UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
For the quarterly period ended
For the transition period from ______ to ______
Commission File Number:
(Exact name of registrant as specified in its charter) |
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(State or other jurisdiction of incorporation or organization) |
| (I.R.S. Employer Identification No.) |
(Address of principal executive offices)
+1 ( (Registrant’s telephone number, including area code) |
Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class | Trading Symbol(s) | Name of Each Exchange on Which Registered |
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. ☒
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☒
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 | ☐ |
☒ | Smaller reporting company | ||
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| Emerging growth company | ☐ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
As of November 4, 2021, there were
VOLITIONRX LIMITED
QUARTERLY REPORT ON FORM 10-Q
FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2021
TABLE OF CONTENTS
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MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS | 29 |
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Use of Terms
Except as otherwise indicated by the context, references in this Quarterly Report on Form 10-Q to the “Company,” “VolitionRx,” “Volition,” “we,” “us,” and “our” are references to VolitionRx Limited and its wholly-owned subsidiaries, Volition Global Services SRL, Singapore Volition Pte. Limited, Belgian Volition SRL, Volition Diagnostics UK Limited, Volition America, Inc., Volition Germany GmbH, and its majority-owned subsidiary Volition Veterinary Diagnostics Development LLC. Additionally, unless otherwise specified, all references to “$” refer to the legal currency of the United States of America.
NucleosomicsTM and Nu.Q® and their respective logos are trademarks and/or service marks of VolitionRx and its subsidiaries. All other trademarks, service marks and trade names referred to herein are the property of their respective owners.
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Table of Contents |
CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
This Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2021, or this Report, contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. These forward-looking statements are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact included in this Report or incorporated by reference into this Report are forward-looking statements. These statements include, among other things, any predictions of earnings, revenues, expenses or other financial items; plans or expectations with respect to our development activities or business strategy; statements concerning clinical studies and results; statements concerning industry trends; statements regarding anticipated demand for our products, or the products of our competitors; statements relating to manufacturing forecasts, and the potential impact of our relationship with contract manufacturers and original equipment manufacturers on our business; statements relating to the commercialization of our products, assumptions regarding the future cost and potential benefits of our research and development efforts; forecasts of our liquidity position or available cash resources; statements relating to the impact of pending litigation; statements regarding the anticipated impact of the COVID-19 pandemic and statements relating to the assumptions underlying any of the foregoing. Throughout this Report, we have attempted to identify forward-looking statements by using words such as “may,” “believe,” “will,” “could,” “project,” “anticipate,” “expect,” “estimate,” “should,” “continue,” “potential,” “plan,” “forecasts,” “goal,” “seek,” “intend,” other forms of these words or similar words or expressions or the negative thereof (although not all forward-looking statements contain these words).
We have based our forward-looking statements on our current expectations and projections about trends affecting our business and industry and other future events. Although we do not make forward-looking statements unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy. Forward-looking statements are subject to substantial risks and uncertainties that could cause our future business, financial condition, results of operations or performance, to differ materially from our historical results or those expressed or implied in any forward-looking statement contained in this Report. For instance, if we fail to develop and commercialize diagnostic products, we may be unable to execute our plan of operations. Other risks and uncertainties include those associated with:
| · | the COVID-19 pandemic; |
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| · | our failure to obtain necessary regulatory clearances or approvals to distribute and market future products in the veterinary or clinical in-vitro diagnostics, or IVD, market; |
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| · | a failure by the marketplace to accept the products in our development pipeline or any other diagnostic products we might develop; |
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| · | our failure to secure adequate intellectual property protection; |
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| · | the potential obsolescence of our intended products due to the highly competitive nature of the diagnostics market and its rapid technological change; and |
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| · | other risks identified elsewhere in this Report, as well as in our other filings with the Securities and Exchange Commission, or the SEC. |
In addition, actual results may differ as a result of additional risks and uncertainties of which we are currently unaware or which we do not currently view as material to our business. For these reasons, readers are cautioned not to place undue reliance on any forward-looking statements. Our actual financial condition and results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those discussed in the sections entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020, as filed with the SEC on March 22, 2021, or our Annual Report, this Report, the documents that we file as exhibits to this Report and the documents that we incorporate by reference into this Report, with the understanding that our future results may be materially different from what we currently expect. The forward-looking statements we make speak only as of the date on which they are made. We expressly disclaim any intent or obligation to update any forward-looking statements after the date hereof to conform such statements to actual results or to changes in our opinions or expectations. If we do update or correct any forward-looking statements, readers should not conclude that we will make additional updates or corrections.
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Table of Contents |
PART I FINANCIAL INFORMATION
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ITEM 1. FINANCIAL STATEMENTS (UNAUDITED) |
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Condensed Consolidated Statements of Operations and Comprehensive Loss |
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Table of Contents |
VOLITIONRX LIMITED
Condensed Consolidated Balance Sheets
(Expressed in United States Dollars, except share numbers)
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ASSETS |
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Current Assets |
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Cash and cash equivalents |
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Accounts receivable |
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Prepaid expenses |
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Other current assets |
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Total Current Assets |
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Property and equipment, net |
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Operating lease right-of-use assets |
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Intangible assets, net |
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Total Assets |
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LIABILITIES AND STOCKHOLDERS' EQUITY |
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Current Liabilities |
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Accounts payable |
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Accrued liabilities |
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Management and directors’ fees payable |
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Current portion of long-term debt |
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Current portion of finance lease liabilities |
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Current portion of operating lease liabilities |
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Current portion of grant repayable |
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Total Current Liabilities |
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Long-term debt, net of current portion |
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Finance lease liabilities, net of current portion |
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Operating lease liabilities, net of current portion |
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Grant repayable, net of current portion |
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Total Liabilities |
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STOCKHOLDERS’ EQUITY |
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Common Stock |
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Authorized: Issued and outstanding: |
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Additional paid-in capital |
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Accumulated other comprehensive income (loss) |
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Accumulated deficit |
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Total VolitionRx Limited Stockholders' Equity |
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Non-controlling interest |
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Total Stockholders’ Equity |
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Total Liabilities and Stockholders’ Equity |
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(The accompanying notes are an integral part of these condensed consolidated financial statements) |
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Table of Contents |
VOLITIONRX LIMITED
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)
(Expressed in United States Dollars, except share numbers)
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Revenues |
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Product |
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Total Revenues |
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Operating Expenses |
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Research and development |
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General and administrative |
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Sales and marketing |
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Total Operating Expenses |
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Operating Loss |
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Other Income (Expenses) |
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Grant income |
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Gain / ( Loss) on disposal of fixed assets |
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Interest income |
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Interest expense |
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Total Other Income |
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Net Loss |
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Net Loss attributable to Non-Controlling Interest |
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Net Loss attributable to VolitionRx Limited Stockholders |
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Other Comprehensive (Loss) / Income |
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Foreign currency translation adjustments |
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Net Comprehensive Loss |
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Net Loss Per Share – Basic and Diluted attributable to VolitionRx Limited |
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Weighted Average Shares Outstanding |
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– Basic and Diluted |
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(The accompanying notes are an integral part of these condensed consolidated financial statements) |
6 |
Table of Contents |
VOLITIONRX LIMITED
Condensed Consolidated Statements of Stockholders’ Equity (Unaudited)
(Expressed in United States Dollars, except share numbers)
For the Nine Months Ended September 30, 2021 and September 30, 2020 | ||||||||||||||||||||||||||||
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| Accumulated |
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Balance, December 31, 2020 |
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Common stock issued for cash |
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Common stock issued for cashless exercise of stock options and settlement of RSUs |
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Stock-based compensation |
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Tax withholdings paid related to stock-based compensation |
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Foreign currency translation |
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Net loss for the period |
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Balance, March 31, 2021 |
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Common stock issued for cash |
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Common stock issued for cashless exercise of stock options and settlement of RSUs |
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Stock-based compensation |
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Tax withholdings paid related to stock-based compensation |
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Foreign currency translation |
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Net loss for the period |
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Balance, June 30, 2021 |
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Common stock issued for cash |
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Stock-based compensation |
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Stock-based compensation in relation to modification of options |
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Foreign currency translation |
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Net loss for the period |
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Balance, September 30, 2021 |
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(The accompanying notes are an integral part of these condensed consolidated financial statements) |
7 |
Table of Contents |
VOLITIONRX LIMITED
Condensed Consolidated Statements of Stockholders’ Equity (Unaudited)
(Expressed in United States Dollars, except share numbers)
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Balance, December 31, 2019 |
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Common stock issued for Director compensation in Volition Germany |
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Common stock issued for cashless exercise of stock options |
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Stock-based compensation |
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Stock repurchase |
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| ( | ) | |||
Foreign currency translation |
|
| - |
|
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| - |
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| |||||
Net loss for the period |
|
| - |
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| ( | ) |
|
| ( | ) |
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| ( | ) | |||
Balance, March 31, 2020 |
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| ( | ) |
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| ( | ) |
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Common stock issued for cash, net |
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Stock-based compensation |
|
| - |
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| ||||||
Foreign currency translation |
|
| - |
|
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|
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|
| ( | ) |
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|
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|
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| ( | ) | ||||
Net loss for the period |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
| ( | ) |
|
| ( | ) |
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| ( | ) | |||
Balance, June 30, 2020 |
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| ( | ) |
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| ( | ) |
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Common stock issued in exercise of warrants |
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Common stock issued in exercise of stock options |
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Common stock issued for cash exercise of warrants |
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Stock-based compensation |
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| - |
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| ||||||
Tax withholdings paid related to stock-based compensation |
|
| - |
|
|
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|
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| ( | ) |
|
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| ( | ) | ||||
Foreign currency translation |
|
| - |
|
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| ( | ) |
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| ( | ) | ||||
Net loss for the period |
|
| - |
|
|
|
|
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|
|
|
|
|
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| ( | ) |
|
| ( | ) |
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| ( | ) | |||
Balance, September 30, 2020 |
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| ( | ) |
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| ( | ) |
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| ( | ) |
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(The accompanying notes are an integral part of these condensed consolidated financial statements) |
8 |
Table of Contents |
VOLITIONRX LIMITED
Condensed Consolidated Statements of Cash Flows (Unaudited)
(Expressed in United States Dollars)
|
| Nine Months Ended September 30, |
| |||||
| 2021 |
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| 2020 |
| |||
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| $ |
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| $ |
| ||
Operating Activities |
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| ||
Net loss |
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| ( | ) |
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| ( | ) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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| ||
Amortization of operating lease right-of-use assets |
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Loss (Gain) on disposal of fixed assets |
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| ( | ) | |
Stock-based compensation |
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| ||
Common stock issued for Director compensation in Volition Germany |
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| ||
Changes in operating assets and liabilities: |
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Prepaid expenses |
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| ( | ) |
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| ( | ) |
Accounts receivable |
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| ( | ) |
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| ( | ) |
Other current assets |
|
| ( | ) |
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| ( | ) |
Accounts payable and accrued liabilities |
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| ( | ) |
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| |
Management and directors’ fees payable |
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| ( | ) |
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| |
Right-of-use assets operating leases liabilities |
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| ( | ) |
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| ( | ) |
Net Cash Used In Operating Activities |
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| ( | ) |
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| ( | ) |
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Investing Activities: |
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Purchases of property and equipment |
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| ( | ) |
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| ( | ) |
Proceeds from sales of property and equipment |
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| ||
Net Cash Used In Investing Activities |
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| ( | ) |
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| ( | ) |
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Financing Activities: |
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Net proceeds from issuances of common stock |
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Tax withholdings paid related to stock-based compensation |
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| ( | ) |
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| ( | ) |
Common stock repurchased |
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| ( | ) | |
Proceeds from grants repayable |
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| ||
Proceeds from long-term debt |
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Payments on long-term debt |
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| ( | ) |
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| ( | ) |
Payments on grants repayable |
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| ( | ) |
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| ( | ) |
Payments on finance lease obligations |
|
| ( | ) |
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| ( | ) |
Net Cash Provided By Financing Activities |
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| ||
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Effect of foreign exchange on cash |
|
| ( | ) |
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| ( | ) |
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Net Change in Cash |
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Cash and cash equivalents – Beginning of Period |
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Cash and cash equivalents – End of Period |
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Supplemental Disclosures of Cash Flow Information: |
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Interest paid |
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Non-Cash Financing Activities: |
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Common stock issued on cashless exercises of stock options |
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| ||
Offering costs from issuance of common stock |
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(The accompanying notes are an integral part of these condensed consolidated financial statements) |
9 |
Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 1 – Basis of Presentation and Summary of Significant Accounting Policies
Basis of Presentation
The interim consolidated financial statements of VolitionRx Limited (the “Company”, "VolitionRx," "we" or "us") for the three and nine months ended September 30, 2021 and September 30, 2020, respectively, are not audited. Our consolidated financial statements are prepared in accordance with the requirements for unaudited interim periods and, consequently, do not include all disclosures required to be made in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). In the opinion of our management, the accompanying consolidated financial statements contain all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation of our financial position as of September 30, 2021, and our results of operations and cash flows for the periods ended September 30, 2021 and September 30, 2020, respectively. The results of operations for the periods ended September 30, 2021 and September 30, 2020, respectively, are not necessarily indicative of the results for a full-year period. These interim consolidated financial statements should be read in conjunction with the financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2020, which was filed with the Securities and Exchange Commission (the "SEC") on March 22, 2021.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. The Company also regularly evaluates estimates and assumptions related to deferred income tax asset valuation allowances, useful lives of property and equipment and intangible assets, borrowing rate used in operating lease right-of-use asset and liability valuations, impairment analysis of intangible assets, and valuations of stock-based compensation.
The Company bases its estimates and assumptions on current facts, historical experience and various other factors that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the accrual of costs and expenses that are not readily apparent from other sources. The actual results experienced by the Company may differ materially and adversely from the Company’s estimates. To the extent there are material differences between the estimates and the actual results, future results of operations could be affected.
Principles of Consolidation
The accompanying condensed consolidated financial statements for the period ended September 30, 2021 include the accounts of the Company and its subsidiaries. The Company has two wholly-owned subsidiaries Singapore Volition Pte. Limited (“Singapore Volition”) and Volition Global Services SRL (“Volition Global”). Singapore Volition has one wholly-owned subsidiary, Belgian Volition SRL (“Belgian Volition”). Belgian Volition has four subsidiaries, Volition Diagnostics UK Limited (“Volition Diagnostics”), Volition America, Inc. (“Volition America”), Volition Germany GmbH (“Volition Germany”), and its one majority-owned subsidiary Volition Veterinary Diagnostics Development LLC (“Volition Vet”). See Note 8(f) for more information regarding Volition Vet and Volition Germany. All intercompany balances and transactions have been eliminated in consolidation.
Cash and Cash Equivalents
For the purposes of the statements of cash flows, the Company considers interest bearing deposits with original maturity dates of three months or less to be cash equivalents. The Company invests excess cash from its operating cash accounts in overnight investments and reflects these amounts in cash and cash equivalents in the condensed consolidated balance sheets at fair value using quoted prices in active markets for identical assets. As of September 30, 2021, cash and cash equivalents totaled approximately $
10 |
Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 1 - Basis of Presentation and Summary of Significant Accounting Policies (continued)
Accounts Receivables
Trade accounts receivable are stated at the amount the Company expects to collect. Due to the nature of the accounts receivable balance, the Company believes the risk of doubtful accounts is minimal and therefore no allowance is recorded. If the financial condition of the Company’s customers were to deteriorate, adversely affecting their ability to make payments, additional allowances would be required. The Company may provide for estimated uncollectible amounts through a charge to earnings and a credit to a valuation allowance. Balances that remain outstanding after the Company has used reasonable collection efforts are written off through a charge to the valuation allowance and a credit to accounts receivable. As of September 30, 2021, the accounts receivable balance was $
Revenue Recognition
The Company adopted Accounting Standards Codification (“ASC”) 606, “Revenue from Contracts with Customers,” effective January 1, 2019. Under ASC 606, the Company recognizes revenues when the customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. The Company recognizes revenues following the five step model prescribed under ASC 606: (i) identify contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenues when (or as) the Company satisfies the performance obligation(s).
The Company generates product revenues from the sale of its Nu.Q® Vet Cancer Screening Test, from the sale of nucleosomes, and from the sale of Research Use Only kits pursuant to its license agreement with Active Motif, Inc. (“Active Motif”) from which the Company receives royalties. In addition, revenue is received from external third parties for services the Company performs for them in its laboratory.
Revenues, and their respective treatment for financial reporting purposes under ASC 606, are as follows:
Royalty
The Company receives royalty revenues on the net sales recognized during the period in which the revenue is earned, and the amount is determinable from the licensee. These are presented in “Royalty” in the consolidated statements of operations and comprehensive loss. The Company does not have future performance obligations under this revenue stream. In accordance with ASC 606, the Company records these revenues based on estimates of the net sales that occurred during the relevant period from the licensee. The relevant period estimates of these royalties are based on preliminary gross sales data provided by Active Motif and analysis of historical gross-to-net adjustments. Differences between actual and estimated royalty revenues are adjusted for in the period in which they become known.
Product
The Company includes revenue from product sales recognized during the period in which goods are shipped to third parties, and the amount is deemed collectable from the third parties. These are presented in “Product” in the consolidated statements of operations and comprehensive loss.
11 |
Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 1 - Basis of Presentation and Summary of Significant Accounting Policies (continued)
Services
The Company includes revenue recognized from laboratory services performed in the Company’s laboratory on behalf of third parties in “Services” in the consolidated statements of operations and comprehensive loss.
For each development and/or commercialization agreement that results in revenues, the Company identifies all performance obligations, aside from those that are immaterial, which may include a license to intellectual property and know-how, development activities and/or transition activities. In order to determine the transaction price, in addition to any upfront payment, the Company estimates the amount of variable consideration at the outset of the contract either utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract. The Company constrains (reduces) the estimates of variable consideration such that it is probable that a significant reversal of previously recognized revenue will not occur throughout the life of the contract. When determining if variable consideration should be constrained, management considers whether there are factors outside the Company’s control that could result in a significant reversal of revenue. In making these assessments, the Company considers the likelihood and magnitude of a potential reversal of revenue. These estimates are re-assessed each reporting period as required.
Basic and Diluted Net Loss Per Share
The Company computes net loss per share in accordance with ASC 260, “Earnings Per Share,” which requires presentation of both basic and diluted earnings per share (“EPS”) on the face of the statement of operations and comprehensive loss. Basic EPS is computed by dividing net loss available to common stockholders (numerator) by the weighted average number of shares outstanding (denominator) during the period. Diluted EPS gives effect to all dilutive potential common shares outstanding during the period using the treasury stock method. In computing diluted EPS, the average stock price for the period is used in determining the number of shares assumed to be purchased from the exercise of stock options or warrants. As of September 30, 2021,
Reclassification
Certain amounts presented in previously issued financial statements have been reclassified to be consistent with the current period presentation. The Company has reclassified the prior period comparative amounts in the statement of stockholders’ equity and cash flows to be consistent with the current year classification.
Recent Accounting Pronouncements
The Company has implemented all new accounting pronouncements that are in effect. The Company does not believe there are any other new accounting pronouncements that have been issued that might have a material impact on its financial position or results of operations.
12 |
Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 1 - Basis of Presentation and Summary of Significant Accounting Policies (continued)
COVID-19 Pandemic Impact
As of the date of this filing, there continue to be widespread concerns regarding the ongoing impacts and disruptions caused by the COVID-19 pandemic in the regions in which the Company operates. As a result of the COVID-19 pandemic, the Company has experienced and may continue to experience disruptions that could impact our clinical trials, including delays enrolling patients and in sample collection.
The extent to which the COVID-19 pandemic will impact the Company’s business, financial condition, and results of operations in the future is highly uncertain and will be affected by a number of factors. These include the duration and extent of the COVID-19 pandemic, the development of new variants of the COVID-19 virus that may be more contagious or virulent than previous versions, the scope of mandated or recommended containment and mitigation measures, the effect of government stabilization and recovery efforts, and the success of vaccine distribution programs.
Note 2 - Going Concern
The Company's condensed consolidated financial statements are prepared using U.S. GAAP applicable to a going concern which contemplates the realization of assets and liquidation of liabilities in the normal course of business. The Company has incurred losses since inception of $
The future of the Company as an operating business will depend on its ability to obtain sufficient capital contributions, financing and/or to generate revenues as may be required to sustain its operations. Management plans to address the above as needed by (a) securing additional grant funds, (b) obtaining additional financing through debt or equity transactions, (c) granting licenses to third parties in exchange for specified up-front and/or back-end payments and (d) developing and commercializing its products on an accelerated timeline. Management continues to exercise tight cost controls to conserve cash.
The ability of the Company to continue as a going concern is dependent upon its ability to successfully accomplish the plans described in the preceding paragraph and eventually attain profitable operations. The accompanying condensed consolidated financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern. If the Company is unable to obtain adequate capital, it could be forced to cease operations.
13 |
Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 3 - Property and Equipment
The Company’s property and equipment consisted of the following amounts as of September 30, 2021 and December 31, 2020:
|
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| September 30, |
| ||||||
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| 2021 |
| ||||||
|
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|
| Accumulated |
|
| Net Carrying |
| |||||
|
|
| Cost |
|
| Depreciation |
|
| Value |
| ||||
|
| Useful Life |
| $ |
|
| $ |
|
| $ |
| |||
Computer hardware and software |
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| ||||
Laboratory equipment |
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Office furniture and equipment |
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| ||||
Buildings |
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| ||||
Building improvements |
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Land |
| Not amortized |
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| December 31, |
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| 2020 |
| |
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| Accumulated |
|
| Net Carrying |
| ||
|
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|
| Cost |
|
| Depreciation |
|
| Value |
| |||
|
| Useful Life |
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| $ |
|
| $ |
|
| $ |
| ||
Computer hardware and software |
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| ||||
Laboratory equipment |
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| ||||
Office furniture and equipment |
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| ||||
Buildings |
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Building improvements |
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Land |
| Not amortized |
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During the nine-month periods ended September 30, 2021 and September 30, 2020, the Company recognized $
14 |
Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 4 - Intangible Assets
The Company’s intangible assets consist of patents, mainly acquired in the acquisition of Belgian Volition. The patents are being amortized over the assets’ estimated useful lives, which range from 8 to 20 years.
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| September 30, |
| |||
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| 2021 |
| |||
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| Accumulated |
|
| Net Carrying |
| |||
|
| Cost |
|
| Amortization |
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| Value |
| |||
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| $ |
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| $ |
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| $ |
| |||
Patents |
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| December 31, |
| |
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| 2020 |
| |
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| Accumulated |
|
| Net Carrying |
| ||
|
| Cost |
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| Amortization |
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| Value |
| |||
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| $ |
|
| $ |
|
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| $ |
| |
Patents |
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During the nine-month periods ended September 30, 2021 and September 30, 2020, the Company recognized $
The Company amortizes the patents on a straight-line basis with terms ranging from
2021 - remaining |
| $ |
| |
2022 |
| $ |
| |
2023 |
| $ |
| |
2024 |
| $ |
| |
2025 |
| $ |
| |
Total Intangible Assets |
| $ |
|
The Company periodically reviews its long-lived assets to ensure that their carrying value does not exceed their fair market value. The Company carried out such a review in accordance with ASC 360 Topic “Property, Plant and Equipment” as of December 31, 2020. The result of this review confirmed that the ongoing value of the patents was not impaired as of December 31, 2020.
Note 5 - Related Party Transactions
Refer to Note 6, Common Stock, for common stock issued to related parties and Note 7, Stock-Based Compensation, for stock options, warrants and RSUs issued to related parties. The Company has agreements with related parties for the purchase of products and consultancy services which are accrued under management and directors’ fees payable (see condensed consolidated balance sheets).
15 |
Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 6 - Common Stock
As of September 30, 2021, the Company was authorized to issue 100 million shares of common stock par value $
Stock Option Exercises and RSU Settlements
From January 13, 2021 to March 19, 2021,
On January 20, 2021,
On February 2, 2021,
On February 8, 2021,
From February 8, 2021 to February 9, 2021,
On February 8, 2021,
On April 13, 2021,
Equity Capital Raise
On February 10, 2021, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Cantor Fitzgerald & Co (“Cantor”). in connection with an underwritten public offering of
16 |
Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 6 - Common Stock (continued)
Equity Distribution Agreements
On September 24, 2021, the Company entered into an equity distribution agreement (the “2021 EDA”) with Cantor and Oppenheimer & Co. Inc. (“Oppenheimer”), to sell shares of its common stock having an aggregate offering price of up to $
On November 10, 2020, the Company entered into an equity distribution agreement (the “2020 EDA”) with Cantor and Oppenheimer to sell shares of its common stock having an aggregate offering price of up to $
On September 7, 2018, the Company entered into an equity distribution agreement (as amended, the “2018 EDA”) with Oppenheimer to sell shares of common stock having an aggregate offering price of up to $
17 |
Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 7 – Stock-Based Compensation
a) Warrants
The following table summarizes the changes in warrants outstanding of the Company during the nine-month period ended September 30, 2021:
|
| Number of |
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| Weighted Average |
| ||
|
| Warrants |
|
| Exercise Price ($) |
| ||
Outstanding at December 31, 2020 |
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| ||
Granted |
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Outstanding at September 30, 2021 |
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Exercisable at September 30, 2021 |
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Effective January 1, 2021, the Company granted warrants to purchase
Effective February 1, 2021, the Company granted warrants to purchase
Below is a table summarizing the warrants issued and outstanding as of September 30, 2021, which have an aggregate weighted average remaining contractual life of
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18 |
Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 7 – Stock-Based Compensation (continued)
a) Warrants (continued)
Stock-based compensation expense related to warrants of $
b) Options
The following table summarizes the changes in options outstanding of the Company during the nine-month period ended September 30, 2021:
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| Number of |
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| Weighted Average |
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| Options |
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| Exercise Price ($) |
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Outstanding at December 31, 2020 |
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Granted |
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Exercised |
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Expired/Cancelled |
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Outstanding at September 30, 2021 |
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Exercisable at September 30, 2021 |
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Effective May 20, 2021, the Company granted stock options to purchase
On July 14, 2021, the Company amended the terms of certain outstanding options granted pursuant to the 2011 Equity Incentive Plan such that (i) the expiration date for outstanding options to purchase up to an aggregate of
Effective August 3, 2021, the Company approved the granting of options under the 2015 Stock Incentive Plan vesting upon achievement of certain corporate goals (see additional details in Note 8 (h)). Pursuant to this approval, the Company granted stock options to purchase an aggregate of
19 |
Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 7 – Stock-Based Compensation (continued)
b) Options (continued)
Effective September 7, 2021, the Company granted stock options to purchase
On September 21, 2021, the Company amended the terms of certain outstanding options such that (i) the expiration date for outstanding options to purchase up to an aggregate of
Below is a table summarizing the options issued and outstanding as of September 30, 2021, all of which were issued pursuant to the 2011 Equity Incentive Plan (for option issuances prior to 2016) or the 2015 Stock Incentive Plan (for option issuances commencing in 2016) and which have an aggregate weighted average remaining contractual life of
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Stock-based compensation expense related to stock options of $
20 |
Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 7 – Stock-Based Compensation (continued)
c) Restricted Stock Units (RSUs)
Below is a table summarizing the RSUs issued and outstanding as of September 30, 2021, all of which were issued pursuant to the 2015 Stock Incentive Plan.
