bioAffinity Technologies’
+Added: proprietary platform uses flow cytometry and automated data analysis built by machine learning, a form of artificial intelligence, to
+Added: preferentially target cancer cell populations and other cell populations indicative of a diseased state.
+Added: The Company’s first diagnostic
+Added: test, CyPath ® Lung, is a noninvasive test for early detection of lung cancer, the leading cause of cancer-related deaths.
+Added: CyPath ® Lung is offered for sale to physicians by the Company’s subsidiary, Precision Pathology Laboratory Services,
+Added: LLC (“PPLS”).
+Added: The Company also conducted and intends to seek strategic partners to advance therapeutic discoveries that could
+Added: in the future result in broad-spectrum cancer treatments.
+Added: Research and optimization of the Company’s proprietary platform technologies
+Added: are conducted in laboratories at PPLS and laboratory space leased at The University of Texas at San Antonio.
Company was formed on March 26, 2014, as a Delaware corporation with its corporate offices located in San Antonio, Texas.
1 unchanged sentence
On August 14, 2023, the Company formed a wholly owned subsidiary, PPLS, as a Texas limited liability company, to acquire the assets of
−Removed: Village Oaks Pathology Services, P.A., a Texas professional association d/b/a Precision Pathology Services, including the clinical pathology
−Removed: laboratory it owned.
+Added: Village Oaks Pathology Services, P.A.
+Added: (“Village Oaks”), a Texas professional association d/b/a Precision Pathology Services,
+Added: including the clinical pathology laboratory it owned.
of Presentation
3 unchanged sentences
Securities and Exchange Commission (“SEC”).
−Removed: Going Concern
+Added: and Capital Resources
accordance with Accounting Standards Update (“ASU”) 2014-15, Presentation of Financial Statements – Going Concern
4 unchanged sentences
As a result, the Company had an accumulated deficit of $ 53.6 million at December
−Removed: The Company’s cash and cash equivalents at December 31, 2023, were approximately $ 2.8 million, representing 34 % of total
−Removed: Based on the Company’s current expected level of operating expenditures and the cash and cash equivalents on hand at December
−Removed: 31, 2023, management concludes that there is substantial doubt about the Company’s ability to continue as a going concern for a
−Removed: period of at least twelve (12) months subsequent to the issuance of the accompanying consolidated financial statements.
−Removed: Therefore, the
−Removed: Company may need to raise further capital through the sale of additional equity or debt securities or other debt instruments, strategic
−Removed: relationships or grants, or other arrangements to support its future operations.
−Removed: If such funding is not available or not available on
−Removed: terms acceptable to the Company, the Company’s current development plan may be curtailed.
−Removed: On March 8, 2024, the Company issued
−Removed: to certain investors, pursuant to a Securities Purchase Agreement (the “Purchase Agreement”) (1) 1,600,000 shares of the
−Removed: Company’s common stock (the “Shares”), par value $ 0.007 per share (“Common Stock”) in a registered direct
−Removed: offering, and (2) warrants to purchase an aggregate of 1,600,000 shares of Common Stock (the “Common Warrants”) with an exercise
−Removed: price of $ 1.64 , in a concurrent private placement.
−Removed: The direct offering resulted in net proceeds of $ 2.05 million.
+Added: The Company’s cash and cash equivalents at December 31, 2024, were approximately $ 1.1 million.
+Added: Based on the Company’s
+Added: current expected level of operating expenditures and the cash and cash equivalents on hand at December 31, 2024, management concludes
+Added: that there is substantial doubt about the Company’s ability to continue as a going concern for a period of at least twelve (12)
+Added: months subsequent to the issuance of the accompanying consolidated financial statements.
+Added: Without funding from the proceeds of a capital raise or strategic relationship
+Added: or grant, management anticipates that the Company’s cash resources are sufficient to continue operations through April 2025.
+Added: The Company may need to raise further
+Added: capital through the sale of additional equity or debt securities or other debt instruments, strategic relationships or grants, or other
+Added: arrangements to support its future operations, if revenue from operations does not significantly increase.
+Added: If such funding is not available
+Added: or not available on terms acceptable to the Company, the Company’s current development plan may be curtailed.
Furthermore, an alternative
−Removed: source of funding to the sale of additional equity or debt securities is the exercising of outstanding warrants.
−Removed: No adjustments have
−Removed: been made to the presented consolidated financial statements as a result of this uncertainty.
+Added: source of funding to the sale of additional equity or debt securities is the exercise of outstanding warrants for which there can be
+Added: no guarantee.
+Added: No adjustments have been made to the presented consolidated financial statements as a result of this uncertainty.
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
−Removed: preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect
−Removed: the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial
−Removed: statements and the reported amounts of revenues and expenses during the reporting period.
−Removed: Actual results could differ from those estimates.
−Removed: Significant estimates include the valuation allowance on the Company’s deferred tax assets, stock-based compensation, valuation
−Removed: of goodwill and intangible assets related to the business combination, allowance for contractual adjustments and discounts related to
−Removed: service revenues, and the useful lives of fixed assets.
+Added: The preparation of financial statements in conformity with GAAP in the U.S.
+Added: requires management to make significant
+Added: judgments and estimates that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities
+Added: at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period.
+Added: Management bases
+Added: these significant judgments and estimates on historical experience and other assumptions it believes to be reasonable based upon information
+Added: presently available.
+Added: Actual results could differ from those estimates under different assumptions, judgments, or conditions.
of Consolidation
11 unchanged sentences
may result in the Company consolidating or deconsolidating one or more of its collaborators or partners.
−Removed: September 18, 2023, the Company, in connection with the Asset Purchase Agreement it entered into with Village Oaks (the “Seller”)
−Removed: Joyce, M.D., dated September 18, 2023, acquired substantially all the assets and assumed certain liabilities of Village Oaks
−Removed: in exchange for total consideration of $ 3,500,000 ,
−Removed: which consists of:
−Removed: million in cash paid at closing and (2) 564,972
−Removed: shares of the Company’s common stock valued
−Removed: The assets purchased included
−Removed: a clinical pathology laboratory regulated by the Centers for Medicare and Medicaid Services (“CMS”) and accredited by the
−Removed: College of American Pathologists (“CAP”) and certified under the Clinical Laboratory Improvement Amendments (“CLIA”)
−Removed: The primary reason for the acquisition is control of the laboratory in which CyPath® Lung is ordered and processed.
