UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

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

For the quarterly period endedSeptember June 30, 20172018

 

[   ]  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

Document1.jpg 

(Exact name of registrant as specified in its charter)

Delaware

 

91-1949078

(State or other jurisdiction of incorporation


or organization)

 

(I.R.S. Employer Identification No.)

 

1 Scotts Road

#24-05 Shaw Centre

Singapore 228208

(Address of principal executive offices)

 

+1 (646) 650-1351

(Registrant’s telephone number, including area code)

 

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] [X] Yes  [   ] No

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post 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

 

[   ] (Do not check if a smaller reporting company)

 

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 7(a)(2)(B)13(a) of the SecuritiesExchange Act. [   ]

 

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

 

As of NovemberAugust 8, 2017,2018, there were 26,518,70030,031,225 shares of the registrant’s $0.001 par value common stock issued and outstanding.




1


VOLITIONRX LIMITED

QUARTERLY REPORT ON FORM 10-Q

FOR THE THREE MONTHS AND NINESIX MONTHS ENDED SEPTEMBERJUNE 30, 20172018

 

TABLE OF CONTENTS

  

 

 

 

PAGE

PART I

 

FINANCIAL INFORMATION

 

ITEM 1.

FINANCIAL STATEMENTS

3

ITEM 2.

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

19

ITEM 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

26

ITEM 4.

CONTROLS AND PROCEDURES

26

PART II

OTHER INFORMATION

 

 

 

 

 

 

ITEM 1.

 

FINANCIAL STATEMENTS

3

ITEM 2.

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

17

ITEM 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

25

ITEM 4.

CONTROLS AND PROCEDURES

25

PART II

OTHER INFORMATION

ITEM 1.

LEGAL PROCEEDINGS

26

ITEM 1A.

 

LEGAL PROCEEDINGS

RISK FACTORS

 

28

2826

 

ITEM 2.

 

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

2826

 

ITEM 3.

 

DEFAULTS UPON SENIOR SECURITIES

 

2826

 

ITEM 4.

 

MINE SAFETY DISCLOSURES

 

2826

 

ITEM 5.

 

OTHER INFORMATION

 

2826

 

ITEM 6.

 

EXHIBITS

 

2927

 

 

 

 

 

SIGNATURES

 

 

 

2928

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. Ltd,Limited, Belgian Volition SPRL, Hypergenomics Pte. Ltd,Limited, Volition America, Inc. and Volition Diagnostics UK Limited. Additionally, unless otherwise specified, all references to “United States Dollars” or “$” refer to the legal currency of the United States of America.

 

Nucleosomics®, Nu.QTMand HyperGenomics® and their respective logos are trademarks and/or service marks of VolitionRx. All other trademarks, service marks and trade names referred to in this report are the property of their respective owners.


2



PART I - FINANCIAL INFORMATION

 

ITEM 1.FINANCIAL STATEMENTS 

 

 

PAGE

 

 

Condensed Consolidated Balance Sheets (Unaudited)

4

 

 

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)

5

 

 

Condensed Consolidated Statements of Cash Flows (Unaudited)

6

 

 

Notes to the Condensed Consolidated Financial Statements (Unaudited)

7


3



VOLITIONRX LIMITED

Condensed Consolidated Balance Sheets (Unaudited)

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

 

September 30,

2017

$

 

December 31,

2016

$

June 30,

2018

$

 

December 31,

2017

$

(UNAUDITED)

 

 

(UNAUDITED)

 

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

13,840,930

 

21,678,734

11,894,166

 

10,116,263

Prepaid expenses

244,667

 

165,927

425,613

 

248,661

Other current assets

170,883

 

166,887

200,629

 

202,295

 

 

 

 

 

 

Total Current Assets

14,256,480

 

22,011,548

12,520,408

 

10,567,219

 

 

 

 

 

 

Property and equipment, net

3,510,355

 

2,119,027

3,257,434

 

3,480,782

Intangible assets, net

592,876

 

602,193

519,910

 

576,397

 

 

 

 

 

 

Total Assets

18,359,711

 

24,732,768

16,297,752

 

14,624,398

 

 

 

 

 

 

LIABILITIES

 

 

 

 

 

 

 

 

 

 

 

 

Accounts payable

431,734

 

281,179

1,155,949

 

351,735

Accrued liabilities

1,759,161

 

1,439,275

1,701,614

 

1,278,428

Management and directors’ fees payable

54,994

 

81,057

26,708

 

35,397

Current portion of long-term debt

408,307

 

30,655

282,159

 

443,908

Current portion of capital lease liabilities

136,307

 

119,016

137,455

 

139,084

Deferred grant income

-

 

45,510

Current portion of grant repayable

41,356

 

36,804

40,917

 

41,930

 

 

 

 

 

 

Total Current Liabilities

2,831,859

 

2,033,496

3,344,802

 

2,290,482

 

 

 

 

 

 

Long-term debt

1,050,536

 

432,027

Capital lease liabilities

897,303

 

889,810

Grant repayable

185,991

 

202,325

Long-term debt, net of current portion

1,976,389

 

1,312,785

Capital lease liabilities, net of current portion

784,364

 

874,684

Grant repayable, net of current portion

143,100

 

188,579

 

 

 

 

 

 

Total Liabilities

4,965,689

 

3,557,658

6,248,655

 

4,666,530

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

 

Common Stock

 

 

 

 

 

 

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

 

 

 

 

 

 

Issued and outstanding: 26,518,700 shares and 26,126,049 shares, respectively

26,519

 

26,126

Issued and outstanding: 30,031,225 shares and 26,519,394 shares, respectively

30,031

 

26,519

Additional paid-in capital

65,151,681

 

62,287,252

74,959,980

 

65,774,870

Accumulated other comprehensive loss

(132,882)

 

(193,297)

Accumulated other comprehensive income(loss)

17,761

 

(129,343)

Accumulated deficit

(51,651,296)

 

(40,944,971)

(64,958,675)

 

(55,714,178)

 

 

 

 

 

 

Total Stockholders’ Equity

13,394,022

 

21,175,110

10,049,097

 

9,957,868

 

 

 

 

 

 

Total Liabilities and Stockholders’ Equity

18,359,711

 

24,732,768

16,297,752

 

14,624,398

 

 

 

 

 

 

 

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


4



VOLITIONRX LIMITED

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)

(Expressed in United States Dollars, except share numbers)

 

 

 

For the three months ended

September 30,

2017

$

 

For the three months ended

September 30,

2016

$

 

For the nine months ended

September 30,

2017

$

 

For the nine months ended

September 30,

2016

$

 

 

 

 

 

 

 

 

 

Revenue

 

 

 

 

 

 

 

 

 

 

 

 

 

Expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

General and administrative

 

226,606

 

163,870

 

729,449

 

558,120

Sales and marketing

 

134,737

 

88,989

 

435,971

 

249,591

Professional fees

 

520,372

 

400,698

 

1,182,837

 

1,272,638

Salaries and office administrative fees

 

943,510

 

857,093

 

2,720,620

 

1,686,210

Research and development

 

2,203,985

 

1,968,490

 

5,774,004

 

5,180,466

 

 

 

 

 

 

 

 

 

Total Operating Expenses

 

4,029,210

 

3,479,140

 

10,842,881

 

8,947,025

 

 

 

 

 

 

 

 

 

Net Operating Loss

 

(4,029,210)

 

(3,479,140)

 

(10,842,881)

 

(8,947,025)

 

 

 

 

 

 

 

 

 

Other Income

 

 

 

 

 

 

 

 

Grants received

 

136,556

 

 

136,556

 

25,891

 

 

 

 

 

 

 

 

 

Total Other Income

 

136,556

 

 

136,556

 

25,891

 

 

 

 

 

 

 

 

 

Income tax expense

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Loss

 

(3,892,654)

 

(3,479,140)

 

(10,706,325)

 

(8,921,134)

 

 

 

 

 

 

 

 

 

Other Comprehensive Income/(Loss)

 

 

 

 

 

 

 

 

Foreign currency translation adjustments

 

(32,399)

 

15,462

 

60,415

 

(33,583)

Total Other Comprehensive Income/(Loss)

 

(32,399)

 

15,462

 

60,415

 

(33,583)

Net Comprehensive Loss

 

(3,925,053)

 

(3,463,678)

 

(10,645,910)

 

(8,954,717)

Net Loss per Share – Basic and Diluted

 

(0.15)

 

(0.15)

 

(0.41)

 

(0.40)

Weighted Average Shares Outstanding – Basic and Diluted

 

26,512,195

 

23,524,982

 

26,343,101

 

22,075,538

 

 

 

 

 

 

 

 

 

 

 

Three-Months Ended June 30,

 

Six-Months Ended June 30,

 

 

2018

$

 

2017

$

 

2018

$

 

2017

$

Revenue

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating Expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

2,686,473

 

1,807,636

 

5,109,675

 

3,480,987

General and administrative

 

1,643,681

 

1,427,875

 

3,485,774

 

2,823,594

Sales and marketing

 

235,366

 

207,042

 

599,510

 

476,450

 

 

 

 

 

 

 

 

 

Total Operating Expenses

 

4,565,520

 

3,442,553

 

9,194,959

 

6,781,031

 

 

 

 

 

 

 

 

 

Operating Loss

 

(4,565,520)

 

(3,442,553)

 

(9,194,959)

 

(6,781,031)

 

 

 

 

 

 

 

 

 

Other Expenses

 

 

 

 

 

 

 

 

Interest expense

 

26,556

 

20,435

 

49,538

 

32,640

Net Loss

 

(4,592,076)

 

(3,462,988)

 

(9,244,497)

 

(6,813,671)

 

 

 

 

 

 

 

 

 

Other Comprehensive Loss

 

 

 

 

 

 

 

 

Foreign currency translation adjustments

 

132,157

 

61,309

 

147,104

 

92,814

 

 

 

 

 

 

 

 

 

Net Comprehensive Loss

 

(4,459,919)

 

(3,401,679)

 

(9,097,393)

 

(6,720,857)

 

 

 

 

 

 

 

 

 

Net Loss per Share – Basic and Diluted

 

(0.15)

 

(0.13)

 

(0.32)

 

(0.26)

 

 

 

 

 

 

 

 

 

Weighted Average Shares Outstanding – Basic and Diluted

 

30,027,260

 

26,383,228

 

28,655,711

 

26,137,241

 

 

 

 

 

 

 

 

 

 