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| Weighted Average |
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| RSUs |
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| Share Price ($) |
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Outstanding at December 31, 2020 |
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Effective January 1, 2021, the Company granted RSUs of
Effective March 25, 2021, the
On March 25, 2021,
On April 13, 2021,
Effective May 1, 2021, the Company granted RSUs of
Effective August 3, 2021, the Company approved the granting of RSU’s under the 2015 Stock Incentive Plan vesting upon achievement of certain corporate goals (see additional details in Note 8 (h)). Pursuant to this approval, the Company granted RSUs of
Effective September 7, 2021, the Company granted RSUs of
21 |
Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 7 – Stock-Based Compensation (continued)
c) Restricted Stock Units (RSUs) (continued)
Below is a table summarizing the RSUs issued and outstanding as of September 30, 2021 and which have an aggregate weighted average remaining contractual life of
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Stock-based compensation expense related to RSUs of $
Note 8 – Commitments and Contingencies
a) Finance Lease Obligations
In 2016, the Company entered into a real estate finance lease with ING Asset Finance Belgium S.A. (“ING”) to purchase a property located in Belgium for €
In 2018, the Company entered into a capital lease with BNP Paribas leasing solutions to purchase a freezer for the Belgium facility for €
The following is a schedule showing the future minimum lease payments under finance leases by years and the present value of the minimum payments as of September 30, 2021.
2021 - remaining |
| $ |
| |
2022 |
| $ |
| |
2023 |
| $ |
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2024 |
| $ |
| |
2025 |
| $ |
| |
Greater than 5 years |
| $ |
| |
Total |
| $ |
| |
Less: Amount representing interest |
| $ | ( | ) |
Present value of minimum lease payments |
| $ |
| |
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22 |
Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 8 – Commitments and Contingencies (continued)
b) Operating Lease Right-of-Use Obligations
As all the existing leases subject to the new lease standard ASC 842 (“Leases”) were previously classified as operating leases by the Company, they were similarly classified as operating leases under the new standard. The Company has determined that the identified operating leases did not contain non-lease components and require no further allocation of the total lease cost. Additionally, the agreements in place did not contain information to determine the rate implicit in the leases, so the Company used its incremental borrowing rate as the discount rate. The Company’s weighted average discount rate is
As of September 30, 2021, operating lease right-of-use assets and liabilities arising from operating leases were $
The following is a schedule showing the future minimum lease payments under operating leases by years and the present value of the minimum payments as of September 30, 2021.
2021 - remaining |
| $ |
| |
2022 |
| $ |
| |
2023 |
| $ |
| |
2024 |
| $ |
| |
2025 |
| $ |
| |
Total Operating Lease Obligations |
| $ |
| |
Less: Amount representing interest |
| $ | ( | ) |
Present Value of minimum lease payments |
| $ |
|
The Company’s office space leases are short-term and the Company has elected under the short-term recognition exemption not to recognize them on the balance sheet. During the nine months ended September 30, 2021, $
2021 - remaining |
| $ |
| |
2022 |
| $ |
| |
Total Operating Lease Liabilities |
| $ |
|
c) Grants Repayable
In 2010, the Company entered into an agreement with the Walloon Region government in Belgium for a colorectal cancer research grant for €1.05 million. Per the terms of the agreement, €314,406 of the grant is to be repaid, by installments over the period from June 30, 2014 to June 30, 2023. In the event that the Company receives revenue from products or services as defined in the agreement,
In 2018, the Company entered into an agreement with the Walloon Region government in Belgium for a colorectal cancer research grant for €
23 |
Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 8 – Commitments and Contingencies (continued)
c) Grants Repayable (continued)
In 2020, the Company entered into an agreement with the Walloon Region government in Belgium for a research grant for €
In 2020, the Company entered into an agreement with the Walloon Region government in Belgium for a research grant for €
As of September 30, 2021, the total grant balance repayable was $301,544 and the payments remaining were as follows:
2021 - remaining |
| $ |
| |
2022 |
| $ |
| |
2023 |
| $ |
| |
2024 |
| $ |
| |
2025 |
| $ |
| |
Greater than 5 years |
| $ |
| |
Total Grants Repayable |
| $ |
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d) Long-Term Debt
In 2016, the Company entered into a 7-year loan agreement with Namur Invest for €
In 2016, the Company entered into a 15-year loan agreement with ING for €
In 2017, the Company entered into a 4-year loan agreement with Namur Invest for €
In 2017, the Company entered into a 7-year loan agreement with SOFINEX for up to €
In 2018, the Company entered into a 4-year loan agreement with Namur Innovation and Growth for €
In 2019, the Company entered into a 4-year loan agreement with Namur Innovation and Growth for €
On October 13, 2020, the Company entered into a 10-year loan agreement with Namur Invest for a maximum of €
24 |
Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 8 – Commitments and Contingencies (continued)
d) Long-Term Debt (continued)
As of September 30, 2021, the total balance for long-term debt payable was $
2021 - remaining |
| $ |
| |
2022 |
| $ |
| |
2023 |
| $ |
| |
2024 |
| $ |
| |
2025 |
| $ |
| |
Greater than 5 years |
| $ |
| |
Total |
| $ |
| |
Less: Amount representing interest |
| $ | ( | ) |
Total Long-Term Debt |
| $ |
|
e) Collaborative Agreement Obligations
In 2016, the Company entered into a research co-operation agreement with DKFZ in Germany for a five-year period for €
In 2018, the Company entered into a research collaboration agreement with the University of Taiwan for a three-year period for a cost to the Company of up to $
In 2019, the
In 2019, the Company entered into a funded sponsored research agreement with the Texas A&M University (“TAMU”) in consideration for the license granted to the Company for a five-year period for a cost to the Company of up to $
On September 16, 2020, the Company entered into a research agreement for the bioinformatic analysis of cell-free DNA fragments from whole-genome sequencing with the Hebrew University of Jerusalem for six months for a cost to the Company of €
As of September 30, 2021, the total amount to be paid for future research and collaboration commitments was approximately $
2021 - remaining |
| $ |
| |
2022 - 2025 |
| $ |
| |
Total Collaborative Agreement Obligations |
| $ |
|
25 |
Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 8 – Commitments and Contingencies (continued)
f) Other Commitments
Volition Vet
On October 25, 2019, the Company entered into an agreement with TAMU for provision of in kind services of personnel, animal samples and laboratory equipment in exchange for a non-controlling interest of
Volition Germany
On January 10, 2020, the Company, through its wholly-owned subsidiary Belgian Volition, acquired an epigenetic reagent company, Octamer GmbH (“Octamer”), based in Munich, Germany, and hired its founder for his expertise and knowledge to be passed to Company personnel. On March 9, 2020, Octamer was renamed to Volition Germany GmbH (or “Volition Germany”).
Upon considering the definition of a business, as defined in ASC 805 “Business Combinations,” paragraph 805-10-20, which is an integrated set of activities and assets that is capable of being conducted and managed for the purpose of providing a return, the Company has determined that this did not constitute a business. This is primarily due to the fact that additional inputs are needed in the form of training personnel further to produce outputs. Accordingly, the Company has treated this transaction as the hiring of a member of management, described below, rather than accounting for the transaction as a business combination.
The Company agreed to terms of the transaction on December 13, 2019 and closed on January 10, 2020. Pursuant to the transaction agreement, the Company purchased all outstanding shares of Octamer. In exchange, the Company agreed to issue
In connection with the transaction agreement, the Company also entered into a two-year Managing Director’s agreement with the founder of Octamer to continue to manage Volition Germany for a payment of €288,000 payable in equal monthly installments over such two-year period and a royalty agreement with the founder providing for the payment of royalties in the amount of
During the three months ended March 31, 2020, the Company recorded approximately $
26 |
Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 8 – Commitments and Contingencies (continued)
Volition America
On November 3, 2020, the Company entered into a professional services master agreement with Diagnostic Oncology CRO, LLC to conduct a pivotal clinical trial and provide regulatory submission and reimbursement related services. Under the terms of the agreement Diagnostic Oncology CRO, LLC will provide ad hoc consulting assistance on a project-by-project basis related to the review and assessment of existing data and information to prepare recommended intended use claims and coverage/reimbursement plans to support the preparation of FDA pre-submissions, clinical trial protocol development and study administration, and potential 510k regulatory marketing submissions of the Company’s diagnostic tests, including those proposed for use as an adjunct diagnostic tool for common and aggressive forms of Non-Hodgkin’s Lymphoma. The initial projects contemplated by the agreement relating to Non-Hodgkin’s Lymphoma obligate
g) Legal Proceedings
There are no legal proceedings which the Company believes will have a material adverse effect on its financial position.
h) Commitments in Respect of Corporate Goals and Performance-Based Awards
In August 2021 the Compensation Committee of the Board of Directors approved the issuance of certain equity-based awards and cash bonuses in order to provide company personnel with an element of performance-based compensation tied to the timely achievement of certain corporate goals focused around product development and commercialization.
Effective August 3, 2021, the Company approved the granting of equity-based awards under the 2015 Stock Incentive Plan as well as cash bonuses, vesting upon achievement of certain corporate goals, to various personnel including directors, executives, members of management, consultants and employees of the Company and/or its subsidiaries.
Conditional upon the achievement by December 31, 2021 of a specified corporate goal as set forth in the minutes of the Compensation Committee dated August 3, 2021, as well as continued service by the award recipient, the Company at the sole discretion of the Chief Executive Officer and the Chief Financial Officer shall pay a cash bonus to such award recipient. The Company estimates the total compensation expense based on current recipients to be $
Conditional upon the achievement by July 1, 2022 of all specified corporate goals as set forth in the minutes of the Compensation Committee dated August 3, 2021, as well as continued service by the award recipient, the Company at the sole discretion of the Chief Executive Officer and the Chief Financial Officer would pay an additional cash bonus to such award recipient. The Company estimates the total compensation expense based on current recipients to be $
As discussed in detail in Note 7, in August 2021 a total of
As of September 30, 2021, the Company has recognized compensation expense of $
27 |
Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 9 – Subsequent Events
Effective October 4, 2021, the Company granted stock options to purchase
Effective October 4, 2021, the Company granted RSUs of
Effective November 1, 2021, the Company granted RSUs of
On November 3, 2021, the Company amended the terms of certain outstanding options under the 2015 Stock Incentive Plan, such that
Date of Grant |
| Nr. Of Options |
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April 15, 2016 |
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June 23, 2016 |
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January 1, 2017 |
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March 30, 2017 |
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January 23, 2018 |
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From October 1 to November 4, 2021, the Company raised aggregate net proceeds (net of broker’s commissions and fees) of $
END NOTES TO FINANCIALS
28 |
Table of Contents |
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of our financial condition and results of operations should be read together with our Unaudited Condensed Consolidated Financial Statements and the related notes included elsewhere in this Report and in our Annual Report. This discussion and analysis contains forward-looking statements that are based on our current expectations and reflect our plans, estimates and anticipated future financial performance. These statements involve numerous risks and uncertainties, including those related to the anticipated impact on our business from, and our response to, the COVID-19 pandemic. Our actual results may differ materially from those expressed or implied by these forward-looking statements as a result of many factors, including those set forth in the section entitled “Risk Factors” in this Report and in our Annual Report, as well as our other public filings with the SEC. Please refer to the section of this Report entitled “Cautionary Note Regarding Forward-Looking Statements” for additional information.
Company Overview
VolitionRx is a multi-national epigenetics company that applies its NucleosomicsTM platform through its subsidiaries to develop simple, easy to use, cost-effective blood tests to help diagnose and monitor a range of life-altering diseases including some cancers and diseases associated with NETosis such as sepsis and COVID-19.We hope that through earlier diagnosis and monitoring we can help save and improve the quality of human and animals’ lives throughout the world.
Our assays are based on the science of NucleosomicsTM, which is the practice of identifying and measuring nucleosomes in the bloodstream or other bodily fluid, since changes in these parameters are an indication that disease is present.
Volition’s approach is to investigate the epigenetic structure of chromatin and nucleosomes rather than investigating only the DNA sequence. We are continuously developing new technologies as well as the facilities to deliver them, including:
| · | A suite of low cost Nu.Q® immunoassays that can accurately measure nucleosomes containing numerous epigenetic signals or structures, now being developed on a range of different platforms including enzyme-linked immunosorbent assay, or ELISA, chemiluminescent immunoassay, or CLIA, and lateral flow, platforms. |
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| · | Nu.Q® Capture - an enabling technology, to capture and concentrate nucleosomes containing particular epigenetic signals for further analysis, more accurate diagnosis and to guide treatment. |
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| · | The production of synthetic (recombinant) nucleosomes, containing exact defined epigenetic signals and structures, which is now in-house. These nucleosomes are used to ensure maximal accuracy of Nu.Q® immunoassay tests but also have many other applications including Research Use Only (Nu.Q® Discover), or RUO, kits and as tools in epigenetic drug development, mass spectrometry and DNA sequencing. |
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| · | The use of the Nu.Q® technology in veterinary applications and the launch of our first product, the Nu.Q® Vet Cancer Screening Test, in the fourth quarter of 2020. We are in the process of developing additional veterinary products, including a treatment monitoring test, a disease recurrence test and a point-of-care platform. Our extensive intellectual property portfolio includes the coverage of veterinary applications. |
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| · | The expansion of our research and development capabilities into the U.S. through the opening of a Research and Development laboratory in San Diego, California. |
Commercialization Strategy
Volition believes that given the global prevalence of cancer and diseases associated with NETosis, and the low-cost, accessible and routine nature of our tests, Nu.Q® could potentially be used throughout the world. We plan to work with partners to commercialize Nu.Q® worldwide.
Commercialization will take multiple forms in various markets and opportunities including, but not limited to:
| · | Licensing and direct sales of the Nu.Q® Vet Cancer Screening Test. |
| · | Sales of veterinary clinical products utilizing Nu.Q® Vet assays and/or Nu.Q® Capture reagents through distributor networks. |
| · | Licensing of intellectual property, or IP, for clinical products utilizing Nu.Q® assays and/or Nu.Q® Capture reagents. |
| · | Sales of clinical products utilizing Nu.Q® assays and/or Nu.Q® Capture reagents through distributor networks. |
| · | Licensing of IP for RUO kit sales of Nu.Q® Discover assays and/or Nu.Q® Capture reagents. |
| · | Licensing of IP for laboratory developed patient testing services utilizing Nu.Q® assays and/or Nu.Q® Capture reagents. |
| · | Provision of direct research services in the processing of samples using Nu.Q® Discover assays and/or Nu.Q® Capture. |
29 |
Table of Contents |
Developments - COVID-19 Pandemic
On March 11, 2020, the World Health Organization designated the outbreak of the novel strain of coronavirus known as COVID-19 as a global pandemic. Governments and businesses around the world have taken unprecedented actions to mitigate the spread of COVID-19, including, but not limited to, shelter-in-place orders, quarantines, significant restrictions on travel, as well as restrictions that prohibit many employees from going to work. Uncertainty with respect to the economic effects of the pandemic has introduced significant volatility in the financial markets.
Throughout 2020 and the first nine months of 2021, we have implemented contingency planning to protect the health and well-being of our employees, with the majority of our employees working remotely where possible. We have implemented travel restrictions as well as protocols limiting visitor access to our facilities, and we are following social distancing practices.
As a result of the COVID-19 pandemic, we have experienced and may continue to experience disruptions that could impact our clinical trials, including:
| · | delays in enrolling patients in clinical trials; |
| · | delays in sample collection; and |
| · | diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as clinical trial sites and hospital staff supporting the conduct of our clinical trials. |
The extent to which the COVID-19 pandemic will impact our business, financial condition, and results of operations in the future is highly uncertain and will be affected by a number of factors. These include the duration and extent of the COVID-19 pandemic, the development of new variants of the COVID-19 virus that may be more contagious or virulent than previous versions, the scope of mandated or recommended containment and mitigation measures, the effect of government stabilization and recovery efforts, and the success of vaccine distribution programs.
Liquidity and Capital Resources
We have financed our operations since inception primarily through private placements and public offerings of our common stock. As of September 30, 2021, we had cash and cash equivalents of approximately $22.9 million.
Net cash used in operating activities was $ 16.4 million and $13.7 million for the nine months ended September 30, 2021 and September 30, 2020, respectively. The increase in cash used in operating activities for the period ended September 30, 2021 when compared to same period in 2020 was primarily due to increased payroll costs reflecting growth in staff numbers, higher legal and professional fees in relation to a registered public offering and an increase in marketing expenses.
Net cash used in investing activities was $0.8 million and $0.6 million for the nine months ended September 30, 2021 and September 30, 2020, respectively. The increase was primarily due to purchases of laboratory equipment.
Net cash provided by financing activities was $20.8 million and $18.5 million for the nine months ended September 30, 2021 and September 30, 2020, respectively. The increase in cash provided by financing activities for the period ended September 30, 2021 when compared to same period in 2020 was primarily due to $18.9 million in net cash received from the issuance of shares of common stock in a registered public offering in February 2021, $1.2 million in cash received from the issuance of shares of common stock pursuant to the 2018 Equity Distribution Agreement and $1.2 million in cash received from the issuance of shares of common stock pursuant to the 2020 Equity Distribution Agreement, compared to $12.7 million in net cash received from the issuance of shares of common stock in a registered public offering in May 2020 and $6.5 million in cash received from the issuance of shares of common stock pursuant to the 2018 Equity Distribution Agreement. For additional information on the “at the market offering program,” refer to Note 6, Common Stock – Equity Distribution Agreements, of the Notes to Condensed Consolidated Financial Statements.
30 |
Table of Contents |
The following table summarizes our approximate contractual payments due by year as of September 30, 2021.
Approximate Payments (Including Interest) Due by Year | ||||||||||||||||
|
|
|
|
|
|
|
|
| ||||||||
|
| Total |
|
| 2021 (Remaining) |
|
| 2022 - 2025 |
|
| 2026 + |
| ||||
Description |
| $ |
|
| $ |
|
| $ |
|
| $ |
| ||||
Finance Lease Obligations |
|
| 665,506 |
|
|
| 18,031 |
|
|
| 250,529 |
|
|
| 396,946 |
|
Operating Lease Obligations |
|
| 336,085 |
|
|
| 69,789 |
|
|
| 266,296 |
|
|
| - |
|
Grants Repayable |
|
| 301,544 |
|
|
| - |
|
|
| 127,910 |
|
|
| 173,634 |
|
Long-Term Debt |
|
| 3,129,707 |
|
|
| 281,249 |
|
|
| 2,081,735 |
|
|
| 766,723 |
|
Collaborative Agreements Obligations |
|
| 932,999 |
|
|
| 816,789 |
|
|
| 116,210 |
|
|
| - |
|
Total |
|
| 5,365,841 |
|
|
| 1,185,858 |
|
|
| 2,842,680 |
|
|
| 1,337,303 |
|
We intend to use our cash reserves to predominantly fund further research and development activities. We do not currently have any substantial source of revenues and expect to rely on additional future financing, through the sale of equity or debt securities, or the sale of licensing rights, to provide sufficient funding to execute our strategic plan. There is no assurance that we will be successful in raising further funds.
In the event that additional financing is delayed, we will prioritize the maintenance of our research and development personnel and facilities, primarily in Belgium, and the maintenance of our patent rights. In such instance, the completion of clinical validation studies and regulatory approval processes for the purpose of bringing products to the IVD and veterinary markets would be delayed. In the event of an ongoing lack of financing, it may be necessary to discontinue operations, which will adversely affect the value of our common stock.
We have not attained profitable operations and are dependent upon obtaining financing to pursue any extensive activities. For these reasons, our auditors stated in their report on our audited financial statements for the year ended December 31, 2020 an explanatory paragraph regarding factors that raise substantial doubt that we will be able to continue as a going concern.
31 |
Table of Contents |
Results of Operations
Comparison of the Three Months Ended September 30, 2021 and September 30, 2020
The following table sets forth our results of operations for the three months ended on September 30, 2021 and September 30, 2020, respectively:
|
| Three Months Ended September 30, |
|
| Increase |
|
| Increase |
| |||||||
|
| 2021 |
|
| 2020 |
|
| (Decrease) |
|
| (Decrease) |
| ||||
|
| $ |
|
| $ |
|
| $ |
|
| % |
| ||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
Royalty |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
Product |
|
| 25,483 |
|
|
| 575 |
|
|
| 24,908 |
|
| >100 | % | |
Total Revenues |
|
| 25,483 |
|
|
| 575 |
|
|
| 24,908 |
|
| >100 | % | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
| 4,445,877 |
|
|
| 3,180,177 |
|
|
| 1,265,700 |
|
|
| 40 | % |
General and administrative |
|
| 2,426,854 |
|
|
| 1,080,308 |
|
|
| 1,346,546 |
|
| >100 | % | |
Sales and marketing |
|
| 715,044 |
|
|
| 244,510 |
|
|
| 470,534 |
|
| >100 | % | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Operating Expenses |
|
| 7,587,775 |
|
|
| 4,504,995 |
|
|
| 3,082,780 |
|
|
| 68 | % |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant income |
|
| 419,271 |
|
|
| - |
|
|
| 419,271 |
|
| >100 | % | |
Gain / (Loss) on disposal of fixed assets |
|
| - |
|
|
| 200,393 |
|
|
| (200,393 | ) |
| (100) | % | |
Interest income |
|
| 290 |
|
|
| 2,801 |
|
|
| (2,511 | ) |
| (90) | % | |
Interest expense |
|
| (38,767 | ) |
|
| (34,722 | ) |
|
| 4,045 |
|
|
| 12 | % |
Total Other Income |
|
| 380,794 |
|
|
| 168,472 |
|
|
| 212,322 |
|
| >100 | % | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
| (7,181,498 | ) |
|
| (4,335,948 | ) |
|
| 2,845,550 |
|
|
| 66 | % |
Revenues
Our operations are still predominantly in the research and development stage and we had limited revenues of $25,483 and $575 during the three months ended September 30, 2021 and September 30, 2020, respectively. The main source of revenues during the three months ended September 30, 2021 was direct sales of the Nu.Q® Vet Cancer Screening Test via the Gastrointestinal Laboratory at Texas A&M University.
Operating Expenses
Total operating expenses increased to $7.6 million from $4.5 million during the three months ended September 30, 2021 and September 30, 2020, respectively, as a result of the factors described below.
32 |
Table of Contents |
Research and Development Expenses
Research and development expenses increased to $4.4 million for the three months ended September 30, 2021 from $3.2 million for the three months ended September 30, 2020. This increase was primarily related to higher personnel expenses and stock-based compensation during the period. The Full Time Equivalent, or FTE, personnel numbers increased by ten to forty-nine compared to the prior year period.
|
| Three Months Ended September 30, |
|
|
| |||||||
|
| 2021 |
|
| 2020 |
|
| Change |
| |||
|
| $ |
|
| $ |
|
| $ |
| |||
Personnel expenses |
|
| 1,840,389 |
|
|
| 1,152,952 |
|
|
| 687,437 |
|
Stock-based compensation |
|
| 413,940 |
|
|
| 75,054 |
|
|
| 338,886 |
|
Direct research and development expenses |
|
| 1,590,247 |
|
|
| 1,606,316 |
|
|
| (16,069 | ) |
Other research and development |
|
| 348,083 |
|
|
| 163,845 |
|
|
| 184,238 |
|
Depreciation and amortization |
|
| 253,218 |
|
|
| 182,010 |
|
|
| 71,208 |
|
Total research and development expenses |
|
| 4,445,877 |
|
|
| 3,180,177 |
|
|
| 1,265,700 |
|
General and Administrative Expenses
General and administrative expenses increased to $2.4 million from $1.1 million for the three months ended September 30, 2021 and September 30, 2020, respectively. This increase was primarily due to higher personnel expenses and stock-based compensation during the period. The FTE personnel number increased by five to twenty compared to the prior year period.
|
| Three Months Ended September 30, |
|
|
| |||||||
|
| 2021 |
|
| 2020 |
|
| Change |
| |||
|
| $ |
|
| $ |
|
| $ |
| |||
Personnel expenses |
|
| 904,188 |
|
|
| 483,033 |
|
|
| 421,155 |
|
Stock-based compensation |
|
| 885,674 |
|
|
| 304,921 |
|
|
| 580,753 |
|
Legal and professional fees |
|
| 354,823 |
|
|
| 327,346 |
|
|
| 27,477 |
|
Other general and administrative |
|
| 249,600 |
|
|
| (87,777 | ) |
|
| 337,377 |
|
Depreciation and amortization |
|
| 32,569 |
|
|
| 52,785 |
|
|
| (20,216 | ) |
Total general and administrative expenses |
|
| 2,426,854 |
|
|
| 1,080,308 |
|
|
| 1,346,546 |
|
Sales and Marketing Expenses
Sales and marketing expenses increased to $0.7 million from $0.2 million for the three months ended September 30, 2021 and September 30, 2020, respectively. This increase was primarily due to higher personnel expenses, stock-based compensation and direct marketing and professional fees during the period. The FTE personnel number increased by five to eight compared to the prior year period.
|
| Three Months Ended September 30, |
|
|
| |||||||
|
| 2021 |
|
| 2020 |
|
| Change |
| |||
|
| $ |
|
| $ |
|
| $ |
| |||
Personnel expenses |
|
| 390,748 |
|
|
| 115,402 |
|
|
| 275,346 |
|
Stock-based compensation |
|
| 200,868 |
|
|
| 48,709 |
|
|
| 152,159 |
|
Direct marketing and professional fees |
|
| 123,428 |
|
|
| 80,399 |
|
|
| 43,029 |
|
Total sales and marketing expenses |
|
| 715,044 |
|
|
| 244,510 |
|
|
| 470,534 |
|
Other Income
For the three months ended September 30, 2021, the Company’s other income was $0.4 million compared to other income of $0.2 million for the three months ended September 30, 2020. The increase in other income was mainly due to grant income.
