Form: 10-Q

Quarterly report pursuant to Section 13 or 15(d)

May 11, 2022

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

     QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended March 31, 2022

 

     TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from       to         

 

Commission File Number: 001-36833

 

VOLITIONRX LIMITED

(Exact name of registrant as specified in its charter)

   

Delaware

91-1949078

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

13215 Bee Cave Parkway

 Suite 125, Galleria Oaks B

 Austin, Texas 78738

 (Address of principal executive offices)

 

 +1 (646) 650–1351

(Registrant’s telephone number, including area code)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of Each Class

Trading Symbol(s)

Name of Each Exchange on Which Registered

Common Stock, par value $0.001 per share

VNRX

NYSE American, LLC

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☒ Yes No

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☒ Yes No

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

Accelerated filer

Non-accelerated Filer

Smaller reporting company

 

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☒ No

 

As of May 5, 2022, there were 53,846,973 shares of the registrant’s $0.001 par value common stock issued and outstanding.

 

 

 

  

VOLITIONRX LIMITED

 

QUARTERLY REPORT ON FORM 10-Q

FOR THE THREE MONTHS ENDED MARCH 31, 2022

 

TABLE OF CONTENTS

 

PART I

FINANCIAL INFORMATION

 

PAGE

 

 

 

 

 

 

Item 1.

FINANCIAL STATEMENTS (UNAUDITED)

 

4

 

 

 

 

 

 

Item 2.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

27

 

 

 

 

 

 

Item 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

33

 

 

 

 

 

 

Item 4.

CONTROLS AND PROCEDURES

 

33

 

 

 

 

 

 

PART II

OTHER INFORMATION

 

 

 

 

 

 

 

 

Item 1.

LEGAL PROCEEDINGS

 

35

 

 

 

 

 

 

Item 1A.

RISK FACTORS

 

35

 

 

 

 

 

 

Item 2.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

35

 

 

 

 

 

 

Item 3.

DEFAULTS UPON SENIOR SECURITIES

 

35

 

 

 

 

 

 

Item 4.

MINE SAFETY DISCLOSURES

 

35

 

 

 

 

 

 

Item 5.

OTHER INFORMATION

 

35

 

 

 

 

 

 

Item 6.

EXHIBITS

 

36

 

 

 

 

 

 

SIGNATURES

 

 

37

 

  

Use of Terms

 

Except as otherwise indicated by the context, references in this Quarterly Report on Form 10-Q to the “Company,” “VolitionRx,” “Volition,” “we,” “us,” and “our” are references to VolitionRx Limited and its wholly owned subsidiaries, Volition Global Services SRL, Singapore Volition Pte. Limited, Belgian Volition SRL, Volition Diagnostics UK Limited, Volition America, Inc., Volition Germany GmbH, and its majority-owned subsidiary, Volition Veterinary Diagnostics Development LLC. Additionally, unless otherwise specified, all references to “$” refer to the legal currency of the United States of America.

 

NucleosomicsTM and Nu.Q® and their respective logos are trademarks and/or service marks of VolitionRx and its subsidiaries. All other trademarks, service marks and trade names referred to herein are the property of their respective owners.

 

 
2

Table Of Contents

 

CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2022, or this Report, contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. These forward-looking statements are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact included in this Report or incorporated by reference into this Report are forward-looking statements. These statements include, among other things, predictions of earnings, revenues, expenses or other financial items; plans or expectations with respect to our development activities or business strategy; statements concerning clinical studies and results; statements concerning industry trends; statements regarding anticipated demand for our products, or the products of our competitors; statements relating to manufacturing forecasts, and the potential impact of our relationship with contract manufacturers and original equipment manufacturers on our business; statements relating to the commercialization of our products, assumptions regarding the future cost and potential benefits of our research and development efforts; forecasts of our liquidity position or available cash resources; statements relating to the impact of pending litigation; statements regarding the anticipated impact of the COVID-19 pandemic and statements relating to the assumptions underlying any of the foregoing. Throughout this Report, we have attempted to identify forward-looking statements by using words such as “may,” “believe,” “will,” “could,” “project,” “anticipate,” “expect,” “estimate,” “should,” “continue,” “potential,” “plan,” “forecasts,” “goal,” “seek,” “intend,” other forms of these words or similar words or expressions or the negative thereof (although not all forward-looking statements contain these words).

 

We have based our forward-looking statements on our current expectations and projections about trends affecting our business and industry and other future events. Although we do not make forward-looking statements unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy. Forward-looking statements are subject to substantial risks and uncertainties that could cause our future business, financial condition, results of operations or performance, to differ materially from our historical results or those expressed or implied in any forward-looking statement contained in this Report.

 

Some significant factors that may impact our estimates and forward-looking statements include, but are not limited to:

 

 

·

Our inability to generate any significant revenue or achieve profitability;

 

·

Our need to raise additional capital in the future;

 

·

Our expectations to expand our product development, research and sales and marketing capabilities could give rise to difficulties in managing our growth;

 

·

Our limited experience with direct sales and marketing;

 

·

The material weaknesses in our internal control over financial reporting that we have identified;

 

·

The possibility that we may not be able to continue to operate, as indicated by the “going concern” opinion from our auditors;

 

·

Our ability to successfully develop, manufacture, market, and sell our future products;

 

·

Our ability to timely obtain necessary regulatory clearances or approvals to distribute and market our future products;

 

·

The acceptance by the marketplace of our future products;

 

·

The highly competitive and rapidly changing nature of the cancer diagnostics market;

 

·

Our reliance on third parties to manufacture and supply our intended products, and such manufacturers’ dependence on third-party suppliers;

 

·

Our dependence on third-party distributors;

 

·

Protection of our patents, intellectual property and trade secrets;

 

·

Business disruptions and economic and other uncertainties surrounding the COVID-19 pandemic; and

 

·

Other risks identified elsewhere in this Report, as well as in our other filings with the Securities and Exchange Commission, or the SEC.

 

In addition, actual results may differ as a result of additional risks and uncertainties of which we are currently unaware or which we do not currently view as material to our business. For these reasons, readers are cautioned not to place undue reliance on any forward-looking statements. Our actual financial condition and results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those discussed in the sections entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021, as filed with the SEC on March 30, 2022, or our Annual Report, this Report, the documents that we file as exhibits to this Report and the documents that we incorporate by reference into this Report, with the understanding that our future results may be materially different from what we currently expect. The forward-looking statements we make speak only as of the date on which they are made. We expressly disclaim any intent or obligation to update any forward-looking statements after the date hereof to conform such statements to actual results or to changes in our opinions or expectations. If we do update or correct any forward-looking statements, readers should not conclude that we will make additional updates or corrections.

 

 

3

Table Of Contents

 

PART  I   FINANCIAL  INFORMATION 

 

ITEM 1.   FINANCIAL STATEMENTS (UNAUDITED)

 

 

Page

 

 

Condensed Consolidated Balance Sheets

5

Condensed Consolidated Statements of Operations and Comprehensive Loss

6

Condensed Consolidated Statements of Stockholders’ Equity

7

Condensed Consolidated Statements of Cash Flows

8

Notes to the Condensed Consolidated Financial Statements

9

 

 
4

Table Of Contents

  

VOLITIONRX LIMITED

Condensed Consolidated Balance Sheets

(Expressed in United States Dollars, except share numbers)

 

 

 

March 31,

 

 

December 31,

 

 

 

2022

 

 

2021

 

 

 

$

 

 

$

 

ASSETS

 

(UNAUDITED)

 

 

 

Current Assets

 

 

 

 

 

 

Cash and cash equivalents

 

 

23,732,379

 

 

 

20,581,313

 

Accounts receivable

 

 

72,371

 

 

 

12,510

 

Prepaid expenses

 

 

1,263,149

 

 

 

598,367

 

Other current assets

 

 

888,827

 

 

 

786,642

 

Total Current Assets

 

 

25,956,726

 

 

 

21,978,832

 

 

 

 

 

 

 

 

 

 

Property and equipment, net

 

 

4,721,065

 

 

 

4,911,077

 

Operating lease right-of-use assets

 

 

830,257

 

 

 

383,551

 

Intangible assets, net

 

 

175,391

 

 

 

216,876

 

Total Assets

 

 

31,683,439

 

 

 

27,490,336

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

Current Liabilities

 

 

 

 

 

 

 

 

Accounts payable

 

 

2,205,240

 

 

 

1,542,457

 

Accrued liabilities

 

 

3,538,881

 

 

 

3,828,501

 

Deferred revenue

 

 

10,000,000

 

 

 

12,512

 

Management and directors’ fees payable

 

 

97,640

 

 

 

71,303

 

Current portion of long-term debt

 

 

1,333,316

 

 

 

797,855

 

Current portion of finance lease liabilities

 

 

46,656

 

 

 

48,958

 

Current portion of operating lease liabilities

 

 

249,051

 

 

 

171,166

 

Current portion of grant repayable

 

 

42,036

 

 

 

43,100

 

Total Current Liabilities

 

 

17,512,820

 

 

 

6,515,852

 

 

 

 

 

 

 

 

 

 

Long-term debt, net of current portion

 

 

2,031,875

 

 

 

2,270,767

 

Finance lease liabilities, net of current portion

 

 

486,690

 

 

 

511,086

 

Operating lease liabilities, net of current portion

 

 

594,392

 

 

 

217,305

 

Grant repayable, net of current portion

 

 

246,970

 

 

 

253,221

 

Total Liabilities

 

 

20,872,747

 

 

 

9,768,231

 

 

 

 

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

Common Stock

 

 

 

 

 

 

 

 

Authorized: 100,000,000 shares of common stock, at $0.001 par value

 

 

 

 

 

 

 

 

Issued and outstanding: 53,790,261 shares and 53,772,261 shares, respectively

 

 

53,790

 

 

 

53,772

 

Additional paid-in capital

 

 

155,655,418

 

 

 

154,730,938

 

Accumulated other comprehensive income

 

 

30,422

 

 

 

148,326

 

Accumulated deficit

 

 

(144,622,666 )

 

 

(136,988,636 )

Total VolitionRx Limited Stockholders’ Equity

 

 

11,116,964

 

 

 

17,944,400

 

Non-controlling interest

 

 

(306,272 )

 

 

(222,295 )

Total Stockholders’ Equity

 

 

10,810,692

 

 

 

17,722,105

 

 

 

 

 

 

 

 

 

 

Total Liabilities and Stockholders’ Equity

 

 

31,683,439

 

 

 

27,490,336

 

 

 

 

 

 

 

 

 

 

(The accompanying notes are an integral part of these condensed consolidated financial statements)

 

 
5

Table Of Contents

 

VOLITIONRX LIMITED

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)