+Added: September 18, 2023, the Company, in connection with the Asset Purchase Agreement it entered into with Village Oaks and Roby P.
+Added: M.D., dated September 18, 2023, acquired substantially all the assets and assumed certain liabilities of Village Oaks in exchange for
+Added: total consideration of $ 3,500,000 , which consists of:
+Added: (1) $ 2.5 million in cash paid at closing and (2) 564,972 shares of the Company’s
+Added: Common Stock valued at $ 1 million.
+Added: The assets purchased included a clinical pathology laboratory regulated by the Centers for Medicare
+Added: and Medicaid Services (“CMS”) and accredited by the College of American Pathologists (“CAP”) and certified under
+Added: the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”).
+Added: The primary reason for the acquisition was control of the
+Added: laboratory in which CyPath ® Lung is ordered and processed.
Company recognized goodwill of $ 1,404,000 arising from the acquisition.
1 unchanged sentence
in accordance with ASC 805.
−Removed: The Company has determined the preliminary fair values of the accounts receivables, accounts payable and
−Removed: accrued expenses that make up the majority of the net working capital assumed in the acquisition.
−Removed: These values are subject to change
−Removed: as the Company performs additional reviews of its assumptions utilized.
−Removed: following table summarizes the purchase price and preliminary purchase price allocations relating to the acquisition:
−Removed: SCHEDULE OF PURCHASE PRICE AND PRELIMINARY PURCHASE PRICE ALLOCATIONS
+Added: The Company has determined the fair values of the accounts receivable, accounts payable, and accrued expenses
+Added: that make up the majority of the net working capital assumed in the acquisition.
+Added: following table summarizes the purchase price and finalized purchase price allocations relating to the acquisition:
+Added: OF PURCHASE PRICE AND FINALIZED PURCHASE PRICE ALLOCATIONS
purchase consideration
5 unchanged sentences
The calculated goodwill is not deductible for tax
−Removed: Consolidated unaudited pro-forma operating results as if the business combination began on January 1, 2022 are net revenues of $ 7.9 million
−Removed: and $ 6.9 million, net loss of ($ 8.6 million) and ($ 8.6 million), and loss per share of ($ 0.99 ) and ($ 1.91 ) for years ended 2023 and 2022,
−Removed: respectively.
−Removed: preliminary purchase price allocations relating to the acquisition previously reported in the 10-Q filed, October 14, 2023, reported
−Removed: Net Working Capital of $ 1,167,000 and Goodwill of $ 1,149,000 .
−Removed: The amounts have been updated to reflect the purchase price adjustments
−Removed: to accounts payable and accounts receivable that existed at the time of the acquisition.
−Removed: The company incurred approximately $ 811,000 in acquisition costs.
+Added: Company incurred and expensed approximately $ 811,000
+Added: in acquisition costs.
and Cash Equivalents
−Removed: the purpose of the statement of cash flows, the Company considers all highly liquid investments with original maturities of three months
−Removed: or less at the time of purchase to be cash equivalents.
−Removed: Cash equivalents are stated at cost, which approximates market value, because
−Removed: of the short maturity of these instruments.
+Added: the purpose of the consolidated statement of cash flows, the Company considers all highly liquid investments with original
+Added: maturities of three months or less at the time of purchase to be cash equivalents.
+Added: Cash equivalents are stated at cost, which
+Added: approximates market value because of the short maturity of these instruments.
Concentration
4 unchanged sentences
Company expenses all advertising costs as incurred.
−Removed: Advertising expenses were approximately $ 89,000 and $ 39,000 for the years ended December
−Removed: 31, 2023, and 2022, respectively.
+Added: Advertising expenses were approximately $ 267,201 and $ 88,832 for the years ended
+Added: December 31, 2024 and 2023, respectively.
loss per share is computed by dividing net loss attributable to common stockholders by the weighted-average number of shares of the Company’s
8 unchanged sentences
as of December 31, 2024 and 2023, as they would be anti-dilutive:
−Removed: SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES
+Added: OF POTENTIALLY DILUTIVE SECURITIES
of December 31,
1 unchanged sentence
Shares underlying warrants outstanding
+Added: Shares underlying unvested
+Added: restricted stock outstanding
Anti-dilutive
−Removed: Post-acquisition
−Removed: of PPLS, additional revenue streams have been consolidated starting September 19, 2023.
−Removed: PPLS generates three sources of revenue:
−Removed: patient service fees, (2) histology service fees, and (3) medical director fees.
−Removed: The revenue is recognized on the date of service (meeting
−Removed: the performance requirement of ASC 606).
−Removed: Pre-acquisition, bioAffinity’s revenue was generated in three ways pre-acquisition:
−Removed: royalties from the Company’s diagnostic test, CyPath ® Lung, (2) clinical flow cytometry services provided to Village
−Removed: Oaks related to the Company’s CyPath ® Lung test, and (3) CyPath ® Lung tests purchased by the U.S.
−Removed: Department of Defense (“DOD”) for an observational study, “Detection of Abnormal Respiratory Cell Populations in Lung
−Removed: Cancer Screening Patients Using the CyPath ® Lung Assay (NCT05870592),” and research and development on using bronchoalveolar
−Removed: lavage fluid as a biological sample to assess cardiopulmonary function and exercise performance in military personnel post COVID-19 infection.
−Removed: The royalty income from CyPath ® Lung and clinical flow cytometry services income, beginning September 19, 2023, are related-party
−Removed: income and, therefore, eliminated from consolidated net revenues.
determine revenue recognition for the arrangements that the Company determines are within the scope of ASC 606, Revenue from Contracts
3 unchanged sentences
the contract, and (5) recognize revenue when (or as) the entity satisfies a performance obligation.