33 |
Table of Contents |
Net Loss
For the three months ended September 30, 2021, the Company’s net loss was $7.2 million in comparison to a net loss of $4.3 million for the three months ended September 30, 2020. The change was primarily a result of the factors described above.
Comparison of the Nine Months Ended September 30, 2021 and September 30, 2020
The following table sets forth our results of operations for the nine months ended on September 30, 2021 and September 30, 2020, respectively:
|
| Nine Months Ended September 30, |
|
| Increase |
|
| Percentage Increase |
| |||||||
|
| 2021 |
|
| 2020 |
|
| (Decrease) |
|
| (Decrease) |
| ||||
|
| $ |
|
| $ |
|
| $ |
|
| % |
| ||||
Royalty |
|
| - |
|
|
| 2,112 |
|
|
| (2,112 | ) |
| (100) | % | |
Product |
|
| 75,795 |
|
|
| 4,201 |
|
|
| 71,594 |
|
| >100 | % | |
Total Revenues |
|
| 75,795 |
|
|
| 6,313 |
|
|
| 69,482 |
|
| >100 | % | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
| 11,968,424 |
|
|
| 10,567,988 |
|
|
| 1,400,436 |
|
|
| 13 | % |
General and administrative |
|
| 6,053,613 |
|
|
| 4,292,666 |
|
|
| 1,760,947 |
|
|
| 41 | % |
Sales and marketing |
|
| 1,601,816 |
|
|
| 734,355 |
|
|
| 867,461 |
|
| >100 | % | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Operating Expenses |
|
| 19,623,853 |
|
|
| 15,595,009 |
|
|
| 4,028,844 |
|
|
| 26 | % |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant income |
|
| 810,803 |
|
|
| 98,870 |
|
|
| 711,933 |
|
| >100 | % | |
(Loss) / Gain on disposal of fixed assets |
|
| (26,167 | ) |
|
| 293,595 |
|
|
| (319,762 | ) |
| (>100) | % | |
Interest income |
|
| 2,503 |
|
|
| 48,956 |
|
|
| (46,453 | ) |
| (95) | % | |
Interest expense |
|
| (120,636 | ) |
|
| (91,105 | ) |
|
| 29,531 |
|
|
| 32 | % |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Other Income |
|
| 666,503 |
|
|
| 350,316 |
|
|
| 316,187 |
|
|
| 90 | % |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
| (18,881,555 | ) |
|
| (15,238,380 | ) |
|
| 3,643,175 |
|
|
| 24 | % |
Revenues
Our operations are still predominantly in the research and development stage and we had limited revenues of $75,795 and $6,313 during the nine months ended September 30, 2021 and September 30, 2020, respectively. The main source of revenues during the nine months ended September 30, 2021 was direct sales of the Nu.Q® Vet Cancer Screening Test via the Gastrointestinal Laboratory at Texas A&M University.
Operating Expenses
Total operating expenses increased to $19.6 million from $15.6 million for the nine months ended September 30, 2021 and September 30, 2020, respectively as a result of the factors described below.
34 |
Table of Contents |
Research and Development Expenses
Research and development expenses increased to $12.0 million for the nine months ended September 30, 2021, from $10.6 million for the nine months ended September 30, 2020. This increase in overall research and development expenditures was primarily related to increased personnel expenses and stock-based compensation. The FTE personnel number increased by ten to forty-nine compared to the prior year period.
|
| Nine Months Ended September 30, |
|
|
| |||||||
|
| 2021 |
|
| 2020 |
|
| Change |
| |||
|
| $ |
|
| $ |
|
| $ |
| |||
Personnel expenses |
|
| 4,869,318 |
|
|
| 3,611,730 |
|
|
| 1,257,588 |
|
Stock-based compensation |
|
| 529,414 |
|
|
| 252,344 |
|
|
| 277,070 |
|
Direct research and development expenses |
|
| 4,833,848 |
|
|
| 4,970,879 |
|
|
| (137,031 | ) |
Other research and development |
|
| 975,893 |
|
|
| 1,178,098 |
|
|
| (202,205 | ) |
Depreciation and amortization |
|
| 759,951 |
|
|
| 554,937 |
|
|
| 205,014 |
|
Total research and development expenses |
|
| 11,968,424 |
|
|
| 10,567,988 |
|
|
| 1,400,436 |
|
General and Administrative Expenses
General and administrative expenses increased to $6.1 million from $4.3 million for the nine months ended September 30, 2021 and September 30, 2020, respectively. This increase was primarily due to higher personnel expenses, stock-based compensation and legal and professional fees during the period. The FTE personnel number increased by five to twenty compared to the prior year period.
|
| Nine Months Ended September 30, |
|
|
| |||||||
|
| 2021 |
|
| 2020 |
|
| Change |
| |||
|
| $ |
|
| $ |
|
| $ |
| |||
Personnel expenses |
|
| 2,298,170 |
|
|
| 1,523,864 |
|
|
| 774,306 |
|
Stock-based compensation |
|
| 1,460,395 |
|
|
| 616,241 |
|
|
| 844,154 |
|
Legal and professional fees |
|
| 1,410,258 |
|
|
| 1,254,935 |
|
|
| 155,323 |
|
Other general and administrative |
|
| 788,146 |
|
|
| 732,664 |
|
|
| 55,482 |
|
Depreciation and amortization |
|
| 96,644 |
|
|
| 164,962 |
|
|
| (68,318 | ) |
Total general and administrative expenses |
|
| 6,053,613 |
|
|
| 4,292,666 |
|
|
| 1,760,947 |
|
Sales and Marketing Expenses
Sales and marketing expenses increased to $1.6 million from $0.7 million for the nine months ended September 30, 2021 and September 30, 2020, respectively. This increase was primarily due to higher personnel expenses, stock-based compensation and direct marketing and professional fees during the period. The FTE personnel number increased by five to eight compared to the prior year period.
|
| Nine Months Ended September 30, |
|
|
| |||||||
|
| 2021 |
|
| 2020 |
|
| Change |
| |||
|
| $ |
|
| $ |
|
| $ |
| |||
Personnel expenses |
|
| 805,967 |
|
|
| 377,100 |
|
|
| 428,867 |
|
Stock-based compensation |
|
| 403,759 |
|
|
| 113,407 |
|
|
| 290,352 |
|
Direct marketing and professional fees |
|
| 392,090 |
|
|
| 243,848 |
|
|
| 148,242 |
|
Total sales and marketing expenses |
|
| 1,601,816 |
|
|
| 734,355 |
|
|
| 867,461 |
|
Other Income
For the nine months ended September 30, 2021, the Company’s other income was $0.7 million compared to other income of $0.4 million for the nine months ended September 30, 2020. This increase in other income was primarily due to grant income.
35 |
Table of Contents |
Net Loss
For the nine months ended September 30, 2021, the Company’s net loss was $18.9 million in comparison to a net loss of $15.2 million for the nine months ended September 30, 2020. The change was a result of the factors described above.
Going Concern
We have not attained profitable operations and are dependent upon obtaining external financing to continue to pursue our operational and strategic plans. For these reasons, management has determined that there is substantial doubt that the business will be able to continue as a going concern without further financing.
Off-Balance Sheet Arrangements
We have no significant off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to stockholders.
Future Financings
We may seek to obtain additional capital through the sale of debt or equity securities, if we deem it desirable or necessary. These sales may include the sale of equity securities from time to time through our “at the market offering program” with Cantor Fitzgerald & Co. and Oppenheimer & Co. Inc. under the Equity Distribution Agreement dated September 24, 2021 (see Note 6 of the notes to the condensed consolidated financial statements). However, we may be unable to obtain such additional capital when needed, or on terms favorable to us or our stockholders, if at all. If we raise additional funds by issuing equity securities, the percentage ownership of our stockholders will be reduced, stockholders may experience additional dilution, or such equity securities may provide for rights, preferences or privileges senior to those of the holders of our common stock. If additional funds are raised through the issuance of debt securities, the terms of such securities may place restrictions on our ability to operate our business.
Critical Accounting Policies
Our interim consolidated financial statements and related condensed notes have been prepared in accordance with United States generally accepted accounting principles, or U.S. GAAP, applied on a consistent basis. The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods.
We regularly evaluate the accounting policies and estimates that we use to prepare our financial statements. A summary of these policies is included in the notes to our financial statements. In general, management's estimates are based on current facts, historical experiences, information from third party professionals and various other factors that it believes to be reasonable under the circumstances. Actual results could differ materially and adversely from those estimates made by management. To the extent there are material differences between the estimates and the actual results, future results of operations could be affected.
Recently Issued Accounting Pronouncements
The Company has implemented all applicable new accounting pronouncements that are in effect. The Company does not believe that there are any other applicable new accounting pronouncements that have been issued that might have a material impact on its financial position or results of operations.
36 |
Table of Contents |
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We are a smaller reporting company and are not required to disclose this information.
ITEM 4. CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
Disclosure controls and procedures are controls and procedures that are designed to ensure that information required to be disclosed in our reports filed under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by our company in the reports that it files or submits under the Exchange Act is accumulated and communicated to our management, including our Principal Executive and Principal Financial Officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
Our management carried out an evaluation, under the supervision and with the participation of our Principal Executive Officer and Principal Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Based upon that evaluation, our Principal Executive Officer and Principal Financial Officer have concluded, as they previously concluded as of December 31, 2020, that our disclosure controls and procedures were not effective as of September 30, 2021, because of material weaknesses in our internal control over financial reporting, as referenced below and described in detail in our Annual Report for the year ended December 31, 2020.
A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.
In our Annual Report for the year ended December 31, 2020, the deficiencies identified involved the segregation of duties in some areas of finance, the oversight in information technologies, where certain processes may affect the internal controls over financial reporting, and the monitoring of review controls with respect to accounting for complex transactions.
During the first nine months of 2021, our management, with oversight from our audit committee, has implemented the following remediation steps to help address and mitigate some of the underlying deficiencies which gave rise to the previously disclosed material weaknesses and to improve our internal control over financial reporting:
Segregation of Duties in Some Areas of Finance
| · | hired an additional full-time Business Controller in Belgium with an appropriate level of experience; |
| · | hired an experienced financial planning and analysis manager to implement forecasting and budgeting processes; and |
| · | changed certain organizational reporting lines and reallocated certain responsibilities to improve segregation of duties. |
We intend to take additional measures around certain processes we have identified which we believe once implemented and in conjunction with the completed actions above will mitigate and remedy this weakness.
Oversight in Information Technologies
| · | ensured that third party support and back up is available as cover for our information technology manager; |
| · | ensured that appropriate finance approvals are taken before adding users or access for financial systems and applications; and |
| · | implemented a quarterly user access control review process across finance and information technology systems. |
As a result of these actions, we believe that this particular deficiency has been remedied.
Monitoring of Review Controls with Respect to Accounting for Complex Transactions
| · | reallocated responsibilities across the finance organization to ensure that the appropriate level of knowledge and experience is applied based on complexity of tasks being undertaken; |
| · | further embedded the use of Certent, an equity management platform, to help with control and reporting of equity awards; |
| · | implemented additional review procedures at each month end close; and |
| · | in the event we encounter or anticipate any new and particularly complex transaction we will engage advisors from our wide professional network. |
37 |
Table of Contents |
As a result of these actions, we believe that this particular deficiency has been remedied.
We intend to take additional steps to further strengthen the control environment. Such measures include but may not be limited to:
| · | recruitment of a specialist in Human Resources to recommend and implement relevant policies and processes that will strengthen the control environment; |
| · | further strengthening our internal processes and reviews, including formal documentation thereof; |
| · | preparation of risk-control matrices to identify key risks and develop and document policies to mitigate those risks; and |
| · | engaging additional resources if necessary to help us assess, document, design and implement control activities related to internal control over financial reporting. |
As we continue to evaluate and test the remediation plan outlined above, we may also identify additional measures to address the material weaknesses or modify certain of the remediation procedures described above. We also may implement additional changes to our internal control over financial reporting as may be appropriate in the course of remediating the material weakness. Management, with the oversight of our audit committee, will continue to take steps necessary to remedy the material weakness to reinforce the overall design and capability of our control environment.
Changes in Internal Control over Financial Reporting
Except for the ongoing remediation of the material weaknesses in internal controls over financial reporting noted above, no changes in our internal control over financial reporting were made during the fiscal quarter ended September 30, 2021, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Limitations of the Effectiveness of Disclosure Controls and Internal Controls
Our management, including our Principal Executive Officer and Principal Financial Officer, does not expect that our disclosure controls and internal controls will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control.
The design of any system of controls is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving our stated goals under all potential future conditions; over time, a control may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
38 |
Table of Contents |
PART II OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
In the ordinary course of business, we may be subject to claims, counter claims, lawsuits and other litigation of the type that generally arise from the conduct of our business. We know of no material, existing or pending legal proceedings against our company, nor are we involved as a plaintiff in any material proceeding or pending litigation. There are no proceedings in which our directors, officers or any affiliates, or any registered or beneficial stockholders, is an adverse party or has a material interest adverse to our interest.
ITEM 1A. RISK FACTORS
There have been no material changes in our assessment of risk factors affecting our business since those presented in Part I, Item 1A of our Annual Report.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Recent Sales of Unregistered Securities
None.
Repurchase of Equity Securities
No equity securities were repurchased during the third quarter of 2021.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5. OTHER INFORMATION
None.
39 |
Table of Contents |
ITEM 6. EXHIBITS
| Incorporated by Reference |
|
| ||||||||||
Exhibit Number | Exhibit Description | Form |
| File No. | Exhibit |
| Filing Date | Filed Herewith | |||||
|
| S-3 | 333-259783 |
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101.INS | XBRL Instance Document. |
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101.SCH | XBRL Taxonomy Extension Schema Document. |
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101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document. |
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101.LAB | XBRL Taxonomy Extension Label Linkbase Document. |
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101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document. |
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101.DEF | XBRL Taxonomy Extension Definition Linkbase Document. |
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104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
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# Indicates a management contract or compensatory plan or arrangement.
† Portions of this exhibit are redacted pursuant to Item 601(a)(6) and/or Item (b)(10)(iv) under Regulation S-K. The registrant agrees to furnish supplementally any omitted schedules to the SEC upon request.
* The certifications attached as Exhibit 32.1 accompany this Quarterly Report pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, and shall not be deemed “filed” by the registrant for purposes of Section 18 of the Exchange Act and are not to be incorporated by reference into any of the registrant’s filings under the Securities Act or the Exchange Act, irrespective of any general incorporation language contained in any such filing.
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Table of Contents |
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 |
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Dated: November 10, 2021 | By: | /s/ Cameron Reynolds |
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| Cameron Reynolds |
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| President and Chief Executive Officer (Authorized Signatory and Principal Executive Officer) |
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Dated: November 10, 2021 | By: | /s/ Terig Hughes |
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| Terig Hughes |
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| Chief Financial Officer and Treasurer (Authorized Signatory and Principal Financial and Accounting Officer) |
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EXHIBIT 10.1
VOLITION AMERICA, INC.
EMPLOYMENT AGREEMENT
CHIEF OPERATING OFFICER
This Employment Agreement (“Agreement”) is effective on September 15, 2021 (the “Effective Date”) by and between Volition America, Inc., a Delaware corporation with its office located at 13215 Bee Cave Parkway, Suite 125 Galleria Oaks B, Austin, Texas 78738 (“Company”) and Gaetan Michel (“Employee”). The Company and Employee are sometimes referred to herein individually as a “Party” or collectively as the “Parties”.
WITNESSETH:
WHEREAS, the Employee was providing services as Chief Operating Officer to VolitionRx Limited (“VolitionRx”) with effect from October 1, 2020, pursuant to a consulting services agreement between the Company’s subsidiary, Volition Germany GmbH (“Volition Germany”), and 3F Management, SPRL (“3F Management”) dated January 29, 2021, as amended.
WHEREAS, the Company desires that Employee be employed by the Company, and to continue to render services as Chief Operating Officer to the Company and its subsidiaries and affiliates, and Employee is willing to be so employed and to render such services, all upon the terms and subject to the conditions contained herein.
WHEREAS, in order to ensure a harmonious ongoing business working relationship among themselves with respect to the conduct pursuant to the terms and conditions outlined in this Employment Agreement, the Parties desire to enter into this Agreement.
AGREEMENT:
NOW, THEREFORE, in consideration of the mutual covenants and agreements contained herein, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree as follows:
1. EMPLOYMENT.
(a) This Agreement supersedes and replaces in its entirety the existing Consulting Services Agreement between Volition Germany and 3F Management dated January 29, 2021, as amended, which is hereby terminated upon mutual agreement and is of no further force and effect as from the Effective Date (other than the provisions expressly surviving termination under Section 4(e)).
(b) Subject to and upon the terms and conditions contained in this Agreement, the Company hereby agrees to employ Employee and Employee agrees to be employed by the Company as of the Effective Date, and, to render to the Company, its affiliates and/or subsidiaries the services described in Section 3 hereof.
2. TERM. Employee’s employment under this Agreement shall commence as of the Effective Date hereof and shall continue until terminated in accordance with the provisions of this Agreement (the “Employment Term”).
3. DUTIES.
(a) Chief Operating Officer. Employee shall serve as the Chief Operating Officer of the Company, reporting directly to the Chief Executive Officer of VolitionRx. Employee shall hold such responsibilities and authorities, and shall perform all duties and services incident to the position held by him.
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(b) Company Policies. Employee agrees to abide by all bylaws and policies of the Company and its affiliates and/or subsidiaries promulgated from time to time by the Company and/or such entities as well as all laws, statutes and regulations.
(c) Place of Work. The normal place of work for the Employee shall be from his home in the U.S., or from such other location as mutually agreed upon between the Company and the Employee. From time to time, the Employee will be required to attend management meetings at the Company’s affiliates’ offices in Belgium, Singapore, London and/or the U.S. (or such other location identified by the Company from time to time) and to be available for domestic and international travel as the Company’s business reasonably requires.
5. COMPENSATION. For the duration of the Employment Term and as compensation for his services and covenants hereunder, Employee shall receive:
(a) Salary. Employee’s base salary shall be Three Hundred and Twenty Thousand U.S. Dollars (US$320,000) per year (“Base Salary”). The Base Salary shall be payable in equal monthly instalments in U.S. Dollars in accordance with the Company’s standard payroll practices and policies for employees. The Base Salary shall be reviewed annually, and any increases will be approved by the VolitionRx Board of Directors or its Compensation Committee, and the Board of the Company.
(b) Incentive Plans. During the Employment Term, the Employee shall be eligible to participate in other employee incentive plans of VolitionRx and/or the Company, if any. The criteria for determining the amount of any allocations to the Employee under such incentive plans for employees, including the criteria for determining the amount of any award, and the conditions that must be satisfied to entitle Employee to receive such award for any year during the term of this Agreement shall be determined, in the sole discretion of the VolitionRx Board of Directors, its Compensation Committee or the Company’s Board, as applicable.
6. EXPENSES. Employee shall be reimbursed for business expenses incurred by him which are reasonable and necessary for Employee to perform his duties under this Agreement, subject to the production of receipts or other appropriate evidence of payment. In claiming expenses, the Employee shall comply with the Company’s Travel and Expenses Policy or any other Expenses Policies implemented by the Company (as amended from time to time), copies of which will be provided.
7. EMPLOYEE BENEFITS.
(a) Paid Time Off (PTO). Employee shall be entitled to 20 days paid PTO days on an annual basis in accordance with the Company’s policies, as may be established from time to time by the Company for its employees, which shall be taken at such time or times as shall be mutually agreed upon by the Parties. Employee shall not carry forward any accrued PTO days to a subsequent year.
(b) Insurance. During the Employment Term, Employee shall be entitled to participate in such group term insurance, disability insurance, health and medical insurance benefits, life insurance and retirement plans or programs as are from time to time generally made available to executive employees of the Company pursuant to the policies of the Company; provided that Employee shall be required to comply with the conditions attendant to coverage by such plans and shall comply with and be entitled to benefits only to the extent former employees are eligible to participate in such arrangements pursuant to the terms of the arrangement, any insurance policy associated therewith and applicable law, and, further, shall be entitled to benefits only in accordance with the terms and conditions of such plans. The Company may withhold from any benefits payable to Employee all federal, state, local and other taxes and amounts as shall be permitted or required to be withheld pursuant to any applicable law, rule or regulation. Further, the Company may amend, modify or rescind any benefit plan or program and change contribution amounts to benefit costs without notice in its discretion. Employee shall further be subject to the indemnification by-laws, policies and/or procedures applicable to senior officers of the Company and shall be included in the Directors & Officers insurance policies maintained by VolitionRx.
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8. DEATH AND DISABILITY.
(a) Death. The Employment Term shall terminate on the date of Employee’s death, in which event the Company shall, within 30 days of the date of death, pay to his estate, any unpaid Base Salary earned up to the date of death, outstanding reimbursable expenses, accrued and unused vacation or PTO time, and any vested benefits expressly payable in accordance with the applicable plan or program owing to Employee through to the date of Employee’s death. Employee will not be entitled to any other compensation upon termination of his employment pursuant to this Section 8(a).
(b) Disability. To the extent permitted by law, the Employment Term shall terminate upon Employee’s Disability. For purposes of this Agreement, “Disability” shall mean that Employee is unable to engage in any substantial gainful activity by reason of any medically determinable physical or mental impairment which can be expected to result in death or can be expected to last for a continuous period of not less than 6 months, or 150 non-consecutive days in any 12-month period. The existence of a Disability shall be determined by a qualified physician nominated by the Company in consultation with Employee. In case of such termination, Employee shall be entitled to receive his unpaid Base Salary earned up to the date of the Company’s determination of Employee’s Disability, outstanding reimbursable expenses and accrued and unused vacation or PTO time, and any vested benefits expressly payable in accordance with the applicable plan or program owing to Employee through the date of termination, which amounts shall be paid within 30 days of the date of the Company’s determination of Employee’s Disability. Employee will not be entitled to any other compensation upon termination of his employment pursuant to this Section 8(b).
9. TERMINATION OF EMPLOYMENT.
(a) Termination With Cause By Company. The Company may terminate this Agreement at any time during the Employment Term for “Cause” upon written notice to Employee, upon which termination shall be effective immediately. For purposes of this Agreement, “Cause” means the following:
| i. | Willful and material failure to adhere to the Company’s and/or its affiliates’ and subsidiaries’ bylaws or written policies, or lawful directives of the Board of the Company or Chief Executive Officer of VolitionRx, provided Employee shall be given no less than fifteen (15) business days to cure the same after written notice of any failure, if curable in the reasonable discretion of the Company; |
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| ii. | Misappropriation (or attempted misappropriation) of any non-trivial Company and/or its affiliates and/or subsidiaries property or funds; |
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| iii. | Conviction of, or the entry of a guilty plea or plea of no contest with respect to, any felony involving moral turpitude; and |
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| iv. | Violation of a fiduciary duty to the Company or its equityholders. |
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(c) Termination By Employee. Employee may terminate this Agreement at any time by providing the Company three (3) months written notice, with or without any reason.
(d) Compensation upon Termination. Upon termination pursuant to this Section 9, Employee shall be entitled to all accrued and unpaid compensation earned as of the date of termination, including Base Salary, outstanding reimbursable expenses, accrued and unused vacation or PTO time, and any vested benefits expressly payable in accordance with the applicable plan or program. Employee shall also receive any awarded and unpaid bonus for a prior completed year, if not yet paid as of the termination date, within 30 days of the termination date.
10. DISCLOSURE OF TRADE SECRETS AND OTHER PROPRIETARY INFORMATION; RESTRICTIVE COVENANTS.
(a) Employee acknowledges that he is prohibited from directly or indirectly disclosing any confidential information about the Company, its affiliates and/or subsidiaries or companies with whom the Company, its affiliates and/or subsidiaries do business, including but not limited to trade secrets, formulas, and financial information, to any party who is not a director, officer or authorized agent of the Company or its subsidiaries and affiliates. The Company will provide Employee with valuable confidential information belonging to the Company or its subsidiaries or its affiliates above and beyond any confidential information previously received by Employee and will associate Employee with the goodwill of the Company or its subsidiaries or its affiliates above and beyond any prior association of Employee with that goodwill. In return, Employee promises never to disclose or misuse such confidential information and never to misuse such goodwill.
(b) Employee will not, during the Employment Term and for a period of six (6) months thereafter, on his behalf or on behalf of any other business enterprise, directly or indirectly, under any circumstance other than at the direction and for the benefit of the Company, its affiliates and/or subsidiaries, (i) solicit for employment or hire any person employed by the Company or any of its subsidiaries or affiliates, or (ii) call on, solicit, or take away any person or entity who was a customer of the Company or any of its subsidiaries or affiliates during Employee’s employment with the Company, in either case for a business that is competitive with the business of the Company, its affiliates and/or subsidiaries. This restriction shall not prevent Employee from soliciting or doing business with any customer with whom he had a pre-existing business relationship and which is identified to the Company in a written list provided by Employee and reasonably agreed upon by the Company within five (5) business days of the end of the Employment Term. To the extent that no such written list is provided by Employee within such period then Employee’s rights to the foregoing carve out shall be deemed waived.