(Expressed in United States Dollars, except share numbers)

 

 

 

Three Months Ended March 31,

 

 

 

2022

 

 

2021

 

 

 

 $

 

 

 

Revenues

 

 

 

 

 

 

Services

 

 

60,254

 

 

 

-

 

Product

 

 

53,957

 

 

 

25,530

 

Total Revenues

 

 

114,211

 

 

 

25,530

 

 

 

 

 

 

 

 

 

 

Operating Expenses

 

 

 

 

 

 

 

 

Research and development

 

 

3,590,053

 

 

 

3,873,079

 

General and administrative

 

 

2,602,152

 

 

 

1,810,160

 

Sales and marketing

 

 

1,598,983

 

 

 

427,401

 

Total Operating Expenses

 

 

7,791,188

 

 

 

6,110,640

 

 

 

 

 

 

 

 

 

 

Operating Loss

 

 

(7,676,977 )

 

 

(6,085,110 )

 

 

 

 

 

 

 

 

 

Other Income (Expenses)

 

 

 

 

 

 

 

 

Interest income

 

 

2

 

 

 

1,721

 

Interest expense

 

 

(41,032 )

 

 

(42,181 )

Total Other Income (Expenses)

 

 

(41,030 )

 

 

(40,460 )

 

 

 

 

 

 

 

 

 

Net Loss

 

 

(7,718,007 )

 

 

(6,125,570 )

Net Loss attributable to Non-Controlling Interest

 

 

83,977

 

 

 

9,424

 

Net Loss attributable to VolitionRx Limited Stockholders

 

 

(7,634,030 )

 

 

(6,116,146 )

 

 

 

 

 

 

 

 

 

Other Comprehensive (Loss) / Income

 

 

 

 

 

 

 

 

Foreign currency translation adjustments

 

 

(117,904 )

 

 

134,133

 

 

 

 

 

 

 

 

 

 

Net Comprehensive Loss

 

 

(7,835,911 )

 

 

(5,991,437 )

 

 

 

 

 

 

 

 

 

Net Loss Per Share – Basic and Diluted

 

 

(0.14 )

 

 

(0.12 )

Weighted Average Shares Outstanding

 

 

 

 

 

 

 

 

– Basic and Diluted

 

 

53,775,096

 

 

 

50,928,742

 

 

 

 

 

 

 

 

 

 

(The accompanying notes are an integral part of these condensed consolidated financial statements)

 

 
6

Table Of Contents

 

VOLITIONRX LIMITED

Condensed Consolidated Statements of Stockholders’ Equity (Unaudited)

(Expressed in United States Dollars, except share numbers)

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

Non

 

 

 

 

 

 

Common Stock

 

 

Paid-in

 

 

Comprehensive

 

 

Accumulated

 

 

Controlling

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Interest

 

 

Total

 

 

 

#

 

 

$

 

 

$

 

 

$

 

 

$

 

 

$

 

$

 

Balance, December 31, 2021

 

 

53,772,261

 

 

 

53,772

 

 

 

154,730,938

 

 

 

148,326

 

 

 

(136,988,636 )

 

 

(222,295 )

 

 

17,722,105

 

Common stock issued for cash

 

 

3,000

 

 

 

3

 

 

 

9,464

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

9,467

 

Common stock issued for settlement of RSUs

 

 

15,000

 

 

 

15

 

 

 

(15 )

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

915,031

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

915,031

 

Foreign currency translation

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(117,904 )

 

 

-

 

 

 

-

 

 

 

(117,904 )

Net loss for the period

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(7,634,030 )

 

 

(83,977 )

 

 

(7,718,007 )

Balance, March 31, 2022

 

 

53,790,261

 

 

 

53,790

 

 

 

155,655,418

 

 

 

30,422

 

 

 

(144,622,666 )

 

 

(306,272 )

 

 

10,810,692

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, December 31, 2020

 

 

48,607,017

 

 

 

48,607

 

 

 

126,526,239

 

 

 

(59,978 )

 

 

(110,173,971 )

 

 

(47,179 )

 

 

16,293,718

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common stock issued for cash

 

 

4,183,533

 

 

 

4,184

 

 

 

20,324,744

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

20,328,928

 

Common stock issued for cashless exercise of stock options and settlement of RSUs

 

 

80,451

 

 

 

80

 

 

 

(80 )

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

555,342

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

555,342

 

Tax withholdings paid related to stock-based compensation

 

 

-

 

 

 

-

 

 

 

(23,758 )

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(23,758 )

Foreign currency translation

 

 

-

 

 

 

-

 

 

 

-

 

 

 

134,133

 

 

 

-

 

 

 

-

 

 

 

134,133

 

Net loss for the period

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(6,116,146 )

 

 

(9,424 )

 

 

(6,125,570 )

 Balance, March 31, 2021

 

 

52,871,001

 

 

 

52,871

 

 

 

147,382,487

 

 

 

74,155

 

 

 

(116,290,117 )

 

 

(56,603 )

 

 

31,162,793

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 (The accompanying notes are an integral part of these condensed consolidated financial statements)

 

 
7

Table Of Contents

 

VOLITIONRX LIMITED

Condensed Consolidated Statements of Cash Flows (Unaudited)

(Expressed in United States Dollars)

 

 

 

Three Months Ended March 31,

 

 

 

2022

 

 

2021

 

 

 

$

 

 

$

 

Operating Activities

 

 

 

 

 

 

Net Loss

 

 

(7,718,007 )

 

 

(6,125,570 )

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

224,310

 

 

 

227,342

 

Amortization of operating lease right-of-use assets

 

 

65,361

 

 

 

50,046

 

Stock-based compensation

 

 

915,031

 

 

 

555,342

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Prepaid expenses

 

 

(664,782 )

 

 

(792,793 )

Accounts receivable

 

 

(59,861 )

 

 

(14,238 )

Other current assets

 

 

(102,185 )

 

 

86,907

 

Deferred Revenue, current and non-current

 

 

10,000,000

 

 

 

-

 

Accounts payable and accrued liabilities

 

 

361,237

 

 

 

(87,002 )

Management and directors’ fees payable

 

 

25,750

 

 

 

(15,690 )

Right-of-use assets operating leases liabilities

 

 

(57,008 )

 

 

(49,485 )

Net Cash Provided By / (Used In) Operating Activities

 

 

2,989,846

 

 

 

(6,165,141 )

 

 

 

 

 

 

 

 

 

Investing Activities:

 

 

 

 

 

Purchases of property and equipment

 

 

(124,648 )

 

 

(483,940 )

Net Cash Used In Investing Activities

 

 

(124,648 )

 

 

(483,940 )

 

 

 

 

 

 

 

 

 

Financing Activities:

 

 

 

 

 

Net proceeds from issuances of common stock

 

 

9,467

 

 

 

20,328,928

 

Tax withholdings paid related to stock-based compensation

 

 

-

 

 

 

(23,758 )

Proceeds from long-term debt

 

 

620,549

 

 

 

79,590

 

Payments on long-term debt

 

 

(250,711 )

 

 

(161,727 )

Payments on finance lease obligations

 

 

(13,133 )

 

 

(14,722 )

Net Cash Provided By Financing Activities

 

 

366,172

 

 

 

20,208,311

 

 

 

 

 

 

 

 

 

 

Effect of foreign exchange on cash

 

 

(80,304 )

 

 

57,744

 

 

 

 

 

 

 

 

 

 

Net Change in Cash

 

 

3,151,066

 

 

 

13,616,974

 

Cash and cash equivalents – Beginning of Period

 

 

20,581,313

 

 

 

19,444,737

 

Cash and cash equivalents – End of Period

 

 

23,732,379

 

 

 

33,061,711

 

 

 

 

 

 

 

 

 

 

Supplemental Disclosures of Cash Flow Information:

 

 

 

 

 

 

 

 

Interest paid

 

 

41,032

 

 

 

42,181

 

Non-Cash Financing Activities:

 

 

 

 

 

 

 

 

Common stock issued on cashless exercises of stock options and settlement of vested RSUs

 

 

15

 

 

 

80

 

Offering costs from issuance of common stock

 

 

-

 

 

 

119,029

 

 

 

 

 

 

 

 

 

 

(The accompanying notes are an integral part of these condensed consolidated financial statements)

 

 
8

Table Of Contents

   

VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

 

Note 1 – Basis of Presentation and Summary of Significant Accounting Policies

 

Basis of Presentation

 

The interim consolidated financial statements of VolitionRx Limited (the “Company”, “VolitionRx,” “we” or “us”) for the three months ended March 31, 2022 and March 31, 2021, respectively, are unaudited. Our consolidated financial statements are prepared in accordance with the requirements for unaudited interim periods and, consequently, do not include all disclosures required to be made in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). In the opinion of our management, the accompanying consolidated financial statements contain all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation of our financial position as of March 31, 2022, and our results of operations and cash flows for the periods ended March 31, 2022 and March 31, 2021, respectively. The results of operations for the periods ended March 31, 2022 and March 31, 2021, respectively, are not necessarily indicative of the results for a full-year period. These interim consolidated financial statements should be read in conjunction with the financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2021, which was filed with the Securities and Exchange Commission (the “SEC”) on March 30, 2022.

 

Use of Estimates

 

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. The Company also regularly evaluates estimates and assumptions related to deferred income tax asset valuation allowances, useful lives of property and equipment and intangible assets, borrowing rate used in operating lease right-of-use asset and liability valuations, impairment analysis of intangible assets, and valuations of stock-based compensation.

 

The Company bases its estimates and assumptions on current facts, historical experience and various other factors that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the accrual of costs and expenses that are not readily apparent from other sources. The actual results experienced by the Company may differ materially and adversely from the Company’s estimates. To the extent there are material differences between the estimates and the actual results, future results of operations could be affected.

 

Principles of Consolidation

 

The accompanying condensed consolidated financial statements for the period ended March 31, 2022 include the accounts of the Company and its subsidiaries. The Company has two wholly-owned subsidiaries Singapore Volition Pte. Limited (“Singapore Volition”) and Volition Global Services SRL (“Volition Global”). Singapore Volition has one wholly-owned subsidiary, Belgian Volition SRL (“Belgian Volition”). Belgian Volition has four subsidiaries, Volition Diagnostics UK Limited (“Volition Diagnostics”), Volition America, Inc. (“Volition America”), Volition Germany GmbH (“Volition Germany”), and its one majority-owned subsidiary Volition Veterinary Diagnostics Development LLC (“Volition Vet”). See Note 8(f) for more information regarding Volition Vet, Volition Germany and Volition America. All intercompany balances and transactions have been eliminated in consolidation.

