Item 9A. Controls and Procedures
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Disclosure controls and procedures are controls and procedures that are designed to ensure that information required to be disclosed in our reports filed under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by our company in the reports that it files or submits under the Exchange Act is accumulated and communicated to our management, including our Principal Executive and Principal Financial Officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
Our management carried out an evaluation, under the supervision and with the participation of our Principal Executive Officer and Principal Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Based upon that evaluation, our Principal Executive Officer and Principal Financial Officer have concluded, as they previously concluded as of December 31, 2023, that our disclosure controls and procedures were not effective as of December 31, 2024, because of material weaknesses in our internal control over financial reporting, as described below.
A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.
We identified a material weakness in our internal controls over financial reporting. In particular we do not have sufficient written documentation of our internal control policies and procedures, including written policies and procedures to ensure the correct application of accounting and financial reporting with respect to the current requirements of GAAP and SEC disclosure requirements.
Notwithstanding the material weakness, we believe that our financial statements contained in this Report fairly present our financial position, results of operations and cash flows for the periods covered by this Report in all material respects.
Our management, with the oversight of our audit committee, has initiated steps and plans to take additional measures to remediate the underlying causes of the material weakness, which we currently believe will be primarily through revising precision level management review controls and gaining additional assurance regarding our outside service providers’ quality control procedures. It is possible that we may determine that additional remediation steps will be necessary in the future.
Management’s Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining a system of internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of our financial reporting and preparation of financial statements for external purposes in accordance with GAAP.
Our management conducted an assessment of the effectiveness of our internal control over financial reporting based on the framework set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control—Integrated Framework (2013) . Based on this assessment, our management, including our Principal Executive Officer and Principal Financial Officer, concluded that our internal control over financial reporting was not effective as of December 31, 2024 due to material weaknesses.
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Planned Remediation of Material Weaknesses
Our management has been actively engaged in developing and implementing remediation plans to address the material weakness described above. These remediation efforts are ongoing and include or are expected to include:
·
replacing our outside service providers to centralize the accounting function in-house;
·
engaging internal control consultants to assist us in performing a financial reporting risk assessment as well as identifying and designing our system of internal controls necessary to mitigate the risks identified;
·
preparation of written documentation of our internal control policies and procedures, and
·
we have engaged external consultants to provide support and to assist us in our evaluation of more complex applications of GAAP.
We continue to enhance corporate oversight over process-level controls and structures to ensure that there is appropriate assignment of authority, responsibility, and accountability to enable remediation of our material weakness. We believe that our remediation plan will be sufficient to remediate the identified material weakness and strengthen our internal control over financial reporting. As we continue to evaluate, and work to improve, our internal control over financial reporting, management may determine that additional measures to address control deficiencies or modifications to the remediation plan are necessary.
Changes in Internal Control Over Financial Reporting
Except for the ongoing remediation of the material weakness in internal controls over financial reporting noted above, no changes in our internal control over financial reporting were made during the year ended December 31, 2024, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Limitations of the Effectiveness of Disclosure Controls and Internal Controls
Our management, including our Principal Executive Officer and Principal Financial Officer, does not expect that our disclosure controls and internal controls will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control.
The design of any system of controls is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving our stated goals under all potential future conditions; over time, a control may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
ITEM 9B. OTHER INFORMATION
None.
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not applicable
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PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
Insider Trading Policies and Procedures
The Company has an insider trading policy and procedures governing the purchase, sale and/or other dispositions of the Company’s securities that applies to all directors, officers, employees and certain other persons. It is also the Company’s policy to take appropriate steps to comply with applicable federal and state securities laws and regulations, as well as applicable stock exchange listing standards, when the Company engages in transactions in the Company’s securities. The Company believes that its insider trading policy and procedures are reasonably designed to promote compliance with insider trading laws, rules and regulations, and listing standards applicable to the Company. A copy of the Company’s insider trading policy is filed as Exhibit 19.1 to this Report.
The remaining information required under this item is incorporated by reference from our definitive proxy statement related to our 2025 Annual Meeting of Stockholders, or the Proxy Statement, to be filed pursuant to Regulation 14A, on or before April 30, 2025.
ITEM 11. EXECUTIVE COMPENSATION
The information required under this item is incorporated herein by reference from the Proxy Statement.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS.
The information required under this item is incorporated herein by reference from the Proxy Statement.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE.
The information required under this item is incorporated herein by reference from the Proxy Statement.
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
The information required under this item is incorporated herein by reference from the Proxy Statement.
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PART IV
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a)
The following documents are filed as part of this Report:
1.
Financial Statements . Included in Part II, Item 8 of this Report and are incorporated by reference herein.
2.
Financial Statement Schedules . Financial statement schedules are omitted because they are not applicable, or the required information is shown in the financial statements or notes thereto.