(c) It is expressly agreed by Employee that the nature and scope of each of the provisions set forth above are reasonable and necessary. If, for any reason, any aspect of the above provisions as it applies to Employee is determined by a court of competent jurisdiction to be unreasonable or unenforceable under applicable law, the provisions shall be modified to the extent required to make the provisions enforceable. Employee acknowledges and agrees that his services are of unique character and expressly grants to the Company or any subsidiary or affiliate of the Company or any successor of any of them, the right to enforce the above provisions through the use of all remedies available at law or in equity, including, but not limited to, injunctive relief.
11. COMPANY PROPERTY.
(a) Any patents, inventions, discoveries, applications, processes, models or financial statements designed, devised, planned, applied, created, discovered or invented by Employee during the Employment Term, regardless of when reduced to writing or practice, which pertain to any aspect of the Company’s or its subsidiaries’ or affiliates’ business as described above shall be the sole and absolute property of the Company, and Employee shall promptly report the same to the Company and promptly execute any and all documents that may from time to time reasonably be requested by the Company to assure the Company the full and complete ownership thereof.
(b) All records, files, lists, including computer generated lists, drawings, documents, equipment and similar items relating to the Company’s, its affiliates’ and/or subsidiaries’ business which Employee shall prepare or receive from the Company shall remain the Company’s, its affiliates’ and/or subsidiaries’ sole and exclusive property. Upon termination of this Agreement, Employee shall promptly return to the Company all property of the Company, its affiliates and/or subsidiaries in his possession. Employee may retain copies of documents evidencing his terms of employment, compensation, or related to his status as an equityholder of the Company, which materials shall continue to be subject to any applicable confidentiality restrictions.
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12. EQUITABLE RELIEF. It is mutually understood and agreed that Employee’s services are special, unique, unusual, extraordinary and of an intellectual character giving them a peculiar value, the loss of which cannot be reasonably or adequately compensated in damages in an action at law. Accordingly, in the event of any breach of this Agreement by Employee, including, but not limited to, the breach of any of the provisions of Sections 10 or 11 hereof, the Company shall be entitled to equitable relief by way of injunction or otherwise in addition to any damages which the Company may be entitled to recover. In the event of any breach of this Agreement by Company the Employee shall be entitled to equitable relief by way of injunction or otherwise in addition to any damages which the Employee may be entitled to recover.
13. APPLICABLE LAW AND DISPUTES. The Employee hereby consents and agrees that federal and state courts located in the State of Texas shall have personal jurisdiction and proper venue with respect to any dispute between the Employee and the Company. In any dispute with the Company, the Employee will not raise, and hereby expressly waives, any objection or defense to any such jurisdiction as an inconvenient forum.
14. NOTICE. Except as otherwise expressly provided, any notice, request, demand or other communication permitted or required to be given under this Agreement shall be in writing, shall be deemed conclusively to have been given: (a) upon receipt, when delivered personally; (b) upon receipt when sent by facsimile or email delivery of a “.pdf” format data file (provided confirmation of transmission is mechanically or electronically generated and kept on file by the sending party; (c) on the third business day following the day timely deposited with Federal Express (or other equivalent international courier), with the cost of delivery prepaid or for the account of the sender; (d) on the seventh business day following the day duly sent by certified or registered mail, postage prepaid; or (e) when otherwise actually received by the addressee on a business day (or on the next business day if received after the close of normal business hours or on any non-business day).
15. INTERPRETATION; HEADINGS. The parties acknowledge and agree that the terms and provisions of this Agreement have been negotiated, shall be construed fairly as to all parties hereto, and shall not be construed in favor of or against any party. The section headings contained in this Agreement are for reference purposes only and shall not affect the meaning or interpretation of this Agreement.
16. SUCCESSORS AND ASSIGNS; ASSIGNMENT; INTENDED BENEFICIARIES. Neither this Agreement, nor any of Employee’s rights, powers, duties or obligations hereunder, may be assigned by Employee. This Agreement shall be binding upon and inure to the benefit of Employee and his heirs and legal representatives and the Company and its successors. Successors of the Company shall include, without limitation, any corporation or corporations acquiring, directly or indirectly, all or substantially all of the assets of the Company, whether by merger, consolidation, purchase, lease or otherwise, and such successor shall thereafter be deemed “the Company” for the purpose hereof.
17. NO WAIVER BY ACTION. Any waiver or consent from the Company respecting any term or provision of this Agreement or any other aspect of the Employee’s conduct or employment shall be effective only in the specific instance and for the specific purpose for which given and shall not be deemed, regardless of frequency given, to be a further or continuing waiver or consent. The failure or delay of the Company at any time or times to require performance of, or to exercise any of its powers, rights or remedies with respect to, any term or provision of this Agreement or any other aspect of the Employee’s conduct or employment in no manner (except as otherwise expressly provided herein) shall affect the Company’s right at a later time to enforce any such term or provision.
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18. COUNTERPARTS; GOVERNING LAW; AMENDMENTS; ENTIRE AGREEMENT; SEVERABILITY; SURVIVAL OF TERMS. This Agreement may be executed in two counterpart copies, each of which may be executed by one of the parties hereto, but all of which, when taken together, shall constitute a single agreement binding upon all of the parties hereto. This Agreement and all other aspects of the Employee’s employment shall be governed by and construed in accordance with the applicable laws of the State of Texas (other than those that would defer to the substantive laws of another jurisdiction). Each and every modification and amendment of this Agreement shall be in writing and signed by the parties hereto, and any waiver of, or consent to any departure from, any term or provision of this Agreement shall be in writing and signed by each affected party hereto. This Agreement contains the entire agreement of the parties and supersedes all prior representations, agreements and understandings, oral or otherwise, between the parties with respect to the matters contained herein, including but not limited to any written offer letter or letter agreement concerning employment. In the event of any conflict, the terms of this Agreement shall control. The invalidity or unenforceability of any provision of this Agreement shall not affect the validity or enforceability of any other provision of this Agreement, which shall remain in full force and effect. Sections 10 through 19 shall survive any termination of this Agreement and the termination of Employee’s employment.
19. TAX AND DEDUCTION. All payments to Employee pursuant to this Agreement are subject to applicable tax, withholding and deduction requirements based on the state and country of Employee’s service.
[Signature page follows.]
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SIGNATURES
IN WITNESS WHEREOF, the Parties hereto have executed this Agreement as of the date set forth above.
By: |
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| By: |
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(“COMPANY”) |
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| (“EMPLOYEE”) |
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Volition America Inc |
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| Gaetan Michel |
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/s/ Jason Terrell | /s/ Gaetan Michel | |||
By: Jason Terrell | By: Gaetan Michel | |||
Its: Chief Executive Officer |
[Signature Page to Volition America Inc. Employment Agreement – Chief Operating Officer]
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EXHIBIT 10.2
CONSULTING SERVICES AGREEMENT
THIS CONSULTING AGREEMENT (the “Agreement”) is effective from September 15, 2020 (the “Effective Date”) by and between by and between Volition Global Services SRL, a company incorporated under the laws of Belgium whose principal office is at 22 Rue Phocas Lejeune, Parc Scientifique, 5032, Isnes, Belgium (the “Company”) and 3F Management SPRL, a company located at [***] (the “Consultant”).
(referred to herein individually as a “Party” or collectively as the “Parties”)
1. Consulting Services.
(a) This Agreement supersedes and replaces in its entirety the existing consultancy agreement between the Consultant and Volition Germany, GmbH dated January 29, 2021, as amended, which is hereby terminated upon mutual agreement and is of no further force and effect (other than the provisions expressly surviving termination).
(b) Subject to and upon the terms and conditions set forth in this Agreement, the Company hereby retains the Consultant, and the Consultant hereby agrees to provide to the Company the consulting services attached to this Agreement as Exhibit A (as may be amended from time to time upon mutual agreement of the Parties, the “Services”). The Services shall be performed in a timely, competent, professional and workmanlike manner by the Consultant and its employees. Consultant may not use a subcontractor or other third party to perform its duties under this Agreement. The Consultant shall make available to the Company, Dr. Gaetan Michel (the “Individual”), one of its employees, to provide the Services under this Agreement. In rendering the Services pursuant to this Agreement, the Consultant shall act solely as an independent contractor and this Agreement shall not be construed to create any employee/employer, agent or representative relationship between the Consultant and the Company. The Consultant and the Individual each acknowledge and agree that all work performed by the Individual, or other employees of the Consultant, shall be performed as employees of the Consultant, on behalf of the Consultant and not as additional independent contractors.
(c) With respect to the conduct of and progress of the Services, the Consultant and the Individual will report to and liaise with the Board of Managers of the Company (the “Board of Managers”) on any matter related to the Services. Consultant shall have the right to control and direct the means, manner and method by which the Services are performed.
(d) The Consultant shall provide the Services hereunder from its offices or the offices of the Company, from such other location that permits the performance of the Services, or as mutually agreed upon by the Consultant and the Company. The Company shall reimburse the Consultant for expenses incurred in connection with the provision of the Services in accordance with Section 3.
(e) The Consultant will perform the Services in accordance with all policies and procedures provided by the Company, including any third-party policies and procedures that the Company is required to comply with.
2. Compensation.
(a) Consultancy Fees. The Company shall, so long as the Consultant is providing Services to the Company under this Agreement, pay the Consultant the consulting fee as detailed in Exhibit A. The Company will not withhold any tax or social security payments due from the Consultant to any governmental taxing authority. The Consultant will be responsible for the payment of any social security, income tax or similar payments required by law to be made in relation to this Agreement. The Consultant will indemnify and hold the Company harmless to the extent of any obligation imposed on the Company (a) to pay in withholding taxes or similar items or (b) resulting from a determination that the Consultant is not an independent contractor. Neither the Consultant nor the Individual shall have any claim against the Company for health or disability benefits, retirement benefits, social security, worker's compensation, unemployment insurance benefits, or employee benefits of any kind.
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3. Expenses.
(a) The Company shall reimburse the Consultant for any actual expenses incurred by the Consultant while rendering Services under this Agreement so long as such expenses are reasonable and necessary, and appropriately documented.
(b) In claiming expenses the Consultant shall comply with the generally applicable policies, practices and procedures of the Company for submission of expense reports, receipts or similar documentation of such expenses (as amended from time to time), a copy of which will be provided.
4. Term; Termination.
(a) This Agreement shall take effect as of the Effective Date and shall continue thereafter in full force until terminated in accordance with the provisions of Section 4(b). The period commencing on the Effective Date and ending on the effective date of termination shall be referred to as the “Term”.
(b) This Agreement and the Services may be terminated at any time by either Party for any reason or no reason upon at least three (3) months prior written notice of termination to the other Party.
| (i) | the Individual is not available to perform the Services for any single continuous period extending beyond 90 days; |
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| (ii) | the Consultant or Individual commits any gross misconduct affecting the business of the Company or its affiliates; |
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| (iii) | the Consultant or Individual commits any serious or repeated breach or non-observance of any material provisions of this Agreement; |
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| (iv) | the Individual is convicted of any serious criminal offence involving a custodial penalty; |
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| (v) | the Consultant makes a resolution for its winding up, makes an arrangement or composition with its creditors or makes an application to a court of competent jurisdiction for protection from its creditors or an administration or winding-up order is made or an administrator or receiver is appointed in relation to the Consultant; |
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| (vi) | the Consultant or the Individual commits any fraud or any acts that are materially adverse to the interests of the Company or its affiliates. |
(d) The rights of the Company under Section 4(c) are without prejudice to any other rights that it might have at law to terminate the Agreement or to accept any breach of this Agreement on the part of the Consultant as having brought the Agreement to an end. Any delay by the Company in exercising its rights to terminate shall not constitute a waiver thereof.
(e) The provisions of Sections 5, 6, 7, 8 and 9 shall survive the expiration or termination of this Agreement, in accordance with their provisions.
5. Confidential Information.
(a) Any non-public information acquired by the Consultant from the Company or any Group Company, directly or indirectly, in writing, orally, or by inspection or observation of tangible items, including, without limitation, the actual or anticipated business, research or development of the Company or any Group Company, any proprietary information, trade secrets and know-how of the Company or any Group Company, and the terms of this Agreement, and any information, data and materials developed in the course of performing the Services contemplated by this Agreement (collectively, “Confidential Information”), will be the sole property of the Company and/or the Group Company, as applicable, and will be maintained in confidence and not used by the Consultant or the Individual except as necessary to perform the Services contemplated by this Agreement. Confidential Information includes, but is not limited to, intellectual property, research, product plans, business operations, processes, products, services, customer lists, development plans, inventions, formulas, technology, designs, drawings, marketing, finances, and other business information. Neither the Consultant nor the Individual will disclose any Confidential Information to any third party, without first obtaining the prior written consent of the Company or the Group Company, as applicable. Each of the Consultant and the Individual will take reasonable precautions to prevent any unauthorized disclosure of Confidential Information. For purposes of this Agreement, “Group Company” shall mean affiliated entities of the Company including its parent (VolitionRx Limited), subsidiaries, subsidiaries of parent and other related entities.
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(b) The provisions of Section 5(a) will not apply to any portion of the Confidential Information that: (i) is or becomes publicly available through no fault of the Consultant; (ii) is lawfully obtained by the Consultant from any third parties who are not under any obligation of confidentiality to the Company or any Group Company with respect to such information and who otherwise have a right to make such disclosure; or (iii) is previously known to the Consultant, without confidentiality obligations, prior to disclosure by the Company or any Group Company as evidenced by the Consultant’s written files and records. In addition, the Consultant may disclose Confidential Information pursuant to a request or order of any court or governmental agency, provided that the Consultant promptly notifies the Company or the Group Company, as applicable, of any such request or order and provides reasonable cooperation (at the Company’s or Group Company’s expense) in the efforts, if any, of the Company to contest or limit the scope of such request or order.
(c) Neither the Consultant nor the Individual shall improperly use or disclose to or for the Company’s or any Group Company’s benefit any confidential information or trade secrets of (i) any former, current or future employer, (ii) any person to whom the Consultant or the Individual has previously provided, currently provides or may in the future provide Services or (iii) any other person to whom the Consultant or the Individual owes an obligation of confidentiality.
(d) The Consultant and the Individual will promptly deliver to the Company or the Group Company, as applicable, upon the termination of this Agreement or upon the request of the Company or such Group Company, all documents and other tangible media (including all originals, copies, digests, abstracts, summaries, analyses, notes, notebooks, drawings, manuals, memoranda, records, reports, plans, specifications, devices, formulas, storage media, including software, and computer printouts) in the Consultant’s and the Individual’s actual or constructive possession or control that contain, reflect, disclose or relate to any Confidential Information, Inventions (as defined below) or intellectual property rights relating to Inventions. The restrictions upon disclosure and use of Confidential Information shall continue for a period of five (5) years from the expiration or termination of this Agreement.
6. Work Product.
(a) Each of the Consultant and the Individual hereby fully assigns and agrees to assign and transfer to the Company all rights, title and interest, in and to any ideas, inventions, improvements, technologies, designs, works of authorship, developments, discoveries, trade secrets or suggestions that (i) are made, conceived, invented, discovered, originated, authored, created, learned or reduced to practice by the Consultant or the Individual, either alone or together with others, in the course of rendering the Services to the Company under this Agreement (regardless of whether or not such Inventions were made, conceived, invented, discovered, originated, authored, created, learned or reduced to practice by the Consultant or the Individual at the Company’s facilities or during regular business hours or utilizing resources of the Company) or (ii) arise out of or are based upon any Confidential Information (collectively, “Inventions”), including, without limitation, all physical embodiments thereof provided by the Consultant or the Individual as well as all other rights therein throughout the world. The obligations of the Consultant and the Individual under this Section 6 are in addition to any other obligations or duties of the Consultant and the Individual, whether express or implied or imposed by applicable law, to assign to the Company the Inventions. Inventions that constitute trademark or copyrightable subject matter, including without limitation, terms, logos, branding or marketing collateral, packaging designs, promotional materials, business stationary or collateral, print or digital copy, artwork, and website design will be considered “works made for hire” as that term is defined in the United States Copyright Act.
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(b) Each of the Consultant and the Individual will give the Company prompt written notice of any Inventions and agrees to execute such instruments of transfer, assignment, conveyance or confirmation and such other documents as the Company or its designees may request to evidence, confirm or perfect the assignment of all of the Consultant’s or the Individual’s (as applicable) right, title and interest in and to any Inventions in all countries. The Consultant’s and the Individual’s obligation to provide assistance will continue after the termination or expiration of this Agreement. The Consultant and the Individual hereby waive and quitclaim to the Company any and all claims of any nature whatsoever that the Consultant and the Individual may now or hereafter have for infringement of any rights assigned hereunder to the Company. Without the prior written consent of the Company neither the Consultant nor the Individual shall, at any time, file any patent or copyright application with respect to, or claiming, any Inventions.
(c) At the request of the Company the Consultant and/or the Individual will assist the Company (including, without limitation, by executing factually accurate patent applications and assignments of patents or copyrights) to obtain and enforce in any country in the world intellectual property rights relating to Inventions. If and to the extent that, at any time after the Term, the Company requests assistance from the Consultant and/or the Individual with respect to obtaining and enforcing in any country in the world any intellectual property rights relating to Inventions, the Company shall compensate the Consultant and/or the Individual at a reasonable rate for the time actually spent by the Consultant or the Individual on such assistance.
(d) The Company’s title in Inventions and intellectual property rights relating to Inventions shall not extend to any pre-existing products, materials, tools and methodologies that are proprietary to the Consultant or the Individual or to any third parties; or in any intellectual property rights embodied in such products, materials, tools and methodologies by implication, estoppel or otherwise except for the rights expressly granted under this Agreement. Title to all such intellectual property shall remain vested in the Consultant, the Individual or any third party (as applicable). If in the course of performing the Services, the Consultant or the Individual incorporates into any Inventions any other work of authorship, invention, improvement, the Consultant’s or the Individual’s pre-existing products, or proprietary information, or other materials owned by the Consultant or the Individual or in which the Consultant or the Individual has an interest, the Consultant or the Individual, as applicable, will grant and does now hereby grant to the Company a non-exclusive, royalty free, perpetual, irrevocable, worldwide license to reproduce, manufacture, modify, distribute, use, import, and otherwise exploit the material as part of or in connection with the Inventions.
(e) If the Consultant’s or the Individual’s unavailability or any other factor prevents the Company from pursuing or applying for any application for any United States or foreign registrations or applications covering any related rights assigned to Company, then the Consultant or the Individual, as applicable, irrevocably designates and appoints the Company as the Consultant’s or the Individual’s agent and attorney in fact for such limited purpose. Accordingly, the Company may act for and in the Consultant’s or the Individual’s behalf and stead to execute and file any applications in conformance with the terms hereof, and to do all other lawfully permitted acts to further the prosecution and issuance of the registrations and applications with the same legal force and effect as if executed by the Consultant or the Individual, as applicable.
7. No Conflicting Obligation. Each of the Consultant and the Individual represents and warrants to the Company that (i) it is free to enter into this Agreement, (ii) it has and will have all requisite ownership, rights, and licenses to fully perform its obligations under this Agreement and to grant to the Company all rights with respect to any related Inventions and rights to be granted under this Agreement, free and clear of any and all agreements, liens, adverse claims, encumbrances, and interests of any person or entity, (iii) nothing contained in the Inventions or required in order for the Consultant or the Individual to create and deliver the Inventions under this Agreement does or will infringe, violate, or misappropriate any intellectual property rights of any third party, (iv) no characteristic of any Invention does or will cause manufacturing, using, maintaining, or selling the Invention to infringe, violate, or misappropriate the rights of any third party, and (v) its performance of all of the terms of this Agreement and of all of its duties as a consultant to the Company do not and will not breach: (a) any agreement to keep in confidence information acquired by the Consultant or the Individual in confidence or in trust; (b) any agreement to assign to any third party inventions made by the Consultant or the Individual; or (c) any agreement not to compete against the business of any third party. Each of the Consultant and the Individual further represents that it has not made and will not make any agreements in conflict with this Agreement.
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8. Non-Compete. It is accepted and acknowledged that the Consultant and the Individual may have employment, consultancy or business interests other than those of the Company and any Group Company and has declared any conflicts that are apparent at present. In the event that the Consultant or the Individual becomes aware of any potential conflicts of interest, these will be disclosed to the Company as soon as apparent. Each of the Consultant and the Individual agrees that it shall not provide services (whether in the nature of employment services, consulting services or otherwise) to any direct commercial competitor of the Company or any Group Company without the prior written consent of the Company for a period of six (6) months from the expiration or termination of this Agreement.
9. Miscellaneous.
(a) This Agreement represents the entire agreement of the Parties with respect to the arrangements contemplated hereby. No prior agreement, whether written or oral, shall be construed to change, amend, alter, repeal or invalidate this Agreement. This Agreement may be amended only by a written instrument executed in one or more counterparts by the Parties.
(b) No consent to or waiver of any breach or default in the performance of any obligations hereunder shall be deemed or construed to be a consent to or waiver of any other breach or default in the performance of any of the same or any other obligations hereunder. Failure on the part of either Party to complain of any act or failure to act of the other Party or to declare the other Party in default, irrespective of the duration of such failure, shall not constitute a waiver of rights hereunder and no waiver hereunder shall be effective unless it is in writing, executed by the Party waiving the breach or default hereunder. Exercise or enforcement by either Party of any right or remedy under this Agreement will not preclude the enforcement by the Party of any other right or remedy under this Agreement or that the Party is entitled by law to enforce.
(c) This Agreement shall be binding upon and inure to the benefit of the Parties hereto and their respective successors and permitted assigns. This Agreement may be assigned by the Company to any affiliate of the Company and to a successor of its business to which this Agreement relates (whether by purchase or otherwise). Neither this Agreement nor any rights under this Agreement may be assigned or otherwise transferred by the Consultant, in whole or in part, whether voluntarily or by operation of law, without the prior written consent of the Company. Any assignment in violation of the foregoing will be null and void.
(d) Any notice, report, payment or document to be given by one Party to the other shall be in writing and shall be deemed given when delivered personally or on the next business day after transmission (in the case of email delivery of a “.pdf” format data file (provided confirmation of transmission is mechanically or electronically generated and kept on file by the sending party).
(e) This Agreement shall be governed by and construed in accordance with the laws of Belgium, without reference to the principles of conflict of laws. The Belgian courts have non-exclusive jurisdiction to settle any dispute and the parties submit to the non-exclusive jurisdiction of the Belgian courts; provided, however, that neither Party shall commence any such action or proceeding unless prior thereto the parties have in good faith attempted to resolve the claim, dispute or cause of action which is the subject of such action or proceeding through mediation by an independent third party.
(f) Section headings of this Agreement are for reference only and shall not affect its interpretation. In the event that any term, condition or provision of this Agreement should be held invalid, unlawful or unenforceable by a court of competent jurisdiction, such court is hereby authorized to amend such provision so as to be enforceable to the fullest extent permitted by law, and all remaining provisions shall continue in full force without being impaired or invalidated in any way.
(g) The parties agree that any breach or threatened breach of Sections 5, 6 or 8 of this Agreement by the Consultant or the Individual would cause irreparable harm to the Company; and that money damages will not provide an adequate remedy. In the event of a breach or threatened breach of Sections 5, 6 or 8 of this Agreement by the Consultant or the Individual, the Company shall, in addition to any other rights and remedies it may have, be entitled to an injunction restraining the Consultant or the Individual from disclosing or using, in whole or in part, any Confidential Information or Inventions or intellectual property rights relating to Inventions, without the need to post bond.
(h) This Agreement may be executed in counterparts, all of which together shall for all purposes constitute one agreement binding on each of the parties hereto notwithstanding that each such Party shall not have signed the same counterpart.
[Signature page follows]
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IN WITNESS WHEREOF, the Parties have signed this Agreement as of the Effective Date intending it to take effect as an instrument under seal.
VOLITION GLOBAL SERVICES SRL |
| 3F MANAGEMENT SPRL |
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/s/ Terig Hughes |
| /s/ Gaeten Michel |
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By: Terig Hughes |
| By: Gaetan Michel |
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Position: Manager |
| Position: Managing Director |
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Notice Address |
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22 Rue Phocas Lejeune, Parc Scientifique |
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5032 Isnes, |
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Belgium |
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E-Mail: |
| E Mail: |
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| Acknowledged and agreed: |
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| INDIVIDUAL |
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| /s/ Gaeten Michel |
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| Gaetan Michel |
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Exhibit A
Scope of engagement: Consultant
Services to be performed:
During the Term the Consultant shall procure that the Individual shall be responsible for all areas that would be expected from the Chief Executive Officer of Volition Global Services SRL (“VGS”), as reasonably and lawfully directed by the Board of Managers of VGS.
Consulting Fee: |
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Fees: |
| From the Effective Date the Monthly Fee shall be €2,100 EUR payable by the Company to the Consultant, based on the Individual spending sufficient time as is reasonably required in the performance of the Services. |
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Payment terms: |
| The Monthly Fee shall be payable to the account nominated by the Consultant in accordance with the Company’s normal payment practices. |
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EXHIBIT 10.3
VOLITION DIAGNOSTICS UK LIMITED
EMPLOYMENT AGREEMENT
GROUP GENERAL COUNSEL
This Employment Agreement (“Agreement”) is dated August 23, 2021 (“Execution Date”), by and between Volition Diagnostics UK Limited, incorporated and registered in England and Wales with company number 09871726, with its office located at 93-95 Gloucester Place, London, W1U 6JQ (“Company”) and Nick Plummer (“Employee”). The Company and Employee are sometimes referred to herein individually as a “Party” or collectively as the “Parties.
WITNESSETH:
WHEREAS, the Company desires that Employee be employed by the Company, and render services to the Company and its subsidiaries and affiliates, and Employee is willing to be so employed and to render such services, all upon the terms and subject to the conditions contained herein.
WHEREAS, in order to ensure a harmonious ongoing business working relationship among themselves with respect to the conduct pursuant to the terms and conditions outlined in this Employment Agreement, the Parties desire to enter into this Agreement.
AGREEMENT:
NOW, THEREFORE, in consideration of the mutual covenants and agreements contained herein, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree as follows:
1. EMPLOYMENT. Subject to and upon the terms and conditions contained in this Agreement, the Company hereby agrees to employ Employee and Employee agrees to be employed by the Company as of the Commencement Date (as defined below), and, to render to the Company, its affiliates and/or subsidiaries the services described in Section 3 hereof.