 

Cash and Cash Equivalents

 

For the purposes of the statements of cash flows, the Company considers interest bearing deposits with original maturity dates of three months or less to be cash equivalents. The Company invests excess cash from its operating cash accounts in overnight investments and reflects these amounts in cash and cash equivalents in the condensed consolidated balance sheets at fair value using quoted prices in active markets for identical assets. As of March 31, 2022, cash and cash equivalents totaled approximately $23.7 million, of which $10.2 million was held in an overnight money market account.

 

 
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VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 1 - Basis of Presentation and Summary of Significant Accounting Policies (continued)

 

Accounts Receivables

 

Trade accounts receivable are stated at the amount the Company expects to collect. Due to the nature of the accounts receivable balance, the Company believes the risk of doubtful accounts is minimal and therefore no allowance is recorded. If the financial condition of the Company’s customers were to deteriorate, adversely affecting their ability to make payments, additional allowances would be required. The Company may provide for estimated uncollectible amounts through a charge to earnings and a credit to a valuation allowance. Balances that remain outstanding after the Company has used reasonable collection efforts are written off through a charge to the valuation allowance and a credit to accounts receivable. As of March 31, 2022, the accounts receivable balance was $72,371 and the allowance for doubtful debts was $nil.

 

Revenue Recognition

 

The Company adopted Accounting Standards Codification (“ASC”)606, “Revenue from Contracts with Customers,” effective January 1, 2019. Under ASC 606, the Company recognizes revenues when the customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. The Company recognizes revenues following the five step model prescribed under ASC 606: (i) identify contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenues when (or as) the Company satisfies the performance obligation(s).

 

The Company generates product revenues from the sale of its Nu.Q® Vet Cancer Screening Test, from the sale of nucleosomes, and from the sale of Research Use Only kits. In addition, revenue is received from external third parties for Nu.Q® Discover services the Company performs for them in its laboratory.

 

Revenues, and their respective treatment for financial reporting purposes under ASC 606, are as follows:

 

Royalty

 

The Company receives royalty revenues on the net sales recognized during the period in which the revenue is earned, and the amount is determinable from the licensee. These are presented in “Royalty” in the consolidated statements of operations and comprehensive loss. The Company does not have future performance obligations under this revenue stream. In accordance with ASC 606, the Company records these revenues based on estimates of the net sales that occurred during the relevant period from the licensee. The relevant period estimates of these royalties are based on preliminary gross sales data provided by Customers and analysis of historical gross-to-net adjustments. Differences between actual and estimated royalty revenues are adjusted for in the period in which they become known.

 

Product

 

The Company includes revenue from product sales recognized during the period in which goods are shipped to third parties, and the amount is deemed collectable from the third parties. These are presented in “Product” in the consolidated statements of operations and comprehensive loss.

 

 
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VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 1 - Basis of Presentation and Summary of Significant Accounting Policies (continued)

 

Services

 

The Company includes revenue recognized from laboratory services performed in the Company’s laboratory on behalf of third parties in “Services” in the consolidated statements of operations and comprehensive loss.

  

For each development and/or commercialization agreement that results in revenues, the Company identifies all performance obligations, aside from those that are immaterial, which may include a license to intellectual property and know-how, development activities and/or transition activities. In order to determine the transaction price, in addition to any upfront payment, the Company estimates the amount of variable consideration at the outset of the contract either utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract. The Company constrains (reduces) the estimates of variable consideration such that it is probable that a significant reversal of previously recognized revenue will not occur throughout the life of the contract. When determining if variable consideration should be constrained, management considers whether there are factors outside the Company’s control that could result in a significant reversal of revenue. In making these assessments, the Company considers the likelihood and magnitude of a potential reversal of revenue. These estimates are re-assessed each reporting period as required.

 

Licensing

 

The Company includes revenue recognized from the licensing of certain rights to third parties in “Licensing” in the consolidated statements of operations. For each development and/or commercialization agreement that results in revenues, the Company identifies all performance obligations, aside from those that are immaterial, which may include a license to intellectual property and know-how, development activities and/or transition activities. In order to determine the transaction price, in addition to any upfront payment, the Company estimates the amount of variable consideration at the outset of the contract either utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract. The Company constrains (reduces) the estimates of variable consideration such that it is probable that a significant reversal of previously recognized revenue will not occur throughout the life of the contract. When determining if variable consideration should be constrained, management considers whether there are factors outside the Company’s control that could result in a significant reversal of revenue. In making these assessments, the Company considers the likelihood and magnitude of a potential reversal of revenue. These estimates are re-assessed each reporting period as required.

 

Deferred Revenue (Contract Liabilities) and Contract Assets

 

Deferred revenue consists of amounts for which we have an unconditional right to bill, and/or amounts for which payment has been received–including non-refundable amounts, but have not been recognized as revenue because the related performance obligations are deemed incomplete. As at March 31, 2022, the Company recorded $10.0 million as deferred revenue in respect of a non-refundable payment received in relation to a licensing and product supply agreement with Heksa Corporation. As at March 31, 2021, the Company recorded $nil deferred revenue. 

 

Contract assets include costs and services incurred on contracts with open performance obligations. These contract assets were immaterial as of March 31, 2022.

 

Basic and Diluted Net Loss Per Share

 

The Company computes net loss per share in accordance with ASC 260, “Earnings Per Share,” which requires presentation of both basic and diluted earnings per share (“EPS”) on the face of the statement of operations and comprehensive loss. Basic EPS is computed by dividing net loss available to common stockholders (numerator) by the weighted average number of shares outstanding (denominator) during the period. Diluted EPS gives effect to all dilutive potential common shares outstanding during the period using the treasury stock method. In computing diluted EPS, the average stock price for the period is used in determining the number of shares assumed to be purchased from the exercise of stock options or warrants. As of March 31, 2022, 6,346,268 potential common shares equivalents from warrants, options, and restricted stock units (“RSUs”) were excluded from the diluted EPS calculations as their effect is anti-dilutive.

 

 
11

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VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 1 - Basis of Presentation and Summary of Significant Accounting Policies (continued)

 

Foreign Currency Translation

 

The Company has functional currencies in Euros, US Dollars and British Pounds Sterling and its reporting currency is the US Dollar. Management has adopted ASC 830-20, “Foreign Currency Matters – Foreign Currency Transactions”. All assets and liabilities denominated in foreign currencies are translated using the exchange rate prevailing at the balance sheet date. For revenues and expenses, the weighted average exchange rate for the period is used. Gains and losses arising on translation of foreign currency denominated transactions are included in other comprehensive income (loss).

 

Research and Development

 

In accordance with ASC 730, the Company follows the policy of expensing its research and development costs in the period in which they are incurred. The Company incurred research and development expenses of $3.6 million and $3.9 million during the three-months ended March 31, 2022, and March 31, 2021, respectively.

 

Stock-Based Compensation

 

The Company records stock-based compensation in accordance with ASC 718, “Compensation – Stock Compensation”. Under the provisions of ASC 718, stock-based compensation cost is measured at the grant date, based on the fair value of the award, and is recognized over the employee’s requisite service period, which is generally the vesting period. The fair value of our stock options and warrants is estimated using a Black-Scholes option valuation model. Restricted stock units are valued based on the closing stock price on the date of grant. Refer to Note 7 for further details.

 

Reclassification

 

Certain amounts presented in previously issued financial statements have been reclassified to be consistent with the current period presentation. The Company has reclassified the prior period comparative amounts in Part I, Item 2. “MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS” of the Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, in relation to Research and Development expenses, General and Administrative expenses and Sales and Marketing expenses to be consistent with the current year classification.

 

Recent Accounting Pronouncements

 

The Company has implemented all new accounting pronouncements that are in effect. The Company does not believe there are any other new accounting pronouncements that have been issued that might have a material impact on its financial position or results of operations.

 

COVID-19 Pandemic Impact

 

As of the date of this filing, there continue to be widespread concerns regarding the ongoing impacts and disruptions caused by the COVID-19 pandemic in the regions in which the Company operates. As a result of the COVID-19 pandemic, the Company has experienced and may continue to experience disruptions that could impact our clinical trials, including delays enrolling patients and in sample collection.

 

The extent to which the COVID-19 pandemic will impact the Company’s business, financial condition, and results of operations in the future is highly uncertain and will be affected by a number of factors. These include the duration and extent of the COVID-19 pandemic, the development of new variants of the COVID-19 virus that may be more contagious or virulent than previous versions, the scope of mandated or recommended containment and mitigation measures, the effect of government stabilization and recovery efforts, and the success of vaccine distribution programs.

 

 
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VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 2 - Going Concern

 

The Company’s condensed consolidated financial statements are prepared using U.S. GAAP applicable to a going concern which contemplates the realization of assets and liquidation of liabilities in the normal course of business. The Company has incurred losses since inception of $144.6 million, has had negative cash flows from operations on an annual basis, and has minimal revenues, which creates substantial doubt about its ability to continue as a going concern for a period of at least one year from the date of issuance of these condensed consolidated financial statements.

 

The future of the Company as an operating business will depend on its ability to obtain sufficient capital contributions, financing and/or to generate revenues as may be required to sustain its operations. Management plans to address the above as needed by (a) securing additional grant funds, (b) obtaining additional financing through debt or equity transactions, (c) granting licenses to third parties in exchange for specified up-front and/or milestone payments and (d) developing and commercializing its products on an accelerated timeline. Management continues to exercise tight cost controls to conserve cash.

 

The ability of the Company to continue as a going concern is dependent upon its ability to successfully accomplish the plans described in the preceding paragraph and eventually attain profitable operations. The accompanying condensed consolidated financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern. If the Company is unable to obtain adequate capital, it could be forced to cease operations.