−Removed: SCHEDULE OF REVENUE RECOGNITION
−Removed: of December 31,
+Added: Post-acquisition
+Added: of PPLS, additional revenue streams have been consolidated starting September 19, 2023.
+Added: PPLS generates three sources of revenue:
+Added: patient service fees, (2) histology service fees, and (3) medical director fees.
+Added: The Company recognizes as revenue the amount that reflects
+Added: the consideration to which it expects to be entitled in exchange for goods sold or services rendered primarily upon completion of the
+Added: testing process (when results are reported) or when services have been rendered.
+Added: Company follows a standard process, which considers historical denial and collection experience and other factors (including the period
+Added: of time that the receivables have been outstanding), to estimate contractual allowances and implicit price concessions, recording adjustments
+Added: in the current period as changes in estimates.
+Added: The process for estimating revenues and the ultimate collection of accounts receivable
+Added: involves significant judgment and estimation.
+Added: Pre-acquisition, bioAffinity’s revenue was generated in three ways:
+Added: (1) royalties from
+Added: the Company’s diagnostic test, CyPath ® Lung, (2) clinical flow cytometry services provided to Village Oaks related
+Added: to the Company’s CyPath ® Lung test, and (3) CyPath ® Lung tests purchased by the U.S.
+Added: Department of
+Added: Defense (“DOD”) for an observational study, “Detection of Abnormal Respiratory Cell Populations in Lung Cancer Screening
+Added: Patients Using the CyPath ® Lung Assay (NCT05870592),” and research and development on using bronchoalveolar lavage
+Added: fluid as a biological sample to assess cardiopulmonary function and exercise performance in military personnel post COVID-19 infection.
+Added: The royalty income from CyPath ® Lung and clinical flow cytometry services income, beginning September 19, 2023, are related
+Added: party income and, therefore, eliminated from consolidated net revenues.
+Added: OF REVENUE RECOGNITION
Patient service
3 unchanged sentences
Other revenues
−Removed: 1 Patient services
−Removed: fees includes direct billing for CyPath® Lung diagnostic test.
−Removed: 2 Other revenues
−Removed: include pre-acquisition CyPath® Lung royalty income and laboratory services.
+Added: services fees include direct billing for CyPath® Lung diagnostic test of approximately $ 516,000 and $ 35,000 for the years
+Added: ended December 31, 2024 and 2023.
Reclassifications
prior year balances have been reclassified to conform to current year presentation.
−Removed: The Company reclassified legal fees and annuity costs
−Removed: relating to patents of approximately $ 236,000 from research and development to selling, general and administrative for the year ended
−Removed: December 31, 2022, respectively, as these expenses are not deemed research and development.
+Added: Any reclassifications had an immaterial effect on the Company’s consolidated financial statements and had no
+Added: effect on prior periods net income or stockholders’ equity.
and Equipment, Net
−Removed: accordance with ASC 360-10, Accounting for the Impairment of Long-Lived Assets , the Company periodically reviews the carrying
−Removed: value of its long-lived assets, such as property, equipment, and definite lived intangible assets, to test whether current events or
−Removed: circumstances indicate that such carrying value may not be recoverable.
−Removed: When evaluating assets for potential impairment, the Company
−Removed: compares the carrying value of the asset to its estimated undiscounted future cash flows.
−Removed: If an asset’s carrying value exceeds
−Removed: such estimated cash flows (undiscounted and with interest charges), the Company records an impairment charge for the difference.
−Removed: Company did not record any impairment for the years end December 31, 2023, or 2022.
+Added: accordance with ASC 360-10, Accounting for the Impairment of Long-Lived
+Added: Assets ( “ASC 360” ) , the Company periodically reviews the carrying value of its long-lived assets, such as property,
+Added: equipment, and definite lived intangible assets, to test whether current events or circumstances indicate that such carrying value may
+Added: not be recoverable.
+Added: When evaluating assets for potential impairment, the Company compares the carrying value of the asset to its estimated
+Added: undiscounted future cash flows.
+Added: If an asset’s carrying value exceeds such estimated cash flows (undiscounted and with interest charges),
+Added: the Company records an impairment charge for the difference.
+Added: The Company did not record any impairment for the years ended December 31,
+Added: 2024 or 2023.
and equipment are carried at cost, net of accumulated depreciation.
5 unchanged sentences
lives of each asset class are as follows:
−Removed: SCHEDULE OF PROPERTY AND EQUIPMENT USEFUL LIFE
+Added: OF PROPERTY AND EQUIPMENT USEFUL LIFE
of lease term or useful life
−Removed: assets, net of accumulated amortization, are summarized as follows as of December 31, 2023:
−Removed: SCHEDULE OF INTANGIBLE ASSETS ADJUSTMENTS
−Removed: Date Acquired
+Added: Company’s acquisition of PPLS on September 18, 2023 identified Goodwill and intangible assets.
+Added: Goodwill represents the purchase
+Added: price in excess of fair values assigned to the underlying identifiable net assets of the acquired business.
+Added: The intangible assets and
+Added: their respective useful lives are as follows:
trade names and trademarks ( 18
+Added: years) and customer relationships ( 14
+Added: Intangible assets, net of accumulated
+Added: amortization, are summarized as follows as of December 31, 2024 and 2023:
+Added: OF INTANGIBLE ASSETS
+Added: Trade names and trademarks
Customer relationships
−Removed: Total Intangible Assets
−Removed: the year ended December 31, 2023, amortization of intangible assets totaled $ 16,528 compared to $ 0 in the prior year comparative periods.
+Added: Accumulated amortization
+Added: Trade names and trademarks
+Added: Customer relationships
+Added: Accumulated amortization
+Added: Intangible assets, net
+Added: the year ended December 31, 2024, amortization of intangible assets totaled $ 58,333 compared to $ 16,528 in the prior year comparative
+Added: Goodwill is reviewed annually for impairment in accordance with ASC
+Added: 350 - Intangibles – Goodwill and Other , and intangible assets are reviewed annually for impairment in accordance with ASC 360
+Added: unless circumstances dictate the need for more frequent assessment.