2. TERM. Employee’s employment under this Agreement shall commence on such date as agreed between the Parties (the “Commencement Date”) and shall continue until terminated in accordance with the provisions of this Agreement (the “Employment Term”).
3. DUTIES.
(a) Group General Counsel. Employee shall serve as the Group General Counsel of the Company, reporting directly to the Chief Executive Officer of VolitionRx Limited (“VolitionRx”). Employee shall hold such responsibilities and authorities, and shall perform all duties and services incident to the position held by him.
(b) Company Policies. Employee agrees to abide by all bylaws and policies of the Company and its affiliates and/or subsidiaries promulgated from time to time by the Company and/or such entities as well as all laws, statutes and regulations.
(c) Place of Work. The normal place of work for the Employee shall be from his home in the U.K., or from such other location as mutually agreed upon between the Company and the Employee. From time to time, the Employee will be required to attend management meetings at the Company’s affiliates’ offices in Belgium, Singapore, London and/or the U.S. (or such other location identified by the Company from time to time) and to be available for domestic and international travel as the Company’s business reasonably requires.
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5. COMPENSATION. For the duration of the Employment Term and as compensation for his services and covenants hereunder, Employee shall receive:
(a) Salary. Employee’s base salary shall be Two Hundred Thousand Pounds Sterling (£200,000) per year (“Base Salary”). The Base Salary shall be payable in equal monthly instalments in Pounds Sterling in accordance with the Company’s standard payroll practices and policies for employees. The Base Salary shall be reviewed annually, and any increases will be approved by the VolitionRx Board of Directors or its Compensation Committee, and the Board of the Company.
(b) Signing Bonus. The Employee shall receive a one-time special signing bonus in an amount equal to Sixteen Thousand Six Hundred Sixty Seven Pounds Sterling (£16,667), subject to the Employee confirming his Commencement Date as agreed upon by the Company, which date shall be within 3 months of the Execution Date of this Agreement. The signing bonus shall be payable in lump sum in cash, less all applicable withholdings, within 15 days of the Employee advising the Company in writing of his Commencement Date and acceptance thereof by the Company. Any signing bonus paid by the Company shall be repaid by the Employee if (i) he does not commence his employment on the Commencement Date, or such revised Commencement Date approved by the Company that is within 3 months from the Execution Date of this Agreement; or (ii) if either the Employee leaves the Company for any or no reason, or the Company terminates the Agreement pursuant to Section 9(a), within 3 months of the Commencement Date.
(c) Stock. The Employee shall be granted Restricted Stock Units (RSUs) to receive such number shares of common stock of VolitionRx underlying the RSUs corresponding in value to £100,000, based on the closing price of VolitionRx’s shares on the NYSE American on the Execution Date of this Agreement. The RSUs shall be granted on or about the Commencement Date and shall vest in two equal installments at 12 months and at 24 months from the grant date, as more specifically provided in the Schedules. The RSUs shall be governed by the terms and conditions of the VolitionRx 2015 Stock Incentive Plan (the “Plan”), the Notice of Restricted Stock Unit Award attached as Schedule 1, and Restricted Stock Unit Agreement attached as Schedule 2.
(d) Incentive Plans. During the Employment Term, the Employee shall also be eligible to participate in other employee incentive plans of VolitionRx and/or the Company, if any. The criteria for determining the amount of any allocations to the Employee under such incentive plans for employees, including the criteria for determining the amount of any award, and the conditions that must be satisfied to entitle Employee to receive such award for any year during the term of this Agreement shall be determined, in the sole discretion of the VolitionRx Board of Directors, its Compensation Committee or the Company’s Board, as applicable.
(e) Pension. Subject to the Company’s compliance with its pension duties in accordance with Part 1 of the Pensions Act 2008, the Company will pay the amount otherwise payable to the Employee under the Company’s pension scheme (currently 5% of the Employee’s Base Salary) to the Employee in cash as a separate allowance to be paid together with his monthly salary.
6. EXPENSES. Employee shall be reimbursed for business expenses incurred by him which are reasonable and necessary for Employee to perform his duties under this Agreement, subject to the production of receipts or other appropriate evidence of payment. In claiming expenses, the Employee shall comply with the Company’s Travel and Expenses Policy or any other Expenses Policies implemented by the Company (as amended from time to time), copies of which will be provided.
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7. EMPLOYEE BENEFITS.
(a) Paid Time Off (PTO). Employee shall be entitled to 25 days paid vacation (excluding public holidays) on an annual basis in accordance with the Company’s policies, as may be established from time to time by the Company for its employees, which shall be taken at such time or times as shall be mutually agreed upon by the Parties. The Employee shall not carry forward any accrued but untaken vacation entitlement to a subsequent calendar year, except as set out in the holiday policy of the Company’s Employee Handbook (as amended from time to time), a copy of which will be provided.
(b) Insurance. During the Employment Term, Employee shall be eligible to participate in the Company’s Group Life Assurance and Critical Illness Scheme. Subject to the terms of the relevant insurance policy (as may be amended from time to time at the Company’s discretion or otherwise), (i) the Group Life Assurance Scheme shall pay your dependents a sum equal to four times (4x) times your Base Salary if you die during the Employment Term; and (ii) the Critical Illness Scheme shall pay up to seventy five percent (75%) of your Base Salary in the event of a covered incapacity. The Employee shall further be entitled to participate in such other group term insurance, disability insurance, health and medical insurance benefits, life insurance and retirement plans or programs as are from time to time generally made available to executive employees of the Company pursuant to the policies of the Company. The Employee’s eligibility to participate in the aforementioned schemes is subject to the Employee complying with the conditions attendant to coverage by such plans, and the Employee shall comply with and be entitled to benefits only to the extent former employees are eligible to participate in such arrangements pursuant to the terms of the arrangement, any insurance policy associated therewith and applicable law, and, further, shall be entitled to benefits only in accordance with the terms and conditions of such plans. The Company may withhold from any benefits payable to Employee all taxes and amounts as shall be permitted or required to be withheld pursuant to any applicable law, rule or regulation. Further, the Company may amend, modify or rescind any benefit plan or program and change contribution amounts to benefit costs without notice in its discretion. Employee shall further be subject to the indemnification by-laws policies and/or procedures applicable to senior officers of the Company and shall be included in the Directors & Officers insurance policies maintained by VolitionRx.
8. DEATH AND DISABILITY.
(a) Death. The Employment Term shall terminate on the date of Employee’s death, in which event the Company shall, within 30 days of the date of death, pay to his estate, any unpaid Base Salary earned up to the date of death, outstanding reimbursable expenses, accrued and unused vacation time, and any vested benefits expressly payable in accordance with the applicable plan or program owing to Employee through to the date of Employee’s death. Employee will not be entitled to any other compensation upon termination of his employment pursuant to this Section 8(a).
(b) Disability. To the extent permitted by law, the Employment Term shall terminate upon Employee’s Disability. For purposes of this Agreement, “Disability” shall mean that Employee is unable to engage in any substantial gainful activity by reason of any medically determinable physical or mental impairment which can be expected to result in death or can be expected to last for a continuous period of not less than 6 months, or 150 non-consecutive days in any 12-month period. The existence of a Disability shall be determined by a qualified physician nominated by the Company in consultation with Employee. In case of such termination, Employee shall be entitled to receive his unpaid Base Salary earned up to the date of the Company’s determination of Employee’s Disability, outstanding reimbursable expenses and accrued and unused vacation or PTO time, and any vested benefits expressly payable in accordance with the applicable plan or program owing to Employee through the date of termination, which amounts shall be paid within 30 days of the date of the Company’s determination of Employee’s Disability. Employee will not be entitled to any other compensation upon termination of his employment pursuant to this Section 8(b).
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9. TERMINATION OF EMPLOYMENT.
(a) Termination With Cause By Company. The Company may terminate this Agreement at any time during the Employment Term for “Cause” upon written notice to Employee, upon which termination shall be effective immediately. For purposes of this Agreement, “Cause” means the following:
| i. | Willful and material failure to adhere to the Company’s and/or its affiliates’ and subsidiaries’ bylaws or written policies, or lawful directives of the Board of the Company or Chief Executive Officer of VolitionRx, provided Employee shall be given no less than fifteen (15) business days to cure the same after written notice of any failure, if curable in the reasonable discretion of the Company; |
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| ii. | Misappropriation (or attempted misappropriation) of any non-trivial Company and/or its affiliates and/or subsidiaries property or funds; |
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| iii. | Conviction of, or the entry of a guilty plea or plea of no contest with respect to, any felony involving moral turpitude; and |
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| iv. | Violation of a fiduciary duty to the Company or its equityholders. |
(c) Termination By Employee. Employee may terminate this Agreement at any time by providing the Company three (3) months written notice, with or without any reason.
(d) Compensation upon Termination. Upon termination pursuant to this Section 9, Employee shall be entitled to all accrued and unpaid compensation earned as of the date of termination, including Base Salary, outstanding reimbursable expenses, accrued and unused vacation or PTO time, and any vested benefits expressly payable in accordance with the applicable plan or program. Employee shall also receive any awarded and unpaid bonus for a prior completed year, if not yet paid as of the termination date, within 30 days of the termination date.
10. DISCLOSURE OF TRADE SECRETS AND OTHER PROPRIETARY INFORMATION; RESTRICTIVE COVENANTS.
(a) Employee acknowledges that he is prohibited from directly or indirectly disclosing any confidential information about the Company, its affiliates and/or subsidiaries or companies with whom the Company, its affiliates and/or subsidiaries do business, including but not limited to trade secrets, formulas, and financial information, to any party who is not a director, officer or authorized agent of the Company or its subsidiaries and affiliates. The Company will provide Employee with valuable confidential information belonging to the Company or its subsidiaries or its affiliates above and beyond any confidential information previously received by Employee and will associate Employee with the goodwill of the Company or its subsidiaries or its affiliates above and beyond any prior association of Employee with that goodwill. In return, Employee promises never to disclose or misuse such confidential information and never to misuse such goodwill.
(b) Employee will not, during the Employment Term and for a period of six (6) months thereafter, on his behalf or on behalf of any other business enterprise, directly or indirectly, under any circumstance other than at the direction and for the benefit of the Company, its affiliates and/or subsidiaries, (i) solicit for employment or hire any person employed by the Company or any of its subsidiaries or affiliates, or (ii) call on, solicit, or take away any person or entity who was a customer of the Company or any of its subsidiaries or affiliates during Employee’s employment with the Company, in either case for a business that is competitive with the business of the Company, its affiliates and/or subsidiaries. This restriction shall not prevent Employee from soliciting or doing business with any customer with whom he had a pre-existing business relationship and which is identified to the Company in a written list provided by Employee at termination of employment.
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(c) It is expressly agreed by Employee that the nature and scope of each of the provisions set forth above are reasonable and necessary. If, for any reason, any aspect of the above provisions as it applies to Employee is determined by a court of competent jurisdiction to be unreasonable or unenforceable under applicable law, the provisions shall be modified to the extent required to make the provisions enforceable. Employee acknowledges and agrees that his services are of unique character and expressly grants to the Company or any subsidiary or affiliate of the Company or any successor of any of them, the right to enforce the above provisions through the use of all remedies available at law or in equity, including, but not limited to, injunctive relief.
11. COMPANY PROPERTY.
(a) Any patents, inventions, discoveries, applications, processes, models or financial statements designed, devised, planned, applied, created, discovered or invented by Employee during the Employment Term, regardless of when reduced to writing or practice, which pertain to any aspect of the Company’s or its subsidiaries’ or affiliates’ business as described above shall be the sole and absolute property of the Company, and Employee shall promptly report the same to the Company and promptly execute any and all documents that may from time to time reasonably be requested by the Company to assure the Company the full and complete ownership thereof.
(b) All records, files, lists, including computer generated lists, drawings, documents, equipment and similar items relating to the Company’s, its affiliates’ and/or subsidiaries’ business which Employee shall prepare or receive from the Company shall remain the Company’s, its affiliates’ and/or subsidiaries’ sole and exclusive property. Upon termination of this Agreement, Employee shall promptly return to the Company all property of the Company, its affiliates and/or subsidiaries in his possession. Employee may retain copies of documents evidencing his terms of employment, compensation, or related to his status as an equityholder of the Company.
12. EQUITABLE RELIEF. It is mutually understood and agreed that Employee’s services are special, unique, unusual, extraordinary and of an intellectual character giving them a peculiar value, the loss of which cannot be reasonably or adequately compensated in damages in an action at law. Accordingly, in the event of any breach of this Agreement by Employee, including, but not limited to, the breach of any of the provisions of Sections 10 or 11 hereof, the Company shall be entitled to equitable relief by way of injunction or otherwise in addition to any damages which the Company may be entitled to recover. In the event of any breach of this Agreement by Company the Employee shall be entitled to equitable relief by way of injunction or otherwise in addition to any damages which the Employee may be entitled to recover.
13. APPLICABLE LAW AND DISPUTES. This Agreement and any dispute or claim arising out of or in connection with it or its subject matter or formation (including non-contractual disputes or claims) shall be governed by and construed in accordance with the law of England and Wales. In any dispute with the Company, the Employee will not raise, and hereby expressly waives, any objection or defense to any such jurisdiction as an inconvenient forum.
14. NOTICE. Except as otherwise expressly provided, any notice, request, demand or other communication permitted or required to be given under this Agreement shall be in writing, shall be deemed conclusively to have been given: (a) upon receipt, when delivered personally; (b) upon receipt when sent by facsimile or email delivery of a “.pdf” format data file (provided confirmation of transmission is mechanically or electronically generated and kept on file by the sending party; (c) on the third business day following the day timely deposited with Federal Express (or other equivalent international courier), with the cost of delivery prepaid or for the account of the sender; (d) on the seventh business day following the day duly sent by certified or registered mail, postage prepaid; or (e) when otherwise actually received by the addressee on a business day (or on the next business day if received after the close of normal business hours or on any non-business day).
15. INTERPRETATION; HEADINGS. The parties acknowledge and agree that the terms and provisions of this Agreement have been negotiated, shall be construed fairly as to all parties hereto, and shall not be construed in favor of or against any party. The section headings contained in this Agreement are for reference purposes only and shall not affect the meaning or interpretation of this Agreement.
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16. SUCCESSORS AND ASSIGNS; ASSIGNMENT; INTENDED BENEFICIARIES. Neither this Agreement, nor any of Employee’s rights, powers, duties or obligations hereunder, may be assigned by Employee. This Agreement shall be binding upon and inure to the benefit of Employee and his heirs and legal representatives and the Company and its successors. Successors of the Company shall include, without limitation, any corporation or corporations acquiring, directly or indirectly, all or substantially all of the assets of the Company, whether by merger, consolidation, purchase, lease or otherwise, and such successor shall thereafter be deemed “the Company” for the purpose hereof.
17. NO WAIVER BY ACTION. Any waiver or consent from the Company respecting any term or provision of this Agreement or any other aspect of the Employee’s conduct or employment shall be effective only in the specific instance and for the specific purpose for which given and shall not be deemed, regardless of frequency given, to be a further or continuing waiver or consent. The failure or delay of the Company at any time or times to require performance of, or to exercise any of its powers, rights or remedies with respect to, any term or provision of this Agreement or any other aspect of the Employee’s conduct or employment in no manner (except as otherwise expressly provided herein) shall affect the Company’s right at a later time to enforce any such term or provision.
18. COUNTERPARTS; JURISDICTION; AMENDMENTS; ENTIRE AGREEMENT; SEVERABILITY; SURVIVAL OF TERMS. This Agreement may be executed in two counterpart copies, each of which may be executed by one of the parties hereto, but all of which, when taken together, shall constitute a single agreement binding upon all of the parties hereto. Each party irrevocably agrees that the courts of England and Wales shall have exclusive jurisdiction to settle any dispute or claim arising out of or in connection with this agreement or its subject matter or formation (including non-contractual disputes or claims). Each and every modification and amendment of this Agreement shall be in writing and signed by the parties hereto, and any waiver of, or consent to any departure from, any term or provision of this Agreement shall be in writing and signed by each affected party hereto. This Agreement contains the entire agreement of the parties and supersedes all prior representations, agreements and understandings, oral or otherwise, between the parties with respect to the matters contained herein, including but not limited to any written offer letter or letter agreement concerning employment. In the event of any conflict, the terms of this Agreement shall control. The invalidity or unenforceability of any provision of this Agreement shall not affect the validity or enforceability of any other provision of this Agreement, which shall remain in full force and effect. Sections 10 through 19 shall survive any termination of this Agreement and the termination of Employee’s employment.
19. TAX AND DEDUCTION. All payments to Employee pursuant to this Agreement are subject to applicable tax, withholding and deduction requirements based on the country of Employee’s service.
[Signature page follows.]
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SIGNATURES
IN WITNESS WHEREOF, the Parties hereto have executed this Agreement as of the date set forth above.
By: | By: | |||
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(“COMPANY”) |
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Volition Diagnostics UK Limited |
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| Nick Plummer |
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/s/ Cameron Reynolds | /s/ Nick Plummer | |||
By: Cameron Reynolds | By: Nick Plummer | |||
Its: Chief Executive Officer |
[Signature Page to Volition Diagnostics UK Limited Employment Agreement – Group General Counsel]
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SCHEDULE 1
RESTRICTED STOCK UNIT AWARD
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NOTICE OF RESTRICTED STOCK UNIT AWARD
VOLITIONRX LIMITED
2015 STOCK INCENTIVE PLAN
Unless otherwise defined herein, the terms defined in the VolitionRx Limited (the “Company”) 2015 Stock Incentive Plan (the “Plan”) shall have the same meanings in this Notice of Restricted Stock Unit Award (the “Notice”) and the attached Restricted Stock Unit Agreement (the “RSU Agreement”). You have been granted an award of Restricted Stock Units (“RSUs”) under the Plan subject to the terms and conditions of the Plan, this Notice and the attached RSU Agreement.
| Name: | Nick Plummer |
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| Number of RSUs: | [Such number of RSUs equivalent to £100,000, based on the closing price of VolitionRx’s shares on the NYSE American on the Execution Date of the Employment Agreement] |
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| Date of Grant: | [Commencement Date of Employment Agreement] |
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| Vesting Commencement Date: | [12 months from Commencement Date} |
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| Expiration Date: | The date on which settlement of all RSUs granted hereunder occurs. This RSU expires earlier if your Service terminates earlier, as described in the RSU Agreement. |
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| Vesting Schedule: | Subject to your continued Service through the applicable vesting date, one-half (1/2) of the Shares underlying the RSUs shall vest on the Vesting Commencement Date, and one-half (1/2) of the Shares underlying the RSUs shall vest twelve (12) months after the Vesting Commencement Date. |
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| Additional Terms: | ☐ If this box is checked, the additional terms and conditions set forth on Attachment 1 hereto (as executed by the Company) are applicable and are incorporated herein by reference. No document need be attached as Attachment 1 if the box is not checked. |
You acknowledge that the vesting of the RSUs pursuant to this Notice is earned only by continuing Service. By accepting this award, you and the Company agree that this award is granted under and governed by the terms and conditions of the Plan, the Notice and the RSU Agreement. You acknowledge and agree that the Vesting Schedule may change prospectively in the event that your Service status changes between full and part-time status in accordance with Company policies relating to work schedules and vesting of awards. You further acknowledge that the grant of this RSU by the Company is at the Company’s sole discretion, and does not entitle you to further grant(s) of RSU(s) or any other award(s) under the Plan or any other plan or program maintained by the Company or any Parent, Subsidiary or Affiliate of the Company. By accepting this RSU, you consent to electronic delivery as set forth in the RSU Agreement.
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| VOLITIONRX LIMITED |
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SCHEDULE 2
RESTRICTED STOCK UNIT AGREEMENT
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RESTRICTED STOCK UNIT AGREEMENT
VOLITIONRX LIMITED
2015 STOCK INCENTIVE PLAN
You have been granted Restricted Stock Units (“RSUs”) by VolitionRx Limited (the “Company”) subject to the terms, restrictions and conditions of the Plan, the Notice of Restricted Stock Unit Award (the “Notice”) and this Restricted Stock Unit Agreement (this “RSU Agreement”).
1. Settlement. Settlement of RSUs shall be made in the same calendar year as the applicable date of vesting under the vesting schedule set forth in the Notice; provided, however, that if the vesting date under the vesting schedule set forth in the Notice is in December, then settlement of any RSUs that vest in December shall be within 30 days of vesting. Settlement of RSUs shall be in Shares. Settlement means the delivery of the Shares vested under an RSU. No fractional RSUs or rights for fractional Shares shall be created pursuant to this RSU Agreement.
2. No Stockholder Rights. Unless and until such time as Shares are issued in settlement of vested RSUs, you shall have no ownership of the Shares allocated to the RSUs and shall have no right to dividends or to vote such Shares.
3. Dividend Equivalents. Dividends, if any (whether in cash or Shares), shall not be credited to you.
4. No Transfer. RSUs may not be sold, assigned, transferred, pledged, hypothecated, or otherwise disposed of in any manner other than by will or by the laws of descent or distribution or court order or unless otherwise permitted by the Committee on a case-by-case basis.
5. Termination. If your Service terminates for any reason, all unvested RSUs shall be forfeited to the Company forthwith, and all rights you have to such RSUs shall immediately terminate. In case of any dispute as to whether your termination of Service has occurred, the Committee shall have sole discretion to determine whether such termination has occurred and the effective date of such termination.
6. Construction. This RSU Agreement is the result of negotiations between and has been reviewed by each of the parties hereto and their respective counsel, if any; accordingly, this RSU Agreement shall be deemed to be the product of all of the parties hereto, and no ambiguity shall be construed in favor of or against any one of the parties hereto.
7. Notices. Any notice to be given under the terms of the Plan shall be addressed to the Company in care of its principal office, and any notice to be given to you shall be addressed to you at the address maintained by the Company for such person or at such other address as you may specify in writing to the Company.
8. Counterparts. This RSU Agreement may be executed in two or more counterparts, each of which shall he deemed an original and all of which together shall constitute one instrument.
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9. Tax Consequences. You acknowledge that you will recognize tax consequences in connection with the RSUs. You should consult a tax adviser regarding your tax obligations in the jurisdiction where you are subject to tax.
(a) U.S. Tax Consequences. You will not recognize taxable income when you are granted or vest in the RSUs. In general, the RSUs will be taxed when they are settled and you will recognize ordinary income equal to the value of the Shares that you receive from the Company.
10. Withholding Taxes and Stock Withholding. Regardless of any action the Company or your actual employer (the “Employer”) takes with respect to any or all income tax, social insurance, payroll tax, payment on account or other tax-related withholding (“Tax-Related Items”), you acknowledge that the ultimate liability for all Tax-Related Items legally due by you is and remains your responsibility and that the Company and/or the Employer (1) make no representations or undertakings regarding the treatment of any Tax-Related Items in connection with any aspect of the award, including the grant, vesting or settlement of the RSUs, the subsequent sale of Shares acquired pursuant to such settlement and the receipt of any dividends; and (2) do not commit to structure the terms of the award or any aspect of the RSUs to reduce or eliminate your liability for Tax-Related Items. You acknowledge that if you are subject to Tax-Related Items in more than one jurisdiction, the Company and/or the Employer may be required to withhold or account for Tax-Related Items in more than one jurisdiction.
Prior to the settlement of your RSUs, you shall pay or make adequate arrangements satisfactory to the Company and/or the Employer to satisfy all withholding and payment on account obligations of the Company and/or the Employer. In this regard, you authorize the Company and/or the Employer to withhold all applicable Tax-Related Items legally payable by you from your wages or other cash compensation paid to you by the Company and/or the Employer. With the Company’s consent, these arrangements may also include, if permissible under local law, (a) withholding Shares that otherwise would be issued to you when your RSUs are settled, provided that the Company only withholds the amount of Shares necessary to satisfy the minimum statutory withholding amount, (b) having the Company withhold taxes from the proceeds of the sale of the Shares, either through a voluntary sale or through a mandatory sale arranged by the Company (on your behalf and you hereby authorize such sales by this authorization), (c) your payment of a cash amount, or (d) any other arrangement approved by the Company; all under such rules as may be established by the Committee and in compliance with the Company’s Insider Trading Policy and 10b5-1 Trading Plan Policy, if applicable; provided however, that if you are a Section 16 officer of the Company under the Exchange Act, then the Committee (as constituted in accordance with Rule 16b-3 under the Exchange Act) shall establish the method of withholding from alternatives (a)-(d) above, and the Committee shall establish the method prior to the Tax-Related Items withholding event. The Fair Market Value of these Shares, determined as of the effective date when taxes otherwise would have been withheld in cash, will be applied as a credit against the withholding taxes. You shall pay to the Company or the Employer any amount of Tax-Related Items that the Company or the Employer may be required to withhold as a result of your participation in the Plan or your purchase of Shares that cannot be satisfied by the means previously described. Finally, you acknowledge that the Company has no obligation to deliver Shares to you until you have satisfied the obligations in connection with the Tax-Related Items as described in this Section.
11. Acknowledgement. The Company and you agree that the RSUs are granted under and governed by the Notice, this RSU Agreement and the provisions of the Plan (incorporated herein by reference). You: (a) acknowledge receipt of a copy of the Plan and the Plan prospectus, (b) represent that you have carefully read and are familiar with their provisions, and (c) hereby accept the RSUs subject to all of the terms and conditions set forth herein and those set forth in the Plan and the Notice. You hereby agree to accept as binding, conclusive and final all decisions or interpretations of the Committee upon any questions relating to the Plan, the Notice and this RSU Agreement.
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12. Entire Agreement; Enforcement of Rights. This RSU Agreement, the Plan and the Notice constitute the entire agreement and understanding of the parties relating to the subject matter herein and supersede all prior discussions between them. Any prior agreements, commitments or negotiations concerning the purchase of the Shares hereunder are superseded. No modification of or amendment to this RSU Agreement, nor any waiver of any rights under this RSU Agreement, shall be effective unless in writing and signed by the parties to this RSU Agreement. The failure by either party to enforce any rights under this RSU Agreement shall not be construed as a waiver of any rights of such party.