 

 
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VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 3 - Property and Equipment

 

The Company’s property and equipment consisted of the following amounts as of March 31, 2022 and December 31, 2021:

 

 

 

 

 

 

 

 

March 31,

 

 

 

 

 

 

 

 

2022

 

 

 

 

 

 

Accumulated

 

 

Net Carrying

 

 

 

 

 

Cost

 

 

Depreciation

 

 

Value

 

 

 

Useful Life

 

 $

 

 

$

 

 

$

 

Computer hardware and software

 

3 years

 

 

589,517

 

 

 

445,310

 

 

 

144,207

 

Laboratory equipment

 

5 years

 

 

3,019,021

 

 

 

1,531,605

 

 

 

1,487,416

 

Office furniture and equipment

 

5 years

 

 

309,799

 

 

 

219,544

 

 

 

90,255

 

Buildings

 

30 years

 

 

2,123,879

 

 

 

255,424

 

 

 

1,868,455

 

Building improvements

 

5-15 years

 

 

1,268,648

 

 

 

271,064

 

 

 

997,584

 

Land

 

Not amortized

 

 

133,148

 

 

 

-

 

 

 

133,148

 

 

 

 

 

 

7,444,012

 

 

 

2,722,947

 

 

 

4,721,065

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31,

 

 

 

 

 

 

 

 

 

 

 

 

 

2021

 

 

 

 

 

 

 

 

 

Accumulated

 

 

Net Carrying

 

 

 

 

 

Cost

 

 

Depreciation

 

 

Value

 

 

 

Useful Life

 

 

 $ 

 

 

$

 

 

$

 

Computer hardware and software

 

3 years

 

 

599,944

 

 

 

474,169

 

 

 

125,775

 

Laboratory equipment

 

5 years

 

 

3,032,108

 

 

 

1,434,347

 

 

 

1,597,761

 

Office furniture and equipment

 

5 years

 

 

293,427

 

 

 

213,244

 

 

 

80,183

 

Buildings

 

30 years

 

 

2,177,641

 

 

 

243,750

 

 

 

1,933,891

 

Building improvements

 

5-15 years

 

 

1,293,258

 

 

 

256,309

 

 

 

1,036,949

 

Land

 

Not amortized

 

 

136,518

 

 

 

-

 

 

 

136,518

 

 

 

 

 

 

7,532,896

 

 

 

2,621,819

 

 

 

4,911,077

 

 

During the three-month periods ended March 31, 2022 and March 31, 2021, the Company recognized $202,423 and $204,049, respectively, in depreciation expense.

 

 
14

Table Of Contents

 

VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 4 - Intangible Assets

 

The Company’s intangible assets consist of patents, mainly acquired in the acquisition of Belgian Volition. The patents are being amortized over the assets’ estimated useful lives, which range from 8 to 20 years.

 

 

 

 

 

 

 

March 31,

 

 

 

 

 

 

 

2022

 

 

 

 

 

 

Accumulated

 

 

Net Carrying

 

 

 

Cost

 

 

Amortization

 

 

Value

 

 

 

 $

 

 

 $

 

 

$

 

Patents

 

 

1,135,896

 

 

 

960,505

 

 

 

175,391

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31,

 

 

 

 

 

 

 

 

 

 

 

2021

 

 

 

 

 

 

 

Accumulated

 

 

Net Carrying

 

 

 

Cost

 

 

Amortization

 

 

Value

 

 

 

 

 

 

 $

 

 

$

 

Patents

 

 

1,178,135

 

 

 

961,259

 

 

 

216,876

 

 

During the three-month periods ended March 31, 2022 and March 31, 2021, the Company recognized $21,887 and $23,293, respectively, in amortization expense.

 

The Company amortizes the patents on a straight-line basis with terms ranging from 8 to 20 years. The annual estimated amortization schedule over the next five years is as follows:

 

2022

 

$ 64,991

 

2023

 

$ 86,655

 

2024

 

$ 23,745

 

Total Intangible Assets

 

$ 175,391

 

 

The Company periodically reviews its long-lived assets to ensure that their carrying value does not exceed their fair market value. The Company carried out such a review in accordance with ASC 360 Topic “Property, Plant and Equipment” as of December 31, 2021. The result of this review confirmed that the ongoing value of the patents was not impaired as of December 31, 2021.

 

Note 5 - Related Party Transactions

 

See Note 6, Common Stock, for common stock issued to related parties and Note 7, Stock-Based Compensation, for stock options, warrants and RSUs issued to related parties. The Company has agreements with related parties for the purchase of products and consultancy services which are accrued under management and directors’ fees payable (see condensed consolidated balance sheets).

 

 
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VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 6 - Common Stock

 

As of March 31, 2022, the Company was authorized to issue 100 million shares of common stock par value $0.001 per share, of which 53,790,261 and 53,772,261 shares were issued and outstanding as of March 31, 2022 and December 31, 2021, respectively.

 

Stock Option Exercises and RSU Settlements

 

On March 28, 2022, 15,000 RSUs vested and resulted in the issuance of 15,000 shares of common stock.

 

Equity Distribution Agreement

 

On September 24, 2021, the Company entered into an equity distribution agreement (the “2021 EDA”) with Cantor Fitzgerald & Co. Inc. (“Cantor”)and Oppenheimer & Co. Inc. (“Oppenheimer”), to sell shares of its common stock having an aggregate offering price of up to $25.0 million from time-to-time, through an “at the market offering program” pursuant to the Company’s effective “shelf” registration statement on Form S-3 (File No. 333-259783) and related prospectuses, through Cantor and Oppenheimer each acting as the Company’s agent and/or principal. The Company was not obligated to sell any shares under the 2021 EDA. During the three months ended March 31, 2022, the Company raised aggregate net proceeds (net of brokers’ commissions and fees) of $9,464 under the 2021 EDA through the sale of 3,000 shares of its common stock. From inception through March 31, 2022, the Company raised aggregate net proceeds (net of brokers’ commissions and fees) of approximately $0.7 million under the 2021 EDA through the sale of 193,600 shares of its common stock. For additional information regarding the 2021 EDA, see Note 9, Subsequent Events.

 

Note 7 – Stock-Based Compensation

 

a) Warrants

 

The following table summarizes the changes in warrants outstanding of the Company during the three-month period ended March 31, 2022:

 

 

 

 

 

 

 

Weighted

Average

 

 

 

Number of

Warrants

 

 

Exercise

Price ($)

 

Outstanding at December 31, 2021

 

 

485,000

 

 

 

3.88

 

Granted

 

 

-

 

 

 

-

 

Outstanding at March 31, 2022

 

 

485,000

 

 

 

3.88

 

 

 

 

 

 

 

 

 

 

Exercisable at March 31, 2022

 

 

485,000

 

 

 

3.88

 

 

Below is a table summarizing the warrants issued and outstanding as of March 31, 2022, which have an aggregate weighted average remaining contractual life of 3.71 years.

 

 

 

 

 

 

 

 

Weighted Average

 

 

 

 

 

 

 

 

 

 

Remaining

 

 

Proceeds to

 

Number

 

 

Number

 

 

Exercise

 

 

Contractual

 

 

Company if

 

Outstanding

 

 

Exercisable

 

 

Price ($)

 

 

Life (Years)

 

 

Exercised ($)

 

 

125,000

 

 

 

125,000

 

 

 

2.47

 

 

 

0.91

 

 

 

308,750

 

 

50,000

 

 

 

50,000

 

 

 

3.45

 

 

 

3.92

 

 

 

172,500

 

 

125,000

 

 

 

125,000

 

 

 

3.95

 

 

 

4.76

 

 

 

493,750

 

 

185,000

 

 

 

185,000

 

 

 

4.90

 

 

 

4.84

 

 

 

906,500

 

 

485,000

 

 

 

485,000

 

 

 

 

 

 

 

 

 

 

 

1,881,500

 

 

 
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VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 7 – Stock-Based Compensation (continued)

 

a) Warrants (continued)

 

Stock-based compensation expense related to warrants of $39,013 and $148,364 was recorded in the three months ended March 31, 2022 and March 31, 2021, respectively. There is no remaining expense to be recognized. As of March 31, 2022, the total intrinsic value of warrants outstanding was $67,500.

 

b) Options

 

The following table summarizes the changes in options outstanding of the Company during the three-month period ended March 31, 2022:

 

 

 

 

 

 

Weighted Average

 

 

 

Number of

Options

 

 

Exercise Price ($)

 

Outstanding at December 31, 2021

 

 

5,027,518

 

 

 

3.87

 

Granted

 

 

-

 

 

 

-

 

Exercised

 

 

-

 

 

 

-

 

Expired/Cancelled

 

 

-

 

 

 

-

 

Outstanding at March 31, 2022

 

 

5,027,518

 

 

 

3.87

 

 

 

 

 

 

 

 

 

 

Exercisable at March 31, 2022

 

 

3,937,518

 

 

 

4.00

 

 

.

Below is a table summarizing the options issued and outstanding as of March 31, 2022, all of which were issued pursuant to the 2011 Equity Incentive Plan (for option issuances prior to 2016) or the 2015 Stock Incentive Plan (for option issuances commencing in 2016) and which have an aggregate weighted average remaining contractual life of 6.00 years. As of March 31, 2022, an aggregate of 6,000,000 shares of common stock were authorized for issuance under the 2015 Stock Incentive Plan, of which 336,352 shares of common stock remained available for future issuance thereunder.

 

 

 

 

 

 

 

 

 

 

Weighted Average

 

 

 

 

 

 

 

 

 

 

 

 

 

Remaining

 

 

Proceeds to

 

Number

 

 

Number

 

 

Exercise

 

 

Contractual

 

 

Company if

 

Outstanding

 

 

Exercisable

 

 

Price ($)

 

 

Life (Years)

 

 

Exercised ($)

 

635,000

 

 

635,000

 

 

3.25

 

 

2.87

 

 

2,063,750

 

2,717

 

 

2,717

 

 

3.35

 

 

1.42

 

 

9,102

 

1,060,000

 

 

10,000

 

 

3.40

 

 

9.35

 

 

3,604,000

 

800,000

 

 

760,000

 

 

3.60

 

 

8.10

 

 

2,880,000

 

1,682,837

 

 

1,682,837

 

 

4.00

 

 

4.51

 

 

6,731,348

 

11,801

 

 

11,801

 

 

4.35

 

 

1.20

 

 

51,334

 

89,163

 

 

89,163

 

 

4.38

 

 

5.82

 

 

390,534

 

50,000

 

 

50,000

 

 

4.80

 

 

4.76

 

 

240,000

 

696,000

 

 

696,000

 

 

5.00

 

 

4.99

 

 

3,480,000

 

5,027,518

 

 

3,937,518

 

 

 

 

 

 

 

 

19,450,068

 

 

 
17

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VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

 

Note 7 – Stock-Based Compensation (continued)

 

b) Options (continued)

 

Stock-based compensation expense related to stock options of $394,053 and $355,076 was recorded in the three months ended March 31, 2022 and March 31, 2021, respectively. Total remaining unrecognized compensation cost related to non-vested stock options is $1,064,229 and is expected to be recognized over a period of 1.51 years. As of March 31, 2022, the total intrinsic value of stock options outstanding was $nil.

 

c) Restricted Stock Units (RSUs)

 

Below is a table summarizing the RSUs issued and outstanding as of March 31, 2022, all of which were issued pursuant to the 2015 Stock Incentive Plan.