+Added: The Company elected to perform a quantitative impairment analysis
+Added: as of December 31, 2024.
+Added: The annual quantitative assessment of the intangible assets was performed utilizing a discounted cash flow analysis
+Added: (“income approach”) .
+Added: The income approach measures the fair value of an interest
+Added: in a business by discounting expected future cash flows to present value.
+Added: The results of the annual quantitative impairment analysis indicated
+Added: that the fair value exceeded the carrying value of the reporting unit and therefore resulted in no impairment needed.
Accounting Pronouncements
Company continues to monitor new accounting pronouncements issued by the Financial Accounting Standards Board (“FASB”) and
−Removed: does not believe any accounting pronouncements issued through the date of this Annual Report will have a material impact on the Company’s
−Removed: consolidated financial statements.
−Removed: Company adopted FASB issued Accounting Standards Update (ASU) No.
−Removed: 2016-13, accounting considerations of Financial Instruments –
−Removed: Credit Losses (Topic 326):
−Removed: Measurement of Credit Losses on Financial Instruments (“CECL”) on September 18, 2023, with the
−Removed: business combination of Village Oaks and PPLS.
−Removed: The Company has patient service fees that are billed to commercial insurance companies,
−Removed: governmental payors, and patients.
−Removed: Under the CECL model, the Company estimates potential credit losses from the patient service fees
−Removed: billed using historical data.
+Added: does not believe any accounting pronouncements issued through the date of this Annual report will have a material impact on the Company’s consolidated
+Added: financial statements.
Company adopted FASB issued Accounting Standards Update (“ASU”) No.
−Removed: 2016-02, Leases (Topic 842) on January 1, 2022, with the business combination
−Removed: of Village Oaks and PPLS.
−Removed: The Company has one operating lease for its real estate and office space and multiple finance leases for lab
−Removed: equipment in Texas that was acquired through the September 18, 2023, Acquisition.
+Added: 2023-07, Segment Reporting (Topic 280):
+Added: Improvements to Reportable
+Added: Segment Disclosures on December 31, 2024, on a retrospective basis.
+Added: The Company used the five steps to ASC 280 to evaluate what, if any, segment reporting
+Added: would be beneficial for shareholders.
+Added: These five steps included:
+Added: 1) evaluate operating segments for aggregation, 2) perform quantitative
+Added: threshold tests, 3) evaluate remaining operating segments for aggregation, 4) ensure that 75% of revenue is reported, and 5) consider
+Added: practical limit.
+Added: Based on the analysis above against those five steps, management concludes that segment reporting is required for two
+Added: segment operations:
+Added: 1) diagnostic R&D and 2) laboratory services (See Note 2).
+Added: The FASB issued Accounting Standards Update (“ASU”)
+Added: ASU 2023-09, Income Taxes (Topic 740):
+Added: Improvement to Income Tax Disclosures which requires public business entities
+Added: to disclose annually a tabular rate reconciliation, including specific items such as state and local income tax, tax credits, nontaxable
+Added: or nondeductible items, among others, and a separate disclosure requiring disaggregation of reconciling items as described above which
+Added: equal or exceed 5% of the product of multiplying income from continuing operations by the applicable statutory income tax rate.
+Added: is effective for all public business entities for annual periods beginning after December 15, 2024.
+Added: The adoption of this standard
+Added: is not expected to have a material effect on the Company’s operating results or financial condition.
taxes are accounted for under the asset and liability method.
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31, 2024 and 2023, and the Company had no accruals for interest and penalties at December 31, 2024 or 2023.
−Removed: Company is organized in two operating segments, Diagnostic Research and Development (R&D) and Laboratory Services, whereby its chief
−Removed: operating decision maker (“CODM”) assesses the performance of and allocates resources.
+Added: The Company is organized in two operating segments, Diagnostic Research and
+Added: Development (“R&D”) and Laboratory Services, whereby its chief operating decision maker (“CODM”) uses operating
+Added: income as the primary measure of segment profit or loss to assess performance and make resource allocation decisions, in addition to monitoring
+Added: revenue growth and research and development progress.
The CODM is the Chief Executive Officer.
−Removed: Diagnostic R&D includes research and development and clinical development on diagnostic tests.
−Removed: Any revenues assigned to Diagnostic
−Removed: R&D are proceeds received from observational studies.
−Removed: Laboratory services include all the operations from Village Oaks and PPLS in
−Removed: addition to sales and marketing costs of CyPath® Lung from bioAffinity.
−Removed: SCHEDULE OF SEGMENT INFORMATION
+Added: R&D includes research and development and clinical development of diagnostic tests.
+Added: Any revenues assigned to Diagnostic R&D are
+Added: proceeds received from observational studies.
+Added: Laboratory services include all the operations from Village Oaks and PPLS in addition to
+Added: sales and marketing costs of CyPath® Lung from bioAffinity.
+Added: OF SEGMENT INFORMATION
of December 31,
6 unchanged sentences
( 9,946,452 )
+Added: ( 3,769,783 )
corporate activities
1 unchanged sentence
( 5,011,347 )
−Removed: operating loss
+Added: Total operating loss
( 8,953,445 )
2 unchanged sentences
income (expense), net
−Removed: ( 4,140,596 )
Net loss before income taxes
6 unchanged sentences
The Company’s research and development expenses consist primarily of
−Removed: expenditures for lab operations, preclinical studies, compensation, and consulting costs.
−Removed: Company incurred research and development expenses of $ 1.5 million and $ 1.4 million for the years ended December 31, 2023 and 2022, respectively.
+Added: expenditures for laboratory operations, preclinical studies, compensation, and consulting costs.
Research and Development Costs
2 unchanged sentences
The Company records the estimated costs of research and development activities based upon the estimated
−Removed: amount of services provided but not yet invoiced and includes these costs in accrued expenses in the accompanying balance sheets and
−Removed: within research and development expense in the accompanying consolidated statements of operations.
+Added: amount of services provided but not yet invoiced and includes these costs in accrued expenses in the accompanying consolidated
+Added: balance sheets and within research and development expense in the accompanying consolidated statements of operations.