3.
Exhibits .
Incorporated by Reference
Exhibit
Number
Exhibit Description
Form
File No.
Exhibit
Filing
Date
Filed
Herewith
2.1
Agreement for Sale and Purchase of Shares by and between Singapore Volition and ValiRX, dated September 22, 2010.
8-K/A
000-30402
2.1
5/8/12
2.2
Supplementary Agreement to the Share Purchase Agreement, by and between Singapore Volition and ValiRX, dated June 9, 2011.
8-K/A
000-30402
10.15
1/11/12
2.3
Share Exchange Agreement by and among Standard Capital Corporation, the controlling shareholders of Standard Capital Corporation, Singapore Volition and the shareholders of Singapore Volition, dated September 26, 2011.
8-K
000-30402
2.1
9/29/11
2.4
Agreement, Consent and Waiver by and between Standard Capital Corporation and its Shareholders, dated September 27, 2011.
8-K/A
000-30402
10.28
4/5/12
3.1
Second Amended and Restated Certificate of Incorporation, as currently in effect.
S-8
333-280974
4.2
7/24/24
3.2
Amended and Restated Bylaws, as currently in effect.
10-Q
001-36833
3.2
5/13/24
4.1
Description of Capital Stock.
10-K
001-36833
4.1
2/20/20
4.2
Form of Underwriter Warrant issued to Prime Executions, Inc. dba Freedom Capital Markets.
8-K
001-36833
4.1
6/5/23
4.3
Form of Pre-Funded Warrant.
8-K
001-36833
4.1
8/12/24
4.4
Form of Series A Common Stock Warrant.
8-K
001-36833
4.2
8/12/24
4.5
Form of Series B Common Stock Warrant.
8-K
001-36833
4.3
8/12/24
4.6
Form of Form A Common Stock Purchase Warrant.
8-K
001-36833
4.1
12/9/24
4.7
Form of Form B Common Stock Purchase Warrant.
8-K
001-36833
4.2
12/9/24
10.1
Non-Exploitation and Third-Party Patent License Agreement, by and among ValiBio SA, ValiRX plc and The Walloon Region, dated December 17, 2009.
8-K/A
000-30402
10.6
2/24/12
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Incorporated by Reference
Exhibit
Number
Exhibit Description
Form
File No.
Exhibit
Filing
Date
Filed
Herewith
10.2#
VolitionRx Limited 2011 Equity Incentive Plan dated November 17, 2011.
8-K
000-30402
4.1
11/18/11
10.3#
VolitionRx Limited 2011 Equity Incentive Plan Form of Stock Option Agreement.
8-K
000-30402
4.2
11/18/11
10.4#
VolitionRx Limited 2011 Equity Incentive Plan Form of Stock Award Agreement for Restricted Stock.
8-K
000-30402
4.3
11/18/11
10.5#
VolitionRx Limited 2015 Stock Incentive Plan, as amended April 17, 2023.
8-K
001-36833
10.1
6/30/23
10.6#
Form of Notice of Stock Option Grant and Stock Option Agreement under the VolitionRx Limited 2015 Stock Incentive Plan.
S-8
333-214118
10.2
10/14/16
10.7#
Form of Notice of Restricted Stock Award and Restricted Stock Agreement under the VolitionRx Limited 2015 Stock Incentive Plan.
S-8
333-214118
10.3
10/14/16
10.8#
Form of Notice of Stock Bonus Award and Stock Bonus Award Agreement under the VolitionRx Limited 2015 Stock Incentive Plan.
S-8
333-214118
10.4
10/14/16
10.9#
Form of Notice of Stock Appreciation Right Award and Stock Appreciation Right Agreement under the VolitionRx Limited 2015 Stock Incentive Plan.
S-8
333-214118
10.5
10/14/16
10.10#
Form of Notice of Restricted Stock Unit Award and Restricted Stock Unit Agreement under the VolitionRx Limited 2015 Stock Incentive Plan.
S-8
333-214118
10.6
10/14/16
10.11#
Form of Notice of Performance Shares Award and Performance Shares Award Agreement under the VolitionRx Limited 2015 Stock Incentive Plan.
S-8
333-214118
10.7
10/14/16
10.12#
Form of Independent Director Agreement.
10-Q
001-36833
10.33
5/12/15
10.13
Real Estate Capital Lease Agreement, by and between Belgian Volition and ING Asset Finance Belgium S.A., dated October 4, 2016 (English translation of French original).
8-K
001-36833
10.1
10/31/16
10.14#
Employment Agreement, by and between Volition Diagnostics UK Limited and Jacob Micallef, dated March 7, 2017.
10-K
001-36833
10.28
3/10/17
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Table of Contents
Incorporated by Reference
Exhibit
Number
Exhibit Description
Form
File No.