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


5



VOLITIONRX LIMITED

Condensed Consolidated Statements of Cash Flows (Unaudited)

(Expressed in United States Dollars)

 

For the

nine months ended

September 30,

2017

 

For the

nine months ended

September 30,

2016

 

Six-Months Ended June 30,

$

 

$

 

2018

 

2017

 

 

 

 

$

 

$

Operating Activities:

 

 

 

Operating Activities

 

 

 

 

 

 

 

 

Net loss

(10,706,325)

 

(8,921,134)

 

(9,244,497)

 

(6,813,671)

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

Depreciation and amortization

371,362

 

230,606

 

317,981

 

225,740

Loss on disposal of property and equipment

11,262

 

3,668

Stock based compensation

1,827,604

 

1,106,623

Loss(gain) on disposal of property and equipment

 

(41)

 

1,929

Stock options issued for services

 

1,388,295

 

1,220,798

Warrants issued for services

38,806

 

105,995

 

4,326

 

28,482

 

 

 

 

 

 

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

Accounts receivable

(12,356)

 

-

Deferred grant income

(50,855)

 

(335)

Prepaid expenses

(75,723)

 

(35,283)

 

(174,504)

 

(131,526)

Other current assets

25,105

 

(36,456)

 

(188,285)

 

31,560

Accounts payable and accrued liabilities

264,266

 

872,934

 

1,406,197

 

(46,685)

 

 

 

Net Cash Used In Operating Activities

(8,306,854)

 

(6,673,382)

Net Cash Used in Operating Activities

 

(6,490,528)

 

(5,483,373)

 

 

 

 

 

 

 

Investing Activities:

 

 

 

 

 

 

 

Purchases of property and equipment

(1,340,230)

 

(89,433)

 

(125,513)

 

(1,234,892)

 

 

 

Net Cash Used in Investing Activities

(1,340,230)

 

(89,433)

 

(125,513)

 

(1,234,892)

 

 

 

 

 

 

 

Financing Activities:

 

 

 

 

 

 

 

Net proceeds from issuance of common shares

998,412

 

13,506,295

 

7,796,001

 

879,412

Proceeds from debt payable

908,075

 

 

875,652

 

664,573

Debt repaid

(29,807)

 

Grants repaid

(38,487)

 

(36,135)

Payments on debt payable

 

(332,856)

 

Payments on grants repayable

 

(40,863)

 

(38,487)

Payments on capital lease obligations

(94,227)

 

(62,225)

 

(72,524)

 

(60,874)

 

 

 

Net Cash Provided By Financing Activities

1,743,966

 

13,407,935

Net Cash Provided by Financing Activities

 

8,225,410

 

1,444,624

 

 

 

 

 

 

 

Effect of foreign exchange on cash

65,314

 

(33,343)

 

168,534

 

100,117

 

 

 

 

 

 

 

(Decrease)/Increase in Cash

(7,837,804)

 

6,611,777

Net change in cash and cash equivalents

 

1,777,903

 

(5,173,524)

 

 

 

 

 

 

 

Cash and cash equivalents – Beginning of Period

21,678,734

 

5,916,006

 

10,116,263

 

21,678,734

 

 

 

 

Cash and cash equivalents – End of Period

13,840,930

 

12,527,783

 

11,894,166

 

16,505,210

 

 

 

 

 

 

 

Supplemental Disclosures of Cash Flow Information:

 

 

 

 

 

 

 

Interest paid

50,234

 

9,159

 

49,737

 

32,639

Income tax paid

 

 

 

 

 

 

 

 

 

 

Non Cash Investing and Financing Activities:

 

 

 

Common stock issued on cashless exercises of stock options

 

21

Capital lease obligation for equipment purchases

 

329,334

Non-Cash Investing and Financing Activities:

 

 

 

 

Common stock issued on cashless exercises of stock options and warrants

 

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

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

Note 1 - Condensed Financial Statements

 

The accompanying financial statements have been prepared by VolitionRx without audit. In the opinion of management, all adjustments (which include only normal recurring adjustments) necessary to present fairly the financial position, results of operations, and cash flows at SeptemberJune 30, 2017,2018, and for all periods presented herein, have been made.

 

Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) have been condensed or omitted. It is suggested that these unaudited condensed consolidated financial statements be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’sCompany’s Annual Report on Form 10-K, for the fiscal year ended December 31, 20162017, as filed with the Securities and Exchange Commission on March 10, 2017.1, 2018. The results of operations for theperiods ended SeptemberJune 30, 20172018 and 20162017 are not necessarily indicative of the operating results for the full years.

 

Note 2 - Going Concern

 

The Company’s 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 $51,651,296,$64,958,675, has negative cash flows from operations, and currently has no revenues, which creates substantial doubt about its ability to continue as a going concern.concern for a period of one year from the date of issuance of these 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,by: (a) securing additional grant funds,funds; (b) obtaining additional financing throughequity or debt financing; (c) granting licenses to third parties in exchange for specified up-front and/or equity financing, (c) up front sales of licensing rightsback 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 accomplishaccomplishment of the plans described in the preceding paragraph and eventually secure other sources of financing and attain profitable operations. The accompanying 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.

 

Note 3 - Summary of Significant Accounting Policies

 

Basis of Presentation

 

The financial statements of the Company have been prepared in accordance with U.S. GAAP and are expressed in United States Dollars. The Company’s fiscal year end is December 31.

 

Use of Estimates

 

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. The Company also regularly evaluates estimates and assumptions related to deferred income tax asset valuation allowances.




VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 3 - Summary of Significant Accounting Policies (continued)

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.


7


VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 3 - SummaryPrinciples of Significant Accounting Policies (continued)Consolidation

 

Principles of Consolidation

The accompanying condensed consolidated financial statements for the periodperiods ended SeptemberJune 30, 20172018 include the accounts of the Company and its wholly-owned subsidiaries, Singapore Volition Pte. Ltd,Limited, Belgian Volition SPRL (“Belgian Volition”), Hypergenomics Pte. Ltd, ,Limited, Volition America, Inc., which was formed on February 3, 2017 (“Volition America”), and Volition Diagnostics UK Limited (“Volition Diagnostics”). All significant intercompany balances and transactions have been eliminated in consolidation.

 

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”) on the face of the income statement. Basic EPS is computed by dividing net loss available to common shareholders (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 and convertible preferred stock using the if-converted method. In computing diluted EPS, the average stock price for the period is used in determining the number of shares assumed to be purchased from the exercise of stock options or warrants. As of SeptemberJune 30, 2017, 850,1512018, 1,959,196 dilutive warrants and options and 2,283,582 potentially dilutivepotential common shares from warrants and options were excluded from the diluted EPS calculation as their effect is anti-dilutive. As of June 30, 2017, 1,828,093 dilutive potential common shares from warrants and options were excluded from the diluted EPS calculation as their effect is anti-dilutive.

 

Reclassification

 

Certain balances in previously issued financial statements have been reclassified to be consistent with the current period presentation.

 

Recent Accounting Pronouncements

 

Management has considered all recent accounting pronouncements issued since the last audit of our consolidated financial statements. The Company’s management believes that these recent pronouncements will not have a material effect on the Company’s consolidated financial statements. However, the following pronouncement has been adopted by the Company:




 

In March 2016, the FASB Issued ASU No. 2016-09, “Compensation – Stock Compensation (Topic 718)”. The amendments in this update simplify aspects of accounting for share-based payment transactions. An entity can now make an entity-wide accounting policy election to either estimate the number of awards that are expected to vest (current GAAP) or account for forfeitures when they occur. The amendments in this update are effective for public business entities for fiscal years, and for interim periods within those fiscal years, beginning after December 15, 2016.


8


VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 4 - Property and Equipment

 

The Company’s property and equipment consist of the following amounts as of SeptemberJune 30, 20172018 and December 31, 2016:2017:

 

 

 

Cost

$

 

Accumulated

Depreciation

$

 

September 30,

2017

Net Carrying

Value

$

 

 

 

June 30,

 

 

 

 

 

2018

 

 

 

 

 

Accumulated

 

Net Carrying

 

 

 

 

 

Cost

 

Depreciation

 

Value

 

Useful Life

 

 

Useful Life

 

$

 

$

 

$

Computer hardware and software

 

3 years

 

267,773

 

110,888

 

156,885

 

3 years

 

300,781

 

128,425

 

172,356

Laboratory equipment

 

5 years

 

817,851

 

262,517

 

555,334

 

5 years

 

1,573,407

 

791,058

 

782,349

Equipment held under capital lease

 

5 years

 

675,293

 

307,562

 

367,731

Office furniture and equipment

 

5 years

 

186,508

 

27,643

 

158,865

 

5 years

 

200,205

 

56,001

 

144,204

Buildings

 

30 years

 

1,549,446

 

30,096

 

1,519,350

 

30 years

 

1,533,006

 

68,123

 

1,464,883

Building improvements

 

5 -15 years

 

683,820

 

26,158

 

657,662

 

5-15 years

 

656,875

 

56,758

 

600,117

Land

 

Not amortized

 

94,528

 

-

 

94,528

 

Not amortized

 

93,525

 

 

93,525

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4,275,219

 

764,864

 

3,510,355

 

 

4,357,799

 

1,100,365

 

3,257,434

 

 

 

 

 

 

 

 

 

 

 

 

December 31,

2016

Net Carrying

Value

$

 

 

 

December 31,

 

 

 

 

 

2017

 

 

Accumulated

Depreciation

$

 

 

 

 

Accumulated

 

Net Carrying

 

 

Cost

$

 

 

 

Cost

 

Depreciation

 

Value

 

Useful Life

 

Accumulated

Depreciation

$

 

Useful Life

 

$

 

$

 

$

Computer hardware and software

 

3 years

 

155,870

 

67,097

88,773

 

3 years

 

239,133

 

93,422

 

145,711

Laboratory equipment

 

5 years

 

313,655

 

151,541

162,114

 

5 years

 

1,575,354

 

653,636

 

921,718

Equipment held under capital lease

 

5 years

 

578,830

 

183,296

 

395,534

Office furniture and equipment

 

5 years

 

32,932

 

23,361

 

9,571

 

5 years

 

207,208

 

54,479

 

152,729

Buildings

 

30 years

 

1,378,911

 

-

 

1,378,911

 

30 years

 

1,571,004

 

43,632

 

1,527,372

Building improvements

 

5 -15 years

 

-

 

-

 

-

 

5-15 years

 

673,157

 

35,748

 

637,409

Land

 

Not amortized

 

84,124

 

-

 

84,124

 

Not amortized

 

95,843

 

 

95,843

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,544,322

 

425,295

 

2,119,027

 

 

4,361,699

 

880,917

 

3,480,782

 

During the nine-month periodsix-month periods ended SeptemberJune 30, 20172018 and the nine-month period ended SeptemberJune 30, 2016,2017, the Company recognized $306,180$271,347 and $165,293$183,323, respectively, in depreciation expense.