Company accrues for these costs based on factors such as estimates of the work completed and in accordance with agreements established
7 unchanged sentences
In the U.S., drugs,
−Removed: biological products, and medical devices are regulated by FDCA, which is administered by the FDA and the Centers for Medicare and Medicaid
−Removed: The Company has not yet obtained marketing authorization from the FDA but is able to market its CyPath® Lung test as a
−Removed: laboratory developed test sold by Precision Pathology Laboratory Services, a CAP-accredited, CLIA-certified clinical pathology laboratory
+Added: biological products, and medical devices are regulated by the federal Food, Drug and Cosmetic Act, which is administered by the FDA and
+Added: The Company has not yet obtained marketing authorization from the FDA but is able to market its CyPath ® Lung test
+Added: as a laboratory developed test sold by Precision Pathology Laboratory Services, a CAP-accredited, CLIA-certified clinical pathology laboratory
and wholly owned subsidiary.
1 unchanged sentence
and other receivables at December 31, 2024 and 2023, are summarized below:
−Removed: SCHEDULE OF ACCOUNTS RECEIVABLE
+Added: OF ACCOUNTS AND OTHER RECEIVABLES
Patient service fees
5 unchanged sentences
expenses and other current assets at December 31, 2024 and 2023, are summarized below:
−Removed: SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
+Added: OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid insurance
Legal and professional
−Removed: Total prepaid expenses
−Removed: and other current assets
+Added: prepaid expenses and other current assets
PROPERTY AND EQUIPMENT, NET
4 unchanged sentences
Leasehold improvements
−Removed: Property and equipment, gross
−Removed: depreciation and amortization
+Added: and equipment, gross
+Added: accumulated depreciation
+Added: and amortization
property and equipment, net
−Removed: Property and equipment depreciation expense was $ 233,064 and $ 10,182 for the years ended December 31, 2023, and 2022,
+Added: property and equipment depreciation and amortization expense was $ 162,332 and $ 233,064 for the years ended December 31, 2024 and 2023,
respectively.
15 unchanged sentences
to the fair value measurement.
+Added: three levels of the hierarchy and the related inputs are as follows:
+Added: Unadjusted quoted prices in active markets for identical assets and liabilities.
+Added: quoted prices in active markets for similar assets and liabilities;
+Added: Unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active;
+Added: Inputs other than quoted prices that are observable for the asset or liability.
+Added: Unobservable inputs for the asset or liability.
estimated fair value of certain financial instruments, including cash and cash equivalents, accounts and other receivables, prepaid and
1 unchanged sentence
their fair values because of the short-term nature of these instruments.
−Removed: Company has one operating lease for its real estate and office space and multiple finance leases for lab equipment in Texas that was
−Removed: acquired through the September 18, 2023, Acquisition.
−Removed: The operating lease has a remaining lease term of 3.58 years as of December 31,
−Removed: The Company has finance leases consisting of office and lab equipment with remaining lease terms ranging from approximately 2.25
−Removed: to 4.0 years as of December 31, 2023, for which the Company has determined that it will use the equipment for a major part of its remaining
−Removed: economic life.
+Added: Company has one operating lease for its real estate and office space for the CAP/CLIA laboratory, as well as multiple finance leases
+Added: for lab equipment in Texas that were acquired through the September 18, 2023 acquisition.
+Added: Additionally, the Company entered into another
+Added: operating lease on September 1, 2024 with regard to office space.
+Added: The Company has operating leases consisting of office space with remaining
+Added: lease terms ranging from 3.1 to 5.9 years as of December 31, 2024.
+Added: The Company has finance leases consisting of office and lab equipment
+Added: with remaining lease terms ranging from approximately 1.25 to 3.0 years as of December 31, 2024, for which the Company has determined
+Added: that it will use the equipment for a major part of its remaining economic life.
lease agreements generally do not provide an implicit borrowing rate.
−Removed: Therefore, the Company used a benchmark approach as of December
−Removed: 31, 2023, to derive an appropriate incremental borrowing rate to discount remaining lease payments.
−Removed: The Company benchmarked itself against
−Removed: other companies of similar credit ratings and comparable quality and derived imputed interest rates ranging from 7.97 % to 8.13 % for the
−Removed: lease term lengths.
−Removed: with an initial term of 12 months or less are not recorded on the balance sheet.
+Added: Therefore, the Company used a benchmark approach as of the date
+Added: of inception of the leases to derive an appropriate incremental borrowing rate to discount remaining lease payments.
+Added: The Company benchmarked
+Added: itself against other companies of similar credit ratings and comparable quality and derived imputed interest rates ranging from 7.41 %
+Added: to 8.03 % for the lease term lengths.
+Added: with an initial term of 12 months or less are not recorded on the consolidated balance sheets.
There are no material residual guarantees associated
10 unchanged sentences
asset and lease liability.
−Removed: Prior to adoption of ASU 2016-02 effective January 1, 2022, the Company accounted for operating lease transactions
−Removed: by recording lease expense on a straight-line basis over the expected term of the lease.
components of lease expense, which are included in selling, general and administrative expense and depreciation and amortization for
7 unchanged sentences
Total lease cost
+Added: Cash paid for amounts included in the measurement
+Added: of lease liabilities:
+Added: Operating cash flows from finance leases
+Added: Operating cash flows from operating leases
SCHEDULE OF BALANCE SHEET INFORMATION RELATING TO LEASES
8 unchanged sentences
Financing lease liability,
−Removed: Financing lease liability,
+Added: Total finance lease
Weighted-average
11 unchanged sentences
Present value of lease
+Added: NOTES PAYABLE
+Added: Corolla - 2024
+Added: 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
+Added: The loan bears fixed interest at a rate of 5.99 % per annum, with monthly payments of $ 467 , which is comprised of principal
+Added: and interest.
+Added: This loan is collateralized by the underlying vehicle.
+Added: The balance of this loan as of December 31, 2024, and 2023 was $ 24,849 and $ 0 , respectively.
+Added: The current portion of the balance of this loan as of December 31, 2024, and 2023
+Added: was $ 5,603 and $ 0 , respectively.