Exhibit
Filing
Date
Filed
Herewith
10.15#
Employment Agreement, by and between Volition Diagnostics UK Limited and Martin Faulkes, dated March 7, 2017.
10-K
001-36833
10.30
3/10/17
10.16
Unsecured Credit Agreement, by and among VolitionRx Limited, SPRL Belgian Volition and Wallonne de Financement a l’ Exportation et de l’Internationalisation des Enterprises Wallones (English translation of French original), dated September 20, 2017.
8-K
001-36833
10.1
9/21/17
10.17
Clinical Study Agreement, by and between Volition America, Inc. and the Regents of the University of Michigan, dated July 17, 2017.
10-Q
001-36833
10.1
11/09/17
10.18
Amendment #1 to Clinical Study Agreement, by and between Volition America, Inc. and the Regents of the University of Michigan, dated February 17, 2020.
10-K
001-36833
10.22
2/20/20
10.19#
Consulting Services Agreement, by and between Singapore Volition Pte. Limited and PB Commodities Pte. Ltd. (Cameron Reynolds), dated December 1, 2020.
10-Q
001-36833
10.1
11/12/20
10.20#†
Common Stock Warrant issued by VolitionRx Limited to Gael Forterre, dated January 1, 2021.
10-K
001-36833
10.18
03/22/21
10.21#†
Singapore Volition Pte. Limited Employment Agreement Group Chief Financial Officer, by and between Singapore Volition Pte. Limited and Terig Hughes, dated January 27, 2021 and effective February 1, 2021, including the form of Common Stock Warrant attached as Schedule 2.
10-K
001-36833
10.19
3/22/21
10.22#†
Volition America, Inc. Employment Agreement Group Chief Commercial Officer, by and between Volition America and Gael Forterre, dated February 1, 2021.
10-K
001-36833
10.20
3/22/21
10.23#
Volition Veterinary Diagnostics Development, LLC Employment Agreement Chief Executive Officer, by and between Volition Veterinary Diagnostics Development, LLC and Salvatore Thomas Butera, dated March 25, 2021.
10-Q
001-36833
10.6
5/11/21
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Table of Contents
Incorporated by Reference
Exhibit
Number
Exhibit Description
Form
File No.
Exhibit
Filing
Date
Filed
Herewith
10.24#
Volition America, Inc. Employment Agreement Chief Operating Officer, by and between Volition America, Inc. and Gaetan Michel, dated September 15, 2021.
10-Q
001-36833
10.1
11/10/21
10.25#†
Consulting Services Agreement, by and between Volition Global Services SRL and 3F Management SPRL (Gaetan Michel), dated September 15, 2020.
10-Q
001-36833
10.2
11/10/21
10.26#
Employment Agreement Group General Counsel, by and between Volition Diagnostics UK Limited and Nick Plummer, dated August 23, 2021.
10-Q
001-36833
10.3
11/10/21
10.27†
Master License and Product Supply Agreement, by and between Belgian Volition SRL and Heska Corporation, dated March 28, 2022.
10-Q
001-36833
10.1
5/11/22
10.28
Equity Distribution Agreement, by and between VolitionRx Limited and Jefferies LLC, dated May 20, 2022.
8-K
001-36833
1.1
5/20/22
10.29
Underwriting Agreement, by and between VolitionRx Limited and Newbridge Securities Corporation, dated February 17, 2023.
8-K
001-36833
1.1
2/21/23
10.30#
Singapore Volition Pte. Limited Employment Agreement Group Chief Executive Officer, by and between Singapore Volition and Cameron Reynolds.
10-K
001-36833
10.27
3/15/23
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Table of Contents
Incorporated by Reference
Exhibit
Number
Exhibit Description
Form
File No.
Exhibit
Filing
Date
Filed
Herewith
10.31
Underwriting Agreement, dated June 1, 2023, by and between Volition Rx Limited and Prime Executions, Inc. dba Freedom Capital Markets.
8-K
001-36833
1.1
6/5/23
10.32#
Contract of Employment, by and between Volition Diagnostics UK Ltd. And Dr. Andrew Retter, dated March 19, 2024
10-K
001-36833
10.36
3/25/24
10.33#
2024 Stock Incentive Plan.
8-K
001-36833
10.1
7/3/24
10.34#
Form of Notice of Stock Option Grant and Stock Option Agreement under the 2024 Stock Incentive Plan
S-8
333-280974
99.1(a)
7/24/24
10.35#
Form of Notice of Performance Shares Award and Performance Shares Agreement under the 2024 Stock Incentive Plan
S-8
333-280974
99.1(b)
7/24/24
10.36#
Form of Notice of Restricted Stock Award and Restricted Stock Agreement under the 2024 Stock Incentive Plan
S-8
333-280974
99.1(c)
7/24/24
10.37#
Form of Notice of Restricted Stock Unit Award and Restricted Stock Unit Agreement under the 2024 Stock Incentive Plan
S-8
333-280974
99.1(d)
7/24/24
10.38#
Form of Notice of Stock Appreciation Right Award and Stock Appreciation Right Award Agreement under the 2024 Stock Incentive Plan.
