UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

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

 

For the quarterly period ended September 30, 2019March 31, 2020

 

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

 

For the transition period from ______ to _____

 

Commission File Number: 001-36833

 

VOLITIONRX LIMITED

(Exact name of registrant as specified in its charter)

 

Delaware

(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) 650–1351

(Registrant’s telephone number, including area code)

 

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

 

Title of Each Class

Trading SymbolsSymbol(s)

Name of Each Exchange on which

Registered

Common Stock

VNRX

NYSE American

 

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 accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

 Large accelerated filer

[   ]

 

 

Accelerated filer

[  ]

Non-accelerated filer

[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.Act).[   ]Yes  [X]No

 

As of November 6, 2019,May 4, 2020, there were 41,092,34041,206,632 shares of the registrant’s $0.001 par value common stock issued and outstanding.




VOLITIONRX LIMITED

QUARTERLY REPORT ON FORM 10-Q

FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2019MARCH 31, 2020

 

TABLE OF CONTENTS

 

 

 

PART I

 

FINANCIAL INFORMATION

 

 

PAGE

 

Item 1.

 

FINANCIAL STATEMENTS (UNAUDITED)

 

 

3

 

Item 2.

 

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

 

 

 

21

 

Item 3.

 

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

 

2827

 

Item 4.

 

CONTROLS AND PROCEDURES

 

 

2827

 

PART II

 

OTHER INFORMATION

 

 

 

Item 1.

 

LEGAL PROCEEDINGS

 

 

3029

 

Item 1A.

 

RISK FACTORS

 

 

3029

 

Item 2.

 

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

 

30

 

Item 3.

 

DEFAULTS UPON SENIOR SECURITIES

 

 

30

 

Item 4.

 

MINE SAFETY DISCLOSURES

 

 

30

 

Item 5.

 

OTHER INFORMATION

 

 

30

 

Item 6.

 

EXHIBITS

 

 

31

 

SIGNATURES

 

 

 

32

 

Use of Terms

 

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

 

NucleosomicsTM and Nu.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 Report are the property of their respective owners.




PART I FINANCIAL INFORMATION

 

ITEM 1.FINANCIAL STATEMENTS (UNAUDITED) 

 

 

Page

 

 

Condensed Consolidated Balance Sheets

4

 

Condensed Consolidated Statements of Operations and Comprehensive Loss

5

 

Condensed Consolidated Statements of Cash FlowsStockholders’ Equity

6

 

Condensed Consolidated Statements of Stockholders’ EquityCash Flows

7

 

Notes to the Condensed Consolidated Financial Statements

98

 

 




VOLITIONRX LIMITED

Condensed Consolidated Balance Sheets

(Expressed in United States Dollars, except share numbers)

 

September 30,

 

December 31,

March 31,

 

December 31,

2019

 

2018

2020

 

2019

$

 

$

$

 

$

ASSETS

(UNAUDITED)

 

 

(UNAUDITED)

 

 

 

 

 

Current Assets

 

 

 

 

 

 

Cash and cash equivalents

19,697,169

 

13,427,222

11,970,217

 

16,966,168

Accounts receivable

16,031

 

-

242

 

-

Prepaid expenses

409,074

 

245,441

753,047

 

267,518

Other current assets

184,856

 

229,755

377,780

 

322,593

Total Current Assets

20,307,130

 

13,902,418

13,101,286

 

17,556,279

 

 

 

 

 

 

Property and equipment, net

2,889,554

 

3,119,643

3,097,465

 

2,981,225

Operating lease right-of-use assets

193,918

 

-

330,131

 

381,483

Intangible assets, net

386,038

 

466,905

346,030

 

372,305

Total Assets

23,776,640

 

17,488,966

16,874,912

 

21,291,292

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS' EQUITY

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

Current Liabilities

 

 

 

 

 

 

Accounts payable

509,276

 

807,162

1,487,769

 

627,253

Accrued liabilities

1,868,994

 

923,034

2,139,085

 

2,168,588

Management and directors’ fees payable

48,775

 

1,200

55,660

 

21,979

Current portion of long-term debt

570,921

 

416,553

612,655

 

647,569

Current portion of finance lease liabilities

116,920

 

145,150

74,033

 

97,946

Current portion of operating lease liabilities

90,270

 

-

226,697

 

257,244

Current portion of grant repayable

38,174

 

40,094

38,583

 

39,295

Total Current Liabilities

3,243,330

 

2,333,193

4,634,482

 

3,859,874

 

 

 

 

 

 

Long-term debt, net of current portion

1,732,354

 

1,984,262

2,063,100

 

2,195,278

Finance lease liabilities, net of current portion

603,503

 

720,013

583,333

 

607,708

Operating lease liabilities, net of current portion

106,181

 

-

112,209

 

131,875

Grant repayable, net of current portion

289,492

 

311,042

296,431

 

297,991

Total Long-Term Liabilities

2,731,530

 

3,015,317

 

 

 

Total Liabilities

5,974,860

 

5,348,510

7,689,555

 

7,092,726

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

Common Stock

 

 

 

 

 

 

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

 

 

 

 

 

 

Issued and outstanding: 41,092,340 shares and 35,335,378 shares, respectively

41,092

 

35,335

Issued and outstanding: 41,206,632 shares and 41,125,303 shares, respectively

41,207

 

41,125

Additional paid-in capital

103,374,419

 

85,604,271

104,325,749

 

103,853,627

Accumulated other comprehensive income

650,819

 

223,651

499,596

 

125,670

Accumulated deficit

(86,264,550)

 

(73,722,801)

(95,681,195)

 

(89,821,856)

 

 

 

Total VolitionRx Limited Stockholders’ Equity

9,194,924

 

14,198,566

Non-controlling interest

(9,567)

 

-

Total Stockholders’ Equity

17,801,780

 

12,140,456

9,185,357

 

14,198,566

 

 

 

 

 

 

Total Liabilities and Stockholders’ Equity

23,776,640

 

17,488,966

16,874,912

 

21,291,292

 

 

 

 

 

 

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

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

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




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,

Three Months ended March 31,

2019

 

2018

 

2019

 

2018

2020

 

2019

$

 

$

 

$

 

$

$

 

$

 

 

 

 

 

 

 

 

 

 

Revenues

 

 

 

 

 

 

 

 

 

 

Service

16,204

 

-

 

16,204

 

-

Royalty

892

 

-

 

892

 

-

240

 

-

 

 

 

 

 

 

 

Product sales

304

 

-

Total Revenues

17,096

 

-

 

17,096

 

-

544

 

-

 

 

 

 

 

 

 

 

 

 

Operating Expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

2,642,610

 

2,737,856

 

7,596,097

 

7,847,531

3,894,966

 

2,474,559

General and administrative

1,354,992

 

1,450,383

 

4,020,893

 

4,949,716

1,703,522

 

1,229,440

Sales and marketing

195,641

 

259,302

 

718,047

 

845,253

273,954

 

284,280

Total Operating Expenses

4,193,243

 

4,447,541

 

12,335,037

 

13,642,500

5,872,442

 

3,988,279

 

 

 

 

 

 

 

 

 

 

Operating Loss

(4,176,147)

 

(4,447,541)

 

(12,317,941)

 

(13,642,500)

(5,871,898)

 

(3,988,279)

 

 

 

 

 

 

 

 

 

 

Other Income (Expenses)

 

 

 

 

 

 

 

 

 

 

Grant income

7,924

 

-

Interest income

27,633

 

-

 

68,656

 

-

38,414

 

11,564

Interest expense

(32,291)

 

(29,108)

 

(95,507)

 

(78,646)

(33,779)

 

(30,101)

Other expenses

-

 

-

 

(196,957)

 

-

-

 

(196,957)

 

 

 

 

 

 

 

Total Other Expenses

(4,658)

 

(29,108)

 

(223,808)

 

(78,646)

Total Other Income (Expenses)

12,559

 

(215,494)

 

 

 

 

 

 

 

 

 

 

Provision for Income Taxes

-

 

-

 

-

 

-

-

 

-

 

 

 

Net Loss

(4,180,805)

 

(4,476,649)

 

(12,541,749)

 

(13,721,146)

(5,859,339)

 

(4,203,773)

Net Loss attributable to Non-Controlling Interest

9,567

 

-

Net Loss attributable to VolitionRx Limited Stockholders

(5,849,772)

 

(4,203,773)

 

 

 

 

 

 

 

 

 

 

Other Comprehensive Income (Loss)

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustments

401,309

 

46,350

 

427,168

 

193,454

373,926

 

(24,055)

 

 

 

Net Comprehensive Loss

(3,779,496)

 

(4,430,299)

 

(12,114,581)

 

(13,527,692)

(5,485,413)

 

(4,227,828)

 

 

 

 

 

 

 

 

 

 

Net Loss Per Share – Basic and Diluted

(0.10)

 

(0.14)

 

(0.33)

 

(0.46)

 

 

 

 

 

 

 

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

(0.14)

 

(0.12)

Weighted Average Shares Outstanding

 

 

 

 

 

 

 

 

 

 

– Basic and Diluted

39,880,246

 

32,826,924

 

38,538,394

 

30,071,635

41,197,125

 

36,212,897

 

 

 

 

 

 

 

 

 

 

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

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

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

 

 

 

 




VOLITIONRX LIMITED

Condensed Consolidated Statements of Cash Flows (Unaudited)

(Expressed in United States Dollars)

 

 

Nine Months ended September 30,

2019

 

2018

$

 

$

Operating Activities

 

 

 

Net loss

(12,541,749)

 

(13,721,146)

 

 

 

 

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

 

 

 

Depreciation and amortization

560,826

 

474,536

Loss on disposal of property and equipment

-

 

1,766

Stock-based compensation

1,084,312

 

1,875,507

Warrants issued for services

6,379

 

6,453

Financing costs for warrants modified

196,957

 

-

 

 

 

 

Changes in operating assets and liabilities:

 

 

 

Prepaid expenses

(163,638)

 

(204,673)

Other current assets

44,904

 

202,290

Accounts receivable

(16,031)

 

-

Accounts payable and accrued liabilities

735,211

 

261,383

Right-of-use assets operating leases liabilities

(48,475)

 

-

 

 

 

 

Net Cash Used In Operating Activities

(10,141,304)

 

(11,103,884)

 

 

 

 

Investing Activities

 

Purchases of property and equipment

(359,502)

 

(183,541)

 

 

 

 

Net Cash Used In Investing Activities

(359,502)