13. Compliance with Laws and Regulations. The issuance of Shares will be subject to and conditioned upon compliance by the Company and you with all applicable state, federal and foreign laws and regulations and with all applicable requirements of any stock exchange or automated quotation system on which the Company’s Common Stock may be listed or quoted at the time of such issuance or transfer. The Shares issued pursuant to this RSU Agreement shall be endorsed with appropriate legends, if any, determined by the Company.
14. Governing Law; Severability. If one or more provisions of this RSU Agreement are held to be unenforceable under applicable law, the parties agree to renegotiate such provision in good faith. In the event that the parties cannot reach a mutually agreeable and enforceable replacement for such provision, then (a) such provision shall be excluded from this RSU Agreement, (b) the balance of this RSU Agreement shall be interpreted as if such provision were so excluded and (c) the balance of this RSU Agreement shall be enforceable in accordance with its terms. This RSU Agreement and all acts and transactions pursuant hereto and the rights and obligations of the parties hereto shall be governed, construed and interpreted in accordance with the laws of the State of Delaware, without giving effect to principles of conflicts of law. For purposes of litigating any dispute that may arise directly or indirectly from the Plan, the Notice and this RSU Agreement, the parties hereby submit and consent to litigation in the exclusive jurisdiction of the State of New York and agree that any such litigation shall be conducted only in the courts of New York in New York County or the federal courts of the United States for the Southern District of New York and no other courts.
15. No Rights as Employee, Director or Consultant. Nothing in this RSU Agreement shall affect in any manner whatsoever the right or power of the Company, or a Parent, Subsidiary or Affiliate of the Company, to terminate your Service, for any reason, with or without Cause.
16. Consent to Electronic Delivery of All Plan Documents and Disclosures. By your acceptance of this RSU, you consent to the electronic delivery of the Notice, this RSU Agreement, the Plan, account statements, Plan prospectuses required by the Securities and Exchange Commission, U.S. financial reports of the Company, and all other documents that the Company is required to deliver to its security holders (including, without limitation, annual reports and proxy statements) or other communications or information related to the RSU. Electronic delivery may include the delivery of a link to a Company intranet or the internet site of a third party involved in administering the Plan, the delivery of the document via e-mail or such other delivery determined at the Company’s discretion. You acknowledge that you may receive from the Company a paper copy of any documents delivered electronically at no cost if you contact the Company by telephone, through a postal service or electronic mail at notice@volition.com. You further acknowledge that you will be provided with a paper copy of any documents delivered electronically if electronic delivery fails; similarly, you understand that you must provide on request to the Company or any designated third party a paper copy of any documents delivered electronically if electronic delivery fails. Also, you understand that your consent may be revoked or changed, including any change in the electronic mail address to which documents are delivered (if you have provided an electronic mail address), at any time by notifying the Company of such revised or revoked consent by telephone, postal service or electronic mail at notice@volition.com. Finally, you understand that you are not required to consent to electronic delivery.
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17. Code Section 409A. For purposes of this RSU Agreement, a termination of employment will be determined consistent with the rules relating to a “separation from service” as defined in Section 409A of the Internal Revenue Code and the regulations thereunder (“Section 409A”). Notwithstanding anything else provided herein, to the extent any payments provided under this RSU Agreement in connection with your termination of employment constitute deferred compensation subject to Section 409A, and you are deemed at the time of such termination of employment to be a “specified employee” under Section 409A, then such payment shall not be made or commence until the earlier of (a) the expiration of the six-month period measured from your separation from service or (b) the date of your death following such a separation from service; provided, however, that such deferral shall only be effected to the extent required to avoid adverse tax treatment to you including, without limitation, the additional tax for which you would otherwise be liable under Section 409A(a)(1)(B) in the absence of such a deferral. To the extent any payment under this RSU Agreement may be classified as a “short-term deferral” within the meaning of Section 409A, such payment shall be deemed a short-term deferral, even if it may also qualify for an exemption from Section 409A under another provision of Section 409A. Payments pursuant to this Section are intended to constitute separate payments for purposes of Section 1.409A-2(b)(2) of the Treasury Regulations.
18. Adjustment. In the event of a stock split, a stock dividend or a similar change in Company stock, the number of Shares covered by the RSUs may be adjusted pursuant to the Plan.
19. Lock-Up Agreement. Upon request of the Company or the underwriters managing any underwritten offering of the Company’s securities, you hereby agree not to sell, make any short sale of, loan, grant any option for the purchase of, or otherwise dispose of any securities of the Company however and whenever acquired (other than those included in the registration) without the prior written consent of the Company or such underwriters, as the case may be, for such period of time (not to exceed one hundred eighty (180) days) from the effective date of such registration as may be requested by the Company or such managing underwriters and to execute an agreement reflecting the foregoing as may be requested by the underwriters at the time of the public offering; provided however that, if during the last seventeen (17) days of the restricted period the Company issues an earnings release or material news or a material event relating to the Company occurs, or prior to the expiration of the restricted period the Company announces that it will release earnings results during the sixteen (16)-day period beginning on the last day of the restricted period, then, upon the request of the managing underwriter, to the extent required by any FINRA rules, the restrictions imposed by this Section shall continue to apply until the end of the third trading day following the expiration of the fifteen (15)-day period beginning on the issuance of the earnings release or the occurrence of the material news or material event. In no event will the restricted period extend beyond two hundred sixteen (216) days after the effective date of the registration statement.
20. Award Subject to Company Clawback or Recoupment. To the extent permitted by applicable law, the RSUs shall be subject to clawback or recoupment pursuant to any compensation clawback or recoupment policy adopted by the Board or required by law during the term of your employment or other Service that is applicable to you. In addition to any other remedies available under such policy, applicable law may require the cancellation of your RSUs (whether vested or unvested) and the recoupment of any gains realized with respect to your RSUs.
BY ACCEPTING THIS RSU, YOU AGREE TO ALL OF THE TERMS AND CONDITIONS DESCRIBED ABOVE AND IN THE PLAN.
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EXHIBIT 31.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Cameron Reynolds, certify that:
1. | I have reviewed this quarterly report on Form 10-Q of VolitionRx Limited; |
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2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
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3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
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4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
| (a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
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| (b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
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| (c) | Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
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| (d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent function): |
| (a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
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| (b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: November 10, 2021 | /s/ Cameron Reynolds |
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| Cameron Reynolds |
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| President and Chief Executive Officer |
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| (Principal Executive Officer) |
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EXHIBIT 31.2
CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Terig Hughes, certify that:
1. | I have reviewed this quarterly report on Form 10-Q of VolitionRx Limited; |
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2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
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3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
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4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
| (a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
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| (b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
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| (c) | Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
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| (d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent function): |
| (a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
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| (b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: November 10, 2021 | /s/ Terig Hughes |
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| Terig Hughes |
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| Chief Financial Officer and Treasurer |
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| (Principal Financial and Accounting Officer) |
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EXHIBIT 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
The following certifications are hereby made in connection with the Quarterly Report on Form 10-Q of VolitionRx Limited (the “Company”) for the quarterly period ended September 30, 2021, as filed with the Securities and Exchange Commission on the date hereof (the “Report”):
I, Cameron Reynolds, President and Chief Executive Officer of the Company, hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to my knowledge, (i) the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, and (ii) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of the dates and for the periods presented.
Date: November 10, 2021 | /s/ Cameron Reynolds |
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| Cameron Reynolds |
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| President and Chief Executive Officer |
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| (Principal Executive Officer) |
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I, Terig Hughes, Chief Financial Officer and Treasurer of the Company, hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to my knowledge, (i) the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, and (ii) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of the dates and for the periods presented.
Date: November 10, 2021 | /s/ Terig Hughes |
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| Terig Hughes |
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| Chief Financial Officer and Treasurer |
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| (Principal Financial and Accounting Officer) |
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Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares |
Sep. 30, 2021 |
Dec. 31, 2020 |
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STOCKHOLDERS' EQUITY | ||
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares par value | $ 0.001 | $ 0.001 |
Common stock, shares issued | 53,223,761 | 48,607,017 |
Common stock, shares outstanding | 53,223,761 | 48,607,017 |
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) |
3 Months Ended | 9 Months Ended | ||
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Sep. 30, 2021 |
Sep. 30, 2020 |
Sep. 30, 2021 |
Sep. 30, 2020 |
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Revenues | ||||
Royalty | $ 0 | $ 0 | $ 0 | $ 2,112 |
Product | 25,483 | 575 | 75,795 | 4,201 |
Total Revenues | 25,483 | 575 | 75,795 | 6,313 |
Operating Expenses | ||||
Research and development | 4,445,877 | 3,180,177 | 11,968,424 | 10,567,988 |
General and administrative | 2,426,854 | 1,080,308 | 6,053,613 | 4,292,666 |
Sales and marketing | 715,044 | 244,510 | 1,601,816 | 734,355 |
Total Operating Expenses | 7,587,775 | 4,504,995 | 19,623,853 | 15,595,009 |
Operating Loss | (7,562,292) | (4,504,420) | (19,548,058) | (15,588,696) |
Other Income (Expenses) | ||||
Grant income | 419,271 | 0 | 810,803 | 98,870 |
Gain / ( Loss) on disposal of fixed assets | 0 | 200,393 | (26,167) | 293,595 |
Interest income | 290 | 2,801 | 2,503 | 48,956 |
Interest expense | (38,767) | (34,722) | (120,636) | (91,105) |
Total Other Income | 380,794 | 168,472 | 666,503 | 350,316 |
Net Loss | (7,181,498) | (4,335,948) | (18,881,555) | (15,238,380) |
Net Loss attributable to Non-Controlling Interest | 45,065 | 8,050 | 102,028 | 23,396 |
Net Loss attributable to VolitionRx Limited Stockholders | (7,136,433) | (4,327,898) | (18,779,527) | (15,214,984) |
Other Comprehensive (Loss) / Income | ||||
Foreign currency translation adjustments | (20,875) | (573,397) | 68,710 | (273,791) |
Net Comprehensive Loss | $ (7,202,373) | $ (4,909,345) | $ (18,812,845) | $ (15,512,171) |
Net Loss Per Share - Basic and Diluted attributable to VolitionRx Limited | $ (0.13) | $ (0.09) | $ (0.36) | $ (0.34) |
Weighted Average Shares Outstanding | ||||
- Basic and Diluted | 53,166,781 | 47,027,011 | 52,355,681 | 44,148,793 |
Basis of Presentation and Summary of Significant Accounting Policies |
9 Months Ended |
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Sep. 30, 2021 | |
Basis of Presentation and Summary of Significant Accounting Policies | |
Note 1 - Basis of Presentation and Summary of Significant Accounting Policies | Note 1 – Basis of Presentation and Summary of Significant Accounting Policies
Basis of Presentation
The interim consolidated financial statements of VolitionRx Limited (the “Company”, "VolitionRx," "we" or "us") for the three and nine months ended September 30, 2021 and September 30, 2020, respectively, are not audited. Our consolidated financial statements are prepared in accordance with the requirements for unaudited interim periods and, consequently, do not include all disclosures required to be made in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). In the opinion of our management, the accompanying consolidated financial statements contain all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation of our financial position as of September 30, 2021, and our results of operations and cash flows for the periods ended September 30, 2021 and September 30, 2020, respectively. The results of operations for the periods ended September 30, 2021 and September 30, 2020, respectively, are not necessarily indicative of the results for a full-year period. These interim consolidated financial statements should be read in conjunction with the financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2020, which was filed with the Securities and Exchange Commission (the "SEC") on March 22, 2021.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. The Company also regularly evaluates estimates and assumptions related to deferred income tax asset valuation allowances, useful lives of property and equipment and intangible assets, borrowing rate used in operating lease right-of-use asset and liability valuations, impairment analysis of intangible assets, and valuations of stock-based compensation.
The Company bases its estimates and assumptions on current facts, historical experience and various other factors that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the accrual of costs and expenses that are not readily apparent from other sources. The actual results experienced by the Company may differ materially and adversely from the Company’s estimates. To the extent there are material differences between the estimates and the actual results, future results of operations could be affected.
Principles of Consolidation
The accompanying condensed consolidated financial statements for the period ended September 30, 2021 include the accounts of the Company and its subsidiaries. The Company has two wholly-owned subsidiaries Singapore Volition Pte. Limited (“Singapore Volition”) and Volition Global Services SRL (“Volition Global”). Singapore Volition has one wholly-owned subsidiary, Belgian Volition SRL (“Belgian Volition”). Belgian Volition has four subsidiaries, Volition Diagnostics UK Limited (“Volition Diagnostics”), Volition America, Inc. (“Volition America”), Volition Germany GmbH (“Volition Germany”), and its one majority-owned subsidiary Volition Veterinary Diagnostics Development LLC (“Volition Vet”). See Note 8(f) for more information regarding Volition Vet and Volition Germany. All intercompany balances and transactions have been eliminated in consolidation.
Cash and Cash Equivalents
For the purposes of the statements of cash flows, the Company considers interest bearing deposits with original maturity dates of three months or less to be cash equivalents. The Company invests excess cash from its operating cash accounts in overnight investments and reflects these amounts in cash and cash equivalents in the condensed consolidated balance sheets at fair value using quoted prices in active markets for identical assets. As of September 30, 2021, cash and cash equivalents totaled approximately $22.9 million, of which $10.2 million was held in an overnight money market account. Accounts Receivables
Trade accounts receivable are stated at the amount the Company expects to collect. Due to the nature of the accounts receivable balance, the Company believes the risk of doubtful accounts is minimal and therefore no allowance is recorded. If the financial condition of the Company’s customers were to deteriorate, adversely affecting their ability to make payments, additional allowances would be required. The Company may provide for estimated uncollectible amounts through a charge to earnings and a credit to a valuation allowance. Balances that remain outstanding after the Company has used reasonable collection efforts are written off through a charge to the valuation allowance and a credit to accounts receivable. As of September 30, 2021, the accounts receivable balance was $19,566 and the allowance for doubtful debts was nil.
Revenue Recognition
The Company adopted Accounting Standards Codification (“ASC”) 606, “Revenue from Contracts with Customers,” effective January 1, 2019. Under ASC 606, the Company recognizes revenues when the customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. The Company recognizes revenues following the five step model prescribed under ASC 606: (i) identify contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenues when (or as) the Company satisfies the performance obligation(s).
The Company generates product revenues from the sale of its Nu.Q® Vet Cancer Screening Test, from the sale of nucleosomes, and from the sale of Research Use Only kits pursuant to its license agreement with Active Motif, Inc. (“Active Motif”) from which the Company receives royalties. In addition, revenue is received from external third parties for services the Company performs for them in its laboratory.
Revenues, and their respective treatment for financial reporting purposes under ASC 606, are as follows:
Royalty
The Company receives royalty revenues on the net sales recognized during the period in which the revenue is earned, and the amount is determinable from the licensee. These are presented in “Royalty” in the consolidated statements of operations and comprehensive loss. The Company does not have future performance obligations under this revenue stream. In accordance with ASC 606, the Company records these revenues based on estimates of the net sales that occurred during the relevant period from the licensee. The relevant period estimates of these royalties are based on preliminary gross sales data provided by Active Motif and analysis of historical gross-to-net adjustments. Differences between actual and estimated royalty revenues are adjusted for in the period in which they become known.
Product
The Company includes revenue from product sales recognized during the period in which goods are shipped to third parties, and the amount is deemed collectable from the third parties. These are presented in “Product” in the consolidated statements of operations and comprehensive loss. Services
The Company includes revenue recognized from laboratory services performed in the Company’s laboratory on behalf of third parties in “Services” in the consolidated statements of operations and comprehensive loss.
For each development and/or commercialization agreement that results in revenues, the Company identifies all performance obligations, aside from those that are immaterial, which may include a license to intellectual property and know-how, development activities and/or transition activities. In order to determine the transaction price, in addition to any upfront payment, the Company estimates the amount of variable consideration at the outset of the contract either utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract. The Company constrains (reduces) the estimates of variable consideration such that it is probable that a significant reversal of previously recognized revenue will not occur throughout the life of the contract. When determining if variable consideration should be constrained, management considers whether there are factors outside the Company’s control that could result in a significant reversal of revenue. In making these assessments, the Company considers the likelihood and magnitude of a potential reversal of revenue. These estimates are re-assessed each reporting period as required.
Basic and Diluted Net Loss Per Share
The Company computes net loss per share in accordance with ASC 260, “Earnings Per Share,” which requires presentation of both basic and diluted earnings per share (“EPS”) on the face of the statement of operations and comprehensive loss. Basic EPS is computed by dividing net loss available to common stockholders (numerator) by the weighted average number of shares outstanding (denominator) during the period. Diluted EPS gives effect to all dilutive potential common shares outstanding during the period using the treasury stock method. In computing diluted EPS, the average stock price for the period is used in determining the number of shares assumed to be purchased from the exercise of stock options or warrants. As of September 30, 2021, 6,143,599 potential common shares equivalents from warrants, options, and restricted stock units (“RSUs”) were excluded from the diluted EPS calculations as their effect is anti-dilutive.
Reclassification
Certain amounts presented in previously issued financial statements have been reclassified to be consistent with the current period presentation. The Company has reclassified the prior period comparative amounts in the statement of stockholders’ equity and cash flows to be consistent with the current year classification.
Recent Accounting Pronouncements
The Company has implemented all new accounting pronouncements that are in effect. The Company does not believe there are any other new accounting pronouncements that have been issued that might have a material impact on its financial position or results of operations. COVID-19 Pandemic Impact
As of the date of this filing, there continue to be widespread concerns regarding the ongoing impacts and disruptions caused by the COVID-19 pandemic in the regions in which the Company operates. As a result of the COVID-19 pandemic, the Company has experienced and may continue to experience disruptions that could impact our clinical trials, including delays enrolling patients and in sample collection.
The extent to which the COVID-19 pandemic will impact the Company’s business, financial condition, and results of operations in the future is highly uncertain and will be affected by a number of factors. These include the duration and extent of the COVID-19 pandemic, the development of new variants of the COVID-19 virus that may be more contagious or virulent than previous versions, the scope of mandated or recommended containment and mitigation measures, the effect of government stabilization and recovery efforts, and the success of vaccine distribution programs. |
Going Concern |
9 Months Ended |
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Sep. 30, 2021 | |
Going Concern | |
Note 2 - Going Concern | Note 2 - Going Concern
The Company's condensed consolidated financial statements are prepared using U.S. GAAP applicable to a going concern which contemplates the realization of assets and liquidation of liabilities in the normal course of business. The Company has incurred losses since inception of $129.0 million, has negative cash flows from operations, and has minimal revenues, which creates substantial doubt about its ability to continue as a going concern for a period of at least one year from the date of issuance of these condensed consolidated financial statements.
The future of the Company as an operating business will depend on its ability to obtain sufficient capital contributions, financing and/or to generate revenues as may be required to sustain its operations. Management plans to address the above as needed by (a) securing additional grant funds, (b) obtaining additional financing through debt or equity transactions, (c) granting licenses to third parties in exchange for specified up-front and/or back-end payments and (d) developing and commercializing its products on an accelerated timeline. Management continues to exercise tight cost controls to conserve cash.
The ability of the Company to continue as a going concern is dependent upon its ability to successfully accomplish the plans described in the preceding paragraph and eventually attain profitable operations. The accompanying condensed consolidated financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern. If the Company is unable to obtain adequate capital, it could be forced to cease operations. |
Property and Equipment |
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Note 3 - Property and Equipment | Note 3 - Property and Equipment
The Company’s property and equipment consisted of the following amounts as of September 30, 2021 and December 31, 2020:
During the nine-month periods ended September 30, 2021 and September 30, 2020, the Company recognized $639,091 and $459,450, respectively, in depreciation expense. |
Intangible Assets |
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Note 4 - Intangible Assets | Note 4 - Intangible Assets
The Company’s intangible assets consist of patents, mainly acquired in the acquisition of Belgian Volition. The patents are being amortized over the assets’ estimated useful lives, which range from 8 to 20 years.
During the nine-month periods ended September 30, 2021 and September 30, 2020, the Company recognized $69,410 and $65,567, respectively, in amortization expense.
The Company amortizes the patents on a straight-line basis with terms ranging from 8 to 20 years. The annual estimated amortization schedule over the next five years is as follows:
The Company periodically reviews its long-lived assets to ensure that their carrying value does not exceed their fair market value. The Company carried out such a review in accordance with ASC 360 Topic “Property, Plant and Equipment” as of December 31, 2020. The result of this review confirmed that the ongoing value of the patents was not impaired as of December 31, 2020. |
Related Party Transactions |
9 Months Ended |
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Sep. 30, 2021 | |
Related Party Transactions | |
Note 5 - Related Party Transactions | Note 5 - Related Party Transactions
Refer to Note 6, Common Stock, for common stock issued to related parties and Note 7, Stock-Based Compensation, for stock options, warrants and RSUs issued to related parties. The Company has agreements with related parties for the purchase of products and consultancy services which are accrued under management and directors’ fees payable (see condensed consolidated balance sheets). |
Common Stock |
9 Months Ended |
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Sep. 30, 2021 | |
Common Stock | |
Note 6 - Common Stock | Note 6 - Common Stock
As of September 30, 2021, the Company was authorized to issue 100 million shares of common stock par value $0.001 per share, of which 53,223,761 and 48,607,017 shares were issued and outstanding as of September 30, 2021 and December 31, 2020, respectively.
Stock Option Exercises and RSU Settlements
From January 13, 2021 to March 19, 2021, 7,634 stock options were exercised to purchase shares of common stock at $3.35 per share in a cashless exercise that resulted in the issuance of 948 shares of common stock.
On January 20, 2021, 5,000 RSUs vested and resulted in the issuance of 3,000 shares of common stock (the remaining 2,000 shares were withheld for taxes and returned as authorized shares under the 2015 Stock Incentive Plan).
On February 2, 2021, 20,000 stock options were exercised to purchase shares of common stock at $3.80 per share in a cashless exercise that resulted in the issuance of 6,181 shares of common stock.
On February 8, 2021, 100,000 stock options were exercised to purchase shares of common stock at $5.00 per share in a cashless exercise that resulted in the issuance of 19,446 shares of common stock.
From February 8, 2021 to February 9, 2021, 100,000 stock options were exercised to purchase shares of common stock at $4.00 per share in cashless exercises that resulted in the issuance of 32,126 shares of common stock.
On February 8, 2021, 50,000 stock options were exercised to purchase shares of common stock at $3.25 per share in a cashless exercise that resulted in the issuance of 18,750 shares of common stock.
On April 13, 2021, 26,250 RSUs vested and resulted in the issuance of 21,712 shares of common stock (the remaining 4,538 shares were withheld for taxes and returned as authorized shares under the 2015 Stock Incentive Plan).
Equity Capital Raise
On February 10, 2021, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Cantor Fitzgerald & Co (“Cantor”). in connection with an underwritten public offering of 3,809,524 shares (the “Firm Shares”) of the Company’s common stock, pursuant to the Company’s shelf registration statement on Form S-3 (declared effective by the SEC on September 28, 2018, File No. 333-227248). Cantor purchased the Firm Shares from the Company at a price of $4.9533 per share on February 12, 2021. The net proceeds received by the Company for the sale and issuance of the Firm Shares were approximately $18.9 million. Under the terms of the Underwriting Agreement, the Company granted Cantor an option, exercisable for 30 days, to purchase up to an additional 571,428 shares of common stock at the same price per share as the Firm Shares which option was not exercised. Equity Distribution Agreements
On September 24, 2021, the Company entered into an equity distribution agreement (the “2021 EDA”) with Cantor and Oppenheimer & Co. Inc. (“Oppenheimer”), to sell shares of its common stock having an aggregate offering price of up to $25.0 million from time-to-time, through an “at the market offering program” pursuant to the Company’s effective “shelf” registration statement on Form S-3 (File No. 333-259783) and related prospectuses, through Cantor and Oppenheimer each acting as the Company’s agent and/or principal. The Company is not obligated to sell any shares under the 2021 EDA. No sales of shares have been made under the 2021 EDA as of the date of filing of the Company's Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2021. The 2021 EDA replaces the 2020 EDA effective as of November 8, 2021 and no further sales will be made under the 2020 EDA as of such date.
On November 10, 2020, the Company entered into an equity distribution agreement (the “2020 EDA”) with Cantor and Oppenheimer to sell shares of its common stock having an aggregate offering price of up to $25.0 million from time-to-time, through an “at the market offering program” pursuant to the Company’s effective “shelf” registration statement on Form S-3 (File No. 333-227248) and related prospectuses, through Cantor and Oppenheimer each acting as the Company’s agent and/or principal. The Company is not obligated to sell any shares under the 2020 EDA. During the three months ended September 30, 2021, the Company raised aggregate net proceeds (net of broker’s commissions and fees) of $259,397 under the 2020 EDA through the sale of 79,679 shares of its common stock. From inception through September 30, 2021, the Company raised aggregate net proceeds (net of broker’s commissions and fees) of $1,460,564 under the 2020 EDA through the sale of 396,448 shares of its common stock. The 2021 EDA replaces the 2020 EDA effective as of November 8, 2021 and no further sales will be made under the 2020 EDA as of such date.
On September 7, 2018, the Company entered into an equity distribution agreement (as amended, the “2018 EDA”) with Oppenheimer to sell shares of common stock having an aggregate offering price of up to $10.0 million from time-to-time, through an “at the market offering program” pursuant to the Company’s effective “shelf” registration statement on Form S-3 (File No 333-227248) and related prospectuses, through Oppenheimer acting as the Company’s agent and/or principal. From inception through March 31, 2021, the Company raised aggregate net proceeds (net of broker’s commissions and fees) of approximately $9.7 million under the 2018 EDA through the sale of 2,539,606 shares of its common stock and fully utilized the availability under the 2018 EDA during the quarter ended March 31, 2021. No further sales will be made under the 2018 EDA. |
Stock-Based Compensation |
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Note 7 - Stock-based Compensation | Note 7 – Stock-Based Compensation
a) Warrants
The following table summarizes the changes in warrants outstanding of the Company during the nine-month period ended September 30, 2021:
Effective January 1, 2021, the Company granted warrants to purchase 125,000 shares of common stock to a Company employee for services to the Company. These warrants vest on January 1, 2022 (subject to continued employment through such date) and expire on January 1, 2027, with an exercise price of $3.95 per share. The Company has calculated the estimated fair market value of these warrants at $242,877, using the Black-Scholes model and the following assumptions: term 3.5 years, stock price $3.80, exercise price $3.95, 74.53% volatility, 0.50% risk free rate, and no forfeiture rate.
