UNITED STATES

SECURITIESUNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington,Washington, D.C. 20549

 

FORMFORM 10-Q

 

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

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

  

For the quarterly periodended SeptemberJune 30, 20202021

 

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

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

For the transition period from ______ to _____

   

For the transition period from ______ to _____

Commission File Number: 001-36833

VOLITIONRX LIMITED

(Exact name of registrant as specified in its charter)

 

DelawareVOLITIONRX LIMITED

(Exact name of registrant as specified in its charter)

Delaware

91-1949078

(State or other jurisdiction of incorporation

or organization)

 

91-1949078

(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) 650–1351650-1351

(Registrant’sRegistrant'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 whichWhich

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. [X] 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). [X] 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"large accelerated filer,” “accelerated" "accelerated filer,” “smaller" "smaller reporting company," and “emerging"emerging growth company”company" in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

[   ]

Accelerated filer

[  ]

Non-accelerated filer

[X] 

 

Smaller reporting company

[X]

 

 

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     [X] No

 

As of November 4, 2020,August 5, 2021, there were 48,197,68753,145,239 shares of the registrant’sregistrant's $0.001 par value common stock issued and outstanding.




VOLITIONRX LIMITED

QUARTERLY REPORTVOLITIONRX LIMITED

QUARTERLYREPORT ON FORM 10-Q

FOR THE THREE AND NINESIX MONTHS ENDED SEPTEMBERJUNE 30, 20202021

 

TABLETABLE OF CONTENTS

 

PART I

FINANCIAL INFORMATION

 

FINANCIAL INFORMATIONPAGE

 

 

PAGE

Item 1.

FINANCIAL STATEMENTS (UNAUDITED)

 

 

3Item 1.

FINANCIAL STATEMENTS (UNAUDITED)

4

Item 2.

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

 

26

 

24

Item 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

34

Item 4.

CONTROLS AND PROCEDURES

34

 

 

31

Item 4.

CONTROLS AND PROCEDURES

 

 

31

PART II

OTHER INFORMATION

 

OTHER INFORMATION

 

 

 

Item 1.

 

LEGAL PROCEEDINGS

 

 

33

Item 1A.1.

RISK FACTORSLEGAL PROCEEDINGS

 

35

33

Item 2.1A.

RISK FACTORS

 

35

Item 2.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

35

33

Item 3.

DEFAULTS UPON SENIOR SECURITIES

 

35

33

Item 4.

MINE SAFETY DISCLOSURES

 

35

33

Item 5.

OTHER INFORMATION

 

35

33

Item 6.

EXHIBITS

 

36

35

 

SIGNATURES

 

 

 

36

SIGNATURES

37

 

UseUse of Terms

 

Except as otherwise indicated by the context, references in this Quarterly Report on Form 10-Q to “Company,” “VolitionRx,” “Volition,” “we,” “us,”the "Company," "VolitionRx," "Volition," "we," "us," and “our”"our" are references to VolitionRx Limited and its wholly-owned subsidiaries, Singapore Volition Pte. Limited, Belgian Volition SPRL,SRL, Volition Diagnostics UK Limited, Volition America, Inc., Volition Germany GmbH, as well asand 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.QTM® 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 in this Reportherein are the property of their respective owners.




PART

2

Table of Contents

CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS

This Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2021, 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, any 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. For instance, if we fail to develop and commercialize diagnostic products, we may be unable to execute our plan of operations. Other risks and uncertainties include those associated with:

·

the COVID-19 pandemic;

·

our failure to obtain necessary regulatory clearances or approvals to distribute and market future products in the veterinary or clinical in-vitro diagnostics, or IVD, market;

·

a failure by the marketplace to accept the products in our development pipeline or any other diagnostic products we might develop;

·

our failure to secure adequate intellectual property protection;

·

the potential obsolescence of our intended products due to the highly competitive nature of the diagnostics market and its rapid technological change; 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, 2020, as filed with the SEC on March 22, 2021, 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

4

5

Condensed Consolidated Statements of Operations and Comprehensive Loss

5

6

Condensed Consolidated Statements of Stockholders’ Equity

6

 7

Condensed Consolidated Statements of Cash Flows

8

9

Notes to the Condensed Consolidated Financial Statements

9

 

10

4

Table of Contents



VOLITIONRX LIMITED

VOLITIONRX LIMITED

Condensed Consolidated Balance Sheets

(Expressed in United States Dollars, except share numbers)

 

 

June 30,

 

 

December 31,

 

 

 

2021

 

 

2020

 

 

 

 

 

 $

 

ASSETS

 

(UNAUDITED)

 

 

 

 

 

 

 

 

 

 

Current Assets

 

 

 

 

 

 

Cash and cash equivalents

 

 

27,913,169

 

 

 

19,444,737

 

Accounts receivable

 

 

15,832

 

 

 

7,118

 

Prepaid expenses

 

 

935,498

 

 

 

303,178

 

Other current assets

 

 

527,827

 

 

 

576,660

 

Total Current Assets

 

 

29,392,326

 

 

 

20,331,693

 

 

 

 

 

 

 

 

 

 

Property and equipment, net

 

 

5,266,646

 

 

 

5,171,134

 

Operating lease right-of-use assets

 

 

318,393

 

 

 

326,085

 

Intangible assets, net

 

 

266,586

 

 

 

321,641

 

Total Assets

 

 

35,243,951

 

 

 

26,150,553

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS' EQUITY

 

 

 

 

 

 

 

 

 

 

 

Current Liabilities

 

 

 

 

 

 

 

 

Accounts payable

 

 

1,083,214

 

 

 

1,539,547

 

Accrued liabilities

 

 

3,152,019

 

 

 

3,491,740

 

Management and directors' fees payable

 

 

91,695

 

 

 

55,174

 

Current portion of long-term debt

 

 

822,369

 

 

 

841,319

 

Current portion of finance lease liabilities

 

 

55,335

 

 

 

59,930

 

Current portion of operating lease liabilities

 

 

157,911

 

 

 

179,624

 

Current portion of grant repayable

 

 

35,554

 

 

 

69,218

 

Total Current Liabilities

 

 

5,398,097

 

 

 

6,236,552

 

 

 

 

 

 

 

 

 

 

Long-term debt, net of current portion

 

 

2,219,748

 

 

 

2,606,885

 

Finance lease liabilities, net of current portion

 

 

557,338

 

 

 

601,967

 

Operating lease liabilities, net of current portion

 

 

166,085

 

 

 

151,828

 

Grant repayable, net of current portion

 

 

273,138

 

 

 

259,603

 

Total Liabilities

 

 

8,614,406

 

 

 

9,856,835

 

 

 

 

 

 

 

 

 

 

STOCKHOLDERS' EQUITY

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common Stock

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

Issued and outstanding: 53,144,082 shares and 48,607,017 shares, respectively

 

 

53,144

 

 

 

48,607

 

Additional paid-in capital

 

 

148,468,001

 

 

 

126,526,239

 

Accumulated other comprehensive income (loss)

 

 

29,607

 

 

 

(59,978)

Accumulated deficit

 

 

(121,817,065)

 

 

(110,173,971)

Total VolitionRx Limited Stockholders' Equity

 

 

26,733,687

 

 

 

16,340,897

 

Non-controlling interest

 

 

(104,142)

 

 

(47,179)

Total Stockholders' Equity

 

 

26,629,545

 

 

 

16,293,718

 

 

 

 

 

 

 

 

 

 

Total Liabilities and Stockholders' Equity

 

 

35,243,951

 

 

 

26,150,553

 

(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)

 

September 30,

 

December 31,

 

2020

 

2019

 

$

 

$

ASSETS

(UNAUDITED)

 

 

Current Assets

 

 

 

Cash and cash equivalents

20,927,729

 

16,966,168

Accounts receivable

573

 

-

Prepaid expenses

444,872

 

267,518

Other current assets

791,349

 

322,593

Total Current Assets

22,164,523

 

17,556,279

 

 

 

 

Property and equipment, net

3,343,297

 

2,981,225

Operating lease right-of-use assets

257,903

 

381,483

Intangible assets, net

321,848

 

372,305

Total Assets

26,087,571

 

21,291,292

 

 

 

 

LIABILITIES AND STOCKHOLDERS' EQUITY

 

 

 

 

 

Current Liabilities

 

 

 

Accounts payable

849,146

 

627,253

Accrued liabilities

2,403,102

 

2,168,588

Management and directors’ fees payable

47,675

 

21,979

Current portion of long-term debt

765,151

 

647,569

Current portion of finance lease liabilities

57,047

 

97,946

Current portion of operating lease liabilities

157,796

 

257,244

Current portion of grant repayable

37,992

 

39,295

Total Current Liabilities

4,317,909

 

3,859,874

 

 

 

 

Long-term debt, net of current portion

1,831,021

 

2,195,278

Finance lease liabilities, net of current portion

591,658

 

607,708

Operating lease liabilities, net of current portion

108,305

 

131,875

Grant repayable, net of current portion

277,267

 

297,991

Total Liabilities

7,126,160

 

7,092,726

 

 

 

 

STOCKHOLDERS’ EQUITY

 

 

 

Common Stock

 

 

 

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

 

 

 

Issued and outstanding: 48,064,575 shares and 41,125,303 shares, respectively

48,065

 

41,125

Additional paid-in capital

124,121,703

 

103,853,627

Accumulated other comprehensive income

(148,121)

 

125,670

Accumulated deficit

(105,036,840)

 

(89,821,856)

Total VolitionRx Limited Stockholders' Equity

18,984,807

 

14,198,566

  Non-controlling interest

(23,396)

 

-

Total Stockholders’ Equity

18,961,411

 

14,198,566

 

 

 

 

Total Liabilities and Stockholders’ Equity

26,087,571

 

21,291,292

 

 

 

 

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




 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

 

 

$

 

 

$

 

 

$

 

 

$

 

Revenues

 

 

 

 

 

 

 

 

 

 

 

 

Royalty

 

 

0

 

 

 

1,872

 

 

 

0

 

 

 

2,112

 

Product

 

 

24,782

 

 

 

3,322

 

 

 

50,312

 

 

 

3,626

 

Total Revenues

 

 

24,782

 

 

 

5,194

 

 

 

50,312

 

 

 

5,738

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating Expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

3,649,469

 

 

 

3,492,845

 

 

 

7,522,547

 

 

 

7,387,811

 

General and administrative

 

 

1,816,599

 

 

 

1,508,836

 

 

 

3,626,759

 

 

 

3,212,358

 

Sales and marketing

 

 

459,371

 

 

 

215,891

 

 

 

886,772

 

 

 

489,845

 

Total Operating Expenses

 

 

5,925,439

 

 

 

5,217,572

 

 

 

12,036,078

 

 

 

11,090,014

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating Loss

 

 

(5,900,657)

 

 

(5,212,378)

 

 

(11,985,766)

 

 

(11,084,276)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other Income (Expenses)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Grant income

 

 

391,532

 

 

 

90,946

 

 

 

391,532

 

 

 

98,870

 

(Loss) / Gain on disposal of fixed assets

 

 

(26,166)

 

 

93,202

 

 

 

(26,167)

 

 

93,202

 

Interest income

 

 

492

 

 

 

7,741

 

 

 

2,213

 

 

 

46,155

 

Interest expense

 

 

(39,688)

 

 

(22,604)

 

 

(81,869)

 

 

(56,383)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Other Income (Expenses)

 

 

326,170

 

 

 

169,285

 

 

 

285,709

 

 

 

181,844

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Loss

 

 

(5,574,487)

 

 

(5,043,093)

 

 

(11,700,057)

 

 

(10,902,432)

Net Loss attributable to Non-Controlling Interest

 

 

47,539

 

 

 

5,779

 

 

 

56,963

 

 

 

15,346

 

Net Loss attributable to VolitionRx Limited Stockholders

 

 

(5,526,948)

 

 

(5,037,314)

 

 

(11,643,094)

 

 

(10,887,086)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other Comprehensive Income (Loss)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustments

 

 

(44,548)

 

 

(74,320)

 

 

89,585

 

 

 

299,606

 

Net Comprehensive Loss

 

 

(5,619,035)

 

 

(5,117,413)

 

 

(11,610,472)

 

 

(10,602,826)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Loss Per Share - Basic and Diluted attributable to VolitionRx Limited

 

 

(0.10)

 

 

(0.12)

 

 

(0.22)

 

 

(0.26)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted Average Shares Outstanding

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

- Basic and Diluted

 

 

52,947,173

 

 

 

43,414,318

 

 

 

51,943,534

 

 

 

42,312,172

 

VOLITIONRX

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

6

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

September 30,

 

Nine Months ended

September 30,

2020

 

2019

 

2020

 

2019

$

 

$

 

$

 

$

 

 

 

 

 

 

 

 

Revenues

 

 

 

 

 

 

 

Services

-

 

16,204

 

-

 

16,204

Royalty

-

 

892

 

2,112

 

892

Product

575

 

-

 

4,201

 

-

Total Revenues

575

 

17,096

 

6,313

 

17,096

 

 

 

 

 

 

 

 

Operating Expenses

 

 

 

 

 

 

 

Research and development

3,180,177

 

2,642,610

 

10,567,988

 

7,596,097

General and administrative

1,080,308

 

1,354,992

 

4,292,666

 

4,020,893

Sales and marketing

244,510

 

195,641

 

734,355

 

718,047

Total Operating Expenses

4,504,995

 

4,193,243

 

15,595,009

 

12,335,037

 

Operating Loss

(4,504,420)

 

(4,176,147)

 

(15,588,696)

 

(12,317,941)

 

 

 

 

 

 

 

 

Other Income (Expenses)

 

 

 

 

 

 

 

   Grant income

-

 

-

 

98,870

 

-

   Gain on disposal of fixed assets

200,393

 

-

 

293,595

 

-

   Interest income

2,801

 

27,633

 

48,956

 

68,656

   Interest expense

(34,722)

 

(32,291)

 

(91,105)

 

(95,507)

   Other expenses

-

 

-

 

-

 

(196,957)

 

 

 

 

 

 

 

 

Total Other Income (Expenses)

168,472

 

(4,658)

 

350,316

 

(223,808)

 

 

 

 

 

 

 

 

Provision for Income Taxes

-

 

-

 

-

 

-

 

Net Loss

(4,335,948)

 

(4,180,805)

 

(15,238,380)

 

(12,541,749)

Net Loss attributable to Non-Controlling Interest

8,050

 

-

 

23,396

 

-

Net Loss attributable to VolitionRx Limited Stockholders

(4,327,898)

 

(4,180,805)

 

(15,214,984)

 

(12,541,749)

 

 

 

 

 

 

 

 