 

(183,541)

 

 

 

 

Financing Activities

 

Net proceeds from issuances of common shares

16,488,257

 

16,796,000

Proceeds from grants repayable

32,652

 

177,079

Proceeds from long-term debt

282,513

 

875,418

Payments on long-term debt

(262,661)

 

(369,915)

Payments on grants repayable

(39,261)

 

(40,864)

Payments on finance lease obligations

(106,616)

 

(103,999)

 

Net Cash Provided By Financing Activities

16,394,884

 

17,333,719

 

 

 

 

Effect of foreign exchange on cash

375,869

 

211,871

 

 

 

 

Net Change in Cash

6,269,947

 

6,258,165

 

 

 

 

Cash and cash equivalents – Beginning of Period

13,427,222

 

10,116,263

 

 

 

 

Cash and cash equivalents – End of Period

19,697,169

 

16,374,428

 

 

 

 

Supplemental Disclosures of Cash Flow Information:

 

 

 

Interest paid

95,507

 

78,646

 

 

 

 

Non-Cash Financing Activities:

 

 

 

Common Stock issued on cashless exercises of stock options

2

 

12

Offering costs from issuance of common stock

-

 

604,000

 

 

 

 

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




VOLITIONRX LIMITED

Condensed Consolidated Statements of Stockholders’ Equity (Unaudited)

(Expressed in United States Dollars, except share numbers)

For the NineThree Months ended September 30,March 31, 2020 and March 31, 2019 and September 30, 2018

 

 

 

Additional

Other

 

 

Common Stock

Paid-in

Comprehensive

Accumulated

 

 

 

 

 

 

 

Shares

Amount

Capital

Income (Loss)

Deficit

Total

 

 

 

Accumulated

 

 

#

$

$

$

$

$

 

 

Additional

Other

 

Non

 

Balance, December 31, 2018

35,335,378

35,335

85,604,271

223,651

(73,722,801)

12,140,456

 

 

 

 

 

 

Common Stock

Paid-in

Comprehensive

Accumulated

Controlling

 

Common stock issued for cash

2,478,613

2,479

6,658,192

-

-

6,660,671

Employee stock options granted for services

-

-

338,331

-

-

338,331

Warrants granted for services

-

-

2,127

-

-

2,127

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

 

 

 

 

 

 

Shares

Amount

Capital

Income (Loss)

Deficit

Interest

Total

Common stock issued for cash

1,666,667

1,667

4,998,334

-

-

5,000,001

Employee stock options granted for services

-

-

377,507

-

-

377,507

Warrants granted for services

-

-

2,000

-

-

2,000

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 for cash

1,609,195

1,609

4,825,976

-

-

4,827,585

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 for cashless exercise of stock options

2,487

2

(2)

-

-

-

19,430

20

(20)

-

-

-

Employee stock options granted for services

-

-

368,474

-

-

368,474

-

-

165,464

-

-

165,464

Warrants granted for services

-

-

2,252

-

-

2,252

-

-

27,205

-

-

27,205

Stock repurchase

(11,364)

(11)

(54,423)

-

-

(54,434)

Foreign currency translation

-

-

-

401,309

-

401,309

-

-

-

373,926

-

373,926

Net loss for the period

-

-

-

-

(4,180,805)

(4,180,805)

-

-

-

-

(5,849,772)

(9,567)

(5,859,339)

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)

Balance, March 31, 2020

41,206,632

41,207

104,325,749

499,596

(95,671,628)

(9,567)

9,185,357

 

 

 

 

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 for cash

2,478,613

2,479

6,658,192

-

-

-

6,660,671

Employee stock options granted for services

-

-

338,331

-

-

-

338,331

Warrants granted for services

-

-

2,127

-

-

-

2,127

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

 

 

 

 

 

 

 

 

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




VOLITIONRX LIMITED

Condensed Consolidated Statements of Stockholders’ EquityCash Flows (Unaudited)

(Expressed in United States Dollars, except share numbers)Dollars)

 

 

Three Months ended March 31,

2020

 

2019

$

 

$

Operating Activities

 

 

 

Net loss

(5,859,339)

 

(4,203,773)

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

 

 

 

Depreciation and amortization

180,188

 

167,786

Amortization of operating lease right-of-use assets

63,025

 

12,062

Stock based compensation

165,464

 

338,331

Warrants issued for services

27,205

 

2,127

Shares issued for Director compensation in Volition Germany

333,969

 

-

Financing costs for warrants modified

-

 

196,957

Changes in operating assets and liabilities:

 

 

 

Prepaid expenses

(485,529)

 

(412,643)

Accounts receivable

(242)

 

-

Other current assets

(55,182)

 

(17,745)

Accounts payable and accrued liabilities

859,478

 

273,365

Management and directors’ fees payable

33,681

 

4,076

Right-of-use assets operating leases liabilities

(61,614)

 

(11,440)

Net Cash Used In Operating Activities

(4,798,896)

 

(3,650,897)

 

 

 

 

Investing Activities:

 

Purchases of property and equipment

(330,691)

 

(112,102)

Net Cash Used In Investing Activities

(330,691)

 

(112,102)

 

 

 

 

Financing Activities:

 

Net proceeds from issuances of common shares

-

 

6,660,671

Common stock repurchased

(54,434)

 

-

Proceeds from grants repayable

3,802

 

32,652

Payments on long-term debt

(115,884)

 

(87,577)

Payments on finance lease obligations

(35,575)

 

(35,678)

Net Cash (Used In) Provided By Financing Activities

(202,091)

 

6,570,068

 

 

 

 

Effect of foreign exchange on cash

335,727

 

(68,019)

 

 

 

 

Net Change in Cash

(4,995,951)

 

2,739,050

 

 

 

 

Cash and cash equivalents – Beginning of Period

16,966,168

 

13,427,222

 

 

 

 

Cash and cash equivalents – End of Period

11,970,217

 

16,166,272

 

 

 

 

Supplemental Disclosures of Cash Flow Information:

 

 

 

Interest paid

33,779

 

30,101

 

Non-Cash Financing Activities:

 

 

 

Common Stock issued on cashless exercises of stock options

20

 

-

 

 

 

 

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

For the Nine Months ended September 30, 2019 and September 30, 2018 (continued)



 

 

 

 

Additional

Other

 

 

 

Common Stock

Paid-in

Comprehensive

Accumulated

 

 

Shares

Amount

Capital

Income (Loss)

Deficit

Total

#

$

$

$

$

$

 

 

 

 

 

 

 

Balance, December 31, 2017

26,519,394

26,519

65,774,870

(129,343)

(55,714,178)

9,957,868

 

 

 

 

 

 

 

Common stock issued for cash

3,500,000

3,500

7,792,500

-

-

7,796,000

Common stock issued for cashless exercise of warrants

11,399

12

(12)

-

-

-

Employee stock options granted for services

-

-

895,226

-

-

895,226

Warrants granted for services

-

-

2,199

-

-

2,199

Foreign currency translation

-

-

-

14,947

-

14,947

Net loss for the period

-

-

-

-

(4,652,421)

(4,652,421)

Balance, March 31, 2018

30,030,793

30,031

74,464,783

(114,396)

(60,366,599)

14,013,819

 

 

 

 

 

 

 

Common stock issued for cash

432

-

-

-

-

-

Employee stock options granted for services

-

-

493,070

-

-

493,070

Warrants granted for services

-

-

2,127

-

-

2,127

Foreign currency translation

-

-

-

132,157

-

132,157

Net loss for the period

-

-

-

-

(4,592,076)

(4,592,076)

Balance, June 30, 2018

30,031,225

30,031

74,959,980

17,761

(64,958,675)

10,049,097

 

 

 

 

 

 

 

Common stock issued for cash

5,000,000

5,000

8,995,000

-

-

9,000,000

Employee stock options granted for services

-

-

487,211

-

-

487,211

Warrants granted for services

-

-

2,127

-

-

2,127

Foreign currency translation

-

-

-

46,350

-

46,350

Net loss for the period

-

-

-

-

(4,476,649)

(4,476,649)

Balance, September 30, 2018

35,031,225

35,031

84,444,318

64,111

(69,435,324)

15,108,136

 

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




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 accompanying unaudited condensedinterim consolidated financial statements of VolitionRx Limited should be read in conjunction with(the “Company,” “VolitionRx,” “we” or “us”) for the auditedthree months ended March 31, 2020 and 2019, respectively, are not audited. Our consolidated financial statements and notes thereto includedare prepared in the Company's Annual Report on Form 10-K for the year ended December 31, 2018, as filedaccordance with the Securitiesrequirements for unaudited interim periods and, Exchange Commission (the “SEC”) on March 13, 2019. The accompanying condensed consolidated financial statements have been prepared usingconsequently, 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”) for interim financial information and with. In the instructions to Form 10-Q. Accordingly, since they are interim statements,opinion of our management, the accompanying condensed consolidated financial statements do not include all of the information and notes required by U.S. GAAP for complete financial statements. The accompanying condensed consolidated financial statements reflectcontain all adjustments, consisting of normal recurring adjustments, that are, in the opinion of management, necessary to presentfor a fair statementpresentation of theour financial position as of March 31, 2020 and 2019, respectively, and our results of operations and cash flows for the interimthree months ended March 31, 2020 and 2019, respectively. The results of operations for the periods presented. Interim resultsended March 31, 2020 and 2019, respectively, are not necessarily indicative of the results for a full year.

Except as detailed below, there have been no material changes to the Company’s significant accounting policies during the nine months ended September 30, 2019, as compared to the significant accounting policies disclosed in Note 3 of thefull-year period. These interim consolidated financial statements should be read in conjunction with the Company’s 2018financial statements included in our Annual Report on Form 10-K.10-K for the year ended December 31, 2019, which was filed with the Securities and Exchange Commission (the “SEC”) on February 20, 2020.

 

Use of Estimates

 

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. The Company also regularly evaluates estimates and assumptions related to impairment of long-lived assets and stock-based compensation.