9



VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 5 - Intangible Assets

 

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

 

 

Cost

$

 

Accumulated

Amortization

$

 

September 30,

2017

Net Carrying

Value

$

 

 

 

June 30,

 

 

 

 

2018

 

 

 

Accumulated

 

Net Carrying

 

Cost

 

Amortization

 

Value

 

$

 

$

 

$

 

 

 

 

 

 

 

 

 

 

 

 

Patents

 

1,198,930

 

 

606,054

 

592,876

1,187,959

 

668,049

 

519,910

 

 

 

 

 

 

 

 

 

 

 

 

 

1,198,930

 

 

606,054

 

592,876

 

 

 

December 31,

 

 

 

 

 

 

 

2017

 

Cost

$

 

 

Accumulated

Amortization

$

 

December 31,

2016

Net Carrying

Value

$

 

 

Accumulated

 

Net Carrying

 

 

 

 

Cost

 

Amortization

 

Value

 

 

 

 

$

 

$

 

$

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Patents

 

1,085,133

 

 

482,940

 

602,193

1,213,314

 

636,917

 

576,397

 

1,085,133

 

 

482,940

 

602,193

 

During the nine-month periodsix-month periods ended SeptemberJune 30, 2017,2018 and the nine-month period ended SeptemberJune 30, 2016,2017, the Company recognized $65,182$46,863 and $65,313,$42,417, respectively, in amortization expense.

 

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

 

2017 - remaining

$26,321

2018

$91,504

2018- remaining

 

$

43,719

2019

$91,504

 

$

90,660

2020

$91,504

 

$

90,660

2021

$91,504

 

$

90,660

2022

 

$

90,660

Thereafter

 

$

113,551

 

 

 

Total

 

$

519,910

 

The Company periodically reviews its long-lived assets on an annual basis, 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 as of December 31, 2016.2017. The result of this review confirmed that the fairongoing value of the patents exceeded their carrying valuewas not impaired as of December 31, 2016.2017.


10



VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 6 - Related Party Transactions

 

The Company has agreements with related parties for consultancy services, stock options and warrants. See Notes 8 (a), 8(b) and 9(b), for further details concerning these agreements.

 

Note 7 - Common Stock

 

Issuances Upon Warrant ExercisesAs of June 30, 2018, the Company was authorized to issue 100 million shares of common stock, par value $0.001 per share, of which 30,031,225 and 26,519,394 shares were issued and outstanding as of June 30, 2018 and December 31, 2017, respectively.

 

On January 26, 2017, 2,000 warrants were exercisedMarch 13, 2018, the Company issued 3.5 million shares of common stock in a registered public offering at a price of $2.40 per share, for aggregate gross proceeds of $8.4 million. In connection with the transaction, $0.6 million was incurred for legal and underwriting fees resulting in net cash proceeds of $7.8 million. Pursuant to this offering, the Company of $4,800. As a result, a total of 2,000underwriters had the option to purchase up to an additional 525,000 shares of common stock were issued.for 30 days following the pricing of the initial closing, which option was not exercised.

 

From March 13, 2017 through April 3, 2017, 27,500During the six-monthperiod ended June 30, 2018, 29,375 warrants were exercised to purchase shares of common stock at a price of $2.20$2.00 per share for net cash proceeds toin cashless exercises that resulted in the Companyissuance of $60,500. As a result, a total of 27,50011,831 shares of common stock were issued.stock.

From April 3, 2017 through May 9, 2017, 313,151 warrants were exercised at a price of $2.60 per share, for net cash proceeds to the Company of $814,193. As a result, a total of 313,151 shares of common stock were issued. Of this issuance, 163,499 shares of common stock were issued to related parties, for net cash proceeds to the Company of $425,097.

On July 7, 2017, 5,000 warrants were exercised at a price of $2.20 per share, for net cash proceeds to the Company of $11,000. As a result, a total of 5,000 shares of common stock were issued.

From July 9, 2017 through July 19, 2017, 45,000 warrants were exercised at a price of $2.40 per share for net cash proceeds to the Company of $108,000. As a result, a total of 45,000 shares of common stock were issued.

 

Note 8 – Warrants and Options

 

a)Warrants

 

See Note 7.

The following table summarizes the changes in warrants outstanding of the Company during the nine-monthsix-month period ended SeptemberJune 30, 2017:2018:

 

 

Number of Warrants

 

Weighted Average

Exercise Price ($)

 

Number of Warrants

 

Weighted Average

Exercise Price ($)

Outstanding at December 31, 2016

 

2,162,638

 

2.40

Outstanding at December 31, 2017

 

1,731,680

 

2.36

Granted

 

-

 

-

 

 

Exercised

 

(392,651)

 

(2.38)

 

(29,375)

 

2.00

Expired

 

(38,307)

 

(2.40)

 

(375)

 

2.00

Outstanding at September 30, 2017

 

1,731,680

 

2.36

Outstanding at June 30, 2018

 

1,701,930

 

2.37

 

 

 

 

 

 

 

 

Exercisable at September 30, 2017

 

1,606,680

 

2.35

Exercisable at June 30, 2018

 

1,576,930

 

2.36




 

On February 14, 2017, the Company modified the performance criteria for a vesting milestone on an employee warrant agreement and as a result the Company re-measured warrants held by an employee, to purchase 25,000 shares of common stock at an exercise price of $2.47 per share. These warrants vest on achievement of certain business objectives and expire 3 years from the date of vesting. The Company has calculated the estimated fair market value of these warrants using the Black-Scholes model and the following assumptions: term: 0.5 years, stock price: $4.52, exercise price: $2.47, 55.65% volatility, 0.66% risk free rate.


11


VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 8 – Warrants and Options (continued)

 

On May 10, 2017, 28,307 warrants expired and on September 5, 2017, 10,000 warrants expired.

Effective August 22, 2017, the Company amended the expiry period of 24,000 warrants, originally granted on September 26, 2014. The expiration period was extended from three to four years for all 24,000 warrants, with their new expiration date being September 26, 2018. The Company recalculated the estimated fair market value of these warrants using the Black-Scholes model, but the result was deemed to be immaterially different to the original calculation and the financial statements were not adjusted.

Effective August 22, 2017, the Company amended the expiry period of 19,000 warrants, originally granted on November 17, 2014. The expiration period was extended from three to four years for all 19,000 warrants, with their new expiration date being November 17, 2018. The Company recalculated the estimated fair market value of these warrants using the Black-Scholes model, but the result was deemed to be immaterially different to the original calculation and the financial statements were not adjusted.

Below is a table summarizing the warrants issued and outstanding as of SeptemberJune 30, 2017,2018, which have a weighted average exercise price of $2.36$2.37 per share and an aggregate weighted average remaining contractual life of 1.550.95 years.

 

Date Issued

 

Number Outstanding

 

Number Exercisable

 

Exercise Price ($)

 

Contractual Life (Years)

 

Weighted Average Remaining Contractual Life (Years)

 

Expiration Date

 

Proceeds to Company if Exercised ($)

03/20/13

 

125,000

 

-

 

 

2.47

 

8.0 to 9.0

 

0.26

 

06/30/20 to 12/31/21

 

 

308,750

03/20/13

 

25,000

 

25,000

 

 

2.47

 

7.5

 

0.06

 

09/18/20

 

 

61,750

06/10/13

 

29,750

 

29,750

 

 

2.00

 

5.0

 

0.01

 

06/10/18

 

 

59,500

11/25/13

 

456,063

 

456,063

 

 

2.40

 

5.0

 

0.30

 

11/25/18

 

 

1,094,551

12/31/13

 

64,392

 

64,392

 

 

2.40

 

5.0

 

0.05

 

12/31/18

 

 

154,541

02/26/14

 

948,475

 

948,475

 

 

2.20

 

5.0

 

0.77

 

02/26/19

 

 

2,086,645

09/26/14

 

24,000

 

24,000

 

 

3.00

 

3.0

 

0.01

 

09/26/18

 

 

72,000

11/17/14

 

19,000

 

19,000

 

 

3.75

 

3.0

 

0.01

 

11/17/18

 

 

71,250

11/14/16

 

40,000

 

40,000

 

 

4.53

 

4.0

 

0.07

 

11/14/20

 

 

181,200

 

 

1,731,680

 

1,606,680

 

 

 

 

 

 

1.55

 

 

 

 

4,090,187

Number

Outstanding

 

Number

Exercisable

 

Exercise

Price ($)

 

Weighted

Average

Remaining

Contractual

Life

(Years)

 

Proceeds to Company if

Exercised ($)

 

 

 

 

 

 

 

 

 

948,475

 

948,475

 

2.20

 

0.37

 

2,086,645

520,455

 

520,455

 

2.40

 

0.13

 

1,249,092

150,000

 

25,000

 

2.47

 

0.39

 

370,500

24,000

 

24,000

 

3.00

 

0.00

 

72,000

19,000

 

19,000

 

3.75

 

0.00

 

71,250

40,000

 

40,000

 

4.53

 

0.06

 

181,200

1,701,930

 

1,576,930

 

 

 

0.95

 

4,030,687

 

Warrant expense of $4,326 and $28,482 was recorded in the six-months ended June 30, 2018 and June 30, 2017, respectively. Total remaining unrecognized compensation cost related to non-vested warrants is approximately $41,324$21,264 and is expected to be recognized over a period of 1.32.5 years. As of SeptemberJune 30, 2017,2018, the total intrinsic value of warrants was $570,291.


12


VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)$0.