Other Comprehensive Income (Loss)

 

 

 

 

 

 

 

Foreign currency translation adjustments

(573,397)

 

401,309

 

(273,791)

 

427,168

 

Net Comprehensive Loss

(4,909,345)

 

(3,779,496)

 

(15,512,171)

 

(12,114,581)

 

 

 

 

 

 

 

 

Net Loss Per Share – Basic and Diluted attributable to VolitionRx Limited

(0.09)

 

(0.10)

 

(0.34)

 

(0.33)

 

 

 

 

 

 

 

 

Weighted Average Shares Outstanding

 

 

 

 

 

 

 

– Basic and Diluted

47,027,011

 

39,880,246

 

44,148,793

 

38,538,394

 

 

 

 

 

 

 

 

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




VOLITIONRX LIMITED

Condensed Consolidated Statements of Stockholders’Stockholders' Equity (Unaudited)

(Expressed in United States Dollars, except share numbers)

 

For the Three and Nine Months ended September 30, 2020 and September 30, 2019

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

Additional

Other

 

Non

 

 

Common Stock

Paid-in

Comprehensive

Accumulated

Controlling

 

 

Shares

Amount

Capital

Income (Loss)

Deficit

Interest

Total

#

$

$

$

$

$

$

Balance, December 31, 2019

41,125,303

41,125

103,853,627

125,670

(89,821,856)

-

14,198,566

 

 

 

 

 

 

 

 

Common stock issued for Director compensation in Volition Germany

73,263

73

333,896

-

-

-

333,969

Common stock issued in exercise of stock options

19,430

20

(20)

-

-

-

-

Common stock repurchase and retirement

(11,364)

(11)

(54,423)

-

-

-

(54,434)

Stock-based compensation

-

-

192,669

-

-

-

192,669

Foreign currency translation

-

-

-

373,926

-

-

373,926

Net loss for the period

-

-

-

-

(5,849,772)

(9,567)

(5,859,339)

Balance, March 31, 2020

41,206,632

41,207

104,325,749

499,596

(95,671,628)

(9,567)

9,185,357

Common stock issued in public offering, net

5,452,922

5,453

14,229,160

-

-

-

14,234,613

Stock-based compensation

-

-

360,640

-

-

-

360,640

Foreign currency translation

-

-

-

(74,320)

-

-

(74,320)

Net loss for the period

-

-

-

-

(5,037,314)

(5,779)

(5,043,093)

Balance, June 30, 2020

46,659,554

46,660

118,915,549

425,276

(100,708,942)

(15,346)

18,663,197

Common stock issued in public offering, net

1,252,183

1,252

4,820,839

-

-

-

4,822,091

Common stock issued in exercise of stock options

127,838

128

82,372

-

-

-

82,500

Common stock issued for cash exercise of warrants

25,000

25

61,725

-

-

-

61,750

Stock-based compensation

-

-

428,683

-

-

-

428,683

Tax withholdings paid related to stock-based compensation

-

-

(187,465)

-

-

-

(187,465)

Foreign currency translation

-

-

-

(573,397)

-

-

(573,397)

Net loss for the period

-

-

-

-

(4,327,898)

(8,050)

(4,335,948)

Balance, September 30, 2020

48,064,575

48,065

124,121,703

(148,121)

(105,036,840)

(23,396)

18,961,411

 

 

 

 

 

 

 

 

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




 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

Non

 

 

 

 

 

 

Common Stock

 

 

Paid-in

 

 

Comprehensive

 

 

Accumulated

 

 

Controlling

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Interest

 

 

Total

 

 

 

#

 

 

$

 

 

 

 

$

 

 

 $

 

 

$

 

 

$

 

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

 

 

 

0

 

 

 

0

 

 

 

0

 

 

 

20,328,928

 

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

 

 

80,451

 

 

 

80

 

 

 

(80)

 

 

0

 

 

 

0

 

 

 

0

 

 

 

0

 

Stock-based compensation

 

 

-

 

 

 

0

 

 

 

555,342

 

 

 

0

 

 

 

0

 

 

 

0

 

 

 

555,342

 

Tax withholdings paid related to stock-based compensation

 

 

-

 

 

 

0

 

 

 

(23,758)

 

 

0

 

 

 

0

 

 

 

0

 

 

 

(23,758)

Foreign currency translation

 

 

-

 

 

 

0

 

 

 

0

 

 

 

134,133

 

 

 

0

 

 

 

0

 

 

 

134,133

 

Net loss for the period

 

 

-

 

 

 

0

 

 

 

0

 

 

 

0

 

 

 

(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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common stock issued for cash

 

 

251,369

 

 

 

251

 

 

 

854,460

 

 

 

0

 

 

 

0

 

 

 

0

 

 

 

854,711

 

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

 

 

21,712

 

 

 

22

 

 

 

(22)

 

 

0

 

 

 

0

 

 

 

0

 

 

 

0

 

Stock-based compensation

 

 

-

 

 

 

0

 

 

 

337,744

 

 

 

0

 

 

 

0

 

 

 

0

 

 

 

337,744

 

Tax withholdings paid related to stock-based compensation

 

 

-

 

 

 

0

 

 

 

(106,668)

 

 

0

 

 

 

0

 

 

 

0

 

 

 

(106,668)

Foreign currency translation

 

 

-

 

 

 

0

 

 

 

0

 

 

 

(44,548)

 

 

0

 

 

 

0

 

 

 

(44,548)

Net loss for the period

 

 

-

 

 

 

0

 

 

 

0

 

 

 

0

 

 

 

(5,526,948)

 

 

(47,539)

 

 

(5,574,487)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, June 30, 2021

 

 

53,144,082

 

 

 

53,144

 

 

 

148,468,001

 

 

 

29,607

 

 

 

(121,817,065)

 

 

(104,142)

 

 

26,629,545

 

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

7

Table of Contents

VOLITIONRX LIMITED

Condensed Consolidated Statements of Stockholders’Stockholders' Equity (Unaudited)

(Expressed in United States Dollars, except share numbers)

 

For the Three and Nine Months ended September 30, 2020 and September 30, 2019

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

Additional

Other

 

Non

 

 

Common Stock

Paid-in

Comprehensive

Accumulated

Controlling

 

 

Shares

Amount

Capital

Income (Loss)

Deficit

Interest

Total

#

$

$

$

$

$

$

Balance, December 31, 2018

35,335,378

35,335

85,604,271

223,651

(73,722,801)

-

12,140,456

Common stock issued in exercise of warrants

2,478,613

2,479

6,658,192

-

-

-

6,660,671

Stock-based compensation

-

-

340,458

-

-

-

340,458

Modification of financing warrants

-

-

196,957

-

-

-

196,957

Foreign currency translation

-

-

-

(24,054)

-

 

(24,054)

Net loss for the period

-

-

-

-

(4,203,773)

-

(4,203,773)

Balance, March 31, 2019

37,813,991

37,814

92,799,878

199,597

(77,926,574)

-

15,110,715

Common stock issued in exercise of warrants

1,666,667

1,667

4,998,334

-

-

-

5,000,001

Stock-based compensation

-

-

379,507

-

-

-

379,507

Foreign currency translation

-

-

-

49,913

-

-

49,913

Net loss for the period

-

-

-

-

(4,157,171)

-

(4,157,171)

Balance, June 30, 2019

39,480,658

39,481

98,177,719

249,510

(82,083,745)

-

16,382,965

 

 

 

 

 

 

 

 

Common stock issued in exercise of warrants

1,609,195

1,609

4,825,976

-

-

-

4,827,585

Common stock issued in exercise of stock options

2,487

2

(2)

-

-

-

-

Stock-based compensation

-

-

370,726

-

-

-

370,726

Foreign currency translation

-

-

-

401,309

-

-

401,309

Net loss for the period

-

-

-

-

(4,180,805)

-

(4,180,805)

Balance, September 30, 2019

41,092,340

41,092

103,374,419

650,819

(86,264,550)

-

17,801,780

 

 

 

 

 

 

 

 

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




 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

Non

 

 

 

 

 

 

Common Stock

 

 

Paid-in

 

 

Comprehensive

 

 

Accumulated

 

 

Controlling

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Interest

 

 

Total

 

 

 

#

 

 

$

 

 

$

 

 

$

 

 

 $

 

 

$

 

$

Balance, December 31, 2019

 

 

41,125,303

 

 

 

41,125

 

 

 

103,853,627

 

 

 

125,670

 

 

 

(89,821,856)

 

 

0

 

 

 

14,198,566

 

Common stock issued for Director compensation in Volition Germany

 

 

73,263

 

 

 

73

 

 

 

333,896

 

 

 

0

 

 

 

0

 

 

 

0

 

 

 

333,969

 

Common stock issued for cashless exercise of stock options

 

 

19,430

 

 

 

20

 

 

 

(20)

 

 

0

 

 

 

0

 

 

 

0

 

 

 

0

 

Stock-based compensation

 

 

-

 

 

 

0

 

 

 

192,669

 

 

 

0

 

 

 

0

 

 

 

0

 

 

 

192,669

 

Stock repurchase

 

 

(11,364)

 

 

(11)

 

 

(54,423)

 

 

0

 

 

 

0

 

 

 

0

 

 

 

(54,434)

Foreign currency translation

 

 

-

 

 

 

0

 

 

 

0

 

 

 

373,926

 

 

 

0

 

 

 

 0

 

 

 

373,926

 

Net loss for the period

 

 

-

 

 

 

0

 

 

 

0

 

 

 

0

 

 

 

(5,849,772)

 

 

(9,567)

 

 

(5,859,339)

Balance, March 31, 2020

 

 

41,206,632

 

 

 

41,207

 

 

 

104,325,749

 

 

 

499,596

 

 

 

(95,671,628)

 

 

(9,567)

 

 

9,185,357

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common stock issued for cash, net

 

 

5,452,922

 

 

 

5,453

 

 

 

14,229,160

 

 

 

0

 

 

 

0

 

 

 

0

 

 

 

14,234,613

 

Stock-based compensation

 

 

-

 

 

 

0

 

 

 

360,640

 

 

 

0

 

 

 

0

 

 

 

0

 

 

 

360,640

 

Foreign currency translation

 

 

-

 

 

 

0

 

 

 

0

 

 

 

(74,320)

 

 

0

 

 

 

0

 

 

 

(74,320)

Net loss for the period

 

 

-

 

 

 

0

 

 

 

0

 

 

 

0

 

 

 

(5,037,314)

 

 

(5,779)

 

 

(5,043,093)

Balance, June 30, 2020

 

 

46,659,554

 

 

 

46,660

 

 

 

118,915,549

 

 

 

425,276

 

 

 

(100,708,942)

 

 

(15,346)

 

 

18,663,197

 

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

8

Table of Contents

VOLITIONRX LIMITED

Condensed Consolidated Statements of Cash Flows (Unaudited)


(Expressed in United States Dollars)

 

Nine Months ended September 30,

2020

 

2019

$

 

$

Operating Activities

 

 

 

Net loss

(15,238,380)

 

(12,541,749)

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

 

 

 

Depreciation and amortization

525,150

 

509,736

Amortization of operating lease right-of-use assets

194,749

 

51,090

Gain on disposal of fixed assets

(293,595)

 

-

Stock-based compensation

981,992

 

1,090,691

Common stock issued for Director compensation in Volition Germany

333,969

 

-

Financing costs for warrants modified

-

 

196,957

Changes in operating assets and liabilities:

 

 

 

Prepaid expenses

(177,354)

 

(163,638)

Accounts receivable

(573)

 

(16,031)

Other current assets

(274,398)

 

44,904

Accounts payable and accrued liabilities

365,167

 

687,636

Management and directors’ fees payable

47,672

 

47,575

Right-of-use assets operating leases liabilities

(194,146)

 

(48,475)

Net Cash Used In Operating Activities

(13,729,747)

 

(10,141,304)

 

 

 

 

Investing Activities:

 

Purchases of property and equipment

(679,782)

 

(359,502)

Proceeds from sales of property and equipment

97,388

 

-

Net Cash Used In Investing Activities

(582,394)

 

(359,502)

 

 

 

 

Financing Activities:

 

Net proceeds from issuances of common shares

19,200,954

 

16,488,257

Tax withholdings paid related to stock-based compensation

(187,465)

 

-

Common stock repurchased

(54,434)

 

-

Proceeds from grants repayable

3,802

 

32,652

Proceeds from long-term debt

-

 

282,513

Payments on long-term debt

(356,701)

 

(262,661)

Payments on grants repayable

(41,257)

 

(39,261)

Payments on finance lease obligations

(83,221)

 

(106,616)

Net Cash Provided By Financing Activities

18,481,678

 

16,394,884

 

 

 

 

Effect of foreign exchange on cash

(207,976)

 

375,869

 

 

 

 

Net Change in Cash

3,961,561

 

6,269,947

Cash and cash equivalents – Beginning of Period

16,966,168

 

13,427,222

Cash and cash equivalents – End of Period

20,927,729

 

19,697,169

 

 

 

 

Supplemental Disclosures of Cash Flow Information:

 

 

 

Interest paid

91,105

 

95,507

 

Non-Cash Financing Activities:

 

 

 

Common stock issued on cashless exercises of stock options

118

 

2

Offering costs from issuance of common stock

1,229,169

 

-

 

 

 

 

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




 

 

Six Months Ended June 30,

 

 

 

2021

 

 

2020

 

 

 

$

 

 

$

 

Operating Activities

 

 

 

 

 

 

Net loss

 

 

(11,700,057)

 

 

(10,902,432)

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

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

471,754

 

 

 

359,233

 

Amortization of operating lease right-of-use assets

 

 

99,035

 

 

 

125,871

 

Loss (Gain) on disposal of fixed assets

 

 

26,166

 

 

 

(93,202)

Stock-based compensation

 

 

893,086

 

 

 

553,309

 

Common stock issued for Director compensation in Volition Germany

 

 

0

 

 

 

333,969

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Prepaid expenses

 

 

(632,320)

 

 

(317,795)

Accounts receivable

 

 

(8,682)

 

 

(3,223)

Other current assets

 

 

50,605

 

 

 

(109,213)

Accounts payable and accrued liabilities

 

 

(630,236)

 

 

959,425

 

Management and directors' fees payable

 

 

(36,791)

 

 

(10,497)

Right-of-use assets operating leases liabilities

 

 

(98,789)

 

 

(125,331)

Net Cash Used In Operating Activities

 

 

(11,566,229)

 

 

(9,229,886)

 

 

 

 

 

 

 

 

 

Investing Activities:

 

 

 

 

 

 

 

 

Purchases of property and equipment

 

 

(703,180)

 

 

(597,366)

Net Cash Used In Investing Activities

 

