What changed in this filing

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Item 9A. Controls and Procedures

2021-03-22 compared with 2020-02-20 · 41 added, 35 removed, 122 unchanged (38% of the section changed)

7 unchanged sentences

Management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Exchange Act Rule 13a-15(f).

The Company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with accounting principles U.S GAAP.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.

19 unchanged sentences

Specifically, we have identified and selected a system for financial reporting that will allow further automation of the reporting process, thereby strengthening the control environment over financial reporting.

As we continue to evaluate and work to enhance our internal controls over financial reporting, we may determine that additional measures should be taken to address these or other control deficiencies, and/or that we should modify our remediation plan.

There have been no changes in our internal control over financial reporting that occurred during the fiscal year ended December 31, 2020, other than those described above, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

The Company is not required by current SEC rules to include, and does not include, an auditor’s attestation report.

The Company is not required to include, and does not include an auditor’s attestation report under SEC Rules.

Consequently, the Company’s registered public accounting firm has not attested to management’s reports on the Company’s internal control over financial reporting.

5 unchanged sentences

OTHER INFORMATION

On February 17, 2020, Volition America, Inc., or Volition America, a wholly-owned subsidiary of the Company, entered into an amendment, or the Amendment, to that certain Clinical Study Agreement, or the CSA, by and between Volition America and the Regents of the University of Michigan, or the Regents, with regards to Volition America’s participation with the Regents and the National Cancer Institute, or NCI, Early Detection Research Network in a clinical study involving approximately 13,500 asymptomatic screening samples provided by the Regents and/or NCI (including more than 4,600 previously collected samples) from people aged 50 and over who had not previously undergone screening or diagnostic colonoscopy, referred to as the Original Study.

Pursuant to the terms of the Amendment, the parties acknowledged that, although not fully-completed, the requirements of the Original Study had been satisfied, including any and all payment obligations by Volition America.

Further, the Amendment provided that a new clinical study, referred to as the New Study, would be undertaken at no additional cost to Volition America that involves approximately 1,800 asymptomatic screening samples provided by the Regents and/or NCI (including approximately 500 previously collected samples) from people aged 18 and over (i) who are being seen preoperatively for colon adenocarcinoma or adenoma and who had not previously had any radiation or chemotherapy for the current diagnosis, or (ii) who are undergoing colonoscopy procedures for colonic neoplasia screening, surveillance or resection of known neoplastic lesions.

The screening samples from the New Study will be tested by Volition America for blood-based, cell-free circulating biomarkers on Volition’s proprietary Nu.Q TM platform to validate Volition’s Nu.Q TM Colorectal Cancer Screening Test for U.S.

regulatory purposes.

The enrollment period and sample collection is anticipated to take up to 14 months to complete.

The remaining terms of the CSA remain unchanged.

The foregoing description of the Amendment does not purport to be complete and is qualified in its entirety by such Amendment, a copy of which is filed as Exhibit 10.22 to this Report

DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

29 unchanged sentences

2011 Equity Incentive Plan dated November 17, 2011.

Form Stock Option Agreement.

Form Stock Award Agreement for Restricted Stock under the 2011 Equity Incentive Plan.

8 unchanged sentences

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).

Deed of Sale to the Sale Agreement by and between and Gerard Dekoninck S.A., dated October 25, 2016 (English translation of French original).

Employment Agreement by and between Volition Diagnostics UK Limited and Cameron Reynolds, dated March 7, 2017.

Incorporated by Reference

Exhibit Description

Employment Agreement by and between Volition Diagnostics UK Limited and Jacob Micallef, dated March 7, 2017.

Employment Agreement by and between Volition Diagnostics UK Limited and Martin Faulkes, dated March 7, 2017.

Employment Agreement by and between Volition Diagnostics UK Limited and David Vanston, dated April 10, 2017.

Unsecured Credit Agreement dated September 20, 2017, by and among VolitionRx Limited, Belgian Volition SPRL and SOFINEX (English translation of French original).