 

Note 8 – Warrants and b)Options (continued)

 

b) Options

The following table summarizes the changes in options outstanding of the Company during the nine-monthsix-month period ended SeptemberJune 30, 2017:2018:

 

 

 

Number of

Options

 

Weighted Average

Exercise Price

($)

Outstanding at December 31, 2016

 

2,384,300

 

3.75

Granted

 

871,000

 

4.99

Exercised

 

-

 

-

Expired

 

(211,000)

 

(4.05)

Outstanding at September 30, 2017

 

3,044,300

 

4.08

 

 

 

 

 

Exercisable at September 30, 2017

 

2,173,300

 

3.72

 

 

Number of

Options

 

Weighted Average

Exercise Price ($)

Outstanding at December 31, 2017

 

2,939,134

 

4.09

Granted

 

780,000

 

4.00

Exercised

 

 

Expired/Cancelled

 

(120,167)

 

4.99

Outstanding at June 30, 2018

 

3,598,967

 

4.04

 

 

 

 

 

Exercisable at June 30, 2018

 

2,808,967

 

4.05

 

Effective January 1, 2017,23, 2018, the Company granted stock options to purchase 50,000780,000 shares of common stock. These options vest on January 1, 201823, 2019 and expire 5 years after the vesting date, with an exercise price of $4.80$4.00 per share. The Company has calculated the estimated fair market value of these options at $157,890,$1,930,265, using the Black-Scholes model and the following assumptions: term 6 years, stock price $4.57,$3.75, exercise price $4.80, 80.70%$4.00, 75.4% volatility, 2.26%2.55% risk free rate, and no forfeiture rate.




 

Effective February 13, 2017, the Company granted stock options to purchase 25,000 shares of common stock. These options vest on February 13, 2018 and expire 5 years after the vesting date, with an exercise price of $5.00 per share. The Company has calculated the estimated fair market value of these options at $76,773, using the Black-Scholes model and the following assumptions: term 6 years, stock price $4.52, exercise price $5.00, 80.17% volatility, 2.24% risk free rate.

On March 1, 2017, stock options to purchase 5,000 shares of common stock expired unexercised.

On March 30, 2017, the Company granted stock options to purchase 686,000 shares of common stock. These options vest on March 30, 2018 and expire five years after their vesting date, with an exercise price of $5.00 per share. The Company has calculated the estimated fair market value of these options at $1,898,322, using the Black-Scholes model and the following assumptions: term 6 years, stock price $4.18, exercise price $5.00, 79.41% volatility, 2.25% risk free rate.

Effective April 10, 2017, the Company granted stock options to purchase 100,000 shares of common stock. These options vest on April 10, 2018 and expire 5 years after the vesting date, with an exercise price of $5.00 per share. The Company has calculated the estimated fair market value of these options at $258,077, using the Black-Scholes model and the following assumptions: term 6 years, stock price $3.96, exercise price $5.00, 79.33% volatility, 2.18% risk free rate.

On May 25, 2017, stock options to purchase 101,000 shares of common stock expired unexercised.

On May 31, 2017, stock options to purchase 25,000 shares of common stock expired unexercised.

Effective July 13, 2017, the Company granted stock options to purchase 10,000 shares of common stock. These options vest on July 13, 2018 and expire 5 years after the vesting date, with an exercise price of $5.00 per share. The Company has calculated the estimated fair market value of these options at $19,068, using the Black-Scholes model and the following assumptions: term 6 years, stock price $3.15, exercise price $5.00, 78.41% volatility, 2.16% risk free rate.

Effective August 14, 2017, the Company amended the expiry period of stock options to purchase 37,000 shares of common stock, which options were originally granted on March 20, 2013 and amended on June 27, 2016. The expiration period was extended from four to six years, with the outside expiration date of March 20, 2022, after vesting for all 37,000 stock options. The Company recalculated the estimated fair market value of these options using the Black-Scholes model, but the result was deemed to be immaterially different to the original calculation and the financial statements were not adjusted.


13


VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 8 – Warrants and Options (continued)

 

Effective August 14, 2017, the Company amended the expiry period of stock options to purchase 16,300 shares of common stock, which options were originally granted on September 2, 2013 and amended on June 27, 2016. The expiration period was extended from four to six years, with the outside expiration date of September 2, 2022, after vesting for all 16,300 stock options. The Company recalculated the estimated fair market value of these options using the Black-Scholes model, but the result was deemed to be immaterially different to the original calculation and the financial statements were not adjusted.

On August 31, 2017, stock options to purchase 75,000 shares of common stock expired unexercised.

On September 1, 2017, stock options to purchase 5,000 shares of common stock expired unexercised.

On September 8, 2017, an amendment to the 2015 Stock Incentive Plan (the “2015 Plan”) was approved by stockholders at the annual meeting to increase the number of shares of common stock available for issuance under the 2015 Plan by 750,000 shares to an aggregate maximum of 2,500,000 shares.

Below is a table summarizing the options issued and outstanding as of SeptemberJune 30, 2017,2018, all of which were issued pursuant to the 2011 Equity Incentive Plan (for option issuances prior to 2016) or the 2015 Plan (for option issuances commencing in 2016) and which have a weighted average exercise price of $4.08$4.04 per share and an aggregatea weighted average remaining contractual life of 3.563.59 years. As of June 30, 2018, an aggregate of 59,000 shares of common stock remained available for future issuance under the 2015 Stock Incentive Plan.

 

Date

Issued

 

Number

Outstanding

 

Number

Exercisable

 

Exercise

Price ($)

 

Contractual

Life (Years)

 

Weighted

Average

Remaining

Contractual

Life

(Years)

 

Expiration Date

 

Proceeds to

Company if

Exercised

($)

11/25/11

 

303,000

 

303,000

 

4.00-5.00

 

6.0-7.0

 

0.06

 

11/25/17-11/25/18

 

1,414,000

09/01/12

 

10,000

 

10,000

 

6.31

 

6.0

 

0.00

 

03/01/18-09/01/18

 

63,100

03/20/13

 

37,000

 

37,000

 

2.35-4.35

 

6.5-9.0

 

0.04

 

09/20/19-03/20/22

 

123,950

09/02/13

 

16,300

 

16,300

 

2.35-4.35

 

6.5-9.0

 

0.02

 

03/02/20-09/02/22

 

54,605

05/16/14

 

25,000

 

25,000

 

3.00-5.00

 

3.5-6.0

 

0.01

 

11/16/17-05/16/20

 

100,000

08/18/14

 

645,000

 

645,000

 

2.50 and 3.00

 

4.5 and 5.5

 

0.40

 

02/18/19-02/18/20

 

1,773,750

05/18/15

 

20,000

 

20,000

 

3.80

 

4.5

 

0.01

 

11/18/19

 

76,000

07/23/15

 

317,000

 

317,000

 

4.00

 

4.5

 

0.25

 

01/23/20

 

1,268,000

04/15/16

 

775,000

 

775,000

 

4.00

 

6.0

 

1.16

 

04/15/22

 

3,100,000

06/23/16

 

15,000

 

15,000

 

4.00

 

6.0

 

0.02

 

06/23/22

 

60,000

11/11/16

 

10,000

 

10,000

 

5.00

 

6.0

 

0.02

 

11/11/22

 

50,000

01/01/17

 

50,000

 

-

 

4.80

 

6.0

 

0.09

 

01/01/23

 

240,000

02/13/17

 

25,000

 

-

 

5.00

 

6.0

 

0.04

 

02/13/23

 

125,000

03/30/17

 

686,000

 

-

 

5.00

 

6.0

 

1.24

 

03/30/23

 

3,430,000

04/10/17

 

100,000

 

-

 

5.00

 

6.0

 

0.18

 

04/10/23

 

500,000

07/13/17

 

10,000

 

-

 

5.00

 

6.0

 

0.02

 

07/13/23

 

50,000

 

 

3,044,300

 

2,173,300

 

 

 

 

 

3.56

 

 

 

12,428,405

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Number

Outstanding

 

Number

Exercisable

 

Exercise

Price ($)

 

Weighted

Average

Remaining

Contractual

Life (Years)

 

Proceeds to

Company if

Exercised ($)

17,766

 

17,766

 

2.35

 

0.01

 

41,750

322,500

 

322,500

 

2.50

 

0.06

 

806,250

322,500

 

322,500

 

3.00

 

0.14

 

967,500

17,767

 

17,767

 

3.35

 

0.01

 

59,519

20,000

 

20,000

 

3.80

 

0.01

 

76,000

1,895,333

 

1,115,333

 

4.00

 

2.18

 

7,581,332

17,767

 

17,767

 

4.35

 

0.02

 

77,286

50,000

 

50,000

 

4.80

 

0.06

 

240,000

930,334

 

920,334

 

5.00

 

1.10

 

4,651,670

5,000

 

5,000

 

6.31

 

0.00

 

31,550

3,598,967

 

2,808,967

 

 

 

3.59

 

14,532,857

 

Stock option expense of $1,388,295 and $1,220,798 was recorded in the six-months ended June 30, 2018 and June 30, 2017, respectively. Total remaining unrecognized compensation cost related to non-vested stock options is approximately $1,160,892$1,095,378 and is expected to be recognized over a period of 1.00.57 years. As of SeptemberJune 30, 2017,2018, the total intrinsic value of stock options was $46,900.$0.


14



VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 9 – Commitments and Contingencies

 

a) Walloon Region GrantCapital Lease Obligations

 

On March 16, 2010,In 2015, the Company entered into an agreement with the Walloon Region government in Belgium wherein the Walloon Region would fund upequipment capital lease to a maximum of $1,238,340 (€1,048,020) to help the research endeavors of the Company in the area of colorectal cancer (“CRC”). The Company had received the entirety of these funds in respect of approved expenditures as of June 30, 2014. Under the terms of the agreement, the Company is due to repay $371,502 (€314,406) of this amount by installments over the period from June 30, 2014 to June 30, 2023. The Company has recorded the balance of $866,838 (€733,614) 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 $371,502 (€314,406) and the 6% royalty on revenue, is twice the amount of funding received. As at September 30, 2017, $227,347 (€192,406) was outstanding to be repaid to the Walloon Region under this agreement.

b)Consulting Agreement

On May 11, 2016, Singapore Volition, upon the review and approval by the Company’s Compensation Committee, entered into a consultancy agreement with PB Commodities Pte. Ltd (“PB Commodities”), for the services of Cameron Reynolds (the “2016 Reynolds Consulting Agreement”). Under the terms of the 2016 Reynolds Consulting Agreement, PB Commodities received $25,925 per month for the services provided to Singapore Volition by Mr. Reynolds on its behalf. The 2016 Reynolds Consulting Agreement replaced and terminated the existing consultancy agreement for the provision of office space, office support staff, and consultancy services between Singapore Volition and PB Commodities dated August 6, 2010, as amended. The 2016 Reynolds Consulting Agreement was terminated on March 31, 2017 in connection with Mr. Reynolds entering into an Employment Agreement with Volition Diagnostics, effective April 1, 2017.

c)Lease Obligations Payable

The Company leasespurchase three Tecan machines (automated liquid handling robots) under a lease classified as a capital lease. The total costfor €550,454 Euros.  As of this leased laboratory equipment is $650,416 (€550,454). The leased equipment is depreciated on a straight-line basis over five years. Total depreciation charged toJune 30, 2018, the income statement, related tobalance payable was $186,469.