+Added: and Officers Insurance Policy – 2024
+Added: September 2024, the Company obtained short-term financing of approximately $ 0.26 million with 11 monthly payments of approximately $ 24,000
+Added: and interest at a 6.7 % fixed annual rate for director and officer insurance policies.
+Added: The current portion of the balance of this loan
+Added: as of December 31, 2024, and December 31, 2023, was $ 167,000 and $ 0 , respectively.
COMMITMENTS AND CONTINGENCIES
−Removed: addition to the operating lease listed in Note 9, the Company leases its corporate offices under a month-to-month agreement and leases
−Removed: its laboratory and additional office space under an operating lease that is renewable annually by written notice by the Company and will
−Removed: require renewal in February 2024.
−Removed: Rent expense for office and lab space amounted to $ 112,124 and $ 65,043 for the years ended December
−Removed: 31, 2023, and 2022, respectively.
time to time, the Company is involved in various disputes and litigation matters that arise in the ordinary course of business.
2 unchanged sentences
On June 4, 2024, the Company received
−Removed: stockholder approval to increase the number of authorized shares from 14,285,715 shares to 25,000,000 shares.
−Removed: The Company has issued
−Removed: 9,505,255 shares of Common Stock of which 110,645 are unvested restricted stock shares as of December 31, 2023, and 8,381,324 shares
−Removed: of Common Stock as of December 31, 2022.
+Added: stockholder approval to increase the number of authorized shares of Common Stock from 25,000,000 shares to 100,000,000 shares, and on
+Added: June 5, 2024, the Company filed an amendment to its Certificate of Incorporation with the Secretary of State of the State of Delaware
+Added: to effect the increase.
+Added: The Company has issued 15,576,674 shares of Common Stock, of which 349,057 are unvested restricted stock awards
+Added: 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,
STOCK-BASED COMPENSATION
−Removed: Company grants options and restricted stock awards under its 2014 Equity Incentive Plan (the “Plan”).
−Removed: Under the Plan, the
−Removed: Company is authorized to grant options or restricted stock for up to 2,000,000 shares of Common Stock.
−Removed: On June 6, 2023, the Company received
−Removed: stockholder approval to increase the number of authorized shares from 1,142,857 to 2,000,000 .
−Removed: Options or restricted stock awards may
−Removed: be granted to employees, the Company’s Board of Directors, and external consultants who provide services to the Company.
−Removed: and restricted stock awards granted under the Plan have vesting schedules with terms of one to three years and become fully exercisable
−Removed: based on specific terms imposed at the date of grant.
−Removed: The Plan will terminate according to the respective terms of the Plan in March
+Added: Company granted options and restricted stock awards under its 2014 Equity Incentive Plan (the “2014 Plan”).
+Added: Under the 2014
+Added: Plan, the Company was authorized to grant options or restricted stock for up to 2,000,000 shares of Common Stock.
+Added: On June 6, 2023, the
+Added: Company received stockholder approval to increase the number of authorized shares from 1,142,857 to 2,000,000 .
+Added: Options or restricted
+Added: stock awards may be granted to employees, the Company’s board of directors, and external consultants who provide services to the
+Added: Options and restricted stock awards granted under the 2014 Plan have vesting schedules with terms of one to three years and
+Added: become fully exercisable based on specific terms imposed at the date of grant.
+Added: The 2014 Plan expired according to the respective 10-year
+Added: term of the 2014 Plan in March 2024.
+Added: A new 2024 Incentive Compensation Plan (the “2024 Plan”) was approved at the Annual
+Added: Meeting of Shareholders on June 4, 2024.
Company has recorded stock-based compensation expense related to the issuance of restricted stock awards in the following line items
−Removed: in the accompanying consolidated statement of operations:
+Added: in the accompanying condensed consolidated statements of operations:
SUMMARY OF STOCK-BASED COMPENSATION EXPENSE RECOGNIZED FOR STOCK OPTION AWARDS
Research and development
−Removed: Selling, general
−Removed: and administrative
+Added: Selling, general and
+Added: administrative
stock-based compensation expense
−Removed: following table summarizes stock option activity under the Plan:
+Added: following table summarizes stock option activity under the 2014 and 2024 Plans:
SUMMARY OF OPTION ACTIVITY
−Removed: exercise price
−Removed: term (in years)
−Removed: intrinsic value
Outstanding at December 31,
2 unchanged sentences
at December 31, 2024
−Removed: of December 31, 2023, there was $ 322 unrecognized compensation cost related to non-vested stock options.
−Removed: the year ended December 31, 2023, no options were issued or exercised.
−Removed: During the year ended December 31, 2022, the Company issued options
−Removed: to purchase 7,142 shares of Common Stock to employees.
−Removed: The per share weighted-average fair value of the options granted during 2022 was
−Removed: estimated at $ 2.84 on the date of grant.
−Removed: During the year ended December 31, 2022, 64,848 options were exercised into an equivalent number
−Removed: of common shares.
−Removed: The company received proceeds of approximately $ 75,000 from the exercise of the options.
−Removed: following table summarizes weighted-average assumptions using the Black-Scholes option-pricing model used on the date of the grants issued
−Removed: during the years ended December 31, 2023, and 2022, respectively:
−Removed: SCHEDULE OF FAIR VALUE ASSUMPTIONS
−Removed: Fair value of Common Stock
−Removed: Expected term (years)
−Removed: Risk-free interest rate
−Removed: Dividend yield
−Removed: Black-Scholes
−Removed: requires the use of subjective assumptions which determine the fair value of stock-based awards.
−Removed: These assumptions include:
−Removed: value of Common Stock —The fair value of stock option and restricted share grants are determined based on the closing price
−Removed: of our stock on the date of grant.
−Removed: term —The expected term represents the period that stock-based awards are expected to be outstanding.
−Removed: The expected term for
−Removed: option grants is determined using the simplified method.
−Removed: The simplified method deems the term to be the average of the time-to-vesting
−Removed: and the contractual life of the stock-based awards.