Clinical Study Agreement dated July 17, 2017, by and between Volition America, Inc.

and the Regents of the University of Michigan.

Amendment #1 to Clinical Study Agreement, dated February 17, 2020, by and between Volition America, Inc.

and the Regents of the University of Michigan.

Deed of Sale to the Sale Agreement by and between Belgian Volition and Gerard Dekoninck S.A., dated October 25, 2016 (English translation of French original).

Employment Agreement by and between Volition Diagnostics UK and Jacob Micallef, dated March 7, 2017.

Employment Agreement by and between Volition Diagnostics UK and Martin Faulkes, dated March 7, 2017.

Unsecured Credit Agreement dated September 20, 2017, by and among VolitionRx, Belgian Volition and SOFINEX (English translation of French original).

Clinical Study Agreement dated July 17, 2017, by and between Volition America and the Regents of the University of Michigan.

Amendment #1 to Clinical Study Agreement, dated February 17, 2020, by and between Volition America and the Regents of the University of Michigan.

Common Stock Purchase Agreement, dated August 8, 2018, by and between VolitionRx and Cotterford Company Limited, including the form of Warrant attached as Exhibit B thereto.

Equity Distribution Agreement, dated September 7, 2018, by and between VolitionRx and Oppenheimer & Co.

Warrant to Purchase Common Stock by and between VolitionRx and Jason Terrell MD, dated March 20, 2013;

1 unchanged sentence

and Second Amendment to Warrant Agreement dated July 1, 2019.

Permanent Employment Contract by and between Belgian Volition and Gaetan Michel, dated October 1, 2020.

Incorporated by Reference

Exhibit Description

Equity Distribution Agreement, dated November 12, 2020, by and among VolitionRx, Oppenheimer & Co.

and Cantor Fitzgerald & Co.

Consulting Services Agreement by and between Singapore Volition and PB Commodities Pte.

(Cameron Reynolds), dated December 1, 2020.

Common Stock Warrant issued by VolitionRx to Gael Forterre, dated January 1, 2021.

Singapore Volition Pte.

Limited Employment Agreement by and between Singapore Volition and Terig Hughes, dated January 27, 2021 and effective February 1, 2021, including the form of Common Stock Warrant attached as Schedule 2.

Volition America, Inc.

Employment Agreement by and between Volition America and Gael Forterre, dated February 1, 2021.

Consulting Services Agreement by and between Volition Germany and 3F Management SPRL (Gaetan Michel), dated January 29, 2021;

First Amendment to Consultancy Services Agreement between Volition Germany and 3F Management SPRL, dated February 1, 2021.

Underwriting Agreement, dated February 10, 2021, by and between VolitionRx Limited and Cantor Fitzgerald & Co.

List of Subsidiaries.

Consent of independent registered public accounting firm.

Power of Attorney (included on the signature page of this Report).

Incorporated by Reference

Exhibit Number

Exhibit Description

Power of Attorney (included on the signature page of this Report).

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.

9 unchanged sentences

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.

3 unchanged sentences

VOLITIONRX LIMITED

February 20, 2020

March 22, 2021

/s/ Cameron Reynolds

8 unchanged sentences

(Principal Executive Officer)

February 20, 2020

/s/ David Vanston

David Vanston

March 22, 2021

/s/ Terig Hughes

Chief Financial Officer and Treasurer

(Principal Financial and Accounting Officer)

February 20, 2020

March 22, 2021

Martin Faulkes

February 20, 2020

March 22, 2021

/s/ Guy Innes

February 20, 2020

Phillip Barnes

March 22, 2021

Phil l ip Barnes

Phillip Barnes

February 20, 2020

March 22, 2021

Edward Futcher

February 20, 2020

March 22, 2021

Salvatore Thomas Butera

Salvatore Thomas Butera, D.V.M.

March 22, 2021

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.

What changed 10-K

Item 9A. Controls and Procedures