In 2016, the leased equipment is $97,307 (€82,568) for the nine months ended September 30, 2017 and $92,139 (€82,568) for the nine months ended September 30, 2016.

On October 4, 2016, and effective on October 25, 2016, Belgian VolitionCompany entered into a Real Estate Capital Lease Agreement (the “Capital Lease Agreement”)real estate capital lease with ING Asset Finance Belgium S.A. (“ING”). The Capital Lease Agreement became to purchase a contractual obligation of Belgian Volition upon the execution of the Deed of Sale to acquire the Company’s new research and development facility described below. Pursuant to the Capital Lease Agreement, ING paid $1.32 million (€1.12 million) in return for Belgian Volition granting to ING a right of emphyteusis (a form of leasehold) on the property located in Belgium for €1.12 million Euros.  As of June 30, 2018, the Belgian Créalys zoning at 5032 Isnes-Spy, Rue Phocas Lejeune 22, Gembloux cadastre, 8th division, Section B, n 55 (the “Property”) for a period of 27 years, extendable to the authorized maximum legal term of 99 years. In addition, the Capital Lease Agreement provides that ING shall grant Belgian Volition a 15-year lease over the Property with an option for Belgian Volition to purchase the Property outright upon payment of $39,702 (€33,600) at the end of the lease. The Capital Lease Agreement provides that Belgian Volition make the first lease payment of $519,904 (€440,000) following the execution of the Capital Lease Agreement, and then quarterly lease payments of approximately $15,889 (€13,447), based on a fixed rate of 2.62% for the term of the lease. On October 25, 2016, Belgian Volition acquired the Property by entering into a Deed of Sale to the Sale Agreement with Gerard Dekoninck S.A. The purchase price for the Property consisted of $1.42 million (€1.2 million), exclusive of any closing costs (the “Purchase Price”). The Purchase Pricebalance payable was funded by Belgian Volition with cash on hand and the monies received under the Capital Lease Agreement. Occupation of the Property occurred in March 2017. Total depreciation charged to the income statement, related to the leased building is $30,096 (€25,471) for the nine months ended September 30, 2017 and $nil (€nil) for the nine months ended September 30, 2016.


15


VOLITIONRX LIMITED$735,350.

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

Note 9 – Commitments and Contingencies (continued)

The following is a schedule showing the future minimum lease payments under capital leases by years and the present value of the minimum payments as of SeptemberJune 30, 2017.2018:  

 

2017

 

$

40,216

2018

 

$

160,860

2018- remaining

$

79,577

2019

 

$

160,862

$

159,155

2020

 

$

110,603

$

109,429

2021

 

$

63,555

$

62,880

Thereafter

 

$

659,357

 

 

 

2022

$

62,879

Greater than 5 years

$

589,480

Total minimum lease payments

 

$

1,195,453

$

1,063,400

Less: Amount representing interest

 

$

(161,843)

$

(141,581)

 

 

 

Present value of minimum lease payments

 

$

1,033,610

$

921,819

 

 

 

Made up of:

 

 

 

Current portion

 

$

136,307

Long term portion

 

$

897,303

 

 

 

Present value of minimum lease payments

 

$

1,033,610

 

b)Operating Lease Obligations

The Company also leases premises and facilities under operating leases with terms ranging from 12 months to 60 months. TheAs of June 30, 2018, the annual non-cancelable operating lease payments on these leases are as follows:

 

2017

$

204,965

2018

$

221,240

2018- remaining

$

110,157

2019

$

85,088

$

66,264

2020

$

50,333

$

53,240

2021

$

13,803

$

14,426

Total

$

575,429

Total Operating Lease Obligations

$

244,087

 

d)c)Hvidovre Hospital, Denmark AgreementGrants Repayable

 

On November 2,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.  As of June 30, 2018, the balance repayable was $184,017 and the annual payments remaining were as follows:

2018- remaining

$

2019

$

40,917

2020

$

40,917

2021

$

37,885

2022

$

35,072

Greater than 5 years

$

29,226

Total Grants Repayable

$

184,017




VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

Note 9 – Commitments and Contingencies (continued)

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 June 30, 2018, the principal balance payable was $445,392.

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 June 30, 2018, the principal balance payable was $289,930.

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 June 30, 2018, the principal balance payable was $354,162.

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 June 30, 2018, €500,000 Euros has been drawn down under this agreement and the principal balance payable was $584,532.

On June 27, 2018, the Company entered into a 4-year loan agreement with Namur Innovation andGrowth for €500,000 Euros with a fixed interest rate of 4.00%. As of June 30, 2018, the principal balance payable was $584,532.

As of June 30, 2018, the total balance for long-term debt payable was $2,258,548 and the annual payments remaining were as follows:

2018- remaining

$

133,680

2019

$

494,751

2020

$

702,996

2021

$

629,598

2022

$

273,525

Greater than 5 years

$

325,428

Total

$

2,559,978

Less: Amount representing interest

$

(301,430)

Total Long-Term Debt

$

2,258,548

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 June 30, 2018, $87,680 is still to be paidby the Companyunder 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 June 30, 2018, $261,230 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 June 30, 2018, $177,096 is still to be paid by the Company under this agreement.

In 2016, the Company entered into a phase one clinical research agreement with Hvidovre Hospital, University of Copenhagen in Denmark relating tofor a program2-year period for DKK 15 million Danish Kroner.  As of samples testing associated with CRC and other diseases. The first phase of the agreement will expire on SeptemberJune 30, 2018, and the Company may participate in additional phases upon its election (and payment of required amounts). Total payments (inclusive of local taxes)$727,170 is still to be madepaid by the Company under the agreement for the first phase are $2,382,995 (DKR 15,000,000).this agreement.


16



VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 9 – Commitments and Contingencies (continued)

 

e) Long Term Debt: Preface S.A. Loan Agreements

On September 16, 2016, Belgian Volition entered into an unsecured loan agreement with Namur Invest or Preface S.A. forIn 2017, the amount of $519,904 (€440,000) (the “Loan Agreement”). The proceeds from the Loan Agreement were received by Belgian Volition on October 20, 2016. The Loan Agreement provides for an approximate 7-year term, a fixed interest rate at 4.85%, and interest only payments between the receipt of proceeds and June 30, 2017. Thereafter, monthly repayments of $7,785 (€6,588) will be made. See Note 9(c) for the use of the proceeds from the Loan Agreement.

On May 2, 2017, Belgian Volition entered into an additional unsecured loan agreement with Namur Invest or Preface S.A. for the amount of $413,560 (€350,000) (the “May 2017 Loan Agreement”). The May 2017 Loan Agreement provides for an approximate 3.5-year repayment term, a fixed interest rate at 4.00% and interest only payments between the receipt of proceeds and December 31, 2017. Thereafter, monthly repayments of $10,568 (€8,944) will be made. The proceeds from the May 2017 Loan Agreement will be used to fund a pathway study for our product – the Nu.QTM Colorectal Cancer Screening Triage Test.

f) Long Term Debt: ING Loan Agreement

On October 25, 2016, Belgian VolitionCompany entered into a secured loanresearch collaboration agreement with ING for an amount up to $319,032 (€270,000) (the “Supplemental Loan”). The Supplemental Loan providesNational University Hospital of Singapore for a 15-year term commencing on March 31, 2017, a fixed interest rate at 2.96%, and quarterly repayments2-year period for $48,000.  As of $6,542 (€5,536), commencing on April 28, 2017. The maximum amount of the loan facility had been drawn down by Belgian VolitionJune 30, 2018, $9,600 is still to be paid by the loan commencement date of March 31,Company under this agreement.

In 2017, and interest only payments were made from the initial draw down of the loan until September 30, 2017. The proceeds of the Supplemental Loan were used to finance the construction of a laboratory in the new research and development facility (see Note 9(c)).

g)Clinical Study Agreement with the University of Michigan

On July 17, 2017, Volition AmericaCompany entered into a Clinical Study Agreementclinical study research agreement with the Regents of the University of Michigan (the “University of Michigan”), with regards to Volition America’s participation with the University of Michigan and the National Cancer Institute Early Detection Research Network (“EDRN”), in for a clinical study (the “University of Michigan Clinical Study Agreement”) involving approximately 13,500 samples. The enrollment3-year period and sample collection is anticipated to takefor up to 3 years to complete. The total maximum payment due by Volition America in accordance with the agreement is $3 million spread over 12 equal quarterly installments of $250,000. The foregoing description of the University of Michigan Clinical Study Agreement does not purport to summarize all terms and conditions thereof and is qualified in its entirety by reference to Exhibit 10.1.

h) Straight Loan: ING Loan Agreement

On August 28, 2017, Belgian Volition received prefunding of $236,320 (€200,000) from ING, pursuant to a loan agreement (the “Straight Loan Agreement”) entered into on December 13, 2016 and repayable upon receipt of grants for investment in Créalys business park from the Walloon Region. The term of the Straight Loan Agreement is until July 2018, on a rolling monthly basis at an interest rate of the Euribor rate + 2%. The proceeds of the Straight Loan Agreement were used to finance the investment in the Créalys business park.

i) Long Term Debt: SOFINEX Loan Agreement

On September 20, 2017, VolitionRx and Belgian Volition entered into an unsecured loan agreement with SOFINEX, a Belgian public organization focused on the internationalization of Walloon companies, for an amount of $1,200,000 (€1,000,000) (the “SOFINEX Loan Agreement”). The SOFINEX Loan Agreement provides for a 7-year repayment term, with a grace period for principal payments until December 31, 2019, and a fixed interest rate of 4.5%.million.  As of SeptemberJune 30, 2017, no cash has been drawn down2018, up to $2.25 million is still to be paid by the Company under this agreement.

j) As of June 30, 2018, the total amount to be paid for future research and collaboration commitments was $3,641,359 and the annual payments remaining were as follows:

2018- remaining

$

1,893,518

2019

$

1,140,288

2020

$

607,553

Total Collaborative Agreement Obligations  

$

3,641,359

f)Legal Proceedings

 

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


17


VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 10 – Subsequent Events

 

None.On July 2, 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 over 12 years commencing in 2020.