 

(703,180)

 

 

(597,366)

 

 

 

 

 

 

 

 

 

Financing Activities:

 

 

 

 

 

 

 

 

Net proceeds from issuances of common stock

 

 

21,183,639

 

 

 

14,234,613

 

Tax withholdings paid related to stock-based compensation

 

 

(130,426)

 

 

0

 

Common stock repurchased

 

 

0

 

 

 

(54,434)

Proceeds from grants repayable

 

 

37,672

 

 

 

3,802

 

Proceeds from long-term debt

 

 

79,614

 

 

 

0

 

Payments on long-term debt

 

 

(383,782)

 

 

(234,172)

Payments on grants repayable

 

 

(47,830)

 

 

0

 

Payments on finance lease obligations

 

 

(29,347)

 

 

(69,483)

Net Cash Provided By Financing Activities

 

 

20,709,540

 

 

 

13,880,326

 

 

 

 

 

 

 

 

 

 

Effect of foreign exchange on cash

 

 

28,301

 

 

 

286,024

 

 

 

 

 

 

 

 

 

 

Net Change in Cash

 

 

8,468,432

 

 

 

4,339,098

 

Cash and cash equivalents - Beginning of Period

 

 

19,444,737

 

 

 

16,966,168

 

Cash and cash equivalents - End of Period

 

 

27,913,169

 

 

 

21,305,266

 

 

 

 

 

 

 

 

 

 

Supplemental Disclosures of Cash Flow Information:

 

 

 

 

 

 

 

 

Interest paid

 

 

81,869

 

 

 

56,383

 

Non-Cash Financing Activities:

 

 

 

 

 

 

 

 

Common stock issued on cashless exercises of stock options

 

 

80

 

 

 

20

 

Offering costs from issuance of common stock

 

 

119,029

 

 

 

1,229,169

 

VOLITIONRX

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

9

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”"Company", "VolitionRx," "we" or "us") for the three and ninesix months ended SeptemberJune 30, 20202021 and SeptemberJune 30, 2019,2020, respectively, are not audited. 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”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 SeptemberJune 30, 2020,2021, and our results of operations and cash flows for the periods ended SeptemberJune 30, 20202021 and SeptemberJune 30, 2019,2020, respectively. The results of operations for the periods ended SeptemberJune 30, 20202021 and SeptemberJune 30, 2019,2020, 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, 2019,2020, which was filed with the Securities and Exchange Commission (the "SEC") on February 20, 2020.March 22, 2021.

 

UseofEstimates 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 long-livedintangible assets, the estimateand valuations of the fair value of the lease liability and related right of use assets, allowance for doubtful accounts and valuation of share based payments.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’sCompany's estimates. To the extent there are material differences between the estimates and the actual results, future results of operations willcould be affected.

 

PrinciplesofConsolidationrinciples of Consolidation

 

The accompanying condensed consolidated financial statements for the period ended SeptemberJune 30, 20202021 include the accounts of the Company and its subsidiaries. The Company has one wholly-owned subsidiary, Singapore Volition Pte. Limited (“("Singapore Volition”Volition"). Singapore Volition has one wholly-owned subsidiary, Belgian Volition SPRL (“SRL ("Belgian Volition”Volition"). Belgian Volition has four subsidiaries, Volition Diagnostics UK Limited (“("Volition Diagnostics”Diagnostics"), Volition America, Inc. (“("Volition America”America"), Volition Germany GmbH (“("Volition Germany”Germany"), and its one majority-owned subsidiary Volition Veterinary Diagnostics Development LLC (“("Volition Vet”Vet"). See Note 8(f) for more information regarding Volition Vet and Volition Germany. 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 SeptemberJune 30, 2020,2021, cash and cash equivalents totaled approximately $20.9$27.9 million, of which $14.7$20.2 million was held in an overnight money market account.

 

10

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 (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’sCompany'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 SeptemberJune 30, 2020,2021, the accounts receivable balance was $573$15,832 and the allowance for doubtful debts was $nil.

 

Revenue Recognition

 

The Company adopted Accounting Standards Codification (“ASC”("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 revenueproduct 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 pursuant to its license agreement with Active Motif, Inc. (“("Active Motif”Motif") for the sale of Research Use Only kits from which the Company receives royalties. In addition, revenue is received from external third parties for product sales and/or 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”"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 Active Motif 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 ”"Product" in the consolidated statements of operations and comprehensive loss.

 

11

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 (continued)

Services

 

The Company includes revenue recognized from laboratory services performed in the Company’sCompany's laboratory on behalf of third parties in “Services”"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’sCompany'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.




VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

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

BasicandDilutedNetLossPerShareDiluted 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”("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 SeptemberJune 30, 2020, 4,551,1192021, 4,732,235 potential common shares equivalents from warrants, options, and restricted stock units (“RSUs”("RSUs") were excluded from the diluted EPS calculations as their effect is anti-dilutive.

 

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 the statement of stockholders’stockholders' equity and cash flows 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 applicable accounting pronouncements that have been issued that might have a material impact on its financial position or results of operations.

 

12

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 (continued)

COVID-19 Pandemic Impact

 

On March 11, 2020, the World Health Organization designated the outbreakAs of the novel straindate of coronavirus known asthis filing, there continue to be widespread concerns regarding the ongoing impacts and disruptions caused by the COVID-19 aspandemic in the regions in which the Company operates. As a global pandemic. Governments and businesses around the world have taken unprecedented actions to mitigate the spread of COVID-19, including, but not limited to, shelter-in-place orders, quarantines, significant restrictions on travel, as well as restrictions that prohibit many employees from going to work. Uncertainty with respect to the economic impactsresult of the COVID-19 pandemic, the Company has introduced significant volatilityexperienced 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 markets. The Company did not observe significant impacts on its business orcondition, and results of operations forin the threefuture is highly uncertain and nine months ended September 30, 2020 due towill be affected by a number of factors. These include the global emergenceduration and extent of COVID-19. While the extent to which COVID-19 impactspandemic, the Company’s future results will depend on future developments,development of new variants of the pandemicCOVID-19 virus that may be more contagious or virulent than previous versions, the scope of mandated or recommended containment and associated economic impacts could result in a material impact tomitigation measures, the Company’s future financial condition, resultseffect of operationsgovernment stabilization and cash flows.recovery efforts, and the success of vaccine distribution programs.

 

NoteNote 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 $105.0$121.8 million, has negative cash flows from operations, and currently has limitedminimal 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 back-end 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.




13

Table of Contents

VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 3 - Property and Equipment

 

The Company’sCompany's property and equipment consistconsisted of the following amounts as of SeptemberJune 30, 20202021 and December 31, 2019:2020:

 

 

 

 

 

 

 

September 30,

 

 

 

 

 

 

 

 

June 30,

 

 

 

 

 

 

 

2020

 

 

 

 

 

 

 

 

2021

 

 

 

 

 

Accumulated

 

Net Carrying

 

 

 

 

 

 

Accumulated

 

Net Carrying

 

 

 

Cost

 

Depreciation

 

Value

 

 

 

 

Cost

 

Depreciation

 

Value

 

Useful Life

 

$

 

$

 

$

 

 

Useful Life

 

 $

 

 

 

 

$

 

Computer hardware and software

3 years

 

490,687

 

369,584

 

121,103

 

 

3 years

 

579,410

 

455,285

 

124,125

 

Laboratory equipment

5 years

 

1,980,047

 

920,295

 

1,059,752

 

 

5 years

 

3,026,194

 

1,271,580

 

1,754,614

 

Office furniture and equipment

5 years

 

235,740

 

152,240

 

83,500

 

 

5 years

 

297,841

 

193,087

 

104,754

 

Buildings

30 years

 

1,537,352

 

183,600

 

1,353,752

 

 

30 years

 

2,293,345

 

239,727

 

2,053,618

 

Building improvements

5-15 years

 

792,282

 

160,882

 

631,400

 

 

5-15 years

 

1,310,063

 

222,745

 

1,087,318

 

Land

Not amortized

 

93,790

 

-

 

93,790

 

 

Not amortized

 

 

142,217

 

 

 

0

 

 

 

142,217

 

 

 

5,129,898

 

1,786,601

 

3,343,297

 

 

 

 

 

7,649,070

 

 

 

2,382,424

 

 

 

5,266,646

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31,

 

 

 

 

 

 

 

 

December 31,

 

 

 

 

 

 

 

2019

 

 

 

 

 

 

 

 

2020

 

 

 

 

 

Accumulated

 

Net Carrying

 

 

 

 

 

 

Accumulated

 

Net Carrying

 

 

 

Cost

 

Depreciation

 

Value

 

 

 

 

Cost

 

Depreciation

 

Value

 

Useful Life

 

$

 

$

 

$

 

 

Useful Life

 

 

 

 

 $

 

 

$

 

Computer hardware and software

3 years

 

426,461

 

280,554

 

145,907

 

 

3 years

 

550,254

 

412,805

 

137,449

 

Laboratory equipment

5 years

 

2,052,348

 

1,256,637

 

795,711

 

 

5 years

 

2,586,997

 

1,060,153

 

1,526,844

 

Office furniture and equipment

5 years

 

217,545

 

114,242

 

103,303

 

 

5 years

 

271,656

 

171,247

 

100,409

 

Buildings

30 years

 

1,472,211

 

139,021

 

1,333,190

 

 

30 years

 

2,366,236

 

207,111

 

2,159,125

 

Building improvements

5-15 years

 

630,824

 

117,526

 

513,298

 

 

5-15 years

 

1,285,383

 

184,813

 

1,100,570

 

Land

Not amortized

 

89,816

 

-

 

89,816

 

 

Not amortized

 

 

146,737

 

 

 

0

 

 

 

146,737

 

 

 

4,889,205

 

1,907,980

 

2,981,225

 

 

 

 

 

7,207,263

 

 

 

2,036,129

 

 

 

5,171,134

 

 

During the nine-monthsix-month periods ended SeptemberJune 30, 20202021 and SeptemberJune 30, 2019,2020, the Company recognized $459,450$425,187 and $443,972,$316,405, respectively, in depreciation expense.

 

14

During the nine-month period ended September 30, 2020, the Company sold laboratory equipment for $293,595, resulting in a gain on disposal of equipment of $293,595. As of September 30, 2020, the Company has received $97,388 in payment for the laboratory equipment, with the remaining receivable of $196,207 recorded in other current assets.

Table of Contents

  

Note 4 - Intangible Assets

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

 

 

 

 

 

September 30,

 

 

 

 

 

2020

 

 

 

Accumulated

 

Net Carrying

 

Cost

 

Amortization

 

Value

 

$

 

$

 

$

Patents

1,197,312

 

875,464

 

321,848

 

 

 

 

 

 

 

 

 

 

 

December 31,

 

 

 

 

 

2019

 

 

 

Accumulated

 

Net Carrying

 

Cost

 

Amortization

 

Value

 

$

 

$

 

$

Patents

1,147,391

 

775,086

 

372,305




VOLITIONRXVOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 4 - Intangible Assets (continued)

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.

 

 

 

 

 

 

 

 

June 30,

 

 

 

 

 

 

 

 

 

2021

 

 

 

 

 

 

Accumulated

 

 

Net Carrying

 

 

 

Cost

 

 

Amortization

 

 

Value

 

 

 

 $

 

 

$

 

 

$

 

Patents

 

 

1,219,693

 

 

 

953,107

 

 

 

266,586

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31,

 

 

 

 

 

 

 

 

 

 

 

2020

 

 

 

 

 

 

 

Accumulated

 

 

Net Carrying

 

 

 

Cost

 

 

Amortization

 

 

Value

 

 

 

 

 

 

 $

 

 

$

 

Patents

 

 

1,256,064

 

 

 

934,423

 

 

 

321,641

 

 

During the nine-monthsix-month periods ended SeptemberJune 30, 20202021 and SeptemberJune 30, 2019,2020, the Company recognized $65,567$46,567 and $65,761,$42,828, 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:

 

2020 - remaining

$

24,749

2021

$

90,883

2021 - remaining

 

$45,326

 

2022

$

90,883

 

$91,015

 

2023

$

90,883

 

$91,015

 

2024

$

24,450

 

$39,230

 

2025

 

$0

 

Total Intangible Assets

$

321,848

 

$266,586

 

 

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,”Equipment" as of December 31, 2019.2020. The result of this review confirmed that the ongoing value of the patents was not impaired as of December 31, 2019.2020.

 

Note 5 - Related Party Transactions

 

SeeRefer to 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’directors' fees payable (see condensed consolidated balance sheets).

 

15

Table of Contents

VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

Note 6 - Common Stock

 

As of SeptemberJune 30, 2020,2021, the Company was authorized to issue 100 million shares of common stock par value $0.001 per share, of which 48,064,57553,144,082 and 41,125,30348,607,017 shares were issued and outstanding as of SeptemberJune 30, 20202021 and December 31, 2019,2020, respectively.

 

Stock Issuances Upon Warrant and Option Exercises and RSU Settlements

 

From January 7, 202013, 2021 to August 17, 2020, 97,500March 19, 2021, 7,634 stock options were exercised to purchase shares of common stock at $2.50$3.35 per share in a cashless exercisesexercise that resulted in the issuance of 30,033948 shares of common stock.

 

FromOn January 7, 2020 to August 17, 2020, 97,50020, 2021, 5,000 RSUs vested and resulted in the issuance of 3,000 shares of common stock (the remaining 2,000 shares were withheld for taxes and returned as authorized shares under the 2015 Stock Incentive Plan).

On February 2, 2021, 20,000 stock options were exercised to purchase shares of common stock at $3.00$3.80 per share in a cashless exercisesexercise that resulted in the issuance of 16,5396,181 shares of common stock.

 

On January 7, 2020, 35,000February 8, 2021, 100,000 stock options were exercised to purchase shares of common stock at $5.00 per share in a cashless exercise that resulted in the issuance of 19,446 shares of common stock.

From February 8, 2021 to February 9, 2021, 100,000 stock options were exercised to purchase shares of common stock at $4.00 per share in cashless exercises that resulted in the issuance of 6,48632,126 shares of common stock.

 

FromOn February 24, 2020 to September 2, 2020, 11,5998, 2021, 50,000 stock options were exercised to purchase shares of common stock at $2.35$3.25 per share in a cashless exercisesexercise that resulted in the issuance of 2,752 shares of common stock.

From July 16, 2020 to August 10, 2020, 210,000 stock options were exercised to purchase shares of common stock at $2.50 per share in cashless exercises and withholding of shares for taxes that resulted in the issuance of 39,197 shares of common stock.