 

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

 

Principles of Consolidation

 

The accompanying condensedinterim consolidated financial statements for the period ended September 30, 2019March 31, 2020 include the accounts of the Company and its wholly owned subsidiariessubsidiaries. The Company has one-wholly-owned subsidiary, Singapore Volition.  Singapore Volition Pte. Limited (“Singapore Volition”),has one wholly-owned subsidiary, Belgian Volition SPRL (“Belgian Volition”),.  Belgian Volition has four subsidiaries, Volition Diagnostics UK Limited (“Volition Diagnostics”), Volition America, Inc. (“Volition America”), as well asVolition Germany GmbH (“Volition Germany”), and its majority-owned subsidiary Volition Veterinary Diagnostics Development LLC (“Volition Vet”). See Note 8 for more information regarding Volition Vet and Volition Germany. All intercompany balances and transactions have been eliminated in consolidation.  Except as otherwise indicated by the context, references to the “Company,” “we” and “our” are references to VolitionRx Limited and its subsidiaries.

 

Cash and Cash Equivalents

 

For the purposes of the statements of cash flows, we consider interest bearing deposits with original maturity date 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. At September 30, 2019,March 31, 2020, cash and cash equivalents totaled approximately $19.7$12.0 million, of which $13.1$8.1 million was held in an overnight money market account.

 

Accounts Receivables

 

Trade accounts receivable are stated at the amount the Company expects to collect. Due to the nature of the accounts receivable balance, the Company believes the risk of doubtful accounts is minimal and therefore no allowance is recorded. If the financial condition of the Company’s customers were to deteriorate, adversely affecting their ability to make payments, additional allowances would be required.  The Company may provide for estimated uncollectible amounts through a charge to earnings and a credit to a valuation allowance. Balances that remain outstanding after the Company has used reasonable collection efforts are written off through a charge to the valuation allowance and a credit to accounts receivable. At September 30, 2019,March 31, 2020, the accounts receivable balance was $16,031.$242.




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)

 

Revenue Recognition

 

Beginning in 2014, Financial Accounting Standards Board (“FASB”) issued several Accounting Standards Updates establishing Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” (“ASC 606”).  ASC 606 replaces most industry-specific revenue recognition guidance in U.S. GAAP with a new principles-based, five-step revenue recognition model.  The Company adopted ASC 606 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-stepfive 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) we satisfy the performance obligation(s).

 

The Company generates revenue from its license agreement with Active Motif Inc. (“Active 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” in the consolidated statements of income.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 Sales

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 sales” in the consolidated statements of operations and comprehensive loss.

Services

 

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

 

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



 

Leases

In February of 2016, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update No. 2016-02 –Leases (“Topic 842”), which significantly amends the way companies are required to account for leases. Under the updated leasing guidance, some leases that did not have to be reported previously are now required to be presented as an asset and liability on the balance sheet. In addition, for certain leases, what was previously classified as an operating expense must now be allocated between amortization expense and interest expense. The Company adopted Topic 842 as of January 1, 2019 using the modified retrospective transition method and prior periods have not been restated. Upon implementation, the Company recognized an initial operating lease right-of-use asset of $110,630 and operating lease liability of $110,630. Due to the simplistic nature of the Company's leases, no retained earnings adjustment was required. See Note 8(b) for further details.




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)

 

Basic and Diluted Net Loss Per Share

 

The Company computes net loss per share in accordance with Accounting Standards Codification (“ASC”) 260,Earnings Per Share,,” which requires presentation of both basic and diluted earnings per share (“EPS”)(EPS) on the face of the income statement. 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 September 30, 2019, 4,407,860March 31, 2020, 4,325,419 potential common shares equivalents from warrants and options 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. In the statement of operations and comprehensive loss, the Company has reclassified the prior year comparative amounts of research and development, sales and marketing and general and administrative expenses and cash flows to be consistent with the current year classification.

 

Recent Accounting Pronouncements

 

The Company has implemented the new applicable accounting pronouncements that are in effect listed above. The Company does not believe that 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.

 

COVID-19 Pandemic Impact

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 impacts of the pandemic has introduced significant volatility in the financial markets. The Company did not observe significant impacts on its business or results of operations for the three months ended March 31, 2020 due to the global emergence of COVID-19. While the extent to which COVID-19 impacts the Company’s future results will depend on future developments, the pandemic and associated economic impacts could result in a material impact to the Company’s future financial condition, results of operations and cash flows.

Note 2 - Going Concern

 

The Company'sCompany’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 $86.3$95.7 million, has negative cash flows from operations, and currently has limited revenues, which creates substantial doubt about its ability to continue as a going concern for a period of 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 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.




VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 3 - Property and Equipment

 

The Company’s property and equipment consist of the following amounts as of September 30, 2019March 31, 2020 and December 31, 2018:2019:

 

 

 

 

 

 

 

 

September 30,

 

 

 

 

 

 

 

2019

 

 

 

 

 

Accumulated

 

Net Carrying

 

 

 

Cost

 

Depreciation

 

Value

 

Useful Life

 

$

 

$

 

$

Computer hardware and software

3 years

 

389,962

 

241,656

 

148,306

Laboratory equipment

5 years

 

1,867,507

 

1,136,923

 

730,584

Office furniture and equipment

5 years

 

208,428

 

100,973

 

107,455

Buildings

30 years

 

1,430,227

 

123,139

 

1,307,088

Building improvements

5-15 years

 

612,836

 

103,970

 

508,866

Land

Not amortized

 

87,255

 

-

 

87,255

 

 

 

4,596,215

 

1,706,661

 

2,889,554

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31,

 

 

 

 

 

 

 

2018

 

 

 

 

 

Accumulated

 

Net Carrying

 

 

 

Cost

 

Depreciation

 

Value

 

Useful Life

 

$

 

$

 

$

Computer hardware and software

3 years

 

344,383

 

166,750

 

177,633

Laboratory equipment

5 years

 

1,673,215

 

928,841

 

744,374

Office furniture and equipment

5 years

 

204,129

 

75,137

 

128,992

Buildings

30 years

 

1,502,171

 

91,785

 

1,410,386

Building improvements

5-15 years

 

643,663

 

77,049

 

566,614

Land

Not amortized

 

91,644

 

-

 

91,644

 

 

 

4,459,205

 

1,339,562

 

3,119,643

 

 

 

 

 

 

 

March 31,

 

 

 

 

 

 

 

2020

 

 

 

 

 

Accumulated

 

Net Carrying

 

 

 

Cost

 

Depreciation

 

Value

 

Useful Life

 

$

 

$

 

$

Computer hardware and software

3 years

 

444,944

 

300,082

 

144,862

Laboratory equipment

5 years

 

2,219,840

 

1,329,976

 

889,864

Office furniture and equipment

5 years

 

220,239

 

122,440

 

97,799

Buildings

30 years

 

1,445,535

 

148,546

 

1,296,989

Building improvements

5-15 years

 

706,929

 

127,167

 

579,762

Land

Not amortized

 

88,189

 

-

 

88,189

 

 

 

5,125,676

 

2,028,211

 

3,097,465

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31,

 

 

 

 

 

 

 

2019

 

 

 

 

 

Accumulated

 

Net Carrying

 

 

 

Cost

 

Depreciation

 

Value

 

Useful Life

 

$

 

$

 

$

Computer hardware and software

3 years

 

426,461

 

280,554

 

145,907

Laboratory equipment

5 years

 

2,052,348

 

1,256,637

 

795,711

Office furniture and equipment

5 years

 

217,545

 

114,242

 

103,303

Buildings

30 years

 

1,472,211

 

139,021

 

1,333,190

Building improvements

5-15 years

 

630,824

 

117,526

 

513,298

Land

Not amortized

 

89,816

 

-

 

89,816

 

 

 

4,889,205

 

1,907,980

 

2,981,225

 

 

 

 

 

 

 

 

During the nine-monththree-month periods ended September 30,March 31, 2020 and March 31, 2019, and September 30, 2018, the Company recognized $495,062$158,768 and $406,986,$145,683, respectively, in depreciation expense.




VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 4 - Intangible Assets

 

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

 

 

 

 

 

 

September 30,

 

 

 

 

 

2019

 

 

 

Accumulated

 

Net Carrying

 

Cost

 

Amortization

 

Value

 

$

 

$

 

$

 

 

 

 

 

 

Patents

1,119,375

 

733,337

 

386,038

 

 

 

 

 

 

 

 

 

 

 

December 31,

 

 

 

 

 

2018

 

 

 

Accumulated

 

Net Carrying

 

Cost

 

Amortization

 

Value

 

$

 

$

 

$

 

 

 

 

 

 

Patents

1,167,383

 

700,478

 

466,905

 

 

 

 

 

March 31,

 

 

 

 

 

2020

 

 

 

Accumulated

 

Net Carrying

 

Cost

 

Amortization

 

Value

 

$

 

$

 

$

Patents

1,129,591

 

783,561

 

346,030

 

 

 

 

 

 

 

 

 

 

 

December 31,

 

 

 

 

 

2019

 

 

 

Accumulated

 

Net Carrying

 

Cost

 

Amortization

 

Value

 

$

 

$

 

$

Patents

1,147,391

 

775,086

 

372,305

 

 

 

 

 

 

During the nine-monththree-month periods ended September 30,March 31, 2020 and March 31, 2019, and September 30, 2018, the Company recognized $65,761$21,420 and $69,584,$22,103, respectively, in amortization expense.

 

The Company amortizes the long-lived assets 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:

 

2019 - remaining

$

17,917

2020

$

85,384

2021

$

85,384

2022

$

85,384

2023

$

85,384

Greater than 5 years

$

26,585

Total Intangible Assets

$

386,038

2020 - remaining

$

64,639

2021

$

86,170

2022

$

86,170

2023

$

86,170

2024

$

22,881

Total Intangible Assets

$

346,030

 

 

 

The Company periodically reviews its long-lived assets to ensure that their carrying value does not exceed their fair market value. The Company carried out such a review in accordance with ASC 360 Topic Property, Plant and Equipment” as of December 31, 2018.2019. The result of this review confirmed that the ongoing value of the patents was not impaired as of December 31, 2018.2019.

 

Note 5 - Related Party Transactions

 

See Note 6 for common stock issued to related parties and Note 7 for stock options and warrants issued to related parties. The Company has agreements with related parties for consultancy services which are accrued under management and directors’ fees payable (see condensed consolidated balance sheets).




VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 6 - Common Stock

 

As of September 30, 2019,March 31, 2020, the Company was authorized to issue 100 million shares of common stock par value $0.001 per share, of which 41,092,34041,206,632 and 35,335,37841,125,303 shares were issued outstanding as of September 30, 2019March 31, 2020 and December 31, 2018,2019, respectively.

 

On June 14, 2019, an amendment to the 2015 Stock Incentive Plan (the “2015 Plan”) was approved by the stockholders at the annual meeting to increase the number of shares of common stock available for issuance under the 2015 Plan by 1,000,000 shares to an aggregate maximum of 4,250,000 shares.