 

On July 9, 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.

On August 10, 2018, the Company issued to Cotterford Company Limited in a private placement offering (PIPE) 5 million shares of common stock at a purchase price of $1.80 per share, as well as a warrant to purchase up to an additional 5 million shares of common stock at an exercise price of $3.00 per share payable in cash, for aggregate gross proceeds, before the deduction of offering expenses, of $9 million (excluding the proceeds from any exercise of the warrant). The warrant has an expiration date of August 10, 2019 and is exercisable for a period of 6 months commencing on February 10, 2019.

END NOTES TO FINANCIALS




ITEM 2.

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

18


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 SeptemberJune 30, 20172018, or thethis 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; and statements relating to the assumptions underlying any of the foregoing. Throughout this Report, we have attempted to identify forward-looking statements by using words such as “may,” “believe,” “will,” “could,” “project,” “anticipate,” “expect,” “estimate,” “should,” “continue,” “potential,” “plan,” “forecasts,” “goal,” “seek,” “intend,” other forms of these words or similar words or expressions or the negative thereof (although not all forward-looking statements contain these words).

We have based our forward-looking statements on our current expectations and projections about trends affecting our business and industry and other future events. Although we do not make forward-looking statements unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy. Forward-looking statements are subject to substantial risks and uncertainties that could cause our future business, financial condition, results of operations or performance, to differ materially from our historical results or those expressed or implied in any forward-looking statement contained in this Report. For instance, if we fail to develop and commercialize diagnostic products, we may be unable to execute our plan of operations. Other risks and uncertainties include our failure to obtain necessary regulatory clearances or approvals to distribute and market future products in the clinical in-vitro diagnostics, or IVD market; a failure by the marketplace to accept the products in our development pipeline or any other diagnostic products we might develop; 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, 2017, as filed with the SEC on March 10, 2017,1, 2018, 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.


19



Company Overview

 

VolitionVolitionRx is a multi-national life sciences company developing simple, easy to use, blood-based cancercost effective blood tests to accuratelyhelp diagnose a range of cancers. TheWe 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 Nucleosomics,®, which is the practice of identifying and measuring nucleosomes in the bloodstream or other bodily fluid - an indication that disease is present. We have developed a novel suite of blood assays for epigenetically altered circulating nucleosomes as biomarkers in cancer.  Nu.Qproducts are simple, low-cost, ELISA platform tests and can incorporate other off patent, low cost ELISA tests in our panels (e.g. CEA, PSA, and CA125) for higher accuracy.

As cancer screening programs becomeOur diagnostic target in the blood includes the same tumor chromosome fragment as targeted by ctDNA tests, but our approach is to test for chromosome protein and nucleic acid changes in intact chromosome fragments by ELISA, rather than chemically extracting, amplifying, and sequencing the 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 tests are exponentially more widespread, our products aim to helpprevalent in diagnosing a range of cancers quickly, simply, accurately, cost effectivelycirculating blood, and with much higher population compliance. Early diagnosis through widespread screening has the potential to not only prolong the life of patients, but also to improve their quality of life.detectable using simple laboratory methods.

We are developing blood-based diagnostics for the most prevalent cancers, beginning with Colorectal Cancer,colorectal cancer, or CRC. Following CRC, we anticipate focusing on lung cancer, prostate and pancreatic cancer, using our Nucleosomics® biomarker discovery platform. Our development pipeline includes assays to be used for symptomatic patients or asymptomatic (screening) populations. The platform employs a range of simpleNu.QTMimmunoassays on an industry standard ELISA format, which allows rapid quantification of epigenetic changes in biofluids (whole blood, plasma, serum, sputum, urine, etc.) compared to other more complicated and expensive approaches such as bisulfite conversion and polymerase chain reaction. Our Nu.QTM biomarkers can be used alone, or in combination to generate profiles related to specific conditions.

We have developed thirty-nineare developing forty-eight Nu.QTM blood-based assays to date to detect specific biomarkers that can be used individually or in combination to generate a profile which forms the basis of a product for a particular cancer or disease. We are also looking at a range of additional low cost orthogonal ELISA markers that may add to the test accuracy while maintaining our aim of providing a low-cost test that requires only a small amount of blood.

We anticipate that because of their ease of use and cost efficiency, our tests have the potential to become the first method of choice for cancer diagnostics, allowing detection of a range of cancers at an earlier stage. We anticipate the initial use will be for the testing of individuals who, for reasons such as time, cost, or aversion to current methods, are not currently screened, or are not up to date with their screening.

We intend to commercialize our products in the future through various channels within the European Union, the United States and throughout the rest of the world, beginning with Asia. Patient compliance is critical for asymptomatic CRC population screening programs; however, current CRC screening programs have poor compliance. For example, in the United States there are several recommended CRC screening test options, including: colonoscopy, fecal tests and computed tomography colonoscopy; however, the participation rate as of 2014 was just 65.7% of the eligible patient population. The UK, like many European countries, employs a front-line fecal test for screening that also has a low compliance rate of between 59% and 67%. These figures indicate that about one-third of the populations of the United States and the UK are unscreened. The unscreened populations of many other countries are much higher. This low level of screening participation is a serious issue as it often leads to the late diagnosis of cancer when it is much harder to treat.

We believe that the only viable option to achieve high levels of compliance will come from affordable blood tests that use a small amount of blood taken as part of the patient’s normal health check procedure. We aim to launch such a front-line CRC population screening test for asymptomatic people who are non-compliant with current screening methods in Europe in 20182019 and in Asia soon after. This product will require a small amount of blood and will use the same established, robust, low-cost ELISA methodology employed in the PSA test for prostate cancer.




We are also very serious about meeting this urgent need for a highly compliant asymptomatic CRC screening test in the United States. To this end, in July 2017 we signed a contract to participate in a large 13,500 screening subject trial in the United States in conjunction with the National Cancer Institute’s Early Detection Research Network. Over 4,500 samples have already been collected and up to 9,000 samples will now be collected prospectively over the coming two to three years. The aim of this study is to validate a panel of biomarkers including our Nu.QTM Colorectal Cancer Screening Test in a large asymptomatic population to support U.S. regulatory approval.

 

Our first product – the Nu.QTM Colorectal Cancer Screening Triage Test, which we refer to as the Triage Test, achieved the CE Mark in December 2016, allowing us to start commercialization in the European Union. This test is undergoing continuing development. In addition, in conjunction with our collaborators in Denmark, we are undertaking a pathway design study.

We are also taking our first regulatory steps in Asia as we prepare the submission of our tests to numerous Asian regulatory authorities. We aim to announce several trials in Asia for our various potential CRC products in the coming quarters.


20


Overview of Plan of Operations

 

Management hasWe 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 theour 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 theour business plan, regardingin particular the progression of clinical validation studies and regulatory approval processes for the purpose of bringing products to the IVD market.

 

We do not anticipate earning significantOur 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 2017exchange for specified up-front and/or back end payments; and until such time as we are able to fully market(d) developing and commercializing our intended products on the IVD market. 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 ability to successfully accomplish our planaccomplishment of operationsthe plans described herein, obtain financingin the preceding paragraph and eventually to attain profitable operations. The accompanying 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 SeptemberJune 30, 2017, the Company2018, we had cash and cash equivalents of $13,840,930, prepayments of $244,667, other current assets of $170,883 and current liabilities of $2,831,859. This represents a working capital surplus of $11,424,621.approximately $11.9 million.

 

The CompanyNet cash used $8,306,854 in net cash for operating activities was $6.5 million and $5.5 million for the nine monthssix-months ended SeptemberJune 30, 2018 and June 30, 2017, compared to $6,673,382 for the nine months ended September 30, 2016.respectively. The increase in cash used year-over-year is,in operating activities for the period ended June 30, 2018 when compared to a large extent,same period in 2017 was primarily due to increased expenditures on research and development activities, in the current period. The increase in salariesgeneral and office administrative fees is mainly a result of non-cash adjusting, stock and warrant amortization. See “Results of Operations” for more detail.activities, including increases to stock-based compensation.

 

Net cash used in investing activities was $0.1 million and $1.2 million for the six-months ended June 30, 2018 and June 30, 2017, respectively. The Companydecrease in cash used $1,340,230 in net cash for investing activities for the nine monthsperiod ended SeptemberJune 30, 2017,2018 when compared to $89,433 for the nine months ended September 30, 2016. This increasesame period in cash used year-over-year is2017 was primarily a result of the purchase of equipment and buildingfacility improvements for the new research and development facility in Belgium.Belgium and investment in our information technology infrastructure in 2017.

 

Net cash provided by financing activities amounted to $1,743,966was $8.2 million and $1.4 million for the nine monthssix-months ended SeptemberJune 30, 2018 and June 30, 2017, respectively. The increase in cash provided by financing activities for the period ended June 30, 2018 when compared to $13,407,935 forsame period in 2017 was primarily the nine months ended September 30, 2016. Primarily the Company received combined proceedsresult of $908,075 from an ING bank loan and a Preface S.A. loan in the nine months ended September 30, 2017 along with approximately $998,412$7.8 million in net cash proceeds from the exercise of warrants. During the comparable 2016 period, the Company raised $13,107,030 in net cash proceeds in March 20162018 through the sale and issuance of approximately 4.33.5 million shares of common stock in a public offering and raised $399,265 in net cash proceeds from the exercise of warrants.offering.

 

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 additional equity or debt securities, or raising of debt orthe sale of licensing rights, but thererights. 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. However, theThe completion of clinical validation studies and regulatory approval processes for the purpose of bringing products to the IVD market 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.

 

Going Concern

We have not attained profitable operations and are dependent upon obtaining financing to pursue any extensive activities. For these reasons, our auditors statedhave included in their report on our audited financial statements for the fiscal year ended December 31, 20162017 an explanatory paragraph regarding factors that they haveraise substantial doubt that we will be able to continue as a going concern without further financing.


21



The following table summarizes our approximate contractual payments including interest due by year as of June 30, 2018.