From July 21, 2020 to August 12, 2020, 210,000 stock options were exercised to purchase shares of common stock at $3.00 per share in cashless exercises and withholding of shares for taxes that resulted in the issuance of 22,26118,750 shares of common stock.

 

On August 12, 2020, 15,000 stock options were exercised to purchase shares of common stock at $2.50 per share thatApril 13, 2021, 26,250 RSUs vested and resulted in the issuance of 15,00021,712 shares of common stock (the remaining 4,538 shares were withheld for proceeds totaxes and returned as authorized shares under the Company of $37,500.2015 Stock Incentive Plan).

EquityCapital Raise

 

On AugustFebruary 10, 2021, the Company entered into an underwriting agreement (the "Underwriting Agreement") with Cantor Fitzgerald & Co. (the "Underwriter") in connection with an underwritten public offering of 3,809,524 shares (the "Firm Shares") of the Company's common stock pursuant to the Company's shelf registration statement on Form S-3 (declared effective by the SEC on September 28, 2018, File No. 333-227248). The Underwriter purchased the Firm Shares from the Company at a price of $4.9533 per share on February 12, 2020, 15,000 stock options2021. The net proceeds received by the Company for the sale and issuance of the Firm Shares were exercisedapproximately $18.9 million. Under the terms of the Underwriting Agreement, the Company granted the Underwriter an option, exercisable for 30 days, to purchase up to an additional 571,428 shares of Common Stock at the same price per share as the Firm Shares which option was not exercised.

EquityDistribution Agreements

On November 10, 2020, the Company entered into an equity distribution agreement (the "2020 EDA") with Cantor Fitzgerald & Co. ("Cantor") and Oppenheimer & Co. Inc. ("Oppenheimer"), to sell shares of its common stock at $3.00 per share that resulted inhaving an aggregate offering price of up to $25.0 million from time-to-time, through an "at the issuancemarket offering program" pursuant to the Company's effective "shelf" registration statement on Form S-3 (File No. 333-227248) and related prospectuses, through Cantor and Oppenheimer each acting as the Company's agent and/or principal. The Company is not obligated to sell any shares under the 2020 EDA. During the three months ended June 30, 2021, the Company raised aggregate net proceeds (net of 15,000broker's commissions and fees) of $857,211 under the 2020 EDA through the sale of 251,369 shares of its common stock for proceeds tostock. From inception through June 30, 2021, the Company raised aggregate net proceeds (net of $45,000.broker's commissions and fees) of $1,201,167 under the 2020 EDA through the sale of 316,769 shares of its common stock.




VOLITIONRX

16

Table of Contents

VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 6 - Common Stock (continued)

 

On September 18, 2020, 25,000 warrants were exercised to purchase shares of common stock at $2.47 per share that resulted in the issuance of 25,000 shares of common stock for proceeds to the Company of $61,750.

Stock Issuance for Services

On January 9, 2020, 73,263 shares were issued as fully paid shares of common stock valued at $333,969 as compensation to a managing director of Volition Germany (see Note 8(f)).

Stock Repurchase

On January 12, 2020, the Company purchased from its Chief Medical Officer 11,364 shares of our common stock at $4.79 per share, for a total cost to the Company of $54,434. These shares were subsequently retired.

Equity Capital Raise

On May 20, 2020, the Company entered into an underwriting agreement with National Securities Corporation, acting on its own behalf and as representative of the several underwriters, in connection with the public offering, issuance and sale by the Company of 4,365,000 shares of the Company’s common stock, at the public offering price of $2.75 per share, less underwriting discounts and commissions. Under the terms of the agreement, the Company granted the underwriters an option, exercisable for 30 days from the date of the agreement, to purchase up to 654,750 additional shares of the Company’s common stock to cover overallotments, if any, at the public offering price of $2.75 per share, less underwriting discounts and commissions.  On May 21, 2020, the underwriters exercised the overallotment option in full. As a result of the equity capital raise, the Company issued a total of approximately 5 million shares for aggregate gross proceeds of $13.8 million. Additionally, in connection with this transaction, $1.1 million was incurred in fees relating to the equity offering, resulting in net proceeds of $12.7 million.

Equity Distribution Agreement

On September 7, 2018, the Company entered into an equity distribution agreement (as amended, the “Equity Distribution Agreement”"2018 EDA") with Oppenheimer & Co. Inc. (“Oppenheimer”), which agreement allows it to offer and sell shares of common stock having an aggregate offering price of up to $10.0 million from time-to-time, through an "at the market offering program" pursuant to a shelfthe Company's effective "shelf" registration statement on Form S-3 (declared effective by the SEC on September 28, 2018, File No.333-227248)(File No 333-227248) and related prospectuses, through Oppenheimer acting as the Company’sCompany's agent and/or principal. From inception through September 30, 2020,March 31, 2021, the Company raised aggregate net proceeds (net of broker's commissions and fees) of approximately $6.5$9.7 million under the Equity Distribution Agreement2018 EDA through the sale of 1,688,5552,539,606 shares of its common stock.stock and fully utilized the availability under the 2018 EDA during the quarter ended March 31, 2021. No further sales will be made under the 2018 EDA.

 

During the nine-month period ended September 30, 2020, the Company raised aggregate net proceeds of approximately $6.5 million under the Equity Distribution Agreement through the sale of 1,685,355 shares of its common stock. Additionally, in connection with this transaction $104,813 was incurred in fees relating to the Equity Distribution Agreement. See Note 9 for details regarding additional sales of common stock under the Equity Distribution Agreement after September 30, 2020.




VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)7 - Stock-Based Compensation

 

Note 7 – Stock-based Compensation

a)a) Warrants

 

The following table summarizes the changes in warrants outstanding of the Company during the nine-monthsix-month period ended SeptemberJune 30, 2020:2021:

  

 

Number of

 

Weighted Average

 

Warrants

 

Exercise Price ($)

Outstanding at December 31, 2019

190,000

 

2.90

Granted

50,000

 

3.45

Exercised

(25,000)

 

2.47

Expired

-

 

-

Outstanding at September 30, 2020

215,000

 

3.08

 

 

 

 

Exercisable at September 30, 2020

165,000

 

2.97

 

 

Number of

 

 

Weighted Average

 

 

 

Warrants

 

 

Exercise Price ($)

 

Outstanding at December 31, 2020

 

 

175,000

 

 

 

2.75

 

Granted

 

 

310,000

 

 

 

4.52

 

Outstanding at June 30, 2021

 

 

485,000

 

 

 

3.88

 

 

 

 

 

 

 

 

 

 

Exercisable at June 30, 2021

 

 

125,000

 

 

 

2.47

 

 

Effective February 26, 2020, the vesting criteria of the remaining installment of a warrant originally granted March 20, 2013 to an officer of the Company, and previously amended, was deemed met pursuant to the approval of the Compensation Committee, resulting in the vesting of the Warrant as to 125,000 shares effective February 26, 2020, with an expiration date of February 26, 2023.

Effective MarchJanuary 1, 2020,2021, the Company granted warrants to purchase 50,000125,000 shares of common stock to a Company employee for services to the Company. These warrants vest on SeptemberJanuary 1, 20212022 (subject to continued employment through such date) and expire on MarchJanuary 1, 2026,2027, with an exercise price of $3.45$3.95 per share. The Company has calculated the estimated fair market value of these warrants at $86,771,$242,877, using the Black-Scholes model and the following assumptions: term 3.753.5 years, stock price $3.44,$3.95, exercise price $3.45, 69.03%$3.80, 74.53% volatility, 0.95%0.50% risk free rate, and no forfeiture rate.

Effective February 1, 2021, the Company granted warrants to purchase 185,000 shares of common stock to a Company employee for services to the Company. These warrants vest on February 1, 2022 (subject to continued employment through such date) and expire on February 1, 2027, with an exercise price of $4.90 per share. The Company has calculated the estimated fair market value of these warrants at $459,352, using the Black-Scholes model and the following assumptions: term 3.5 years, stock price $4.90, exercise price $4.80, 75.03% volatility, 0.59% risk free rate, and no forfeiture rate.

 

Below is a table summarizing the warrants issued and outstanding as of SeptemberJune 30, 2020,2021, which have an aggregate weighted average remaining contractual life of 2.684.46 years.

 

 

 

 

 

 

 

Weighted

 

 

 

 

 

 

 

 

Average

 

 

 

 

 

 

 

Remaining

Proceeds to

Number

 

Number

 

Exercise

 

Contractual

Company if

Outstanding

 

Exercisable

 

Price ($)

 

Life (Years)

Exercised ($)

125,000

 

125,000

 

2.47

 

2.41

 

308,750

50,000

 

-

 

3.45

 

5.42

 

172,500

40,000

 

40,000

 

4.53

 

0.12

 

181,200

215,000

 

165,000

 

 

 

 

 

662,450

 

 

 

 

 

 

 

Weighted Average

 

 

 

 

 

 

 

 

 

 

Remaining

 

 

Proceeds to

 

Number

 

 

Number

 

 

Exercise

 

 

Contractual

 

 

Company if

 

Outstanding

 

 

Exercisable

 

 

Price ($)

 

 

Life (Years)

 

 

Exercised ($)

 

 

125,000

 

 

 

125,000

 

 

 

2.47

 

 

 

0.83

 

 

 

308,750

 

 

50,000

 

 

 

-

 

 

 

3.45

 

 

 

4.67

 

 

 

172,500

 

 

185,000

 

 

 

-

 

 

 

4.90

 

 

 

5.59

 

 

 

906,500

 

 

125,000

 

 

 

-

 

 

 

3.95

 

 

 

5.51

 

 

 

493,750

 

 

485,000

 

 

 

125,000

 

 

 

 

 

 

 

 

 

 

 

1,881,500

 

17

Table of Contents

   

Stock-based compensation expense related to warrants of $56,127 and $6,379 was recorded in the nine months ended September 30, 2020 and September 30, 2019, respectively. Total remaining unrecognized compensation cost related to non-vested warrants is $53,105 and is expected to be recognized over a period of 0.92 years. As of September 30, 2020, the total intrinsic value of warrants outstanding was $92,500.




VOLITIONRXVOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 7 – Stock-based- Stock-Based Compensation (continued)

 

b)a) Warrants (continued)

Stock-based compensation expense related to warrants of $337,823 and $41,587 was recorded in the six months ended June 30, 2021 and June 30, 2020, respectively. Total remaining unrecognized compensation cost related to non-vested warrants is $402,971 and is expected to be recognized over a period of 0.59 years. As of June 30, 2021, the total intrinsic value of warrants outstanding was $102,500.

b) Options

 

The following table summarizes the changes in options outstanding of the Company during the nine-monthsix-month period ended SeptemberJune 30, 2020:2021:

 

 

 

Number of

 

Weighted Average

 

 

Options

 

Exercise Price ($)

Outstanding at December 31, 2019

 

4,169,301

 

3.88

Granted

 

835,000

 

3.60

Exercised

 

(691,599)

 

2.81

Expired/Cancelled

 

(29,083)

 

4.52

Outstanding at September 30, 2020

 

4,283,619

 

4.00

 

 

 

 

 

Exercisable at September 30, 2020

 

3,448,619

 

4.10

 

 

 

 

Weighted

 

 

 

 

 

Average

 

 

 

Number of

 

 

Exercise

 

 

 

Options

 

 

Price ($)

 

Outstanding at December 31, 2020

 

 

4,278,619

 

 

 

4.00

 

Granted

 

 

40,000

 

 

 

3.60

 

Exercised

 

 

(277,634)

 

 

4.19

 

Outstanding at June 30, 2021

 

 

4,040,985

 

 

 

3.99

 

 

 

 

 

 

 

 

 

 

Exercisable at June 30, 2021

 

 

3,990,985

 

 

 

3.99

 

 

Effective April 13, 2020,May 20, 2021, the Company granted stock options to purchase 835,00040,000 shares of common stock to variousa Company personnel (including directors, executives, members of management and employees)employee in exchange for services provided to the Company. These options vest on April 13, 2021May 20, 2022 and expire 5five years after the vesting date, with an exercise price of $3.60 per share. The Company has calculated the estimated fair market value of these options at $1,481,709,$73,641, using the Black-Scholes model and the following assumptions: term 3.5 years, stock price $3.52,$3.50, exercise price $3.60, 72.94%76.16% volatility, 0.54%0.58% risk free rate, and no forfeiture rate.

 

Below is a table summarizing the options issued and outstanding as of SeptemberJune 30, 2020,2021, 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 3.23 years.2.54 years. As of SeptemberJune 30, 2020, 2021, an aggregate of 4,250,0006,000,000 shares of common stock were authorized for issuance under the 2015 Stock Incentive Plan, of which 261,8671,968,852 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 ($)

685,000

 

685,000

 

3.25

 

4.37

 

2,226,250

10,351

 

10,351

 

3.35

 

0.58

 

34,676

835,000

 

-

 

3.60

 

5.54

 

3,006,000

20,000

 

20,000

 

3.80

 

0.63

 

76,000

1,782,837

 

1,782,837

 

4.00

 

2.06

 

7,131,348

15,268

 

15,268

 

4.35

 

1.40

 

66,416

89,163

 

89,163

 

4.38

 

3.32

 

390,534

50,000

 

50,000

 

4.80

 

2.25

 

240,000

796,000

 

796,000

 

5.00

 

2.49

 

3,980,000

4,283,619

 

3,448,619

 

 

 

 

 

17,151,224

 

 

 

 

 

 

 

Weighted Average

 

 

 

 

 

 

 

 

 

 

Remaining

 

 

Proceeds to

 

Number

 

 

Number

 

 

Exercise

 

 

Contractual

 

 

Company if

 

Outstanding

 

 

Exercisable

 

 

Price ($)

 

 

Life (Years)

 

 

Exercised ($)

 

 

635,000

 

 

 

635,000

 

 

 

3.25

 

 

 

3.62

 

 

 

2,063,750

 

 

2,717

 

 

 

2,717

 

 

 

3.35

 

 

 

0.18

 

 

 

9,102

 

 

10,000

 

 

 

-

 

 

 

3.40

 

 

 

5.42

 

 

 

34,000

 

 

860,000

 

 

 

820,000

 

 

 

3.60

 

 

 

4.85

 

 

 

3,096,000

 

 

1,682,837

 

 

 

1,682,837

 

 

 

4.00

 

 

 

1.26

 

 

 

6,731,348

 

 

15,268

 

 

 

15,268

 

 

 

4.35

 

 

 

0.65

 

 

 

66,416

 

 

89,163

 

 

 

89,163

 

 

 

4.38

 

 

 

2.57

 

 

 

390,534

 

 

50,000

 

 

 

50,000

 

 

 

4.80

 

 

 

1.51

 

 

 

240,000

 

 

696,000

 

 

 

696,000

 

 

 

5.00

 

 

 

1.74

 

 

 

3,480,000

 

 

4,040,985

 

 

 

3,990,985

 

 

 

 

 

 

 

 

 

 

 

16,111,150

 

18

Table of Contents

  

Stock-based compensation expense related to stock options of $861,312 and $1,084,312 was recorded in the nine months ended September 30, 2020 and September 30, 2019, respectively. Total remaining unrecognized compensation cost related to non-vested stock options is $791,598. As of September 30, 2020, the total intrinsic value of stock options outstanding was $nil.




VOLITIONRXVOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 7 – Stock-based- Stock-Based Compensation (continued)

 

c)b) Options (continued)

Stock-based compensation expense related to stock options of $418,292 and $482,103 was recorded in the six months ended June 30, 2021 and June 30, 2020, respectively. Total remaining unrecognized compensation cost related to non-vested stock options is $72,095 and is expected to be recognized over a period of 0.89 years. As of June 30, 2021, the total intrinsic value of stock options outstanding was $25,400.

c) Restricted Stock Units (RSUs)

 

Below is a table summarizing the RSUs issued and outstanding as of SeptemberJune 30, 2020,2021, all of which were issued pursuant to the 2015 Stock Incentive Plan.

 

Number of

 

 

 

Number of RSUs

 

 

Share Price ($)

 

RSUs

 

Share Price ($)

Outstanding at December 31, 2019

-

 

-

Outstanding at December 31, 2020

 

67,500

 

3.47

 

Granted

52,500

 

3.52

 

185,000

 

3.37

 

Vested

-

 

-

 

(31,250)

 

3.56

 

Cancelled

-

 

-

 

 

(15,000)

 

 

3.30

 

Outstanding at September 30, 2020

52,500

 

3.52

Outstanding at June 30, 2021

 

 

206,250

 

 

 

3.38

 

 

Effective April 13, 2020,January 1, 2021, the Company granted RSUs of 52,5005,000 shares of common stock to variousa Company personnel (including a directoremployee in exchange for services provided to the Company. These RSUs vested immediately, on January 1, 2021 and an employee)resulted in the issuance of 3,000 shares (the remaining 2,000 shares were withheld for taxes and returned as authorized shares under the 2015 Stock Incentive Plan) and total compensation expense of $19,450.

Effective March 25, 2021, the Company granted aggregate RSUs of 30,000 shares of common stock to two non-executive directors in exchange for services provided to the Company. These RSUs vest over 2two years, with 50% vesting on each of April 13, 2021March 25, 2022 and April 13, 2022March 25, 2023 and will result in total compensation expense of $184,800.$107,700.

On March 25, 2021, 15,000 RSUs previously granted to a non-executive director were cancelled and returned as authorized shares under the 2015 Stock Incentive Plan upon the resignation of such director prior to vesting.

On April 13, 2021, 26,250 RSUs vested and resulted in the issuance of 21,712 shares (the remaining 4,538 shares were withheld for taxes and returned as authorized shares under the 2015 Stock Incentive Plan).

Effective May 1, 2021, the Company granted RSUs of 150,000 shares of common stock to an employee in exchange for services provided to the Company. These RSUs vest over three years with 50,000 units vesting on each of May 1, 2022, May 1, 2023 and May 1, 2024, respectively, and will result in total compensation expense of $496,500

19

Table of Contents

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 SeptemberJune 30, 20202021 and which have an aggregate weighted average remaining contractual life of 1.031.62 years.

 

 

 

 

 

 

 

Weighted

 

 

 

 

 

 

Average

 

 

 

 

 

 

Remaining

Number

 

Number

 

Share

 

Contractual

Outstanding

 

Exercisable

 

Price ($)

 

Life (Years)

52,500

 

-

 

3.52

 

1.03

 

 

 

 

 

Weighted

 

 

 

 

 

 

Average

 

 

 

 

 

 

Remaining

 

Number

 

 

Share

 

 

Contractual

 

Outstanding

 

 

Price ($)

 

 

Life (Years)

 

 

150,000

 

 

 

3.31

 

 

 

1.84

 

 

26,250

 

 

 

3.52

 

 

 

0.39

 

 

30,000

 

 

 

3.59

 

 

 

1.23

 

 

206,250

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense related to RSUs of $64,553$136,971 and $nil$29,619 was recorded in the ninesix months ended SeptemberJune 30, 20202021 and SeptemberJune 30, 2019,2020, respectively. Total remaining unrecognized compensation cost related to non-vested RSUs is $120,246.$568,243. As of SeptemberJune 30, 2020,2021, the total intrinsic value of the RSUs outstanding was $nil.

 

Note 8 - Commitments and Contingencies

 

a)Finance Lease Obligations

In 2015, the Company entered into an equipment finance lease to purchase three Tecan machines (automated liquid handling robots) for €550,454 Euros that matured in May 2020. As of September 30, 2020, the balance payable was $nil.

 

In 2016, the Company entered into a real estate finance lease with ING Asset Finance Belgium S.A. (“ING”("ING") to purchase a property located in Belgium for €1.12 million, Euros, maturing in May 2031.2031 with implicit interest of 2.62%. As of SeptemberJune 30, 2020,2021, the balance payable was $635,130.$606,213.

 

In 2018, the Company entered into a financecapital lease with BNP Paribas leasing solutions to purchase a freezer for the Belgium facility for €25,000, Euros, maturing in January 2022.2022 with implicit interest of 1.35%. The leased equipment is amortized on a straight-line basis over 5 years. As of SeptemberJune 30, 2020,2021, the balance payable was $13,575.




VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

Note 8 – Commitments and Contingencies (continued)

a)Finance Lease Obligations (continued)$6,460.

 

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 SeptemberJune 30, 2020.2021.

  

2020 - remaining

$

18,259

2021

$

73,042

2021 - remaining

 

$36,917

 

2022

$

64,531

 

$65,234

 

2023

$

63,058

 

$63,745

 

2024

$

63,057

 

$63,744

 

2025

 

$63,744

 

Greater than 5 years

$

465,037

 

$406,356

 

Total

$

746,984

 

$699,740

 

Less: Amount representing interest

$

(98,279)

 

$(87,067)

Present value of minimum lease payments

$

648,705

 

$612,673

 

20

Table of Contents

  

VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

Note 8 - Commitments and Contingencies (continued)

b)Operating Lease Right-of-Use Obligations

 

As all the existing leases subject to the new lease standard ASC 842 Leases,”("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 wethe Company used ourits incremental borrowing rate as the discount rate. OurThe Company's weighted average discount rate is 4.48%4.49% and the weighted average remaining lease term is 2433 months.

 

As of SeptemberJune 30, 2020,2021, operating lease right-of-use assets and liabilities arising from operating leases were $257,903$318,393 and $266,101,$323,996, respectively. During the ninesix months ended SeptemberJune 30, 2020,2021, cash paid for amounts included for the measurement of lease liabilities was $184,769$44,059 and the Company recorded operating lease expense of $185,077.$44,355.

 

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 SeptemberJune 30, 2020.2021.

 

2020 - remaining

$

74,831

2021

$

109,716

2021 - remaining

 

$103,130

 

2022

$

50,652

 

$101,644

 

2023

$

32,917

 

$76,422

 

2024

$

10,665

 

$50,027

 

2025

 

$5,417

 

Total Operating Lease Obligations

$

278,781

 

$336,640

 

Less: Amount representing interest

$

(12,680)

 

$(12,644)

Present Value of minimum lease payments

$

266,101

 

$323,996

 

 

The Company’sCompany'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 ninesix months ended SeptemberJune 30, 2020, $10,7372021, $37,417 was recognized in short-term lease costs associated with office space leases. The annual payments remaining for short-term office leases were as follows:

  

2020 - remaining

$

-

Total Operating Lease Obligations

$

-




VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

2021 - remaining

 

$38,855

 

2022

 

$38,222

 

Total Operating Lease Liabilities

 

$77,077

 

 

Note 8 – Commitments and Contingencies (continued)

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 Euros.million. Per the terms of the agreement, €314,406 Euros 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 Euros and the 6% royalty on revenue, is equal to twice the amount of funding received. As of SeptemberJune 30, 2020,2021, the grant balance repayable was $102,473.$65,183.

 

In 2018, the Company entered into an agreement with the Walloon Region government in Belgium for a colorectal cancer research grant for €605,000 Euros.€605,000. Per the terms of the agreement, €181,500 Euros 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 Euros and the 3.53% royalty on revenue, is equal to the amount of funding received. As of SeptemberJune 30, 2020,2021, the grant balance repayable was $212,786.$127,215.

21

Table of Contents

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)

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 June 30, 2021, the grant balance repayable was $55,040.

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 June 30, 2021, the grant balance repayable was $61,254.

 

As of SeptemberJune 30, 2020,2021, the total grant balance repayable was $315,259$308,692 and the payments remaining were as follows:

  

2020 - remaining

$

14,186

2021

$

52,178

2021 - remaining

 

$0

 

2022

$

49,357

 

$46,138

 

2023

$

50,579

 

$44,367

 

2024

$

21,279

 

$19,253

 

2025

 

$21,194

 

Greater than 5 years

$

127,680

 

$177,740

 

Total Grants Repayable

$

315,259

 

$308,692

 

 

d)Long-Term Debt

 

In 2016, the Company entered into a 7-year loan agreement with Namur Invest for €440,000 Euros with a fixed interest rate of 4.85%, maturing in December 2023. As of SeptemberJune 30, 2020,2021, the principal balance payable was $284,741.$220,175.

 

In 2016, the Company entered into a 15-year loan agreement with ING for €270,000 Euros with a fixed interest rate of 2.62%, maturing in December 2031. As of SeptemberJune 30, 2020,2021, the principal balance payable was $249,887.$238,224.

 

In 2017, the Company entered into a 4-year loan agreement with Namur Invest for €350,000 Euros with a fixed interest rate of 4.00%, maturing in June 2021. As of SeptemberJune 30, 2020,2021, the principal balance payable was $102,962.$0.

 

In 2017, the Company entered into a 7-year loan agreement with SOFINEX for up to €1 million Euros with a fixed interest rate of 4.50%, maturing in September 2024. As of SeptemberJune 30, 2020,2021, €1 million Euros hashad been drawn down under this agreement and the principal balance payable was $1,055,139.$888,857.

 

In 2018, the Company entered into a 4-year loan agreement with Namur Innovation and Growth for €500,000 Euros with a fixed interest rate of 4.00%4.0%, maturing in June 2022. As of SeptemberJune 30, 2020,2021, the principal balance payable was $317,254.$177,839.

 

In 2019, the Company entered into a 4-year loan agreement with Namur Innovation and Growth for €500,000 Euros with a fixed interest rate of 4.80%, maturing in September 2023.2024. As of SeptemberJune 30, 2020,2021, the principal balance payable was $586,189.$553,460.




VOLITIONRX

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 June 30, 2021, the principal balance payable was $963,562.

22

Table of Contents

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 SeptemberJune 30, 2020,2021, the total balance for long-term debt payable was $2,596,172$3,042,117 and the payments remaining were as follows:

 

2020 - remaining

$

286,719

2021

$

777,691

2021 - remaining

 

$508,394

 

2022

$

652,975

 

$779,595

 

2023

$

552,544

 

$678,071

 

2024

$

403,760

 

$527,666

 

2025

 

$145,755

 

Greater than 5 years

$

181,739

 

$784,900

 

Total

$

2,855,428

 

$3,424,381

 

Less: Amount representing interest

$

(259,256)

 

$(382,264)

Total Long-Term Debt

$

2,596,172

 

$3,042,117

 

 

e) Collaborative Agreement Obligations

In 2015, the Company entered into a research sponsorship agreement with DKFZ in Germany for a 3-year period for €338,984 Euros. As of September 30, 2020, $87,928 is still to be paid by the Company under this agreement.

 

In 2016, the Company entered into a research co-operation agreement with DKFZ in Germany for a 5-yearfive-year period for €400,000 Euros.€400,000. As of SeptemberJune 30, 2020, $234,4752021, $237,029 is still to be paid by the Company under this agreement.

In 2017, the Company entered into a collaborative research agreement with Munich University in Germany for a 3-year period for €360,000 Euros.  As of September 30, 2020, $0 is still to be paid by the Company under this agreement.

In 2017, the Company entered into a clinical study research agreement with the University of Michigan for a 3-year period for up to $3 million. This agreement was amended in February 2020 to redefine a new clinical study. Pursuant to the terms of the amendment, the parties acknowledged that, although not fully completed, the requirements of the original clinical study had been satisfied, including any and all payment obligations by the Company. Further, the Amendment provided that a new clinical study would be undertaken at no additional cost to the Company. As of September 30, 2020, up to $138,000 is still accrued by the Company for any additional expenses for the new clinical study.

 

In 2018, the Company entered into a research collaboration agreement with the University of Taiwan for a 3-yearthree-year period for a cost to the Company of up to $2.55 million payable over such period. As of SeptemberJune 30, 2020, $892,5002021, $510,000 is still to be paid by the Company under this agreement.

 

In 2019, the Company entered into a research collaboration agreement with the University of Taiwan for a 2-yeartwo-year period to collect a total of 1,200 samples for a cost to the Company of up to $320,000 payable over such period. As of SeptemberJune 30, 2020, $160,0002021, $0 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”("TAMU") in consideration for the license granted to the Company for a 5-yearfive-year period for a cost to the Company of up to $400,000 payable over such period. As of SeptemberJune 30, 2020, $329,986 is still to be paid by the Company under this agreement.

In 2019, the Company entered into a lyophilization study and a CE marking project including GMP validation and documentation with Biomerica Inc. for $160,000. As of September 30, 2020, $54,6632021, $122,123 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 6six months for a cost to the Company of €54,879 Euros.€54,879. Subsequently the parties entered into an amendment to the agreement with an additional cost to the Company of €155,115. As of SeptemberJune 30, 2020, $64,3382021, $94,947 is still to be paid by the Company under thisthe amended agreement.