 

Issuances Upon Warrant and Option Exercises

 

FromOn January 30, 2019 to February 26, 2019, warrants7, 2020, 12,500 stock options were exercised to purchase 754,475 shares of our common stock were exercised at a price of $2.20$2.50 per share for gross proceeds toin a cashless exercise that resulted in the Companyissuance of approximately $1.66 million.6,135 shares of common stock.

 

On March 8, 2019, Cotterford Company Limited partiallyJanuary 7, 2020, 12,500 stock options were exercised its warrant and purchased 1,724,138to purchase shares of our common stock at a price of $2.90$3.00 per share for gross proceeds toin a cashless exercise that resulted in the Companyissuance of $5.0 million.4,862 shares of common stock.

 

On May 3, 2019, Cotterford Company Limited partiallyJanuary 7, 2020, 35,000 stock options were exercised its warrant and purchased 1,666,667to purchase shares of our common stock at a price of $3.00$4.00 per share for gross proceeds toin a cashless exercise that resulted in the Companyissuance of $5.0 million.6,486 shares of common stock.

 

On July 24, 2019, Cotterford Company Limited exercised the remainder of its warrant and purchased 1,609,195January 9, 2020, 73,263 shares were issued as fully paid shares of our common stock valued at $333,969 as compensation to a pricemanaging director of $3.00 per share, for gross proceeds to the Company of $4.8 million.Volition Germany (see Note 8(f)).

 

From AugustFebruary 24, 2020 to March 20, 2019 to September 20, 2019, 6,1662020, 8,882 stock options were exercised to purchase shares of common stock at $2.35 per share in a cashless exerciseexercises that resulted in the issuance of 2,4871,947 shares of common stock.

Stock Repurchase

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

 

Equity Distribution Agreement

 

On September 7, 2018, the Company entered into an equity distribution agreement 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 pursuant to a shelf registration statement on Form S-3 (declared effective by the SEC on September 28, 2018, File No. 333-227248) through Oppenheimer acting as the Company’s agent and/or principal. AsThrough December 31, 2019, the Companyraised aggregate net proceeds (net of September 30, 2019,broker commissions and fees) of $16,547 under the equity distribution agreementthrough the sale of 3,200 shares of its common stock. The Company used the net proceeds raised to date for continued product development, clinical studies, product commercialization, working capital and other general corporate purposes. During the three months ended March 31, 2020, the Company haddid not soldsell any shares under the equity distribution agreement.




VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 7 - Warrants and Options

 

a)Warrants 

 

The following table summarizes the changes in warrants outstanding of the Company during the nine-monththree-month period ended September 30, 2019:March 31, 2020:

 

Number of

 

Weighted Average

Number of

 

Weighted Average

Warrants

 

Exercise Price ($)

Warrants

 

Exercise Price ($)

Outstanding at December 31, 2018

6,107,617

 

2.88

Outstanding at December 31, 2019

190,000

 

2.90

Granted

-

 

-

50,000

 

3.45

Exercised

(5,754,475)

 

2.87

-

 

-

Expired

(133,750)

 

2.20

-

 

-

Outstanding at September 30, 2019

219,392

 

2.84

Outstanding at March 31, 2020

240,000

 

3.02

 

 

 

 

 

 

Exercisable at September 30, 2019

94,392

 

3.32

Exercisable at March 31, 2020

190,000

 

2.90

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 March 5, 2019,1, 2020, the Company entered into an amendment to an outstanding warrantgranted warrants to purchase up to an aggregate of 5.0 million shares of our common stock, originally issued to Cotterford Company Limited, a significant stockholder, in connection with an equity financing completed on or about August 10, 2018.  The amendment temporarily reduced the exercise price of such warrant from $3.00 per share to $2.90 per share through the close of business on March 8, 2019. As a result of this amendment, $196,957 of financing costs were recorded in other expenses.

On March 8, 2019, Cotterford Company Limited partially exercised its warrant and purchased 1,724,138 shares of our common stock at $2.90 per share resulting in gross proceeds to the Company of $5.0 million.

On May 3, 2019, Cotterford Company Limited partially exercised its warrant and purchased 1,666,667 shares of our common stock at $3.00 per share resulting in gross proceeds of $5.0 million to the Company.

On July 1, 2019, the Company modified the performance criteria for certain vesting milestones on an employee warrant agreement and as a result the Company re-measured warrants held by the employee, to purchase 125,00050,000 shares of common stock atto a Company employee for services to the Company. These warrants vest on September 1, 2021 (subject to continued employment through such date) and expire on March 1, 2026, with an exercise price of $2.47$3.45 per share, resulting in $11,829 of additional warrant expense to be recorded overshare. The Company has calculated the vesting period. These warrants vest on achievement of certain business objectives and expire 3 years from the date of vesting.

On July 24, 2019, Cotterford Company Limited exercised the remainder of its warrant and purchased 1,609,195 shares of our common stock at $3.00 per share resulting in gross proceeds of $4.8 million to the Company.

During the first three quarters of 2019, warrants to purchase an aggregate of 5,754,475 shares of our common stock were exercised (including the exercises by Cotterford Company Limited referenced above) for gross cash proceeds to the Company of approximately of $16.5 million. Refer to Note 6 for the detailsestimated fair market value of these exercises.warrants at $86,771, using the Black-Scholes model and the following assumptions: term 3.75 years, stock price $3.44, exercise price $3.45, 69.03% volatility, 0.95% risk free rate, and no forfeiture rate.

 

Below is a table summarizing the warrants issued and outstanding as of September 30, 2019,March 31, 2020, which have an aggregate weighted average remaining contractual life of 2.772.90 years.

 

 

 

 

 

 

 

Weighted

 

 

 

 

 

 

 

 

Average

 

 

 

 

 

 

 

Remaining

Proceeds to

Number

 

Number

 

Exercise

 

Contractual

Company if

Outstanding

 

Exercisable

 

Price ($)

 

Life (Years)

Exercised ($)

29,392

 

29,392

 

2.40

 

0.25

 

70,541

150,000

 

25,000

 

2.47

 

3.71

 

370,500

40,000

 

40,000

 

4.53

 

1.13

 

181,200

219,392

 

94,392

 

 

 

 

 

622,241

 

 

 

 

 

 

Weighted

 

 

 

 

 

 

 

 

Average

 

 

 

 

 

 

 

Remaining

Proceeds to

Number

 

Number

 

Exercise

 

Contractual

Company if

Outstanding

 

Exercisable

 

Price ($)

 

Life (Years)

Exercised ($)

150,000

 

150,000

 

2.47

 

1.69

 

370,500

50,000

 

-

 

3.45

 

5.92

 

172,500

40,000

 

40,000

 

4.53

 

0.62

 

181,200

240,000

 

190,000

 

 

 

 

 

724,200

 

 

 

 

 

 

 

 

 

Warrant expense of $6,379$27,205 and $6,453$2,127 was recorded in the ninethree months ended September 30,March 31, 2020 and March 31, 2019, and September 30, 2018, respectively. Total remaining unrecognized compensation cost related to non-vested warrants is approximately $22,462$79,902 and is expected to be recognized over a period of 1.31.4 years. As of September 30, 2019,March 31, 2020, the total intrinsic value of outstanding warrants was $610,742.$96,000.




VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 7 - Warrants and Options (continued)

 

b)Options 

 

The following table summarizes the changes in options outstanding of the Company during the nine-monththree-month period ended September 30, 2019:March 31, 2020:

 

 

 

Number of

 

Weighted Average

 

 

Options

 

Exercise Price ($)

Outstanding at December 31, 2018

 

3,498,801

 

4.00

Granted

 

730,000

 

3.25

Exercised

 

(6,166)

 

2.35

Expired/Cancelled

 

(34,167)

 

3.34

Outstanding at September 30, 2019

 

4,188,468

 

3.88

 

 

 

 

 

Exercisable at September 30, 2019

 

3,488,468

 

4.01

Effective February 11, 2019, the Company granted stock options to purchase 730,000 shares of common stock to various Company personnel (including directors, executives, members of management and employees) for services to the Company. These options vest on February 11, 2020 and expire 5 years after the vesting date, with an exercise price of $3.25 per share. The Company has calculated the estimated fair market value of these options at $1,569,816, using the Black-Scholes model and the following assumptions: term 6 years, stock price $3.16, exercise price $3.25, 77.86% volatility, 2.52% risk free rate, and no forfeiture rate. Subsequent to the February 2019 grant, stock options to purchase 30,000 shares of common stock subject to the grant were forfeited.

 

 

Number of

 

Weighted Average

 

 

Options

 

Exercise Price ($)

Outstanding at December 31, 2019

 

4,169,301

 

3.88

Granted

 

-

 

-

Exercised

 

(68,882)

 

3.33

Expired/Cancelled

 

(15,000)

 

5.00

Outstanding at March 31, 2020

 

4,085,419

 

3.90

 

 

 

 

 

Exercisable at March 31, 2020

 

4,085,419

 

3.90

 

 

 

 

 

Below is a table summarizing the options issued and outstanding as of September 30, 2019,March 31, 2020, 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 3.222.74 years. As of September 30, 2019,March 31, 2020, a total of 1,099,0001,149,367 shares of common stock remained available for future issuance under the 2015 Stock Incentive Plan.