−Removed: volatility — Since the Company does not have sufficient trading history for its Common Stock, the expected volatility is estimated
−Removed: based on the average volatility for comparable publicly traded biotechnology companies over a period equal to the expected term of the
−Removed: stock-based awards.
−Removed: The comparable companies were chosen based on their similar size, stage in the life cycle, or area of specialty.
−Removed: The Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own
−Removed: stock price becomes available.
−Removed: interest rate —The risk-free interest rate is based on the U.S.
−Removed: Treasury zero coupon issues in effect at the time of grant for
−Removed: periods corresponding with the expected term of a stock-based award.
−Removed: dividend —The Company has never paid dividends on its Common Stock and has no plans to pay dividends on its Common Stock.
−Removed: the Company used an expected dividend yield of zero.
−Removed: following table summarizes restricted stock award activity under the Plan:
−Removed: OF RESTRICTED STOCK AWARD
+Added: of December 31, 2024, there was no unrecognized compensation cost related to non-vested stock options.
+Added: 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.
+Added: following table summarizes restricted stock award activity under the 2014 and 2024 Plan:
+Added: SUMMARY OF RESTRICTED STOCK AWARD
+Added: As of December 31, 2024
Balance at December 31, 2023
11 unchanged sentences
During the year ended December 31, 2023, 59,051 shares vested from RSAs previously issued.
−Removed: account for Common Stock warrants as either equity instruments or derivative liabilities depending on the specific terms of the warrant
−Removed: Warrants are accounted for as derivative liabilities if the warrants allow for cash settlement or provide for modification
−Removed: of the warrant exercise price in the event subsequent sales of Common Stock by the Company are at a lower price per share than the then-current
−Removed: warrant exercise price.
−Removed: We classify derivative warrant liabilities on the balance sheet at fair value, and changes in fair value during
−Removed: the periods presented in the consolidated statement of operations, which is revalued at each consolidated balance sheet date subsequent
−Removed: to the initial issuance of the stock warrant.
−Removed: of December 31, 2023, and December 31, 2022, the Company had 4,649,952 warrants outstanding to purchase one share of the Company’s
−Removed: Common Stock for each warrant at a weighted average exercise price of $ 5.03 and various expiration dates through September 2027.
−Removed: year end December 31, 2023, no warrants were exercised into an equivalent number of Common Shares as compared to 1,036,486 warrants being
−Removed: exercised during the year ended December 31, 2022.
−Removed: September 17, 2023, the Company entered into a warrant amendment with certain holders of (1) tradeable warrants (the “Tradeable
−Removed: Warrants”) who have the right to purchase 73,568 shares of Common Stock;
−Removed: (2) non-tradeable warrants (the “Non-Tradeable Warrants”)
−Removed: who have the right to purchase 73,568 shares of Common Stock and (3) other outstanding warrants (the “Pre-IPO Warrants”)
−Removed: who have the right to purchase 1,109,475 shares of Common Stock.
−Removed: The warrant amendment provides that such warrants will not be exercisable
−Removed: until the date that the Company files a certificate of amendment to its certificate of incorporation with the State of Delaware which
−Removed: increases the number of shares of its authorized Common Stock to allow for sufficient authorized and unissued shares of Common Stock
−Removed: for the full exercise of all of the outstanding Pre-IPO Warrants, Tradeable Warrants, and Non-Tradeable Warrants of the Company and the
−Removed: issuance of all of the shares of Common Stock underlying such warrants.
+Added: Company’s outstanding Common Stock warrants are equity classified.
+Added: As of December 31, 2024 and 2023, the Company
+Added: had 12,298,124
+Added: and 4,649,952
+Added: warrants outstanding, respectively, to purchase one share of the Company’s Common Stock for each warrant at a weighted average exercise price
+Added: and expire at various dates through October 2029.
+Added: During the year ended December 31, 2024, a total number of 1,066,767
+Added: warrants were exercised into an equivalent number of shares of Common Stock as compared to no
+Added: warrants being exercised during the year ended December 31, 2023.
+Added: The proceeds of the exercised warrants for the year ended December
+Added: 31, 2024, was $ 1,343,390 ,
+Added: compared to no
+Added: proceeds during the year ended December 31, 2023.
+Added: March 8, 2024, the Company issued to certain investors (1) in a registered direct offering, 1,600,000 shares of the Company’s
+Added: Common Stock and (2) in a concurrent private placement, warrants to purchase an aggregate of 1,600,000 shares of Common Stock,
+Added: with an exercise price of $ 1.64 (collectively, the “Transaction”), which Transaction constitutes a Dilutive Issuance
+Added: under the terms of the warrants.
+Added: In addition, the placement agent was granted warrants to purchase 32,000 shares of Common
+Added: Stock, with an exercise price of $ 1.64 .
+Added: August 5, 2024, the Company entered into warrant exercise agreements with three existing accredited investors to exercise certain outstanding
+Added: warrants to purchase an aggregate of 1,041,667 of the Company’s shares of Common Stock (the “Existing Warrants”).
+Added: exercising holders received in a private placement new unregistered warrants (the “New Warrants”) to purchase up to an aggregate
+Added: 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
+Added: approval of the exercise of the New Warrants is obtained and will expire five years from the date of such approval.
+Added: In connection with
+Added: 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
+Added: The exercise of the Existing Warrants and the issuance of the New Warrants occurred on August 5, 2024.
+Added: The change in the exercise price of the Existing Warrants resulted in a fair value adjustment of $ 27,757 which
+Added: was recorded to Additional paid-in capital for the exercised warrants.
+Added: August 5, 2024, the Company also entered into a securities purchase agreement with an institutional
+Added: investor (the “Purchaser”), pursuant to which the Company issued to the Purchaser, (1) in a registered direct offering, 360,000
+Added: shares of Common Stock, and (2) in a concurrent private placement, warrants (the “Private Warrants”) to purchase an aggregate
+Added: of 450,000 shares of Common Stock (the “Private Warrant Shares”), with an exercise price of $ 1.50 (collectively, the “Offering”).
+Added: In addition, designees of the placement agent for the Offering were granted warrants to purchase an aggregate of up to 49,862 shares
+Added: of Common Stock, with an exercise price of $ 1.50 .