Effective February 1, 2021, the Company granted warrants to purchase 185,000 shares of common stock to a Company employee for services to the Company. These warrants vest on February 1, 2022 (subject to continued employment through such date) and expire on February 1, 2027, with an exercise price of $4.90 per share. The Company has calculated the estimated fair market value of these warrants at $459,352, using the Black-Scholes model and the following assumptions: term 3.5 years, stock price $4.80, exercise price $4.90, 75.03% volatility, 0.59% risk free rate, and no forfeiture rate.
Below is a table summarizing the warrants issued and outstanding as of September 30, 2021, which have an aggregate weighted average remaining contractual life of 4.21 years.
Stock-based compensation expense related to warrants of $524,780 and $56,127 was recorded in the nine months ended September 30, 2021 and September 30, 2020, respectively. Total remaining unrecognized compensation cost related to non-vested warrants is $216,014 and is expected to be recognized over a period of 0.34 years. As of September 30, 2021, the total intrinsic value of warrants outstanding was $78,750.
b) Options
The following table summarizes the changes in options outstanding of the Company during the nine-month period ended September 30, 2021:
Effective May 20, 2021, the Company granted stock options to purchase 40,000 shares of common stock to a Company employee in exchange for services provided to the Company. These options vest on May 20, 2022 and expire five years after the vesting date, with an exercise price of $3.60 per share. The Company has calculated the estimated fair market value of these options at $73,641, using the Black-Scholes model and the following assumptions: term 3.5 years, stock price $3.50, exercise price $3.60, 76.16% volatility, 0.58% risk free rate, and no forfeiture rate.
On July 14, 2021, the Company amended the terms of certain outstanding options granted pursuant to the 2011 Equity Incentive Plan such that (i) the expiration date for outstanding options to purchase up to an aggregate of 292,000 shares of the Company’s common stock, granted on July 23, 2015, was extended from five years and six months after vesting to ten years from the date of grant, or an expiration date of July 23, 2025, (ii) the expiration date for outstanding options to purchase up to an aggregate of 6,367 shares of the Company’s common stock, granted on March 20, 2013, was extended from six years after vesting to ten years from the date of grant, or an expiration date of March 20, 2023, and (iii) the expiration date for outstanding options to purchase up to an aggregate of 8,151 shares of the Company’s common stock, granted September 2, 2013, was extended from six years after vesting to ten years from the date of grant, or an expiration date of September 2, 2023. As a result of these amendments $452,433 was recorded as additional options expense.
Effective August 3, 2021, the Company approved the granting of options under the 2015 Stock Incentive Plan vesting upon achievement of certain corporate goals (see additional details in Note 8 (h)). Pursuant to this approval, the Company granted stock options to purchase an aggregate of 926,640 shares of common stock to various personnel (including directors, executives, members of management and employees of the Company and/or its subsidiaries) in exchange for services provided to the Company and/or its subsidiaries. These options vest over two years with options to purchase up to 463,328 shares vesting on August 3, 2022, and options to purchase up to 463,312 shares vesting on August 3, 2023, subject to continued service by the optionee, and expire 10 years from the date of grant with an exercise price of $3.40 per share. The actual number of options that are eligible for the time-based vesting is contingent upon the timely achievement of certain pre-determined corporate goals by the Company and/or its subsidiaries as set forth in the grant documents. The Company has calculated the estimated fair market value of these options at $1,811,216, using the Black-Scholes model and the following assumptions: term 5.5 years, stock price $3.31, exercise price $3.40, 69.13% volatility, 1.19% risk free rate, and no forfeiture rate. Effective September 7, 2021, the Company granted stock options to purchase 50,000 shares of common stock to two employees in exchange for services provided to the Company and/or its subsidiaries. These options vest over two years with 25,000 shares vesting on September 7, 2022, and 25,000 shares vesting on September 7, 2023 subject to continued service by the optionee and expire 10 years from the date of grant with an exercise price of $3.40 per share. The Company has calculated the estimated fair market value of these options at $98,322, using the Black-Scholes model and the following assumptions: term 5.5 years, stock price $3.32, exercise price $3.40, 68.98% volatility, 1.38% risk free rate, and no forfeiture rate.
On September 21, 2021, the Company amended the terms of certain outstanding options such that (i) the expiration date for outstanding options to purchase up to an aggregate of 335,000 shares of the Company’s common stock, granted on April 13, 2020 under the 2015 Stock Incentive Plan, were extended from six (6) to ten (10) years from the date of the grant. (ii) the expiration date for outstanding options to purchase up to an aggregate of 89,163 shares of the Company’s common stock, granted on January 23, 2018 and amended on December 16, 2019 under the 2015 Stock Incentive Plan, were extended from six (6) to ten (10) years from the date of the grant and (iii) the expiration date for outstanding options to purchase up to an aggregate of 308,066 shares of the Company’s common stock, granted on February 13, 2017 and March 30, 2017 (and amended on December 16, 2019) under the 2015 Stock Incentive Plan, were extended from six (6) to ten (10) years from the date of the grant. As a result of these amendments $315,858 was recorded as additional options expense.
Below is a table summarizing the options issued and outstanding as of September 30, 2021, all of which were issued pursuant to the 2011 Equity Incentive Plan (for option issuances prior to 2016) or the 2015 Stock Incentive Plan (for option issuances commencing in 2016) and which have an aggregate weighted average remaining contractual life of 4.58 years. As of September 30, 2021, an aggregate of 6,000,000 shares of common stock were authorized for issuance under the 2015 Stock Incentive Plan, of which 554,021 shares of common stock remained available for future issuance thereunder.
Stock-based compensation expense related to stock options of $664,819 and $861,312 was recorded in the nine months ended September 30, 2021 and September 30, 2020, respectively. Total remaining unrecognized compensation cost related to non-vested stock options is $1,738,661 and is expected to be recognized over a period of 1.94 years. As of September 30, 2021, the total intrinsic value of stock options outstanding was nil. c) Restricted Stock Units (RSUs)
Below is a table summarizing the RSUs issued and outstanding as of September 30, 2021, all of which were issued pursuant to the 2015 Stock Incentive Plan.
Effective January 1, 2021, the Company granted RSUs of 5,000 shares of common stock to a Company employee in exchange for services provided to the Company. These RSUs vested immediately, on January 1, 2021 and resulted in the issuance of 3,000 shares (the remaining 2,000 shares were withheld for taxes and returned as authorized shares under the 2015 Stock Incentive Plan) and total compensation expense of $19,450.
Effective March 25, 2021, the Company granted aggregate RSUs of 30,000 shares of common stock to two non-executive directors in exchange for services provided to the Company. These RSUs vest over two years, with 50% vesting on each of March 25, 2022 and March 25, 2023, subject to continued service, and will result in total compensation expense of $107,700.
On March 25, 2021, 15,000 RSUs previously granted to a non-executive director were cancelled and returned as authorized shares under the 2015 Stock Incentive Plan upon the resignation of such director prior to vesting.
On April 13, 2021, 26,250 RSUs vested and resulted in the issuance of 21,712 shares (the remaining 4,538 shares were withheld for taxes and returned as authorized shares under the 2015 Stock Incentive Plan).
Effective May 1, 2021, the Company granted RSUs of 150,000 shares of common stock to an employee in exchange for services provided to the Company. These RSUs vest over three years with 50,000 units vesting on each of May 1, 2022, May 1, 2023 and May 1, 2024, respectively, subject to continued service, and will result in total compensation expense of $496,500.
Effective August 3, 2021, the Company approved the granting of RSU’s under the 2015 Stock Incentive Plan vesting upon achievement of certain corporate goals (see additional details in Note 8 (h)). Pursuant to this approval, the Company granted RSUs of 460,191 shares of common stock to various personnel (including directors, executives, members of management and employees of the Company and/or its subsidiaries) in exchange for services provided to the Company and/or its subsidiaries). The actual number of RSUs that are eligible for the time-based vesting is contingent based upon the timely achievement of certain pre-determined corporate goals by the Company and/or its subsidiaries as set forth in the grant documents. The RSUs eligible for vesting shall vest in two equal installments at 12 months and 24 months from the grant date, subject to continued service. These RSUs vest over two years with up to 230,102 units vesting on August 3, 2022, and up to 230,089 units vesting on August 3, 2023 and will result in total compensation expense of $1,523,232.
Effective September 7, 2021, the Company granted RSUs of 38,000 shares of common stock to various employees of the Company and/or its subsidiaries in exchange for services provided to the Company and/or its subsidiaries. These RSUs vest over two years with 19,000 units vesting on September 7, 2022, and 19,000 units vesting on September 7, 2023, subject to continued service and will result in total compensation expense of $126,160. Below is a table summarizing the RSUs issued and outstanding as of September 30, 2021 and which have an aggregate weighted average remaining contractual life of 1.35 years.
Stock-based compensation expense related to RSUs of $435,678 and $64,553 was recorded in the nine months ended September 30, 2021 and September 30, 2020, respectively. Total remaining unrecognized compensation cost related to non-vested RSUs is $1,972,118. As of September 30, 2021, the total intrinsic value of the RSUs outstanding was nil. |
Commitments and Contingencies |
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Note 8 - Commitments and Contingencies | Note 8 – Commitments and Contingencies
a) Finance Lease Obligations
In 2016, the Company entered into a real estate finance lease with ING Asset Finance Belgium S.A. (“ING”) to purchase a property located in Belgium for €1.12 million, maturing in May 2031 with implicit interest of 2.62%. As of September 30, 2021, the balance payable was $580,355.
In 2018, the Company entered into a capital lease with BNP Paribas leasing solutions to purchase a freezer for the Belgium facility for €25,000, maturing in January 2022 with implicit interest of 1.35%. The leased equipment is amortized on a straight-line basis over 5 years. As of September 30, 2021, the balance payable was $3,896.
The following is a schedule showing the future minimum lease payments under finance leases by years and the present value of the minimum payments as of September 30, 2021.
b) Operating Lease Right-of-Use Obligations
As all the existing leases subject to the new lease standard ASC 842 (“Leases”) were previously classified as operating leases by the Company, they were similarly classified as operating leases under the new standard. The Company has determined that the identified operating leases did not contain non-lease components and require no further allocation of the total lease cost. Additionally, the agreements in place did not contain information to determine the rate implicit in the leases, so the Company used its incremental borrowing rate as the discount rate. The Company’s weighted average discount rate is 4.49% and the weighted average remaining lease term is 30 months.
As of September 30, 2021, operating lease right-of-use assets and liabilities arising from operating leases were $263,440 and $268,870, respectively. During the nine months ended September 30, 2021, cash paid for amounts included for the measurement of lease liabilities was $151,003 and the Company recorded operating lease expense of $151,635.
The following is a schedule showing the future minimum lease payments under operating leases by years and the present value of the minimum payments as of September 30, 2021.
The Company’s office space leases are short-term and the Company has elected under the short-term recognition exemption not to recognize them on the balance sheet. During the nine months ended September 30, 2021, $58,720 was recognized in short-term lease costs associated with office space leases. The annual payments remaining for short-term office leases were as follows:
c) Grants Repayable
In 2010, the Company entered into an agreement with the Walloon Region government in Belgium for a colorectal cancer research grant for €1.05 million. Per the terms of the agreement, €314,406 of the grant is to be repaid, by installments over the period from June 30, 2014 to June 30, 2023. In the event that the Company receives revenue from products or services as defined in the agreement, it is due to pay a 6% royalty on such revenue to the Walloon Region. The maximum amount payable to the Walloon Region, in respect of the aggregate of the amount repayable of €314,406 and the 6% royalty on revenue, is equal to twice the amount of funding received. As of September 30, 2021, the grant balance repayable was $63,673.
In 2018, the Company entered into an agreement with the Walloon Region government in Belgium for a colorectal cancer research grant for €605,000. Per the terms of the agreement, €181,500 of the grant is to be repaid by installments over 12 years commencing in 2020. In the event that the Company receives revenue from products or services as defined in the agreement, it is due to pay a 3.53% royalty on such revenue to the Walloon Region. The maximum amount payable to the Walloon Region, in respect of the aggregate of the amount repayable of €181,500 and the 3.53% royalty on revenue, is equal to the amount of funding received. As of September 30, 2021, the grant balance repayable was $124,270. In 2020, the Company entered into an agreement with the Walloon Region government in Belgium for a research grant for €929,433. Per the terms of the agreement, €278,830 of the grant is to be repaid by installments over 15 years commencing in 2022. In the event that the Company receives revenue from products or services as defined in the agreement, it is due to pay a 4.34% royalty on such revenue to the Walloon Region. The maximum amount payable to the Walloon Region, in respect of the aggregate of the amount repayable of €278,830 and the 4.34% royalty on revenue, is equal to the amount of funding received. As of September 30, 2021, the grant balance repayable was $53,765.
In 2020, the Company entered into an agreement with the Walloon Region government in Belgium for a research grant for €495,000. Per the terms of the agreement, €148,500 of the grant is to be repaid by installments over 10 years commencing in 2023. In the event that the Company receives revenue from products or services as defined in the agreement, it is due to pay a 2.89% royalty on such revenue to the Walloon Region. The maximum amount payable to the Walloon Region, in respect of the aggregate of the amount repayable of €148,500 and the 2.89% royalty on revenue, is equal to the amount of funding received. As of September 30, 2021, the grant balance repayable was $59,836.
As of September 30, 2021, the total grant balance repayable was $301,544 and the payments remaining were as follows:
d) Long-Term Debt
In 2016, the Company entered into a 7-year loan agreement with Namur Invest for €440,000 with a fixed interest rate of 4.85%, maturing in December 2023. As of September 30, 2021, the principal balance payable was $194,720.
In 2016, the Company entered into a 15-year loan agreement with ING for €270,000 with a fixed interest rate of 2.62%, maturing in December 2031.As of September 30, 2021, the principal balance payable was $227,954.
In 2017, the Company entered into a 4-year loan agreement with Namur Invest for €350,000 with a fixed interest rate of 4.00%, maturing in June 2021. As of September 30, 2021, the principal balance payable was nil.
In 2017, the Company entered into a 7-year loan agreement with SOFINEX for up to €1 million with a fixed interest rate of 4.50%, maturing in September 2024. As of September 30, 2021, €1 million had been drawn down under this agreement and the principal balance payable was $810,388.
In 2018, the Company entered into a 4-year loan agreement with Namur Innovation and Growth for €500,000 with a fixed interest rate of 4.0%, maturing in June 2022. As of September 30, 2021, the principal balance payable was $130,938.
In 2019, the Company entered into a 4-year loan agreement with Namur Innovation and Growth for €500,000 with a fixed interest rate of 4.80%, maturing in September 2024. As of September 30, 2021, the principal balance payable was $501,978.
On October 13, 2020, the Company entered into a 10-year loan agreement with Namur Invest for a maximum of €830,000 with fixed interest rate of 4.00%, maturing March 2031. As of September 30, 2021, the principal balance payable was $921,411. As of September 30, 2021, the total balance for long-term debt payable was $2,787,389 and the payments remaining were as follows:
e) Collaborative Agreement Obligations
In 2016, the Company entered into a research co-operation agreement with DKFZ in Germany for a five-year period for €400,000. As of September 30, 2021, $231,539 is still to be paid by the Company under this agreement.
In 2018, the Company entered into a research collaboration agreement with the University of Taiwan for a three-year period for a cost to the Company of up to $2.55 million payable over such period. As of September 30, 2021, $510,000 is still to be paid by the Company under this agreement.
In 2019, the Company entered into a research collaboration agreement with the University of Taiwan for a two-year period to collect a total of 1,200 samples for a cost to the Company of up to $320,000 payable over such period. As of September 30, 2021, nil is still to be paid by the Company under this agreement.
In 2019, the Company entered into a funded sponsored research agreement with the Texas A&M University (“TAMU”) in consideration for the license granted to the Company for a five-year period for a cost to the Company of up to $400,000 payable over such period. As of September 30, 2021, $98,711 is still to be paid by the Company under this agreement.
On September 16, 2020, the Company entered into a research agreement for the bioinformatic analysis of cell-free DNA fragments from whole-genome sequencing with the Hebrew University of Jerusalem for six months for a cost to the Company of €54,879. Subsequently the parties entered into an amendment to the agreement with an additional cost to the Company of €155,115. As of September 30, 2021, $92,749 is still to be paid by the Company under the amended agreement.
As of September 30, 2021, the total amount to be paid for future research and collaboration commitments was approximately $ 932,999 and the payments remaining were as follows:
f) Other Commitments
Volition Vet
On October 25, 2019, the Company entered into an agreement with TAMU for provision of in kind services of personnel, animal samples and laboratory equipment in exchange for a non-controlling interest of 7.5% in Volition Vet with an additional 5%, vesting in a year from the date of the agreement, giving TAMU in aggregate, a 12.5% equity interest as of such date. As of September 30, 2021, TAMU has a 12.5 % equity interest in Volition Vet.
Volition Germany
On January 10, 2020, the Company, through its wholly-owned subsidiary Belgian Volition, acquired an epigenetic reagent company, Octamer GmbH (“Octamer”), based in Munich, Germany, and hired its founder for his expertise and knowledge to be passed to Company personnel. On March 9, 2020, Octamer was renamed to Volition Germany GmbH (or “Volition Germany”).
Upon considering the definition of a business, as defined in ASC 805 “Business Combinations,” paragraph 805-10-20, which is an integrated set of activities and assets that is capable of being conducted and managed for the purpose of providing a return, the Company has determined that this did not constitute a business. This is primarily due to the fact that additional inputs are needed in the form of training personnel further to produce outputs. Accordingly, the Company has treated this transaction as the hiring of a member of management, described below, rather than accounting for the transaction as a business combination.
The Company agreed to terms of the transaction on December 13, 2019 and closed on January 10, 2020. Pursuant to the transaction agreement, the Company purchased all outstanding shares of Octamer. In exchange, the Company agreed to issue 73,263 newly issued restricted shares of Company common stock valued at $333,969 (based on the $4.56 per share volume weighted trading price for the five days prior to December 13, 2019), committed to pay approximately €350,000, subject to adjustments, and agreed to pay off certain Octamer expenses leading up to the agreement (representing net liabilities of $6,535). At closing, the Company issued 73,263 restricted shares of Company common stock, paid an adjusted amount of approximately $357,000 (€321,736) and recorded a holdback liability of $55,404 (€50,000). During the three months ended March 31, 2021, an amount of €43,152 was paid in full settlement of the amount due.
In connection with the transaction agreement, the Company also entered into a two-year Managing Director’s agreement with the founder of Octamer to continue to manage Volition Germany for a payment of €288,000 payable in equal monthly installments over such two-year period and a royalty agreement with the founder providing for the payment of royalties in the amount of 6% of net sales of Volition Germany’s nucleosomes as reagents to pharmaceutical companies for use in the development, manufacture and screening of molecules for use as therapeutic drugs for a period of five years post-closing.
During the three months ended March 31, 2020, the Company recorded approximately $753,000 in January 2020 as compensation expense as a result of cash paid in, holdback liability, stock issued and assumption of expenses. As of September 30, 2021,$41,677 is still to be paid by the Company under the Managing Director’s agreement and $229 is payable under the 6% royalty agreement. Volition America
On November 3, 2020, the Company entered into a professional services master agreement with Diagnostic Oncology CRO, LLC to conduct a pivotal clinical trial and provide regulatory submission and reimbursement related services. Under the terms of the agreement Diagnostic Oncology CRO, LLC will provide ad hoc consulting assistance on a project-by-project basis related to the review and assessment of existing data and information to prepare recommended intended use claims and coverage/reimbursement plans to support the preparation of FDA pre-submissions, clinical trial protocol development and study administration, and potential 510k regulatory marketing submissions of the Company’s diagnostic tests, including those proposed for use as an adjunct diagnostic tool for common and aggressive forms of Non-Hodgkin’s Lymphoma. The initial projects contemplated by the agreement relating to Non-Hodgkin’s Lymphoma obligate the Company to pay in aggregate of up to $2.9 million over a period of 22 months. Such payment obligations are on a project-by-project basis as deliverables are executed and subject to certain terms and conditions. Additionally, the Company may terminate the agreement or any project with or without cause upon at least 30 days’ prior written notice. Unless earlier terminated, the term of the agreement is until December 31, 2025 or such later date as when all projects have been completed. As of September 30, 2021, nil is payable by Company for services rendered under the agreement.
g) Legal Proceedings
There are no legal proceedings which the Company believes will have a material adverse effect on its financial position.
h) Commitments in Respect of Corporate Goals and Performance-Based Awards
In August 2021 the Compensation Committee of the Board of Directors approved the issuance of certain equity-based awards and cash bonuses in order to provide company personnel with an element of performance-based compensation tied to the timely achievement of certain corporate goals focused around product development and commercialization.
Effective August 3, 2021, the Company approved the granting of equity-based awards under the 2015 Stock Incentive Plan as well as cash bonuses, vesting upon achievement of certain corporate goals, to various personnel including directors, executives, members of management, consultants and employees of the Company and/or its subsidiaries.
Conditional upon the achievement by December 31, 2021 of a specified corporate goal as set forth in the minutes of the Compensation Committee dated August 3, 2021, as well as continued service by the award recipient, the Company at the sole discretion of the Chief Executive Officer and the Chief Financial Officer shall pay a cash bonus to such award recipient. The Company estimates the total compensation expense based on current recipients to be $330,837. As of September 30, 2021, the Company has accrued compensation expense of $229,900 based on the probable outcomes related to the prescribed performance targets.
Conditional upon the achievement by July 1, 2022 of all specified corporate goals as set forth in the minutes of the Compensation Committee dated August 3, 2021, as well as continued service by the award recipient, the Company at the sole discretion of the Chief Executive Officer and the Chief Financial Officer would pay an additional cash bonus to such award recipient. The Company estimates the total compensation expense based on current recipients to be $467,269. As of September 30, 2021, the Company has accrued compensation expense of $116,121 based on the probable outcomes related to the prescribed performance targets.
As discussed in detail in Note 7, in August 2021 a total of 926,640 stock options and 460,191 restricted stock units were issued under the 2015 Stock Incentive Plan.
As of September 30, 2021, the Company has recognized compensation expense of $219,077 in relation to such stock options and $190,981 in relation to such restricted stock units, based on the probable outcomes related to the prescribed performance targets on the outstanding awards. |
Subsequent Events |
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Note 9 - Subsequent Events | Note 9 – Subsequent Events
Effective October 4, 2021, the Company granted stock options to purchase 73,360 shares of common stock to an officer of the Company and/or its subsidiaries in exchange for services provided to the Company and/or its subsidiaries. These options vest over two years with options to purchase up to 50% of the shares vesting on October 4, 2022, and options to purchase up to 50% of the shares vesting on October 4, 2023, subject to continued service by the optionee, and expire 10 years from the date of grant with an exercise price of $3.40 per share. The actual number of options that are eligible for the time-based vesting is contingent upon the timely achievement of certain pre-determined corporate goals by the Company and/or its subsidiaries set forth in the grant documents. The Company has calculated the estimated fair market value of these options at $128,003, using the Black-Scholes model and the following assumptions: term 5.5 years, stock price $3.04, exercise price $3.40, 68.80% volatility, 1.49% risk free rate, and no forfeiture rate.
Effective October 4, 2021, the Company granted RSUs of 39,809 shares of common stock to an officer of the Company and/or its subsidiaries in exchange for services provided to the Company and/or its subsidiaries. The actual number of RSUs that are eligible for the time-based vesting is contingent upon the timely achievement of certain pre-determined corporate milestones by the Company and/or its subsidiaries as set forth in the grant documents. The RSUs eligible for vesting shall vest in two equal installments at 12 months and 24 months from the grant date, subject to continued service. These RSUs vest over two years with up to 50% of the units vesting on October 4, 2022, and up to 50% of the units vesting on October 4, 2023, and will result in total compensation expense of $121,019.
Effective November 1, 2021, the Company granted RSUs of 43,500 shares of common stock to an officer of the Company and/or its subsidiaries in exchange for services provided to the Company and/or its subsidiaries. The RSUs shall vest in two equal installments at 12 months and 24 months from the grant date, subject to continued service. These RSUs vest over two years with up to 50% of the units vesting on November 1, 2022, and up to 50% of the units vesting on November 1, 2023, and will result in total compensation expense of $152,685.
On November 3, 2021, the Company amended the terms of certain outstanding options under the 2015 Stock Incentive Plan, such that the expiration dates were extended from six (6) to ten (10) years from the date of the grant. As a result of these amendments $1,475,096 will be recorded as additional option expense. The options extended are detailed in the table below:
From October 1 to November 4, 2021, the Company raised aggregate net proceeds (net of broker’s commissions and fees) of $1,209,709 under the 2020 EDA through the sale of 357,900 shares of its common stock. |
Basis of Presentation and Summary of Significant Accounting Policies (Policies) |
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Basis of Presentation and Summary of Significant Accounting Policies (Policies) | |
Basis of Presentation | The interim consolidated financial statements of VolitionRx Limited (the “Company”, "VolitionRx," "we" or "us") for the three and nine months ended September 30, 2021 and September 30, 2020, respectively, are not audited. Our consolidated financial statements are prepared in accordance with the requirements for unaudited interim periods and, consequently, do not include all disclosures required to be made in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). In the opinion of our management, the accompanying consolidated financial statements contain all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation of our financial position as of September 30, 2021, and our results of operations and cash flows for the periods ended September 30, 2021 and September 30, 2020, respectively. The results of operations for the periods ended September 30, 2021 and September 30, 2020, respectively, are not necessarily indicative of the results for a full-year period. These interim consolidated financial statements should be read in conjunction with the financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2020, which was filed with the Securities and Exchange Commission (the "SEC") on March 22, 2021. |
Use of Estimates | The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. The Company also regularly evaluates estimates and assumptions related to deferred income tax asset valuation allowances, useful lives of property and equipment and intangible assets, borrowing rate used in operating lease right-of-use asset and liability valuations, impairment analysis of intangible assets, and valuations of stock-based compensation.