 

 

 

Number of

 

 

Weighted Average

 

 

 

RSUs

 

 

Share Price ($)

 

Outstanding at December 31, 2021

 

 

810,750

 

 

 

3.33

 

Granted

 

 

38,000

 

 

 

2.81

 

Vested/Settled

 

 

(15,000 )

 

 

3.59

 

Cancelled

 

 

-

 

 

 

-

 

Outstanding at March 31, 2022

 

 

833,750

 

 

 

3.30

 

 

Effective February 8, 2022, the Company granted aggregate RSUs of 8,000 shares of common stock to an employee in exchange for services provided to the Company. These RSUs vest over two years, with 50% vesting on each of February 8, 2023 and February 8, 2024, subject to continued service, and will result in total compensation expense of $22,640.

 

Effective March 1, 2022, the Company granted aggregate RSUs of 30,000 shares of common stock to various employees in exchange for services provided to the Company. These RSUs vest over two years, with 50% vesting on each of March 1, 2023 and March 1, 2024, subject to continued service, and will result in total compensation expense of $84,300.

 

On March 28, 2022, 15,000 RSUs vested and resulted in the issuance of 15,000 shares of common stock.

 

 
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VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

 

Note 7 – Stock-based Compensation (continued)

 

c) Restricted Stock Units (RSUs) (continued)

 

Below is a table summarizing the RSUs issued and outstanding as of March 31, 2022 and which have an aggregate weighted average remaining contractual life of 0.92 years.

 

 

 

 

 

 

 

Weighted

 

 

 

 

 

 

 

Average

 

 

 

 

 

 

 

Remaining

 

Number

 

 

Share

 

 

Contractual

 

Outstanding

 

 

Price ($)

 

 

Life (Years)

 

30,000

 

 

2.81

 

 

1.42

 

8,000

 

 

2.83

 

 

1.36

 

39,809

 

 

3.04

 

 

1.01

 

610,191

 

 

3.31

 

 

0.86

 

38,000

 

 

3.32

 

 

0.94

 

23,000

 

 

3.38

 

 

1.21

 

43,500

 

 

3.51

 

 

1.09

 

26,250

 

 

3.52

 

 

0.04

 

15,000

 

 

3.59

 

 

0.98

 

833,750

 

 

 

 

 

 

 

 

Stock-based compensation expense related to RSUs of $481,962 and $51,902 was recorded in the three months ended March 31, 2022 and March 31, 2021, respectively. Total remaining unrecognized compensation cost related to non-vested RSUs is $1,435,500. As of March 31, 2022, the total intrinsic value of the RSUs outstanding was $7,440.

 

 
19

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VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 8 – Commitments and Contingencies

 

a) Finance Lease Obligations

 

In 2016, the Company entered into a capital lease with ING Asset Finance Belgium S.A. (“ING”) to purchase a property located in Belgium for €1.12 million, maturing in May 2031 with implicit interest of 2.62%. As of March 31, 2022, the balance payable was $533,346.

 

In 2018, the Company entered into a capital lease with BNP Paribas leasing solutions to purchase a freezer for the Belgium facility for €25,000, that matured in January 2022 with implicit interest of 1.35%. The leased equipment is amortized on a straight-line basis over 5 years. As of March 31, 2022, the balance payable was $nil.

 

The following is a schedule showing the future minimum lease payments under finance leases by years and the present value of the minimum payments as of March 31, 2022.

 

2022

 

$ 44,760

 

2023

 

$ 59,680

 

2024

 

$ 59,679

 

2025

 

$ 59,679

 

2026

 

$ 59,680

 

Greater than 5 years

 

$ 320,764

 

Total

 

$ 604,242

 

Less: Amount representing interest

 

$ (70,896 )

Present value of minimum lease payments

 

$ 533,346

 

 

b) Operating Lease Right-of-Use Obligations

 

As all the existing leases subject to the new lease standard ASC 842 (“Leases”) were previously classified as operating leases by the Company, they were similarly classified as operating leases under the new standard. The Company has determined that the identified operating leases did not contain non-lease components and require no further allocation of the total lease cost. Additionally, the agreements in place did not contain information to determine the rate implicit in the leases, so the Company used its incremental borrowing rate as the discount rate. The Company’s weighted average discount rate is 2.45% and the weighted average remaining lease term is 35 months.

 

During the three months ended March 31, 2022, the Company entered into a new lease agreement. The lease is initially for 62 months and the initial rent is $7,642 a month. In connection with the new lease agreement the Company recorded $461,341 of right-of-use assets in exchange for right-of-use liabilities.

 

As of March 31, 2022, operating lease right-of-use assets and liabilities arising from operating leases were $830,257 and $843,443, respectively. During the three months ended March 31, 2022, cash paid for amounts included for the measurement of lease liabilities was $55,975 and the Company recorded operating lease expense of $72,865.

 

 
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VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 8 – Commitments and Contingencies

 

b) Operating Lease Right-of-Use Obligations (continued)

 

The following is a schedule showing the future minimum lease payments under operating leases by years and the present value of the minimum payments as of March 31, 2022.

 

2022

 

$ 206,063

 

2023

 

$ 266,837

 

2024

 

$ 166,837

 

2025

 

$ 120,887

 

2026

 

$ 120,400

 

Total Operating Lease Obligations

 

$ 881,024

 

Less: Amount representing interest

 

$ (37,581 )

Present Value of minimum lease payments

 

$ 843,443

 

 

 

The Company’s office space leases are short-term and the Company has elected under the short-term recognition exemption not to recognize them on the balance sheet. During the three months ended March 31, 2022, the Company recognized $20,854 in short-term lease costs associated with office space leases. The annual payments remaining for short-term office leases were as follows:

 

2022

 

$ 23,037

 

Total Operating Lease Liabilities

 

$ 23,037

 

 

c) Grants Repayable

 

In 2010, the Company entered into an agreement with the Walloon Region government in Belgium for a colorectal cancer research grant for €1.05 million. Per the terms of the agreement, €314,406 of the grant is to be repaid, by installments over the period from June 30, 2014 to June 30, 2023. In the event that the Company receives revenue from products or services as defined in the agreement, it is due to pay a 6% royalty on such revenue to the Walloon Region. The maximum amount payable to the Walloon Region, in respect of the aggregate of the amount repayable of €314,406 and the 6% royalty on revenue, is equal to twice the amount of funding received. As of March 31, 2022, the grant balance repayable was $61,026.

 

In 2018, the Company entered into an agreement with the Walloon Region government in Belgium for a colorectal cancer research grant for €605,000. Per the terms of the agreement, €181,500 of the grant is to be repaid by installments over 12 years commencing in 2020. In the event that the Company receives revenue from products or services as defined in the agreement, it is due to pay a 3.53% royalty on such revenue to the Walloon Region. The maximum amount payable to the Walloon Region, in respect of the aggregate of the amount repayable of €181,500 and the 3.53% royalty on revenue, is equal to the amount of funding received. As of March 31, 2022, the grant balance repayable was $119,102.

 

In 2020, the Company entered into an agreement with the Walloon Region government in Belgium for a research grant for €929,433. Per the terms of the agreement, €278,830 of the grant is to be repaid by installments over 15 years commencing in 2022. In the event that the Company receives revenue from products or services as defined in the agreement, it is due to pay a 4.34% royalty on such revenue to the Walloon Region. The maximum amount payable to the Walloon Region, in respect of the aggregate of the amount repayable of €278,830 and the 4.34% royalty on revenue, is equal to the amount of funding received. As of March 31, 2022, the grant balance repayable was $51,530.

 

In 2020, the Company entered into an agreement with the Walloon Region government in Belgium for a research grant for €495,000. Per the terms of the agreement, €148,500 of the grant is to be repaid by installments over 10 years commencing in 2023. In the event that the Company receives revenue from products or services as defined in the agreement, it is due to pay a 2.89% royalty on such revenue to the Walloon Region. The maximum amount payable to the Walloon Region, in respect of the aggregate of the amount repayable of €148,500 and the 2.89% royalty on revenue, is equal to the amount of funding received. As of March 31, 2022, the grant balance repayable was $57,348.

 

 
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VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 8 – Commitments and Contingencies (continued)

 

c) Grants Repayable (continued)

 

As of March 31, 2022, the total grant balance repayable was $289,006 and the payments remaining were as follows:

 

2022

 

$ 43,195

 

2023

 

$ 41,537

 

2024

 

$ 18,026

 

2025

 

$ 19,842

 

2026

 

$ 26,081

 

Greater than 5 years

 

$ 140,325

 

Total Grants Repayable

 

$ 289,006

 

 

d) Long-Term Debt

 

In 2016, the Company entered into a 7-year loan agreement with Namur Invest for €440,000 with a fixed interest rate of 4.85%, maturing in December 2023. As of March 31, 2022, the principal balance payable was $146,891.

 

In 2016, the Company entered into a 15-year loan agreement with ING for €270,000 with a fixed interest rate of 2.62%, maturing in December 2031. As of March 31, 2022, the principal balance payable was $209,267.

 

In 2017, the Company entered into a 7-year loan agreement with SOFINEX for up to €1 million with a fixed interest rate of 4.50%, maturing in September 2024. As of March 31, 2022, €1 million had been drawn down under this agreement and the principal balance payable was $665,738.

 

In 2018, the Company entered into a 4-year loan agreement with Namur Innovation and Growth for €500,000 with a fixed interest rate of 4.0%, maturing in June 2022. As of March 31, 2022, the principal balance payable was $42,250.

 

In 2019, the Company entered into a 4-year loan agreement with Namur Innovation and Growth for €500,000 with a fixed interest rate of 4.80%, maturing in September 2024. As of March 31, 2022, the principal balance payable was $405,646.

 

On October 13, 2020, the Company entered into a 10-year loan agreement with Namur Invest for a maximum of €830,000 with fixed interest rate of 4.00%, maturing March 2031. As of March 31, 2022, the amount that has been drawn down under this agreement was €761,106, representing a principal balance payable of $844,496.

 

On November 23, 2021, the Company entered into a 3 ½ year loan agreement with SOFINEX for a maximum of €450,000 with fixed interest rate of 5.00%, maturing June 2025. As of March 31, 2022, the amount that has been drawn down under this agreement was €450,000, representing a principal balance payable of $499,304.

 

On February 5, 2022, the Company entered into a 9-month loan agreement with First Insurance Funding for a maximum of $620,549 with fixed interest rate of 3.57%, maturing November 2022. As of March 31, 2022, the amount that has been drawn down under this agreement was $620,549 and the principal balance payable was $551,599.