 

 

 

 

 

 

 

Weighted

 

 

 

 

 

 

 

 

Average

 

 

 

 

 

 

 

 

Remaining

 

Proceeds to

Number

 

Number

 

Exercise

 

Contractual

 

Company if

Outstanding

 

Exercisable

 

Price ($)

 

Life (Years)

 

Exercised ($)

11,599

 

11,599

 

2.35

 

0.61

 

27,258

322,500

 

322,500

 

2.50

 

0.88

 

806,250

322,500

 

322,500

 

3.00

 

0.88

 

967,500

700,000

 

-

 

3.25

 

5.37

 

2,275,000

17,767

 

17,767

 

3.35

 

1.45

 

59,519

20,000

 

20,000

 

3.80

 

1.63

 

76,000

1,907,000

 

1,907,000

 

4.00

 

3.28

 

7,628,000

17,768

 

17,768

 

4.35

 

2.45

 

77,291

50,000

 

50,000

 

4.80

 

3.26

 

240,000

819,334

 

819,334

 

5.00

 

2.23

 

4,096,670

4,188,468

 

3,488,468

 

 

 

 

 

16,253,488

 

 

 

 

 

 

Weighted

 

 

 

 

 

 

 

 

Average

 

 

 

 

 

 

 

 

Remaining

 

Proceeds to

Number

 

Number

 

Exercise

 

Contractual

 

Company if

Outstanding

 

Exercisable

 

Price ($)

 

Life (Years)

 

Exercised ($)

2,717

 

2,717

 

2.35

 

0.42

 

6,385

310,000

 

310,000

 

2.50

 

0.38

 

775,000

310,000

 

310,000

 

3.00

 

0.38

 

930,000

685,000

 

685,000

 

3.25

 

4.87

 

2,226,250

17,767

 

17,767

 

3.35

 

0.87

 

59,519

20,000

 

20,000

 

3.80

 

1.13

 

76,000

1,782,837

 

1,782,837

 

4.00

 

2.56

 

7,131,348

17,768

 

17,768

 

4.35

 

1.87

 

77,291

89,163

 

89,163

 

4.38

 

3.82

 

390,534

50,000

 

50,000

 

4.80

 

2.76

 

240,000

800,167

 

800,167

 

5.00

 

2.81

 

4,000,835

4,085,419

 

4,085,419

 

 

 

 

 

15,913,162

 

Stock option expense of $1,084,312$165,464 and $1,875,507$338,331 was recorded in the ninethree months ended September 30,March 31, 2020 and March 31, 2019, and September 30, 2018, respectively. Total remaining unrecognized compensation cost related to non-vested stock options is approximately $571,344 and is expected to be recognized over a period of 0.36 years.$Nil. As of September 30, 2019,March 31, 2020, the total intrinsic value of outstanding stock options was $7,285,702.$225,264.




VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 8 – Commitments and Contingencies

 

a)Finance Lease Obligations 

 

In 2015, the Company entered into an equipment finance lease to purchase three Tecan machines (automated liquid handling robots) for €550,454 Euros, maturing May 2020. As of September 30, 2019,March 31, 2020, the balance payable was $65,345.$21,155.

 

In 2016, the Company entered into a real estate finance lease with ING Asset Finance Belgium S.A. (“ING”) to purchase a property located in Belgium for €1.12 million Euros, maturing May 2031. As of September 30, 2019,March 31, 2020, the balance payable was $633,861.$619,061.

 

In 2018, the Company entered into a finance lease with BNP Paribas leasing solutions to purchase a freezer for the Belgium facility for €25,000 Euros, maturing January 2022. The leased equipment is amortized on a straight-line basis over 5 years. As of September 30, 2019,March 31, 2020, the balance payable was $21,217.$17,150.

 

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 September 30, 2019.March 31, 2020.

 

2019

$

39,442

2020

$

111,379

2020 - remaining

$

71,843

2021

$

67,952

$

68,679

2022

$

60,035

$

60,677

2023

$

58,665

$

59,292

2024

$

59,292

Greater than 5 years

$

491,296

$

437,261

Total

$

828,769

$

757,044

Less: Amount representing interest

$

(108,346)

$

(99,678)

Present value of minimum lease payments

$

720,423

$

657,366

 

b)Operating Lease Right-of-Use Obligations 

The Company adopted Topic 842 on January 1, 2019. The Company elected to adopt this standard using the optional modified retrospective transition method and recognized a cumulative-effect adjustment to the condensed consolidated balance sheet on the date of adoption. Prior periods have not been restated. With the adoption of Topic 842, the Company’s condensed consolidated balance sheet now contains the following line items: Operating lease right-of-use assets, Current portion of operating lease liabilities and Operating lease liabilities, net of current portion.

 

As all the existing leases subject to the new lease standard 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 we used our incremental borrowing rate as the discount rate. Our weighted average discount rate is 4.44%4.47% and the weighted average remaining lease term is 2122 months.

 

As of September 30, 2019,March 31, 2020, operating lease right-of-use assets and liabilities arising from operating leases were $193,918$330,131 and $196,451,$338,906, respectively. During the ninethree months ended September 30, 2019,March 31, 2020, cash paid for amounts included for the measurement of lease liabilities was $53,393$62,089 and the Company recorded operating lease expense of $48,393.$63,035.

 

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 September 30, 2019.March 31, 2020.

 

2019 - remaining

$

24,122

2020

$

96,796

2020 - remaining

$

198,899

2021

$

64,717

$

96,497

2022

$

21,180

$

40,473

2023

$

16,569

2024

$

1,036

Total Operating Lease Obligations

$

206,815

$

353,474

Less: Amount representing interest

$

(10,364)

$

(14,568)

Present Value of minimum lease payments

$

196,451

$

338,906




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 (continued)

 

The Company’s office space leases are short term and the Company has elected under the short-term recognition exemption not to recognize them on the balance sheet. During the ninethree months ended September 30, 2019, $129,121March 31, 2020, $5,466 was recognized in short-term lease costs associated with office space leases. The annual payments remaining for short-term office leases were as follows:

 

2019

$

43,749

2020

$

25,326

Total Operating Lease Obligations

$

69,075

2020 - remaining

$

6,940

Total Operating Lease Obligations

$

6,940

 

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. Per the terms of the agreement, €314,406 Euros of the grant is to be repaid, by instalments over the period from June 30, 2014 to June 30, 2023. The Company has recorded the balance of €733,614 Euros to other income in previous years as there is no obligation to repay this amount. 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 twice the amount of funding received. As of September 30, 2019,March 31, 2020, the grant balance repayable was $133,506.$134,935.

 

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.  Per the terms of the agreement, €181,500 Euros of the grant is to be repaid by instalments 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 September 30, 2019,March 31, 2020, the grant balance repayable was $194,160.$200,079.

 

As of September 30, 2019,March 31, 2020, the total grant balance repayable was $327,666$335,014 and the payments remaining were as follows:

 

2020

$

51,371

2021

$

48,542

2022

$

45,918

2023

$

47,054

2024 - Greater than 5 years

$

134,781

Total Grants Repayable

$

327,666

2020 - remaining

$

51,921

2021

$

49,062

2022

$

46,409

2023

$

47,558

2024

$

20,008

Greater than 5 years

$

120,056

Total Grants Repayable

$

335,014

 

 

 

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%. As of September 30, 2019,March 31, 2020, the principal balance payable was $330,561.$304,298.

 

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%. As of September 30, 2019,March 31, 2020, the principal balance payable was $249,679.$243,720.

 

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%. As of September 30, 2019,March 31, 2020, the principal balance payable was $197,536.$153,372.



VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

Note 8 – Commitments and Contingencies (continued)

 

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%.  As of September 30, 2019,March 31, 2020, €1 million Euros has been drawn down under this agreement and the principal balance payable was $1,090,686.$1,047,242.

 

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%. As of September 30, 2019,March 31, 2020, the principal balance payable was $434,813.




VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)$375,943.

 

Note 8 – CommitmentsIn 2019, the Company entered into a 4-year loan agreement with Namur Innovation and Contingencies (continued)

d)Long-Term Debt (continued)Growth for €500,000 Euros with fixed interest rate of 4.80%, maturing September 2024. As of March 31, 2020, the principal balance payable was $551,180.

 

As of September 30, 2019,March 31, 2020, the total balance for long-term debt payable was approximately $2.3 million$2,675,755 and the payments remaining were as follows:

 

2019 - remaining

$

165,574

2020

$

655,862

2020 - remaining

$

620,894

2021

$

587,387

$

728,742

2022

$

435,423

$

611,476

2023

$

341,991

$

517,044

2024

$

322,027

Greater than 5 years

$

360,512

$

170,885

Total

$

2,546,749

$

2,971,068

Less: Amount representing interest

$

(243,474)

$

(295,313)

Total Long-Term Debt

$

2,303,275

$

2,675,755

 

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, 2019, $81,801March 31, 2020, $82,677 is still to be paidby the Company under this agreement.

 

In 2016, the Company entered into a research co-operation agreement with DKFZ in Germany for a 5-year period for €400,000 Euros. As of September 30, 2019, $218,139March 31, 2020, $220,472 is still to be paid by the Company under this agreement.

 

In 2016, 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, 2019, $159,240March 31, 2020, $108,031 is still to be paid by the Company under this agreement.

 

In 2017, the Company entered into a clinical study research agreement withthe University of Michigan for a 3-year period forup 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 Volition America. Further, the Amendment provided that a new clinical study would be undertaken at no additional cost to Volition America. As of September 30, 2019,March 31, 2020,up to $138,000 is still to be paidaccruedby the Company under this agreement.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-year period for a cost to the Company of up to $2.55 million payable over such period. As of September 30, 2019, $1.66March 31, 2020, $1.28 million is still to be paid by the Company under this agreement.

 

InOn May 1, 2019, the Company entered into a research collaboration agreement with the University of Taiwan to collect a total of 1,200 samples for a 2-year period for a cost to the Company of up to $320,000 payable over such period. As of September 30, 2019, $288,000March 31, 2020, $224,000 is still to be paid by the Company under this agreement.



 

As of September 30, 2019, the total amount to be paid for existing researchand collaboration commitments was approximately $2.54 million and the annual payments remaining were as follows:

2019 - remaining

$

554,293

2020

$

999,887

2021

$

988,500

Total Collaborative Agreement Obligations  

$

2,542,680

 

 

 




VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 8 – Commitments and Contingencies (continued)

As of March 31, 2020, the total amount to be paid for future researchand collaboration commitments was approximately $2.05 million and the annual payments remaining were as follows:

2020 - remaining

$

1,059,680

2021

$

988,500

Total Collaborative Agreement Obligations  

$

2,048,180

 

f)Other Commitments 

Volition Vet

 

On August 7, 2019, the Company entered into a consulting services agreement with Novis Animal Solutions LLC to provide chief executive officer services for Volition Vet in exchange for payment of consultancy fees and a potential equity interest of 5% in Volition Vet upon achievement of revenue milestones.

 

On October 25, 2019, the Company entered into agreement with the Texas A&M University (“TAMU”) System for provision of in kind services of personnel, animal samples and laboratories equipment for a non-controlling interest of 7.5% in Volition Vet and in a year from the agreement TAMU would receive a further 5%, giving them in total 12.5%.

Volition Germany

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

Upon considering the definition of a business, as defined in ASC 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, we have 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 and acquisition of assets.