VOLITIONRX

As of June 30, 2021, the total amount to be paid for future research and collaboration commitments was approximately $964,099 and the payments remaining were as follows:

2021 - remaining

 

$842,026

 

2022 - 2025

 

$122,073

 

Total Collaborative Agreement Obligations 

 

$964,099

 

23

Table of Contents

VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 8 - Commitments and Contingencies (continued)

f) Other Commitments

 

e) Collaborative Agreement Obligations (continued)

As of September 30, 2020, the total amount to be paid for future research and collaboration commitments was approximately $1.96 million and the annual payments remaining were as follows:

2020 - remaining

$

625,464

2021 - 2024

$

1,336,426

Total Collaborative Agreement Obligations  

$

1,961,890

f)Other Commitments

Volition Vet

On August 15, 2020, the Company entered into a consulting services agreement with Novis Animal Solutions LLC (“Novis”), to provide chief commercial officer services for Volition Vet in exchange for payment of consultancy fees, 5% sales commission on third party sales capped at $20,000 per quarter and a potential equity interest of up to 2% in Volition Vet upon achievement of revenue milestones. The agreement superseded the existing consulting services agreement between the parties dated August 7, 2019 which terminated and is of no further effect. The term of the contract is perpetual and terminable on 2 months’ written notice from either party. As of September 30, 2020, Novis has no equity interest in Volition Vet. See Note 9 for details regarding termination of the consulting services agreement after September 30, 2020.

 

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 SeptemberJune 30, 2020,2021, TAMU has a 7.5%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”("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”"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-issuednewly 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, Euros, 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 Euros)321,736) and recorded a holdback liability of $55,404 (€50,000 Euros) to be50,000). During the three months ended March 31, 2021, an amount of €43,152 was paid afterin full settlement of the holdback period of 9 months following the closing (subject to offset for breaches of representations and warranties).amount due.

 

In connection with the transaction agreement, the Company also entered into a 2-yeartwo-year Managing Director’sDirector's agreement with the founder of Octamer to continue to manage Volition Germany for a payment of €288,000 Euros payable in equal monthly installments over such 2-yeartwo-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’sGermany'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 5five years post-closing.




VOLITIONRX

During the three months ended March 31, 2020, the Company recorded approximately $753,000 in January 2020 as compensation expense as a result of cash paid in, holdback liability, stock issued and assumption of expenses. As of June 30, 2021, $85,330 is still to be paid by the Company under the Managing Director's agreement and $229 is payable under the 6% royalty agreement.

24

Table of Contents

VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

NoteNote 8 - Commitments and Contingencies (continued)

f) Other Commitments (continued)

 

f)Other Commitments (continued)

The Company recorded approximately $753,000 in compensation expense as a result of cash paid, holdback liability, stock issued and assumption of expenses. As of September 30, 2020, $211,028 is still to be paid by the Company under the Managing Director’s agreement and $229 is payable under the 6% royalty agreement.

g)Legal Proceedings

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

Note 9 – Subsequent Events

From October 1 to November 4, 2020, the Company raised aggregate net proceeds of approximately $471,600 under the equity distribution agreement through the sale of 133,122 shares of its common stock in accordance with a Rule 10b5-1 plan.

On October 1, 2020, the Company signed a new office lease in London, UK for total fee payable of approximately $111,540 (£86,400) at a rental rate of approximately $7,000 (£5,400) per month for a period of 16 months until January 31, 2022.

On October 5, 2020, the Company borrowed $973,000 (€830,000 Euros) from Preface S.A at an interest rate of 4%, repayable over 10 years to finance the acquisition and construction of a production facility in Belgium.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’sCompany's diagnostic tests, including those proposed for use as an adjunct diagnostic tool for common and aggressive forms of Non-Hodgkin’sNon-Hodgkin's Lymphoma. The initial projects contemplated by the agreement relating to Non-Hodgkin’sNon-Hodgkin's Lymphoma obligate the Company to pay anin 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’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 June 30, 2021, $18,344 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.

Note 9 - Subsequent Events

 

On November 4, 2020,July 14, 2021, the Board of Directors of the Company terminated a consulting services agreement with Novis Animal Solutions LLC (“Novis”) to provide chief commercial officer services for Volition Vet. The termination was effective immediately andamended the compensation payable to Novis for the required two-month notice period and a general releaseterms of any claims will be $19,000.

On November 10, 2020, the Company entered into a consulting services agreement through a related party transaction between its wholly-owned subsidiary, Singapore Volition and PB Commodities Pte Ltd (“PB Commodities”). This agreement is effective December 1, 2020 and provides for consultancy services to be rendered by Cameron Reynolds through PB Commodities to Singapore Volition. Singapore Volition will also make available the services of Mr. Reynolds, as Group Chief Executive Officer, to the Company and its subsidiaries,certain outstanding options granted pursuant to the services agreements entered into by2011 Equity Incentive Plan such that (i) the expiration date for outstanding options to purchase up to an aggregate of 292,000 shares of the Company's common stock, granted on July 23, 2015, was extended from five years and between Singapore Volitionsix months after vesting to ten years from the date of grant, or an expiration date of July 23, 2025, (ii) the expiration date for outstanding options to purchase up to an aggregate of 6,367 shares of the Company's common stock, granted on March 20, 2013, was extended from six years after vesting to ten years from the date of grant, or an expiration date of March 20, 2023, and (iii) the expiration date for outstanding options to purchase up to an aggregate of 8,151 shares of the Company's common stock, granted September 2, 2013, was extended from six years after vesting to ten years from the date of grant, or an expiration date of September 2, 2023. As a result of these amendments $452,433 will be recorded as additional options expense.

From July 1 to August 5, 2021, the Company or its subsidiaries. The termraised aggregate net proceeds (net of broker's commissions and fees) of approximately $3,830 under the agreement is perpetual, commencing on December 1, 2020 until terminated upon six months’ prior notice. The agreement includes a six-month non-compete following terminationEDA through the sale of the agreement. The consulting services agreement replaces in its entirety the employment agreement by and between Volition Diagnostics and Mr. Reynolds, dated March 7, 2017, which was terminated upon mutual agreement of the parties.  PB Commodities will receive a monthly fee of $35,650 in exchange for the services provided by Mr. Reynolds.




VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

Note 9 – Subsequent Events (continued)

On November 12, 2020, the Company entered into an Equity Distribution Agreement (the “EDA”) with Cantor Fitzgerald & Co. (“Cantor”) and Oppenheimer, to sell1,157 shares of its Common Stock, par value $0.001 (the “Common Stock”), havingcommon stock.

Effective August 3, 2021, the Company granted stock options to purchase an aggregate offering pricemaximum of up to $25,000,000 (the “Shares”) from time to time, through an “at the market” offering program (the “New ATM Offering”) under which Oppenheimer and Cantor will jointly act as sales agents (the “Sales Agents”).  The offer and sale926,640 shares of the Shares will be madecommon stock, pursuant to the Company’s effective “shelf” registration statement on Form S-3 (File No. 333-227248),2015 Stock Incentive Plan, to various designated directors, officers and employees, with an exercise price of $3.40 per share. The actual number of options that are eligible for the base prospectus contained therein, dated September 28, 2018,time-based vesting is fixed based upon the timely achievement of certain pre-determined corporate milestones by the Company as set forth in the grant documents. The options eligible for vesting shall vest in two equal installments at 12 months and a prospectus supplement related24 months from the grant date, subject to continued service and expire 10 years from the New ATM Offering, dated November 12, 2020.  Thedate of grant. 

Effective August 3, 2021, the Company is not obligated to sell anygranted RSUs for an aggregate maximum of 460,191 shares under the EDA.  The Company will pay the Sales Agents a commission of up to 3% of the aggregate gross proceeds from each sale of Shares occurringcommon stock, pursuant to the EDA, if any.2015 Stock Incentive Plan, to various designated directors, officers and employees. The actual number of RSUs that are eligible for the time-based vesting is fixed based upon the timely achievement of certain pre-determined corporate milestones by the Company has also agreed to reimburse the Sales Agents for legal fees and disbursements, not to exceed $50,000as set forth in the aggregate,grant documents. The RSUs eligible for vesting shall vest in connection withtwo equal installments at 12 months and 24 months from the EDA. The EDA may be terminated by the Sales Agents or the Company at any time upon written noticegrant date, subject to the other party(ies), as permitted therein.continued service.

 

END NOTES TO FINANCIALS




25

Table of Contents

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

 

Cautionary Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020, 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, any 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. For instance, if we fail to develop and commercialize diagnostic products, we may be unable to execute our plan of operations. Other risks and uncertainties include those associated with the COVID-19 pandemic; our failure to obtain necessary regulatory clearances or approvals to distribute and market future products in the veterinary or clinical in-vitro diagnostics, or IVD, market; a failure by the marketplace to accept the products in our development pipeline or any other diagnostic products we might develop; our failure to secure adequate intellectual property protection; we will face fierce competition and our intended products may become obsolete due to the highly competitive nature of the diagnostics market and its rapid technological change; 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.

You should read this Report in its entirety, together with our Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as filed with the SEC on February 20, 2020, or our Annual 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.




Company Overview

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 conjunctionthis 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 interim consolidated financial statements and related condensed notes thereto, which are included in Part ISEC. Please refer to the section of this Report.Report entitled "Cautionary Note Regarding Forward-Looking Statements" for additional information.

Company Overview

 

VolitionRx is a multi-national epigenetics company that applies its NucleosomicsTM platform through its subsidiaries to develop simple, easy to use, cost-effective blood tests to help diagnose a range of cancers and some other diseases. diseases, including sepsis and COVID-19, that are associated with the presence in the blood of networks of fibers released from activated neutrophils, a phenomenon known as NETosis. We hope that through earlier diagnosis we can help save and improve the quality of human and animals' lives throughout the world.

Our testsassays are based on the science of NucleosomicsTM, which is the practice of identifying and measuring nucleosomes in the bloodstream or other bodily fluid, - since changes in these parameters are an indication that disease is present.

 

OurVolition's approach is to investigate the epigenetic structure of chromatin and nucleosomes rather than investigating only the DNA sequence. We are continuously developing new technologies including:

 

·A suite of low cost Nu.QTM immunoassays that can accurately measure nucleosomes containing numerous epigenetic signals or structure. 

·

A suite of low cost Nu.Q® immunoassays that can accurately measure nucleosomes containing numerous epigenetic signals or structures, now being developed on a range of different enzyme-linked immunosorbent assay, or ELISA, platforms.

·

Nu.Q® Capture technology to isolate or enrich nucleosomes containing particular epigenetic signals or structures for a wide range of potential scientific and medical applications, e.g., the enrichment of nucleosomes of tumor origin in blood samples taken from cancer patients.

·

The production of synthetic (recombinant) nucleosomes, containing exact defined epigenetic signals and structures, which is now in-house. These nucleosomes are used to ensure maximal accuracy of Nu.Q® immunoassay tests but also have many other applications including Research Use Only, or RUO, kits and as tools in epigenetic drug development.

 

·Nu.QTM Capture technology to isolate or enrich nucleosomes containing particular epigenetic signals or structures for a wide range of potential scientific and medical applications, such as the enrichment of nucleosomes of tumor origin in blood samples taken from cancer patients.  

·We plan to develop an ability to produce synthetic (recombinant) nucleosomes containing exact defined epigenetic signals and structures. These are used to ensure exquisite accuracy of Nu.QTM immunoassay tests butVolition has also have many other applications including as tools in epigenetic drug development. 

In addition to human diagnostics we are also developingdeveloped the use of the Nu.QTM® technology in veterinary applications and are planning the launch oflaunched its first product, the Nu.QTM® Vet Cancer Screening Test, in latethe fourth quarter of 2020.  Further studiesWe are ongoing or planned to extendin the rangeprocess of cancers detected in dogsdeveloping additional veterinary products, including a treatment monitoring test, a disease recurrence test and then in other animals.a point-of-care platform. Our extensive intellectual property portfolio includes the coverage of veterinary applications.

 

Commercialization Strategy

Volition believes that 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 plan to work with partners to commercialize Nu.Q®worldwide.

Commercialization will take multiple forms in various markets and opportunities including, but not limited to:

·

Licensing and direct sales of the Nu.Q® Vet Cancer Screening Test.

·

Sales of veterinary clinical products utilizing Nu.Q® Vet assays and/or Nu.Q® Capture reagents through distributor networks.

·

Licensing of intellectual property, or IP, for clinical products utilizing Nu.Q® assays and/or Nu.Q® Capture reagents.

·

Sales of clinical products utilizing Nu.Q® assays and/or Nu.Q® Capture reagents through distributor networks.

·

Licensing of IP for RUO kit sales of Nu.Q® assays and/or Nu.Q® Capture reagents.

·

Licensing of IP for laboratory developed patient testing services utilizing Nu.Q® assays and/or Nu.Q® Capture reagents.

·

Provision of direct research services in the processing of samples using Nu.Q® RUO assays and/or Nu.Q® Capture.

26

Table of Contents

Developments - COVID-19 Pandemic

 

On March 11, 2020, the World Health Organization designated the outbreak of the novel strain of coronavirus known as COVID-19 as a global pandemic. Governments and businesses around the world have taken unprecedented actions to mitigate the spread of COVID-19, including, but not limited to, shelter-in-place orders, quarantines, significant restrictions on travel, as well as restrictions that prohibit many employees from going to work. Uncertainty with respect to the economic effects of the pandemic has introduced significant volatility in the financial markets.

 

DuringThroughout 2020 and the first ninesix months of 2020,2021, we have implemented contingency planning to protect the health and well-being of our employees, with mostthe majority of our employees working remotely where possible. We have implemented travel restrictions as well as protocols limiting visitor protocolsaccess to our facilities, and we are following social distancing practices. We did not observe significant impacts on

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, orfinancial condition, and results of operations forin the quarter ended September 30, 2020 due tofuture is highly uncertain and will be affected by a number of factors. These include the global emergenceduration 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 actions taken to slow its spread. Tomeasures, the extenteffect of government stabilization and recovery efforts, and the pandemic worsens, we cannot predict the effects it may have on our business, in particular with respect to demand for our services, our strategy, and our prospects, or the impact on our financial results.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 SeptemberJune 30, 2020,2021, we had cash and cash equivalents of approximately $20.9$27.9 million.

 

Net cash used in operating activities was $13.7$11.6 million and $10.1$9.2 million for the ninesix months ended SeptemberJune 30, 20202021 and SeptemberJune 30, 2019,2020, respectively. The increase in cash used in operating activities for the period ended SeptemberJune 30, 20202021 when compared to same period in 20192020 was primarily due to increased expenditures on antibodies, sample purchases, stage paymentpayroll costs reflecting growth in staff numbers, higher legal and professional fees in relation to a collaborator partnerthe registered public offering and common stock issued for services.an increase in marketing expenses.

 

Net cash used in investing activities was $0.6$0.7 million and $0.4$0.6 million for the ninesix months ended SeptemberJune 30, 20202021 and SeptemberJune 30, 2019,2020, respectively. The increase was primarily due to purchases of laboratory equipment.