 

 
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VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 8 – Commitments and Contingencies (continued)

 

d) Long-Term Debt (continued)

 

As of March 31, 2022, the total balance for long-term debt payable was $3,365,191 and the payments remaining were as follows:

 

2022

 

$ 1,250,098

 

2023

 

$ 818,927

 

2024

 

$ 669,827

 

2025

 

$ 221,222

 

2026

 

$ 136,460

 

Greater than 5 years

 

$ 598,386

 

Total

 

$ 3,694,920

 

Less: Amount representing interest

 

$ (329,729 )

Total Long-Term Debt

 

$ 3,365,191

 

 

e) Collaborative Agreement Obligations

 

In 2016, the Company entered into a research co-operation agreement with DKFZ in Germany for a five-year period for €400,000. As of March 31, 2022, $221,913 is still to be paid by the Company under this agreement.

 

In 2018, the Company entered into a research collaboration agreement with the University of Taiwan for a three-year period for a cost to the Company of up to $2.55 million payable over such period. As of March 31, 2022, $510,000 is still to be paid by the Company under this agreement.

 

In 2019, the Company entered into a funded sponsored research agreement with the Texas A&M University (“TAMU”) in consideration for the license granted to the Company for a five-year period for a cost to the Company of up to $400,000 payable over such period. As of March 31, 2022, $18,994 is still to be paid by the Company under this agreement.

 

On September 16, 2020, the Company entered into a research agreement for the bioinformatic analysis of cell-free DNA fragments from whole-genome sequencing with the Hebrew University of Jerusalem for six months for a cost to the Company of €54,879. Subsequently the parties entered into an amendment to the agreement with an additional cost to the Company of €155,115. As of March 31, 2022, $16,771 is still to be paid by the Company under the amended agreement.

 

As of March 31, 2022, the total amount to be paid for future research and collaboration commitments was approximately $767,678 and the payments remaining were as follows:

 

2022 - remaining

 

$ 767,678

 

2022 - 2026

 

$ -

 

Total Collaborative Agreement Obligations

 

$ 767,678

 

 

 
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VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 8 – Commitments and Contingencies (continued)

 

f) Other Commitments

 

Volition Vet

 

On October 25, 2019, the Company entered into an agreement with TAMU for provision of in kind services of personnel, animal samples and laboratory equipment in exchange for a non-controlling interest of 7.5% in Volition Vet with an additional 5%, vesting in a year from the date of the agreement, giving TAMU in aggregate, a 12.5% equity interest as of such date. As of March 31, 2022, TAMU has a 12.5% equity interest in Volition Vet.

  

Volition Germany

 

On January 10, 2020, the Company, through its wholly-owned subsidiary Belgian Volition, acquired an epigenetic reagent company, Octamer GmbH (“Octamer”), based in Munich, Germany, and hired its founder for his expertise and knowledge to be passed to Company personnel. On March 9, 2020, Octamer was renamed to Volition Germany GmbH (or “Volition Germany”).

 

Upon considering the definition of a business, as defined in ASC 805 “Business Combinations,” paragraph 805-10-20, which is an integrated set of activities and assets that is capable of being conducted and managed for the purpose of providing a return, the Company has determined that this did not constitute a business. This is primarily due to the fact that additional inputs are needed in the form of training personnel further to produce outputs. Accordingly, the Company has treated this transaction as the hiring of a member of management, described below, rather than accounting for the transaction as a business combination.

 

The Company agreed to terms of the transaction on December 13, 2019 and closed on January 10, 2020. Pursuant to the transaction agreement, the Company purchased all outstanding shares of Octamer. In exchange, the Company agreed to issue 73,263 newly issued restricted shares of Company common stock valued at $333,969 (based on the $4.56 per share volume weighted trading price for the five days prior to December 13, 2019), committed to pay approximately €350,000, subject to adjustments, and agreed to pay off certain Octamer expenses leading up to the agreement (representing net liabilities of $6,535). At closing, the Company issued 73,263 restricted shares of Company common stock, paid an adjusted amount of approximately $357,000 (€321,736) and recorded a holdback liability of $55,404 (€50,000) to be paid after the holdback period of 9 months following the closing (subject to offset for breaches of representations and warranties). During the year ended December 31, 2021, an amount of €43,152 was paid in full settlement of the amount due. The Company has no further financial obligations under the transaction agreement.

 

In connection with the transaction agreement, the Company also entered into a two-year Managing Director’s agreement with the founder of Octamer to continue to manage Volition Germany for a payment of €288,000 payable in equal monthly installments over such two-year period and a royalty agreement with the founder providing for the payment of royalties in the amount of 6% of net sales of Volition Germany’s nucleosomes as reagents to pharmaceutical companies for use in the development, manufacture and screening of molecules for use as therapeutic drugs for a period of five years post-closing.

 

The Company recorded approximately $753,000 in compensation expense during the year 2020, as a result of cash paid, holdback liability, stock issued and assumption of expenses. As of March 31, 2022, $nil is still to be paid by the Company under the Managing Director’s agreement and $217 is payable under the 6% royalty agreement on sales to date (towards the Company’s aggregate minimum royalty obligation of $134,217).

 

 
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VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 8 – Commitments and Contingencies (continued)

 

f) Other Commitments (Continued)

 

Volition America

 

On November 3, 2020, the Company entered into a professional services master agreement with Diagnostic Oncology CRO, LLC to conduct a pivotal clinical trial and provide regulatory submission and reimbursement related services. Under the terms of the agreement Diagnostic Oncology CRO, LLC will provide ad hoc consulting assistance on a project-by-project basis related to the review and assessment of existing data and information to prepare recommended intended use claims and coverage/reimbursement plans to support the preparation of FDA pre-submissions, clinical trial protocol development and study administration, and potential 510k regulatory marketing submissions of the Company’s diagnostic tests, including those proposed for use as an adjunct diagnostic tool for common and aggressive forms of Non-Hodgkin’s Lymphoma. The initial projects contemplated by the agreement relating to Non-Hodgkin’s Lymphoma obligate the Company to pay in aggregate of up to $2.9 million over a period of 22 months. Such payment obligations are on a project-by-project basis as deliverables are executed and subject to certain terms and conditions. Additionally, the Company may terminate the agreement or any project with or without cause upon at least 30 days’ prior written notice. Unless earlier terminated, the term of the agreement is until December 31, 2025 or such later date as when all projects have been completed. As of March 31, 2022, $9,588 is payable by Company for services rendered under the agreement.

 

g) Legal Proceedings

 

There are no legal proceedings which the Company believes will have a material adverse effect on its financial position.

 

h) Commitments in Respect of Corporate Goals and Performance-Based Awards

 

In August 2021 and October 2021 the Compensation Committee of the Board of Directors approved the granting of equity-based awards under the 2015 Stock Incentive Plan as well as cash bonuses, vesting upon achievement of certain corporate goals focused around product development and commercialization, to various personnel including directors, executives, members of management, consultants and employees of the Company and/or its subsidiaries.

 

Conditional upon the achievement by July 1, 2022 of all specified corporate goals as set forth in the minutes of the Compensation Committee, as well as continued service by the award recipient, the Company at the sole discretion of the Chief Executive Officer and the Chief Financial Officer would pay a cash bonus to such award recipient. The Company estimates the total compensation expense based on current recipients to be $805,840. As of March 31, 2022, the Company has accrued compensation expense of $601,000 based on the probable outcomes related to the prescribed performance targets.

 

As discussed in detail in Note 8 - Stock-Based Compensation, of the notes to consolidated financial statements contained in the Annual Report on Form 10-K for the year ended December 31, 2021, an aggregate of 1,000,000 stock options and 500,000 restricted stock units were issued under the 2015 Stock Incentive Plan in connection with the August and October 2021 grants.

 

As of March 31, 2022, the Company has recognized compensation expense of $941,848 in relation to such stock options and $803,207 in relation to such restricted stock units, based on the probable outcomes related to the prescribed performance targets on the outstanding awards.

 

 
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VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 9 – Subsequent Events

 

RSU and Warrant Grants

 

Effective April 4, 2022, the Company granted RSUs of 32,000 shares of common stock to employees of the Company and/or its subsidiaries in exchange for services provided to the Company and/or its subsidiaries. The RSUs shall vest in two equal installments at 12 months and 24 months from the grant date, subject to continued service, and will result in total compensation expense of $94,400.

 

Effective April 4, 2022, the Company granted RSUs of 104,000 shares of common stock to employees of the Company and/or its subsidiaries in exchange for services provided to the Company and/or its subsidiaries. The RSUs shall vest in three equal installments at 12 months, 24 months and 36 months from the grant date, subject to continued service, and will result in total compensation expense of $306,800.

 

Effective April 4, 2022, the Company granted a warrant to purchase 54,000 shares of common stock to a Company employee for services to the Company and/or its subsidiaries. This warrant shall vest in two equal installments at 12 months and 24 months from the grant date, subject to continued service and expire on April 4, 2028 and April 4, 2029, respectively, with an exercise price of $3.05 per share. The Company has calculated the estimated fair market value of this warrant at $80,901, using the Black-Scholes model and the following assumptions: term 3.5 years, stock price $2.95, exercise price $3.05, 71.07% volatility, 2.53% risk-free rate, and no forfeiture rate.

 

Subsequent to March 31, 2022, 76,250 RSUs vested and resulted in the issuance of 56,712 shares of common stock (the remaining 19,538 shares of common stock were withheld for taxes and returned as authorized and unissued shares under the 2015 Stock Incentive Plan).

 

Equity Distribution Agreements

 

Termination of Equity Distribution Agreement

 

Effective May 7, 2022, the Company terminated its 2021 EDA and no further sales of the Company’s common stock will be made under the 2021 EDA. From April 1, 2022 to May 7, 2022, the Company made no additional sales under the 2021 EDA.

 

END NOTES TO FINANCIALS

 

 
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ITEM 2 MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

 

The following discussion and analysis of our financial condition and results of operations should be read together with our Unaudited Condensed Consolidated Financial Statements and the related notes included elsewhere in this Report and in our Annual Report. This discussion and analysis contains forward-looking statements that are based on our current expectations and reflect our plans, estimates and anticipated future financial performance. These statements involve numerous risks and uncertainties, including those related to the anticipated impact on our business from, and our response to, the COVID-19 pandemic. Our actual results may differ materially from those expressed or implied by these forward-looking statements as a result of many factors, including those set forth in the section entitled “Risk Factors” in this Report and in our Annual Report, as well as our other public filings with the SEC. Please refer to the section of this Report entitled “Cautionary Note Regarding Forward-Looking Statements” for additional information.

 

Overview

 

Volition is a multi-national epigenetics company that applies its Nucleosomics™ platform through its subsidiaries to develop simple, easy to use, cost-effective blood tests to help diagnose and monitor a range of life-altering diseases including certain cancers and diseases associated with NETosis such as sepsis and COVID-19. Our mission is to save lives and improve outcomes for millions of people and animals worldwide. Early diagnosis and monitoring have the potential to not only prolong the life of patients, but also to improve their quality of life.