S-8
333-280974
99.1(e)
7/24/24
10.39#
Form of Notice of Stock Bonus Award and Stock Bonus Award Agreement under the 2024 Stock Incentive Plan
S-8
333-280974
99.1(f)
7/24/24
10.40
Form of Securities Purchase Agreement, dated August 8, 2024, by and among the Company and the purchaser party thereto.
8-K
001-36833
10.1
8/12/24
10.41#†
Permanent employment contract, by and among Belgian Volition SPRL and Gaetan Michel, effective September 2, 2024 .
10-Q
001-36833
10.3
11/14/24
10.42#†
First amendment to Consulting Services Agreement, between Volition Global Services SRL and 3F Management SPRL, effective September 1, 2024.
10-Q
001-36833
10.4
11/14/24
10.43#†
Independent Director Agreement, dated November 6, 2024, by and between VolitionRx Limited and Timothy I. Still
X
10.44
Securities Purchase Agreement, dated as of December 5, 2024, by and among the Company and the purchasers on the signature pages thereto.
8-K
001-36833
10.1
12/9/24
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Table of Contents
Incorporated by Reference
Exhibit
Number
Exhibit Description
Form
File No.
Exhibit
Filing
Date
Filed
Herewith
19.1
Insider Trading & Blackout Policy.
X
21.1
List of Subsidiaries.
X
23.1
Consent of Independent Registered Public Accounting Firm.
X
24.1
Power of Attorney (included on the signature page of this Report).
X
31.1
Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended.
X
31.2
Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended.
X
32.1*
Certifications of Chief Executive Officer and Chief Financial Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
X
97.1
Clawback and Forfeiture Policy
10-K
001-36833
97.1
3/25/24
91
Table of Contents
Incorporated by Reference
Exhibit
Number
Exhibit Description
Form
File No.
Exhibit
Filing
Date
Filed
Herewith
10.1 INS
Inline XBRL Instance Document
X
101.SCH
Inline XBRL Taxonomy Extension Schema Document.
X
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document.
X
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document.
X
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document.
X
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document.
X
104
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
X
#
Indicates a management contract or compensatory plan or arrangement.
†
Portions of this exhibit are redacted pursuant to Item 601(a)(6) and/or Item (b)(10)(iv) under Regulation S-K. The registrant agrees to furnish supplementally any omitted schedules to the SEC upon request.
*
The certifications attached as Exhibit 32.1 accompany this Report pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, and shall not be deemed “filed” by the registrant for purposes of Section 18 of the Exchange Act and are not to be incorporated by reference into any of the registrant's filings under the Securities Act or the Exchange Act, irrespective of any general incorporation language contained in any such filing.
ITEM 16. FORM 10-K SUMMARY
None.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized.
VOLITIONRX LIMITED
Dated: March 31, 2025
By:
/s/ Cameron Reynolds
Cameron Reynolds
President, Chief Executive Officer and Director
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS that each individual whose signature appears below constitutes and appoints Cameron Reynolds and Rodney Rootsaert, and each or either of them, acting individually, his or her true and lawful attorney-in-fact and agent, with full power of substitution, for him or her and in his or her name, place and stead, in any and all capacities, to sign any and all amendments to this Report on Form 10-K, and to file the same, with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or either of them, or his, her or their substitute or substitutes, may lawfully do or cause to be done or by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this Report on Form 10-K has been signed below by the following persons in the capacities and on the date indicated.
Signature
Title
Date
/s/ Cameron Reynolds
President, Chief Executive Officer and Director
March 31, 2025
Cameron Reynolds
(Principal Executive Officer)
/s/ Terig Hughes
Chief Financial Officer and Treasurer
March 31, 2025
Terig Hughes
(Principal Financial and Accounting Officer)
/s/ Timothy I Still
Director
March 31, 2025
Timothy I. Still
/s/ Guy Innes
Director
March 31, 2025
Guy Innes
/s/ Dr. Alan Colman
Director
March 31, 2025
Dr. Alan Colman
/s/ Dr. Phillip Barnes
Director
March 31, 2025
Dr. Phillip Barnes
/s/ Dr. Ethel Rubin
Director
March 31, 2025
Dr. Ethel Rubin
/s/ Kim Nguyen
Director
March 31, 2025
Kim Nguyen
/s/ Mickie Henshall
Director
March 31, 2025
Mickie Henshall
93