+Added: 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
+Added: (the “Common Warrants”) to purchase an aggregate of 2,662,782 shares of Common Stock (the “Common Warrant
+Added: Shares”), with an exercise price of $ 1.50 , pursuant to a securities purchase agreement, dated October 18, 2024 with institutional investors (the “Purchasers”).
+Added: Such registered direct offering and concurrent private
+Added: placement are collectively referred to as the “Offerings.” In addition, designees of the placement agent for the Offering
+Added: were granted warrants to purchase an aggregate of up to 61,448 shares of Common Stock, with an exercise price of $ 1.50 .
+Added: 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
+Added: Common Stock outstanding and non-tradeable warrants to purchase an aggregate of up to 2,704,458 shares of Common Stock outstanding.
+Added: SCHEDULE OF CLASS OF WARRANT
+Added: warrants issued
+Added: Weighted-average
+Added: exercise price
+Added: warrants exercised
+Added: warrants outstanding
+Added: Pre-IPO convertible notes
+Added: IPO tradeable
+Added: IPO non-tradeable
+Added: Direct offering March 8, 2024
+Added: ( 1,066,667 )
+Added: Placement agent direct offering March 8,
+Added: Inducement/direct offering August 5, 2024
+Added: Placement agent direct offering August 5,
+Added: Direct offering October 21, 2024
+Added: Placement agent direct
+Added: offering October 21, 2024
+Added: Balance at December
+Added: ( 2,103,253 )
tax assets and valuation allowance
18 unchanged sentences
Capitalized R&E
+Added: Bad debt expense
Operating lease liabilities
2 unchanged sentences
Right-of-use asset tax
+Added: $ ( 261,215 )
and amortization
3 unchanged sentences
( 7,809,487 )
−Removed: property and equipment, net
+Added: tax assets (liabilities), net
reconciliation of the statutory federal income tax rate to the Company’s effective tax rate for the years ended December 31, 2024
14 unchanged sentences
Beginning balance
−Removed: Additions based on tax positions related
+Added: Deductions based on tax positions related
to the prior year
−Removed: Additions based on tax positions related
−Removed: to the current year
+Added: Additions based on
+Added: tax positions related to the current year
Ending balance
SUBSEQUENT EVENTS
−Removed: March 8, 2024, the Company issued to certain investors, (i) in a registered direct offering, 1,600,000 shares of the Company’s
−Removed: common stock and (ii) in a concurrent private placement, warrants to purchase an aggregate of 1,600,000 shares of Common Stock, with
−Removed: an exercise price of $ 1.64 (collectively, the “Transaction”), which Transaction constitutes a Dilutive Issuance under the
−Removed: terms of the Warrants.
−Removed: 3(b) of the Warrants provides that in the event of a Dilutive Issuance, the Exercise Price of the Warrants shall be reduced and only
−Removed: reduced to equal the effective price per share of the Dilutive Issuance (the “Base Share Price”) and the number of Warrant
−Removed: Shares issuable thereunder shall be increased such that the aggregate Exercise Price payable pursuant to the Warrant, after taking into
−Removed: account the decrease in the Exercise Price, shall be equal to the aggregate Exercise Price prior to such adjustment, provided that the
−Removed: Base Share Price shall not be less than $3.0625 (50% of the public offering price of the Units sold in the Company’s initial public
−Removed: offering) (subject to adjustment for reverse and forward stock splits, recapitalizations and similar transactions).
−Removed: effect of the Transaction is such that the Exercise Price of the Warrants shall be reduced to $ 3.0625 per share.
−Removed: The new number of Warrant
−Removed: Shares is calculated by dividing (x) the number of Warrant Shares underlying the Warrant immediately prior to the Transaction multiplied
−Removed: by the Exercise Price in effect immediately prior to the Transaction, by (y) $ 3.0625 .
−Removed: The calculations will be made to the nearest cent
−Removed: or the nearest 1/100th of a share.
−Removed: of March 8, 2024 and prior to the Transaction, there were Tradeable Warrants to purchase up to an aggregate of 1,601,258 shares of common
−Removed: stock outstanding and Non-Tradeable Warrants to purchase an aggregate of up to 2,704,554 shares of common stock outstanding.
+Added: March 7, 2025, the Company announced targeted strategic actions to improve financial performance and accelerate the commercial
+Added: growth of CyPath ® Lung, taking steps to deliver approximately $ 4 million in annual cost savings at its subsidiary
+Added: Precision Pathology Laboratory Services (PPLS), while increasing resources to expand CyPath ® Lung sales in
+Added: high-potential national markets.
+Added: Specifically, cost savings are a result of labor cost reductions, operational efficiency
+Added: enhancements, and discontinuing certain pathology services with suboptimal profit margins to focus on high-margin services such as
+Added: CyPath ® Lung and by discontinuing certain pathology services with suboptimal profit margins.
+Added: February 26, 2025, pursuant to the terms of a warrant inducement agreement (the “February Inducement Agreement”), dated
+Added: February 25, 2025 that the Company entered into with certain holders of existing warrants, such holders exercised for cash (i)
+Added: warrants to purchase an aggregate of up to 1,302,082
+Added: shares of Common Stock issued on October 21, 2024 (the “October Warrants”), at the reduced exercise price of $ 0.58
+Added: per share, and (ii) warrants to purchase an aggregate of up to 1,136,391
+Added: shares of Common Stock issued on August 5, 2024 (the “August Warrants”), at the reduced exercise price of $ 0.58
+Added: The Company received aggregate gross proceeds of approximately $ 1.4
+Added: million, before deducting advisory fees and other expenses payable by it.
+Added: In consideration of the immediate exercise of the October
+Added: Warrants and August Warrants by the holders thereof in accordance with the February Inducement Agreement, the Company issued unregistered
+Added: common warrants to purchase an aggregate of up to 2,926,166
+Added: shares of Common Stock ( 120 %
+Added: of the number of shares of Common Stock issuable upon exercise of the October Warrants and August Warrants) to such
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.