The Company agreed to terms of the transaction on December 13, 2019 and closed on January 10, 2020. Pursuant to the transaction agreement, the Company purchased all outstanding shares of Octamer. In exchange, the Company agreed to issue 73,263 newly-issued restricted shares of Company common stock valued at $333,969 (based on the $4.56 per share volume weighted trading price for the five days prior to December 13, 2019), committed to pay approximately €350,000, subject to adjustments, and agreed to pay off certain Octamer expenses leading up to the agreement (representing net liabilities of $6,535). At closing, the Company issued 73,263 restricted shares of Company common stock,  paid an adjusted amount of approximately $357,000 (€321,736) and recorded a holdback liability of $55,404 (€50,000) to be paid after the holdback period of 9 months following the closing (subject to offset for breaches of representations and warranties).

In connection with the transaction agreement, the Company also entered into a 2-year Managing Director’s agreement with the founder of Octamer for a payment of €288,000 Euros payable in equal monthly installments over such 2-year period and a royalty agreement with the founder providing for the payment of royalties in the amount of 6% of net sales of Octamer’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 5 years post-closing.

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 March 31, 2020, $277,794 is still to be paid by the Company under the Managing Director’s agreement.



VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

Note 8 – Commitments and Contingencies (continued)

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 October 25, 2019,April 13, 2020, the Company entered into agreements with Texas A&M Universitygranted stock options to develop veterinary diagnostic products in exchange for an approximate 12.5% equity stake in Volition Vet as well as payment by the Company ofpurchase an aggregate of $400,000835,000 shares of common stock. These options vest on April 13, 2021 and expire 5 years after the vesting date, with an exercise price of $3.60 per share. In addition, the Company granted Restricted Stock Units (“RSUs”) to Texas A&M Universityreceive an aggregate of 52,500 shares of common stock. These RSUs vest 50% on April 13, 2021 and affiliated entities towards the collaboration.50% on April 13, 2022.

 

 

END NOTES TO FINANCIALS




ITEM 2.

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

 

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, 2019,March 31, 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,���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;or veterinary markets; 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, 2018,2019, as filed with the SEC on March 13, 2019,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 in conjunction with the interim consolidated financial statements and related condensed notes thereto, which are included in Part I of this Report.

 

VolitionRx is a multi-national life sciencesepigenetics company that applies its NucleosomicsTM platform through its subsidiaries to develop and bring to market simple, easy to use, cost-effective blood tests designed to help diagnose a range of cancers and other diseases. We hope that through earlier diagnosis we can help save and improve the quality of many people’s lives throughout the world.

Our tests are based mainly 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. We are developing a novel suite of blood assays for epigenetically-altered circulating nucleosomes as biomarkers in cancer and other diseases. Nu.QTM products are simple, low-cost, enzyme-linked immunosorbent assay, or ELISA, platform tests and can incorporate other biomarkers such as anti-inflammatory markers and/or off patent, low cost ELISA tests in our panels (e.g. CEA, PSA, and CA125) for higher accuracy. We have successfully used our technology platform to develop Research Use Only kits that are being sold through our licensee, Active Motif, Inc., and offer laboratory analytical services to other scientific institutions. We are at the early stages of revenue for these services.

 

Our diagnostic target in the blood includes the same tumor chromosome fragment as targeted by ctDNA tests, but our approach is to test for chromosome proteininvestigate the epigenetic structure of chromatin and nucleic acid changes in intact chromosome fragments by ELISA,nucleosomes rather than chemically extracting, amplifying, and sequencinginvestigating only the circulating tumor DNA or ctDNA, and discarding the rest of the nucleosome. ELISA is possible because the targets of our tests occur globally across all nucleosomes within a tumor cell, whereas individual ctDNA changes must be identified within the three billion base-pair genomes. This means that the targets of our testssequence. We are exponentially more prevalent in circulating blood, and detectable using simple laboratory methods.continuously developing new technologies including:

 

We are developing blood-based testsA suite of low cost Nu.QTM immunoassays that can accurately measure nucleosomes containing numerous epigenetic signals or structure.

Nu.QTM Capture technology to isolate or enrich nucleosomes containing particular epigenetic signals or structures for the most prevalent cancers focusing on colorectal cancer, lung cancer, prostate cancer and pancreatic cancer, using our Nucleosomics biomarker discovery platform. Our development pipeline includes assays to be used for symptomatic patients, asymptomatic (screening) patients and high-risk populations. The platform employs a wide range of simple Nu.Q immunoassays on industry standard ELISA formats, which allows more rapid quantificationpotential scientific and medical applications. For example, the enrichment of epigenetic changesnucleosomes of tumor origin in biofluids (whole blood plasma, serum, sputum, urine, etc.) than afforded by other approaches such as bisulfite conversion and polymerase chain reaction. We are researching the use of our assays across multiple platforms worldwide.samples taken from cancer patients.

 

We believe that given the global prevalence of cancer and the low cost, accessible routine nature of our tests, Nu.Q will eventually be used throughout the world. Our launch sequence is determined to a large extent by regulatory hurdles - consequently, we aim to launch in Europe and Asia, and subsequently in the United States. We plan to work with partners and/or distributors to commercialize Nu.Q worldwide. Additionally, we are working on complete Nucleosome analysis (Nu.Q Capture). The goal of this project is to investigate ways to specifically target ctDNA. Thedevelop an ability to enrich for ctDNA will allow usproduce synthetic (recombinant) nucleosomes containing exact defined epigenetic signals and structures. These are used to use mass spectrometry to analyze histone and DNA modifications and moreover to sequence the DNA present around the nucleosomes. This extremely valuable information might enable cancer diagnosis to identify the tissueensure exquisite accuracy of origin of that given cancer.Nu.QTM immunoassay tests but also have many other applications including as tools in epigenetic drug development.

 

In addition to human diagnostics we are also researchingdeveloping the use of the Nu.QTM technology in veterinary applications.  An initial proof of concept study demonstrated that nucleosomes can be detected in dogs and, therefore, have the potential to differentiate cancer from other diseases. We will now test Nu.Q VetTM platform in larger trials in veterinary medicine. Our extensive intellectual property portfolio includes coverage of veterinary medicine applications.

The U.S. is currently the largest veterinary market in the world and has a clearly defined regulatory pathway via the USDA, requiring fewer and smaller clinical studies than the FDA process for human diagnostics.  This generally allows a much faster route to revenue for veterinary products as compared to human products.

 

OverviewDevelopments - 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.

During the first quarter of 2020, we implemented contingency planning to protect the health and well-being of our employees, with most employees working remotely where possible. We have implemented travel restrictions as well as visitor protocols and we are following social distancing practices. We did not observe significant impacts on our business or results of operations for the quarter ended March 31, 2020 due to the global emergence of COVID-19 or the mitigation actions taken to slow its spread. To the extent 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. See Part II, Item 1A “Risk Factors” of this Quarterly Report on Form 10-Q for further discussion of the potential impact of the COVID-19 pandemic on our business

Plan of Operations

 

We have identified the specific processes and resources required to achieve the near and medium-term objectives of our business plan, including personnel, facilities, equipment, research and testing materials including antibodies and clinical samples, and the protection of intellectual property. To date, operations have proceeded satisfactorily in relation to our business plan. However, it is possible that some resources will not readily become available in a suitable form or on a timely basis or at an acceptable cost. It is also possible that the results of some processes may not be as expected, and that modifications of procedures and materials may be required. Such events could result in delays to the achievement of the near and medium-term objectives of our business plan, in particular the progression of clinical validation studies and regulatory approval processes for the purpose of bringing products to the IVD and veterinary markets.

 

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




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

 

Liquidity and Capital Resources

 

We have financed our operations since inception primarily through private placements and public offerings of our common stock. As of September 30, 2019,March 31, 2020, we had cash and cash equivalents of approximately $19.7$12.0 million.

 

Net cash used in operating activities was $10.1$4.8 million and $11.1$3.7 million for the ninethree months ended September 30,March 31, 2020 and March 31, 2019, and September 30, 2018, respectively. The decreaseincrease in cash used in operating activities for the period ended March 31, 2020 when compared to same period in 2019 was primarily due to decreasedincreased expenditures on researchanti-bodies, stage payment to a collaborator partner and development and general and administrative activities.common stock issued for services.

 

Net cash used in investing activities was $0.4$0.3 million and $0.2$0.1 million for the ninethree months ended September 30,March 31, 2020 and March 31, 2019, and September 30, 2018, respectively. The increase was primarily due to investment in software andpurchases of laboratory equipment.

 

Net cash used by financing activities was $0.2 million for the three months ended March 31, 2020 and net cash provided by financing activities was $16.4 million and $17.3$6.6 million for the nine monthscomparable period ended September 30, 2019 and September 30, 2018, respectively.March 31, 2019. The decrease in cash provided by financing activities for the period ended September 30, 2019March 31, 2020 when compared to same period in 20182019 was primarily due to $16.5 million inthe cash received from the exercise of warrants in 2019 compared to $16.8of $6.7 million in net cash proceeds through the sale and issuance of 8.5 million shares of common stock in 2018.2019.

 

The following table summarizes our approximate contractual payments due by year as of September 30, 2019.March 31, 2020.

 

Approximate Payments (Including Interest) Due by Year

 

 

Total

 

2019 (Remaining)

 

2020 - 2023

 

2024 +

 

Total

 

2020

(Remaining)

 

2021 - 2024

 

2025 +

Description

 

$

 

$

 

$

 

$

 

$

 

$

 

$

 

$

Finance Lease Obligations

 

828,769

 

39,442

 

298,031

 

491,296

 

757,044

 

71,843

 

247,940

 

437,261

Operating Lease Obligations

 

275,890

 

67,871

 

208,019

 

-

 

360,414

 

205,839

 

154,575

 

-

Grants Repayable

 

327,666

 

-

 

192,885

 

134,781

 

335,014

 

51,921

 

163,037

 

120,056

Long-Term Debt

 

2,546,749

 

165,574

 

2,020,663

 

360,512

 

2,971,068

 

620,894

 

2,179,289

 

170,885

Collaborative Agreements Obligations

 

2,542,680

 

554,293

 

1,988,387

 

-

 

2,048,180

 

1,059,680

 

988,500

 

-

Total

 

6,521,754

 

827,180

 

4,707,985

 

986,589

 

6,471,720

 

2,010,177

 

3,733,341

 

728,202

 

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 fiscal year ended December 31, 20182019 an explanatory paragraph regarding factors that raise substantial doubt that we will be able to continue as a going concern.