The Company bases its estimates and assumptions on current facts, historical experience and various other factors that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the accrual of costs and expenses that are not readily apparent from other sources. The actual results experienced by the Company may differ materially and adversely from the Company’s estimates. To the extent there are material differences between the estimates and the actual results, future results of operations could be affected. |
Principles of Consolidation | The accompanying condensed consolidated financial statements for the period ended September 30, 2021 include the accounts of the Company and its subsidiaries. The Company has two wholly-owned subsidiaries Singapore Volition Pte. Limited (“Singapore Volition”) and Volition Global Services SRL (“Volition Global”). Singapore Volition has one wholly-owned subsidiary, Belgian Volition SRL (“Belgian Volition”). Belgian Volition has four subsidiaries, Volition Diagnostics UK Limited (“Volition Diagnostics”), Volition America, Inc. (“Volition America”), Volition Germany GmbH (“Volition Germany”), and its one majority-owned subsidiary Volition Veterinary Diagnostics Development LLC (“Volition Vet”). See Note 8(f) for more information regarding Volition Vet and Volition Germany. All intercompany balances and transactions have been eliminated in consolidation. |
Cash and Cash Equivalents | For the purposes of the statements of cash flows, the Company considers interest bearing deposits with original maturity dates of three months or less to be cash equivalents. The Company invests excess cash from its operating cash accounts in overnight investments and reflects these amounts in cash and cash equivalents in the condensed consolidated balance sheets at fair value using quoted prices in active markets for identical assets. As of September 30, 2021, cash and cash equivalents totaled approximately $22.9 million, of which $10.2 million was held in an overnight money market account. |
Accounts Receivables | Trade accounts receivable are stated at the amount the Company expects to collect. Due to the nature of the accounts receivable balance, the Company believes the risk of doubtful accounts is minimal and therefore no allowance is recorded. If the financial condition of the Company’s customers were to deteriorate, adversely affecting their ability to make payments, additional allowances would be required. The Company may provide for estimated uncollectible amounts through a charge to earnings and a credit to a valuation allowance. Balances that remain outstanding after the Company has used reasonable collection efforts are written off through a charge to the valuation allowance and a credit to accounts receivable. As of September 30, 2021, the accounts receivable balance was $19,566 and the allowance for doubtful debts was nil. |
Revenue Recognition | The Company adopted Accounting Standards Codification (“ASC”) 606, “Revenue from Contracts with Customers,” effective January 1, 2019. Under ASC 606, the Company recognizes revenues when the customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. The Company recognizes revenues following the five step model prescribed under ASC 606: (i) identify contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenues when (or as) the Company satisfies the performance obligation(s).
The Company generates product revenues from the sale of its Nu.Q® Vet Cancer Screening Test, from the sale of nucleosomes, and from the sale of Research Use Only kits pursuant to its license agreement with Active Motif, Inc. (“Active Motif”) from which the Company receives royalties. In addition, revenue is received from external third parties for services the Company performs for them in its laboratory.
Revenues, and their respective treatment for financial reporting purposes under ASC 606, are as follows:
Royalty
The Company receives royalty revenues on the net sales recognized during the period in which the revenue is earned, and the amount is determinable from the licensee. These are presented in “Royalty” in the consolidated statements of operations and comprehensive loss. The Company does not have future performance obligations under this revenue stream. In accordance with ASC 606, the Company records these revenues based on estimates of the net sales that occurred during the relevant period from the licensee. The relevant period estimates of these royalties are based on preliminary gross sales data provided by Active Motif and analysis of historical gross-to-net adjustments. Differences between actual and estimated royalty revenues are adjusted for in the period in which they become known.
Product
The Company includes revenue from product sales recognized during the period in which goods are shipped to third parties, and the amount is deemed collectable from the third parties. These are presented in “Product” in the consolidated statements of operations and comprehensive loss. Services
The Company includes revenue recognized from laboratory services performed in the Company’s laboratory on behalf of third parties in “Services” in the consolidated statements of operations and comprehensive loss.
For each development and/or commercialization agreement that results in revenues, the Company identifies all performance obligations, aside from those that are immaterial, which may include a license to intellectual property and know-how, development activities and/or transition activities. In order to determine the transaction price, in addition to any upfront payment, the Company estimates the amount of variable consideration at the outset of the contract either utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract. The Company constrains (reduces) the estimates of variable consideration such that it is probable that a significant reversal of previously recognized revenue will not occur throughout the life of the contract. When determining if variable consideration should be constrained, management considers whether there are factors outside the Company’s control that could result in a significant reversal of revenue. In making these assessments, the Company considers the likelihood and magnitude of a potential reversal of revenue. These estimates are re-assessed each reporting period as required. |
Basic and Diluted Net Loss Per Share | The Company computes net loss per share in accordance with ASC 260, “Earnings Per Share,” which requires presentation of both basic and diluted earnings per share (“EPS”) on the face of the statement of operations and comprehensive loss. Basic EPS is computed by dividing net loss available to common stockholders (numerator) by the weighted average number of shares outstanding (denominator) during the period. Diluted EPS gives effect to all dilutive potential common shares outstanding during the period using the treasury stock method. In computing diluted EPS, the average stock price for the period is used in determining the number of shares assumed to be purchased from the exercise of stock options or warrants. As of September 30, 2021, 6,143,599 potential common shares equivalents from warrants, options, and restricted stock units (“RSUs”) were excluded from the diluted EPS calculations as their effect is anti-dilutive. |
Reclassification | Certain amounts presented in previously issued financial statements have been reclassified to be consistent with the current period presentation. The Company has reclassified the prior period comparative amounts in the statement of stockholders’ equity and cash flows to be consistent with the current year classification. |
Recent Accounting Pronouncements | The Company has implemented all new accounting pronouncements that are in effect. The Company does not believe there are any other new accounting pronouncements that have been issued that might have a material impact on its financial position or results of operations. |
COVID-19 Pandemic Impact | As of the date of this filing, there continue to be widespread concerns regarding the ongoing impacts and disruptions caused by the COVID-19 pandemic in the regions in which the Company operates. As a result of the COVID-19 pandemic, the Company has experienced and may continue to experience disruptions that could impact our clinical trials, including delays enrolling patients and in sample collection.
The extent to which the COVID-19 pandemic will impact the Company’s business, financial condition, and results of operations in the future is highly uncertain and will be affected by a number of factors. These include the duration and extent of the COVID-19 pandemic, the development of new variants of the COVID-19 virus that may be more contagious or virulent than previous versions, the scope of mandated or recommended containment and mitigation measures, the effect of government stabilization and recovery efforts, and the success of vaccine distribution programs. |
Property and Equipment (Tables) |
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Schedule of Property and Equipment |
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Intangible Assets (Tables) |
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Intangible Assets | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Intangible Assets |
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Schedule of annual estimated amortization |
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Stock-Based Compensation (Tables) |
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Summary of changes in warrants outstanding |
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Summarizing the warrants issued and outstanding |
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Summarizes the changes in options outstanding |
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Summarizing the options issued and outstanding |
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Summarizing the RSUs issued and outstanding |
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Summarizing the RSUs issued and outstanding maturity life |
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Commitments and Contingencies (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||
Commitments and Contingencies | |||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of future minimum lease payments under financing leases |
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Schedule of future minimum lease payments under operating leases |
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Schedule of recognized in short-term lease costs |
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Schedule of Grants Repayable |
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Schedule of annual payments of collaborative cgreement obligations |
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Schedule of long-term debt payable |
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Subsequent Events (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||
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Sep. 30, 2021 | |||||||||||||||||||||||||||||||
Subsequent Events | |||||||||||||||||||||||||||||||
Options extended are detailed |
|
Basis of Presentation and Summary of Significant Accounting Policies (Details Narrative) - USD ($) |
9 Months Ended | |
---|---|---|
Sep. 30, 2021 |
Dec. 31, 2020 |
|
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | ||
Cash and cash equivalents | $ 22,900,000 | |
Cash and cash equivalents money market account | 10,200,000 | |
Accounts receivable | 19,566 | $ 7,118 |
Allowance for doubtful Debts | $ 0 | |
Potentially dilutive securities excluded from the computation of EPS | 6,143,599 |
Going Concern (Details Narrative) $ in Millions |
9 Months Ended |
---|---|
Sep. 30, 2021
USD ($)
| |
Going Concern | |
Net loss since inception | $ 129.0 |
Property and Equipment (Details Narrative) - USD ($) |
9 Months Ended | |
---|---|---|
Sep. 30, 2021 |
Sep. 30, 2020 |
|
Property and Equipment | ||
Depreciation Expense | $ 639,091 | $ 459,450 |
Intangible Assets (Details) - USD ($) |
Sep. 30, 2021 |
Dec. 31, 2020 |
---|---|---|
Net Carrying Value | $ 240,954 | $ 321,641 |
Patents [Member] | ||
Net Carrying Value | 240,954 | 321,641 |
Cost | 1,195,677 | 1,256,064 |
Accumulated Amortization | $ 954,723 | $ 934,423 |
Intangible Assets (Details 1) - USD ($) |
Sep. 30, 2021 |
Dec. 31, 2020 |
---|---|---|
Intangible Assets | ||
2021 - remaining | $ 22,852 | |
2022 | 91,015 | |
2023 | 91,015 | |
2024 | 36,072 | |
2025 | 0 | |
Total Intangible Assets | $ 240,954 | $ 321,641 |
Intangible Assets (Details Narrative) - USD ($) |
9 Months Ended | |
---|---|---|
Sep. 30, 2021 |
Sep. 30, 2020 |
|
Amortization expense | $ 69,410 | $ 65,567 |
Minimum [Member] | Patents And Intellectual Property [Member] | ||
Amortization of long-lived asset on straight line basis | 8 years | |
Maximum [Member] | Patents And Intellectual Property [Member] | ||
Amortization of long-lived asset on straight line basis | 20 years |
Stock-Based Compensation (Details) - Warrants Four [Member] |
9 Months Ended |
---|---|
Sep. 30, 2021
$ / shares
shares
| |
Number of warrants Outstanding beginning balance | shares | 175,000 |
Number of warrants granted | shares | 310,000 |
Number of warrants outstanding ending balance | shares | 485,000 |
Number of Warrants Exercisable | shares | 175,000 |
Weighted Average Exercise Price Outstanding balance | $ / shares | $ 2.75 |
Weighted Average Exercise Price Granted | $ / shares | 4.52 |
Weighted Average Exercise Price ending balance | $ / shares | 3.88 |
Weighted Average Exercise Price exercisable | $ / shares | $ 2.75 |
Stock-Based Compensation (Details 2) - Option Four [Member] |
9 Months Ended |
---|---|
Sep. 30, 2021
USD ($)
$ / shares
shares
| |
Number of options outstanding beginning balance | shares | 4,278,619 |
Granted | shares | 1,016,640 |
Exercised | shares | (277,634) |
Number of Expired/Cancelled | $ | $ (63,467) |
Number of option outstanding ending balance | shares | 4,954,158 |
Number of options exercisable | shares | 3,927,518 |
Weighted Average Exercise Price Outstanding balance | $ 4.00 |
Weighted Average Exercise Price Granted | 3.41 |
Weighted Average Exercise Price Exercised | 4.19 |
Weighted Average Exercise Price expires/cancelled | 3.64 |
Weighted Average Exercise Price ending balance | 3.88 |
Weighted Average Exercise Price exercisable balance | $ 4.00 |
Stock-Based Compensation (Details 4) - Stock Options [Member] |
9 Months Ended |
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Sep. 30, 2021
$ / shares
shares
| |
Number of RSUs outstanding begining balance | shares | 67,500 |
Granted | shares | 683,191 |
Vested | shares | (31,250) |
Cancelled | shares | (15,000) |
Number of RSUs outstanding ending balance | shares | 704,441 |
Share price beginning balance | $ / shares | $ 3.47 |
Share price granted | $ / shares | 3.32 |
Share price vested | $ / shares | 3.56 |
Cancelled net | $ / shares | 3.30 |
Share price ending balance | $ / shares | $ 3.33 |
Stock-Based Compensation (Details 5) |
9 Months Ended |
---|---|
Sep. 30, 2021
$ / shares
shares
| |
Options One [Member] | |
Number of stock Outstanding balance | shares | 38,000 |
Share price | $ / shares | $ 3.32 |
Weighted average remaining contractual life (Years) | 1 year 5 months 8 days |
Option Three [Member] | |
Number of stock Outstanding balance | shares | 30,000 |
Share price | $ / shares | $ 3.59 |
Weighted average remaining contractual life (Years) | 11 months 23 days |
Options Two [Member] | |
Number of stock Outstanding balance | shares | 26,250 |
Share price | $ / shares | $ 3.52 |
Weighted average remaining contractual life (Years) | 6 months 10 days |
Total Option [Member] | |
Number of stock Outstanding balance | shares | 704,441 |
Share price | $ / shares | $ 0.00 |
Weighted average remaining contractual life (Years) | 1 year 4 months 6 days |
Stock Options [Member] | |
Number of stock Outstanding balance | shares | 610,191 |
Share price | $ / shares | $ 3.31 |
Weighted average remaining contractual life (Years) | 1 year 4 months 6 days |
Stock-Based Compensation (Details Narrative) - USD ($) |
1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Aug. 03, 2021 |
Jul. 14, 2021 |
Apr. 13, 2021 |
Sep. 02, 2013 |
Mar. 25, 2021 |
Mar. 20, 2013 |
Sep. 30, 2021 |
Sep. 30, 2021 |
Sep. 30, 2020 |
Feb. 01, 2021 |
Jan. 01, 2021 |
|
Stock compensation expenses | $ 524,780 | $ 56,127 | |||||||||
Compensation cost related to non-vested warrants | $ 216,014 | ||||||||||
Vesting term | 4 months 2 days | ||||||||||
Common stock shares issuable upon exercise of warrants | 5,000 | ||||||||||
Common stock shares purchase aggregate shares | 292,000 | 6,367 | |||||||||
Restricted stock units description | Company granted aggregate RSUs of 30,000 shares of common stock to two non-executive directors in exchange for services provided to the Company. These RSUs vest over two years, with 50% vesting on each of March 25, 2022 and March 25, 2023 | ||||||||||
Restricted stock units, shares | 15,000 | ||||||||||
Aggregate weighted average remaining contractual life | 4 years 2 months 15 days | ||||||||||
Price per share | $ 4.90 | $ 3.95 | |||||||||
Intrinsic value | $ 78,750 | $ 78,750 | |||||||||
Stock-based compensation expense | 768,291 | ||||||||||
Restricted Stock Units [Member] | |||||||||||
Stock compensation expenses | 435,678 | 64,553 | |||||||||
Compensation cost related to non-vested warrants | $ 1,972,118 | ||||||||||
Aggregate weighted average remaining contractual life | 1 year 4 months 6 days | ||||||||||
Intrinsic value | 0 | $ 0 | |||||||||
2011 Equity Incentive Plan [Member] | |||||||||||
Vesting period descriptions | extended from five years and six months after vesting to ten years from the date of grant, or an expiration date of July 23, 2025 | ||||||||||
Additional option expense | $ 452,433 | ||||||||||
2015 Equity Incentive Plan [Member] | Option [Member] | |||||||||||
Compensation cost related to non-vested warrants | $ 1,738,661 | ||||||||||
Aggregate weighted average remaining contractual life | 4 years 6 months 29 days | ||||||||||
Intrinsic value | $ 0 | $ 0 | |||||||||
Risk free rate | 1.19% | ||||||||||
Exercise price | $ 3.40 | $ 3.40 | |||||||||
Volatility | 69.13% | ||||||||||
Stock price | $ 3.31 | $ 3.31 | |||||||||
Term | 1 year 11 months 8 days | ||||||||||
Fair market value of options | $ 1,811,216 | ||||||||||
Vesting period descriptions | These options vest over two years with options to purchase up to 463,328 shares vesting on August 3, 2022, and options to purchase up to 463,312 shares vesting on August 3, 2023, subject to continued service by the optionee, and expire 10 years from the date of grant with an exercise price of $3.40 per share. | extended from six years after vesting to ten years from the date of grant, or an expiration date of September 2, 2023 | extended from six years after vesting to ten years from the date of grant, or an expiration date of March 20, 2023 | ||||||||
Stock-based compensation expense | $ 664,819 | 861,312 | |||||||||
Common stock shares reserved for future issuance | 554,021 | 554,021 | |||||||||
RSUs granted upon common shares | 926,640 | ||||||||||
Common stock, shares authorized | 6,000,000 | 6,000,000 | |||||||||
2015 Equity Incentive Plan [Member] | Restricted Stock Units [Member] | |||||||||||
Restricted stock units description | The RSUs eligible for vesting shall vest in two equal installments at 12 months and 24 months from the grant date, subject to continued service. These RSUs vest over two years with up to 230,102 units vesting on August 3, 2022, and up to 230,089 units vesting on August 3, 2023 | ||||||||||
Total compensation expense | $ 1,523,232 | ||||||||||
Granted RSUs share | 460,191 | ||||||||||
September 7, 2021 [Member] | |||||||||||
Restricted stock units description | These RSUs vest over two years with 19,000 units vesting on September 7, 2022, and 19,000 units vesting on September 7, 2023, subject to continued service | ||||||||||
Risk free rate | 1.38% | ||||||||||
Exercise price | $ 3.40 | $ 3.40 | |||||||||
Volatility | 68.98% | ||||||||||
Stock price | $ 3.32 | $ 3.32 | |||||||||
Term | 5 years 6 months | ||||||||||
Fair market value of options | $ 98,322 | ||||||||||
Stock options purchase shares of common stock | 50,000 | ||||||||||
Vesting period descriptions | These options vest over two years with 25,000 shares vesting on September 7, 2022, and 25,000 shares vesting on September 7, 2023 subject to continued service by the optionee and expire 10 years from the date of grant with an exercise price of $3.40 per share | ||||||||||
Total compensation expense | $ 126,160 | ||||||||||
Granted RSUs share | 38,000 | ||||||||||
September 21, 2021 [Member] | |||||||||||
Common stock shares purchase aggregate shares | 335,000 | 8,151 | |||||||||
Additional option expense | $ 315,858 | ||||||||||
Expire description | the Company’s common stock, granted on April 13, 2020 under the 2015 Stock Incentive Plan, were extended from six (6) to ten (10) years from the date of the grant | ||||||||||
May 1, 2021 [Member] | |||||||||||
Stock compensation expenses | $ 496,500 | ||||||||||
Restricted stock units description | These RSUs vest over three years with 50,000 units vesting on each of May 1, 2022, May 1, 2023 and May 1, 2024 | ||||||||||
RSUs vested shares | 150,000 | 150,000 | |||||||||
On 20, May 2021 [Member] | Option [Member] | |||||||||||
Risk free rate | 0.58% | ||||||||||
Exercise price | $ 3.60 | $ 3.60 | |||||||||
Volatility | 76.16% | ||||||||||
Stock price | 3.50 | $ 3.50 | |||||||||
Term | 3 years 6 months | ||||||||||
Fair market value of options | $ 73,641 | ||||||||||
Stock options purchase shares of common stock | 40,000 | ||||||||||
Expire description | These options vest on May 20, 2022 and expire five years after the vesting date, with an exercise price of $3.60 per share | ||||||||||
January 1, 2021 [Member] | |||||||||||
Risk free rate | 0.50% | ||||||||||
Exercise price | 3.95 | $ 3.95 | |||||||||
Volatility | 74.53% | ||||||||||
Stock price | 3.80 | $ 3.80 | |||||||||
Term | 3 years 6 months | ||||||||||
Total compensation expense | $ 107,700 | $ 19,450 | |||||||||
Expire description | These warrants vest on January 1, 2022 (subject to continued employment through such date) and expire on January 1, 2027, with an exercise price of $3.95 per share | ||||||||||
Common stock, share issued upon cashless exercise | 3,000 | ||||||||||
Warrant grant to common stock | 125,000 | ||||||||||
Estimated fair market value of warrants | $ 242,877 | ||||||||||
February 1, 2021 [Member] | |||||||||||
Risk free rate | 0.59% | ||||||||||
Exercise price | 4.90 | $ 4.90 | |||||||||
Volatility | 75.03% | ||||||||||
Stock price | $ 4.80 | $ 4.80 | |||||||||
Term | 3 years 6 months | ||||||||||
Expire description | These warrants vest on February 1, 2022 (subject to continued employment through such date) and expire on February 1, 2027, with an exercise price of $4.90 per share | ||||||||||
Warrant grant to common stock | 185,000 | ||||||||||
Estimated fair market value of warrants | $ 459,352 | ||||||||||
On 13, April 2021 [Member] | Option [Member] | |||||||||||
RSUs vested shares | 26,250 | 26,250 | |||||||||
Common stock, share issued upon cashless exercise | 21,712 | ||||||||||
Withheld shares returned remaining | 4,538 |
Commitments and Contingencies (Details) - Finance Lease Obligations [Member] |
Sep. 30, 2021
USD ($)
|
---|---|
2021 - remaining | $ 18,031 |
2022 | 63,724 |
2023 | 62,269 |
2024 | 62,268 |
2025 | 62,268 |
Greater than 5 years | 396,946 |
Total | 665,506 |
Less: Amount representing interest | (81,255) |
Present value of minimum lease payments | $ 584,251 |
Commitments and Contingencies (Details 1) |
Sep. 30, 2021
USD ($)
|
---|---|
Total Operating Lease Obligations | $ 57,104 |
Operating Lease Right of Use Obligations [Member] | |
2021 - remaining | 50,545 |
2022 | 99,623 |
2023 | 74,653 |
2024 | 48,868 |
2025 | 5,292 |
Total Operating Lease Obligations | 278,981 |
Less: Amount representing interest | (10,111) |
Present value of minimum lease payments | $ 268,870 |
Commitments and Contingencies (Details 2) |
Sep. 30, 2021
USD ($)
|
---|---|
Commitments and Contingencies | |
2021 - remaining | $ 19,244 |
2022 | 37,860 |
Total Operating Lease Liabilities | $ 57,104 |
Commitments and Contingencies (Details 3) - USD ($) |
Sep. 30, 2021 |
Dec. 31, 2020 |
---|---|---|
2021 - remaining | $ 34,731 | $ 69,218 |
Grants Repayable [Member] | ||
2021 - remaining | 0 | |
2022 | 45,069 | |
2023 | 43,330 | |
2024 | 18,808 | |
2025 | 20,703 | |
Greater than 5 years | 173,634 | |
Total Grants Repayable | $ 301,544 |
Commitments and Contingencies (Details 4) |
Sep. 30, 2021
USD ($)
|
---|---|
Commitments and Contingencies | |
2021 - remaining | $ 281,249 |
2022 | 761,541 |
2023 | 662,368 |
2024 | 515,446 |
2025 | 142,380 |
Greater than 5 years | 766,723 |
Total | 3,129,707 |
Less: Amount representing interest | (342,318) |
Total Long-Term Debt | $ 2,787,389 |
Commitments and Contingencies (Details 5) |
Sep. 30, 2021
USD ($)
|
---|---|
Commitments and Contingencies | |
2021 - remaining | $ 816,789 |
2022 - 2025 | 116,210 |
Total Collaborative Agreement Obligations | $ 932,999 |
Subsequent Events (Details) - shares |
1 Months Ended | ||||
---|---|---|---|---|---|
Jan. 23, 2018 |
Mar. 30, 2017 |
Jan. 01, 2017 |
Jun. 23, 2016 |
Apr. 15, 2016 |
|
Stock Options [Member] | |||||
Options or rights granted during period | 615,837 | 387,934 | 50,000 | 15,000 | 760,000 |
Subsequent Events (Details Narrative) - USD ($) |
1 Months Ended | 3 Months Ended | 9 Months Ended | 120 Months Ended | |||
---|---|---|---|---|---|---|---|
Oct. 04, 2021 |
Nov. 04, 2021 |
Nov. 03, 2021 |
Nov. 01, 2021 |
Sep. 30, 2021 |
Sep. 30, 2021 |
Sep. 30, 2021 |
|
Share based compensation expense | $ 768,291 | ||||||
Equity Distribution Agreement [Member] | |||||||
Sale of stock number shares issued | 79,679 | 396,448 | |||||
Subsequent Event [Member] | Restricted Stock Units [Member] | |||||||
Share based compensation expense | $ 121,019 | $ 152,685 | |||||
Options or rights, Vesting period description | These RSUs vest over two years with up to 50% of the units vesting on October 4, 2022, and up to 50% of the units vesting on October 4, 2023 | These RSUs vest over two years with up to 50% of the units vesting on November 1, 2022, and up to 50% of the units vesting on November 1, 2023 | |||||
Common stock shares issuable upon exercise of rights | 39,809 | 43,500 | |||||
Subsequent Event [Member] | 2015 Stock Incentive Plan [Member] | |||||||
Options or rights, amendment to expiration period description | the expiration dates were extended from six (6) to ten (10) years from the date of the grant | ||||||
Additional option expense | $ 1,475,096 | ||||||
Subsequent Event [Member] | Stock Options [Member] | |||||||
Options or rights, Vesting period description | These options vest over two years with options to purchase up to 50% of the shares vesting on October 4, 2022, and options to purchase up to 50% of the shares vesting on October 4, 2023 | ||||||
Common stock shares issuable upon exercise of rights | 73,360 | ||||||
Options or Rights, exercise price | $ 3.40 | ||||||
Options or rights, expiration period | 10 years | ||||||
Options or rights granted, fair value | $ 128,003 | ||||||
Fair value assumptions, term | 5 years 6 months | ||||||
Share price | $ 3.04 | ||||||
Fair value assumptions, volatility rate | 68.80% | ||||||
Fair value assumptions, risk free interest rate | 1.49% | ||||||
Subsequent Event [Member] | Equity Distribution Agreement [Member] | |||||||
Sale of stock number shares issued | 357,900 | ||||||
Proceed from sale of stock | $ 1,209,709 |
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