 

Our blood tests are based on the science of Nucleosomics™, which is the practice of identifying and measuring nucleosomes in the bloodstream or other bodily fluid-an indication that disease is present. We are primarily focused on human diagnostics and monitoring but also have a subsidiary focused on animal diagnostics and monitoring.

 

We have five key pillars of focus, all of which use the same proprietary Nu.Q® platform to commercialize in different areas.

 

 

·

Nu.Q® Vet - cost-effective, easy-to-use cancer screening blood test for dogs and other animals

 

·

Nu.Q® NETs - monitoring the immune system to save lives

 

·

Nu.Q® - detecting cancer early to save lives

 

·

Nu.Q® Capture - capturing and concentrating samples for more accurate diagnosis

 

·

Nu.Q® Discover - a complete solution to profiling nucleosomes

 

Our research and development activities are centered in Belgium, with an innovation laboratory in California, and additional offices in Texas, London, and Singapore, where we focus on bringing our diagnostic and disease monitoring products to market.

 

Commercialization Strategy

 

We believe, given the global prevalence of cancer and diseases associated with NETosis, and the low-cost, accessible and routine nature of our tests, Nu.Q® could potentially be used throughout the world.

 

We have developed and are continuing to develop a large portfolio of intellectual property (“IP”), centered around the science of identifying and measuring nucleosomes in the bloodstream. We call this science Nucleosomics™. Our technologies have a large range of applications, both in humans and animals, to screen, diagnose, and risk stratify patients, as well as to monitor treatments, disease progression and potential remissions. While we initially focused on screening for cancer, we have broadened the range of indications our blood tests can detect to include several diseases associated with NETosis, including sepsis and COVID-19, which is estimated to be responsible for one in five deaths worldwide.

 

We aim to remain an IP powerhouse in the Nucleosomics™ space and expect to monetize our IP and technologies through licensing and distribution contracts with companies with established distribution networks on a worldwide or regional basis, in both human and animal care.

 

To this end, on March 28, 2022, Volition entered into a license and product supply agreement with Heska Corporation, a leading global provider of advanced veterinary diagnostics. In exchange for granting Heska Corporation exclusive worldwide rights to sell the Nu.Q® Vet Cancer Test at the point of care for companion animals, Volition received a $10 million upfront payment on signing and is eligible to receive up to an additional $18 million based upon the achievement of near and mid-term milestones. In addition, Volition has granted Heska non-exclusive rights to sell the Nu.Q® Vet Cancer Screening Test in kit format for companion animals, through Heska’s network of central reference laboratories.

 

 
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Following the roll-out of our Nu.Q® Vet canine cancer screening test and Nu.Q® Discover, the next series of products we anticipate launching are as follows:

 

 

·

a canine cancer monitoring test;

 

·

NETosis related screening and monitoring tests for use in sepsis and COVID-19;

 

·

cancer tests for humans in Non-Hodgkin’s Lymphoma, colorectal cancer and lung cancer.

 

Our Nucleosomics™ technology is transferable to multiple platforms including ELISA 96-well plates and, bead-based chemiluminescent and we are currently working on transferring our technology to the widely-utilized homogeneous immunoassay, or HIA, platform and several point of care platforms to enable rapid turnaround of results in–clinic and in the doctor’s office.

 

Additionally, we are working on complete nucleosome analysis with our Nu.Q® Capture technology. The goal of this project is to investigate ways to specifically target circulating tumor DNA (“ctDNA”). The ability to enrich ctDNA will allow us to use mass spectrometry to analyze histone and DNA modifications, and to sequence DNA present around nucleosomes. This information could enable cancer diagnosis to identify the tissue of origin of a particular cancer.

 

Developments - COVID-19 Pandemic

 

Since the beginning of the COVID-19 pandemic in March 2020, we have implemented contingency planning to protect the health and well-being of our employees and to mitigate the impacts of the pandemic on our business. We have implemented travel restrictions as well as protocols limiting visitor access to our facilities, and we are following social distancing practices. As a result of the COVID-19 pandemic, we have experienced and may continue to experience disruptions that could impact our clinical trials, including:

 

 

·

delays in enrolling patients in clinical trials;

 

·

delays in sample collection; and

 

·

diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as clinical trial sites and hospital staff supporting the conduct of our clinical trials.

 

The extent to which the COVID-19 pandemic will impact our business, financial condition, and results of operations in the future remains uncertain and will be affected by a number of factors outside of our control, including the duration and extent of the pandemic, the development of new variants of the COVID-19 virus that may be more contagious or virulent than previous versions, the scope of mandated or recommended containment and mitigation measures, the effect of government stabilization and recovery efforts, and the success of vaccine distribution programs.

 

Liquidity and Capital Resources

 

We have financed our operations since inception primarily through private placements and public offerings of our common stock. As of March 31, 2022, we had cash and cash equivalents of approximately $23.7 million.

 

Net cash provided by operating activities was $3.0 million for the three months ended March 31, 2022 and net cash used in operating activities was $6.2 million for the three months ended March 31, 2021, respectively. The increase in cash provided from operating activities for the period ended March 31, 2022 when compared to same period in 2021 was primarily due to a $10.0 million payment received pursuant to our license and product supply agreement with Heska Corporation, partly offset by higher payroll costs, and higher amounts paid to suppliers during the period.

 

Net cash used in investing activities was $0.1 million and $0.5 million for the three months ended March 31, 2022 and March 31, 2021, respectively. The decrease was primarily due to a decrease in purchases of laboratory equipment.

 

Net cash provided by financing activities was $0.4 million for the three months ended March 31, 2022 and net cash provided by financing activities was $20.2 million for the comparable period ended March 31, 2021. The decrease in cash provided by financing activities for the period ended March 31, 2022 when compared to same period in 2021 was primarily due to $18.9 million in net cash received from the issuance of shares of common stock in a registered public offering in February 2021 and $1.5 million in net cash received from the issuance of shares of common stock under our ATM facility during the period ended March 31, 2021.

 

 
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The following table summarizes our approximate contractual payments due by year as of March 31, 2022.

 

Approximate Payments (Including Interest) Due by Year

 

 

 

 

 

 

 

 

 

 

 

Total

 

 

2022 (Remaining)

 

 

2023 - 2026

 

 

2027 +

 

Description

 

$

 

 

 $

 

 

$

 

 

 $

 

Finance Lease Obligations

 

 

604,242

 

 

 

44,760

 

 

 

238,718

 

 

 

320,764

 

Operating Lease Obligations

 

 

904,061

 

 

 

229,100

 

 

 

674,961

 

 

 

-

 

Grants Repayable

 

 

289,006

 

 

 

43,195

 

 

 

105,486

 

 

 

140,325

 

Long-Term Debt

 

 

3,694,920

 

 

 

1,250,098

 

 

 

1,846,436

 

 

 

598,386

 

Collaborative Agreements Obligations

 

 

767,678

 

 

 

767,678

 

 

 

-

 

 

 

-

 

Total

 

 

6,259,907

 

 

 

2,334,831

 

 

 

2,865,601

 

 

 

1,059,475

 

 

We intend to use our cash reserves to fund further research and development activities and launch new products. We do not currently have sufficient revenues to cover our annual expenses and expect to rely on financing our operations in future periods, mainly through the sale of equity or debt securities, and licensing rights, to provide sufficient funding to execute our strategic plan. However, there can be no assurance that we will be successful in raising additional funds, or that we will be able to do so on terms that are satisfactory to us.

 

In the event that additional financing is delayed, we will prioritize the maintenance of our research and development personnel and facilities, primarily in Belgium, and the maintenance of our patent rights. In such instance, the completion of clinical validation studies and regulatory approval processes for the purpose of bringing products to the in vitro diagnostics markets would be delayed. In the event of an ongoing lack of financing, it may be necessary to discontinue operations, which will adversely affect the value of our common stock.

 

We have not attained profitable operations on an ongoing basis and are dependent upon obtaining financing to pursue any extensive activities. For these reasons, our auditors stated in their report on our audited financial statements for the fiscal year ended December 31, 2021 an explanatory paragraph regarding factors that raise substantial doubt that we will be able to continue as a going concern.

 

 
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Results of Operations

 

Comparison of the Three-Months Ended March 31, 2022 and March 31, 2021.

 

The following table sets forth our results of operations for the three months ended on March 31, 2022 and March 31, 2021, respectively.

 

 

 

Three Months Ended March 31,

 

 

Increase

 

 

Increase

 

 

 

2022

 

 

2021

 

 

(Decrease)

 

 

(Decrease)

 

 

 

$

 

 

$

 

 

$

 

 

%

 

Services

 

 

60,254

 

 

 

-

 

 

 

60,254

 

 

>100 %

Product

 

 

53,957

 

 

 

25,530

 

 

 

28,427

 

 

>100 %

Total Revenues

 

 

114,211

 

 

 

25,530

 

 

 

88,681

 

 

>100 %

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

3,590,053

 

 

 

3,873,079

 

 

 

(283,026 )

 

(7

%)

General and administrative

 

 

2,602,152

 

 

 

1,810,160

 

 

 

791,992

 

 

 

44 %

Sales and marketing

 

 

1,598,983

 

 

 

427,401

 

 

 

1,171,582

 

 

>100 %

Total Operating Expenses

 

 

7,791,188

 

 

 

6,110,640

 

 

 

1,680,548

 

 

 

28 %

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

2

 

 

 

1,721

 

 

 

(1,719 )

 

(100

%)

Interest expense

 

 

(41,032 )

 

 

(42,181 )

 

 

1,149

 

 

(3

%)

Total Other Income / (Expenses)

 

 

(41,030 )

 

 

(40,460 )

 

 

(570 )

 

 

1 %

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Loss

 

 

(7,718,007 )

 

 

(6,125,570 )

 

 

1,592,437

 

 

 

26 %

 

Revenues

 

Our operations are transitioning from a research and development focused stage to a commercialization stage. Revenues during the three-months ended March 31, 2022 were $114,211, compared with $25,530 for the three-months ended March 31, 2021. The main source of revenue during the three months ended March 31, 2022 was services revenues from our Nu.Q® Discover offering and product revenues from sales of the Nu.Q® Vet Cancer Screening Test and H3.1 kits. The primary source of revenue during the three-months ended March 31, 2021 was direct sales of the Nu.Q® Vet Cancer Screening Test via the Gastrointestinal Laboratory at Texas A&M University.

 

Operating Expenses

 

Total operating expenses increased to $7.8 million for the three months ended March 31, 2022 from $6.1 million for the three months ended March 31, 2021, as a result of the factors described below.