Results of Operations

 

Comparison of the Three Months Ended September 30, 2019March 31, 2020 and September 30, 2018March 31, 2019.

 

The following table sets forth our results of operations for the three months ended on September 30,March 31, 2020, and March 31, 2019, and September 30, 2018, respectively:respectively.

 

 

Three Months ended

September 30,

 

Increase

 

Percentage Increase

 

2019

 

2018

 

(Decrease)

 

(Decrease)

 

$

 

$

 

$

 

%

 

 

 

 

 

 

 

 

Service

16,204

 

-

 

16,204

 

-%

Royalty

892

 

-

 

892

 

-%

 

Total Revenues

17,096

 

-

 

17,096

 

-%

 

 

 

 

 

 

 

 

Research and development

2,642,610

 

2,737,856

 

(95,246)

 

(3%)

General and administrative

1,354,992

 

1,450,383

 

(95,391)

 

(7%)

Sales and marketing

195,641

 

259,302

 

(63,661)

 

(25%)

 

 

 

 

 

 

 

 

Total Operating Expenses

(4,193,243)

 

(4,447,541)

 

(254,298)

 

(6%)

 

 

 

 

 

 

 

 

Interest income

27,633

 

-

 

27,633

 

-%

Interest expense

(32,291)

 

(29,108)

 

3,183

 

11%

 

 

 

 

 

 

 

 

Total Other Expenses

(4,658)

 

(29,108)

 

(24,450)

 

(84%)

 

 

 

 

 

 

 

 

Net Loss

(4,180,805)

 

(4,476,649)

 

(295,844)

 

(7%)

 

 

 

 

 

 

 

 

Net Loss Per Share – Basic and Diluted

(0.10)

 

(0.14)

 

(0.04)

 

(29%)

 

 

 

 

 

 

 

 

Weighted Average Shares Outstanding - Basic and Diluted

39,880,246

 

32,826,924

 

7,053,322

 

21%

 

Three Months Ended

March 31,

 

Increase

 

Percentage Increase

 

2020

 

2019

 

(Decrease)

 

(Decrease)

 

$

 

$

 

$

 

%

Royalty

240

 

-

 

240

 

100%

Product sales

304

 

-

 

304

 

100%

 

 

 

 

 

 

 

 

Total Revenues

544

 

-

 

544

 

100%

 

 

 

 

 

 

 

 

Research and development

3,894,966

 

2,474,559

 

1,420,407

 

57%

General and administrative

1,703,522

 

1,229,440

 

474,082

 

39%

Sales and marketing

273,954

 

284,280

 

(10,326)

 

(4%)

 

 

 

 

 

 

 

 

Total Operating Expenses

5,872,442

 

3,988,279

 

1,884,163

 

47%

 

 

 

 

 

 

 

 

Grant income

7,924

 

-

 

7,924

 

100%

Interest income

38,414

 

11,564

 

26,850

 

232%

Interest expense

(33,779)

 

(30,101)

 

3,678

 

12%

Other expenses

-

 

(196,957)

 

(196,957)

 

(100%)

 

 

 

 

 

 

 

 

Total Other Income (Expenses)

12,559

 

(215,494)

 

(228,053)

 

(106%)

 

 

 

 

 

 

 

 

Net Loss

(5,859,339)

 

(4,203,773)

 

1,655,566

 

39%

 

 

 

 

 

 

 

 

Revenues

 

Our operations are still predominantly in the research and development stage and we had limited revenues of $17,096 and $nil during the three months ended September 30,March 31, 2020 and March 31, 2019, and September 30, 2018, respectively.

 

Operating Expenses

 

Total operating expenses decreasedincreased to $4.2 million from $4.4$5.9 million for the three months ended September 30,March 31, 2020 from $4.0 million for the three months ended March 31, 2019, and September 30, 2018, respectively, as a result of the factors described below.



 

Research and Development Expenses

 

Research and development expenses decreasedincreased by $1.4 million to $2.6 million from $2.7$3.9 million for the three months ended September 30, 2019March 31, 2020 from $2.5 million for the three months ended March 31, 2019. This increase in overall research and September 30, 2018, respectively. Thisdevelopment expenditures was primarily duerelated to less work undertaken with our collaboration partners, partially offset by increasedhigher antibody costs, laboratory costsexpenses, personnel expenses and personnel costs.management compensation connected to Volition Germany during the period.

 

 

Three Months ended

September 30,

 

 

 

2019

 

2018

 

Change

 

$

 

$

 

$

Personnel expenses

992,868

 

856,508

 

136,360

Stock-based compensation

99,423

 

126,879

 

(27,456)

Direct research and development expenses

1,048,195

 

1,473,139

 

(424,944)

Other research and development

328,611

 

131,739

 

196,872

Depreciation and amortization

173,513

 

149,591

 

23,922

Total research and development expenses

2,642,610

 

2,737,856

 

(95,246)




 

Three Months Ended

March 31,

 

 

 

2020

 

2019

 

Change

 

$

 

$

 

$

Personnel expenses

1,294,147

 

933,123

 

361,024

Stock-based compensation

62,419

 

94,991

 

(32,572)

Direct research and development expenses

1,428,438

 

1,012,154

 

416,284

Other research and development

923,675

 

263,673

 

660,002

Depreciation and amortization

186,287

 

170,618

 

15,669

Total research and development expenses

3,894,966

 

2,474,559

 

1,420,407

General and Administrative Expenses

 

General and administrative expenses decreasedincreased to $1.4 million from $1.5$1.7 million for the three months ended September 30, 2019March 31, 2020, from $1.2 million for the three months ended March 31, 2019. This increase in overall general and September 30, 2018, respectively. Thisadministrative expenditures was primarily due to higher foreign exchange costs and legal expenses offset by lower stock-based compensation costs and legal and professional fees, partially offset by higher foreign exchange costs.charges during the period.

 

Three Months ended

September 30,

 

 

Three Months Ended

March 31,

 

 

2019

 

2018

 

Change

2020

 

2019

 

Change

$

 

$

 

$

$

 

$

 

$

Personnel expenses

562,964

 

539,778

 

23,186

529,179

 

577,529

 

(48,350)

Stock-based compensation

224,874

 

328,153

 

(103,279)

107,265

 

195,064

 

(87,799)

Legal and professional fees

196,020

 

371,700

 

(175,680)

419,857

 

309,458

 

110,399

Other general and administrative

349,733

 

201,983

 

147,750

590,295

 

138,162

 

452,133

Depreciation and amortization

21,401

 

8,769

 

12,632

56,926

 

9,227

 

47,699

Total general and administrative expenses

1,354,992

 

1,450,383

 

(95,391)

1,703,522

 

1,229,440

 

474,082

 

Sales and Marketing Expenses

 

Sales and marketing expenses decreased to $195,641 from $259,302were at the same level at $0.3 million for the three months ended September 30,March 31, 2020 and March 31, 2019, and September 30, 2018, respectively. There was an increase in marketing professional fees offset by lower stock-based compensation costs during the period.

 

Three Months Ended

March 31,

 

 

 

2020

 

2019

 

Change

 

$

 

$

 

$

Personnel expenses

150,945

 

157,839

 

(6,894)

Stock-based compensation

22,985

 

50,403

 

(27,418)

Direct marketing and professional fees

100,024

 

76,038

 

23,986

Total sales and marketing expenses

273,954

 

284,280

 

(10,326)



Other Income (Expenses)

For the three months ended March 31, 2020, the Company’s other income was $12,559 compared to other expenses of $215,494 for the three months ended March 31, 2019. This decrease was primarily related to lower salary costs during the period.

 

Three Months ended

September 30,

 

 

 

2019

 

2018

 

Change

 

$

 

$

 

$

Personnel expenses

135,680

 

206,527

 

(70,847)

Stock-based compensation

46,088

 

34,307

 

11,781

Direct marketing and professional fees

13,873

 

18,468

 

(4,595)

Total sales and marketing expenses

195,641

 

259,302

 

(63,661)

Other Expenses

The Company’s other expenses decreasedamendment to $4,658 compared to $29,108 for the three months ended September 30, 2019 and September 30, 2018, respectively. This decrease was primarily due to interest income received from cash on an overnight money market account deposit, partially offset by additional interestCotterford warrants which resulted in a $196,957 expense on long-term debt.in the same period in 2019.

 

Net Loss

 

For the three months ended September 30, 2019,March 31, 2020, the Company’s net loss was $4.2$5.9 million, a decreasean increase of approximately $0.3$1.7 million or 7%, in comparison to a net loss of $4.5$4.2 million for the three months ended September 30, 2018. The change was a result of the factors described above.




Comparison of the Nine Months Ended September 30, 2019 and September 30, 2018

The following table sets forth our results of operations for the nine months ended on September 30, 2019 and September 30, 2018, respectively:

 

Nine Months Ended

September 30,

 

Increase

 

Percentage Increase

 

2019

 

2018

 

(Decrease)

 

(Decrease)

 

$

 

$

 

$

 

%

 

 

 

 

 

 

 

 

Service

16,204

 

-

 

16,204

 

-%

Royalty

892

 

-

 

892

 

-%

 

 

 

 

 

 

 

 

Total Revenues

17,096

 

-

 

17,096

 

-%

 

 

 

 

 

 

 

 

Research and development

7,596,097

 

7,847,531

 

(251,434)

 

(3%)

General and administrative

4,020,893

 

4,949,716

 

(928,823)

 

(19%)

Sales and marketing

718,047

 

845,253

 

(127,206)

 

(15%)

 

 

 

 

 

 

 

 

Total Operating Expenses

(12,335,037)

 

(13,642,500)

 

(1,307,463)

 

(10%)

 

 

 

 

 

 

 

 

Interest income

68,656

 

-

 

68,656

 

-%

Interest expense

(95,507)

 

(78,646)

 

(16,861)

 

21%

Other expenses

(196,957)

 

-

 

(196,957)

 

-%

 

 

 

 

 

 

 

 

Total Other Expenses

(223,808)

 

(78,646)

 

145,162

 

185%

 

 

 

 

 

 

 

 

Net Loss

(12,541,749)

 

(13,721,146)

 

(1,179,397)

 

(9%)

 

 

 

 

 

 

 

 

Net Loss Per Share – Basic and Diluted

(0.33)

 

(0.46)

 

(0.13)

 

(28%)

 

 

 

 

 

 

 

 

Weighted Average Shares Outstanding - Basic and Diluted

38,538,394

 

30,071,635

 

8,466,759

 

28%

Revenues

Our operations are still predominantly in the research and development stage and we had limited revenues of $17,096 and $nil during the nine months ended September 30, 2019 and September 30, 2018, respectively.