Approximate Payments (Including Interest) Due by Year

 

 

Total

 

2018

(Remaining)

 

2019 - 2022

 

2023 +

Description

 

$

 

$

 

$

 

$

Capital Lease Obligations

 

1,063,400

 

79,577

 

394,343

 

589,480

Operating Lease Obligations

 

244,087

 

110,157

 

133,930

 

Grants Repayable

 

184,017

 

 

154,791

 

29,226

Long-Term Debt(1)

 

3,180,722

 

133,680

 

2,294,059

 

752,983

Collaborative Agreements Obligations

 

3,641,359

 

1,893,518

 

1,747,841

 

                                                        Total

 

8,313,585

 

2,216,932

 

4,724,964

 

1,371,689

(1)Long-term debt includes the total value of the SOFINEX loan of €1.0 million Euros although only €500,000 Euros had been drawn down as of June 30, 2018. See Note 9(d) to theCondensed Consolidated Financial Statements for further details. 

Results of Operations

 

Three MonthsComparison of the Three-Months Ended SeptemberJune 30, 20172018 and SeptemberJune 30, 20162017.

 

The following table sets forth the Company’sour results of operations for the three monthsthree-months ended on SeptemberJune 30, 2018 and June 30, 2017, and the comparative period for the three months ended September 30, 2016.respectively.

 

 

 

Three months

Ended

September 30,

2017

($)

 

Three months

Ended

September 30,

2016

($)

 

Increase/

(Decrease)

($)

 

Percentage

Increase/

(Decrease)

(%)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenues

 

-

 

-

 

-

 

-

 

 

 

 

 

��

 

 

 

General and administrative expenses

 

226,606

 

163,870

 

62,736

 

38%

Sales and marketing expenses

 

134,737

 

88,989

 

45,748

 

51%

Professional fees

 

520,372

 

400,698

 

119,674

 

30%

Salaries and office administrative fees

 

943,510

 

857,093

 

86,417

 

10%

Research and development expenses

 

2,203,985

 

1,968,490

 

235,495

 

12%

 

 

 

 

 

 

 

 

 

Total Operating Expenses

 

(4,029,210)

 

(3,479,140)

 

550,070

 

16%

 

 

 

 

 

 

 

 

 

Other Income

 

136,556

 

-

 

136,556

 

100%

 

 

 

 

 

 

 

 

 

Income Taxes

 

-

 

-

 

-

 

-

 

 

 

 

 

 

 

 

 

Net Loss

 

(3,892,654)

 

(3,479,140)

 

413,514

 

12%

 

 

 

 

 

 

 

 

 

Basic and Diluted Loss Per Common Share

 

(0.15)

 

(0.15)

 

-

 

-

 

 

 

 

 

 

 

 

 

Weighted Average Basic and Diluted Common Shares Outstanding

 

26,512,195

 

23,524,982

 

2,987,213

 

13%

 

 

 

 

 

 

 

 

Percentage

 

 

Three-Months Ended June 30,

 

Increase

 

Increase

 

 

2018

 

2017

 

(Decrease)

 

(Decrease)

 

 

$

 

$

 

$

 

%

Revenues

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

(2,686,473)

 

(1,807,636)

 

878,837

 

49%

General and administrative

 

(1,643,681)

 

(1,427,875)

 

215,806

 

15%

Sales and marketing

 

(235,366)

 

(207,042)

 

28,324

 

14%

 

 

 

 

 

 

 

 

 

Total Operating Expenses

 

(4,565,520)

 

(3,442,553)

 

1,122,967

 

33%

 

 

 

 

 

 

 

 

 

Interest expense

 

(26,556)

 

(20,435)

 

6,121

 

30%

 

 

 

 

 

 

 

 

 

Net Loss

 

(4,592,076)

 

(3,462,988)

 

1,129,088

 

33%

 

 

 

 

 

 

 

 

 

Net Loss Per Share – Basic and Diluted

 

(0.15)

 

(0.13)

 

0.02

 

15%

 

 

 

 

 

 

 

 

 

Weighted Average Shares Outstanding - Basic and Diluted

 

30,027,260

 

26,383,228

 

3,644,032

 

14%




Revenues

 

The Company had not generated revenues from operations in either the three months ended September 30, 2017 or the three months ended September 30, 2016. The Company’sRevenues

Our operations are still predominantly in the research and development stage. stage and we had no revenues during the three-months ended June 30, 2018 and June 30, 2017, respectively.

 

Total Operating Expenses

 

For the three months ended September 30, 2017, the Company’s totalTotal operating expenses increased by $550,070, or 16%, compared to $4.6 million for the same periodthree-months ended June 30, 2018 from $3.4 million forthe three-months ended June 30, 2017.

Research and Development Expenses

Research and development expenses increased to $2.7 million for the three-months ended June 30, 2018 from $1.8 million for the three-months ended June 30, 2017. This increase in 2016. Total operating expenses are comprised of general and administrative expenses, sales and marketing expenses, professional fees, salaries and office administrative fees, andoverall research and development expenses described below.expenditures was primarily related to our participation in the trial with the University of Michigan and increased headcountduring the period.

 

 

Three-Months Ended June 30,

 

 

 

2018

 

2017

 

Change

 

$

 

$

 

$

Personnel expenses

867,114

 

782,258

 

84,856

Stock-based compensation

125,522

 

156,018

 

(30,496)

Direct research and development expenses

1,626,742

 

487,852

 

1,138,890

Other research and development  

(80,603)

 

257,080

 

(337,683)

Depreciation and amortization

147,698

 

124,428

 

23,270

Total Research and Development expenses

2,686,473

 

1,807,636

 

878,837

General and Administrative Expenses

General and administrative expenses increased by $62,736, or 38%, into $1.6 million for the three-month periodthree-months ended SeptemberJune 30, 2017 compared to2018, from $1.4 million for the prior year period. Thethree-months ended June 30, 2017. This increase in the 2017 periodoverall general and administrative expenditures was in partprimarily due to additionalhigher foreign exchange costs from operating a larger UK office, incurring costs of $18,775, an increased level of insurance coverage, incurring costs of $19,456, and increased IT costs of $13,911. The incremental IT costs mainly related to investments associated with increased IT security and controls.during the period.

 

 

Three-Months Ended June 30,

 

 

 

2018

 

2017

 

Change

 

$

 

$

 

$

Personnel expenses

523,224

 

479,432

 

43,792

Stock-based compensation

330,986

 

464,561

 

(133,575)

Legal and professional fees

261,819

 

318,487

 

(56,668)

Other general and administrative   

518,527

 

165,100

 

353,427

Depreciation and amortization

9,125

 

295

 

8,830

Total General and Administrative expenses

1,643,681

 

1,427,875

 

215,806




Sales and Marketing Expenses

 

Sales and marketing expenses increased by $45,748, or 51%,to $235,366 for the three-months ended June 30,2018 from$207,042 for the three-months ended June 30, 2017. This increase in the three-month period ended September 30, 2017 compared to the prior year period. The increase was primarily a result of the recruitment of additionaloverall sales and marketing personnel, incurring newexpenditures was primarily related to increased staff costs of $67,806 in 2017. These increased costs were offset against decreases in marketing fees across certain areas.  during the period.


22


 

Three-Months Ended June 30,

 

 

 

2018

 

2017

 

Change

 

$

 

$

 

$

Personnel expenses

166,475

 

124,505

 

41,970

Stock-based compensation

38,688

 

34,496

 

4,192

Direct marketing and professional fees

30,203

 

48,041

 

(17,838)

Total Sales and Marketingexpenses

235,366

 

207,042

 

28,324

Professional FeesOther Expenses

 

Professional fees increased by $119,674, or 30%For the three-months ended June 30, 2018, the Company’s other expenses, in the three-month period ended September 30, 2017comprised of interest expense, were $26,556 compared to $20,435 for the prior year period. The increase was mainly due to higher consultancy fees of $88,234 for preparation of Sarbanes-Oxley compliance and conference costs of $22,848.three-months ended June 30, 2017.

 

Salaries and Office Administrative FeesNet Loss

 

Salaries and office administrative fees increased by $86,417, or 10%, in the three-month period ended September 30, 2017 compared to the prior year period. The increase was mainly the result of increased stock option and warrant amortization costs of $53,441, with increased employee headcount and staff salaries also contributing to the total change.

Research and Development Expenses

Research and development expenses increased by $235,495, or 12%, in the three-month period ended September 30, 2017 compared to the prior year period. The increase was predominantly due to the first-time payment required for the EDRN study in the United States of $250,000.

Other Income

Other income amounted to $136,556 for the three months ended September 30, 2017 of grant funds from public bodies for approved expenditure with no obligation to repay. For the comparable period in 2016, no grant income was received.

Net Loss

For the three monthsthree-months ended SeptemberJune 30, 2017,2018, the Company’s net loss was $3,892,654,$4.6 million, an increase of $413,514,approximately $1.1 million, or 12%33%, in comparison to a net loss of $3,479,140$3.5 million for the three monthsthree-months ended SeptemberJune 30, 2016.2017. The change was a result of the factors described above.


23


Nine Months Ended September 30, 2017 and September 30, 2016

 

Comparison of the Six-Months Ended June 30, 2018 and June 30, 2017.

The following table sets forth the Company’sour results of operations for the nine monthssix-months ended on SeptemberJune 30, 2018 and June 30, 2017, and the comparative period for the nine months ended September 30, 2016.respectively.