Net cash provided by financing activities was $18.5$20.7 million and $16.4$13.9 million for the ninesix months ended SeptemberJune 30, 20202021 and SeptemberJune 30, 2019,2020, respectively. The increase in cash provided by financing activities for the period ended SeptemberJune 30, 20202021 when compared to same period in 20192020 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, $1.2 million in cash received from the issuance of shares of common stock pursuant to the 2018 Equity Distribution Agreement and $1.2 million in cash received from the issuance of shares of common stock pursuant to the 2020 Equity Distribution Agreement, compared to $12.7 million in net cash received from the issuance of shares of common stock in a registered public offering in May 2020 and $6.5$1.7 million in net cash received from the issuance of shares of common stock pursuant to the 2018 Equity Distribution Agreement. For additional information on the "at the market offering program," refer to Note 6, Common Stock - Equity Distribution Agreements, of the Notes to Condensed Consolidated Financial Statements.

27

Table of Contents

 

The following table summarizes our approximate contractual payments due by year as of SeptemberJune 30, 2020.2021.

 

Approximate Payments (Including Interest) Due by Year

Approximate Payments (Including Interest) Due by Year

Approximate Payments (Including Interest) Due by Year

 

 

 

 

 

 

 

 

 

 

Total

 

2020 (Remaining)

 

2021 - 2024

 

2025 +

 

Total

 

2021 (Remaining)

 

2022 - 2025

 

2026 +

 

Description

 

$

 

$

 

$

 

$

 

$

 

 

$

 

 

$

 

 

$

 

Finance Lease Obligations

 

746,984

 

18,259

 

263,688

 

465,037

 

699,740

 

36,917

 

256,467

 

406,356

 

Operating Lease Obligations

 

278,781

 

74,831

 

203,950

 

-

 

413,717

 

141,985

 

271,732

 

-

 

Grants Repayable

 

315,259

 

14,186

 

173,393

 

127,680

 

308,692

 

-

 

130,952

 

177,740

 

Long-Term Debt

 

2,855,428

 

286,719

 

2,386,970

 

181,739

 

3,424,381

 

508,394

 

2,131,087

 

784,900

 

Collaborative Agreements Obligations

 

1,961,890

 

625,464

 

1,336,426

 

-

 

 

964,099

 

 

 

842,026

 

 

 

122,073

 

 

 

-

 

Total

 

6,158,342

 

1,019,459

 

4,364,427

 

774,456

 

 

5,810,629

 

 

 

1,529,322

 

 

 

2,912,311

 

 

 

1,368,996

 

  

We intend to use our cash reserves to predominantly fund further research and development activities. We do not currently have any substantial source of revenues and expect to rely on additional future financing, through the sale of equity or debt securities, or the sale of licensing rights, to provide sufficient funding to execute our strategic plan. There is no assurance that we will be successful in raising further funds.

 

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 IVD and veterinary marketmarkets 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 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 year ended December 31, 20192020 an explanatory paragraph regarding factors that raise substantial doubt that we will be able to continue as a going concern.




28

Table of Contents

Results of Operations

 

Comparison of the Three Months Ended SeptemberJune 30, 20202021 and SeptemberJune 30, 20192020

 

The following table sets forth our results of operations for the three months ended on SeptemberJune 30, 2021 and June 30, 2020, and September 30, 2019, respectively:

 

Three Months ended September 30,

 

Increase

 

Percentage Increase

 

Three Months Ended June 30,

 

Increase

 

Increase

 

2020

 

2019

 

(Decrease)

 

(Decrease)

 

2021

 

2020

 

(Decrease)

 

(Decrease)

 

$

 

$

 

$

 

%

 

$

 

 $

 

 $

 

 %

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Service

-

 

16,204

 

(16,204)

 

(100%)

Royalty

-

 

892

 

(892)

 

(100%)

 

-

 

1,872

 

(1,872)

 

(100%)

 

Product

575

 

-

 

575

 

100%

 

 

24,782

 

 

 

3,322

 

 

 

21,460

 

 

>100%

Total Revenues

575

 

17,096

 

(16,521)

 

(97%)

 

 

24,782

 

 

 

5,194

 

 

 

19,588

 

 

>100%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

3,180,177

 

2,642,610

 

537,567

 

20%

 

3,649,469

 

3,492,845

 

156,624

 

4%

General and administrative

1,080,308

 

1,354,992

 

(274,684)

 

(20%)

 

1,816,599

 

1,508,836

 

307,763

 

20%

Sales and marketing

244,510

 

195,641

 

48,869

 

25%

 

 

459,371

 

 

 

215,891

 

 

 

243,480

 

 

>100%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Operating Expenses

4,504,995

 

4,193,243

 

311,752

 

7%

 

 

5,925,439

 

 

 

5,217,572

 

 

 

707,867

 

 

 

14%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Grant income

-

 

-

 

-

 

-%

 

391,532

 

90,946

 

300,586

 

>100%

Gain on disposal of fixed assets

200,393

 

-

 

200,393

 

100%

(Loss) Gain on disposal of fixed assets

 

(26,166)

 

93,202

 

(119,368)

 

(100%)

 

Interest income

2,801

 

27,633

 

(24,832)

 

(90%)

 

492

 

7,741

 

(7,249)

 

(94%)

 

Interest expense

(34,722)

 

(32,291)

 

2,431

 

8%

 

 

(39,688)

 

 

(22,604)

 

 

17,084

 

 

 

76%

Other expenses

-

 

-

 

-

 

-%

Total Other Income

 

326,170

 

169,285

 

156,885

 

93%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Other Income (Expenses)

168,472

 

(4,658)

 

173,130

 

>100%

Net Loss

(4,335,948)

 

(4,180,805)

 

155,143

 

4%

 

 

(5,574,487)

 

 

(5,043,093)

 

 

531,394

 

 

 

11%

 

Revenues

 

Our operations are still predominantly in the research and development stage and we had limited revenues of $575$24,782 and $17,096$5,194 during the three months ended SeptemberJune 30, 2021 and June 30, 2020, and Septemberrespectively. The main source of revenues during the three months ended June 30, 2019, respectively.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 $4.5$5.9 million from $4.2$5.2 million forduring the three months ended SeptemberJune 30, 20202021 and SeptemberJune 30, 2019,2020, respectively, as a result of the factors described below.




29

Table of Contents

Research and Development Expenses

 

Research and development expenses increased to $3.2 million from $2.6$3.6 million for the three months ended SeptemberJune 30, 2020 and September2021 from $3.5 million for the three months ended June 30, 2019, respectively.2020. This increase was primarily related to higher antibodypersonnel expenses offset by lower research and collaboration costs sample costs, laboratoryduring the period.

 

 

Three Months Ended June 30,

 

 

 

 

 

 

2021

 

 

2020

 

 

Change

 

 

 

$

 

 

$

 

 

$

 

Personnel expenses

 

 

1,536,490

 

 

 

1,212,777

 

 

 

323,713

 

Stock-based compensation

 

 

25,347

 

 

 

114,872

 

 

 

(89,525)

Direct research and development expenses

 

 

1,664,941

 

 

 

1,936,125

 

 

 

(271,184)

Other research and development

 

 

161,830

 

 

 

(50,770)

 

 

212,600

 

Depreciation and amortization

 

 

260,861

 

 

 

279,841

 

 

 

(18,980)

Total research and development expenses

 

 

3,649,469

 

 

 

3,492,845

 

 

 

156,624

 

General and Administrative Expenses

General and administrative expenses increased to $1.8 million from $1.5 million for the three months ended June 30, 2021 and June 30, 2020, respectively. This increase was primarily due to higher personnel expenses during the period.

 

Three Months ended

September 30,

 

 

 

Three Months Ended June 30,

 

 

2020

 

2019

 

Change

 

2021

 

2020

 

Change

 

$

 

$

 

$

 

$

 

 

$

 

 

$

 

Personnel expenses

1,152,952

 

992,868

 

160,084

 

776,911

 

511,652

 

265,259

 

Stock-based compensation

75,054

 

99,423

 

(24,369)

 

240,855

 

204,055

 

36,800

 

Direct research and development expenses

1,606,316

 

1,048,195

 

558,121

Other research and development

163,845

 

328,611

 

(164,766)

Legal and professional fees

 

490,777

 

507,732

 

(16,955)

Other general and administrative

 

275,499

 

230,146

 

45,353

 

Depreciation and amortization

182,010

 

173,513

 

8,497

 

 

32,557

 

 

 

55,251

 

 

 

(22,694)

Total research and development expenses

3,180,177

 

2,642,610

 

537,567

Total general and administrative expenses

 

 

1,816,599

 

 

 

1,508,836

 

 

 

307,763

 

 

General and Administrative Expenses

General and administrative expenses decreased to $1.1 million from $1.4 million for the three months ended September 30, 2020 and September 30, 2019, respectively. This was primarily due to lower personnel costs offset by higher professional fees in respect of financing activities during the period.

 

Three Months ended

September 30,

 

 

 

2020

 

2019

 

Change

 

$

 

$

 

$

Personnel expenses

483,033

 

562,964

 

(79,931)

Stock-based compensation

304,921

 

224,874

 

80,047

Legal and professional fees

327,346

 

196,020

 

131,326

Other general and administrative

(87,777)

 

349,733

 

(437,510)

Depreciation and amortization

52,785

 

21,401

 

31,384

Total general and administrative expenses

1,080,308

 

1,354,992

 

(274,684)

Sales and Marketing Expenses

 

Sales and marketing expenses were at the same level ofincreased to $0.5 million from $0.2 million for the three months ended SeptemberJune 30, 2021 and June 30, 2020, and September 30, 2019, respectively. ThereThis increase was an increase inprimarily due to higher personnel expenses during the period and direct marketing and professional fees offset by lower travel and personnel costs during the period.fees. 

 

Three Months ended

September 30,

 

 

 

Three Months Ended June 30,

 

 

2020

 

2019

 

Change

 

2021

 

2020

 

Change

 

$

 

$

 

$

 

$

 

 

$

 

 

$

 

Personnel expenses

115,402

 

135,680

 

(20,278)

 

231,082

 

110,753

 

120,329

 

Stock-based compensation

48,709

 

46,088

 

2,621

 

71,542

��

 

41,713

 

29,829

 

Direct marketing and professional fees

80,399

 

13,873

 

66,526

 

 

156,747

 

 

 

63,425

 

 

 

93,322

 

Total sales and marketing expenses

244,510

 

195,641

 

48,869

 

 

459,371

 

 

 

215,891

 

 

 

243,480

 

 

Other Income (Expenses)

 

For the three months ended SeptemberJune 30, 2020,2021, the Company’sCompany's other income was $168,472$326,170 compared to other expensesincome of $4,658$169,285 for the three months ended SeptemberJune 30, 2019.2020. The increase in other income was mainly due to a gain on disposal of a fixed asset, offset by less interest received from cash deposited in an overnight money market deposit account.grant income.

 

Net Loss

 

For the three months ended SeptemberJune 30, 2020,2021, the Company’sCompany's net loss was $4.3$5.6 million in comparison to a net loss of $4.2$5.0 million for the three months ended SeptemberJune 30, 2019.2020. The change was primarily a result of the factors described above.




30

Table of Contents

Comparison of the NineSix Months Ended SeptemberJune 30, 20202021 and SeptemberJune 30, 20192020

 

The following table sets forth our results of operations for the ninesix months ended on SeptemberJune 30, 2021 and June 30, 2020, and September 30, 2019, respectively:

 

Nine Months Ended

September 30,

 

Increase

 

Percentage Increase

 

Six Months Ended June 30,

 

Increase

 

Percentage Increase

 

2020

 

2019

 

(Decrease)

 

(Decrease)

 

2021

 

2020

 

(Decrease)

 

(Decrease)

 

$

 

$

 

$

 

%

 

$

 

$

 

$

 

$

 

 

 

 

 

 

 

 

Service

-

 

16,204

 

(16,204)

 

(100%)

Royalty

2,112

 

892

 

1,220

 

>100%

 

-

 

2,112

 

(2,112)

 

(100)%

Product

4,201

 

-

 

4,201

 

100%

 

 

50,312

 

 

 

3,626

 

 

 

46,686

 

 

>100%

Total Revenues

6,313

 

17,096

 

(10,783)

 

(63%)

 

 

50,312

 

 

 

5,738

 

 

 

44,574

 

 

>100%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

10,567,988

 

7,596,097

 

2,971,891

 

39%

 

7,522,547

 

7,387,811

 

134,736

 

2%

General and administrative

4,292,666

 

4,020,893

 

271,773

 

7%

 

3,626,759

 

3,212,358

 

414,401

 

13%

Sales and marketing

734,355

 

718,047

 

16,308

 

2%

 

 

886,772

 

 

 

489,845

 

 

 

396,927

 

 

 

81%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Operating Expenses

15,595,009

 

12,335,037

 

3,259,972

 

26%

 

 

12,036,078

 

 

 

11,090,014

 

 

 

946,064

 

 

 

9%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Grant income

98,870

 

-

 

98,870

 

100%

 

391,532

 

98,870

 

292,662

 

>100%

Gain on disposal of fixed assets

293,595

 

-

 

293,595

 

100%

(Loss) / Gain on disposal of fixed assets

 

(26,167)

 

93,202

 

(119,369)

 

(100)%

Interest income

48,956

 

68,656

 

(19,700)

 

(29%)

 

2,213

 

46,155

 

(43,942)

 

(95)%

Interest expense

(91,105)

 

(95,507)

 

(4,402)

 

(5%)

 

 

(81,869)

 

 

(56,383)

 

 

25,486

 

 

 

45%

Other expenses

-

 

(196,957)

 

(196,957)

 

(100%)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Other Income (Expenses)

350,316

 

(223,808)

 

574,124

 

>100%

Total Other Income

 

285,709

 

181,844

 

103,865

 

57%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Loss

(15,238,380)

 

(12,541,749)

 

2,696,631

 

22%

 

 

(11,700,057)

 

 

(10,902,432)

 

 

797,625

 

 

 

7%

 

 

 

 

 

 

 

Revenues

 

Our operations are still predominantly in the research and development stage and we had limited revenues of $6,313$50,312 and $17,096$5,738 during the ninesix months ended SeptemberJune 30, 2021 and June 30, 2020, and Septemberrespectively. The main source of revenues during the six months ended June 30, 2019, respectively.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 $15.6$12.0 million from $12.3$11.1 million for the ninesix months ended SeptemberJune 30, 20202021 and SeptemberJune 30, 2019,2020, respectively as a result of the factors described below.

 

31

Table of Contents

Research and Development Expenses

 

Research and development expenses increased to $10.6$7.5 million for the ninesix months ended SeptemberJune 30, 2020,2021, from $7.6$7.4 million for the ninesix months ended SeptemberJune 30, 2019.2020. This increase in overall research and development expenditures was primarily related to higher antibody costs, higher sample costs, laboratory expenses andincreased personnel expenses offset by lower antibody and research and collaboration costs during the 2020 period.