 

 
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Research and Development Expenses

 

Research and development expenses declined to $3.6 million from $3.9 million and for the three-months ended March 31, 2022 and March 31, 2021, respectively. This decline was primarily related to lower direct and other research and development expenses, partly offset by higher personnel expenses and stock-based compensation. The number of full-time equivalent (“FTE”) personnel we employed in this division increased by 10 to 55 compared to the prior year period.

 

 

 

Three Months Ended March 31,

 

 

 

 

 

2022

 

 

2021

 

 

Change

 

 

 

$

 

 

$

 

 

$

 

Personnel expenses

 

 

1,775,719

 

 

 

1,492,444

 

 

 

283,275

 

Stock-based compensation

 

 

191,167

 

 

 

90,127

 

 

 

101,040

 

Direct research and development expenses

 

 

1,331,283

 

 

 

1,642,619

 

 

 

(311,336 )

Other research and development

 

 

145,333

 

 

 

402,017

 

 

 

(256,684 )

Depreciation and amortization

 

 

146,551

 

 

 

245,872

 

 

 

(99,321 )

Total research and development expenses

 

 

3,590,053

 

 

 

3,873,079

 

 

 

(283,026 )

 

General and Administrative Expenses

 

General and administrative expenses increased to $2.6 million from $1.8 million for the three-months ended March 31, 2022 and March 31, 2021, respectively. This increase was primarily due to higher personnel expenses and stock-based compensation during the period. The FTE personnel number within this division increased by 5 to 19 compared to the prior year period.

 

 

 

Three Months Ended March 31,

 

 

 

 

 

2022

 

 

2021

 

 

Change

 

 

 

$

 

 

 $

 

 

$

 

Personnel expenses

 

 

1,173,180

 

 

 

617,071

 

 

 

556,109

 

Stock-based compensation

 

 

444,801

 

 

 

333,866

 

 

 

110,935

 

Legal and professional fees

 

 

505,853

 

 

 

560,778

 

 

 

(54,925 )

Other general and administrative

 

 

347,384

 

 

 

266,927

 

 

 

80,457

 

Depreciation and amortization

 

 

130,934

 

 

 

31,518

 

 

 

99,416

 

Total general and administrative expenses

 

 

2,602,152

 

 

 

1,810,160

 

 

 

791,992

 

 

Sales and Marketing Expenses

 

Sales and marketing expenses increased to $1.6 million from $0.4 million for the three-months ended March 31, 2022 and March 31, 2021, respectively. This increase was primarily due to higher personnel expenses, stock-based compensation and direct marketing and professional fees during the period. The FTE personnel number within this division increased by 11 to 18 compared to the prior year period.

 

 

 

Three Months Ended March 31,

 

 

 

 

 

2022

 

 

2021

 

 

Change

 

 

 

 $

 

 

 $

 

 

$

 

Personnel expenses

 

 

1,017,091

 

 

 

184,137

 

 

 

832,954

 

Stock-based compensation

 

 

279,063

 

 

 

131,349

 

 

 

147,714

 

Direct marketing and professional fees

 

 

290,643

 

 

 

111,915

 

 

 

178,728

 

Depreciation and amortization

 

 

12,186

 

 

 

-

 

 

 

12,186

 

Total sales and marketing expenses

 

 

1,598,983

 

 

 

427,401

 

 

 

1,171,582

 

 

 
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Other Income (Expenses)

 

For the three-months ended March 31, 2022, the Company’s other expenses were $41,030 compared to other expenses of $40,460 for the three-months ended March 31, 2021. This increase in other expenses was primarily related to the decrease in interest earned during the period.

 

Net Loss

 

For the three-months ended March 31, 2022, the Company’s net loss was $7.7 million, an increase of approximately $1.6 million in comparison to a net loss of $6.1 million for the three-months ended March 31, 2021. The change was a result of the factors described above.

 

Going Concern

 

We have not attained profitable operations on an ongoing basis and are dependent upon obtaining external financing to continue to pursue our operational and strategic plans. For these reasons, management has determined that there is substantial doubt that the business will be able to continue as a going concern without further financing.

 

Off-Balance Sheet Arrangements

 

We have no significant off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to stockholders.

 

Future Financings

 

We may seek to obtain additional capital through the sale of debt or equity securities if we deem it desirable or necessary. These sales may include the sale of equity securities from time to time through an “at the market offering program” under an Equity Distribution Agreement. However, we may be unable to obtain such additional capital when needed, or on terms favorable to us or our stockholders, if at all. If we raise additional funds by issuing equity securities, the percentage ownership of our stockholders will be reduced, stockholders may experience additional dilution, or such equity securities may provide for rights, preferences or privileges senior to those of the holders of our common stock. If additional funds are raised through the issuance of debt securities, the terms of such securities may place restrictions on our ability to operate our business.

 

Critical Accounting Policies and Estimates

 

Our interim condensed consolidated financial statements and accompanying notes have been prepared in accordance with United States generally accepted accounting principles, or U.S. GAAP, applied on a consistent basis. The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods.

 

We regularly evaluate the accounting policies and estimates that we use to prepare our financial statements. A summary of these policies is included in the notes to our financial statements. In general, management’s estimates are based on current facts, historical experiences, information from third party professionals and various other factors that it believes to be reasonable under the circumstances. Actual results could differ materially and adversely from those estimates made by management. To the extent there are material differences between the estimates and the actual results, future results of operations could be affected.

 

Recently Issued Accounting Pronouncements

 

The Company has implemented all applicable new accounting pronouncements that are in effect. The Company does not believe that there are any other applicable new accounting pronouncements that have been issued that might have a material impact on its financial position or results of operations.

 

 
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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

We are a smaller reporting company and are not required to disclose this information.

 

ITEM 4. CONTROLS AND PROCEDURES

 

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, 2021, that our disclosure controls and procedures were not effective as of March 31, 2022, because of material weaknesses in our internal control over financial reporting, as referenced below and described in detail in our Annual Report.

 

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.

 

In our Annual Report, the deficiencies identified involved the segregation of duties in some areas of finance.

 

We have already taken steps towards remediating such deficiencies including:

 

 

·

hired an additional full-time Business Controller in Belgium with an appropriate level of experience;

 

·

hired an experienced financial planning and analysis manager to implement forecasting and budgeting processes;

 

·

changed organizational reporting lines and reallocated certain responsibilities to improve segregation of duties; and

 

·

implemented additional review procedures at each month end close.

 

We intend to take additional measures around certain processes we have identified which we believe once implemented in conjunction with the completed actions above will mitigate and remedy this weakness.

 

We also intend to take additional steps to further strengthen the control environment. Such measures include but may not be limited to:

 

 

·

recruitment of a specialist in Human Resources to recommend and implement relevant policies and processes that will strengthen the control environment;

 

·

further strengthening our internal processes and reviews, including formal documentation thereof;

 

·

preparation of risk-control matrices to identify key risks and develop and document policies to mitigate those risks; and

 

·

engaging additional resources if necessary to help us assess, document, design and implement control activities related to internal control over financial reporting.

 

As we continue to evaluate and test the remediation plan outlined above, we may also identify additional measures to address the material weaknesses or modify certain of the remediation procedures described above. We also may implement additional changes to our internal control over financial reporting as may be appropriate in the course of remediating the material weakness. Management, with the oversight of our audit committee, will continue to take steps necessary to remedy the material weakness to reinforce the overall design and capability of our control environment.

 

 
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Changes in Internal Control over Financial Reporting

 

Except for the ongoing remediation of the material weaknesses in internal controls over financial reporting noted above, no changes in our internal control over financial reporting were made during the fiscal quarter ended March 31, 2022, 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.

 

 
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PART II OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS

 

In the ordinary course of business, we may be subject to claims, counter claims, lawsuits and other litigation of the type that generally arise from the conduct of our business. We know of no material, existing or pending legal proceedings against our company, nor are we involved as a plaintiff in any material proceeding or pending litigation. There are no proceedings in which our directors, officers or any affiliates, or any registered or beneficial stockholders, is an adverse party or has a material interest adverse to our interest.

 

ITEM 1A. RISK FACTORS

 

There have been no material changes in our assessment of risk factors affecting our business since those presented in Part I, Item 1A of our Annual Report.

 

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

Recent Sales of Unregistered Securities

 

None.

 

Repurchase of Equity Securities

 

No equity securities were repurchased during the first quarter of 2022.

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

 

None.

 

ITEM 4. MINE SAFETY DISCLOSURES

 

Not applicable.

 

ITEM 5. OTHER INFORMATION

 

Termination of Equity Distribution Agreement

 

Effective May 7, 2022, the Company terminated its Equity Distribution Agreement dated September 24, 2021 with Cantor Fitzgerald & Co. and Oppenheimer & Co. Inc. (the “2021 EDA”) and no further sales of the Company’s common stock will be made under the 2021 EDA. From inception through May 7, 2022, the Company raised aggregate net proceeds (net of brokers’ commissions and fees) of approximately $0.7 million under the 2021 EDA through the sale of 193,600 shares of its common stock.

 

 
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ITEM 6. EXHIBITS

 

 

 

 

Incorporated by Reference

Exhibit

Number

 

Exhibit Description

 

Form

 

File No.

 

Exhibit

 

Filing

Date

 

Filed

Herewith

10.1†

 

License and Supply Agreement between Belgian Volition and Heska Corporation, dated March 28, 2022.

 

 

 

 

 

 

 

 

 

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.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

101.INS

 

XBRL Instance Document.

 

 

 

 

 

 

 

 

 

X

101.SCH

 

XBRL Taxonomy Extension Schema Document.

 

 

 

 

 

 

 

 

 

X

101.CAL

 

XBRL Taxonomy Extension Calculation Linkbase Document.

 

 

 

 

 

 

 

 

 

X

101.LAB

 

XBRL Taxonomy Extension Label Linkbase Document.

 

 

 

 

 

 

 

 

 

X

101.PRE

 

XBRL Taxonomy Extension Presentation Linkbase Document.

 

 

 

 

 

 

 

 

 

X

101.DEF

 

XBRL Taxonomy Extension Definition Linkbase Document.

 

 

 

 

 

 

 

 

 

X

104

 

Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

 

 

 

 

 

 

 

 

 

X

 

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 Quarterly 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.

 

 
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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

VOLITIONRX LIMITED

       

Dated: May 11, 2022

By:

/s/ Cameron Reynolds

 

 

Cameron Reynolds  
    President and Chief Executive Officer  
    (Authorized Signatory and Principal Executive Officer)  

 

       

Dated: May 11, 2022

By: /s/ Terig Hughes

 

 

Terig Hughes  
    Chief Financial Officer and Treasurer  
   

(Authorized Signatory and Principal Financial

and Accounting Officer)

 

 

 
37