 

 

 

Nine months

Ended

September 30,

2017

($)

 

Nine months

Ended

September 30,

2016

($)

 

Increase/

(Decrease)

($)

 

Percentage

Increase/

(Decrease)

(%)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenues

 

-

 

-

 

-

 

-

 

 

 

 

 

 

 

 

 

General and administrative expenses

 

729,449

 

558,120

 

171,329

 

31%

Sales and marketing expenses

 

435,971

 

249,591

 

186,380

 

75%

Professional fees

 

1,182,837

 

1,272,638

 

(89,801)

 

(7%)

Salaries and office administrative fees

 

2,720,620

 

1,686,210

 

1,034,410

 

61%

Research and development expenses

 

5,774,004

 

5,180,466

 

593,538

 

11%

 

 

 

 

 

 

 

 

 

Total Operating Expenses

 

(10,842,881)

 

(8,947,025)

 

1,895,856

 

21%

 

 

 

 

 

 

 

 

 

Other Income

 

136,556

 

25,891

 

110,665

 

427%

 

 

 

 

 

 

 

 

 

Income Taxes

 

-

 

-

 

-

 

-

 

 

 

 

 

 

 

 

 

Net Loss

 

(10,706,325)

 

(8,921,134)

 

1,785,191

 

20%

 

 

 

 

 

 

 

 

 

Basic and Diluted Loss Per Common Share

 

(0.41)

 

(0.40)

 

0.01

 

3%

 

 

 

 

 

 

 

 

 

Weighted Average Basic and Diluted Common Shares Outstanding

 

26,343,101

 

22,075,538

 

4,267,563

 

19%

 

 

 

 

 

 

 

 

Percentage

 

 

Six-Months Ended June 30,

 

Increase

 

Increase

 

 

2018

 

2017

 

(Decrease)

 

(Decrease)

 

 

$

 

$

 

$

 

%

Revenues

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

(5,109,675)

 

(3,480,987)

 

1,628,688

 

47%

General and administrative

 

(3,485,774)

 

(2,823,594)

 

662,180

 

23%

Sales and marketing

 

(599,510)

 

(476,450)

 

123,060

 

26%

 

 

 

 

 

 

 

 

 

Total Operating Expenses

 

(9,194,959)

 

(6,781,031)

 

2,413,928

 

36%

 

 

 

 

 

 

 

 

 

Interest expense

 

(49,538)

 

(32,640)

 

16,898

 

52%

 

 

 

 

 

 

 

 

 

Net Loss

 

(9,244,497)

 

(6,813,671)

 

2,430,826

 

36%

 

 

 

 

 

 

 

 

 

Net Loss Per Share – Basic and Diluted

 

(0.32)

 

(0.26)

 

0.06

 

23%

 

 

 

 

 

 

 

 

 

Weighted Average Shares Outstanding - Basic and Diluted

 

28,655,711

 

26,137,241

 

2,518,470

 

10%




Revenues

 

The Company had not generated revenues from operations in either the nine months ended September 30, 2017 or the nine months ended September 30, 2016. The Company’sRevenues

Our operations are still predominantly in the research and development stage.  stage and we had no revenues during the six-months ended June 30, 2018 and June 30, 2017, respectively.

 

Total Operating Expenses

 

For the nine months ended September 30, 2017, the Company’s totalTotal operating expenses increased by $1,895,856, or 21%, compared to $9.2 million for the same periodsix-months ended June 30, 2018 from $6.8 million for the six-months ended June 30, 2017.

Research and Development Expenses

Research and development expenses increased to $5.1 million for the six-months ended June 30, 2018 from $3.5 million for the six-months ended June 30, 2017. This increase in 2016. Total operating expenses are comprised of general and administrative expenses, sales and marketing expenses, professional fees, salaries and office administrative fees andoverall research and development expenses.expenditures was primarily related to our participation in the trial with the University of Michigan and increased headcount during the period.

 

 

Six-Months Ended June 30,

 

 

 

2018

 

2017

 

Change

 

$

 

$

 

$

Personnel expenses

1,829,454

 

1,301,937

 

527,517

Stock-based compensation

340,029

 

348,389

 

(8,360)

Direct research and development expenses

2,558,177

 

1,109,224

 

1,448,953

Other research and development  

82,035

 

503,374

 

(421,339)

Depreciation and amortization

299,980

 

218,063

 

81,917

Total Research and Development expenses

5,109,675

 

3,480,987

 

1,628,688

General and Administrative Expenses

 

General and administrative expenses increased by $171,329, or 31%,to $3.5 million for the six-months ended June 30, 2018, from $2.8 million for the six-months ended June 30, 2017. This increase in the nine-month period ended September 30, 2017 comparedoverall general and administrative expenditures was primarily due to higher foreign exchange costs and legal costs in relation to the prior yearcapital raise during the period. The increase was primarily the result of the Company’s insurance costs, which rose by $52,393, additional costs of $52,450 due to the move to a larger UK office, along with an increase in IT costs of $50,121 associated with investments in IT security and controls.

 

 

Six-Months Ended June 30,

 

 

 

2018

 

2017

 

Change

 

$

 

$

 

$

Personnel expenses

1,068,308

 

1,001,570

 

66,738

Stock-based compensation

950,481

 

866,016

 

84,465

Legal and professional fees

838,072

 

592,739

 

245,333

Other general and administrative   

610,683

 

362,974

 

247,709

Depreciation and amortization

18,230

 

295

 

17,935

Total General and Administrative expenses

3,485,774

 

2,823,594

 

662,180




Sales and Marketing Expenses

 

Sales and marketing expenses increased by $186,380, or 75%to $599,510 for the six-months ended June 30, 2018, from the $476,450 for the six-months ended June 30, 2017. This increase in overall sales and marketing expenditures was primarily related to increased marketing and professional fees during the period.

 

Six-Months Ended June 30,

 

 

 

2018

 

2017

 

Change

 

$

 

$

 

$

Personnel expenses

321,392

 

356,629

 

(35,237)

Stock-based compensation

102,111

 

34,875

 

67,236

Direct marketing and professional fees

176,007

 

84,946

 

91,061

Total Sales and Marketingexpenses

599,510

 

476,450

 

123,060

Other Expenses

For the six-months ended June 30, 2018, the Company’s other expenses, in the nine-month period ended September 30, 2017comprised of interest expense, were $49,538 compared to $32,640 for the prior year period. The increase was primarily a result of the recruitment of additional marketing personnel, incurring new costs of $182,399. 


24


Professional Feessix-months ended June 30, 2017.

 

Professional fees decreased by $89,801, or 7%, in the nine-month period ended September 30, 2017 compared to the prior year period. The decrease in professional fees was mainly as a result of reduced legal fees in respect of capital raises in 2016.Net Loss

 

Salaries and Office Administrative Fees

Salaries and office administrative fees increased by $1,034,410, or 61%, in the nine-month period ended September 30, 2017 compared to the prior year period. The increase was the result of an increase in the cost of stock option and warrant amortization expense of $604,950 year-over-year, as well as some headcount and remuneration increases.

Research and Development Expenses

Research and development expenses increased by $593,538, or 11%, in the nine-month period ended September 30, 2017 compared to the prior year period. Increases in costs on a year-over-year basis include the first payment for the EDRN study in the United States of $250,000, increase in employment costs due to headcount and remuneration of $235,063, and an increase in the cost of stock option amortization expense of $59,150. Depreciation expense also increased by $81,255 year-over-year due to the new research and development facility in March 2017.

Other Income

Other income increased to $136,556 for the nine months ended September 30, 2017 compared to the comparable figure in 2016 of $25,891, relating to grant funds received from public bodies in respect of approved expenditure with no obligation to repay.

Net Loss

For the nine monthssix-months ended SeptemberJune 30, 2017,2018, the Company’s net loss was $10,706,325,$9.2 million, an increase of $1,785,191,approximately $2.4 million, or 20%36%, in comparison to a net loss of $8,921,134$6.8 million for the nine monthssix-months ended SeptemberJune 30, 2016.2017. The change was a result of the factors described above.

 

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

 

We regularly evaluate the accounting policies and estimates that we use to prepare our financial statements.  A 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.


25


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 

Evaluation of Disclosure Controls and Procedures

 

Disclosure controls and procedures are controls and procedures that are designed to ensure that information required to be disclosed in our reports filed under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’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, 2016,2017, that our disclosure controls and procedures continuenot to not be effective as of SeptemberJune 30, 2017,2018, 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 SeptemberJune 30, 2017,2018, we did not maintain sufficient internal controls over financial reporting:

 

due to a lack of adequate segregation of duties in some areas of Finance; and 

 

due to a lack of sufficient oversight in the area of IT, where certain processes may affect the internal controls over financial reporting. 

 

We have developed, and are currently implementing, a remediation plan for such 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 SeptemberJune 30, 2017,2018, other than those described above, that have materially affected, or are reasonably likely to materially affect, our internal controls over financial reporting.




26


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.


27


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, areis an adverse party or havehas a material interest adverse to our interest.

 

ITEM 1A.RISK FACTORS 

 

There have been no material changes in our assessment of risk factors affecting our business since those presented in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2016 as filed with the Securities and Exchange Commission on March 10, 2017, as amended by those presented in our Quarterly Report on Form 10-Q, Item 1A., for the quarter ended March 31, 2017, as filed with the Securities and Exchange Commission on May 11, 2017.Report.

 

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

 

During the quarter ended September 30, 2017, the Company issued the shares described below in private placements pursuant to Section 4(a)(2) of the Securities Act, and Rule 506 of Regulation D, in each case on the basis that the shares were offered and sold in a non-public offering to an “accredited investor” as defined in Rule 501 of Regulation D. Additionally, at the time of the issuances, unless registered for resale, the shares were deemed to be restricted securities under the Securities Act and the certificates evidencing such shares bear a legend to that effect.None.

 

On July 7, 2017, 5,000 warrants were exercised at a price of $2.20 per share, for net cash proceeds to the Company of $11,000. As a result, a total of 5,000 shares of common stock were issued to one U.S. accredited investor. The shares were registered for resale on Form S-3 (Registration No. 333-195213).

From July 9, 2017 through July 19, 2017, 45,000 warrants were exercised at a price of $2.40 per share for net cash proceeds to the Company of $108,000. As a result, a total of 15,000 shares of common stock were issued to one (1) U.S. accredited investor and 30,000 shares of common stock were issued to two (2) non – U.S. accredited investors.

ITEM 3.DEFAULTS UPON SENIOR SECURITIES 

 

None.

 

ITEM 4.MINE SAFETY DISCLOSURES 

 

Not Applicable.

 

ITEM 5.OTHER INFORMATION 

 

None.


28



ITEM 6.EXHIBITS 

 

 

 

 

 

Incorporated by Reference

 

Exhibit Number

 

Exhibit Description

 

Form

 

File No.

 

Exhibit

 

Filing Date

 

Filed Herewith

 

 

 

 

 

 

 

 

 

 

 

 

 

10.1

 

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

 

 

 

 

 

 

 

 

 

X

10.2

 

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

 

8-K

 

001-36833

 

10.1

 

09/21/17

 

 

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

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

 

*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

 

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 9, 2017DatedAugust 13, 2018

 

By:/s/ Cameron Reynolds

 

 

Cameron Reynolds

 

 

President and Chief Executive Officer

(Authorized Signatory and Principal Executive Officer)

 

 

 

 

 

 

Dated: November 9, 2017DatedAugust 13, 2018

 

By:/s/ David Vanston

 

 

David Vanston

 

 

Chief Financial Officer and Treasurer

(Authorized Signatory and Principal Financial and Accounting Officer)

 


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