 

 

Nine Months Ended

September 30,

 

 

 

2020

 

2019

 

Change

 

$

 

$

 

$

Personnel expenses

3,611,730

 

2,850,614

 

761,116

Stock-based compensation

252,344

 

298,686

 

(46,342)

Direct research and development expenses

4,970,879

 

3,276,582

 

1,694,297

Other research and development

1,178,098

 

651,764

 

526,334

Depreciation and amortization

554,937

 

518,451

 

36,486

Total research and development expenses

10,567,988

 

7,596,097

 

2,971,891




 

 

Six Months Ended June 30,

 

 

 

 

 

2021

 

 

2020

 

 

Change

 

 

 

$

 

 

$

 

 

$

 

Personnel expenses

 

 

3,028,929

 

 

 

2,506,925

 

 

 

522,004

 

Stock-based compensation

 

 

115,474

 

 

 

177,291

 

 

 

(61,817)

Direct research and development expenses

 

 

3,243,601

 

 

 

3,364,563

 

 

 

(120,962)

Other research and development

 

 

627,810

 

 

 

966,105

 

 

 

(338,295)

Depreciation and amortization

 

 

506,733

 

 

 

372,927

 

 

 

133,806

 

Total research and development expenses

 

 

7,522,547

 

 

 

7,387,811

 

 

 

134,736

 

General and Administrative Expenses

 

General and administrative expenses increased to $4.3$3.6 million from $4.0$3.2 million for the ninesix months ended SeptemberJune 30, 20202021 and SeptemberJune 30, 2019,2020, respectively. This increase was primarily due to higher professional fees in respect of financing activities, offset by lower personnel expenses and stock-based compensation chargeslegal fees during the 2020 period.

 

Nine Months Ended

September 30,

 

 

 

Six Months Ended June 30,

 

 

2020

 

2019

 

Change

 

2021

 

2020

 

Change

 

$

 

$

 

$

 

$

 

 

$

 

 

$

 

Personnel expenses

1,523,864

 

1,688,747

 

(164,883)

 

1,393,982

 

1,040,831

 

353,151

 

Stock-based compensation

616,241

 

655,639

 

(39,398)

 

574,721

 

311,320

 

263,401

 

Legal and professional fees

1,254,935

 

882,815

 

372,120

 

1,055,435

 

927,589

 

127,846

 

Other general and administrative

732,664

 

751,320

 

(18,656)

 

538,546

 

820,441

 

(281,895)

Depreciation and amortization

164,962

 

42,372

 

122,590

 

 

64,075

 

 

 

112,177

 

 

 

(48,102)

Total general and administrative expenses

4,292,666

 

4,020,893

 

271,773

 

 

3,626,759

 

 

 

3,212,358

 

 

 

414,401

 

 

Sales and Marketing Expenses

 

Sales and marketing expenses were at the same level of $0.7increased to $0.9 million from $0.5 million for the ninesix months ended SeptemberJune 30, 2021 and June 30, 2020, and September 30, 2019, respectively. ThereThis increase was an increase inprimarily due to higher personnel expenses and direct marketing and professional fees offset by lower stock-based compensation costs and travel costs during the 2020 period.

    

Nine Months Ended

September 30,

 

 

 

Six Months Ended June 30,

 

 

2020

 

2019

 

Change

 

2021

 

2020

 

Change

 

$

 

$

 

$

 

$

 

 

$

 

 

$

 

Personnel expenses

377,100

 

463,466

 

(86,366)

 

415,219

 

261,698

 

153,521

 

Stock-based compensation

113,407

 

136,368

 

(22,961)

 

202,891

 

64,698

 

138,193

 

Direct marketing and professional fees

243,848

 

118,213

 

125,635

 

 

268,662

 

 

 

163,449

 

 

 

105,213

 

Total sales and marketing expenses

734,355

 

718,047

 

16,308

 

 

886,772

 

 

 

489,845

 

 

 

396,927

 

 

Other Income (Expenses)

 

For the ninesix months ended SeptemberJune 30, 2020,2021, the Company’sCompany's other income was $350,316$285,709 compared to other expensesincome of $223,808$181,844 for the ninesix months ended SeptemberJune 30, 2019.2020. This increase in other income was primarily due to gain on disposal of fixed assets, and grant income received, offset by other expenses related to the amendment to outstanding warrants which resulted in a $196,957 expense in the same period in 2019.income.

 

32

Table of Contents

Net Loss

 

For the ninesix months ended SeptemberJune 30, 2020,2021, the Company’sCompany's net loss was $15.2$11.7 million in comparison to a net loss of $12.5$10.9 million for the ninesix months ended SeptemberJune 30, 2019.2020. The change was a result of the factors described above.

 

Going Concern

 

We have not attained profitable operations 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 our "at the market offering program" with Cantor Fitzgerald & Co. and Oppenheimer & Co. Inc. under the Equity Distribution Agreement dated November 10, 2020 (see Note 6 of the notes to the condensed consolidated financial statements). 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

 

Our interim consolidated financial statements and accompanyingrelated condensed 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 complete summary of these policies is included in the notes to our financial statements. In general, management's estimates are based on current facts, historical experience, onexperiences, information from third party professionals and on various other assumptionsfactors that are believedit believes to be reasonable under the facts and 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.

 

33

Table of Contents

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information underdisclose this item.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 pursuant to(as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act.Act). Based upon that evaluation, our Principal Executive Officer and Principal Financial Officer have concluded, as they previously concluded as of December 31, 2019,2020, that our disclosure controls and procedures continue towere not be effective as of SeptemberJune 30, 2020,2021, because of material weaknesses in our internal control over financial reporting, as describedreferenced below and described in detail in our Annual Report.Report for the year ended December 31, 2020.




Changes

A material weakness is a deficiency, or a combination of deficiencies, in Internal Controlinternal control over Financial Reportingfinancial 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.

 

The Audit Committee ofdeficiencies identified involve the Board of Directors meets regularly with our financial management, and with the independent registered public accounting firm engaged by us. Internal accounting controls and the quality of financial reporting are discussed during these meetings. The Audit Committee has discussed with the independent registered public accounting firm matters required to be discussed by the auditing standards adopted or established by the Public Company Accounting Oversight Board (“PCAOB”). In addition, the Audit Committee and the independent registered public accounting firm have discussed the independent registered public accounting firm’s independence from the Company and its management, including the matters in the written disclosures required by PCAOB Rule 3526, “Communicating with Audit Committees Concerning Independence.”

As of September 30, 2020, we did not maintain sufficient internal controls over financial reporting due to insufficient:

·segregation of duties in some areas of Finance;   

·finance, the oversight in the area of Information Technology,information technologies, where certain processes may affect the internal controls over financial reporting;reporting, and

·the monitoring of review controls with respect to accounting for complex transactions.

During the first half of 2021, our management, with oversight from our audit committee, has implemented the following remediation steps to help address and mitigate some of the underlying deficiencies which gave rise to the previously disclosed material weaknesses and to improve our internal control over financial reporting:

·

hired additional full-time accounting resources and financial planning and analysis resources with appropriate levels of experience;

·

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

·

reallocated responsibilities across the finance and accounting organization to ensure that the appropriate level of knowledge and experience is applied based on complexity of tasks being undertaken.

  

We have developed, and are currently implementing, a remediation plan for these material weaknesses. Specifically, we have identified and selected a system for financial reporting that will allow further automation ofintend to take additional steps to mitigate the reporting process, thereby strengthening the control environment over financial reporting. issues identified. Such measures include but may not be limited to:

·

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 worktest the remediation plan outlined above, we may also identify additional measures to enhanceaddress 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.

Changes in Internal Control over Financial Reporting

Except for the ongoing remediation of the material weaknesses in internal controls over financial reporting we may determine that additional measures should be taken to address these or other control deficiencies, and/or that we should modify our remediation plan considering the Company’s size and growth.

There have beennoted above, no changes in our internal controlscontrol over financial reporting that occurredwere made during the fiscal quarter ended SeptemberJune 30, 2020, other than those described above,2021, that have materially affected, or are reasonably likely to materially affect, our internal controlscontrol over financial reporting.

 

Once the Company is engaged in stable business operations and has sufficient personnel and resources available, then our Board of Directors, in particular and in connection with the aforementioned deficiencies, will establish the following remediation measures:

·Additional Finance resources will be recruited to resolve the segregation of duties control weaknesses noted above; 

·Internal audit resources will be contracted to review and advise on control weaknesses across the organization; and  

·Specialist resources in IT and Human Resources will be recruited to recommend and implement relevant policy and processes to strengthen IT and Human Resources internal controls associated with 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.




PART

34

Table of Contents

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, as supplemented in Part II, Item 1A of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020.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 second quarter of 2021.

ITEM 3.DEFAULTS UPON SENIOR SECURITIES

 

None.

 

ITEM 4.MINE SAFETY DISCLOSURES

 

Not applicable.

 

ITEM 5.OTHER INFORMATION

 

Consulting Agreement

On November 10, 2020, the Company entered into a consulting services agreement through a related party transaction between its wholly-owned subsidiary, Singapore Volition and PB Commodities Pte. Ltd (“PB Commodities”).  The agreement is effective as of December 1, 2020 and provides for consultancy services to be rendered by Cameron Reynolds through PB Commodities to Singapore Volition.  Singapore Volition will also make available the services of Mr. Reynolds, as Group Chief Executive Officer, to the Company and its other subsidiaries, pursuant to services agreements entered into by and between Singapore Volition and the Company or its subsidiaries. PB Commodities will receive a monthly fee of $35,650 in exchange for the services provided by Mr. Reynolds.  The term of the agreement is perpetual until terminated upon six months’ prior notice. The agreement includes a six-month non-compete following termination of the agreement.  The consulting services agreement replaces in its entirety the employment agreement by and between Volition Diagnostics and Mr. Reynolds, dated March 7, 2017, which was terminated upon mutual agreement of the parties. The foregoing description of the consulting services agreement does not purport to be complete and is qualified in its entirety by such consulting services agreement, a copy of which is filed as Exhibit 10.1 to this Report.




Equity Distribution Agreement

On November 12, 2020, the Company entered into an Equity Distribution Agreement (the “EDA”) with Cantor Fitzgerald & Co. (“Cantor”) and Oppenheimer & Co. Inc. (“Oppenheimer”), to sell shares of its Common Stock, par value $0.001 (the “Common Stock”), having an aggregate offering price of up to $25,000,000 (the “Shares”) from time to time, through an “at the market” offering program (the “New ATM Offering”) under which Oppenheimer and Cantor will jointly act as sales agents (the “Sales Agents”).  The offer and sale of the Shares will be made pursuant to the Company’s effective “shelf” registration statement on Form S-3 (File No. 333-227248), the base prospectus contained therein, dated September 28, 2018, and a prospectus supplement related to the New ATM Offering, dated November 12, 2020.  The Company is not obligated to sell any shares under the EDA.  Subject to the terms and conditions of the EDA, the Sales Agents will use commercially reasonable efforts to sell on the Company’s behalf all of the Common Stock requested to be sold by the Company, consistent with its normal trading and sales practices, upon the Company’s instructions, including any price, time or size limits specified by the Company.  The Sales Agents’ obligations to sell Shares under the EDA are subject to the satisfaction of certain conditions. The Company will pay the Sales Agents a commission of up to 3% of the aggregate gross proceeds from each sale of Shares occurring pursuant to the EDA, if any, and has agreed to provide the Sales Agents with customary indemnification and contribution rights, including with respect to certain liabilities under the Securities Act of 1933, as amended. The Company has also agreed to reimburse the Sales Agents for legal fees and disbursements, not to exceed $50,000 in the aggregate, in connection with the EDA.  The EDA may be terminated by the Sales Agents or the Company at any time upon written notice to the other party(ies), as permitted therein. The foregoing description of the EDA does not purport to be complete and is qualified in its entirety by such EDA, a copy of which is filed as Exhibit 1.1 to this Report on Form 10-Q.

The legal opinion of Stradling Yocca Carlson & Rauth, P.C., counsel to the Company, related to the Shares is filed as Exhibit 5.1 to this Report.




ITEM 6. EXHIBITSNone.

 

35

Table of Contents

ITEM 6. EXHIBITS

 

 

 

 

Incorporated by Reference

 

Exhibit Number

 

Exhibit Description

 

Form

 

File No.

 

Exhibit

 

Filing Date

 

Filed

Herewith

 

 

 

 

 

 

 

 

 

 

 

 

 

1.110.1#

 

Equity Distribution Agreement, dated November 12, 2020, by and among the Company, Oppenheimer & Co. Inc. and Cantor Fitzgerald & Co.2015 Stock Incentive Plan, as amended

 

8-K

001-36833

10.1

06/22/21

 

 

 

X

5.110.2#†

 

Legal Opinion of Stradling Yocca Carlson & Rauth, P.C.

X

10.1#

Consulting Services Agreement dated November 10, 2020, by and between Singapore Volition Pte. LimitedGermany and PB Commodities Pte. Ltd.

X

23.13F Management SPRL (Gaetan Michel), dated January 29, 2021; First Amendment dated February 1, 2021; Second Amendment dated May 1, 2021.

 

Consent of Stradling Yocca Carlson & Rauth, P.C. (included in Exhibit 5.1 above).

10-Q

 

001-36833

 

10.7

 

05/11/21

 

 

 

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

32.132.1**

 

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.

2002.

 

 

 

 

 

 

 

 

 

X

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

 

#Indicates a management contract or compensatory plan or arrangement.

 

† Portions of this exhibit are redacted pursuant to Item 601(a)(6) and/or Item (b)(10)(iv) under Regulation S-K. The registrant agrees to furnish supplementally any omitted schedules to the SEC upon request.

*The certifications attached as Exhibit 32.1 accompany this 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”"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’sregistrant's filings under the Securities Act or the Exchange Act, irrespective of any general incorporation language contained in any such filing.




36

Table of Contents

SIGNATURESIGNATURES

 

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

VOLITIONRX LIMITED

Dated: August 11, 2021By:/s/ Cameron Reynolds

 

 

Cameron Reynolds

Dated: November 12, 2020

By:  /s/ Cameron Reynolds                                    

Cameron Reynolds

President and Chief Executive Officer

(Authorized Signatory and Principal Executive Officer)

Dated: August 11, 2021

 

/s/ Terig Hughes

 

 

 

Terig Hughes

 

Dated: November 12, 2020

By:  /s/ David Vanston                   ��                       

David Vanston

 

 

Chief Financial Officer and Treasurer

(Authorized Signatory and Principal Financial

Financial and Accounting Officer)

37


36