Operating Expenses

Total operating expenses decreased to $12.3 million from $13.6 million for the nine months ended September 30, 2019 and September 30, 2018, respectively as a result of the factors described below.

Research and Development Expenses

Research and development expenses decreased to $7.6 million from $7.8 million for the nine months ended September 30, 2019 and September 30, 2018, respectively. This decrease was primarily due to less work undertaken with our collaboration partners, partially offset by increased laboratory costs and sample costs.

 

Nine Months Ended

September 30,

 

 

 

2019

 

2018

 

Change

 

$

 

$

 

$

Personnel expenses

2,850,614

 

2,669,426

 

181,188

Stock-based compensation

298,686

 

466,908

 

(168,222)

Direct research and development expenses

3,276,582

 

4,047,852

 

(771,270)

Other research and development

651,764

 

213,774

 

437,990

Depreciation and amortization

518,451

 

449,571

 

68,880

Total research and development expenses

7,596,097

 

7,847,531

 

(251,434)




General and Administrative Expenses

General and administrative expenses decreased to $4.0 million from $4.9 million for the nine months ended September 30, 2019 and September 30, 2018, respectively. This decrease was primarily due to lower stock–based compensation charges and reduced legal fees as a result of decreased external capital raising activities inMarch 31, 2019.

 

Nine Months Ended

September 30,

 

 

 

2019

 

2018

 

Change

 

$

 

$

 

$

Personnel expenses

1,688,747

 

1,629,390

 

59,357

Stock-based compensation

655,639

 

1,278,634

 

(622,995)

Legal and professional fees

882,815

 

1,209,772

 

(326,957)

Other general and administrative

751,320

 

804,921

 

(53,601)

Depreciation and amortization

42,372

 

26,999

 

15,373

Total general and administrative expenses

4,020,893

 

4,949,716

 

(928,823)

Sales and Marketing Expenses

Sales and marketing expenses decreased to $718,047 from $845,253 for the nine months ended September 30, 2019 and September 30, 2018, respectively. This decrease was primarily due to decreased marketing and professional fees and as well as reduced salary expenditures during the period.

 

Nine Months Ended

September 30,

 

 

 

2019

 

2018

 

Change

 

$

 

$

 

$

Personnel expenses

463,466

 

515,704

 

(52,238)

Stock-based compensation

136,368

 

136,418

 

(50)

Direct marketing and professional fees

118,213

 

193,131

 

(74,918)

Total sales and marketing expenses

718,047

 

845,253

 

(127,206)

Other Expenses

The Company’s other expenses increased to $223,808 from $78,646 for the nine months ended September 30, 2019 and September 30, 2018, respectively. This increase was primarily due the exercise of warrants to purchase approximately 1.7 million shares of our common stock by Cotterford Company Limited during the 2019 period at an amended price of $2.90 which resulted in a $196,957 expense, partially offset by interest income received from cash deposited in an overnight money market account.

Net Loss

For the nine months ended September 30, 2019, the Company’s net loss was $12.5 million, a decrease of approximately $1.2 million, or 9%, in comparison to a net loss of $13.7 million for the nine months ended September 30, 2018. 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. 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'smanagement’s estimates are based on historical experience, on information from third party professionals, and on various other assumptions that are believed to be reasonable under the facts and circumstances. Actual results could differ from those estimates made by management.

 

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.



 

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 under this item.

 

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'sSEC’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 Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Based upon that evaluation, our Principal Executive Officer and Principal Financial Officer have concluded, as they previously concluded as of December 31, 2018,2019, that our disclosure controls and procedures continue to not be effective as of September 30, 2019,March 31, 2020, because of material weaknesses in our internal control over financial reporting, as described below and in detail in our Annual Report.

 

Changes in Internal Control over Financial Reporting

 

The Audit Committee of 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, 2019,March 31, 2020, we did not maintain sufficient internal controls over financial reporting due to insufficient:

 

segregation of duties in some areas of Finance; 

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

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

 

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 of the reporting process, thereby strengthening the control environment over financial reporting.

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

 

There have been no changes in our internal controls over financial reporting that occurred during the fiscal quarter ended September 30, 2019,March 31, 2020, other than those described above, that have materially affected, or are reasonably likely to materially affect, our internal controls 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 II  OTHER INFORMATION

 

ITEM 1.LEGAL PROCEEDINGS 

 

In the ordinary course of business, we may be subject to claims, counter claims, suits 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 shareholders,stockholders, is an adverse party or has a material interest adverse to our interest.

 

ITEM 1A.RISK FACTORS 

 

ThereExcept as set forth below, 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.

 

The COVID-19 pandemic could adversely impact our business, including our clinical trials, development activities, business and operations.

In December 2019, a novel strain of coronavirus, COVID-19, was reported to have surfaced in Wuhan, China. Since then, the COVID-19 coronavirus has spread worldwide, including the United States and Europe. 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 around the world have taken unprecedented actions to mitigate the spread of COVID-19, including stay-at-home orders, quarantine requirements, and limitations on travel, including the closing of national borders. As a result of these restrictions, most of our employees are working remotely where possible and we have limited employee travel.

As a result of the COVID-19 pandemic, we have experienced and may continue to experience disruptions that could severely impact our business and clinical trials, including:

delays or difficulties in enrolling patients in clinical trials;

delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff;

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;

interruption of key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by governments, employers and others;

limitations in employee resources that would otherwise be focused on the conduct of clinical trials, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people;

shutdowns or other business disruptions at our customers and collaborators;

diversion of management resources to focus on mitigating the impacts of the COVID-19 pandemic; and

impacts from prolonged remote work arrangements, such as strains on our business continuity plans and the inability of certain employees to perform their work remotely.

The global outbreak of the COVID-19 coronavirus continues to rapidly evolve. The extent to which the COVID-19 pandemic may impact our business and clinical trials and development activities will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate duration and severity of the pandemic, travel restrictions and social distancing requirements in the countries where we conduct business, the effectiveness of actions taken to contain and treat the disease, and how quickly and to what extent more normalized economic and operating conditions can resume.  If we or our customers experience prolonged shutdowns or other business disruptions beyond current expectations, our ability to conduct our business could be materially and adversely impacted, and our business, liquidity, and financial results may be adversely affected.

The continued spread of COVID-19 has led to disruption and volatility in the global capital markets, which increases the cost of, and adversely impacts access to, capital and increases economic uncertainty. This volatility and uncertainty may adversely affect our stock price. The actions that governments and individuals have taken in response to COVID-19 have led to a sharp contraction in many aspects of economies worldwide. The pandemic may cause an economic slowdown of potentially extended duration, and it is possible that it could cause a global recession. If this occurs, it could negatively impact our ability to develop and commercialize our products, among other things. Even after the COVID-19 pandemic has subsided, we may continue to experience material adverse effects to our business as a result of the global economic impact of the pandemic.



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

 

None.Unregistered Sales of Equity Securities

On January 9, 2020, the Company issued 73,263 shares of our common stock to a managing director of Volition Germany valued at $333,969 ($4.56 per share) as compensation (see Note 8(f) in the condensed notes of the interim consolidated financial statements).

Effective March 1, 2020, the Company granted warrants to purchase 50,000 shares of common stock to the Chief Scientific Officer of Volition America for services. These warrants vest on September 1, 2021 (subject to continued employment through such date) and expire on March 1, 2026, with an exercise price of $3.45 per share.

Neither of the above issuances involved any underwriters, underwriting discounts or commissions, or any public offering and we believe were exempt from the registration requirements of the Securities Act by virtue of Section 4(a)(2) and/or Regulation D due to, among other things, the fact that there was no general solicitation or advertising, the transactions did not involve a public offering of securities, the representations of investment intent by the investors, and the securities were restricted from further transfer as evidenced by legend thereon.

Purchases of Equity Securities

On January 14, 2020, the Company purchased 11,364 shares of our common stock at $4.79 per share from our Chief Medical Officer, for a total cost to the Company of $54,434. These shares were subsequently retired.  The shares were purchased in a private transaction and not part of a publicly announced plan or program.  No additional shares were purchased by the Company during the three months ended March 31, 2020.

 

ITEM 3.DEFAULTS UPON SENIOR SECURITIES 

 

None.

 

ITEM 4.MINE SAFETY DISCLOSURES 

 

Not applicable.

 

ITEM 5.OTHER INFORMATION 

 

None.




ITEM 6.EXHIBITS 

 

Incorporated by Reference

Exhibit

Number

Exhibit Description

Form

File No.

Exhibit

Filing Date

Filed

Herewith

31.1

Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended.

X

31.2

Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended.

X

32.1*

Certifications of Chief Executive Officer and Chief Financial Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

X

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

ITEM 6.EXHIBITS

 

 

 

 

Incorporated by Reference

 

Exhibit

Number

 

Exhibit Description

 

Form

 

File No.

 

Exhibit

 

Filing Date

 

Filed

Herewith

 

 

 

 

 

 

 

 

 

 

 

 

 

10.1

 

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

 

10-K

 

001-36833

 

10.22

 

2/20/20

 

 

31.1

 

Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended.

 

 

 

 

 

 

 

 

 

X

31.2

 

Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended.

 

 

 

 

 

 

 

 

 

X

32.1*

 

Certifications of Chief Executive Officer and Chief Financial Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

 

 

 

 

 

 

 

X

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

 

*            The certifications attached as Exhibit 32.1 accompany this Quarterly Report pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, and shall not be deemed “filed” by the registrant for purposes of Section 18 of the Exchange Act and are not to be incorporated by reference into any of the registrant’s filings under the Securities Act or the Exchange Act, irrespective of any general incorporation language contained in any such filing.




SIGNATURES

 

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

 

 

 

VOLITIONRX LIMITED

 

 

 

 

 

 

 

 

Dated: November 12, 2019May 7, 2020

 

By:  /s/ Cameron Reynolds                                    

 

 

 

Cameron Reynolds

 

 

 

President and Chief Executive Officer

(Authorized Signatory and Principal Executive Officer)

 

 

 

 

 

 

 

 

Dated: November 12, 2019May 7, 2020

 

By:  /s/ David Vanston                                           

 

 

 

David Vanston

 

 

 

Chief Financial Officer and Treasurer

(Authorized Signatory and Principal Financial

and Accounting Officer)


32